Jump To:Drug Shortages
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:
- Canadian Pharmacists Association – Drug Shortages: A Guide for Assessment and Patient Management
- ISMP Canada Safety Bulletin – Drug Shortages and Medication Safety Concerns
- Government of Ontario’s Ethical Framework for Resource Allocation During the Drug Supply Shortage
Required Reference Guide for Ontario Pharmacies (Pharmacy Library)
Updated September 2018
Legislative Reference: Drug and Pharmacies Regulation Act, Ontario Regulation 264/16
Background:
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.
Ontario College of Pharmacists and Regulatory Publications
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:
- Federal Legislation (Government of Canada’s Justice Laws website)
- Provincial Legislation (Government of Ontario’s eLaws website)
- OCP Policies and Guidelines
- By-laws
- Code of Ethics
- Standards of Practice
- Additional resources such as:
- Prescription Regulation Summary Chart (Summary of Laws)
- National Association of Pharmacy Regulatory Authorities (NAPRA) – National Drug Schedules
- Quick Links to Ontario Public Drug Programs, MOHLTC
- Internet access to the Ministry of Health and Long-Term Care (MOHLTC) Ontario Drug Program e-Formulary/Comparative Drug Index
Library Requirements
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:
- A Canadian Drug Reference / Compendium
- A Drug Interaction Publication
- A Drug Therapy Publication
- A Patient Counselling Guide
- Additional references should be selected based on the pharmacy’s patient population to support the specific services provided. For example: natural health products, pediatrics, compounding, geriatrics, etc.
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.
Procurement
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.
Quick Links to Health Canada: Health Products and Food Branch
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:
- Biological drugs and vaccines (Food and Drug Regulations, Part C – Division 4)
- Radiopharmaceuticals (Food and Drug Regulations, Part C – Division 3)
Helpful links
- Biosimilar biologic drugs in Canada: Fact Sheet
- Handbook for health care professionals on biosimilar biologic drugs
Marketed Health Products Directorate (MHPD)
The MHPD regulates health products by:
- Collecting, monitoring and analyzing adverse reactions and post-marketing surveillance data
- Communicating product-related risks to health care professionals and the public
- Overseeing the advertising regulatory requirements of health products
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:
- Biological drugs and vaccines
- Radiopharmaceuticals
- Natural health products
- Non-prescription drugs
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.
Helpful links
- Canada Vigilance Program
- Incident reporting for medical devices: Guidance document
- Overview: Mandatory Reporting of Serious Adverse Drug Reactions and Medical Device Incidents by Hospitals
- Health Product InfoWatch, a monthly publication with clinically relevant safety information on pharmaceuticals, biologics, medical devices and natural health products
- Online portal to report a side effect (adverse reaction) to any drug, vaccine, device or natural health product
- Online forms:
- Recalls, Advisories and Safety Alerts database
- Safety reviews
- Other publications such as Fact Sheet and Guidance documents
Advertising of health products:
- Marketing of drugs and medical devices
- Fact Sheet: Regulating Advertising of Health Products
- Filing a drug or device marketing complaint
Medical Devices Directorate (MDD)
The MDD regulates medical devices for human use under the Medical Devices Regulations by:
- Reviewing Investigational Testing Authorizations (ITAs)
- Reviewing scientific information to assess devices for safety, efficacy, quality, potential benefits and risks
- Making non-marketed devices available when conventional therapies have failed, are not suitable, or are not available (See Special access program: Medical devices)
Helpful Links
- Medical Devices Active Licence Listing (MDALL)
- List of Medical Devices – Notification of Shortages
- Guidance Documents and Policies
Natural and Non-Prescription Health Product Directorate (NNHPD)
The NNHPD regulates:
- Natural health products (Natural Health Products Regulations)
- Non-prescription drugs (Food and Drug Regulations Part C – Division 9)
- Hard-surface disinfectants
Helpful Links
- Licensed Natural Health Products Database (LNHPD)
- Natural Health Products Ingredients Database
- Compendium of monographs
- Natural Health Product (NHP) Compounding Policy
- Policies and FAQs – Regulation of Natural Health Products
Pharmaceutical Drugs Directorate (PDD)
The PDD regulates prescription drugs for human use by:
- reviewing Clinical Trial Applications (CTAs)
- reviewing scientific information to assess drugs for safety, efficacy, quality, potential benefits and risks
- making non-marketed drugs available when conventional therapies have failed, are not suitable, or are not available
Special access programs (SAP):
- Drugs
- Medical devices
- Emergency drug release program for veterinary drugs
Helpful Links
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.
Helpful Links
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.
Helpful Links
- Good Manufacturing Practices (Food and Drug Regulations, Part C – Division 2)
- Guidance on Establishment Licenses (Food and Drug Regulations, Part C – Division 1A)
- Import and export of drugs and health products (Food and Drug Regulations, Part A)
Quick Links to the Office of the Information and Privacy Commissioner of Ontario (IPC)
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.
info@ipc.on.ca 416-326-3333/1-800-387-0073
General
- A Guide to PHIPA (for healthcare providers)
- Frequently Asked Questions: Personal Health Information Protection Act
- Circle of Care: Sharing Personal Health Information for Health-Care Purposes
- Dispelling Some Myths about the Personal Health Information Protection Act
- Frequently Asked Questions: Health Cards and Health Numbers
- Your Health Information and Your Privacy Brochures and Posters (for posting by healthcare providers)
Guidance Documents
- Guidelines on Facsimile Transmission Security
- Yes, You Can. Dispelling the Myths About Sharing Information with Children’s Aid Societies
- Get rid of it Securely to keep it Private: Best Practices for the Secure Destruction of Personal Health Information
- Guidelines for the Use of Video Surveillance
- Guidance for Health Information Custodians Changing Practice
- Guideline – Privacy and Security Considerations for Virtual Healthcare Visits
- Sharing Information in Situations Involving Intimate Partner Violence: Guidance for Professionals
Privacy Breach Information
- Responding to a Health Privacy Breach – Guidelines for the Health Sector
- Reporting a Breach to the Privacy Commissioner – Guidelines for the Health Sector
- Health Privacy Breach Statistical Report – FAQ
- Workbook and Completion Guide: Statistical Report for IPC on PHI Privacy Breaches
Personal Health Information
- Collecting Personal Health Information
- Use of Personal Health Information
- Disclosure of Personal Health Information
- Access and Correction of Personal Health Information
- Unauthorized Access
PHIPA Fact Sheets
- Accessing Your Deceased Relative’s Personal Information (Apr 2019)
- Communicating Personal Health Information by Email (Sept 2016)
- Disclosure of Information Permitted in Emergency or other Urgent Circumstances (July 2005)
- Disclosure of Personal Information to Law Enforcement (Nov 2018)
- Health-Care Requirement for Strong Encryption (July 2010)
- Lock Box (withdrawal of consent) (July 2005)
- Protecting Against Ransomware (October 2022)
- Safeguarding Personal Health Information (Jan 2005)
- Secure Destruction of Personal Health Information (Dec 2005)
- Disposing of Your Electronic Media (Mar 2018)
- Secure Transfer of Personal Health Information (Aug 2012)
- Video Surveillance (Nov 2016)
Quick Links to Ontario Ministry of Health and Public Drug Programs
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
- Monitored Drugs List
- List of identification
- Frequently Asked Questions
- Resources
- Ontario Drug Programs Reference Manual
Professional Pharmacy Services
- Annual and Follow-up
- For Ontarians living with Diabetes
- At Home
- Fill, Print & Save Forms
- Frequently Asked Questions
Medscheck.Moh@ontario.ca
1-866-255-6701
Pharmaceutical Opinion Program
Pharmacy Smoking Cessation Program
Telehealth Ontario
1-866-797-0000
Universal Influenza Immunization Program (UIIP)
- Vaccine Storage and Handling Guidelines
- For questions regarding vaccine storage and handling, vaccine ordering, or local distribution, contact your local public health unit.
uiip.moh@ontario.ca
1-877-844-1944
Ontario’s Public Drug Programs
PublicDrugPrgrms.moh@ontario.ca
Tel: 1-866-811-9893
Fax: 1-866-598-6530
Exceptional Access Program (EAP)
OHIP+: Children and Youth Pharmacare
Ontario Drug Benefit (ODB) Program
PublicDrugPrgrms.moh@ontario.ca
Help Desk: 1-800-668-6641
Ontario Naloxone Program for Pharmacies (ONPP)
Senior’s Co-payment Program (SCP)
- Application form (for patients)
Seniors@ontariodrugbenefit.ca
1-888-405-0405
trillium@ontariodrugbenefit.ca
1-800-575-5386
Other Publicly Funded Drug Programs
Quick Links to Cannabis Legislation
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.
FEDERAL
- Cannabis Act
- Regulates the production, distribution, sale and possession of cannabis for non-medical (recreational) and medical use in Canada
- Cannabis Regulations
- Apply to a cannabis plant or any part of a cannabis plant, including the phytocannabinoids, cannabidiol (CBD) and tetrahydrocannabinol (THC), and health products containing cannabis
- PART 8: Drugs Containing Cannabis
- PART 14: Cannabis for Medical Purposes
Controlled Substances and Cannabis Branch (CSCB) of Health Canada
- The mandate of the CSCB is to reduce or prevent the harms associated with cannabis through a comprehensive public health approach, carried out through two Cannabis Directorates (Compliance and Licensing & Medical Access)
- cannabis@canada.ca or 1-866-337-7705
Helpful Links
- Health products containing cannabis: Guidance for the Cannabis Act, the Food and Drugs Act, and related regulations
- Information on Cannabis for medical purposes
- Cannabis recalls, adverse reactions and reporting
- The legalization and regulation of cannabis
PROVINCIAL
- Cannabis Control Act
- Establishes systems for overseeing the distribution and sale of recreational cannabis
- Sets out prohibitions relating to the purchase, possession, transport, cultivation, propagation and harvesting of recreational cannabis
- Cannabis Licence Act and O. Reg. 468/18
- Establishes requirements for retail operator licenses, retail store authorizations and cannabis retail manager licences
- Ontario Cannabis Retail Corporation Act
- Ontario Cannabis Store (OCS)
- A Crown agency of the Government of Ontario
- The only legal supplier for private retail stores and online store for recreational cannabis
- Ontario Cannabis Store (OCS)
Alcohol and Gaming Commission of Ontario (AGCO) (affiliated with the Ministry of the Attorney General)
- The AGCO is responsible for regulating the appropriate sale of recreational cannabis by private retail stores though activities such as licensing, training, setting standards and carrying out compliance inspections
- customer.service@agco.ca or 1-800-522-2876
Helpful Links
- Responsibilities of the provinces and territories
- Cannabis Retail Regulation Guide
- AGCO Registrar’s Standards for Cannabis Retail Stores
Helpful Links