Most of us will take medication at some point in our lives, and any of us can be susceptible to experiencing an Adverse Drug Reaction (ADR) – an unexpected, undesirable response to a drug product – even if we are taking the medication as intended. The effect of an ADR can happen immediately after taking a drug as prescribed, or years later, and can range from a minor skin irritation to major organ failure, or even death in rare cases. Every day, healthcare professionals administer many medications to patients, clients and residents, so it’s important to learn all we can about ADRs to keep people safe.

The reporting of suspected ADRs by healthcare providers is considered the most reliable method for collecting information about these issues. In fact, new federal legislation, called “Vanessa’s Law”, and recently-added Accreditation Canada standards both aim to promote reporting of ADRs by healthcare organizations to Health Canada, recognizing the valuable information providers can offer.  Tools have been available in parts of BC’s healthcare system for several years to support ADR reporting, but current processes are not widely known or fully used. Paper forms are the usual reporting mechanism and these are often cumbersome for healthcare staff to use and hard to find on busy hospital wards or hospital Intranet sites. And there are variations in the way data is collected from across the province, hindering our ability to learn and improve on a provincial or national scale.

A different approach is required and we’re pleased to announce that a better system is on the way!

Over the past year, BC Patient Safety & Learning System (BC PSLS) Central Office has been working with Health Canada’s Canada Vigilance Program – the federal body responsible for collecting and analyzing information about suspected ADRs in Canada – and pharmacy representatives from the BC Health Authorities to enable data collection about ADRs through BC PSLS.

BC’s healthcare providers have been reporting medication events and other patient safety issues in BC PSLS since 2008, so offering a way to report ADRs within the same system is a practical approach for all involved. Online reporting through BC PSLS will not only make ADR reporting more efficient and easier for reporters, it will significantly improve data quality and provide a better way to learn more about ADRs and promote medication safety within the Health Authorities, at the provincial level and nationally.


Purple maple leaf icon for the new ADR specialty report form on the BC PSLS landing page.

The group’s first step was to collaborate on the development of a new ADR specialty report form. Questions on the new form are based largely on the current Canada Vigilance Adverse Reaction Reporting Form and additional, standard BC PSLS questions are included so Medication Safety Officers, pharmacy representatives and others can follow-up with reporters or patients if necessary.  The role of medication safety officers in review and “handling” of ADR reports for the pilot phase was clarified, and a process identified so that BC PSLS Central Office can securely provide de-identified reports to Canada Vigilance. 

Fraser Health will be the first Health Authority to Go Live with the new form in December. A campaign and slogan Any Person-Any Drug-Any Time – will help get the word out to staff on the front lines, with Fraser Health Pharmacy Coordinators wearing ADR buttons and answering questions about the new initiative. Posters will also be on display in Emergency Departments and other locations across Fraser Health to raise awareness. This first launch is our pilot project and will be evaluated before other Health Authorities Go Live in 2015

From now and into next year, BC PSLS Central Office, Canada Vigilance and the Health Authorities will continue to work together to promote medication safety for Canadians.

Stay tuned for updates over the coming months!

BC PSLS Central Office would like to acknowledge and thank participants from the BC Health Authorities and Canada Vigilance for their input and assistance with developing the new ADR reporting form and processes.

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