An educational intervention to improve physician reporting of adverse drug reactions: a cluster-randomized controlled trial

JAMA : the Journal of the American Medical Association
Adolfo FigueirasJuan Jesus Gestal-Otero

Abstract

Data on the adverse effects of newly marketed drugs are limited. Voluntary reporting is an important part of postmarketing surveillance but is underused by physicians. To evaluate the effectiveness of educational outreach visits for improving adverse drug reaction (ADR) reporting by physicians. A cluster-randomized controlled trial covering all National Health System physicians in the north of Portugal, with intervention in March 2004 through July 2004, and 13 to 16 months of follow-up. A total of 1388 physicians were assigned in 4 spatial clusters to the intervention group, and 5063 were assigned in 11 clusters to the control group. One-hour educational outreach visits tailored to training needs identified in a previous study. Change in total number of reported ADRs and number of serious, high-causality, unexpected, and new-drug-related ADRs, using generalized linear mixed models adjusted for baseline ADR reporting, age, specialty, and work setting. At baseline, ADR reporting rates (per 1000 physician-years) did not differ significantly between the intervention groups and the control groups in reporting ADRs overall (7.6 vs 11.3), nor did they differ significantly by category: serious, 4.3 vs 6.0; high-causality, 5.4 vs 7.6; u...Continue Reading

Associated Clinical Trials

May 9, 2014·Fabiana Rossi Varallo, Fabiana Rossi Varallo

Citations

Oct 16, 2009·International Archives of Occupational and Environmental Health·Annet F LenderinkFrank J H van Dijk
Jul 14, 2012·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Maria T HerdeiroAdolfo Figueiras
May 4, 2013·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Cristian Gonzalez-GonzalezAdolfo Figueiras
Apr 7, 2009·Substance Abuse : Official Publication of the Association for Medical Education and Research in Substance Abuse·Steven L BernsteinKarin V Rhodes
Nov 13, 2008·BMJ : British Medical Journal·Merrick ZwarensteinPragmatic Trials in Healthcare (Practihc) group
Aug 13, 2009·BMC Clinical Pharmacology·Kazeem A Oshikoya, Jacob O Awobusuyi
Dec 3, 2013·International Journal of Technology Assessment in Health Care·Caroline PagottoPatrícia Mastroianni
Mar 7, 2012·American Journal of Public Health·Julius Sim, Angus Dawson
Mar 10, 2007·European Journal of Clinical Pharmacology·Susanna M WallerstedtLars Ny
Jan 8, 2009·European Journal of Clinical Pharmacology·Marie-Louise JohanssonSusanna M Wallerstedt
Jun 17, 2010·European Journal of Clinical Pharmacology·Gloria CerezaJosep M Arnau
Jun 19, 2012·European Journal of Clinical Pharmacology·Chiara BiagiDomenico Motola
Sep 1, 2008·Expert Review of Clinical Pharmacology·Peter Ian Pillans
Nov 6, 2014·Expert Opinion on Drug Safety·Niels S VermeerMarie L De Bruin
Jan 10, 2009·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Elena Lopez-GonzalezAdolfo Figueiras
Jan 10, 2009·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Consuelo PedrósJosep M Arnau
Nov 2, 2007·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Marta IrujoBerta Lasheras
Aug 13, 2011·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Roald GerritsenEugène van Puijenbroek
Sep 3, 2009·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Anneke PassierEugène van Puijenbroek
Jun 18, 2009·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Vincent NicholsJohanne Collin
May 11, 2011·Journal of the American Pharmacists Association : JAPhA·Paul GavazaMary Steinhardt
Oct 2, 2012·Journal of the American Pharmacists Association : JAPhA·Paul GavazaJames P Wilson
Sep 12, 2015·Journal of the American Society of Echocardiography : Official Publication of the American Society of Echocardiography·Kevin LevittR Sacha Bhatia
Dec 12, 2007·Seminars in Cutaneous Medicine and Surgery·Jonathan Cotliar
Jun 24, 2009·Pharmacoepidemiology and Drug Safety·N JarernsiripornkulN Nasritha
Sep 21, 2007·Transfusion·Kathryn E Webert
Jul 16, 2013·Journal of Clinical Pharmacology·Lee Hilary GoldsteinMatitiyahu Berkovitch
Jun 14, 2013·Pharmacoepidemiology and Drug Safety·Ana MiguelAltamiro Costa Pereira
Oct 21, 2015·Journal of Nursing Management·Joana Isabel O Mendes MarquesMaria T Herdeiro
May 18, 2016·Indian Journal of Endocrinology and Metabolism·Pramod Kumar SharmaPuneet Dhamija
Sep 10, 2013·Health Policy·Paolo PellegrinoSonia Radice
Dec 30, 2014·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Elena Lopez-GonzalezGREPHEPI group
Aug 26, 2014·Healthcare Informatics Research·Noriko NakamuraChiemi Maeda
Feb 16, 2016·Current Medical Research and Opinion·António Teixeira RodriguesMaria T Herdeiro
Jul 4, 2016·Reumatología clinica·José M Serra López-MatencioSantos Castañeda
Nov 19, 2010·Postgraduate Medicine·Richard PushkinStephanie Kim
May 5, 2016·Revista de saúde pública·Inês Ribeiro-VazRicardo Cruz-Correia
Feb 7, 2018·Medical Principles and Practice : International Journal of the Kuwait University, Health Science Centre·Jacinthe LemayTania Bayoud
Dec 23, 2017·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·François MontastrucJean-Louis Montastruc

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Hereditary Sensory Autonomic Neuropathy

Hereditary Sensory Autonomic Neuropathies are a group of inherited neurodegenerative disorders characterized clinically by loss of sensation and autonomic dysfunction. Here is the latest research on these neuropathies.

Spatio-Temporal Regulation of DNA Repair

DNA repair is a complex process regulated by several different classes of enzymes, including ligases, endonucleases, and polymerases. This feed focuses on the spatial and temporal regulation that accompanies DNA damage signaling and repair enzymes and processes.

Glut1 Deficiency

Glut1 deficiency, an autosomal dominant, genetic metabolic disorder associated with a deficiency of GLUT1, the protein that transports glucose across the blood brain barrier, is characterized by mental and motor developmental delays and infantile seizures. Follow the latest research on Glut1 deficiency with this feed.

Separation Anxiety

Separation anxiety is a type of anxiety disorder that involves excessive distress and anxiety with separation. This may include separation from places or people to which they have a strong emotional connection with. It often affects children more than adults. Here is the latest research on separation anxiety.

KIF1A Associated Neurological Disorder

KIF1A associated neurological disorder (KAND) is a rare neurodegenerative condition caused by mutations in the KIF1A gene. KAND may present with a wide range and severity of symptoms including stiff or weak leg muscles, low muscle tone, a lack of muscle coordination and balance, and intellectual disability. Find the latest research on KAND here.

Regulation of Vocal-Motor Plasticity

Dopaminergic projections to the basal ganglia and nucleus accumbens shape the learning and plasticity of motivated behaviors across species including the regulation of vocal-motor plasticity and performance in songbirds. Discover the latest research on the regulation of vocal-motor plasticity here.