Why Do Drug Shortages Happen?
In my article Navigating Drug Shortages, I covered some basics on drug shortages. Before getting into why drug shortages happen, I want to reiterate some data on drug shortages in Canada for context.
According to Canadian pharmacists, drug shortages have increased during the past 3 to 5 years.1 In the past 3 years, 25% of Canadians had directly been affected by a drug shortage or knows someone who has been.2 Per the Toronto Star, “Of the roughly 7,000 prescription drug products available in Canada, over 1,800 are shorted." That’s 26% of drugs.3 In fact, as of August 6, 2019, drug shortages were becoming so prevalent and problematic to Canadian pharmacists, the Canadian Pharmacists Association wrote a letter to Prime Minister Justin Trudeau about the problem.
Why do drug shortages occur?
There are a number of reasons drug shortages happen-—probably too many for me to even understand because the whole production and supply chain is a complicated thing.
Here are some of them, according to Health Canada and the United States Food and Drug Administration (FDA):
- Raw material shortages. Shortages of core ingredients needed to make the drug in question and contamination of these materials, often shipped internationally, is a primary reason for these shortages per Health Canada.4
- Manufacturing issues. Increased demand for one product in shared production space decreases the availability of another product, contamination of the product during manufacturing, and procedural changes that lead to slowing or stopping production (most planned, some unplanned).4 The FDA also notes in the case of some “older sterile injectable drugs," there are only a “limited number of production lines" actually able to manufacture the drug.5 Manufacturing issues leading to recalls can be due to the drug itself being high-risk to cause harm, or low-risk due to something like the wrong expiration date being printed on drug packaging.5
- Contracting issues. This includes those around single suppliers of necessary materials and large contracts with only one manufacturer (i.e. “sole source contracts”).4
- Business decisions. Discontinuing old drug manufacturing in preference of newer, higher profit drugs, or due to lack of demand/profit.4,5
- Voluntary drug recalls.
Why are drugs recalled?
As above, drugs may be recalled by the manufacturer either voluntarily or under mandatory orders from a health regulatory administration, such as Health Canada or the FDA. There are two types of recalls:
Voluntary recalls in which the product is not defective or dangerous, or not known to be dangerous, but exhibits an issue that may be problematic if ineffectively communicated to the user. For instance, if an expiration date is misprinted, many people may feel safe taking their regularly-taken drug, since they know their supply will not expire before the unprinted expiration date anyway.
A notable voluntary recall is that of the EpiPen in Spring 2019. The devices were known to stick to their protective tubes due to a labeling issue, but the issue could be mitigated by users by removing their EpiPens from the storage tube to ensure it was removable prior to an emergency. The manufacturer would replace all EpiPens in the lot, defective or not, but consumers could “self-test” to determine a problem and if they felt need to replace their medication.
Last year’s recalls of losartan-containing blood pressure medications was also voluntary, as the contaminant is “potentially a human carcinogen, which means that long term exposure could increase the potential risk of cancer”—-not that it will cause harm with certainty.6 These recalls might be considered an “abundance of caution” versus an “absolute danger".
Mandatory recalls occur when a drug or device is found to be contaminated or otherwise harmful to consumers and use must be stopped by the patient. In the case of drugs, recalls are usually facilitated by the patient’s pharmacy, where drugs are tracked and returned. For devices, some may be implantable and may require surgery to remove and replace.7
How do health systems enforce and respond to recalls?
Mandatory recalls look different in the U.S. and Canada.
In the United States
In the U.S., “The FDA cannot currently force a mandatory recall of drugs, it can order a manufacturer to recall a medical device by statute if it finds there is a reasonable probability that a device may cause serious injuries or death."7 If a company does not recall a medical device as ordered by the FDA, it can face a lawsuit.
However, the agency also states “Although the FDA can order manufacturers to recall medical devices, the agency cannot force a company to recall defective or potentially harmful drugs.”7 Yes, please feel free to write your lawmakers about this, American friends, because that is BANANAS, is it not?!
Per an amendment to the Food and Drugs Act, Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law), section 21.3 states, “If the Minister believes that a therapeutic product presents a serious or imminent risk of injury to health, he or she may order a person who sells the product to recall the product." Furthermore, “No person shall sell a therapeutic product that the Minister orders them, or another person, to recall."
And of course, if drugs are pulled off the shelves due to recalls, supply goes down and demand goes up! This means that regulatory authorities also need to plan for how manufacturers should take action when a drug shortage is identified to resolve the issue without harm to patients.
Drug recalls are increasing
As drug recalls have been increasing, I think it is important that we advocate and make lawmakers aware of this in order to improve regulations that are meant to keep drugs, and therefore patients, safe. If in the past 3 years this has affected 25% of people in my country, I think we should certainly be doing more to respond to it, should we not?
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