Wednesday, April 11, 2012 – Globe and Mail
ANNA MEHLER PAPERNY and KIM MACKRAEL
When the only drug that effectively stopped Karen Reeves’s seizures became unavailable in Canada, she didn’t find out until her pharmacist couldn’t fill her prescription – the medication wasn’t there. Replacement shipments never showed up.
Welcome to the new normal of prescription drug supplies.
A string of calamities at Sandoz Canada’s plant in Boucherville, Que., has created a national shortage of a particular breed of injectable painkillers. It’s prompted parliamentary hearings, a stop-gap drug-approval process and a promise from Ottawa of a national strategy.
This is only the latest shortage in a long-simmering crisis that’s forced manufacturers, buyers and health-care facilities to change the way they provide and stock generic drugs.
The problem is global. But Canada’s drug-purchasing process, and the fact that manufacturers are not obliged to give advance notice of pending shortages, make a supply problem more likely to reach crisis level.
And it’s something Ottawa was warned about years ago.
A shifting industry
If a drug’s path from raw ingredient to patient is a supply chain, changes in the structure of the global pharmaceutical industry mean there are fewer independent chains operating on their own, and many more co-dependent, accident-prone links.
One factory could be the source of active pharmaceutical ingredients for several generic drugs. And one drug could go through multiple manufacturing sites before it reaches the patient.
This means more opportunity for mishap, and fewer backup options.
A regulator spooked
In early 2008, contaminated batches of Chinese-manufactured heparin, a widely used blood thinner, killed dozens of people in the United States. Since then, the U.S. Food and Drug Administration has taken its role much more seriously. While no one would fault the body for doing so, the switch in tactics in monitoring an industry full of potentially under-regulated factories has an impact.
Manufacturers, for their part, would like a little more flexibility, says Jim Keon, president of the Canadian Generic Pharmaceutical Association. “Companies would appreciate more of a consultative, back-and-forth approach.”
Here, the worldwide quandary is worse. Canada’s market is a tiny fraction of the U.S. And huge bulk purchases often mean health-care providers rely on sole suppliers and inadvertently kill off the competition.
“The Canadian market awards contracts to specific groups. The question is, can the other company survive?” asks Jin-Hyeun Huh, director of pharmacy operations for inpatients at Toronto’s University Health Network. Chronic shortages have changed the way hospitals manage their vital drug supplies: The University Health Network, which has eight to 10 people working full-time almost exclusively on medication stock, has doubled its supply cushion, he says.
“I would hope, after this experience, that we would probably look at the Canadian landscape in terms of where our risks are. … Is this really the best way to do business?”
The increased likelihood of these sudden shortages isn’t news to the federal government. Ottawa was warned about this from the Competition Bureau as far back as five years ago.
Health Canada, for its part, argues this is a provincial issue.
Ottawa is open to imposing regulations making it mandatory for drug suppliers to give several months’ advance notice prior to a shortage – a requirement other countries already have. But it’s not always possible to know well in advance whether a shortage is going to occur.
Purchasers could create backup plans – approve a secondary supplier in case the primary contractor fall short. Ottawa has no interest in stepping in here: That’s up to provinces and purchasers.
Last fall, one of Canada’s biggest bulk purchasers put supply reliability among its top priorities in drawing up contracts. “If a drug isn’t available,” said HealthPro vice-president of services Kathy Boyle, “it doesn’t matter how safe it is and how cheap it is.”
There’s a cost to that reliability. It isn’t clear whether hospitals, and the provincial governments that fund them, can stomach that increase in price.
From a doctor’s view, however, debates around competition and purchasing process are outweighed by the reality of patients’ needs. “For those patients in Canada who need regular medication, they are a lifeline,” says Canadian Medical Association president John Haggie. “We’re not talking discretionary purchases.”