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1 병원약사회지 (2019), 제 36 권제 3 호 J. Kor. Soc. Health-Syst. Pharm., Vol. 36, No. 3, 309 ~ 314 (2019) 특집 처방복잡도평가의연구동향과국내적용 이선민인하대학교병원약제팀 1. 처방복잡도와평가지표약사가복약지도를하다보면처방된약의개수가많고복용방법이복잡하여환자들이용법에맞게복용하지못하는경우를자주접하게된다. 노인환자와만성복합질환환자가늘어나면서많은종류의약을동시에복용해야하는환자들이늘어나고있다. 이러한상황에서처방된지시사항에따라조제하다보면복용법이너무복잡해지는경우도있다. 복용하는약의개수가많아지는것외에도환자들이처방을복잡하게느끼는요인은다양하다. 처방의복잡도를높이는요인으로는약의제형, 복용횟수, 의료진의복용시지시사항, 보관방법등이있다. 1) 환자는처방된약의제형이다양하고, 1일복용횟수가많을수록복용할때어려움을겪는다. 또복용시지켜야할의료진의지시사항이많거나, 약품보관방법이까다로울수록처방이복잡하다고느낀다. 처방이복잡한정도는환자의입원기간이길어지거나의료기관을이동하는과정에서도점차심화되는경향이있다고알려져있다. 2) 처방복잡도의증가는복약순응도저하의주요한요인으로연구되고있다. 3) 복약순응도저하는약물요법의실패와의료비상승을야기한다고알려져있다. 4) 또한여러연구를통하여처방의복잡도가증가할수록재입원률이높아지고부작용보고가증가한다고확인되었다. 5) 해외에서처방의복잡한정도를객관적으로평가하기위한여러연구들이있었다. 1) 그중대표적인처방분석지표로 2004년도호주에서개발된 Medication Regimen Complexity Index (MRCI) 가있다. MRCI 는제형 (A항목), 1일복용횟수 (B항목), 지시사항 (C항목 ) 의 3가지항목을점수화하여그총점으로처방의복잡한정도를나타낸지표이다. 6) A항목에서는처방전을근거로제형에따른투약난이도에따라복잡한정도를점수로표현한다. B항목는약품별복용횟수의합으로나타낸다. C항목은처방전에기재된약품별지시사항의종류와개수를점수로나타낸다. 이 3가지항목의점수를합하여상대적인처방내역의복잡한정도를수치화한것이다. 총점이높을수록처방이더복잡하다는것을나타낸다. MRCI는임상결과와관련한연구에서가장많이사용되어왔다. MRCI를기초로하여포르투갈 Pharmacotherapy Complexity Index (PCI), 7) 독일 German version of MRCI (MRCI -D), 8) 미국 Patient-Level Medication Regimen Complexity Index, 9) 스페인 Spanish version of MRCI (MRCI-E), 10) 터키 Turkish version of MRCI, 11) 브라질 Brazilian version of MRCI 12) 과한국 Korean version of MRCI (MRCI-K) 13) 에서자국언어로번역되고신뢰도와타당도가검증되어처방복잡도평가와중재에관련한연구에사용되고있다 (Table 1). 2. 처방복잡도감소중재활동에관한해외연구사례 MRCI는처방의복잡도를 3가지항목의합계점수로나타내는척도로자동화할경우더욱효율적으로이용할수있다. 이미광범위한질환과대규모환자군을대상으로한연구의경우기관내전산자료를추출하고 MRCI의계산을자동수식화하여사용하고있다. 미국

2 JKSHP, VOL.36, NO.3 (2019) Table 1 Description of studies that validated the medication regimen complexity Index Study description Reference Year Nation Author Age N Patient ) 2004 Australia George J 134 COPD (9.8) Dorit ) 2010 German 20 Stange (13.8) Betul ) 2016 Turkish 100 Elderly Okuyan (7.58) Medication number Prescribed medications 8.2 (4.0) 8 patients (Endocrine disorders), patients (4.12) (Renal conditions) 4.75 (2.34) MRCI* score Section A Dosage 4.65 (3.05) Section B Frequency (5.74) Section C Instruction 3.50 (3.14) Sum A+B+C (9.58) (8.89) Ana Brazilian 4 7) 2007 Carolina Diabetes Portuguese Melchiors 4.5 (2.5) 15.7 (8.36) Javier ) 2016 Spanish Saez de 60 (4.7) la Fuente Discharge treatment 9.8 (3.8) 6.7 (4.5) 14.1 (6.0) 6.4 (4.1) 27.2 (11.9) 6 Older adults 12) 2018 Brazilian Lais LN Pantuzza (7.5) in primary care (2.3) ) 2019 Korean Lee S 331 Discharge treatment (15.3) (3.3) 2.4 (1.7) 11.8 (6.0) 14.0 (8.1) 28.2 (14.2) * MRCI, Medication Regimen Complexity Index COPD, chronic obstructive pulmonary disease 의한기관에서는 89,645건의처방을자동수식화로처방복잡도평가를시행하여처방의복잡도를높이는주요한원인이복용횟수의증가임을확인하였다. 14) 또다른연구에서는 MRCI 수식화를통하여다기관간의질환별점수분포를확인할수있었다. 9) 처방복잡도중재에관련된다양한연구도약사를중심으로진행중이다 (Table 2). 약사는약물중재활동과정에서 MRCI를중재의결과지표로사용하였고긍정적인약물치료결과에기여할수있을것으로기대되고있다. 미국의제2형당뇨병관리프로그램에서는약물중재활동의평가지표로 MRCI를이용하였다. 이연구에서중재를시행한중재군은대조군과비교하여 HbA1c가감소하였고 MRCI 값도증가하지않도록 조절될수있었다. 15) 호주의한병원에서는노인환자를대상으로처방의복잡도감소를위한처방검토가이드라인을개발하였다. 약사가처방복잡성을관리할수있는질문항목을설정하여그항목을기준으로중재를시행하였다. 중재결과처방의복잡도를낮출수있었고투약시간을일치시킴으로써투약담당자의만족도를높일수있었다. 이연구에서주요하게사용된약사중재방법으로는상호작용분석과일일용량변경을통한투약시간조정및제형변경등이있었다. 약물중재행위결과약사간의행위일치도도타당하게나타나가이드라인의신뢰도를확인할수있었다. 16) 또다른호주연구에서병동담당약사가 MRCI를활

3 이선민 : 처방복잡도평가의연구동향과국내적용 Table 2 Interventional studies with Medication Regimen Complexity Index Author Year Nation Age N Patient Intervention Outcome Conclusion Elliott R. A ) Australia Discharged inpatients Educational intervention, Simplification during medication regimen reviews Proportion of pharmacistled MRCI* changes Simplification of older inpatients regimens is feasible when training in regimen simplification is provided Dorit Stange ) 63.8 German 240 (13.8) Inpatients with hypertension, diabetes, and/or dyslipidemia Simplifications of cardiovascular and antidiabetic medications, additional explanatory information Adherence, MRCI-D, Patient quality of life (QoL), satisfaction with information The complexity of cardiovascular and antidiabetic hospital medications can be reduced. For a sustainable simplification of outpatient medication, information about the modifications was needed Candis M ) USA DIMM 62.2 (8.1) PCP 62.4 (10.0) DIMM (99) PCP (56) Type2 diabetes Education during an average of three 60-minute visits over 6 months Medication Regimen Complexity, Glycemic Control. Treating patients with an innovative DIMM model can help complex T2D patients achieve glycemic control without increasing the MRC to more than a comparator group Chen EY 82.3 Australia ) (9.8) Residents of aged care facilities Implicit tool comprising of 5 simplification guide Inter-rater agreement Implicit tool is a promising new tool to guide medication regimen simplification in aged care * MRCI; Medication Regimen Complexity Index MRCI-D; German version of MRCI DIMM; Diabetes Intense Medical Management PCP; primary care provider T2D; type 2 diabetes MRC; Medication Regimen Complexity 용하여교육과중재활동을진행하였다. 약사가약사와의료진을교육하여처방복잡성에대한인식을높이고처방단계에서불필요하게처방이복잡해지는것을예방할수있었다. 검토처방중 45.7% 가중재되었고처방변경수용도는 63.1% 였다. 처방의복잡도를낮추기위한중재활동은퇴원단계에서도이루어졌으며이러한중재는의료기관이동이후에도환자의약물복용에영향을미치는것으로나타났다. 복용횟수감소, 복용단위감소, 처방중단, 제형변경및투약시간조정등이주요한중재활동이었다. 2) 독일의만성질환환자를대상으로한연구에서는 MRCI를평가지표로이용하여약사가처방복잡도관리를시행하였다. 퇴원환자의중재결과중재군은대조군과비교하여복잡도관리가잘이루어졌다. 또한퇴원기관에서복잡도관리시행에관한정보를이동한기관에제공하는것이지속적인복잡도관리와복약순응도향상에도움이되는것으로나타났다. 17) 3. 국내처방복잡도지표개발과적용처방복잡도평가지표로대표적으로사용되고있는 MRCI를기초로신뢰도와타당도를검증하고재구성

4 JKSHP, VOL.36, NO.3 (2019) 처방의복잡도평가 항목별평가 A 항목 = 약품제형에대한가중치 MRCI-K* = A 항목 +B 항목 +C 항목 B 항목 = 약품별복용횟수가중치의합 C 항목 = 약품별지시사항가중치의합 * MRCI-K; Korean version of Medication Regimen Complexity Index Fig. 1 Korean version of Medication Regimen Complexity Index 하여한국형처방복잡도평가지수 Korean version of MRCI (MRCI-K) 를개발하였다 (Fig. 1). 2017년 1 월부터 3월까지인하대학교병원호흡기내과병동에서퇴원한환자에게투약된처방의복잡도를 MRCI-K로평가하였다. 그결과 MRCI-K의평균점수가유사한해외의연구결과보다높은것으로나타났다. 특히처방의지시사항에대한 C영역의점수가총점에서차지하는비중이가장높았다. 이것은해외에서는투약횟수가처방의복잡도를높이는주요항목인반면한국에서는복용법과관련된지시사항이처방복잡도의가장큰원인인것을의미한다. 13) 추후연구를통해 MRCI-K가자동수식화된다면국내에서도 MRCI 관련연구가더늘어날것으로생각된다. 다기관연구나대규모환자군에적용하기위해서도자동수식화관련연구가필요하다. MRCI를이용한해외중재연구에서살펴본바와같이외래와입원환자에따른처방복잡도차이와분포를파악하고관련된중재연구도진행될수있을것으로생각된다. 병원약사는환자의기관이동시퇴원환자정보제공단계에서처방복잡도감소를위한중재를할수있을것이다. 또한외래환자를대상으로하는약사의경우 MRCI- K을적용하여중재여부를결정하거나약물중재활동결과를객관적으로평가할수있을것이다. 그결과환자중심의합리적인약물사용을유도함으로써환자들의만족감상승시킬수있고높은복약순응도를이끌어낼수있을것으로생각된다. 3),18) 처방복잡도의증가가약물치료에부정적인영향을 미치기때문에복잡도감소를위한다학제적인노력이필요하다. 18) 이를위하여약사를중심으로 MRCI-K를활용한다양한약료서비스모델개발을생각해볼수있다. 먼저해외중재사례에서와같이약사와의료진에게처방복잡도에대한교육활동이선행되어야한다. 더불어각기관에적합한중재가이드라인을설정하고 MRCI-K를적용하여약물중재활동을평가할수있을것이다. 특히처방의복잡도는의료기간이동과정중에높아지게된다. 입퇴원시시행하는약물검토과정에서 MRCI-K 지표를적용해볼수있다. 예컨대입원시지참약의 MRCI-K 점수가높은경우이러한환자군을선별하여재원기간중처방의복잡도를중재할수있고퇴원시타의료기관에약물투약에대한가이드를제공하여이후의처방복잡도관리에도움을줄수있을것이다. 4. 요약 1) 환자들은처방내역이복잡해짐에따라복용상어려움을겪고그결과질환치료에부정적인영향을미친다. 2) 처방의복잡도는객관적인지표로측정될수있으며한국형처방복잡도지수 (MRCI-K) 로평가가능하다. 3) 한국형처방복잡도지수 (MRCI-K) 를이용하여처방복잡도관리를위한약물서비스모델을개발할수있다

5 이선민 : 처방복잡도평가의연구동향과국내적용 참고문헌 1) Paquin AM, Zimmerman KM, Kostas TR et al. Complexity perplexity: a systematic review to describe the measurement of medication regimen complexity. Expert opinion on drug safety. 2013;12(6): ) Elliott RA. Reducing medication regimen complexity for older patients prior to discharge from hospital: feasibility and barriers. Journal of clinical pharmacy and therapeutics. 2012;37(6): ) Pantuzza LL, Ceccato M, Silveira MR et al. Association between medication regimen complexity and pharmacotherapy adherence: a systematic review. Eur J Clin Pharmacol. 2017;73(11): ) Albert NM. Improving medication adherence in chronic cardiovascular disease. Critical care nurse. 2008;28(5): ) Alves-Conceicao V, Rocha KSS, Silva FVN et al. Medication Regimen Complexity Measured by MRCI: A Systematic Review to Identify Health Outcomes. Ann Pharmacother. 2018; 52(11): ) George J, Phun YT, Bailey MJ et al. Development and validation of the medication regimen complexity index. Ann Pharmacother. 2004;38(9): ) Melchiors AC, Correr CJ, Fernandez-Llimos F. Translation and validation into Portuguese language of the medication regimen complexity index. Arq Bras Cardiol. 2007;89(4): ) Stange D, Kriston L, Langebrake C et al. Development and psychometric evaluation of the German version of the Medication Regimen Complexity Index (MRCI-D). J Eval Clin Pract. 2012;18(3): ) Hirsch JD, Metz KR, Hosokawa PW et al. Validation of a patient-level medication regimen complexity index as a possible tool to identify patients for medication therapy management intervention. Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy. 2014;34(8): ) Saez de la Fuente J, Such Diaz A. Canamares-Orbis et al. Cross-cultural Adaptation and Validation of the Medication Regimen Complexity Index Adapted to Spanish. Ann Pharmacother. 2016;50(11): ) Okuyan B, Babi B, Sancar M et al. Validation of the Turkish version of medication regimen complexity index among elderly patients. Journal of evaluation in clinical practice. 2016;22(5): ) Pantuzza LL, Ceccato M, Silveira MR et al.validation and standardization of the Brazilian version of the Medication Regimen Complexity Index for older adults in primary care. Geriatr Gerontol Int. 2018;18(6): ) Lee S, Jang J, Yang S et al. Development and validation of the Korean version of the medication regimen complexity index. PloS one. 2019;14:e ) McDonald MV, Peng TR, Sridharan S et al. Automating the medication regimen complexity index. Journal of the American Medical Informatics Association. 2012;20: ) Morello CM, Rotunno T, Khoan J et al. Improved Glycemic Control with Minimal Change in Medication Regimen Complexity in a Pharmacist-Endocrinologist Diabetes Intense Medical Management (DIMM)Tune Up Clinic. Annals of Pharmacotherapy. 2018;52(11): ) Chen EY, Sluggett JK, Ilomaki J et al. Development and validation of the medica

6 JKSHP, VOL.36, NO.3 (2019) tion regimen simplification guide for residential aged CarE (MRS GRACE). Clinical interventions in aging. 2018;13: ) Stange D, Kriston L, von-wolff A et al. Reducing cardiovascular medication complexity in a German university hospital: effects of a structured pharmaceutical management intervention on adherence. Journal of Managed Care Pharmacy. 2013; 19(5): ) Alves-Conceicao V, Rocha KSS, Silva FVN et al. Medication Regimen Complexity Measured by MRCI: A Systematic Review to Identify Health Outcomes. Ann Pharmacother. 2018:52(11): ) Sluggett JK, Chen EYH, Ilomaki J et al. SImplification of Medications Prescribed to Long-tErm care Residents (SIMPLER): study protocol for a cluster randomised controlled trial. Trials. 2018;19(1):

Rheu-suppl hwp

Rheu-suppl hwp Objective: This paper reviews the existing Korean medical and public health, and nursing academy articles on disease-specific and domain-specific quality of life, and provides recommendations for the universally