четверг, 23 февраля 2012 г.

Drug imports a thorny issue.(Focus)

PHILADELPHIA -- Whether referred to in warnings about counterfeit drugs or discussed in debates over medication reimportation, the subject of pharmaceuticals crossing the border from Canada and elsewhere continues to draw concern.

The National Association of Chain Drug Stores and the National Boards of Pharmacy, together with the retailers and regulators those groups represent, are among those drawing attention to the dangers medications and fake drugs from other sources may pose to United States consumers.

Hundreds of millions of dollars worth of drugs from abroad and are being delivered into the hands of millions of Americans. And only minimal amounts of such drugs are confiscated at the Canadian border.

Several speakers at the recent NACDS Pharmacy and Technology Conference pointed out that U.S. residents have little if any way of verifying where such drugs originate.

And recent news reports support those apprehensions. In Miami, for example, a mother and son were sentenced to federal prison earlier this month for running an unlicensed Internet pharmacy that filled orders from the woman's home.

In Bergen County, N.J., a bodybuilder was charged with operating a black market that bought AIDS medications from drug users and then sold them to wholesalers across the country--which in turn may have unknowingly stocked pharmacy shelves with potentially damaged drugs.

In Iowa, a Dubuque pharmacy's license was suspended by the state pharmacy board after the panel asserted that the business, Union Family Pharmacy, was using the Internet to sell drugs from the Virgin Islands. The pharmacy board said the arrangement allowed patients to obtain what it called dangerous and highly addictive drugs (such as diazepam and hydrocodone) without a valid physician-patient relationship. In addition, it charges the drugs were dispensed without verification that they were for legitimate reasons and without proper documentation.

Even managed care plans are beginning to sponsor Canadian prescription programs, despite warnings from the Food and Drug Administration they are in violation of civil and criminal laws by making such purchases possible.

Earlier this month the Justice Department, at the urging of the FDA, asked a court to stop Rx Depot Inc. from reimporting discounted prescription drugs from Canada. Rx Depot president Carl Moore vows to fight the lawsuit.

A suit was filed in a federal court in Oklahoma to block Rx Depot, which has 85 locations across the United States.

With so many drugs moving across the border, Canada is beginning to experience shortages of some pharmaceutical products.

But drug manufacturers in this country are fighting back.

For the most part, Internet companies that deal in exceptionally large volumes of such prescriptions have drawn the most attention from pharmaceutical firms. New tactics, however, are emerging.

Pfizer Inc., for example, has told approximately 50 Canadian pharmacies to begin buying directly from it instead of from wholesalers, a move similar to that previously taken by AstraZeneca PLC, GlaxoSmithKline and Wyeth.

In Canada an association that defends physicians in that country in malpractice lawsuits has warned those doctors they will be without coverage if they are sued over a prescription written for a U.S. patient.

Similarly, the Ontario College of Pharmacists has brought charges against Canadian Drugstore Inc., an Internet pharmacy group, as well as disciplinary action against the physician who wrote prescriptions for that web-based operation.

The FDA has also sent an advisory letter to state officials in California in response to inquiries from a legislator. In that correspondence the agency reiterates that "if any state, county, city, pension program or Indian tribe were to import prescription drugs from Canada it would violate federal law" in virtually every instance.

California officials had sought the FDA's opinion as they pondered purchasing prescriptions from Canada to save funds in the state's public employees health program.

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