On October 10, 2013, the Minister of Health and Long-Term Care introduced Bill 117, Enhancing Patient Care and Pharmacy Safety (Statute Law Amendment) Act. If passed, Bill 117 will amend certain statutes, including the Drugs and Pharmacies Regulation Act, in respect of the regulation of pharmacies and other matters concerning regulated health care professionals. The aim of the legislation is to address a gap in regulation perceived over compounded drugs supplied to and administered in hospitals.
Following the discovery of under-dosed chemotherapy drugs at four Ontario hospitals and one New Brunswick hospital reported earlier this year, the Ontario government appointed Dr. Thiessen, a pharmacy expert, to review the cause of the incidences and provide recommendations to strengthen the health care system, and in particular the hospital drug supply system. Immediately following the under-dosing discovery, the government implemented a number of measures, including the requirement of drug compounders to declare their regulatory framework, accreditation, and quality assurance practices; and the requirement of all hospitals to ensure quality assurance processes are in place for all drugs, whether externally purchased or prepared in the hospital. Health Canada also issued an interim statement which provides guidance on compounding and admixing of medications.
The Ontario government has endorsed the recommendations of Dr. Thiessen and this legislation was introduced in response to his report, A Review of the Oncology Under-Dosing Incident.
Summary of the Proposed Legislation
Currently, hospital pharmacies are overseen by the individual hospital corporations, whereas community pharmacies are regulated by the Ontario College of Pharmacists (the ”College”). The Bill will expand the College’s authority to inspect, oversee and license pharmacies within both public and private hospitals, in addition to community pharmacies.
Among other things, the proposed legislation also seeks to:
- Provide the College with the ability to conduct regular inspections of hospital pharmacies in order to monitor compliance and enforce licensing requirement;
- Allow the College to make regulations to set out the details and standards for licensing and inspection; and
- Enhance information sharing, including complaints-related information, between the College, other regulatory colleges, hospitals and other public health authorities for the purposes of administering the Health Protection and Promotion Act.
Link to Bill 117: