Dependability is what Canadians look for from public utilities, and come what may, the suppliers live up to expectations by reliably cranking out your electricity, pumping your tap-water, collecting your recyclables, and processing your sewage. Similarly, Tim Horton’s, rightly regarded as the greatest of all Canadian bulwarks, achieved its exalted status in part because it never exhausts its inventory of double-doubles while you’re making your way to the counter. Following those principles, it should never have to occur to patients that Canadian drugstores might run out of drugs. Except that it has. And they have.
The great drug shortage of 2010, documented recently on the front pages of newspapers from Saskatchewan to Newfoundland, arrives at an especially suspicious time. For more than a decade, patients have hearing suggestions that Ottawa’s price controls on branded pharmaceuticals, in a globally driven marketplace, might one day suppress needed local supplies of newly introduced products, including difficult-to-manufacture biologicals.
However, this current situation seems to have nothing to do with new branded drugs. According to reports, the shelves seem to be increasingly bare of mainstay generic therapies. The Star-Phoenix newspaper of Saskatoon reports community pharmacies on an average business day are short of up to 40 prescription drugs (full story here.) Says one local druggist: “I’ve been a pharmacist for 17 years and I’ve never seen anything like this before. And I’ve never seen it be such a mystery, such as why this shortage is happening. Even our provincial registrar, our top boss, said that he doesn’t know why.”
The scarcity has challenged the ingenuity of pharmacists. Pill-counters have been forced to brush up on their long-dormant compounding skills. According to the Telegram of St. John’s, pharmacists in Newfoundland are reformulating children’s liquid versions of Rxs, to compensate for the inavailability of adult-strength tablets (check it out here.)
The shortage, while officially inexplicable, seems to have been on the horizon at least since this January, when Apotex announced without explanation that it would discontinue Apo-Levocarb CR, its version of anti-Parkinsonian Tx Sinemet CR (Bristol-Myers Squibb.) The company, known for its exceptionally loquacious founder and management, lately has been close-lipped on supply matters, and the Canadian Generic Pharmaceutical Association, which previously has been able to explain just about anything, is uncharacteristically at a loss for words. However, the CGPA’s Julie Tam did seem to infer that changing economics might play a role. Ontario recently enacted Bill 16, reducing formulary pricing for generics, effectively slicing the price it pays by up to half. Other provinces appear poised to follow. Ms. Tam, acknowledging that margins have been tightened, tells the Telegram: “Depending on the drug you don’t always have the luxury of making lots of extra batches.”
Some anxious commentators have rushed to conclude that generics manufacturers may be dialing down supplies as a means of protesting Ontario’s actions. While I have found some fault, on occasion, with certain practices of the generics industry, I just can’t accept that the current drug shortages are part of a design intended to punish politicians by alarming the public.
It is more plausible to blame Barack Obama.
By enacting expanded health coverage in the US, President Obama has broadened the stateside market for generic drugs. Resultantly, Canadian generic manufacturers have sought FDA certification to produce medicine for export to the US, which first requires a stringent review by inspectors of operating and quality assurance procedures. The process, according to some accounts, may be responsible for slowing or disrupting domestic supply lines in Canada. It’s one theory that, in the absence of other explanations, has some resonance.
Regardless of the cause, the shortages must be viewed with grave concern. A recent article in the journal Neurology (2009;73:213-217) entitled “Causes and costs of a generic drug shortage” examined the consequences of the inavailability in the US of Parkinsonian Tx selegiline (a compound for which, coincidentally, five out of six scrips are filled by Apotex.) The article’s authors provide a prescient comment: “Generic drug shortages carry economic and health implications. Given ongoing consolidation in the generics drug industry, these shortages may become more common and may require heightened regulatory scrutiny of the generic drug industry.” Here’s the link to the article.
For Ottawa, this should be a simple puzzle to solve. The way to ensure a dependable and affordable armamentarium of generic drugs is to encourage a greater degree of competition in the sector — which can be quickly achieved by opening up our market to reputable foreign suppliers. Honorable Leona Aglukkaq? Where do you stand on this issue?