Informativeness of Patient Initial Reports of Adverse Drug Reactions. Can It Be Improved by a Pharmacovigilance Centre?

Overview

Journal Eur J Clin Pharmacol

Specialty Pharmacology

Date 2017 Apr 10

PMID 28391408

Citations 7

Authors

F Kheloufi

A Default

F Rouby

D Laugier-Castellan

M Boyer

B Rodrigues

J Ponte-Astoul

M J Jean-Pastor

O Blin

J Micallef

Affiliations

Soon will be listed here.

Abstract

Purpose: Little is known about the informativeness of initial patient reports before they are reviewed by a pharmacovigilance centre (PVC). We aim to describe the patterns of patient adverse drug reaction (ADR) reporting in France and estimate the contribution of a review by a PVC assessor on the informativeness of these reports.

Methods: A retrospective study was conducted on patient reports between July 2011 and July 2015. Informativeness of 16 key elements of information (including drug start and end date, duration of treatment, time to onset and duration of the ADR, outcome, medical history and concomitant medication) was assessed in initial reports before and after review by a pharmacovigilance assessor.

Results: Overall, 240 reports concerning 522 ADR and involving 278 drugs were reported over this 4-year period. Mean number of available key elements of information in initial reports was increased from 11/16 to 15/16 after review of reports by the PVC. Time to onset and duration of the ADR were respectively available in only 51 and 58% of the reports before review compared to 83 and 90% after review. Medical history and concomitant medication were missing in 75% of the initial reports compared to less than 30% of the reports after review. Contacting the reporter enabled an increase of informativeness of most elements of information for more than 90% of the reports.

Conclusion: Patient reports often need to be completed on key elements of information that are required to assess reports. Both upstream education of patients and downstream intervention of a pharmacovigilance assessor to complete missing information could help to enhance the informativeness of such reports.

Citing Articles

Data-Driven Identification of Factors That Influence the Quality of Adverse Event Reports: 15-Year Interpretable Machine Learning and Time-Series Analyses of VigiBase and QUEST.

Choo S, Sartori D, Lee S, Yang H, Syed-Abdul S JMIR Med Inform. 2024; 12:e49643.

PMID: 38568722 PMC: 11024759. DOI: 10.2196/49643.

Comparative Analysis of Information Provided in German Adverse Drug Reaction Reports Sent by Physicians, Pharmacists and Consumers.

Christ P, Dubrall D, Schmid M, Sachs B Drug Saf. 2023; 46(12):1363-1379.

PMID: 37987966 PMC: 10684666. DOI: 10.1007/s40264-023-01355-8.

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

Sienkiewicz K, Burzynska M, Rydlewska-Liszkowska I, Sienkiewicz J, Gaszynska E Int J Environ Res Public Health. 2022; 19(1).

PMID: 35010673 PMC: 8745009. DOI: 10.3390/ijerph19010413.

The Role of European Patient Organizations in Pharmacovigilance.

Matos C, Weits G, van Hunsel F Drug Saf. 2018; 42(4):547-557.

PMID: 30357648 DOI: 10.1007/s40264-018-0748-x.

Current trends in pharmacovigilance: value and gaps of patient reporting.

Inacio P, Cavaco A, Airaksinen M Int J Clin Pharm. 2018; 40(4):754-757.

PMID: 30006734 DOI: 10.1007/s11096-018-0689-6.

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