Vaccinovigilance in Europe: need for timeliness, standardization and resources
OBJECTIVE: To identify gaps in the systems for reporting adverse events following immunization (AEFI) in Europe by means of an interactive database constructed using a standardized approach. METHODS: A comparative survey was conducted in 1999-2000, using structured questionnaires addressed to the go...
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| Format: | Article |
| Language: | English |
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The World Health Organization
2004-11-01
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| Series: | Bulletin of the World Health Organization |
| Subjects: | |
| Online Access: | http://www.scielosp.org/scielo.php?script=sci_arttext&pid=S0042-96862004001100007&lng=en&tlng=en |
| _version_ | 1797285258776805376 |
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| author | Kari S. Lankinen Satu Pastila Terhi Kilpi Hanna Nohynek P. Helena Mäkelä Patrick Olin |
| author_facet | Kari S. Lankinen Satu Pastila Terhi Kilpi Hanna Nohynek P. Helena Mäkelä Patrick Olin |
| author_sort | Kari S. Lankinen |
| collection | DOAJ |
| description | OBJECTIVE: To identify gaps in the systems for reporting adverse events following immunization (AEFI) in Europe by means of an interactive database constructed using a standardized approach. METHODS: A comparative survey was conducted in 1999-2000, using structured questionnaires addressed to the government authorities responsible for national immunization programmes and drug safety surveillance in all European Union (EU) Member States and in Norway and Switzerland. FINDINGS: The reporting of adverse vaccine reactions (AVRs) is covered by regulations in 13 of the 17 countries. Four countries have a specialized expert group with responsibility for vaccine safety. Only six professionals work full-time on vaccine safety in the 17 countries; in four of these countries the person is medically qualified. Fourteen countries have centralized reporting systems; in 14 countries the responsible authority is the drug regulatory agency. AEFI are reported using the procedure used for adverse drug reactions (ADRs) in all except four countries. The reporting form is not usually designed for vaccines and important details may therefore not be requested. Clinical definitions for vaccine reactions are not available. Twelve countries have appropriate official definitions for events or reactions, but the list of reportable events varies considerably between countries. The assessment of adverse vaccine reactions (AVRs) is hampered by lack of exact denominator data. Feedback to the rapporteurs was provided in 13 countries, but its quality was highly variable. CONCLUSION: The database facilitated a simple comparison of vaccinovigilance systems across participating countries. Most of the problems identified related to the reporting and analysis of AEFI could be solved through standardization and intensified international collaboration. On a national level, functional vaccinovigilance systems should be the shared responsibility of the drug regulatory authority and the national immunization programme. The resources for development and management of vaccine safety systems should be urgently improved. |
| first_indexed | 2024-03-07T18:00:33Z |
| format | Article |
| id | doaj.art-4bf7f932c53f4ee1a3fe2baf9aebad80 |
| institution | Directory Open Access Journal |
| issn | 0042-9686 |
| language | English |
| last_indexed | 2024-03-07T18:00:33Z |
| publishDate | 2004-11-01 |
| publisher | The World Health Organization |
| record_format | Article |
| series | Bulletin of the World Health Organization |
| spelling | doaj.art-4bf7f932c53f4ee1a3fe2baf9aebad802024-03-02T10:58:24ZengThe World Health OrganizationBulletin of the World Health Organization0042-96862004-11-018211828835S0042-96862004001100007Vaccinovigilance in Europe: need for timeliness, standardization and resourcesKari S. Lankinen0Satu Pastila1Terhi Kilpi2Hanna Nohynek3P. Helena Mäkelä4Patrick Olin5PSR Consulting LtdPSR Consulting LtdNational Public Health InstituteNational Public Health InstituteNational Public Health InstituteSwedish Institute for Infectious Disease ControlOBJECTIVE: To identify gaps in the systems for reporting adverse events following immunization (AEFI) in Europe by means of an interactive database constructed using a standardized approach. METHODS: A comparative survey was conducted in 1999-2000, using structured questionnaires addressed to the government authorities responsible for national immunization programmes and drug safety surveillance in all European Union (EU) Member States and in Norway and Switzerland. FINDINGS: The reporting of adverse vaccine reactions (AVRs) is covered by regulations in 13 of the 17 countries. Four countries have a specialized expert group with responsibility for vaccine safety. Only six professionals work full-time on vaccine safety in the 17 countries; in four of these countries the person is medically qualified. Fourteen countries have centralized reporting systems; in 14 countries the responsible authority is the drug regulatory agency. AEFI are reported using the procedure used for adverse drug reactions (ADRs) in all except four countries. The reporting form is not usually designed for vaccines and important details may therefore not be requested. Clinical definitions for vaccine reactions are not available. Twelve countries have appropriate official definitions for events or reactions, but the list of reportable events varies considerably between countries. The assessment of adverse vaccine reactions (AVRs) is hampered by lack of exact denominator data. Feedback to the rapporteurs was provided in 13 countries, but its quality was highly variable. CONCLUSION: The database facilitated a simple comparison of vaccinovigilance systems across participating countries. Most of the problems identified related to the reporting and analysis of AEFI could be solved through standardization and intensified international collaboration. On a national level, functional vaccinovigilance systems should be the shared responsibility of the drug regulatory authority and the national immunization programme. The resources for development and management of vaccine safety systems should be urgently improved.http://www.scielosp.org/scielo.php?script=sci_arttext&pid=S0042-96862004001100007&lng=en&tlng=enVacunasSistemas de registro de reacción adversa a medicamentosVigilancia de productos comercializadosLegislación de medicamentosBases de datos factualesEstudio comparativoCooperación internacionalUnión EuropeaNoruegaSuiza |
| spellingShingle | Kari S. Lankinen Satu Pastila Terhi Kilpi Hanna Nohynek P. Helena Mäkelä Patrick Olin Vaccinovigilance in Europe: need for timeliness, standardization and resources Bulletin of the World Health Organization Vacunas Sistemas de registro de reacción adversa a medicamentos Vigilancia de productos comercializados Legislación de medicamentos Bases de datos factuales Estudio comparativo Cooperación internacional Unión Europea Noruega Suiza |
| title | Vaccinovigilance in Europe: need for timeliness, standardization and resources |
| title_full | Vaccinovigilance in Europe: need for timeliness, standardization and resources |
| title_fullStr | Vaccinovigilance in Europe: need for timeliness, standardization and resources |
| title_full_unstemmed | Vaccinovigilance in Europe: need for timeliness, standardization and resources |
| title_short | Vaccinovigilance in Europe: need for timeliness, standardization and resources |
| title_sort | vaccinovigilance in europe need for timeliness standardization and resources |
| topic | Vacunas Sistemas de registro de reacción adversa a medicamentos Vigilancia de productos comercializados Legislación de medicamentos Bases de datos factuales Estudio comparativo Cooperación internacional Unión Europea Noruega Suiza |
| url | http://www.scielosp.org/scielo.php?script=sci_arttext&pid=S0042-96862004001100007&lng=en&tlng=en |
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