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BACKGROUND(OBJECTIVE) Association of South-East Asian Nations (ASEAN) has been emerged as the main export region of pharmaceutical products. Therefore, the cooperation with member countries of ASEAN has been emphasized and, it is necessary to understand ASEAN pharmaceutical regulatory guidelines for the growth of the pharmaceutical industry. METHODS This study investigated the regulatory guidelines adopted by ASEAN through the search of homepage, internet articles, and various regulatory information. RESULTS The main contents of ASEAN Common Technical Dossiers (ACTD) and ASEAN Common Technical Requirements (ACTR) published were presented. They were implemented by all members of ASEAN countries even though there was a slight difference in implementation timing and content. The differences as well as common features of regulatory guidelines among ASEAN member countries were presented. Detail description on regulatory agency, certificate of a pharmaceutical product (CPP), product labelling, and official product approval timelines were also described. International pharmacopoeia such as USP, BP, EP, and JP were legally recognized in ASEAN. Pharmacovigilance and risk management plans in ASEAN followed the ICH guidelines without specific requirements. The cooperation on regulatory harmonization has been continued. Especially joint assessment procedure, formal procedure including simultaneous marketing authorization application to ASEAN member countries and joint assessment reports, will be implemented in the near future. CONCLUSION Understanding and monitoring for ASEAN regulatory guideline will help make the export of domestic pharmaceutical products to the ASEAN region faster and more efficient.

BACKGROUND Chronic diseases including diabetes and hypertension are well managed with medication therapy which prevent complication and increase the quality of life of patients. Also most of chronic diseases are managed through smoking cessation, continuous exercises weight control, and diet. OBJECTIVE This study investigate the relationship between multiple health risk behaviors of hypertention and/or diabetes patients and drug adherence. METHODS We used the 2011 Korean Health Panel (KHP) beta version data and hire logistic regression analysis to explore the relationship between multiple health risk behaviors of hypertention and/or diabetes patients and drug adherence. RESULTS The number of chronic disease patients including hypertention and/or diabetes were increasing during last 4 years. Drug adherence rate which are measured with self answered subjective response is about 85% in 2011. But, drug adherence which are measured with the Morisky Scale is as low as 73%. Patients who do not drink are more likely to have high rate of drug adherence. Patients who are practicing exercise are more likely to have high rate of drug adherence. CONCLUSION Health risk behaviors such as drinking and practicing exercise are found as important factors of drug adherence. To decrease the medical expenditures and to increase the quality of life of chronic patient, health authorities and health insurance should make endeavor to improve the health risk behaviors of chronic disease patients.

BACKGROUND AND OBJECTIVE The quality of life (QoL) of patients with chronic disease could be lowered by the lack of their education and limited understanding about the treatment and disease. QoL is important for the treatment success because low QoL may negatively affect patients’ treatment or drug adherence. Thus, the “Chronic Disease Management (CDM)” program was implemented to help patients improve their QoL and treatment adherence in Korea. This study was aimed to evaluate the cost-utility outcome of a hypothetical CDM program for hypertension and diabetes patients. METHOD We conducted cost-utility analysis of the CDM program for both the registered and non-registered groups at baseline, 1-, 4- and 10-year follow ups with a limited social perspective. The costs for operating CDM program and direct/indirect medical cost were discounted at 5%. The main outcome measure was incremental cost-utility ratio (ICUR). Sensitivity analyses for discount rate were performed to assess the robustness of the results. RESULTS The CDM program increased patients’ QALYs by 0.044 per patient (from 0.902 to 0.946). The incremental cost was 237,431 won per person and the ICUR was 2,762,950 won/QALY. In addition, when the ICUR is calculated by reflecting the reduction cost for 10 years after the completion of CDM program, the ICUR becomes negative from 4 years later. ICUR/GDP is 0.29 at the first year of CDM program. DISCUSSION AND CONCLUSION This study showed that the CDM program could be cost-effective for patients with hypertension and diabetes. We suggest the current CDM program to be expanded in Korea.

OBJECTIVE We aimed to investigate the purchasing behavior and its associated factors of safe and readily available drugs (SRAD)” at convenience store among college students. We expect that our results would help to understand the potential problems and to identify areas to improve SRAD system among young consumers in Korea. METHODS We conducted a voluntary-basis online survey with 292 college students from September 10 to 23, 2018. The survey included the questions about the frequency and reasons of purchasing SRAD, the extent of understanding about the policy of SRAD, attitude toward SRAD, experience of adverse drug reaction after taking SRAD. We performed a regression analysis to identify factors associated with the frequency of purchasing SRAD. Covariates of the regression model were selected on the basis of Anderson’s health behavior model. RESULTS About 63 percent of the respondents were aware of the SRAD system. Of the 292 respondents, 219 (75%) reported that they had purchased SRAD. The highest proportion of the respondents answered that they purchased SRAD twice per year (26.4%), followed by once (15.4%) and three times (12.3%). From the regression analysis results, positive attitude toward the SRAD system is the only significant predictor of the frequency of purchasing SRAD (β = 1.353 for neural attitude (p<0.05) and β = 2.265 for positive attitude (p<0.05)). CONCLUSION We learned that most of the college students had experience of purchasing SRAD. The correlation between positive attitude toward SRAD and the frequency of purchasing SRAD implies that trust in SRAD system is a key element to increase utilization of SRAD.

INTRODUCTION As the use of medicines increases due to the aging population and the increase of chronic diseases, most countries operate various systems for the proper use of medicines. In Korea, a few local governments have attempted comprehensive medication management services in conjunction with community pharmacies, but it is not a social insurance service. This study was aimed to review the articles deal with pharmacy fees for the medication therapy management (MTM) service in the United States. METHODS Literature search for relevant articles published from January 2000 to March 2019 across PubMed was conducted. A search strategy was built using keywords about pharmacy or pharmacist services not restricting as MTM service. And searches of websites of payers were also conducted. Articles were included if they were introduced patients eligibility criteria, service description, and pharmacy fees which were paid by a third-party payer. Descriptive information of each study was extracted, including the region, study model and duration, data source, payer. RESULTS Eight studies were met the inclusion criteria. Depending on the state, the range of fees covered for MTM service was large. Range of $20-70 for an initial medication review, $10-34 for a follow-up review, and $10-25 for each additional 15 minutes were paid for service fee. CONCLUSION It is necessary to continue to develop services, such as comprehensive medication management that could contribute to safe and appropriate drug use by taking advantage of pharmacists’ expertise and accessibility of pharmacies, as well as to conduct researches on a proper level of compensation to pharmacy.

OBJECTIVE This study was conducted to investigate the use and awareness of vitamin from the general public. METHODS 22-items questionnaire verified by a pilot test was used. Adults aged 20 or older were enrolled by convenience sampling during November 4 to 15, 2018. Data were analyzed descriptively using Microsoft Excel program. RESULTS Of 400 adults, 41% men (166) and 69% women (234), 69.8% of the subjects had vitamin intake over the past year. The most used route for access to vitamin-related information was internet, it showed that they often depended on nonprofessional information through online or acquaintances, which could limit their access to the right information. When purchasing vitamins, the proportion of people taking content of ingredients into consideration was high in the case of having a history of disease, according to the past 1 year. Despite the high rate of vitamin intake, there were many cases in which people paid less attention to directions related to indication and usages, doses and administration, precautions when taking vitamins, and the proportion of such cases was relatively high among 20’s and 30’s(p=0.001). CONCLUSION This study suggests that general consumers lack professional knowledge on vitamins and make limited choices, so it is necessary to improve people’s awareness of vitamins by providing consumers with correct information from professionals, which can increase the effects and prevent any unnecessary intake and adverse reactions of vitamins.