Announcement

Collapse
No announcement yet.

U.S. questions home drug stockpiles for flu pandemic

Collapse
X
 
  • Filter
  • Time
  • Show
Clear All
new posts

  • U.S. questions home drug stockpiles for flu pandemic

    U.S. questions home drug stockpiles for flu pandemic
    Updated Thu. Oct. 30 2008 8:16 AM ET

    Helen Branswell

    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.

    The group did indicate, through a 20-6 vote (with one abstention), that the FDA should require the two pharmaceutical companies that would produce the flu medkits to undertake more research than the companies have so far proposed.

    Hoffman-La Roche, the maker of Tamiflu, and GlaxoSmithKline, which makes Relenza, were suggesting relatively minimal new research.

    The companies, which have been asked to pursue development of medkits by HHS's Office of Biomedical Advanced Research and Development Authority, proposed studies to see if people can understand the proposed medkit labelling and could - in the case of Relenza - use the inhaler device needed to administer the drug.

    Both companies also proposed to distribute medkits to a number of people with instructions not to use it for seasonal flu. They planned to later follow up to see whether the kits were still intact after one flu season.

    The idea of medkits for pandemic flu comes from the doctrine of "shared responsibility," Dr. Robin Robinson, director of theBiomedical Advanced Research and Development Authority, said in an interview.

    The U.S. federal government understands, he said, that it cannot meet every need in a crisis. Other parties in society have a role to play.

    Robinson likened it to the philosophy of personal preparedness that was espoused in the civil defence programs of the 1950s - a time when people stockpiled food and even built fall-out shelters in anticipation of feared nuclear attacks.

    "This is a return to that self-reliance," Robinson said. "Because all responsible officials tell people that the federal government is not going to be able to help provide everything all the time."

    "Individuals, local (and) state governments, businesses and the federal government all have roles in this type of responsibility."

    Canada does not currently envisage this approach to antiviral stockpiling.

    Robinson said he knew of no other country that is pursuing a similar plan, but said other countries are watching the U.S. discussions to see where the debate leads.

    Like many others, the U.S. federal government is stockpiling millions of doses of antiviral drugs for treatment of the ill in a pandemic. And some states too have bought additional stocks of the drugs. But how those drugs will be distributed when a pandemic hits is a dilemma many jurisdictions are struggling with.

    It is expected that doctors and hospitals will be overwhelmed and won't be able to handle an influx of sick people looking for antiviral drugs. And it is thought distribution centres would spread disease at least as efficiently as they spread drugs.

    "This is a real tough nut to crack for us," said panel member Robert Mauskapf, the director of emergency operations for Virginia's department of health.

    He said his state has bought a large supply of antiviral drugs, but so far has been unable to figure out how to close the distribution gap that will be created when doctors are too busy to write prescriptions and emergency departments are "clobbered."

    Mauskapf said he thought the medkit proposal might help close that gap.

    Robinson said questions remain to be answered before any decision can be made.

    "This is exploratory. This is a concept and we're trying to find the best way. If at the end of the day we can, then we would like to move forward with them in collaboration with physician groups and other health-care providers. And if there's not data there, then we won't go forward with it."

    Last edited by Sally Furniss; November 2, 2008, 04:13 PM. Reason: Correct author named. Hat tip crof
    The salvage of human life ought to be placed above barter and exchange ~ Louis Harris, 1918
Working...
X