HIRA

환자안전 중심 약제평가 지표 개발 연구

  • 271
  • 169
Metadata Downloads
Type
Research report
Author(s)
김유정이태훈동재용
Issued Date
2021-02
Abstract
Background
Pharmaceutical Care Quality Assessment under the National Health Insurance Service (hereafter PCQA) holds significance as a ‘drug consumption volume control policy’. There is a growing need for drug expenditure management as Korea continued to expand NHI coverage in the face of aging society. Recently, healthcare environment in Korea has seen much demographic changes, including aging society. Yet, current PCQA fails to reflect such changes in healthcare. This study aims to develop new medication safety indicators for patient safety and efficiency, reflecting such environmental changes in healthcare.

Methods
First, overview and current status of PCQA on drugs were examined, and limitations and issues were identified based on relevant literature review.
Second, using literature review, operational definitions were produced for patient safety, medication safety, and patient-centered PCQA for drugs. Based on existing reports, core areas for the study was produced by reviewing current status of major issues of medication safety in Korea.
Third, medication safety indicator candidates were selected by collecting quality indicators in medication safety and efficiency of other nations, and applying selection/exclusion criteria. And fourth, selected candidates were validated based on status in other nations, clinical guidelines in Korea and abroad, benefit claims data analysis, advisory council and working level meeting, and expert review using the RAND-modified Delphi method.

Result
This study concluded that utility and effectiveness of 20-year old quality indicators have run out, which calls for needs to develop new quality indicators for drugs. Based on literature review, we found the key area of medication safety Korea needs to manage. Medication safety area includes managed drugs for the elderly (geriatric precaution medicine), narcotics,
prescribing in primary care indicators (OECD HCQI), polypharmacy, therapeutic duplication (identical ingredients, therapeutic group), antipsychotic medicines, and steroids. Efficiency area includes wasted drug management (generic, bio-similar indicators). Based on prior literature, 383 indicators were collected from the U.K., Wales, the U.S., France, OECD prescribing in primary care indicators, and WHO prescription indicators. After applying exclusion criteria, 9 candidates were selected, consisting of 5 geriatric precaution medicine indicators, 2 therapeutic duplication indicators, 1 antipsychotic medicine indicator, and 1
polypharmacy indicator. The selected indicators were classified into short, mid, and long term in consideration of feasibility and etc. Finally, 3 short-term indicators were selected based on comprehensive review on validity, expert meeting outcome, and analysis using the RAND-modified Delphi method, which are simultaneous prescription rate of 2 or more
anticholinergic medications for older adults, geriatric precaution medicine prescription rate for older adults, and prescription rate of 5 or more medicines for adults aged 75 or older.

Discussion & Conclusion
Due to limitations of this study, more follow-up studies are required. This study did not include adverse drug effect, one of the important elements of medication safety. After upgrading current Drug Utilization Review system, follow-up researches should attempt to develop adverse effect related quality indicators. More in-depth study is needed to identify
areas for management, such as Korean medication safety issues and long-term application of pharmaceutical care quality assessment upon individual patients. As drug policy changes, introduction of additional quality indicators for future should be reviewed. The significance of this study lies in that it suggested development of quality indicators for medication safety for the first time in Korea. The three short-term indicators proposed in this study will be applicable to quality assessment of new drugs with priority. There should be continued systematic effort to develop more quality indicators for medication safety, using this study as
the starting point for medication safety assessment system development.
Publisher
건강보험심사평가원
URI
https://repository.hira.or.kr/handle/2019.oak/2998
Alternative Title
Development of Medication Safety Indicators for Pharmaceutical Care Quality Assessment
Table Of Contents
요 약 ⅰ

제1장 서론 ······································································································· 1
1. 연구 배경 및 필요성 ······················································································ 1
가. 약제급여 적정성 평가의 중요성 ································································································ 1
나. 현행 약제급여적정성 평가의 한계점 ································································································ 4
다. 제도적 요구사항 및 환자안전 트렌드를 반영한 신규지표 개발 필요 ································································································ 5
2. 연구 목적 ······································································································· 7
3. 연구 내용 및 방법 ························································································· 8
4. 연구 수행체계 ································································································ 9

제2장 국내 약제급여 적정성 평가 제도 개요 및 문헌고찰 ···························· 10
1. 개요 ·············································································································· 10
가. 배경 ································································································10
2. 현황 및 문제점 ·························································································· 14
3. 관련 국내 문헌고찰 ····················································································· 20
가. 약제급여 적정성 평가 개선방안 연구(2009) ····················································································· 20
나. 약제급여 적정성 평가 항목 확대방안(2013) ····················································································· 22
다. 약제급여 적정성지표 보완(2016) ····················································································· 26
4. 소결 ·············································································································· 29

제3장 국내 주요 약물안전 영역 실태 및 현황 ·············································· 31
1. 개요 ·············································································································· 31
가. 개념 및 정의 ·············································································································· 31
2. 주요 영역 관련 실태 및 현황, 문제점 ······················································· 35
가. 노인주의 의약품 ····················································································· 36
나. 마약류 의약품 ····················································································· 41
다. OECD 일차의료 약제처방 지표 ····················································································· 51
라. 다제병용(Polypharmacy) ····················································································· 59
마. 중복처방 ····················································································· 62
바. 스테로이드(Corticosteroid) ····················································································· 68
사. 항정신병 약물(Antipsychotics) ····················································································· 75
3. 소결(연구의 중점영역 선정) ········································································ 80

제4장 신규 약제평가 지표 개발 ···································································· 81
1. 국외 약제지표 현황 ····················································································· 81
가. 영국 ····················································································· 81
나. 웨일스 ····················································································· 86
다. 미국 ····················································································· 88
라. 프랑스 ····················································································· 89
마. 국제기구(WHO) ····················································································· 90
2. 약제평가 지표 검토 및 선정과정 ································································ 91
가. 지표 선정 과정 ····················································································· 91
나. 외부 전문가 의견 ····················································································· 93
다. 내부 실무진 의견 ····················································································· 95
라. 최종 선정된 후보지표 ····················································································· 96
3. 후보 약제평가 지표의 타당성 검토 ···························································· 97
가. 국외 후보 지표 평가 기준 ····················································································· 97
나. 후보 지표의 평가 기준 ····················································································· 100
다. 후보 지표별 검토 ····················································································· 101
라. 지표별 타당성 검토 ····················································································· 106
4. 소결 ·········································································································· 183

제5장 지표 개발(안) 도출 ············································································ 189
1. 델파이 조사 ································································································ 189
가. 개요 ································································································ 189
나. 분석 방법 ································································································ 190
2. 약제평가 지표 개발을 위한 델파이 조사 ················································· 191
가. 조사 개요 ································································································ 191
나. 조사 패널 구성 ································································································ 191
3. 조사 결과 ··································································································· 194
가. 회신 ································································································ 194
나. 항목별 중요도 결과 ································································································ 194
4. 추가 의견 ··································································································· 199
5. 소결 ············································································································ 200

제6장 결론 및 제언 ····················································································· 201
1. 결론 ·········································································································· 201
가. 연구 결과 고찰 ································································································ 201
나. 환자안전 중심 약제평가 신규지표 제안 ································································································ 205
2. 연구의 한계 및 제언 ··············································································· 207
가. 연구의 한계 ································································································ 207
나. 제언 ································································································ 209

참고문헌 ······································································································· 212
ABSTRACT ································································································· 220
부 록 ········································································································· 224
Publisher
건강보험심사평가원
Location
KOR
Citation
김유정 et al. (202102). 환자안전 중심 약제평가 지표 개발 연구.
Appears in Collections:
HIRA 연구 > 1. 자체연구
Authorize & License
  • Authorize공개
Files in This Item:

열람하신 정보에 대해 만족하십니까?

Comment

Items in Repository are protected by copyright, with all rights reserved, unless otherwise indicated.