Three manufacturers of Ritalin and its generic equivalent are reporting shortfalls of various doses of the popular treatment for attention deficit hyperactivity disorder, a shortage that underscores a persistent struggle to keep drugstores and hospitals stocked with medications.
The Ritalin alerts are among more than 550 notices of actual or anticipated shortages that Canada’s drug companies have posted since March, 2012, when the industry launched a website to voluntarily make the information public shortly after quality concerns and a fire at a Quebec pharmaceutical factory thrust the issue into the headlines.
Groups representing Canada’s doctors and Quebec’s pharmacists say that although the site, drugshortages.ca, is a step in the right direction, it does not go far enough. They are calling on Health Canada to make shortage alerts mandatory – something Health Minister Rona Ambrose has said she would consider – and to draw up a list of as many as 400 essential drugs that manufacturers would be required to maintain in a three-to-six-month reserve.
“The voluntary reporting system is not working,” said Diane Lamarre, president of the Quebec Order of Pharmacists. “When we have a drug shortage, each day counts because if we want to find alternatives, most of the time we have to import [them] from other countries.”
The president of the Canadian Medical Association echoed those concerns. “If it’s voluntary, there’s no monitoring to it,” Louis Hugo Francescutti said. “I could have a morphine shortage in Alberta that never shows up on that list because it’s voluntary.”
Last month, two drugs used to treat irregular heartbeats were in short supply across Canada, while a shortage of a lotion used to treat scabies hindered an Oakville hospital’s attempts to subdue an outbreak of the contagious skin infection. A gap in the system was exposed when AA Pharma, the only Canadian manufacturer of the generic cardiac drug flecainide, temporarily ran out and failed to notify the website until after it received a call from Health Canada. “We did get a call from Health Canada, but that’s not why we [alerted the website,]” said Norman Paul, president of AA Pharma, which reported the shortage in late January and declared it resolved Feb. 13. “It’s not to our advantage to not post it or be secretive.”
Keith McIntosh, senior director for scientific and regulatory affairs for Canada’s Research-Based Pharmaceutical Companies, said that reflects the views of his member companies, which are working hard to be transparent about shortages. “Our members have made the commitment to post and we’ve made it clear that if at any point somebody has identified a shortage that has not been reported that we’ll follow up,” he said, adding he is not aware of any unreported shortages.
Ms. Lamarre raised a red flag this week after Quebec pharmacists began scrambling to get their hands on commonly prescribed 10-milligram doses of Ritalin and its generic counterpart, both of which contain the active ingredient methylphenidate hydrochloride. Novartis Pharmaceuticals Canada Inc., which makes the brand-name version, notified the website about a shortfall of the 10-mg dose Feb. 5.
Two generic producers, Pharmascience Inc. and Apotex Inc., followed suit on Wednesday and Thursday of this week, respectively. Pharmascience is out of the 10-mg dose and Apotex is out of the 10-mg and 20-mg doses. A Novartis spokeswoman stressed that 20-mg doses, which are still available, are scored so they can easily be cut in half. The company has fast-tracked a shipment and is expecting to replenish its supply in early April. As well, Health Canada said nine companies in Canada are authorized to produce the 10-mg doses, meaning there could be other sources for the stimulant.
But with three producers already reporting shortages, Ms. Lamarre fears a “cascade effect” could make Ritalin harder to find in the coming weeks. “With this health problem [ADHD], the dosage and the medication choice is tailored to the patient so we cannot switch easily to another medication or formulation,” she said.
The reason for the short supply of some Ritalin doses is difficult to pin down, much like a satisfying explanation for other drug shortages in Canada and internationally. Explanations range from shortages of raw ingredients to manufacturing hiccups overseas to provincial governments driving down the price of generic medications, prompting companies to discontinue or scale back production of older drugs that are less profitable.
In the case of Ritalin, Novartis spokeswoman Andrea Gilpin said by e-mail that “a manufacturer of generic methylphenidate went on back order and this has increased demand for both generic methylphenidate and Ritalin.”
It’s not clear which generic producer or why. Pharmascience did not return a call seeking comment and Apotex did not respond to an e-mail asking that question.