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Thursday, November 18, 2010

Drug Safety and Effectiveness in Canada - David U Responds

David U, President and CEO, Institute for Safe Medication Practices Canada

On behalf of the Institute for Safe Medication Practices Canada (ISMP Canada), I would like to thank and congratulate the Health Council of Canada for preparing and disseminating their findings on the important topic of drug safety in Canada. It is encouraging to learn that a number of new initiatives are being put in place to enhance post-marketing surveillance and monitoring such as the “progressive licensing” approach, working with industry to encourage Phase 4 studies on marketed drugs, supporting Canadian research centres to focus on selected drugs for studying their real world effectiveness and safety, as well as creating the Drug Safety and Effectiveness Network. The discussion paper facilitates learning from information available nationally as well as internationally and will help enhance Canada’s ability to ensure the drugs being marketed and used in Canada are safe and will not trigger undesirable and potentially harmful side effects.

I would also like to take this opportunity to emphasize that we must ensure drugs are being used appropriately to prevent harm. Medication incidents (medication errors) leading to harm and death can be prevented. For example, there have been a number of fatal incidents involving the fentanyl transdermal system (fentanyl patches) and important information about this has been published by Health Canada. One such publication is the July 2008 issue of the Canadian Adverse Reaction Newsletter which highlights 52 cases with fatal outcome involving fentanyl patches; examples include incidents (errors) which involve healthcare professionals and consumers. ISMP Canada has also received incident reports related to fentanyl patches, and has issued several alerts and safety bulletins to healthcare practitioners as well as sharing learnings with manufacturer(s) for the purpose of enhancing labelling and packaging.

As part of Canadian Medication Incident Reporting and Prevention System (CMIRPS), the incident reports received by ISMP Canada contribute to knowledge in medication safety. For example, contributing to some harmful medication incidents is the confusion that has occurred from look-alike/sound-alike drug names and from look-alike labelling and packaging of pharmaceutical products. In October 2008, Health Canada initiated the development of a conceptual framework for the assessment of health product names for look-alike/sound-alike name attributes. An Expert Advisory Panel was created to support this development process, with representation from Health Canada, the Food and Drug Administration in the United States, ISMP Canada along with experts in the area of psycholinguistics and human factors. The proposed conceptual framework will inform the basis for the revision of the current Health Canada Guidance for Industry - Drug Name Review: Look-alike Sound-alike (LA/SA) Health Product Names. The guidance document will strive to bring greater scientific validity, transparency, objectivity and predictability to the evaluation of health product names for look-alike/sound-alike attributes. It is proposed that the framework and guidance will apply to the following product types for human use: prescription and non-prescription drugs, biologics, and natural health products. Over the past year, efforts have been focused on putting a number of health product names through each step of the proposed name review process to establish "proof of concept". It is anticipated that data gathering and analysis will be complete by 2011 followed by stakeholder consultation. Development of a similar framework is planned for labelling and packaging of pharmaceutical drugs for human use.

Learning from medication incidents occurs from reports received by both consumers and healthcare professionals as it provides useful information in detecting problems in the medication use system. In the spring of 2010, ISMP Canada launched a consumer medication incident reporting and learning web site: Consumer reporting in Canada has resulted in important contributions to medication safety —10 newsletters and alerts have been published to provide incident learning and prevention strategies for all Canadians.

Another key project towards drug safety is the collaborative Canadian Pharmaceutical Bar Coding Project which aims to implement standardized bar codes on all aspects of pharmaceutical labelling. Headed jointly by the Institute for Safe Medication Practices Canada (ISMP Canada) and the Canadian Patient Safety Institute (CPSI), the initiative is guided by a national Implementation Committee and being developed with assistance from a 34-member Technical Task Force (TTF), representing six identified healthcare sectors. Adoption of the GS1 global standard for automated identification (e.g., bar coding) of pharmaceutical products in Canada has been endorsed. The multiphase project has developed draft technical requirements for Canadian pharmaceuticals in the following areas: bar code components and symbologies, product database elements, medications to be included in the categories to be bar coded, and packaging levels and bar code placement.
The report prepared by the Health Council of Canada will no doubt help to further raise the profile of drug safety. It provides the opportunity for the collective challenge in Canada for all of us to move collaboratively towards the common goal of drug safety.

David U is the President and CEO at the Institute for Safe Medication Practices Canada (

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