Assessment of the European community system of pharmacovigilance:
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| Format: | Book |
|---|---|
| Language: | English |
| Published: |
Stuttgart
Fraunhofer-IRB-Verl.
2006
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| Series: | Innovationspotenziale
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| Subjects: | |
| Online Access: | Inhaltstext Inhaltsverzeichnis |
| Item Description: | Literaturverz. S. 162 - 165 |
| Physical Description: | IX, 190 S. graph. Darst. 24 cm |
| ISBN: | 9783816772330 3816772331 |
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Record in the Search Index
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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
11 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
1
IV Assessment of the European Community System of Pharmacovigilance
Final Report November 2005
List of Tables
Table 0.1. Total national staff for PhV per capita 4
Table 0.2. Existence and use of data on the consumption of
medicines 7
Table 2.1. Tasks and work steps 17
Table 2.2. Datasets for the analyses 20
Table 2.3. Site visits for interviews 21
Table 2.4. Correlations of population based reporting rates with
external criteria 23
Table 2.5. Correlations of sales based reporting rates with external
criteria 24
Table 2.6. Criteria for the evaluation of indicators in the Delphi
survey 26
Table 3.1. Number of approvals for NMEs per country in 2003 and
2004 70
Table 3.2. Time acting for the Community as Rapporteur 70
Table 3.3. Time acting for the Community as RMS 71
Table 3.4. Number of physicians 72
Table 3.5. Agency budget 2004 73
Table 3.7. PhV staff in different process stages (multiple responses
possible) 75
Table 3.8. Total national staff for PhV per capita 76
Table 3.9. Tasks of regional PhV centres 77
Table 3.10. Number of ICSRs collected by regional PhV centres 77
Table 3.11. Contracts with other actors in PhV assessments 78
Table 3.12. Competences available in countries 78
Table 3.13. Expert committee meetings per year 79
Table 3.14. Contributions to EEA PhV system 79
Table 3.15. Submission of reports on ADRs [ % of ICSRs] as of July
2005 86
Table 3.16. Suspected ADRs from reporter groups 89
Table 3.17. Reporting rates different indices 89
Assessment of the European Community System of Pharmacovigilance V
Final Report November 2005
Table 3.18. ICSRs by MA procedure 93
Table 3.19. Reporting rates for total populations, number of ICSRs
divided by pharmaceutical sales in the respective country 93
Table 3.20. Reporting rates for total populations, number of ICSRs
divided by number of physicians 94
Table 3.21. PSURs by MA procedure 96
Table 3.22. Existence and use of population based health/disease
registries 97
Table 3.23. Existence and use of data on the consumption of
medicines 98
Table 3.24. Most important literature sources 100
Table 3.25. Information collected 100
Table 3.26. Data quality 101
Table 3.27. Informational needs for signal detection 105
Table 3.28. Routinely inform on safety issues 110
Table 3.29. Communication procedures 110
Table 3.30. Possible actions to prevent ADRs 111
Table 3.31. Regulatory actions 112
Table 3.32. Impact of regulatory action audited 113
Table 3.33. Existence of outcome studies 114
Table 3.34. Outcome studies 115
Table 3.35. Incidence of ADR relevant diseases 115
Table 5.1. Draft list of critical success factors 117
Table 6.1. Most important performance indicators 120
Table 8.1. Indicators for Data Collection 129
Table 8.2. Indicators for Data Management 130
Table 8.3. Indicators for signal detection Availability of data
sources 131
Table 8.4. Indicators for signal detection Analysis tools and
resources 132
Table 8.5. Indicators for safety issue assessment 133
VI Assessment of the European Community System of Pharmacovigilance
Final Report November 2005
Table 8.6. Indicators for decision making 134
Table 8.7. Indicators for communication/action 135
Table 8.8. Indicators for communication/action with HCPs 135
Table 8.9. Indicators for information provided to HCPs 136
Assessment of the European Community System of Pharmacovlgilance VII
Final Report November 2005
List of Figures
Figure 0.1. Cooperation between national agencies and EMEA 5
Figure 0.2. Compliance of MAHs in analysis of signals 6
Figure 0.3. Preparation for last crisis by routine data 7
Figure 0.4. Receive support from experts routinely 9
Figure 0.5. Decisions for safety issues found in adequate time 9
Figure 0.6. Influence of agencies' communications on prescription
behaviour 10
Figure 2.1. Delphi survey form for the evaluation of success factors
(part) 25
Figure 2.2. Delphi survey form for the evaluation of performance
indicators (part) 25
Figure 3.1. Authorisation Procedures 30
Figure 3.2. Regulation (EC) No 726/2004 31
Figure 3.3. Directive 2001/83/EC 33
Figure 3.4. Related guidance documents 34
Figure 3.5. Key points guideline E2A 36
Figure 3.6. Key points guideline E2B(M) 36
Figure 3.7. Key points guideline E2C 37
Figure 3.8. Key points guideline E2C Addendum 38
Figure 3.9. Key points guideline E2D 39
Figure 3.10. Key points guideline E2E 40
Figure 3.11. Key requirements to the pharmacovigilance systems of
MAHs 43
Figure 3.12. Overview of processes in collection of data relevant to
medicines safety 45
Figure 3.13. Expedited reporting obligations by MS Authorities 46
Figure 3.14. Expedited reporting by the EMEA 47
Figure 3.15. Types of notification of safety concerns and exchange of
information 48
Figure 3.16. Expedited reporting by MAHs 49
1
VIII Assessment of the European Community System of Pharmacovigilance
Final Report November 2005
Figure 3.17. The responsibilities of the qualified person 51
Figure 3.18. Organisation of pharmacovigilance regarding centrally
authorised medicinal products 58
Figure 3.19. Organisation of pharmacovigilance regarding non
centrally authorised medicinal products 59
Figure 3.20. Expedited reporting requirements in the USA 61
Figure 3.21. Reports qualifying for inclusion in a US periodic report 62
Figure 3.22. Expedited reporting requirements in Japan 64
Figure 3.23. Expedited reporting requirements in Canada 66
Figure 3.24. Reports qualifying for inclusion in a Canadian summary
report 67
Figure 3.25. Political support for PhV 73
Figure 3.26. Average agency budget in 2004 74
Figure 3.27. Existence of regional centres 76
Figure 3.28. Cooperation between national agencies and EMEA 80
Figure 3.29. Duplication of work 80
Figure 3.30. Assessment of IT resources 81
Figure 3.31. Guidance in national version (part 1) 82
Figure 3.32. Guidance in national version (part 2) 82
Figure 3.33. Meeting of internal targets 84
Figure 3.34. ICSRs received 2003 and 2004 (countries with numbers
of ICSRs *2000) 87
Figure 3.35. ICSRs received 2003 and 2004 (countries with numbers
of ICSRs 2000) 87
Figure 3.36. Total number of ADR reports in the national databases 88
Figure 3.37. Reporting rates for total populations over time, number of
ICSRs divided by population size 90
Figure 3.38. Reporting rates for total populations 2003 and 2004,
number of ICSRs divided by population size 90
Figure 3.39. Reporting rates for children over time, number of ICSRs
2004 divided by number of children 91
Figure 3.40. Reporting rates for children S19 years, number of ICSRs
2004 divided by number of children 92
Assessment of the European Community System of Pharmacovigilance IX
Final Report November 2005
Figure 3.41. Reporting rates for total populations; number of ICSRs
2004 divided by pharmaceutical sales 94
Figure 3.42. Reporting rates for total populations, number of ICSRs
2004 divided by number of physicians 95
Figure 3.43. Time for data processing 102
Figure 3.44. Compliance of MAHs in analysis of signals 103
Figure 3.45. Assessment of statistical tools for signal detection 103
Figure 3.46. Preparation for last crisis by routine data 104
Figure 3.47. Usefulness of routine data 104
Figure 3.48. Receive support from experts routinely 106
Figure 3.49. Adequate decisions found for safety issues 107
Figure 3.50. Decisions for safety issues found in adequate time 108
Figure 3.51. Kinetics of total process from signal detection and
reporting 108
Figure 3.52. Transparency of decision making within the companies 109
Figure 3.53. Consistency of communications 113
Figure 3.54. Influence of agencies' communications on prescription
behaviour 114
Figure 5.1. Systematic of critical success factors 119 |
| adam_txt |
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
11 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
1
IV Assessment of the European Community System of Pharmacovigilance
Final Report November 2005
List of Tables
Table 0.1. Total national staff for PhV per capita 4
Table 0.2. Existence and use of data on the consumption of
medicines 7
Table 2.1. Tasks and work steps 17
Table 2.2. Datasets for the analyses 20
Table 2.3. Site visits for interviews 21
Table 2.4. Correlations of population based reporting rates with
external criteria 23
Table 2.5. Correlations of sales based reporting rates with external
criteria 24
Table 2.6. Criteria for the evaluation of indicators in the Delphi
survey 26
Table 3.1. Number of approvals for NMEs per country in 2003 and
2004 70
Table 3.2. Time acting for the Community as Rapporteur 70
Table 3.3. Time acting for the Community as RMS 71
Table 3.4. Number of physicians 72
Table 3.5. Agency budget 2004 73
Table 3.7. PhV staff in different process stages (multiple responses
possible) 75
Table 3.8. Total national staff for PhV per capita 76
Table 3.9. Tasks of regional PhV centres 77
Table 3.10. Number of ICSRs collected by regional PhV centres 77
Table 3.11. Contracts with other actors in PhV assessments 78
Table 3.12. Competences available in countries 78
Table 3.13. Expert committee meetings per year 79
Table 3.14. Contributions to EEA PhV system 79
Table 3.15. Submission of reports on ADRs [ % of ICSRs] as of July
2005 86
Table 3.16. Suspected ADRs from reporter groups 89
Table 3.17. Reporting rates different indices 89
Assessment of the European Community System of Pharmacovigilance V
Final Report November 2005
Table 3.18. ICSRs by MA procedure 93
Table 3.19. Reporting rates for total populations, number of ICSRs
divided by pharmaceutical sales in the respective country 93
Table 3.20. Reporting rates for total populations, number of ICSRs
divided by number of physicians 94
Table 3.21. PSURs by MA procedure 96
Table 3.22. Existence and use of population based health/disease
registries 97
Table 3.23. Existence and use of data on the consumption of
medicines 98
Table 3.24. Most important literature sources 100
Table 3.25. Information collected 100
Table 3.26. Data quality 101
Table 3.27. Informational needs for signal detection 105
Table 3.28. Routinely inform on safety issues 110
Table 3.29. Communication procedures 110
Table 3.30. Possible actions to prevent ADRs 111
Table 3.31. Regulatory actions 112
Table 3.32. Impact of regulatory action audited 113
Table 3.33. Existence of outcome studies 114
Table 3.34. Outcome studies 115
Table 3.35. Incidence of ADR relevant diseases 115
Table 5.1. Draft list of critical success factors 117
Table 6.1. Most important performance indicators 120
Table 8.1. Indicators for Data Collection 129
Table 8.2. Indicators for Data Management 130
Table 8.3. Indicators for signal detection Availability of data
sources 131
Table 8.4. Indicators for signal detection Analysis tools and
resources 132
Table 8.5. Indicators for safety issue assessment 133
VI Assessment of the European Community System of Pharmacovigilance
Final Report November 2005
Table 8.6. Indicators for decision making 134
Table 8.7. Indicators for communication/action 135
Table 8.8. Indicators for communication/action with HCPs 135
Table 8.9. Indicators for information provided to HCPs 136
Assessment of the European Community System of Pharmacovlgilance VII
Final Report November 2005
List of Figures
Figure 0.1. Cooperation between national agencies and EMEA 5
Figure 0.2. Compliance of MAHs in analysis of signals 6
Figure 0.3. Preparation for last crisis by routine data 7
Figure 0.4. Receive support from experts routinely 9
Figure 0.5. Decisions for safety issues found in adequate time 9
Figure 0.6. Influence of agencies' communications on prescription
behaviour 10
Figure 2.1. Delphi survey form for the evaluation of success factors
(part) 25
Figure 2.2. Delphi survey form for the evaluation of performance
indicators (part) 25
Figure 3.1. Authorisation Procedures 30
Figure 3.2. Regulation (EC) No 726/2004 31
Figure 3.3. Directive 2001/83/EC 33
Figure 3.4. Related guidance documents 34
Figure 3.5. Key points guideline E2A 36
Figure 3.6. Key points guideline E2B(M) 36
Figure 3.7. Key points guideline E2C 37
Figure 3.8. Key points guideline E2C Addendum 38
Figure 3.9. Key points guideline E2D 39
Figure 3.10. Key points guideline E2E 40
Figure 3.11. Key requirements to the pharmacovigilance systems of
MAHs 43
Figure 3.12. Overview of processes in collection of data relevant to
medicines safety 45
Figure 3.13. Expedited reporting obligations by MS Authorities 46
Figure 3.14. Expedited reporting by the EMEA 47
Figure 3.15. Types of notification of safety concerns and exchange of
information 48
Figure 3.16. Expedited reporting by MAHs 49
1
VIII Assessment of the European Community System of Pharmacovigilance
Final Report November 2005
Figure 3.17. The responsibilities of the qualified person 51
Figure 3.18. Organisation of pharmacovigilance regarding centrally
authorised medicinal products 58
Figure 3.19. Organisation of pharmacovigilance regarding non
centrally authorised medicinal products 59
Figure 3.20. Expedited reporting requirements in the USA 61
Figure 3.21. Reports qualifying for inclusion in a US periodic report 62
Figure 3.22. Expedited reporting requirements in Japan 64
Figure 3.23. Expedited reporting requirements in Canada 66
Figure 3.24. Reports qualifying for inclusion in a Canadian summary
report 67
Figure 3.25. Political support for PhV 73
Figure 3.26. Average agency budget in 2004 74
Figure 3.27. Existence of regional centres 76
Figure 3.28. Cooperation between national agencies and EMEA 80
Figure 3.29. Duplication of work 80
Figure 3.30. Assessment of IT resources 81
Figure 3.31. Guidance in national version (part 1) 82
Figure 3.32. Guidance in national version (part 2) 82
Figure 3.33. Meeting of internal targets 84
Figure 3.34. ICSRs received 2003 and 2004 (countries with numbers
of ICSRs *2000) 87
Figure 3.35. ICSRs received 2003 and 2004 (countries with numbers
of ICSRs 2000) 87
Figure 3.36. Total number of ADR reports in the national databases 88
Figure 3.37. Reporting rates for total populations over time, number of
ICSRs divided by population size 90
Figure 3.38. Reporting rates for total populations 2003 and 2004,
number of ICSRs divided by population size 90
Figure 3.39. Reporting rates for children over time, number of ICSRs
2004 divided by number of children 91
Figure 3.40. Reporting rates for children S19 years, number of ICSRs
2004 divided by number of children 92
Assessment of the European Community System of Pharmacovigilance IX
Final Report November 2005
Figure 3.41. Reporting rates for total populations; number of ICSRs
2004 divided by pharmaceutical sales 94
Figure 3.42. Reporting rates for total populations, number of ICSRs
2004 divided by number of physicians 95
Figure 3.43. Time for data processing 102
Figure 3.44. Compliance of MAHs in analysis of signals 103
Figure 3.45. Assessment of statistical tools for signal detection 103
Figure 3.46. Preparation for last crisis by routine data 104
Figure 3.47. Usefulness of routine data 104
Figure 3.48. Receive support from experts routinely 106
Figure 3.49. Adequate decisions found for safety issues 107
Figure 3.50. Decisions for safety issues found in adequate time 108
Figure 3.51. Kinetics of total process from signal detection and
reporting 108
Figure 3.52. Transparency of decision making within the companies 109
Figure 3.53. Consistency of communications 113
Figure 3.54. Influence of agencies' communications on prescription
behaviour 114
Figure 5.1. Systematic of critical success factors 119 |
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| bvnumber | BV022429524 |
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| dewey-full | 363.1946094 |
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| discipline_str_mv | Soziologie |
| format | Book |
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| id | DE-604.BV022429524 |
| illustrated | Illustrated |
| index_date | 2024-07-02T17:28:43Z |
| indexdate | 2025-01-02T11:17:21Z |
| institution | BVB |
| isbn | 9783816772330 3816772331 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-015637735 |
| oclc_num | 160082659 |
| open_access_boolean | |
| owner | DE-12 |
| owner_facet | DE-12 |
| physical | IX, 190 S. graph. Darst. 24 cm |
| publishDate | 2006 |
| publishDateSearch | 2006 |
| publishDateSort | 2006 |
| publisher | Fraunhofer-IRB-Verl. |
| record_format | marc |
| series2 | Innovationspotenziale |
| spelling | Assessment of the European community system of pharmacovigilance Bernhard Bührlen ... Stuttgart Fraunhofer-IRB-Verl. 2006 IX, 190 S. graph. Darst. 24 cm txt rdacontent n rdamedia nc rdacarrier Innovationspotenziale Literaturverz. S. 162 - 165 Europäische Union (DE-588)5098525-5 gnd rswk-swf Arzneimittelüberwachung (DE-588)4437717-4 gnd rswk-swf Europäische Union (DE-588)5098525-5 b Arzneimittelüberwachung (DE-588)4437717-4 s DE-604 Bührlen, Bernhard Sonstige (DE-588)122398815 oth text/html http://deposit.dnb.de/cgi-bin/dokserv?id=2897765&prov=M&dok_var=1&dok_ext=htm Inhaltstext HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=015637735&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Assessment of the European community system of pharmacovigilance Europäische Union (DE-588)5098525-5 gnd Arzneimittelüberwachung (DE-588)4437717-4 gnd |
| subject_GND | (DE-588)5098525-5 (DE-588)4437717-4 |
| title | Assessment of the European community system of pharmacovigilance |
| title_auth | Assessment of the European community system of pharmacovigilance |
| title_exact_search | Assessment of the European community system of pharmacovigilance |
| title_exact_search_txtP | Assessment of the European community system of pharmacovigilance |
| title_full | Assessment of the European community system of pharmacovigilance Bernhard Bührlen ... |
| title_fullStr | Assessment of the European community system of pharmacovigilance Bernhard Bührlen ... |
| title_full_unstemmed | Assessment of the European community system of pharmacovigilance Bernhard Bührlen ... |
| title_short | Assessment of the European community system of pharmacovigilance |
| title_sort | assessment of the european community system of pharmacovigilance |
| topic | Europäische Union (DE-588)5098525-5 gnd Arzneimittelüberwachung (DE-588)4437717-4 gnd |
| topic_facet | Europäische Union Arzneimittelüberwachung |
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