Adverse drug reactions: Analysis of spontaneous reporting system in Europe in 2007-2009

European Journal of Clinical Pharmacology

Volumn 68, Issue 7, 2012, Pages 1057-1063

  Srba, Jindrich ^a,b   Descikova, Veronika ^a   Vlcek, Jiri ^a  

^a Charles University in Prague Faculty of Pharmacy   (Czech Republic)

^b U Vodojemu 1685 ^*  (Czech Republic)

Author keywords

Adverse drug reaction; EudraVigilance; Regulatory authority; Reporting ratio; Spontaneous reporting system

Indexed keywords

ARTICLE; COMPARATIVE EFFECTIVENESS; CORRELATION COEFFICIENT; DRUG CONTROL; DRUG COST; DRUG SURVEILLANCE PROGRAM; EUROPE; FACTUAL DATABASE; GEOGRAPHIC DISTRIBUTION; HEALTH CARE COST; INFORMATION PROCESSING; OBSERVATIONAL STUDY; POPULATION RESEARCH; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; RELIABILITY; RETROSPECTIVE STUDY; RISK ASSESSMENT; TREATMENT OUTCOME; TREND STUDY; VALIDATION PROCESS;

ADVERSE DRUG REACTION REPORTING SYSTEMS; DATA COLLECTION; DATABASES, FACTUAL; EUROPE; PATIENT PARTICIPATION; PHARMACOVIGILANCE;

EID: 84864279797     PISSN: 00316970     EISSN: 14321041     Source Type: Journal    
DOI: 10.1007/s00228-012-1219-4     Document Type: Article

References (42)

1. Mann RD, Andrews EB (2007) Introduction. In: Mann RD, Andrews EB (eds) Pharmacovigilance, 2nd edn. John Wiley & Sons, Chichester, pp 1-12
2. Bührlen B, Reiß T, Beckmann C, et al. on behalf of Fraunhofer Institute for Systems and Innovation Research (2006) Assessment of the European Community System of Pharmacovigilance. Stuttgart: Fraunhofer IRB, 2006 sample. Available at: http://www.cbg-meb.nl/NR/rdonlyres/497C7834-7B4F-4D03-BE31- 226F96234696/0/20060317rappfraunhofer.pdf. Accessed 2 Dec 2010
3. Nelson RC, Palsulich B, Gogolak V (2002) Good pharmacovigilance practices: technology enabled. Drug Saf 25(6):407-14 (Pubitemid 34729139)
4. van Puijenbroek EP, van Grootheest K, Diemont WL, et al (2001) Determinants of signal selection in a spontaneous reporting system for adverse drug reactions. Br J Clin Pharmacol 52(5):579-86
5. EudraVigilance Expert Working Group (2010) Note for guidance - EudraVigilance Human - Processing of safety messages and individual case safety reports (ICSRs) EMA/H/20665/04/Final Rev. 2, 15 October, 2010. European Medicines Agency, London
6. Lindquist M (2007) Use of triage strategies in the WHO signaldetection process. Drug Saf 30(7):635-7 (Pubitemid 47037328)
7. Hazell L, Shakir SA (2006) Under-reporting of adverse drug reactions: a systematic review. Drug Saf 29(5):385-96
8. Lopez-Gonzalez E, Herdeiro MT, Figueiras A (2009) Determinants of under reporting of adverse drug reactions: a systematic review. Drug Saf 32(1):19-31
9. Edwards IR (1999) Spontaneous reporting - of what? Clinical concerns about drugs. Br J Clin Pharmacol 48(2):138-41 (Pubitemid 29349447)
10. Härmark L, van Grootheest AC (2008) Pharmacovigilance: methods, recent developments and future perspectives. Eur J Clin Pharmacol 64(8):743-52
11. Clarke A, Deeks JJ, Shakir SA (2006) An assessment of the publicly disseminated evidence of safety used in decisions to withdraw medicinal products from the UK and US markets. Drug Saf 29(2):175-81 (Pubitemid 43213891)
12. Eland IA, Belton KJ, van Grootheest AC et al (1999) Attitudinal survey of voluntary reporting of adverse drug reactions. Br J Clin Pharmacol 48(4):623-7 (Pubitemid 29454245)
13. Eurostat. Available at: http://epp.eurostat.ec.europa.eu/. Accessed 20 Dec 2010.
14. OECD Health Data (2011) Available from URL: http://www.oecd.org/document/ 16/0,3746,en-2649-34631-2085200-1-1-1-1,00.html (Accessed 2011 Jul 15).
15. Meyboom RH, Egberts AC, Gribnau FW et al (1999) Pharmacovigilance in perspective. Drug Saf 21(6):429-47 (Pubitemid 30021100)
16. European Medicine Agency (2009). Annual report 2009. Adopted by the Management Board in March 2010. Office of the Executive Director, EMA/MB/69923/2010, 18 May 2010. Available at: http://www.ema.europa.eu/docs/en- GB/document-library/Annual-report/2010/05/WC500090712.pdf. Accessed 20 Nov 2010
17. Danish Medicines Agency (2010) The Danish Medicines Agency's annual pharmacovigilance report 2009. Denmark. Available at: http:// laegemiddelstyrelsen.dk/~/media/3BA70671B3974D3B96C3B48AF503CC2E.ashx. Accessed 26 Dec 2010
18. Medical Products Agency (2010) Health care reported adverse events in 2009 (in Swedish). Sweden. Available at: http://www.lakemedelsverket.se/Alla- nyheter/NYHETER-2010/Rapporteradebiverkningar-2009/. Accessed 26 Dec 26 2010
19. Irish Medicine Board (2008) Annual Report 2008, protecting public and animal health. Available at: http://www.imb.ie/images/uploaded/documents/ Annual%20Report%202008.pdf. Accessed 26 Dec 2010
20. Icelandic Medicine Agency (2009). Annual report 2009 (in Icelandic). Available at: http://www.lyfjastofnun.is/media/arsskyrslur/Arsskyrsla-2009- 2009a.pdf. Accessed 26 Dec 2010
21. Norwegian Medicine Agency (2009) Annual report 2009 (in Danish). Denmark. Available at: http://www.legemiddelverket.no/upload/Arsrapport%202009.pdf. Accessed 26 Dec 2010
22. Medicines Evaluation Board (2010). Annual report 2009 (in Dutch). The Netherlands. Available at: http://www.cbg-meb.nl/NR/rdonlyres/EF948F73-374A- 41DA-9406-52F135A64F31/0/jaarverslag2009.pdf. Accessed 27 Dec 2010
23. Medicines Authority (2009). Annual report 2009. Malta. Available at: http://www.medicinesauthority.gov.mt/reports.htm. Accessed 27 Dec 2010
24. The Medicines and Healthcare products Regulatory Agency (2010). MHRA annual statistics 2009/10. United Kingdom. Available at: http://www.mhra.gov.uk/ Publications/Corporate/AnnualReports/CON087861. Accessed 27 Dec 2010
25. Agence française de sécurité sanitaire des produits de santé (Afssaps). Annual report 2009 (in French). France. Available at: http://www.afssaps.fr/var/afssaps-site/storage/original/application/ a40deaca3add3f9e767493ab831897e0.pdf. Accessed 27 Dec 2010
26. The Austrian Agency for Health and Food Safety (2010). Annual report 2009. Austria. Available at: http://www.ages.at/uploads/media/JBR-Vetmed-ENGL- WEB-FINAL.pdf. Accessed 28 Dec 2010
27. Federal Agency for Medicines and Health Products (2010). Annual report 2009. Belgium. Available at: http://www.fagg-afmps.be/en/binaries/ Annual%20Report%202009-tcm292-103495.pdf. Accessed 28 Dec 28 2010
28. Agencia Española de Medicamentos y Productos Sanitarios (2010). Report on activities in 2009. Spain. Available at: http://www.aemps.es/ actividad/nosotros/docs/memoria2009.pdf. Accessed 28 Dec 2010
29. World health statistics (2010) Available at: http://www.who.int/whosis/ whostat/EN-WHS10-Full.pdf. Accessed 3 Dec 2010
30. Alemayehu D (2009) Evaluation of Reporting Bias in Postmarketing Risk Assessment Based on Spontaneous Reporting Systems. Pharmaceut Med 4(23):195-200
31. Lindquist M (2004) Data quality management in pharmacovigilance. Drug Saf 27(12):857-70 (Pubitemid 39331684)
32. Lindquist M, Stahl M, Bate A, Edwards IR, Meyboom RH (2000) A retrospective evaluation of a data mining approach to aid finding new adverse drug reaction signals in the WHO international database Drug Saf 23(6):533-42
33. Butt TF, Cox AR, Lewis H et al (2011) Patient experiences of serious adverse drug reactions and their attitudes to medicines: a qualitative study of survivors of Stevens-Johnson syndrome and toxic epidermal necrolysis in the UK. Drug Saf 34(4):319-28
34. McLernon DJ, Bond CM, Hannaford PC et al (2010) Yellow Card Collaboration. Adverse drug reaction reporting in the UK: a retrospective observational comparison of yellow card reports submitted by patients and healthcare professionals. Drug Saf 33(9):775-88
35. Blenkinsopp A, Wilkie P, Wang M et al (2007) Patient reporting of suspected adverse drug reactions: a review of published literature and international experience. Br J Clin Pharmacol 63(2):148-56 (Pubitemid 46072099)
36. Anton C, Cox AR, Ferner RE (2009) Improving follow-up rates in spontaneous adverse drug reaction reporting: effectiveness of a targeted letter used by a regional centre in the UK. Drug Saf 32 (12):1135-40
37. Gony M, Badie K, Sommet A et al (2010) Improving adverse drug reaction reporting in hospitals: results of the French Pharmacovigilance in Midi-Pyrénées region (PharmacoMIP) network 2-year pilot study. Drug Saf 33(5):409-16
38. Priya B, Panos T, Waller PC (2007) Regulatory pharmacovigilance in the EU. In: Mann RD, Andrews EB (eds) Pharmacovigilance, 2nd edn. John Wiley & Sons, Chichester, pp 185-98
39. Centro regionale di farmakovigilanza (2010). Farmacosorveglianza: la segnalazione delle reazioni avverse da farmaci in Emilia - Romagna nel 2009 (in Italian). Italy. Available at: http://www.saluter.it/documentazione/rapporti/ farmacosorveglianza-lasegnalazione-delle-reazioni-avverse-da-farmaci-in- emiliaromagna-nel-2009. Accessed 5 Jan 2011
40. European Union (2004) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code relating to medicinal products for human use as amended. In: Official Journal of the European Communities. Office for Official Publications of the European Communities, Luxembourg, L 311, 28/11/2004, pp 67-128.
41. European Union (2004) Regulation (EEC) No. 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. In: Official Journal of the European Communities. Office for Official Publications of the European Communities, Luxembourg, L 136, 30/04/2004, pp 1-33
42. European Union (2008) Volume 9A of The Rules Governing Medicinal Products in the European Union. Guidelines on pharmacovigilance for medicinal products for human use. September 2008. EU Commission, Brussels