U.S. looks at whether home drug stockpiles for flu pandemic makes sense

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U.S. looks at whether home drug stockpiles for flu pandemic makes

sense Oct 29, 2008 The Canadian 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. 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 GlaxoKline, 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 , 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.

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, " 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.

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

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.

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. "