ABSTRACT
OBJECTIVES: Underreporting of adverse drug reactions (ADRs) limits and delays the detection of signs. The aim of this systematic review with meta-analyses was to synthesize the evidence of educational interventions (EIs) efficacy in health professionals to increase ADR reporting, attitudes, and knowledge of pharmacovigilance. EVIDENCE ACQUISITION: A systematic literature review was carried out to identify randomized clinical trials evaluating the efficacy of EI in pharmacovigilance in health professionals to improve ADR reports, knowledge, and attitude toward pharmacovigilance. ADR reports were pooled by calculating Odds Ratio (OR) with a 95% confidence interval (95%CI), while pharmacovigilance knowledge and attitude were pooled by calculating a mean difference (MD) with 95%CI. In addition, the subanalysis was performed by EI type. Meta-analysis was performed with RevMan 5.4 software. PROSPERO registry CRD42021254270. RESULTS: Eight hundred seventy-five articles were identified as potentially relevant, and 11 were included in the systematic review. Metanalysis showed that EI increased ADR reporting in comparison with control group (OR = 4.74, [95%CI, 2.46 to 9.12], I2 = 93%, 5 studies). In subgroup analysis, the workshops (OR = 6.26, [95%CI, 4.03 to 9.73], I2 = 57%, 3 studies) increased ADR reporting more than telephone-based interventions (OR = 2.59, [95%CI, 0.77 to 8.73], I2 = 29%, 2 studies) or combined interventions (OR = 5.14, [95%CI, 0.97 to 27.26], I2 = 93%, 3 studies). No difference was observed in pharmacovigilance knowledge. However, the subanalysis revealed that workshops increase pharmacovigilance knowledge (SMD = 1.85 [95%CI, 1.44 to 2.27], 1 study). Only one study evaluated ADR reporting attitude among participants and showed a positive effect after the intervention. CONCLUSION: EI improves ADR reports and increases pharmacovigilance knowledge. Workshops are the most effective EI to increase ADR reporting.
Subject(s)
Adverse Drug Reaction Reporting Systems , Drug-Related Side Effects and Adverse Reactions , Health Knowledge, Attitudes, Practice , Health Personnel , Pharmacovigilance , Humans , Health Personnel/education , Drug-Related Side Effects and Adverse Reactions/prevention & controlABSTRACT
INTRODUCTION: Midazolam is a benzodiazepine used for sedation, however, can cause respiratory depression and increases morbidity in patients. Melatonin is an effective alternative to manage anxiety in the perioperative period and could help to reduce the use of benzodiazepines during surgery. The aim of this clinical trial was to determine the efficacy of pre-operative sedation with a single-dose melatonin to reduce intraoperative use of midazolam in women under total abdominal hysterectomy (TAH). MATERIALS AND METHODS: This is a double-blind randomized clinical trial conducted in women over 25 years, scheduled for TAH, with American Society of Anesthesiologists Grade I or II. Each patient was randomly assigned to receive 5 mg of melatonin prolonged-release oral capsules or placebo. Midazolam use for anesthetic management was the decision of the treating anesthesiologist and sedation status was determined using the observer's assessment of alertness/sedation scale. RESULTS: In patients receiving melatonin, the use of midazolam during surgery was less than in patients receiving placebo. In addition, melatonin produces sedation 30 min after administration, the sedative effect was maintained at 60- and 90-min. Furthermore, hospital stay was shorter in patients who received melatonin (p = 0.006). CONCLUSION: Melatonin is effective for reduces intraoperative midazolam consumption and hospital stay in women undergoing TAH.
INTRODUCCIÓN: El midazolam es una benzodiazepina utilizada para la sedación, sin embargo, puede causar depresión respiratoria y aumentar la morbilidad en los pacientes. La melatonina es una alternativa eficaz para controlar la ansiedad en el período perioperatorio y podría ayudar a reducir el uso de benzodiazepinas durante la cirugía. El objetivo de este ensayo clínico fue determinar la eficacia de la sedación preoperatoria con una dosis única de melatonina para reducir el uso intraoperatorio de midazolam en mujeres sometidas a histerectomía abdominal total (HTA). MATERIAL Y MÉTODOS: Se trata de un ensayo clínico aleatorizado doble ciego realizado en mujeres mayores de 25 años, programadas para TAH, con American Society of Anesthesiologists Grado I o II. Cada paciente fue asignado al azar para recibir 5 mg de cápsulas orales de liberación prolongada de melatonina o placebo. El uso de midazolam para el manejo anestésico fue decisión del anestesiólogo tratante y el estado de sedación se determinó mediante la escala OAA/S. RESULTADOS: En las pacientes que recibieron melatonina, el uso de midazolam durante la cirugía fue menor que en las pacientes que recibieron placebo. Además, la melatonina produce sedación 30 min después de la administración, el efecto sedante se mantuvo a los 60 y 90 min. Además, la estancia hospitalaria fue más corta en los pacientes que recibieron melatonina (p = 0.006). CONCLUSIÓN: La melatonina es eficaz para reducir el consumo de midazolam intraoperatorio y la estancia hospitalaria en mujeres sometidas a HTA.
