• Title/Summary/Keyword: Drug Review

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The Effect of Korean Prospective Drug Utilization Review Program on the Prescription Rate of Drug-Drug Interactions (의약품 처방·조제지원서비스(Drug Utilization Review)사업이 병용금기 처방률에 미치는 영향)

  • Kim, Dong-Sook;Park, Juhee;Jeon, Ha-Rim;Park, Chanmi;Kang, Hyeun Ah
    • Health Policy and Management
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    • v.24 no.2
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    • pp.120-127
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    • 2014
  • Background: Since December 2010, online computerized prospective drug utilization review (pDUR) has been implemented in Korea. pDUR involves the review of each prescription before the medication is dispensed to the individual patient. The pDUR is performed electronically by Health Insurance Review & Assessment Service (HIRA), which is a Korean governmental agency, and then HIRA provides medical institutions and pharmacies with information that can be helpful to them in preventing potential drug problems such as drug/drug interactions or ingredient duplication. The aim of this study was to assess the impact of the Korean pDUR implementation on the proportion of drug-drug interactions (DDIs) using claims data from HIRA. Methods: A before-after comparison of the prevalence of DDIs between prescription was conducted, using HIRA administrative claims data of medical institution from January 2010 to December 2011. The analysis unit was the prescription issued and pairs before and after. The main outcome measures were the proportion of DDIs within- (control group) or between- physician encounters. To examine the difference, a paired t-test was applied. Results: We found that DDIs proportion between prescription decreased significantly (t=3.04, p=0.0026) after the implementation of pDUR, whereas there is no significant reduction within prescription (t=1.15, p=0.2518). With respect to the prevalence of DDIs between drug groups, the most dramatic reduction was occurred between 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors and anti-fungal agents. Conclusion: It seems effective that giving a direct feedback to prescribers by a prospective DUR. Further research is needed to assess the impact of DUR to final outcomes such as hospitalization.

Retrospective Drugs Utilization Review Study for Chronic Kidney Disease Using National Health Insurance Database (건강보험 자료를 이용한 만성신부전 환자의 신독성 약물사용 현황)

  • Kim, Dong-Sook;Lee, Hyun-Jeong;Son, In-Ja;Kim, Gui-Sook;Shin, Joo-Young;Lee, Kun-Sei
    • YAKHAK HOEJI
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    • v.53 no.3
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    • pp.138-144
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    • 2009
  • The purpose was to implement drug utilization review (DUR) for whom were diagnosed with chronic kidney disease (CKD) population using health insurance claim data. This study constructed drug utilization database using Health Insurance Review and Assessment Service (HIRA) database and selected contraindicated drugs with kidney based on previously developed drug utilization guide and reviewing other countries' examples. Main outcome measures were the proportion of prescription for 1 or more drugs of concern. The cohort included 115,948 subjects, who were diagnosed with chronic kidney disease. Inappropriate drugs with CKD patients was some used, and the most commonly prescribed classes were aluminum drugs. However it is difficult to find problems with inappropriate drug because claims data doesn't have laboratory data. Based on the result of retrospective drug utilization review study, more studies should be analysed drug utilization patterns and monitoring system should be developed.

Retrospective Drug Utilization Review of Drug-Drug Interaction Criteria Based on Real World Data: Analysis in Terms of Dispensing Types (건강보험심사청구 자료에 근거한 병용금기 약물의 후향적 약물사용평가 : 처방전 조제 형태별 분석)

  • Lee, Young-Sook;Shin, Hyun-Taek
    • Korean Journal of Clinical Pharmacy
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    • v.21 no.3
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    • pp.249-255
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    • 2011
  • Objective: To examine the drug use (prescribing) pattern of serious drug-drug interactions (DDIs, contraindicated drug interactions) using real world data. Prescription patterns were examined in terms of dispensing types. Method: Retrospective drug utilization review (DUR) study was performed. One hundred and six datasets of serious DDIs (DDI pairs) were determined among DDI datasets that Ministry of Health & Welfare announced for the DUR system from 2004 to 2005. Electronically transacted ambulatory patients' prescription database to Health Insurance Assessment and Review Services (HIRA) from July, 2005 to June, 2006 was collected with personal information deidentified and analyzed in terms of types of dispensing as a contributing factor. Results: After prescription data analysis per each patient, total number of DDI cases using 95 DDI pairs was 5,511, which accounted for 2.6 cases per patients. DDI cases between two drugs from each of community pharmacy dispensing- type prescription were considerable (63% vs. 24% in those from each of in-institutional dispensing-type prescription and vs. 13% in those from a community pharmacy dispensing-type prescription and an in-institutional dispensingtype prescription). Conclusions: DDI cases from different prescribers were found to be significant. Thus, the concurrent DUR process between prescriptions from different physicians and institutions should be implemented for the safe drug use.

Promotion of Adverse Drug Reactions Report through Expansion of Drug Utilization Review (의약품 사용평가(DUR) 확대를 통한 의약품 부작용 보고 활성화 방안)

  • Jeong, Su-Cheol
    • The Journal of the Korea Contents Association
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    • v.19 no.1
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    • pp.234-241
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    • 2019
  • The side effects of using drugs can greatly threaten the health of the public. The reality is that there are very few reports of current side effects. This can be activated by linking adverse drug reactions reporting to the Drug Utilization Review (DUR) currently used by pharmacies. A study of the U.S. medication management system, where drug use assessment is activated, can find ways to activate adverse drug reactions reporting. In 'Pharm IT 3000', which is used as a medication management program in pharmacies, we examined how to enable reporting of adverse drug reactions. The literature study and research on actual program operation have found a convenient way to report side effects by linking the Pharm IT 3000 prescription preparation assessment to the item.

The Effects after Implementing a Drug Utilization Review System on Contraindicated Drug use: A Systematic Review (사용금기 약물에 대한 의약품안전사용서비스의 효과에 대한 체계적 문헌고찰)

  • Lee, Heeyoung;Choi, Hyea Suk;Ji, Eunhee
    • Korean Journal of Clinical Pharmacy
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    • v.29 no.1
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    • pp.9-17
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    • 2019
  • Objective: The objective of the present study was to evaluate the effects of implementing a systematic Drug Utilization Review (DUR) system on contraindicated drug use and pharmaceutical expenditures in Korea. Methods: A literature search was conducted using search engines such as PubMed, EMBASE, NDSL, and RISS for relevant systematic studies. The database search was performed and updated in April 2018. Two independent reviewers evaluated the abstracts to find potentially eligible articles. Results: In total, 1433 potentially eligible studies were selected, and 11 articles were eventually shortlisted for inclusion in the present review system. The outcome showed that contraindicated drug use decreased after implementation of the DUR system in Korea. The analysis also showed that the DUR system contributed to a reduction in pharmaceutical expenditures. Conclusions: Our study showed that implementing the DUR system reduced both contraindicated drug use and pharmaceutical expenditures in Korea.

Analysis of Frequent Therapeutic Duplication Drug Classes Based on National Health Insurance Claimed Data in Korea (국내 건강보험심사청구자료에 근거한 다빈도 치료중복 의약품 약효군 분석)

  • Sohn, Hyun-Soon;Lee, Young-Sook;Choi, Kyung-Eob;Shin, Hyun-Taek
    • Korean Journal of Clinical Pharmacy
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    • v.20 no.3
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    • pp.262-267
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    • 2010
  • Therapeutic duplication of prescriptions is the most frequently reported inappropriate drug use in Korea. To prevent significant problems during drug prescribing and dispensing, prospectively, development of standard including drug lists considered as therapeutic duplications for the prioritized drug classes first would be necessary. This study was aimed to analyze frequent drug classes of therapeutic duplications by healthcare providers in clinical practice settings. National health claims data for drug review and reimbursement (1,426,065 prescriptions dated March 19, 2008) were analyzed. Therapeutic duplication was defined as the prescription including more than 2 ingredients belonging to the same KFDA drug classification numbers that considered to have therapeutic similarities. The following 3 drug classes were mostly frequent therapeutic duplication classes: 114 anti-pyretics, analgesics and anti-inflammatory drugs; 117 drugs for psycho-nervous system; 141 Antihistamines. About 3.5% of overall prescriptions analyzed showed therapeutic duplications. This result might be starting step to develop DUR therapeutic duplication standard.

A Study on the Changes in Regulations Regarding Approval, Notification and Review of Herbal Medicinal Preparations and Crude Drug Preparations - From 1948 to 2012 - (한약・생약제제 품목허가신고심사 규정 변화에 관한 고찰 - 건국이후부터 2012년까지 -)

  • Eom, Seok-Ki
    • The Journal of Korean Medical History
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    • v.27 no.2
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    • pp.11-37
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    • 2014
  • Objectives : The purpose of this study was to analyze and identify the problems of the changes in regulations that are relevant to approval, notification, and review of herbal medicinal preparations and crude drug preparations. Methods : I collected the regulations of approval, notification, and review of medicinal products mostly from official gazettes, analyzed enactment and amendments regarding herbal medicinal preparations and crude drug preparations, and studied it from the view point of Korean medicine field. Results : Regulations in regards to approval, notification, and review of herbal medicinal preparations and crude drug preparations were first established in 1978. Herbal drugs started to be categorized as crude drug preparations in 1981 and the regulatory outlines were completed in 1999. From 2008 to 2012, the regulatory standards that let crude drug preparations be new drugs from natural products were established. Through those procedures, the followings became crude drug preparations: 1) wholly new prescriptions that are not recorded in Korean Medical Classics, 2) prescriptions that are recorded in Korean Medical classics but prepared with new standard, composition and efficacy, 3) prescriptions that are recorded in Korean Medical classics but prepared with new formulation, and 4) herbal drugs. In case of herbal medicinal preparations, however, only regulations that are related to 1) drugs prepared with new compositions that are not recorded in Korean Medical Classics, 2) drugs with same prescription and same formulation, and 3) drugs with new formulation were arranged. Conclusions : Actual circumstances on crude drug-oriented regulations regarding approval, notification and review and future forms of prescription and drug administration in Korean Medical Institutions can be expected due to expansion in range of herbal medicinal preparations and shrink in that of on-site preparations. Reasonable improvement in efficient usage of modernized herbal medicinal preparations in Korean medical institutions and prospective cooperation from related pharmaceutical industry are needed.

Strategic Plans for the Implementation of Pharmacometric Methodology in Drug Regulatory Review Decisions (효율적인 의약품 평가를 위한 약물계량학 분석법 도입의 전략 방안)

  • Lee, Sang-Min;Choi, Bo-Yoon;Yun, Hwi-Yeol;Jun, Da-Hae;Kim, Myung-Gou;Ha, Ji-Hye;Kim, Young-Hoon;Ji, Eun-Hee;Kang, Won-Ku;Han, Na-Young;Shin, Wan-Gyoon;Oh, Jung-Mi
    • Korean Journal of Clinical Pharmacy
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    • v.21 no.4
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    • pp.339-346
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    • 2011
  • Over the past few decades, drug regulatory agencies in advanced countries have been emphasizing pharmacometrics as a tool for an effective and efficient drug evaluation. Despite this international movement, the value of pharmacometrics is still poorly recognized by the Korean drug evaluation system. This study aimed to analyze the current state of utilization of pharmacometrics by foreign drug regulatory agencies and develop a road map to guide the implementation pharmacometrics into the Korean drug evaluation system. MEDLINE and foreign drug regulatory agency database were extensively searched to obtain scientific research articles, guidance, regulations and pharmacometric review reports on foreign pharmacometric drug evaluation system. A systematic roadmap comprised of 3 stages to implement pharmacometrics in Korean drug evaluation system was formulated after analyzing the collected data in tune with the current evaluation system. Pharmacometrics is an urgently required tool to achieve an efficient drug evaluation and review in Korea. The road map developed by this study is expected to aid in setting up a policy to implement and utilize pharmacometrics in Korea.

A Review of HLA Genes in Pharmacogenetics: Risk Assessment of Adverse Drug Reactions

  • Yu, Shinae
    • Journal of Interdisciplinary Genomics
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    • v.3 no.1
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    • pp.7-12
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    • 2021
  • Adverse drug reactions (ADRs) is a hypersensitivity reactions to specific medications, and remain a common and major problem in healthcare. ADRs suchc as drug-induced liver injury and life-threatening severe cutaneous adverse drug reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms can be occurred by uncontrolled expansion of oligoclonal T cells according to genetically predisposing HLA. In this review, I summarized the alleles of HLA genes which have been proposed to have association with ADRs caused by different drugs.

Retrospective Drug Utilization Review on the Same-Day Multiple Prescriptions for Pediatric Outpatients (동일날짜 처방전 2매 이상인 외래 소아환자 의약품처방의 적정성에 대한 후향적 평가)

  • NamGoong, Bo-Ra;Sohn, Hyun-Soon;Choi, Kyung-Eob;Shin, Hyun-Taek
    • Korean Journal of Clinical Pharmacy
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    • v.22 no.1
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    • pp.73-80
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    • 2012
  • This study was to determine the inappropriate drug use in pediatric outpatients who received 2 or more prescriptions on the same day. Retrospective drug utilization reviews (DURs) were implemented to samples obtained from national health insurance claims data during December 2008 to February 2009, using 5 DUR criteria (duplication, drug-drug interaction, drug-disease interaction, drug-age contraindication, incorrect dosage) established in the Drug Information Framework (DIF)-$Korea^{TM}$, DUR program. Among 38,451 claims analyzed in the study, 74.7% had more than one conflicts in the 5 DUR modules. Among 16,472 patients analyzed, 49.6% had conflicts with duplication criteria composing of ingredient duplication (23.3%) and therapeutic class duplication (39.6%). Incorrect dosages were found in 73.6% of patients and under-dosage conflicts accounted for 59.9%, which was higher than over-dosage conflicts (38.3%). In this study, inappropriate drug prescriptions such as under-dose, pediatric contraindication and therapeutic duplication were prevalent in pediatric outpatient settings, suggesting much more awareness to the society, to prevent drug related problems in a vulnerable pediatric group.