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Impact of the COVID-19 outbreak on the reporting of adverse drug reactions associated with self-medication - 02/09/21

Impact de l’épidémie de COVID-19 sur les notifications d’effet indésirables médicamenteux associés à l’automédication

Doi : 10.1016/j.pharma.2021.02.003 
M. Gras a, V. Gras-Champel a, b, J. Moragny a, P. Delaunay c, D. Laugier d, K. Masmoudi a, S. Liabeuf a, b,
a Department of Clinical Pharmacology, Amiens University Hospital, Amiens, France 
b MP3CV Laboratory, EA7517, Jules-Verne University of Picardie, Amiens, France 
c Department of Clincal Pharmacology and Vigilances, Poitiers University Hospital, Poitiers, France 
d Regional Pharmacovigilance Centre Marseille – Provence – Corse, Sainte-Marguerite Hospital, AP–HM, Marseille, France 

Corresponding author at: Department of Clinical Pharmacology, Amiens University Hospital, Amiens, France.Department of Clinical Pharmacology, Amiens University HospitalAmiensFrance

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Highlights

Self-medication is not risk-free, it can induce adverse drug reactions, microbial resistance, drug interactions, addiction, and substance abuse.
Preliminary evidence suggests that symptoms of anxiety and depression and self-reported stress are common psychological reactions to the COVID-19 pandemic; in turn, these reactions might lead to unjustified self-medication.
The present study is the first to give an overview of officially notified ADRs linked to self-medication during the COVID-19 outbreak in 2020 first wave .
Our results highlighted a higher proportion of ADRs linked with self-medication during the COVID-19 period, relative to the same calendar period 12 months previously.
Half of the notified ADRs were considered to be “serious”, and 62.5% were linked to overdoses and medication errors. Accidental ingestion of drugs by children was a particular concern.

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Summary

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.

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Résumé

Objectifs

L’objectif principal de la présente étude était de décrire les caractéristiques des effets indésirables médicamenteux (EIM) liés à l’automédication qui ont été notifiés dans la base nationale française de pharmacovigilance (BNPV) lors de l’épidémie de COVID-19 pendant la première vague de 2020. L’objectif secondaire était de comparer les caractéristiques de ces EI en 2020 avec celles notifiées au cours de la même période calendaire un an auparavant.

Matériel et méthodes

Nous avons analysé les effets indésirables enregistrés dans la BNPV entre le 15 mars et le 31 mai 2020 par rapport aux mêmes dates en 2019. Seuls les EIM liés à l’automédication ont été analysés. Des statistiques descriptives ont été utilisées pour obtenir un aperçu des types et des caractéristiques de ces effets indésirables.

Résultats

Sur 3114 effets indésirables notifiés au FPVD au cours de la période étudiée en 2020, 114 (3,7 %) étaient liés à l’automédication. La proportion équivalente en 2019 était de 1,6 % (113 sur 7097). La moitié des EIM notifiés en 2020 étaient « graves ». L’âge médian des patients était de 30,5 ans et 22 % des EIM concernaient des enfants. Sur les 114 EIM liés à l’automédication, 107 (66 %) concernaient des médicaments sur prescription uniquement. Les trois classes les plus fréquemment suspectées étaient les analgésiques, les psycholeptiques et les antibactériens à usage systémique. Les effets indésirables les plus fréquents étaient les troubles généraux, les troubles gastro-intestinaux et les troubles du système nerveux. La principale différence entre la période COVID-19 et la période non-COVID-19 était la proportion plus élevée d’erreurs de prise médicamenteuse pendant la période COVID-19.

Conclusion

Cette étude est la première à rapporter les EIM associés à l’automédication et notifiés pendant une période de confinement. D’autres études portant sur les conséquences de l’automédication en période de pandémie semblent importantes à mener afin de cibler des messages de prévention.

Il testo completo di questo articolo è disponibile in PDF.

Keywords : Self-medication, Pharmacovigilance, Adverse drug reaction, COVID-19

Mots clés : Automédication, Pharmacovigilance, Effet indésirable médicamenteux, COVID-19


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Vol 79 - N° 5

P. 522-529 - Settembre 2021 Ritorno al numero
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