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1 한국임상약학회지제 28 권제 3 호 Korean J Clin Pharm, Vol. 28, No. 3, 2018 Original Article Korean Journal of Clinical Pharmacy Official Journal of Korean College of Clinical Pharmacy pissn eissn X Korean journal of clinical pharmacy (Online) URL: 지역약국에서보고된전문의약품과일반의약품의이상사례보고현황비교분석 이모세 1,2# 박소희 2# 김나영 1 오인선 2 이정민 1 이의경 2 신주영 2* 대한약사회지역의약품안전센터 1, 성균관대학교약학대학 2 (2018년 4월 23일접수 2018년 6월 12일수정 2018년 6월 14일승인 ) Comparative Analysis of Ethical-the-counter Drugs and Over-the-counter Drugs for the Adverse Events from the Community Pharmacy Mo-Se Lee 1,2#, So-Hee Park 2#, Na-Young Kim 1, In-Sun Oh 2, Jung-Min Lee 1, Eui-kyung Lee 2, and Ju-Young Shin 2* 1 Regional pharmacovigilance center, The Korea Pharmaceutical Association, Seoul 06108, Republic of Korea 2 School of pharmacy, Sungkyunkwan University, Gyeonggi-do 16419, Republic of Korea (Received April 23, 2018 Revised June 12, 2018 Accepted June 14, 2018) ABSTRACT Objective: To compare adverse event reporting patterns between ethical-the-counter and over-the-counter drugs from community pharmacies and outpatient settings. Methods: We conducted a descriptive study using the adverse event reporting database, wherein data were collected from the regional pharmacovigilance centers of the Korean Pharmaceutical Association between January 1, 2016 and December 31, The reported drugs were classified into either ethical-the-counter or over-thecounter drugs, and we compared the distribution of patient age and gender, frequent adverse events and medications, serious adverse events, and causality assessment results, where causality assessments were performed according to the World Health Organization-The Uppsala Monitoring Centre s system. Results: We included 17,570 reports (75,451 drug-adverse event pairs). Ethical-the-counter and over-the-counter drugs accounted for 81.4% and 18.6% of the total adverse event reports, respectively. The use of over-the-counter drugs was higher in females and patients aged <18 years, whereas the use of ethical-the-counter drugs was higher in those aged >65 years. Alimentary tract and metabolism drugs, and respiratory system drugs were the most frequent ethical-the-counter and over-the-counter drugs, respectively. From causality assessment results, possible (75.4%) was the most commonly assigned category for ethical-the-counter drugs, while possible (44.0%) and unlikely (47.7%) were the most common categories for over-the-counter drugs. The distribution of serious adverse events were similar for both ethical-thecounter and over-the-counter drugs. Conclusion: Differences were observed in age, gender, reported medications, and symptoms for both ethical-the-counter and over-the-counter drugs. Further pharmacovigilance activities considering the adverse event characteristics of over-the-counter drugs, which are comparable to ethical-the-counter drugs, should be performed. KEY WORDS: Prescription drugs, nonprescription drugs, pharmacovigilance, community pharmacy, outpatients 약물이상반응 (adverse drug reaction, ADR) 은의약품등을정상적인용량에따라약물을투여한후발생한유해하고의도하지않은약물반응으로해당의약품과의인과관계를배제할수없는경우를말한다. 1) ADR은환자의입원기간과치료기간연장을유발하고, 치료비용을상승시켜환자와보험제정모두의경제적부담을가중시킨다. 2) 이외에도환자가연장된입원기간동안일을쉬게되거나, ADR 발생에따른불안장애 유병률이증가하는등의간접비용이추가로발생한다. 3) 영국과유럽의여러국가들, 호주, 캐나다등의병원의료기록을바탕으로연구한논문에서입원환자에서약물이상반응유병률은 2.3~21.2% 라고제시했다. 4) 미국의경우약물이상반응을겪지않은사람들에비해약물이상반응을겪은사람들이평균적으로입원기간이 1.2~3.8일더길고, 이로인해환자당 2,284~5,640 달러를추가로지불한다는결과를보였다. 5) 한편, *Correspondence to: Ju-Young Shin, School of Pharmacy, Sungkyunkwan University, 2066 Seobu-ro, Jangan-gu, Suwon-si, Gyeonggi-do 16419, Republic of Korea Tel: , Fax: shin.jy@skku.edu # Mo-se Lee and So-Hee Park contributed equally to this work. 230

2 지역약국에서보고된전문의약품과일반의약품의이상사례보고현황비교분석 / 년도에수행된체계적문헌고찰연구에서는, 1,2차의료기관을방문한외래환자에서약물이상반응관련유병률은 2.8~ 34.7% 를차지한다고보고하였다. 이는입원환자의유병률과비슷한수치이며, 이중부적절한약물사용으로인하여발생한약물이상사례의유병률은 11.0~27.5% 에달할정도로높은비중을차지한다고알려져있다. 6) 외래방문환자에서약물이상반응관련유병률이입원환자의유병률과유사함에도불구하고, 우리나라의 ADR 보고내용에관한연구들은대부분입원환자사례중심이며, 외래환자사례를다룬연구는부족한실정이다. 2) 특히우리나라의 2015년전체의료기관의외래환자수는입원환자수의약 8배이고, 평균급여일수는약 6배로입원환자보다규모가크며, 7) 전체원외처방의약 79% 가의원급에서발생한다. 8) 의원에서처방한약은지역약국에서조제하므로본연구에서다룰지역약국에서보고된약물이상반응보고자료는의원급외래환자의약물이상사례를대표하는정보가될수있다. 2017년도의약품등안전성정보보고동향에따르면 2017년한해동안지역의약품안전센터에보고된병의원의보고건수는 23,393건, 약국의이상사례보고건수는 23,640건으로유사하고, 9) 전국지역약국과외래환자를대상으로활동을수행하는 2) 대한약사회지역의약품안전센터에접수된이상사례는 2013~2016년사이약 3.7배가증가하여, 2) 약물감시의양적인규모면에서급성장을이루었다고볼수있다. 약국기반의약물감시활동이병원기반의약물감시활동과차별화되는점은전문의약품이아닌일반의약품의이상사례감시가가능하다는점일것이다. 그러나외래기반약국의이상사례규모확대에도불구하고, 전문의약품과일반의약품간이상사례보고양상에대한연구는현재까지발표된바가없다. 따라서본연구에서는이상사례보고양상을전문의약품과일반의약품으로나누어서의약품분류의구분에따른연령, 성별등인구학적특징의차이, 다빈도로보고되는의약품계열, 다빈도로보고되는부작용의종류및인과성의강도등을조사하고자하였다. 연구방법 연구자료본연구에서는 2016년 1월부터당해 12월까지전국지역약국과외래환자로부터대한약사회산하의지역의약품안전관리센터에보고된이상사례를대상으로하였다. 전체 17,757건, 총 75,720 약물-부작용조합중의약품종류구분항목에전문의약품이나일반의약품으로분류되지않는건강기능식품 68 건, 약국에서판매하지않는일반의약품인안전상비의약품 11 건, 기타분류 15건의조합을제외했다. 또한, 보고상태분류항목에반려 60건, 삭제 30건, 임시 20건, 접수 65건의조합을 제외하여총 269 조합을제외한 75,451 약물-부작용조합을분석대상으로삼았다. 본연구는성균관대학교생명윤리위원회의승인을받고진행하였다 (SKKU-IRB ). 전문의약품과일반의약품의구분식품의약품안전처에서식품의약품안전처고시제 호의약품분류기준에관한규정에근거하여의약품을전문의약품과일반의약품으로분류하여허가를낸다. 약리작용, 적응증으로볼때전문의의진단과지시, 감독에따라사용되어야하거나, 용법, 용량을준수하거나설정시또는투여경로의특성상전문의의지시가필요한경우, 약물상호작용이나부작용이심하거나습관성, 의존성, 내성, 오남용의우려가있는경우, 이외에신약이나마약, 향정신성의약품, 독약등의경우에전문의약품으로분류한다. 전문의약품에속하지않는경우일반의약품으로분류한다. 10) 대한약사회약학정보원에서는식품의약품안전처의허가사항을토대로표준의약품 DB를구축하였고, DB의분류체계를본연구에활용하였다. 11) 환자기본정보분류전문의약품과일반의약품보고건을분류한후, 환자의기본정보중성별과연령이어떤차이가있는지분석하였다. 환자의연령의경우증상발생당시의연령또는연령대로수집이되는데, 본연구에서는발생당시연령에해당하는연령대를기준으로분석을실시하였다. 연령대는 12세미만, 12~19세미만, 19~65세미만, 65세이상으로분류하여총 4개의분류로나누었다. 이상사례증상분류전문의약품과일반의약품보고건중에서, 다빈도로보고되는이상사례의증상을기술하기위하여, 세계보건기구 (WHO) 협력센터인웁살라모니터링센터 (Uppsala Monitoring Center; UMC) 에서개발한 WHO-ART 092 버전의부작용코드체계를사용하였다. WHO-ART코드는기관분류 (System Organ Classes; SOC) 와상급용어 (High level terms) 및우선용어 (Preferred terms; PT), 포함용어 (Included term; IT) 의 4개의계층으로분류된다. 12) 본연구에서는보고된 PT와 IT에해당되는 SOC의첫번째주분류를분석에포함하였다. 원인약물의분류이상사례의심약물의성분명에해당하는 Anatomical Therapeutic Chemical (ATC) 코드를이용하여분류하였다. ATC 코드는 WHO 산하기관인 WHOCC (WHO-collaboration centre) 의국제적으로통용되는의약품분류코드로약물이작용하는해부학적분류, 치료적분류, 약물학적분류, 화학적특성에따른분류등에따라 5단계로분류된다. 본연구에서는제 1단계

3 232 / Korean J Clin Pharm, Vol. 28, No. 3, 2018 분류인약이적용되는해부학적부위에따른 14 개의대분류군으로분석을진행하였다. 13) 이상사례의인과성평가 WHO-UMC 기준을근거로약물과이상사례간의인과성평가를하였으며, 확실함 (Certain), 상당히확실함 (Probable/ likely), 가능함 (Possible), 가능성적음 (Unlikely), 평가곤란 (Conditional/Unclassified) 의 5단계로분류하였다. 전문의약품과일반의약품각각에서인과성평가의분포를빈도와분율로제시하였고, 그차이에대한분석을시행하였다. 14) 중대이상사례존재여부분석중대한이상사례 (Serious Adverse Event) 는이상사례중사망또는생명을위협하는경우, 입원또는입원기간연장, 지속적또는중대한불구나기능저하, 선천적기형또는이상, 기타의학적으로중요한상황중하나에해당하는경우를말한다. 본연구에서는전체보고건중에서, 중대한이상사례가차지하는분율을전문의약품과일반의약품두군에서각각기술하였다. 처방일반의약품과비처방일반의약품의이상사례보고양상비교일반의약품의경우에도, 의사의처방과약사의조제에의해서의약품이소비되는경우와약국에서일반의약품을환자가구입하는경우두가지로구분할수있다. 본연구에서처방일반의약품과비처방의약품을구분하여이상사례의보고양상을추가적으로기술하였다. 처방일반의약품은대한약사회이상사례보고시스템의보고구분에서처방조제이면서전문 / 일반의약품구분에서일반의약품에해당하는자료를분석대상으로하였고, 비처방일반의약품은보고구분에서일반의약품에해당하는자료를분석대상으로하였다. 처방과비처방일반의약품을대상으로연령별보고양상을연령대를기준으로 12세미만, 12~19세미만, 19~65세미만, 65세이상으로분류하였고, 이상사례인과성평가보고양상을 WHO-UMC 기준을근거로 확실함 (Certain), 상당히확실함 (Prabable/likely), 가능함 (Possible), 가능성적음 (Unlikely), 평가곤란 (Conditional/Unclassified) 의 5단계로분류하여분석을진행하였다. 통계분석전문의약품과일반의약품에대한이상사례보고양상을성별과연령대별, 이상사례별, 약물분류별, 인과성평가, 중대이상사례등의차원에서비교분석하여보고건수와분율로제시하고, 카이제곱검정을실시하여분포의차이를확인하였다. 추가적으로, 일반의약품안에서도소그룹분석으로처방일반 의약품과비처방일반의약품의이상사례보고양상을연령별, 인과성평가차원에서비교분석하여보고건수와분율로제시하고카이제곱검정을실시하여분포의차이를확인하였다. 본연구에서는 0.05 유의수준에서통계적검증을실시하였으며, SAS ver. 9.4 (SAS Institute Inc., Cary, NC) 를이용하였다. 연구결과 2016년대한약사회산하의지역의약품안전센터로보고된이상사례중연구범위에속하는이상사례 17,570건에서건당 4~5 건의약물-부작용조합이생성되어총 75,451 약물-부작용조합을연구대상으로하였다. 보고된이상사례의특성을보면, 전문의약품이 61,390건으로 81.4% 이고, 일반의약품이 14,027건으로 18.6% 이었다. 전문의약품, 일반의약품간인구통계학적특징여자의부작용보고율이전문의약품에서 68.3% 으로일반의약품에서의분율 66.3% 보다약간더높은것으로나타났다. 연령대별보고분포는 12세미만소아와 12세이상 18세미만청소년에서는일반의약품의이상사례보고분율이각각 7.6% 와 2.1% 로전문의약품보다높았고, 65세이상노인에서는전문의약품의이상사례보고분율이 29.1% 로상대적으로일반의약품보다더높게나타났다 (Table 1). 전문의약품, 일반의약품간 WHO-ART 기관분류기준다빈도부작용분포 SOC를기준으로한이상사례분포는전문의약품과일반의약품간유의한차이가없었으며, 두개의약품분류모두에서위장관계장애, 정신질환, 중추및말초신경계장애순으로보고건수가많았다 (Table 2). Table 1. General characteristics of adverse events in ethicalthe-counter drugs and over-the-counter drugs reported at community pharmacy in 2016 Ethical-the-counter drugs (n=61,390) Over-the-counter drugs (n=14,027) Age group <12 1,490 (2.4) 1,072 (7.6) < ,012 (1.7) 290 (2.1) ,507 (66.0) 9,132 (65.1) >64 17,863 (29.1) 3,338 (23.8) Missing 518 (0.8) 195 (1.4) Gender Male 17,351 (28.2) 3,684 (26.2) Female 41,903 (68.3) 9,366 (66.8) Missing 2136 (3.5) 977 (7.0)

4 지역약국에서보고된전문의약품과일반의약품의이상사례보고현황비교분석 / 233 Table 2. Classification by disease according to system organ classes (SOC) of adverse events in ethical-the-counter drugs and overthe-counter drugs reported at community pharmacy in 2016 Type of adverse events categorized by system organ classes Ethical-the-counter drugs (n=61,390) Over-the-counter drugs (n=14,027) Gastro-intestinal system disorders 20,511 (33.4) 4,459 (31.8) 0.27 Psychiatric disorders 11,895 (19.4) 2,679 (19.1) Central & peripheral nervous system disorders 8,076 (13.2) 1,729 (12.3) General disorders 5,910 (9.6) 1,305 (9.3) Skin and appendages disorders 5,349 (8.7) 1,172 (8.4) Urinary system disorders 2,251 (3.7) 498 (3.6) Respiratory system disorders 1,015 (1.6) 201 (1.4) Metabolic and nutritional disorders 1,002 (1.6) 216 (1.5) Musculo-skeletal system disorders 858 (1.4) 196 (1.4) Heart rate and rhythm disorders 816 (1.3) 200 (1.4) Vision disorders 652 (1.1) 183 (1.3) Special senses other, disorders 337 (0.6) 66 (0.5) Cardiovascular disorders, general 324 (0.5) 59 (0.4) Reproductive disorders, female 318 (0.5) 65 (0.5) Platelet, bleeding & clotting disorders 268 (0.4) 73 (0.5) Others 613 (1.0) 134 (1.0) Missing 1195 (2.0) 792 (5.6) Table 3. Classification by medications using ATC code level 1 of adverse events in ethical-the-counter drugs and over-the-counter drugs reported at community pharmacy in 2016 ATC code level 1 Ethical-the-counter drugs (n=61,390) Over-the-counter drugs (n=14,027) Alimentary tract and metabolism 13,177 (21.4) 4,224 (30.1) < Respiratory system 9,996 (16.3) 4,712 (33.6) Musculo-skeletal system 9,159 (15.0) 1,528 (10.9) Nervous system 7,354 (12.0) 2,176 (15.5) Antiinfectives for systemic use 6,106 (10.0) 2 (0.0) Cardiovascular system 5,484 (9.0) 100 (0.7) Blood and blood forming organs 2,881 (4.7) 775 (5.5) Systemic hormonal preparations, excl. sex hormones and insulins 2,072 (3.4) 0 (0.0) Genito urinary system and sex hormones 1,304 (2.1) 106 (0.8) Sensory organs 652 (1.1) 38 (0.3) Dermatologicals 576 (0.9) 281 (2.0) Antineoplastic and immunomodulating agent 564 (0.9) 0 (0.0) Antiparasitic products, insecticides and repellents 143 (0.2) 1 (0.0) Various 28 (0.0) 8 (0.0) Missing 1894 (3.0) 76 (0.5) 전문의약품, 일반의약품간 ATC 약물코드기준다빈도의약품계열분포약물분류별이상사례분포는전문의약품은소화기관및대사가 21.4%, 호흡기계 16.3%, 근골격계 15.0%, 신경계 12.0% 순이었고, 일반의약품은호흡기계 33.6%, 소화기관및대사 30.1%, 신경계 15.5%, 근골격계 10.9% 순으로유의한차이를보였다 (P<0.0001) (Table 3). 전문의약품, 일반의약품간인과성평가결과및중대이상사례인과성평가결과는전문의약품의경우 확실함 0.8%, 상당히확실함 3.0%, 가능함 75.4%, 가능성적음 19.0% 순이었지만, 일반의약품의경우는 확실함 0.7%, 상당히확실함 2.0%, 가능함 44.0%, 가능성적음 47.7% 로 가능성적음 의비중이상대적으로높았다. 중대이상사례의경우전문의약품,

5 234 / Korean J Clin Pharm, Vol. 28, No. 3, 2018 Table 4. Causality assessment and serious adverse events number of adverse events in ethical-the-counter drugs and overthe-counter drugs reported at community pharmacy in 2016 Ethical-thecounter drugs (n=61,390) Over-thecounter drugs (n=14,027) 일반의약품모두발생비율이 0.4% 로동일했다 (Table 4). Causality assessment Certain 464 (0.8) 101 (0.7) < Prabable/Likely 1,845 (3.0) 285 (2.0) Possible 46,289 (75.4) 6,169 (44.0) Unlikely 11,655 (19.0) 6,687 (47.7) Conditional/Unclassified 23 (0.0) 14 (0.1) Missing 1114 (1.8) 771 (5.5) Serious adverse events Yes 242 (0.4) 51 (0.4) < No (99.6) (99.6) Table 5. Age group and causality assessment of adverse events in prescription and non-prescription over-the-counter drugs reported at community pharmacy in 2016 Prescription-OTC (n=13,486) Nonprescription- OTC (n=574) Age group <12 1,064 (7.8) 8 (1.4) < (2.1) 8 (1.4) ,737 (64.8) 408 (71.1) >64 3,229 (24.0) 129 (22.5) Missing 174 (1.3) 21 (3.6) Causality assessment Certain 47 (0.4) 56 (9.8) < Probable/Likely 177 (1.3) 108 (18.8) Possible 6,022 (44.7) 177 (30.8) Unlikely 6,678 (49.5) 9 (1.6) Conditional/Unclassified 7 (0.0) 8 (1.4) Missing 555 (4.1) 216 (37.6) 일반의약품처방, 비처방보고양상비교일반의약품을대상으로처방과비처방의보고양상을비교한결과 12세미만의경우처방일반의약품 (7.8%) 이비처방일반의약품 (1.4%) 보다이상사례보고율이높게나타났다. 또한처방일반의약품의경우 확실함 0.4%, 상당히확실함 1.3% 로 상당히확실함 이상의인과성평가결과가낮게나타났으나비처방일반의약품의경우 ' 확실함 ' 9.8%, 상당히확실함 18.8% 로 상당히확실함 이상의평가가높게나타났다 (Table 5). 일반의약품의중대이상사례의경우처방일반의약품은 51 건이있었으나비처방일반의약품은보고사례가없었다. 고찰 본연구는 2016년전국의약국으로부터대한약사회지역의약품안전센터에보고된외래환자의약물이상사례를분석한것으로, 전문의약품과일반의약품의보고양상의차이와일반의약품내에서처방과비처방의차이를분석하였다. 보고된이상사례는전문의약품의비중이일반의약품보다높았다. 인 Fig. 1. Study flow diagram describing reports of adverse event and drug-adverse event pairs

6 지역약국에서보고된전문의약품과일반의약품의이상사례보고현황비교분석 / 235 과성평가에서전문의약품에서일반의약품보다 가능함 이상의비율이더높았고, 비처방일반의약품의경우처방일반의약품보다 상당히확실함 이상의비율이높았다. 중대이상사례는전문의약품과일반의약품에서의보고비율이동일하였고, 비처방일반의약품에서는보고사례가없었다. 일반적으로약사법상부작용이심하거나용법, 용량을준수하는데전문성이필요한의약품은전문의약품으로분류되고부작용의범위가좁고그유효성, 안전성이확보된의약품을일반의약품으로분류한다. 10) 일반의약품은 2017년총급여의약품등재품목수 21,399개중 1,872개로 8.7% 에불과해 15) 약물감시에관심을두지않을가능성이높다. 그러나 2016년건강보험처방의전문의약품청구금액비중은 96% 이며일반의약품의청구금액비중은 4% 에불과하나일반의약품청구건수가전문의약품의 42% 로실제사용량이많고, 16) 대한약사회지역의약품안전센터에보고된이상사례중전문의약품이 81.4% 로많은비중을차지하고있으나일반의약품도 18.6% 라는적지않은보고가되고있어이에대한약물감시에도관심을기울일필요성이있다. 본연구에서이상사례보고환자중여성의비율이남성보다높은것으로나타났는데, 이것은이전의연구에서일반적으로약물이상반응이여성에서남성보다약 1.5배정도많이보고된다는것과일치한다. 17) 약물이상반응이발생되는기관에따라분류하였을때, 전문의약품과일반의약품모두동일하게위장관계장애, 정신질환, 중추말초신경계장애가많이나타났으며이전의연구와유사하다. 18,19) 이상반응유발원인약물분류에따라분석한결과지역약국에서보고된이상사례를분석한유윤미, et al. 의연구와마찬가지로전문의약품은위장관계약물이포함된소화기관및대사약물의빈도가 21.4% 로가장높았으나, 2) 일반의약품에서는소화기관및대사약물이아닌호흡기계약물 (33.6%) 의빈도가가장높았다. 또한, 일반의약품에서의호흡기계약물빈도 (33.6%) 는전문의약품에서동일한호흡기계약물의이상사례빈도 (16.3%) 보다차지하는비중이 2배가량높았다. 이는항생제, 호르몬제, 혈압약, 고지혈증약, 당뇨약등의분류군전체가전문의약품이므로일반의약품내에서의소화기, 호흡기비중은높을수밖에없으며, 우리나라국민들이가벼운감기에도병원을이용하는것때문에호흡기질환에콧물, 기침등대증요법이주를이루는일반의약품사용량이많아전체일반의약품사용량중호흡기계약물의비율이높은것으로보인다. 또한, 2013년에비해최신경향을반영하고, 7 만건이상의이상사례분석을통해조금더전체모수의특성에가까운결과일것으로기대된다. 이외에이상사례보고자의태도와지식에의해보고내용이영향받아원인약물이달라질수도있는것으로알려져있다 ) 추가적으로파악하지못한원인이존재할수도있으므로일반의약품으로분류된호흡기계약물의이상사례를 정밀하게분석하여호흡기계약물의적정사용여부, 연령제한등을검토해볼필요가있겠다. 소아의경우에는전문의약품보다일반의약품에서이상사례보고율이높고, 처방일반의약품이비처방일반의약품보다이상사례보고율이높다. 건강보험심사평가원의다빈도질병통계에따르면 2016년 0-9세에서질병별환자수감기질환인급성비인두염과감기의 2차질환인급성기관지염, 급성편도염, 급성부비동염등이상위 10위안에 7개가해당할정도로소아에서발병빈도가높다. 23) 소아에서의약물대사능력은나이에따라차이가있지만일반적으로어릴수록대사효소의미성숙으로약물의대사가성인보다저하되어약물의제거율이떨어지고따라서혈액내농도가높아지거나독성을일으킬가능성이높아약물복용시에위험이있어감기와같은경질환에도약국에서일반의약품을구매하기보다는병원에내원하는경우가많아이와같은양상을보이는것으로생각된다. 24) 65세이상에서는전문의약품의이상사례보고비율이우세하나, 이에못지않게일반의약품의비율도높은데, 이는우리나라노인의 90.9% 가 1가지이상의만성질환을앓고있고, 복합적으로여러질환을가지고있는경우가많아여러병원에서처방을받아약을복용하는경우가많기때문에하루복용하는평균약물수가 7.22개로타연령층에비해높아서그에따른약물이상사례비율도더높은것으로보인다. 25) 인과성평가결과전문의약품의경우가능함이 75.4% 로상급종합병원입원환자를대상으로약물이상반응인과성평가를진행한연구와비슷한결과이다. 26,27) 처방조제일반의약품의경우 가능함 44.7%, 가능성적음 49.5% 로 가능성적음 의비중이상대적으로높았다. 우리나라는한사람에게동시에처방되는약이많은국가에속하며전문의약품과일반의약품이모두보험적용을받아동시에처방되는경우도많아발생하는이상사례가함께복용하는전문의약품에의해발생될수도있기때문이라생각된다. 또한비처방의약품의경우이상사례의 0.8% 에불과하나 상당히확실함 또는 확실함 으로평가되는사례가 28.6% 에달하는데그이유는약국에서비처방의약품을구매하는환자의경우경증의증상을가지고있는건강한사람인경우가많아기저질환이없어이전에없던증상이생기면쉽게관찰할수있을뿐아니라병용약물이없을가능성이높아다른의약품에의한이상사례일가능성이배제됐기때문이라판단된다. 따라서약국가에서는처방전문, 일반의약품뿐아니라비처방일반의약품에대한약물감시에도많은관심을기울여야할것이다. 중대이상사례의경우전문의약품에서와동일하게일반의약품에서도 0.4% 가나타났으므로일반의약품의중대이상사례감시에도주의를기울일필요가있다. 일반의약품만을대상으로분석했을때처방조제에의한이

7 236 / Korean J Clin Pharm, Vol. 28, No. 3, 2018 상반응이 13,486건으로 96% 이고비처방일반의약품이 574건으로 4% 로처방이비처방보다월등하게많이보고된것은시사하는바가크다. 처방조제에서인과성평가결과가능성적음이높은것으로보아처방조제에의한이상사례는병용하는전문의약품이나기저질환에의할가능성이높고, 비처방에서 상당히확실함, 확실함 의비율이높은것으로보아실제일반의약품에의한이상사례는비처방에서보고된자료로판단하는것이더정확하다고생각된다. 현재외래처방환자이상사례를중심으로하는지역의약품안전센터는전국 27개센터중에대한약사회지역의약품안전센터 1개센터에불과해외래처방이상사례모니터링체계구축을위한정부의추가적인지원이따른다면일반의약품에서의보다정확한이상사례모니터링이가능할것으로보인다. 2016년지부별보고건수중경기지역이 33.8%, 서울지역이 27% 로수도권지역이 60.8% 를차지한다. 실제약국분포는수도권지역이 44% 으로실제약국수대비수도권지역의보고건수가더높기때문에본연구의결과가우리나라전체의결과를고르게반영하지못했다는한계점이있다. 추후통계분석시지역별이상사례보고건수와약국분포까지고려한추가적인연구가필요하겠다. 또한약물감시교육, 홍보등을통해강원지역, 대구지역등약국수대비보고건수가다른지역에비해특히낮은지역은활성화하려는노력이필요하다. 2017년 4월대한약사회지역의약품안전관리센터에보고된이상사례자료를바탕으로충실도점검을한결과환자병력 / 사용력, 의약품조치, 재투여시이상사례여부, 투여목적 ( 적응증 ), 과거병력등의다섯가지항목의응답률이낮아충실도평가점수가낮게나타났다. 지역약국에서보고된이상사례의특성상환자의약력, 검사기록, 병존질환에관한정보가부족하여인과성평가에한계가있을수밖에없으나, 약국가에서는환자대면시에기초정보를수집하는노력이필요하겠고, 제도적으로는일반병, 의원에서발행되는처방전에질병코드기재를의무화하도록하는것과환자의최근처방정보가함께보고되도록시스템을보완하면환자약력파악이용이하게될것이라생각된다. 결론 일반의약품은전문의약품보다안전하여처방없이사용이가능한약물로분류되었으나, 지역약국의외래환자에서보고된이상사례중일반의약품도적지않은비중을차지하고있어약물감시에주의를기울일필요가있다. 또한일반의약품만을대상으로분석했을때비처방에서의이상사례인과성이높은것으로나타나약국가에서는비처방일반의약품에대한약물감시에도많은관심을기울여야하겠고, 약물감시교육, 홍보와충실도향상을위한노력, 정부차원에서의외래처방 이상사례모니터링체계구축지원등이추후시행된다면보다구체적이고질적으로우수한일반의약품이상사례연구수행이가능해질것이다. 감사의말씀 본연구는식품의약품안전처의 2018년도지역의약품안전센터운영에대한사업비지원에의해수행되었습니다. 참고문헌 1. Korea Institute of Drug Safety and Risk Management. Pharmacovigilance terms. Available from information/egovdrugwatchterm.do. Accessed April 18, Yu YM, Choi SA, Lee MS, et al. The clinical characteristics of adverse drug reactions reported from the community pharmacy. Korean J Clin Pharm 2014; Sultana J, Cutroneo P, Trifirò G. Clinical and economic burden of adverse drug reactions. J Pharmacol Pharmacother 2013;4(Suppl1): S Chan SL, Ang X, Sani LL, et al. Prevalence and characteristics of adverse drug reactions at admission to hospital: a prospective observational study. Br J Clin Pharmacol 2016;82(6): Rodriguez-Monguio R, Otero MJ, Rovira J. Assessing the economic impact of adverse drug effects. Pharmacoeconomics 2003;21(9): Taché SV, Sönnichsen A, Ashcroft DM. Prevalence of adverse drug events in ambulatory care: a systematic review. Ann Pharmacother 2011;45(7-8): Korean Statistical Information Service. Results of medical care benefits by type of medical care institutions and medical type (Total). Available from 7. Accessed March 7, Korean Statistical Information Service. Outpatients prescription number by prescription day and type of medical care institutions. Available from _28. Accessed March 7, Korea Institute of Drug Safety and Risk Management Trends in safety information reporting pharmaceuticals. Available from open.drugsafe.or.kr/trend/trend/read.jsp?ntt_id=2081. Accessed April 12, Ministry of Food and Drug Safety. Regulation on standard of medicines category: Notification No , article 2 Enforcement November 11, Korea Institute of Drug Safety & Risk Management. Adverse Drug Reaction Assessment Report, 1st ed. Korea: Korea Institute of Drug Safety & Risk Management 2013; Lim KH, Shin HT, Sohn HS, et al. Comparison of WHO-ART Versus MedDRA, Internationally Standardized Terminology of adverse Drug Reaction Classification. Korean J Clin Pharm 2007;17(1): WHO collaboration Centre for Drug Statistics Methodology. ATC Structure and principls. Available from structure_and_principles/. Accessed March 28, Uppsala Monitoring Centre. The use of the WHO-UMC system for standardised case causality assessment. Available from Accessed June 11, Korean Statistical Information Service. OTC drugs regestration status.

8 지역약국에서보고된전문의약품과일반의약품의이상사례보고현황비교분석 / 237 Available from DT_354004N_007. Accessed March 23, Korean Statistical Information Service. ETC/OTC drugs claim status. Available from tblid= DT_354004N_020. Accessed November 21, Rademaker M. Do women have more adverse drug reactions? Am J Clin Dermatol 2001;2(6): Rew SY, Koh YI, Shin HY, et al. Reporting and clinical features of adverse drug reactions from a single university hospital. Korean J Asthma Allergy Clin Immunol 2011;31(3): Kim MG, Kang HR, Kim JH, et al. Analysis of adverse drug reactions collected by an electronic reporting system in a single hospital. Korean J Med 2009;77(5): Gavaza P, Brown CM, Lawson KA, et al. Influence of attitudes on pharmacists' intention to report serious adverse drug events to the Food and Drug Administration. Br J Clin Pharmacol 2011; 72(1): Cosentino M, Leoni O, Oria C, et al. Hospital-based survey of doctors' attitudes to adverse drug reactions and perception of drug-related risk for adverse reaction occurrence. Pharmacoepidemiol Drug Saf 1999; 8(Suppl 1): S Kim H. Attitude and knowlege of community pharmacists to adverse drug reaction reporting. Korean J Clin Pharm 2009;19(2): Health Insurance Review and Assessment Service. Frequent disease statistics. Available from SickInfo.do. Accessed March 28, Chung EH. Clinical implication of adverse drug reaction surveillance in children. Allergy Asthma Respir Dis 2016;4(5): Lee JK. Factors associated with drug misuse behaviors among polypharmacy elderly. Korean J Adult Nurs 2011;23(6): Choi YH, Sohn UD. The surveillance of adverse drug reaction(adr) reported. Korean J Clin Pharm 2003;13(2): Sriram S, Ghasemi A, Ramasamy R, et al. Prevalence of adverse drug reactions at a private tertiary care hospital in south India. J Res Med Sci 2011;16(1):16.

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1.. Volume 12, Number 1, 6~16, Factors influencing consultation time and waiting time of ambulatory patients in a tertiary teaching hospital Jee-In Hwang College of Nursing Science, Kyung Hee University :