This week, White Coat Black Art kicks off its seventh season with a full edition devoted to prescription drug shortages. It's a problem that sooner or later will affect your well being or that of someone you know and love.
This is one of the big issues in health care I've been following since our sixth season ended last January. I first caught wind of the story last year when the antibiotic cephalexin - one I prescribe at least once or twice a shift for skin infections - was on back order. The issue picked up steam last winter when drug maker Sandoz Canada was forced to temporarily shut down part of its Quebec plant over quality issues. Then the plant was hit by a fire, further deepening the shortages.
According to the web site Drug Shortages
- a staggering 250 drugs are in short supply here in Canada. The list includes the aforementioned antibiotics, plus narcotic pain relievers, anaesthetics, anti-epilepsy drugs, cancer chemotherapy, and many more. All or most of these drugs are generics, so cost is not an issue.
On the program, you'll hear Alena Rossnagel, a clinical nutritionist from Portage la Prairie, Manitoba tell how she developed permanent dizziness from taking an antibiotic called gentamicin, a drug only prescribed to her because her usual antibiotic trimethoprim was on back order.
The condition Rossnagel suffers from is known as 'oscillopsia', a well known side effect of gentamicin toxicity. There may be issues regarding the way gentamicin was prescribed to Rossnagel and how she was monitored. But you can't argue with the fact that she would not have been thus afflicted were it not for the drug shortage.
To me, that's an outrageous price to pay for a shortage of one of the most commonly-prescribed antibiotics around. It's even more disturbing that Rossnagel was given no advice on how to obtain an alternate supply of her preferred antibiotic.
You'll also hear from Christine Sorenson, whose 14-year old son Derek depends on a little-prescribed anti-epileptic drug called Zarontin ® (ethosuxamide) to control his seizures. It's a drug that Pharma could stop manufacturing at any time.
For Derek, the stakes couldn't be higher. If he goes off his usual medications - for any reason, drug shortage included - there's a good chance his condition will once again go out of control.
We also heard from doctors and pharmacists on the front lines. The Ottawa hospital has an estimated 100 drugs in short supply. Pharmacy head Mario Bedard told us that all too often, he has to scramble to maintain a supply of essential medications on very short notice.
Rick Hall, an anaesthesiologist and critical care specialist at QEII Health Sciences Centre in Halifax, said he faces constant drug shortages. Earlier this year, he surveyed more than 1900 colleagues across Canada, and found that half of them are experiencing shortages at any one time. Hall told WCBA he wonders each time he goes to the operating room how he'll manage looking after his patients.
Last March, two hospitals in Vancouver (St. Paul's and Vancouver General Hospital) became the first two in Canada to cancel elective cardiac surgery because of a perceived shortage of the drug protamine.
You can sense the outrage among anaesthesiologists. Through improvements in technology and patient monitoring, plus impressive clinical skill, anaesthesiologists have reduced the anaesthetic death rate by a factor of twenty. It's galling to anaesthesiologists to believe that a drug shortage might put those hard-fought gains in jeopardy.
Jackie Duffin, a medical historian, hematologist and cancer specialist at Queen's University in Kinsgton probably knows more about drug shortages than almost anyone in Canada. Her own personal brush with a shortage of blood pressure pills led Jackie to set up Canada Drug Shortage
- a comprehensive portal on the problem.
"The causes are unknown to most people -patients, pharmacists, and physicians-who are dealing with this problem," writes Duffin on her web site.
"Those who do know the causes are reluctant to publicize them."
Duffin lists eight separate hypotheses to try and explain the drug shortage situation in Canada and around the world, among them:
o Big pharmaceutical companies discontinuing less profitable generics in order to enhance sales of newer, more expensive, brand-name drugs. Sometimes companies discourage sales of their own cheaper brands.
o Prices of generic drugs fixed at prices too low to cover manufacturing costs (e.g., in USA Medicare).
o Pharmacists choosing not to stock cheaper drugs because profit margin is too narrow.
o Shortage of materials to make drugs.
o Growing demand for medicines in developing world.
o Manufacturing or quality control breakdowns within production lines owing to lack of investment to improve or maintain standards.
o Manufacturing slowdowns owing to greater vigilance by the US Food and Drug Administration.
o Canada has almost no drug manufacturing industry of its own and is vulnerable to changes elsewhere.
o Legislative changes to financing arrangements for generic drugs, for example in Ontario, resulting in declining profitability for pharmacists and manufacturers. Pharmacists decide not to stock the drugs, and manufacturing further declines in response to lower demand.
o No Canadian controls require the pharmaceutical industry to warn of shortages in advance, let alone provide the reasons.
o Effect of large Hospital Group Purchasing Organizations in USA-in effect a "monopsony" (single buyer, many sellers) [also "monopsomy"].
I have lots of questions and almost no answers. What role do brand name manufacturers play in the ebb and flow of generic drug supplies? Did Ontario's banning of kickbacks to pharmacists stop them from stocking generic drugs? To what extent do anti-competitive contracting practices, kickbacks, and other forms of self-dealing cause drug shortages in Canada, as has been suggested in the US
I wish I could wave a magic wand and make the problem disappear. Getting Sandoz Canada back in production - as is starting to happen - will help in the short term. But it will not fix most of the systemic factors listed by Jackie Duffin (see above).
To solve this problem, I think we need several things to happen. First, we need a public inquiry to get to the roots of the drug shortage situation. That's the only way to compel Pharma to open up long-secret business practices as regards stakeholders and the federal and provincial governments to public scrutiny.
Second, the federal government must order all drug companies to give six months' notice of impending shortages or face heavy penalties. That won't solve the problem but it will buy time for stakeholders to make plans to deal with the fallout.
Third, as suggested in a recent editorial in the Canadian Medical Association Journal
, we need the provinces and the federal government to work together to coordinate strategy during times of shortfall. For instance, there is no reason why provinces can't ship excess supplies to provinces more severely affected by a shortfall.
Fourth, I call on stakeholders across Canada to establish a common list of essential medications - ones that are too important to the welfare of Canadians to be left to the marketplace.
Finally, we have to end our dependence on one or two suppliers of essential drugs. How you make a supplier about to cut off Derek Sorenson's supply of Zarontin continue production is beyond me. I think the provinces, in tandem with the federal government and perhaps with the cooperation of other countries should band together to become the manufacturer of last resort for discontinued drugs and those in short supply.
This problem won't go away while we bury our heads in the sand. It will get worse.