Web-based intensive monitoring: From passive to active drug surveillance

Expert Opinion on Drug Safety

Volumn 11, Issue 1, 2012, Pages 45-51

  Hrmark, Linda ^a,b   Van Grootheest, Kees ^a,b  

^a Netherlands Pharmacovigilance Centre Lareb   (Netherlands)

^b UNIVERSITY OF GRONINGEN   (Netherlands)

Author keywords

Intensive monitoring; Patient reporting; Pharmacovigilance; Web

Indexed keywords

2009 H1N1 INFLUENZA; COHORT ANALYSIS; DRUG INFORMATION; DRUG SURVEILLANCE PROGRAM; HEALTH CARE PERSONNEL; HEALTH CARE SYSTEM; HUMAN; INTERVENTION STUDY; METHODOLOGY; OBSERVATIONAL STUDY; OFF LABEL DRUG USE; PATIENT COMPLIANCE; POSTMARKETING SURVEILLANCE; QUESTIONNAIRE; REVIEW; WEB BROWSER;

ADVERSE DRUG REACTION REPORTING SYSTEMS; DRUG MONITORING; EUROPEAN UNION; HUMANS; INTERNET; LEGISLATION, DRUG; PHARMACEUTICAL PREPARATIONS; PHARMACOVIGILANCE; QUESTIONNAIRES;

EID: 84555190232     PISSN: 14740338     EISSN: 1744764X     Source Type: Journal    
DOI: 10.1517/14740338.2012.629184     Document Type: Review

References (31)

1. Merck Announces Voluntary Worldwide Withdrawal of VIOXX. Merck & Co. 2004. Available from: http://www.merck.com/newsroom/vioxx/pdf/vioxx-press- release-final.pdf Last accessed 24 June 2011
2. Bresalier RS, Sandler RS, Quan H, et al. Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial. N Engl J Med 2005;352:1092-102 (Pubitemid 40365350)
3. Krumholz HM, Ross JS, Presler AH, Egilman DS. What have we learnt from Vioxx? BMJ 2007;334:120-3 (Pubitemid 46173951)
4. Strom BL. How the US drug safety system should be changed. JAMA 2006;295:2072-5 (Pubitemid 44794008)
5. Mitka M. Report criticizes lack of FDA oversight. JAMA 2006;296:920-2 (Pubitemid 44285357)
6. The importance of Pharmacovigilance. WHO 2002. Available from: http://whqlibdoc.who.int/hq/2002/a75646.pdf Last accessed 24 June 2011
7. Committe on the Assessment of the US Drug Safety System. In: Baciu A, Stratton K, Burke SP. editors. The future of drug safety: promoting and protecting the health of the public. Institute of Medicine; Washington DC: 2006
8. Assessment of the European Community System of Pharmacovigilance. Fraunhofer 2006. Available from: http://www.cbg-meb.nl/NR/rdonlyres/497C7834- 7B4F-4D03-BE31-226F96234696/0/20060317rappfraunhofer.pdf Last accessed 24 June 2011
9. Strategy to better protect public health by strengthening and rationalising EU pharmacovigilance. European Commission Enterprise and Industry Directorate-general; 2007
10. Regulation 1235/2010. Official Journal of the European Union 10 A.D.,L. 348-1-16. Available from: http://eur-lex. europa.eu.proxy-ub.rug.nl/LexUriServ/ LexUriServ.do?uri=OJ:L:2010:348:0001: 0016:EN:PDF Last accessed 24 June 2011
11. Directive 2010/84/EU. Official Journal of the European Union 2010,L. 348-74-99. Available from: http://eur-lex.europa.eu. proxy-ub.rug.nl/LexUriServ/ LexUriServ. do?uri=OJ:L:2010:348:0074:0099:EN: PDF Last accessed 24 June 2011
12. Waller P. Getting to grips with the new European Union pharmacovigilance legislation. Pharmacoepidemiol Drug Saf 2011;20:544-9
13. Raine JM. Risk management-a European regulatory view. In: Mann R, Andrews E, editors. Pharmacovigilance. 2nd edition. John Wiley & Sons, Ltd; Chichester, UK: 2007. p. 553-8
14. Borg JJ, Aislaitner G, Pirozynski M, Mifsud S. Strengthening and rationalizing pharmacovigilance in the EU: where is Europe heading to? A review of the new EU legislation on pharmacovigilance. Drug Saf 2011;34:187-97
15. Garattini S, Bertele V. Anything new in EU pharmacovigilance? Eur J Clin Pharmacol 2011;Published online 4 May 2011
16. Waller PC, Evans SJ. A model for the future conduct of pharmacovigilance. Pharmacoepidemiol Drug Saf 2003;12:17-29 (Pubitemid 36192946)
17. Härmark L, Van Puijenbroek E, Straus S, Van Grootheest K. Intensive monitoring of pregabalin results from an observational, web-based, prospective cohort study using patients as a source of information. Drug Saf 2011;34:221-31
18. Mackay FJ. Post-marketing studies: the work of the Drug Safety Research Unit. Drug Saf 1998;19:343-53
19. Harrison-Woolrych M, Coulter DM. PEM in New Zealand. In: Mann R, Andrews E, editors. Pharmacovigilance. 2nd edition. John Wiley & Sons Ltd; Chichester, UK: 2007. p. 317-32
20. Shakir SAW. PEM in the UK. In:. Mann RAndrews E, editors. Pharmacovigilance. 2nd edition. John Wiley & Sons Ltd; Chichester, UK: 2007. p. 307-16
21. de Langen J, van Hunsel F, Passier A, et al. Adverse drug reaction reporting by patients in the Netherlands: three years of experience. Drug Saf 2008;31:515-24 (Pubitemid 351693684)
22. Aagaard L, Nielsen LH, Hansen EH. Consumer reporting of adverse drug reactions: a retrospective analysis of the Danish adverse drug reaction database from 2004 to 2006. Drug Saf 2009;32:1067-74
23. McLernon DJ, Bond CM, Hannaford PC, et al. Adverse drug reaction reporting in the UK: a retrospective observational comparison of yellow card reports submitted by patients and healthcare professionals. Drug Saf 2010;33:775-88
24. van Hunsel F, Talsma A, van Puijenbroek E, et al. The proportion of patient reports of suspected ADRs to signal detection in the Netherlands: case-control study. Pharmacoepidemiol Drug Saf 2011;20:286-91
25. Härmark L, Puijenbroek E, Grootheest K. Longitudinal monitoring of the safety of drugs by using a web-based system: the case of pregabalin. Pharmacoepidemiol Drug Saf 2011;20:591-7
26. Human Medicines-EMEA Pre-Submission Guidance 2007. Available from: www.emea.eu
27. Guideline on Risk management Systems for Medicinal Products for Human Use 2005. Available from: www.ema.europa.eu
28. Segal ES, Valette C, Oster L, et al. Risk management strategies in the postmarketing period: safety experience with the US and European bosentan surveillance programmes. Drug Saf 2005;28:971-80 (Pubitemid 41483704)
29. Layton D, Rutherford D, MacDonald TM, et al. Pilot swine flu vaccination active surveillance study: design and rationale abstract. Drug Saf 2011;33:898
30. Layton D, Rutherford D, MacDonald TM, et al. Pilot Swine Flu Vaccination Active Surveillance Study: Interim results abstract. Drug Saf 2011;30:898-9
31. Härmark L, van Hunsel F, Hak E, van Grootheest K. Monitoring the safety of influenza A (H1N1) vaccine using web-based intensive monitoring. Vaccine 2011;29:1941-7