Have federal policies reduced Canada’s drug shortage?

According to a new report, Canada’s drug shortage, which worsened during the first months of the COVID-19 pandemic, improved in 2020 after the federal government introduced new aid measures.

The improvements stabilized in 2021, however, and shortages began to increase again by the end of March 2022. Measures should be maintained and developed to create long-term change and minimize harm to patients, the authors wrote. of study.

Dr. Mina Tadrous

“Drug shortages have a wide-ranging impact on many clinical areas and types of clinical care, from primary care and preventive treatments to ICU drugs and contrast dye,” Mina Tadrous, PharmD, PhD, one of the study authors and Women’s Scientist College Hospital Institute for Health System Solutions and Virtual Care in Toronto, Ontario, Canada said Medscape Medical News.

“Most importantly, many patients will be affected and potential clinical consequences could occur,” he said. “This adds further effort to our already extensive health systems: imagine the time and effort to change patients already stable on medications or find alternatives or even delay procedures further.”

The study was published online June 13 in Journal of the Canadian Medical Association.

Progress and Plateau

Drug shortages have become a persistent problem in Canada and around the world in recent years, and the pandemic has exposed vulnerabilities as supply chains stopped from countries producing pharmaceuticals and raw materials, the study authors wrote.

In March 2020, the Canadian government introduced new measures to address these shortcomings, including an amendment to the Patent Act that allowed manufacturers to manufacture, use or sell proprietary versions of drugs without having to negotiate with patent holders. The federal government also issued an interim order for some drugs that had high shortage risks, which allowed them to be imported from other countries. The interim measures were made permanent in March 2022.

Using a cross-sectional design, the researchers analyzed information from the Drug Shortages Canada database to track changes in drug deficiency over time by calculating a 30-day moving average from April 2017 to April 2022.

They found that of the 13,329 pharmaceutical products at risk of shortage, nearly 45%, or 5,953 products, have had at least one shortage event in the past 5 years.

Of the 5953 products that experienced a shortage, many experienced multiple events over the 5-year period, with an average of 2.1 reports per drug identification number. About 88% of the deficiencies were resolved after around 140 days, or nearly 5 months. About 11% of the deficiencies remained unsolved and had been ongoing for an average of 2.5 years.

Average daily prevalence rates of the deficiency increased from 901 in April 2017 to a peak of 2345 in April 2020. Thereafter, the deficiencies decreased significantly, dropping to a rate of 1611 by the end of the first year after. implementation of new policy measures.

However, there was no significant reduction in shortage rates in the second year. Rates plateaued around 1500 and then climbed above 1600 by the end of March 2022.

Lorian Hardcastle

“Although COVID has shed light on the issue of drug shortages, it has been an ongoing problem in Canada for many years,” Lorian Hardcastle, SJD, one of the study’s authors and assistant professor of community health sciences at the University of Calgary , Alberta, Canada said Medscape.

“Although manufacturers report shortages, patients and healthcare professionals are often caught off guard by shortages and the response from policy makers has generally been reactive,” he said. “This suggests that a better systemic response is needed, whereby policy makers closely follow and act on shortage reports to minimize disruption of patient care.”

International collaboration required

Future research should focus on specific types of drugs that face shortages, as well as potential measures for improvement, the study authors wrote.

In the present study, all therapeutic classes were affected by deficiencies, with the highest average daily deficiency rates in the sensory, cardiovascular and dermatological classes.

Hardcastle et al are now looking into the shortage of veterinary drugs, which often share raw materials with human drugs, as well as the shortage of antimicrobial drugs, which could play a role in antimicrobial resistance.

“While our paper focuses on the domestic impact of shortages, it is also important that Canadian policy makers collaborate on this issue internationally, as many of our pharmaceuticals or their raw materials come from overseas,” he said. Hardcastle. “As we have seen during COVID, there can be equity concerns about how scarce pharmaceuticals are allocated globally.”

Public health experts and lawmakers also need a better understanding of drug deficiency data, its causes and possible help from new policies.

Dr. Jacalyn Duffin

“We need more information like this. The government should produce annual reports on the number of shortages over time. There is no other way to gauge the impact of policy changes without measurement, “said Jacalyn Duffin, MD, PhD, professor emeritus who held the Hannah Chair in History of Medicine at Queen’s University, Kingston, Ontario. Canada Medscape.

Duffin, who was not involved in this study, opened a website in 2012 to monitor drug shortages in Canada and around the world called CanadaDrugShortage.com. He continues to update the website, including more than a dozen possible causes of shortages related to supply, demand, prices, quality control, raw materials and global crises.

“Drug shortages are a serious and long-standing problem that has had many negative impacts on human and animal health, including disease and death,” he said. “To solve it, we need to understand the causes.”

The authors received no direct financial support for the development of the manuscript. Tadrous has received a grant from the Canadian Institutes of Health Research and advisory boards from the Canadian Agency for Health Drugs and Technologies and Green Shield Canada. Hardcastle and Duffin did not report any relevant information.

CMAJ. Published online June 13, 2022. Full text.

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