Omeprazole (Risek®) Use in Inpatient and Outpatient Departments: A Post-marketing Surveillance Investigation

Abstract

Proton pump inhibitors (PPIs) are widely used for the treatment of acid-related gastrointestinal disorders. However, their overuse or inappropriate prescription can lead to adverse effects, increased healthcare costs, and development of antibiotic-resistant infections. Objectives: To ascertain whether the Omeprazole (Risek®)-PPIs prescription patterns by practitioners in the inpatient and outpatient departments of various healthcare facilities in Pakistan are in compliance with the therapeutic indications and to evaluate the safety profile associated with each therapeutic indication. Methods: A cross-sectional multicenter study was conducted for 4 months at various healthcare facilities inpatient and outpatient departments. A total of 1384 patients ≥ 18 years prescribed Omeprazole (Risek®) were enrolled while pregnant or lactating women, patients with chronic diarrhea, those with a history of Omeprazole allergic reaction, and with diagnosed malignancy of the GI tract were excluded. The drug use was determined based on the prescribed frequency, dosage, and duration of therapy with respect to each indication. Results: Of the total, 29.8% were already taking oral PPI or Histamine H2-Receptor Antagonists. The common indication for Omeprazole (Risek®) was Gastroesophageal Reflux Disease (GERD), followed by peptic ulcer. Mostly the drug was infused/injected in 40 mg dosage, once daily and for five days among 76.6% and 41.8%, respectively. Around 13.3% of patients experienced mild adverse events like flatulence, fever, vomiting, abdominal pain, constipation, diarrhea, nausea, rash, etc. Most off-label uses were observed in GERD concerning the duration of therapy (55.9%), prescribed frequency (19.7%), and dosage (5.9%). The Omeprazole (Risek®) treatment was also prescribed for stress ulcer prophylaxis and upper GI bleeding against the treatment protocol for the particular therapeutic indication. The adverse events were most frequent among patients with GERD, followed by NSAID-induced ulcers. Conclusions: This study provides clinical evidence on the Omeprazole (Risek®) use in concordance with the product label, in both inpatient and outpatient departments of Pakistan for various therapeutic indications.