A Practical Handbook on the Pharmacovigilance of Antimalarial Medicines Book

A Introduction 1

B Passive or active pharmacovigilance? 2

C Spontaneous reporting 3

D Cohort event monitoring 13

E Data processing 38

F Special types of event 42

G Relationship/causality assessment 48

H Signal identification 57

I Strengthening the signal 64

J Identifying risk factors 66

K Analyses 69

L Differences between spontaneous reporting and cohort event monitoring 71

M Organization 73

N Communication 79

O Annex 81

Annex 1 CEM reporting form sides A and B 82

Annex 2 Coding sheet-sample from the IMMP 85

Annex 3 Major Clinical Categories IMMP Events Dictionary 86

Annex 4 Clinical Category Eyes, IMMP events dictionary 87

Annex 5 Events collation, Circulatory, omeprazole, - IMMP sample listing 88

Annex 6 Comparative events profiles (celecoxib and rofecoxib)-IMMP 89

Annex 7A Pregnancy enquiry questonnaire 90

Annex 7B Pregnancy progress questionnaire 91

Annex 7C Pregnancy outcome questionnaire 92

Annex 8 Deaths (as events) with omeprazole - IMMP sample listing 93

Annex 9 Eye events listing from IMMP 94

Annex 10 Drug-drug associations with celecoxib - IMMP sample listing 96

Annex 11 A selection of helpful web sites 97

Annex 12 Resources 100

Annex 13 Contacts 101

Annex 14 The importance of communication 103