한국과 영국의 건강불평등 국가 데이터베이스 비교: 중독 물질 오남용 관련 정신건강 및 호흡기 질환을 중심으로

이인향,Lee, Iyn-Hyang 한국임상약학회 2021 한국임상약학회지 Vol.31 No.3

Objective: Taking action on health inequalities starts with the production of information laying out the problems of inequalities, but Korean society has no national database to view related data at a glance. This study aimed to compare Korean national database with the Public Health Profile (PHP), a health inequality database of the UK. Methods: Data were collected from the websites of government and relevant organizations in the both countries between March and August 2020, which was updated in August 2021. Two themes including Co-occurring substance misuse and mental health issues in mental health and INteractive Health Atlas of Lung conditions in England were selected for comparison in terms of data accessibility, data usability and data visualization. Results: The British PHP is being served on a web-based platform, Fingertips. The data collected at the regional level were presented on 31 health inequality themes. The data are displayed at a level that can be compared between comparable communities, and visualized into various tables and figures. Comparable Korean data were scattered in several themes and websites, and mostly provided as a 17 administrative region base, which was too vast to make a meaningful comparisons. Conclusion: The findings proposed several considerations which could be useful for establishing a database of health inequality in the Korean society.

일반의약품 설명서의 이해도와 적정 사용가능성 평가

이인향(Iyn-Hyang Lee),이형원(Hyung Won Lee),제남경(Nam Kyung Je),이숙향(Sukhyang Lee) 대한약학회 2012 약학회지 Vol.56 No.5

A product labelling is one of key tools in ensuring that a patient uses drugs safely and effectively in self-care without professional support. This study aimed to explore the readability and comprehensibility of the information contained on two package inserts of medicines. Two package inserts were tested with first year college students. Fifty-one potential consumers underlined words they could not understand and answered 10 scenario questions. Any differences among groups with different characteristics were statistically tested. Secondly, the readability of two package inserts was assessed with comparison to the level of the 6th grade Korean textbooks. As results, more than 80% of participants properly replied to straightforward questions concerning indication, dosage, duplication, use in pregnancy and contraindication, and 73% about formulation. Less than half answered correctly in multiple choice questions about pediatric use (41%) and side effects (35%). Little discrepancy was observed in the comprehensibility between participants' characteristics. Drug inserts contained about 20% more professional-level words than 6th grade textbooks. In conclusion, Korean consumers may face challenges to understand drug information due to professional terminology and outdated expressions in the current package inserts. To secure safe and effective use of over-the-counter agents, greater efforts should be made to develop more consumer friendly labels. In the other hand, educational supports are required to prepare consumers in a proper level of knowledge for the safe use of drugs.

약학회담(藥學會談) : 의약품 허가외사용 관리 체계 발전 방안

이인향 ( Iyn Hyang Lee ),서미경 ( Mikyeong Seo ),이영숙 ( Young Sook Lee ),계승희 ( Seunghee Kye ),김현아 ( Hyunah Kim ),이숙향 ( Sukhyang Lee ) 영남대학교 약품개발연구소 2014 영남대학교 약품개발연구소 연구업적집 Vol.24 No.0

This study aimed to develop a regulation system for off-label drug use to secure the safe use of marketeddrugs. We searched governmental documents for national and global regulating systems of off-label drug uses and a bodyof academic literature to explore current regulating trends. We included European Union, United Kingdom, United Statesof America, Australia and Japan, and critically reviewed the regulation of off-label drug use in four issues, which were a regulatorystructure, safety control before and after off-label use, and information management. The findings of the presentinvestigation called for several measures in off-label drug uses: enhancing prescribers` self-regulation, providing up-to-dateinformation to prescribers for evidence-based practice and to patients for their informed consent, making evidence with scientificrigor, building an official registering process for off-label use in good quality and extending the role of pharmaceuticalindustry in pharmacovigilance. At last, we proposed a new system so as to regulate and evaluate off-label drug uses bothat national and institutional level. In the new system, we suggested a clear-cut definition for clinical evidence that applicantswould submit. We newly introduced an official ‘Off-Label Drug Use Report’ to evaluate the safety and clinical efficacy of agiven off-label drug use. In addition, we developed an algorism of the regulation of off-label drug use within an institutionto help set up the culture of evidence-based practices in off-label drug uses.

의약품 인허가 과정에서 허가참조제도에 대한 전문가 심층 의견

이인향(Iyn-Hyang Lee),권진원(Jin-Won Kwon),송윤경(Yun-Kyoung Song),이승미(Seung-Mi Lee),박은혜(Eun-Hye Park) 한국보건사회약료경영학회 2022 한국보건사회약료경영학회지 Vol.10 No.2

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.

약학회담(藥學會談) : 일반의약품 설명서의 이해도와 적정 사용가능성 평가

이인향 ( Iyn Hyang Lee ),이형원 ( Hyung Won Lee ),제남경 ( Nam Kyung Je ),이숙향 ( Sukhyang Lee ) 영남대학교 약품개발연구소 2013 영남대학교 약품개발연구소 연구업적집 Vol.23 No.0

A product labelling is one of key tools in ensuring that a patient uses drugs safely and effectively in self-care without professional support. This study aimed to explore the readability and comprehensibility of the information contained on two package inserts of medicines. Two package inserts were tested with first year college students. Fifty-one potential consumers underlined words they could not understand and answered 10 scenario questions. Any differences among groups with different characteristics were statistically tested. Secondly, the readability of two package inserts was assessed with comparison to the level of the 6th grade Korean textbooks. As results, more than 80% of participants properly replied to straightforward questions concerning indication, dosage, duplication, use in pregnancy and contraindication, and 73% about formulation. Less than half answered correctly in multiple choice questions about pediatric use (41%) and side effects (35%). Little discrepancy was observed in the comprehensibility between participants` characteristics. Drug inserts contained about 20% more professional-level words than 6th grade textbooks. In conclusion, Korean consumers may face challenges to understand drug information due to professional terminology and outdated expressions in the current package inserts. To secure safe and effective use of over-the-counter agents, greater efforts should be made to develop more consumer friendly labels. In the other hand, educational supports are required to prepare consumers in a proper level of knowledge for the safe use of drugs.

약물사용검토 서비스에 대한 개국약사들의 인식을 탐구한 질적 연구

이인향 ( Iyn Hyang Lee ),제남경 ( Nam Kyung Je ),경은정 ( Eun Jung Kyung ),김종윤 ( Jong Yoon Kim ),이숙향 ( Su Khyang Lee ) 한국보건경제정책학회(구 한국보건경제학회) 2011 보건경제와 정책연구 Vol.17 No.3

‘의약품 처방조제지원서비스’의 전국 확대의 즈음에 개국약사들의 인식을 고찰하고 이들의 시각에서 해당 제도의 효율성을 높이고 효과를 향상시킬 수 있는 방안을 모색하고자 하였다. 질적 연구. 유의추출법(purposive sampling)과 눈덩이모집법(snowballing sampling)을 이용하여 모집된 지역약국 약사를 전화 또는 대면 심층인터뷰를 하였고 수집된 자료를 프레임분석기법을 이용하여 분석하였다. 개국약사 31명이 연구에 참여하였으며, 이들 중 2인 미만 소형약국의 개설약사가 과반수이상으로 우리나라 개국약국가의 전형적 특성을 보였다. 지금까지 약사들은 지식정보의 한계, 시간적 제약, 처방의사와의 관계, 환자들의 부정적 반응 등의 현실적 어려움 때문에 자발적 약물사용검토를 습관적, 수동적, 소극적으로 제공하는 경향을 보였다. 정보기술 기반 네트워크를 이용한 의무적 약물사용검토 제도는 상존하던 어려움들 중 일부(환자의 약물복용 정보의 실시간 제공, 의/약사 최소한의 소통을 하도록 할 것)에는 긍정적인 영향을 미칠 수 있을 것으로 생각되었다. 다른 한편, 새로운 제도가 약사 업무를 가중시키거나, 의사나 환자와의 관계를 악화시킬 것이라는 등 부정적인 전망도 상당하였고, 불합리하다고 느낀 사항을 구조적으로 개선하고 발전시키고자 노력하기 보다는 손쉬운 개별적 우회로를 찾아 어려움을 해결하려고 할 가능성이 있어보였다. ‘처방조제지원서비스’가 ‘환자의 안전한 약물 사용’이라는 궁극적 목적을 달성할 수 있기 위해서 거시적, 미시적 측면의 정책적 함의가 도출되었다. 전자는 관련 정책전반에 대한 공감대 형성, 관련전문가 간 신뢰제고, 수요자를 고려한 쌍방형 정보의 제공 등을, 후자는 ‘처방조제지원서비스’이 제공하는 정보의 질과 양에 대한 지속적 모니터링과 향상, 융통성 있는 제도운영 등이 포함되었다. 주치약사제도가 ‘처방조제지원서비스’만으로 극복할 수 없는 현실적 문제점을 해결해 줄 수 있는 정책적 대안으로 제시되었다. 약학대학 및 관련 전문가단체는 약사가 사회가 요구하는 전문직능인으로서의 역량을 발전시킬 수 있도록 교육적 뒷받침을 제공할 필요성이 컸다. The study aimed to investigate community pharmacists`` perceptions on drug utilization review (DUR) in South Korea. The concrete situation of this newly launched system at practices as well as challenges and prospects were explored. A qualitative study. We performed indepth interviews with 31 community pharmacists who were recruited through a purposive sampling or a snowballing sampling. Data were analyzed using the framework approach. Community pharmacists have provided DUR services only to the limited degree due to the shortage of available information and time. Poor communication with prescribers and negative response from patients have also discouraged the pharmacists from being actively engaged. A newly launched, computerized DUR system has being expected to reduce some of the difficulties and contribute to the rational utilization of medicines by giving relevant information in a timely manner and putting legal responsibility on prescribers and dispensers. In the other hand, participants concerned heavier work load and increasing tensions with doctors or patients. Additionally, there were some signs indicating that the system could be operated far from the purpose if service givers sought an individual "bypass" against possible disadvantages. To achieve the aims of the DUR system in South Korea, dual policy efforts should be made at a macro level (e.g. making social consensus, giving appropriate professional training) and a micro level (e.g. monitoring the quality of DUR information, settling down the system technically).

보훈의료지원 대상자의 외래 처방의약품 사용경향과 적정성 평가

이인향,심다영,Lee, Iyn-Hyang,Shim, Da-Young 한국임상약학회 2018 한국임상약학회지 Vol.28 No.2

Objective: This study analyzed the national claims data of veterans to generate scientific evidence of the trends and appropriateness of their drug utilization in an outpatient setting. Methods: The claims data were provided by the Health Insurance Review & Assessment (HIRA). Through sampling and matching data, we selected two comparable groups; Veterans vs. National Health Insurance (NHI) patients and Veterans vs. Medical Aid (MAID) patients. Drug use and costs were compared between groups by using multivariate gamma regression models to account for the skewed distribution, and therapeutic duplication was analyzed by using multivariate logistic regression models. Results: In equivalent conditions, veteran patients made fewer visits to medical institutions (0.88 vs. 1), had 1.86 times more drug use, and paid 1.4 times more drug costs than NHI patients (p<0.05); similarly, veteran patients made fewer visits to medical institutions (0.96 vs. 1), had 1.11 times more drug use, and paid 0.95 times less drug costs than MAID patients (p<0.05). The risk of therapeutic duplication was 1.7 times higher (OR=1.657) in veteran patients than in NHI patients and 1.3 times higher (OR=1.311) than in MAID patients (p<0.0001). Conclusion: Similar patterns of drug use were found in veteran patients and MAID patients. There were greater concerns about the drug use behavior in veteran patients, with longer prescribing days and a higher rate of therapeutic duplication, than in MAID patients. Efforts should be made to measure if any inefficiency exists in veterans' drug use behavior.

의약품의 허가외사용 정보제공과 동의에 대한 일반인 인식

이인향 ( Iyn Hyang Lee ),계승희 ( Seung Hee Kye ),제남경 ( Nam Kyung Je ),이숙향 ( Suk Hyang Lee ) 영남대학교 약품개발연구소 2015 영남대학교 약품개발연구소 연구업적집 Vol.25 No.-

Objective: This study aims to explore the perception of off-label use of medications and the provision of informed consents from the general public’s perspective. Methods: The study subjects (n=291) were recruited from 7 cities in Korea through a convenience sampling method. The self-administered questionnaire with 13 items was issued and collected. The study subjects who have had a pharmaceutical job were excluded. Results: The total of 231 respondents was included. Only 23% of respondents were familiar with the concept of off-label use of medications. Eighty five percent of respondents (n=196) stated that the prescribers should explain the off-label use of a medication to their patients. The preferred method for delivering the message was the oral explanation (n=122, 53%), followed by oral explanation plus a pamphlet (n=94, 41%). The safety issue is the most concerned aspect regarding the off-label drug use, also effectiveness and insurance coverage. The majority of respondents (n=217, 94%) agreed that the prescriber should get a consent from patients before prescribing medications for off-label use. They preferred written consent to oral consent (140 vs. 77). Conclusion: This study demonstrated general publics are infrequently aware of off-label use of medications. It is important to raise public awareness of the off-label use of medications and to openly discuss its pros and cons for safe and effective drug therapy.

근거중심 의약품 정책 결정; 극복하기 어려운 과제인가? 한국 전문가의 생생한 의견

이인향 ( Iyn Hyang Lee ) 영남대학교 약품개발연구소 2014 영남대학교 약품개발연구소 연구업적집 Vol.24 No.0

This study aims to explore the difficulties of evidence-based pharmaceutical policy-making in the Korean context where several pharmaceutical policies were introduced within a short period. Semi-structured in-depth interviews were performed with eight experts in the Korean pharmaceutical arena. The key challenge in Korean situation might be the apparent lack of available evidence caused by the limited resources, the lack of policy consistency and coordination ability in the authorities and distrust across stakeholders. To build an evidencebased tradition, it is essential to resolve the tangible lack. At once, more fundamental changes seem to be required in the intangible policy environments.

국내 의약품정보에 대한 소비자의 시각 및 활용도

이인향 ( Iyn Hyang Lee ),계승희 ( Seunghee Kye ),이숙향 ( Sukhyang Lee ) 영남대학교 약품개발연구소 2014 영남대학교 약품개발연구소 연구업적집 Vol.24 No.0

Purpose: This study aims to investigate consumers` demand of and perspective on drug information domestically availableand uncover hurdles that they faced while utilizing information. Methods: We conducted a survey of 101 consumers,face-to-face after obtaining informed consent. Chi-squared, or Fisher`s exact tests, and multivariate logistic modelswere used to investigate the association between participants` perceptions and characteristics. Results: As results, participantsshowed the highest demand for “Adverse effects >90%”; “Drug interactions/Dosage/Drug-food interactions/ Indication>80%”, and utilized package inserts (52%), doctors (41%) and pharmacists (36%) most often as informationsources. Generally, the most common difficulty consumers suffered with was that “it is hard to understand (51%)”. With public sources of drug information, sixty one percent of participants were “unaware of the provision of information”,resulting in strikingly low usage rates (5~11%). Subgroup analyses indicated that the older (≥ 50 years) and thedisadvantaged might have been placed in the blind spot of information mostly developed online (p<0.05).Conclusion:In conclusion, public sources of drug information that have been developed online might fail to meet consumers`demand. Greater efforts should be made to balance the development of the information sources between online andoffline, and to increase accessibility of the established information sources.