Que. pharmacists worry patients could lose 'exceptional' medications due to health reform

A pharmacy worker prepares to count pills for a prescription on Thursday, March 11, 2021. THE CANADIAN PRESS/Ryan Remiorz

The fear of seeing seriously ill patients lose access to drugs given in exceptional circumstances, was once again raised in a parliamentary committee on Bill 15. This time, it was the pharmacists who work in institutions who expressed their misgivings to Health Minister Christian Dubé.

According to the way Article 336 of the future "Act to make the health and social services system more efficient" is written, institutional pharmacists would lose a certain autonomy that would allow them to administer an exceptional treatment to rare patients who do not meet the recommendation criteria of the National Institute of Excellence in Health and Social Services (INESSS).

The president of the Association des pharmaciens des établissements de santé du Québec (APES), Julie Racicot, wanted to give the minister the benefit of the doubt and argued that "this cannot be the intention behind what is written (in the bill) because we would end up depriving patients of care."

Whether it is intentional or not, patients with lymphoma, cancer or rare diseases will lose access to treatment if no changes are made. The Association of Councils of Physicians, Dentists and Pharmacists of Quebec (ACMDPQ) sounded the alarm over this issue last month.

Currently, if a drug has not been recommended for use by INESSS, but a hospital's pharmacology committee is aware of new scientific literature that supports the treatment, it can decide to go ahead and administer it to the patient.

However, this would no longer be possible because of Article 336 of Bill 15, which reads: "The committee may not grant its authorization if the National Institute of Excellence in Health and Social Services has, in an opinion to the Minister, refused to recognize the therapeutic value of the drug for the therapeutic indication for which the authorization is requested."

In the parliamentary committee, the APES explained to elected officials that according to the procedure, a drug that has received an unfavorable opinion will not be re-evaluated by the INESSS if the manufacturer does not file a new application. However, new medical knowledge may have emerged without such an application having being made.

Another example provided, concerned a patient who does not respond to primary therapy or has contraindications to that therapy. In such cases, physicians and pharmacists may agree to make an exception to offer an alternative that may sometimes go against INESSS recommendations.

The institutional pharmacists propose the creation of a centralized registry of drugs that are given in exceptional circumstances. In addition to making it easier to share information about these treatments, it would also allow the INESSS to prioritize the drugs that should be re-evaluated according to the needs of the network. They would no longer have to rely solely on manufacturers' requests before launching new evaluations on the therapeutic effectiveness of a product.

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This report was first published by The Canadian Press on May 23, 2023.