ABSTRACT
Explain what has changed the practice: As part of the Covid-19 vaccination campaign, the ANSM and all the 31 regional pharmacovigilance centers have been mobilised in an exceptional reinforced surveillance program. The aim of this national system is not to be exhaustive nor to compare vaccines but to detect safety signals in addition to European and international pharmacovigilance actions. It is based on the daily analysis of adverse reactions cases reported in the national pharmacovigilance database by experts in charge of the surveillance of each Covid-19 vaccines. As for other Covid vaccines, the number of administered doses of Astrazeneca Covid-19 vaccine (ChAdOx1-S vaccine) has been collected via the VACSI platform and spontaneous reports were extracted from the French Pharmacovigilance Database on 12/30/2021 and reviewed. On 30/12/2021, 7 832 223 doses of ChAdOx1-S vaccine were administered in France with 28 313 notifications corresponding to 53 389 adverse events, of among which one fifth were considered serious according to WHO criteria. The first pharmacovigilance signal, which appeared after the first injections, was unexpectedly severe flulike syndromes, according to the SPC. It was quickly followed by a more serious problem that would have a major impact on the vaccination campaign at both national and European level: Immune thrombotic thrombocytopenia (ITT). Subsequently, other signals highlighted during pharmacovigilance monitoring, such as Guillain-Barré syndromes, facial paralysis, capillary leak syndromes, urticaria and angioedema, and more recently, immune thrombocytopenia and cerebral venous thrombosis all of which remind the importance of post-authorisation monitoring. All those signals were transmitted to the European authorities, some of which led to the updating of the VaxZevria SPC. Today, the AstraZeneca vaccine has only a marginal place in the national vaccination strategy, but pharmacovigilance monitoring is still ongoing.
ABSTRACT
OBJECTIVES: The primary objective of the present study was to describe the characteristics of adverse drug reactions (ADRs) linked to self-medication that were notified to the French Pharmacovigilance Database (FPVD) during the COVID-19 outbreak in 2020 first wave. The secondary objective was to compare the characteristics of these ADRs in 2020 with those notified during the same calendar period a year previously. MATERIAL AND METHODS: We analyzed ADRs recorded in the FPVD between March 15th and May 31st, 2020 vs. the same dates in 2019. Only ADRs linked to self-medication were analyzed. Descriptive statistics were used to obtain an overview of the types and characteristics of these ADRs. RESULTS: Of 3114 ADRs notified to the FPVD during the COVID-19 period in 2020, 114 (3.7%) were linked to self-medication. The equivalent proportion in 2019 was 1.6% (113 out of 7097). Half of the ADRs notified in 2020 were "serious". The median age of affected patients was 30.5, and 22% of the ADRs concerned children. Of the 114 ADRs linked to self-medication, 107 (66%) were for prescription-only drugs. The three mostly frequently suspected ATC classes were analgesics, psycholeptics, and antibacterials for systemic use. The most frequent ADRs were general disorders, gastrointestinal disorders, and nervous system disorders. The main difference between the non-COVID-19 period and the COVID-19 period was the higher proportion of medication errors during the latter. CONCLUSION: The present study is the first to have reported on ADRs linked to self-medication and notified during a COVID-19 outbreak. Further studies of self-medication patterns and their consequences in a pandemic context are mandatory and effective information on medication use (including self-medication and its dangers) during a pandemic is essential.