Tu1171 INCIDENCE OF ADVERSE DRUG REACTIONS OF POLYETHYLENE GLYCOL ELECTROLYTES POWDER: THE ANALYSIS OF REPORTS IN CHINA

Abstract

Since 2018, the National Medical Products Administration of China has issued a notice on the Direct Reporting of Adverse Drug Reactions (ADRs) by Marketing Authorization Holders (MAH), which has ushered in a new era in the reporting of ADRs in China. Objective: Niflec (Polyethylene Glycol Electrolytes Powder, PEG-ELP) is one of the most widely used oral intestinal lavage preparation agents in China. The purpose of this study is to analyze the incidence of Niflec ADRs reported in the database of ADR monitoring system in the first six months after the MAH reporting policy, and to evaluate the clinical safety of Niflec. The reports of ADRs caused by Niflec were screened out from the database of ADR monitoring system, and they were analyzed by gender, age, primary disease, concomitant drugs, occurrence time, history of allergy, ADR types, causality, and severity. From December 15, 2018 to June 15, 2019, thirty-two ADR cases were reported, including one serious adverse event. The adverse reactions were more in patients aged 60 and over (50.0%) and more in female (71.9%). Only one patient had a clear history of drug allergy. The main adverse reactions occurred in the gastrointestinal system (53.1%) or skin and mucous membrane (34.4%). The top three manifestations were vomiting, nausea and rash. Most of the ADRs were observed within 30 minutes after the first use, accounting for 37.5%. Concomitant drugs were taken by 9.4% of the patients. The one serious adverse event was intestinal obstruction with shock. According to Pharmaceutical DataBase (PDB) data, the market size of Niflec in China was approximately 2 million bags in the first and second quarter of 2019. The number of drug users was estimated to be 679,896. Based on the above analysis, the overall incidence of ADR of Niflec was relatively low, less than 5 per 100,000 patients. The total incidence of serious ADR was less than 1.5 per million, which was very rare. All patients recovered or improved after proper treatments. The safety of PEG-ELP is confirmed by this study. However, it is still necessary to pay attention to the correct preparation and proper use. The bowel preparation personnel should be alert to monitor ADRs, especially on patients aged 60 and over, and take corresponding measures if any of these reactions are encountered.