White Coat, Black Art

More Trouble With Drug Shortages

Drug companies have often struggled to meet demands, and once again, some crucial drugs are in short supply. We have covered drug shortages before on WCBA. This month, the US is dealing with a critical shortage of a lifesaving medication. And the situation in Canada cries out for concerted efforts to find a solution.
  If prescription drugs help fight disease, then shortages do the opposite. Drug companies have often struggled to meet demands ... and now once again, some crucial drugs are in short supply.  We have covered  drug shortages before on WCBA.  This month, the US is dealing with a critical shortage of a lifesaving medication.  And the situation in Canada cries out for concerted efforts to find a solution.

  In February 2014, US drug maker Baxter International told US hospitals it was sharply cutting supplies of intravenous nitroglycerin, which is critical for treating life threatening conditions that include angina, heart failure and high blood pressure. Last week, Dr. Frederick Blum, an emergency physician at Ruby Memorial Hospital in West Virginia that sees trauma patients, told the  New York Times, "if we had one or two patients that were really sick that needed extended drips, it could exhaust our supply pretty quickly."

  I am not aware of a similar shortage of intravenous nitroglycerin in Canada, but it would not surprise me to see it here some time soon.

  But it's not as if Canadians receive timely information on drug shortages.  That's because the government has not made reporting by pharma of impending and actual shortages mandatory.  Cobbling together company and anecdotal reports from across Canada, it is generally believed that more than three hundred drugs are in short supply. 

  If you look at the web site  Canadian Drug Shortage Database, you'll see recent notices of shortages of injected narcotics used to manage severe pain due to surgery, anti-nausea drugs used by patients undergoing cancer chemotherapy, antibiotics, drugs for epilepsy.  I could go on an on.  Earlier this month, three makers of the drug Ritalin, prescribed to kids with attention deficit hyperactivity disorder (ADHD), announced shortfalls. 

  As an ER physician, recently, I have experienced first hand a shortage of Dilaudid (hydromorphone), the injected narcotic I prefer to give my patients. Dilaudid is my 'go-to' drug for patients with severe pain due to everything from broken hips to kidney stones.  Not having it on hand means I have to give a substitute medication that I believe has more side effects.

  The problem of drug shortages in Canada is pervasive. A  2013 survey by the Canadian Pharmaceutical Association and the Canadian Medical Association said seventy-eight percent of pharmacists said they had to deal with a drug shortfall during their most recent shift at work and virtually all of them said it happens at least once a week.  The hospital and community pharmacists I talk to say they're spending more and more of their time scrambling to make up for drugs in short supply and to find substitutes. 

  You may recall hearing about the  drug shortage problem with Sandoz in Quebec back in 2012. Since that situation was resolved, you might think drugs are in good supply.  In the 2013 survey I mentioned, more than two thirds said that lately, the problem has gotten worse.

  I suspect some health professionals don't complain about drug shortages because they see them as the 'new normal'.  But let's not forget these drug shortages have adverse effects on the health of Canadians. Without effective anti-nausea medications, patients who receive chemotherapy develop severe nausea and vomiting. Patients with epilepsy who don't have access to their medications risk having more frequent seizures. 

  Earlier this year, McGill University Health Centre hospitals in Montreal  reportedly ran out of a medication called protamine, an essential drug used in heart surgery to reverse the effects of a blood thinner called heparin. 

  A  survey of twelve hundred anaesthesiologists in Canada found that drug shortages may have contributed to four deaths and triggered two medical malpractice lawsuits.  I suspect that number is an underestimate because doctors are more apt to attribute a death to a serious illness than to a drug used to combat the illness that's in short supply.

  Since drug shortages aren't a new problem, some are asking why are they still happening. In my opinion, other than patients whose health is affected directly, the problem has not moved Canadians to demand action. 

  As well, there are suspicions that drug companies that makes both expensive new drugs and older generics discontinue the manufacture of generic drugs to sell more brand name drugs - and boost their profits. Some say the price point for generic drugs may be so low that it's just not worth it for drug companies to keep making them. Others blame shortages on large group purchasing organizations (GPOs) that bulk purchase generic drugs for hospitals.  For a good article on GPOs, check out  healthydebate

Critics accuse GPOs of unethical practices such as vendor kickbacks and something called 'pay for delay', which means paying a would be maker of generic drugs a lot of money NOT to make the generic, thereby boosting the market for expensive brand name drugs.

  I think much can be done to address drug shortages. Right now, the reporting of shortages by drug makers is voluntary.  In a  Globe and Mail article published earlier this year, drug-shortage watcher Dr. Jackie Duffin of Queen's University said the federal government must make the reporting of shortages mandatory.  It's hard to know the scope of a problem if you don't track it properly.  We could do well to follow the lead of the US on that score. 

  I think the provinces have to do a better job of keeping tabs on and regulating the business practices of drug makers.  I also think that we need to draft a list of essential drugs that can't be permitted to be in short supply.  I would be in favour of Canada developing the capacity to be a drug maker of last resort so shortages of key drugs don't happen.

  But most of all, we need Canadians to take this problem as seriously as the patient whose lives depend on drugs in short supply.

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