Thai Food and Drug Journal

Editorial

Thanakrish Prasertsarn — 2024-10-28

Software Artificial Intelligence for Medical Device Regulation in Thailand

Nakorn Tangwancharoenchai — 2024-10-28

Factors Associated with Dietary Supplement Consumption Behaviour among Men Who Have Sex with Men

Jirawat Timasan — 2024-10-28

Background: Men who have sex with men (MSM) group is a demographic group that values physical appearance in order to be accepted in society and be a source of sexual attraction to gay men themselves. Dietary supplements may be sought to help enhance health and physical appearance according to the values of the MSM group. The MSM therefore a group at risk for side effects that are harmful to their health from inappropriate dietary supplement consumption behaviour.

Objectives: This survey research aimed to explore dietary supplement consumption behaviour and the factors associated with dietary supplement consumption behaviour among the MSM.

Methods: This study was cross-sectional survey research between December 2023 to February 2024, using the PRECEDE-PROCEDE model in phase 3 educational and ecological assessment. This model included predisposing, enabling and reinforcing factors, along with the theory of reasoned action to develop a conceptual framework for analyzing the variables of concern. The samples comprised of 318 people, receiving health services at the Rainbow Sky Medical Technical Clinic Ramkhamhaeng Branch and the Rainbow Sky Association of Thailand. Participants were selected using purposive sampling methods. The data were collected using an online self-administered questionnaire via Google Forms and analyzed using descriptive statistics, including frequency, percentage, mean, and standard deviation. Correlations were analyzed showed Pearson correlation coefficient, One-way ANOVA and Independent t-test.

Results: The results showed that the majority of samples were aged between 19 to 62 years old, their average income were 29,762.07 THB, most of them graduated in undergraduate (70.40%), no underlying diseases (74.80%), occupation in company employee (60.40%) and most of them had sex role in both (43.40%), top (36.50%) and bottom (43.40%) respectively. The result of predisposing factors included body image values (mean = 4.16) was at high level. their dietary supplement consumption attitudes (mean = 3.57) and subjective norms beliefs (mean = 3.53) were at moderate level. Reinforcing factors include channel of distribution accessibility (mean = 3.63) was at moderate level. Enabling factors include influence of media about dietary supplement consumption (mean = 3.59) was at moderate level. Dietary supplement consumption behaviour (mean = 3.26) was at moderate level. Factors significantly positive associated with dietary supplement consumption behavior included education level (F = 3.81, p-value = 0.023), body image values (r = 0.27, p-value = 0.001), dietary supplement consumption attitudes (r = 0.16, p-value = 0.003), subjective norms beliefs (r = 0.43, p-value < 0.001), channel of distribution accessibility (r = 0.41, p-value < 0.001), influence of media about dietary supplement consumption (r = 0.37, p-value < 0.001).

Conclusions: The MSM group had moderate dietary supplement consumption behavior. They placed a high value on physical appearance, but there was an attitude towards consumption, conformity to the reference group, access to distribution sources, and the influence of the media on the decision to consume dietary supplements at a moderate level. Factors that had a positive relationship with dietary supplement consumption behaviour that was statistically significant included education level, physical appearance values, attitude towards consumption, conformity to the reference group, access to distribution sources, and the influence of the media on decision-making. The findings of this study can be used to design health policy, health education and health promotion intervention program to promote more appropriate dietary supplement consumption behavior among the MSM.

Optimization and Validation of the HPAEC-PAD Method for Quantifying Vi Polysaccharide in the Typhoid Vaccine

Katsama Boonmak — 2024-10-28

Background: The quantitative assessment of Vi polysaccharide in the typhoid vaccine plays a crucial role in ensuring vaccine quality control. It verifies that the specific antigen in the typhoid vaccine corresponds to the information in the registration dossier, thereby guaranteeing the quality, efficacy, and safety of the vaccine. HPAEC-PAD is known for its high accuracy and precision, establishing it as the gold standard method recommended by WHO for the analysis of carbohydrates, oligosaccharides, and polysaccharides.

Objective: To optimise and validate the HPAEC-PAD method for measuring the amount of Vi polysaccharide in the typhoid vaccine, intended for use as a standard method in the laboratory.

Methods: The HPAEC-PAD method was optimized and validated across multiple parameters, such as linearity and range, precision, accuracy, specificity, limit of detection, limit of quantification, and robustness.

Results: The validation of the HPAEC-PAD method showed a linear standard curve in the concentration range of 5 – 40 µg/ml, with a linear regression equation of y = 28.33x + 0.7000 and a correlation coefficient of 0.9999. The precision test conducted on the same day and on different days showed relative standard deviation percentages of 2.25 and 4.44, respectively. The accuracy test demonstrated that HPAEC-PAD can be used to measure the standard substance in the typhoid vaccine, with a percentage of recovery between 92.90 and 115.22. The limits of detection and quantitation of HPAEC-PAD were 2.39 and 10.00 µg/mL, respectively. The specificity test of the HPAEC-PAD method confirmed the absence of interference from other substances and its ability to isolate the target antigen. Additionally, the HPAEC-PAD method demonstrated robustness even with changes in analysts, and all validation method parameters met the acceptance criteria.

Conclusions: The validation of the HPAEC-PAD method for quantifying the amount of Vi polysaccharide in the typhoid vaccine demonstrates that the method met the acceptance criteria. Therefore, the HPAEC-PAD method is suitable for use as a standard laboratory procedure, thus ensuring that consumers receive high-quality vaccines for disease prevention.

Situations of Ampoules, Vials, and Syringes Containing Cosmetic Products in Chiang Mai Province and Regulatory Measures for Pre and Post-marketing

Piyaporn Chaichanapunphon — 2024-10-28

Background: Cosmetic products packaged in vials were typically classified in the low-risk group (auto-submission) rather than the high-risk group. However, there exists a regulatory gap between pre- and post-marketing stage in Chiang Mai.

Objectives:This study aimed to explore the regulatory situation for cosmetics packaged in ampoules, vials, and syringes, as well as identify regulatory gaps and propose regulatory measures for pre- and post-marketing stage in Chiang Mai.

Methods: The study employed methodology (quantitative and qualitative research) and was conducted in Chiang Mai from August to December 2023.

Results: Pre-marketing registration yielded nine importation licences for ampoules, vials, and syringes containing cosmetic products. Within this group, a problem related to misuse in aesthetic clinics was identified, which could potentially harm consumers. To address pre- and post-marketing regulatory gaps in Chiang Mai, this research proposes the following measures. Conduct post-audits after automatic registration approval within 7 days, with a specific focus on facial skin care cosmetics packaged in glass or plastic bottles. This measure aligns with Thai food and drug administration procedures and aims to prevent incorrect group submissions. Regularly inspect cosmetic production and import locations every 6 months post-approval to prevent unrelated production or imports without proper registration. Collaborate with post-marketing and health service staff to monitor and inspect mis-indication use, ensuring efficient regulation and enforcement. Scrutinise ampoules, vials, and syringes containing cosmetic products based on importation licence details and actual product labels.

Conclusion: This research illuminates the regulatory gaps associated with ampoules, vials, and syringes containing cosmetic products in Chiang Mai. During the pre-marketing stage, discrepancies between filed registrations and actual products were rectified. Additionally, misuse was addressed during the post-marketing stage. Policy suggestions and regulatory measures have been systematically integrated and developed in the Chiang Mai Provincial Public Health Office to safeguard consumer health.

Mechanisms for Enhancing the Efficiency of the Food Product Regulatory System of the Provincial Public Health Office to Provide Additional Authority in the Regions

Yanapol Kawponsri — 2024-10-28

Background: The Thai Food and Drug Administration (Thai FDA) is responsible for ensuring that consumers are safe, worthwhile, and profitable through onsite audits and considers food products to comply with the Food Act B.E. 2522. This includes developing laws, standards, and regulations that are internationally aligned and appropriate for the situation, controlling, inspecting, supervising, and monitoring food, food establishments, and advertising to ensure compliance with the law. In order to cover the entire country, the Thai FDA has delegated authority to provincial governors and the Office of Provincial Public Health Offices (PPHO) to carry out work in their respective areas, covering both pre-market and post-market activities. The focus is on convenience, speed, and alignment with the context of the area. The development of such a mechanism requires the development of both the FDA and the PPHO. To ensure that this development is effective, there is a need to review and analyse data on the situation and operations to identify problems, obstacles, and limitations of operations under the current delegation of authority order and to find solutions to the problems in order to expand the scope of delegation of authority to enforce the food law to provincial governors and assign officials as licensees to ensure flexibility in operations.

Objectives: To find out the situation, problems, and limitations of both pre-market and post-market activities in the PPHO and to propose a mechanism to enhance the efficiency of food safety surveillance in both pre-market and post-market of the PPHO.

Method: This research was qualitative and studied from December 2023 To May 2024 It was a purposive sampling of 14 people among PPHO officials who had over 10 years of work-experience in 13 provinces in the North, North-east, Central Region, and South that had a supplement food factor in the area. Additionally, the Director of the Rural and Local Consumer Health Product Protection and Promotion Division office at Thai FDA was included in the study. The research interviewed the samples by issuing a questionnaire.

Results: From the interviews, it was found that 100% of the sample group believed that delegating authority to provinces would facilitates operations and enhances business efficiency more than centralizing power. Additionally, 85.72% of respondents believed that delegating authority allows the PPHO to manage according to the specific local context and operate more comprehensively across all areas. Meanwhile, regarding further delegation of authority in the future, the interviewees believed that granting comprehensive authority will enhance consumer protection, as it allows for easier management within the area. In addition, the top five major problems and obstacles found in the operations were: (1) the staff lacked expertise in food technology and legal knowledge by 100%; (2) the staff lacked a clear understanding that can be applied to their work by 100%; (3) the services provided were not standardized; (4) there were delays in granting permissions because authority was given only to senior provincial executives; and (5) the budget was insufficient for operations at 85.71, 71.24, and 57.41, respectively. Furthermore, there were proposals to enhance the efficiency of the food product regulatory system of the PPHO to provide additional authority in the regions in six mechanisms: (1) formulate policies with the participation of the PPHO and ensure communication throughout the organization; (2) legislate laws with the involvement of PPHO staff; (3) delegate authority to the provinces to permit all types of food production that located within their responsible area; (4) communicate guidelines and guidelines in post-market surveillance and increase staffing for positions such as a Food and Drug Technical Officer and Legal Officers; (5) develop a database system and integrate it with the post-market surveillance system and academic knowledge database for staff; and (6) build a regulatory network including education networks in the region to educate entrepreneurs and the public. Also, establish a consumer network for food safety monitoring and educating the public.

Conclusions: Important situations and problems depended on the knowledge and expertise of personnel in the region. The granting of comprehensive authorisation in the future will provide more comprehensive consumer protection. There were proposals for increasing the efficiency of the working mechanism, including policy setting, legal development, improving SOP citizens's guidelines for granting permission, and establishing guidelines for post-market governance operations. In addition, there should be a database system and information linkage that is accurate and complete, including cooperation with government networks, the private sector, and consumer networks. both academic and law enforcement to achieve work that covers all dimensions and is efficient.

Development of Medical Record Query Application for HOSxP for Pharmacy Service in Chiangkhan Hospital, Loei Province

Surawish Vilaskhamphir — 2024-10-28

Background: This research focused on studies in three components of medication errors, including prescribing error, pre-dispensing error, and dispensing error, which were crucial problems in pharmacy services, especially high-alert drugs such as warfarin. It was found that Chiangkhan Hospital, Loei Province, Thailand, still needed more efficient supporting tools for workers, resulting in a small amount of data in the medication error reporting system and inconsistency with the actual amount of problems.

Objectives: To develop the medical record query application for HOSxP and evaluate pharmacy services’ efficiency when using this application in Chiangkhan Hospital, Loei Province.

Methods: This research was action research conducted in one cycle through stages of planning, acting, observing, and reflecting.

Results: There were 6 steps in program development consisting of problem analysis by researchers and gathering opinions from the Pharmacy and Therapeutic Committee, application design, programming in computer language, application testing and editing, generation of application documentation and application maintenance. The results showed that this application could detect more prescribing and pre-dispensing errors, increasing from 0.94 and 2.18 per 1,000 prescriptions to 2.58 and 4.81 per 1000 prescriptions, respectively. In addition, the decreases in dispensing error (from 1.87 to 0.56 per 1,000 prescriptions) and the patient waiting time in dispensing pharmacy (from 30.26±11.84 to 12.90±5.74 min; N=150 and 150, p<0.001) were reported. The application users (N=13) were satisfied at the highest level, with a satisfaction score of 4.69±0.48 based on a 5-point scale.

Conclusions: The medical record query application connected to the HOSxP program could detect and make medication errors more manageable, reduce waiting time for receiving medicine and highly satisfy the users.