Introduction -- Passive or active pharmacovigilance? -- Spontaneous reporting -- Cohort event monitoring -- Data processing -- Special types of event -- Relationship/causality assessment -- Signal identification -- Strengthening the signal -- Identifying risk factors -- Analyses -- Differences between spontaneous reporting and CEM -- Organization -- Communication -- Annexes
Summary
"This is a detailed manual giving a step by step approach to undertaking the pharmacovigilance of antiretrovirals. It is intended to be a source of practical advice for Pharmacovigilance Centres and health professionals involved in HIV/AIDS prevention and treatment programmes. A number of WHO publications are available that provide a background to pharmacovigilance and, as far as possible, that material will not be repeated here."--Publisher's description
Analysis
Drug monitoring
Drugs -- Side effect
Notes
Includes glossary
Bibliography
Includes bibliographical references (pages 122-126)