Abstract
Adverse drug reactions (ADRs) are associated with morbidity and mortality worldwide. Although national systems for reporting ADRs exist there is a low reporting rate. The aim of the current study was to evaluate an intervention plan for improving ADRs reporting among medical professionals (physicians and nurses). A multicentre intervention study was conducted, in which one medical centre was randomly assigned to the intervention group and two medical centres to the control group. The study consisted of 3 phases: baseline data collection, intervention and follow-up of the reporting rate. The questionnaire that was filled in at base line and at the end of study, contained questions about personal/professional demographic variables, and statements regarding knowledge of and behaviour toward ADRs reporting. The intervention program consisted of posters, lectures, distant electronic learning and reminders. An increase in the number of ADRs reports was noted in the intervention group (74 times higher than in the control group) during the intervention period, which was gradually decreased with as the study progressed (adjusted O.R = 74.1, 95% CI = 21.11-260.1, p<0.001). The changes in the "knowledge related to behaviour" (p = 0.01) and in the "behaviour related to reporting" (p<0.001) score was significantly higher in the intervention group. Specialist physicians and nurses (p<0.001), fulfilling additional positions (p<0.001) and those working in other places (p = 0.05) demonstrated a high rate of report. Lectures were preferable as a method to encourage ADRs reporting. The most convenient reporting tools were telephone and online reporting. Thus, implementation and maintenance of a continuous intervention program, by a pharmacovigilance specialist staff member, will improve ADRs reporting rates.
Highlights
An integral part of drug therapy is the adverse reactions associated with the drug [1]
Studies around the world have demonstrated that 3–7% of all hospitalizations are a result of adverse drug reactions (ADRs) and 10–20% of inpatients suffer from drug-related adverse reactions [3, 6,7,8]
This study demonstrates that the rate of ADR reporting increased significantly during the intervention period, and declined gradually thereafter
Summary
An integral part of drug therapy is the adverse reactions associated with the drug [1] These reactions can cause personal injury, hospitalization overload and increase in health costs, thereby creating a heavy burden on national healthcare systems [2,3,4,5]. Serious ADRs were found to be the fourth to sixth causes of death in hospitalized patients in the US, leading to extended hospitalization and doubling of the cost of treating these patients [9,10] Both healthcare teams and patients share a common goal of early detection and prevention of ADRs. Pharmacovigilance is defined by the WHO as the science and activities relating to the detection, assessment, understanding and prevention of adverse reactions or any other drug-related problem. Inadequate ADR reporting may lead to loss of clinical information that could prevent substantial damage to patients and minimize health costs
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