DEVELOPING INDONESIAN GUIDELINES ON CLAIMS FOR HEALTH SUPPLEMENTS FOR THE ELDERLY BASED ON ASEAN GUIDELINES USING THE DELPHI TECHNIQUE

Abstract

In Indonesia, specific regulation on health supplement claims is yet to be developed. Clear guidance is needed for Health Supplement (HS) registrants who have registered their product to the Indonesian National Agency for Drug and Food Control. Regarding the content of new standards or regulations, the traditional way of pooling opinions is through face-to-face meetings. This study aims to develop the Indonesian Guidelines on Claims for Health Supplements for the Elderly (IGCHSE) using the Delphi technique. The method is employed to gain insight into the needs of all the stakeholders in order to obtain qualified and quantified guideline content. The main content of the IGCHSE is based on ASEAN guidelines on claims, which is in line with ASEAN harmonization of standard implementation. Some adaptations and modifications to the current Indonesia regulations, together with a review of international regulations on claims, have been used to enrich and expand the guideline content. The two-round Delphi technique process aimed to obtain consensus on the IGCHSE concept. Representatives from internal and external organizations worked together as an expert panel to develop and establish the guidelines. In the first round, the experts were given a structured questionnaire of items in the draft of guideline, interspersed with the ASEAN guidelines on claims. The list of items in the guideline concept was rated by the Delphi experts using a 5-point Likert scale. The feedback process allowed for and encouraged the Delphi experts to reassess their initial evaluation of the information provided in the previous version of the draft guidelines. This information was used to redevelop the second version. In the analysis, in rounds one and two the consensus data were calculated based on the median, inter-quartile range, quartile deviation, standard deviation and coefficient variation. In the two rounds of the Delphi panel, the median value was higher than 4, and the frequency of the 4 and 5 percentage values was higher than 50%, showing that the level of importance of the items was high. According to the level of consensus, the quartile deviation (QD) rate of the Round 2 Delphi panel was lower or equal to 0.5 (QD ≤ 0.5), which means that all items achieved consensus. In conclusion, the IGCHSE concept reached consensus by using the two round Delphi techniques.