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1 w wz 15«2y Kor. J. Clin. Pharm., Vol. 15, No ù xw t wš x Á Á½ Á x Á x Á xk w w w w w Current Drug Classification System in Korea and Its Improvement Hyun Soon Sohn 1, Ock Hee Oh 2, Jong Joo Kim 2, So Hyun Lee 2, Sun Hye Byun 2, Hyun Taek Shin 1 1 College of Pharmacy 2 Drug Information Research Institute, Sookmyung Women's University, Seoul, Korea Appropriate drug classification is important for rational drug consumption. This study was conducted to evaluate the appropriateness of current drug classification system and suggest possible ways for improving the system. Nonprescription drug market has been decreased. Since total 27,962 products had been classified (prescription 17,187 vs. nonprescription 10,775 products, 61.5% vs. 38.5%) in July 2000 for implementing separation of drug prescribing and dispensing system, there are no classification changes. Reclassification is not motivated by product holder and regulatory system did not lead classification change either. Consumers ease access to some nonprescription drugs is demanded. But point of public awareness and cultural and health environmental views, safe drug use rather than advantages from broad supply of nonprescription drugs is more critical. We concluded that current 2-categorized (prescription and nonprescription) drug classification system is appropriate, and addition of general sale category should be approached carefully with long term preparations such as establishment of better nonprescription drug consuming infrastructure by public information provision and education for improving public medicinal knowledge and strengthening self medication guidance, and review of current classification status of marketed drugs and switching possibilities. For systemizing and encouraging reclassification, introduction of regulatory renewal system as a continuous reevaluation program which is the best way to review appropriateness of drug classification as well as provision of detailed guidance for industry including policy, requirement and process for reclassification application, are necessary. KeyG words Drug Classification System, Prescription Drug, Nonprescription Drug, Switching, Drug Reclassification t û y š w w» wš w e t ƒ v w t y t w w w. ù xw t ƒ l ww w 27,962t t 17,187t (61.5%) t 10,775t (38.5%) w t 1) w š. z t w y wš w sƒw w mƒ v w ù, w 5 t w ƒ w., z t y wš, x t Correspondence to : xk w w w q 2ƒ 53-12( ) Tel: , Fax: shingo@sdic.sookmyung.ac.kr sƒw, ù w t w wš w. z» t w» w t q w m xz IMS y w. xw t sƒw» w ü ³ mwš, (,, ) t t w» w ƒ ³ yr w w. wr, xz œ t ƒ y w š, p ù ƒ t wš, ƒ t w. w 1

2 Kor. J. Clin. Pharm., Vol. 15, No. 2, 2005 x k ù x t w w» w w. ü t q (1) w z t wk 10 t, w 60% w t 2003 31.03%. 2)» z t e wì, ³ y t xƒ³ t w k, t ƒ ë, š w t t ƒ t t ƒ q š. : t 2) t 61.5%:38.5% 39.

2 2 Kor. J. Clin. Pharm., Vol. 15, No. 2, 2005 x k ù x t w w» w w. ü t q (1) w z t wk 10 t, w 60% w t %. 2)» z t e wì, ³ y t xƒ³ t w k, t ƒ ë, š w t t ƒ t t ƒ q š. : t 2) t 61.5%:38.5% 39.0%:61.0% w, w t ƒ s y. t w z t 1) ƒw t x š (Fig. 1). t t % z % % ùkû. ³ 3) t ƒw, t Fig. 1. Prescription and nonprescription drugs market ( ) w. 3) wr, t x % % ƒw, t x % % ƒw. t 3) ƒ 5% x š, t (Table 1) t 3.7% ƒ x ƒ 12.5% ƒ f ù x 1% w, t x w. x t ql t x m w. r z t x, q wš t w w w v w, t x t w wš t t t x e w w. (2) t m ù x t t t w, t œ š t œ. w t 2 ƒ ù y p y w w, t, š w. 5 y t ƒ f š ù t Ÿ w q x ƒ ƒ w š», w q w w w ³ ƒ v w. Ÿ q ƒ x t ( q )ƒ v w» y, w t r w ƒ. ù t» j y d w w. ù,» Table 1. Insurance covered or not-covered pharmaceutical market ( ) (unit : million won) Year Insurance covered Total 3,241,237 3,705,464 4,468,261 4,793,829 5,577,971 Prescription 2,755,463 3,244,891 3,904,817 4,236,970 4,951,376 Nonprescription 485, , , , ,595 Insurance not-covered Total 1,424,004 1,653,271 1,495,931 1,278,611 1,314,325 Prescription 228, , , , ,456 Nonprescription 1,195,727 1,410,142 1,290,502 1,059,995 1,049,869 (source : IMS data)

3 ù xw t w š 3 t t» w ³ 1) t sƒ 2) t xƒ«w w» mw ƒ w š4) w», ù» w e. ù t 2000 w w q t 17,187t t, 10,775t t w t. z ƒ, t ƒ t q w» xƒ«t š, w t sƒ y w w. t q z š,, sƒ ù 4~6 ƒ xƒ«qz wš š, z sƒ»ƒ 10 { w» ƒ» w š., xƒ«ƒ t w w yw w k, t ƒ q z x ü sƒ mw t w v w. t xƒ«¼ ƒ, ³ e w š w w eƒ v w. ù t š»» t w w v ƒ. t» w, w wš t t t š v w z t z l t w w š. t (1) t t(prescription drugs) t(non-prescription drugs) w» ù w. 5),, n, z z ƒ t e t w, t» x x w t z q w ƒ». t z 6) t wš w w z w w t ù sƒƒ wš, w y,, t y, sƒ š w t w w, z y w» w» ( e 3 ) qz w. 6) t qz Á š( ù t š ),, q z (PMS, q z 6» w, q w, 2000 ),» sƒ.» sƒ mw t t» y wš, t 5 z Á sƒw renewal. t», z, t»» w» t w, t z w wš ù w. ù t ƒ š, t z ü zƒ t» ù ƒ. (2) t (Prescription Only Medicine, POM), (Pharmacy Medicine, P), q (General Sale List, GSL) 3 wš, q w p. 7)» ù w, w 1z n ù 1, w, x, s. w š, v w, w q œ. ù q» w, w. q ƒ w x ù x š p w w r f Ÿ w q ƒ w r œw. 7,8), ƒ w w x r w ƒ w., z ù w ƒ wš, w w ƒ w q œ w. w w ƒ v š q (Fig. 2). w 7) š š, w q» ù z q ƒ w., x y

4 4 Kor. J. Clin. Pharm., Vol. 15, No. 2, 2005 Fig. 2. Drug Reclassification in UK. w ƒ v w w š, q ù y w y w y w t 8) yw w ƒ t Ÿ w wš, t n wš wš yw š. 9) w w y q ƒ y ƒ,, xz,», y, ƒe w, y y wš, z w -r r ƒwš r t ³ š sƒ. 10) ù, y» w. x, x,» ü e(mhra Guidance Note 11 : Changing the legal classification 8) in the United Kingdom of a medicine for human use) œ š. t ƒ w w w. t q 5 zw xƒ«5 (renewal) w w, w w t ƒ w»zƒ. 11)» t z w» sƒ mw t mw ƒ wš z ƒ z. t Medicines and Healthcare Products Regulatory Agency( w MHRA w) Post-Licensing Division w. Post-Licensing Division Post- Licensing Assessment Group w, y, wš. 12) t MHRA Reclassification Unit m sƒw, z(committee on Safety of Medicines) w. (3) t (Prescription Drugs) (Non-prescription Drugs, OTC ew) w. (r, r f ) ƒ w OTC 1997 $20.6 billion z ƒ» 13) x OTC w w š. ƒ w 10 t 6 ƒ OTC š, 800 z 100,000 OTC q š,» e l ¾ 80ƒ e t sw. 14) NDA e, Time and Extent Application ( w TEA w)ù»(citizen Petition) mw OTC Monograph System 15,16) ƒ w. TEA 1972 z NDA q t, ü q x t OTC Monograph wt ù z ƒ ƒ t OTC Drug Monograph System ü sw w mw» 2002 l y š. TEA q (q» q ) w. wù ƒ y TEA» wš e( )(A draft guidance for industry for TEA application) 16) 5 OTC q š t w, k ƒ q x w OTC w q w ù w ƒ, ù»k w w v w. w t (Post- Marketing Surveillance, Adverse Event Reporting System, MedWatch Program, Medication error reports, Therapeutic 17) Inequivalence Reporting ) mw OTC q z ƒ š. OTC FDA CDER Drug Evaluation Office V OTC w, Nonprescription Drugs Advisory Committee w z œ. 14) (4) t ƒ t z w w k t û w w e., w, ƒ xkƒ š t w œm». ù : t

5 ù xw t w š 5 w 2 ƒ (Table 2). ù q wš y ƒn r w š».» ü t ƒ t z š y ƒ š ù. w e y š q z sƒ mw t ƒ e š, ù t w w ù w e w eƒ w. (5) t w ƒ w t w ƒ xƒ w ƒ. ù ƒ ƒ(,, ) t (Table 3), ù q t q t (Table 4), š ƒ t ƒ y (Table 5) w. 18) t ƒ xy r,, ù ƒ ù ƒ t w, x ù mw w š,, t y y w ù y y w Table 3. Comparison of classification between korea and other countries Ingredient (Administration Route) Korea Japan US UK Erythromycin (topical) OTC * Rx Rx ** Rx Mefenamic acid (internal) OTC Rx Rx Rx Mupirocin (topical) OTC Rx Rx Rx Silver sulfadiazine (topical) OTC Rx Rx Rx Cimetidine (internal) Rx OTC OTC OTC Famotidine (internal) Rx OTC OTC OTC Loperamide (internal) Rx OTC OTC OTC Ranitidine (internal) Rx OTC OTC OTC Diphenhydramine (internal) Rx OTC OTC OTC Nizatidine (internal) Rx Rx OTC OTC Omeprazole (internal) Rx Rx OTC OTC Loratadine (internal) Rx Rx OTC OTC Ephedrine (internal) Rx OTC OTC OTC *OTC : Non-Prescription Drug ** Rx : Prescription Drug source: 1. OTC ingredients table. World Self-Medication Industry. source: 2. Drug Information Service, KFDA. source: 3. Drugs@FDA, US FDA, cder/drugsatfda source: 4. Medicines and Healthcare Products Regulatory Agency, source: 5. Japanese Drug Index w v ƒ. t t ü x ƒ w w v w. Table 2. Drug classification system Korea Japan US UK Prescription Prescription Prescription Prescription Only Medicine Nonprescription Nonprescription Nonprescription Pharmacy Medicine General Sale List Table 4. Products list classified as general sale list in UK Ingredient Administration route Classification in Korea Classification in UK acyclovir topical OTC GSL aspirin internal OTC GSL beclomethasone dipropionate topical Rx GSL cetirizine HCl internal OTC GSL clotrimazole topical OTC GSL famotidine internal Rx GSL hyoscine butylbromide internal OTC GSL ibuprofen topical/internal OTC GSL ketoconazole topical OTC GSL loratadine internal Rx GSL miconazole nitrate topical OTC GSL nicotine topical/gum OTC GSL terbinafine HCl topical OTC GSL

6 6 Kor. J. Clin. Pharm., Vol. 15, No. 2, 2005 Table 5. Reclassification Products List Japan US UK Ingredient Year Ingredient Year Ingredient Year Clemastine 1979 Chlorpheniramine 1976 Ibuprofen(topical) 1983 Bufexamac(topical) 1980 Dexchlorpheniramine 1976 Hydrocortisone(topical) 1987 Clotrimazole(topical) 1980 Oxymetazoline 1976 Mebendazole 1989 Picosulfate(sodium) 1983 Pseudoephedrine 1976 Dextromethorphan 1989 Ibuprofen(oral) 1985 Xylometazoline (nasal) 1976 Nicotine(gum) 1991 Indomethacin(topical) 1985 Hydrocortisone(topical) 1979 Dihydrocodeine 1992 Dimemorfan 1985 Ephedrine(topical) 1980 Paracetamol + dihydrocodeine 1992 Ciclopirox olamine 1987 Epinephrine(not for asthma) (adrenaline) 1980 Clotrimazole(vaginal) 1992 Miconazole(topical) 1987 Phenylephrine 1980 Econazole 1992 Hyoscine(Scopolamine) 1987 Diphenhydramine 1981 Miconazole(vaginal) 1992 Bromhexine 1987 Haloprogin(topical) 1982 Hyoscine(Scopolamine) 1992 Cetraxate 1987 Miconazole(topical) 1982 Ketoprofen 1993 Econazole 1988 Dexbrompheniramine 1982 Acrivastine 1993 Carbocisteine 1988 Trip(r) olidine 1982 Cetirizine 1993 Loperamide 1989 Dyclonine(oral) 1982 Loratadine 1993 Ibuprofen(topical) 1990 Ibuprofen(oral) 1984 Aciclovir(topical) 1993 Mequitazine 1990 Pyrantel 1986 Felbinac(topical) 1994 Hydrocortisone(topical) 1990 Chlophendianol 1987 Piroxicam(topical) 1994 Ubidecarenone 1990 Loperamide 1988 Tioconazole 1994 Tioconazole 1991 Clotrimazole(topical) 1989 Minoxidil(topical) 1994 Prednisolone 1992 Clotrimazole(vaginal) 1990 Beclometasone(nasal) 1994 Bifonazole 1993 Miconazole(vaginal) 1991 Flunisolide(nasal) 1994 Oxiconazole 1993 Clemastine 1992 Cimetidine 1994 Sulconazole nitrate 1993 Naproxen 1994 Famotidine 1994 Ketoprofen(topical) 1994 Ketoprofen 1995 Ranitidine 1994 Piroxicam(topical) 1994 Butoconazole 1995 Oxetacaine 1994 Felbinac(topical) 1995 Cimetidine 1995 Pseudoephedrine 1994 Oxetacaine 1995 Famotidine 1995 Aluminium(topical) 1994 Cimetidine 1997 Ranitidine 1995 Fluconazole(oral) 1995 Famotidine 1997 Minoxidil(topical) 1996 Ketoconazole(topical) 1995 Ranitidine 1997 Nizatidine 1996 Hydroxyzine 1995 Cromoglicate(sodium) 1997 Nicotine(gum) 1996 Budesonide(nasal) 1995 Minoxidil(topical) 1999 Nicotine(patch) 1996 Azelastine 1996 Nicotine(gum) 2001 Ketoconazole(topical) 1997 Nizatidine 1996 Amorolfine(topical) 2002 Tioconazole 1997 Lactitol 1996 Butenafine 2002 Cromoglicate(sodium) 1997 Mebeverine 1997 Neticonazole(topical) 2002 Terbinafine 1999 Miconazole & Hydro-cortisone(topical) 1998 Terbinafine 2002 Docosanol(topical) 2000 Levocabastine 1998 Pseudoephedrine 2002 Cetirizine 2002 Domperidone 1998 Loratadine 2002 Terbinafine 2000 Nicotine(sublingual) 2002 Nicotine(nasal spray) 2000 Omeprazole 2003 Flurbiprofen(oral topical) 2001 Fenticonazole(topical) 2001 Prochlorperazine 2001 Clobetasone butyrate 2001 Levonorgestrel 2001 Nicotine(sublingual) 2001 Fluticasone 2002 source : OTC ingredients table. World Self-Medication Industry.

7 ù xw t w š 7 š t r f q x ƒ ñ» š x ù y, ƒ r w š z w y q w ù w 3» q w v w. ƒ x 2 w q t ƒ w sƒwš w y yw t mw w v w y, t w w z q ƒ mw k w., t w š w q x r t û w j. ƒ š ù, w ƒe w w ¾ w. t q ƒ š FDAƒ t w q w w mwš v ƒ. y t q ƒ x z r w w z j., 2000 w t ww t û w, k t y w 3 t w y z ƒ. (1) t w v : t š w w œ v y ƒ v wš, y w eƒ v w. w, œ ƒe w w j» w y œw w. w ƒ w ƒ w y w ƒe ƒ wš t p y w, ƒ 24 y wš ƒ e w wš s r yw w. š, ƒe w t k w œ œœ w w t, sƒ œ w v w» (,,» w) ƒ v w. (2) t m 1) ƒ t m : ù ƒ t, ù» mwš v w» v w. 2) q w t m : ù q t ( : j, q e ), x t ƒ w mw v ƒ. ÿw,» t q ƒ x, q ƒ t»., t Ÿ q š w» t ù t ƒ w t w m v w. (3) x w : x x t ù t yƒ w. p t ƒ ƒw x w eš q ƒ ƒ m y». t, t w x w. (4) t w sƒ : ƒ ƒ q t w e»z y k š xw. k ƒ q w» š w», t w w. ù, q z x w ƒ y t w sƒ y w ƒ y wš t ƒ y, sƒ mw y x ù t w w. w. 1) t p y w» w e : t w» e mw t sƒwš w v š, w w e e wù. ù v w š yw w e œ, ƒ z.

8 8 Kor. J. Clin. Pharm., Vol. 15, No. 2, 2005 t w e ù», ƒ ƒ ù y w» p wš n w w» y ù w t e w. w t w š ƒe w e» w,,. z,, w wwš w w, ƒ w. ù w e». t : t wš, z ù w ƒ t w., t x y t w. t e : t t w e(table 6) 19) w v w. t» : xw t» w ³ 4) t t ƒƒ». t : w w. Á :, k ( t w ) Á / z : z. p t w ƒ w. š, qz, x, t x wš, ƒ x s w w. Á» : ü Áy : xƒ w ü Á ƒ š : w t t» w w w ƒ w Table 6. Switch principles pharmacologic attributes consumer use and label comprehension 1. Does the switch candidate have special toxicity in its class? 2. Does the candidate have a large margin of safety? 3. Does the candidate s frequency of dosing affect its safe use? 4. Has the candidate s safety profile been defined at high dose? 5. Has the candidate been used for a sufficiently long time on the prescription market to enable a full characterization of its safety profile? 6. What is the worldwide marketing experience of the switch candidate? 7. What foreign countries market the candidate OTC? What is its experience in those countries? 8. What do the use data (from National Prescription Audit, the National Drug/Disease Audit, and/or other sources) show? 9. Has a vigorous risk analysis been performed? 10. Has the efficacy literature been reviewed in a way to support the expected usage and labeling of the switch candidate? 11. Is there a full understanding of the pharmacy-dynamics of the switch candidate? 12. Is the minimally effective dose for the proposed OTC indication known? 13. Have possible drug interactions for the switch candidate been characterized? Fundamentals 1. Can the candidate be adequately self-diagnosed? 2. Can the condition be successfully self-treated? 3. Is the self-treatment product safe and effective for consumer use, under conditions of actual use? Points to consider 1. Is there a need for physician evaluation of the condition? 2. What is the nature and severity of adverse effects of consumer misdiagnosis and delay in correct diagnosis? 3. Regarding effective product use, what is the nature of consumer understanding of product use? 4. What is the consumer understanding of the expected benefit? 5. Does the consumer have the ability to assess treatment effect? Safe Product Use 1. What is the consumer understanding of product directions for safe use? 2. What is the consumer understanding of what to do if the product isn Øt working? 3. What is the consumer ability to identify adverse effects, and the consumer ability to determine when adverse events may require professional care? 4. What is the consumer expectation of safety?

9 ù xw t w š 9 sƒ 2) t : t q z š z w sƒ ƒ y ù v w. w mw t».,»xƒ t sƒ, ù wwš ƒ (renewal) w v ƒ. q t x m z sƒ w t w xƒˆ z 5 w w w «, w t šw. 3) y( ) z z sƒ : w w», w z z sƒw w. ù, t t y y y, ƒ, y, ƒe r ùkù.,» t y, p t t yw, t ƒe» w z z w sƒ ƒ, ƒe t ƒ ù y y y w z w ñ ý». (5) y : x t ³ š š w., y w š y y, š mw sƒ w l wš, sƒ t sƒ y w w. š, t w l y w œ ƒe t y. ww Á r k w t w wš, t y t r w jš, w z š w t y» w» w t ƒ w ù w y š, w 5 ù s ƒw t ƒ w w w m w š w. û š wš r j, w t mw yw r yw e. k y y w» š, w ³ e» ƒ w. ƒ t yw» š t ƒ ƒ w w wš, y w t w w,. wr, / t xw 2 / / q 3 w,» š t rq, r w t p w ƒ z w w š. w» v wù(0405-po ) w w w w. š x 1. - t t xz. œ IMS data t» w³. š y, Pharmaceutical Administration and Regulations in Japan. Japan Pharmaceutical Manufacturers Association. March t e Changing the legal classification in the United Kingdom of a medicine for human use (MHRA Guidance Note 11) ( 8. Licensing of Medicines : Legal status and reclassification of medicines ( (Last updated : ) 9. Article on new reclassification process in MAIL 130 (March/April 2002): MCA News ( gov.uk)

10 10 Kor. J. Clin. Pharm., Vol. 15, No. 2, Andersson F, Hatziandreu E. The costs and benefits of switching a drug from prescription-only to over-the-counter status: a review of methodological issues and current evidence. Pharmacoeconomics Nov; 2(5): Maintaining your license: Renewals ( gov.uk/ourwork/licensingmeds/maintaining/renewals.htm) (Last updated : ) 12. MHRA : Contact us ( (Last updated : ) 13. Lowe NK, Ryan-Wenger NM. Over-the-counter medications and self-care. Nurse Pract Dec; 24(12): US FDA CDER Division of OTC Office of Drug Evaluation V Division of OTC - Who We Are, What We Do ( CFR Sec Additional criteria and procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded 16. A draft guidance for industry for TEA applications ( / 17. FDA CDER Postmarketing Surveillance Programs ( OTC ingredients table. World Self-Medication Industry ( 19. R. William Soller. Prescription-to-over-the-counter switch criteria. Drug Information Journal. 2002; 36:

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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