Pharmacy professionals should stay informed on medication, health product and medical device issues that may affect patient safety, including recalls, shortages, adverse reactions and other safety notices.
Link to Health Canada resources regarding recalls, adverse reactions and other safety notices, including a searchable database, are available in the Additional Resources – Health Canada: Health Products section.
Information about current and upcoming drug shortages can be found at Drug Shortages Canada (www.drugshortagescanada.ca) and in memos sent directly to pharmacies from the Ministry of Health and Long-Term Care and drug manufacturers/suppliers. For more information please visit Health Canada’s Drug Shortages in Canada webpage.
Other resources for pharmacy professionals related to drug shortages:
Updated September 2018
Legislative Reference: Drug and Pharmacies Regulation Act, Ontario Regulation 264/16
It is a standard of accreditation for a pharmacy to have available the references and resources that are required by registrants practicing in the pharmacy to meet the standards of practice of the profession and to support the pharmacy services the registrants provide.
The Board has approved the use of electronic and web-based library reference materials as an alternative to hard copy texts. Regardless of the format chosen, the Designated Manager/delegate must ensure sources of information are readily accessible and freely available to the pharmacy staff working in the pharmacy.
Pharmacy professionals must have access to, and should be familiar with navigating, the OCP website.
Links to current legislation and OCP references are located under Regulations & Standards, including, but not limited to:
To enable registrants to meet the standards of practice, at a minimum, every pharmacy1 should have at least one reference in each of the following areas:
The College does not recommend a particular reference in any area. It is up to the Designated Manager/delegate to research and compare the different options available and to select the appropriate references for the pharmacy.
1Note that this section does not apply to remote dispensing locations (RDLs) where all drugs are dispensed from an automated pharmacy system as the accredited pharmacy operating the RDL must have the required resources to support pharmacy services for both the accredited
pharmacy and the RDL.
As practice is constantly evolving, it is critical that the reference is the current edition or latest version available, and is updated regularly. The selection of references should be reviewed and evaluated on a regular basis to ensure each remains relevant and suitable for its intended purpose. Textbooks may be procured from various sources, such as directly from the publisher, the bookstore of a local university, or various retail outlets including on-line booksellers. The College does not evaluate or endorse suppliers.
Health Canada’s Health Products and Food Branch is the regulatory authority responsible for evaluating and monitoring the safety, quality and efficacy of health products (including pharmaceutical, biological and radiopharmaceutical drugs, medical devices, and natural health products), foods and veterinary drugs in accordance with the Food and Drugs Act and its regulations. These activities are carried out through various Directorates, listed below along with selected information and resources that are most relevant to drug products.
Biologic and Radiopharmaceutical Drugs Directorate (BRDD)
The BRDD regulates:
Marketed Health Products Directorate (MHPD)
The MHPD regulates health products by:
Under the MHPD, the Marketed Pharmaceuticals Bureau conducts post-market surveillance of prescription drugs and the Bureau of Biologics, Radiopharmaceuticals and Self-Care Products conducts post-market surveillance of:
The MHPD MedEffect Program provides centralized access for the public and health professionals to report and obtain important safety information.
To report an adverse reaction, health professionals and consumers may call 1-866-234-2345.
Advertising of health products:
Medical Devices Directorate (MDD)
The MDD regulates medical devices for human use under the Medical Devices Regulations by:
Natural and Non-Prescription Health Product Directorate (NNHPD)
The NNHPD regulates:
Pharmaceutical Drugs Directorate (PDD)
The PDD regulates prescription drugs for human use by:
Special access programs (SAP):
Veterinary Drugs Directorate (VDD)
The VDD ensures that veterinary drugs (Food and Drug Regulations, Part C – Division 1) are safe, effective and of high quality.
Health Products and Food Branch Inspectorate (HPFBI)
Certain activities with drugs, health products and medical devices (i.e., fabricating or manufacturing, packaging, importing, exporting, distributing and wholesaling) require issuance of an Establishment License from Health Canada. The Regulatory Operations and Enforcement Branch (ROEB) is responsible for compliance monitoring and enforcement activities such as inspections.
The mandate of the IPC is set out in the Personal Health Information Protection Act, 2004 (PHIPA), governing the responsibilities of heath information custodians in handling personal health information.
Privacy Breach Information
Annual Reporting of Privacy Breach Statistics to the Commissioner – Requirements for the Health Sector
Personal Health Information
PHIPA Fact Sheets
Under the Ministry of Health, Drugs and Devices Division, the Drug Programs Delivery Branch is responsible for administering Ontario’s Public Drug Programs, Assistive Devices Program (ADP), and additional programs including those listed below.
Ministry of Health Programs
Professional Pharmacy Services
Pharmaceutical Opinion Program
Pharmacy Smoking Cessation Program
Universal Influenza Immunization Program (UIIP)
Ontario’s Public Drug Programs
Exceptional Access Program (EAP)
OHIP+: Children and Youth Pharmacare
Ontario Drug Benefit (ODB) Program
Help Desk: 1-800-668-6641
Ontario Naloxone Program for Pharmacies (ONPP)
Senior’s Co-payment Program (SCP)
Other Publicly Funded Drug Programs
In Canada, medical cannabis is regulated at the federal level. Cannabis for recreational use is regulated at the federal as well as the provincial/territorial and municipal levels. Activities with cannabis outside of what the law allows remain illegal and subject to criminal penalties.
Controlled Substances and Cannabis Branch (CSCB) of Health Canada
Alcohol and Gaming Commission of Ontario (AGCO) (affiliated with the Ministry of the Attorney General)