Information
May 25, 2004
Health Canada & Patient Safety Fact Sheet
Overview
Canada has a quality health care system that delivers safe and effective care to Canadians every
day. However, even with the best system in place, adverse events can happen. We can only improve
safety by promoting a culture of sharing and learning that breaks the culture of silence that surrounds
adverse effects.
What is Patient Safety?
Safety -"freedom from accidental injury"- does not reside in a person, device or department. Instead,
it emerges from the interactions of components within the health care system. Ensuring patient safety,
therefore, requires systems and processes that increase the reliability of patient care.
The Canadian Patient Safety Dictionary defines patient safety as "the reduction and mitigation of
unsafe acts within the health-care system, as well as through the use of best practices shown to
lead to optimal patient outcomes." Essentially, patient safety is about constantly working to avoid,
manage and treat unsafe acts within the health care system.
The Role of Health Canada in Patient Safety
Health Canada has an ongoing commitment to quality of care and patient safety. This is reflected
in its multi-faceted role in legislation, regulation, surveillance, research, information dissemination
and health care delivery to First Nations and Inuit populations.
Our Partners
Governments, health professionals and other interested groups recognize the need to work together
to share best practices for patient safety. To that end, Health Canada collaborates with a variety
of interested groups, including provincial and territorial governments, health care organizations
and regulatory bodies, as well as the research community and the public.
A Snapshot of Patient Safety Activities at Health Canada
Canadian Adverse Drug Reaction Information System (CADRIS)
The Canadian Adverse Drug Reaction Information System (CADRIS) is the name of the computerized database
that houses Canadian suspected adverse reactions (AR) which have been reported to Health Canada's
Canadian Adverse Drug Reaction Monitoring Program (CADRMP). CADRMP collects AR reports for the following
Canadian marketed health products:
- pharmaceuticals;
- biologics (including fractionated blood products, as well as therapeutic and diagnostic vaccines),
- natural health products; and,
- radiopharmaceuticals.
Adverse reaction reports are submitted by health professionals and consumers on a voluntary basis,
either directly to Health Canada or via market authorization holders. It is mandatory for all Health
Product Market Authorization holders (manufacturers) to report adverse reactions to Health Canada
according to the Food and Drugs Act and Regulations and the Natural Health Products Regulations.
For further information, please visit:
For other related initiatives such as Adverse Reaction Reporting by Health Professionals and
Consumers and How Adverse Reaction Information on Health Products is Used, please
visit:
Look-alike/Sound-alike Health Products (LA/SA)
Many health products are similar when written or spoken, which can create confusion and lead to
injury. Health Canada critically reviews scientific information and works to ensure that health products
in Canada are safe, effective and of high quality. To date, a Health Products and Food Branch inter-directorate
working group has reviewed and analyzed issues associated with LA/SA similarities and has recommended
a course of action to reduce the potential for LA/SA confusion between products.
For further information, please visit:
Medical Device Problem Reporting by health care facilities, medical
professionals and other device users
Manufacturers and importers must report problems with medical devices to Health Canada's Health
Products and Food Branch Inspectorate (HPFBI). As a central clearing house for such reports, the
HPFBI can link isolated reports to identify problems that would otherwise go unnoticed or be dismissed.
It encourages anyone purchasing, using or maintaining these products to report problems.
For further information please visit:
Health Policy Research Program (HPRP)
This program funds research with a broad socio-economic focus that will ultimately help Health Canada
make policy decisions. The program, which enables Health Canada to enter into partnerships to achieve
its goals, has connections to both national and international research. Results from the current
research project, "Governance Choices and Health Care Quality: A Focus on Patient Safety," are expected
in 2005.
For more information, please visit:
A Snapshot of Patient Safety Activities shared between Health Canada and its partners
The Canadian Patient Safety Institute (CPSI)
In September 2002 the National Steering Committee on Patient Safety released the report, Building
a Safer System: A National Integrated Strategy for Improving Patient Safety In Canadian Health
Care, which made 19 recommendations, including the creation of a patient safety institute.
The 2003 First Ministers' Accord on Health Care Renewal also acknowledged the importance of patient
safety.
In response, the Government of Canada's Budget 2003 provided $10 million annually to support patient
safety, including the creation of the Canadian Patient Safety Institute (CPSI). An Interim Committee
comprised of groups interested in health care, provincial and territorial governments, and Health
Canada oversaw the Institute's development.
In December 2003, federal, provincial and territorial Ministers of Health announced the establishment
of the CPSI in Edmonton, Alberta, as well as its founding Board of Directors. The Institute will
help build a culture of patient safety and quality improvement throughout the Canadian health care
system. A non-profit corporation at arm's length from government, it will promote best practices,
raise awareness and advise on effective strategies to improve patient safety.
For additional background information, please visit:
For current information on the CPSI, please visit:
Canadian Medication Incident Reporting and Prevention System (CMIRPS)
This system will assist health professionals, health organizations, community-based pharmacies and
governments, among others, to recognize potential problems before they occur and implement appropriate
preventative strategies. The main objective of the CMIRPS is the reduction of harm caused by preventable
medication incidents. This will be accomplished through the collection and analysis of standardized
incident data; and the development and dissemination of timely and targeted information to the health
care community and consumers, including best practices in safe medication use systems. Partnerships
and collaboration will be a key factor in the success of the CMIRPS. Health Canada has been integral
in coordinating initial implementation of the system in conjunction with the Canadian Institute for
Health Information (CIHI) and the Institute for Safe Medication Practices - Canada (ISMP-Canada).
For further information on CMIRPS please visit:
Healthy Work Environment Best Practice Guidelines (BPG) Project
The Registered Nurses Association of Ontario and Health Canada's Office of Nursing Policy are developing
six evidence-based guidelines to promote healthy work environments for nurses. To that end, they
have established expert panels that represent nurses, as well as different practice settings and
geographical settings. Health Canada and the Ontario Ministry of Health and Long Term Care are funding
the project.
For further information, please visit: http://www.hc-sc.gc.ca/onp-bpsi/
english/current_research/bpg_project_e.html
Canada Health Infoway Inc.
Canada Health Infoway Inc. (Infoway) supports the creation of an infostructure that provides
Canadians and their health care providers with timely, appropriate and secure access to the right
information when and where they enter into the health care system. It will foster and accelerate
the development and adoption of electronic health information systems with compatible standards and
communications technologies on a pan-Canadian basis with tangible benefits to Canadians. Infoway was
created in response to a commitment of Canada's First Ministers to "work together to strengthen a
Canada-wide health infostructure to improve quality, access and timeliness of health care for Canadians." For
further information on Infoway, please visit:  http://www.infoway-inforoute.ca/
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