B.C. researchers testing software solution to chronic under-reporting of dangerous drug events

Dr. Corinne Hohl, MD, is trying to create more awareness about adverse drug events — harm done by medical drugs given to patients — but she refuses to report cases to Health Canada.

“You report all this information and it disappears in a black box — and nobody really knows what [Health Canada officials] do with the information,” said Hohl, a Vancouver-based emergency room (ER) physician and UBC medical professor, in an interview.

Hohl is not alone. Most Canadian doctors don’t comply with the Protecting Canadians from Unsafe Drugs Act, also known as Vanessa’s Law, which requires hospitals and their affiliated out-patient clinics to report ADEs to Health Canada. Only an estimated five per cent of hospitals are complying with the legislation, which is named after Vanessa Young, a 15-year-old girl in Oakville, Ont., who died of cardiac arrythmia in 2000 after an adverse reaction to the since-banned drug cisapride.

“It would take about 30 minutes for me to report an adverse drug event,” said Hohl. “I can tell you that I just don’t have the time.”

“[Health Canada] set up these reporting platforms with very little input from physicians or pharmacists… If I have 20 patients in my waiting room, I want to go see the next patient.”

Hohl added that Health Canada’s lengthy online ADE reporting forms require the duplication of data and are not compatible with hospital electronic-medical-record systems.

Health Canada was not able to respond by deadline to questions from Research Money.

Hohl is instead collaborating with Simon Fraser University communications professor Dr. Ellen Balka on a software application called ActionADE to enable ER physicians and other doctors to communicate with Pharmanet, B.C.’s provincial drug-dispensing network. The software was developed over the past decade through research funding from federal, provincial and foundation sources, including the Canadian Institutes for Health Research and Michael Smith Foundation.

ActionADE enables ER doctors and other hospital-based physicians to document ADEs and alert each other about potential repeats in real time. Today, the software is being used in nine hospitals on B.C.'s Lower Mainland as part of a research trial. The technology has documented 864 ADEs over approximately the past year, said Balka in an interview with Research Money.

Hohl and Balka are now conducting a randomized study of 3,600 patients, slated to be completed in 2022, that could lead to more widespread use of ActionADE in B.C. and elsewhere.

Researchers hoping for national ADE-reporting network

Vanessa’s Law became enforceable in December 2019 after being enacted in 2016. ADEs are defined as harmful and unintended consequences, or responses, to medication use, including drug interactions, dosing issues and drug allergies.

According to Hohl and Balka, ADEs send about two million Canadians to ERs each year. A B.C. healthy ministry webpage says that province alone accounts for 276,000 ER visits, 102,000 hospital admissions, 4,500 deaths and $100 million in health costs annually.

Most ADEs are anticipated, common and preventable, said Hohl, but unforeseen repeats are risking patients’ lives and costing the Canadian healthcare system millions. The situation is being compounded by patients who may not be able to communicate their ADE history due to language barriers or a lack of health literacy.

“The fact that every eighth or ninth emergency department [patient] in Canada has an adverse drug event that diseases are causing or contributing to, that's a huge cost to the system. It's incredibly inefficient and it's a lot of patient harm."

The B.C. researchers said ActionADE ultimately succeeded through its integration with Pharmanet. It took an “incredible” amount of time and energy to figure out who to deal with at the local health authority, provincial health ministry and Pharmanet, said Balka. However, once the administrative layers were navigated and approvals were granted, ActionADE’s implementation was not technically complicated or overly expensive.

“What we need [are] standard operating procedures for the introduction of integrated [ADE-reporting] software in every province in Canada,” said Balka.

Hohl, Balka and others who are seeking a national ADE-reporting network also want Ottawa to set up a national prescription-dispensing network so that the two systems could link to each other.

Barriers to a national system are political, not technical

Dr. Paul Grootendorst, PhD, an economist in the University of Toronto’s Faculty of Pharmacy, said the proposed national ADE-reporting network requires too much joint political will — at the federal, provincial and territorial levels — to become a reality.

“I'll give it the same chance as a snowball's chance in hell,” Grootendorst said. “I mean it's simply not going to happen."

He also said a national prescription-dispensing network is “a complete pipe dream.”

He has not investigated the possible cost of setting up a national prescription-dispensing network but said it “would not be prohibitive.” Some ADEs, he added, can be explained by a lack of patient oversight.

Dr. Joel Lexchin, MD, a Toronto-based ER physician, agreed with Grootendorst that there's little chance of establishing a national network. Lexchin, who collaborated on early research leading to ActionADE’s development, does not report ADE cases to Health Canada. He criticized the federal ministry for not providing feedback on ADEs or even confirming that suspected ADEs occurred.

“I'm probably like most [ER doctors] in that I probably don’t recognize a lot of the problems that are based on adverse drug events that people present with,” said Lexchin, who also serves as a University of Toronto family and community medicine professor.

Lexchin added that Health Canada spends around three times more money on approving new drugs than monitoring medications already on the market. Citing figures that he obtained through access-to-information requests, Lexchin said Health Canada spent $108.32 million on approval efforts and only $30.77 million on monitoring in 2020.

The number of Health Canada full-time employees working on approvals (875) also dwarfed those focused on monitoring (249).

B.C.’s Pharmanet, as far as he knows, is the only database in Canada that documents every prescription dispensed. In Ontario, he noted, the provincial dispensing network only records prescription covered by the province’s drug-benefit program.

B.C. and Alberta have best prescription-dispensing networks, says CAEP director

Dr. Eddy Lang, MD, a Calgary-based ER doctor and a Canadian Association of Emergency Physicians (CAEP) director, believes a national ADE-reporting network would help to prevent doctors from overprescribing medications. It would also help prevent misdiagnoses of depression — which have been exacerbated by the COVID-19 pandemic — and other health problems.

Lang believes access to ADE information in a national prescription-information network would help patients make better healthcare choices, become more active in the decision-making process and help prevent inappropriate prescriptions “at the get-go.”

But, he suggested, it will be a challenge for provincial medication-dispensing networks to integrate. Quebec and Ontario lag behind B.C. and Alberta when it comes to ERs, doctor offices and pharmacy networks sharing patients’ prescription history.

“You can't know if there's overprescribing unless you have good data,” said Lang, who is also a University of Calgary emergency medicine professor.

“It's complicated, because you would think that we have the computer power to do a national system and we're wasting a lot of resources, with each province reinventing the wheel.”

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