Evaluation of adherence to established FDA and INVIMA regulations on the use of omeprazole in a high-complexity hospital in northeast Colombia

Abstract

Introduction: In clinical practice worldwide, proton pump inhibitors (PPIs) are widely used due to their effectiveness in treating various gastrointestinal disorders. However, they are not without adverse reactions, and their use should be strictly guided by precise clinical indications. Indiscriminate or prolonged use can increase the risk of side effects such as nutritional deficiencies, alterations in the gut microbiota, and a higher risk of bone fractures, among others. Therefore, their prescription must be based on an individualized evaluation of the patient and aligned with the indications provided by the United States Food and Drug Administration (FDA) and the Colombian National Institute for Food and Drug Surveillance (INVIMA).Objective:To evaluate adherence to FDA and INVIMA regulations regarding the use of omeprazole in a high-complexity hospital in northeastern Colombia. Methodology:Retrospective, observational study with a quantitative approach was conducted. A total of 373 medical records were analyzed, selected through non- probabilistic convenience sampling, applying inclusion and exclusion criteria. Data collection was carried out via documentary analysis using Google Forms. Descriptive statistical methods (tables and frequency graphs) and analytical methods, including ANOVA tests and Pearson correlation, were applied to evaluate the relationship between variables such as dosage, pathologies, and prescription years, as well as adherence to FDA and INVIMA regulations.Results:A total of 373 medical records of patients admitted to the emergency department with omeprazole prescriptions between January 2020 and 2024 were analyzed. Only 1.07% of the prescriptions met the indications established by the FDA and INVIMA. The most frequent associated pathologies were COVID-19 (12%), acute myocardial infarction (9%), and community-acquired pneumonia (5.4%), all without clinical indications for omeprazole use. Prescriptions were mainly made by general practitioners and internists, with the most common dosage being 40 mg IV/day. No significant differences were found in treatment duration between different doses. There was no significant association between dosage and the treated pathology, although a significant relationship was found with gastrointestinal conditions, especially upper gastrointestinal bleeding, emesis, and abdominal pain.Conclusions:The study revealed low adherence (1.07%) to FDA and INVIMA-approved indications for IV omeprazole use in a high-complexity hospital in northeastern Colombia. Omeprazole was frequently used in conditions without regulatory support and was often prescribed inappropriately, particularly among older adults with comorbidities. Most prescriptions were made by general practitioners in emergency settings. In response, an institutional protocol was developed to optimize its use, promote patient safety, and strengthen adherence to international clinical guidelines.