Transforming and Supporting Patient Care - Health Professions ...

70Chapter 3 - A New Drug Approvals Framework For OntarioThis approach would take a broader, more proactive and strategic approachto drug approvals by ensuring a consistent process and full review ofrequests for approvals of therapeutic classes of drugs in the regulations,and a thorough examination of the agents that would be authorized for theprofession based on its scope of practice.A New Drug Approvals Framework for OntarioAfter reviewing these options, HPRAC concludes that a rigorous two-stageprocess is required for all designated drug approvals and that the processshould be conducted by an independent agency to ensure that patientsafety considerations prevail.The first stage of the process would entail a comprehensive review of ahealth profession’s request for a new class of drug or other authoritiesrespecting drugs, to determine if the request is within a profession’s scopeof practice, if a change in scope of practice is needed, and if this changeis appropriate.Following the determination that it is in the public interest that a new classof drugs be added to a profession’s prescribing authority, a recommendationwould be made to the Minister to include the therapeutic class in the healthprofession’s designated drug regulation. An expedited regulation-makingand approvals process would follow this recommendation.To accomplish this, HPRAC is recommending that the proposed Councilon Health Professions Regulatory Excellence (CHPRE) oversee thedevelopment of recommendations for the addition and removal oftherapeutic drug classes for health professions in Ontario. CHPRE wouldreceive requests directly from health regulatory colleges for authority to:• Perform controlled acts of prescribing, dispensing, compoundingor selling drugs;• Administer substances by injection or inhalation;• Use drugs in the course of the practice of the profession, and• Add new therapeutic classes of drugs to regulations underhealth profession Acts for any of these purposes.Following specific protocols, CHPRE would conduct a scope of practicereview, investigating whether the request falls within the existing scope ofpractice of the profession, or whether there was a legitimate reason to alteror expand the scope of practice.CHPRE would also examine whether the health profession has appropriatecompetencies to perform the controlled act requested and whetheradditional education, training, standards of practice or other safeguardsneeded to be put into place. If CHPRE finds the request for the additionof a drug class to be reasonable and that it addresses patient safetyconsiderations, CHPRE would make a recommendation to the Minister thatthe process for regulation approval should proceed.HPRAC Critical Links January 2009