The number of U.S. politicians who have reversed course and now publicly endorse the importation of prescription drugs from Canada would seem to reflect newly found evidence that drugs imported from Canada are safe. But that is not the case. Indeed, new evidence points to the danger of expanding importation.
In a memorandum dated December 24, 2003, Minnesota’s Board of Pharmacy details the findings of a board-approved evaluation trip made by Cody Wiberg, pharmacy program manager for the Minnesota Department of Human Services, and two pharmacy board surveyors.
The purpose of the trip was to evaluate Canadian pharmacies for possible affiliation with Republican Governor Tim Pawlenty’s new State of Minnesota prescription drug Web site. The board evaluated eight pharmacies in Toronto, Winnipeg, Calgary, and Vancouver.
The December memo states, “We found significant differences in pharmacy practices between those owned primarily by pharmacists and those owned by non-pharmacist business partners.” Several of the pharmacies visited were termed “… the ‘Super 6’ and were among the first pharmacies in Canada to begin the Internet practice of selling Canadian prescription drugs to U.S. customers.”
All but one of the pharmacies visited was a member of the Canadian International Pharmacy Association (CIPA). But even among the CIPA member pharmacies, the Minnesota team found quality standards varied greatly from pharmacy to pharmacy; some CIPA members appeared to have no standards at all.
In Harm’s Way
The team of evaluators said its visits were not inspections, since they had no legal authority to conduct inspections. They visited the pharmacies by invitation. In many cases, they were shown only limited information and were not allowed to move freely about the premises. While the memo cites numerous examples of conditions the evaluators deemed “poor pharmacy practices,” not all are reported here. The full report is now a matter of public record and online at www.phcybrd.state.mn.us/canada_memo.pdf.
- One pharmacy was not labeling most dispensed drugs. Instead, the labels were shipped unattached in the same shipping container as the stock medicine containers. This took place even when patients were being shipped multiple medications.
- In one pharmacy, unsupervised technicians were working in several different buildings “at a technician to pharmacist ratio that far exceeded the allowable technician ratio in Minnesota.”
- In another pharmacy visited, “an unsupervised technician appeared to be responsible for contacting the American prescriber by telephone if something on the original prescription needed to be clarified. This is a task that a pharmacy technician would not be allowed to perform under Minnesota pharmacy laws and rules, even if pharmacist supervision were present.”
- One pharmacy had no procedures in place to handle drug recalls. When the evaluators asked about this they were told, “The patient could contact the pharmacy about a recall if they wished.”
- An incomplete patient profile was kept at many of the pharmacies. One pharmacy did not require drug allergy information to be obtained and other patient profiles were incomplete. According to the Minnesota Pharmacy Board report, “This is poor pharmacy practice at best and very dangerous at worst.”
- A Quality Assurance check is required of all Minnesota pharmacies. Two pharmacists must review all new prescriptions to verify the accuracy of the computer-generated prescription. The Minnesota team reported this quality control procedure appeared to be taking place at only one of the eight Canadian pharmacies visited.
- One pharmacy had on its shelves filled medication containers with remnants of removed pharmacy prescription labels. The report states, “When we inquired about this practice we were told that these were products returned from Customs. The pharmacy owner, a non-pharmacist, stated that as long as the patient had not received the product they could continue to use them.”
- About half of the prescriptions filled by one Canadian pharmacy went to a single pharmacy in San Francisco, which had sent the prescriptions to pharmacies in England to be filled and shipped to U.S. consumers.
- One pharmacy required customers to sign a patient disclaimer that waives any and all liability in case of harm resulting from adverse effects or death as a result of purchasing across-border drugs.
The Minnesota group admits its findings represent an incomplete picture of Canadian pharmacy practices, and it acknowledges some of the practices observed were actually better than the standard employed by some Minnesota pharmacies.
The board concluded its report saying, “If laws were such that licensing Canadian pharmacies would be a possibility and if Minnesota Board of Pharmacy surveyors were able to make unannounced inspection visits, some of these Canadian pharmacies should be as good as or better than the U.S. mail order pharmacies that we currently license.”
The report nevertheless raises the level of doubt surrounding the quality and safety of importing and reimporting prescription drugs across borders, whether from Canada, the European Union, or the Far East. Only 60 percent of the Canadian drug supply is initially purchased from the United States. That leaves 40 percent of the Canadian drug supply coming from unknown sources.
As the co-founder and president of one the pharmacies visited told the Minnesota evaluators, “We won’t have any problem getting drugs, we have creative ways to get them.”
Conrad F. Meier is managing editor of Health Care News. His email address is [email protected].