A Practical handbook on the pharmacovigilance of antimalarial medicines.
Contributors: World Health Organization.
Publisher: World Health Organization
Published: 2008
Place of publication: Geneva, Switzerland
Language: eng
Number of pages: 108
ISBN-13: 9789241547499
Subjects: Drug monitoring; Antimalarials -- Side effects; Adverse Drug Reaction Reporting Systems; Antimalarials -- adverse effects; Antimalarials -- standards; Drug Monitoring; Drug Utilization Review -- methods; Pharmacoepidemiology -- methods; Product Surveillance, Postmarketing
Description: This publication is a detailed manual giving a step by step approach to undertaking the pharmacovigilance of antimalarials. It provides information on spontaneous reporting of adverse drug reactions as a complement to other WHO publications. In addition, it provides details on how to conduct cohort event monitoring, which is a method of active safety surveillance collecting information on all adverse events occurring after treatment. It also details how to perform causality assessment and signal identification, applicable to both methods of surveillance.--Publisher's description.
Notes: Also available online.
Table of contents: title: A. Introduction; title: B. Passive or active pharmacovigilance?; title: C. Spontaneous reporting; title: D. Cohort event monitoring; title: E. Data processing; title: F. Special types of event; title: G. Relationship/causality assessment; title: H. Signal identification; title: I. Strengthening the signal; title: J. Identifying risk factors; title: K. Analyses; title: L. Differences between spontaneous reporting and cohort event monitoring; title: M. Organization; title: N. Communication; title: Annex.