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Drug Safety
Published in: Drug Safety 9/2005

01-09-2005 | Original Research Article

Physicians’ Attitudes and Adverse Drug Reaction Reporting

A Case-Control Study in Portugal

Authors: Maria T. Herdeiro, Professor Adolfo Figueiras, Jorge Polónia, Juan Jesus Gestal-Otero

Published in: Drug Safety | Issue 9/2005

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Abstract

Objectives: Voluntary adverse drug reaction (ADR) reporting is fundamental to medical drug safety surveillance; however, substantial under-reporting exists and is the main limitation of the system. This study sought to identify the knowledge-and attitude-related factors associated with ADR reporting by physicians in Northern Portugal.
Methods: Case-control study covering a population of National Health Service medical practitioners. The 88 cases comprised physicians who had reported at least one ADR to the drug surveillance unit from the year 2000 to the date of enrolment in the study. The 771 controls were randomly selected from among the remaining physicians. All interviews were conducted using a self-administered questionnaire. Knowledge and attitudes regarding spontaneous ADR reporting were based on Inman’s ‘seven deadly sins’. Agreement with the questions included in the questionnaire was measured using a horizontal, continuous visual analogue scale, which was unnumbered. Recorded answers were read in a range from zero (total disagreement) to ten (total agreement). We used logistic regression to determine the ADR reporting adjusted odds ratio (ORadj) for a change in exposure corresponding to the interquartile range for each attitude.
Results: A total of 397 questionnaires were received from 731 eligible practitioners (54.3%). Physicians who worked in primary versus hospital care (ORadj 7.74 [95% CI 1.85, 32.30]) and in general medicine (ORadj 1.05 [95% CI 0.30, 3.69]) versus medical specialities were more likely to report ADRs. In contrast, physicians working in the medical-surgical/surgical fields were significantly less likely to report ADRs compared with medical specialists (ORadj 0.10 [95% CI 0.02, 0.46]). Attitudes to ADRs were strongly associated with reporting probability. Hence, an interquartile decrease in any of the following attitudes increased the probability of reporting by: (i) 87% (p < 0.05) for complacency (the belief that really serious ADRs are well documented by the time a drug is marketed); (ii) 109% (p < 0.01) for insecurity (the belief that it is nearly impossible to determine whether a drug is responsible for a particular adverse reaction); (iii) 143% (p < 0.001) for diffidence (the belief that one would only report an ADR if one were sure that it was related to the use of a particular drug); (iv) 220% (p < 0.001) for indifference (the belief that the one case an individual doctor might see could not contribute to medical knowledge); and (v) 71% (p < 0.05) for ignorance (the belief that it is only necessary to report serious or unexpected ADRs).
Conclusion: This study shows that there are attitudes strongly associated with under-reporting. The implementation of purpose-designed educational interventions based on the attitudes identified in this study may serve to improve reporting substantially.
Literature
1.
Cosentino M, Leoni O, Banfi F, et al. Attitudes to adverse drug reaction reporting by medical practitioners in a Northern Italian District. Pharmacol Res 1997; 35: 85–8PubMedCrossRef
2.
McGettigan P, Golden J, Conroy RM, et al. Reporting of adverse drug reactions by hospital doctors and the response to intervention. Br J Clin Pharmacol 1997; 44: 98–100PubMedCrossRef
3.
Meyboom RH, Egberts AC, Gribnau FW, et al. Pharmacovigilance in perspective. Drug Saf 1999; 21: 429–47PubMedCrossRef
4.
Erill S. Avances en las tecnicas de detección de reacciones adverses a los medicamentos. In: Laporte J, Salva JÁ, editors. Avances en terapéutica 5. Barcelona: Editorial Salvat, 1973: 124–48
5.
Lawson DH, Hutcheon AW, Jick H. Life threatening drug reactions amongst medical in-patients. Scott Med J 1979; 24: 127–30PubMed
6.
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: 307–11PubMed
7.
Rawlins MD. Spontaneous reporting of adverse drug reactions: I. the data. Br J Clin Pharmacol 1988; 26: 1–5PubMedCrossRef
8.
Smith CC, Bennett PM, Pearce HM, et al. Adverse drug reaction in a hospital general medical unit meriting notification to the Committee on Safety of Medicine. Br J Clin Pharmacol 1996; 42: 423–9PubMedCrossRef
9.
Ibanez L, Laporte JR, Carne X. Adverse drug reactions leading to hospital admission. Drug Saf 1991; 6: 450–9PubMedCrossRef
10.
Rawlins MD. Pharmacovigilance: paradise lost, regained or postponed? J R Coll Physicians Lond 1995; 29: 41–9PubMed
11.
Pirmohamed M, Breckenridge A, Kitteringham N, et al. Adverse drug reactions. BMJ 1998; 316: 1295–8PubMedCrossRef
12.
Instituto Nacional da Farmácia e do Medicamento, Ministério da Saúde. Farmacovigilancia em Portugal. Lisbon: INFARMED, 2003
13.
Rogers AS, Israel E, Smith CR, et al. Physician knowledge, attitudes, and behaviour to reporting adverse drug events. Arch Intern Med 1988; 148: 1596–600PubMedCrossRef
14.
Inman WHW. Assessment drug safety problems. In: Gent M, Shigmatsu I, editors. Epidemiological issues in reported drug-induced illnesses. Honolulu, Ontario: McMaster University Library Press, 1976: 17–24
15.
Leiper JM, Lawson DH. Why do doctors not report adverse drug reactions? Neth J Med 1985; 28: 546–50PubMed
16.
Scott HD, Thacher-Renshaw A, Rosenbaum SE, et al. Physician reporting of adverse drug reactions: results of Rhode Island adverse drug reaction reporting project. JAMA 1990; 263: 1785–8PubMedCrossRef
17.
Castel JM, Figueiras A, Pedros C, et al. Stimulating adverse drug reaction reporting: effect of a drug safety bulletin and of including yellow cards in prescription pads. Drug Saf 2003; 26: 1049–55PubMedCrossRef
18.
Figueiras A, Tato F, Fontainas J, et al. Influence of physicians attitudes on reporting adverse drug events. Med Care 1999; 37: 809–14PubMedCrossRef
19.
Eland IA, Belton KJ, Van Grootheest AC, et al. Attitudinal survey of voluntary reporting of adverse drug reactions. Br J Clin Pharmacol 1999; 48: 623–7PubMedCrossRef
20.
Backstrom M, Mjorndal T, Dahlqvist R. Attitudes to reporting adverse drug reactions in northern Sweden. Eur J Clin Pharmacol 2000; 56: 729–32PubMedCrossRef
21.
Bateman DN, Sanders GLS, Rawlins MD. Attitudes to adverse drug reaction reporting in the Northern Region. Br J Clin Pharmacol 1992; 34: 421–6PubMedCrossRef
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: 223–6PubMedCrossRef
23.
Biriell C, Edwards IR. Reasons for reporting adverse drug reactions: some thoughts based on an international review. Pharmacoepidemiol Drug Saf 1997; 6: 21–6PubMedCrossRef
24.
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: 945–50PubMedCrossRef
25.
Scott HD, Thatcher A, Rosenbaum SE, et al. Adverse drug reaction reporting systems: the United Kingdom and the United States. R I Med J 1988; 71: 179–84PubMed
26.
Milstein JB, Faich GA, Hsu JP, et al. Factors affecting physician reporting of adverse drug reactions. Drug Inf J 1986; 20: 157–64
27.
Belton KJ. Attitude survey of adverse drug-reaction reporting by health care professionals across the European Union. Eur J Clin Pharmacol 1997; 52: 423–7PubMedCrossRef
28.
Grant S, Aitchison T, Henderson E, et al. A comparison of the reproducibility and the sensitivity to change of visual analogue scales, org scales, and Likert scales in normal subjects during submaximal exercise. Chest 1999; 116: 1208–17PubMedCrossRef
29.
Pirmohamed M, James S, Meakin S, Green C, et al, editor. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients. BMJ 2004; 3(329): 15–9
30.
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; 329: 15–9PubMedCrossRef
31.
Beijer HJM, Blaey CJ. Hospitalisations caused by adverse drug reactions (ADR): a meta-analysis of observational studies. Pharm World Sci 2002; 24: 46–54PubMedCrossRef
32.
Martin MT, Codina C, Tuset M, et al. Drug related problems as a cause of hospital admission. Med Clin (Barc) 2002; 118: 205–10
33.
Einarson TR. Drug-related hospital admissions. Ann Pharmacother 1993; 27: 832–40PubMed
34.
Rodrigues-Monguio R, Otero MJ, Rovira J. Assessing the economic impact of adverse drug effects. Pharmacoeconomics 2003; 21: 623–50CrossRef
35.
Bates DW. Costs of drug-related morbidity and mortality: enormous and growing rapidly. J Am Pharm Assoc 2001; 41: 156–7
36.
Classen DC, Pestotnik SL, Evans RS, et al. Adverse drug events in hospitalized patients: excess length of stay, extra costs, and attributable mortality. JAMA 1997; 277: 301–6PubMedCrossRef
37.
Davis DA, Thomson MA, Oxman AD, et al. Evidence for the effectiveness of CME. JAMA 1992; 268: 1111–7PubMedCrossRef
38.
Rehan HS, Vasudev K, Tripathi CD. Adverse drug reaction monitoring: knowledge, attitude and practices of medical students and prescribers. Natl Med J India 2002; 15: 24–6PubMed
39.
Cox AR, Marriott JF, Wilson KA, et al. Adverse drug reaction teaching in UK undergraduate medical and pharmacy programmes. J Clin Pharm Ther 2004; 29: 31–5PubMedCrossRef
40.
Taziaux P, Franck J, Ludovice R, et al. A study of general practitioners’ prescribing behaviour to the elderly in Wallonia, Belgium. Eur J Public Health 1996; 6: 49–57CrossRef
41.
Cosentino M, Leoni O, Oria C, et al. Hospital-based survey of doctors’ attitudes to adverse drug reactions and perception of drug-related risk of adverse reaction occurrence. Pharmacoepidemiol Drug Saf 1999; 8: S27–35PubMedCrossRef
42.
Koch-Weser J, Sidel VW, Sweet RH, et al. Factors determining physician reporting of adverse drug reactions. N Engl J Med 1969; 280: 20–6PubMedCrossRef
43.
Inman WHW. Attitudes to adverse drug reaction reporting. Br J Clin Pharmacol 1996; 41: 434–5PubMed
44.
Herdeiro MT, Polónia 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: 483–9PubMedCrossRef
45.
Varela P, Amorim I, Sanches M, et al. Photosensitivity induced by piroxicam. Acta Med Port 1998; 11: 997–1001PubMed
46.
Serrano Cozar G, Esteban Calvo C, Gijón Porta JA, et al. Reacciones adversas a medicamentos y programa de notificación espontánea: una encuesta de opinión a médicos de atención primaria. Aten Primaria 1997; 187: 780–4
Metadata
Title
Physicians’ Attitudes and Adverse Drug Reaction Reporting
A Case-Control Study in Portugal
Authors
Maria T. Herdeiro
Professor Adolfo Figueiras
Jorge Polónia
Juan Jesus Gestal-Otero
Publication date
01-09-2005
Publisher
Springer International Publishing
Published in
Drug Safety / Issue 9/2005
Print ISSN: 0114-5916
Electronic ISSN: 1179-1942
DOI
https://doi.org/10.2165/00002018-200528090-00007

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