Adverse drug reaction reporting by patients: An overview of fifty countries

Drug Safety

Volumn 37, Issue 6, 2014, Pages 409-419

  Margraff, Florence ^a   Bertram, Delphine ^a  

^a HOSPICES CIVILS DE LYON   (France)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; DEVELOPING COUNTRY; DRUG LEGISLATION; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; HEALTH CARE PERSONNEL; HUMAN; MEDICAL HISTORY; PATIENT EDUCATION; PATIENT PARTICIPATION; PRIORITY JOURNAL; QUESTIONNAIRE; WORLD HEALTH ORGANIZATION; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; STATISTICS AND NUMERICAL DATA;

ADVERSE DRUG REACTION REPORTING SYSTEMS; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; HEALTH PERSONNEL; HUMANS;

EID: 84901921309     PISSN: 01145916     EISSN: 11791942     Source Type: Journal    
DOI: 10.1007/s40264-014-0162-y     Document Type: Article

References (31)

1. REGULATION (EU) No 1235/2010 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products; 2010. http://ec.europa.eu/health/files/eudralex/vol-1/reg-2010-1235/reg-2010-1235-en. pdf. Accessed 21 Oct 2013.
2. DIRECTIVE 2010/84/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use; 2010. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0074:0099: EN:PDF. Accessed 21 Oct 2013.
3. 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 - article 107a. Official Journal L. 2004;311:67-128.
4. World Health Organization website. http://apps.who.int/medicinedocs/fr/d/ Jh1465e/4.html. Accessed 20 Sept 2013.
5. Egberts TC, Smulders M, de Koning FH, Meyboom RH, Leufkens HG. Can adverse drug reactions be detected earlier? A comparison of reports by patients and professionals. BMJ. 1996;313(7056):530-1. (Pubitemid 26336138)
6. De Langen J, Van Hunsel F, Passier A, De Jong-Van den Berg L, Van Grootheest K. Adverse drug reaction reporting by patients in the Netherlands: three years of experience. Drug Saf. 2008;31(6):515-24. (Pubitemid 351693684)
7. Blenkinsopp A, Wilkie P, Wang M, Routledge PA. Patient reporting of suspected adverse drug reactions: a review of published literature and international experience. Br J Clin Pharmacol. 2007;63(2):148-56. (Pubitemid 46072099)
8. Herxheimer A, Crombag R, Alves TL. Direct patient reporting of adverse drug reactions: a fifteen-country survey and literature review. Health Action International Europe; 2010. http://www.haiweb.org/10052010/10-May-2010-Report- Direct-Patient-Reporting-of-ADRs.pdf. Accessed 20 Jun 2013.
9. Cumber SL, Heffer SJ, Gandhi S, Avery AJ. The Yellow Card Scheme: experience of patient reporting of adverse drug reactions 5 years since launch. Pharmacoepidemiol Drug Saf. 2010;19:S321.
10. Van Hunsel F, Härmark L, Pal S, Olsson S, Van Grotheest K. Experiences with adverse drug reaction reporting by patients: an 11-country survey. Drug Saf. 2012;35(1):45-60.
11. Basch E. The missing voice of patients in drug-safety reporting. N Engl J Med. 2010;362(10):865-9.
12. Van Hunsel F, Talsma A, Van Puijenbroek E, De Jong-Van den Berg L, Van Grootheest K. The proportion of patient reports of suspected ADRs to signal detection in the Netherlands: case-control study. Pharmacoepidemiol Drug Saf. 2011;20(3):286-91.
13. Hazell L, Cornelius V, Shakir S, Avery AJ. Patient reporting of adverse drug reactions in the UK: potential signals generated by patients compared to healthcare professionals [poster abstract no. 227]. Pharmacoepidemiol Drug Saf. 2010;19(Suppl. 1):S97-8.
14. Hazell L, Cornelius V, Hannaford P, Shakir S, Avery AJ. How do patients contribute to signal detection? Drug Saf. 2013;36(3):199-206.
15. White RW, Tatonetti NP, Shah NH, Altman RB, Horvitz E. Web-scale pharmacovigilance: listening to signals from the crowd. J Am Med Inform Assoc. 2013;20(3):404-8.
16. Banerjee AK, Okun S, Edwards IR, Wicks P, Smith M, Mayall S, Flamion B, Cleland C, Basch E. Patient-reported outcome measures in safety event reporting - PROSPER consortium guidance. Drug Saf. 2013;36:1129-49.
17. Van Hunsel F, Van der Welle C, Passier A, Van Puijenbroek E, Van Grootheest K. Motives for reporting adverse drug reactions by patient-reporters in the Netherlands. Eur J Clin Pharmacol. 2010;66(11):1143-50.
18. Van Hunsel F, Ten Berge EA, Borgsteede SD, Van Grootheest K. What motivates patients to report an adverse drug reaction? Ann Pharmacother. 2010;44(5):936-7.
19. Anderson C, Krska J, Murphy E, Avery A. The importance of direct patient reporting of suspected adverse drug reactions: a patient perspective. Br J Clin Pharmacol. 2011;72(5):806-22.
20. http://www.who-umc.org/DynPage.aspx?id=98080&mn1=7347&mn2= 7252&mn3=7322&mn4=7324. Accessed 20 Mar 2014.
21. Hoffmann E, Fouretier A, Vergne C, Bertram D. Pharmacovigilance regulatory requirements in Latin America. Pharm Med. 2012;26:1-12.
22. Isah AO, Pal SN, Olsson S, Dodoo A, Bencheikh RS. Specific features of medicines safety and pharmacovigilance in Africa. Ther Adv Drug Saf. 2012;3(1):25-34.
23. http://apps.who.int/medicinedocs/pdf/s4893e/s4893e.pdf. Accessed 20 Mar 2014.
24. The Erice declaration: the critical role of communication in drug safety. Hugman B Drug Saf. 2006;29(1):91-3.
25. Avery AJ, Anderson C, Bond CM, et al. Evaluation of patient reporting of adverse drug reactions to theUK'Yellow Card Scheme': literature review, descriptive and qualitative analyses, and questionnaire surveys. Health Technol Assess. 2011;15(20):1-234, iii-iv.
26. Robertson J, Newby DA. Low awareness of adverse drug reaction reporting systems: a consumer survey. Med J Aust. 2013;199(10):684-6.
27. Irish Medicines Board. Tract "Medicines and side effects". http://www.imb.ie/images/uploaded/documents/SideEffects.pdf. Accessed 3 Nov 2013.
28. 9th Call for Proposals 2013 - Innovative Medicines Initiative - IMI/DORA-2013-03180. http://www.imi.europa.eu. Accessed 29 Oct 2013.
29. Singh A, Bhatt P. Comparative evaluation of adverse drug reaction reporting forms for introduction of a spontaneous generic ADR form. J Pharmacol Pharmacother. 2012;3(3):228-32.
30. Olsson S, Pal SN, Stergachis A, Couper M. Pharmacovigilance activities in 55 low- and middle-income countries: a questionnaire-based analysis. Drug Saf. 2010;33(8):689-703.
31. Chiahemen T. Interview: how NAFDAC checkmates adverse drug reaction with PRASCOR - Mrs. Osakwe. National Accord Newspaper; 2013.