Advocates push for mandatory reporting of severe adverse drug reactions, preventative solutions

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Every year, thousands of Canadians will experience adverse reactions to medication meant to save their life and make them better, but instead makes them significantly worse.

Advocates say it is a leading cause of death in Canada and are pushing for new rules around monitoring side effects, tracking the reactions, and implementing solutions that would minimize these potentially life-threatening reactions.

Mike Sawatsky had a pre-existing kidney condition, but was an otherwise healthy father, husband, and avid outdoorsman. In 2013, he received an approved monoclonal antibody therapy, rituximab, to treat his kidney disease. But instead of getting better, his body had a reaction to the drug so severe it damaged his short term memory function, leaving him permanently disabled.

Sawatsky said his throat felt like it was swollen shut, his temperature spiked, but worse was the impact on his brain. The inflammation worsened slowly over the months until the symptoms became unbearable. His memory became so short, it felt like he was living in the minute.

“I’m losing words, I couldn’t come up with words that I knew. I forgot how to spell … punctuation just completely obliterated. And that went on for about three years,” he said from his home in Whitehorse, Yukon.

“I had no consistency in my thoughts. Everything is kind of broken and fractured….The broken thoughts and vocabulary started increasing to the point where I couldn’t even discuss with Crystal anything.”

Crystal is Sawatsky’s wife. She witnessed her husband turn into a totally different person following his treatment.

“It completely changed our lives because we were active outdoors people. We had kids, we had lots of friends, we’re very social. And we went to being a recluse,” she said. They stopped many of their previous social and outdoor activities, and sold their cabin on the lake.

Worse, Sawatsky was navigating fruitlessly through the health-care system, seeing countless specialists, trying to get someone to acknowledge what had happened and get a proper diagnosis.

Not knowing what was wrong with him, doctors would prescribe more drugs.

“I was like, look, I’m obliterated. I don’t need any more drugs,” he said. “None of them would accept the fact that it was an adverse drug reaction.”

Sawatsky knew if he continued down that path he was not going to last long. After two and a half years, his nephrologist finally attributed his condition to an adverse drug reaction, he said.

Sawatsky says he has myalgic encephalomyelitis triggered by the drug reaction. Today, he is still disabled and, with doctors unable to help him regain his strength, he is dependent on his wife.

Health Canada received more than 96,500 domestic reports of adverse reactions in 2019 involving more than 208,000 drugs and natural health products, according to the agency’s website. Adverse Drug Reaction Canada (ADR Canada), a Vancouver-based national support and advocacy group, estimates there are 200,000 severe adverse drug reactions in Canada each year that can kill up to 22,000 Canadians.

Amani Saini, who founded the charity after her sister suffered a serious reaction to ibuprofen in 2010, suspects that these estimates are inaccurate and that actual numbers may be higher because the Canada Vigilance Program, which has an online database of adverse reactions, relies on a voluntary reporting system, meaning not all adverse drug reactions are recorded or tracked.

Changing the regulations so that reporting is mandatory is one of the organization’s primary goals. A law came into effect in 2019 that required hospitals to report serious adverse drug reactions and medical device incidents to Health Canada within 30 days of documentation, which Saini says is a good first step but does not go far enough. She points to long-term care homes as an example where reporting an incident is not required, but should be.

“We see such a large, large number of Canadians suffering … people having prolonged lifelong conditions, impacting their organs, and this is something that’s preventable and we’re not doing enough,” she said.

Saini’s sister almost died after taking ibuprofen provided by a walk-in clinic she visited for a regular cold. She had developed a condition called toxic epidermal necrolysis, a rare and life-threatening skin condition commonly due to a negative reaction to the medication. The condition results in severe skin peeling and blistering that progresses extremely quickly. Saini said her sister spent three weeks in the burn plastic trauma unit and then intensive care where the family was told she was unlikely to survive.

“We were really lucky that she did end up recovering from that experience. And to this day even though 10 years have passed, she still continues to have problems with her eyes,” Saini said.

One solution that places like the U.K., Singapore, Thailand, and Taiwan have adopted is genetic testing for patients, Saini says. A health professional would use the person’s genetic profile to help determine the right medication and drug dose that will be most effective and also help avoid potentially dangerous drug reactions.

She believes that pharmacogenetic screening, which would look at how a person’s genetic makeup determines their response to medication, would have likely prevented her sister from developing the deadly skin condition.

This type of screening is not entirely new. A 2010 case study published in the CMAJ documented how genotyping could have a role in helping to identify patients at risk for potentially deadly negative drug reactions. It is a growing area of research and there has been mounting pressure in recent years to incorporate genetic testing into decisions around drug prescriptions. ADR Canada wants to see publicly funded genetic testing to identify gene variants that can lead to adverse drug reactions.

“Genetic testing would make a big difference in preventing severe reactions, the kinds of things that people end up in an intensive care unit. We can do genetic testing for a lot of those and bring that down dramatically and it would be, frankly, I think, easy to do that,” said Dr. Neil Shear, the head of dermatology at Sunnybrook Health Sciences Centre in Toronto. His research focuses around severe drug reactions and how to help patients with severe skin disease.

He adds that doctors should pay very close attention to specific side effects early.

But all of these potential solutions come too late for Mike Sawatsky, however. With his health still declining, he applied for and was approved for a medically assisted death that would allow him to end his suffering at a time of his own choosing.


Sources: CTV News

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