Nearly half of hospitals failed to report adverse drug reactions despite laws requiring them to, analysis finds

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Nearly half of the hospitals across Canada failed to report any serious adverse drug reactions in their facilities in the three years after the introduction of mandatory reporting requirements, raising concerns about the quality of information Health Canada uses to assess drug safety.

In December, 2019, it became mandatory for hospitals across the country to report serious adverse drug reactions to Health Canada. The Globe and Mail obtained, through an access to information request, the first three years of data reported to the government after the law came into force.

An analysis of the data shows significant variances in what hospitals are reporting. The explanations offered by some low-reporting health care institutions indicate that not all of them are operating by the same playbook – raising questions about the effectiveness of the law, and whether Health Canada needs to offer more guidance, or possibly enforcement, of the regulation.

The data set, which provides the number of reports from each hospital, showed that 401 of 867 Canadian health institutions required to report to Health Canada have provided no reports since the law came into force.

Of the remaining institutions that disclosed adverse reactions, 308 reported between one and 10 incidents over the three-year period. In contrast, the highest-reporting hospitals had more than 1,000 reactions.

Experts in drug safety say some of the figures are impossibly low. “Those kinds of numbers are just not credible,” said Joel Lexchin, a retired emergency-room doctor and a former professor at York University.

Corinne Hohl, an emergency-room doctor who studies adverse drug events, said “adverse drug reactions are ubiquitous if you are treating patients with medications.”

She added that treating patients with drugs is the most common medical intervention, even among surgical patients.

Others say the inconsistent reporting across hospitals could be a failure of the regulator to properly communicate obligations.

Lucas Chartier, vice-president of quality and safety and chief patient safety officer for the University Health Network, said Health Canada may need to work on clarifying what hospitals are required to report. “It appears as though there’s an incomplete understanding,” Dr. Chartier said.

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Dr. Hohl estimates based on her research that around 2 per cent of all emergency-room admissions are because of drug reactions that would meet Health Canada’s definition of serious. Academic literature shows that drug reactions, which could include ones that don’t meet the definition of serious, can account for anywhere between about 5 and 10 per cent of hospital admissions.

Vanessa’s Law, named after the late daughter of Terence Young, a former Conservative MP, made it mandatory for hospitals across the country to report such incidents. The law defines a reaction as any incident that “requires in-patient hospitalization or prolongation of existing hospitalization, that causes congenital malformation, that results in persistent or significant disability or incapacity, that is life-threatening or that results in death.” Data on incidents such as these are used to flag potential issues with drugs on the market and are particularly important for new treatments.

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“The fact that they have any hospital that didn’t report any is like a three-alarm fire,” said Mr. Young. His 15-year-old daughter died in March, 2000, after taking a drug called Prepulsid (cisapride) to help treat a mild form of bulimia. An Ontario coroner’s inquest found Prepulsid contributed to an arrhythmia and cardiac arrest. The drug was later pulled from the Canadian and American markets because of similar cardiac side effects.

Mr. Young’s advocacy as a private citizen and MP helped create the Protecting Canadians from Unsafe Drugs Act, or Vanessa’s Law, passed in 2014. It includes penalties for companies making unsafe products. Five years later, the government finalized the mandatory adverse drug reaction reporting requirement for hospitals.

Experts say there are serious risks of not having the data. “The people who are prescribing and the people who are taking the drug don’t have a good idea how safe or unsafe it is,” Dr. Lexchin said.

Health Canada uses the information it collects through the required reports to inform decisions around drug recalls and advisories. Having solid information on adverse drug reactions is particularly important for recently approved drugs. “When new drugs come on the market, we actually know very little about the safety because they’ve been tested in a very narrow range of people,” Dr. Lexchin said.

The data obtained by The Globe show significant variability in reporting between institutions. While the majority of sites listed fewer than 10 incidents over the three-year period, the top reporters – CHU de Québec-Laval University and Vancouver General Hospital – reported 1,713 and 1,149 serious reactions, respectively.

Of the institutions that reported zero incidents, some were small regional facilities, such as the Centre de santé Notre-Dame Health Centre in Manitoba. Rizwan Ahmed, a director with Southern Health-Santé Sud, the health region responsible for the centre, explained that the reason it reported no incidents was likely because patients with suspected serious adverse drug reactions were transferred to a regional site or urban centre which, he said, would be obliged to report the reaction.

Interior Health, a regional health authority in British Columbia, had three hospitals report no incidents. Ashley Stewart, a communications officer with the health region, said employees and medical staff are encouraged to report adverse events, noting that “the numbers reported are consistent with what we would expect to see based on facility size and the number of overall reports for the Interior Health region.”

More than 200 institutions that meet Health Canada’s regulatory definition for a hospital did not appear in the data set; it is unclear why.

The Globe’s analysis shows that six of the 10 largest hospitals in Canada by bed count had fewer than 100 incidents each during the three-year time frame. For example, Sunnybrook Health Sciences Centre in Toronto, one of the largest hospitals in the country, reported only 24 incidents during this time.

When questioned, some low-reporting hospitals said they are complying with the law. Jennifer Palisoc, communications adviser at Sunnybrook, said the hospital is following the reporting requirements outlined by the government. Spokesperson Lisa Cipriano said the Scarborough Health Network, which reported 37 incidents during the three-year period across eight sites, including three major urban hospitals, was also meeting its obligations.

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The University Health Network, which includes the Toronto General Hospital, Toronto Western Hospital and the Princess Margaret Cancer Centre, reported 38 incidents in the three years. Dr. Chartier said, “I have all the confidence in our system at UHN where people do feel very welcome to report.”

He said UHN’s comparatively low numbers can be attributed to the network moving from a paper-based system that was less streamlined, the pressures of the pandemic, and the hospital’s interpretation of the law. He said while UHN captures all serious incidents that are unexpected, the hospital network may not report serious incidents that involve known effects of certain drugs.

Anne Génier, senior media relations adviser at Health Canada, said in an e-mailed statement that, according to the law, hospitals must report all serious adverse drug reactions, including known effects and those that are unexpected.

Despite the low number of reports from the majority of hospitals, Health Canada has celebrated its results in communications materials. A newsletter sent in December said in the first 2½ months of mandatory reporting, there was a 321-per-cent increase in reports since before the requirements were put in place.

Health Canada could not explain what accounted for the low numbers coming from some hospitals. However, after the implementation of the law, the department expected that hospitals would need time and resources to ramp up reporting, adding in an e-mailed statement that the pandemic could have played a role.

“With the arrival of the COVID-19 pandemic in early 2020, it is likely that the hospitals experienced additional costs and disruptions,” Ms. Génier said.

Dr. Hohl believes the issue is one of system design. The emergency-room doctor at Vancouver General Hospital said “they’re asking people like myself who have a waiting room of patients who’ve been sitting there for 10 hours waiting to see me to take 20 minutes to report all these details about these adverse drug reactions.”

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The two institutions with the most reports, CHU de Québec–Laval University and Vancouver General Hospital, have created more user-friendly systems separate from Health Canada’s mechanism to provide this data to the regulator.

Michèle Schaffner-Junius, the public and government affairs adviser for CHU de Québec-Laval University, called Health Canada’s reporting form “long and complex.” She said her network of hospitals has created a reporting system that allows clinicians to make a report in less than two minutes. The longer Health Canada form is later filled out by a dedicated agent.

Dr. Hohl is the project lead on a system called ActionADE with a similar approach at Vancouver Coastal Health, which includes Vancouver General Hospital. She said their platform not only streamlines the process but also makes note of adverse drug reactions on patient files to ensure that they are not unintentionally re-exposed to the same drug.

Ms. Schaffner-Junius said the network has been taking a variety of other steps to prioritize reporting under Vanessa’s Law. The centre has conducted dozens of presentations for physicians, pharmacists and specialized nurse practitioners and has created a community of practice to promote its reporting philosophy and best practices. As a result, she said, health care professionals at the hospital have “strengthened their capacity to identify and manage ADRs [adverse drug reactions], thereby elevating the quality of care.”

Dr. Lexchin said insufficient training in recognizing adverse drug reactions could also be playing a role in the low numbers coming from hospitals, because “if you don’t recognize it, you can’t report it.” He said there are thousands of drugs on the market, and even for the smaller group of drugs used by specialists or general practitioners regularly, “maintaining and knowing the information on all of those drugs is not that easy.”

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Furthermore, while Vanessa’s Law made it mandatory for hospitals to report any documented serious adverse drug reaction, it is not mandatory for doctors or other hospital staff to document these reactions. Dr. Lexchin said he believes most doctors are not aware of the law.

Mr. Young blames a lack of penalties. “You have to have some kind of penalty or administrative action that gets people’s attention, and obviously they are not doing that,” he said. Mr. Young, who now has been working on this issue for 23 years, calls the reporting levels across the country an embarrassment. “They didn’t do what they were supposed to do by law. They didn’t do what they were supposed to do for Canadian patients.”

Health Canada says its approach to the collection of adverse reaction reports from hospitals has been collaborative. The department strives to “pro-actively promote hospital compliance through projects aiming to better understand hospital challenges with reporting serious ADRs and find ways to help them improve their compliance,” said Ms. Génier, adding that the approach seeks to minimize resource impacts on hospitals.

However, the department says it can use provisions in the Food and Drugs Act to compel a hospital to comply with Vanessa’s Law – for example, by seeking an injunction to legally oblige hospitals to report this data. Ms. Génier said, “to date, the department has not taken any enforcement actions on hospitals with respect to compliance with mandatory ADR reporting.”

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