Uso de medicamentos off-label e a prevalência de reação adversa a medicamentos em unidade de terapia intensiva adulto de hospital público brasileiro

Abstract

Introduction: The use of off-label drugs is a prescribing practice different from the description contained in package inserts. In view of the high frequency of use of these drugs in the Intensive Care Unit (ICU), it is necessary to monitor the occurrence of adverse drug reactions (ADRs) related to these drugs. Objective: To identify the use of off-label drugs and the occurrence of ADRs in patients admitted to an adult ICU from March to August / 2018. Methodology: Variables such as age, sex and prescribed drugs were collected. Regarding the categorization of the use of off-label drugs, therapeutic indication, dosage, route of administration, type and volume of the diluent and time of administration were used. Drugs were classified as: label, off-label or unlicensed, the last two being defined using the databases available in the National Health Surveillance Agency (ANVISA) and MICROMEDEX 2.0. The pharmacotherapeutic profile was determined according to the Anatomical Therapeutic Chemical (ATC) classification. Potentially Hazardous Drugs (PHD) have been described. As for the development of ADR, the evaluation was according to the NARANJO algorithm, in which the suspected ADR drugs were dichotomized for label and off-label. Results: A total of 100 patients were included, the majority being male (n = 51; 51%) and with mean age of 56.72 years (SD: 17.48) years. The prevalence of off-label use was 73.0%, with 73.9% of these drugs being prescribed after admission to the ICU. Regarding the category of off-label se, 23.6% of uses were due to the volume of the diluent. The predominant drug class was systemic antimicrobials (16.8%). PHDs represented 68.7% of off-label drugs. 26 patients with suspected ADRs were registered, accounting 60 suspected ADRs. Of these, 85.0% resulted from off-label drug use. The most prevalent reactions were classified as probable (n = 49; 81.7%). Diarrhea was the most frequent outcome. There were significant associations between the use of off-label drugs and PHD prescriptions and occurrence of ADR (p <0.05). Conclusion: The findings showed that the occurrence of ADR was more prevalent in patients who had a higher number of off-label medications and PHD prescriptions. Prevention of ADRs is important for patient safety and must be at the forefront of safe medication practices.