COVER STORY

SURF AND TURF WARS

Pharmacists are increasingly concerned about the growth of rogue Internet pharmacies, especially those from Canada

While a hard core of rogue Internet drug sellers continues to do business virtually unchecked, a new on-line health risk has emerged in the North.

In the past year or so, dozens of Canadian pharmacies, many operating on-line, have leaped into the mail-order prescription business, using their powerful competitive price advantage to lure American consumers hammered by high medication costs. The Internet has greatly extended Canadian pharmacies' marketing reach, which was once limited to border states.

Philip P. Burgess, R.Ph., national director of pharmacy affairs at Walgreens, said Canadian pharmacies have even run full-page ads in newspapers in Arizona and Florida trying to induce consumers, mostly retirees, to save money by buying their prescription drugs on-line. He said the drug chain had identified about 100 "entities" that are shipping prescription drugs into this country by mail from Canada. "Many of them are on-line," he said.

Although most of these pharmacies require prescriptions from U.S. physicians—which are rewritten by Canadian doctors and dispensed by Canadian pharmacists—the process bypasses traditional Food & Drug Administration quality assurance safeguards as well as the drug utilization review safety net provided by American community pharmacies.

Consumer media coverage about the growth of Canadian mail-order pharmacies has generally played down the health risks and emphasized the plight of elderly individuals who have been able to save hundreds, if not thousands, of dollars a year by going on-line or crossing the border to buy their medications.

The subliminal message conveyed by this coverage is that it would be risky to political health to come down hard on mail-order prescription traffic from Canada while Congress remains deadlocked on a Medicare drug plan to benefit the elderly, about two-thirds of whom have marginal or no prescription insurance. Indeed, some politicians have abetted the personal import practice by hiring buses to take elderly constituents across the border to obtain their medications.

Even the FDA seems to have relaxed its guard on the Canadian pharmacy issue. For one thing, the agency's authority outside this country is limited to inspections of foreign manufacturing plants that make pharmaceuticals for the U.S. mar- ket. For another, while it may be illegal for a person to import drugs, the practice of individuals' obtaining medications from other countries for their own use lies in a regulatory no-man's land. Since the 1950s, the FDA has permitted patients with serious illnesses to travel out of the United States to get medications not yet approved in this country. Drugs for AIDS and Alzheimer's are past examples of this "personal use exemption" allowed by the FDA.

Even rogue sites have latched on to the FDA personal use exemption in an attempt to legitimize their clearly illicit operations, according to Carmen Catizone, R.Ph., M.S., executive director of the National Association of Boards of Pharmacy.

Most medications now being shipped through Canadian pharmacies are not covered by the stipulations of the personal use exemption. Rather, the motivation for buying north of the border has been almost entirely economic. But the FDA's political antenna is as sensitive as any officeholder's, and the agency has not been aggressive on the Canadian pharmacy issue compared with, say, its actions against domestic Internet sites selling so-called lifestyle drugs without prescriptions.

Still, that hasn't stopped individuals at the agency from speaking about the risks of buying drugs outside of the FDA's protective umbrella. Tom McGinnis, R.Ph., FDA's director of pharmacy affairs, noted that it was difficult, if not impossible, to determine whether drugs coming from Canadian pharmacies were manufactured in FDA-approved plants and thus comparable in quality to drugs available in U.S. pharmacies.

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