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1 w wz «y Kor. J. Clin. Pharm., Vol., No.. y sƒ Áwx Á ³ Á Ÿ y w w w w w Analysis of Drug Use Reviews in Pediatirc Inpatients Eun Jeong Shin, Hun Joo Ha Wan Gyoon Shin and Kwang Jun Park Graduate School of Clinical Health Sciences, Ewha Womans University, -, Korea College of Pharmacy, Seoul National University, -, Korea Department of Pharmacy, Seoul National University Hospital, -, Korea This study was intended to contribute towards the development of proper drug use system for pediatric patients by investigationg problems related to their medication and identifying drugs that need to be developed into low dosage tablets or syrups for pediatric use based on our analysis on the prescriptions for pediatric inpatients from hospitals in South Korea on a day of Feb.. The usage rates in the proportion of less than. and per unit of oral solid formulation were.% and.% in hospitals with beds or more,. and.% in hospitals with to less than beds,.% and.% in hospitals with less than beds. Of the oral solid formulation products that were used two or more times in the proportion of less than. units, products (.%) were used as such despite the fact that syrups and lower dosage tablets or capsules were available in the market, and products (.%) so even when syrup formulations were available. Therefore, it would be desirable that pharmacist communities in charge of dispensing identify the most frequently crushed drugs or those that require special attention in choosing dispensing powders or solutions and develop dispensing guidelines that can be adopted by pharmacists in practice. Moreover, government-led policies are needed to encourage development and manufacture of the formulations for pediatrics and to correct unsound prescription and dispensing practices such as using crushed forms of certain oral solid formulations although alternative formulations are available in the market. Key wordsg pediatric inpatient, oral solid formulation, dispensing, prescription, pediatric use ¾ š š, xƒ q w y ù y», w xƒ w xƒ z j ƒ w., šx dopamine š Ÿ w w w xƒƒ ƒ. ), xƒ n w z ƒ ù w w, m ) x w ù z ù w w x. Correspondence to : ³ w w w/ w w w p - Tel: +--, Fax: -- wgshin@snu.ac.kr ù, z m x mw w wš ƒw, p w ù e j»», w n w w ƒ. w w x w ù v gq š, ù w p w z» w»,»ù w. ), ù» w z w ƒ x w x y ú ƒ w,»ù s» w n. ) t z ƒ š x w. t x k x wš x w ù w š z

2 Kor. J. Clin. Pharm., Vol., No., r. t x n w ƒ z» w. y m w y n š, ù ƒ v w r, w w w» wš w. l w y œ ³ (,,,, ), šx w sƒw wš w. ƒ., s œ ³ Table ù., y ƒ sw. ù. y w ³ w y, x š šx ( ), šx x z n (.,, w š.,,. w ) w. w x. w š ƒà š q w»., šx x z n. z t wš ü w ù šx ƒ ƒ w. l w MS office excel w, t ü xƒxy ü BIT DRUGINFO database w w. ƒ. ƒ y w y Table. Distribution of hospitals and the number of pediatric patients in this study Hospital No. District The number of beds The number of pediatric patients Busan/Gyeongnam, Seoul, A Seoul, With not less than, beds Seoul, Seoul, Sub. total B With beds to less than beds C With less than beds Seoul Busan/Gyeongnam Daegu/Gyeongbuk Seoul Busan/Gyeongnam Gangwon Gyeonggi Seoul Gwangju/Jeonnam Gwangju/Jeonnam Gangwon Seoul Sub. total Busan/Gyeongnam Gyeonggi Seoul Seoul Gyeonggi Sub. total Total,

3 y sƒ,,,, w ƒ y w y Table ùkü. ¾ y ù e x w»» x v w y, ƒ y w, ³,.%, ³,.%, ³.%, y.% (Table ). ù. x š š x ( ) w n w x w p w» w z» (Feroba-U, valproate), (Medilac-S), d (Bease) ù w ³ w ƒ e (nifedifine, tocopherol) x š. x Table. The percentage of patients not more than five years of age Hospital No. A With not less than, beds B With beds to less than, beds The Nunmber of total pediatric patients The number of patients not more than yr(%) (.) (.) (.) (.) (.) Sub. total (.) (.) (.) (.) (.) (.) (.) (.) (.) (.) (.) (.) (.) Sub. total (.) (.) (.) C (.) With less than beds (.) (.) Sub. total (.) Total (.) š bromhexine, folic acid, spironolactone, furosemide, mequitazine, domperidone, streptokinase/ streptodornase, chloropheniramine, ursodeoxycholic acid, fenoterol, digoxin. x š šx z Table ùkü.. šx x z n (.,, w.,,. w ) ³,,,, šx x z n.,..,..,.,..,,.,.,.,, w z w Table ùkü. x / Table. Most frequently crushed drugs due to prescription in proportions of less than formulation unit Generic name Content Formulation Frequency Bromhexine mg T Folic acid mg T Spironolactone mg T Furosemide mg T Mequitazine mg T Domperidone mg T Streptokinase/streptodornase,IU/,IU T Chlorpheniramine mg T Ursodeoxycholic acid mg T Fenoterol.mg T Acetaminophen mg T Ambroxol mg T Phenobarbital mg T N-acetylcysteine mg C Tocopherol mg LC Formoterol fumarate mcg T Formoterol fumarate mcg T Digoxin.mg T Captopril.mg T Gastropylore/cyanocobalamine mg/.mg C Ranitidine mg T Sulfamethoxazol/trimethoprim mg/ mg T Biphenyl-dimethyl-dicarboxylate mg T Clostridium mg T Hydrochlorothiazide mg T Pseudoephedrine mg T T: tablets, C: capsules, LC: liquid filled capsules

Kor. J. Clin. Pharm., Vol., No., 조제되는 비율이 병상규모,이상, 이상,미만, 미만 별로 각각.%,.%,.%나 되었다(Table ). 단위 제형 당.미만의 경구고형제를 사용한 비율은 병상 수,이상의 병원에서는.%, 병상 수 이상, 미만의 병원에서는.%, 병상 수 미만의 병원에서는.%였으며, 미만을 사용한 비율은 각각.%,.%,.%로 병상규모가 작아질수록 현저하게 그 비율이 높아졌 다.

4 Kor. J. Clin. Pharm., Vol., No., 조제되는 비율이 병상규모,이상, 이상,미만, 미만 별로 각각.%,.%,.%나 되었다(Table ). 단위 제형 당.미만의 경구고형제를 사용한 비율은 병상 수,이상의 병원에서는.%, 병상 수 이상, 미만의 병원에서는.%, 병상 수 미만의 병원에서는.%였으며, 미만을 사용한 비율은 각각.%,.%,.%로 병상규모가 작아질수록 현저하게 그 비율이 높아졌 다. 및 이상을 제외한 사용비율(각각.%,.%,.%),.,,. 및 이상을 제외한 사용비율(각각. %,.%,.%)도 비슷한 양상을 나타내었다(Fig. ). 라. 경구고형제 중 단위 제형 당 회 투여량이.미만인 용량으로 회 이상 사용된 약물을 대체할 수 있는 시럽제나 소용량의 경구 고형제 국내 존재 유무 조사대상 전체 병원을 대상으로 경구고형제 중.단위 용 량 미만으로 회 이상 사용된 약물 및 대체할 수 있는 소아 용 제형 유무를 Table 에 나타내었다. 총 품목 중 품목 (.%)이 시럽 또는 소용량의 정제나 캡슐제가 유통되고 있 Fig. Usage rate per unit of oral solid formulation for the following proportions; less than., less than, exclusion of, and above, exclusion of.,,., and above, by hospital group (A: not less than beds, B: beds to less than beds C: less than beds). Table. Usage per unit of oral solid formulation for the prescription(a: not less than, beds, B: beds to less than, beds C: less than beds) Hospital ~.*.~.*.~.* A Sub. total B Sub. total C Sub. total *Not less than a less than b **More than a less than b Usage per unit of oral solid formulation..~.**.~ * ~.**..~** Total >,,

5 y sƒ Table. Availability of syrups or smaller dosage oral solid formulations in list of tablets or capsules that were used two or more times in the proportion of less than. units Generic name Content Formulation Availability of syrups Availability of lower dosage oral solid formulation Acepifylline mg T N N Acetaminophen mg T Y Y Acetaminophen mg T Y Y Acetylcysteine mg C Y N Acetylcysteine mg C Y Y Acetylmidecamycin mg T Y N Allopurinol mg T N N Ambroxol mg T Y N Aminophylline mg T N N Aspirin mg T N N Aspirin- microcoated mg T N N Aspirin- microcoated mg T N N Azithromycin mg T Y N Baclofen mg T N Y Biphenyl-dimethyl-dicarboxylate mg T N Y Bromhexine mg T N N Cefaclor mg C Y N Chlorpheniramine maleate mg T Y N Chlorpheniramine maleate mg T Y Y Cimetidine mg T N N Clonazepam.mg T N N Captopril.mg T N N Captopril mg T N Y Diazepam mg T N N Digoxin.mg T Y N Diphenylhydantoin mg T Y N Domperidone mg T Y N Enalapril mg T N N Erythromycin mg T Y Y Famotidine mg T N Y Fenoterol.mg T N N Folic acid mg T N N Formoterol fumarate mcg T Y Y Formoterol fumarate mcg T Y N Furosemide mg T Y N Hydrochlorothiazide mg T N N Hydroxyzine mg T Y N Ibuprofen mg T Y N Indomethacin mg C N N Lamivudine mg T Y N Lamotrigine mg T N Y Mequitazine mg T Y N Methylephedrine mg T N N Methylprednisolone mg T N N Metoclopramide mg T N N Mirtazapine mg T N N N-acetylcysteine mg C Y Y Nifedipine mg LC N Y Nizatidine mg T N Y Omeprazole mg C N Y Phenobarbital mg T N N Prednisolone mg T N N Pseudoephedrine mg T N Y Pseudoephedrine mg T N N Ranitidine mg T N Y S-carboxymethylcysteine mg C Y Y Sildenafil mg T N N Spironolactone mg T N N Streptokinase/streptodornase,U/,U T N N Sulfamethoxazol/trimethoprim mg/mg T Y N Ursodeoxycholic acid mg T N N Vigabatrin mg T N N Warfarin mg T N N T: tablets, C: capsules, LC: liquid filled capsules, Y: yes, N: no

6 Kor. J. Clin. Pharm., Vol., No.,, ƒ t (.%) ù. š ù n w» w x w š, w š ö yww w ¾ š. ù w š w ù, d p w x z ù š w š w n š. y x ü y x w ph y z q, š w e g y w. ) ù w phenobarbital mg z. mg w,, bithree, galantase, ebioseƒ š ù ƒ», w. ) ù e ƒ w t» w ƒ». ù e w n w y, ³ w w., w s ù hw ý, v w ù n ƒ n w. yw ƒ ù e n w, cefuroxime ù enalapril n w w ù., x Sorbitol š k šƒ, ù ƒ w». w ) n w ƒ %ƒ» w lƒ w ùk û. ) ù w ù w ƒ w w, EU w w» w ƒ (National Healthcare Service) t t z(pharmaceutical Quality Control Committee) z(working party) w w t e š, ƒ w wš. w w q w.,) ù w wì,, ww x ƒ ƒvw k ¾ w z e w œw w., ù e x w» x v w w y w, x. šx w û ùkù wš wš., ü wš., ü w y v w š. p w x v w ù q y ü n ƒ ƒ w w ù p w w compounding pharmacy v w.,. z šx.%ƒ ù e ƒ m š wš. w w ùƒ» w ù er w. z ù w w» x w, ƒ ƒ w wš ù ù w š., ww x ƒvw w w, k ¾ w z e w œw w. wš, wš šx n w š ùƒ» w ù er w. š x. Banner W. Off label prescribing in children. BMJ. ; : -.. Nahata MC. Pediatric drug formulation: challenges and

7 y sƒ potential solution. Ann. Pharmacother. ; : -..,, ½, y. y x y w. z. ; (): -.. x.. z. ; (): -.. Ÿ. w p z k. z. ; (): -.. Nahata MC. Lack of pediatric drug formulations. Pediatrics. ; : -.. Nunn AJ. Making medicines that children can take. Arch. Dis. Child. ; : -.. Nunn T, Using Unlicensed and Off label Medicines. ;

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16(2)-7(p ).fm w wz 16«2y Kor. J. Clin. Pharm., Vol. 16, No. 2. 2006 ü t xy y w tœ ½ BÁ x BC B y w w w C y w w w Current Status and Expectations of Orphan Drugs in Korea -In point of supplying medicines for the rare