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FDA to research prescription treatments
by Meghann Myers, Medill News Service
Silver Spring, Md. (UPI) Apr 3, 2012

disclaimer: image is for illustration purposes only

Weapons of mass destruction may have faded from the national discussion of public health threats but the U.S. government continues to plan strategies to fight bioterrorism attacks on U.S. soil.

The Federal Drug Administration's Anti-Infective Drug and Nonprescription Drug Advisory Committees convened a group of physicians, public health officials and other infectious disease specialists Monday to discuss development of a federally regulated, prescription emergency antibiotic kit for use in the event of anthrax exposure.

Though emergency treatments have undergone pilot studies in recent years, the government is looking into creating a user-friendly consumer MedKit that the average American could buy, store at home and use properly in case of a bioterrorism attack.

"Something could occur and people would not have access to their doctor or a pharmacist, so this needs to stand on its own," said Barbara Cohen, an official with the FDA's Office of Drug Evaluation.

The inevitability of human error is the major challenge in developing the kits, primarily the misuse of the enclosed doxycycline antibiotics.

The experts agreed that some sort of antibiotic anthrax treatment must be readily available to the public in case of an attack but differences arose over how to distribute the medication.

Ultimately the government is seeking to answer two questions: Should the treatments be available to the general public to store in their homes rather than stockpiled by community public health organizations for distribution following an event; and how can a kit be packaged to make the treatment as simple to use as possible?

"Obviously, if people can't understand the label, they're not going to be able to use the product correctly," Cohen added.

The FDA will need to evaluate, through consumer studies, whether the general public is able to properly identify the correct situation in which to use the kit, follow instructions under stressful circumstances, properly prepare the pills for children and others who can't swallow pills and recognize if doxycycline will cause an adverse reaction with other medications.

Research by the Centers for Disease Control and the Minneapolis Department of Health concluded the majority of participants were able to properly store doxycycline kits in their homes and return them undamaged upon request.

However, as Dr. Robert Bass of the Public Institute of Medicine pointed out, some specific factors may have contributed to the overall success of those studies.

"We question whether those special circumstances can be applied to the general public without the financial incentive, short-term follow-up and employer supervision in those studies," Bass said.

Going forward, the FDA will have to conduct its own studies before developing, manufacturing and sending the MedKit to market.

"The research that's been presented today is really rather inadequate to answer these questions," said Dr. Andrew Pavia of the Infectious Diseases Society of America. "The most effective systems will be those that are adapted to local systems and not a one-size-fits-all approach."

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