Prescription and Non-Prescription Drug Classification Systems Across Countries: Lessons Learned for Thailand

Abstract

Purpose

The drug classification system, as prescription or non-prescription drug category, has been utilized as a regulatory strategy to ensure patient safety. In Thailand, the same system has been used for decades, though the drug classification criteria were updated to accommodate drug re-classification in 2016. These new criteria, however, have not been applied retroactively. Inconsistency in drug classification has been observed leading to concerns regarding the drug classification system. This has prompted the need for a review of the drug classification system in Thailand. This study aims to explore Thailand and other selected countries’ regulatory management regarding the drug classification system, drug classification criteria, and drug classification itself.

Methods

The drug classification systems of the United States, the United Kingdom, Japan, Singapore, Malaysia, the Philippines, and Canada were selected to study alongside Thailand’s system. The regulatory review was conducted through each country’s drug regulatory agency website and available published research. Complementary interviews with drug regulatory authorities were conducted when written documentation was unclear and had limited access. Fifty-two common drugs were selected to compare their actual classifications across the different countries.

Results

All selected countries classified drugs into two major groups: prescription drugs and non-prescription drugs. The studied countries further sub-classified non-prescription drugs into 1–4 categories. Principles of drug classification criteria among countries are similar; they comprised of three themes: disease characteristics, drug safety profile, and other drug characteristics. Actual drug classification of antibiotics, dyslipidemia treatments, and hypertension treatments in Thailand are notedly different from other countries. Furthermore, 77.4% of drugs studied in Thailand fall into the behind-the-counter (dangerous) drug category, which varied from antihistamines to antibiotics, dyslipidemia treatments, and vaccines.

Conclusion

Thailand’s drug classification criteria are comparable with other nations; however, there is a need to review drug classification statuses as many drugs have been classified into improper drug categories.

Keywords:

• drug category
• classification criteria
• prescription
• non-prescription
• OTC
• drug regulatory

Acknowledgments

The Scholarship from the Graduate School, Chulalongkorn University to commemorate the 72nd anniversary of his Majesty King Bhumibol Adulyadej is gratefully acknowledged.

We also would like to extend our appreciation to Assistant Professor Rungpetch Sakulbumringsil, Assistant Professor Suthira Taychakhoonavudh, and Associate Professor Susi Ari Kristina, for their recommendations, which helped to improve this study.

In addition, our sincere thanks also goes to Nattaporn Piensaknusorn and Sirisopa Nakawong, Nantarat Sukrod, Dr Mohd Shahezwan Abd Wahab, Mallenrose Kristine Marcelo Ofrecio, Taichi Hiraga, and Fumiya Seki for providing valuable information and translating several non-English documents. Last, but not least, we would like to thank Stephen Pinder and Laura Saxton for their dedicated English proofreading.

Disclosure

Noppadon Adjimatera is a committee of the Thailand Self Medication Industry Association and an employee of Reckitt Benckiser (Thailand) Ltd. Lawanworn Broese Van Groenou is an employee of DKSH (Thailand) Limited. The authors report no other potential conflicts of interest in this work.