(182) Impact of the COVID-19 Pandemic on Drug Safety Surveillance: An Analysis of The Canadian Spontaneous Reporting Database

Publication Number: 513

Background: The COVID-19 pandemic has had an important impact on health care resource use and access, which might have led to changes in adverse event (AE) reporting to voluntary pharmacovigilance systems. Since spontaneous reporting is considered to be the main safety surveillance tool in the post-market setting, it is important to determine whether the COVID-19 pandemic has compromised the ability to detect safety signals.

Objectives: To describe the effect of the COVID-19 pandemic on spontaneous reporting practices in Canada by assessing trends over time in reporting rates before and after the start of the pandemic.

Methods: All AE reports from 11 March 2018 to 24 July 2021 available in Canada Vigilance, the Canadian national reporting system, were obtained. The start of the pandemic was defined as the date the WHO declared COVID-19 as a pandemic (11 March 2020). A time trend analysis was conducted on the weekly number of reports using the ARIMA model with a step intervention function (short-term effect) and a ramp intervention function (long-term effect). The effect of the pandemic was assessed by comparing observed trends with predicted trends. Trends were stratified by reporter type (HCPs and non-HCPs) and by report seriousness. A sub-analysis targeted opioids and biologics, which are under heightened surveillance scrutiny in Canada.

Results: A total of 286,308 AE reports were found in Canada Vigilance over the study period. Compared to the pre-pandemic period, overall number of weekly reports decreased significantly by 29.7% immediately after the start of the pandemic, which was statistically significant according to the step intervention function from the ARIMA model (-456, 95% CI: -717 to -194). The observed decrease was more pronounced for reports made by HCPs (-22.2%) than non-HCPs (-2.0%) and for non serious reports (-42.4%) compared to serious reports (-23.3%). For drugs under heightened surveillance, a statistically significant decrease in reporting was observed for opioids (-42.4%) but not for biologics (-11.1%). For all analyses, no significant slope change (ramp) was observed, which indicates that the decrease in reporting rates was transient and only present at the beginning of the pandemic.

Conclusions: The COVID-19 pandemic had an immediate effect on the reporting of AEs at the beginning of the pandemic, when health care access was the most restricted. No lasting effect on reporting practices was however observed.