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Vol.16 No.3 2011년 9월 서울을지병원약제부의약정보실_발행인_ 임상택 편집인_ 김명진임지희심봉순양은덕 www.eulji.or.kr 1) 피오글리타존제제 2011. 6.

1 Vol.16 No 년 9월 서울을지병원약제부의약정보실_발행인_ 임상택 편집인_ 김명진임지희심봉순양은덕 1) 피오글리타존제제 액토스메트, 액피오, 액토스, 액토존, 글레존, 글루코논, 피오디아정 제2 형당뇨병환자( 인슐린비의존형) 의혈당조절을위한보조치료 사유 : 프랑스 Afssaps, 방광암 위험성증가사유로 피오글리타존 성분단일제및복합제사용중지결정 주요내용 : KFDA 에서는동제제의안전한사용을위한정보를제공하고, 동내용에충분히유의하여처방 투약할것 을당부하였으며, 필요한조치를취할계획임 2) 덱스라존산제제 카디옥산주 500밀리그램 진행성유방암환자의안트라사이클린치료시독소루비신이나에피루비신으로인한심장독성방지 사유 : 유럽 EMA, 동제제의 급성골수성백혈병 및 골수형성이상증후군 증가를사유로안트라사이클린을기투 여받은진행성또는전이성유방암성인환자에게만사용할것과 18세이하환자에게사용제한할것 을권고 주요내용 : KFDA 에서는동제제의안전한사용을위한정보를제공하고, 동내용에충분히유의하여처방 투약할 것을당부하였으며, 필요한조치를취할계획임. 동품목의허가사항( 사용상의주의사항) 에소아신중투 여및 이약과화학요법을병용투여받고있는소아호치킨병또는소아급성림프구성백혈병환자에서 이차성급성골수성백혈병(AML) / 골수형성이상증후군(MDS) 이보고되었다 등의내용이이미반영됨 3) 니메수리드제제 메수리드정 급성통증 ( 수술후통증, 치통, 두통, 요통) 등 사유 : 유럽 EMA 산하인체의약품위원회(CHMP), 급성통증등치료제인 니메수리드 제제의간독성위험증가 로 ' 골관절염' 적응증사용금지권고 ( 급성통증및원발성월경통으로적응증제한) 주요내용 : KFDA 에서는동제제의안전한사용을위한정보를제공하고, 이에따라처방, 투약및복약지도할것 을당부함. 동품목의허가사항( 사용상의주의사항) 중경고항에 이약투여로황달, 치명적전격성간 염, 간괴사, 간부전을포함한중증의간관련이상반응이드물게보고되었다. 로이미반영되어있음 4) 발프로에이트제제 데파코트정, 오르필정, 오르필캡슐, 오르필시럽, 오르필주, 발폰주 간질과간질에뒤따르는성격, 행동장애의예방과치료등 사유 : 미국 FDA, 임부복용시, 출산한소아의인지발달장애위험주의권고 주요내용 : KFDA 에서는동제제의안전한사용을위한정보를제공하고, 이에따라처방, 투약및복약지도할것 을당부함. 동약품을복용하는임신가능여성에게사용시, 신경관결함등주요선천성기형위험증 가에대해지속적으로상담하도록할것

2 연령이증가함에따라체내지방의증가로분포용적이증가하고자연적으로신기능이감소하여반감기가연장되고혈중농 도는증가하는등노인은약동학적(Pharmacokinetics), 약력학적(Pharmacodynamics) 특징이변하므로저용량의약물에도반 응이증가하여약물유해반응이증가할가능성이매우높아진다. 또한노인의만성질환을치료하기위한약물의장기치료및 병용요법은부적절한약물처방의위험을높인다. 노인환자처방시에는복용중인약물을정확히파악해야불필요한중복처방을피할수있고약물상호작용이나약물유해반 응을예방할수있다. 1. 다중약물처방 (polypharmacy) 다약제복용은필요이상많은약물을복용하는경우를의미하며, 약물상호작용및약물유해반응빈도를증가시킬수있으므로 되도록피해야한다. 또한다약제복용은환자로하여금약물순응도를떨어뜨리는중요한요인중하나이다. 약물순응도가떨어져약물을중단하게되면치료약물의효과를더이상기대하기힘들기때문에임상질환의경과가더욱 나빠져약물로인한부작용의위험과치료비용을높이게된다. 전문의약품, 일반의약품, 생약제제등을포함한모든약물이노인에게널리사용되고있으므로다약제복용예방을위해서는 환자가의료기관에내원할때복약중인모든의약품을확인하여야하며노인환자는내원하는병원이나진료과의수를최 소로해야중복처방을예방할수있다. 2. 노인주의의약품 1991년 beers 등은노인환자에부적절한약물처방을평가할수있는기준을만들어발표하였다. 노인의학, 장기요양보험, 노 인약학, 노인정신약학, 약물역학등각전문분야의미국과캐나다 13 명의전문가로구성된전문가패널은노인환자의진단, 약물의양및빈도와관계없이처방되어서는안될것으로생각되는 고혈압약물, 경구용혈당강하제, Nsaids 계열약물, 진통제등이포함되었다. 30 개의약물처방명단을만들었는데향정신성약물, 항 처음발표된이후 beers criteria 는내용이개정되었으며, 2001년도에 Zhan등은개정된내용을더욱보완하여항상피해야 하는약, 거의적절하지않은약, 어떤적응증에는사용가능하지만종종오용될수있는약등의세가지로분류하였다. [table 1] 2002년개정된 beers criteria에의하면일반적으로노인환자에게피해야할약물처방 48가지와진단및조건에따라피해야 할약물처방 20 가지가제시되었다. [table 2] beers criteria는국제적으로노인관련의약학계에서널리연구및적용되고있으며 beers criteria 외에노인환자군에서의 약품의적정성을평가하기위한기준으로 IPET Criteria, START, STOPP 선별검사등이있으나 beers criteria만큼널리알려지 고사용되는기준은많지않다. beers criteria 에의해부적절하다고분류된약물의치료는논쟁의여지가있다. 예를들어 1994년미국에서행해진연구에따 르면금기약물 20가지중적어도하나이상을사용하는노인이 23.5% 에달했다. 또한부작용에대한자료가문헌조사에한 정되어있으며연구대상환자군의편중성 ( 외래내원환자, 간호요양시설거주환자), 대체약물의국내현실과의괴리등한계점 을나타내고있다. 또한환자의임상상태에대해여러가지고려가필요하나특정약물을단순하게주의의약품으로지정하는 것은논란을야기할수있으며노인에게주의할의약품이라도개별환자의임상상태에대한의료진의판단에따라적절히 사용할수있으므로 beers criteria 분류가최선의방법은아닐것이나, 그럼에도불구하고 beers criteria는노인의료의질을 평가하는데점점더많이사용되고있으며부작용을예측하는유효성역시여러연구결과입증되고있다. 이와같이노인환 자에게부작용을초래할수있는약물의적절한모니터링평가기준을마련하는것은예방가능한부작용의발생을줄이는 데중요한역할을하게될것이다. 3. 노인의약물처방에서고려해야할사항 일반적으로노인에게는처방없이복용하는약물이반드시있을거라고생각하고환자의모든복용약물을파악한다. 약복용의이유와방법들을쉽고분명한말투로설명해주어야한다. 반드시필요한경우에만약물을사용하며해당증상이 없어진경우에는즉시약을끊어야한다. 약물과관련된기능적지표를충분히모니터링하며저용량부터사용하여효과가나 타날때가지천천히증량하고 (start low & go slow) 충분히치료한다. 복용방법을단순화하는등순응도를높일수있도록노력하며약물복용이제대로이루어지는지평가해야한다. 특히신약 사용시에는주의가필요하다. 가능하면약물치료이외의방법을고려해야한다.

3 [Table 1] 2001 Zhan's classification Drug therapy Therapy description Reason for concern Always avoid Barbiturates Hypnotic ly addictive Belladonna (buscopan) Antispasmodic Strong anticholinergic properties Chlorpropamide Oral antihyperglycemic Long half-life, inappropriate ADH secretion Dicycloverine Antispasmodic Strong anticholinergic properties Flurazepam Benzodiazepine Long half-life (If benzodiazepine therapy is unavoidable, use short-acting agents) Hyoscyamine Antispasmodic Strong anticholinergic properties Meprobamate Hypnotic ly addictive Pentazocine Opioid Poor adverse effect profile Pethidine (Meperidine) Opioid Causes confusion and its metabolites can cause seizures Propantheline Antispasmodic Strong anticholinergic properties Trimethobenzamide Antiemetic Extrapyramidal adverse effects Rarely appropriate Carisoprodol Skeletal Muscle relaxants Strong anticholinergic properties, sedation and weakness Chlordiazepoxide Benzodiazepine Long half-life Chlorzoxazone Skeletal Muscle relaxants Strong anticholinergic properties, sedation and weakness Cyclobenazprine Skeletal Muscle relaxants Strong anticholinergic properties, sedation and weakness Diazepam Benzodiazepine Long half-life Metaxalone Skeletal Muscle relaxants Strong anticholinergic properties, sedation and weakness Methocarbamol Skeletal Muscle relaxants Strong anticholinergic properties, sedation and weakness Propoxyphene Opioid Poor adverse effect profile Some indication (but often misused) Amitriptyline Antidepressants Strong anticholinergic properties and sedation Chlorpheniramine Antihistamines Strong anticholinergic properties (use nonanticholinergic antihistamines rather than these agents) Cyproheptadine Antihistamines Strong anticholinergic properties Diphenhydramine Antihistamines Strong anticholinergic properties Dipyridamole Platelet inhibitor Orthostatic hypotension Disopyramide Antiarrhythmic Can induce heart failure. Strong anticholinergic properties Doxepin Antidepressants Strong anticholinergic properties and sedation Hydroxyzine Antihistamines Strong anticholinergic properties Indomethacin Nsaids More CNS adverse effects than other Nsaids Methyldopa Antihypertensive Can causes bradycardia and can exacerbate depression Oxybutynin Antimuscarinic Strong anticholinergic properties, sedation and weakness Promethazine Antihistamines Strong anticholinergic properties Reserpine Antihypertensive Can induce depression and sedation Ticlopidine Platelet inhibitor Poor adverse effect profile. No more effective than ASA in preventing clotting [Table 2] Beers criteria drugs /2002 Independent of disease or condition Drug Concern Severity 1 st antihistamine : (chlorpheniramine, cyproheptadine, Diphenhydramine, hydroxyzine) Anticholinergics Potent anticholinergic properties Belladonna alkaloid (buscopan) ly anticholinergic effects (especially long-term use) Oxybutynin (except XL) Anticholinergic adverse effects, sedation, weakness

4 Drug Concern Severity Analgesics Indomethacin The most CNS adverse effect of Nsaids Ketolorac Asymptomatic GI trouble Pethidine (Meperidine) Confusion, 다른 narcotic drugs보다부작용많음 Pentazocine More CNS adverse effects than other narcotics Non-cox-selective NSAIDs (naproxen,oxaprozin, piroxicam) GI bleeding, renal failure, high BP, heart failure (long half-life, long-term use of full dose) Cardiovascular drugs Amiodarone QT interval problem, risk of provoking torsades de pointes Nifedipine (short acting) Potential for hypotension and constipation Ticlopidine <aspirin effect & ADE, safer more effective alternatives exist Chlorpropamide Prolonged half-life & Cause SIADH Digoxin ( 0.125mg/day except Af) CLcr toxic effect Low Dipyridamole (short acting) May cause orthostatic hypotension Low Doxazosin Hypotension, dry mouth, urinary problems Low Nervous system drugs Amphetamines CNS stimulant adverse effects Amitriptyline, Doxepine Strong anticholinergic, sedation (antidepressant) Barbiturates (ex : phenobarbital) ly addictive and adverse effect Fluoxetine Long half life, excessive CNS stimulation, sleep disturbance, agitation, safer alternatives exist Flurazepam Extremely long half life: sedation, fracture/falls Long acting benzodiazepine : chlordiazepoxide, diazepam, chlorazepate Short acting benzodiazepine: (Alprazolam 2mg/day, Lorazepam 3mg/day Triazolam 0.25mg/day) Long half life (often several days) Sensitivity to benzodiazepine smaller doses may be effective as well as safer Others Bisacodyl ( 장기사용) Bowel dysfunction의악화 Methyldopa Can causes bradycardia and can exacerbate depression Methyltestosterone Potential for prostatic hypertrophy and cardiac problems Mineral oil Potential for aspiration and adverse effects Muscle relaxant: (Carisoprodol, Chlorzoxazone, Cyclobenazprine, Methocarbamol, Orphenadrine) Anticholinergic properties, sedation and weakness Cimetidine Confusion 등 CNS 부작용 Low Estrogen only (oral) Carcinogenic potential, lack of cardioprotective effect Low Ferrous sulfate ( 325mg/d) 흡수율증가에비해 constipation만증가 Low Considering diagnosis or conditions Condition Drug Concern Severity Depression Long-term benzodiazepine use May produce or exacerbate depression Gastric or duodenal ulcers NSAIDs and aspirin ( 325mg) (Coxibs 제외) Exacerbate existing ulcers or produce new ulcers Hypertension Pseudoephedrine, diet pill, amphetamines May produce elevation of blood pressure Insomnia Parkinson disease Decongestants, Theophylline Methylphenidate, MAOI Metoclopramide Conventional antipsychotics CNS stimulant Antidopaminergic effects Seizures or epilepsy Clozapine, chlorpromazine, thioridazine May lower seizure thresholds Short-to-intermediate acting BDZs and Produce ataxia, impaired psychomotor Syncope or falls TCAs function, syncope, and additional falls SIADH/ SSRIs: fluoxetine, citalopram, fluvoxamine, Exacerbate of cause SIADH Low hyponatremia paroxetine, sertraline

5 2 차약사위원회통과품목 ( ) [ 약품성분 ABC순] 성분명영명분류제약회사비고 Adapalene + Benzoyl peroxide Epiduo gel 여드름치료제갈더마코리아이소트렉신겔대체 Amino acid 14% 500mL Aminopool Inj 500ml 영양수액제한올바이오파마신규 Amlodipine + Olmesartan Sevikar tab 5/40mg, 10/40mg 혈압강하제( 복합제) 한국다이이찌산쿄제형, Amlodopine + Valsartan Exforge tab 10/160mg 혈압강하제( 복합제) 한국노바티스제형, Atomoxetine Strattera cap 10mg, 25mg, 80mg 중추신경용약한국릴리제형, Blonanserin Lonasen tab 2mg, 4mg 정신신경용제부광약품신규 CanCetil tab 8mg, 16mg 신풍제약 제형, Candesartan CanDelotan tab 8mg, 16mg 혈압강하제 일동제약 제형, CandeMore tab 8mg, 16mg 종근당 제형, CanDelotan plus tab 16/12.5mg 일동제약 제형, Candesartan+ Hydrochlorothizaide CanCetil plus tab 16/12.5mg 혈압강하제( 복합제) 신풍제약 제형, CandeMore plus tab 16/12.5mg 종근당 제형, Clopidogrel Pilgrel tab 75mg 동맥경화용제제일약품제형, Deferasirox Exjade 500mg 해독제한국노바티스제형, Dexibuprofen Maxpro syrup 12mg/ml 해열, 진통, 소염제일성신약신규 Eburnamonine + Ascorbic acid Edamon-A cap 20/40mg 순환계용약진양제약신규 Ecabet sodium Ecarex susp 1g 12ml/1pack 소화성궤양용제광동제약제형, Eperisone Erixon tab 50mg 골격근이완제하원제약제형, Exenatide Byetta inj 10 μg, 5μg당뇨병용제한국릴리신규 Fimasartan potassium Kanarb tab 120mg, 60mg 혈압강하제보령제약모노프릴대체 Fluoxetine 20mg Prozac cap 20mg 정신신경용제한국릴리푸로작확산정대체 Gliclazide 60mg Diamicron MR tab 60mg 당뇨병용제한국세르비에( 주) 제형, Imiquimod Aldara cream 250mg/1 포피부연화제동아제약신규 Iopamidol Pamiray ml, 30ml 조영제동국제약라디센스대체 Irbesartan Irbesartan+ hydrochlorothiazide AprTan tab 150mg, 300mg 동아제약제형, 혈압강하제 Arb-IB tab 150mg 삼진제약제형, Coizarbelltan tab 150/12.5mg, 300/12.5mg 혈압강하제( 복합제) 종근당 제형, CoaprTan tab 150/12.5mg, 300/12.5mg 동아제약 제형, Isosorbide Isobide solution 1ml 이뇨제근화제약신규 Lafutidine Stogar tab 10mg 소화성궤양용제보령제약유란탁대체 Levodopa/Carbidopa/Entacapone Stalevo 200/50/200mg 중추신경용약한국노바티스제형, Memantine HCl Ebixa Oral Drops 10mg/g 중추신경용약한국룬드벡제형, Meropenem trihydrate Merocin inj 1g 항생제신풍제약제형, Methylprednisolone aceponate Topisol milk lotion 50g 스레로이드로션제코오롱제약제형, Metronidazole Merogel 10g tube 기타의외피용약비씨월드제약제형, Montelukast Sodium Lukair 4mg, 5mg, 10mg, Granule 4mg 알레르기용약씨제이제일제당싱글레어대체 Mosapride citrate 5mg Gasrid tab 5mg 유한양행제형, Mosamed tab 5mg 제일약품제형, 소화기관용약 Mosaone tab 5mg 씨제이제일제당제형, Mosapin tab 5mg 셀트리온제약제형, Nitroglycerin Nitrolingual spary 12.2ml/ btl 혈관확장제삼신무역상사제형, Olanzapine ZyrePin tab 10mg, 5mg, 2.5mg 정신신경용제환인제약제형, Oxycodone + naloxone targin tab 10/5mg, 20/10mg 합성마약한국먼디파마옥시콘틴대체 Pentoxifylline Harin tab 400mg 순환계용약셀트리온제약제형, Polysorbate Eyedew Ophthalmic Solution 안과용제제이더블유중외신약비바아이드롭대체 Poractant alfa Curosurf 120mg /1.5ml 호흡기관용제코오롱제약뉴팩탄대체 Pramipexole Mirapex ER tab 1.5mg 중추신경계용약한국베링거인겔하임제형, Proparacaine HCl Paracain ophthalmic 0.8ml 국소마취제한미약품알카라인점안액대체 Ramosetron HCl Irribow tab 5mcg 소화기관용약한국아스텔라스제약티로메드대체 Rivaroxaban Xarelto tab 10mg 혈액응고저지제바이엘코리아신규 Telmisartan + Amlodipine Twynsta tab 40/5mg, 80/5mg 혈압강하제( 복합제) 한국베링거인겔하임신규 Thormbin 5000IU Thrombin Lyophilized power 지혈제이연제약신규 Tropicamide+Phenylephrine Tropherine ophthalmic soln 0.8mL 안과용제한미약품미드린피점안액대체 Tulobuterol Hokunalin Patch 1mg 진해거담제한국애보트 ` 제형, Udenafil 50mg Zydena tab 50mg 발기부전치료제동아제약제형, Vancomycin hydrochloride 1g/v Vancocin CP inj 1g 항생제인비다코리아제형, Voriconazole Vfend inj 200mg 화학요법제한국화이자제약신규

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ÇÐ¼úº¸°í2¿ìÈñ°æ 병원약사회지 (2014), 제 31 권제 5 호 J. Kor. Soc. Health-Syst. Pharm., Vol. 31, No. 5, 983 ~ 991 (2014) 회원학술보고 외래노인환자의약물사용현황분석및적절성평가 우희경, 신은정, 임정미, 이혜숙, 김향숙서울대학교병원약제부 Drug Use Review, Analysis, and Adequacy Assessment