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Investigating Canada’s Drug Scarcity

Severe medication shortages have become the new normal for Canadian doctors, leaving patients with no affordable alternatives – or, worse, no treatment at all.

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Investigating Canada's Drug ScarcityPhoto: Hans Laurendeau

Pauline Graat waited for Christie, her daughter, to pick her up for a morning of errands. Is the iron off? she wondered. The 67-year-old racked her memory, retracing her steps over the past 10 minutes, but couldn’t recall. She checked. It was off. She sat back down in front of Good Morning America. Nothing about the show registered.

Four days earlier, on May 17, 2014, Graat’s pharmacy in Windsor, Ont., had run out of her usual anticonvulsant medication, Teva-Clobazam, which she was prescribed in 2005, after brain surgery put her at risk of seizures. As a stopgap, the pharmacist had given her another version of the generic drug. The next night, she had woken with a stabbing headache. The pain had soon turned into a brain fog-a clouding of her senses bordering on delirium-accompanied by extreme fatigue.

Christie let herself into her mother’s home and called out. No response. She walked into the living room, where Graat was sitting. As Graat looked blankly from the television to her daughter, Christie grew alarmed. “Mom? Something isn’t right.”

“I know, Christie,” Graat said, shaping each word slowly and carefully. “I’m not well.”

Clobazam first appeared on the market in 1975 and was soon discovered to be effective in dealing with seizures. Doctors began prescribing the generic drug for epilepsy, and today, the Canadian Epilepsy Alliance estimates that roughly 45,000 Canadians currently rely on it-at least 5,250 in Ontario alone. This spring, these patients became the latest victims of the country’s broken drug-supply system.

Graat couldn’t fathom life without clobazam. The drug became necessary when, a year after having a brain tumour removed in 2004, she suffered a grand mal seizure that landed her in the hospital in an induced coma for four days. Two 10-milligram pills of Teva a day have successfully tamped down the seizures and, in doing so, helped her maintain an active social life, including never missing her oldest grandson’s evening baseball games. “I owed a great deal to clobazam,” she says.

In February 2014, Graat stopped by the Shoppers Drug Mart to refill her prescription. When she got home and looked inside the bag, she called the pharmacy right away. They had given her Apo-an alternative form of her preferred drug. The pharmacist explained that a nationwide clobazam shortage had hit Windsor, and they were switching patients to whatever substitute was available. Four clobazam products are sold in Canada, each manufactured by a different company. All were becoming scarce, but luckily there were enough different clobazams floating around in the supply chain. Unlike most anti-epileptics, the various versions-which share the same active ingredients-are considered interchangeable, meaning 90 per cent of patients can switch seamlessly among them.

Graat, however, is not one of those patients. She had tried Apo during another shortage in 2011, and it had left her debilitated by headaches. “I never told my daughters about that first incident,” Graat says, referring to Christie and her sister, Meaghan. “I didn’t want them to worry.” Graat had suffered alone for two weeks as she waited for her medication to come back in stock.

Until recently, such a prolonged shortfall would have been unthinkable. While it’s not uncommon for pharmacies to run out-one month, there’s an increase in specific prescriptions in a certain area; another month, a shipment is late-the lapse has usually been temporary. To fix it, a pharmacist will typically source supplies from a nearby drugstore. But over the past four years, the severity and duration of shortages have escalated. According to a 2013 survey by three of the country’s major pharmacists’ groups, including the Canadian Medical Association, over 75 per cent of pharmacists said shortages were having a significant impact on their workloads. “You call other pharmacies, you call the doctor to discuss options, you call the manufacturer to find out when the drug is expected,” says Jeff Morrison of the Canadian Pharmacists Association. “It’s a lot of added pressure, and it can force us to hand out alternatives that are less effective or even harmful.”

Since 2012, there have been over 500 reports of pharmaceuticals in short supply or not available at all. To date, nearly 250 drugs have been implicated. That might seem like a small portion of the 8,754 prescription drugs currently marketed in Canada. The shortfalls, however, affect critical-care drugs, such as anaesthetics, antibiotics, painkillers and anti-inflammatories, and can cause chaos across Canada’s health-care system.

Teva’s disappearance wasn’t a one-off but part of a breakdown endangering the health of millions of Canadians: from bladder cancer patients who, deprived of their only effective drug treatment, face having their organs removed, to glaucoma sufferers, for whom a shortage in eye drops means the risk of going blind. In Graat’s case, she remembered the crushing sense of confusion and lost time brought on by Apo in 2011. It was an experience she was determined not to repeat. “I cannot take these pills,” she told the pharmacist. He promised to help. He sought out the city’s dwindling supply of Teva and came up with 200 pills. It was three months’ worth, meant to get her through the shortage. It didn’t. When that ran out, Graat went back to the pharmacist. “The last time, I scoured all of Windsor. That was it,” he told her. “It’s on back order.” He had no clue when to expect a new batch.

It was Apo or nothing. “I had a meltdown in the drugstore,” Graat says. “I felt hopeless.”

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Graat’s story doesn’t surprise Jacalyn Duffin. A hematologist in Kingston, Ont., she’s part of a growing faction of Canadian physicians who believe that governments and pharmaceutical industries aren’t treating the shortage crisis with the seriousness it deserves. Duffin first got wind of the problem in 2010, when one of her patients called to say that, with no access to her anti-nausea medication, prochlorperazine, the chemo for her breast cancer had become almost unbearable. “It made no sense,” says Duffin. How could an effective, reliable, generic drug-prochlorperazine has been on the market for over a quarter of a century-disappear in a country like Canada? “So I started digging.”

Duffin discovered that, since 2010, shortages have forced the majority of Canadian physicians to change treatment decisions on the fly. Over a month-long period in 2012, as the Public Health Agency of Canada debated dipping into an emergency stock, a morphine shortage led hospitals to postpone dozens of surgeries-more than 50 in Quebec alone-and left hundreds of palliative care patients in big cities like Calgary in fear of living out their last days in pain. The previous year, a nationwide shortage of carboplatin (used to treat lung and ovarian cancers) caused Alberta Health Services to ration the drug, limiting its use to only curable patients, while oncologists had no choice but to treat those with advanced cancer using makeshift chemicals that could cause severe kidney damage. Other people have suffered permanent damage from alternative treatments gone wrong. In 2010, Alena Rossnagel was told to take a daily dose of the antibiotic trimethoprim in anticipation of a kidney stone operation. One month before the 58-year-old’s surgery, however, her Toronto pharmacy couldn’t refill her prescription. Her doctor recommended gentamicin instead, an intravenous substitute that led to devastating side effects. Rossnagel lost 90 per cent of her vestibular function, causing severe imbalance and permanent oscillopsia-she is functionally blind when she moves her head or walks.

When Duffin began investigating, there was little attention on the issue. The media wasn’t reporting shortages and neither were drug companies. Duffin set up Canadian Drug Shortage (canadadrugshortage.com) in 2011 as a way to highlight and track the problem. Patients and doctors soon began calling and emailing with their experiences, and Duffin’s website became the go-to platform for people like Rossnagel to share stories as well as industry reports and studies that weren’t easily accessed by the public.

Conveying the true scope of the crisis, however, continues to be a challenge. Duffin spends hours every week trawling the Internet, pharmaceutical sites and the government’s own drug shortage database (drugshortages.ca). But with drug companies not required to admit to shortages, her information is rarely timely. Early this year, a shortage of the cardiac drug flecainide went unreported until Health Canada urged the manufacturer, AA Pharma, to notify the public. By mid-September, the shortage remained, but AA Pharma still posted a resupply date of August 25, 2014.

These incidents underscore the struggle patients like Graat endure to acquire the drugs they need without advance notice of impending shortages. They usually find out when they visit the pharmacy. Often, that’s when pharmacists and doctors find out, too. “I started learning about this almost four years ago,” says Duffin. “Today, the situation is much worse.”

Kelly Foster is a hospital pharmacist working in Halifax. At any given time, she deals with up to 25 drug shortages, including intravenous magnesium, used to regulate blood pressure, and injectable lorazepam, which treats anxiety. She has often sequestered medications in the pharmacy to ensure they are being distributed in the most conservative way possible. Foster recalls one shortage of intravenous Septra about which she was particularly concerned. The hospital was down to 10 vials of the antibiotic-a typical stock is about 100-for a patient who was resistant to other antibiotics and had no options left. “You’re just hoping you’ll get more,” says Foster. “Every day I had to tell the doctor, ‘We only have 10 vials left. We only have eight vials left.'” The shortage resolved itself in time for the patient to continue treatment. “But the next time,” she says, “they might not be so lucky.”

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Federal and provincial health ministers, along with drug makers, blame the shortages on the industry’s increasing globalization. Most companies in Canada also operate in the United States, Asia, South America and Europe; with their distribution chains spanning the world, a scarcity of raw ingredients in one country can affect manufacturers in another. A growing middle class in nations like China, Brazil and Russia has also added pressure on manufacturers. More countries can now afford more drugs-from 2009 to 2011, China spent an estimated $175 billion on new hospitals and clinics-and demand often outpaces supply. Ramped-up plant inspections are cited as another reason for unstable drug stocks, with the most recent incident being the Sandoz shutdown in 2012. Sandoz was supplying up to 90 per cent of the injectable drugs in Canada when an FDA inspection and subsequent fire at the plant in Boucherville, Que., forced the company to halt production.

While scarce raw materials, growing demand and facility inspections play a part, Aidan Hollis believes the main problem is profit-as in, generic drugs don’t always generate much. An economics professor at the University of Calgary, Hollis has, during his 20 years of studying the pharmaceutical industry, seen generic drug prices plummet. This may seem like a positive development: cheaper drug plans mean more money for provinces to spend elsewhere. But Hollis says inexpensive generics are a driving force behind shortages. That’s because each province sets the pharmacies’ reimbursement rate for selling a generic drug. In the past, the standard rate was 75 per cent of the brand-name alternative, but the provinces decided this was too high and slashed the rate. In 2010, reimbursement in Ontario shrunk to 25 per cent. In fact, prices have fallen so low that certain generics cannot be manufactured for less than the provinces’ proposed prices. “You keep pushing prices down, and manufacturers just start dropping that product because they can’t make any money on it,” says Hollis. This appears to be the case with clobazam, where one manufacturer, Dominion Pharmacal, pulled its product completely.

“You get to a point where you have one manufacturer for a product,” says Hollis. Even with one supplier monopolizing the market, the profit margin can still be too tiny. “Are they going to make a huge effort to supply the drug?” he asks. “It’s not really that central for them.”

By June 17 of this year, Graat had been taking APO for nearly a month. The heaviness in her head persisted. She stopped going for walks and attending her grandson’s baseball games. Graat kept trying to hide her suffering from her daughters, but it was obvious. “There was nothing they could do. So I told them what the pharmacist had told me: the pills would be in by week’s end,” says Graat. But every week she’d call the pharmacy, and the news was bad. That’s when Graat contacted the Epilepsy Support Centre in Windsor, which put her in touch with Suzanne Nurse.

Nurse, an information specialist with Epilepsy Ontario, had heard variations on Graat’s story before. This past January and February, panicked emails and calls were coming in from Canadians whose pharmacies were out of clobazam. Nurse provided Graat with updates on the dwindling stock, then, a week and a half later, she located a three-month supply in a distributor’s warehouse in Chatham, Ont. Graat was back on Teva after a few days. “I was a happy camper,” she says. “The first thing I noticed was I could read an article. My head was lighter.”

According to manufacturers, a global shortage of medicinal ingredients is what depleted clobazam stocks this past spring. It’s not clear whether each generic version went missing at the same time or whether there was a domino effect, where the lack of one product increased demand for another until the entire supply ran low. Nurse says clobazam manufacturers failed to meet expectations from a protocol they had endorsed in 2013-expectations that include giving advance notice as soon as shortages are anticipated, and providing updates about when a new supply is expected. Julie Tam, the vice-president of professional and scientific affairs of the Canadian Generic Pharmaceutical Association, admits that reporting isn’t “100 per cent perfect,” but argues there are challenges to knowing exactly when shortages begin. “Once drugs are in the hands of wholesalers, manufacturers don’t necessarily monitor inventory on the market,” she says. “This makes it hard for them to know the moment supplies start dwindling in commun­ity pharmacies.”

Nurse counters that the shortages had been going on for weeks before she was apprised. One manufacturer didn’t post a notification until two weeks after she asked them to do so, and two other companies never bothered to report a shortage at all.

What’s needed, according to Nurse, is for Canada to adopt a system that legally forces companies to give six months’ notice when a drug might run out. This would allow pharmacists time to stockpile or plan alternative treatments. Last May, after lobbying from doctors and pharmacists, Health Canada launched a six-week public consultation on reforming the current system of notifications, but has yet to release the results. Mandatory reporting, of course, won’t fix shortages, but pricing-policy reform might. After hitting all-time lows for generic drug pricing last year, Alberta has conceded to manufacturers’ demands for better reimbursement rates; in February 2014, the province introduced a tiered pricing model for generic drugs. If there’s only one supplier, prices are set high to encourage that company to stick around, with the baseline reimbursement rate for a single generic around 70 per cent. If it works, it’s likely the rest of Canada will follow.

Meanwhile, Graat’s neurologist stopped prescribing clobazam-his faith in the drug supply was gone. On August 12, Graat began the two-month process of transitioning from Teva-Clobazam to levetiracetam, the generic version of Keppra. She likes her new medication but knows even levetiracetam could be vulnerable to shortages. Still, she remains optimistic. “I just know these new pills will work out,” she says. “They have to.”

Shortfall Fixes
Feel defenceless against drug shortages? Here are some ways to address the problem:

*Websites help track missing meds. Along with drugshortages.ca and canadadrugshortage.com, you can visit vendredipm.ca (run by Sigma Sante, the primary Group
Purchasing Organization in Quebec) and medsask.usask.ca (from the University of Saskatchewan). *If you see your drug posted on a shortage website, don’t panic. Ask your pharmacist how much medication he or she has in stock.

*If your medication runs short and your pharmacist can’t suggest an alternative, contact your doctor immediately. Don’t make any changes (i.e., skipping or reducing doses) without consulting a professional.

*As a precaution, fill your prescription several days before running out. This provides a buffer for you to seek solutions if a shortage occurs.