Tuesday, August 30, 2011

Drugs Posing as Supplementals May Contain Dangerous Ingredients - NYTimes.com

Drugs Posing as Supplementals May Contain Dangerous Ingredients - NYTimes.com ('via Blog this')

A good read on the shaky tension between legitimate, tainted, and dangerous supplements. The supplement industry blames the FDA for failing to institute mandatory recalls and seize tainted goods.

In a nutshell:

Daniel Fabricant of the FDA says, "the growing availability of tainted products represents a serious public health problem, one that could taint the dietary supplement industry as a whole."
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Friday, August 26, 2011

FDA Hurricane Preparedness Checklist

Be safe, be well.

In the interest of public safety, I'm providing the full text of the FDA Hurricane Preparedness Checklist for your quick reference:

The FDA reminds consumers to take precautions for storing water and ensuring the safety of their food and medical supplies for themselves and their pets during and after this week’s expected hurricane-related rain, possible flooding and power outages.
The agency also reminds consumers that it is important to have a plan in place for emergency medication and medical supplies for both people and animals. This is especially true for those with health concerns, particularly if the power goes out.
In general, FDA encourages consumers to:
Food• Do not eat any food that may have come into contact with flood water. If in doubt, throw it out.• Do not eat food packed in plastic, paper, cardboard, cloth and similar containers that have been water-damaged.

• Discard food and beverage containers with screw-caps, snap lids, crimped caps (soda bottles), twist caps, flip tops and home canned foods, if they have come in contact with flood water. These containers cannot be disinfected.
• Check to ensure that the freezer temperature is at or below 0 °F and the refrigerator is at or below 40 °F.
• Keep the refrigerator and freezer doors closed as much as possible to maintain the cold temperature.
• For more information, see Hurricanes and Floods: Key Tips for Consumers About Food and Water Safety http://www.fda.gov/Food/ResourcesForYou/Consumers/ucm077029.htm and Power Outages: Key Tips for Consumers About Food and Water Safety
Water• Area health departments will determine whether local tap water can be used for drinking. If the water cannot be used or is questionable, and bottled water is not available, then use the directions in the next bullet to purify it.
• Boiling water will kill most types of disease-causing organisms that may be present. If the water is cloudy, filter it through clean cloths or allow it to settle and draw off the clear water for boiling. Boil the water for one minute, let it cool and store it in clean containers with covers.
• For more information, see Food Safety for Consumers Returning Home After a Hurricane and/or Floodinghttp://www.fda.gov/Food/ResourcesForYou/Consumers/ucm076993.htm
Pets• If you have to leave your home, take your pet with you if at all possible. You are the best person to take care of your pet.
• Pets should be contained in a carrier or on a leash.
• Emergencies can make pets display unexpected or uncharacteristic behaviors. It may take several weeks before your pet’s behavior is back to normal.
• Allow your pet plenty of time to rest and get used to new surroundings. Provide familiar toys, if possible.
• For more information see Taking Care of Pets During a Disaster or Emergencyhttp://www.fda.gov/AnimalVeterinary/ResourcesforYou/ucm047099.htm
Drugs Exposed to Water• For lifesaving drugs exposed to water, when replacements may not be readily available, if the container is contaminated but the contents appear unaffected –if the pills are dry—the pills may be used until a replacement can be obtained. However, if the pill is wet it is contaminated and should be discarded.
• Other drug products (pills, oral liquids, drugs for injections, inhalers, skin medications) —even those in their original containers—should be discarded if they have come into contact with flood or contaminated water. In the ideal setting, capsules, tablets, and liquids in drug containers with screw-top caps, snap lids, or droppers, should be discarded if they are contaminated. In addition, medications that have been placed in any alternative storage containers should be discarded if they have come in contact with flood or contaminated water.
• For more information, see Safe Drug Use After a Natural Disaster http://www.fda.gov/Drugs/EmergencyPreparedness/ucm085200.htm
Insulin Storage and Switching Between Products in an Emergency• As a general rule, insulin loses its potency according to the temperature it is exposed to and length of that exposure. Under emergency conditions, you might still need to use insulin that has been stored above 86 °F. Such extreme temperatures may cause insulin to lose potency, which could result in loss of blood glucose control over time.
• In any case, you should try to keep insulin as cool as possible. Try to keep insulin away from direct heat and out of direct sunlight, but if you are using ice, also avoid freezing the insulin.
• When properly stored insulin becomes available, discard and replace the insulin vials that have been exposed to these extreme conditions.
• For more information see Information Regarding Insulin Storage and Switching Between Products in an Emergencyhttp://www.fda.gov/Drugs/EmergencyPreparedness/ucm085213.htm
Medical Devices• If you have a “life-supporting” or “life-sustaining” device that depends on electricity, you should contact your healthcare provider for information on how to maintain function in the event of a loss of power.
• Keep your device and supplies clean and dry. If possible, notify your local Public Health Authority to request evacuation prior to adverse weather events.
• For more information, see FDA Offers Tips about Medical Devices and Hurricane Disastershttp://www.fda.gov/MedicalDevices/Safety/EmergencySituations/ucm055987.htm
Vaccines, Blood, Biologics• If the power goes out, make note of the time and keep refrigerators and freezers closed as much as possible. 
• When the power is restored, if possible, determine the temperature in the refrigerator or freezer before the temperature starts to go back down.
• If the power outage continues, consider removing products from the refrigerator or freezer and packing them in ice or dry ice as appropriate.
• If contact with flood water occurs, the product should be considered contaminated and should not be used.
• For more information, see Impact of Severe Weather Conditions on Biological Productshttp://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ProductSecurity/ucm147243.htm

Find more information for consumers and industry on all FDA-regulated products at
For more hurricane preparedness information: Hurricanes at http://www.ready.gov/america/beinformed/hurricanes.html 

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Wednesday, August 24, 2011

GMP Proper Documentation Tips - Free

Updated 10/19/2015:
The post below is outdated.  You might be interested in cGMP training by SkillsPlus Intl Inc.


I found this helpful document, it's free, Documentation - Rules for Completion (GMP Trainers' Survival Kit II) - PDF

It could be especially useful for classroom trainers, or for staff trying to reinforce GMP good documentation practices.

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Tuesday, August 23, 2011

Online Pharmacy Dangers Lurk

Beware, if you search for pharmacies online, there's a good chance you'll encounter infected websites, and rogue and illegal pharmacies: http://consumer.healthday.com/Article.asp?AID=655839

Monday, August 22, 2011

IATA Perishable Cargo Regulations

The International Air Transport Association (IATA) represents some 230 airlines comprising 93% of scheduled international air traffic.

IATA publishes The Perishable Cargo Regulations Manual: THE standard for cargo handling (buy online)

According to IATA, The Perishable Cargo Regulations (PCR) manual is the leader in temperature control and cold chain management for goods from the health care and food sectors, including pharmaceutical products and non-hazardous biological materials and includes everything you need to properly prepare, package and handle time and temperature sensitive goods quickly and efficiently.

Additional IATA resources related to perishable cargo

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Saturday, August 20, 2011

GMP Library Search Tool - Free

Updated April 9, 2015:  Unfortunately, the GMP Library, mentioned below, is no longer active.

- - - - - -

PharmOut, a professional consultancy specializing in GMP compliance, has created an online database of GMP guidelines.

This database is free to access and allows the user to search across all English language GMP guidelines, past and present:

GMP Library Search by PharmOut
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Friday, August 19, 2011

The Pfizer Inside Story - WOW

The latest issue of Fortune magazine (Aug 15, 2011) found its way into my hands this morning.

The title screamed loudly to me, Inside Pfizer's palace coup (full text Fortune magazine story online) - Did CEO Jeff Kindler get pushed out because he was shaking up the dysfunctional pharmaceutical giant - - - or because he was an ineffective leader?

I can't describe this compelling story any better than the Fortune magazine cover:

What happened at Pfizer. The inside story of revenge, betrayal, and power at the top of the world's largest drug company.
The tale is a gripping must read. Kudos to the authors:  Peter Elkind and Jennifer Reingold (with Doris Burke)
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Monday, August 15, 2011

Medical Device Premarket Review - FDA Draft Guidance

For the first time, the U.S. FDA (Food and Drug Administration) has provided draft guidance clarifying how benefit-risk determinations are made during premarket review of certain medical devices.

The guidance focuses on premarket approval applications (PMAs), the regulatory pathway for high-risk medical devices. The recommendations made in the guidance are intended to improve the predictability, consistency and transparency of the premarket review process for applicable devices, and should help manufacturers navigate the approval process more easily.

In its review of PMAs, the FDA uses safety data and effectiveness data. The safety data addresses risk, and the manufacturer’s ability to mitigate that risk. The effectiveness data considers benefits, as well as other information, to determine whether the probable benefits outweigh the probable risks associated with use of the device.

Safety and effectiveness data alone may not provide a complete picture of the benefits and risks. FDA medical device reviewers objectively look at other factors such as the severity of the disease the product diagnoses or treats and whether or not alternative tests or treatments are available.

Device reviewers also may consider whether the device is new or a first-of-a-kind technology as part of the benefit-risk determination, particularly if the device treats a disease that has no other treatment.

The guidance also proposes that medical device reviewers use a worksheet to document how they make benefit-risk determinations. In certain cases, this document could be made public post-approval, making the FDA’s decision making process even more transparent.

Learn more:
FDA - Draft Guidance for Industry and Food and Drug Administration Staff - Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review
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Monday, August 1, 2011

Colon Cleansing Risky - Controversy

Updated Sept 8, 2016

You might also be interested in:
You Asked: Is Getting a Colonic Dangerous? - TIME

- -  original post follows below  - -

I've never had a colon cleanse, though I know friends who swear by them.

I'm inclined to avoid them, after reading about the latest findings reported by Mishori (reported in the Journal of Family Practice).

For a quick read, go to WebMD and read, Colon Cleansing May Be Risky, Study Finds - Hazards May Include Nausea, Vomiting, Kidney Failure; Advocates Cite Energy Boost, Other Health Benefits.

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