DOH ISSUES DEPARTMENT CIRCULAR ON BLOOD SERVICES FOR PREGNANT WOMEN
http://www.doh.gov.ph/node/2717.html
Press Release/29 June 2010
The Department of Health (DOH), cognizant of the fact that postpartum hemorrhage accounts for a large number of maternal deaths in the Philippines, issued a Department Circular providing for the availability blood and blood transfusion services for pregnant women under the Maternal, Neonatal and Child Health and Nutrition Strategy (MNCHN). Department Circular 2010-0181 seeks to complement Administrative Order 2008-0029 (Implementing Health Reforms for Rapid Reduction of Maternal and Neonatal Mortality) and Department Circular 2010-0013 (Operation Guidelines for National Blood Voluntary Services Program), and was published on Sunday, June 27.
The MNHCN is the national program driven under the auspices of the DOH that seeks to reduce maternal and child mortality rates in the entire country. At present, the Philippines is unlikely to meet the target for maternal mortality rate under Millennium Development Goal 5, necessitating more interventions on the part of the government.
Under the circular, pregnant women and their husbands shall undergo blood typing during one of the prenatal visits. After passing donor selection and screening standards, the husbands and relatives of the pregnant women shall donate blood, with priority access to the blood pool going to the pregnant women in time of need.
Units of blood will be reserved for pregnant women in identified blood banks or blood stations. These facilities are required to ensure the availability of blood when needed, ideally one week before a pregnant women’s expected date of confinement.
In addition, indigent families with pregnant women will be enrolled in Philhealth for the reimbursement of the cost of prenatal care and blood services. Centers of Health Development (CHD) are also required to allocate money for the reimbursement of blood service fees.
“We hope that the issuance of this circular will make a huge difference in our pursuit of promoting safe childbirths in the country.”, said Health Secretary Esperanza Cabral. “Ultimately our goal is to save the lives of more Filipino mothers and children, and in the process reach our targets under the Millennium Development Goals.”, she further added.
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Last Modified: Thursday, 10-Dec-2009 11:49:48 EST
http://www.nhtsa.gov/people/injury/pedbimot/ped/
People: Injury Prevention: Pedestrian Safety
Mature Adults: Be Healthy, Walk Safely
Pedestrian Safety
http://www.cdc.gov/Features/PedestrianSafety/
Whenever you walk to your destination, take steps to stay safe.
Are You Ready?
An In-depth Guide to Citizen Preparedness
http://www.fema.gov/pdf/areyouready/areyouready_full.pdf
Heat Stress in the Elderly
http://www.bt.cdc.gov/disasters/extremeheat/elderlyheat.asp
Tuesday, June 29, 2010
Sunday, June 27, 2010
On June 26, 2010:
Guard, at entrance to McDonald's restaurant, at J.P. Rizal, Makati, didn't inspect my luggage/subject said luggage to scanning with metal detector. Said luggage was large enough to contain grenades and firearms. Also, there was no express
lane in said restaurant for senior citizens and no sign regarding the privileges of senior citizens. I believe said restaurant violated the implementing rules and regulations of the Expanded Senior Citizens Act of 2003.
Guard, at entrance to Mercury Drug store at J.P. Rizal St., Makati, idn't inspect my luggage/subject said luggage to scanning with metal detector. Said luggage was large enough to contain grenades and firearms. Also,there was no sign
in the customer area of said store regarding the privileges of senior citizens. I
believe said store violated the Expanded Senior Citizens Act of 2003.
Employee, at package counter of Tru Value store at Rockwell Power Plant Makati, accepted for deposit my locked luggage without first inspecting said luggage/subjecting said luggage to scanning with metal detector. Said luggage was large enough to contain grenades and firearms. Also, there was no express lane in said restaurant for senior citizens and no sign regarding the privileges of senior citizens. I believe said store. violated the implementing rules and regulations of
the Expanded Senior Citizens Act of 2003.
Guard, near entrance sign at Rustan's supermarket at Power Plant building in Makati, didn't inspect my luggage/subject said luggage to scanning with metal detector. Said luggage was large enough to contain grenades and firearms Also, employee at said store didn't inspect my luggage/didn't subject said luggage scanning with metal detector. Said luggage was large enough to contain grenades and firearms. Also, employee at said store acceoted for deposit my luggage without first inspecting said luggage/scanning said luggage with metal detector.While I was at said store, there was no sign in the customer area of said store regarding the privileges of senior citizens. I believe said store. violated the implementing rules and regulations of
the Expanded Senior Citizens Act of 2003.
Guard, at entrance to McDonald's restaurant, at Rockwell Power Plant, in Makati, didn't inspect my luggage/subject said luggage to scanning with metal detector. Said luggage was large enough to contain grenades and firearms. Also,there was no sign
in the customer area of said store regarding the privileges of senior citizens. I believe said store violated the Expanded Senior Citizens Act of 2003.
_____________________________________________________________________________________
Disaster Mental Health Awareness
http://mentalhealth.samhsa.gov/disasterrelief/
For Professionals:
Developing Cultural Competence in Disaster Mental Health Programs (SMA03-3828)
Download PDF (872K)
Field Manual for Mental Health and Human Service Workers in Major Disasters (ADM90-0537)
View HTML Version
Managing Stress During Disaster Events: A Guide for Emergency and Disaster Response Workers (NMH05-0211)
Psychological First Aid: A Guide for Emergency and Disaster Response Workers (NMH05-0210)
Download PDF (401K)
Psychosocial Issues for Children and Adolescents in Disasters (ADM86-1070R)
View HTML Version
Psychosocial Issues for Older Adults in Disasters (SMA99-3323)
Download PDF (245K)
Returning Home After a Disaster: A Guide for Emergency and Disaster Response Workers Brochure (NMH05-0219)
Download PDF (4.2 MB)
Returning Home After Disaster Relief Work: A Guide for Families of Emergency and Disaster Response Workers Brochure (NMH05-0220)
Download PDF (4.5 MB)
Returning Home After Disaster Relief Work: A Guide for Supervisors of Deployed Personnel Brochure (NMH05-0218)
Download PDF (3 MB)
Self-Care Tips for Emergency and Disaster Response Workers (KEN01-0098R)
View HTML Version
Tips for First Responders: Possible Alcohol and Substance Abuse Indicators (NMH05-0212)
Download PDF (186K)
For the General Public:
Tips for Survivors of a Traumatic Event: Managing Your Stress During a Disaster (NMH05-0209R)
Download PDF (282K)
Tips for Talking to Children and Youth After Traumatic Events: A Guide for Parents and Educators (KEN01-0093R)
Download PDF (454K)
____________________________________________________________________________________________________________________________________________
Emergency Preparedness and Older Adults
http://www.cdc.gov/aging/emergency/index.htm
Emergency Preparedness and Older Adults
CDC’s Healthy Aging Program is committed to protecting the health and safety of older adults during times of disaster.
Podcast
(released December 2008)
Emergency Preparedness Concerns for Older Adults
This podcast discusses the special concerns many older adults face during a disaster.
Critical Issue Briefs
(released March 2007)
These briefs describe the work CDC is doing to protect the health and safety of vulnerable older adults during emergencies, and offer planning tips to older adults and their caregivers.
• CDC’s Disaster Planning Goal: Protect Vulnerable Older Adults Adobe PDF file [PDF–169KB]
• Disaster Planning Tips for Older Adults and their Families Adobe PDF file [PDF–103KB]
Specific Topics of Concern
(from CDC’s Emergency Preparedness and Response Program)
H1N1 Virus
Heat Stress in Older Adults
Disaster Information for People with Chronic Conditions
Related Resources
AARP Adobe PDF file [PDF–354KB]External Web Site Icon – We Can Do Better: Lessons Learned for Protecting Older Persons in Disasters
American Red CrossExternal Web Site Icon – Tips for older adults and their families
Florida Department of Elder AffairsExternal Web Site Icon – Disaster Preparedness Guide for Elders
SAMHSAExternal Web Site Icon – Disaster Relief Information
_________________________________________________________________________________________________________________________________________________
Heat Stress in the Elderly
http://www.bt.cdc.gov/disasters/extremeheat/elderlyheat.asp
Elderly people (that is, people aged 65 years and older) are more prone to heat stress than younger people for several reasons:
* Elderly people do not adjust as well as young people to sudden changes in temperature.
* They are more likely to have a chronic medical condition that changes normal body responses to heat.
* They are more likely to take prescription medicines that impair the body's ability to regulate its temperature or that inhibit perspiration.
Heat Stroke
Heat stroke is the most serious heat-related illness. It occurs when the body becomes unable to control its temperature: the body's temperature rises rapidly, the body loses its ability to sweat, and it is unable to cool down. Body temperatures rise to 106°F or higher within 10 to 15 minutes. Heat stroke can cause death or permanent disability if emergency treatment is not provided.
Signs and Symptoms of Heat Stroke
Warning signs vary but may include the following:
* An extremely high body temperature (above 103°F)
* Red, hot, and dry skin (no sweating)
* Rapid, strong pulse
* Throbbing headache
* Dizziness
* Nausea
Heat Exhaustion
Heat exhaustion is a milder form of heat-related illness that can develop after several days of exposure to high temperatures and inadequate or unbalanced replacement of fluids.
Signs and Symptoms of Heat Exhaustion
Warning signs vary but may include the following:
* Heavy sweating
* Paleness
* Muscle Cramps
* Tiredness
* Weakness
* Dizziness
* Headache
* Nausea or vomiting
* Fainting
* Skin: may be cool and moist
* Pulse rate: fast and weak
* Breathing: fast and shallow
What You Can Do to Protect Yourself
You can follow these prevention tips to protect yourself from heat-related stress:
* Photo of elderly couple drinking water outdoors.Drink cool, nonalcoholic beverages. (If your doctor generally limits the amount of fluid you drink or has you on water pills, ask him how much you should drink when the weather is hot. Also, avoid extremely cold liquids because they can cause cramps.)
* Rest.
* Take a cool shower, bath, or sponge bath.
* If possible, seek an air-conditioned environment. (If you don't have air conditioning, consider visiting an air-conditioned shopping mall or public library to cool off.)
* Wear lightweight clothing.
* If possible, remain indoors in the heat of the day.
* Do not engage in strenuous activities.
What You Can Do to Help Protect Elderly Relatives and Neighbors
If you have elderly relatives or neighbors, you can help them protect themselves from heat-related stress:
* Visit older adults at risk at least twice a day and watch them for signs of heat exhaustion or heat stroke.
* Encourage them to increase their fluid intake by drinking cool, nonalcoholic beverages regardless of their activity level.
Warning: If their doctor generally limits the amount of fluid they drink or they are on water pills, they will need to ask their doctor how much they should drink while the weather is hot.
* Take them to air-conditioned locations if they have transportation problems.
What You Can Do for Someone With Heat Stress
If you see any signs of severe heat stress, you may be dealing with a life-threatening emergency. Have someone call for immediate medical assistance while you begin cooling the affected person. Do the following:
* Photo of water coming out of shower head.Get the person to a shady area.
* Cool the person rapidly, using whatever methods you can. For example, immerse the person in a tub of cool water; place the person in a cool shower; spray the person with cool water from a garden hose; sponge the person with cool water; or if the humidity is low, wrap the person in a cool, wet sheet and fan him or her vigorously.
* Monitor body temperature and continue cooling efforts until the body temperature drops to 101°–102°F
* If emergency medical personnel are delayed, call the hospital emergency room for further instructions.
* Do not give the person alcohol to drink.
* Get medical assistance as soon as possible.
* Page last updated July 31, 2009
* Content source: National Center for Environmental Health (NCEH)/Agency for Toxic Substances and Disease Registry (ATSDR), Office of Noncommunicable Diseases, Injury and Environmental Health, National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), National Center on Birth Defects and Developmental Disabilities (NCBDDD)
_____________________________________________________________________________________
CPSC Moms Ask Questions About Crib Safety
http://www.cpsc.gov/info/cribs/index.html
The picture, text and audio sequence is as follows:
CPSC Mom Patricia: What is a drop-side crib?
Patty Edwards, CPSC Engineer: A drop-side is a movable side of the crib that gives mom, dad, grandmom or any caregiver easier access to the inside of the crib. A traditional drop-side slides up and down.
CPSC Mom Lisa: Are all drop-side cribs bad?
Patty Edwards: Not necessarily. CPSC only hears about cribs with problems, not the ones that are fine. On the whole, a drop-side crib has a tendency to be less structurally sound than an identical fixed sided crib and thus it is more susceptible to problems from use, being moved, storage and assembly.
CPSC Mom Amy: How can I tell whether my crib is safe for my baby?
Patty Edwards: Every time you change the sheets, check that all visible hardware - every bolt, screw, track and clamp - is securely in place. Make sure the drop-side is on its track and functions well.
With the mattress out of the crib, wiggle the crib to see how tight all the joints are. If the crib remains wobbly after tightening all hardware, look for loose wood-to-wood joints that may be causing the problem. Stop using the crib if loose wood-to-wood joints are found or if you cannot fully tighten any screw.
Also, if one side of your crib is loose, do NOT push the loose side against a wall and continue to use the crib. The wall, along with a loose side, can create a space in which a child can get caught and smother.
CPSC Mom Patricia: What are immobilizers? Should I use one?
Patty Edwards, CPSC Engineer: Immobilizers are protective devices that stop drop sides from moving up, down and outwards.
If your manufacturer makes an immobilizer specifically for your crib, CPSC staff recommends that you get one and install it on your crib.
Only use immobilizers on cribs that don't have missing or broken hardware. These devices protect your crib's hardware and limit movement so that a child can't get stuck between the dropside and the rest of the crib.
CPSC Mom Mary: Can't I just fix my crib myself?
Patty Edwards, CPSC Engineer: Do NOT try to fix your crib. Do-it-yourself crib repair can be very dangerous and the results can be deadly. Infants and toddlers have died in cribs with makeshift repairs. . Untested screws can loosen and all kinds of tape, wire, and zip ties stretch -- no matter how tight they may be at first.
CPSC Mom Daisha: My crib has a drop side but I don't use it. Do I still need to check my crib?
Yes, you should always do regular checks on your crib to make sure that components are tight and not broken. Parts can still break or become loose, even if the drop side is not used.
CPSC Mom Amy: My crib has broken or missing pieces. Now what?
Patty Edwards: Stop using the crib and contact the manufacturer and report the problem to the CPSC.
CPSC Mom Daisha: Stop using my crib? So where do I put my baby to sleep?
Patty Edwards: If your baby is less than six months old and is not yet able to push up on their hands and knees, you can put your baby in a bassinet. If your child is older, you can use a play yard. If you believe your child is too big or able to climb out of a play yard, use a mattress on the floor or a toddler bed.
Final Screen: Look for crib recalls @
http://www.cpsc.gov/cgi-bin/cribs.aspx
_____________________________________________________________________________________
Kellogg Company Voluntarily Recalls Select Packages of
Kellogg's® Corn Pops®, Kellogg's® Honey Smacks®, Kellogg's® Froot Loops®
and Kellogg's® Apple Jacks®
http://www.fda.gov/Safety/Recalls/ucm217338.htm
Contact:
Kellogg Media Hotline
269-961-3799
media.hotline@kellogg.com
____________________________________________________________________________________________________________________________________________________________________
Seven Manufacturers Announce Recalls to Repair Cribs to Address Entrapment, Suffocation and Fall Hazards
http://www.cpsc.gov/cpscpub/prerel/prhtml10/10270.html
Industry Launches New Initiative to Secure Drop Sides with Free Immobilization Devices
WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission (CPSC), with the cooperation of seven firms, is announcing voluntary recalls of more than two million cribs to address drop-side hazards and other hazards that affect the safety of young children. The recalling firms are providing consumers with free repair kits to immobilize the drop sides or other remedies. Do not attempt to fix these cribs with homemade remedies.
The drop-side and fixed-side crib recalls announced today are of units manufactured between 2000 and 2009 by the companies listed below. Consumers should contact these firms directly for the appropriate remedy:
* Child Craft, (this firm is out of business): Fixed-Side | Drop-Side
* Delta Enterprise Corp., of New York, N.Y.
* Evenflo, of Miamisburg, Ohio
* Jardine Enterprises, of Taipei, Taiwan
* LaJobi, of Cranbury, N.J.
* Million Dollar Baby, of Montebello, Calif.
* Simmons Juvenile Products Inc. (SJP), of New London, Wis.
“Cribs should be the safest place in the home for infants and toddlers,” said CPSC Chairman Inez Tenenbaum. “CPSC is committed to addressing the hazards with cribs and to restoring parents’ confidence that their child will have a safe sleep.”
CPSC continues to actively investigate various cribs for potential drop-side and other hazards as part of a larger effort by the agency to rid the marketplace and homes of unsafe cribs. CPSC staff is also working on a new mandatory standard to make cribs safer, which is targeted for completion in 2010.
The Juvenile Products Manufacturers Association (JPMA) has also launched a new crib safety initiative. The listed manufacturers are providing free drop-side crib immobilization kits to prevent the drop side from detaching, plus replacement hardware and assembly instructions for cribs manufactured by participating firms. These materials are available free to any consumer by request.
The firms involved in today’s recalls are providing immobilization devices or other remedies as part of JPMA’s crib safety initiative. Consumers can visit JPMA’s website, www.cribsafety.org, for a list of participating manufacturers and for downloadable materials about ensuring that children have a safe sleep.
The immobilization devices, which will be available in the next few weeks, should be attached to keep the drop side from detaching from the cribs. Immobilization devices are not a solution for cribs with broken or damaged drop-side hardware. If your drop-side hardware is broken, contact the manufacturer for an alternative remedy.
CPSC issued a warning last month alerting parents and caregivers that there can be deadly hazards associated with drop-side cribs. Nine million drop-side cribs have been recalled over the past five years. CPSC staff has determined drop-side cribs generally have a tendency to be less structurally sound than cribs with four fixed sides.
Drop-side crib incidents can also occur due to incorrect assembly or age-related wear and tear. Age is a factor in the safety of any crib. At a minimum, CPSC staff recommends that you not use a crib that is older than 10 years. Many older cribs do not meet current voluntary standards and can have numerous safety problems.
Important Message from CPSC:
The safest place for your baby to sleep is in a crib or bassinet depending on their age. If your crib has been recalled or it has missing, broken or loose parts, find an alternate safe sleep environment intended for a baby. If your baby is less than six months old and is not yet able to push up to his/her hands and knees, you can put your baby to sleep in a bassinet. Make sure your bassinet has not been recalled. Here’s a list. Also, you can use a play yard.
Do not put additional bedding such as pillows, thick quilts, comforters or anything plush into your baby’s sleeping space. More babies die every year from suffocation in plush sleeping environments than from defective cribs. Always place your baby on his or her back to reduce the risk of Sudden Infant Death Syndrome (SIDS).
Visit CPSC's Crib Information Center for more information on Crib Safety and Recalls.
Guard, at entrance to McDonald's restaurant, at J.P. Rizal, Makati, didn't inspect my luggage/subject said luggage to scanning with metal detector. Said luggage was large enough to contain grenades and firearms. Also, there was no express
lane in said restaurant for senior citizens and no sign regarding the privileges of senior citizens. I believe said restaurant violated the implementing rules and regulations of the Expanded Senior Citizens Act of 2003.
Guard, at entrance to Mercury Drug store at J.P. Rizal St., Makati, idn't inspect my luggage/subject said luggage to scanning with metal detector. Said luggage was large enough to contain grenades and firearms. Also,there was no sign
in the customer area of said store regarding the privileges of senior citizens. I
believe said store violated the Expanded Senior Citizens Act of 2003.
Employee, at package counter of Tru Value store at Rockwell Power Plant Makati, accepted for deposit my locked luggage without first inspecting said luggage/subjecting said luggage to scanning with metal detector. Said luggage was large enough to contain grenades and firearms. Also, there was no express lane in said restaurant for senior citizens and no sign regarding the privileges of senior citizens. I believe said store. violated the implementing rules and regulations of
the Expanded Senior Citizens Act of 2003.
Guard, near entrance sign at Rustan's supermarket at Power Plant building in Makati, didn't inspect my luggage/subject said luggage to scanning with metal detector. Said luggage was large enough to contain grenades and firearms Also, employee at said store didn't inspect my luggage/didn't subject said luggage scanning with metal detector. Said luggage was large enough to contain grenades and firearms. Also, employee at said store acceoted for deposit my luggage without first inspecting said luggage/scanning said luggage with metal detector.While I was at said store, there was no sign in the customer area of said store regarding the privileges of senior citizens. I believe said store. violated the implementing rules and regulations of
the Expanded Senior Citizens Act of 2003.
Guard, at entrance to McDonald's restaurant, at Rockwell Power Plant, in Makati, didn't inspect my luggage/subject said luggage to scanning with metal detector. Said luggage was large enough to contain grenades and firearms. Also,there was no sign
in the customer area of said store regarding the privileges of senior citizens. I believe said store violated the Expanded Senior Citizens Act of 2003.
_____________________________________________________________________________________
Disaster Mental Health Awareness
http://mentalhealth.samhsa.gov/disasterrelief/
For Professionals:
Developing Cultural Competence in Disaster Mental Health Programs (SMA03-3828)
Download PDF (872K)
Field Manual for Mental Health and Human Service Workers in Major Disasters (ADM90-0537)
View HTML Version
Managing Stress During Disaster Events: A Guide for Emergency and Disaster Response Workers (NMH05-0211)
Psychological First Aid: A Guide for Emergency and Disaster Response Workers (NMH05-0210)
Download PDF (401K)
Psychosocial Issues for Children and Adolescents in Disasters (ADM86-1070R)
View HTML Version
Psychosocial Issues for Older Adults in Disasters (SMA99-3323)
Download PDF (245K)
Returning Home After a Disaster: A Guide for Emergency and Disaster Response Workers Brochure (NMH05-0219)
Download PDF (4.2 MB)
Returning Home After Disaster Relief Work: A Guide for Families of Emergency and Disaster Response Workers Brochure (NMH05-0220)
Download PDF (4.5 MB)
Returning Home After Disaster Relief Work: A Guide for Supervisors of Deployed Personnel Brochure (NMH05-0218)
Download PDF (3 MB)
Self-Care Tips for Emergency and Disaster Response Workers (KEN01-0098R)
View HTML Version
Tips for First Responders: Possible Alcohol and Substance Abuse Indicators (NMH05-0212)
Download PDF (186K)
For the General Public:
Tips for Survivors of a Traumatic Event: Managing Your Stress During a Disaster (NMH05-0209R)
Download PDF (282K)
Tips for Talking to Children and Youth After Traumatic Events: A Guide for Parents and Educators (KEN01-0093R)
Download PDF (454K)
____________________________________________________________________________________________________________________________________________
Emergency Preparedness and Older Adults
http://www.cdc.gov/aging/emergency/index.htm
Emergency Preparedness and Older Adults
CDC’s Healthy Aging Program is committed to protecting the health and safety of older adults during times of disaster.
Podcast
(released December 2008)
Emergency Preparedness Concerns for Older Adults
This podcast discusses the special concerns many older adults face during a disaster.
Critical Issue Briefs
(released March 2007)
These briefs describe the work CDC is doing to protect the health and safety of vulnerable older adults during emergencies, and offer planning tips to older adults and their caregivers.
• CDC’s Disaster Planning Goal: Protect Vulnerable Older Adults Adobe PDF file [PDF–169KB]
• Disaster Planning Tips for Older Adults and their Families Adobe PDF file [PDF–103KB]
Specific Topics of Concern
(from CDC’s Emergency Preparedness and Response Program)
H1N1 Virus
Heat Stress in Older Adults
Disaster Information for People with Chronic Conditions
Related Resources
AARP Adobe PDF file [PDF–354KB]External Web Site Icon – We Can Do Better: Lessons Learned for Protecting Older Persons in Disasters
American Red CrossExternal Web Site Icon – Tips for older adults and their families
Florida Department of Elder AffairsExternal Web Site Icon – Disaster Preparedness Guide for Elders
SAMHSAExternal Web Site Icon – Disaster Relief Information
_________________________________________________________________________________________________________________________________________________
Heat Stress in the Elderly
http://www.bt.cdc.gov/disasters/extremeheat/elderlyheat.asp
Elderly people (that is, people aged 65 years and older) are more prone to heat stress than younger people for several reasons:
* Elderly people do not adjust as well as young people to sudden changes in temperature.
* They are more likely to have a chronic medical condition that changes normal body responses to heat.
* They are more likely to take prescription medicines that impair the body's ability to regulate its temperature or that inhibit perspiration.
Heat Stroke
Heat stroke is the most serious heat-related illness. It occurs when the body becomes unable to control its temperature: the body's temperature rises rapidly, the body loses its ability to sweat, and it is unable to cool down. Body temperatures rise to 106°F or higher within 10 to 15 minutes. Heat stroke can cause death or permanent disability if emergency treatment is not provided.
Signs and Symptoms of Heat Stroke
Warning signs vary but may include the following:
* An extremely high body temperature (above 103°F)
* Red, hot, and dry skin (no sweating)
* Rapid, strong pulse
* Throbbing headache
* Dizziness
* Nausea
Heat Exhaustion
Heat exhaustion is a milder form of heat-related illness that can develop after several days of exposure to high temperatures and inadequate or unbalanced replacement of fluids.
Signs and Symptoms of Heat Exhaustion
Warning signs vary but may include the following:
* Heavy sweating
* Paleness
* Muscle Cramps
* Tiredness
* Weakness
* Dizziness
* Headache
* Nausea or vomiting
* Fainting
* Skin: may be cool and moist
* Pulse rate: fast and weak
* Breathing: fast and shallow
What You Can Do to Protect Yourself
You can follow these prevention tips to protect yourself from heat-related stress:
* Photo of elderly couple drinking water outdoors.Drink cool, nonalcoholic beverages. (If your doctor generally limits the amount of fluid you drink or has you on water pills, ask him how much you should drink when the weather is hot. Also, avoid extremely cold liquids because they can cause cramps.)
* Rest.
* Take a cool shower, bath, or sponge bath.
* If possible, seek an air-conditioned environment. (If you don't have air conditioning, consider visiting an air-conditioned shopping mall or public library to cool off.)
* Wear lightweight clothing.
* If possible, remain indoors in the heat of the day.
* Do not engage in strenuous activities.
What You Can Do to Help Protect Elderly Relatives and Neighbors
If you have elderly relatives or neighbors, you can help them protect themselves from heat-related stress:
* Visit older adults at risk at least twice a day and watch them for signs of heat exhaustion or heat stroke.
* Encourage them to increase their fluid intake by drinking cool, nonalcoholic beverages regardless of their activity level.
Warning: If their doctor generally limits the amount of fluid they drink or they are on water pills, they will need to ask their doctor how much they should drink while the weather is hot.
* Take them to air-conditioned locations if they have transportation problems.
What You Can Do for Someone With Heat Stress
If you see any signs of severe heat stress, you may be dealing with a life-threatening emergency. Have someone call for immediate medical assistance while you begin cooling the affected person. Do the following:
* Photo of water coming out of shower head.Get the person to a shady area.
* Cool the person rapidly, using whatever methods you can. For example, immerse the person in a tub of cool water; place the person in a cool shower; spray the person with cool water from a garden hose; sponge the person with cool water; or if the humidity is low, wrap the person in a cool, wet sheet and fan him or her vigorously.
* Monitor body temperature and continue cooling efforts until the body temperature drops to 101°–102°F
* If emergency medical personnel are delayed, call the hospital emergency room for further instructions.
* Do not give the person alcohol to drink.
* Get medical assistance as soon as possible.
* Page last updated July 31, 2009
* Content source: National Center for Environmental Health (NCEH)/Agency for Toxic Substances and Disease Registry (ATSDR), Office of Noncommunicable Diseases, Injury and Environmental Health, National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), National Center on Birth Defects and Developmental Disabilities (NCBDDD)
_____________________________________________________________________________________
CPSC Moms Ask Questions About Crib Safety
http://www.cpsc.gov/info/cribs/index.html
The picture, text and audio sequence is as follows:
CPSC Mom Patricia: What is a drop-side crib?
Patty Edwards, CPSC Engineer: A drop-side is a movable side of the crib that gives mom, dad, grandmom or any caregiver easier access to the inside of the crib. A traditional drop-side slides up and down.
CPSC Mom Lisa: Are all drop-side cribs bad?
Patty Edwards: Not necessarily. CPSC only hears about cribs with problems, not the ones that are fine. On the whole, a drop-side crib has a tendency to be less structurally sound than an identical fixed sided crib and thus it is more susceptible to problems from use, being moved, storage and assembly.
CPSC Mom Amy: How can I tell whether my crib is safe for my baby?
Patty Edwards: Every time you change the sheets, check that all visible hardware - every bolt, screw, track and clamp - is securely in place. Make sure the drop-side is on its track and functions well.
With the mattress out of the crib, wiggle the crib to see how tight all the joints are. If the crib remains wobbly after tightening all hardware, look for loose wood-to-wood joints that may be causing the problem. Stop using the crib if loose wood-to-wood joints are found or if you cannot fully tighten any screw.
Also, if one side of your crib is loose, do NOT push the loose side against a wall and continue to use the crib. The wall, along with a loose side, can create a space in which a child can get caught and smother.
CPSC Mom Patricia: What are immobilizers? Should I use one?
Patty Edwards, CPSC Engineer: Immobilizers are protective devices that stop drop sides from moving up, down and outwards.
If your manufacturer makes an immobilizer specifically for your crib, CPSC staff recommends that you get one and install it on your crib.
Only use immobilizers on cribs that don't have missing or broken hardware. These devices protect your crib's hardware and limit movement so that a child can't get stuck between the dropside and the rest of the crib.
CPSC Mom Mary: Can't I just fix my crib myself?
Patty Edwards, CPSC Engineer: Do NOT try to fix your crib. Do-it-yourself crib repair can be very dangerous and the results can be deadly. Infants and toddlers have died in cribs with makeshift repairs. . Untested screws can loosen and all kinds of tape, wire, and zip ties stretch -- no matter how tight they may be at first.
CPSC Mom Daisha: My crib has a drop side but I don't use it. Do I still need to check my crib?
Yes, you should always do regular checks on your crib to make sure that components are tight and not broken. Parts can still break or become loose, even if the drop side is not used.
CPSC Mom Amy: My crib has broken or missing pieces. Now what?
Patty Edwards: Stop using the crib and contact the manufacturer and report the problem to the CPSC.
CPSC Mom Daisha: Stop using my crib? So where do I put my baby to sleep?
Patty Edwards: If your baby is less than six months old and is not yet able to push up on their hands and knees, you can put your baby in a bassinet. If your child is older, you can use a play yard. If you believe your child is too big or able to climb out of a play yard, use a mattress on the floor or a toddler bed.
Final Screen: Look for crib recalls @
http://www.cpsc.gov/cgi-bin/cribs.aspx
_____________________________________________________________________________________
Kellogg Company Voluntarily Recalls Select Packages of
Kellogg's® Corn Pops®, Kellogg's® Honey Smacks®, Kellogg's® Froot Loops®
and Kellogg's® Apple Jacks®
http://www.fda.gov/Safety/Recalls/ucm217338.htm
Contact:
Kellogg Media Hotline
269-961-3799
media.hotline@kellogg.com
____________________________________________________________________________________________________________________________________________________________________
Seven Manufacturers Announce Recalls to Repair Cribs to Address Entrapment, Suffocation and Fall Hazards
http://www.cpsc.gov/cpscpub/prerel/prhtml10/10270.html
Industry Launches New Initiative to Secure Drop Sides with Free Immobilization Devices
WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission (CPSC), with the cooperation of seven firms, is announcing voluntary recalls of more than two million cribs to address drop-side hazards and other hazards that affect the safety of young children. The recalling firms are providing consumers with free repair kits to immobilize the drop sides or other remedies. Do not attempt to fix these cribs with homemade remedies.
The drop-side and fixed-side crib recalls announced today are of units manufactured between 2000 and 2009 by the companies listed below. Consumers should contact these firms directly for the appropriate remedy:
* Child Craft, (this firm is out of business): Fixed-Side | Drop-Side
* Delta Enterprise Corp., of New York, N.Y.
* Evenflo, of Miamisburg, Ohio
* Jardine Enterprises, of Taipei, Taiwan
* LaJobi, of Cranbury, N.J.
* Million Dollar Baby, of Montebello, Calif.
* Simmons Juvenile Products Inc. (SJP), of New London, Wis.
“Cribs should be the safest place in the home for infants and toddlers,” said CPSC Chairman Inez Tenenbaum. “CPSC is committed to addressing the hazards with cribs and to restoring parents’ confidence that their child will have a safe sleep.”
CPSC continues to actively investigate various cribs for potential drop-side and other hazards as part of a larger effort by the agency to rid the marketplace and homes of unsafe cribs. CPSC staff is also working on a new mandatory standard to make cribs safer, which is targeted for completion in 2010.
The Juvenile Products Manufacturers Association (JPMA) has also launched a new crib safety initiative. The listed manufacturers are providing free drop-side crib immobilization kits to prevent the drop side from detaching, plus replacement hardware and assembly instructions for cribs manufactured by participating firms. These materials are available free to any consumer by request.
The firms involved in today’s recalls are providing immobilization devices or other remedies as part of JPMA’s crib safety initiative. Consumers can visit JPMA’s website, www.cribsafety.org, for a list of participating manufacturers and for downloadable materials about ensuring that children have a safe sleep.
The immobilization devices, which will be available in the next few weeks, should be attached to keep the drop side from detaching from the cribs. Immobilization devices are not a solution for cribs with broken or damaged drop-side hardware. If your drop-side hardware is broken, contact the manufacturer for an alternative remedy.
CPSC issued a warning last month alerting parents and caregivers that there can be deadly hazards associated with drop-side cribs. Nine million drop-side cribs have been recalled over the past five years. CPSC staff has determined drop-side cribs generally have a tendency to be less structurally sound than cribs with four fixed sides.
Drop-side crib incidents can also occur due to incorrect assembly or age-related wear and tear. Age is a factor in the safety of any crib. At a minimum, CPSC staff recommends that you not use a crib that is older than 10 years. Many older cribs do not meet current voluntary standards and can have numerous safety problems.
Important Message from CPSC:
The safest place for your baby to sleep is in a crib or bassinet depending on their age. If your crib has been recalled or it has missing, broken or loose parts, find an alternate safe sleep environment intended for a baby. If your baby is less than six months old and is not yet able to push up to his/her hands and knees, you can put your baby to sleep in a bassinet. Make sure your bassinet has not been recalled. Here’s a list. Also, you can use a play yard.
Do not put additional bedding such as pillows, thick quilts, comforters or anything plush into your baby’s sleeping space. More babies die every year from suffocation in plush sleeping environments than from defective cribs. Always place your baby on his or her back to reduce the risk of Sudden Infant Death Syndrome (SIDS).
Visit CPSC's Crib Information Center for more information on Crib Safety and Recalls.
Wednesday, June 23, 2010
On June 23, 2010 at SM Megamall, Mandaluyong, Metro Manila:
security guards at entrance to BPI bank branch at said mall,didn't inspect/subject to scanning with metal detector luggage.
Said luggage was large enough to contain grenades and firearms.
The following stores at said mall didn't have required express lanes for senior citizens: Chow King, Jollibee, NT computer.
I believe said stores violated the Expanded Senior Citizens Act of 2003.
http://www.cdc.gov/family/checkuplist/index.htm
Check-Up Checklist: Things to Do Before Your Next Check-Up
Getting check-ups is one of many things you can do to help stay healthy and prevent disease and disability.
You’ve made the appointment to see your health care provider.
You’ve reviewed the instructions on how to prepare for certain tests.
You’ve done the usual paperwork.
Done, right?
Not quite.
Before your next check-up, make sure you do these four things.
Review your family health history.
Are there any new conditions or diseases that have occurred in your close relatives since your last visit? If so, let your health care provider know. Family history might influence your risk of developing heart disease, stroke, diabetes, or cancer. Your provider will assess your risk of disease based on your family history and other factors. Your provider may also recommend things you can do to help prevent disease, such as exercising more, changing your diet, or using screening tests to help detect disease early.
Find out if you are due for any general screenings or vaccinations.
Have you had the recommended screening tests based on your age, general health, family history, and lifestyle? Check with your health care provider to see if its time for any vaccinations, follow-up exams, or tests. For example, it might be time for you to get a Pap test, mammogram, prostate cancer screening, colon cancer screening, sexually transmitted disease screening, blood pressure check, tetanus shot, eye check, or other screening.
Write down a list of issues and questions to take with you.
Review any existing health problems and note any changes.
* Have you noticed any body changes, including lumps or skin changes?
* Are you having pain, dizziness, fatigue, problems with urine or stool, or menstrual cycle changes?
* Have your eating habits changed?
* Are you experiencing depression, anxiety, trauma, distress, or sleeping problems?
If so, note when the change began, how it’s different from before, and any other observation that you think might be helpful.
Be honest with your provider. If you haven’t been taking your medication as directed, exercising as much, or anything else, say so. You may be at risk for certain diseases and conditions because of how you live, work, and play. Your provider develops a plan based partly on what you say you do. Help ensure that you get the best guidance by providing the most up-to-date and accurate information about you.
Be sure to write your questions down beforehand. Once you’re in the office or exam room, it can be hard to remember everything you want to know. Leave room between questions to write down your provider’s answers.
Consider your future.
Are there specific health issues that need addressing concerning your future? Are you thinking about having infertility treatment, losing weight, taking a hazardous job, or quitting smoking? Discuss any issues with your provider so that you can make better decisions regarding your health and safety.
Mcneil Consumer Healthcare Recalls Four Product Lots of Benadryl® Allergy Ultratab™ Tablets, 100 Count, and One Product Lot of Extra Strength Tylenol® Rapid Release Gels, 50 Count
http://www.fda.gov/Safety/Recalls/ucm215921.htm
FOR IMMEDIATE RELEASE - Fort Washington, PA - June 15, 2010 - McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is recalling five product lots as an addition to the list of products included in the company’s January 15th, 2010 product recall. The additional lots involved are four product lots of BENADRYL® ALLERGY ULTRATAB™ TABLETS, 100 count, sold in the U.S.; and one product lot of EXTRA STRENGTH TYLENOL® Rapid Release Gels, 50 count sold in the U.S., Trinidad and Tobago, Bermuda, and Puerto Rico (FULL RECALLED PRODUCT LIST BELOW). This recall is a follow-up to the product recall that McNeil Consumer Healthcare announced on January 15th, 2010 and is being taken because the products were inadvertently omitted from the initial recall action. McNeil Consumer Healthcare identified the omission and informed the U.S. Food and Drug Administration (FDA) of its decision to add these product lots to the recall list. All these products were produced before the January 15th, 2010 recall. Since January, McNeil Consumer Healthcare has continued to analyze and evaluate 2,4,6-tribromoanisole (TBA) and has shared that information with the FDA. This further analysis confirms that the risk of serious adverse medical events is remote. This recall is being conducted with the knowledge of the FDA.
BENADRYL® ALLERGY ULTRATAB™ TABLETS is sold over-the-counter and is indicated for the relief of allergy associated symptoms such as sneezing, runny nose, itchy throat, and itchy and watery eyes. EXTRA STRENGTH TYLENOL® Rapid Release Gels is sold over-the-counter and is indicated for the temporary reduction of fever and for the temporary relief of minor aches and pains due to headache, muscular aches, backache, minor arthritis pain, the common cold, toothache, pre-menstrual and menstrual cramps, and flu.
The January 15th, 2010 recall was initiated as a result of consumer complaints of a musty or moldy odor that has since been linked to the presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA). After a thorough investigation, it was determined that the source of TBA was the result of a breakdown of a chemical that is applied to wood used to build wooden pallets that transport and store product packaging materials.
Consumers who purchased product from the lots included in this recall should stop using the product and contact McNeil Consumer Healthcare for instructions on a refund or replacement. For these instructions or information regarding how to return or dispose of the product, consumers should log on to the internet at www.mcneilproductrecall.com1 or call 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time). Requests for reimbursement can be made at www.mcneilproductrecall.com2. Consumers who have medical concerns or questions should contact their healthcare provider.
Any adverse reactions may also be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at http:www.fda.gov/safety/medwatch/default.htm.
The product lot numbers for the recalled products can be found on the side of the bottle label.
FULL RECALLED PRODUCT LIST:
Product Name Product Form Lot Number NDC Number UPC Code
BENADRYL Allergy ULTRATAB Tablets 100 count Ultratab Tablet AJA008, ADA194, ABA022, ABA264 50580-226-10 312547170338
EXTRA STRENGTH Tylenol Rapid Release Gels 50 count Rapid Release Gelcap ASA202 50580-488-50 300450488503
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RSS Feed for FDA Recalls Information3 [what's this?4]
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Page Last Updated: 06/17/2010
CPSC Announces International Initiative for Strong Safety Standards on Window Coverings
http://www.cpsc.gov/cpscpub/prerel/prhtml10/10265.html
NEWS from CPSC
U.S. Consumer Product Safety Commission
Office of Information and Public Affairs Washington, DC 20207
FOR IMMEDIATE RELEASE
June 17, 2010
Release #10-265 CPSC Recall Hotline: (800) 638-2772
CPSC Media Contact: (301) 504-7908
CPSC Announces International Initiative for Strong Safety Standards on Window Coverings
WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission (CPSC), Health Canada and the European Commission’s Directorate General for Health and Consumers (DG SANCO) have joined together to call for strong and comprehensive international safety standards on window coverings from manufacturers and standards organizations.
This international, multi-lateral call for immediate action (pdf) is the first time the three safety agencies, representing consumers in 29 countries, have joined together to demand strong worldwide safety standards on a specific product.
A coordinated effort by the three safety agencies and standards organizations in the U.S., Canada and Europe could lead to cost-effective product development and testing and manufacturing processes in the global economy while putting the safety of children first.
Corded window coverings cause strangulation deaths and significant injuries in children worldwide. In the United States, CPSC staff is aware of 120 fatalities and 113 non-fatal incidents related to corded window coverings since 1999. Health Canada has received reports of 28 strangulation deaths and 23 near-strangulations linked to corded window coverings since 1986. In seven Member States of Europe, 90 children were reported to have visited hospital emergency departments for injuries caused by corded window coverings in 2002. More recently, at least six children in Europe have died from corded window coverings since 2008.
Since December 2009, CPSC has recalled tens of millions of corded Roman shades and roll-up blinds sold by a variety of manufacturers and retailers. These window coverings pose a serious risk of strangulation to young children. CPSC continues to urge parents and caregivers to make sure that there are no accessible cords on the front, side or back of their window coverings.
CPSC recommends the use of cordless window coverings in all homes where children live or visit.
Eating Outdoors, Handling Food Safely
http://www.fda.gov/Food/ResourcesForYou/Consumers/ucm109899.htm
Food Facts
* Pack and Transport Food Safely
* Quick Tips for Picnic Site Prep
* Follow Safe Grilling Tips
* Serving Picnic Food: Keep it Cold/Hot
Picnic and barbecue season offers lots of opportunities for outdoor fun with family and friends. But these warm weather events also present opportunities for foodborne bacteria to thrive. As food heats up in summer temperatures, bacteria multiply rapidly.
To protect yourself, your family, and friends from foodborne illness during warm-weather months, safe food handling when eating outdoors is critical. Read on for simple food safety guidelines for transporting your food to the picnic site, and preparing and serving it safely once you've arrived.
coolers and picnic equipment
Pack and Transport Food Safely
Keep your food safe: from the refrigerator/freezer . . .
all the way to the picnic table.
Quick Tips for Picnic Site Prep
Food safety begins with proper hand cleaning — including outdoor settings. Before you begin setting out your picnic feast, make sure hands and surfaces are clean.
* Outdoor Hand Cleaning: If you don’t have access to running water, simply use a water jug, some soap, and paper towels. Or, consider using moist disposable towelettes for cleaning your hands.
* Utensils and Serving Dishes: Take care to keep all utensils and platters clean when preparing food.
* Keep cold food cold. Place cold food in a cooler with ice or frozen gel packs. Cold food should be stored at 40°F or below to prevent bacterial growth. Meat, poultry, and seafood may be packed while still frozen so that they stay colder longer.
* Organize cooler contents. Consider packing beverages in one cooler and perishable foods in another. That way, as picnickers open and reopen the beverage cooler to replenish their drinks, the perishable foods won’t be exposed to warm outdoor air temperatures.
* Keep coolers closed. Once at the picnic site, limit the number of times the cooler is opened as much as you can. This helps to keep the contents cold longer.
* Don’t cross-contaminate. Be sure to keep raw meat, poultry, and seafood securely wrapped. This keeps their juices from contaminating prepared/cooked foods or foods that will be eaten raw, such as fruits and vegetables.
* Clean your produce. Rinse fresh fruits and vegetables under running tap water before packing them in the cooler - including those with skins and rinds that are not eaten. Rub firm-skinned fruits and vegetables under running tap water or scrub with a clean vegetable brush while rinsing with running tap water. Dry fruits and vegetables with a clean cloth towel or paper towel.
— Packaged fruits and vegetables that are labeled "ready-to-eat," "washed," or "triple washed" need not be washed.
Safe Food Temperature Chart Food Temperature
Steaks and roasts 145°F
Fish 145°F
Pork 160°F
Ground beef 160°F
Egg dishes 160°F
Chicken breasts 165°F
Whole poultry 165°F
Shrimp, lobster, and crabs cook until pearly and opaque
Clams, oysters, and mussels cook until the shells are open
Follow Safe Grilling Tips
Grilling and picnicking often go hand-in-hand. And just as with cooking indoors, there are important guidelines that should be followed to ensure that your grilled food reaches the table safely.
* Marinate safely. Marinate foods in the refrigerator - never on the kitchen counter or outdoors. In addition, if you plan to use some of the marinade as a sauce on the cooked food, reserve a portion separately before adding the raw meat, poultry, or seafood. Don’t reuse marinade.
* Cook immediately after "partial cooking." If you partially cook food to reduce grilling time, do so immediately before the food goes on the hot grill.
* Cook food thoroughly. When it’s time to cook the food, have your food thermometer ready. Always use it to be sure your food is cooked thoroughly.
* Keep "ready" food hot. Grilled food can be kept hot until served by moving it to the side of the grill rack, just away from the coals. This keeps it hot but prevents overcooking.
* Don't reuse platters or utensils. Using the same platter or utensils that previously held raw meat, poultry, or seafood allows bacteria from the raw food’s juices to spread to the cooked food. Instead, have a clean platter and utensils ready at grill-side to serve your food.
Serving Picnic Food: Keep it COLD / HOT
Keeping food at proper temperatures - indoor and out - is critical in preventing the growth of foodborne bacteria. The key is to never let your picnic food remain in the "Danger Zone" - between 40° F and 140° F - for more than 2 hours, or 1 hour if outdoor temperatures are above 90° F. This is when bacteria in food can multiply rapidly, and lead to foodborne illness.
Instead, follow these simple rules for keeping cold foods cold and hot foods hot.
Platter Warning:
person in apron cleaning a bowl
Prevent "Cross-Contamination" When Serving
Never reuse a plate or utensils that previously held raw meat, poultry, or seafood for serving — unless they’ve been washed first in hot, soapy water. Otherwise, you can spread bacteria from the raw juices to your cooked or ready-to-eat food.
This is particularly important to remember when serving cooked foods from the grill.
COLD FOOD
Cold perishable food should be kept in the cooler at 40° F or below until serving time.
* Once you've served it, it should not sit out for longer than 2 hours, or 1 hour if the outdoor temperature is above 90° F. If it does - discard it.
* Foods like chicken salad and desserts in individual serving dishes can be placed directly on ice, or in a shallow container set in a deep pan filled with ice. Drain off water as ice melts and replace ice frequently.
HOT FOOD
Hot food should be kept hot, at or above 140° F.
* Wrap it well and place it in an insulated container until serving.
* Just as with cold food - these foods should not sit out for more than 2 hours, or 1 hour in temperatures above 90° F. If food is left out longer, throw it away to be safe.
Everyone can practice safe food handling
by following these four simple steps:
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-
Links on this page:
Page Last Updated: 06/19/2009
FDA: Pfizer Voluntarily Withdraws Cancer Treatment Mylotarg from U.S. Market
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm216448.htm
FDA NEWS RELEASE
For Immediate Release: June 21, 2010
Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA: Pfizer Voluntarily Withdraws Cancer Treatment Mylotarg from U.S. Market
Pfizer Inc. today announced the voluntary withdrawal from the U.S. market of the drug Mylotarg (gemtuzumab ozogamicin) for patients with acute myeloid leukemia (AML), a bone marrow cancer. The company took the action at the request of the U.S. Food and Drug Administration after results from a recent clinical trial raised new concerns about the product’s safety and the drug failed to demonstrate clinical benefit to patients enrolled in trials.
Mylotarg was approved in May 2000 under the FDA’s accelerated approval program. This program allows the agency to approve a drug to treat serious diseases with an unmet medical need based on a surrogate endpoint – a laboratory measurement or a physical sign used as a substitute for a clinically meaningful endpoint that directly measures how a patient feels, functions, or survives.
Under accelerated approval, the company is required to conduct additional clinical trials after approval to confirm the drug’s benefit. If those trials fail to confirm clinical benefit to patients, or if the company does not pursue the required confirmatory trials with due diligence, the FDA can withdraw the drug from the market using expedited procedures.
Mylotarg was approved to treat patients ages 60 years and older with recurrent AML who were not considered candidates for other chemotherapy. The initial approval was based on the surrogate endpoint of response rate (i.e., the percentage of patients whose leukemia decreased or disappeared in laboratory tests), observed in 142 patients with AML across three clinical trials.
A confirmatory, post approval clinical trial was begun by Wyeth (now Pfizer) in 2004. The trial was designed to determine whether adding Mylotarg to standard chemotherapy demonstrated an improvement in clinical benefit (survival time) to AML patients. The trial was stopped early when no improvement in clinical benefit was observed, and after a greater number of deaths occurred in the group of patients who received Mylotarg compared with those receiving chemotherapy alone.
At initial approval, Mylotarg was associated with a serious liver condition called veno-occlusive disease, which can be fatal. This rate has increased in the postmarket setting.
“Mylotarg was granted an accelerated approval to allow patient access to what was believed to be a promising new treatment for a devastating form of cancer,” said Richard Pazdur, M.D., director, Office of Oncology Drug Products, part of FDA’s Center for Drug Evaluation and Research. “However, a confirmatory clinical trial and years of postmarketing experience with the product have not shown evidence of clinical benefit in patients with AML.”
As a result of the withdrawal, Mylotarg will not be commercially available to new patients. Patients who are currently receiving the drug may complete their therapy following consultation with their health care professional. Health care professionals should inform all patients receiving Mylotarg of the product’s potential safety risks.
Following the withdrawal, any future use of Mylotarg in the United States will require submission of an investigational new drug application to FDA.
Mylotarg is manufactured by New York City-based Pfizer.
For more information:
Pfizer: Mylotarg Withdrawal
FDA: Access to Investigational Drugs
FDA: Office of Oncology Drug Products
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3. http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm091745.htm
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Page Last Updated: 06/21/2010
Food Label Helps Consumers Make Healthier Choices
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm094536.htm
* Nutrient Highs and Lows
* Confusing Claims
* Ask and You May Receive
* For More Information
Consumers often compare prices of food items in the grocery store to choose the best value for their money. But comparing items using the food label can help them choose the best value for their health.
The food label identifies a variety of information about a product, such as the ingredients, net weight, and nutrition facts.
"The food label is one of the most valuable tools consumers have," says Barbara Schneeman, Ph.D., Director of the Food and Drug Administration's (FDA's) Office of Nutrition, Labeling and Dietary Supplements. "The food label gives consumers the power to compare foods quickly and easily so they can judge for themselves which products best fit their dietary needs."
For example, someone with high blood pressure who needs to watch salt (sodium) intake may be faced with five different types of tomato soup on the shelf, says Schneeman. You can quickly and easily compare the sodium content of each product by looking at the part of the label that lists nutrition information (Nutrition Facts Label) to choose the one with the lowest sodium content.
FDA regulations require nutrition information to appear on most foods, and any claims on food products must be truthful and not misleading. In addition, "low sodium," "reduced fat," and "high fiber" must meet strict government definitions. FDA has defined other terms used to describe the content of a nutrient, such as "low," "reduced," "high," "free," "lean," "extra lean," "good source," "less," "light," and "more." So a consumer who wants to reduce sodium intake can be assured that the manufacturer of a product claiming to be "low sodium" or "reduced in sodium" has met these definitions.
But you don't have to memorize the definitions. Just look at the Nutrition Facts Label to compare the claims of different products with similar serving sizes.
Nutrient Highs and Lows
Most nutrients must be declared on the Nutrition Facts Label as "percent Daily Value" (%DV), which tells the percent of the recommended daily intake in a serving of that product and helps the consumer create a balanced diet. The %DV allows you to see at a glance if a product has a high or low amount of a nutrient. The rule of thumb is 20% DV or more is high and 5% DV or less is low.
Health experts recommend keeping your intake of saturated fat, trans fat, and cholesterol as low as possible because these nutrients may increase your risk for heart disease. This is where the %DV on the Nutrition Facts Label can be helpful, says Schneeman. There is no %DV for trans fat, but you can use the label to find out whether the saturated fat and cholesterol are high or low, she says. When comparing products, look at the total amount of saturated fat plus trans fat to find the one lowest in both of these types of fat.
For beneficial nutrients, like fiber or calcium, you can use the %DV to choose products that contain higher amounts. Research has shown that eating a diet rich in fiber may lower your chances of getting heart disease and some types of cancer. And eating foods containing calcium may help lower your risk of getting the bone-weakening disease, osteoporosis.
Confusing Claims
The terms "natural," "healthy," and "organic" often cause confusion. "Consumers seem to think that 'natural' and 'organic' imply 'healthy,'" says Schneeman. "But these terms have different meanings from a regulatory point of view."
According to FDA policy, "natural" means the product does not contain synthetic or artificial ingredients. "Healthy," which is defined by regulation, means the product must meet certain criteria that limit the amounts of fat, saturated fat, cholesterol, and sodium, and require specific minimum amounts of vitamins, minerals, or other beneficial nutrients.
Food labeled "organic" must meet the standards set by the Department of Agriculture (USDA). Organic food differs from conventionally produced food in the way it is grown or produced. But USDA makes no claims that organically produced food is safer or more nutritious than conventionally produced food.
For example, says Schneeman, "A premium ice cream could be 'natural' or 'organic' and still be high in fat or saturated fat, so would not meet the criteria for 'healthy.'"
Ask and You May Receive
Most packaged foods are required by law to carry nutrition labeling. This labeling is voluntary for many raw foods, such as fruits, vegetables, and fish. FDA encourages stores that sell raw foods to display or distribute, near these foods, nutrition information to shoppers. To make it easy for retailers, FDA has created colorful posters that can be downloaded and printed from its Web site. The posters show nutrition information for the 20 most frequently consumed raw fruits, vegetables, and fish in the United States.
"If the nutrition information is not displayed for these raw foods, we want consumers to ask, 'where's the nutrition information on your fresh products?'" says Camille Brewer, Deputy Director of FDA's Office of Nutrition, Labeling and Dietary Supplements. Industry responds to consumer demand, says Brewer. "Industry tells us all the time, 'if consumers ask, we'll give it to them.'"
FDA also encourages consumers to request nutrition information in full-service or fast-food restaurants. This information would help consumers make healthier choices outside the home, where Americans now spend nearly half of their total food budget, according to the National Restaurant Association and USDA's Economic Research Service.
Providing nutrition information for restaurant food is voluntary unless a nutrient content claim or a health claim is made for a menu item or meal. A nutrient content claim might be "low in fat," and a health claim might be "heart healthy." If such claims are made, the restaurant is required to give customers the appropriate nutrition information for these items when requested. This information does not have to be on the menu or on a menu board that's clearly visible to the consumer. The restaurant has the option of offering this information in various ways, such as in a brochure.
Many food service establishments have nutrition information for their offerings and will provide the information on the Internet or to customers who request it.
This article appears on FDA's Consumer Update page5, which features the latest on all FDA-regulated products.
Date Posted: March 27, 2008
Start at the Store: 7 Ways to Prevent Foodborne Illness
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm094535.htm
* Check for cleanliness
* Keep certain foods separated
* Inspect cans and jars
* Inspect frozen food packaging
* Select frozen foods and perishables last
* Choose fresh eggs carefully
* Be mindful of time and temperature
Safeguarding your home against foodborne illnesses begins not at home, but at the supermarket, grocery store, or any other place where you buy food that you plan to store and serve.
Combating foodborne illnesses is a top priority at the Food and Drug Administration (FDA). That's because, according to the Centers for Disease Control and Prevention (CDC), foodborne ailments cause about 325,000 hospitalizations and 5,200 deaths nationwide each year.
You as a consumer can play a key role in preventing these illnesses. While shopping for food, you should:
1. Check for cleanliness
Buying from a retailer who follows proper food handling practices helps assure that the food is safe. Ask yourself: What is the general impression of this facility? Does it look and smell clean?
2. Keep certain foods separated
Separate raw meat, poultry, and seafood from other foods in your grocery shopping cart. Place these foods in plastic bags to prevent their juices from dripping on other foods. It is also best to separate these foods from other foods at checkout and in your grocery bags.
3. Inspect cans and jars
Don't buy food in cans that are bulging or dented. Also, don't buy food in jars that are cracked or have loose or bulging lids.
Since foods sold in cans or jars are processed to be sterile, they can "keep" for a long time if the can or jar is intact. A bulging can or jar lid may mean the food was under-processed and is contaminated. A dent in a can, especially if the dent affects a seam, may cause an opening in the seam which may allow contamination, as would a crack in a jar. A loose lid on a jar means the vacuum has been lost and the product may be contaminated. Don't buy a food product whose seal seems tampered with or damaged.
4. Inspect frozen food packaging
Don't buy frozen food if the package is damaged. Packages should not be open, torn or crushed on the edges. Also, avoid packages that are above the frost line in the store's freezer. If the package cover is transparent, look for signs of frost or ice crystals. This could mean that the food in the package has either been stored for a long time or thawed and refrozen. In such cases, choose another package.
5. Select frozen foods and perishables last
Meat, poultry, fish and eggs should be the last items placed in your shopping cart. Always put these products in separate plastic bags so that drippings don't contaminate other foods.
6. Choose fresh eggs carefully
Before putting eggs in your cart, open the carton and make sure that the eggs are clean and none is cracked. Buy only refrigerated eggs and follow the "Safe Handling Instructions" on the carton.
7. Be mindful of time and temperature
It's important to refrigerate perishable products as soon as possible after grocery shopping. Food safety experts stress the "2-hour rule"—because harmful bacteria can multiply in the "danger zone" (between 40° and 140° F), perishable foods should not be left at room temperature longer than 2 hours. Modify that rule to 1 hour when temperatures are above 90° F, as they often are in cars that have been parked in the sun.
If it will take more than an hour to get your groceries home, use an ice chest to keep frozen and perishable foods cold. Also, when the weather is warm and you are using your car's air conditioner, keep your groceries in the passenger compartment, not the trunk.
This article appears on FDA's Consumer Update page5, which features the latest on all FDA-regulated products.
Date Posted: May 13, 2008
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For More Information
* Start at the Store: Prevent Foodborne Illness (video)6
* Inicio en la tienda: 7 maneras de prevenir las enfermedades de transmisión alimentaria7
* Eat for a Healthy Heart8
* Food Safety Tips for Healthy Holidays9
* Survey Shows Gains in Food-Label Use, Health/Diet Awareness10
* Reporting Problems to FDA (video)11
* Consumer Complaint Coordinators12
* USDA Food Safety and Inspection Service: Reporting Problems with Food Products13
* Bad Bug Book: Introduction14
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U.S. FDA Inspections, Compliance, Enforcement, and Criminal Investigations
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm215405.htm
Inspections, Compliance, Enforcement, and Criminal Investigations
Pfizer, Inc. 5/26/10
Department of Health and Human Services logoDepartment of Health and Human Services
Public Health Service
Food and Drug Administration
New York District
158-15 Liberty Ave.
Jamaica, NY 11433
May 26, 2010
WARNING LETTER NYK 2010-19
VIA UPS
Jeffrey B. Kindler
Chairman and Chief Executive Officer
Pfizer, Inc.
235 East 42nd Street
New York, NY 10017
Dear Mr. Kindler:
During the period from June 29, 2009 through August 10, 2009, an inspection was conducted by investigators of the U.S. Food and Drug Administration (FDA or Agency) of your firm located at 235 East 42nd Street, New York, NY to determine your firm's compliance with the Postmarketing Adverse Drug Experience (PADE) reporting requirements of Section 505(k) of the Federal Food, Drug, and Cosmetic Act (the Act)) [21 U.S.C. § 355(k)], and Title 21, Code of Federal Regulations (21 CFR) 314.80 and 314.81.
Section 505(k)(1) of the Act [21 U.S.C. § 355(k)(1)] and 21 CFR 314.80 and 314.81 require an applicant to establish and maintain records and to report data relating to clinical experience, along with other data or information, for drugs for which an approved application is in effect. Failure to comply with Section 505(k) is a prohibited act under Section 301(e) of the Act [21 U.S.C. § 331(e)].
I. Deviations from 21 CFR 314.80 and 21 CFR 314.81 include the following:
1. Failure to submit Adverse Drug Experience (ADE) reports to FDA as required by 21 CFR 314.80(c). Specifically:
(a) The following are examples of ADEs and information regarding ADEs that were not submitted to the FDA:
Report # Mfg. Report # Product Pfizer's Seriousness/Expectedness Determination Date Received by Pfizer
1. 2009236922 Dalacin (Clindamycin HCI) Serious outcome and failure to assess expectedness 05/04/09
2. 2009236510 Camptosar Serious/unexpected 12/11/08
3. 2009221607 Lyrica Serious outcome and failure to assess expectedness 06/01/09
4. 2009206349 Lipitor Serious/unexpected 04/29/09
We have reviewed your firm's response dated September 9, 2009, and have determined that it is inadequate. The response acknowledges that the above-listed reports contained serious and unexpected adverse events which were not submitted within 15 days to FDA. These reports were not submitted until they were identified during the FDA inspection. Your firm's rationale for the failure to submit these reports included a lack of file tracking control as well as a lack of adequate training in utilizing the (b)(4) system. Your firm received FDA Forms 483 on July 29, 2004 and April 18, 2006 for similar postmarketing adverse drug experience violations and your corrective actions for these observations, including training, have been shown to be ineffective. FDA expects drug manufacturers to establish and implement reasonable mechanisms to assure that all serious and unexpected experiences are promptly recorded and investigated to determine whether or not 15-day Alert reports should be submitted to FDA.
(b) FDA's Center for Drug Evaluation and Research, Division of Reproductive and Urologic Drug Products, sent you a letter dated July 14, 2005, requesting that "all manufacturers of PDE5 inhibitors for treatment of erectile dysfunction (ED) continue to submit serious reports of postmarketing ophthalmologic adverse events that might reflect non-arteritic ischemic optic neuropathy (NAION) as 15-day Alert reports." In your letter to FDA dated October 18, 2005, your firm committed to provide 15-day Alert reports for these reported outcomes.
Your firm failed to submit 15-day Alert reports for the following serious visual adverse events that met the postmarketing reporting requirement for Viagra (sildenafil citrate) by misclassifying and/or downgrading reports to non-serious without reasonable justification:
Mfg. Report No. Serious Outcome Date Received
1. 2009230915 "Lost right eye vision" 06/22/09
2. 2009187335 "Blindness" 03/19/09
3. 2009193299 "Blind in right eye" 03/27/09
4. 2009213305 "Decreased vision" 05/12/09
5. 2009213306 "Decreased vision" 05/12/09
6. 2009202206 "Decreased vision" 04/22/09
7. 2009179071 "Visual acuity loss" 02/26/09
8. 2008063424 "Visual acuity reduced" 07/24/08
9. 2008086429 "Decreased vision" 10/10/08
10. 2008055517 "Visual deficiency" 07/01&10/08
11. 2008071566 "Difficulty seeing" 8/25/08
We have reviewed your firm's response dated September 9, 2009 and have concluded that it is inadequate. Your response indicates that only four of the above reports contained serious and/or expected reports of postmarketing ophthalmologic adverse events requiring a 15-day Alert report. However, the remaining seven adverse events were deemed as non-serious although serious outcomes such as "visual acuity loss/reduction" were noted.
2. Inadequate written procedures for the surveillance, receipt, evaluation, and reporting of adverse events as required by 21 CFR 314.80(b). Specifically:
Your firm does not have adequate written procedures in place to ensure that adverse drug experiences are correctly identified, assessed, and reported to FDA in accordance with postmarketing commitments.
For fosphenytoin, in your firm's letter to FDA dated February 13, 2009, your firm agreed to develop and implement an effective plan which would include criteria to correctly identify, assess, and report cases that are not labeled as Purple Glove Syndrome (PGS), but that are suggestive of this syndrome in association with fosphenytoin sodium use. However, your firm failed to do so.
Your firm also agreed to train all pharmacovigilance staff in the worldwide affiliates by February 15, 2009. Training was to include an overview of PGS and specific directions regarding the process for expediting any adverse event reports involving fosphenytoin use to Drug Safety Surveillance (DSS).
Despite your agreement, only six out of the required sixty-three country offices worldwide were trained and some of the offices that were trained were not trained on time, including the core DSS offices. 1
Your firm's response dated September 9, 2009 remains inadequate because it fails to include an effective plan to identify cases suggestive of PGS and fails to require medical evaluation of reports suggestive of PGS. Additionally, provisions for adequate training and documentation of training were not provided.
3. Failure to submit adverse drug experiences that are both serious and unexpected to FDA 'within 15 calendar days of initial receipt of the information as required by 21 CFR 314.80(c) (1)(i). Specifically:
(a) During the time period of approximately March 1, 2006 through December 7, 2008, there were 80,560 15-day Alert Reports submitted to FDA by your firm, of which 3558 (4%) were late. Between December 8, 2008 through June 28, 2009, approximately 1508 (9%) were submitted late, a further decline in the timeliness of reporting.
The following are examples of ADE reports that contained serious and unexpected events, but were submitted late to FDA:
Mfg. Report No. Product Reason Late No. of Days Late
1. 2007039077 Lipitor Delay due to case processing/other 1141
2. 2007039077 Lipitor Delay due to resubmission 1102
3. 2007048456 Azithromycin Delay forwarding to safety site 687
4. 2008037900 Azithromycin Delay due to case revision 393
5. 2009229922 Amlodipine Besilate Delay due to clerical/data entry issue 438
6. 2008040787 Prostin VR Delay due to resubmission 285
7. 2009231444 Atorvastatin Calcium Delay forwarding to safety site 274
8. 2009212979 Epirubicin HCI Delay forwarding to safety site 728
9. 2009195911 Eplerenone Delay due to clerical/data entry issue 356
According to your firm's response, implementation of (b)(4) created problems for the timely submission of 15-day Alert reports. A review of the explanations for the late reports indicates reasons such as cases being initially identified as non-serious then upgraded to serious, user error in routing cases within the safety system, case distribution errors, case processing issues, and technical errors. The firm purports to have addressed these problems by updating user manuals, reinforcing training, additional prospective and retrospective quality review of cases, updating system configuration errors, and other unspecified corrective actions with supplying organizations and partners. Your response indicates reporting improved after May 2009 and that errors significantly declined once colleagues became more experienced with the new safety system. However, your firm's response did not include comparable metrics for the post-May 2009 time period. Although the Agency recognizes the benefits to implementing a new and improved computerized tracking system, such a system can only be an improvement if there is adequate staff to make accurate data entries and if the users are adequately trained in its implementation. Your firm's response also fails to address other factors that possibly contributed to the tardiness of the reports, including personnel training in the categorization of serious versus non-serious reports, training in use of the new (b)(4) system, development of SOPs, development of standardized documentation practices, and development of compliance metrics. A signed copy of your revised corrective action plan should be included in your response to this Warning Letter.
(b) On November 8, 2004, FDA granted a waiver to your firm allowing for serious and unexpected suspected adverse drug reactions for NDA 11-839 (Provera and medroxyprogesterone acetate) to be submitted no later than 30 calendar days of initial receipt of the information, instead of within 15 calendar days of receipt of the information. However, between June 8, 2005 and March 16, 2009, your firm failed to submit approximately 25 reports within 30 days. The following are examples of these late reports:
Mfg. Report No. No. of Days Late
1. 2009230289 1720
2. 2008151639 128
3. 2009200493 1641
The response comments addressed for item 3(a) also apply to this point.
(c) On August 28, 2006, FDA granted a waiver to your firm allowing for serious and unexpected suspected adverse drug reactions for Bextra (valdecoxib) to be submitted no later than 60 calendar days of initial receipt of the information, instead of within 15 calendar days of receipt of the information. The firm, however, failed to submit approximately 220 of these reports within 60 days. The following are examples of the late reports:
Mfg. report No. No. of Days Late
1. 2006153496 264
2. 2006134600 219
3. 2007046238 140
4. 2007002471 90
5. 2007098335 139
The response comments addressed for item 3(a) also apply to this point.
4. Failure to submit a 15-day Alert report for adverse drug experiences obtained from postmarketing studies in which the applicant concludes that there is a reasonable possibility that the drug caused the adverse experience, as required by 21 CFR 314.80(e)(1). Specifically:
Fifteen-day Alert reports have not been submitted for all adverse drug experiences during postmarketing studies where there is a reasonable possibility that the drug caused the adverse experience. In your firm's letter dated March 18, 2008, your firm committed to submit 15-day Alert reports for Selzentry (Maraviroc) for the following events during the postmarketing period: liver-related deaths and liver failure, fatal and non-fatal myocardial infarctions, and all non-AIDS defining malignancies. The following ADE reports for Selzentry (Maraviroc) from postmarketing studies were required to be submitted to FDA as 15-day Alert reports, because they either met these criteria described in the March 18, 2008 letter, or they otherwise contain serious and unexpected events in which there is a reasonable possibility that the drug caused the event.
Mfg. Report No.
1. 2009154994
2. 2009187951
3. 2007067649
4. 2007076241
5. 2005162672
6. 2006136607
7. 2008003965
Your response has been reviewed and found inadequate. In a letter to the Agency dated March 18, 2008, your firm acknowledged expedited 15-day reporting for liver-related deaths, liver failure, fatal and non-fatal myocardial infarctions and all non-AIDS defining malignancies from spontaneous and clinical trial sources. No reasons for late submission of reports 2006136607 and 2008003965 were provided in your response. Your response states that reports 2009154994, 2009187951, and 2005162672 were incorrectly not submitted due to errors in distribution. Your response further states that reports 2007067649 and 2007076241 were not submitted because they were received by the firm before clarification from the Agency advising that clinical trial cases were subject to special reporting requirements. However, after receipt of clarification that cases 2007067649 and 2007076241 were subject to reporting, your firm did not submit them to the Agency.
5. Serious and unexpected ADE reports are not promptly investigated as required by 21 CFR 314.80(c)(1)(ii). Specifically:
Adverse drug experiences that were the subject of postmarketing 15-day Alert reports were not investigated and/or documented. Specifically, in your firm's letter dated August 18, 2005, your firm submitted revised procedures to investigate all cases of postmarketing ophthalmologic ADEs that might reflect NAION involving Viagra. Your firm committed in these procedures to submit a pre-specified list of questions to reporters in order to obtain clinical and diagnostic information concerning visual symptoms and risk factors for the event. However, in cases reviewed during the inspection, your firm failed to provide documentation that adequate follow-up information had been requested. In addition, during the inspection, it was observed that some reports were either misclassified or downgraded in severity to non-serious without a reasonable justification.
Your response acknowledges that documentation of follow-up calls and the use of the questions during the calls were not handled consistently. Although the FDA does not mandate a particular method of requesting follow-up information, documentation that all postmarketing ophthalmologic events that might reflect NAION were investigated should be maintained.
6. Failure to submit 15-day Alert reports for serious adverse drug experiences as a non-applicant to the applicant within 5 calendar days of receipt as required by 21 CFR 314.80(c)(1) (iii).
Pfizer, as a non-applicant, elected to submit to the applicant (rather than to FDA) all reports of serious adverse drug experiences. However, you did not submit each report to the applicant within five calendar days of your receipt of the information.
Specifically, your firm's name is on the label of at least ten products (amoxicillin, finasteride, ondansetron, lamotrigine, metformin, penicillin V potassium, stavudine, tiotropium bromide, donepezil, interferon beta-la) for which you are required to submit serious ADE reports to the applicant within five calendar days. Of the 398 reports received by your firm for these products, 132 (33%) were sent to the applicants more than five calendar days after your receipt of them.
Your response acknowledged a need to improve on the timeliness of your submission of serious ADE reports to the applicants for products for which Pfizer does not hold the NDA or ANDA, but appears on the label as a distributor. Your response stated that activities such as targeted training and presentations have resulted in reporting timeframe improvement. However, a review of the overall time reporting for 5-day rule products in a time table provided to the investigators on July 9, 2009, for the period from December 8, 2008 to June 30, 2009, shows the contrary. As demonstrated by your report compiled for inspection entitled "5-Day Rule Products Sent to License Party between 08 Dec 2008 and 30 Jun 2009", there was a decline in the timeliness of reporting during this period.
7. Failure to promptly review all adverse drug experience information obtained or otherwise received by the applicant from any source as required by 21 CFR 314.80(b). Specifically:
Adverse drug experience information obtained or otherwise received from any source was not promptly reviewed, including information from commercial marketing experience and postmarketing epidemiological/surveillance activities.
The following are examples of serious ADEs that wvere not forwarded for case processing within 2-4 business days as required by your SOP AEM-01-02, dated July 14, 2008, pages 3 - 5:
Mfg. Report No. No. of Days Received Late
1. 2009202904 30
2. 2008150853 9
Your response provided an explanation for the lateness of these reports and stated that the firm has "robust quality processes in place to oversee performance ..." This response is deemed inadequate because your affiliates failed to comply with defined time fines for case processing as required by SOP AEM-01.
Your response commits the firm to implement "additional enhancements to tools enabling enhanced proactive management of case workload" to mitigate late reporting. A signed copy of your revised corrective action plan should be included in your response to this Warning Letter. Adequacy of the corrective action will be determined during subsequent inspection(s).
8. Failure to submit periodic adverse drug experience reports at quarterly intervals for each adverse drug experience which is not reported as a I5-day Alert report, for 3 years from the date of approval of the application, and then at annual intervals submitted within 60 days of the anniversary date of approval of the application as required by 21 CFR 314.80(c)(2). Specifically:
Individual ADEs which were not reported to FDA in a postmarketing IS-day Alert report have not been included in a periodic safety report.
Specifically, the following ADEs were not reported to FDA in a periodic safety report:
Mfg. Report No.
1. 2009189370
2. 2009205745
3. 2009206342
4. 2009211979
5. 2009178032
6. 2009186019
7. 2009152113
8. 2009166186
Your response to this observation reports a short term corrective action of nightly sweeps of the (b)(4) System with a permanent system correction to be implemented by the fourth quarter of 2009. Adequacy of the corrective action will be determined during subsequent follow-up inspection(s).
II. Deviations from 21 U.S.C. § 353(d) include the following:
In addition to the above violations of Postmarketing Adverse Drug Experience (PADE) reporting requirements, you have significant deviations from the requirements of Section 503(d) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 353(d)] and Title 21, Code of Federal Regulations, Part 203. Based on the information collected during the inspection, non-compliance with the requirements of the Prescription Drug Marketing Act (PDMA), include:
1. Failure to conduct an immediate investigation, to notify FDA within 5 working days, and provide written investigation reports within 30 days of initial notification of prescription drug sample thefts, significant losses, and falsification of prescription drug sample records as required by 21 CFR 203.37(a)(1),(2), and (3) and (b)(1), (2), and (3).
21 CFR 203.37(a)(1) and (b)(1) requires a manufacturer or authorized distributor of record to notify FDA within five working days of becoming aware of a significant loss, any known theft, or suspected falsification involving drug samples. 21 CFR 203.37(a)(2) and (b)(2) requires an immediate initiation of an investigation of a suspected significant loss, any known theft, or suspected falsification. 21 CFR 203.37(a)(3) and (b)(3) requires that FDA be provided with a complete written report, including the reason for and the results of the investigation, not later than 30 days after the date of the initial notification.
The FDA 483 observations concern Pfizer's failure to notify and follow up with FDA regarding significant losses, known thefts, or suspected falsifications in accordance with these PDMA legal requirements. Pfizer's response to the FDA 483 in this regard does not address how Pfizer will meet the Section 203.37 requirements. We recognize your intent to reduce the inventory period, but the reduction you describe would still not meet the five working day reporting requirement.
Examples of incidents of significant losses and confirmed variances in drug sample annual inventory reconciliation re orts that exceeded the established threshold for significant loss in Pfizer's SOP 010 (b)(4) that were not reported to FDA are as follows:
• Employee ID (b)(6) had a total inventory loss of approximately (b)(4) on July 17, 2009. At the time of inspection, FDA had not been notified.
• Employee ID (b)(6) had a possible theft of (b)(4) totaling a loss of (b)(4) on March 11, 2008. A police report was filed on May 13, 2008, yet Pfizer did not notify FDA until May 30, 2008.
• Employee ID (b)(6) had a variance of (b)(4) on Aug 19, 2008. FDA was not notified until approximately two months later.
2. Failure to conduct, at least annually, a complete and accurate physical inventory of all drug samples distributed and to record the results of such inventory as required by 21 CFR 203.31(d).
21 CFR 203.31 (d) requires that each drug manufacturer or authorized distributor of record that distributes drug samples by means of representatives shall conduct, at least annually, a complete and accurate physical inventory of all drug samples. All drug samples in the possession or control of each manufacturer's and distributor's representatives are required to be inventoried and the results of the inventory are required to be recorded in an inventory record. In addition, manufacturers and distributors shall reconcile the results of the physical inventory with the most recently completed prior physical inventory and create a report documenting the reconciliation process.
Annual inventory reconciliations are not conducted once a year as per your SOP 010. Specifically, out of 35 inventories reviewed by FDA, the following employees did not have their inventories taken annually:
Employee (b)(6)
Employee (b)(6)
Employee (b)(6)
Employee (b)(6)
Employee (b)(6)
Employee (b)(6)
Employee (b)(6)
Employee (b)(6)
Employee (b)(6)
Employee (b)(6)
Employee (b)(6)
Employee (b)(6)
Employee (b)(6)
Employee (b)(6)
Your response relays the intent to revise SOP 010 to assure that all future employee inventories are performed within 12 months from the initial inventory review rather than once each calendar year. However, we have not yet received your revised SOP and you have not addressed the status of inventories for the above employees. Therefore, the adequacy of your response cannot be determined.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your firm. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, prosecution or injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts. Additionally, FDA may withhold approval of requests for export certificates, or approval of pending new drug applications, listing your facility as a supplier or manufacturer until the above violations are corrected. A reinspection may be necessary.
You should notify this office upon receipt of this letter to arrange for a meeting to discuss the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to prevent the recurrence of similar violations. If corrective action cannot be completed within 15 working days, state the reason for delay and the time within which corrections will be completed.
Your reply should be sent to Compliance Branch, Food and Drug Administration, 158-15 Liberty Avenue, Jamaica, NY 11433 Attention: Lillian C. Aveta, Compliance Officer.
Sincerely,
/S/
Ronald M. Pace
District Director
New York District
1 The Milan office, which is one of the core DSS offices, was not trained until July 2009.
Enclosure: Form FDA 483 dated August 10, 2009
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Links on this page:
Page Last Updated: 06/14/2010
CPSC Launches National Campaign to Change the Way People Think and Act about Pool and Spa Safety
Pool Safely Campaign Aims to Reduce Child Drownings and Entrapments
http://www.cpsc.gov/cpscpub/prerel/prhtml10/10241.html
FORT LAUDERDALE, FL - The U.S. Consumer Product Safety Commission (CPSC) today kicks-off the Pool Safely campaign (www.poolsafely.gov), a first-of-its-kind national public education effort to reduce child drownings and non-fatal submersions, and entrapments in swimming pools and spas. At a press conference at the Fort Lauderdale Aquatic Complex today, Olympic swimmers Jason Lezak and Janet Evans joined Inez Tenenbaum, Chairman of the CPSC; U.S. Rep. Debbie Wasserman Schultz (D-FL); and Nancy Baker, mother of Virginia Graeme Baker, to officially launch Pool Safely and release the CPSC's annual submersion and entrapment reports.
The Pool Safely campaign is a key part of the CPSC's efforts to carry out the requirements of Section 1407 of the Virginia Graeme Baker Pool and Spa Safety Act (P&SS Act), federal legislation signed into law in 2007 mandating new requirements for pool and spa safety. It includes a requirement for a national public education campaign designed to raise public awareness, support industry compliance, and improve safety at pools and spas.
"I have been involved in the issue of pool safety throughout my career and today marks a key milestone in the ongoing fight to reduce accidental drowning," said Congresswoman Debbie Wasserman Schultz, author of the Virginia Graeme Baker Pool and Spa Safety Act. "Educating communities on the potential dangers of swimming pools is a critical tool in saving the lives of our children. I am so pleased to have worked with my colleagues in Congress to provide the funds needed for implementation of this important campaign."
The Pool Safely campaign will deliver an important and simple message: just adding an extra safety step in and around the water can make all the difference. Your greatest water safety assurance comes from adopting and practicing as many water safety measures as possible, including: barriers that completely surround the pool with self-closing, self-latching gates; staying close, being alert, and watching children at the pool; learning and practicing water safety skills (knowing how to swim and perform CPR); and having the appropriate equipment (compliant drain covers, alarms, barriers and sensors).
The campaign will highlight the need to implement a "personal system of safety" that consists of adding as many proven water safety practices as possible in and around pools and spas.
"As a parent of young children, I know there's no single, sure-fire way to ensure their safety around pools and spas," added Janet Evans, five-time Olympic medalist in swimming. "Whether it's enrolling them in swimming lessons or simply watching them at all times, there is always one more thing I can do. The Pool Safely campaign offers a variety of simple steps we can all take to protect our children in pools and spas."
Pool Safely will serve as an information hub delivering campaign tools and resources to various outreach channels. CPSC has taken the lead by partnering with national, regional and local organizations in the children's safety and drowning prevention communities. By engaging key partners, the campaign will reach the widest possible audience and build a sustainable network that will ensure the campaign's messaging is delivered for years to come.
"Knowing how to swim helped me win gold in the water, but it takes adding as many water safety steps as possible to ensure a safe environment for children in and around pools and spas, " said seven-time Olympic medalist in swimming Jason Lezak. "No matter how responsible you already are, there is always one more safety step you can take to protect your child. That is how you can Pool Safely. "
"I understand the need to bring together the public and dedicated partners in the water safety community to begin a national conversation about water safety," said Nancy Baker, the mother of Virginia Graeme for whom the Act is named. "I am honored to be involved in the Pool Safely campaign and look forward to working together to promote additional water safety steps we all can take in protecting our loved ones in and around pools and spas. Simple steps save lives."
The Pool Safely campaign - a national public education effort by the Consumer Product Safety Commission - is proud to partner with leading organizations, including American Red Cross, YMCA of the USA, Safe Kids USA, National Drowning Prevention Alliance (NDPA), World Waterpark Association (WWA), and Abbey's Hope. For more information, visit the website at www.poolsafely.gov or follow the campaign on Twitter @poolsafely
http://www.poolsafely.gov/
# Drowning is preventable, especially among children. http://www.poolsafely.gov/ #poolsafely #pools 2 days ago
http://www.ready.gov/america/getakit/seniors.html
Disaster Preparedness for Older People
Each person's needs and abilities are unique, but every individual can take important steps to prepare for all kinds of emergencies and put plans in place. By evaluating your own personal needs and making an emergency plan, you can be better prepared for any situation. A commitment to planning today will help you prepare for any emergency situation. Preparing makes sense. Get ready now.
* Consider how a disaster might affect your individual needs.
* Plan to make it on your own, at least for a period of time. It's possible that you will not have access to a medical facility or even a drugstore.
* Identify what kind of resources you use on a daily basis and what you might do if they are limited or not available.
* Get an emergency supply kit.
* If you must evacuate, take your pets with you, if possible. However, if you are going to a public shelter, it is important to understand that animals may not be
allowed inside.
* Plan in advance for shelter alternatives that will work for both you and your pets; consider loved ones or friends outside of your immediate area who would be
willing to host you and your pets in an emergency.
*
Create a Support Network
* If you anticipate needing assistance during a disaster talk to family, friends and others who will be part of your personal support network.
* Write down and share each aspect of your emergency plan with everyone in your support network.
* Make sure everyone knows how you plan to evacuate your home or workplace and where you will go in case of a disaster.
* Make sure that someone in your local network has an extra key to your home and knows where you keep your emergency supplies.
* Teach those who will help you how to use any lifesaving equipment, administer medicine in case of an emergency.
* Practice your plan with those who have agreed to be part of your network.
Additional Supplies and Documents:
Medications and Medical Supplies
If you take medicine or use a medical treatment on a daily basis, be sure you have what you need to make it on your own for at least a week, maybe longer.
* Make a list of prescription medicines including dosage, treatment and allergy information.
* Talk to your pharmacist or doctor about what else you need to prepare.
* If you undergo routine treatments administered by a clinic or hospital or if you receive regular services such as home health care, treatment or transportation, talk to your service provider about their emergency plans. Work with them to identify back-up service providers and incorporate them into your personal support network.
* Consider other personal needs such as eyeglasses, hearing aids and hearing aid batteries, wheelchair batteries, and oxygen.
Emergency Documents
Include copies of important documents in your emergency supply kits such as family records, medical records, wills, deeds, social security number, charge and bank accounts information and tax records.
* Have copies of your medical insurance and Medicare cards readily available.
* Keep a list of the style and serial number of medical devices or other life-sustaining devices. Include operating information and instructions.
* Make sure that a friend or family member has copies of these documents.
* Include the names and contact information of your support network, as well as your medical providers.
* If you have a communication disability, make sure your emergency information notes the best way to communicate with you.
* Keep these documents in a water proof container for quick and easy access.
More Information
For more information, see Disaster Preparedness For People With Disabilities Adobe Acrobat Reader Required from FEMA, and the Red Cross website.
security guards at entrance to BPI bank branch at said mall,didn't inspect/subject to scanning with metal detector luggage.
Said luggage was large enough to contain grenades and firearms.
The following stores at said mall didn't have required express lanes for senior citizens: Chow King, Jollibee, NT computer.
I believe said stores violated the Expanded Senior Citizens Act of 2003.
http://www.cdc.gov/family/checkuplist/index.htm
Check-Up Checklist: Things to Do Before Your Next Check-Up
Getting check-ups is one of many things you can do to help stay healthy and prevent disease and disability.
You’ve made the appointment to see your health care provider.
You’ve reviewed the instructions on how to prepare for certain tests.
You’ve done the usual paperwork.
Done, right?
Not quite.
Before your next check-up, make sure you do these four things.
Review your family health history.
Are there any new conditions or diseases that have occurred in your close relatives since your last visit? If so, let your health care provider know. Family history might influence your risk of developing heart disease, stroke, diabetes, or cancer. Your provider will assess your risk of disease based on your family history and other factors. Your provider may also recommend things you can do to help prevent disease, such as exercising more, changing your diet, or using screening tests to help detect disease early.
Find out if you are due for any general screenings or vaccinations.
Have you had the recommended screening tests based on your age, general health, family history, and lifestyle? Check with your health care provider to see if its time for any vaccinations, follow-up exams, or tests. For example, it might be time for you to get a Pap test, mammogram, prostate cancer screening, colon cancer screening, sexually transmitted disease screening, blood pressure check, tetanus shot, eye check, or other screening.
Write down a list of issues and questions to take with you.
Review any existing health problems and note any changes.
* Have you noticed any body changes, including lumps or skin changes?
* Are you having pain, dizziness, fatigue, problems with urine or stool, or menstrual cycle changes?
* Have your eating habits changed?
* Are you experiencing depression, anxiety, trauma, distress, or sleeping problems?
If so, note when the change began, how it’s different from before, and any other observation that you think might be helpful.
Be honest with your provider. If you haven’t been taking your medication as directed, exercising as much, or anything else, say so. You may be at risk for certain diseases and conditions because of how you live, work, and play. Your provider develops a plan based partly on what you say you do. Help ensure that you get the best guidance by providing the most up-to-date and accurate information about you.
Be sure to write your questions down beforehand. Once you’re in the office or exam room, it can be hard to remember everything you want to know. Leave room between questions to write down your provider’s answers.
Consider your future.
Are there specific health issues that need addressing concerning your future? Are you thinking about having infertility treatment, losing weight, taking a hazardous job, or quitting smoking? Discuss any issues with your provider so that you can make better decisions regarding your health and safety.
Mcneil Consumer Healthcare Recalls Four Product Lots of Benadryl® Allergy Ultratab™ Tablets, 100 Count, and One Product Lot of Extra Strength Tylenol® Rapid Release Gels, 50 Count
http://www.fda.gov/Safety/Recalls/ucm215921.htm
FOR IMMEDIATE RELEASE - Fort Washington, PA - June 15, 2010 - McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is recalling five product lots as an addition to the list of products included in the company’s January 15th, 2010 product recall. The additional lots involved are four product lots of BENADRYL® ALLERGY ULTRATAB™ TABLETS, 100 count, sold in the U.S.; and one product lot of EXTRA STRENGTH TYLENOL® Rapid Release Gels, 50 count sold in the U.S., Trinidad and Tobago, Bermuda, and Puerto Rico (FULL RECALLED PRODUCT LIST BELOW). This recall is a follow-up to the product recall that McNeil Consumer Healthcare announced on January 15th, 2010 and is being taken because the products were inadvertently omitted from the initial recall action. McNeil Consumer Healthcare identified the omission and informed the U.S. Food and Drug Administration (FDA) of its decision to add these product lots to the recall list. All these products were produced before the January 15th, 2010 recall. Since January, McNeil Consumer Healthcare has continued to analyze and evaluate 2,4,6-tribromoanisole (TBA) and has shared that information with the FDA. This further analysis confirms that the risk of serious adverse medical events is remote. This recall is being conducted with the knowledge of the FDA.
BENADRYL® ALLERGY ULTRATAB™ TABLETS is sold over-the-counter and is indicated for the relief of allergy associated symptoms such as sneezing, runny nose, itchy throat, and itchy and watery eyes. EXTRA STRENGTH TYLENOL® Rapid Release Gels is sold over-the-counter and is indicated for the temporary reduction of fever and for the temporary relief of minor aches and pains due to headache, muscular aches, backache, minor arthritis pain, the common cold, toothache, pre-menstrual and menstrual cramps, and flu.
The January 15th, 2010 recall was initiated as a result of consumer complaints of a musty or moldy odor that has since been linked to the presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA). After a thorough investigation, it was determined that the source of TBA was the result of a breakdown of a chemical that is applied to wood used to build wooden pallets that transport and store product packaging materials.
Consumers who purchased product from the lots included in this recall should stop using the product and contact McNeil Consumer Healthcare for instructions on a refund or replacement. For these instructions or information regarding how to return or dispose of the product, consumers should log on to the internet at www.mcneilproductrecall.com1 or call 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time). Requests for reimbursement can be made at www.mcneilproductrecall.com2. Consumers who have medical concerns or questions should contact their healthcare provider.
Any adverse reactions may also be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at http:www.fda.gov/safety/medwatch/default.htm.
The product lot numbers for the recalled products can be found on the side of the bottle label.
FULL RECALLED PRODUCT LIST:
Product Name Product Form Lot Number NDC Number UPC Code
BENADRYL Allergy ULTRATAB Tablets 100 count Ultratab Tablet AJA008, ADA194, ABA022, ABA264 50580-226-10 312547170338
EXTRA STRENGTH Tylenol Rapid Release Gels 50 count Rapid Release Gelcap ASA202 50580-488-50 300450488503
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Page Last Updated: 06/17/2010
CPSC Announces International Initiative for Strong Safety Standards on Window Coverings
http://www.cpsc.gov/cpscpub/prerel/prhtml10/10265.html
NEWS from CPSC
U.S. Consumer Product Safety Commission
Office of Information and Public Affairs Washington, DC 20207
FOR IMMEDIATE RELEASE
June 17, 2010
Release #10-265 CPSC Recall Hotline: (800) 638-2772
CPSC Media Contact: (301) 504-7908
CPSC Announces International Initiative for Strong Safety Standards on Window Coverings
WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission (CPSC), Health Canada and the European Commission’s Directorate General for Health and Consumers (DG SANCO) have joined together to call for strong and comprehensive international safety standards on window coverings from manufacturers and standards organizations.
This international, multi-lateral call for immediate action (pdf) is the first time the three safety agencies, representing consumers in 29 countries, have joined together to demand strong worldwide safety standards on a specific product.
A coordinated effort by the three safety agencies and standards organizations in the U.S., Canada and Europe could lead to cost-effective product development and testing and manufacturing processes in the global economy while putting the safety of children first.
Corded window coverings cause strangulation deaths and significant injuries in children worldwide. In the United States, CPSC staff is aware of 120 fatalities and 113 non-fatal incidents related to corded window coverings since 1999. Health Canada has received reports of 28 strangulation deaths and 23 near-strangulations linked to corded window coverings since 1986. In seven Member States of Europe, 90 children were reported to have visited hospital emergency departments for injuries caused by corded window coverings in 2002. More recently, at least six children in Europe have died from corded window coverings since 2008.
Since December 2009, CPSC has recalled tens of millions of corded Roman shades and roll-up blinds sold by a variety of manufacturers and retailers. These window coverings pose a serious risk of strangulation to young children. CPSC continues to urge parents and caregivers to make sure that there are no accessible cords on the front, side or back of their window coverings.
CPSC recommends the use of cordless window coverings in all homes where children live or visit.
Eating Outdoors, Handling Food Safely
http://www.fda.gov/Food/ResourcesForYou/Consumers/ucm109899.htm
Food Facts
* Pack and Transport Food Safely
* Quick Tips for Picnic Site Prep
* Follow Safe Grilling Tips
* Serving Picnic Food: Keep it Cold/Hot
Picnic and barbecue season offers lots of opportunities for outdoor fun with family and friends. But these warm weather events also present opportunities for foodborne bacteria to thrive. As food heats up in summer temperatures, bacteria multiply rapidly.
To protect yourself, your family, and friends from foodborne illness during warm-weather months, safe food handling when eating outdoors is critical. Read on for simple food safety guidelines for transporting your food to the picnic site, and preparing and serving it safely once you've arrived.
coolers and picnic equipment
Pack and Transport Food Safely
Keep your food safe: from the refrigerator/freezer . . .
all the way to the picnic table.
Quick Tips for Picnic Site Prep
Food safety begins with proper hand cleaning — including outdoor settings. Before you begin setting out your picnic feast, make sure hands and surfaces are clean.
* Outdoor Hand Cleaning: If you don’t have access to running water, simply use a water jug, some soap, and paper towels. Or, consider using moist disposable towelettes for cleaning your hands.
* Utensils and Serving Dishes: Take care to keep all utensils and platters clean when preparing food.
* Keep cold food cold. Place cold food in a cooler with ice or frozen gel packs. Cold food should be stored at 40°F or below to prevent bacterial growth. Meat, poultry, and seafood may be packed while still frozen so that they stay colder longer.
* Organize cooler contents. Consider packing beverages in one cooler and perishable foods in another. That way, as picnickers open and reopen the beverage cooler to replenish their drinks, the perishable foods won’t be exposed to warm outdoor air temperatures.
* Keep coolers closed. Once at the picnic site, limit the number of times the cooler is opened as much as you can. This helps to keep the contents cold longer.
* Don’t cross-contaminate. Be sure to keep raw meat, poultry, and seafood securely wrapped. This keeps their juices from contaminating prepared/cooked foods or foods that will be eaten raw, such as fruits and vegetables.
* Clean your produce. Rinse fresh fruits and vegetables under running tap water before packing them in the cooler - including those with skins and rinds that are not eaten. Rub firm-skinned fruits and vegetables under running tap water or scrub with a clean vegetable brush while rinsing with running tap water. Dry fruits and vegetables with a clean cloth towel or paper towel.
— Packaged fruits and vegetables that are labeled "ready-to-eat," "washed," or "triple washed" need not be washed.
Safe Food Temperature Chart Food Temperature
Steaks and roasts 145°F
Fish 145°F
Pork 160°F
Ground beef 160°F
Egg dishes 160°F
Chicken breasts 165°F
Whole poultry 165°F
Shrimp, lobster, and crabs cook until pearly and opaque
Clams, oysters, and mussels cook until the shells are open
Follow Safe Grilling Tips
Grilling and picnicking often go hand-in-hand. And just as with cooking indoors, there are important guidelines that should be followed to ensure that your grilled food reaches the table safely.
* Marinate safely. Marinate foods in the refrigerator - never on the kitchen counter or outdoors. In addition, if you plan to use some of the marinade as a sauce on the cooked food, reserve a portion separately before adding the raw meat, poultry, or seafood. Don’t reuse marinade.
* Cook immediately after "partial cooking." If you partially cook food to reduce grilling time, do so immediately before the food goes on the hot grill.
* Cook food thoroughly. When it’s time to cook the food, have your food thermometer ready. Always use it to be sure your food is cooked thoroughly.
* Keep "ready" food hot. Grilled food can be kept hot until served by moving it to the side of the grill rack, just away from the coals. This keeps it hot but prevents overcooking.
* Don't reuse platters or utensils. Using the same platter or utensils that previously held raw meat, poultry, or seafood allows bacteria from the raw food’s juices to spread to the cooked food. Instead, have a clean platter and utensils ready at grill-side to serve your food.
Serving Picnic Food: Keep it COLD / HOT
Keeping food at proper temperatures - indoor and out - is critical in preventing the growth of foodborne bacteria. The key is to never let your picnic food remain in the "Danger Zone" - between 40° F and 140° F - for more than 2 hours, or 1 hour if outdoor temperatures are above 90° F. This is when bacteria in food can multiply rapidly, and lead to foodborne illness.
Instead, follow these simple rules for keeping cold foods cold and hot foods hot.
Platter Warning:
person in apron cleaning a bowl
Prevent "Cross-Contamination" When Serving
Never reuse a plate or utensils that previously held raw meat, poultry, or seafood for serving — unless they’ve been washed first in hot, soapy water. Otherwise, you can spread bacteria from the raw juices to your cooked or ready-to-eat food.
This is particularly important to remember when serving cooked foods from the grill.
COLD FOOD
Cold perishable food should be kept in the cooler at 40° F or below until serving time.
* Once you've served it, it should not sit out for longer than 2 hours, or 1 hour if the outdoor temperature is above 90° F. If it does - discard it.
* Foods like chicken salad and desserts in individual serving dishes can be placed directly on ice, or in a shallow container set in a deep pan filled with ice. Drain off water as ice melts and replace ice frequently.
HOT FOOD
Hot food should be kept hot, at or above 140° F.
* Wrap it well and place it in an insulated container until serving.
* Just as with cold food - these foods should not sit out for more than 2 hours, or 1 hour in temperatures above 90° F. If food is left out longer, throw it away to be safe.
Everyone can practice safe food handling
by following these four simple steps:
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Links on this page:
Page Last Updated: 06/19/2009
FDA: Pfizer Voluntarily Withdraws Cancer Treatment Mylotarg from U.S. Market
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm216448.htm
FDA NEWS RELEASE
For Immediate Release: June 21, 2010
Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA: Pfizer Voluntarily Withdraws Cancer Treatment Mylotarg from U.S. Market
Pfizer Inc. today announced the voluntary withdrawal from the U.S. market of the drug Mylotarg (gemtuzumab ozogamicin) for patients with acute myeloid leukemia (AML), a bone marrow cancer. The company took the action at the request of the U.S. Food and Drug Administration after results from a recent clinical trial raised new concerns about the product’s safety and the drug failed to demonstrate clinical benefit to patients enrolled in trials.
Mylotarg was approved in May 2000 under the FDA’s accelerated approval program. This program allows the agency to approve a drug to treat serious diseases with an unmet medical need based on a surrogate endpoint – a laboratory measurement or a physical sign used as a substitute for a clinically meaningful endpoint that directly measures how a patient feels, functions, or survives.
Under accelerated approval, the company is required to conduct additional clinical trials after approval to confirm the drug’s benefit. If those trials fail to confirm clinical benefit to patients, or if the company does not pursue the required confirmatory trials with due diligence, the FDA can withdraw the drug from the market using expedited procedures.
Mylotarg was approved to treat patients ages 60 years and older with recurrent AML who were not considered candidates for other chemotherapy. The initial approval was based on the surrogate endpoint of response rate (i.e., the percentage of patients whose leukemia decreased or disappeared in laboratory tests), observed in 142 patients with AML across three clinical trials.
A confirmatory, post approval clinical trial was begun by Wyeth (now Pfizer) in 2004. The trial was designed to determine whether adding Mylotarg to standard chemotherapy demonstrated an improvement in clinical benefit (survival time) to AML patients. The trial was stopped early when no improvement in clinical benefit was observed, and after a greater number of deaths occurred in the group of patients who received Mylotarg compared with those receiving chemotherapy alone.
At initial approval, Mylotarg was associated with a serious liver condition called veno-occlusive disease, which can be fatal. This rate has increased in the postmarket setting.
“Mylotarg was granted an accelerated approval to allow patient access to what was believed to be a promising new treatment for a devastating form of cancer,” said Richard Pazdur, M.D., director, Office of Oncology Drug Products, part of FDA’s Center for Drug Evaluation and Research. “However, a confirmatory clinical trial and years of postmarketing experience with the product have not shown evidence of clinical benefit in patients with AML.”
As a result of the withdrawal, Mylotarg will not be commercially available to new patients. Patients who are currently receiving the drug may complete their therapy following consultation with their health care professional. Health care professionals should inform all patients receiving Mylotarg of the product’s potential safety risks.
Following the withdrawal, any future use of Mylotarg in the United States will require submission of an investigational new drug application to FDA.
Mylotarg is manufactured by New York City-based Pfizer.
For more information:
Pfizer: Mylotarg Withdrawal
FDA: Access to Investigational Drugs
FDA: Office of Oncology Drug Products
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Page Last Updated: 06/21/2010
Food Label Helps Consumers Make Healthier Choices
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm094536.htm
* Nutrient Highs and Lows
* Confusing Claims
* Ask and You May Receive
* For More Information
Consumers often compare prices of food items in the grocery store to choose the best value for their money. But comparing items using the food label can help them choose the best value for their health.
The food label identifies a variety of information about a product, such as the ingredients, net weight, and nutrition facts.
"The food label is one of the most valuable tools consumers have," says Barbara Schneeman, Ph.D., Director of the Food and Drug Administration's (FDA's) Office of Nutrition, Labeling and Dietary Supplements. "The food label gives consumers the power to compare foods quickly and easily so they can judge for themselves which products best fit their dietary needs."
For example, someone with high blood pressure who needs to watch salt (sodium) intake may be faced with five different types of tomato soup on the shelf, says Schneeman. You can quickly and easily compare the sodium content of each product by looking at the part of the label that lists nutrition information (Nutrition Facts Label) to choose the one with the lowest sodium content.
FDA regulations require nutrition information to appear on most foods, and any claims on food products must be truthful and not misleading. In addition, "low sodium," "reduced fat," and "high fiber" must meet strict government definitions. FDA has defined other terms used to describe the content of a nutrient, such as "low," "reduced," "high," "free," "lean," "extra lean," "good source," "less," "light," and "more." So a consumer who wants to reduce sodium intake can be assured that the manufacturer of a product claiming to be "low sodium" or "reduced in sodium" has met these definitions.
But you don't have to memorize the definitions. Just look at the Nutrition Facts Label to compare the claims of different products with similar serving sizes.
Nutrient Highs and Lows
Most nutrients must be declared on the Nutrition Facts Label as "percent Daily Value" (%DV), which tells the percent of the recommended daily intake in a serving of that product and helps the consumer create a balanced diet. The %DV allows you to see at a glance if a product has a high or low amount of a nutrient. The rule of thumb is 20% DV or more is high and 5% DV or less is low.
Health experts recommend keeping your intake of saturated fat, trans fat, and cholesterol as low as possible because these nutrients may increase your risk for heart disease. This is where the %DV on the Nutrition Facts Label can be helpful, says Schneeman. There is no %DV for trans fat, but you can use the label to find out whether the saturated fat and cholesterol are high or low, she says. When comparing products, look at the total amount of saturated fat plus trans fat to find the one lowest in both of these types of fat.
For beneficial nutrients, like fiber or calcium, you can use the %DV to choose products that contain higher amounts. Research has shown that eating a diet rich in fiber may lower your chances of getting heart disease and some types of cancer. And eating foods containing calcium may help lower your risk of getting the bone-weakening disease, osteoporosis.
Confusing Claims
The terms "natural," "healthy," and "organic" often cause confusion. "Consumers seem to think that 'natural' and 'organic' imply 'healthy,'" says Schneeman. "But these terms have different meanings from a regulatory point of view."
According to FDA policy, "natural" means the product does not contain synthetic or artificial ingredients. "Healthy," which is defined by regulation, means the product must meet certain criteria that limit the amounts of fat, saturated fat, cholesterol, and sodium, and require specific minimum amounts of vitamins, minerals, or other beneficial nutrients.
Food labeled "organic" must meet the standards set by the Department of Agriculture (USDA). Organic food differs from conventionally produced food in the way it is grown or produced. But USDA makes no claims that organically produced food is safer or more nutritious than conventionally produced food.
For example, says Schneeman, "A premium ice cream could be 'natural' or 'organic' and still be high in fat or saturated fat, so would not meet the criteria for 'healthy.'"
Ask and You May Receive
Most packaged foods are required by law to carry nutrition labeling. This labeling is voluntary for many raw foods, such as fruits, vegetables, and fish. FDA encourages stores that sell raw foods to display or distribute, near these foods, nutrition information to shoppers. To make it easy for retailers, FDA has created colorful posters that can be downloaded and printed from its Web site. The posters show nutrition information for the 20 most frequently consumed raw fruits, vegetables, and fish in the United States.
"If the nutrition information is not displayed for these raw foods, we want consumers to ask, 'where's the nutrition information on your fresh products?'" says Camille Brewer, Deputy Director of FDA's Office of Nutrition, Labeling and Dietary Supplements. Industry responds to consumer demand, says Brewer. "Industry tells us all the time, 'if consumers ask, we'll give it to them.'"
FDA also encourages consumers to request nutrition information in full-service or fast-food restaurants. This information would help consumers make healthier choices outside the home, where Americans now spend nearly half of their total food budget, according to the National Restaurant Association and USDA's Economic Research Service.
Providing nutrition information for restaurant food is voluntary unless a nutrient content claim or a health claim is made for a menu item or meal. A nutrient content claim might be "low in fat," and a health claim might be "heart healthy." If such claims are made, the restaurant is required to give customers the appropriate nutrition information for these items when requested. This information does not have to be on the menu or on a menu board that's clearly visible to the consumer. The restaurant has the option of offering this information in various ways, such as in a brochure.
Many food service establishments have nutrition information for their offerings and will provide the information on the Internet or to customers who request it.
This article appears on FDA's Consumer Update page5, which features the latest on all FDA-regulated products.
Date Posted: March 27, 2008
Start at the Store: 7 Ways to Prevent Foodborne Illness
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm094535.htm
* Check for cleanliness
* Keep certain foods separated
* Inspect cans and jars
* Inspect frozen food packaging
* Select frozen foods and perishables last
* Choose fresh eggs carefully
* Be mindful of time and temperature
Safeguarding your home against foodborne illnesses begins not at home, but at the supermarket, grocery store, or any other place where you buy food that you plan to store and serve.
Combating foodborne illnesses is a top priority at the Food and Drug Administration (FDA). That's because, according to the Centers for Disease Control and Prevention (CDC), foodborne ailments cause about 325,000 hospitalizations and 5,200 deaths nationwide each year.
You as a consumer can play a key role in preventing these illnesses. While shopping for food, you should:
1. Check for cleanliness
Buying from a retailer who follows proper food handling practices helps assure that the food is safe. Ask yourself: What is the general impression of this facility? Does it look and smell clean?
2. Keep certain foods separated
Separate raw meat, poultry, and seafood from other foods in your grocery shopping cart. Place these foods in plastic bags to prevent their juices from dripping on other foods. It is also best to separate these foods from other foods at checkout and in your grocery bags.
3. Inspect cans and jars
Don't buy food in cans that are bulging or dented. Also, don't buy food in jars that are cracked or have loose or bulging lids.
Since foods sold in cans or jars are processed to be sterile, they can "keep" for a long time if the can or jar is intact. A bulging can or jar lid may mean the food was under-processed and is contaminated. A dent in a can, especially if the dent affects a seam, may cause an opening in the seam which may allow contamination, as would a crack in a jar. A loose lid on a jar means the vacuum has been lost and the product may be contaminated. Don't buy a food product whose seal seems tampered with or damaged.
4. Inspect frozen food packaging
Don't buy frozen food if the package is damaged. Packages should not be open, torn or crushed on the edges. Also, avoid packages that are above the frost line in the store's freezer. If the package cover is transparent, look for signs of frost or ice crystals. This could mean that the food in the package has either been stored for a long time or thawed and refrozen. In such cases, choose another package.
5. Select frozen foods and perishables last
Meat, poultry, fish and eggs should be the last items placed in your shopping cart. Always put these products in separate plastic bags so that drippings don't contaminate other foods.
6. Choose fresh eggs carefully
Before putting eggs in your cart, open the carton and make sure that the eggs are clean and none is cracked. Buy only refrigerated eggs and follow the "Safe Handling Instructions" on the carton.
7. Be mindful of time and temperature
It's important to refrigerate perishable products as soon as possible after grocery shopping. Food safety experts stress the "2-hour rule"—because harmful bacteria can multiply in the "danger zone" (between 40° and 140° F), perishable foods should not be left at room temperature longer than 2 hours. Modify that rule to 1 hour when temperatures are above 90° F, as they often are in cars that have been parked in the sun.
If it will take more than an hour to get your groceries home, use an ice chest to keep frozen and perishable foods cold. Also, when the weather is warm and you are using your car's air conditioner, keep your groceries in the passenger compartment, not the trunk.
This article appears on FDA's Consumer Update page5, which features the latest on all FDA-regulated products.
Date Posted: May 13, 2008
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For More Information
* Start at the Store: Prevent Foodborne Illness (video)6
* Inicio en la tienda: 7 maneras de prevenir las enfermedades de transmisión alimentaria7
* Eat for a Healthy Heart8
* Food Safety Tips for Healthy Holidays9
* Survey Shows Gains in Food-Label Use, Health/Diet Awareness10
* Reporting Problems to FDA (video)11
* Consumer Complaint Coordinators12
* USDA Food Safety and Inspection Service: Reporting Problems with Food Products13
* Bad Bug Book: Introduction14
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U.S. FDA Inspections, Compliance, Enforcement, and Criminal Investigations
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm215405.htm
Inspections, Compliance, Enforcement, and Criminal Investigations
Pfizer, Inc. 5/26/10
Department of Health and Human Services logoDepartment of Health and Human Services
Public Health Service
Food and Drug Administration
New York District
158-15 Liberty Ave.
Jamaica, NY 11433
May 26, 2010
WARNING LETTER NYK 2010-19
VIA UPS
Jeffrey B. Kindler
Chairman and Chief Executive Officer
Pfizer, Inc.
235 East 42nd Street
New York, NY 10017
Dear Mr. Kindler:
During the period from June 29, 2009 through August 10, 2009, an inspection was conducted by investigators of the U.S. Food and Drug Administration (FDA or Agency) of your firm located at 235 East 42nd Street, New York, NY to determine your firm's compliance with the Postmarketing Adverse Drug Experience (PADE) reporting requirements of Section 505(k) of the Federal Food, Drug, and Cosmetic Act (the Act)) [21 U.S.C. § 355(k)], and Title 21, Code of Federal Regulations (21 CFR) 314.80 and 314.81.
Section 505(k)(1) of the Act [21 U.S.C. § 355(k)(1)] and 21 CFR 314.80 and 314.81 require an applicant to establish and maintain records and to report data relating to clinical experience, along with other data or information, for drugs for which an approved application is in effect. Failure to comply with Section 505(k) is a prohibited act under Section 301(e) of the Act [21 U.S.C. § 331(e)].
I. Deviations from 21 CFR 314.80 and 21 CFR 314.81 include the following:
1. Failure to submit Adverse Drug Experience (ADE) reports to FDA as required by 21 CFR 314.80(c). Specifically:
(a) The following are examples of ADEs and information regarding ADEs that were not submitted to the FDA:
Report # Mfg. Report # Product Pfizer's Seriousness/Expectedness Determination Date Received by Pfizer
1. 2009236922 Dalacin (Clindamycin HCI) Serious outcome and failure to assess expectedness 05/04/09
2. 2009236510 Camptosar Serious/unexpected 12/11/08
3. 2009221607 Lyrica Serious outcome and failure to assess expectedness 06/01/09
4. 2009206349 Lipitor Serious/unexpected 04/29/09
We have reviewed your firm's response dated September 9, 2009, and have determined that it is inadequate. The response acknowledges that the above-listed reports contained serious and unexpected adverse events which were not submitted within 15 days to FDA. These reports were not submitted until they were identified during the FDA inspection. Your firm's rationale for the failure to submit these reports included a lack of file tracking control as well as a lack of adequate training in utilizing the (b)(4) system. Your firm received FDA Forms 483 on July 29, 2004 and April 18, 2006 for similar postmarketing adverse drug experience violations and your corrective actions for these observations, including training, have been shown to be ineffective. FDA expects drug manufacturers to establish and implement reasonable mechanisms to assure that all serious and unexpected experiences are promptly recorded and investigated to determine whether or not 15-day Alert reports should be submitted to FDA.
(b) FDA's Center for Drug Evaluation and Research, Division of Reproductive and Urologic Drug Products, sent you a letter dated July 14, 2005, requesting that "all manufacturers of PDE5 inhibitors for treatment of erectile dysfunction (ED) continue to submit serious reports of postmarketing ophthalmologic adverse events that might reflect non-arteritic ischemic optic neuropathy (NAION) as 15-day Alert reports." In your letter to FDA dated October 18, 2005, your firm committed to provide 15-day Alert reports for these reported outcomes.
Your firm failed to submit 15-day Alert reports for the following serious visual adverse events that met the postmarketing reporting requirement for Viagra (sildenafil citrate) by misclassifying and/or downgrading reports to non-serious without reasonable justification:
Mfg. Report No. Serious Outcome Date Received
1. 2009230915 "Lost right eye vision" 06/22/09
2. 2009187335 "Blindness" 03/19/09
3. 2009193299 "Blind in right eye" 03/27/09
4. 2009213305 "Decreased vision" 05/12/09
5. 2009213306 "Decreased vision" 05/12/09
6. 2009202206 "Decreased vision" 04/22/09
7. 2009179071 "Visual acuity loss" 02/26/09
8. 2008063424 "Visual acuity reduced" 07/24/08
9. 2008086429 "Decreased vision" 10/10/08
10. 2008055517 "Visual deficiency" 07/01&10/08
11. 2008071566 "Difficulty seeing" 8/25/08
We have reviewed your firm's response dated September 9, 2009 and have concluded that it is inadequate. Your response indicates that only four of the above reports contained serious and/or expected reports of postmarketing ophthalmologic adverse events requiring a 15-day Alert report. However, the remaining seven adverse events were deemed as non-serious although serious outcomes such as "visual acuity loss/reduction" were noted.
2. Inadequate written procedures for the surveillance, receipt, evaluation, and reporting of adverse events as required by 21 CFR 314.80(b). Specifically:
Your firm does not have adequate written procedures in place to ensure that adverse drug experiences are correctly identified, assessed, and reported to FDA in accordance with postmarketing commitments.
For fosphenytoin, in your firm's letter to FDA dated February 13, 2009, your firm agreed to develop and implement an effective plan which would include criteria to correctly identify, assess, and report cases that are not labeled as Purple Glove Syndrome (PGS), but that are suggestive of this syndrome in association with fosphenytoin sodium use. However, your firm failed to do so.
Your firm also agreed to train all pharmacovigilance staff in the worldwide affiliates by February 15, 2009. Training was to include an overview of PGS and specific directions regarding the process for expediting any adverse event reports involving fosphenytoin use to Drug Safety Surveillance (DSS).
Despite your agreement, only six out of the required sixty-three country offices worldwide were trained and some of the offices that were trained were not trained on time, including the core DSS offices. 1
Your firm's response dated September 9, 2009 remains inadequate because it fails to include an effective plan to identify cases suggestive of PGS and fails to require medical evaluation of reports suggestive of PGS. Additionally, provisions for adequate training and documentation of training were not provided.
3. Failure to submit adverse drug experiences that are both serious and unexpected to FDA 'within 15 calendar days of initial receipt of the information as required by 21 CFR 314.80(c) (1)(i). Specifically:
(a) During the time period of approximately March 1, 2006 through December 7, 2008, there were 80,560 15-day Alert Reports submitted to FDA by your firm, of which 3558 (4%) were late. Between December 8, 2008 through June 28, 2009, approximately 1508 (9%) were submitted late, a further decline in the timeliness of reporting.
The following are examples of ADE reports that contained serious and unexpected events, but were submitted late to FDA:
Mfg. Report No. Product Reason Late No. of Days Late
1. 2007039077 Lipitor Delay due to case processing/other 1141
2. 2007039077 Lipitor Delay due to resubmission 1102
3. 2007048456 Azithromycin Delay forwarding to safety site 687
4. 2008037900 Azithromycin Delay due to case revision 393
5. 2009229922 Amlodipine Besilate Delay due to clerical/data entry issue 438
6. 2008040787 Prostin VR Delay due to resubmission 285
7. 2009231444 Atorvastatin Calcium Delay forwarding to safety site 274
8. 2009212979 Epirubicin HCI Delay forwarding to safety site 728
9. 2009195911 Eplerenone Delay due to clerical/data entry issue 356
According to your firm's response, implementation of (b)(4) created problems for the timely submission of 15-day Alert reports. A review of the explanations for the late reports indicates reasons such as cases being initially identified as non-serious then upgraded to serious, user error in routing cases within the safety system, case distribution errors, case processing issues, and technical errors. The firm purports to have addressed these problems by updating user manuals, reinforcing training, additional prospective and retrospective quality review of cases, updating system configuration errors, and other unspecified corrective actions with supplying organizations and partners. Your response indicates reporting improved after May 2009 and that errors significantly declined once colleagues became more experienced with the new safety system. However, your firm's response did not include comparable metrics for the post-May 2009 time period. Although the Agency recognizes the benefits to implementing a new and improved computerized tracking system, such a system can only be an improvement if there is adequate staff to make accurate data entries and if the users are adequately trained in its implementation. Your firm's response also fails to address other factors that possibly contributed to the tardiness of the reports, including personnel training in the categorization of serious versus non-serious reports, training in use of the new (b)(4) system, development of SOPs, development of standardized documentation practices, and development of compliance metrics. A signed copy of your revised corrective action plan should be included in your response to this Warning Letter.
(b) On November 8, 2004, FDA granted a waiver to your firm allowing for serious and unexpected suspected adverse drug reactions for NDA 11-839 (Provera and medroxyprogesterone acetate) to be submitted no later than 30 calendar days of initial receipt of the information, instead of within 15 calendar days of receipt of the information. However, between June 8, 2005 and March 16, 2009, your firm failed to submit approximately 25 reports within 30 days. The following are examples of these late reports:
Mfg. Report No. No. of Days Late
1. 2009230289 1720
2. 2008151639 128
3. 2009200493 1641
The response comments addressed for item 3(a) also apply to this point.
(c) On August 28, 2006, FDA granted a waiver to your firm allowing for serious and unexpected suspected adverse drug reactions for Bextra (valdecoxib) to be submitted no later than 60 calendar days of initial receipt of the information, instead of within 15 calendar days of receipt of the information. The firm, however, failed to submit approximately 220 of these reports within 60 days. The following are examples of the late reports:
Mfg. report No. No. of Days Late
1. 2006153496 264
2. 2006134600 219
3. 2007046238 140
4. 2007002471 90
5. 2007098335 139
The response comments addressed for item 3(a) also apply to this point.
4. Failure to submit a 15-day Alert report for adverse drug experiences obtained from postmarketing studies in which the applicant concludes that there is a reasonable possibility that the drug caused the adverse experience, as required by 21 CFR 314.80(e)(1). Specifically:
Fifteen-day Alert reports have not been submitted for all adverse drug experiences during postmarketing studies where there is a reasonable possibility that the drug caused the adverse experience. In your firm's letter dated March 18, 2008, your firm committed to submit 15-day Alert reports for Selzentry (Maraviroc) for the following events during the postmarketing period: liver-related deaths and liver failure, fatal and non-fatal myocardial infarctions, and all non-AIDS defining malignancies. The following ADE reports for Selzentry (Maraviroc) from postmarketing studies were required to be submitted to FDA as 15-day Alert reports, because they either met these criteria described in the March 18, 2008 letter, or they otherwise contain serious and unexpected events in which there is a reasonable possibility that the drug caused the event.
Mfg. Report No.
1. 2009154994
2. 2009187951
3. 2007067649
4. 2007076241
5. 2005162672
6. 2006136607
7. 2008003965
Your response has been reviewed and found inadequate. In a letter to the Agency dated March 18, 2008, your firm acknowledged expedited 15-day reporting for liver-related deaths, liver failure, fatal and non-fatal myocardial infarctions and all non-AIDS defining malignancies from spontaneous and clinical trial sources. No reasons for late submission of reports 2006136607 and 2008003965 were provided in your response. Your response states that reports 2009154994, 2009187951, and 2005162672 were incorrectly not submitted due to errors in distribution. Your response further states that reports 2007067649 and 2007076241 were not submitted because they were received by the firm before clarification from the Agency advising that clinical trial cases were subject to special reporting requirements. However, after receipt of clarification that cases 2007067649 and 2007076241 were subject to reporting, your firm did not submit them to the Agency.
5. Serious and unexpected ADE reports are not promptly investigated as required by 21 CFR 314.80(c)(1)(ii). Specifically:
Adverse drug experiences that were the subject of postmarketing 15-day Alert reports were not investigated and/or documented. Specifically, in your firm's letter dated August 18, 2005, your firm submitted revised procedures to investigate all cases of postmarketing ophthalmologic ADEs that might reflect NAION involving Viagra. Your firm committed in these procedures to submit a pre-specified list of questions to reporters in order to obtain clinical and diagnostic information concerning visual symptoms and risk factors for the event. However, in cases reviewed during the inspection, your firm failed to provide documentation that adequate follow-up information had been requested. In addition, during the inspection, it was observed that some reports were either misclassified or downgraded in severity to non-serious without a reasonable justification.
Your response acknowledges that documentation of follow-up calls and the use of the questions during the calls were not handled consistently. Although the FDA does not mandate a particular method of requesting follow-up information, documentation that all postmarketing ophthalmologic events that might reflect NAION were investigated should be maintained.
6. Failure to submit 15-day Alert reports for serious adverse drug experiences as a non-applicant to the applicant within 5 calendar days of receipt as required by 21 CFR 314.80(c)(1) (iii).
Pfizer, as a non-applicant, elected to submit to the applicant (rather than to FDA) all reports of serious adverse drug experiences. However, you did not submit each report to the applicant within five calendar days of your receipt of the information.
Specifically, your firm's name is on the label of at least ten products (amoxicillin, finasteride, ondansetron, lamotrigine, metformin, penicillin V potassium, stavudine, tiotropium bromide, donepezil, interferon beta-la) for which you are required to submit serious ADE reports to the applicant within five calendar days. Of the 398 reports received by your firm for these products, 132 (33%) were sent to the applicants more than five calendar days after your receipt of them.
Your response acknowledged a need to improve on the timeliness of your submission of serious ADE reports to the applicants for products for which Pfizer does not hold the NDA or ANDA, but appears on the label as a distributor. Your response stated that activities such as targeted training and presentations have resulted in reporting timeframe improvement. However, a review of the overall time reporting for 5-day rule products in a time table provided to the investigators on July 9, 2009, for the period from December 8, 2008 to June 30, 2009, shows the contrary. As demonstrated by your report compiled for inspection entitled "5-Day Rule Products Sent to License Party between 08 Dec 2008 and 30 Jun 2009", there was a decline in the timeliness of reporting during this period.
7. Failure to promptly review all adverse drug experience information obtained or otherwise received by the applicant from any source as required by 21 CFR 314.80(b). Specifically:
Adverse drug experience information obtained or otherwise received from any source was not promptly reviewed, including information from commercial marketing experience and postmarketing epidemiological/surveillance activities.
The following are examples of serious ADEs that wvere not forwarded for case processing within 2-4 business days as required by your SOP AEM-01-02, dated July 14, 2008, pages 3 - 5:
Mfg. Report No. No. of Days Received Late
1. 2009202904 30
2. 2008150853 9
Your response provided an explanation for the lateness of these reports and stated that the firm has "robust quality processes in place to oversee performance ..." This response is deemed inadequate because your affiliates failed to comply with defined time fines for case processing as required by SOP AEM-01.
Your response commits the firm to implement "additional enhancements to tools enabling enhanced proactive management of case workload" to mitigate late reporting. A signed copy of your revised corrective action plan should be included in your response to this Warning Letter. Adequacy of the corrective action will be determined during subsequent inspection(s).
8. Failure to submit periodic adverse drug experience reports at quarterly intervals for each adverse drug experience which is not reported as a I5-day Alert report, for 3 years from the date of approval of the application, and then at annual intervals submitted within 60 days of the anniversary date of approval of the application as required by 21 CFR 314.80(c)(2). Specifically:
Individual ADEs which were not reported to FDA in a postmarketing IS-day Alert report have not been included in a periodic safety report.
Specifically, the following ADEs were not reported to FDA in a periodic safety report:
Mfg. Report No.
1. 2009189370
2. 2009205745
3. 2009206342
4. 2009211979
5. 2009178032
6. 2009186019
7. 2009152113
8. 2009166186
Your response to this observation reports a short term corrective action of nightly sweeps of the (b)(4) System with a permanent system correction to be implemented by the fourth quarter of 2009. Adequacy of the corrective action will be determined during subsequent follow-up inspection(s).
II. Deviations from 21 U.S.C. § 353(d) include the following:
In addition to the above violations of Postmarketing Adverse Drug Experience (PADE) reporting requirements, you have significant deviations from the requirements of Section 503(d) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 353(d)] and Title 21, Code of Federal Regulations, Part 203. Based on the information collected during the inspection, non-compliance with the requirements of the Prescription Drug Marketing Act (PDMA), include:
1. Failure to conduct an immediate investigation, to notify FDA within 5 working days, and provide written investigation reports within 30 days of initial notification of prescription drug sample thefts, significant losses, and falsification of prescription drug sample records as required by 21 CFR 203.37(a)(1),(2), and (3) and (b)(1), (2), and (3).
21 CFR 203.37(a)(1) and (b)(1) requires a manufacturer or authorized distributor of record to notify FDA within five working days of becoming aware of a significant loss, any known theft, or suspected falsification involving drug samples. 21 CFR 203.37(a)(2) and (b)(2) requires an immediate initiation of an investigation of a suspected significant loss, any known theft, or suspected falsification. 21 CFR 203.37(a)(3) and (b)(3) requires that FDA be provided with a complete written report, including the reason for and the results of the investigation, not later than 30 days after the date of the initial notification.
The FDA 483 observations concern Pfizer's failure to notify and follow up with FDA regarding significant losses, known thefts, or suspected falsifications in accordance with these PDMA legal requirements. Pfizer's response to the FDA 483 in this regard does not address how Pfizer will meet the Section 203.37 requirements. We recognize your intent to reduce the inventory period, but the reduction you describe would still not meet the five working day reporting requirement.
Examples of incidents of significant losses and confirmed variances in drug sample annual inventory reconciliation re orts that exceeded the established threshold for significant loss in Pfizer's SOP 010 (b)(4) that were not reported to FDA are as follows:
• Employee ID (b)(6) had a total inventory loss of approximately (b)(4) on July 17, 2009. At the time of inspection, FDA had not been notified.
• Employee ID (b)(6) had a possible theft of (b)(4) totaling a loss of (b)(4) on March 11, 2008. A police report was filed on May 13, 2008, yet Pfizer did not notify FDA until May 30, 2008.
• Employee ID (b)(6) had a variance of (b)(4) on Aug 19, 2008. FDA was not notified until approximately two months later.
2. Failure to conduct, at least annually, a complete and accurate physical inventory of all drug samples distributed and to record the results of such inventory as required by 21 CFR 203.31(d).
21 CFR 203.31 (d) requires that each drug manufacturer or authorized distributor of record that distributes drug samples by means of representatives shall conduct, at least annually, a complete and accurate physical inventory of all drug samples. All drug samples in the possession or control of each manufacturer's and distributor's representatives are required to be inventoried and the results of the inventory are required to be recorded in an inventory record. In addition, manufacturers and distributors shall reconcile the results of the physical inventory with the most recently completed prior physical inventory and create a report documenting the reconciliation process.
Annual inventory reconciliations are not conducted once a year as per your SOP 010. Specifically, out of 35 inventories reviewed by FDA, the following employees did not have their inventories taken annually:
Employee (b)(6)
Employee (b)(6)
Employee (b)(6)
Employee (b)(6)
Employee (b)(6)
Employee (b)(6)
Employee (b)(6)
Employee (b)(6)
Employee (b)(6)
Employee (b)(6)
Employee (b)(6)
Employee (b)(6)
Employee (b)(6)
Employee (b)(6)
Your response relays the intent to revise SOP 010 to assure that all future employee inventories are performed within 12 months from the initial inventory review rather than once each calendar year. However, we have not yet received your revised SOP and you have not addressed the status of inventories for the above employees. Therefore, the adequacy of your response cannot be determined.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your firm. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, prosecution or injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts. Additionally, FDA may withhold approval of requests for export certificates, or approval of pending new drug applications, listing your facility as a supplier or manufacturer until the above violations are corrected. A reinspection may be necessary.
You should notify this office upon receipt of this letter to arrange for a meeting to discuss the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to prevent the recurrence of similar violations. If corrective action cannot be completed within 15 working days, state the reason for delay and the time within which corrections will be completed.
Your reply should be sent to Compliance Branch, Food and Drug Administration, 158-15 Liberty Avenue, Jamaica, NY 11433 Attention: Lillian C. Aveta, Compliance Officer.
Sincerely,
/S/
Ronald M. Pace
District Director
New York District
1 The Milan office, which is one of the core DSS offices, was not trained until July 2009.
Enclosure: Form FDA 483 dated August 10, 2009
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Page Last Updated: 06/14/2010
CPSC Launches National Campaign to Change the Way People Think and Act about Pool and Spa Safety
Pool Safely Campaign Aims to Reduce Child Drownings and Entrapments
http://www.cpsc.gov/cpscpub/prerel/prhtml10/10241.html
FORT LAUDERDALE, FL - The U.S. Consumer Product Safety Commission (CPSC) today kicks-off the Pool Safely campaign (www.poolsafely.gov), a first-of-its-kind national public education effort to reduce child drownings and non-fatal submersions, and entrapments in swimming pools and spas. At a press conference at the Fort Lauderdale Aquatic Complex today, Olympic swimmers Jason Lezak and Janet Evans joined Inez Tenenbaum, Chairman of the CPSC; U.S. Rep. Debbie Wasserman Schultz (D-FL); and Nancy Baker, mother of Virginia Graeme Baker, to officially launch Pool Safely and release the CPSC's annual submersion and entrapment reports.
The Pool Safely campaign is a key part of the CPSC's efforts to carry out the requirements of Section 1407 of the Virginia Graeme Baker Pool and Spa Safety Act (P&SS Act), federal legislation signed into law in 2007 mandating new requirements for pool and spa safety. It includes a requirement for a national public education campaign designed to raise public awareness, support industry compliance, and improve safety at pools and spas.
"I have been involved in the issue of pool safety throughout my career and today marks a key milestone in the ongoing fight to reduce accidental drowning," said Congresswoman Debbie Wasserman Schultz, author of the Virginia Graeme Baker Pool and Spa Safety Act. "Educating communities on the potential dangers of swimming pools is a critical tool in saving the lives of our children. I am so pleased to have worked with my colleagues in Congress to provide the funds needed for implementation of this important campaign."
The Pool Safely campaign will deliver an important and simple message: just adding an extra safety step in and around the water can make all the difference. Your greatest water safety assurance comes from adopting and practicing as many water safety measures as possible, including: barriers that completely surround the pool with self-closing, self-latching gates; staying close, being alert, and watching children at the pool; learning and practicing water safety skills (knowing how to swim and perform CPR); and having the appropriate equipment (compliant drain covers, alarms, barriers and sensors).
The campaign will highlight the need to implement a "personal system of safety" that consists of adding as many proven water safety practices as possible in and around pools and spas.
"As a parent of young children, I know there's no single, sure-fire way to ensure their safety around pools and spas," added Janet Evans, five-time Olympic medalist in swimming. "Whether it's enrolling them in swimming lessons or simply watching them at all times, there is always one more thing I can do. The Pool Safely campaign offers a variety of simple steps we can all take to protect our children in pools and spas."
Pool Safely will serve as an information hub delivering campaign tools and resources to various outreach channels. CPSC has taken the lead by partnering with national, regional and local organizations in the children's safety and drowning prevention communities. By engaging key partners, the campaign will reach the widest possible audience and build a sustainable network that will ensure the campaign's messaging is delivered for years to come.
"Knowing how to swim helped me win gold in the water, but it takes adding as many water safety steps as possible to ensure a safe environment for children in and around pools and spas, " said seven-time Olympic medalist in swimming Jason Lezak. "No matter how responsible you already are, there is always one more safety step you can take to protect your child. That is how you can Pool Safely. "
"I understand the need to bring together the public and dedicated partners in the water safety community to begin a national conversation about water safety," said Nancy Baker, the mother of Virginia Graeme for whom the Act is named. "I am honored to be involved in the Pool Safely campaign and look forward to working together to promote additional water safety steps we all can take in protecting our loved ones in and around pools and spas. Simple steps save lives."
The Pool Safely campaign - a national public education effort by the Consumer Product Safety Commission - is proud to partner with leading organizations, including American Red Cross, YMCA of the USA, Safe Kids USA, National Drowning Prevention Alliance (NDPA), World Waterpark Association (WWA), and Abbey's Hope. For more information, visit the website at www.poolsafely.gov or follow the campaign on Twitter @poolsafely
http://www.poolsafely.gov/
# Drowning is preventable, especially among children. http://www.poolsafely.gov/ #poolsafely #pools 2 days ago
http://www.ready.gov/america/getakit/seniors.html
Disaster Preparedness for Older People
Each person's needs and abilities are unique, but every individual can take important steps to prepare for all kinds of emergencies and put plans in place. By evaluating your own personal needs and making an emergency plan, you can be better prepared for any situation. A commitment to planning today will help you prepare for any emergency situation. Preparing makes sense. Get ready now.
* Consider how a disaster might affect your individual needs.
* Plan to make it on your own, at least for a period of time. It's possible that you will not have access to a medical facility or even a drugstore.
* Identify what kind of resources you use on a daily basis and what you might do if they are limited or not available.
* Get an emergency supply kit.
* If you must evacuate, take your pets with you, if possible. However, if you are going to a public shelter, it is important to understand that animals may not be
allowed inside.
* Plan in advance for shelter alternatives that will work for both you and your pets; consider loved ones or friends outside of your immediate area who would be
willing to host you and your pets in an emergency.
*
Create a Support Network
* If you anticipate needing assistance during a disaster talk to family, friends and others who will be part of your personal support network.
* Write down and share each aspect of your emergency plan with everyone in your support network.
* Make sure everyone knows how you plan to evacuate your home or workplace and where you will go in case of a disaster.
* Make sure that someone in your local network has an extra key to your home and knows where you keep your emergency supplies.
* Teach those who will help you how to use any lifesaving equipment, administer medicine in case of an emergency.
* Practice your plan with those who have agreed to be part of your network.
Additional Supplies and Documents:
Medications and Medical Supplies
If you take medicine or use a medical treatment on a daily basis, be sure you have what you need to make it on your own for at least a week, maybe longer.
* Make a list of prescription medicines including dosage, treatment and allergy information.
* Talk to your pharmacist or doctor about what else you need to prepare.
* If you undergo routine treatments administered by a clinic or hospital or if you receive regular services such as home health care, treatment or transportation, talk to your service provider about their emergency plans. Work with them to identify back-up service providers and incorporate them into your personal support network.
* Consider other personal needs such as eyeglasses, hearing aids and hearing aid batteries, wheelchair batteries, and oxygen.
Emergency Documents
Include copies of important documents in your emergency supply kits such as family records, medical records, wills, deeds, social security number, charge and bank accounts information and tax records.
* Have copies of your medical insurance and Medicare cards readily available.
* Keep a list of the style and serial number of medical devices or other life-sustaining devices. Include operating information and instructions.
* Make sure that a friend or family member has copies of these documents.
* Include the names and contact information of your support network, as well as your medical providers.
* If you have a communication disability, make sure your emergency information notes the best way to communicate with you.
* Keep these documents in a water proof container for quick and easy access.
More Information
For more information, see Disaster Preparedness For People With Disabilities Adobe Acrobat Reader Required from FEMA, and the Red Cross website.
On June 23, 2010 at SM Megamall, Mandaluyong, Metro Manila:
security guards at entrance to BPI bank branch at said maii,didn't inspect/subject to scanning with metal detector luggage.
Said luggage was large enough to contain grenades and firearms.
The following stores at said mall didn't have required express lanes for senior citizens: Chow King, Jollibee, NT computer.
I believe said stores violated the Expanded Senior Citizens Act of 2003.
http://www.cdc.gov/family/checkuplist/index.htm
Check-Up Checklist: Things to Do Before Your Next Check-Up
Getting check-ups is one of many things you can do to help stay healthy and prevent disease and disability.
You’ve made the appointment to see your health care provider.
You’ve reviewed the instructions on how to prepare for certain tests.
You’ve done the usual paperwork.
Done, right?
Not quite.
Before your next check-up, make sure you do these four things.
Review your family health history.
Are there any new conditions or diseases that have occurred in your close relatives since your last visit? If so, let your health care provider know. Family history might influence your risk of developing heart disease, stroke, diabetes, or cancer. Your provider will assess your risk of disease based on your family history and other factors. Your provider may also recommend things you can do to help prevent disease, such as exercising more, changing your diet, or using screening tests to help detect disease early.
Find out if you are due for any general screenings or vaccinations.
Have you had the recommended screening tests based on your age, general health, family history, and lifestyle? Check with your health care provider to see if its time for any vaccinations, follow-up exams, or tests. For example, it might be time for you to get a Pap test, mammogram, prostate cancer screening, colon cancer screening, sexually transmitted disease screening, blood pressure check, tetanus shot, eye check, or other screening.
Write down a list of issues and questions to take with you.
Review any existing health problems and note any changes.
* Have you noticed any body changes, including lumps or skin changes?
* Are you having pain, dizziness, fatigue, problems with urine or stool, or menstrual cycle changes?
* Have your eating habits changed?
* Are you experiencing depression, anxiety, trauma, distress, or sleeping problems?
If so, note when the change began, how it’s different from before, and any other observation that you think might be helpful.
Be honest with your provider. If you haven’t been taking your medication as directed, exercising as much, or anything else, say so. You may be at risk for certain diseases and conditions because of how you live, work, and play. Your provider develops a plan based partly on what you say you do. Help ensure that you get the best guidance by providing the most up-to-date and accurate information about you.
Be sure to write your questions down beforehand. Once you’re in the office or exam room, it can be hard to remember everything you want to know. Leave room between questions to write down your provider’s answers.
Consider your future.
Are there specific health issues that need addressing concerning your future? Are you thinking about having infertility treatment, losing weight, taking a hazardous job, or quitting smoking? Discuss any issues with your provider so that you can make better decisions regarding your health and safety.
Mcneil Consumer Healthcare Recalls Four Product Lots of Benadryl® Allergy Ultratab™ Tablets, 100 Count, and One Product Lot of Extra Strength Tylenol® Rapid Release Gels, 50 Count
http://www.fda.gov/Safety/Recalls/ucm215921.htm
FOR IMMEDIATE RELEASE - Fort Washington, PA - June 15, 2010 - McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is recalling five product lots as an addition to the list of products included in the company’s January 15th, 2010 product recall. The additional lots involved are four product lots of BENADRYL® ALLERGY ULTRATAB™ TABLETS, 100 count, sold in the U.S.; and one product lot of EXTRA STRENGTH TYLENOL® Rapid Release Gels, 50 count sold in the U.S., Trinidad and Tobago, Bermuda, and Puerto Rico (FULL RECALLED PRODUCT LIST BELOW). This recall is a follow-up to the product recall that McNeil Consumer Healthcare announced on January 15th, 2010 and is being taken because the products were inadvertently omitted from the initial recall action. McNeil Consumer Healthcare identified the omission and informed the U.S. Food and Drug Administration (FDA) of its decision to add these product lots to the recall list. All these products were produced before the January 15th, 2010 recall. Since January, McNeil Consumer Healthcare has continued to analyze and evaluate 2,4,6-tribromoanisole (TBA) and has shared that information with the FDA. This further analysis confirms that the risk of serious adverse medical events is remote. This recall is being conducted with the knowledge of the FDA.
BENADRYL® ALLERGY ULTRATAB™ TABLETS is sold over-the-counter and is indicated for the relief of allergy associated symptoms such as sneezing, runny nose, itchy throat, and itchy and watery eyes. EXTRA STRENGTH TYLENOL® Rapid Release Gels is sold over-the-counter and is indicated for the temporary reduction of fever and for the temporary relief of minor aches and pains due to headache, muscular aches, backache, minor arthritis pain, the common cold, toothache, pre-menstrual and menstrual cramps, and flu.
The January 15th, 2010 recall was initiated as a result of consumer complaints of a musty or moldy odor that has since been linked to the presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA). After a thorough investigation, it was determined that the source of TBA was the result of a breakdown of a chemical that is applied to wood used to build wooden pallets that transport and store product packaging materials.
Consumers who purchased product from the lots included in this recall should stop using the product and contact McNeil Consumer Healthcare for instructions on a refund or replacement. For these instructions or information regarding how to return or dispose of the product, consumers should log on to the internet at www.mcneilproductrecall.com1 or call 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time). Requests for reimbursement can be made at www.mcneilproductrecall.com2. Consumers who have medical concerns or questions should contact their healthcare provider.
Any adverse reactions may also be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at http:www.fda.gov/safety/medwatch/default.htm.
The product lot numbers for the recalled products can be found on the side of the bottle label.
FULL RECALLED PRODUCT LIST:
Product Name Product Form Lot Number NDC Number UPC Code
BENADRYL Allergy ULTRATAB Tablets 100 count Ultratab Tablet AJA008, ADA194, ABA022, ABA264 50580-226-10 312547170338
EXTRA STRENGTH Tylenol Rapid Release Gels 50 count Rapid Release Gelcap ASA202 50580-488-50 300450488503
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Page Last Updated: 06/17/2010
CPSC Announces International Initiative for Strong Safety Standards on Window Coverings
http://www.cpsc.gov/cpscpub/prerel/prhtml10/10265.html
NEWS from CPSC
U.S. Consumer Product Safety Commission
Office of Information and Public Affairs Washington, DC 20207
FOR IMMEDIATE RELEASE
June 17, 2010
Release #10-265 CPSC Recall Hotline: (800) 638-2772
CPSC Media Contact: (301) 504-7908
CPSC Announces International Initiative for Strong Safety Standards on Window Coverings
WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission (CPSC), Health Canada and the European Commission’s Directorate General for Health and Consumers (DG SANCO) have joined together to call for strong and comprehensive international safety standards on window coverings from manufacturers and standards organizations.
This international, multi-lateral call for immediate action (pdf) is the first time the three safety agencies, representing consumers in 29 countries, have joined together to demand strong worldwide safety standards on a specific product.
A coordinated effort by the three safety agencies and standards organizations in the U.S., Canada and Europe could lead to cost-effective product development and testing and manufacturing processes in the global economy while putting the safety of children first.
Corded window coverings cause strangulation deaths and significant injuries in children worldwide. In the United States, CPSC staff is aware of 120 fatalities and 113 non-fatal incidents related to corded window coverings since 1999. Health Canada has received reports of 28 strangulation deaths and 23 near-strangulations linked to corded window coverings since 1986. In seven Member States of Europe, 90 children were reported to have visited hospital emergency departments for injuries caused by corded window coverings in 2002. More recently, at least six children in Europe have died from corded window coverings since 2008.
Since December 2009, CPSC has recalled tens of millions of corded Roman shades and roll-up blinds sold by a variety of manufacturers and retailers. These window coverings pose a serious risk of strangulation to young children. CPSC continues to urge parents and caregivers to make sure that there are no accessible cords on the front, side or back of their window coverings.
CPSC recommends the use of cordless window coverings in all homes where children live or visit.
Eating Outdoors, Handling Food Safely
http://www.fda.gov/Food/ResourcesForYou/Consumers/ucm109899.htm
Food Facts
* Pack and Transport Food Safely
* Quick Tips for Picnic Site Prep
* Follow Safe Grilling Tips
* Serving Picnic Food: Keep it Cold/Hot
Picnic and barbecue season offers lots of opportunities for outdoor fun with family and friends. But these warm weather events also present opportunities for foodborne bacteria to thrive. As food heats up in summer temperatures, bacteria multiply rapidly.
To protect yourself, your family, and friends from foodborne illness during warm-weather months, safe food handling when eating outdoors is critical. Read on for simple food safety guidelines for transporting your food to the picnic site, and preparing and serving it safely once you've arrived.
coolers and picnic equipment
Pack and Transport Food Safely
Keep your food safe: from the refrigerator/freezer . . .
all the way to the picnic table.
Quick Tips for Picnic Site Prep
Food safety begins with proper hand cleaning — including outdoor settings. Before you begin setting out your picnic feast, make sure hands and surfaces are clean.
* Outdoor Hand Cleaning: If you don’t have access to running water, simply use a water jug, some soap, and paper towels. Or, consider using moist disposable towelettes for cleaning your hands.
* Utensils and Serving Dishes: Take care to keep all utensils and platters clean when preparing food.
* Keep cold food cold. Place cold food in a cooler with ice or frozen gel packs. Cold food should be stored at 40°F or below to prevent bacterial growth. Meat, poultry, and seafood may be packed while still frozen so that they stay colder longer.
* Organize cooler contents. Consider packing beverages in one cooler and perishable foods in another. That way, as picnickers open and reopen the beverage cooler to replenish their drinks, the perishable foods won’t be exposed to warm outdoor air temperatures.
* Keep coolers closed. Once at the picnic site, limit the number of times the cooler is opened as much as you can. This helps to keep the contents cold longer.
* Don’t cross-contaminate. Be sure to keep raw meat, poultry, and seafood securely wrapped. This keeps their juices from contaminating prepared/cooked foods or foods that will be eaten raw, such as fruits and vegetables.
* Clean your produce. Rinse fresh fruits and vegetables under running tap water before packing them in the cooler - including those with skins and rinds that are not eaten. Rub firm-skinned fruits and vegetables under running tap water or scrub with a clean vegetable brush while rinsing with running tap water. Dry fruits and vegetables with a clean cloth towel or paper towel.
— Packaged fruits and vegetables that are labeled "ready-to-eat," "washed," or "triple washed" need not be washed.
Safe Food Temperature Chart Food Temperature
Steaks and roasts 145°F
Fish 145°F
Pork 160°F
Ground beef 160°F
Egg dishes 160°F
Chicken breasts 165°F
Whole poultry 165°F
Shrimp, lobster, and crabs cook until pearly and opaque
Clams, oysters, and mussels cook until the shells are open
Follow Safe Grilling Tips
Grilling and picnicking often go hand-in-hand. And just as with cooking indoors, there are important guidelines that should be followed to ensure that your grilled food reaches the table safely.
* Marinate safely. Marinate foods in the refrigerator - never on the kitchen counter or outdoors. In addition, if you plan to use some of the marinade as a sauce on the cooked food, reserve a portion separately before adding the raw meat, poultry, or seafood. Don’t reuse marinade.
* Cook immediately after "partial cooking." If you partially cook food to reduce grilling time, do so immediately before the food goes on the hot grill.
* Cook food thoroughly. When it’s time to cook the food, have your food thermometer ready. Always use it to be sure your food is cooked thoroughly.
* Keep "ready" food hot. Grilled food can be kept hot until served by moving it to the side of the grill rack, just away from the coals. This keeps it hot but prevents overcooking.
* Don't reuse platters or utensils. Using the same platter or utensils that previously held raw meat, poultry, or seafood allows bacteria from the raw food’s juices to spread to the cooked food. Instead, have a clean platter and utensils ready at grill-side to serve your food.
Serving Picnic Food: Keep it COLD / HOT
Keeping food at proper temperatures - indoor and out - is critical in preventing the growth of foodborne bacteria. The key is to never let your picnic food remain in the "Danger Zone" - between 40° F and 140° F - for more than 2 hours, or 1 hour if outdoor temperatures are above 90° F. This is when bacteria in food can multiply rapidly, and lead to foodborne illness.
Instead, follow these simple rules for keeping cold foods cold and hot foods hot.
Platter Warning:
person in apron cleaning a bowl
Prevent "Cross-Contamination" When Serving
Never reuse a plate or utensils that previously held raw meat, poultry, or seafood for serving — unless they’ve been washed first in hot, soapy water. Otherwise, you can spread bacteria from the raw juices to your cooked or ready-to-eat food.
This is particularly important to remember when serving cooked foods from the grill.
COLD FOOD
Cold perishable food should be kept in the cooler at 40° F or below until serving time.
* Once you've served it, it should not sit out for longer than 2 hours, or 1 hour if the outdoor temperature is above 90° F. If it does - discard it.
* Foods like chicken salad and desserts in individual serving dishes can be placed directly on ice, or in a shallow container set in a deep pan filled with ice. Drain off water as ice melts and replace ice frequently.
HOT FOOD
Hot food should be kept hot, at or above 140° F.
* Wrap it well and place it in an insulated container until serving.
* Just as with cold food - these foods should not sit out for more than 2 hours, or 1 hour in temperatures above 90° F. If food is left out longer, throw it away to be safe.
Everyone can practice safe food handling
by following these four simple steps:
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Page Last Updated: 06/19/2009
FDA: Pfizer Voluntarily Withdraws Cancer Treatment Mylotarg from U.S. Market
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm216448.htm
FDA NEWS RELEASE
For Immediate Release: June 21, 2010
Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA: Pfizer Voluntarily Withdraws Cancer Treatment Mylotarg from U.S. Market
Pfizer Inc. today announced the voluntary withdrawal from the U.S. market of the drug Mylotarg (gemtuzumab ozogamicin) for patients with acute myeloid leukemia (AML), a bone marrow cancer. The company took the action at the request of the U.S. Food and Drug Administration after results from a recent clinical trial raised new concerns about the product’s safety and the drug failed to demonstrate clinical benefit to patients enrolled in trials.
Mylotarg was approved in May 2000 under the FDA’s accelerated approval program. This program allows the agency to approve a drug to treat serious diseases with an unmet medical need based on a surrogate endpoint – a laboratory measurement or a physical sign used as a substitute for a clinically meaningful endpoint that directly measures how a patient feels, functions, or survives.
Under accelerated approval, the company is required to conduct additional clinical trials after approval to confirm the drug’s benefit. If those trials fail to confirm clinical benefit to patients, or if the company does not pursue the required confirmatory trials with due diligence, the FDA can withdraw the drug from the market using expedited procedures.
Mylotarg was approved to treat patients ages 60 years and older with recurrent AML who were not considered candidates for other chemotherapy. The initial approval was based on the surrogate endpoint of response rate (i.e., the percentage of patients whose leukemia decreased or disappeared in laboratory tests), observed in 142 patients with AML across three clinical trials.
A confirmatory, post approval clinical trial was begun by Wyeth (now Pfizer) in 2004. The trial was designed to determine whether adding Mylotarg to standard chemotherapy demonstrated an improvement in clinical benefit (survival time) to AML patients. The trial was stopped early when no improvement in clinical benefit was observed, and after a greater number of deaths occurred in the group of patients who received Mylotarg compared with those receiving chemotherapy alone.
At initial approval, Mylotarg was associated with a serious liver condition called veno-occlusive disease, which can be fatal. This rate has increased in the postmarket setting.
“Mylotarg was granted an accelerated approval to allow patient access to what was believed to be a promising new treatment for a devastating form of cancer,” said Richard Pazdur, M.D., director, Office of Oncology Drug Products, part of FDA’s Center for Drug Evaluation and Research. “However, a confirmatory clinical trial and years of postmarketing experience with the product have not shown evidence of clinical benefit in patients with AML.”
As a result of the withdrawal, Mylotarg will not be commercially available to new patients. Patients who are currently receiving the drug may complete their therapy following consultation with their health care professional. Health care professionals should inform all patients receiving Mylotarg of the product’s potential safety risks.
Following the withdrawal, any future use of Mylotarg in the United States will require submission of an investigational new drug application to FDA.
Mylotarg is manufactured by New York City-based Pfizer.
For more information:
Pfizer: Mylotarg Withdrawal
FDA: Access to Investigational Drugs
FDA: Office of Oncology Drug Products
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Page Last Updated: 06/21/2010
Food Label Helps Consumers Make Healthier Choices
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm094536.htm
* Nutrient Highs and Lows
* Confusing Claims
* Ask and You May Receive
* For More Information
Consumers often compare prices of food items in the grocery store to choose the best value for their money. But comparing items using the food label can help them choose the best value for their health.
The food label identifies a variety of information about a product, such as the ingredients, net weight, and nutrition facts.
"The food label is one of the most valuable tools consumers have," says Barbara Schneeman, Ph.D., Director of the Food and Drug Administration's (FDA's) Office of Nutrition, Labeling and Dietary Supplements. "The food label gives consumers the power to compare foods quickly and easily so they can judge for themselves which products best fit their dietary needs."
For example, someone with high blood pressure who needs to watch salt (sodium) intake may be faced with five different types of tomato soup on the shelf, says Schneeman. You can quickly and easily compare the sodium content of each product by looking at the part of the label that lists nutrition information (Nutrition Facts Label) to choose the one with the lowest sodium content.
FDA regulations require nutrition information to appear on most foods, and any claims on food products must be truthful and not misleading. In addition, "low sodium," "reduced fat," and "high fiber" must meet strict government definitions. FDA has defined other terms used to describe the content of a nutrient, such as "low," "reduced," "high," "free," "lean," "extra lean," "good source," "less," "light," and "more." So a consumer who wants to reduce sodium intake can be assured that the manufacturer of a product claiming to be "low sodium" or "reduced in sodium" has met these definitions.
But you don't have to memorize the definitions. Just look at the Nutrition Facts Label to compare the claims of different products with similar serving sizes.
Nutrient Highs and Lows
Most nutrients must be declared on the Nutrition Facts Label as "percent Daily Value" (%DV), which tells the percent of the recommended daily intake in a serving of that product and helps the consumer create a balanced diet. The %DV allows you to see at a glance if a product has a high or low amount of a nutrient. The rule of thumb is 20% DV or more is high and 5% DV or less is low.
Health experts recommend keeping your intake of saturated fat, trans fat, and cholesterol as low as possible because these nutrients may increase your risk for heart disease. This is where the %DV on the Nutrition Facts Label can be helpful, says Schneeman. There is no %DV for trans fat, but you can use the label to find out whether the saturated fat and cholesterol are high or low, she says. When comparing products, look at the total amount of saturated fat plus trans fat to find the one lowest in both of these types of fat.
For beneficial nutrients, like fiber or calcium, you can use the %DV to choose products that contain higher amounts. Research has shown that eating a diet rich in fiber may lower your chances of getting heart disease and some types of cancer. And eating foods containing calcium may help lower your risk of getting the bone-weakening disease, osteoporosis.
Confusing Claims
The terms "natural," "healthy," and "organic" often cause confusion. "Consumers seem to think that 'natural' and 'organic' imply 'healthy,'" says Schneeman. "But these terms have different meanings from a regulatory point of view."
According to FDA policy, "natural" means the product does not contain synthetic or artificial ingredients. "Healthy," which is defined by regulation, means the product must meet certain criteria that limit the amounts of fat, saturated fat, cholesterol, and sodium, and require specific minimum amounts of vitamins, minerals, or other beneficial nutrients.
Food labeled "organic" must meet the standards set by the Department of Agriculture (USDA). Organic food differs from conventionally produced food in the way it is grown or produced. But USDA makes no claims that organically produced food is safer or more nutritious than conventionally produced food.
For example, says Schneeman, "A premium ice cream could be 'natural' or 'organic' and still be high in fat or saturated fat, so would not meet the criteria for 'healthy.'"
Ask and You May Receive
Most packaged foods are required by law to carry nutrition labeling. This labeling is voluntary for many raw foods, such as fruits, vegetables, and fish. FDA encourages stores that sell raw foods to display or distribute, near these foods, nutrition information to shoppers. To make it easy for retailers, FDA has created colorful posters that can be downloaded and printed from its Web site. The posters show nutrition information for the 20 most frequently consumed raw fruits, vegetables, and fish in the United States.
"If the nutrition information is not displayed for these raw foods, we want consumers to ask, 'where's the nutrition information on your fresh products?'" says Camille Brewer, Deputy Director of FDA's Office of Nutrition, Labeling and Dietary Supplements. Industry responds to consumer demand, says Brewer. "Industry tells us all the time, 'if consumers ask, we'll give it to them.'"
FDA also encourages consumers to request nutrition information in full-service or fast-food restaurants. This information would help consumers make healthier choices outside the home, where Americans now spend nearly half of their total food budget, according to the National Restaurant Association and USDA's Economic Research Service.
Providing nutrition information for restaurant food is voluntary unless a nutrient content claim or a health claim is made for a menu item or meal. A nutrient content claim might be "low in fat," and a health claim might be "heart healthy." If such claims are made, the restaurant is required to give customers the appropriate nutrition information for these items when requested. This information does not have to be on the menu or on a menu board that's clearly visible to the consumer. The restaurant has the option of offering this information in various ways, such as in a brochure.
Many food service establishments have nutrition information for their offerings and will provide the information on the Internet or to customers who request it.
This article appears on FDA's Consumer Update page5, which features the latest on all FDA-regulated products.
Date Posted: March 27, 2008
Start at the Store: 7 Ways to Prevent Foodborne Illness
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm094535.htm
* Check for cleanliness
* Keep certain foods separated
* Inspect cans and jars
* Inspect frozen food packaging
* Select frozen foods and perishables last
* Choose fresh eggs carefully
* Be mindful of time and temperature
Safeguarding your home against foodborne illnesses begins not at home, but at the supermarket, grocery store, or any other place where you buy food that you plan to store and serve.
Combating foodborne illnesses is a top priority at the Food and Drug Administration (FDA). That's because, according to the Centers for Disease Control and Prevention (CDC), foodborne ailments cause about 325,000 hospitalizations and 5,200 deaths nationwide each year.
You as a consumer can play a key role in preventing these illnesses. While shopping for food, you should:
1. Check for cleanliness
Buying from a retailer who follows proper food handling practices helps assure that the food is safe. Ask yourself: What is the general impression of this facility? Does it look and smell clean?
2. Keep certain foods separated
Separate raw meat, poultry, and seafood from other foods in your grocery shopping cart. Place these foods in plastic bags to prevent their juices from dripping on other foods. It is also best to separate these foods from other foods at checkout and in your grocery bags.
3. Inspect cans and jars
Don't buy food in cans that are bulging or dented. Also, don't buy food in jars that are cracked or have loose or bulging lids.
Since foods sold in cans or jars are processed to be sterile, they can "keep" for a long time if the can or jar is intact. A bulging can or jar lid may mean the food was under-processed and is contaminated. A dent in a can, especially if the dent affects a seam, may cause an opening in the seam which may allow contamination, as would a crack in a jar. A loose lid on a jar means the vacuum has been lost and the product may be contaminated. Don't buy a food product whose seal seems tampered with or damaged.
4. Inspect frozen food packaging
Don't buy frozen food if the package is damaged. Packages should not be open, torn or crushed on the edges. Also, avoid packages that are above the frost line in the store's freezer. If the package cover is transparent, look for signs of frost or ice crystals. This could mean that the food in the package has either been stored for a long time or thawed and refrozen. In such cases, choose another package.
5. Select frozen foods and perishables last
Meat, poultry, fish and eggs should be the last items placed in your shopping cart. Always put these products in separate plastic bags so that drippings don't contaminate other foods.
6. Choose fresh eggs carefully
Before putting eggs in your cart, open the carton and make sure that the eggs are clean and none is cracked. Buy only refrigerated eggs and follow the "Safe Handling Instructions" on the carton.
7. Be mindful of time and temperature
It's important to refrigerate perishable products as soon as possible after grocery shopping. Food safety experts stress the "2-hour rule"—because harmful bacteria can multiply in the "danger zone" (between 40° and 140° F), perishable foods should not be left at room temperature longer than 2 hours. Modify that rule to 1 hour when temperatures are above 90° F, as they often are in cars that have been parked in the sun.
If it will take more than an hour to get your groceries home, use an ice chest to keep frozen and perishable foods cold. Also, when the weather is warm and you are using your car's air conditioner, keep your groceries in the passenger compartment, not the trunk.
This article appears on FDA's Consumer Update page5, which features the latest on all FDA-regulated products.
Date Posted: May 13, 2008
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For More Information
* Start at the Store: Prevent Foodborne Illness (video)6
* Inicio en la tienda: 7 maneras de prevenir las enfermedades de transmisión alimentaria7
* Eat for a Healthy Heart8
* Food Safety Tips for Healthy Holidays9
* Survey Shows Gains in Food-Label Use, Health/Diet Awareness10
* Reporting Problems to FDA (video)11
* Consumer Complaint Coordinators12
* USDA Food Safety and Inspection Service: Reporting Problems with Food Products13
* Bad Bug Book: Introduction14
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U.S. FDA Inspections, Compliance, Enforcement, and Criminal Investigations
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm215405.htm
Inspections, Compliance, Enforcement, and Criminal Investigations
Pfizer, Inc. 5/26/10
Department of Health and Human Services logoDepartment of Health and Human Services
Public Health Service
Food and Drug Administration
New York District
158-15 Liberty Ave.
Jamaica, NY 11433
May 26, 2010
WARNING LETTER NYK 2010-19
VIA UPS
Jeffrey B. Kindler
Chairman and Chief Executive Officer
Pfizer, Inc.
235 East 42nd Street
New York, NY 10017
Dear Mr. Kindler:
During the period from June 29, 2009 through August 10, 2009, an inspection was conducted by investigators of the U.S. Food and Drug Administration (FDA or Agency) of your firm located at 235 East 42nd Street, New York, NY to determine your firm's compliance with the Postmarketing Adverse Drug Experience (PADE) reporting requirements of Section 505(k) of the Federal Food, Drug, and Cosmetic Act (the Act)) [21 U.S.C. § 355(k)], and Title 21, Code of Federal Regulations (21 CFR) 314.80 and 314.81.
Section 505(k)(1) of the Act [21 U.S.C. § 355(k)(1)] and 21 CFR 314.80 and 314.81 require an applicant to establish and maintain records and to report data relating to clinical experience, along with other data or information, for drugs for which an approved application is in effect. Failure to comply with Section 505(k) is a prohibited act under Section 301(e) of the Act [21 U.S.C. § 331(e)].
I. Deviations from 21 CFR 314.80 and 21 CFR 314.81 include the following:
1. Failure to submit Adverse Drug Experience (ADE) reports to FDA as required by 21 CFR 314.80(c). Specifically:
(a) The following are examples of ADEs and information regarding ADEs that were not submitted to the FDA:
Report # Mfg. Report # Product Pfizer's Seriousness/Expectedness Determination Date Received by Pfizer
1. 2009236922 Dalacin (Clindamycin HCI) Serious outcome and failure to assess expectedness 05/04/09
2. 2009236510 Camptosar Serious/unexpected 12/11/08
3. 2009221607 Lyrica Serious outcome and failure to assess expectedness 06/01/09
4. 2009206349 Lipitor Serious/unexpected 04/29/09
We have reviewed your firm's response dated September 9, 2009, and have determined that it is inadequate. The response acknowledges that the above-listed reports contained serious and unexpected adverse events which were not submitted within 15 days to FDA. These reports were not submitted until they were identified during the FDA inspection. Your firm's rationale for the failure to submit these reports included a lack of file tracking control as well as a lack of adequate training in utilizing the (b)(4) system. Your firm received FDA Forms 483 on July 29, 2004 and April 18, 2006 for similar postmarketing adverse drug experience violations and your corrective actions for these observations, including training, have been shown to be ineffective. FDA expects drug manufacturers to establish and implement reasonable mechanisms to assure that all serious and unexpected experiences are promptly recorded and investigated to determine whether or not 15-day Alert reports should be submitted to FDA.
(b) FDA's Center for Drug Evaluation and Research, Division of Reproductive and Urologic Drug Products, sent you a letter dated July 14, 2005, requesting that "all manufacturers of PDE5 inhibitors for treatment of erectile dysfunction (ED) continue to submit serious reports of postmarketing ophthalmologic adverse events that might reflect non-arteritic ischemic optic neuropathy (NAION) as 15-day Alert reports." In your letter to FDA dated October 18, 2005, your firm committed to provide 15-day Alert reports for these reported outcomes.
Your firm failed to submit 15-day Alert reports for the following serious visual adverse events that met the postmarketing reporting requirement for Viagra (sildenafil citrate) by misclassifying and/or downgrading reports to non-serious without reasonable justification:
Mfg. Report No. Serious Outcome Date Received
1. 2009230915 "Lost right eye vision" 06/22/09
2. 2009187335 "Blindness" 03/19/09
3. 2009193299 "Blind in right eye" 03/27/09
4. 2009213305 "Decreased vision" 05/12/09
5. 2009213306 "Decreased vision" 05/12/09
6. 2009202206 "Decreased vision" 04/22/09
7. 2009179071 "Visual acuity loss" 02/26/09
8. 2008063424 "Visual acuity reduced" 07/24/08
9. 2008086429 "Decreased vision" 10/10/08
10. 2008055517 "Visual deficiency" 07/01&10/08
11. 2008071566 "Difficulty seeing" 8/25/08
We have reviewed your firm's response dated September 9, 2009 and have concluded that it is inadequate. Your response indicates that only four of the above reports contained serious and/or expected reports of postmarketing ophthalmologic adverse events requiring a 15-day Alert report. However, the remaining seven adverse events were deemed as non-serious although serious outcomes such as "visual acuity loss/reduction" were noted.
2. Inadequate written procedures for the surveillance, receipt, evaluation, and reporting of adverse events as required by 21 CFR 314.80(b). Specifically:
Your firm does not have adequate written procedures in place to ensure that adverse drug experiences are correctly identified, assessed, and reported to FDA in accordance with postmarketing commitments.
For fosphenytoin, in your firm's letter to FDA dated February 13, 2009, your firm agreed to develop and implement an effective plan which would include criteria to correctly identify, assess, and report cases that are not labeled as Purple Glove Syndrome (PGS), but that are suggestive of this syndrome in association with fosphenytoin sodium use. However, your firm failed to do so.
Your firm also agreed to train all pharmacovigilance staff in the worldwide affiliates by February 15, 2009. Training was to include an overview of PGS and specific directions regarding the process for expediting any adverse event reports involving fosphenytoin use to Drug Safety Surveillance (DSS).
Despite your agreement, only six out of the required sixty-three country offices worldwide were trained and some of the offices that were trained were not trained on time, including the core DSS offices. 1
Your firm's response dated September 9, 2009 remains inadequate because it fails to include an effective plan to identify cases suggestive of PGS and fails to require medical evaluation of reports suggestive of PGS. Additionally, provisions for adequate training and documentation of training were not provided.
3. Failure to submit adverse drug experiences that are both serious and unexpected to FDA 'within 15 calendar days of initial receipt of the information as required by 21 CFR 314.80(c) (1)(i). Specifically:
(a) During the time period of approximately March 1, 2006 through December 7, 2008, there were 80,560 15-day Alert Reports submitted to FDA by your firm, of which 3558 (4%) were late. Between December 8, 2008 through June 28, 2009, approximately 1508 (9%) were submitted late, a further decline in the timeliness of reporting.
The following are examples of ADE reports that contained serious and unexpected events, but were submitted late to FDA:
Mfg. Report No. Product Reason Late No. of Days Late
1. 2007039077 Lipitor Delay due to case processing/other 1141
2. 2007039077 Lipitor Delay due to resubmission 1102
3. 2007048456 Azithromycin Delay forwarding to safety site 687
4. 2008037900 Azithromycin Delay due to case revision 393
5. 2009229922 Amlodipine Besilate Delay due to clerical/data entry issue 438
6. 2008040787 Prostin VR Delay due to resubmission 285
7. 2009231444 Atorvastatin Calcium Delay forwarding to safety site 274
8. 2009212979 Epirubicin HCI Delay forwarding to safety site 728
9. 2009195911 Eplerenone Delay due to clerical/data entry issue 356
According to your firm's response, implementation of (b)(4) created problems for the timely submission of 15-day Alert reports. A review of the explanations for the late reports indicates reasons such as cases being initially identified as non-serious then upgraded to serious, user error in routing cases within the safety system, case distribution errors, case processing issues, and technical errors. The firm purports to have addressed these problems by updating user manuals, reinforcing training, additional prospective and retrospective quality review of cases, updating system configuration errors, and other unspecified corrective actions with supplying organizations and partners. Your response indicates reporting improved after May 2009 and that errors significantly declined once colleagues became more experienced with the new safety system. However, your firm's response did not include comparable metrics for the post-May 2009 time period. Although the Agency recognizes the benefits to implementing a new and improved computerized tracking system, such a system can only be an improvement if there is adequate staff to make accurate data entries and if the users are adequately trained in its implementation. Your firm's response also fails to address other factors that possibly contributed to the tardiness of the reports, including personnel training in the categorization of serious versus non-serious reports, training in use of the new (b)(4) system, development of SOPs, development of standardized documentation practices, and development of compliance metrics. A signed copy of your revised corrective action plan should be included in your response to this Warning Letter.
(b) On November 8, 2004, FDA granted a waiver to your firm allowing for serious and unexpected suspected adverse drug reactions for NDA 11-839 (Provera and medroxyprogesterone acetate) to be submitted no later than 30 calendar days of initial receipt of the information, instead of within 15 calendar days of receipt of the information. However, between June 8, 2005 and March 16, 2009, your firm failed to submit approximately 25 reports within 30 days. The following are examples of these late reports:
Mfg. Report No. No. of Days Late
1. 2009230289 1720
2. 2008151639 128
3. 2009200493 1641
The response comments addressed for item 3(a) also apply to this point.
(c) On August 28, 2006, FDA granted a waiver to your firm allowing for serious and unexpected suspected adverse drug reactions for Bextra (valdecoxib) to be submitted no later than 60 calendar days of initial receipt of the information, instead of within 15 calendar days of receipt of the information. The firm, however, failed to submit approximately 220 of these reports within 60 days. The following are examples of the late reports:
Mfg. report No. No. of Days Late
1. 2006153496 264
2. 2006134600 219
3. 2007046238 140
4. 2007002471 90
5. 2007098335 139
The response comments addressed for item 3(a) also apply to this point.
4. Failure to submit a 15-day Alert report for adverse drug experiences obtained from postmarketing studies in which the applicant concludes that there is a reasonable possibility that the drug caused the adverse experience, as required by 21 CFR 314.80(e)(1). Specifically:
Fifteen-day Alert reports have not been submitted for all adverse drug experiences during postmarketing studies where there is a reasonable possibility that the drug caused the adverse experience. In your firm's letter dated March 18, 2008, your firm committed to submit 15-day Alert reports for Selzentry (Maraviroc) for the following events during the postmarketing period: liver-related deaths and liver failure, fatal and non-fatal myocardial infarctions, and all non-AIDS defining malignancies. The following ADE reports for Selzentry (Maraviroc) from postmarketing studies were required to be submitted to FDA as 15-day Alert reports, because they either met these criteria described in the March 18, 2008 letter, or they otherwise contain serious and unexpected events in which there is a reasonable possibility that the drug caused the event.
Mfg. Report No.
1. 2009154994
2. 2009187951
3. 2007067649
4. 2007076241
5. 2005162672
6. 2006136607
7. 2008003965
Your response has been reviewed and found inadequate. In a letter to the Agency dated March 18, 2008, your firm acknowledged expedited 15-day reporting for liver-related deaths, liver failure, fatal and non-fatal myocardial infarctions and all non-AIDS defining malignancies from spontaneous and clinical trial sources. No reasons for late submission of reports 2006136607 and 2008003965 were provided in your response. Your response states that reports 2009154994, 2009187951, and 2005162672 were incorrectly not submitted due to errors in distribution. Your response further states that reports 2007067649 and 2007076241 were not submitted because they were received by the firm before clarification from the Agency advising that clinical trial cases were subject to special reporting requirements. However, after receipt of clarification that cases 2007067649 and 2007076241 were subject to reporting, your firm did not submit them to the Agency.
5. Serious and unexpected ADE reports are not promptly investigated as required by 21 CFR 314.80(c)(1)(ii). Specifically:
Adverse drug experiences that were the subject of postmarketing 15-day Alert reports were not investigated and/or documented. Specifically, in your firm's letter dated August 18, 2005, your firm submitted revised procedures to investigate all cases of postmarketing ophthalmologic ADEs that might reflect NAION involving Viagra. Your firm committed in these procedures to submit a pre-specified list of questions to reporters in order to obtain clinical and diagnostic information concerning visual symptoms and risk factors for the event. However, in cases reviewed during the inspection, your firm failed to provide documentation that adequate follow-up information had been requested. In addition, during the inspection, it was observed that some reports were either misclassified or downgraded in severity to non-serious without a reasonable justification.
Your response acknowledges that documentation of follow-up calls and the use of the questions during the calls were not handled consistently. Although the FDA does not mandate a particular method of requesting follow-up information, documentation that all postmarketing ophthalmologic events that might reflect NAION were investigated should be maintained.
6. Failure to submit 15-day Alert reports for serious adverse drug experiences as a non-applicant to the applicant within 5 calendar days of receipt as required by 21 CFR 314.80(c)(1) (iii).
Pfizer, as a non-applicant, elected to submit to the applicant (rather than to FDA) all reports of serious adverse drug experiences. However, you did not submit each report to the applicant within five calendar days of your receipt of the information.
Specifically, your firm's name is on the label of at least ten products (amoxicillin, finasteride, ondansetron, lamotrigine, metformin, penicillin V potassium, stavudine, tiotropium bromide, donepezil, interferon beta-la) for which you are required to submit serious ADE reports to the applicant within five calendar days. Of the 398 reports received by your firm for these products, 132 (33%) were sent to the applicants more than five calendar days after your receipt of them.
Your response acknowledged a need to improve on the timeliness of your submission of serious ADE reports to the applicants for products for which Pfizer does not hold the NDA or ANDA, but appears on the label as a distributor. Your response stated that activities such as targeted training and presentations have resulted in reporting timeframe improvement. However, a review of the overall time reporting for 5-day rule products in a time table provided to the investigators on July 9, 2009, for the period from December 8, 2008 to June 30, 2009, shows the contrary. As demonstrated by your report compiled for inspection entitled "5-Day Rule Products Sent to License Party between 08 Dec 2008 and 30 Jun 2009", there was a decline in the timeliness of reporting during this period.
7. Failure to promptly review all adverse drug experience information obtained or otherwise received by the applicant from any source as required by 21 CFR 314.80(b). Specifically:
Adverse drug experience information obtained or otherwise received from any source was not promptly reviewed, including information from commercial marketing experience and postmarketing epidemiological/surveillance activities.
The following are examples of serious ADEs that wvere not forwarded for case processing within 2-4 business days as required by your SOP AEM-01-02, dated July 14, 2008, pages 3 - 5:
Mfg. Report No. No. of Days Received Late
1. 2009202904 30
2. 2008150853 9
Your response provided an explanation for the lateness of these reports and stated that the firm has "robust quality processes in place to oversee performance ..." This response is deemed inadequate because your affiliates failed to comply with defined time fines for case processing as required by SOP AEM-01.
Your response commits the firm to implement "additional enhancements to tools enabling enhanced proactive management of case workload" to mitigate late reporting. A signed copy of your revised corrective action plan should be included in your response to this Warning Letter. Adequacy of the corrective action will be determined during subsequent inspection(s).
8. Failure to submit periodic adverse drug experience reports at quarterly intervals for each adverse drug experience which is not reported as a I5-day Alert report, for 3 years from the date of approval of the application, and then at annual intervals submitted within 60 days of the anniversary date of approval of the application as required by 21 CFR 314.80(c)(2). Specifically:
Individual ADEs which were not reported to FDA in a postmarketing IS-day Alert report have not been included in a periodic safety report.
Specifically, the following ADEs were not reported to FDA in a periodic safety report:
Mfg. Report No.
1. 2009189370
2. 2009205745
3. 2009206342
4. 2009211979
5. 2009178032
6. 2009186019
7. 2009152113
8. 2009166186
Your response to this observation reports a short term corrective action of nightly sweeps of the (b)(4) System with a permanent system correction to be implemented by the fourth quarter of 2009. Adequacy of the corrective action will be determined during subsequent follow-up inspection(s).
II. Deviations from 21 U.S.C. § 353(d) include the following:
In addition to the above violations of Postmarketing Adverse Drug Experience (PADE) reporting requirements, you have significant deviations from the requirements of Section 503(d) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 353(d)] and Title 21, Code of Federal Regulations, Part 203. Based on the information collected during the inspection, non-compliance with the requirements of the Prescription Drug Marketing Act (PDMA), include:
1. Failure to conduct an immediate investigation, to notify FDA within 5 working days, and provide written investigation reports within 30 days of initial notification of prescription drug sample thefts, significant losses, and falsification of prescription drug sample records as required by 21 CFR 203.37(a)(1),(2), and (3) and (b)(1), (2), and (3).
21 CFR 203.37(a)(1) and (b)(1) requires a manufacturer or authorized distributor of record to notify FDA within five working days of becoming aware of a significant loss, any known theft, or suspected falsification involving drug samples. 21 CFR 203.37(a)(2) and (b)(2) requires an immediate initiation of an investigation of a suspected significant loss, any known theft, or suspected falsification. 21 CFR 203.37(a)(3) and (b)(3) requires that FDA be provided with a complete written report, including the reason for and the results of the investigation, not later than 30 days after the date of the initial notification.
The FDA 483 observations concern Pfizer's failure to notify and follow up with FDA regarding significant losses, known thefts, or suspected falsifications in accordance with these PDMA legal requirements. Pfizer's response to the FDA 483 in this regard does not address how Pfizer will meet the Section 203.37 requirements. We recognize your intent to reduce the inventory period, but the reduction you describe would still not meet the five working day reporting requirement.
Examples of incidents of significant losses and confirmed variances in drug sample annual inventory reconciliation re orts that exceeded the established threshold for significant loss in Pfizer's SOP 010 (b)(4) that were not reported to FDA are as follows:
• Employee ID (b)(6) had a total inventory loss of approximately (b)(4) on July 17, 2009. At the time of inspection, FDA had not been notified.
• Employee ID (b)(6) had a possible theft of (b)(4) totaling a loss of (b)(4) on March 11, 2008. A police report was filed on May 13, 2008, yet Pfizer did not notify FDA until May 30, 2008.
• Employee ID (b)(6) had a variance of (b)(4) on Aug 19, 2008. FDA was not notified until approximately two months later.
2. Failure to conduct, at least annually, a complete and accurate physical inventory of all drug samples distributed and to record the results of such inventory as required by 21 CFR 203.31(d).
21 CFR 203.31 (d) requires that each drug manufacturer or authorized distributor of record that distributes drug samples by means of representatives shall conduct, at least annually, a complete and accurate physical inventory of all drug samples. All drug samples in the possession or control of each manufacturer's and distributor's representatives are required to be inventoried and the results of the inventory are required to be recorded in an inventory record. In addition, manufacturers and distributors shall reconcile the results of the physical inventory with the most recently completed prior physical inventory and create a report documenting the reconciliation process.
Annual inventory reconciliations are not conducted once a year as per your SOP 010. Specifically, out of 35 inventories reviewed by FDA, the following employees did not have their inventories taken annually:
Employee (b)(6)
Employee (b)(6)
Employee (b)(6)
Employee (b)(6)
Employee (b)(6)
Employee (b)(6)
Employee (b)(6)
Employee (b)(6)
Employee (b)(6)
Employee (b)(6)
Employee (b)(6)
Employee (b)(6)
Employee (b)(6)
Employee (b)(6)
Your response relays the intent to revise SOP 010 to assure that all future employee inventories are performed within 12 months from the initial inventory review rather than once each calendar year. However, we have not yet received your revised SOP and you have not addressed the status of inventories for the above employees. Therefore, the adequacy of your response cannot be determined.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your firm. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, prosecution or injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts. Additionally, FDA may withhold approval of requests for export certificates, or approval of pending new drug applications, listing your facility as a supplier or manufacturer until the above violations are corrected. A reinspection may be necessary.
You should notify this office upon receipt of this letter to arrange for a meeting to discuss the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to prevent the recurrence of similar violations. If corrective action cannot be completed within 15 working days, state the reason for delay and the time within which corrections will be completed.
Your reply should be sent to Compliance Branch, Food and Drug Administration, 158-15 Liberty Avenue, Jamaica, NY 11433 Attention: Lillian C. Aveta, Compliance Officer.
Sincerely,
/S/
Ronald M. Pace
District Director
New York District
1 The Milan office, which is one of the core DSS offices, was not trained until July 2009.
Enclosure: Form FDA 483 dated August 10, 2009
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Page Last Updated: 06/14/2010
CPSC Launches National Campaign to Change the Way People Think and Act about Pool and Spa Safety
Pool Safely Campaign Aims to Reduce Child Drownings and Entrapments
http://www.cpsc.gov/cpscpub/prerel/prhtml10/10241.html
FORT LAUDERDALE, FL - The U.S. Consumer Product Safety Commission (CPSC) today kicks-off the Pool Safely campaign (www.poolsafely.gov), a first-of-its-kind national public education effort to reduce child drownings and non-fatal submersions, and entrapments in swimming pools and spas. At a press conference at the Fort Lauderdale Aquatic Complex today, Olympic swimmers Jason Lezak and Janet Evans joined Inez Tenenbaum, Chairman of the CPSC; U.S. Rep. Debbie Wasserman Schultz (D-FL); and Nancy Baker, mother of Virginia Graeme Baker, to officially launch Pool Safely and release the CPSC's annual submersion and entrapment reports.
The Pool Safely campaign is a key part of the CPSC's efforts to carry out the requirements of Section 1407 of the Virginia Graeme Baker Pool and Spa Safety Act (P&SS Act), federal legislation signed into law in 2007 mandating new requirements for pool and spa safety. It includes a requirement for a national public education campaign designed to raise public awareness, support industry compliance, and improve safety at pools and spas.
"I have been involved in the issue of pool safety throughout my career and today marks a key milestone in the ongoing fight to reduce accidental drowning," said Congresswoman Debbie Wasserman Schultz, author of the Virginia Graeme Baker Pool and Spa Safety Act. "Educating communities on the potential dangers of swimming pools is a critical tool in saving the lives of our children. I am so pleased to have worked with my colleagues in Congress to provide the funds needed for implementation of this important campaign."
The Pool Safely campaign will deliver an important and simple message: just adding an extra safety step in and around the water can make all the difference. Your greatest water safety assurance comes from adopting and practicing as many water safety measures as possible, including: barriers that completely surround the pool with self-closing, self-latching gates; staying close, being alert, and watching children at the pool; learning and practicing water safety skills (knowing how to swim and perform CPR); and having the appropriate equipment (compliant drain covers, alarms, barriers and sensors).
The campaign will highlight the need to implement a "personal system of safety" that consists of adding as many proven water safety practices as possible in and around pools and spas.
"As a parent of young children, I know there's no single, sure-fire way to ensure their safety around pools and spas," added Janet Evans, five-time Olympic medalist in swimming. "Whether it's enrolling them in swimming lessons or simply watching them at all times, there is always one more thing I can do. The Pool Safely campaign offers a variety of simple steps we can all take to protect our children in pools and spas."
Pool Safely will serve as an information hub delivering campaign tools and resources to various outreach channels. CPSC has taken the lead by partnering with national, regional and local organizations in the children's safety and drowning prevention communities. By engaging key partners, the campaign will reach the widest possible audience and build a sustainable network that will ensure the campaign's messaging is delivered for years to come.
"Knowing how to swim helped me win gold in the water, but it takes adding as many water safety steps as possible to ensure a safe environment for children in and around pools and spas, " said seven-time Olympic medalist in swimming Jason Lezak. "No matter how responsible you already are, there is always one more safety step you can take to protect your child. That is how you can Pool Safely. "
"I understand the need to bring together the public and dedicated partners in the water safety community to begin a national conversation about water safety," said Nancy Baker, the mother of Virginia Graeme for whom the Act is named. "I am honored to be involved in the Pool Safely campaign and look forward to working together to promote additional water safety steps we all can take in protecting our loved ones in and around pools and spas. Simple steps save lives."
The Pool Safely campaign - a national public education effort by the Consumer Product Safety Commission - is proud to partner with leading organizations, including American Red Cross, YMCA of the USA, Safe Kids USA, National Drowning Prevention Alliance (NDPA), World Waterpark Association (WWA), and Abbey's Hope. For more information, visit the website at www.poolsafely.gov or follow the campaign on Twitter @poolsafely
http://www.poolsafely.gov/
# Drowning is preventable, especially among children. http://www.poolsafely.gov/ #poolsafely #pools 2 days ago
http://www.ready.gov/america/getakit/seniors.html
Disaster Preparedness for Older People
Each person's needs and abilities are unique, but every individual can take important steps to prepare for all kinds of emergencies and put plans in place. By evaluating your own personal needs and making an emergency plan, you can be better prepared for any situation. A commitment to planning today will help you prepare for any emergency situation. Preparing makes sense. Get ready now.
* Consider how a disaster might affect your individual needs.
* Plan to make it on your own, at least for a period of time. It's possible that you will not have access to a medical facility or even a drugstore.
* Identify what kind of resources you use on a daily basis and what you might do if they are limited or not available.
* Get an emergency supply kit.
* If you must evacuate, take your pets with you, if possible. However, if you are going to a public shelter, it is important to understand that animals may not be
allowed inside.
* Plan in advance for shelter alternatives that will work for both you and your pets; consider loved ones or friends outside of your immediate area who would be
willing to host you and your pets in an emergency.
*
Create a Support Network
* If you anticipate needing assistance during a disaster talk to family, friends and others who will be part of your personal support network.
* Write down and share each aspect of your emergency plan with everyone in your support network.
* Make sure everyone knows how you plan to evacuate your home or workplace and where you will go in case of a disaster.
* Make sure that someone in your local network has an extra key to your home and knows where you keep your emergency supplies.
* Teach those who will help you how to use any lifesaving equipment, administer medicine in case of an emergency.
* Practice your plan with those who have agreed to be part of your network.
Additional Supplies and Documents:
Medications and Medical Supplies
If you take medicine or use a medical treatment on a daily basis, be sure you have what you need to make it on your own for at least a week, maybe longer.
* Make a list of prescription medicines including dosage, treatment and allergy information.
* Talk to your pharmacist or doctor about what else you need to prepare.
* If you undergo routine treatments administered by a clinic or hospital or if you receive regular services such as home health care, treatment or transportation, talk to your service provider about their emergency plans. Work with them to identify back-up service providers and incorporate them into your personal support network.
* Consider other personal needs such as eyeglasses, hearing aids and hearing aid batteries, wheelchair batteries, and oxygen.
Emergency Documents
Include copies of important documents in your emergency supply kits such as family records, medical records, wills, deeds, social security number, charge and bank accounts information and tax records.
* Have copies of your medical insurance and Medicare cards readily available.
* Keep a list of the style and serial number of medical devices or other life-sustaining devices. Include operating information and instructions.
* Make sure that a friend or family member has copies of these documents.
* Include the names and contact information of your support network, as well as your medical providers.
* If you have a communication disability, make sure your emergency information notes the best way to communicate with you.
* Keep these documents in a water proof container for quick and easy access.
More Information
For more information, see Disaster Preparedness For People With Disabilities Adobe Acrobat Reader Required from FEMA, and the Red Cross website.
security guards at entrance to BPI bank branch at said maii,didn't inspect/subject to scanning with metal detector luggage.
Said luggage was large enough to contain grenades and firearms.
The following stores at said mall didn't have required express lanes for senior citizens: Chow King, Jollibee, NT computer.
I believe said stores violated the Expanded Senior Citizens Act of 2003.
http://www.cdc.gov/family/checkuplist/index.htm
Check-Up Checklist: Things to Do Before Your Next Check-Up
Getting check-ups is one of many things you can do to help stay healthy and prevent disease and disability.
You’ve made the appointment to see your health care provider.
You’ve reviewed the instructions on how to prepare for certain tests.
You’ve done the usual paperwork.
Done, right?
Not quite.
Before your next check-up, make sure you do these four things.
Review your family health history.
Are there any new conditions or diseases that have occurred in your close relatives since your last visit? If so, let your health care provider know. Family history might influence your risk of developing heart disease, stroke, diabetes, or cancer. Your provider will assess your risk of disease based on your family history and other factors. Your provider may also recommend things you can do to help prevent disease, such as exercising more, changing your diet, or using screening tests to help detect disease early.
Find out if you are due for any general screenings or vaccinations.
Have you had the recommended screening tests based on your age, general health, family history, and lifestyle? Check with your health care provider to see if its time for any vaccinations, follow-up exams, or tests. For example, it might be time for you to get a Pap test, mammogram, prostate cancer screening, colon cancer screening, sexually transmitted disease screening, blood pressure check, tetanus shot, eye check, or other screening.
Write down a list of issues and questions to take with you.
Review any existing health problems and note any changes.
* Have you noticed any body changes, including lumps or skin changes?
* Are you having pain, dizziness, fatigue, problems with urine or stool, or menstrual cycle changes?
* Have your eating habits changed?
* Are you experiencing depression, anxiety, trauma, distress, or sleeping problems?
If so, note when the change began, how it’s different from before, and any other observation that you think might be helpful.
Be honest with your provider. If you haven’t been taking your medication as directed, exercising as much, or anything else, say so. You may be at risk for certain diseases and conditions because of how you live, work, and play. Your provider develops a plan based partly on what you say you do. Help ensure that you get the best guidance by providing the most up-to-date and accurate information about you.
Be sure to write your questions down beforehand. Once you’re in the office or exam room, it can be hard to remember everything you want to know. Leave room between questions to write down your provider’s answers.
Consider your future.
Are there specific health issues that need addressing concerning your future? Are you thinking about having infertility treatment, losing weight, taking a hazardous job, or quitting smoking? Discuss any issues with your provider so that you can make better decisions regarding your health and safety.
Mcneil Consumer Healthcare Recalls Four Product Lots of Benadryl® Allergy Ultratab™ Tablets, 100 Count, and One Product Lot of Extra Strength Tylenol® Rapid Release Gels, 50 Count
http://www.fda.gov/Safety/Recalls/ucm215921.htm
FOR IMMEDIATE RELEASE - Fort Washington, PA - June 15, 2010 - McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is recalling five product lots as an addition to the list of products included in the company’s January 15th, 2010 product recall. The additional lots involved are four product lots of BENADRYL® ALLERGY ULTRATAB™ TABLETS, 100 count, sold in the U.S.; and one product lot of EXTRA STRENGTH TYLENOL® Rapid Release Gels, 50 count sold in the U.S., Trinidad and Tobago, Bermuda, and Puerto Rico (FULL RECALLED PRODUCT LIST BELOW). This recall is a follow-up to the product recall that McNeil Consumer Healthcare announced on January 15th, 2010 and is being taken because the products were inadvertently omitted from the initial recall action. McNeil Consumer Healthcare identified the omission and informed the U.S. Food and Drug Administration (FDA) of its decision to add these product lots to the recall list. All these products were produced before the January 15th, 2010 recall. Since January, McNeil Consumer Healthcare has continued to analyze and evaluate 2,4,6-tribromoanisole (TBA) and has shared that information with the FDA. This further analysis confirms that the risk of serious adverse medical events is remote. This recall is being conducted with the knowledge of the FDA.
BENADRYL® ALLERGY ULTRATAB™ TABLETS is sold over-the-counter and is indicated for the relief of allergy associated symptoms such as sneezing, runny nose, itchy throat, and itchy and watery eyes. EXTRA STRENGTH TYLENOL® Rapid Release Gels is sold over-the-counter and is indicated for the temporary reduction of fever and for the temporary relief of minor aches and pains due to headache, muscular aches, backache, minor arthritis pain, the common cold, toothache, pre-menstrual and menstrual cramps, and flu.
The January 15th, 2010 recall was initiated as a result of consumer complaints of a musty or moldy odor that has since been linked to the presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA). After a thorough investigation, it was determined that the source of TBA was the result of a breakdown of a chemical that is applied to wood used to build wooden pallets that transport and store product packaging materials.
Consumers who purchased product from the lots included in this recall should stop using the product and contact McNeil Consumer Healthcare for instructions on a refund or replacement. For these instructions or information regarding how to return or dispose of the product, consumers should log on to the internet at www.mcneilproductrecall.com1 or call 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time). Requests for reimbursement can be made at www.mcneilproductrecall.com2. Consumers who have medical concerns or questions should contact their healthcare provider.
Any adverse reactions may also be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at http:www.fda.gov/safety/medwatch/default.htm.
The product lot numbers for the recalled products can be found on the side of the bottle label.
FULL RECALLED PRODUCT LIST:
Product Name Product Form Lot Number NDC Number UPC Code
BENADRYL Allergy ULTRATAB Tablets 100 count Ultratab Tablet AJA008, ADA194, ABA022, ABA264 50580-226-10 312547170338
EXTRA STRENGTH Tylenol Rapid Release Gels 50 count Rapid Release Gelcap ASA202 50580-488-50 300450488503
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2. http://www.mcneilproductrecall.com
3. /AboutFDA/ContactFDA/StayInformed/RSSFeeds/Recalls/rss.xml
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Page Last Updated: 06/17/2010
CPSC Announces International Initiative for Strong Safety Standards on Window Coverings
http://www.cpsc.gov/cpscpub/prerel/prhtml10/10265.html
NEWS from CPSC
U.S. Consumer Product Safety Commission
Office of Information and Public Affairs Washington, DC 20207
FOR IMMEDIATE RELEASE
June 17, 2010
Release #10-265 CPSC Recall Hotline: (800) 638-2772
CPSC Media Contact: (301) 504-7908
CPSC Announces International Initiative for Strong Safety Standards on Window Coverings
WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission (CPSC), Health Canada and the European Commission’s Directorate General for Health and Consumers (DG SANCO) have joined together to call for strong and comprehensive international safety standards on window coverings from manufacturers and standards organizations.
This international, multi-lateral call for immediate action (pdf) is the first time the three safety agencies, representing consumers in 29 countries, have joined together to demand strong worldwide safety standards on a specific product.
A coordinated effort by the three safety agencies and standards organizations in the U.S., Canada and Europe could lead to cost-effective product development and testing and manufacturing processes in the global economy while putting the safety of children first.
Corded window coverings cause strangulation deaths and significant injuries in children worldwide. In the United States, CPSC staff is aware of 120 fatalities and 113 non-fatal incidents related to corded window coverings since 1999. Health Canada has received reports of 28 strangulation deaths and 23 near-strangulations linked to corded window coverings since 1986. In seven Member States of Europe, 90 children were reported to have visited hospital emergency departments for injuries caused by corded window coverings in 2002. More recently, at least six children in Europe have died from corded window coverings since 2008.
Since December 2009, CPSC has recalled tens of millions of corded Roman shades and roll-up blinds sold by a variety of manufacturers and retailers. These window coverings pose a serious risk of strangulation to young children. CPSC continues to urge parents and caregivers to make sure that there are no accessible cords on the front, side or back of their window coverings.
CPSC recommends the use of cordless window coverings in all homes where children live or visit.
Eating Outdoors, Handling Food Safely
http://www.fda.gov/Food/ResourcesForYou/Consumers/ucm109899.htm
Food Facts
* Pack and Transport Food Safely
* Quick Tips for Picnic Site Prep
* Follow Safe Grilling Tips
* Serving Picnic Food: Keep it Cold/Hot
Picnic and barbecue season offers lots of opportunities for outdoor fun with family and friends. But these warm weather events also present opportunities for foodborne bacteria to thrive. As food heats up in summer temperatures, bacteria multiply rapidly.
To protect yourself, your family, and friends from foodborne illness during warm-weather months, safe food handling when eating outdoors is critical. Read on for simple food safety guidelines for transporting your food to the picnic site, and preparing and serving it safely once you've arrived.
coolers and picnic equipment
Pack and Transport Food Safely
Keep your food safe: from the refrigerator/freezer . . .
all the way to the picnic table.
Quick Tips for Picnic Site Prep
Food safety begins with proper hand cleaning — including outdoor settings. Before you begin setting out your picnic feast, make sure hands and surfaces are clean.
* Outdoor Hand Cleaning: If you don’t have access to running water, simply use a water jug, some soap, and paper towels. Or, consider using moist disposable towelettes for cleaning your hands.
* Utensils and Serving Dishes: Take care to keep all utensils and platters clean when preparing food.
* Keep cold food cold. Place cold food in a cooler with ice or frozen gel packs. Cold food should be stored at 40°F or below to prevent bacterial growth. Meat, poultry, and seafood may be packed while still frozen so that they stay colder longer.
* Organize cooler contents. Consider packing beverages in one cooler and perishable foods in another. That way, as picnickers open and reopen the beverage cooler to replenish their drinks, the perishable foods won’t be exposed to warm outdoor air temperatures.
* Keep coolers closed. Once at the picnic site, limit the number of times the cooler is opened as much as you can. This helps to keep the contents cold longer.
* Don’t cross-contaminate. Be sure to keep raw meat, poultry, and seafood securely wrapped. This keeps their juices from contaminating prepared/cooked foods or foods that will be eaten raw, such as fruits and vegetables.
* Clean your produce. Rinse fresh fruits and vegetables under running tap water before packing them in the cooler - including those with skins and rinds that are not eaten. Rub firm-skinned fruits and vegetables under running tap water or scrub with a clean vegetable brush while rinsing with running tap water. Dry fruits and vegetables with a clean cloth towel or paper towel.
— Packaged fruits and vegetables that are labeled "ready-to-eat," "washed," or "triple washed" need not be washed.
Safe Food Temperature Chart Food Temperature
Steaks and roasts 145°F
Fish 145°F
Pork 160°F
Ground beef 160°F
Egg dishes 160°F
Chicken breasts 165°F
Whole poultry 165°F
Shrimp, lobster, and crabs cook until pearly and opaque
Clams, oysters, and mussels cook until the shells are open
Follow Safe Grilling Tips
Grilling and picnicking often go hand-in-hand. And just as with cooking indoors, there are important guidelines that should be followed to ensure that your grilled food reaches the table safely.
* Marinate safely. Marinate foods in the refrigerator - never on the kitchen counter or outdoors. In addition, if you plan to use some of the marinade as a sauce on the cooked food, reserve a portion separately before adding the raw meat, poultry, or seafood. Don’t reuse marinade.
* Cook immediately after "partial cooking." If you partially cook food to reduce grilling time, do so immediately before the food goes on the hot grill.
* Cook food thoroughly. When it’s time to cook the food, have your food thermometer ready. Always use it to be sure your food is cooked thoroughly.
* Keep "ready" food hot. Grilled food can be kept hot until served by moving it to the side of the grill rack, just away from the coals. This keeps it hot but prevents overcooking.
* Don't reuse platters or utensils. Using the same platter or utensils that previously held raw meat, poultry, or seafood allows bacteria from the raw food’s juices to spread to the cooked food. Instead, have a clean platter and utensils ready at grill-side to serve your food.
Serving Picnic Food: Keep it COLD / HOT
Keeping food at proper temperatures - indoor and out - is critical in preventing the growth of foodborne bacteria. The key is to never let your picnic food remain in the "Danger Zone" - between 40° F and 140° F - for more than 2 hours, or 1 hour if outdoor temperatures are above 90° F. This is when bacteria in food can multiply rapidly, and lead to foodborne illness.
Instead, follow these simple rules for keeping cold foods cold and hot foods hot.
Platter Warning:
person in apron cleaning a bowl
Prevent "Cross-Contamination" When Serving
Never reuse a plate or utensils that previously held raw meat, poultry, or seafood for serving — unless they’ve been washed first in hot, soapy water. Otherwise, you can spread bacteria from the raw juices to your cooked or ready-to-eat food.
This is particularly important to remember when serving cooked foods from the grill.
COLD FOOD
Cold perishable food should be kept in the cooler at 40° F or below until serving time.
* Once you've served it, it should not sit out for longer than 2 hours, or 1 hour if the outdoor temperature is above 90° F. If it does - discard it.
* Foods like chicken salad and desserts in individual serving dishes can be placed directly on ice, or in a shallow container set in a deep pan filled with ice. Drain off water as ice melts and replace ice frequently.
HOT FOOD
Hot food should be kept hot, at or above 140° F.
* Wrap it well and place it in an insulated container until serving.
* Just as with cold food - these foods should not sit out for more than 2 hours, or 1 hour in temperatures above 90° F. If food is left out longer, throw it away to be safe.
Everyone can practice safe food handling
by following these four simple steps:
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Links on this page:
Page Last Updated: 06/19/2009
FDA: Pfizer Voluntarily Withdraws Cancer Treatment Mylotarg from U.S. Market
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm216448.htm
FDA NEWS RELEASE
For Immediate Release: June 21, 2010
Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA: Pfizer Voluntarily Withdraws Cancer Treatment Mylotarg from U.S. Market
Pfizer Inc. today announced the voluntary withdrawal from the U.S. market of the drug Mylotarg (gemtuzumab ozogamicin) for patients with acute myeloid leukemia (AML), a bone marrow cancer. The company took the action at the request of the U.S. Food and Drug Administration after results from a recent clinical trial raised new concerns about the product’s safety and the drug failed to demonstrate clinical benefit to patients enrolled in trials.
Mylotarg was approved in May 2000 under the FDA’s accelerated approval program. This program allows the agency to approve a drug to treat serious diseases with an unmet medical need based on a surrogate endpoint – a laboratory measurement or a physical sign used as a substitute for a clinically meaningful endpoint that directly measures how a patient feels, functions, or survives.
Under accelerated approval, the company is required to conduct additional clinical trials after approval to confirm the drug’s benefit. If those trials fail to confirm clinical benefit to patients, or if the company does not pursue the required confirmatory trials with due diligence, the FDA can withdraw the drug from the market using expedited procedures.
Mylotarg was approved to treat patients ages 60 years and older with recurrent AML who were not considered candidates for other chemotherapy. The initial approval was based on the surrogate endpoint of response rate (i.e., the percentage of patients whose leukemia decreased or disappeared in laboratory tests), observed in 142 patients with AML across three clinical trials.
A confirmatory, post approval clinical trial was begun by Wyeth (now Pfizer) in 2004. The trial was designed to determine whether adding Mylotarg to standard chemotherapy demonstrated an improvement in clinical benefit (survival time) to AML patients. The trial was stopped early when no improvement in clinical benefit was observed, and after a greater number of deaths occurred in the group of patients who received Mylotarg compared with those receiving chemotherapy alone.
At initial approval, Mylotarg was associated with a serious liver condition called veno-occlusive disease, which can be fatal. This rate has increased in the postmarket setting.
“Mylotarg was granted an accelerated approval to allow patient access to what was believed to be a promising new treatment for a devastating form of cancer,” said Richard Pazdur, M.D., director, Office of Oncology Drug Products, part of FDA’s Center for Drug Evaluation and Research. “However, a confirmatory clinical trial and years of postmarketing experience with the product have not shown evidence of clinical benefit in patients with AML.”
As a result of the withdrawal, Mylotarg will not be commercially available to new patients. Patients who are currently receiving the drug may complete their therapy following consultation with their health care professional. Health care professionals should inform all patients receiving Mylotarg of the product’s potential safety risks.
Following the withdrawal, any future use of Mylotarg in the United States will require submission of an investigational new drug application to FDA.
Mylotarg is manufactured by New York City-based Pfizer.
For more information:
Pfizer: Mylotarg Withdrawal
FDA: Access to Investigational Drugs
FDA: Office of Oncology Drug Products
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3. http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm091745.htm
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Page Last Updated: 06/21/2010
Food Label Helps Consumers Make Healthier Choices
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm094536.htm
* Nutrient Highs and Lows
* Confusing Claims
* Ask and You May Receive
* For More Information
Consumers often compare prices of food items in the grocery store to choose the best value for their money. But comparing items using the food label can help them choose the best value for their health.
The food label identifies a variety of information about a product, such as the ingredients, net weight, and nutrition facts.
"The food label is one of the most valuable tools consumers have," says Barbara Schneeman, Ph.D., Director of the Food and Drug Administration's (FDA's) Office of Nutrition, Labeling and Dietary Supplements. "The food label gives consumers the power to compare foods quickly and easily so they can judge for themselves which products best fit their dietary needs."
For example, someone with high blood pressure who needs to watch salt (sodium) intake may be faced with five different types of tomato soup on the shelf, says Schneeman. You can quickly and easily compare the sodium content of each product by looking at the part of the label that lists nutrition information (Nutrition Facts Label) to choose the one with the lowest sodium content.
FDA regulations require nutrition information to appear on most foods, and any claims on food products must be truthful and not misleading. In addition, "low sodium," "reduced fat," and "high fiber" must meet strict government definitions. FDA has defined other terms used to describe the content of a nutrient, such as "low," "reduced," "high," "free," "lean," "extra lean," "good source," "less," "light," and "more." So a consumer who wants to reduce sodium intake can be assured that the manufacturer of a product claiming to be "low sodium" or "reduced in sodium" has met these definitions.
But you don't have to memorize the definitions. Just look at the Nutrition Facts Label to compare the claims of different products with similar serving sizes.
Nutrient Highs and Lows
Most nutrients must be declared on the Nutrition Facts Label as "percent Daily Value" (%DV), which tells the percent of the recommended daily intake in a serving of that product and helps the consumer create a balanced diet. The %DV allows you to see at a glance if a product has a high or low amount of a nutrient. The rule of thumb is 20% DV or more is high and 5% DV or less is low.
Health experts recommend keeping your intake of saturated fat, trans fat, and cholesterol as low as possible because these nutrients may increase your risk for heart disease. This is where the %DV on the Nutrition Facts Label can be helpful, says Schneeman. There is no %DV for trans fat, but you can use the label to find out whether the saturated fat and cholesterol are high or low, she says. When comparing products, look at the total amount of saturated fat plus trans fat to find the one lowest in both of these types of fat.
For beneficial nutrients, like fiber or calcium, you can use the %DV to choose products that contain higher amounts. Research has shown that eating a diet rich in fiber may lower your chances of getting heart disease and some types of cancer. And eating foods containing calcium may help lower your risk of getting the bone-weakening disease, osteoporosis.
Confusing Claims
The terms "natural," "healthy," and "organic" often cause confusion. "Consumers seem to think that 'natural' and 'organic' imply 'healthy,'" says Schneeman. "But these terms have different meanings from a regulatory point of view."
According to FDA policy, "natural" means the product does not contain synthetic or artificial ingredients. "Healthy," which is defined by regulation, means the product must meet certain criteria that limit the amounts of fat, saturated fat, cholesterol, and sodium, and require specific minimum amounts of vitamins, minerals, or other beneficial nutrients.
Food labeled "organic" must meet the standards set by the Department of Agriculture (USDA). Organic food differs from conventionally produced food in the way it is grown or produced. But USDA makes no claims that organically produced food is safer or more nutritious than conventionally produced food.
For example, says Schneeman, "A premium ice cream could be 'natural' or 'organic' and still be high in fat or saturated fat, so would not meet the criteria for 'healthy.'"
Ask and You May Receive
Most packaged foods are required by law to carry nutrition labeling. This labeling is voluntary for many raw foods, such as fruits, vegetables, and fish. FDA encourages stores that sell raw foods to display or distribute, near these foods, nutrition information to shoppers. To make it easy for retailers, FDA has created colorful posters that can be downloaded and printed from its Web site. The posters show nutrition information for the 20 most frequently consumed raw fruits, vegetables, and fish in the United States.
"If the nutrition information is not displayed for these raw foods, we want consumers to ask, 'where's the nutrition information on your fresh products?'" says Camille Brewer, Deputy Director of FDA's Office of Nutrition, Labeling and Dietary Supplements. Industry responds to consumer demand, says Brewer. "Industry tells us all the time, 'if consumers ask, we'll give it to them.'"
FDA also encourages consumers to request nutrition information in full-service or fast-food restaurants. This information would help consumers make healthier choices outside the home, where Americans now spend nearly half of their total food budget, according to the National Restaurant Association and USDA's Economic Research Service.
Providing nutrition information for restaurant food is voluntary unless a nutrient content claim or a health claim is made for a menu item or meal. A nutrient content claim might be "low in fat," and a health claim might be "heart healthy." If such claims are made, the restaurant is required to give customers the appropriate nutrition information for these items when requested. This information does not have to be on the menu or on a menu board that's clearly visible to the consumer. The restaurant has the option of offering this information in various ways, such as in a brochure.
Many food service establishments have nutrition information for their offerings and will provide the information on the Internet or to customers who request it.
This article appears on FDA's Consumer Update page5, which features the latest on all FDA-regulated products.
Date Posted: March 27, 2008
Start at the Store: 7 Ways to Prevent Foodborne Illness
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm094535.htm
* Check for cleanliness
* Keep certain foods separated
* Inspect cans and jars
* Inspect frozen food packaging
* Select frozen foods and perishables last
* Choose fresh eggs carefully
* Be mindful of time and temperature
Safeguarding your home against foodborne illnesses begins not at home, but at the supermarket, grocery store, or any other place where you buy food that you plan to store and serve.
Combating foodborne illnesses is a top priority at the Food and Drug Administration (FDA). That's because, according to the Centers for Disease Control and Prevention (CDC), foodborne ailments cause about 325,000 hospitalizations and 5,200 deaths nationwide each year.
You as a consumer can play a key role in preventing these illnesses. While shopping for food, you should:
1. Check for cleanliness
Buying from a retailer who follows proper food handling practices helps assure that the food is safe. Ask yourself: What is the general impression of this facility? Does it look and smell clean?
2. Keep certain foods separated
Separate raw meat, poultry, and seafood from other foods in your grocery shopping cart. Place these foods in plastic bags to prevent their juices from dripping on other foods. It is also best to separate these foods from other foods at checkout and in your grocery bags.
3. Inspect cans and jars
Don't buy food in cans that are bulging or dented. Also, don't buy food in jars that are cracked or have loose or bulging lids.
Since foods sold in cans or jars are processed to be sterile, they can "keep" for a long time if the can or jar is intact. A bulging can or jar lid may mean the food was under-processed and is contaminated. A dent in a can, especially if the dent affects a seam, may cause an opening in the seam which may allow contamination, as would a crack in a jar. A loose lid on a jar means the vacuum has been lost and the product may be contaminated. Don't buy a food product whose seal seems tampered with or damaged.
4. Inspect frozen food packaging
Don't buy frozen food if the package is damaged. Packages should not be open, torn or crushed on the edges. Also, avoid packages that are above the frost line in the store's freezer. If the package cover is transparent, look for signs of frost or ice crystals. This could mean that the food in the package has either been stored for a long time or thawed and refrozen. In such cases, choose another package.
5. Select frozen foods and perishables last
Meat, poultry, fish and eggs should be the last items placed in your shopping cart. Always put these products in separate plastic bags so that drippings don't contaminate other foods.
6. Choose fresh eggs carefully
Before putting eggs in your cart, open the carton and make sure that the eggs are clean and none is cracked. Buy only refrigerated eggs and follow the "Safe Handling Instructions" on the carton.
7. Be mindful of time and temperature
It's important to refrigerate perishable products as soon as possible after grocery shopping. Food safety experts stress the "2-hour rule"—because harmful bacteria can multiply in the "danger zone" (between 40° and 140° F), perishable foods should not be left at room temperature longer than 2 hours. Modify that rule to 1 hour when temperatures are above 90° F, as they often are in cars that have been parked in the sun.
If it will take more than an hour to get your groceries home, use an ice chest to keep frozen and perishable foods cold. Also, when the weather is warm and you are using your car's air conditioner, keep your groceries in the passenger compartment, not the trunk.
This article appears on FDA's Consumer Update page5, which features the latest on all FDA-regulated products.
Date Posted: May 13, 2008
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For More Information
* Start at the Store: Prevent Foodborne Illness (video)6
* Inicio en la tienda: 7 maneras de prevenir las enfermedades de transmisión alimentaria7
* Eat for a Healthy Heart8
* Food Safety Tips for Healthy Holidays9
* Survey Shows Gains in Food-Label Use, Health/Diet Awareness10
* Reporting Problems to FDA (video)11
* Consumer Complaint Coordinators12
* USDA Food Safety and Inspection Service: Reporting Problems with Food Products13
* Bad Bug Book: Introduction14
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U.S. FDA Inspections, Compliance, Enforcement, and Criminal Investigations
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm215405.htm
Inspections, Compliance, Enforcement, and Criminal Investigations
Pfizer, Inc. 5/26/10
Department of Health and Human Services logoDepartment of Health and Human Services
Public Health Service
Food and Drug Administration
New York District
158-15 Liberty Ave.
Jamaica, NY 11433
May 26, 2010
WARNING LETTER NYK 2010-19
VIA UPS
Jeffrey B. Kindler
Chairman and Chief Executive Officer
Pfizer, Inc.
235 East 42nd Street
New York, NY 10017
Dear Mr. Kindler:
During the period from June 29, 2009 through August 10, 2009, an inspection was conducted by investigators of the U.S. Food and Drug Administration (FDA or Agency) of your firm located at 235 East 42nd Street, New York, NY to determine your firm's compliance with the Postmarketing Adverse Drug Experience (PADE) reporting requirements of Section 505(k) of the Federal Food, Drug, and Cosmetic Act (the Act)) [21 U.S.C. § 355(k)], and Title 21, Code of Federal Regulations (21 CFR) 314.80 and 314.81.
Section 505(k)(1) of the Act [21 U.S.C. § 355(k)(1)] and 21 CFR 314.80 and 314.81 require an applicant to establish and maintain records and to report data relating to clinical experience, along with other data or information, for drugs for which an approved application is in effect. Failure to comply with Section 505(k) is a prohibited act under Section 301(e) of the Act [21 U.S.C. § 331(e)].
I. Deviations from 21 CFR 314.80 and 21 CFR 314.81 include the following:
1. Failure to submit Adverse Drug Experience (ADE) reports to FDA as required by 21 CFR 314.80(c). Specifically:
(a) The following are examples of ADEs and information regarding ADEs that were not submitted to the FDA:
Report # Mfg. Report # Product Pfizer's Seriousness/Expectedness Determination Date Received by Pfizer
1. 2009236922 Dalacin (Clindamycin HCI) Serious outcome and failure to assess expectedness 05/04/09
2. 2009236510 Camptosar Serious/unexpected 12/11/08
3. 2009221607 Lyrica Serious outcome and failure to assess expectedness 06/01/09
4. 2009206349 Lipitor Serious/unexpected 04/29/09
We have reviewed your firm's response dated September 9, 2009, and have determined that it is inadequate. The response acknowledges that the above-listed reports contained serious and unexpected adverse events which were not submitted within 15 days to FDA. These reports were not submitted until they were identified during the FDA inspection. Your firm's rationale for the failure to submit these reports included a lack of file tracking control as well as a lack of adequate training in utilizing the (b)(4) system. Your firm received FDA Forms 483 on July 29, 2004 and April 18, 2006 for similar postmarketing adverse drug experience violations and your corrective actions for these observations, including training, have been shown to be ineffective. FDA expects drug manufacturers to establish and implement reasonable mechanisms to assure that all serious and unexpected experiences are promptly recorded and investigated to determine whether or not 15-day Alert reports should be submitted to FDA.
(b) FDA's Center for Drug Evaluation and Research, Division of Reproductive and Urologic Drug Products, sent you a letter dated July 14, 2005, requesting that "all manufacturers of PDE5 inhibitors for treatment of erectile dysfunction (ED) continue to submit serious reports of postmarketing ophthalmologic adverse events that might reflect non-arteritic ischemic optic neuropathy (NAION) as 15-day Alert reports." In your letter to FDA dated October 18, 2005, your firm committed to provide 15-day Alert reports for these reported outcomes.
Your firm failed to submit 15-day Alert reports for the following serious visual adverse events that met the postmarketing reporting requirement for Viagra (sildenafil citrate) by misclassifying and/or downgrading reports to non-serious without reasonable justification:
Mfg. Report No. Serious Outcome Date Received
1. 2009230915 "Lost right eye vision" 06/22/09
2. 2009187335 "Blindness" 03/19/09
3. 2009193299 "Blind in right eye" 03/27/09
4. 2009213305 "Decreased vision" 05/12/09
5. 2009213306 "Decreased vision" 05/12/09
6. 2009202206 "Decreased vision" 04/22/09
7. 2009179071 "Visual acuity loss" 02/26/09
8. 2008063424 "Visual acuity reduced" 07/24/08
9. 2008086429 "Decreased vision" 10/10/08
10. 2008055517 "Visual deficiency" 07/01&10/08
11. 2008071566 "Difficulty seeing" 8/25/08
We have reviewed your firm's response dated September 9, 2009 and have concluded that it is inadequate. Your response indicates that only four of the above reports contained serious and/or expected reports of postmarketing ophthalmologic adverse events requiring a 15-day Alert report. However, the remaining seven adverse events were deemed as non-serious although serious outcomes such as "visual acuity loss/reduction" were noted.
2. Inadequate written procedures for the surveillance, receipt, evaluation, and reporting of adverse events as required by 21 CFR 314.80(b). Specifically:
Your firm does not have adequate written procedures in place to ensure that adverse drug experiences are correctly identified, assessed, and reported to FDA in accordance with postmarketing commitments.
For fosphenytoin, in your firm's letter to FDA dated February 13, 2009, your firm agreed to develop and implement an effective plan which would include criteria to correctly identify, assess, and report cases that are not labeled as Purple Glove Syndrome (PGS), but that are suggestive of this syndrome in association with fosphenytoin sodium use. However, your firm failed to do so.
Your firm also agreed to train all pharmacovigilance staff in the worldwide affiliates by February 15, 2009. Training was to include an overview of PGS and specific directions regarding the process for expediting any adverse event reports involving fosphenytoin use to Drug Safety Surveillance (DSS).
Despite your agreement, only six out of the required sixty-three country offices worldwide were trained and some of the offices that were trained were not trained on time, including the core DSS offices. 1
Your firm's response dated September 9, 2009 remains inadequate because it fails to include an effective plan to identify cases suggestive of PGS and fails to require medical evaluation of reports suggestive of PGS. Additionally, provisions for adequate training and documentation of training were not provided.
3. Failure to submit adverse drug experiences that are both serious and unexpected to FDA 'within 15 calendar days of initial receipt of the information as required by 21 CFR 314.80(c) (1)(i). Specifically:
(a) During the time period of approximately March 1, 2006 through December 7, 2008, there were 80,560 15-day Alert Reports submitted to FDA by your firm, of which 3558 (4%) were late. Between December 8, 2008 through June 28, 2009, approximately 1508 (9%) were submitted late, a further decline in the timeliness of reporting.
The following are examples of ADE reports that contained serious and unexpected events, but were submitted late to FDA:
Mfg. Report No. Product Reason Late No. of Days Late
1. 2007039077 Lipitor Delay due to case processing/other 1141
2. 2007039077 Lipitor Delay due to resubmission 1102
3. 2007048456 Azithromycin Delay forwarding to safety site 687
4. 2008037900 Azithromycin Delay due to case revision 393
5. 2009229922 Amlodipine Besilate Delay due to clerical/data entry issue 438
6. 2008040787 Prostin VR Delay due to resubmission 285
7. 2009231444 Atorvastatin Calcium Delay forwarding to safety site 274
8. 2009212979 Epirubicin HCI Delay forwarding to safety site 728
9. 2009195911 Eplerenone Delay due to clerical/data entry issue 356
According to your firm's response, implementation of (b)(4) created problems for the timely submission of 15-day Alert reports. A review of the explanations for the late reports indicates reasons such as cases being initially identified as non-serious then upgraded to serious, user error in routing cases within the safety system, case distribution errors, case processing issues, and technical errors. The firm purports to have addressed these problems by updating user manuals, reinforcing training, additional prospective and retrospective quality review of cases, updating system configuration errors, and other unspecified corrective actions with supplying organizations and partners. Your response indicates reporting improved after May 2009 and that errors significantly declined once colleagues became more experienced with the new safety system. However, your firm's response did not include comparable metrics for the post-May 2009 time period. Although the Agency recognizes the benefits to implementing a new and improved computerized tracking system, such a system can only be an improvement if there is adequate staff to make accurate data entries and if the users are adequately trained in its implementation. Your firm's response also fails to address other factors that possibly contributed to the tardiness of the reports, including personnel training in the categorization of serious versus non-serious reports, training in use of the new (b)(4) system, development of SOPs, development of standardized documentation practices, and development of compliance metrics. A signed copy of your revised corrective action plan should be included in your response to this Warning Letter.
(b) On November 8, 2004, FDA granted a waiver to your firm allowing for serious and unexpected suspected adverse drug reactions for NDA 11-839 (Provera and medroxyprogesterone acetate) to be submitted no later than 30 calendar days of initial receipt of the information, instead of within 15 calendar days of receipt of the information. However, between June 8, 2005 and March 16, 2009, your firm failed to submit approximately 25 reports within 30 days. The following are examples of these late reports:
Mfg. Report No. No. of Days Late
1. 2009230289 1720
2. 2008151639 128
3. 2009200493 1641
The response comments addressed for item 3(a) also apply to this point.
(c) On August 28, 2006, FDA granted a waiver to your firm allowing for serious and unexpected suspected adverse drug reactions for Bextra (valdecoxib) to be submitted no later than 60 calendar days of initial receipt of the information, instead of within 15 calendar days of receipt of the information. The firm, however, failed to submit approximately 220 of these reports within 60 days. The following are examples of the late reports:
Mfg. report No. No. of Days Late
1. 2006153496 264
2. 2006134600 219
3. 2007046238 140
4. 2007002471 90
5. 2007098335 139
The response comments addressed for item 3(a) also apply to this point.
4. Failure to submit a 15-day Alert report for adverse drug experiences obtained from postmarketing studies in which the applicant concludes that there is a reasonable possibility that the drug caused the adverse experience, as required by 21 CFR 314.80(e)(1). Specifically:
Fifteen-day Alert reports have not been submitted for all adverse drug experiences during postmarketing studies where there is a reasonable possibility that the drug caused the adverse experience. In your firm's letter dated March 18, 2008, your firm committed to submit 15-day Alert reports for Selzentry (Maraviroc) for the following events during the postmarketing period: liver-related deaths and liver failure, fatal and non-fatal myocardial infarctions, and all non-AIDS defining malignancies. The following ADE reports for Selzentry (Maraviroc) from postmarketing studies were required to be submitted to FDA as 15-day Alert reports, because they either met these criteria described in the March 18, 2008 letter, or they otherwise contain serious and unexpected events in which there is a reasonable possibility that the drug caused the event.
Mfg. Report No.
1. 2009154994
2. 2009187951
3. 2007067649
4. 2007076241
5. 2005162672
6. 2006136607
7. 2008003965
Your response has been reviewed and found inadequate. In a letter to the Agency dated March 18, 2008, your firm acknowledged expedited 15-day reporting for liver-related deaths, liver failure, fatal and non-fatal myocardial infarctions and all non-AIDS defining malignancies from spontaneous and clinical trial sources. No reasons for late submission of reports 2006136607 and 2008003965 were provided in your response. Your response states that reports 2009154994, 2009187951, and 2005162672 were incorrectly not submitted due to errors in distribution. Your response further states that reports 2007067649 and 2007076241 were not submitted because they were received by the firm before clarification from the Agency advising that clinical trial cases were subject to special reporting requirements. However, after receipt of clarification that cases 2007067649 and 2007076241 were subject to reporting, your firm did not submit them to the Agency.
5. Serious and unexpected ADE reports are not promptly investigated as required by 21 CFR 314.80(c)(1)(ii). Specifically:
Adverse drug experiences that were the subject of postmarketing 15-day Alert reports were not investigated and/or documented. Specifically, in your firm's letter dated August 18, 2005, your firm submitted revised procedures to investigate all cases of postmarketing ophthalmologic ADEs that might reflect NAION involving Viagra. Your firm committed in these procedures to submit a pre-specified list of questions to reporters in order to obtain clinical and diagnostic information concerning visual symptoms and risk factors for the event. However, in cases reviewed during the inspection, your firm failed to provide documentation that adequate follow-up information had been requested. In addition, during the inspection, it was observed that some reports were either misclassified or downgraded in severity to non-serious without a reasonable justification.
Your response acknowledges that documentation of follow-up calls and the use of the questions during the calls were not handled consistently. Although the FDA does not mandate a particular method of requesting follow-up information, documentation that all postmarketing ophthalmologic events that might reflect NAION were investigated should be maintained.
6. Failure to submit 15-day Alert reports for serious adverse drug experiences as a non-applicant to the applicant within 5 calendar days of receipt as required by 21 CFR 314.80(c)(1) (iii).
Pfizer, as a non-applicant, elected to submit to the applicant (rather than to FDA) all reports of serious adverse drug experiences. However, you did not submit each report to the applicant within five calendar days of your receipt of the information.
Specifically, your firm's name is on the label of at least ten products (amoxicillin, finasteride, ondansetron, lamotrigine, metformin, penicillin V potassium, stavudine, tiotropium bromide, donepezil, interferon beta-la) for which you are required to submit serious ADE reports to the applicant within five calendar days. Of the 398 reports received by your firm for these products, 132 (33%) were sent to the applicants more than five calendar days after your receipt of them.
Your response acknowledged a need to improve on the timeliness of your submission of serious ADE reports to the applicants for products for which Pfizer does not hold the NDA or ANDA, but appears on the label as a distributor. Your response stated that activities such as targeted training and presentations have resulted in reporting timeframe improvement. However, a review of the overall time reporting for 5-day rule products in a time table provided to the investigators on July 9, 2009, for the period from December 8, 2008 to June 30, 2009, shows the contrary. As demonstrated by your report compiled for inspection entitled "5-Day Rule Products Sent to License Party between 08 Dec 2008 and 30 Jun 2009", there was a decline in the timeliness of reporting during this period.
7. Failure to promptly review all adverse drug experience information obtained or otherwise received by the applicant from any source as required by 21 CFR 314.80(b). Specifically:
Adverse drug experience information obtained or otherwise received from any source was not promptly reviewed, including information from commercial marketing experience and postmarketing epidemiological/surveillance activities.
The following are examples of serious ADEs that wvere not forwarded for case processing within 2-4 business days as required by your SOP AEM-01-02, dated July 14, 2008, pages 3 - 5:
Mfg. Report No. No. of Days Received Late
1. 2009202904 30
2. 2008150853 9
Your response provided an explanation for the lateness of these reports and stated that the firm has "robust quality processes in place to oversee performance ..." This response is deemed inadequate because your affiliates failed to comply with defined time fines for case processing as required by SOP AEM-01.
Your response commits the firm to implement "additional enhancements to tools enabling enhanced proactive management of case workload" to mitigate late reporting. A signed copy of your revised corrective action plan should be included in your response to this Warning Letter. Adequacy of the corrective action will be determined during subsequent inspection(s).
8. Failure to submit periodic adverse drug experience reports at quarterly intervals for each adverse drug experience which is not reported as a I5-day Alert report, for 3 years from the date of approval of the application, and then at annual intervals submitted within 60 days of the anniversary date of approval of the application as required by 21 CFR 314.80(c)(2). Specifically:
Individual ADEs which were not reported to FDA in a postmarketing IS-day Alert report have not been included in a periodic safety report.
Specifically, the following ADEs were not reported to FDA in a periodic safety report:
Mfg. Report No.
1. 2009189370
2. 2009205745
3. 2009206342
4. 2009211979
5. 2009178032
6. 2009186019
7. 2009152113
8. 2009166186
Your response to this observation reports a short term corrective action of nightly sweeps of the (b)(4) System with a permanent system correction to be implemented by the fourth quarter of 2009. Adequacy of the corrective action will be determined during subsequent follow-up inspection(s).
II. Deviations from 21 U.S.C. § 353(d) include the following:
In addition to the above violations of Postmarketing Adverse Drug Experience (PADE) reporting requirements, you have significant deviations from the requirements of Section 503(d) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 353(d)] and Title 21, Code of Federal Regulations, Part 203. Based on the information collected during the inspection, non-compliance with the requirements of the Prescription Drug Marketing Act (PDMA), include:
1. Failure to conduct an immediate investigation, to notify FDA within 5 working days, and provide written investigation reports within 30 days of initial notification of prescription drug sample thefts, significant losses, and falsification of prescription drug sample records as required by 21 CFR 203.37(a)(1),(2), and (3) and (b)(1), (2), and (3).
21 CFR 203.37(a)(1) and (b)(1) requires a manufacturer or authorized distributor of record to notify FDA within five working days of becoming aware of a significant loss, any known theft, or suspected falsification involving drug samples. 21 CFR 203.37(a)(2) and (b)(2) requires an immediate initiation of an investigation of a suspected significant loss, any known theft, or suspected falsification. 21 CFR 203.37(a)(3) and (b)(3) requires that FDA be provided with a complete written report, including the reason for and the results of the investigation, not later than 30 days after the date of the initial notification.
The FDA 483 observations concern Pfizer's failure to notify and follow up with FDA regarding significant losses, known thefts, or suspected falsifications in accordance with these PDMA legal requirements. Pfizer's response to the FDA 483 in this regard does not address how Pfizer will meet the Section 203.37 requirements. We recognize your intent to reduce the inventory period, but the reduction you describe would still not meet the five working day reporting requirement.
Examples of incidents of significant losses and confirmed variances in drug sample annual inventory reconciliation re orts that exceeded the established threshold for significant loss in Pfizer's SOP 010 (b)(4) that were not reported to FDA are as follows:
• Employee ID (b)(6) had a total inventory loss of approximately (b)(4) on July 17, 2009. At the time of inspection, FDA had not been notified.
• Employee ID (b)(6) had a possible theft of (b)(4) totaling a loss of (b)(4) on March 11, 2008. A police report was filed on May 13, 2008, yet Pfizer did not notify FDA until May 30, 2008.
• Employee ID (b)(6) had a variance of (b)(4) on Aug 19, 2008. FDA was not notified until approximately two months later.
2. Failure to conduct, at least annually, a complete and accurate physical inventory of all drug samples distributed and to record the results of such inventory as required by 21 CFR 203.31(d).
21 CFR 203.31 (d) requires that each drug manufacturer or authorized distributor of record that distributes drug samples by means of representatives shall conduct, at least annually, a complete and accurate physical inventory of all drug samples. All drug samples in the possession or control of each manufacturer's and distributor's representatives are required to be inventoried and the results of the inventory are required to be recorded in an inventory record. In addition, manufacturers and distributors shall reconcile the results of the physical inventory with the most recently completed prior physical inventory and create a report documenting the reconciliation process.
Annual inventory reconciliations are not conducted once a year as per your SOP 010. Specifically, out of 35 inventories reviewed by FDA, the following employees did not have their inventories taken annually:
Employee (b)(6)
Employee (b)(6)
Employee (b)(6)
Employee (b)(6)
Employee (b)(6)
Employee (b)(6)
Employee (b)(6)
Employee (b)(6)
Employee (b)(6)
Employee (b)(6)
Employee (b)(6)
Employee (b)(6)
Employee (b)(6)
Employee (b)(6)
Your response relays the intent to revise SOP 010 to assure that all future employee inventories are performed within 12 months from the initial inventory review rather than once each calendar year. However, we have not yet received your revised SOP and you have not addressed the status of inventories for the above employees. Therefore, the adequacy of your response cannot be determined.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your firm. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, prosecution or injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts. Additionally, FDA may withhold approval of requests for export certificates, or approval of pending new drug applications, listing your facility as a supplier or manufacturer until the above violations are corrected. A reinspection may be necessary.
You should notify this office upon receipt of this letter to arrange for a meeting to discuss the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to prevent the recurrence of similar violations. If corrective action cannot be completed within 15 working days, state the reason for delay and the time within which corrections will be completed.
Your reply should be sent to Compliance Branch, Food and Drug Administration, 158-15 Liberty Avenue, Jamaica, NY 11433 Attention: Lillian C. Aveta, Compliance Officer.
Sincerely,
/S/
Ronald M. Pace
District Director
New York District
1 The Milan office, which is one of the core DSS offices, was not trained until July 2009.
Enclosure: Form FDA 483 dated August 10, 2009
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Page Last Updated: 06/14/2010
CPSC Launches National Campaign to Change the Way People Think and Act about Pool and Spa Safety
Pool Safely Campaign Aims to Reduce Child Drownings and Entrapments
http://www.cpsc.gov/cpscpub/prerel/prhtml10/10241.html
FORT LAUDERDALE, FL - The U.S. Consumer Product Safety Commission (CPSC) today kicks-off the Pool Safely campaign (www.poolsafely.gov), a first-of-its-kind national public education effort to reduce child drownings and non-fatal submersions, and entrapments in swimming pools and spas. At a press conference at the Fort Lauderdale Aquatic Complex today, Olympic swimmers Jason Lezak and Janet Evans joined Inez Tenenbaum, Chairman of the CPSC; U.S. Rep. Debbie Wasserman Schultz (D-FL); and Nancy Baker, mother of Virginia Graeme Baker, to officially launch Pool Safely and release the CPSC's annual submersion and entrapment reports.
The Pool Safely campaign is a key part of the CPSC's efforts to carry out the requirements of Section 1407 of the Virginia Graeme Baker Pool and Spa Safety Act (P&SS Act), federal legislation signed into law in 2007 mandating new requirements for pool and spa safety. It includes a requirement for a national public education campaign designed to raise public awareness, support industry compliance, and improve safety at pools and spas.
"I have been involved in the issue of pool safety throughout my career and today marks a key milestone in the ongoing fight to reduce accidental drowning," said Congresswoman Debbie Wasserman Schultz, author of the Virginia Graeme Baker Pool and Spa Safety Act. "Educating communities on the potential dangers of swimming pools is a critical tool in saving the lives of our children. I am so pleased to have worked with my colleagues in Congress to provide the funds needed for implementation of this important campaign."
The Pool Safely campaign will deliver an important and simple message: just adding an extra safety step in and around the water can make all the difference. Your greatest water safety assurance comes from adopting and practicing as many water safety measures as possible, including: barriers that completely surround the pool with self-closing, self-latching gates; staying close, being alert, and watching children at the pool; learning and practicing water safety skills (knowing how to swim and perform CPR); and having the appropriate equipment (compliant drain covers, alarms, barriers and sensors).
The campaign will highlight the need to implement a "personal system of safety" that consists of adding as many proven water safety practices as possible in and around pools and spas.
"As a parent of young children, I know there's no single, sure-fire way to ensure their safety around pools and spas," added Janet Evans, five-time Olympic medalist in swimming. "Whether it's enrolling them in swimming lessons or simply watching them at all times, there is always one more thing I can do. The Pool Safely campaign offers a variety of simple steps we can all take to protect our children in pools and spas."
Pool Safely will serve as an information hub delivering campaign tools and resources to various outreach channels. CPSC has taken the lead by partnering with national, regional and local organizations in the children's safety and drowning prevention communities. By engaging key partners, the campaign will reach the widest possible audience and build a sustainable network that will ensure the campaign's messaging is delivered for years to come.
"Knowing how to swim helped me win gold in the water, but it takes adding as many water safety steps as possible to ensure a safe environment for children in and around pools and spas, " said seven-time Olympic medalist in swimming Jason Lezak. "No matter how responsible you already are, there is always one more safety step you can take to protect your child. That is how you can Pool Safely. "
"I understand the need to bring together the public and dedicated partners in the water safety community to begin a national conversation about water safety," said Nancy Baker, the mother of Virginia Graeme for whom the Act is named. "I am honored to be involved in the Pool Safely campaign and look forward to working together to promote additional water safety steps we all can take in protecting our loved ones in and around pools and spas. Simple steps save lives."
The Pool Safely campaign - a national public education effort by the Consumer Product Safety Commission - is proud to partner with leading organizations, including American Red Cross, YMCA of the USA, Safe Kids USA, National Drowning Prevention Alliance (NDPA), World Waterpark Association (WWA), and Abbey's Hope. For more information, visit the website at www.poolsafely.gov or follow the campaign on Twitter @poolsafely
http://www.poolsafely.gov/
# Drowning is preventable, especially among children. http://www.poolsafely.gov/ #poolsafely #pools 2 days ago
http://www.ready.gov/america/getakit/seniors.html
Disaster Preparedness for Older People
Each person's needs and abilities are unique, but every individual can take important steps to prepare for all kinds of emergencies and put plans in place. By evaluating your own personal needs and making an emergency plan, you can be better prepared for any situation. A commitment to planning today will help you prepare for any emergency situation. Preparing makes sense. Get ready now.
* Consider how a disaster might affect your individual needs.
* Plan to make it on your own, at least for a period of time. It's possible that you will not have access to a medical facility or even a drugstore.
* Identify what kind of resources you use on a daily basis and what you might do if they are limited or not available.
* Get an emergency supply kit.
* If you must evacuate, take your pets with you, if possible. However, if you are going to a public shelter, it is important to understand that animals may not be
allowed inside.
* Plan in advance for shelter alternatives that will work for both you and your pets; consider loved ones or friends outside of your immediate area who would be
willing to host you and your pets in an emergency.
*
Create a Support Network
* If you anticipate needing assistance during a disaster talk to family, friends and others who will be part of your personal support network.
* Write down and share each aspect of your emergency plan with everyone in your support network.
* Make sure everyone knows how you plan to evacuate your home or workplace and where you will go in case of a disaster.
* Make sure that someone in your local network has an extra key to your home and knows where you keep your emergency supplies.
* Teach those who will help you how to use any lifesaving equipment, administer medicine in case of an emergency.
* Practice your plan with those who have agreed to be part of your network.
Additional Supplies and Documents:
Medications and Medical Supplies
If you take medicine or use a medical treatment on a daily basis, be sure you have what you need to make it on your own for at least a week, maybe longer.
* Make a list of prescription medicines including dosage, treatment and allergy information.
* Talk to your pharmacist or doctor about what else you need to prepare.
* If you undergo routine treatments administered by a clinic or hospital or if you receive regular services such as home health care, treatment or transportation, talk to your service provider about their emergency plans. Work with them to identify back-up service providers and incorporate them into your personal support network.
* Consider other personal needs such as eyeglasses, hearing aids and hearing aid batteries, wheelchair batteries, and oxygen.
Emergency Documents
Include copies of important documents in your emergency supply kits such as family records, medical records, wills, deeds, social security number, charge and bank accounts information and tax records.
* Have copies of your medical insurance and Medicare cards readily available.
* Keep a list of the style and serial number of medical devices or other life-sustaining devices. Include operating information and instructions.
* Make sure that a friend or family member has copies of these documents.
* Include the names and contact information of your support network, as well as your medical providers.
* If you have a communication disability, make sure your emergency information notes the best way to communicate with you.
* Keep these documents in a water proof container for quick and easy access.
More Information
For more information, see Disaster Preparedness For People With Disabilities Adobe Acrobat Reader Required from FEMA, and the Red Cross website.
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