Traceability of Biologics in The Netherlands: An Analysis of Information-Recording Systems in Clinical Practice and Spontaneous ADR Reports

• Published in: Drug safety Vol. 39; no. 2; pp. 185 - 192
• Main Authors: Klein, Kevin, Scholl, Joep H. G., Vermeer, Niels S., Broekmans, André W., Van Puijenbroek, Eugène P., De Bruin, Marie L., Stolk, Pieter
• Format: Journal Article
• Language: English
• Published: Cham Springer International Publishing 01.02.2016; Springer Nature B.V
• Subjects: Adverse Drug Reaction Reporting Systems - organization & administration; Adverse Drug Reaction Reporting Systems - standards; Biological products; Biological Products - classification; Biological Products - standards; Brand names; Clinical medicine; Databases, Pharmaceutical; Drug Prescriptions - standards; Drug Safety and Pharmacovigilance; Drug stores; Electronic health records; Funding; Manufacturing; Medicine; Medicine & Public Health; Netherlands; Original; Original Research Article; Pharmacists; Pharmacology/Toxicology; Pharmacovigilance; Practice Patterns, Physicians' - organization & administration; Practice Patterns, Physicians' - standards; Questionnaires; Studies; Surveys and Questionnaires; Netherlands; Adverse Drug Reaction; Community Pharmacist; Product Class; Hospital Pharmacist; Adverse Drug Reaction Report

Introduction and Objective Pharmacovigilance requirements for biologics mandate that EU Member States shall ensure that any biologic that is the subject of a suspected adverse drug reaction (ADR) is identifiable by brand name and batch number. Recent studies showed that brand name identification is...