The Process of Listing Prostheses and Medical Devices in Thailand's Universal Health Coverage.

OBJECTIVES: This study aimed to characterize the processes of listing prostheses and medical devices in all insurance schemes. METHODS: A literature review was performed, and in-depth interviews were conducted with the representatives of 6 insurance agencies. Civil Servant Medical Benefits Scheme (CSMBS), Social Security Scheme, Local Government Officer Scheme (LGOS), State Enterprise Scheme (SES), Universal Coverage Scheme (UCS), and Non-Thai Resident Scheme (NTRS). RESULTS: The outcomes of interest were structure details and the body of the working groups, listing processes, and key assessment criteria. Each insurance scheme's process can be summarized in 5 steps: (1) receiving the proposed topics of health technologies, (2) screening, (3) selection, (4) consideration, and (5) approval and publicization. Notably, the organizational structures and working group compositions vary across schemes, leading to differences in process activities and assessment criteria. LGOS and SES are exceptions because they follow the application process of CSMBS. UCS demonstrates the most transparent process, providing specific working groups that are competent in undertaking each activity. The processes of listing prostheses and medical devices vary across health insurance in Thailand, leading to varying numbers of health technologies covered by insurance schemes. CONCLUSIONS: This study characterizes prostheses and medical device listing processes in 6 Thai Universal Health Coverage insurance schemes (CSMBS, Social Security Scheme, UCS, LGOS, SES, and Non-Thai Resident Scheme). Variations in processes result in differing technology listings. It offers essential insights for healthcare professionals and policy makers.

Genetic polymorphisms influencing deferasirox pharmacokinetics, efficacy, and adverse drug reactions: a systematic review and meta-analysis.

Objective: Deferasirox is an iron-chelating agent prescribed to patients with iron overload. Due to the interindividual variability of deferasirox responses reported in various populations, this study aims to determine the genetic polymorphisms that influence drug responses. Methods: A systematic search was performed from inception to March 2022 on electronic databases. All studies investigating genetic associations of deferasirox in humans were included, and the outcomes of interest included pharmacokinetics, efficacy, and adverse drug reactions. Fixed- and random-effects model meta-analyses using the ratio of means (ROM) were performed. Results: Seven studies involving 367 participants were included in a meta-analysis. The results showed that subjects carrying the A allele (AG/AA) of ABCC2 rs2273697 had a 1.23-fold increase in deferasirox Cmax (ROM = 1.23; 95% confidence interval [CI]:1.06-1.43; p = 0.007) and a lower Vd (ROM = 0.48; 95% CI: 0.36-0.63; p < 0.00001), compared to those with GG. A significant attenuated area under the curve of deferasirox was observed in the subjects with UGT1A3 rs3806596 AG/GG by 1.28-fold (ROM = 0.78; 95% CI: 0.60-0.99; p = 0.04). In addition, two SNPs of CYP24A1 were also associated with the decreased Ctrough: rs2248359 CC (ROM = 0.50; 95% CI: 0.29-0.87; p = 0.01) and rs2585428 GG (ROM = 0.47; 95% CI: 0.35-0.63; p < 0.00001). Only rs2248359 CC was associated with decreased Cmin (ROM = 0.26; 95% CI: 0.08-0.93; p = 0.04), while rs2585428 GG was associated with a shorter half-life (ROM = 0.44; 95% CI: 0.23-0.83; p = 0.01). Conclusion: This research summarizes the current evidence supporting the influence of variations in genes involved with drug transporters, drug-metabolizing enzymes, and vitamin D metabolism on deferasirox responses.

Efficacy and safety of cannabidiol for the treatment of canine osteoarthritis: a systematic review and meta-analysis of animal intervention studies.

Introduction: Canine osteoarthritis (OA) is a degenerative disease with chronic inflammation of internal and external joint structures in dogs. Cannabis spp. contains cannabidiol (CBD), a substance known for various potential indications, such as pain relief and anti-inflammatory in various types of animals, including dogs with OA. As CBD is increasingly in the spotlight for medical use, we aimed to perform a systematic review and meta-analysis to evaluate the efficacy and safety of CBD in treating canine OA. Methods: We searched PubMed, Embase, Scopus, and CAB Direct for animal intervention studies investigating the effects of CBD for canine OA from database inception until February 28, 2023. Study characteristics and findings were summarized. A risk of bias in the included studies was assessed. Meta-analyses were performed using a random-effects model to estimate the effects of CBD on pain scores (0-10), expressed as mean difference (MD) and 95% confidence interval (95% CI). Certainty of evidence was assessed using GRADE. Results: Five articles were included, which investigated the effects of CBD in 117 dogs with OA. All studies were rated as having a high risk of bias. CBD products varied substantially, i.e., oral full-spectrum CBD oil in four studies, and isolated CBD oil and liposomal CBD oil in another study. Treatment duration varied from 4-12 weeks. Meta-analyses of three studies found that, in dogs with OA, treatment with oral full-spectrum CBD oil may reduce pain severity scores (MD; -0.60, 95% CI; -1.51 to 0.31, I2 = 45.64%, p = 0.19) and pain interference scores (MD; -1.52, 95% CI; -3.84 to 0.80, I2 = 89.59%, p = 0.20) but the certainty of evidence was very low. CBD is generally considered safe and well-tolerated in the short-run, with few mild adverse events observed, such as vomiting and asymptomatic increase in alkaline phosphatase level. Conclusion: CBD is considered safe for treating canine OA. CBD may reduce pain scores, but the evidence is very uncertain to conclude its clinical efficacy. High-quality clinical trials are needed to further evaluate the roles of CBD in canine OA.

Thai veterinarians' perceptions of cannabidiol products for dogs with osteoarthritis: a qualitative interview study.

Introduction: The global popularity of cannabidiol (CBD) led to its approval for human use in Thailand and potential use in animals. Many studies revealed CBD's efficacy in treating chronic osteoarthritis (OA) in dogs. To facilitate tailored CBD product development for canine OA and ensure market success, this study explores Thai veterinarians' perception of CBD for canine OA. Methods: In-depth interviews were conducted with experienced veterinarians who treated OA in ≥25% of their canine patients. Interview questions covered treatment, CBD perception, and adoption. Interviews were held from January to March 2023. Results: Eleven out of twenty invited veterinarians participated in the study. Though all favored non-steroidal anti-inflammatory drugs (NSAIDs) for OA in dogs, concerns about adverse reactions, including ulcers and renal failure, emerged. CBD was widely known and was perceived positively for pain, inflammation, cancer, and epilepsy. However, half distinguished CBD from marijuana and tetrahydrocannabinol (THC). Ten expressed willingness to prescribe CBD for OA upon robust clinical evidence. Worries centered on product consistency and impurities. Many suggested CBD should be under veterinarians' supervision at first, but this can be relaxing once safety and efficacy are established. CBD products should be chewable tablets, oils, or gelatin capsules with flavors like beef, liver, pork, fish, or seafood. Conclusion: Though CBD benefits were recognized, knowledge gaps among the participants persisted, warranting robust CBD safety, efficacy, and quality evidence to ensure Thai market success. Comprehensive education, including continuing education for those in practice and incorporating CBD-related topics into the Schools of Veterinary's curriculum, is recommended.

Community Pharmacists' Experiences and Attitudes towards the Provision of Sexual and Reproductive Health Services: An International Survey.

Access to comprehensive sexual and reproductive health (SRH) services remains a challenge worldwide. Describing community pharmacists' SRH services in countries with different scopes of practice will aid in understanding how pharmacists view their roles and how to support them in providing needed services. A cross-sectional web-based survey was administered to pharmacists working in community pharmacies in Japan, Thailand, and Canada. The survey covered 7 SRH categories: pregnancy tests, ovulation tests, contraception, emergency contraception, sexually transmitted and blood-borne infections, maternal and perinatal health, and general sexual health. Descriptive statistics were used to analyze the data. A total of 922 eligible responses were included in the analysis (Japan = 534, Thailand = 85, and Canada = 303). Most Thai and Canadian participants reported dispensing hormonal contraceptives (Thailand = 99%, Canada = 98%) and emergency contraceptive pills (Thailand = 98%, Canada = 97%). Most Japanese participants provided patient education on barrier contraceptives for men (56%) and information on the safety of medications in pregnancy (74%) and breastfeeding (76%). The majority of participants expressed interest in additional training and expanding their roles in SRH. Sharing international experiences can guide challenges faced by the evolution of pharmacists' practice in SRH. Providing pharmacists support could help their readiness for this role.

Defining and supporting a professional role for pharmacists associated with traditional and complementary medicines: a cross-country survey of pharmacists.

Introduction: An estimated 80% of the world's population use traditional and complementary medicine (T&CM) products as part of their healthcare, with many accessed through pharmacy. This cross-cultural study posed a set of professional practice responsibilities and actions to pharmacists related to T&CM products, with a view toward developing consensus, safeguarding, and promoting the health of the public. Methods: Data were collected from 2,810 pharmacists across nine countries during 2022 via a cross-sectional online survey reported in accordance with the guidelines of STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) and the Checklist for Reporting Results of Internet E-Surveys (CHERRIES). Results: Of the 2,810 participants from nine countries, 2,341 completed all sections of the survey. Of these, most agreed (69%) that T&CM product use was common in the community they served, but most did not have adequate training to support consumer needs. Over 75% acknowledged that there were known and unknown safety risks associated with T&CM use. Of 18 professional responsibilities posed, 92% agreed that pharmacists should be able to inform consumers about potential risks, including T&CM side effects and drug-herb interactions. The provision of accurate scientific information on the effectiveness of T&CM products, skills to guide consumers in making informed decisions, and communication with other healthcare professionals to support appropriate and safe T&CM product use were all ranked with high levels of agreement. In order to effectively fulfill these responsibilities, pharmacists agreed that regulatory reforms, development of T&CM education and training, and access to quality products supported by high-quality evidence were needed. Conclusion: General agreement from across nine countries on eighteen professional responsibilities and several stakeholder actions serve as a foundation for the discussion and development of international T&CM guidelines for pharmacists.

Evaluation of drug information from carton boxes, leaflets and pharmacy personnel: situation analysis in Myanmar.

OBJECTIVE: This study assessed how Myanmar consumers received drug information from the drug products and dispensers of community pharmacies. METHODS: Content analysis was used to evaluate drug information attached to 3 drug categories of 30 drug samples, and simulated patient studies at 247 pharmacies of selected townships in Yangon region were performed. Descriptive statistics and independent t-test were used for data analysis. KEY FINDINGS: Among 30 proxy drug products, more than 80% provided information in English language both on the carton boxes and on leaflets. About 86.7% of leaflets were intended only for healthcare professional uses and not understandable for lay consumers. The simulated patient study found that overall drug information provided by dispensers was limited as confirmed by information providing mean score of 4.25 ± 2.06 out of a total of 18 points. Many other important information items such as drug name, concomitant drugs use, common side effects and when to stop taking medicine were rarely provided. None of the simulated patients received carton box or leaflet. CONCLUSIONS: This study proved that Myanmar consumers did not receive enough drug information from both the products and dispensers, and thus the provision of understandable drug information for patients is required to improve patients' safe use of medications.

Evaluation of pharmaceutical pictogram comprehension among adults in the Philippines.

BACKGROUND: The use of pharmaceutical pictograms to enhance patients' understanding of drug regimens has been proven effective in many countries. There are two reference systems for pictograms generally used in pharmacy: the United States Pharmacopeia (USP) and International Pharmacy Federation (FIP). This study aimed to evaluate the effectiveness of USP and FIP pictograms among adults in the Philippines by identifying how many pictograms would pass the American National Standards Institute (ANSI) criterion of 85% comprehension, and to describe the factors affecting pictograms' comprehension. METHODS: A descriptive cross-sectional research using a face-to-face interview was performed to evaluate 108 pictograms in 52 Filipino adults enrolled through quota sampling. Descriptive statistics, Mann-Whitney U test (Wilcoxon rank-sum test), univariate linear regression, and multiple linear regression were used to statistically analyze the data collected. RESULTS: Only 17 (16 USP and 1 FIP) out of the 108 pictograms (15.74%) passed the ANSI criterion. The median score of Filipinos was 71 out of 108 pictograms (Interquartile range: 10-96). The multivariate model (R2 = 0.5645, F (4,47) = 15.23) suggested that the score was lower by 5.85 points if the user was female, 21.58 points lower if the participant was below Grade 12 education level, and 1.20 points lower if the patient was greater than 46 years old. Education level was identified as the significant predictor (p-value < 0.0000*, power = 99.98%). The participant with greater than Grade 12 has a higher comprehension score of rank-sum 952.5 (Expected = 689) compared to only 425.5 (Expected = 689). CONCLUSIONS: Since only 17 pictograms passed as stand-alone tool for patient information material, the researchers recommend the use of verbal and written instructions to complement pictograms to enhance comprehension. Furthermore, the government should consider the inclusion of health pictograms in basic health education.

Financing Strategies to Facilitate Access to High-Cost Anticancer Drugs: A Systematic Review of the Literature.

BACKGROUND: Each country manages access to anticancer drugs differently due to variations in the structure and financing of the health system, but a summary of the various strategies used is absent. This study aimed to review and summarize financing strategies implemented across countries to facilitate access to high-cost anticancer drugs. METHODS: We conducted a systematic review of articles referenced in PubMed, Embase, and Web of Science through May 12, 2021. Articles published in the English language from 2000 that describe strategies implemented in different countries to facilitate access to high-cost anticancer drugs were included. Letters, news articles, and proposed strategies were excluded. Quality assessment was not performed as we aimed to summarize the strategies. Data were analyzed by thematic analysis. A review protocol was registered at PROSPERO (CRD42018068616). RESULTS: The review included 204 studies from 176 countries. Three themes of financing strategies were identified: (1) Basic pharmaceutical reimbursement and pricing policies, (2) Alternative funding strategies specific to high-cost drugs, and (3) Financial assistance for individual patients. Access in most countries depends mainly on basic pharmaceutical reimbursement policies (165 of 176 countries). Apart from that, high-income countries (HICs) tended to use funding strategies targeting high-cost drugs (72% of HICs vs 0%-24% of the rest), such as managed entry agreements (MEAs) or dedicated funds for high-cost drugs. In contrast, lower-income countries tended to implement financial assistance programs for cancer patients as a tool to increase access (32% of HICs vs 62%-79% of the rest). CONCLUSION: Many countries have implemented a combination of strategies to increase access to high-cost anticancer drugs. Most low- and middle-income countries utilized placement of anticancer drugs on a national list of essential medicines and patient assistance programs (PAPs) to facilitate access, while many HICs implemented a broader range of strategies.

Prevalence of chronic kidney disease stages 3-5 in low- and middle-income countries in Asia: A systematic review and meta-analysis.

Chronic kidney disease (CKD) is a major public health problem in low- and middle-income countries (LMICs). Although CKD prevalence has been rapidly increasing in LMICs, particularly in Asia, quantitative studies on the current epidemiology of CKD in this region are limited. This study aimed to identify the prevalence of CKD stages 3-5 in LMICs in Asia, by subregion, country economy classification, identification of CKD, traditional and non-traditional risk factors. A systematic review and meta-analysis of observational studies was conducted through a literature search of seven electronic databases and grey literature search published until November 2021. The Newcastle-Ottawa quality assessment scale (NOS) was used to assess the risk of bias of each study. A random-effects model was used to estimate pooled prevalence. The protocol is registered in the International Prospective Register of Systematic Reviews (PROSPERO CRD42019120519). Of 4,548 potentially relevant records, 110 studies with moderate and high quality were included with 4,760,147 subjects. The average prevalence (95% CI) of CKD stages 3-5 in 14 LMICs in Asia was 11.2% (9.3-13.2%). The prevalence of CKD stages 3-5 was varied among subregions and country economic classification. CKD prevalence was 8.6% (7.2-10.2%) in east Asia, 12.0% (7.7-17.0%) in south-east Asia, 13.1% (8.7-18.2%) in western Asia, and 13.5% (9.5-18.0%) in south Asia. CKD prevalence was 9.8% (8.3-11.5%) in upper-middle-income countries and 13.8% (9.9-18.3%) in lower-middle-income countries. Prevalence of CKD stage 3-5 in LMICs in Asia is comparable to global prevalence. High level of heterogeneity was observed. Study of factors and interventions that lead to the delay of CKD progression is needed.

Reproductive Health Services: Attitudes and Practice of Japanese Community Pharmacists.

The provision of sexual and reproductive health (SRH) services is an important part of a community pharmacist's role in many countries. However, such services are not traditionally provided by pharmacists in Japan. We surveyed the practice and attitudes regarding the provision of SRH services among Japanese community pharmacists with a focus on reproductive health (RH) topics. The participants were asked about the provision of RH services, attitudes toward their role as SRH providers, and self-reported confidence in providing education to patients on RH topics. We obtained 534 effective responses. About half of the participants reported providing RH services, and only 21% were involved in dispensing emergency contraception pills. Although the proportion of pharmacists providing education on these topics was considerably lower, about 80% recognized the importance of their role as SRH advisors. Confidence in providing patient education about RH topics depended on their experience in providing such services. Most participants were interested in additional SRH training (80%). Our results suggest that training programs could help to expand Japanese community pharmacists' roles as SRH providers and increase their confidence in the education of patients. This study provides useful insights to expand pharmacists' roles in Japan as providers of comprehensive SRH services.

Modifiable Factors and Colon Cancer Risk in Thai Population.

To demonstrate the possible impact of modifiable factors on colon cancer development in Thai population, we conducted this case-control study from June 2016 until June 2017. The study was conducted in 11 Thai provincial hospitals. The hospitals in this study were selected by stratification by regions. Patients included 504 ones who were newly diagnosed with colon cancer within 1 month. In the control group, 997 health individuals were enrolled. Both case and control were adjusted by age. The results of this study showed that age and socioeconomic factors were associated with colon cancer risk. In addition, it was found that family history of colon cancer had very high association with colon cancer risk. Behavioral factors, including smoking, inadequate physical exercise, and salty food consumption were associated with colon cancer. We detected no association between obesity, alcohol consumption, and colon cancer. The results suggested that colon cancer might have higher association with genetic factors than behavioral factors among Thai patients. Based on the results of this study, stop smoking and promote adequate physical activity are suggested to reduce the incidence of colon cancrr among Thai patients.

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

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.

Performance assessment of the Thai National Center for Pharmacovigilance.

BACKGROUND: The Thai National Pharmacovigilance Center (NPVC) has operated since 1983, but its performance has never been formally assessed. OBJECTIVE: The paper aimed to present the main findings of performance assessment of the Thai NPVC. METHODS: A survey was conducted. Data from January 2011-December 2013 were collected. The performance was assessed through four indicator domains. RESULTS: The NPVC has a clear mission to guide its roles and responsibilities. The center has a well-established structure, adequate budget, qualified personnel, and good IT infrastructure, but it has no in-house IT personnel.Safety surveillance function was considered excellent. The Thai adverse drug reaction database accumulate a number of quality reports. Typically, new signals of traditional or herbal medicines could be generated from the database.The risk management process was well established and carried out. The National Drug Safety Advisory Sub-Committee was composed of qualified representatives from related disciplines. Not only do these committee members make safety decisions, but they also provide key safety messages and communicate these to their member audiences.The risk communication function was evaluated to be unsatisfactory. It was not effectively distributed to individual health care professionals. CONCLUSIONS: The overall performance of the Thai NPVC was considerably good. The findings suggested that risk communication should be improved. Moreover, organizational performance should be routinely evaluated. If possible, benchmarking with international pharmacovigilance centers should also be performed.