Patient Reporting in the EU: Analysis of EudraVigilance Data.

ABSTRACT

INTRODUCTION: New pharmacovigilance legislation was adopted in the EU in 2010 and became operational in July 2012. The legislation placed an obligation on all national competent authorities (NCAs) and marketing authorisation holders (MAHs) to record and report cases of suspected adverse drug reactions (ADRs) received from patients. OBJECTIVES: This descriptive study aims to provide insight into patient reporting for the totality of the EU by querying the EudraVigilance (EV) database for the period of 3 years before the new pharmacovigilance legislation became operational and the 3 years after as well as comparing patient reports with those from healthcare professionals (HCPs) where feasible. METHODS: We queried the EV database for the following characteristics of patient and HCP reports demographics (patient sex and age), seriousness, reported ADR terms, reported indications, number of ADRs per report, time to report an ADR, and most reported substances. Wherever feasible, direct comparisons between patient reports and HCP reports were performed using relative risks. RESULTS: The EV database contained a total of 53,130 patient reports in the 3 years preceding the legislation operation period and 113,371 in the 3 years after. Member states contributing the most patient reports to the EV database were the Netherlands, the UK, Germany, France and Italy. The results for indications and substances show that patients were more likely than HCPs to report for genitourinary, hormonal and reproductive indications. Patients reported more in general disorders and administration site conditions Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), whereas HCPs reported more Preferred Terms (PTs) belonging in the Investigations SOC. However, 13 of the 20 reactions most frequently reported by patients were also among the top 20 reactions reported by HCPs. CONCLUSION: Patient reporting complemented reporting by HCPs. Patients were motivated to report ADRs, especially those that affected their quality of life. Sharing these results with NCAs and patient associations can inform training and awareness on patient reporting.