Abstract
BackgroundReporting of adverse drug reactions (ADRs) has traditionally been the sole province of healthcare professionals. In the European Union, more countries have allowed consumers to report ADRs directly to the regulatory agencies. The aim of this study was to characterize ADRs reported by European consumer for nervous system medications.MethodsADRs reported by consumers for nervous system medications (ATC group N) from 2007 to 2011 and located in the European ADR database, EudraVigilance, were analysed. Data were categorized with respect to age and sex, category and seriousness of reported ADRs and medications. The unit of analysis was one ADR.ResultsWe located 4766 ADRs reported for nervous system medications, and one half of these were serious including 19 deaths. Less than 5% of ADRs were reported in children. Totally, 58% of ADRs were reported for women, 42% for men. The majority of reported ADRs were of the types “nervous system disorders” (18% of total ADRs) followed by “psychiatric disorders” (18% of total ADRs) and “general disorders” (15% of total ADRs) which also were the system organ classes in which the majority of serious ADRs were found. ADR reports encompassed medicines from the therapeutic groups: antiepileptics (ATC group N03) (36% of total ADRs), parasympathomimetics (ATC group N07) (22% of total ADRs) and antidepressants ATC group N06A (9% of total ADRs). Antiepileptics were the therapeutic group with the highest share of serious ADRs (60%) followed by antidepressants (15%). Many serious ADRs were reported for pregabalin and varenicline.ConclusionsThe majority of ADRs from nervous system mediations reported by consumers that were identified from the EudraVigilance database were serious. The value of consumer reports in pharmacovigilance still remains unclarified.
Highlights
Reporting of adverse drug reactions (ADRs) has traditionally been the sole province of healthcare professionals
In Sweden, it has been possible for consumers to ADR report directly to the non-profit organization KILEN since 1978 [2], and research conducted on these data has been published in several papers and reports [7,8,9,10]
The medicinal products reported are referenced based on their active substance and in this article we present ADR data at anatomical therapeutic chemical (ATC) level 1 and 5 [19]
Summary
Reporting of adverse drug reactions (ADRs) has traditionally been the sole province of healthcare professionals. In the European Union, more countries have allowed consumers to report ADRs directly to the regulatory agencies. Reporting of adverse drug reactions (ADRs) to national databases has traditionally been the sole province of health care professionals [1]. Experience with consumer reporting (2004 to 2007) in the Netherlands was recently published showing differences in the categories of seriousness and outcome of the reported ADRs between patients and healthcare professionals [11]. A study from Denmark analysing differences in ADR reporting patterns between consumers and healthcare professionals (2004 to 2006) showed that patients were more likely to report ADRs from nervous and psychiatric medications, that patients’ share of reports on serious ADRs was comparable to that of physicians, and that patients provided new and unknown information about ADRs [12]. The objective of this study was to investigate ADR reports submitted by consumers for nervous system medications in Europe during the first 5 years of electronic reporting to the EV ADR database
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