Prescription Drugs' Use and Canada

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Neena Quirion, director of the Maine Council of Senior Citizens in Augusta, has organized bus trips to Canada for her members and estimates that 25 seniors collectively saved about $19,000 on an overnight trip in March. "Paying for drugs is a real hardship for so many people," she says. "One lady takes about 15 different medications."

Quirion says they've obtained prescriptions from a doctor who is licensed to practice medicine in both Maine and Canada and who performs a physical examination on each person before writing prescriptions. "Our feeling is that the quality of the drugs is the same," she says. "Everything's very regulated in Canada."

Greg Thompson, Pharm.D, a pharmacy professor at the University of Southern California, agrees. "Getting drugs from Canada under the doctor's orders is different than getting drugs from Mexico on your own," he says. "Regulations in Mexico aren't as strict."

But even if you obtain drugs from a place or in a manner that you consider to be safe, according to the FDA, you are almost always obtaining unapproved drugs. "The law applies evenly to all countries outside of FDA's jurisdiction," says Thomas McGinnis, Pharm.D, director of pharmacy affairs in the FDA's Office of Policy, Planning, and Legislation.

So what about the belief often mentioned in the media that drugs sold in Canada are exactly the same as drugs sold in the United States--made in the exact same manufacturing plants? Some may be, and some may not. For example, drugs sold and distributed in Canada by Eli Lilly Canada come from the company's manufacturing facilities throughout the world--the United States, Europe, Asia, and South America.

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Manufacturing facilities that make drugs for Canadians have been approved and registered by Health Canada's Health Products and Food Branch, the federal agency responsible for regulating drugs sold in Canada. This agency is responsible for approving the product labeling, which must be made available in Canada's two official languages, English and French.

But the FDA does not have authority to approve drugs sold in Canada. And if a Canadian company is selling drugs only for export to the United States, and not to Canadian citizens, Health Canada may not regulate the drugs or the company at all. Drugs coming to the United States from Canada may be coming from some other country and simply passing through Canada. The drugs could also be counterfeit, contaminated, or subpotent, among other things (see "Potential Health Risks With Imported Drugs").

FDA experts say it would be hard for you to know whether drugs sold outside of the United States meet FDA standards and have been manufactured in a plant listed on an FDA-approved new drug application. "Even if you did know," McCallion says, "existing law requires you to prove it. The burden is on the importer to prove that the drug meets legal requirements--that includes having an FDA-approved label in English." The fact also remains that a drug made in this country can only be re-imported back into this country by the original manufacturer, he adds.

Barbara Wells, executive director of the National Association of Pharmacy Regulatory Authorities (NAPRA) in Ontario, Canada, says the practice of U.S. residents filling prescriptions in Canada is an issue that her organization is concerned about. "Our members do not feel that Canadian pharmacists should be breaking laws of jurisdictions in which their patients reside," she says.

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By Michelle Meadows

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