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.
Highlights
IntroductionThe data on the safety of medicinal products application provided by a Marketing
Prakasam et al showed that about 11% to 35% adverse reactions reported by the patients were not identified in those which were voluntarily reported by healthcare providers, and the percentage of adverse reactions reported by patients and unregistered in medical records ranged from 5.6% to 66% [22]
From 2011 to 2013 the participation of patients and their caregivers reports increased by approx. 24%; from 2014 it reached around 30% of overall reported reactions every year, so patient reporting appears to play an important part in the pharmacovigilance system and provide a source of safety information throughout their use in healthcare practice
Summary
The data on the safety of medicinal products application provided by a Marketing. Authorization Holder (MAH) while obtaining the first marketing authorization come mainly from preclinical and clinical trials. The data obtained in clinical trials are still limited owing to, among others, the sample size and lack of data collected from specific populations (e.g., pregnant women, seniors, renal or hepatic failure patients). After having been authorized in the European Union, each medication becomes subject to constant monitoring and safety assessments of its use. It is organized as a pharmacovigilance system that is designed to protect human life and health by the detection, analysis and minimalization of adverse drug reactions and other drug-related problems [1,2]
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