(177) Post-Marketing Safety Profile of Pethidine in Indonesia

Publication Number: 508

Background: Pethidine, along with Morphine and Tramadol, is one of the frequently used drugs for post-operative pain management. Though some countries and facilities have restricted Pethidine from their formularies, the agent is still widely prescribed around the world. It is important to ensure the product’s safety and, ultimately, the safety of the patients as users of Pethidine.

Objectives: We aim to evaluate the safety profile of Pethidine among the Indonesian population.

Methods: A post-marketing surveillance study was conducted with a retrospective cross-sectional design using medical records and hospital pharmacy data in patients admitted to the inpatient or emergency department of Dr. Sardjito General Hospital Yogyakarta between January and December 2016. The data were analyzed descriptively to estimate the proportion of adverse events (AEs), including serious adverse events (SAE). The causality analysis of AE/SAE was identified by a team panel of experts consisting of a pharmacologist, specialist doctor, epidemiologist, and pharmacist using Naranjo’s scores.

Results: Of the 576 patients hospitalized at the Dr. Sardjito General Hospital, 200 medical records were selected using a consecutive sampling method. A total of 120 of the 200 subjects were found to have 245 any Adverse Events (AE), including Serious Adverse Events (SAE) following the administration of Pethidine. There were 23 classifications of expected AE and 148 classifications of unexpected AE following the administration of Pethidine. The duration of AE/SAE found ranged from 0 to 11 days. A total of 101 (50.5%) and 85 (42.5%) subjects experienced AE/SAE with duration < 24 hours and between 1 to 2 days, respectively. The most extended duration of the event was pain with 11 days. There were 23 types of expected AE/SAE from Pethidine found in subjects, with the highest number of expected AE/SAE were weakness, vomiting, and dizziness of 24 (25%), 16 (16.8%), and 10 (10.5%), respectively. The expert panel team, with consideration of other concomitant medications, concluded five types of unexpected SAEs that are possible to Pethidine, including respiratory acidosis, urinary tract infections, acute kidney injury, icteric, and electrolyte imbalance.

Conclusions: A post-marketing surveillance study provides a 50 mg/ml pethidine safety profile in Indonesia. A total of 120 of the 200 subjects who received Pethidine experienced 245 Adverse Events (AEs) or Serious Adverse Events (SAEs). AEs/SAEs were divided into 23 expected events and 148 types of unexpected events. According to expert panel review, few SAEs were considered possibly related to Pethidine. No evidence emerged of previously unknown side effects.