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.

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.

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.

페경기 여성에서 호르몬 대체요법의 지질대사 및 골밀도에 대한 효과: 지속적 요법과 순차적 요법의 비교

이창연,이숙향,Lee, Chang Yun,Lee, Sukhyang 한국임상약학회 2000 한국임상약학회지 Vol.10 No.3

Menopausal women experience urogenitory and vasomotor symptoms with increased risk of osteoporosis and cardiovascular diseases, which can be reduced by hormone replacement therapy. However unopposed estrogen therapy has been associated with an increased risk of endometrial hypeiplasia or cancer. The objectives of this study were to compare effects of continuous vs. sequential hormone replacement therapy (HRT) on lipid profile, bone mineral density and menopausal symptoms of postmenopausal women and to assess how they perceive the menopause and HRT culturally. In this retrospective study, women in menopause longer than 6 months, normal in the mam-mogram and Papanicolaou smear, cholesterol level lower than 190 mg/dL or triglyceride level lower 4han 500 mg/dL were treated with Srogen (conjugated equine estrogen 0.625 mg tablet) and Provera (medroxyprogesterone acetate 2.5 mg tablet) for continuous treatment(CT) or Cycloprogynova (Estradiol valerate 2 mg and Norgestrel 0.5 mg complex tablet) for sequential treatment(ST). They were evaluated for lipid profile, bone mineral density, menopausal symptoms, side effects and their perception of menopause and HRT. As results, total sixty-seven patients out of ninety-four enrollees were included in final analysis (33 in continuous therapy, 34 in sequential therapy). There were significant decrease in total cholesterol ($15.04\pm3.17$, p=0.0001), LDL ($19.72\pm3.27$, p=0.0001), and increase in HDL ($5.89\pm1.63$, p=0.0001). Bone minora) density increased significantly with HRT ($0.02\pm0.11$, p=0.0001). But, there were no significant differences in change of lipid profile between continuous and sequential therapy: Total cholesterol, $13.12\pm4.7\;vs.\;16.91\pm4.3;\;LDL\;20.53\pm4.1\;vs.\;18.93\pm5.12:HDL\;7.15\pm2.3\;vs.\;4.67\pm2.2,\;p>0.05$. Incidences of flush reduced from $75\%\;(CT)\;to\;3.13\%\;and\;71.88\%\;(ST)\;to\;9.35\%$. The change of endometrium and breast were found 3 (CT) and 5 (ST) women, respectively. Most of women recognized that HRT is necessary $(70\%)$ for postmenopausal period but did not understand well the cardiovascular protective effect. In conclusion, hormone replacement therapy was effective in improving lipid profile, bone mineral density and menopausal symptoms in both continuous and sequential treatments with similar efficacy.

비판막성심방세동 환자에서 직접작용 경구용 항응고제 임상적 효과와 부작용 연구

홍지원,정민지,이숙향,Hong, Jiwon,Jung, Minji,Lee, Sukhyang 한국임상약학회 2022 한국임상약학회지 Vol.32 No.1

Background: Non-valvular atrial fibrillation (NVAF) is associated with ischemic stroke risk in the aging population. Observational studies have indicated beneficial effects of direct-acting oral anticoagulant (DOAC) against ischemic stroke compared to warfarin. This study aimed to investigate ischemic stroke incidence and bleeding risk in patients on DOAC therapy. Methods: Using the database of Korean Health Insurance Review and Assessment-Aged Patient Sample 2015, we conducted a retrospective cohort study. Study subjects with NVAF diagnosis and prescribed anticoagulants were enrolled. Propensity score (PS) matching by age, sex, comorbidities, and medications were used. The clinical outcomes were major adverse cerebro-cardiovascular events (MACCEs, ischemic stroke/systemic embolism, myocardial infarction, cardiac death) and bleeding events. A cox proportional hazard model analysis was performed to compare the outcomes with hazard ratio (HR) and 95% confidence interval (CI). Results: Total 4,773 elderly patients with NVAF were initially included. Four PS-matched groups including rivaroxaban vs. warfarin-only (n=1,079), dabigatran vs. warfarin-only (n=721), rivaroxaban vs. dabigatran (n=721), and switchers of warfarin to rivaroxaban vs. warfarin-only (n=287) were analyzed. Every group showed statistically similar results of MACCEs and bleeding events, except for the group of rivaroxaban vs. dabigatran. Rivaroxaban users showed higher risks of bleeding events than dabigatran users (HR 2.25, 95% CI 1.01-4.99). Conclusion: In the elderly patients with NVAF, efficacy and safety outcomes among oral anticoagulants including DOACs and warfarin were similar, while rivaroxaban are more likely to have higher bleeding risks than dabigatran. Further research using large size sample is needed.

태블릿 PC 기반 자기결정교수학습모델(SDLMI)중재가 초등학교 중도 지적장애 학생의 수업참여행동과 문제행동에 미치는 영향

염지혜 ( Jihye Yeom ),이숙향 ( Sukhyang Lee ) 한국특수아동학회 2015 특수아동교육연구 Vol.17 No.3

본 연구는 태블릿 PC를 기반으로 시각적 자료를 사용하여 재구조화한 SDLMI 중재가 장애학생의 수업참여행동과 문제행동 발생률에 미치는 영향을 알아보았다. 이를 위해 경기도 G시 소재공립 초등학교 특수학급의 중도 지적장애 학생 3명을 대상으로 해당 특수학급에서 점심시간이나 방과 후 시간에 태블릿 PC를 기반으로 시각적 자료를 사용하여 재구조화한 SDLMI 중재를 연구자가 참여학생에게 일대일로 실시하였다. 실험은 대상자 간 중다 간헐 기초선 설계 방법을 사용하여 기초선, 중재, 일반화, 유지의 순으로 진행되었다. 연구 결과, 참여학생 3명 모두 SDLMI 중재 동안 특수학급 국어시간에 각자가 선택한 수업참여행동의 발생률이 기초선 기간보다 증가하였고 문제행동은 기초선에 비해 감소하였으며, 이러한 긍정적인 변화는 특수학급 수학시간에도 일반화 되었고 중재 종료 후에도 유지되었다. 이와 같이 본 연구는 장애학생을 위한 효과적인 자기결정교수학습모델로 보고된 중재전략인 SDLMI를 중도 지적장애 학생들의 특성을 고려하여 그림으로 재구성하고 태블릿 PC를 통해 제시함으로써 중도 지적장애 학생에게 긍정적인 효과를 입증하였다는 데 의의가 있다. The purpose of this study was to examine the effects of SDLMI intervention restructured by using tablet PC-based visual aids on the academic engagement and problem behaviors. The participants of this study were three students with severe intellectual disability in a special education classroom at a public elementary school located in G City, Gyeonggi-do. The experiment was implemented at the special-education classroom of the participating students, and it was done as one-to-one intervention between the researcher and the students during lunch time or after-school class. Multiple probe baseline across subjects design was applied for this study, including baseline, intervention, generalization, and maintenance periods. According to the results of this study, during the invention, the academic engagement behaviors that the three students had chosen were more frequently observed and their problem behaviors were less observed in Korean language class of special-education classroom compared to that of in the baseline period. This positive changes were also generalized in the math class and maintained even after the intervention. This study is significant in that it has proved that SDLMI, one of the intervention strategic reported as an effective self-determination teaching-learning model for students with disabilities, has positive effects on students with severe intellectual disabilities by restructuring it using visual materials based on the characteristics of students with severe intellectual disabilities and presenting them through a tablet PC.

입원 노인환자의 부적절 약물사용현황 및 용량적절성 평가

홍유리(Yurhee Hong),이숙향(Sukhyang Lee) 대한약학회 2010 약학회지 Vol.54 No.3

This study aimed to evaluate the patterns of inappropriate medication use and inappropriate dosage in elderly patients in Korea. A retrospective study was performed for the elderly 65 years or older admitted from January 2007 to December 2007 in a medical center, Seoul, Korea. Potentially inappropriate medication (PIM) use in the elderly was evaluated using Beers criteria. Eighteen drugs out of Beers criteria were included in the formulary of the institute. Inappropriate dosage was set using Beers criteria, CMS (the Centers for Medicare& Medicaid Services) guideline, Geriatric Dosage Handbook. As results, the patients with PIM were 2,172 during the study period. The commonly used inappropriate medications were drugs for the nervous system (n=1237, 44.78%), the alimentary System (n=663, 24.54%) and the cardiovascular system (n=494, 18.28%). The elderly patients with prescription of inappropriate dosage were 10% out of patients with PIMs. The commonly inappropriate dosage drugs were digoxin (n=75, 27.27%), diazepam (n=70, 22.55%) and ferrous sulfate (n=66, 24.00%). Logistic regression analysis showed the number of PIM, days of hospital stay as predictors related to inappropriate dosage use. In conclusion, CNS drugs were frequently prescribed as PIM and inappropriate dosages were identified. It is needed to develop a means of decreasing adverse drug events in elderly.

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.

자폐스펙트럼장애 아동의 식행동 및 영양섭취 특성 관련 문헌연구

박지연(Park, Jiyeon),김유리(Kim, Yuri),이숙향(Lee, Sukhyang),김유리(Kim, Yuri),오지은(Oh, Jieun),정서진(Jung, Seojin),안혜신(An, Hyesin) 한국자폐학회 2019 자폐성 장애연구 Vol.19 No.3

본 연구는 자폐스펙트럼장애 아동의 식행동 및 영양섭취 관련 선행연구에 대한 고찰 및 분석을 통해 자폐스펙트럼장애 아동의 건강한 식생활 지원을 위한 향후 과제에 주는 시사점을 모색하고자 하였다. 이를 위해 지난 15년 동안 발표된 선행연구 총 26편을 선정하고, 선정된 논문의 전반적 연구 동향과 자폐스펙트럼장애 아동의 식행동 및 영양섭취 특성을 분석하였다. 선행연구의 분석결과는 다음과 같다. 첫째, 대부분의 선행연구들은 자폐스펙트럼장애 아동과 일반아동의 식행동을 비교하여 자폐스펙트럼장애 아동의 비전형적인 특성을 조사하였다. 둘째, 연구자료 수집은 주로 부모가 질문지에 응답하거나 부모의 아동 관찰을 통해 이루어졌다. 셋째, 여러 선행연구에서 자폐스펙트럼장애 아동의 식행동과 개인변인 간에 관계가 있음을 보고하였으나, 그들의 식행동과 가족변인 간의 관계를 조사한 연구는 상대적으로 부족하였다. 넷째, 자폐스펙트럼장애 아동의 영양섭취 및 영양상태에 대한 연구는 그 편수가 많지 않고, 몇몇 선행연구는 상충된 결과를 보고 하기도 하였다. 본 연구의 분석결과를 토대로 자폐스펙트럼장애 아동의 식행동 및 영양관련 향후 연구과제에 대한 시사점이 논의되었다. This study was to review literature on eating behaviors and nutrient intake in children with autism spectrum disorders, and provide directions for future research. Twenty-six studies published over the last 15 years were identified and analyzed. The results of this synthesis indicated that the majority of the studies focused on comparing eating behaviors in children with autism spectrum disorders to those of children without autism spectrum disorders, and identified atypical eating behaviors of children with autism spectrum disorders. The common procedure for collecting information about the eating behaviors and nutrient intake of children with autism spectrum disorders was a questionnaire and observations. Overall, the studies exhibited that there were relationships between individual variables and eating behaviors of children with autism spectrum disorders, but few studies examined relationships between family variables and eating behaviors of children with autism spectrum disorders. There were also a small number of studies of nutrient intake and nutritional adequacy among children with autism spectrum disorders, and several studies produced conflicting results. Based on the findings, the future directions for eating behaviors and nutrition of children with autism spectrum disorders were discussed.

Cilostazol이 제2형 당뇨병 환자의 심혈관 합병증과 혈청지질에 미치는 영향

이영숙,이영미,김광원,최경업,이숙향 한국병원약사회 2002 병원약사회지 Vol.19 No.4

PURPOSE: Cliostazol, a phosphodiesterase Ⅲ inhibitor, is an antiplatelet agent for treatment of ischemic symptoms of peripheral vascular disease in the diabetes. In addition, it has been claimed to have beneficial effect on plasma lipid level. The objective of this study was to evaluate retrospectively the effect of cilostazol administration on cardiovascular events and serum lipid levels in patients with type 2 diabetes mellitus (DM). METHODS: DM patients on cilostazol for longer than 6 months were evaluated from September, 1996 to June, 2000 for lipid profile, HbA1c, postprandial glucose, urinary albumin excretion, cardiovascular events. Dosage of cilostazol was 100㎎/day with range of 50-200㎎/day. Primary outcome variable was any cardiovascular events during treatment and secondary variables were changes in lipid level, urinary albumin excretion and adverse events. Lipid level was compared between the groups with or without lipid lowering agents. Patients were evaluated for bleeding events in combination with other antiplatelet agents, such as aspirin, ticlopidine and warfarin. RESULTS: Total 180 patients were included Mean age was 60.8±9.9 years; number of male patient, 90(50%); DM duration, 12.4±8.1 years; family history of DM, 61(33.9%); family history of cardiovascular events, 15(8.3%) and smoking, 32(17.8%). The cardiovascular events were noted in 8 cases out of 180 (4.4%). Systolic blood pressure and age were risk factors in correlation with cardiovascular events. During treatment with cilostazol, there were no significant changes in blood glucose. Among 19 patients with serum lipid profile before and after cilostazol treatment, there were no significant changes in serum lipid levels with LDL-cholesterol reduced form 130.8±30.3 ㎎/㎗ at baseline to 120.0±43.1 at 1 yr and 125.4±27.3 at 3 yr (p=0.052). Bleeding event was in 1 case of co-administration with other antiplatelet agents that were aspirin (87), ticlopidene(7), warfarin(2) CONCLUSION: Cilostazol has been used for peripheral vascular disease in DM patients with antiplatelet activity and lipid lowering effect in part. Small effect on lipid level can be expected by itself or in combination with other lipid lowering agents and the cardiovascular can be prevented in patients with type 2 DM.