The drug shortage hits home

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Harriet Berkal has religiously visited a pharmacist for the past 30 years to fill her prescriptions for the antidepressant that helps keeps her symptoms at bay.

Not long ago, she also needed to start filling prescriptions for the same drug for her 15-year-old son, which didn't come as a major surprise to her, considering many people in Ms. Berkal's family have been diagnosed with depression.

What Ms. Berkal wasn't expecting during a recent visit to her local drugstore was the news that the generic drug she relies on, imipramine, was not available and might not be for months.

Baffled, Ms. Berkal, a 52-year-old Winnipeg resident who works in freelance communications, began looking for answers. Instead, she was confronted with a confusing series of runarounds that left her frustrated, and exposed serious shortcomings in Canada's drug supply system.

"There is no substitute for this [drug]" Ms. Berkal said. "This is not a minor inconvenience."

Ms. Berkal's story is not unique. In the past year, the shortage of older generic drugs - those that don't have a huge market but are still in demand from patients and health professionals - has jumped alarmingly.

In a December report released by the Canadian Pharmacists Association, nearly 90 per cent of pharmacists across the country said shortages have greatly increased in the past year. Antibiotics, anti-nausea and heart drugs are among the top medications that pharmacists say are in shortest supply. The top drug in shortest supply across the country is amitriptyline, an antidepressant that's similar to the drug Ms. Berkal has had difficulty finding.

The drug shortage is sparking growing concern among medical professionals and patients who are worried about the supply of important medications, and have no idea when drugs will become available again or which will be run short next.

"You're living from day to day not knowing," Ms. Berkal said.

She was angry that no one had informed her the drug she has taken for years was in short supply and that new supplies wouldn't be available for an extended period. She was also frustrated that she had to search for the reasons behind the shortage and still can't get many answers.

"The onus is on the patient. I find this unconscionable," Ms. Berkal said.

Once she discovered that imipramine was not in stock at the pharmacy, she scrambled to other drugstores throughout the city to see if they could help her. She eventually found a pharmacy that had a limited supply of the drug and she had her prescription transferred there.

She also set out on a mission to discover why the drug is in short supply in the first place. Ms. Berkal called Apotex Inc., which marketed imipramine until last year. She said Apotex told her it had sold the drug last August to another company called AA Pharma Inc. When she called AA Pharma, Ms. Berkal said, she was told the antidepressant was being reformulated and there was no indication when it would get back in circulation.

Weeks later, Ms. Berkal is starting to run out of the remaining imipramine she managed to scrounge and is growing concerned about what will happen if new supplies don't come. She hasn't told her son about the situation to prevent him from becoming worried or anxious.

Pharmacists and other health professionals are also becoming increasingly concerned about the continuing drug shortages and the serious consequences they could have on patients.

"For the average front-line pharmacists at the store level, they are extremely frustrated by this," said Jeff Morrison, director of government relations and public affairs at the Canadian Pharmacists Association.

Experts say there are many reasons behind the drug shortages, including problems with the supply of active raw ingredients, manufacturing glitches and regulatory challenges.

But drug companies are not required to inform the federal government of shortages or explain why certain drugs may be in limited supply, which often leaves health professionals and patients such as Ms. Berkal in the dark.

A growing number of people in the medical community say Health Canada must get more actively involved in monitoring shortages and assessing problems that have been plaguing the country's supply of generic drugs.

Apotex did not respond to several requests for comment.

Norman Paul, president of AA Pharma, said in an interview that imipramine is now back in stock and that Ms. Berkal's issues in getting the drug may be tied to distribution by wholesalers.

He said the company has been working to fix shortages of many drugs and that he doesn't anticipate many future problems.

"The reasons for drug shortages are complex. Part of it is production time and part of it is regulatory issues. It's a very complex business," Mr. Paul said. "It's not like some worldwide conspiracy to keep Canada out of drugs."

But many of the problems with drug shortages don't appear to be waning. Last week, Canadian anesthesiologists sounded the alarm after learning sodium thiopental, a common anesthetic, would no longer be available in Canada.

Their fears are compounded by the fact a popular and commonly used anesthetic, propofol, has been in short supply in the United States and some parts of Canada, leading to concern a major shortage of anesthetics may be looming.

"My feeling is that going down the road, we're going to see more and more of this," said Rick Chisholm, president of the Canadian Anesthesiologists' Society. "Maybe we need some kind of a system to monitor this just so we know what's going on."

Ms. Berkal said people like her, who can't get access to their primary drug of choice, may be forced to go without or take alternatives, which could lead to serious side effects. She fears that, left unabated, the situation could cause someone with depression to commit suicide or lead other patients to experience serious health problems because they couldn't get the drugs they needed.

"There's going to be a life-threatening situation here," she said.