According to an observational study published today in the Canadian Medical Association Journal (CMAJ).
The researchers noted that, as in many other countries, drug shortages are common in Canada, with shortages reported for almost half of all prescription drugs during the study period. When the pandemic began, supply chain disruptions in China and India – which are estimated to supply up to 80% of raw ingredients and medicines globally – and increased demand for antidiabetic drugs COVID-19, have further threatened Canada’s drug supply.
To help ensure a steady supply of drugs, Canada’s Minister of Health has authorized the importation of key drugs at high risk of shortages from countries with equally stringent regulatory systems. The government also revised the country’s patent law on March 25, 2020 to allow the manufacture and sale of versions of patented drugs without having to negotiate with patent holders. The changes were made permanent in March 2022.
Shortages peaked in April 2020
Led by researchers at the University of Calgary, the time-series analysis used data from the Canadian Drug Shortages Database, which identifies and tracks shortages by drug over time. The database was created in 2012 and, from 2017, pharmaceutical companies were required to report expected and actual shortages. The study also included data from Health Canada’s Drug Products Database and Patent Register.
The team tracked drug shortages from April 15, 2017 to April 1, 2022 to model and determine the significance of pattern changes after the mitigation policies were enacted.
The 30-day average rolling shortages for 10,000 drug identification numbers peaked in April 2020, at 2,345, compared to 901 shortages 5 years earlier. But after the policy measures were implemented, shortages dropped significantly, especially for generic drugs, to 1,611 in March 2021.
The positive trend, however, began to level off shortly thereafter, with rates falling below 1,500 and then climbing above 1,600 in March 2022, although the researchers said the decline was not not statistically significant. Most new imports took place in the summer of 2020 and then declined thereafter.
During the study period, an average of 8,354 drug products per day were at risk; they included both large and small molecule drugs and spanned all therapeutic classes, with the greatest effects on sensory organ (3771), cardiovascular (2876) and dermatological (2613) drugs. Of the 13,329 drugs at risk of shortage, 44.7% were in short supply at least once during the 5-year study period, and 1,803 drugs, on average, were in shortage each day.
Of the 5,953 drugs in shortage at any given time, many were in short supply multiple times (mean, 2.1 reports per drug). A strong majority of shortages (88.5%) were resolved after an average of 4.7 months, but 11.3% were still unresolved after an average of 2.5 years.
Brand name drug trends did not show significant changes over the course of the study. “Although our study does not provide an explanation for this phenomenon (for example, manufacturers may have more resources or incentives to treat more lucrative products with special care), the implication is that patent protection preventing multiple vendors from entering the market is unlikely to be a major cause of drug shortages in Canada,” the authors wrote.
Can the improvements be sustainable?
Drug shortages “interfere with patients’ ability to regularly take drugs to manage chronic conditions; disrupt the work of healthcare providers, as they must spend time struggling to find suitable substitutes for hard-to-obtain drugs that are free of contraindications given patients’ other medications; and may drive up costs for insurers and patients if alternative products are more expensive or not covered by insurance,” the researchers wrote.
Also, they noted, some drugs used to treat acute illnesses may not have a suitable alternative.
“New measures to address and reduce shortages during the COVID-19 pandemic appear to have had a substantial positive impact,” lead author Reed Beall, PhD, of the University of Calgary, said in a statement. CMAJ press release emailed to journalists. “These measures must be maintained, supported and strengthened over the long term to minimize harm to patient care and professional practice.”
The authors acknowledged that the reduction in shortages may come from factors other than policy changes, such as fewer healthcare visits and reduced demand for drugs under pandemic restrictions. “Demand may have been further smoothed temporarily when pharmacists in some provinces began dispensing only 30-day supplies to reduce supply chain stress in the few months after March 2020,” they said. they wrote.
The researchers also said they were unsure if the shortage reductions could be further improved or sustained. “It is possible that the benefits of the measures are limited,” the researchers wrote. “For example, not all shortages can be solved by exceptional importation when shortages are global. Moreover, the reforms put in place depend on human action to reduce shortages.”
They called for future studies to better understand the reasons for observed improvements in shortages, suggesting qualitative interviews with actors involved in addressing shortages.