Transforming and Supporting Patient Care - Health Professions ...

73Chapter 3 - A New Drug Approvals Framework For OntarioWithin these classes of drugs, specific agents can be listed by CHPRE withor without additional restrictions (e.g., penicillin, penicillin for oral use,penicillin for the treatment of strep throat, penicillin for patients over 18years of age) or any combination of these and additional restrictions.The Approval ProcessIn sum, HPRAC is recommending a new regulatory framework, with a twostepapprovals approach that would place therapeutic classes of drugswithin the regulations under the health profession Acts. A separate processwould define the Drug List, by adding or removing individual drugs oragents from the authorized classes, and attaching terms, limitations orconditions, if any, to the use of drugs within the classes authorized for eachprofession. This process would not involve regulation approvals, but shouldbe carried out by the new DTFC, and approved and published by CHPRE.As part of this process, CHPRE would be expected to establish genericcriteria that a health profession would respond to when applying for a newdrug authority or a new class of drugs. The criteria would include thefollowing essential elements:• Competencies and educational requirements;• Collaborative relationships with other health professions;• Continuing competence; and• Quality assurance and improvement programs.Once criteria are established, CHPRE will begin to receive applications fromhealth professions for the addition of classes of drugs to their professionspecificdrug regulation. For each request for a class, CHPRE will conduct ascope of practice review to determine whether the request requires anexpansion to the scope of practice and whether the request is reasonableand appropriate. CHPRE would follow established methods in its reviewincluding research, literature and jurisdictional reviews, and a consultativeprogram with key informants and interested parties.In some cases, the addition of a new class of drug in a designated drugregulation would require colleges to enhance their existing standards ofpractice. Each college council would continue to establish its ownstandards, limitations and conditions for the drug authority concerningmatters that would fall within their standards of practice, based on theinvolvement of a collaborative standards of practice committee. Thestandards of practice include the competencies required (education andtraining), quality assurance and improvement and mandatory referral andconsultation with others.Based on the results of the scope of practice review and the advice ofexperts in the fields of medicine, pharmacology and others, CHPRE wouldthen recommend that the Minister add a new class of drugs to a regulationunder a health profession Act. If CHPRE is not satisfied that the requestshould go forward, it would return the request to the health college,identifying where additional work may be required. CHPRE could alsoreject the request.HPRAC Critical Links January 2009