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의약품 사용평가(DUR) 사업의 미국 47개주 Medicaid 자료비교 및 정책적 함의 고찰
전하림 ( Jeon Ha Lim ),박주희 ( Park Ju Hee ),김동숙 ( Kim Dong Sook ),최병철 ( Choi Byung Chul ) 한국보건사회연구원 2014 保健社會硏究 Vol.34 No.3
부적절한 약물 사용은 약물위해사건을 발생시킴으로써 병원 입원과 같은 불필요한 의료 비용 지출을 유도한다. 약물의 부적절한 사용을 예방할 수 있는 방법으로 제시되는 의약품사용평가(Drug Utilization Review, DUR) 프로그램은 처방전을 점검하여 잠재적인 의약품 관련 문제를 줄임으로써 국민 건강 보호 및 피할 수 있는 의료비용 지출을 줄일 수 있다. 미국에서는 OBRA`90 법안에 메디케이드 프로그램은 DUR을 적용하도록 규정하고 있어 1993년 1월부터 미국 전체 주에서 DUR를 실시하게 되었고 각 주 메디케이드에서는 DUR프로그램의 경고발생현황, 처방분석, 비용절감 등에 대해 메디케어 및 메디케이드 관리부서(Center for Medicare and Medicaid Services, CMS)에 보고서를 제출하고 있다. 미국의 DUR를 벤치마킹하여 국내에서 2008년 4월에 시작한 DUR 사업인 `의약품안심서비스`는 범위 확대의 필요성이 지속적으로 제기되고 있으나 새롭게 확대시킬 항목에 대한 국내 경고발생률, 경고수용률 등의 비교할 근거자료를 찾아볼 수 없는 실정이다. 본 연구에서는 회계연도 2010년인 미국의 메디케이드 DUR 연간보고서를 검토함으로써 국내 DUR제도의 발전방향을 제시하고자 한다. 47개 주의 메디케이드 연간 보고서를 검토한 결과, 국내 DUR은 점검영역 및 점검기준을 더욱 확대할 필요가 있으며 데이터베이스 정보의 수준과 점검기준의 특이도를 향상시켜야 할 것이다. 또한 의약품의 안전하고 적절한 사용에 대한 통합적 관리 및 후향적 DUR 수행을 위한 방안이 마련되어야 한다. Inappropriate drug use induces the increase of unnecessary medical expenditure caused by adverse drug events. Drug Utilization Review(DUR), which is one way for preventing inappropriate prescribing, screening prescription claims to identify drug related problems, and finally it should be improved patient safety and reduced the evitable medical costs. In the United States, Omnibus Budget Reconciliation Act of 1990 (OBRA`90) requires to be reported on each state`s prescribing patterns, cost savings to Center for Medicare and Medicaid Services (CMS) via Medicaid Drug Utilization Review Annual Report Survey. A Korea`s DUR program was implemented in partial area in April, 2008. Afterward, the necessity for expanding to the nationwide area has been required, but there have insufficient data to be referred for assessment, criteria and plan. The purpose of this study was to review DUR annual Report for FFY 2010 of United States, and to suggest a development plan suitable for use with domestic situation. We reviewed that Medicaid DUR annual report of 47 states and summarized POS vendor, the types of criteria, etc, and described retrospective DUR case of some states. Based on the review of DUR annual report in the USA, we suggest that the expansion of the scope and criteria of Korea`s DUR. Moreover, the integrated management for appropriate medication use and retrospective DUR should be conducted.
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의약품의 해부학적·치료학적 분류별 광고심의 5개년 현황과 광고의 질 개선을 위한 요인 분석
조우연(Woo-Yeon Cho),전하림(Ha-Lim Jeon) 대한약학회 2023 약학회지 Vol.67 No.5
There has been no study investigating which drug advertisements have recently increased or what decisions the Drug Advertisement Review Committee made based on the therapeutic classification of the drug. This study aimed to examine the status and trend of drug advertisement review by the Anatomical Therapeutic Chemical (ATC) Classification over the 5 years and identify factors that may increase the likelihood of receiving a decision other than ‘accepted’. We obtained drug advertise review data from the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (2017- 2021). The number of reviewed drugs and 5-year increase rate were calculated by ATC classification. We performed a logistic regression to compute odds ratios (ORs) for potential contributing factors. From 2017 to 2021, the overall reviewed drugs increased by 84.3%. The 5-year increase rate for ‘modification-needed’ (236.3%) and ‘inadequate’ (312.8%) decisions was higher than the overall 5-year increase rate. Drugs related to the Alimentary Tract and Metabolism underwent more advertisement reviews than those from other categories. Nearly all categories demonstrated an increasing trend in online media. Online media [OR=1.34; 95% confidence interval (CI), 1.27-1.42], drugs for Musculo-skeletal system (OR=1.13, 95% CI, 1.01-1.22) and sensory organs(OR, 1.82; 95% CI=1.58-2.08) were significantly increase the probability of receiving a decision other than ‘accepted’. Our results will be useful to improve drug advertisement review system and promote self-censorship of pharmaceutical companies.
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전문가 조사를 활용한 약제급여 적정성 평가 항목 및 지표 확대방안 도출
김보연(Bo-Yun Kim),김동숙(Dong-Sook Kim),전하림(Ha-Lim Jeon) 大韓藥學會 2015 약학회지 Vol.59 No.4
Evaluation Project on Appropriate Prescribing (EPAP) which is analysing prescribing pattern and providing physicians feedback has begun in 2001. EPAP indicators are related to antibiotics for acute respiratory tract infections, overuse of injection, polypharmacy (no. of drugs prescribed together, no. of prescriptions with 6 or more drugs), prescribing of specific medication group (drugs for acid related disorders, NSAIDs, corticosteroids) and medication expenditure per prescription day. The aim of this study was to suggest a development plan for EPAP indicators suitable for domestic situation. A consensus group consisting of seventeen health care professionals evaluated significance of each therapeutic class for EPAP indicators expansion considering information such as magnitude of issue, prescribing indicators of foreign countries, reimbursement criteria by each therapeutic class. Based on the data and group survey, 5 classes were selected as candidates for prescribing indicators and we presented 24 indicators regarding 5 classes. The results suggested that we need to augment evaluation indicators of additional area.
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의약품 광고심의 기준 및 절차 개선을 위한 전문가 의견 조사
김지현(Jihyun Kim), 조우연(Wooyeon Cho), 신성환(Seonghwan Shin), 박지우(Jeewoo Park), 김주경(Ju Kyoung Kim), 정재훈(Jae-Hoon Cheong), 전하림(Ha-Lim Jeon) 한국보건사회약료경영학회 2023 한국보건사회약료경영학회지 Vol.11 No.1
BACKGROUNDS Since the number of drug advertisements is increasing due to the expansion of advertising markets and the emergence of a new type of advertisement, it is important to review drug advertisements accurately and efficiently. OBJECTIVE We aim to gather and analyze the expert’s opinions regarding the criteria and procedures of drug advertisement review. METHODS Survey questionnaire was sent to 42 members of the drug advertisement review committee. The questionnaire included the key principle of drug advertisement review, the importance of prohibition by type of advertisement, the necessity of permitting by type of advertisement, and questions about current procedures of drug advertisement review. RESULTS In total, 23 of 42 members participated (54.7% response rate). Survey results showed that the ‘Proper expression of efficacy and effectiveness’ and ‘Fair competition among drugs’ were important principles. Prohibition of ‘False advertisements’ and ‘Advertisements that distort facts’ were considered important. The degree of agreement in the need for permission was relatively low, but it was considered relatively necessary to allow ‘Advertisements that present drugs which have been recognized for safe use, such as vitamins.’ All respondents agreed that the number of drug advertisement reviews was high. Approximately 70% of respondents answered that current review fees are not adequate. CONCLUSION This study shows the degree of consensus of experts and provides evidence for further amendment on criteria and procedures of drug advertisement review.
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