Winter 2015 (Volume 25, Number 4)

Therapeutic Updates:
Where We Stand

By Carter Thorne, MD, FRCPC, FACP

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The CRA is undergoing a transformation in order to better serve its members and fulfill its mission. As part of the reorganization, we have made changes to the Secretariat—we now have a CEO position—and have reviewed committees, both regarding their accountability and mandates. We now have “Board” committees and “Operational” committees, the former overseeing the mission of the CRA, and the latter tasked with implementation.

The “old” Therapeutics Committee has now been spilt into the Guidelines Committee whose mandate is review, development and implementation of guidelines; chaired by Dr. Shahin Jamal, their activities are more often than not reflective and proactive. The “new” Therapeutics Committee is tasked with the review of issues that may present themselves, including requests from members, agencies, and payers, which are often reactive.

Recent examples include the success the CRA had in securing access to naproxen suspension; see “An Advocacy Success Story", in the Winter 2014 CRAJ for more details. In that case, the CRA was able to facilitate a process that was expected to take two years and complete it within only 10 months.

More recently, our pediatric colleagues identified another care gap, notably the absence of triamcinolone hexacetonide (TH) from the retail market; this agent is particularly favoured for young patients. Though the Drug Identification Number (DIN) was still held by a Canadian company, we were unable to generate any interest from that source. Contacts developed by members of the committee were identified and a strategy meeting was held in Newmarket in July 2015, which included
Dr. Deborah Levy, Christine Charnock, Denis Morrice, Ken D'Entremont of Medexus, and myself. Ken was able to identify an European Medicines Agency (EMA)-approved manufacturing source in Europe, secured a commitment for supply, and made application to Health Canada through the appropriate regulatory pathway. At the same time, the CRA contacted individuals at Health Canada to provide background and garner their commitment to this project. Within one month, we had received Health Canada approval for a Special Access Program (SAP) for TH, and product “landed” in Canada for distribution in August 2015 – a remarkable timeline of less than six weeks!

Projects under development include a response to pharmacists regarding drug interactions with methotrexate, and addressing ophthalmology concerns about hydroxychloroquine.

Any members interested in participating in the action-oriented Therapeutics Committee: please contact myself or Christine Charnock.

Carter Thorne, MD, FRCPC, FACP
Past-President,
Canadian Rheumatology Association
Medical Director,
The Arthritis Program & Chief Division of Rheumatology,
Southlake Regional Health Centre
Newmarket, Ontario