Have you heard of Vanessa’s Law?
Officially known as the Protecting Canadians from Unsafe Drugs Act, Vanessa’s Law is named after Vanessa Young, a fifteen-year-old girl who died of a cardiac arrhythmia after being prescribed Prepulsid® (cisapride) for a stomach disorder.
Vanessa’s Law was introduced in 2013, and amends the Food and Drugs Act to help safeguard Canadians from risks related to drugs and medical devices by strengthening Health Canada’s ability to collect post-market safety information and take action when a serious risk is identified.
The Law also gives Health Canada the power to order recalls, impose tougher penalties for unsafe products, and compel drug companies to revise labels or do further testing on products.
Now, after several years of extensive engagement with stakeholders across the country, Health Canada has finalized regulations to advance a key objective of Vanessa’s Law: to improve the quality and increase the quantity of adverse drug reaction (ADR) and medical device incident (MDI) reports.
The regulations make the reporting of serious ADRs and MDIs mandatory beginning on December 16, 2019, requiring all hospitals in Canada to report such incidents to Health Canada within 30 days of them being documented within the hospital.
Sound daunting? Not to worry!
BCPSLS has been ramping up its game to make reporting ADRs and MDIs as quick and easy as possible.
What are ADRs and MDIs?
Let’s begin with what ADRs and MDIs aren’t.
They aren’t errors in care, or what we typically think of as patient safety incidents or events.
ADRs and MDIs can happen unexpectedly to any patient at any time, even though processes, procedures, and instructions are followed correctly.
For example, a patient may have an unanticipated, life-threatening reaction to an antibiotic that was given correctly: the right drug, the right dose, the right route, the right time, the right patient.
Or an infusion pump might stop working and fail to give an alarm, giving a patient more or less medication than planned. While correctly reported as a medication event, flagging the involvement of the medical device facilitates expert review and identification of the MDI.
Thankfully, it isn’t likely that you’ll encounter ADRs or MDIs every day. But when you do, it’s important to report them.
Reporting ADRs and MDIs in BCPSLS
Our Central Office team has been working with Health Canada, BC’s Ministry of Health, and the health authorities to ensure everything is in place to support mandatory reporting when it comes into effect this December.
If you’ve already been reporting ADRs and equipment problems in BCPSLS, you won’t need to do anything differently. Our system has facilitated voluntary reporting of ADRs since 2014. MDIs are identified through the process of reporting patient safety events, such as medication incidents and falls, where equipment is a contributing factor.
When you report ADRs and MDIs in PSLS, we will ensure that your reports are reviewed, de-identified if necessary, and submitted to Health Canada within the 30-day deadline.
In addition to reviewing processes and updating forms, we’re developing a suite of communication tools and an online education module that will provide everything you need to know about mandatory reporting. You’ll be hearing lots more about all of this in the coming months, so stay tuned!
Email Central Office at email@example.com or contact your health authority PSLS Coordinator.
For questions about the mandatory reporting requirements, contact Thanh Vu from Health Canada at firstname.lastname@example.org.
If you haven’t already, you can stay on top of updates and announcements by following our blog.
We’re looking forward to working with you to help make drugs and devices safer for all of us!
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