Investigation of the Reporting System of Schedule-4 Psychotropic Substances in Thailand: A Case Study of Pinazepam

Abstract

Objectives: The leakage of schedule-4 psychotropic substances from the formal distribution channel is a crucial problem but still unexplored. This study aimed to investigate the reporting system of the substances using pinazepam as a study drug. Method: In this cross-sectional study, we investigated the reports both in paper-based and online formats submitted to the FDA during 2014 – 2015. These reports were obtained from manufacturers, importers, distributors, healthcare facilities and drugstores. Data of purchase and sale volume at each step of distribution were compared and reported as descriptive statistics, i.e. frequencies and percentages. Results: In 2014, 40 kg of pinazepam was imported to Thailand, i.e. 15 kg being permitted to manufacture finished product for domestic use and 25 kg for exportation. Seven batches of the finished products for domestic use were produced with a capacity of 2,639,500 capsules (or 94.27% actual yield). After the sale of 1,990,000 capsules to 168 healthcare facilities and drugstores combined, 649,500 capsules were left in the inventory of the manufacturers and distributors (as of July 31, 2015). As only 64 healthcare facilities and drugstores (38.10%) submitted the reports to the FDA, the distribution to the consumers could not be examined. Conclusion: There was no leakage of pinazepam in the distribution from the manufacturers to the healthcare facilities and drugstores. However, the distribution to the consumers could not be verified. It is recommended that more officers should be allocated to the data verification task and a more comprehensive online reporting system should be in place. Keywords: reporting system, schedule-4 psychotropic substances, pinazepam