Developing indicators and method of drug classification according to Thai law

Abstract

Keywords: Drug classification; Prescription only medicines; Pharmacy medicines; General sale list

Objective: This study aimed to develop suitable criteria, indicators and the method of drug classification according to the Drug Act, B.E.2510 (A.D.1967) and its amendments.

Methods: A 7-step study was carried out by first analyzing the Act, related laws, and minutes of the Drug Committee, followed by organizing the experts meeting and conducting an in-depth interview with knowledgeable persons involved in drug law and regulations. After collecting enough essential information and valuable opinions, the appropriate criteria and indicators for the drug classification as well as practical method of the classification were developed. Finally, all created tools were tested to ensure their validity.                                                                                           

Results: Five criteria including safety, related disease and diagnosis, administration, abuse/misuse and novelty were created. Under these five criteria, there are 16 indicators used for suitably classifying registered drugs in Thailand into three categories as special control drugs, dangerous drugs and over-the-counter (OTC) drugs.

Conclusion: The newly developed criteria with indicators and the method of drug classification can be effectively used to classify registered drugs in Thailand.