The Importance of Direct Patient Reporting of Adverse Drug Reactions in the Safety Monitoring Process

Kamila Sienkiewicz; Monika Burzyńska; Izabela Rydlewska-Liszkowska; Jacek Sienkiewicz; Ewelina Gaszyńska

doi:10.3390/ijerph19010413

The Importance of Direct Patient Reporting of Adverse Drug Reactions in the Safety Monitoring Process

Int J Environ Res Public Health. 2021 Dec 31;19(1):413. doi: 10.3390/ijerph19010413.

Authors

Kamila Sienkiewicz¹, Monika Burzyńska², Izabela Rydlewska-Liszkowska¹, Jacek Sienkiewicz¹, Ewelina Gaszyńska³

Affiliations

¹ Department of Management and Logistics in Healthcare, Medical University of Lodz, Lindleya Street 6, 90-131 Lodz, Poland.
² Department of Epidemiology and Biostatistics, Medical University of Lodz, Żeligowskiego Street 7/9, 90-752 Lodz, Poland.
³ Department of Nutrition and Epidemiology, Medical University of Lodz, Żeligowskiego Street 7/9, 90-752 Lodz, Poland.

Abstract

All medicinal products authorized in the European Union are subjects of constant drug-safety monitoring processes. It is organized in a pharmacovigilance system that is designed to protect human health and life by the detection, analysis and prevention of adverse drug reactions (ADRs) and other drug-related problems. The main role of the aforementioned system is to collect and analyze adverse drug reaction reports. Legislation introduced several years ago allowed patients, their legal representatives and caregivers to report adverse drug reactions, which caused them to be an additional source of safety data. This paper presents the analysis of EudraVigilance data related to adverse drug reactions provided by patients, their representatives, as well as those obtained from healthcare professionals related to medicines which belong to M01A anti-inflammatory and antirheumatic products, a non-steroid group. The objective of the study was to identify the changes in the number and structure of adverse reaction reporting after the introduction of pharmacovigilance (PV) obligations in EU. A review of scientific literature was also conducted to assess the differences in adverse reactions reported by patients or their representatives and by healthcare professionals. We also identified other factors which, according to literature review, influenced the number of adverse reaction reports provided by patients. Analysis of data collected from the EudraVigilance showed that from 2011 to 2013 the number of reports made by patients and their caregivers increased by approx. 24 percentage points, and then, from 2014, it constituted around 30% of the total of reported reactions every year, so patient reporting is an important part of pharmacovigilance system and a source of drugs' safety information throughout their use in healthcare practice. Additionally, there was no interrelationship between the seriousness of reported adverse reactions and the overall number of patient reports when compared to reports form healthcare professionals.

Keywords: EudraVigilance; adverse reaction; patient reporting; pharmacovigilance; safety monitoring.

Publication types

Review

MeSH terms

Adverse Drug Reaction Reporting Systems*
Drug-Related Side Effects and Adverse Reactions* / epidemiology
European Union
Health Personnel
Humans
Pharmacovigilance