환자안전 중심 약제평가 지표 개발 연구

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.