According to CBS News on Wednesday, massive shortages of “vital medicines used in hospitals and other healthcare facilities have become routine throughout the U.S., jeopardizing patient health, comfort and safety and, ultimately, adding to already high health care costs.”
And in Canada, a study published this month by the C.D. Howe Institute chronicles the growing shortage of drugs in the country. The shortages are forcing pharmacists and physicians to substitute products or look for alternative treatments with different medications that might not be suited or fully intended for the treatment of the patient.
When we talk about drug shortages, we are including everything from sterile IV products, like sodium chloride and lidocaine hydrochloride to theophylline extended relief tablets and EpiPens. The shortage of EpiPens is so bad in Canada, that Health Canada has recommended using expired injectors, reports CBC Canada.
AMA adopts a new policy on drug shortage
Physicians at the American Medical Association’s (AMA) Annual Meeting adopted a policy to further combat national drug shortages that jeopardize patient care and safety.
William E. Kobler, MD, AMA board member, said in a press release. “The fact that drug shortages worsened when major hurricanes struck drug production facilities on Puerto Rico highlights the need to evaluate and plan for hazards that pose a threat to critical infrastructure for manufacturing pharmaceutical and medical products.”
The AMA is calling for the Department of Homeland Security (DHS) and the Department of Health and Human Services (HHS) to investigate the drug shortages, something that quite frankly, should have been done before this point in time.
It took the damages to the drug manufacturing plants in Puerto Rico, caused by Hurricane Maria in 2017 to put the spotlight on the drug shortages. For months after the hurricane, hospitals and other health facilities on the mainland scrambled to find alternatives to Puerto Rican-produced IV bags that hold saline solution and are used to dilute and administer medication.
The hurricane also disrupted the manufacture and distribution of about 90 other medical products and medicines made in Puerto Rico. But keep in mind this one point – The drug and medication shortages were already rampant well before Hurricane Maria hit.
Erin Fox is the senior director of the University of Utah’s drug information and support services. Fox tracks drug shortages for the American Society of Health-System Pharmacists.
While the AMA is asking that manufacturers be more transparent about production locations for drugs and other medical products, as well as any issues resulting in any shortages, Fox puts the blame on problems at mainland pharmaceutical manufacturing plants
“Most of the time, the problem is some type of quality issue related to machinery or raw materials,” explained Fox. “It could be contaminated particles, bacteria, metal shavings, glass particles — all kinds of things. There’s a real quality control problem.”
Health Canada and drug shortages
Interestingly, Jacalyn Duffin, a doctor and medical historian who co-authored the C.D. Howe Institute study, found that 1 in 10 drugs in Canada has been affected by shortages since 2016, the first year drug shortages were made publicly available on a Health Canada-mandated website.
Duffin surmises there is no definite, overriding cause for the drug shortage, although she also mentions the damages to Puerto Rico’s drug manufacturing facilities as one cause for the shortages. Duffin also suggests that per-dose generic prices are so low they are not profitable for a company, a hard fact to digest when someone is on a generic drug that is needed every single day.
But the point is, in making her assessment, Duffin says there is more to the problem that any one issue. “People want you to point a finger at the evil drug companies, but it’s more complex than that,” Duffin said.
Duffin, a professor emerita at Queen’s University is one of those curious academics that make the world so much more interesting because they want answers to questions. She founded a website for shortage information in 2010, which for years was the only source in Canada for information on drug shortages.
How can a drug shortage occur in a developed country?
You could expect a drug shortage in a developing country, and we see this situation played out in the world news frequently, from shortages of polio vaccine to medications to treat malaria. But in countries like Canada and the U.S., we have been lulled into a sense of complacency.
We have been led to assume that if needed, a medicine will always be available, and that just isn’t true today. One thing the AMA policy and Duffin’s latest assessment on the drug shortage agree on is the need for government action.
Both reports echo the conclusions in a report published by the World Health Organization earlier this year through the International Generic and Biosimilars Medicine Association (IGBA).
“Globally, medicines likely to be in short supply have a low [profit] margin, are difficult to formulate or produce (high-cost), have a short shelf life, and/or have few or only one manufacturer.”
