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CMAJ
Authorities on both sides of the border are trying to deal with legal uncertainties surrounding the operation of Canadian online/mail-order pharmacies that fill prescriptions for Americans.
"There is a lot of ambiguity and greyness as to what is the law," says Susan Wedlake, registrar for the Nova Scotia Pharmaceutical Society, the provincial regulator. She says sending drugs over the border is illegal in the US, "but it appears to us that enforcing this hasn't been a high priority for the FDA [Food and Drug Administration]."
Online Canadian pharmacies have become popular with Americans because drugs are much cheaper here due to government regulation. Jeff Poston, executive director of the Canadian Pharmacists Association, says the FDA doesn't want to interfere because many of the patients involved are seniors without adequate insurance. "If they started to prosecute seniors, they would have a difficult moral position to defend," he says. "The real issue here is [the lack of] decent pharmaceutical benefits if you're a senior citizen in the US."
The issue entered the spotlight Jan. 21 when the North American subsidiary of GlaxoSmithKline announced that it would stop supplying drugs to Canada's online pharmacies. Glaxo cited numerous reasons for its decision, including risks associated with ordering drugs over the Internet. "The Internet poses risks for patients, since the origin and authenticity of the product cannot be guaranteed and offers no assurances that patients have access to appropriate physician involvement or access to the dispensing pharmacist."
The Manitoba International Pharmacists Association, which comprises more than 100 pharmacists from the online/mail-order industry, said the company was putting personal profit ahead of public health.
But Canadian authorities are also concerned about this same lack of accountability. For instance, a Canadian physician must sign every prescription filled here. However, every province has different standards of practice for pharmacists and physicians. Ron Guse, Manitoba's pharmacy registrar, says it's possible for online pharmacies to bypass professional standards — such as the existence of a physician–patient relationship as a prerequisite for writing a prescription — by using physicians from other provinces. "Frankly, they can do so without being discovered because I can't share that info," says Guse, explaining that he and several other registrars can legally report only to their provincial authorities. "The travesty is that we're unable to provide the level of care required because of this loophole."
The US-based National Association of Pharmacy Regulatory Authorities (NAPRA) held a forum in February involving federal, provincial and American health and trade officials. Barbara Wells, NAPRA's executive director, said the goal was to determine the exact responsibilities for each of these groups.
If the law doesn't provide that clarity, Wells hopes the free market will. NAPRA has signed an agreement with the National Association of Boards of Pharmacy (NABP) in the US to begin using the voluntary Verified Internet Pharmacy Practice Site program, which gives sites that meet certain criteria a seal of approval they can present to the public.
NABP head Carmen Catizone says the program requires a bona fide relationship between physician and patient, which means that online consultations or questionnaires would not count. Also, pharmacies would have to obey the laws of the jurisdiction in which customers live. "Any pharmacy that sells medication to the US will not qualify," says Catizone.
The Canadian Internet-based drug businesses responded to Glaxo's sales boycott by asking customers to boycott the company's consumer health care products, such as Nicorette, Nicoderm and Tums. Glaxo's response? "It is unfortunate that some individuals, who are profiting from the cross-border sale of non-FDA approved drugs that may be putting patients at risk, are calling on Canadian Web pharmacy customers to act in a way that supports their own commercial interests." — Brian Whitwham, CMAJ
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Copyright 1995-2003, Canadian Medical Association. All rights reserved. ISSN 1488-2329
(e) 0820-3946 (p)
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