Reporting System of High-risk Drug Abuse of Thai Food and Drug Administration: A Case Study of Tramadol

Abstract

Background: Tramadol is an opioid group that used as a pain reliever for moderate to severe pain. However, some effects were euphoria that was caused by the combination of this, which relieved pain, and the depressant effect of the nervous system. Therefore, it was found as used in an inappropriate among Thai adolescents. The Thai Food and Drug Administration, which is responsible for overseeing and regulating the distribution of high-risk drugs, has a reporting system that cover the import of pharmaceutical chemicals and finished drugs, the manufacture of finished medicines, and the distribution of finished medicines. However, there were no adequate studies on the reporting system in controlling the distribution of high-risk drugs.

Objectives: To analyze import data of pharmaceutical chemicals and finished drugs of tramadol produced within the country, as well as evaluate tramadol distribution controls from the Food and Drug Administration's reporting system.

Methods: This research was descriptive research. Population data was the importing volumes of pharmaceutical chemicals and tramadol, and tramadol production between 2017 and 2018 from the information in the reporting system (License per Invoice: LPI), also reporting information that licensees bring or order modern drugs into the Kingdom from modern drug manufacturers reporting to the Thai FDA. The amount of pharmaceutical chemicals used was then calculated backwards by using the formula 1,000,000 mg/50 mg = number of capsules or tablets or water pills, where one capsule/tablet/potion contains 50 mg of API Tramadol to compare the imported quantities with the quantity produced.

Results: From the report of imports of pharmaceutical chemicals used to produce tramadol in the LPI base during the years, it was found that the total imported volume was 17,360 kg, classified in 2017 and 2018, amounting to 14,550 and 2,810 kg, respectively. When considering the data on the sale of pharmaceutical chemicals through the FDA Reporter system, under which the law has been in force since May 2018, it found that the import of raw material reports amounted to 12,971.02 kg and had a sales report of 7,633 kg (58.85%) by selling to licensees to produce modern drugs and modern drug sales licensees, 95.41 and 4.59 %, respectively. However, when reviewing the report of the sale of pharmaceutical chemicals to the pharmaceutical licensee and the list of 53 raw materials used in the production of drugs, it was found that the consistency was 7.55%. Only in 2017, there were reports of 93,221,290 capsules/tablets/ml, which were classified as 55.19% capsules, 3.85% tablets, and 40.96% liquid pills. When calculating the amount of finished drug tramadol produced reverted to the number of pharmaceutical chemicals used in production, it was found that the information was consistent at 92.37%. And in terms of considering the amount of tramadol-finished drugs imported for sale in the country in the LPI base during the last 2 years, it was found that 1,251,250.00 capsules were imported. The list of drugs brought or ordered to Thailand found that they were not 100% consistent with the legal form. For the evaluation of tramadol distribution control from the reporting system, it was discovered that it had vague information that was not in a form that could be readily analysed. For example, the form does not specify what information to enter; specific data with a lack of important information to link specific data, such as production data in the Batch Processing Record (BPR) stored at the production site, resulting in no data linking the whole system; etc.

Conclusions: The existing tramadol drug reporting system of the Thai FDA could control the distribution of pharmaceutical chemicals in the country in terms of import volume. On the other hand, there were restrictions that do not cover the sale of pharmaceutical chemicals; missing links to important information due to legal requirements; and the form for importing the finished drug tramadol did not specify a clear reporting format. Therefore, the law should be tightened to control the distribution of high-risk drugs, improve the form of the report, add data links in databases to verify the data rechecking, and develop it into a whole digital reporting system.