The fear of seeing seriously ill patients lose access to exceptional drugs was again raised in parliamentary committee on Bill 15. This time, it was the pharmacists of establishments who expressed their incomprehension to the Minister of Health, Christian Dubé.
According to the way section 336 of the future “Act to make the health and social services system more efficient” is drafted, institutional pharmacists would lose a certain amount of autonomy allowing them to administer 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 of Pharmacists of Quebec Health Institutions (APES), Julie Racicot, wanted to give the minister the benefit of the doubt by arguing that “that cannot be the intention behind what is written [dans le projet de loi] because we would end up depriving patients of treatment”.
“There’s a way to rephrase things there. I think we do not see the scope of the sentence which would deprive patients of treatment, ”she added in an exchange with Liberal health critic André Fortin.
However, whether intentional or not, patients with lymphoma, cancer or a rare disease will lose access to their treatment if no changes are made. The Association of Councils of Physicians, Dentists and Pharmacists of Quebec (ACMDPQ) sounded the alert on this issue last month.
hands tied
In current practice, if the use of a drug has not been recommended by INESSS, but the pharmacological committee of a hospital is aware of new favorable scientific literature, it may decide to go forward and administer the treatment to the patient.
However, this would no longer be possible because of the famous section 336 of Bill 15, which reads as follows: “The committee may not grant its authorization if the National Institute of Excellence in Health and Social Services has, in a notice to the Minister, refusing to recognize the therapeutic value of the drug for the therapeutic indication that is the subject of the application for authorization. »
In parliamentary committee, the APES explained to the elected officials that according to the procedure, a drug that has been the subject of an unfavorable opinion will not be re-evaluated by INESSS if the manufacturer does not file a new application. However, new medical knowledge may have emerged without such a request seeing the light of day.
Julie Racicot maintains that “it is unrealistic to believe” that pharmacological companies will resubmit requests to INESSS “every time new conclusive data becomes available”.
Doctors and pharmacists would also have their hands tied to prescribe new drugs available on the market, but whose approval times sometimes take several years. Between the request for approval from Health Canada, the certification of the product, the evaluation by INESSS, then the negotiation between the government and the manufacturer, it can take a few years. During this time, patients would be deprived of a possible effective treatment.
The APES also gave the example of a patient who does not respond to the recognized primary treatment or who presents contraindications to this treatment. In such cases, physicians and pharmacists can agree on an exception in order to offer them an alternative that can sometimes go against INESSS recommendations.
“We must keep the power of the pharmacology committee to receive requests for patients, on a case-by-case basis”, insisted Mme Racicot, recalling that this only concerns rare patients for whom this exception can make a big difference.
A registry for exceptional drugs?
In order to resolve the impasse, institutional pharmacists are proposing a possible solution, namely the creation of a centralized register of exceptional medications. In addition to facilitating the sharing of information on these treatments, this would also allow INESSS to prioritize the drugs to be reassessed based on the needs of the network.
“INESSS could thus act upstream, without waiting for a request from the manufacturer,” suggests Ms.me Racicot.
Just after the testimony of the APES, it was the representatives of the Order of Pharmacists of Quebec who addressed the elected officials. Its outgoing president, Bertrand Bolduc, also deplored the fact that we are “tightening the conditions of access” for drugs described as being “of particular need”.
Mr. Bolduc reiterated that “the scientific literature [progresse] faster than INESSS recommendations”.
Minister Christian Dubé has shown himself to be sensitive to the need for flexibility of healthcare teams and very favorable to the creation of a centralized register of exceptional medications. He has clearly expressed his interest in improving INESSS’s agility and speed of action.
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