Transforming and Supporting Patient Care - Health Professions ...

66Chapter 3 - A New Drug Approvals Framework For OntarioOver the next few years, a key focus for the province’s e-Health strategywill be drug information initiatives such as ePrescribing. ePrescribing willelectronically transmit prescriptions from physicians and other prescribersto the pharmacists or dispensers using the provincial drug repository.To date, this program is at the pilot stage. The province is also expandingaccess to a drug profile viewer that currently allows authorized healthprofessionals in hospital emergency departments to access drug claimsinformation of 2.3 million Ontario Drug Benefit recipients. Access to thissystem will be expanded to full drug information system capability overthe next few years.HPRAC heard repeatedly from stakeholders that there is a need to proceedexpeditiously with an EHR for Ontarians.Drug Approvals in Ontario TodayThe system for approving designated drugs in regulations under healthprofessions’ Acts is frequently described by health colleges as slow,frustrating and cumbersome. This process is rooted in Ontario’s regulationmakingand approvals process. It involves a series of complex steps thatcause delays that can make the adoption of best practices for prescribingand administering of medications difficult to achieve. With expeditedapproval, a drug regulation will take a minimum of a year to move throughthe system. HPRAC reported in New Directions of regulation requests thathave remained in the approval process for several years. 34In the course of earlier reviews of the RHPA, HPRAC was made aware ofserious concerns related to government examination and approval ofproposed regulations made under health profession Acts. HPRAC’s reviewindicated that the consideration of proposed regulations was often tardy,inconsistent and unresponsive.HPRAC learned that many of the proposals submitted to the Ministry byhealth colleges remained outstanding for several years. Some collegesreported that proposals submitted to the Ministry remained outstandingso long they eventually became outdated, requiring them to be rescinded.One request for an “expedited approval” of an emergency proposal forapproval of a drug took a year to complete.The Case for ChangeClearly, serious problems in the general regulation-making and approvalprocess create an unnecessary risk to members of the public, who may notbe able to access the most up-to-date pharmaceuticals from their healthprofessionals. Non-physician prescribers may not be able to follow bestpractices by prescribing or using based on the latest research and practiceswithin the profession. Inefficiencies in the drug approval process useresources that could be allocated elsewhere.34New Directions, Health Professions Regulatory Advisory Council. April 2006: 62-71.HPRAC Critical Links January 2009