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Chimeric antigen receptor (CAR)-T cell therapy, a cell based gene therapy, has been covered as a condition of the performance- based refund under national health insurance system since April 2022. Accordingly, the effectiveness and adverse drug reaction of CAR-T cell therapy should be reported to the Health Insurance Review and Assessment. (HIRA). Hospital pharmacists are expected to be responsible for monitoring the CAR-T cell therapy. Thus, literature review was conducted to determine the role of hospital pharmacists in the CAR-T cell therapy. There were no related articles in searching the domestic database, and seven articles were selected from PubMED database. Most of them were review-type papers describing the role of pharmacists, and one of them developed practical guidelines for hospital pharmacies. The roles of pharmacists were summarized into nineteen categories. Critical roles include developing standard operating procedures, training staff and patients, managing T cell collection, preparing and storing CAR-T cell, and monitoring and managing adverse drug reaction. The participation of hospital pharmacists in the process of CAR-T cell therapy can improve the effectiveness and safety of patients, and the responsibilities of hospital pharmacists should be standardized within a multidisciplinary team.

BACKGROUND Research into pharmacy students’ awareness of unused medications in terms of experience, knowledge, social and environmental issues, and how to effectively collect unused medications remains limited. METHODS In January 2022, an online survey was distributed to pharmacy students who are Korean National Association for Pharmaceutical Students members. The questionnaire comprised four sections: 1) experience; 2) knowledge and awareness; 3) awareness of social and environmental problems; and 4) opinions on promoting the proper disposal of unused medications. A total of 113 responses were obtained, of which 100 were valid. RESULTS Roughly two-thirds of the respondents revealed knowledge of the proper disposal of unused medications, but 60% of the respondents discarded unused medications in trash cans which is not a proper disposal method. Less than half of the respondents (42%) had opted to dispose of unused medications in pharmacies. All respondents answered that unused medications should be disposed at designated places, but 65% of respondents claimed they should be disposed separately by drug formulation. Only 62% of the respondents mentioned the possibility of drug abuse due to indiscriminate disposal of unused medications, indicating a slightly lower level of awareness in terms of environmental pollution (94%). CONCLUSION Although the changing policy for disposing of unused medication is a potential opportunity and motivation for pharmacists to expand their role, no systematic education exists for future pharmacists. Thus, creating an environment that can educate prospective pharmacists on the current issues and policies of pharmacist society is crucial.

As technological development accelerates, regulatory authorities have to collect relevant information to address rapid and safe introduction of new drugs with advanced technology. In this study, we investigated the cases of selected high-income countries that took advantage of horizon scanning, a systematic information collection method, for their early response to new drugs and advanced technologies in health care settings. To this end, we reviewed the contents available at the website of the relevant institution, as well as the literature such as white reports and journal articles. The International Coalition of Medicine Regulatory Authorities (ICMRA) was engaged in activities to prevent overlapping work in each country and to harmonize of regulatory procedures. ICMRA's Horizon Scanning Project suggested specific methodologies through an analysis of global best practices, identified regulatory science areas to address emerging technologies, and provided policy options to promote market access of new medicines. The PharmaScan database, in which manufacturers directly input information, was operated and used for horizon scanning in the UK. Considering the implications obtained through case review of each country, horizon scanning will contribute to improving regulatory approval process and to enhancing early market access of new drugs in Korea.

BACKGROUND This study was conducted to provide insight into the considerations for developing an e-prescription system as a core infrastructure in the era of digital healthcare. METHOD Denmark, Finland, Australia, Germany, and Japan were selected according to the level of spread of e-prescription system in primary health care. Through the latest literature reviews of each country's health authorities website, google, and several academic DBs, each country's case was studied focusing on the history of introduction, system structure and operation, success factors and challenges. RESULTS In all countries surveyed, the e-prescription system was being developed along with personal health record service as a core body of the national medical digitalization strategy. In order to introduce e-prescription system, it was important to invest in standard development and to ensure interoperability between systems. A key challenge for disseminating e-prescription system has been software certification and increasing the acceptance of health care providers based on positive perceptions from successful pilot projects. CONCLUSION We were able to get implications for policy considerations from various overseas cases. Further studies on technical standard details, cost mechanisms, and third party intermediary services are needed.

Each country is trying to enhance the efficiency of pharmaceutical licensing procedure by designating their own reference countries that have extensive experience in pharmaceutical regulatory affairs. This study aimed to investigate how Korea can become a regulatory advanced country that other countries can refer to in the pharmaceutical licensing procedure. Focus group or in-depth interviews were conducted with 8 pharmaceutical regulatory experts. The collected data were analyzed using the framework analysis technique. The three themes that emerged from the interviews were; the effectiveness of reference country system, possibilities and obstacles for Korea to become a reference country for other countries, and the prospect for Korea to become a reference country. The positive and negative aspects of reference country system were discussed. The possibility of Korea becoming a reference country for other countries was discussed in two ways; mutual recognition and unilateral recognition. Lastly, it was discussed that it is necessary to enhance the international status of the Ministry of Food and Drug Safety and to change the paradigm of the domestic pharmaceutical market in order for Korea to become a reference country. Based on the above results, short-term and mid-to-long-term strategies were presented for Korea to become a reference country for pharmaceutical licensing procedure as a measure to promote overseas expansion of domestic pharmaceutical companies.

The blood business in Korea has established a governance system based on the Blood Management Act (BMA) and Pharmaceutical Affairs Act (PA). The Korean government has constructed a non-profit securing and supplying system for blood recommended by the WHO. In recent years, the blood self-sufficiency rate is decreasing due to the aging population, increasing the number of indications of plasma-derived medicinal products (PDMPs). It is predicted that the number of people who can voluntarily donate blood is decreasing due to the prolonged COVID-19. Plasma for fractionation (PF) is used as a raw material to manufacture PDMPs that include albumin, immunoglobulins, and clotting factors. The United States is the largest supplier of PF in the world, and Korea imports PF from the United States to meet domestic demand. Although the FDA licenses plasma from the United States, it is vital to confirm the safety and quality of imported plasma. Manufacturing quality management of PF products is carried out in most developed countries based on the GMP guidelines; however, each country has different governance systems. This study compared the Japanese regulatory system with the Korean system to draw implications for improving the efficiency of plasma regulation in Korea.

OBJECTIVES The purpose of this study is to understand the status of clinical research in advanced regenerative medicine, and to analyze each detailed item with a focus on researcher-led and pharmaceutical company -led clinical research. METHODS Among the documents registered in PubMed from 1 January 2018 to 29 June 2021, the clinical research literature was selected as the literature that corresponds to the advanced regenerative medicine clinical research and contains adverse reaction information. Publication year, country, indication type, and follow-up period were selected as variables to analyze clinical research literature by research funding. RESULTS As a result of the study, 220 eligible studies were identified through a literature search. 163 cases (74%) of researcher-led clinical research and 57 cases (26%) of pharmaceutical company -led clinical research were investigated. In the case of advanced regenerative medicine indications, researcher-led clinical research conducted overwhelmingly in clinical studies of brain/neuro/psychiatric diseases and eye diseases. As a result of analyzing the adverse events described in the entire clinical research literature, in the order of headache, nausea, fatigue, fever, and anemia were observed in pharmaceutical company-led clinical research and fatigue, prexia, headache, and hypertension in researcherled clinical research. CONCLUSIONS We expect this study will maximize the efficiency of clinical research information utilization and will help concentrate on building a safety management system.