Adverse drug reactions detected by stimulated spontaneous reporting in an internal medicine department in Romania

Abstract

Background: It is generally recognized that adverse drug reactions (ADRs) represent a major concern of health systems in terms of early recognition, proper management and prevention. The aims of this study were to identify the most frequent ADRs recognized by the attending physicians, study their nature and target these ADRs in order to take future preventive measures.

Methods: A prospective study was conducted over a 12-month period in an internal medicine department using stimulated spontaneous reporting for identifying ADRs. All ADRs reported by physicians were followed up to the patient's discharge and evaluated by an independent group of pharmacologists. Causality, severity and preventability were assessed.

Results: Of the 1854 admissions, 112 ADRs in 94 patients (5.07%) were validated from the total of 118 ADRs reported. The overall incidence of serious ADRs in the hospitalized patients was 4.7%. According to the MedDRA classification, the most frequent ADRs affected the gastrointestinal system, followed by metabolic and vascular systems. The drugs most frequently involved were cardiovascular agents, anticoagulants and NSAIDs. Drug interactions were responsible for 25.9% of ADRs. According to the selected preventability scale, 40.18% ADRs were classified as 'potentially preventable' and 9.82% 'definitely preventable'. Most of the ADRs were 'type A' reactions and as such could have been avoided simply by adjusting the doses or by avoiding drug interactions.

Conclusions: Serious ADRs in hospitalized patients are common and often preventable. Preventing strategies should target drug prescription. Adequate training regarding pharmacology and optimization of drug therapy might help reduce ADRs' morbidity and mortality.