Underreporting of recognized adverse drug reactions by primary care physicians: An exploratory study

Pharmacoepidemiology and Drug Safety

Volumn 20, Issue 12, 2011, Pages 1287-1294

  González Rubio, Francisca ^a   Calderón Larrañaga, Amaia ^a   Poblador Plou, Beatriz ^a   Navarro Pemán, Cristina ^a,b   López Cabañas, Anselmo ^a   Prados Torres, Alexandra ^a  

^a INSTITUTO DE INVESTIGACIÓN SANITARIA ARAGÓN IIS ARAGÓN   (Spain)

^b Centro de Farmacovigilancia de Aragon   (Spain)

Author keywords

Adverse drug reactions; Electronic medical records; Patient safety; Pharmacovigilance; Spontaneous reporting

Indexed keywords

AGENTS ACTING ON THE GENITAL SYSTEM; AGENTS ACTING ON THE PERIPHERAL NERVOUS AND NEUROMUSCULAR SYSTEMS; ANTIINFECTIVE AGENT; ANTINEOPLASTIC AGENT; ANTIPARASITIC AGENT; CARDIOVASCULAR AGENT; DERMATOLOGICAL AGENT; HORMONES AND AGENTS ACTING ON THE ENDOCRINE SYSTEM;

ADOLESCENT; ADULT; AGED; ARTICLE; CHILD; DRUG SURVEILLANCE PROGRAM; ELECTRONIC MEDICAL RECORD; FEMALE; GENERAL PRACTITIONER; GENITAL SYSTEM; HEALTH CENTER; HUMAN; INFANT; LOGISTIC REGRESSION ANALYSIS; MAJOR CLINICAL STUDY; MALE; MENTAL DISEASE; PATIENT SAFETY; PRESCHOOL CHILD; PRIORITY JOURNAL; PROBABILITY; RETROSPECTIVE STUDY; SCHOOL CHILD; SPAIN; UNSPECIFIED SIDE EFFECT;

ADOLESCENT; ADULT; ADVERSE DRUG REACTION REPORTING SYSTEMS; AGE FACTORS; AGED; CHILD; CHILD, PRESCHOOL; ELECTRONIC HEALTH RECORDS; FEMALE; HUMANS; INFANT; LOGISTIC MODELS; MALE; MIDDLE AGED; PHARMACOVIGILANCE; PHYSICIANS, PRIMARY CARE; RETROSPECTIVE STUDIES; SPAIN; YOUNG ADULT;

EID: 81955163020     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.2172     Document Type: Article

References (39)

1. Lewis JA. Postmarketing surveillance: how many patients? Trends Pharmacol Sci 1981; 2: 93-94.
2. Bland JM, Jones DR, Bennett S, Cook DG, Haines AP, MacFarlane AJ. Is the clinical trial evidence about new drugs statistically adequate? Br J Clin Pharmacol 1985; 19: 155-160.
3. Laporte JR, Tognoni G. Estudio de utilización de medicamentos y de farmacovigilancia. In Drug utilization studies. Methods and uses (2nd edn), Dukes MNG (ed.). The WHO Regional Office for Europe, WHO Regional Publications: Copenhagen. European Series, 1993; pp. 23-41.
4. Rawlins MD. Spontaneous reporting of adverse drug reactions I: the data. Br J Clin Pharmacol 1988; 26: 1-5.
5. Laporte JR, Capellà D. El sistema español de farmacovigilancia. Med Clin Barc 1994; 103: 335-336.
6. Wiholm BE, Olsson S, Moore N, et al. Spontaneous reporting systems outside the United States. In Pharmacoepidemiology (2nd edn), Strom BL (ed.). Wiley: Cichester, 1994; pp. 139-155.
7. Ley 29/2006 de 26 de julio, de garantías y uso racional de los medicamentos y productos sanitarios, 2006.
8. Hazell L, Shakir SA. Under-reporting of adverse drug reactions: a systematic review. Drug Saf 2006; 29: 385-396.
9. Lamberts HWM. ICPC: International Classification of Primary Care. Oxford University Press: Oxford, 1987.
10. WHO Collaborating Centre for Drug Statistics Methodology. Anatomical Chemical Classification Index with Defined Daily Doses (DDD), 2008.
11. Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA 1998; 279: 1200-1205.
12. Lundkvist J, Jonsson B. Pharmacoeconomics of adverse drug reactions. Fundam Clin Pharmacol 2004; 18: 275-280.
13. Cox AR, Anton C, McDowell SE, Marriott JF, Ferner RE. Correlates of spontaneous reporting of adverse drug reactions within primary care: the paradox of low prescribers who are high reporters. Br J Clin Pharmacol 2010; 69: 529-534.
14. El sistema español de farmacovigilancia de medicamentos de uso humano: datos del programa de notificación espontánea 2005 y 2006. Agencia Española de Medicamentos y Productos Sanitarios: Madrid, 2007.
15. Star K, Lindquist M. Who, where, and what in spontaneous reports. The Uppsala Monitoring Centre, WHO Collaborating Centre for International Drug Monitoring: Uppsala, Sweden, 2004.
16. Joyanes A, Higueras LM, de Leon JM, Sanz E. Analysis of adverse drug reactions detected in a primary health care center. Aten Primaria 1996; 17: 262-267.
17. de Frutos Hernansanz MJ, Lazaro DA, Llinares GV, Azpiazu GM, Serrano VA, Lopez de CF. Adverse reactions to drugs in a health center. Aten Primaria 1994; 14: 783-786.
18. Kane-Gill SL, Van Den Bos J, Handler SM. Adverse drug reactions in hospital and ambulatory care settings identified using a large administrative database. Ann Pharmacother 2010; 44: 983-993.
19. Hasford J, Goettler M, Munter KH, Muller-Oerlinghausen B. Physicians' knowledge and attitudes regarding the spontaneous reporting system for adverse drug reactions. J Clin Epidemiol 2002; 55: 945-950.
20. Eland IA, Belton KJ, van Grootheest AC, Meiners AP, Rawlins MD, Stricker BH. Attitudinal survey of voluntary reporting of adverse drug reactions. Br J Clin Pharmacol 1999; 48: 623-627.
21. Backstrom M, Mjorndal T, Dahlqvist R, Nordkvist-Olsson T. Attitudes to reporting adverse drug reactions in northern Sweden. Eur J Clin Pharmacol 2000; 56: 729-732.
22. Moride Y, Haramburu F, Requejo AA, Begaud B. Under-reporting of adverse drug reactions in general practice. Br J Clin Pharmacol 1997; 43: 177-181.
23. Alvarez-Requejo A, Carvajal A, Begaud B, Moride Y, Vega T, Arias LH. Under-reporting of adverse drug reactions. Estimate based on a spontaneous reporting scheme and a sentinel system. Eur J Clin Pharmacol 1998; 54: 483-488.
24. Real Decreto 1344/2007 de 11 de octubre, por el que se regula la farmacovigilancia de medicamentos de uso humano, 2007.
25. Lopez-Gonzalez E, Herdeiro MT, Figueiras A. Determinants of under-reporting of adverse drug reactions: a systematic review. Drug Saf 2009; 32: 19-31.
26. Belton KJ. Attitude survey of adverse drug-reaction reporting by health care professionals across the European Union. The European Pharmacovigilance Research Group. Eur J Clin Pharmacol 1997; 52: 423-427.
27. Morales-Olivas FJ, Martinez-Mir I, Ferrer JM, Rubio E, Palop V. Adverse drug reactions in children reported by means of the yellow card in Spain. J Clin Epidemiol 2000; 53: 1076-1080.
28. Jonville-Bera AP, Giraudeau B, Blanc P, Beau-Salinas F, Autret-Leca E. Frequency of adverse drug reactions in children: a prospective study. Br J Clin Pharmacol 2002; 53: 207-210.
29. Napoleone E. Children and ADRs (Adverse Drug Reactions). Ital J Pediatr 2010; 36: 4.
30. CPMP Paediatric Expert Group (PEG). Concept Paper: Conduct of Pharmacovigilance for Medicines used by Children. EMEA/19253/03. 2002.
31. Bonati M. Epidemiologic evaluation of drug use in children. J Clin Pharmacol 1994; 34: 300-305.
32. Routledge PA, O'Mahony MS, Woodhouse KW. Adverse drug reactions in elderly patients. Br J Clin Pharmacol 2004; 57: 121-126.
33. Roughead EE, Gilbert AL, Primrose JG, Sansom LN. Drug-related hospital admissions: a review of Australian studies published 1988-1996. Med J Aust 1998; 168: 405-408.
34. Klein LE, German PS, Levine DM. Adverse drug reactions among the elderly: a reassessment. J Am Geriatr Soc 1981; 29: 525-530.
35. Camargo AL, Cardoso Ferreira MB, Heineck I. Adverse drug reactions: a cohort study in internal medicine units at a university hospital. Eur J Clin Pharmacol 2006; 62: 143-149.
36. Zopf Y, Rabe C, Neubert A. et al. Gender-based differences in drug prescription: relation to adverse drug reactions. Pharmacology 2009; 84: 333-339.
37. Zopf Y, Rabe C, Neubert A, et al. Women encounter ADRs more often than do men. Eur J Clin Pharmacol 2008; 64: 999-1004.
38. Sistema de Información de Atención Primaria (SIAP), Instituto de Información Sanitaria. Actividad ordinaria en centros de Atención Primaria. Informe resumen evolutivo del Sistema Nacional de Salud 2007-2009.
39. Anderson GD. Sex and racial differences in pharmacological response: where is the evidence? Pharmacogenetics, pharmacokinetics, and pharmacodynamics. J Womens Health Larchmt 2005; 14: 19-29.