Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
Drug Safety
Published in: Drug Safety 4/2008

01-04-2008 | Original Research Article

Improving the Reporting of Adverse Drug Reactions

A Cluster-Randomized Trial Among Pharmacists in Portugal

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

Published in: Drug Safety | Issue 4/2008

Login to get access

Abstract

Background: Adverse drug reaction (ADR) reporting systems are the basic component for comprehensive postmarketing surveillance of the risk of drug-induced adverse effects. The aim of this study was to evaluate the effectiveness of educational outreach visits aimed at improving ADR reporting by pharmacists.
Methods: The study population comprised all pharmacists working in a catchment area covered by Portugal’s Northern Regional Health Authority. Using unequal randomization, four spatial-clusters were assigned to the intervention group (n = 342) and eleven to the control group (n = 1091). The intervention took the form of 1-hour long educational outreach visits tailored to training needs detected in a previous study, with a 13- to 16-month follow-up period (March–June 2004 through June 2005). This study is registered as an international standard randomized controlled trial, number ISRCTN45 894687.
Results: At baseline, ADR reporting rates (per 1000 pharmacist-years) did not differ significantly between the intervention and control groups (32.28 vs 29.16). The adjusted increase in ADR reporting attributable to the intervention was 275.63 per 1000 pharmacist-years (95% CI 162.15, 389.12; relative risk RR] = 5.87, 95% CI 1.98, 17.39). The intervention succeeded in multiplying the reporting rate of: serious ADRs, 10-fold (RR = 9.79; 95% CI 2.24, 42.66); unexpected ADRs, 4-fold (RR = 4.41; 95% CI 1.11, 17.53); high-causality ADRs, 9-fold (RR = 8.67; 95% CI 2.12, 35.42); and new drug-related ADRs, 9-fold (RR = 9.33; 95% CI 2.53, 34.40). While the greatest effect was registered during the first 4 months post-intervention, differences remained statistically significant for 8 months.
Conclusions: Educational outreach visits improve ADR reporting by pharmacists in terms of quantity and relevance.
Literature
1.
2.
Johnson JA, Bootman JL. Drug-related morbidity and mortality: a cost-of-illness model. Arch Intern Med 1995; 155: 1949–56PubMedCrossRef
3.
Hazell L, Shakir SA. Under-reporting of adverse drug reactions: a systematic review. Drug Saf 2006; 29: 385–96PubMedCrossRef
4.
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
5.
Green CG, Mottram DR, Raval D, et al. Community pharmacists’ attitudes to adverse drug reaction reporting. Int J Pharm Pract 1999; 7: 92–9CrossRef
6.
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
7.
Forster AJ, Halil RB, Tierney MG. Pharmacist surveillance of adverse drug events. Am J Health Syst Pharm 2004; 61: 1466–72PubMed
8.
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
9.
Lee KKC, Chan TYK, Raymond K, et al. Pharmacists’ attitudes toward adverse drug reaction reporting in Hong Kong. Ann Pharmacother 1994; 28: 1400–3PubMed
10.
Roberts PI, Wolfson DJ, Booth TG. The role of pharmacists in adverse drug reaction reporting. Drug Saf 1994; 11: 7–11PubMedCrossRef
11.
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
12.
Nazario M, Feliu JF, Rivera GC. Adverse drug reactions: the San Juan Department of Veterans Affairs Medical Center experience. Hosp Pharm 1994: 244–6, 249–250
13.
Fincham J. A statewide program to stimulate reporting of adverse drug reactions. J Pharm Pract 1989; 2: 239–44CrossRef
14.
Kimelblatt BJ, Young SH, Heywood PM, et al. Improved reporting of adverse drug reactions. Am J Hosp Pharm 1988; 45: 1086–9PubMed
15.
Herdeiro MT, Figueiras A, Polónia J, et al. Influence of pharmacists’ attitudes on adverse drug reaction reporting: a case-control study in Portugal. Drug Saf 2006; 29: 331–40PubMedCrossRef
16.
Torgerson DJ, Campbell MK. Use of unequal randomisation to aid the economic efficiency of clinical trials. BMJ 2000; 321: 759PubMedCrossRef
17.
Pocock SJ. Clinical trials: a practical approach. Chichester: John Wiley & Sons, 1983: 87
18.
Grimshaw JM, Shirran L, Thomas R, et al. Changing provider behavior: an overview of systematic reviews of interventions. Med Care 2001; 39: II2–45PubMedCrossRef
19.
Inman WHW. Assessment of drug safety problems. In: Gent M, Shigematsu I, editors. Epidemiological issues in reported drug-induced illnesses. Hamilton (ON): McMaster University Library Press, 1976: 17–24
20.
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: 1086–93PubMedCrossRef
21.
The European Agency for the Evaluation of Medical Products. International Conference on Harmonisation (Step 5) Guideline for Good Clinical Practice. Ambler (PA): Drug Information Association, 1997
22.
Heeley E, Riley J, Layton D, et al. Prescription-event monitoring and reporting of adverse drug reactions. Lancet 2001; 358: 1872–3PubMedCrossRef
23.
24.
25.
Instituto Nacional da Farmácia e do Medicamento (Portugal). Farmacovigilância em Portugal. Lisbon: INFARMED, 2003
26.
Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet 2000; 356: 1255–9PubMedCrossRef
27.
Brown HK, Prescott RJ. Applied mixed models in medicine. West Sussex: John Wiley & Sons, 1999
28.
29.
Ukoumunne OC, Gulliford MC, Chinn S, et al. Methods for evaluating area-wide and organisation-based interventions in health and health care: a systematic review. Health Technol Assess 1999; 3: iii–92PubMed
30.
Hollis S, Campbell F. What is meant by intention to treat analysis? Survey of published randomised controlled trials. BMJ 1999; 319: 670–4 344PubMedCrossRef
31.
Heo M, Leon AC. Comparison of statistical methods for analysis of clustered binary observations. Stat Med 2005; 24: 911–23PubMedCrossRef
32.
Granas AG, Buajordet M, Stenberg-Nilsen H, et al. Pharmacists’ attitudes towards the reporting of suspected adverse drug reactions in Norway. Pharmacoepidemiol Drug Saf 2007; 16(4): 429–34PubMedCrossRef
33.
Major E. The yellow card scheme and the role of pharmacists as reporters. Pharm J 2002; 269: 25–26
34.
Davis DA, Thomson MA, Oxman AD, et al. Changing physician performance: a systematic review of the effect of continuing medical education strategies. JAMA 1995; 274: 700–5PubMedCrossRef
35.
Thomson O’Brien MA, Oxman AD, Davis DA, et al. Educational outreach visits: effects on professional practice and health care outcomes. Cochrane Database Syst Rev 2000; (2): CD000409
36.
Avorn J, Soumerai SB. Improving drug-therapy decisions through educational outreach: a randomized controlled trial of academically based “detailing”. N Engl J Med 1983; 308: 1457–63PubMedCrossRef
37.
Schlienger RG, Luscher TF, Schoenenberger RA, et al. Academic detailing improves identification and reporting of adverse drug events. Pharm Worl Sci 1999; 21: 110–5CrossRef
38.
Fletcher AP. Spontaneous adverse drug reaction reporting vs event monitoring: a comparison. J R Soc Med 1991; 84: 341–4PubMed
39.
40.
Klarl N, Darlington G. Methods for modelling change in cluster randomization trials. Statist Med 2004; 23: 2341–57CrossRef
41.
Thomson O’Brien MA, Freemantle N, Oxman AD, et al. Continuing education meetings and workshops: effects on professional practice and health care outcomes. Cochrane Database Syst Rev 2001; (2): CD003030
42.
Richards D, Toop L, Graham P. Do clinical practice education groups result in sustained change in GP prescribing? Fam Pract 2003; 20: 199–206
43.
44.
Fontanarosa PB, Rennie D, DeAngelis CD. Postmarketing surveillance: lack of vigilance, lack of trust. JAMA 2004; 292: 2647–50PubMedCrossRef
45.
Horton R. Safety concerns at the FDA editorial]. Lancet 2004; 365
Metadata
Title
Improving the Reporting of Adverse Drug Reactions
A Cluster-Randomized Trial Among Pharmacists in Portugal
Authors
Maria T. Herdeiro
Jorge Polónia
Juan J. Gestal-Otero
Professor Dr Adolfo Figueiras
Publication date
01-04-2008
Publisher
Springer International Publishing
Published in
Drug Safety / Issue 4/2008
Print ISSN: 0114-5916
Electronic ISSN: 1179-1942
DOI
https://doi.org/10.2165/00002018-200831040-00007

Other articles of this Issue 4/2008

Drug Safety 4/2008 Go to the issue

Original Research Article

Hepatic Events Associated with Atomoxetine Treatment for Attention-Deficit Hyperactivity Disorder

Correspondence

Publishing Histories of Adverse Reactions to Medicaments Anecdotally

Original Research Article

Hepatic Effects of Lovastatin Exposure in Patients with Liver Disease

Review Article

Dysglycaemias and Fluoroquinolones

Review Article

A Benefit-Risk Review of Systemic Haemostatic Agents

Original Research Article

Safety Profile of Esomeprazole