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Erschienen in: Drug Safety 4/2006

01.04.2006 | Original Research Article

Influence of Pharmacists’ Attitudes on Adverse Drug Reaction Reporting

A Case-Control Study in Portugal

verfasst von: Maria T. Herdeiro, Professor Adolfo Figueiras, Jorge Polónia, J J Gestal-Otero

Erschienen in: Drug Safety | Ausgabe 4/2006

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Abstract

Introduction: Pharmacists can play a fundamental role in adverse drug reaction (ADR) reporting, although the factors that affect underreporting among these professionals are unknown. The objectives of this study were to identify (i) professional or demographic characteristics; and (ii) attitudes associated with pharmacists’ ADR reporting in northern Portugal.
Methods: We conducted a case-control study on a population of pharmacists employed in hospital and community pharmacies across Portugal’s Northern Regional Health Authority catchment area in 2003. Cases (n = 34) comprised pharmacists who had reported at least one ADR to the northern region’s drug surveillance unit, and controls (n = 280) were randomly sampled from pharmacists who had never reported an ADR. All were interviewed using a mail questionnaire. Most attitudes were based on Inman’s ‘seven deadly sins’ and were measured using a continuous visual analogue scale. Answers were recorded in a range from 0 (total disagreement) to 10 (total agreement). Logistic regression was used to determine the ADR reporting adjusted odds ratio (OR) for a change in exposure corresponding to the interquartile range for each attitude.
Results: The response rate was 86.8%. Reporting probability proved higher among hospital versus community pharmacists (adjusted OR 20.0; 95 CI 3.3, 125.0; p < 0.001). 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) 223% (95% CI 51, 595; p < 0.05) for “Really serious ADRs are well documented by the time a drug is marketed”; (ii) 240% (95% CI 89, 508; p = 0.002) for “I would only report an ADR if I were sure that it was related to the use of a particular drug”; (iii) 316% (95% CI 44, 1104; p = 0.010) for It is only necessary to report serious or unexpected ADRs; and (iv) 171% (95% CI 13, 549; p = 0.020) for “I do not have time to think about the involvement of the drug or other causes in ADRs”.
Conclusions: ADR under-reporting is strongly associated with certain attitudes, possibly indicating that under-reporting could be minimised through educational interventions targeted at changing such attitudes. Pharmacists’ ADR education must be improved and educational programmes should be focused on altering attitudes identified by the study as being associated with under-reporting. Our data also indicate that community pharmacists must be a priority target for this intervention.
Fußnoten
1
The full questionnaire is available on the {itDrug Safety} website ({rs|http://www.adisonline.com/drs|url|}).
 
Literatur
1.
Zurück zum Zitat Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalised patients. JAMA 1998; 279: 1200–5PubMedCrossRef Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalised patients. JAMA 1998; 279: 1200–5PubMedCrossRef
2.
Zurück zum Zitat Einarson TR. Drug-related hospital admissions. Ann Pharmacother 1993; 27: 832–40PubMed Einarson TR. Drug-related hospital admissions. Ann Pharmacother 1993; 27: 832–40PubMed
3.
Zurück zum Zitat 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: 15–9CrossRef 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: 15–9CrossRef
4.
Zurück zum Zitat Beijer HJM, Blaey CJ. Hospitalisations caused by adverse drug reactions (ADR): a meta-analysis of observational studies. Pharm World Sci 2002; 24: 46–54PubMedCrossRef Beijer HJM, Blaey CJ. Hospitalisations caused by adverse drug reactions (ADR): a meta-analysis of observational studies. Pharm World Sci 2002; 24: 46–54PubMedCrossRef
5.
Zurück zum Zitat Rawlins MD. Pharmacovigilance: paradise lost, regained or postponed? J R Coll Physicians Lond 1995; 29: 41–9PubMed Rawlins MD. Pharmacovigilance: paradise lost, regained or postponed? J R Coll Physicians Lond 1995; 29: 41–9PubMed
6.
Zurück zum Zitat Martin RM, Kapoor KV, Wilton LV, et al. Underreporting of suspected adverse drug reactions to newly marketed “black triangle” drugs in general practice: observational study. BMJ 1998; 317: 119–20PubMedCrossRef Martin RM, Kapoor KV, Wilton LV, et al. Underreporting of suspected adverse drug reactions to newly marketed “black triangle” drugs in general practice: observational study. BMJ 1998; 317: 119–20PubMedCrossRef
7.
Zurück zum Zitat Backstrom M, Mjorndal T, Dahlqvist R. Under-reporting of serious adverse drug reactions in Sweden. Pharmacoepidemiol Drug Saf 2004; 13: 483–7PubMedCrossRef Backstrom M, Mjorndal T, Dahlqvist R. Under-reporting of serious adverse drug reactions in Sweden. Pharmacoepidemiol Drug Saf 2004; 13: 483–7PubMedCrossRef
8.
Zurück zum Zitat Mittmann N, Knowles SR, Gomez M, et al. Evaluation of the extent of under-reporting of serious adverse drug reactions: the case of toxic epidermal necrolysis. Drug Saf 2004; 27: 477–87PubMedCrossRef Mittmann N, Knowles SR, Gomez M, et al. Evaluation of the extent of under-reporting of serious adverse drug reactions: the case of toxic epidermal necrolysis. Drug Saf 2004; 27: 477–87PubMedCrossRef
9.
Zurück zum Zitat Instituto Nacional da Farmacia e do Medicamento (INFARMED). Farmacovigilancia em Portugal. Lisboa: INFARMED, 2003 Instituto Nacional da Farmacia e do Medicamento (INFARMED). Farmacovigilancia em Portugal. Lisboa: INFARMED, 2003
10.
Zurück zum Zitat Generali JA, Danish MA, Rosenbaum SE. Knowledge of and attitudes about adverse drug reaction reporting among Rhode Island pharmacists. Ann Pharmacother 1995; 29: 365–9PubMed Generali JA, Danish MA, Rosenbaum SE. Knowledge of and attitudes about adverse drug reaction reporting among Rhode Island pharmacists. Ann Pharmacother 1995; 29: 365–9PubMed
11.
Zurück zum Zitat Lee KKC, Chan TYK, Raymond K, et al. Pharmacists’ attitudes toward adverse drug reaction reporting in Hong Kong. Ann Pharmacother 1994; 28: 1400–3PubMed Lee KKC, Chan TYK, Raymond K, et al. Pharmacists’ attitudes toward adverse drug reaction reporting in Hong Kong. Ann Pharmacother 1994; 28: 1400–3PubMed
12.
Zurück zum Zitat Roberts PI, Wolfson DJ, Booth TG. The role of pharmacists in adverse drug reaction reporting. Drug Saf 1994; 11: 7–11PubMedCrossRef Roberts PI, Wolfson DJ, Booth TG. The role of pharmacists in adverse drug reaction reporting. Drug Saf 1994; 11: 7–11PubMedCrossRef
13.
Zurück zum Zitat Fincham JE. Adverse drug reaction reporting and pharmacists. J Clin Pharm Ther 1989; 14: 79–81PubMedCrossRef Fincham JE. Adverse drug reaction reporting and pharmacists. J Clin Pharm Ther 1989; 14: 79–81PubMedCrossRef
14.
Zurück zum Zitat Van Grootheest AC, Van Puijenbroek EP, Jong-van den Berg LTW. Contribution of pharmacists to the reporting of adverse drug reactions. Pharmacoepidemiol Drug Saf 2002; 11: 205–10PubMedCrossRef Van Grootheest AC, Van Puijenbroek EP, Jong-van den Berg LTW. Contribution of pharmacists to the reporting of adverse drug reactions. Pharmacoepidemiol Drug Saf 2002; 11: 205–10PubMedCrossRef
15.
Zurück zum Zitat Green CG, Mottram DR, Raval D, et al. Community pharmacists’ attitudes to adverse drug reaction reporting. Int J Pharm Pract 1999; 7: 92–9CrossRef Green CG, Mottram DR, Raval D, et al. Community pharmacists’ attitudes to adverse drug reaction reporting. Int J Pharm Pract 1999; 7: 92–9CrossRef
16.
Zurück zum Zitat Emerson A, Martin RM, Tomlin M, et al. Prospective cohort study of adverse events monitored by hospital pharmacists. Pharmacoepidemiol Drug Saf 2001; 10: 95–103PubMedCrossRef Emerson A, Martin RM, Tomlin M, et al. Prospective cohort study of adverse events monitored by hospital pharmacists. Pharmacoepidemiol Drug Saf 2001; 10: 95–103PubMedCrossRef
17.
Zurück zum Zitat Forster AJ, Halil RB, Tierney MG. Pharmacist surveillance of adverse drug events. Am J Health Syst Pharm 2004; 61: 1466–72PubMed Forster AJ, Halil RB, Tierney MG. Pharmacist surveillance of adverse drug events. Am J Health Syst Pharm 2004; 61: 1466–72PubMed
18.
Zurück zum Zitat Sinclair HK, Bond CM, Hannaford PC. Pharmacovigilance of over-the-counter products based in community pharmacy: a feasible option? Pharmacoepidemiol Drug Saf 1999; 8: 479–91PubMedCrossRef Sinclair HK, Bond CM, Hannaford PC. Pharmacovigilance of over-the-counter products based in community pharmacy: a feasible option? Pharmacoepidemiol Drug Saf 1999; 8: 479–91PubMedCrossRef
19.
Zurück zum Zitat Barnes J. Pharmacovigilance of herbal medicines: a UK perspective. Drug Saf 2003; 26: 829–51PubMedCrossRef Barnes J. Pharmacovigilance of herbal medicines: a UK perspective. Drug Saf 2003; 26: 829–51PubMedCrossRef
20.
Zurück zum Zitat van Grootheest AC. Improving pharmacovigilance and the role of the pharmacist [thesis]. Groningen: University of Groningen, 2003 van Grootheest AC. Improving pharmacovigilance and the role of the pharmacist [thesis]. Groningen: University of Groningen, 2003
21.
Zurück zum Zitat Gree CF, Mottram DR, Rowe P, et al. An investigation into adverse drug reaction monitoring by United Kingdom hospital pharmacy departments. Int J Pharm Pract 1997; 5: 202–8CrossRef Gree CF, Mottram DR, Rowe P, et al. An investigation into adverse drug reaction monitoring by United Kingdom hospital pharmacy departments. Int J Pharm Pract 1997; 5: 202–8CrossRef
22.
Zurück zum Zitat Sweis D, Wong ICK. A survey on factors could affect adverse drug reaction reporting according to hospital pharmacists in Great Britain. Drug Saf 2000; 23: 165–72PubMedCrossRef Sweis D, Wong ICK. A survey on factors could affect adverse drug reaction reporting according to hospital pharmacists in Great Britain. Drug Saf 2000; 23: 165–72PubMedCrossRef
23.
Zurück zum Zitat 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: 457–64PubMedCrossRef 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: 457–64PubMedCrossRef
24.
Zurück zum Zitat 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: 1–7PubMed 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: 1–7PubMed
25.
Zurück zum Zitat Williams D, Feely J. Underreporting of adverse drug reaction attitudes of Irish doctors. Ir J Med Sci 1999; 168: 257–61PubMedCrossRef Williams D, Feely J. Underreporting of adverse drug reaction attitudes of Irish doctors. Ir J Med Sci 1999; 168: 257–61PubMedCrossRef
26.
Zurück zum Zitat 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 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
27.
Zurück zum Zitat Figueiras A, Tato F, Fontainas J, et al. Influence of physicians’ attitudes on reporting adverse drug events. Med Care 1999; 37: 809–14PubMedCrossRef Figueiras A, Tato F, Fontainas J, et al. Influence of physicians’ attitudes on reporting adverse drug events. Med Care 1999; 37: 809–14PubMedCrossRef
28.
Zurück zum Zitat 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 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
29.
Zurück zum Zitat Bateman DN, Sanders GLS, Rawlins MD. Attitudes to adverse drug reaction reporting in the Northern Region. Br J Clin Pharmacol 1992; 34: 421–6PubMedCrossRef Bateman DN, Sanders GLS, Rawlins MD. Attitudes to adverse drug reaction reporting in the Northern Region. Br J Clin Pharmacol 1992; 34: 421–6PubMedCrossRef
30.
Zurück zum Zitat 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 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
31.
Zurück zum Zitat 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 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
32.
Zurück zum Zitat Herdeiro MT, Figueiras A, Polönia J, et al. Physicians’ attitudes and adverse drug reaction reporting: a case-control study in Portugal. Drug Saf 2005; 28(9): 825–33PubMedCrossRef Herdeiro MT, Figueiras A, Polönia J, et al. Physicians’ attitudes and adverse drug reaction reporting: a case-control study in Portugal. Drug Saf 2005; 28(9): 825–33PubMedCrossRef
33.
Zurück zum Zitat Green FC, Mottram DR, Rowe PH, et al. Attitudes and knowledge of hospital pharmacists to adverse drug reaction reporting. Br J Clin Pharmacol 2001; 51: 81–6PubMedCrossRef Green FC, Mottram DR, Rowe PH, et al. Attitudes and knowledge of hospital pharmacists to adverse drug reaction reporting. Br J Clin Pharmacol 2001; 51: 81–6PubMedCrossRef
34.
Zurück zum Zitat 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 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
35.
Zurück zum Zitat Backstrom M, Mjorndal T, Dahlqvist R. Attitudes to reporting adverse drug reactions in northern Sweden. Eur J Clin Pharmacol 2000; 56: 729–32PubMedCrossRef Backstrom M, Mjorndal T, Dahlqvist R. Attitudes to reporting adverse drug reactions in northern Sweden. Eur J Clin Pharmacol 2000; 56: 729–32PubMedCrossRef
36.
Zurück zum Zitat 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 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
37.
Zurück zum Zitat Grant S, Aitchison T, Henderson E, et al. A comparison of the reproducibility and the sensitivity to change of visual analogue scales, Borg scales, and Likert scales in normal subjects during submaximal exercise. Chest 1999; 116: 1208–17PubMedCrossRef Grant S, Aitchison T, Henderson E, et al. A comparison of the reproducibility and the sensitivity to change of visual analogue scales, Borg scales, and Likert scales in normal subjects during submaximal exercise. Chest 1999; 116: 1208–17PubMedCrossRef
38.
Zurück zum Zitat Lee A, Bateman DN, Edwards C, et al. Reporting of adverse drug reactions by hospital pharmacists: pilot scheme. BMJ 1997; 315(7107): 519PubMedCrossRef Lee A, Bateman DN, Edwards C, et al. Reporting of adverse drug reactions by hospital pharmacists: pilot scheme. BMJ 1997; 315(7107): 519PubMedCrossRef
39.
Zurück zum Zitat Fincham J. A statewide program to stimulate reporting of adverse drug reactions. J Pharm Pract 1989; 4: 239–44CrossRef Fincham J. A statewide program to stimulate reporting of adverse drug reactions. J Pharm Pract 1989; 4: 239–44CrossRef
40.
Zurück zum Zitat Taras-Zasowski KM, Einarson TR. Review of Canadian pharmacist involvement in adverse drug reaction reporting. Can J Hosp Pharm 1989; 42: 105–9PubMed Taras-Zasowski KM, Einarson TR. Review of Canadian pharmacist involvement in adverse drug reaction reporting. Can J Hosp Pharm 1989; 42: 105–9PubMed
41.
Zurück zum Zitat Calvert RT. Clinical pharmacy: a hospital perspective. Br J Clin Pharmacol 19990; 47: 231–8PubMedCrossRef Calvert RT. Clinical pharmacy: a hospital perspective. Br J Clin Pharmacol 19990; 47: 231–8PubMedCrossRef
42.
Zurück zum Zitat 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: 483–9PubMedCrossRef 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: 483–9PubMedCrossRef
43.
Zurück zum Zitat Inman WHW. Attitudes to adverse drug reaction reporting. Br J Clin Pharmacol 1996; 41: 434–5PubMed Inman WHW. Attitudes to adverse drug reaction reporting. Br J Clin Pharmacol 1996; 41: 434–5PubMed
44.
Zurück zum Zitat 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 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
45.
Zurück zum Zitat Moore N. The role of the clinical pharmacologist in the management of adverse drug reactions. Drug Saf 2001; 24: 1–7PubMedCrossRef Moore N. The role of the clinical pharmacologist in the management of adverse drug reactions. Drug Saf 2001; 24: 1–7PubMedCrossRef
46.
Zurück zum Zitat Figueiras A, Montes A, Gestal-Otero JJ. Participacion de los medicos en encuestas por correo [letter]. Med Clin (Barc) 1994; 103: 719 Figueiras A, Montes A, Gestal-Otero JJ. Participacion de los medicos en encuestas por correo [letter]. Med Clin (Barc) 1994; 103: 719
Metadaten
Titel
Influence of Pharmacists’ Attitudes on Adverse Drug Reaction Reporting
A Case-Control Study in Portugal
verfasst von
Maria T. Herdeiro
Professor Adolfo Figueiras
Jorge Polónia
J J Gestal-Otero
Publikationsdatum
01.04.2006
Verlag
Springer International Publishing
Erschienen in
Drug Safety / Ausgabe 4/2006
Print ISSN: 0114-5916
Elektronische ISSN: 1179-1942
DOI
https://doi.org/10.2165/00002018-200629040-00004

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