In the fall of 2022, we saw severe shortages of acetaminophen and ibuprofen containing drugs, especially the preparations for children. I have been responding to numerous requests from journalists to explain it. Actually, reports had been surfacing since last spring. But we were told that this current crisis is owing to an increase in demand. The extraordinary increase in children’s respiratory infections is occurring earlier in the season and with greater intensity than usual. This may be because kids were sheltered by the COVID-19 rules. In other words, we have a double cohort of susceptible children as pandemic rules relaxed. What’s more, parents have been hoarding the meds during the pandemic to avoid being caught short should their kids fall ill.
It is important to remember that these shortages are occurring on top of an already fragile supply chain. Yes, COVID-19 unmasked these problems — drugs to help intubate patients in the ICU, drugs to control infection and help breathing. The border closures meant it was hard to ship the raw materials and the finished products; the pandemic meant factories were working with fewer staff and falling behind. But it has been since 2010 that we’ve been tracking drug shortages in vastly greater numbers than occurred in the past. Also at the time these shortages for kids’ medicines are appearing, we Canadians have more than 1800 OTHER drug products in short supply.
It is also important to know that shortages of the same drugs for adults as well as children–especially of paracetamol (another name for acetaminophen) –are reported in several other countries in Europe and in Asia. It is a GLOBAL problem.
Journalists call us about shortages of meds for kids because it is upsetting and frightening– AND especially because kids have motivated anxious and sometimes angry parents who fuss until they get attention. The same happened with a shortage of epilepsy drugs in 2012 and with a shortage of Epipens in the summer of 2019. Elderly adults with chronic illnesses and cancer rarely have the energy or the familial advocates to draw attention to their plight. Furthermore, in this case, it is over the counter remedies that are missing — so the empty shelves are glaringly obvious.
I have already explained how the decline in numbers of manufacturers leads to vulnerabilities in the supply chain– and I’ve shown how that works specifically for the prescription drugs, Tamoxifen and beta-blockers. Now it is time to apply the same historical analysis to over-the-counter ibuprofen and acetaminophen.
As before, I used the Health Products Database and the drugshortage.ca database (as well as its now defunct predecessor launched in 2012) to explore the number of products marketed or cancelled over time. Companies have been required to report shortages –preferably in advance– since 2017. Only some of them do so.
Ibuprofen was discovered in the early 1960s by scientists looking for a drug that would work like aspirin against inflammation, but with fewer side effects. Aspirin can lead to bleeding in the GI tract; it also hampers clotting power in the blood and it can provoke hearing loss. These problems were regularly seen in people using the drug for arthritis and other chronic inflammatory problems. Aspirin was also associated with a dreadful neurological complication in children called Reyes syndrome.
By 1985 the global patent for ibuprofen, held by Boots pharmaceutical in the UK, had expired — and many other companies began making it in different formats: capsules, tablets, liquids and various doses; sometimes combined with other drugs. The drug was safe for use in kids and had fewer side effects. By 1996 companies began discontinuing some of these products. Discontinuations appeared regularly until they peaked in 2019 and 2021. Sure enough, shortages were reported as early as 2015.
During the 50 years since 1972, 15 companies dropped 42 different forms of ibuprofen in Canada. Eight companies are still marketing 68 different ibuprofen-containing compounds. Unfortunately only two companies (Apotex and Teva) have been reporting shortages at drugshortages.ca, although it is supposed to be mandatory to do so; however, over the counter meds are exempt from the mandatory rule. You have to ask ‘why?’ Since these too are essential drugs, they ought to be on an Essential Medicines List if only Canada bothered to have one. Shortages of any essential medicine should be reported.
NUMBER OF IBUPROFEN PRODUCTS IN CANADA 1972-2022 (by DIN)
Unlike Ibuprofen, acetaminophen was discovered in the 19th century and has not been patented within the last 50 years, although considerable scientific work improved the safety and quality of the product. With the problems of aspirin use in children, the brand Tylenol (made by McNeil labs — now a division of Johnson & Johnson) became a popular best seller. Overdose was known to cause liver problems, but in general it was safer for treating pain and fever in kids.
Over the course of time, 91 different companies have cancelled 510 different products containing acetaminophen. At the moment 30 different companies are still marketing a total of 241 products containing acetaminophen in Canada. However, only 10 companies are reporting shortages at the moment. But we know that the shortages are so severe that replacement drugs are being imported from Australia and the United States. In fact, McNeil the brand-maker of Tylenol has not reported any shortages of acetaminophen, and has only ever reported 4 shortages of entirely different drugs — 2 of which were resolved; 2 of which were discontinued. Janssen, another Johnson & Johnson affiliate making prescription drugs, reported 3 shortages of Tylenol with codeine and 1 with tramadol, all of which ended in discontinuations. McNeil ignores Canada’s rules for mandatory reporting of shortages perhaps because it designates itself as an over-the-counter manufacturer (see above). You would think it would view its product as important and therefore it would be equally important to notify when it is unavailable and when supply will be restored.
To prepare a chart for acetaminophen like the one above for ibuprofen, I would have to click on and open every single one of the 741 files at the Health Products database. I’m not going to do it. I predict that it would look a lot like the chart above: a hey-day period of companies rushing in to produce various formats, a financial-crunch period of abandoning, and more-recent period when shortages appear. Health Canada could easily do it for us. Why don’t you ask them? Here’s the website.
In total there have been 202 shortages of products containing acetaminophen reported by 26 companies since at least 2014. Of these, 132 (65.4%) were resolved, 49 (24.3%) ended with discontinued products, and 21 (10.4 %) are still current. It is interesting that there were MORE acetaminophen shortages reported in 2020 at the height of the first wave of the COVID-19 pandemic than are being reported now. Perhaps they did not involve kids preparations to the same extent, or perhaps there were other even more pressing concerns at the time.
NUMBER OF SHORTAGES OF ACETAMINOPHEN PRODUCTS / YEAR, 2014-2022
This exercise shows–once again–that from once having a multiplicity of makers with a lot of margin in sources of drug supply, we have fewer makers. The change means that any cause of stress in the system–increased demand, shortage of raw materials, difficulty shipping, or factory slowdowns–will provoke shortages. It also shows that many drug companies who have the privilege of marketing in Canada ignore Canada’s rules about reporting their shortages and the reasons for them.
To fix the problem of drug shortages, we need more transparency in the system. We need Health Canada to provide annual reports measuring the shortages. We need an Essential Medicines List. And we need to engage in and lead an international conversation about this global problem.
First we diagnose, then we treat.