The Canadian border poses several issues state pharmacy boards will have to address, including R.Ph. licensure, Internet pharmacies, and cross border medication purchases.
State pharmacy boards are going to have to grapple with some thorny issues posed by their neighbors to the north, warned the executive director of the National Association of Boards of Pharmacy.
Whether Canadian pharmacists should be able to directly sit for the American licensure exam and what to do, if anything, about the movement of medications south across the border are regulatory issues that are going to have to be confronted, according to Carmen Catizone, NABP executive director. In his annual message at the recent NABP meeting in Phoenix, he urged board members to consider that pharmacy is an increasingly global profession that is being shaped by outside forces.
One such outside force is the pharmacist manpower shortage, which is directly tied to the issue of U.S. licensure for Canadian pharmacists. In response, some states have decided to eliminate many of the regulatory hoops foreign pharmacists must jump through to be licensed. While they would let Canadian graduates directly sit for the North American Pharmacy Licensure Examination (NAPLEX), there is still the additional question of whether the education those R.Ph.s receive measures up to American standards.
Pharmacy boards should be getting some guidance from NABP on the NAPLEX issue later this year, Catizone said. Discussions are under way with the American Council on Pharmaceutical Education and the National Association of Pharmacy Regulatory Authorities, which is NABP's Canadian counterpart.
"The only outcomes data we have is the NAPLEX," Catizone said. "Canadian pharmacists perform well, and their [pharmacy school] accreditation standards mirror current BS programs in the United States. So we're either going to say that we've evaluated it and advise the states that Canadian pharmacists can sit directly for the NAPLEX, or we'll advise them not to do it because the [educational] equivalency just isn't there."
Just as with the pharmacist shortage, border states are also feeling the most heat about medications coming from Canada. Senior citizens routinely make medication runs to scoop up drugs that are cheaper in Canada. Add to that the fact that Internet pharmacies based in Canada have caught on among Americans as a source of lower-priced drugs during the past year. So trying to regulate such cross-border practices poses a real dilemma for state pharmacy boards.
Talk in Washington, D.C., of allowing drug reimportation from Canada and media attention to senior bus trips have some people wondering what all the fuss is about, since no one seems to be getting hurt. In fact, NABP and the Federation of State Medical Boards got the cold shoulder from federal regulators when they urged that dispensing Rxs on the sole basis of an Internet questionnaire be outlawed. This was during the recent anthrax scare that triggered an Internet run on Cipro.
"When we met with federal regulators, their response amidst the seriousness of the situation was perplexing," indicated Catizone. "Rather than taking a proactive stance and implementing regulatory strategies ... the response basically asked for us to show them the bodies."
That show-us-the-bodies attitude questions why there aren't casualties if it's so dangerous to ship medications in from Canada. That sentiment may call for a rethinking about how such practices are regulated, Catizone said. "Yes, it's illegal, but if it's illegal simply because the laws haven't caught up to the present situation, then we need to look at the laws," he said. "If it's not dangerous, then we should be changing the laws to make it possible and to make sure it's safe for patients."
In other action at the NABP meeting, the house of delegates approved resolutions to:
Support legislation recognizing pharmacists as healthcare providers and urge NABP members to make their elected officials aware of that support.
Encourage all pharmacy boards to promote education and ensure compliance with current practice standards for the preparation and administration of cytotoxic drugs for all institutions.
Support classification of carisoprodol as a Schedule IV controlled substance, and notify the Drug Enforcement Administration of that stance.
Encourage drug companies to supply medications, as appropriate, in standardized unit-of-use packages that are bar-coded to identify the product, and provide lot number and expiration date.
Support federal legislation providing assistance to pharmacy schools to increase enrollments, and urge state pharmacy board members to ask their representatives to vote for the bill.
Carol Ukens. Border issues a looming problem for profession, warns NABP.