Factors that influence under-reporting of suspected adverse drug reactions among community pharmacists in a Spanish region

Drug Safety

Volumn 30, Issue 11, 2007, Pages 1073-1082

  Irujo, Marta ^a   Beitia, Guadalupe ^a   Bes Rastrollo, Maira ^a   Figueiras, Adolfo ^b   Hernández Díaz, Sonia ^c   Lasheras, Berta ^a  

^a UNIVERSITY OF NAVARRA   (Spain)

^b UNIVERSITY OF SANTIAGO DE COMPOSTELA   (Spain)

^c HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

Author keywords

Adverse drug reactions; Adverse reaction monitoring; Questionnaires

Indexed keywords

ADULT; ARTICLE; CASE CONTROL STUDY; CONTROLLED STUDY; DATA ANALYSIS; DATA COLLECTION METHOD; DISEASE ASSOCIATION; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; FEMALE; HEALTH CARE PERSONNEL; HUMAN; HUMAN EXPERIMENT; MALE; PATIENT PARTICIPATION; PHARMACIST; PHARMACY; PRIORITY JOURNAL; RANDOM SAMPLE; SPAIN; STATISTICAL ANALYSIS;

EID: 35649020853     PISSN: 01145916     EISSN: None     Source Type: Journal    
DOI: 10.2165/00002018-200730110-00006     Document Type: Article

References (40)

1. Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalised patients. JAMA 1998; 279: 1200-5
2. Pirmohamed M, James S, Meakin S, et al. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients. BMJ 2004; 3; 329: 15-9
3. World Health Organization. Safety of medicines. A guide to detecting and reporting adverse drug reactions [online]. Available from URL: http://whqlibdoc.who.int/hq/2002/WHO_EDM_QSM_2002.2.pdf [Accessed 2006 Apr 20]
4. Rawlins MD. Pharmacovigilance: paradise lost, regained or postponed? J R Coll Physicians Lond 1995; 29: 41-9
5. Hazell L, Shakir SAW. Under-reporting of adverse drug reactions: a systematic review. Drug Saf 2006; 29 (5): 385-96
6. Real Decreto 711/2002, de 19 de Julio, por el que se regula la farmacovigilancia de medicamentos de uso humano (BOE 20 Julio 2002). "Royal Decree 711/2002, of 19 July 2002, regulating pharmacovigilance of medicinal products for human use"
7. Van Grootheest K, Olsson S, Couper M, et al. Pharmacists' role in reporting adverse drug reactions in an international perspective. Pharmacoepidemiol Drug Saf 2004; 13: 457-64
8. Sinclair HK, Bond CM, Hannaford PC. Pharmacovigilance of over-the-counter products based in community pharmacy: a feasible option? Pharmacoepidemiol Drug Saf 1999; 8: 479-91
9. Barnes J. Pharmacovigilance of herbal medicines: a UK perspective. Drug Saf 2003; 26: 829-51
10. Ahmad SR, Freiman JP, Graham DJ, et al. Quality of adverse drug experience reports submitted by pharmacists and physicians to the FDA. Pharmacoepidemiol Drug Saf 1996; 5: 1-7
11. Roberts PI, Wolfson DJ, Booth TG. The role of pharmacists in adverse drug reaction reporting. Drug Saf 1994; 11: 7-11
12. Beard K. Introduction. In: Lee A, editors. Adverse drug reactions. London: Pharmaceutical Press, 2001: 1
13. Emerson A, Martin RM, Tomlin M, et al. Prospective cohort study of adverse events monitored by hospital pharmacists. Pharmacoepidemiol Drug Saf 2001; 10: 95-103
14. Green CF, Mottram DR, Raval D, et al. Community pharmacists' attitudes to adverse drug reaction reporting. Int J Pharm Pract 1999; 7: 92-9
15. Sweis D, Wong ICK. A survey on factors that could affect adverse drug reaction reporting according to hospital pharmacists in Great Britain. Drug Saf 2000; 23: 165-72
16. Green FG, Mottram DR, Rowe PH, et al. Attitudes and knowledge of hospital pharmacists to adverse drug reaction reporting. Br J Clin Pharmacol 2001; 51: 81-6
17. Gedde-Dahl A, Harg P, Stenberg-Nilsen H, et al. Characteristics and quality of adverse drug reaction reports by pharmacists in Norway. Pharmacoepidemiol Drug Saf. In Press
18. Van Grootheest AC, Van Puijenbroek EP, Jong-van den Berg LTW. Contribution of pharmacists to the reporting of adverse drug reactions. Pharmacoepeidemiol Drug Saf 2002; 11: 205-10
19. Rogers AS, Israel E, Smith CR, et al. Physician knowledge, attitudes, and behaviour related to reporting adverse drug events. Arch Intern Med 1988; 148: 1596-600
20. Figueiras A, Tato F, Fontainas J, et al. Influence of physicians' attitudes on reporting adverse drug events. Med Care 1999; 37: 809-14
21. Bateman DN, Sanders GLS, Rawlins MD. Attitudes to adverse drug reaction reporting in the Northern Region. Br J Clin Pharmacol 1992; 34: 421-6
22. Belton KJ, Lewis SC, Payne S, et al. Attitudinal survey of adverse drug reaction reporting by medical practitioners in the United Kingdom. Br J Clin Pharmacol 1995; 39: 223-6
23. Belton KJ. Attitude survey of adverse drug-reaction reporting by health care professionals across the European Union. Eur J Clin Pharmacol 1997; 52: 423-7
24. Herdeiro MT, Figueiras A, Polónia J, et al. Physicians' attitudes and adverse drug reaction reporting: a case-control study in Portugal. Drug Saf 2005; 28 (9): 825-33
25. Leiper JM, Lawson DH. Why do doctors not report adverse drug reactions? Neth J Med 1985; 28 (12): 546-50
26. Torelló Iserte J, Castillo Ferrando JR, Laínez MM, et al. Reacciones adversas a medicamentos notificadas por los médicos de atención primaria de Andalucía. Análisis de la infranotificación. Aten Primaria 1994; 13 (6): 307-11
27. Serrano Cózar G, Esteban Calvo C, Gijón Porta JA, et al. Reacciones adversas a medicamentos y programa de notificación espontanea: una encuesta de opinión a médicos de atención primaria. Aten Primaria 1997; 87: 780-4
28. Eland IA, Belton KJ, Van Grootheest AC, et al. Attitudinal survey of voluntary reporting of adverse drug reactions. Br J Clin Pharmacol 1999; 48: 623-7
29. Figueiras A, Tato F, Fontaiñas J, et al. Physicians' attitudes towards voluntary reporting of adverse drug events. J Eval Clin Pract 2001; 7: 347-54
30. Hasford J, Goettler M, Munter KH, et al. Physicians' knowledge and attitudes regarding the spontaneous reporting system for adverse drug reactions. J Clin Epidemiol 2002; 55: 945-50
31. Aziz Z, Siaug TC, Badarudin NS. Reporting of adverse drug reactions: predictors of under-reporting in Malaysia. Pharmacoepidemiol Drug Saf 2007; 16: 223-8
32. Generali JA, Danish MA, Rosenbaum SE. Knowledge of and attitudes about adverse drug reaction reporting among Rhode Island pharmacists. Ann Pharmacother 1995; 29: 365-9
33. Van Grootheest AC, Mes K, Jong-van den Berg LTW. Attitudes of community pharmacists in the Netherlands towards ADR reporting. Int J Pharm Pract 2002; 10: 267-72
34. Herdeiro MT, Figueiras A, Polonia J, et al. Influence of pharmacists' attitudes on adverse drug reaction reporting: a case-control study in Portugal. Drug Saf 2006; 29 (4): 331-40
35. Houghton J, Woods F, Davis S, et al. Community pharmacist reporting of suspected ADRs: attitudes of community pharmacists and general practitioners in Wales. Pharm J 1999; 263: 788-91
36. Herdeiro MT, Polonia J, Gestal-Otero JJ, et al. Factors that influence spontaneous reporting of adverse drug reactions: a model centralized in the medical professional. J Eval Clin Pract 2004; 10: 483-9
37. Inman WHW. Assessment drug safety problems. In: Gent M, Shigmatsu I, editors. Epidemiological issues in reported drug-induced illnesses. Honolulu (ON): McMaster University Library Press, 1976: 17-24
38. Inman WHW. Attitudes to adverse drug reaction reporting. Br J Clin Pharmacol 1996; 41: 434-5
39. Granas AG, Buajordet M, Stenberg-Nilsen H, et al. Pharmacists' attitudes towards the reporting of suspected adverse drug reactions in Norway. Pharmacoepeidemiol Drug Saf 2007; 16: 129-34
40. Figueiras A, Herdeiro MT, Polonia J, et al. An educational intervention to improve physician reporting of adverse drug reactions: a cluster-randomized controlled trial. JAMA 2006; 296: 1086-93