A Post-Marketing Study of Pethidine in Indonesia: Safety Profile

Abstract

Introduction Pethidine along with morphine and tramadol, is one of the frequently used drugs for postoperative pain management. It is important to ensure the safety of the product and ultimately the safety of the patients as users of the pethidine. Methods A post marketing surveillance study was conducted with a retrospective cross-sectional design using medical records and hospital pharmacy’s data in patients who were admitted to inpatient or emergency department of Dr. Sardjito General Hospital Yogyakarta between January and December 2016. The data was analyzed descriptively to estimate the proportion of adverse events (AEs) including serious adverse events (SAE). Results Of the 576 patients hospitalized at the at the Dr. Sardjito General Hospital, 200 medical records were selected using 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 longest duration of event was pain with duration of 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 concluded five types of unexpected SAEs which are possible to pethidine, including respiratory acidosis, urinary tract infections, acute kidney injury, icteric, and electrolyte imbalance. Conclusion A post-marketing surveillance study provides safety profile of 50 mg / ml pethidine 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 types of expected events and 148 types of unexpected events. Few numbers of SAEs were considered possible related to the pethidine according to expert panel review.   Keywords: pethidine, meperidine, post-marketing, pharmacovigilance