Importance of a usual source of care in choosing low-priced generic drugs: a cross-sectional study.

BACKGROUND: The potential to lower pharmaceutical spending exists if physicians prescribe low-priced generics. This study aimed to empirically investigate the determinants of choosing low-priced generic drugs in South Korea. METHODS: The 2018 HIRA-NPS dataset was used for this study. Among 1.45 million individuals, we identified the patients who were prescribed atorvastatin 10 mg for more than 60 days in 2018 as the study subjects, separated the subjects into high- and low-priced groups based on their average unit price, and applied a series of logistic regression models to elucidate the factors affecting low-priced drug choice. RESULTS: Out of 60,984 subjects, only 10,228 (17%) were categorized into the low-priced group. The majority of the subjects (31%) were prescribed drugs at the maximum reimbursement price. Age of the subject, the frequency of visits to the institution, the existence of a usual source of care, and the institution type that a subject mainly visited for prescriptions were associated with being prescribed low-priced generics. CONCLUSION: The association of being prescribed low-priced generics with the primary care institution and the usual source of care could be interpreted as evidence for the role of primary care in the continuity of patient-centred care. Creating health systems under which professionals act as perfect agents of a patient and/or an insurer is required.

Generic drugs with a discounted price compared to their corresponding brand-name drugs could be prescribed for patients. Therefore, spending on pharmaceuticals could be saved if physicians prescribed low-priced generics and/or patients switched from high-priced drugs to low-priced drugs. Policymakers have introduced several ways to encourage choosing low-priced generic drugs. This study focussed on the factors associated with choosing low-priced generic drugs in South Korea. Contrary to our expectations, only a few patients (17% of the total patients) choose low-priced generics, indicating potential to save pharmaceutical expenditure. Geriatric patients, patients who mainly visited primary healthcare institutions, and patients who had a usual source of care were more likely to choose low-priced generics. This study also suggested various ways to encourage choosing low-priced generic drugs in health systems.

Patenting and patent challenges in South Korea after introducing a patent linkage system.

BACKGROUND: South Korea introduced the patent linkage system in 2015 as part of the implementation of free trade agreements with the United States. This study assessed trends in brand-name drug patenting and generic patent challenges in South Korea after the introduction of the system. METHODS: From 2012-19, we constructed a novel dataset that combines information about listed patents with their corresponding brand-name drugs and patent challenges against these brand-name drugs. We analyzed brand-name drug patenting and generic patent challenges and elucidated factors in timely patent challenges using event history analysis. RESULTS: During the study period, 659 brand-name drugs listed their patents in the K-Orange Book and patent challenges against 95 brand-name drugs were initiated. The number of listed patents and their nominal patent term varied by the characteristics of the brand-name drugs. Patent challenges of generic drugs were marginal in South Korea even though the surge of patent challenges of generics were noticed right after the introduction of the patent linkage system. CONCLUSIONS: Patenting and patent challenges are critical factors when introducing generic drugs into the market under the patent linkage system. However, the impact of the patent linkage system on patenting and patent challenges could be varied by the specific form of the patent linkage system and the contexts of pharmaceutical markets.

Perceived impact of the patent linkage system on pharmaceutical market from the viewpoint of the domestic manufacturers in South Korea.

BACKGROUND: The United States requires a patent linkage system in other countries as part of free trade agreements. However, introducing a patent linkage system could be a significant barrier to the timely approval of generic drugs. This study aimed to evaluate the perceived impact of the patent linkage system in South Korea held by domestic manufacturers and analyze variations in evaluating the system according to the characteristics of domestic manufacturers. METHODS: In 2020, we conducted a questionnaire survey of 39 domestic manufacturers. The survey consisted of perceptions of the system, factors affecting patent challenges, and the perceived impact of the system. A 5-point Likert scale was used to rate each item. Domestic manufacturers were categorized into three groups based on their experience of listing a patent and acquiring first generic exclusivity. RESULTS: More than half of the manufacturers surveyed had experience of listing a patent. The patent linkage system could protect the involved patents. However, manufacturers perceived that they could successfully challenge the validity of the involved patents and then obtained market approval for generic drugs. Manufacturers responded that market size, expectations for succeeding in litigation, and expectations for manufacturing the drug were the most relevant factors when they initiated patent challenges. Manufacturers reported that the system, in particular the first generic exclusivity, enhanced the research and development capability of generic manufacturers, increased their domestic sales, and improved access to generic drugs. CONCLUSIONS: The perceived impact of the patent linkage system was limited to the domestic market and generic drugs. In narrowing the impact to the effects on the domestic industry, the system had positive impacts of the system on generic manufacturers. The first generic drug exclusivity lies at the center of this positive perception. However, manufacturers perceived that the current system did not provide enough incentives for domestic manufacturers to be granted first generic drug exclusivity through patent challenges.

Disease severity classification and COVID-19 outcomes, Republic of Korea.

PROBLEM: The surge in coronavirus disease 2019 (COVID-19) cases overwhelmed the health system in the Republic of Korea. APPROACH: To help health-care workers prioritize treatment for patients with more severe disease and to decrease the burden on health systems caused by COVID-19, the government established a system to classify disease severity. Health-care staff in city- and provincial-level patient management teams classified the patients into the different categories according to the patients' pulse, systolic blood pressure, respiratory rate, body temperature and level of consciousness. Patients categorized as having moderate, severe and very severe disease were promptly assigned to beds or negative-pressure isolation rooms for hospital treatment, while patients with mild symptoms were monitored in 16 designated facilities across the country. LOCAL SETTING: The case fatality rate was higher in the city of Daegu and the Gyeongsangbuk-do province (1.6%; 124/7756) than the rest of the country (0.5%; 7/1485). RELEVANT CHANGES: From 25 February to 26 March 2020, the ratio of negative-pressure isolation rooms per COVID-19 patient was below 0.15 in the city of Daegu and the Gyeongsangbuk-do province. In the rest of the country, this ratio decreased from 5.56 to 0.63 during the same period. Before the classification system was in place, eight (15.7%) out of the 51 deaths occurred at home or during transfer from home to health-care institutions. LESSONS LEARNT: Categorizing patients according to their disease severity should be a prioritized measure to ease the burden on health systems and reduce the case fatality rate.

Patent challenges and factors associated with successful patent challengers under the patent linkage system: recent evidence from South Korea after the Korea United States free trade agreement.

OBJECTIVES: The patent linkage system upgraded patent challenges to an important factor in granting timely market approval for generic drugs. We aim to understand patent challenges and identify the factors that are associated with successful patent challengers under the patent linkage system in South Korea. METHODS: We constructed a novel dataset that combined information on manufacturers with detailed data about their patent challenges after introduction of the patent linkage system. Based on the number of successful patent challenges, manufacturers were categorized into non-challengers, passive challengers, and aggressive challengers. Then, two types of logistic models were applied to identify the factors associated with successful and aggressive challengers. FINDINGS: Only 39 active ingredients were challenged by 77 manufacturers from March 2015 to December 2019. Of 171 manufacturers, 94 (55 %) were non-challengers, 58 (34 %) were passive challengers who had succeeded in fewer than 4 patent challenges, and 19 (11 %) were aggressive challengers who had succeeded in 4 or more patent challenges. Higher sales, more employees, and a greater number of reimbursed drugs were associated with being a patent challenger, while a greater number of reimbursed drugs was associated with being an aggressive challenger. CONCLUSION: Some manufacturers utilize patent challenges to strengthen their product portfolios in the market. However, under the patent linkage system, the frequency of patent challenges is limited in South Korea compared to the United States. In particular, patent challenges against drugs in injection form and biologics are very rare.

How can we improve patients' access to new drugs under uncertainties? : South Korea's experience with risk sharing arrangements.

BACKGROUND: New drugs including cancer drugs and orphan drugs are becoming increasingly more expensive. Risk sharing arrangements (RSAs) could manage the risk based on both financial impact and the health outcome of new drugs if reimbursed. To improve patients' access to new drugs under uncertainties, many developed countries have adopted RSAs. In this study, we aimed to understand the effects of RSAs in South Korea on patients' access. METHODS: We reviewed current status of RSA drugs in South Korea. The number of appraisals and time gap between market approval and reimbursement per RSA drug were considered to quantify improvement of patients' access as they showed how rapidly decisions on reimbursement of RSA drugs were derived. Then, we applied a comparative analysis to determine whether the RSA drugs in South Korea were reimbursed in the UK, Italy, and Australia. Most data for this study were obtained from websites of the governmental department/agencies responsible for appraisal of drug reimbursement in each country. And literatures related to RSAs were investigated as well. RESULTS: The eligibility for Korean RSAs had two key components - drugs for cancer and rare diseases and not having other alternative treatments. As of the first half of 2019, there were 39 RSA drugs reimbursed in South Korea, the majority of which were financial-based schemes. Refund and expenditure cap were the representative types (89.7%). After introduction of RSAs, the time gap and number of appraisals were decreased. Based on the indications of RSA drugs, the level of drug coverage in South Korea was found lower than Italy, similar to the UK, and higher than Australia. CONCLUSIONS: RSAs in South Korea significantly enhanced patients' access to new drugs and led to the alleviation of patients' out-of-pocket expenses. The drug coverage of South Korea had a level comparable to that of other countries. This study provides implications for countries that have a dual mission of containing pharmaceutical expenditure and improving access to new drugs.

Understanding the trends in international agreements on pricing and reimbursement for newly marketed medicines and their implications for access to medicines: a computational text analysis.

BACKGROUND: Health systems are struggling with unprecedented drug spending and governments have devised various policy options to manage high-priced medicines. Meanwhile, some pricing and reimbursement processes are currently moving under the jurisdiction of international agreements. This study aims to understand trends in international agreements from the perspectives of pricing and reimbursement policies for newly marketed medicines. METHODS: We proposed the framework to interpret the international agreements as code and applied computational text analysis to understand international agreements as data. In particular, we selected the AUSFTA, KORUS, and TPP to assess the progress and evolution in international agreements and investigate the existing relevant content on the pricing and reimbursement of newly marketed medicines. RESULTS: Similar to the provisions for intellectual property, the scope of international agreements regarding pricing and reimbursement decisions are broadened and strengthened. Over time, the domain of transparency, re-naming procedural fairness, has changed significantly more than the remaining domains. Pharmaceutical companies will have more opportunities to advocate for their positions, to protect their interests in decision processes, to investigate the decisions on listings and setting the amounts of reimbursement, and to challenge these decisions. CONCLUSIONS: Recently signed international agreements favor companies over governments with underscoring procedural fairness and timely access. However, access to affordable medicines is the goal towards which international agreements should aim. In a similar vein, substantial fairness and the accountability of companies should be discussed when negotiating agreements or adopting international agreements through domestic legislation.

Factors affecting the self-rated health of immigrant women married to native men and raising children in South Korea: a cross-sectional study.

BACKGROUND: Since the influx of international immigrants to South Korea (Korea) in the 1980s, the number of immigrants married to native Koreans has increased substantially over the last 30 years. This study aims to provide recent evidence on the self-rated health of immigrant women married to native men and raising children. We evaluated the self-rated health of immigrant women sorted by their country of origin and elucidated factors that affect their self-rated health. METHODS: Data were obtained from the 2015 Korean National Multi-Cultural Family Survey. From the survey, a total of 6960 Korean-Chinese, Han-Chinese, Japanese, Vietnamese, and Filipino women were identified and a series of logistic regressions was conducted to elucidate factors that affected the self-rated health of immigrant women. RESULTS: The majority of immigrant women in Korea perceived that they are healthy. However, the self-rated health of immigrant women varied by country of origin. Korean-Chinese and Japanese immigrants are less likely to perceive that they are healthy compared with Filipino and Vietnamese immigrants. We identified several factors at the individual, household, and community levels and found that the majority of them are likely to be ethnic dependent. However, satisfaction with husband and experience of unmet medical needs presented consistent results in the five ethnicity groups. CONCLUSIONS: Programs that strengthen spousal relationships and policies to enhance access to healthcare could be prioritized options to improve the self-rated health of immigrant women in Korea.

The speed of adoption of new drugs and prescription volume after the amendments in reimbursement coverage: the case of non-vitamin K antagonist oral anticoagulants in South Korea.

BACKGROUND: The speed of adoption of new drugs and frequencies of substitutions leads to changes in health care expenditures as well as patient outcomes. In this study, we aim to understand the speed of adoption of new drugs and their prescription volume in health care institutions and evaluate the impact of policy options to manage pharmaceutical expenditure. METHODS: We conducted a retrospective cohort study of health care institutions prescribing NOACs, including Apixaban, Dabigatran, and Rivaroxaban, to address the speed of adoption and their substitution from October 1, 2010, through December 31, 2015, using the National Health Insurance Service-National Sample Cohort. Two threshold time points, including the extension of reimbursement with the need for the letter of opinion and the withdrawal of the letter of opinion, were noted in this study. Then, we applied a survival analysis to elucidate factors that affected the speed of adoption of NOACs, and interrupted time series analysis to estimate the effect of amendments in reimbursement coverage in prescription volume. RESULTS: Among 934 health care institutions in a study population, 334 institutions (36%) had prescribed NOACs at least one time during the study period, indicating that health care institutions were conservative in adopting new drugs. However, the speed of adoption was related to the characteristics of health care institution. We also found that prescriptions of NOACs before the withdrawal of the need for the letter of opinion were marginal, and the prescription volume of NOACs was significantly increased after the withdrawal of a letter of opinion. CONCLUSIONS: Health care institutions were conservative in adopting new drugs, and the speed of adoption is not closely related to an increased prescription volume in the short run. Thus, policies that are centered on managing pharmaceutical expenditure should be devised with considering the impact of introducing new drugs in the long run. A letter of opinion, which was devised to manage prescriptions of NOACs, was effective in managing pharmaceutical expenditures in health care institutions, particularly for tertiary institutions. Conversely, the withdrawal of the need for the letter of opinion should be implemented with caution.

Incidence, cost and gender differences of oropharyngeal and noncervical anogenital cancers in South Korea.

BACKGROUND: Human papillomavirus (HPV) is associated with a significant public health burden, yet few studies have been conducted in Asia, especially on noncervical cancers. We estimated the incidence and cost of oropharyngeal and noncervical anogenital (anal, vulvar, vaginal, penile) cancer in Korea. METHODS: We conducted a retrospective cohort study using Korea's National Health Insurance (NHI) claim database from 2013 to 2016. The main outcome measures were the number of respective cancer incidences during the study period and the annual costs per patient in the first year after diagnosis, which was adjusted by relevant variables based on the regression analysis. RESULTS: During the study period, 8022 patients with these cancers were identified, and oropharyngeal cancer comprised 46% of them. The crude incidence rate for male oropharyngeal cancer was significantly higher than that of females (3.1 vs. 0.7 per 100,000 as of 2016, respectively). Additionally, the crude incidence of male oropharyngeal cancer increased from 2.7 in 2013 to 3.1 in 2016, whereas that of female and other cancers was stable during the study period. The mean annual incidence-based cost per patient in 2016 was highest for oropharyngeal cancers (21,870 USD), and it was significantly higher in males than in females based on then regression analysis (p < .001). CONCLUSIONS: Oropharyngeal cancer comprises the highest number of HPV-associated noncervical cancer incidences in Korea, and the incidence and cost of oropharyngeal cancer was significantly higher among males than females. More aggressive public health policy toward males may decrease gender gap of oropharyngeal cancer.

Importance of the intellectual property system in attempting compulsory licensing of pharmaceuticals: a cross-sectional analysis.

BACKGROUND: Recently, interest in compulsory licensing of pharmaceuticals has been growing regardless of a country's income- level. We aim to investigate the use of compulsory licensing as a legitimate part of the patent system and tool for the government to utilize by demonstrating that countries with a mature patent system were more likely to utilize compulsory licensing of pharmaceuticals. METHODS: We used a multivariate logistic model to regress attempts to issue compulsory licensing on the characteristics of the intellectual property system, controlling for macro context variables and other explanatory variables at a country level. RESULTS: A total 139 countries, selected from members of the World Trade Organization, were divided into a CL-attempted group (N = 24) and a non-CL-attempted group (N = 115). An attempt to issue compulsory licensing was associated with population (+) and a dummy variable for other regions, including Europe and North America (-). After controlling for macro context variables, mature intellectual property system was positively associated with attempting compulsory licensing. CONCLUSIONS: Our study provided evidence of an association between attempting compulsory licensing and matured patent systems. This finding contradicts our current understanding of compulsory licensing, such as compulsory licensing as a measure to usurp traditional patent systems and sometimes diametrically opposed to the patent system. The findings also suggest a new role of compulsory licensing in current patent systems: compulsory licensing could be a potential alternative or complement to achieve access to medicines in health systems through manufacturing and exporting patented pharmaceuticals.

Moderating the impact of patent linkage on access to medicines: lessons from variations in South Korea, Australia, Canada, and the United States.

BACKGROUND: The inclusion of patent linkage mechanisms in bilateral and plurilateral trade and investment agreements has emerged as a key element in the United States' TRIPS-Plus intellectual property (IP) negotiating agenda. However, the provisions establishing patent linkage mechanisms in several agreements appear to reflect a degree of ambiguity, potentially enabling some flexibility in their implementation. In this study, we reviewed the features of the prototypic patent linkage mechanism established by the Hatch-Waxman Act in the United States, and compared these with the implementation of systems in three countries whose agreements with the US include patent linkage obligations. From these analyses, we draw lessons for moderating the impact of these mechanisms on access to generic medicines. METHODS: We reviewed the features of the patent linkage mechanism in the US, and undertook a detailed analysis of relevant treaty provisions and the manner of implementation in Canada, Australia, and South Korea. RESULTS: A key difference between the US implementation of patent linkage and that of its trading partners is the disparate treatment afforded to biologics. Because of the significant differences in the regulatory frameworks applying to small molecule and biologic medicines in the US, the Hatch- Waxman provisions do not apply to biologics and they are not subject to patent linkage. By contrast, the regulatory frameworks in Canada, Australia and South Korea do not reflect similar distinctions and thus patent linkage mechanisms also capture biologics. Additional variations in implementation, mainly the result of constructive ambiguities in the respective treaty texts, offer potential opportunity for mitigating the adverse impact of patent linkage provisions on market entry of generic medicines. Practical measures include ensuring the availability of an accessible, transparent and easily searchable database of patent information; avoiding automatic stays of generic marketing approval where possible; and requiring certification by rights holders to prevent abuse of the system. CONCLUSIONS: Where countries accept treaty obligations to establish patent linkage mechanisms, the impact on access to generic medicines may be moderated to a degree by retaining and exploiting constructive ambiguities in the treaty text and addressing practical aspects of implementation.

Public value judgments about the criteria for reimbursement of medicines in South Korea.

OBJECTIVES: This study quantified the public value (PV) of the criteria and sub-criteria in the current drug reimbursement systems in South Korea and examined sociodemographic factors that associated with PV. METHODS: The Analytic Hierarchy Process (AHP) was used to quantify the PVs of criteria and sub-criteria. We developed a questionnaire to generate pairwise comparison matrices among criteria and sub-criteria. From 27 March to 1 April 2023, we recruited 1,000 study participants using a quota sampling method stratified by age, sex, and region based on Korean census data. RESULTS: The PVs for the criteria were highest for clinical usefulness (28.5%), followed by cost-effectiveness (27.1%), budget impact (24.3%), and reimbursement in other countries (20.1%). The sociodemographic characteristics of the participants had a significant impact on the PVs of the criteria. Willingness to pay additional premiums for national health insurance was negatively associated with PV for clinical usefulness and cost-effectiveness and positively associated with PV for reimbursement in other countries. CONCLUSIONS: The public prioritized clinical usefulness and cost-effectiveness as the main criteria. However, the PVs of the criteria were divergent and associated with sociodemographic factors. Divergent public interests require an evidence-informed deliberative process for reimbursement decisions.

Which factor reduces pharmaceutical expenditure, number of entrants or price variance? Updated generic drug markets in South Korea.

BACKGROUND: Introducing more generics has been a successful strategy for lowering pharmaceutical prices and expenditure. However, the effect of the strategy depends on the pricing schemes for generics. We aimed to update the South Korean generic markets in terms of effective competition, and to examine the effects of number of manufacturers and price variance on pharmaceutical expenditure. METHODS: We constructed balanced panel data provided by the Health Insurance Review and Assessment Service covering 726 reimbursed substances from 2019 to 2023. We developed original indicators to analyze the generic markets: the maximum-minimum price variance (MMPV) and the maximum-weighted price variance (MWPV). Panel regression with fixed and time-fixed effects was used. RESULTS: Over the study period, the number of manufacturers increased from 17.81 in 2019 to 20.98 in 2020 and then decreased to 18.70 in 2023. The MMPV increased from 204.70 in 2019 to 230.07 in 2022 and then decreased slightly to 225.34 in 2023. The MWPV increased from 59.70 in 2019 to 72.58 in 2023. Two types of segmented markets were noteworthy: low use of low-cost generics with sufficient manufacturers and high use of low-cost generics with insufficient manufacturers. In the fixed and time-fixed effects panel analyses, the MWPV presented a negative association with the number of manufacturers and a positive association with the MMPV. CONCLUSIONS: A newly introduced tiered pricing scheme, designed to differentiate generic prices, was associated with a decrease in the number of manufacturers and an increase in price dispersion. The pricing schemes for generics should be designed with price variance in mind and limit the number of too many generics in South Korea.

Perceptions of risk sharing agreements in South Korea from the viewpoints of key stakeholders: a convergent parallel mixed approach.

OBJECTIVES: In 2013, South Korea introduced risk-sharing agreements (RSAs) as a new reimbursement mechanism to enhance access to new medicines and to manage pharmaceutical expenditures. This study evaluates RSAs in South Korea from the viewpoints of key stakeholders. METHODS: In 2022, a survey and semi-structured interviews were conducted. Study participants were recruited from academia (n = 3), domestic (n = 4) and foreign (n = 6) manufacturers, and government agencies (n = 6) using a purposive sampling method. RESULTS: Key stakeholders perceived the objective of RSAs to be 'access to medicines' and understood RSAs to manage uncertainty about 'expenditures.' They responded that financial- and performance-based RSAs address uncertainty about 'expenditures' and 'clinical effectiveness,' respectively. All stakeholders agreed that RSAs have increased the likelihood that new medicines will be listed and have reduced out-of-pocket expenditures for patients. However, foreign manufacturers insisted that the benefits of RSAs are marginal, while the administrative burden on manufacturers is high. CONCLUSION: The gaps in perception between stakeholders could be narrowed by conducting a comprehensive evaluation. Financial- and performance-based RSAs need to be clearly distinguished and aligned to address the uncertainties of a new medicine in health systems.

Does the first generic exclusivity system provide an economic incentive for early generic entrance under the patent linkage system?

Introduction: A period of exclusivity for the first generics, as part of the patent linkage system, was established in South Korea to provide an economic incentive for early generic entry. This study describes the dynamics of generic penetration and assesses the first mover market share advantages under the patent linkage system. Methods: Pairs of originators and their corresponding generics granted the first generic exclusivity from 2015 to 2020 were identified. We categorized generics into first movers and latecomers, described the penetration curves of generics, and estimated the saturated market share of generics, first movers, and latecomers. Volume-based monthly prescriptions were used to describe the generics' penetration curves. A logistic growth model was adopted to estimate the saturated market shares of generics. Results: We identified 28 pairs of originators and generics, presented penetration curves, and estimated generics market shares. The saturated market share of generics was 30%, and the time to saturation was approximately 33 months. The shapes of penetration varied by nationality, route, and number of generics. The existence of latecomers was associated with the decreased penetration speed over time and decreased market share of generics. However, the first mover market share advantages or latecomers' disadvantages were consistently observed. Conclusion: The generic uptake in South Korea is delayed, limited, and context-dependent. However, first generics' market share advantage suggests that a period of exclusivity, as part of the patent linkage system, could provide an economic incentive for early generic entrance.

Tightened social distancing measures and increased violence during the COVID-19 pandemic in South Korea.

Introduction: In 2020, the South Korean government introduced social distancing measures, varied by region, to address the pandemic. We captured variations in social distancing measures among regions in South Korea and investigated the association between the stringency of measures and the increased incidence of violence. Methods: Incidence reports from calls to violence hotlines, including school and domestic violence and sexual harassment, from 2016 to 2021 were retrieved. The regional per capita incidence rates for each violence hotlines were calculated. Difference-in-difference design with fixed effects was used to elucidate different trends in the incidence rate of violence between regions with stringent social distancing measures and regions with looser measures. Results: Social distancing measures led to a decreased incidence rate of school violence and an increased incidence rate of domestic violence and sexual harassment. Different trends in the incidence of violence were noted between regions with strict social distancing measures and regions with more lenient measures. Tightened measures caused surges in domestic violence and sexual harassment. Conclusion: Social distancing measures have been an inevitable mitigation strategy against virus transmission throughout the pandemic. However, women residing in tightened social distancing measures, in particular urban areas, need more support against domestic violence.

Impact of the COVID-19 Pandemic on the Public Perceptions of the Roles and Functions of Community Pharmacies in South Korea: Updated Cross-Sectional Self-Reported Web-Based Survey.

BACKGROUND: Community pharmacists confronted dual burdens in response to the COVID-19 pandemic by expanding the scope of pharmaceutical practices. OBJECTIVE: This study aimed to assess the perceived roles and functions of community pharmacies during the pandemic and to explore their updated roles after the pandemic began. METHODS: We conducted a self-reported web-based survey in October 2022. Based on Korean census data, we recruited the study participants (n=1000) through quota sampling stratified by age, sex, and region, yielding a 7.45% (1000/13,423) response rate. The questionnaires were composed of 3 sections: demographics, the roles and functions of community pharmacies during the pandemic, and the updated roles of community pharmacies during disasters. Each question in the second and third sections was rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree), and each item's mean scores and SDs were reported. The study participants were categorized into 2 groups: individuals who had a family pharmacy and those who did not. A chi-square test and ordered logistic regression analyses were conducted. RESULTS: Out of 1000 respondents, 418 (41.8%) had a history of COVID-19, and 639 (63.9%) had a family pharmacy. Assigning specific roles and functions to community pharmacies during the pandemic contributed to positive assessments. Respondents gave higher scores to community pharmacies that had responded appropriately (a mean Likert score of 3.66, SD .077 out of 5) and provided continuous pharmaceutical services (mean 3.67, SD 0.87) during the pandemic. The pandemic served as an opportunity to positively recognize the role of community pharmacies (mean 3.59, SD 0.83). In the ordered logistic model, having a family pharmacy was consistently associated with positive perceptions. Respondents perceived that community pharmacies collaborated with general practitioners and health authorities. However, community pharmacies need to function appropriately in terms of knowledge. The mean score of the 4 domains of community pharmacy functions was the highest for collaboration (mean 3.66, SD 0.83), followed by communication (mean 3.57, SD 0.87), responsiveness (mean 3.54, SD 0.87), and knowledge (mean 3.41, SD 0.91). CONCLUSIONS: The pandemic resulted in interprofessional collaboration between community pharmacists and general practitioners. Family pharmacies could be a valuable asset to the comprehensive case management of patients. However, community pharmacists should have the expertise to build solid interprofessional collaborations and fulfill their expanded and updated roles.

The impact of COVID-19 on the number of active small primary care businesses by severity of the pandemic: evidence from South Korea.

BACKGROUND: Health systems have become financially fragile owing to the economic recession caused by the COVID-19 pandemic. However, small primary care businesses have received less policy attention than public health and secondary care. We aimed to estimate the impact of COVID-19 on the number of active small primary care businesses in South Korea. METHODS: We selected clinics, dental clinics, oriental clinics, and pharmacies as primary care businesses. Our estimation took advantage of regional variations in COVID-19 cases in South Korea. We determined the number of active primary care businesses from 2019 1Q to 2021 1Q on a quarterly basis, and conducted interrupted time series analysis to estimate the effects of COVID-19 on this sector. RESULTS: This study found no significant increase or decrease in the number of clinics, dental clinics, and oriental clinics immediately after the pandemic began or in the time trends after the pandemic. However, there was a significant increase in the number of pharmacies immediately after the pandemic. The most affected area presented different trends in the number of pharmacies, dental clinics, and oriental clinics. CONCLUSIONS: Impact of the pandemic on the number of active small primary care business were low in South Korea. However, the impact varied according to the type of primary care setting and severity of the pandemic. The additional public health role of primary care could be associated with the sustenance of primary care businesses.

Understanding long-listed pharmaceutical products without competition in South Korea: policy implications in managing generic entrants and pharmaceutical expenditures.

BACKGROUND: The nature of competition within the pharmaceutical sector has received a great deal of attention from policymakers and researchers. This is the first study to comprehensively analyze long listed single-source products within the South Korean market. METHODS: Long listed single-source products are defined as pharmaceutical drugs that are available in the market for at least 8 years, without competition. We analyzed the determinants that lead to long listed single-source products in the market, and then evaluated their impact on health systems by examining the subsequent price responses of manufacturers. RESULTS: Based on the number of drugs and their market values, pharmaceuticals categorized as long listed single-source products constitute a substantial portion of the market. Characteristics of the market are closely associated with generic entrants. In particular, the market size of a substance is associated with generic entrants, while the price of a brand-name drug is related to being long listed single-source products. CONCLUSIONS: Our analysis supports the creation of a regulatory and/or reimbursement system in order to support robust and effective competition within the marketplace. The first step toward rationalizing the system is to provide widespread information on drugs with limited competition or no competition.