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Jonathan Zipursky, Nathan Stall and Eyal Cohen are physicians and scientists at the University of Toronto. Dr. Zipursky is on the medical staff at Sunnybrook Health Sciences Centre, Dr. Stall at Mount Sinai Hospital, and Dr. Cohen at the Hospital for Sick Children (SickKids).

Last fall and winter, an unprecedented surge in viral respiratory illnesses across Canada led to a national shortage of children’s fever and pain medications. Many parents and caregivers scoured shelves at pharmacies across the country or tried to source medicines from abroad. Some children were likely undertreated for fever and pain, but what we have now discovered was an unexpected surge in dosing errors for pediatric acetaminophen (Tylenol) and ibuprofen (Advil).

Our study, published this week in the New England Journal of Medicine, examined acetaminophen and ibuprofen dosing errors in children during Canada’s drug shortage and found there were more than double the expected number of calls to the Ontario Poison Centre. Even after accounting for the increased demand for these medications because of the surge in respiratory viruses, dosing errors still exceeded the expected levels.

So why did dosing errors increase, despite there being fewer children’s medications available? Leading hospitals and professional societies issued well-intentioned guidance on how to dose adult medications for children. Despite this, desperate parents and caregivers might have mistakenly divided pills, and dosing guidance may have been less accessible or understood by residents whose first language isn’t English, French or one that’s commonly translated. Medications sourced from other countries can also have unfamiliar labelling or dosing instructions.

Somewhat reassuringly, our study found no major differences in the number of children who were hospitalized because of the increased number of dosing errors. But that doesn’t mean no harm was done. Unintentional dosing errors cause enormous stress to patients and caregivers. And the shortages that were at their root have diverse effects. Patients may receive suboptimal treatment, delayed care, or require visits to clinics, emergency departments or hospitals. The use of alternative drugs, which is also likely to have occurred, is sometimes less effective or fraught with side effects.

Preventing future drug shortages requires an understanding of why this happened to begin with. First and foremost: If you fail to prepare, prepare to fail. With the multitude of challenges during last year’s respiratory illness surge, drug supply simply could not meet demand. And the supply that did exist consisted of drugs that were not intended for children, who require smaller doses tailored to their age and weight and often cannot swallow pills.

Second, over-the-counter drugs in Canada require bilingual labelling in order to be distributed. This regulatory issue limited the government from rapidly importing drugs from other countries with an adequate supply. But in a crisis that was months in the making, workarounds (e.g., bilingual leaflets, links to online instructions) must be found.

This recent drug shortage will unfortunately not be the last one. Even after the pediatric acetaminophen and ibuprofen scarcity subsided, drug shortages emerged for pediatric formulations of antibiotics such as amoxicillin, which is widely used to treat ear and chest infections. Between 2019 and 2020, shortages were reported for 29 per cent of all prescription medicines sold in Canada. At present, there are 25 active drug shortages designated as Tier 3 – those with the greatest potential impact on Canada’s drug supply and health care system.

During drug shortages, everyone has a role to play, and timely communication and effective collaboration are essential. Increasing the scope of Health Canada to anticipate and respond to shortages in partnership with manufacturers and distributors is key. This includes building on processes that permit drugs labelled and approved for other markets to be imported into Canada; expediting reviews for alternative medications; and extending the shelf life of a drug if appropriate. Other solutions include increasing drug production and modifying the allocation of drugs to regions with diminishing supply.

Ultimately, prevention is the best medicine, and avoiding drug shortages requires a multifaceted approach. Stockpiling can help address unforeseen demand but is potentially wasteful as the shelf life of many drugs is time-limited. It is also an unrealistic strategy for the thousands of drug products licensed in Canada, and there are ethical concerns about decreasing supply for resource-poor countries. Better strategies include improving our demand-and-supply forecasting capability, ensuring redundancy in the supply of essential medicines, and, chiefly, increasing our domestic production of essential medicines.

As our research has shown, the alternative will not just result in having more exasperated patients and their caregivers, but in creating a real risk of harm to Canadian children.

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