The Preparation of the Positive List of Thai Traditional Medicine Formulas Based on Priority Setting
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Abstract
The preparation of the ‘Positive List of Thai Traditional Medicine Formulas’ was first carried out during the
fiscal year 2019 for the manufacturers to use as a reference when applying for permission to manufacture listed Thai Traditional Medicine formulas or preparations (TTMP) using a listing method, based on the Herbal Products Act B.E. 2562 (2019). The selection of TTMP for inclusion in the positive list is based on the priority setting principle. This article aims to share experiences in the application of the priority setting method for selecting and including a TTMP in the first version of the Positive List which makes the TTMP selection an evidence-based, systematic and transparent approach. Initially, the selection criteria in health care issues were reviewed, gathered and weighed. The weight and scores of the four main selection criteria were then determined, namely 1) efficacy, 2) safety, 3)quality control, and 4) others, i.e. the number of herbal ingredients in the TTMP, whether the TTMP help solve national health problems, and domestic availability of the herbal materials. The scoring of each TTMP was therefore evidence-based and verifiable. However, as it has been known, the availability of evidence regarding efficacy and safety of most TTMP was limited and only a long history of use could be taken into account. Meanwhile, the quality control data was available more for crude drugs than for TTMP. Hence, due to the limitation of the evidence, the selection criteria for TTMP inclusion in the Positive List may need to be revised using an evidence-based approach to the selection of potential TTMP for further research to determine their efficacy, safety and quality. In addition, all stakeholders should get involved in the selection process in order to have TTMP that meet the demand of the users and the manufacturers.
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References
Prioritization Centers for Disease Control and Prevention: Centers for Disease Control and Prevention. Assessment protocol for excellence in Public Health. [Internet] [cited 2019 Apr 26]; Available from: https://www.cdc.gov/nphpsp/documents/Prioritization%20section%20from%20APEXPH%20in%20Practice.pdf.
Sabik LM, Lie RK. Priority setting in health care: Lessons from the experiences of eight countries. Int J Equity
Health. 2008;7:4.
Lertpitakpong C, Chaikledkaew U, Thavorncharoensap M, Tantivess S, Praditsitthikorn N, Youngkong S,
Yothasamut J, Udomsuk K, Sinthitichai K, Teerawattananon Y. A determination of topics for health technology
assessment in Thailand: making decision makers involved. J Med Assoc Thai. 2008;91(Suppl 2):S100-9.
Mohara A, Youngkong S, Velasco RP, Werayingyong P, Pachanee K, Prakongsai P, Tantivess S, Tangcharoensathien V, Lertiendumrong J, Jongudomsuk P, Teerawattananon Y. Using health technology assessment for informing coverage decisions in Thailand. J Comp Eff Res. 2012;1(2):137-46.
National Drug Policy Group. National Lists of Essential Medicine and Evidence-based. [Internet]. 2019 [cited
Apr 14]; Available from: http://ndi.fda.moph.go.th/drug_national. (in Thai)
Chuthaputti A. Herbal medicines in National Lists of Essential Medicines and Evidence-based. [Internet].
[cited 2019 Apr 14]; Availabel from: http://cro.moph. go.th/cppho/download/1861.pdf. (in Thai)
Okello D, Chongtrakul P, COHRED Working Group on priority setting. A manual for research priority setting
using the ENHR strategy. Geneva: Council on Health Research for Development; 2000. 47 p.
Terwindt F, Rajan D, Soucat A. Priority-setting for national health policies, strategies and plans. Geneva:
World Health Organization; 2016. 71 p.
Yothasamut J, Werayingyong P, Teerawattananon Y. Priority setting in health technology assessment in
Thailand: experience from the health intervention and technology assessment program. JPHD. 2009;7(2):101-16.
(in Thai)
International Health Policy Program, Health International and Technology Assessment Program. Research for
development of health benefit package under universal health care coverage scheme; Issue 1. Nonthaburi: THE
GRAPHICO SYSTEMS CO.,LTD.; 2011. 284 p. (in Thai)
The Comptroller General’s Department, Ministry of Finance. Selection criteria of National Essential Drug
List B.E. 2547. [Internet]. [cited 2019 Apr 29]; Available from: https://www.cgd.go.th
Drug Control Division. Guildline of using National Lists of Essential Medicine B.E. 1999. Seminar of National
Lists of Essential Medicine BE 1999; 21 July 1999; Rama Garden Hotel. Bangkok: Food and Drug Administrator;
91 p.
Chongtrakul P, Sumpradit N, Yoongthong W. ISaf E and the evidence-based apporach for essential medicines
selection in Thailand. Essential Drugs Monitor. 2005;34:18-9.
National Drug System Development Committee. National Lists of Essential Medicine B.E. 2556. In: Thai
Subcommittee of National List of Essential Medicines, editor. Nonthaburi: The Agricultural Co-operative Federation of Thailand, LTD, Publish; 2013.
Wibulpolprasert S. The need for guidelines and the use of economic evidence in decision-making in Thailand:
Lessons learnt from the development of the National List of Essential Drugs. J Med Assoc Thai. 2008;91(Suppl
:S1-3.
Limpananont J, Amnuoypol S, Chantraket R. Development of Lists of Herbal Medicine for National Lists of
Essential Medicines. In: Chokevivat V, Wibulpolprasert S, Petrakart P, editors. Health Profiles: Thai traditional,
alternative and indigenous medicine 2008-2009. The War Veterans Organization: Department of Thai Traditional
and Alternative Medicine; 2009. p. 166-7. (in Thai)
World Health Organization. Minimum requirements for assessment of the efficacy of herbal medicines.
Guidelines for the regulation of herbal medicines in the South-East Asia Region. Geneva,Switzerland; 2004. p.
-8
Thai Traditional Medicines and Herbal Medicine Group. Manual of traditional medicines registration. Drug Control Devision, editor. Nonthaburi: Thai Food and Drug Administration; 2018. 104 p. (in Thai)
World Health Organization. General guidelines for methodologies on research and evaluation of traditional
medicine. Geneva: World Health Organization; 2000. 74 p.
World Health Organization. WHO Global report on traditional and complementary medicine 2019. Luxembourg: World Health Organization; 2019. 226 p.
Prathanturarug S. Situation of knowledge management, research and development of Thai traditional medicines. In: Petrakart P, Chantraket R, editors. Report of situation of Thai traditional medicine, indigenous medicine, and alternative medicine B.E. 2548–2550. Nonthaburi: Manus Film; 2007. p. 76-89. (in Thai)
Guideline of trational medicine registration regarding to microbial and heavy metals contamination. Published in Government Gazette, Vol. 121 (2004 Apr 21) (in Thai).
Ministerial Regulation No.25. Published in Government Gazette, Vol. 111 (51Kor) (1994 Nov 16) p. 39-42. (in Thai).
Tosanguan K, Kapol N, Thavorncharoensap M, Suksomboon N, Kulpeng W, Tantivess S, Teerawattananon Y.
Views of health professionals on herbal medicine and policy for promotion of herbal medicine use in healthcare
settings. Journal of Health Systems Research. 2011;5(4):513-21. (in Thai)
WHO Expert Committee on Specifications for Pharmaceutical Preparatons. WHO guidelines for selecting
marker substances of herbal origin for quality control of herbal medicines. World Health Organization; 2017. p
-86.
Kwankhao P, Chuthaputti A, Tantipidok Y, Pathomwichaiwat T, Theantawee W, Buabao S, Chantraket
R, Puttarak P, Petrakart P, Chinsoi P, Chungsiriporn D, Bongcheewin B, Sermsinsiri V. The current situation of
the herbal medicinal product system in Thailand. Journal of Health Science. 2020;29(Suppl.):S82-95.
Chinnacom D, Doungthipsirikul S, Poonchai A, Patchanee K, Prakongsai P. Health technology assessment and
the development of benefit packages under the universal coverage scheme. Journal of Health Systems Research.
;13(1):34-46. (in Thai)