Transforming and Supporting Patient Care - Health Professions ...

69Chapter 3 - A New Drug Approvals Framework For OntarioHPRAC has concerns regarding this model. HPRAC is convinced that thedrug approval process should start with a scope of practice review toconsider whether the drug request is also a request to expand a profession’sscope of practice that may or may not be appropriate depending on thecircumstances. HPRAC has reservations with the objectivity of the colleges,in some instances in this rule-making model, and that they may not considerthe professional scope of practice fully in their deliberations.. There is a riskthat the desire for the expansion of a profession’s scope of practice mightoutweigh patient safety considerations. Colleges with smaller membershipsmight not have sufficient resources to retain pharmacotherapy and otherinterprofessional expertise when determining appropriate terms, limitationsand conditions for an approved drug.Lack of consistency between health professions sharing similar controlledacts is also a matter of concern. Patients should be assured that if healthprofessions share overlapping scopes of practice, including prescribingauthority, mechanisms to ensure equivalent, objective evaluation of drugsand drug products should be in place. Patients should not bedisadvantaged by rules made in one profession that differ from those ofanother profession that provides the same clinical care. Overall, HPRAC isnot convinced that this model will provide adequate safeguards forpatients, and therefore is not recommending this option.3. Enable an Independent Agency to establish the Designated Drugs orAgents outside the regulation-making and approval processUnder this option, regulations under health professions’ Acts woulddesignate the therapeutic classes of drugs that can be administered,prescribed, dispensed, sold or compounded by each authorized healthprofession. The Minister would receive advice from an independent agencyrespecting the therapeutic classes of drugs for each health profession,following an extensive review. The agency would also be charged withproviding advice on other health profession matters and would be familiarwith regulatory issues affecting the health professions.The list of drugs or specific agents within each therapeutic class for eachhealth profession would be recommended to the agency by an objective,expert, independent committee, outside the regulation-making and approvalprocesses, following the agency’s comprehensive review process, includinga review of the scope of practice of the profession. The review by theexpert committee would recommend the specific agents that should beincluded in a therapeutic class, and take into account whether terms,limitations or conditions should be placed on the agents within atherapeutic class that is included in the profession’s regulation.This model is in many ways similar to the Quebec model for chiropodists,podiatrists and midwives, where the list of drugs is controlled by the Officedes professions du Québec after consultation with the affected orders aswell as the orders of medicine and pharmacy. It also draws from GreatBritain’s Council for Healthcare Regulatory Excellence (CHRE) model.HPRAC Critical Links January 2009