Fraunhofer Institute for

Systems and Innovation Research ISI

ISI-Schriftenreihe »lnnovationspotenziale«

Bernhard Buhrlen
Thomas ReiB
Christiane Beckmann
Ulrich M. Gassner
Christoph H. Gleiter

Assessment of the
European Community System
of Pharmacovigilance

Fraunhofer IRB Verlag

 Assessment of the European Community System of Pharmacovigilance I
Final Report November 2005

Table of Content

Foreword 1

Executive summary 3
Overview and aim of the study 3
General aspects 4
Data collection 6
Data management 8
Signal detection 8
Safety issue assessment 8
Decision-making 9
Communication and action 10
Core recommendations 11

Abbreviations 12

1 Overview 14

2 Methods ". 15
2.1 Organisation and implementation of the project 15
2.2 Tasks and methods 16
2.3 Collection and analysis of data 20

3 System analysis and description of the status quo 27

3.1 Description of the regulatory framework of
pharmacovigilance in Europe 27
3.2 Implementation of the European regulatory
framework into practice 58
3.3 Systems of pharmacovigilance in other countries 59
3.4 Other framework conditions 70
3.5 Resources for pharmacovigilance 73
3.6 General quality management 83
II Assessment of the European Community System of Pharmacovigilance
Final Report November 2005

3.7 Phases of pharmacovigilance 85

3.8 Outcomes of regulatory action 113

4 Goals in respect of effectiveness and efficiency 116

5 Critical success factors 117

6 Performance indicators 120

7 Case studies 124

7.1 Statins case 124
7.2 SSRI case 124

8 Best practice 127

8.1 Indicator-based identification of best-practice 127
8.2 Results from the interviews 137

9 Discussion of strengths and weaknesses of the European

system of pharmacovigilance 141
9.1 General factors 141
9.2 Data collection 146
9.3 Data management 148
9.4 Signal detection 149
9.5 Safety issue assessment 150
9.6 Decision-making 151
9.7 Communication and action to protect public health 151

10 Recommendations 154
10.1 General factors 154
10.2 Data collection 157
10.3 Data management 158
10.4 Signal detection 159
10.5 Safety issue assessment 159
 Assessment of the European Community System of Pharmacovigilance III
Final Report November 2005

10.6 Decision-making 160

10.7 Communication and action to protect public health 160
10.8 Core recommendations 161

Annex 1: Literature 162

Annex 2: Questionnaire for Agency survey 166

Annex 3: Results of Delphi survey on critical success factors 176

Annex 4: Results of Delphi survey on performance indicators 184