Did you know that it’s been almost eight weeks since Vanessa’s Law regulations came into effect?

Since December 16, 2019, hospitals have been required to report serious adverse drug reactions (ADRs) and medical device incidents (MDIs) to Health Canada. In BC, this is done through PSLS.

The goal is to increase the quantity and improve the quality of reports received by Health Canada, so it can take action to make drugs and devices safer.

So, how is it working so far?

Well, we’re happy to announce that ADR and MDI reporting in BC is humming along nicely.

But don’t just take our word for it!

Last month, BCPSLS Central Office received a visit from Marc Mes, Director General, Marketed Health Products Directorate, Health Canada. He came to hear about BC’s successes, challenges, and the collaborative approach we adopted to implementing mandatory reporting.

“I am supportive and very appreciative of BCPSLS working with colleagues and counterparts across Canada and sharing their experiences, achievements, and lessons learned with implementation,” says Marc. “It is through collaboration that we will enable the capture of meaningful, high-quality information and advance the safety monitoring objectives of Vanessa’s Law.”

Still not convinced? Let’s take a look at the data.

Adverse drug reactions

Month to month, ADR reporting in PSLS has been fairly consistent since it was launched in 2014, with up to twenty reports submitted each month. However, in October 2019 we saw a big jump in the number of ADR reports and it’s remained consistently higher since then.

There are couple potential explanations for this climb.

One is the increase in awareness about Vanessa’s Law from a variety of sources, including the education and communication efforts of many engaged staff, leaders, and physicians within BC’s health authorities. The campaign took a broad view of ADR reporting, emphasizing the importance of reporting all ADRs from all health care sites, not just serious ADRs documented in hospitals as required by Vanessa’s Law regulations.

Another is that Vancouver Coastal Health (VCH) and Providence Health Care (PHC) are now contributing to the input as they adopted PSLS as their ADR reporting tool in September 2019.

It’s likely that both of these factors played a role in the change.

Unsurprisingly, the facilities submitting the greatest number of ADR reports are large hospitals in the densely populated Lower Mainland.

The top three types of medications identified in ADR reports are:

1. Contrast media – used in medical imaging procedures (e.g. iohexol)
2. Antineoplastics – used for chemotherapy (e.g. nivolumab)
3. Psycholeptics – used to produce a calming effect or to treat mental health conditions (e.g. clozapine)

Of course, ADR reports don’t input themselves into PSLS. So, who is doing all this ADR reporting?

The majority of reports are from nurses, followed by medical imaging staff, pharmacists, physicians, and students.

Medical device incidents

MDI reporting, while less established than ADR reporting, has nonetheless been steady since PSLS launched its MDI report form and updated all other report forms on November 8, 2019.

Although PSLS has long supported the identification of equipment as a contributing factor in patient safety incidents, the new MDI form and new questions added to all other report forms are intended to capture incidents related specifically to the malfunction or failure of a medical device.

Since November 2019, over 1000 incidents involving device malfunction or failure have been reported into PSLS.

Of these, only thirty-nine have met the criteria for mandatory or voluntary reporting. Unlike ADR reports, which are all submitted to Health Canada, only MDIs that meet specific reporting criteria are forwarded on to Health Canada by BCPSLS Central Office.

Mandatory reporting applies to incidents related to the failure of a medical device that result in death or serious deterioration in health of a patient, user, or other person, or could do so were they to recur. For specific examples and criteria, download the MDI-specific criteria and scenarios resource from bcpslscentral.ca.

Incidents flagged for voluntary reporting are tracked by the Canadian Medical Devices Sentinel Network (CMDSNet), a national surveillance program that encourages reporting of medical device problems from a variety of institutions, including hospitals.

The largest category of reported devices is biomedical devices and equipment, such as scopes, IV pumps, and dialysis equipment. The next largest category is non-biomedical devices and equipment, such as wheelchairs and laboratory equipment. This is followed by products, supplies, consumables and disposables, which include infusion tubing, needles, and catheters.

Vanessa’s Law course evaluation

Our 20-minute Vanessa’s Law course was launched on LearningHub and iLearn on October 30, 2019. The course was developed with input from a provincial Vanessa’s Law steering committee, working groups, and stakeholders from a variety of health care disciplines across BC.

Have you taken it, yet?

If you’re someone who likes to read the reviews before committing, check out the following:

“Very informative and relevant to my profession. Thanks and keep up the good work!”

 “Valuable information to improve my nursing.”

“Hands-on practice is excellent!”

“The interactive format is engaging and you can move efficiently through the content. Great job.”

– Anonymous comments from course evaluations

What’s next?

BCPSLS Central Office, Health Canada, and health care leaders across the province will actively monitor and improve ADR and MDI reporting with the long view of it becoming ingrained in practice. To support this, dashboards have been created in PSLS to help leaders monitor ADR and MDI reporting in their areas.

Our Vanessa’s Law page on bcpslscentral.ca will continue to be your one-stop-shop for downloadable resources and links to more information. As processes evolve over time, we will keep you posted with the latest and greatest information.

If you’re attending this year’s Quality Forum, check out BCPSLS’s storyboard entitled “BC’s collaborative approach to advancing Vanessa’s Law”. And be sure not to miss Sarah Hawley from VCH and Emily Rose from Lower Mainland Biomedical Engineering as they demonstrate how to “Apply systematic investigation approaches to medical device incidents” in breakout session C1 on day one of the Forum.

Congratulations, again, to everyone for their initial successes in advancing Vanessa’s Law in BC!