Unavailability of APIs – serious impact on patient safety

Compounding - Mortar & Pestle

Unavailability of APIs – serious impact on patient safety

On behalf of the ACPC Board of Directors, I am writing to all members over recent information that suggests the availability of USP-grade APIs may be in jeopardy. These ingredients are essential in order for compounding to proceed in accordance with national, professional standards of practice. The end result would be the inability to provide properly compounded preparations, prescribed by practitioners for their patients, and ultimately impact negatively upon the health of our patients.

As your Association, we make it our mission to stay current on all issues and activities of governments across Canada.

More importantly, compounded medications are personalized for individual patients. We, as a profession, are on the front line for patients, and it is our duty to act appropriately and swiftly when issues arise that affect that bond between our profession and those we serve.

Between 2015 and 2018, Health Canada has been revising its regulations, policies, and guidance documents visavis Establishment Licence requirements. These changes, as they proceed, could impact upon the availability of USP-grade APIs from sources that pharmacies have used in the past as suppliers of these essential prescription ingredients. One possible consequence could be the unavailability of those APIs to compounding pharmacists. Another foreseeable consequence could be the inability to import reasonable quantities of APIs (either via a licensed establishment, or directly as a pharmacy) necessary for the practice of pharmacy — again, resulting in unavailability to fill compounded prescriptions.

ACPC believes that drug access will become an incredible challenge for patients nationwide. As compounding pharmacies have normally sourced APIs that are no longer commercially available, patients and physicians will be tremendously impacted by these decisions. While this impacts community and retail compounding pharmacies, hospitals will be also affected by this challenge.

To that end, I have instructed our Executive Director, Marc Kealey to reach out to Health Canada for a meeting at the earliest possible date this coming week. At the same time, we will be preparing a series of counter messages and policy statements to assist Health Canada gain a better understanding of our views.

Look for updates on our website – www.acprx.org or contact me directly.

Jarron Yee
Chairman of the Board

For further information contact: Marc Kealey (marckealey@acprx.org)