Cross-border prescriptions: What Canadian pharmacists need to know

Have you ever received a prescription from a patient who lives in the U.S. and the prescription is from a U.S. doctor? This often leads to an exhaustive review of the regulatory frameworks governing foreign prescriptions. For most pharmacists, investing time in this way is simply not sustainable in the everyday pharmacy workflow. However, cross-border prescriptions have become a growing trend.As the prices of medications increase, patients are looking to Canada for affordable options. If there is a price difference between Canada and the US, prescriptions from any therapeutic specialty may be incentivized to find its way across the border. This issue has received a lot of attention in prior years with insulin and most recently with the GLP-1 medications like Ozempic. It will again find its way to the media spotlight as the recently expired Ozempic data exclusivity in Canada has reignited public attention. In anticipation for increased cross-border interest, we must consider the complex, and at times, inconsistent policies governing how Canadian medications can be dispensed to patients outside of Canada.To explore these complexities, we conducted an environmental scan of relevant Canadian regulations from the perspective of patients from the United States trying to fill a prescription here in Canada. Firstly, let’s look at what the U.S. patient is allowed to do. Importing drug products that are not approved by the FDA into the US is illegal under most circumstances. However, the FDA applies its rules more loosely for imports under “personal use.” This approach is largely due to practical limitations of enforcement capacity, creating a grey area for American patients to import medications from Canadian “online” pharmacies. In contrast, Canadian federal authorities take a much firmer stance. Health Canada clearly emphasizes its position against exporting Canadian products to the US to preserve supply in the Canadian market. Note that Health Canada is a federal organization, and therefore places more emphasis on preventing regulated parties from distributing large quantities of Canadian drugs internationally, to avoid shortages, as opposed to barring individual patients importing their own medications. This leaves smaller-scale cross-border drug sale issues under the scope of the policies of professional colleges responsible for the regulation of the practice standards of Physicians and Pharmacists in each province. This leaves room for online pharmacies operating in specific provinces to continue exporting Canadian products to the US, despite Health Canada’s firm stance.In general, Canadian pharmacists can only accept and fill prescriptions written by Canadian prescribers. This rule is ubiquitous among provincial regulators of pharmacists. Online vendors can circumvent this rule by incentivizing Canadian physicians to “co-sign” prescriptions originating from a U.S.-based prescriber. By co-signing, a Canadian physician can make an otherwise invalid American prescription valid in Canada without physically examining the patient. An American patient can send a U.S.-based prescription to a co-signing Canadian physician who validates it for use in Canada, before it is sent to an online pharmacy that fills the medication and delivers it back across the border to the patient. Conducting this long importing process can often be cheaper for American patients than paying for medications in the U.S.Interestingly, many provincial physicians’ colleges have explicit statements advising against co-signing, citing an “established patient-doctor relationship” as an integral part of the prescribing process. For example, New Brunswick College of Physicians clearly labels co-signing for prescriptions originating from the U.S. as “improper.” Some provinces, however, have muddier rules. For example, in Ontario, the CPSO permits physicians to “prescribe on the basis of an assessment conducted by someone else.” Similar variations in policies exist from provincial pharmacist regulators. For example, the OCP explicitly states that “registrants must not facilitate the co-signing of prescriptions authorized by practitioners not licensed in Canada”, whereas the College of Pharmacists of Manitoba resource library has a document outlining an “International prescription service” detailing the process of providing pharmacy services for patients residing outside of Canada. As a result of these gaps within the policies of provincial regulatory colleges, co-signed prescriptions can be transferred between provinces before ultimately being filled and exported to the U.S. (for example, an Ontarian physician may co-sign a prescription for a Manitoban online pharmacy). This practice is not without risk, however, as a majority of regulatory bodies see this practice as a violation of professional and ethical practice standards, and numerous Canadian prescribers have been disciplined for co-signing foreign prescriptions.Ultimately, for Canadian pharmacists receiving a foreign prescription, it is critical to check whether there is a co-signature from a Canadian prescriber. If there is one, ensure that it is valid, and that the provincial regulations relevant to the pharmacy permit filling co-signed prescriptions.For patients and healthcare providers alike, compliance with regulatory bodies is essential and protecting Canada’s drug supply is critical. Efforts to profit from arbitraging prices between the two countries are unproductive to the root causes of high medication costs and cause significant confusion to patients and healthcare professionals. This uncertainty draws attention to the need for more harmonized regulations between health professions across Canada.Jia Qi Gan is a 4th year pharmacy student at the Leslie Dan Faculty of Pharmacy at University of Toronto. Peter Zhang, PharmD, MBA is a technology professional, hospital pharmacist, and a PhD candidate at the University of Toronto studying entrepreneurship education Mina Tadrous is an associate professor at the Leslie Dan Faculty of Pharmacy at University of Toronto and the Tier 2 Canada Research Chair in Real-World Evidence and Pharmaceutical Policy

Cross-border prescriptions: What Canadian pharmacists need to know

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