Thursday, October 30, 2008

FDA Advisory Panel Discussing Merits Of Individual Home Drug Stockpiles

 

 

# 2432

 

 

It is a sticky question, whether to promote the idea of home stockpiling of Tamiflu or antibiotics for use during a pandemic. 

 

Personally, as a responsible adult, and one with a modicum of medical training, I love the idea.  Enough, in fact, that with the assistance of my family physician, I've obtained a small quantity of such medications.

 

But there are legitimate concerns that such individual stockpiles might be misused.  That people may take the meds improperly, or use them for a non-pandemic illness, rather than seeing their doctor.

 

It is an imperfect solution.

 

 

But then, when you are dealing with a pandemic, all solutions are going to be imperfect.  

 

We need to get used to that concept.

 

 

In St. Louis,  the CDC in conjunction with the Missouri Health Department, conducted a test where med kits containing CIPRO were distributed to thousands of selected households, and then at a later date, they were asked to return the medkits.

 

Participants belonged to three cohorts;1) clients and some employees of a community health clinic; 2) corporations; and 3) first responders.

 

The results (from the CBN Report):

 

 

  • 97% (3,946 out of 4,076) of all study respondents returned the MedKits upon completion of the study, and 99% of the returned MedKits were intact (i.e. no pills missing).

 

  • 130 (3%) of households did not return the MedKits; 125 of these could not find their MedKits, and 5 refused to return them. Only 4 households, all in the clinic cohort, reported having used their MedKits.

 

  • 94% or more in each cohort indicated they would like to have a MedKit in their home.

 

  • Approximately 85% indicated they would be willing to pay for a MedKit, for a price, on average, of about $23 per person

 

 

 

While the participants of this study may not be representative of the population at large, this study does show that responsible home stockpiling of medications is  possible.

 

 

And given the logistics of dispensing life saving medications during a public health disaster, such as a bioterrorism attack or a pandemic, having pre-positioned medkits in homes around the nation would solve a lot of problems.

 

 

A panel is currently discussing these issues, and will forward their advice to the FDA, who would have to approve of any Medkit before it could be dispensed.

 

 

 

 

U.S. questions home drug stockpiles for flu pandemic

 

Updated Thu. Oct. 30 2008 8:16 AM ET

The Associated Press

BETHESDA, Md. -- Should people be allowed or even urged to buy and store in their homes flu drugs for use in an influenza pandemic? The U.S. government, which has been grappling with how to distribute antiviral drugs in the anticipated chaos of a pandemic, believes the idea bears exploring.

 

But discussions Wednesday of a panel of experts convened to advise the U.S. Food and Drug Administration on the idea showed just how many sticky issues are enmeshed in the proposal to allow pharmaceutical companies to sell "flu medkits."

 

Concerns were raised about whether people could be trusted to store and use the drugs appropriately and whether misuse might fuel the development of resistance to the few influenza drugs on the market. Some experts worried whether parents would be able to gauge the amount of drug their children would need and mix a solution - by breaking open capsules - based on the child's weight.

 

Still others echoed the concerns raised by representatives of physician and pharmacist groups who argued against taking the responsibility for deciding when a person needs a prescription drug out of the hands of medical professionals.

 

But some members of the panel favoured the notion, reminding colleagues that personal stockpiling of the drugs oseltamivir (Tamiflu) and zanamivir (Relenza) is already taking place.

 

"It's going on already. What we need to do is to figure out a way to do it intelligently," said Dr. John Bradley, director of the division of infectious diseases at the Children's Hospital and Health Center in San Diego, Calif.

 

The meeting was not asked to give the U.S. Department of Health and Human Services (HHS), which is spearheading the idea, a "proceed" or "abandon" type of recommendation.

 

Instead, they were charged with discussing and in some cases voting on a series of questions aimed at fleshing out what kinds of studies the FDA - which would have to approve the marketing of medkits - would need before it could consider the products.

 

(Continue . . . )