Canadian pharmacists and doctors are worried that surgeries will be cancelled and patients put at risk because a common anesthetic will no longer be available in Canada due to concerns about its use in lethal injections in the United States.
Hospira Inc., the Illinois-based company that produces all of the sodium thiopental used in Canada for human anesthesia, announced last week that it has permanently ceased production of the drug as a result of continuing battles over the drug's role in executions.
Sodium thiopental, known by the brand name Pentothal, is no longer the most commonly used anesthetic in Canada, but is critical because it's considered the best drug for geriatric, cardiovascular, obstetric and other patients who may be prone to side effects or complications from other medications.
The problem is compounded by fears that Canada will experience shortages of propofol, one of the most widely used anesthetic drugs, and has prompted new concerns over the shortages of common generic drugs that have been plaguing Canada for months.
News that sodium thiopental will no longer be available in Canada is alarming members of the medical community. "I am concerned," said Rick Chisholm, president of the Canadian Anesthesiologists' Society. "There are other [drugs]we can use, but we don't use them as often, and when you don't use something as often or use it in a different way, that's when mistakes can happen."
As for propofol, the U.S. Food and Drug Administration has reported there is already a shortage in that country. In recent months, Dr. Chisholm said, he has experienced problems getting doses of propofol in certain sizes and has heard anecdotal reports from hospitals that have been unable to obtain it at all.
"If we don't have propofol and we can't have Pentothal … how do we anesthetize 90 per cent of our patients?" Dr. Chisholm said. "It could be like one of these perfect storms."
A December report from the Canadian Pharmacists Association found nearly 90 per cent of pharmacists across the country say drug shortages have dramatically increased in the past year. Experts cite a variety of reasons, including shortages of active ingredients, manufacturing problems and regulatory changes.
But sodium thiopental is a special case. Although Hospira never endorsed the practice, numerous U.S. states have been using the drug during lethal injections administered to prisoners on death row.
For the past year, Pentothal has been unavailable in North America because a third-party company stopped making the drug's active ingredient. As a result, doctors have had to use alternatives, while many U.S. states have faced delays in executions.
Hospira anticipated it would be able to get the drug back in circulation in early 2011 after switching production of Pentothal to the company's plant in Italy. Those plans hit a snag, however, when Italian officials demanded the company ensure the drug be used strictly for medical purposes.
Hospira said those demands, and the potential liability risk, were too great and that it has scrapped plans to resume production of Pentothal as a result. "We regret that we have to take the product off the market for reasons beyond our control and we regret the inconvenience it's causing our customers," said Hospira spokesman Dan Rosenberg.
The American Society of Anesthesiologists said the consequences of losing access to Pentothal will be much greater than if the drug were still available for use in executions. "It is an unfortunate irony that many more lives will be lost or put in jeopardy as a result of not having the drug available for its legitimate medical use," the society said in a statement.
In an e-mail, Health Canada spokesman Gary Holub said hospitals that no longer have Pentothal may be able to use alternatives made available under the department's Special Access Programme. It provides patients with serious or life-threatening conditions who can't use conventional therapies access to drugs that otherwise can't be sold or distributed in Canada.
Dr. Chisholm warned that using alternatives increases a patient's risk of complications or side effects. He criticized Health Canada for failing to warn hospitals and health professionals about drug shortages and said the department should provide better guidance.
Mr. Holub said Health Canada believes it is the industry's responsibility to monitor drug shortages, but added the department has begun looking into the issue of drug shortages across Canada.
Health Minister Leona Aglukkaq was expected to discuss drug shortages Thursday in a meeting with the Canadian Pharmacists Association.