Trial reportDrug safety2008
Improving the reporting of adverse drug reactions: a cluster-randomized trial among pharmacists in Portugal.
Trial report in Drug safety, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02134587 (Implementation of a Hospital Pharmacovigilance Service and Comparison of Algorithms for Adverse Drug Reaction Causality Assessment), which is not on this map. Cited by 29 papers, 8 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Implementation of a Hospital Pharmacovigilance Service and Comparison of Algorithms for Adverse Drug Reaction Causality Assessment
Who cites it
29 citing papers in PubMed, 8 syntheses or guidelines pooled it, 72 citations in OpenAlex.
- Improving adverse drug event reporting by healthcare professionals.The Cochrane database of systematic reviews · 2024Pooled it
- Educational interventions in pharmacovigilance to improve the knowledge, attitude and the report of adverse drug reactions in healthcare professionals: Systematic Review and Meta-analysis.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2024Pooled it
- Understanding Primary Care Physician Vaccination Behaviour: A Systematic Review.International journal of environmental research and public health · 2022Pooled it
- How to promote adverse drug reaction reports using information systems - a systematic review and meta-analysis.BMC medical informatics and decision making · 2016Pooled it
- Tailored interventions to address determinants of practice.The Cochrane database of systematic reviews · 2015Pooled it
- Strategies to improve adverse drug reaction reporting: a critical and systematic review.Drug safety · 2013Pooled it
- Tailored interventions to overcome identified barriers to change: effects on professional practice and health care outcomes.The Cochrane database of systematic reviews · 2010Pooled it
- Pooled it
- Effectiveness of the modified TaWai mobile application for reporting adverse drug reaction in Lao PDR: a cluster randomized controlled trial.Scientific reports · 2024Trial
- Effect of an educational intervention to improve adverse drug reaction reporting in physicians: a cluster randomized controlled trial.Drug safety · 2015Trial
- A real-world data analysis of montelukast in FDA Adverse Event Reporting System (FAERS) database.BMC pharmacology & toxicology · 2025Article
- Outcomes of Community Pharmacy Interventions on Patients with Medicines Under Additional Monitoring.Integrated pharmacy research & practice · 2024Article
- Linking Activity Theory Within User-Centered Design: Novel Framework to Inform Design and Evaluation of Adverse Drug Reaction Reporting Systems in Pharmacy.JMIR human factors · 2023Article
- Delta-8, a Cannabis-Derived Tetrahydrocannabinol Isomer: Evaluating Case Report Data in the Food and Drug Administration Adverse Event Reporting System (FAERS) Database.Drug, healthcare and patient safety · 2023Article
- Pharmacists' experiences on adverse drug reaction: 10 years later.Frontiers in pharmacology · 2022Article
- A narrative review of evidence to guide deprescribing among older adults.Journal of general and family medicine · 2021Review
- Knowledge, awareness, perception and reporting of experienced adverse drug reactions among outpatients in Nigeria.International journal of clinical pharmacy · 2019Article
- Assessing the impact of structured education on the knowledge of hospital pharmacists about adverse drug reactions and reporting methods in Saudi Arabia: an open-label randomised controlled trial.Drugs & therapy perspectives : for rational drug selection and use · 2019Article
- Community pharmacists' knowledge and perspectives of reporting adverse drug reactions in Australia: a cross-sectional survey.International journal of clinical pharmacy · 2018Article
- Adverse Drug Reaction Reports Received Through the Mobile App, VigiBIPDrug safety · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAdverse 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.
methodsThe 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 ISRCTN45894687.
resultsAt 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.
conclusionsEducational outreach visits improve ADR reporting by pharmacists in terms of quantity and relevance.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.