Monday, June 27, 2005

Canadian Bogus Drugs

(Hamilton, Ontario) So far, the regional coroner, Dr. David Eden, has six dead bodies under investigation for possible linkage to the dispensing of counterfeit medication. Hamilton's King West Pharmacy is alleged to have supplied bogus heart medicine disguised as Norvasc, a Pfizer drug, to each of the six older citizens that died. Shut down last Thursday pending replacement of inventory and appointment of new management, King West Pharmacy resumed business Saturday.

The counterfeit Norvasc was confirmed to contain only talcum which is useless for unstable angina and high blood pressure, conditions for which the Pfizer drug is prescribed. However, there's no confirmation yet on how the pharmacy acquired the bogus drugs, on whether other pharmacies are involved, nor whether other patients are at risk. The investigation appears to be at the starting gate. There's no reported knowledge of the scope nor overall culpability for the alleged bogus drug operation.

All that said, one might think this is the start of a major scandal. The Canadian media has reported on the deaths and the possible tie-in with bogus drugs, but none are using the word 'scandal.' But I'm using it.

Let's review some aspects of the scandal that have come to the forefront because of the deaths and the bogus pills. First of all, no arrests have been made. That means the pharmacists are not currently held accountable for anything. However, it's known that they dispensed counterfeit pills. The argument that they may not have known doesn't fly since a patient, I repeat, a patient was able to tell the difference between the genuine and the fake. Now, either the pharmacy knew it was handing out bogus medicine or it's staffed with completely incompetent pharmacists. If the pharmacy knew, somebody should be in jail. If the staffers are incompetent, then the media should be busting down the door of whoever licensed them. Neither of these two actions appears to have taken place.

Secondly, it's now been reported that drugs dispensed by Canadian pharmacies are not regularly tested for content by any governmental or professional agency.

According to the Toronto Star:
Drug quality is under the purview of Health Canada, while the college [Ontario College of Pharmacists] inspects how well pharmacies are run and the conduct of pharmacists.

The college's protocol for inspection includes such measures as checking whether dispensing practices are sanitary and whether medications are properly labelled and locked up.

"We don't go in and inspect the drugs," said Della Croteau, the college's deputy registrar.
On the other hand, according to spokesperson Christopher Williams, Health Canada only inspects pharmaceutical distributors, not pharmacies, on a once-every-36-month cycle. Consequently, it appears that neither the College of Pharmacists nor Health Canada have instituted adequate measures to assure that the actual content of prescribed drugs meets specified requirements.

Suffice it to say that there is a recognized level of risk associated with prescription drugs in Canada. Notably, the risk is not mitigated by exporting Canadian drugs to the United States. Are you listening, Wisconsin, Massachusetts, and other states?

From CFIF.org:
Both the FDA and Health Canada (the FDA's northern counterpart) have repeatedly warned that there are no guarantees when it comes to taking medications imported from Canadian pharmacies, and federal sting operations prove the reality and seriousness of these concerns.

The FDA conducted a perfunctory import blitz in November [2003], finding 1,729 "unapproved drugs" in the 1,982 packages examined. These illegally imported medications included "recalled drugs, drugs requiring special storage conditions, drugs requiring close physician monitoring and drugs containing addictive controlled substances," and the FDA underscored their serious risks, stating that "[u]napproved drugs lack assurances of safety, effectiveness, quality and purity." Quite simply, when Americans buy drugs from foreign pharmacies - even in Canada - those medications are often mislabeled, unapproved, counterfeit or worse, they could be contaminated, the wrong dosage or even another drug altogether.

What's more, while 80 percent of the intercepted packages came from Canada, those prescriptions "revealed that products were manufactured in countries other than Canada." The FDA found medications produced in such medically-advanced and safety-conscious countries as Mexico, Costa Rica, India, Pakistan, Taiwan, Thailand, and a host of others. In other words, imported drugs are often only in Canada long enough to get a new postmark.
In summary, officials in Ontario are investigating whether six recent deaths can be blamed on inadequate control of prescription drugs while readily admitting that there are inadequate controls. One wonders how many people have to die before the safety of prescription drugs is assured to a level above rolling the dice.

[Update 2230 EDT] In a related report, Canadian Health Minister Ujjal Dosanjh recently announced that measures will be implemented to restrict Internet pharmacies from selling prescription drugs to U.S. consumers. Possible measures could include barring Canadian doctors from co-signing prescriptions without examining patients and prohibiting prescriptions for foreigners not physically present in Canada. A proposal will soon be forwarded to Prime Minister Paul Martin.

In another report, consumers are being warned of fraudulent Canadian drug web sites. Consequently, not only do consumers have to accept the risk of questionably controlled Canadian drugs, but there's also the risk that the drugs may be supplied by a disreputable Internet distributor.

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