Earticle

Background: The need for regulatory science development to evaluate advanced regulatory products is gradually increasing without hindering the technological development. Creating a research environment and fostering experts through the establishment of regulatory agency-led policies are essential for the development of regulatory science. Method: This is a comparative study of the United States, Japan, Singapore, and Korea. The literature and websites of each regulatory agency were reviewed, and the focus was on advantages and comparing advantages based on definition, development trends, and expert training projects. Results: The United States is striving to develop regulatory science in response to changes in the new pharmaceutical industry through the regulatory science report, and to foster expert both inside and outside the Food and Drug Administration (FDA). Japan is promoting regulatory science centered on regulatory science centers, and is focusing on researching work-related regulatory science within the Pharmaceuticals and Medical Devices Agency (PMDA) and improving employees’ ability to make regulatory decisions. Singapore was aiming to improve Southeast Asia’s regulatory capabilities under the leadership of Centre of Regulatory Excellence (CoRE) within Duke-NUS University. In 2021, Korea is in its early stages, starting to run a university's degree program related to regulatory science this year. Conclusion: Regulatory science should be developed with the aim of improving the regulatory ability of the Ministry of Food and Drug Safety with Korea’s independent concept of regulatory science.

Background: Most antipsychotic drugs studies have been mainly conducted on side effects, randomized clinical trials, utilization rates, and trends. But there have been few studies on the influencing factors in elderly patients. The purpose of this study was to analyze the influencing factors on the outpatient prescription of antipsychotic drugs in the elderly patients. Methods: Active ingredients of antipsychotic drugs in Korea were selected according to the Korean Pharmaceutical Information Center (KPIC)’s classification. Data source was Korean Health Insurance Review and Assessment Service (HIRA) claims data in 2020 and target patient group was the elderly patient group. We extracted patients who have been prescribed one or more antipsychotic drugs and visited only one medical institution. Data were analyzed using descriptive statistics, chi-square, t-test, negative binomial regression. Results: A number of outpatients were 245,197 and prescriptions were 1,379,092. Most characteristics of patients were 75-85 year’s old, female, health insurance type, no disease (dementia, schizophrenia), atypical drugs, cci score (>2) and characteristics of medical institution were neurology in specialty, rural region, general hospitals. Results of regression showed that patient’s characteristics and medical center characteristics had significant effect on the outpatient prescription of antipsychotic drugs in the elderly patients. Conclusion: This study suggests that national policy of antipsychotic drugs in the elderly patients, with the consideration of the patients’ and medical institutions’ characteristics, is needed.

Background: Osteoporosis is a disease that affects the quality of life and imposes a high socioeconomic burden. Studies have reported that statins, a HMG CoA reductase inhibitor, have a positive or negative effect on osteoporosis. The purpose of this study was to analyze the correlation between statins and osteoporosis risk. Methods: We used the total patient sample data of the Health Insurance Review and Assessment Service (HIRA-NPS-2018). We analyzed the prevalence of osteoporosis in adult patients of Korea who were diagnosed with dyslipidemia and were prescribed statins at the same time. The odds ratio (OR) according to the intensity and type of statin was used to confirming the prevalence. Results: Among the 1,138,899 patients included in the study, 143,895 patients used statins and 27,524 patients (19.13%) were diagnosed with osteoporosis in the statin group. The OR value of statin group was 0.96 (95% CI 0.94-0.98), confirming that the prevalence of osteoporosis decreased, and a significant decrease was seen in all statin intensity. Some of the moderate-intensity statins rather increased the prevalence of osteoporosis, but atorvastatin and rosuvastatin obtained positive results at both medium- and high-intensity doses, and lovastatin, a low-intensity statin, showed the greatest reduction in the prevalence of osteoporosis. Conclusion: We found that the prevalence of osteoporosis was reduced in the statin group, and there was a constant correlation regardless of gender or age. However, a large, prospective, double-blind and randomized study is needed for a long period of time to demonstrate the effectiveness of statins.

Background: Recently, the Korean Association of Pharmacy Education has been focusing on competency-based education (CBE) and has established required areas of competencies to improve the graduation competency. However, competency-based assessment (CBA) tools for implementing CBE have not yet been developed for faculty members and students to successfully access the assessment tests. Moreover, the faculty members in charge in pharmacy schools have encountered various barriers in recruiting individuals with integrated clinical experience to act as virtual patients. Therefore, this study aimed to identify the advantages and limitations of applying CBA tool and faculty assessors in the development of CBE to ensure the reliability of this assessment. Methods: Utilizing CBA tool, the students’ communication skills and styles were assessed. students and faculty assessors were surveyed to evaluate the advantages and limitations of the CBA tool. Results: 8 assessors and 96 students participated in this study. 100% (8/8) of the faculty assessors and 77.4% (65/84) of the students reported that CBA tool is valuable to assess and improve student’s ability. 90.5% (76/84) of the students felt confident in applying knowledge to patient-centered care. CBA tool can be a valuable for the instructors in identifying the competency level of students but can also be associated with limitations in implementation to ensure the objectivity and reliability of the CBA. Conclusions: The CBA tool can be valuable in assessing the level of students’ competency. Faculty assessors have the advantage of well-prepared themselves for patient roles, so that the time and cost required may be minimized.

Background: This study aims to determine whether the new 6-year pharmacy curriculum is designed to help students in their career path based on the employment status of the current 2+4 pharmacy school graduates. Methods: An online survey was conducted to the pharmacists who graduated from Woosuk University College of Pharmacy between 2015 and 2021. The survey questions included the current employment status of the graduates and their feedback on the clinical pharmacy curriculum at Woosuk University. Results: There were a total of 104 graduates who responded to the survey out of 312 graduates of whom the school had current contact information. Most of the graduates are currently working in a community pharmacy (63.5%), followed by hospital pharmacy (27.9%) and pharmaceutical industry (4.8%). Although most graduates were satisfied with clinical pharmacy courses at our college, many thought there needs to be a reinforcement or improvement in the curriculum, including pharmacotherapy and pharmacy practice experiences as well as social pharmacy courses. Conclusion: Based on our study, clinical and social pharmacy are the courses that teach the knowledge and skills required in community and hospital pharmacy and yet, are most in need of improvement. As most graduates work in a community or hospital pharmacy, it is necessary to improve our pharmacy curriculum so that they can learn and demonstrate their clinical skills effectively.

Background: Trust is a key component for the good relationship between patients and healthcare professionals but trust for community pharmacists has not been studied much. Objectives: This study aimed to measure public trust in community pharmacists and to investigate variables that affect trust level in South Korea. Methods: A total of 25 questions, including 13-items for three dimensions of trust (pharmacists’ behavior/attitude, technical competence, communication skills) and 1-item for overall trust were developed. The survey was conducted online and the data from 416 respondents were analyzed with a t-test, an ANOVA and a multiple linear regression analysis. Results: The average scores (mean ± standard deviation) for the three dimensions of trust in community pharmacists were 3.47±1.05 (out of 5 points) for pharmacists’ behavior/attitude, 3.67 ± 0.99 for technical competence, and 3.66±0.99 for communication skills. The average of the 13 items incorporating all parameters was 3.56±1.02 and the overall trust level was 7.16±1.62 (out of 10 points). The total sum of the 13 items differed significantly by age group (p=0.02) and frequency of pharmacy visits (p=0.04). Each dimension had an independent impact on the trust level, and pharmacists’ behavior/attitude had the greatest impact on trust levels. Conclusions: This study showed that pharmacists’ behavior/attitude had the most significant impact on the trust level. However, the level of trust in pharmacists’ behavior/attitude is not yet sufficiently satisfactory, and further improvements are required to increase trust in community pharmacists.

Objective: The disabled are in a blind spot for obtaining information on drugs, and the pharmacies’ counseling on drug use is centered on non-disabled people. Few studies have investigated the current statuses of drug use by type of disability. The purpose of this study is to understand the drug use by type of disability and by life cycle of visually impaired and hearing impaired in Korea. Methods: The study participants consisted of 16 people with visually impairments, 12 people with hearing impairments. One indepth interview was conducted per participant, and each interview was recorded and documented. Results: Common barriers against safe medication and medical service uses across disability types are ‘lack of consideration and service for the disabled, limited access to medical facilities due to disability, limited access to information regarding medication use, psychological anxiety about drug use and side effects, and inconvenience regarding COVID-19 epidemic. The specific factors were ‘difficulties in identifying proper medicines and following prescribed dosages’ in the case of visually impaired, and ‘problems with sign language interpretation system’ for the hearing impaired. Conclusion: Disabled people are hindered from using medicines properly due to various factors. Based on the content derived from this study, it is necessary to eliminate the inhibition factors and devise specific measures for the safety of each type of disorder such as developing a method for medication counseling considering disabilities and establishing communication support systems.

To investigate signals of adverse drug reactions of finasteride by using the Korea Adverse Events Reporting System (KAERS) database. This pharmacovigilance was based on the database of the drug-related adverse reactions reported spontaneously to the KAERS from 2013 to 2017. This study was conducted by disproportionality analysis. Data mining analysis was performed to detect signals of finasteride. The signal was defined by three criteria as proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC). The signals of finasteride were compared with those of the other drugs; dutasteride (similar mechanism of action), minoxidil (different mechanism but similar indications for alopecia), silodosin (different mechanism but similar indications for BPH). It was examined whether the detected signals exist in drug labels in Korea. The total number of adverse eventdrug pairs was reported 2,665,429 from 2013 to 2017, of which 1,426 were associated with finasteride. The number of investigated signals of finasteride was 42. The signals that did not include in the drug label were 29 signals, including mouth dry, hypotension, dysuria etc. The signal of finasteride was similar to that of dutasteride and silodosin but was different to that of minoxidil. Early detection of signals through pharmacovigilance is important to patient safety. We investigated 29 signals of finasteride that do not exist in drug labels in Korea. Further pharmacoepidemiological studies should be needed to evaluate the signal causality with finasteride.