의약품 부작용에 관한 국제 분류체계인 WHO-ART와 …

1 17 1 . Kor. J. Clin. Pharm., Vol. 17, No. 1. 2007. WHO-ART meddra . a a a a a b b b a , b . Comparison of WHO-ART Versus meddra , Internationally Standardized Terminology of Adverse Drug Reaction Classification Kyung Hwa Lima, Hyun Taek Shina, Hyun Soon Sohna, Hyo Jung Juna, Joo Hyun Leea, In Sook Songb, Yoo Jung Leeb, and Young Sook Leeb a College of Pharmacy, bDrug Information Research Institute, Sookmyung Women's University, Seoul, Korea This study was aimed to provide the controlled terminology for adverse drug reactions by selecting an appropriate inter- nationally standardized classifications (WHO-ART or meddra ). We collected the relevant information on ADR termi- nology systems including WHO-ART and meddra by online searching and visiting pharmaceutical companies and WHO UMC (Uppsala Monitoring Centre, Uppsala, Sweden). For meddra , project leader directly communicated with the officer of MSSO (Maintenance and Support Services Organization).

2 Collecting all the pertinent information, two possible terminology classifications or systems (WHO-ART and meddra ) were compared in the views of acceptabil- ity, cost-effectiveness and international feasibility and reviewed by the consultation committee and finally WHO-ART. was selected. Key words Drug, ADR(Adverse Drug Reaction), Terminology, WHO-ART, meddra . (Post Marketing . Surveillance; PMS) 1975 , 1988 , . , 1995 , , , . , 2000 12 , . 2004 4 . 1994 World Health .1,2) , Organization Adverse Reaction Terminology( WHO- 2005 1,841 ART ) Medical 2001 2006 3,770 Dictionary for Regulatory Activities ( meddra ).. , . 10 , 1 .. 3,4).. 2003 37 , 2003 34,000 , WHO-ART . 17,000~18,000 meddra .. Correspondence to : WHO-ART . meddra , , . (140-742) 2 53-12 . meddra . Tel: 02-710-9575, Fax: 02-702-5728. E-mail: meddra . 46. 47. , meddra MSSO 2. WHO-ART meddra (Table 1). (Maintenance and Support Services Organization).

3 WHO-ART5-11). meddra (1) : Adverse reaction coding .. WHO UMC(Uppsala Monitor- (2) : WHO-ART 35 . ing Centre, ) UMC , . , 1990 .. VigiSearch', Vigibase onlin' WHO-ART , Uppsala Monitoring Center , , (UMC; WHO collaborating center for international drug WHO-ART . monitoring) (Preferred Terms; PT) . (WHO-ART meddra ) , (3) : UMC .. , .. , , , , . , , , (4) : WHO-ART 6 ( , , . , , , ) 79 . WHO .. (5) , : WHO-ART . 1.. (1) : 6 3 . ICH(International Conference on Harmonization) .. meddra (Preferred Terms) - . (System-Organ Class; SOC) version: WHO-ART . (Electronic reporting system) .. , (High level WHO Terms; HT) , . ADR WHO-ART (Included Terms;. meddra IT) .. (2) : , 1994 .. WHO-ART meddra .. WHO-ART , No. 2 No. 3 . (Table 2). (All terms) - : ' . , (IT), (PT) (HT) .. (Hierarchy) .. , , . , WHO .. (Table 3). , (ISO) (6) : (SOC) . (ISO TC/215) , , . (ISO#22224 - Electronic (Figure 1).

4 Reporting of Adverse Drug Reactions) (SOC) : .. 3 . 48 Kor. J. Clin. Pharm., Vol. 17, No. 1, 2007. Table 1. Comparison of WHO-ART versus meddra . WHO-ART meddra . Purpose to build up a coding method for adverse reaction to build up a medically validated medical terminology terminology for utilization throughout the regulatory process History since 1990 since 2002. Organization of WHO/WHO Uppsala Monitoring Center ICH/ meddra Maintenance and Support Service development & Organization maintenance Using country 79 WHO member countries US, European Union, Japan, Australia, Canada, New Zealand, Russian Federation, Singapore, South Korea, Taiwan Update Up-date every 3month Up-date every 6month Structure 4 level hierarchial & Multi-axial : 5 level hierarchial & Multi-axial : System-Organ Class(SOC) System Organ Class(SOC). High Level Terms(HT) High Level Group Terms(HLGT). Preferred Terms(PT) High Level Terms(HLT).

5 Included Terms(IT) Preferred Terms(PT). Lower Level Terms (LLT). Quantity of 8,024(2quarter, 2006) 65,857(version ). term Compatibility meddra WHO-ART, COSTART, ICD9-CM, ICD10-CM, HARTS, JART. Searching IT or PT HT and SOC LLT or PT HLT, HLGT and SOC. Access electronic file and paper version license database license, information periodical up-date Coding PT is designated a record number, in consecutive initial assignment in alphabetical order starting order according to introducing sequence with 10000001. sequence number of the PT is 001 assignment the next sequential number according record number of IT is same corresponding PT to new terms addition order HT is assigned from all relevant PT. Current using status several pharmaceutical companies 2~3 CROs, multi national pharmaceutical compa- in Korea nies Using fee reporting to government : free of charge government : free of charge paper version : 2,500 SEK/copy company : annual fee according to revenue electronic file : fee according to user, region, number of update Acceptability to Korea already using for reporting ADR in Korea more complex structure simpler structure and more convenient than meddra company has to use charged core service reporting to government is free of charge.

6 (7) : 2006 2 32 . (HT) : 251 , 2,938 4,803 . , . 8,024 . (Thrombophlebitis leg) (Thrombophlebitis (8) : ICH meddra . arm) , UMC meddra . (Thrombophlebitis) .. WHO WHO adverse reaction report . (PT) : meddra WHO-ART , . ICH WHO-ART . (IT) : . , .. 49. Table 2. WHO-ART system organ class version. Table 4. Coding method of WHO-ART. Table 3. WHO-ART alphabetical version.. (13) : . UMC . 2006 . 1 , 1 . 2,500 SEK (327,500 , 1 SEK=131 KRW ) .. (Electronic file) , . , A50, A42, A38, A13 .. 3 .. (14) : WHO-ART ADR . , meddra . (9) : , , .. , . 2 .. MedDRA12-22). (10) : ( (1) : ICH . org) UMC products & services . , .. National Pharmcovigilance Center (2) : 1990 , , . ( ) ICH . , 1994 meddra 1999 .. 3 1 meddra version . (11) : (Sequential number) (3) : ICH meddra .. MSSO . MSSO ICH IFPMA. 001 002 (International Federation of Pharmaceutical Manufacturers . (RECNO) and Associations) meddra .

7 WHO-ART meddra , . (4) : , , , , , .. ARECNO(Adverse Reaction Record , , , , . Number) . (HL Link) (5) , : MSSO . (Table 4). (3 , 9 ) , . (12) : WHO-ART 2006 9 . meddra MSSO . 92 94 , 48 . 50 Kor. J. Clin. Pharm., Vol. 17, No. 1, 2007.. (High Level Terms-HLT) : . , , , . , (Categorization) .. , .. (Preferred Terms-PT) : , , , . Fig. 1. 4 level hierarchial structure of WHO-ART. , , , , .. , (International medical team) 7 .. ( Lower Level Terms-LLT) : . (6) : meddra (Hierarchical . (LLT) . terminology) SOC , HLGT (PT) . (High-Level Group Terms - ), HLT(High- (7) : 2006 1 Version . Level Terms - ), PT(Preferred Terms- ), 26 , 332 , 1,682 , . LLT(Lower-Level Terms- ) 17,320 , 46,497 65,857 . (Figure 2).. (System Organ Class-SOC) : (8) : meddra ASCII (sets) . ( : SOC Infections and infestations), . ( : SOC Gastrointestinal disorder), ( : SOC . , WHO-ART, COSTART(Coding Symbols for Surgical and medical procedures).)

8 Thesaurus od Adverse Reaction Terminology), ICD9- (HGLT) CM(International Classification of Diseases ninth revision - . Clinical Modification)code, ICD10_CM(International Classifica- (High Level Group Terms-HLGT) : tion of Diseases tenth revision - Clinical Modification)code, , , HARTS(Hoechst Adverse Reaction Terminology System), , JART(Japan Adverse Reaction Terminology) .. (9) : meddra Browser .. , , .. (Multi-axial) .. (10) : ( com) .. license . , . on-line, off-line . Pharm- aceutical companies, CROs(Contract Research Organizations), Biotechnology companies, System developers, Device manufacturers, Support service organizations, . Fig. 2. 5 level hierarchial structure of meddra . (Regulatory authorities) (license) . 51.. (11) : meddra 8 , .. , . (Electronic submission type) .. 10000001 , . , . ICH . (12) : CRO 2~3 license meddra WHO-ART . , . meddra , meddra .. (13) : meddra ICH IFPMA.

9 MSSO 2006 .. , . (Revenue; - ) . (Annual fee) license .. 30 . (14) : 1. ( . Core service , 2004-30 2004. ).. 2. ( 26 2 , . 10 ~100 Core 0~1 26 3 ). 765,000 1,576,000 3. Jason L, Bruce Paul N. Incidence of adverse 100 ~5,000 Core 2 8,104,000 drug reaction in hospitalized patient. JAMA 1998; 279; 15: . 1200-1205. 4. Pirmohamed M, James S, Meakin S, GreenC, Scott Adverse drug reaction as cause of admission to hospital, prospective analysis of 18820 patients. BMJ 2004; 329: 15-19. 5. ( ). (WHO-ART 6. ( ). meddra ) . 7. WHO ( ). 8. WHO annual report 2005. 9. Heater Sherman. Project to develop the international patient WHO-ART . safety event taxonomy. Updated review of the literature WHO-ART 2006 2 2003-2005. 8,024 . WHO-ART 10. Johanna Strandell, Uppsala Monitoring Center. Signal , , detection and analysis. 11. Cecilia Biriell, Uppsala Monitoring Center. Terminologies . WHO-ART for coding of adverse reaction and diseases.

10 , 12. ( 15.). , 13. ( ). 14. (2006. WHO ). 15. ( ). 16. (2006.. ). WHO-ART 17. meddra data retrieval and presentation points to con- 52 Kor. J. Clin. Pharm., Vol. 17, No. 1, 2007. sider, release based on meddra version , 28 March Guide meddra version , March 2006. 2006. 21. Dr. Odette Morin, meddra current status and future per- 18. Fang Dong, pfizer global research and development. Data spectives, the 4th conference of APEC network on phar- extraction & meddra , a SAS coding shortcut. maceutical regulatory science, 2004. 19. What's new meddra terminology version , meddra 22. Data quality, coding and meddra , , MSSO, March 2006. 2004. 20. Medical Dictionary for Regulatory Activities. Introductory