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Canadian mail order pharmacies filling prescriptions for Wisconsin residents are violating the conditions set by the governor, according to on-going analysis by the Pharmacy Society of Wisconsin.
The Pharmacy Society of Wisconsin (PSW) has shown that the three Canadian mail-order pharmacies touted on a state-run Web site are putting residents at risk by flouting the rules set up to allow them to fill scripts for residents. And the Food & Drug Administration is none too happy with the drug importation situation in the Badger State, either.
Since the state went live with a Web site to promote drug importation through three approved Canadian mail-order pharmacies, more than 30% of the scripts shipped to Wisconsin residents have violated the state's agreement, according to a PSW analysis of pharmacy reports submitted to the government. Violations included dispensing 237 drugs that are not listed on the Web site as allowable; dispensing 134 non-FDA-approved drugs; and dispensing six drugs that require refrigeration, which is not permitted by the deal.
The three reports submitted to the state so far have all included violations by the pharmacies. The Web site administrator contended that the latest report was clean, even though PSW staffers found 10 violations. In a letter to the secretaries of the departments of administration and health and family services, PSW executive VP-CEO Chris Decker complained "for three months in a row, violations have been occurring with no consequences to the offending pharmacies. Just one of these many violations would be sufficient to close a licensed Wisconsin pharmacy, yet the state of Wisconsin did not end its relationship with the Canadian pharmacies."
The secretaries have acknowledged receipt of the PSW letter and offered to facilitate a meeting, Decker told Drug Topics. But he's not optimistic that Governor Jim Doyle will follow the association's suggestions that he stop promoting drug importation and move away from the Web site.
Although there was great fanfare when the www.drugsavings.wi.gov Web site was unveiled, only 765 scripts were filled during the first three months of operation, said Decker, who added, "A busy pharmacy dispenses that many scripts in two days." He speculated that one reason for the extremely low usage is that people willing to import their medications were already doing so before the Web site was created. On the other end of the spectrum, many consumers don't have great confidence that it's a good way to meet their healthcare needs.
Jumping on PSW's bandwagon, the FDA urged the governor to reconsider the state's Web site program in light of the continuing violations of the ground rules. In a July 22 letter, the associate commissioner for policy and planning, William Hubbard, told Doyle that the agency is "ready to work with you to provide Wisconsin's citizens with alternative, legal, and broader access to safe and effective drugs."
In an effort to confirm the safety issues raised by PSW, the FDA's Chicago office conducted its own assessment of packages coming from the three Canadian pharmacies. Over a five-day period in late June and July, FDA found that 55 out of 79 parcels sent by the pharmacies contained either generic medications for which there is no equivalent approved by the FDA for sale in the United States or drugs the FDA considers high risk because they have been counterfeited or pose potential safety risks. The drugs included TARO-Warfarin, an unapproved version of warfarin. Hubbard concluded that the pharmacies' noncompliance rates "indicate that the state is not able to control the quality of foreign drugs being dispensed through this program to its residents."
The Canadian pharmacies' violation of the ground rules governing drug importation is a threat to patient safety on two levels, Decker said. "We are concerned about the integrity of the drug product, but the other safety issue is that by using the Internet and having prescription drugs mailed to consumers, it removes [consumers] from the counsel and care of their local pharmacist. The issue we are really concerned about is fragmentation of care and the removal of the patients from their community pharmacy."
Carol Ukens. Wisconsin R.Ph.s bird-dog Rx imports.
Aug. 23, 2004;148:34.