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ISSN 1726 4898,ISBN 978 82 8082 525 4, Suggested citation WHO Collaborating Centre for Drug Statistics Methodology. Guidelines for ATC classification and DDD assignment 2013 Oslo 2012. WHO Collaborating Centre for Drug Statistics Methodology Oslo Norway. Use of all or parts of the material requires reference to the WHO Collaborating. Centre for Drug Statistics Methodology Copying and distribution for commercial. purposes is not allowed Changing or manipulating the material is not allowed. Guidelines for,ATC classification,and DDD assignment. 16th edition, WHO Collaborating Centre for Drug Statistics Methodology. Norwegian Institute of Public Health,P O Box 4404 Nydalen. N 0403 Oslo,Telephone 47 21078160,Telefax 47 21078146. E mail whocc fhi no,Website www whocc no,Previous editions. 1990 Guidelines for ATC classification1,1991 Guidelines for DDD1. 1993 Guidelines for ATC classification,1993 Guidelines for DDD. 1996 Guidelines for ATC classification and DDD assignment. 1998 Guidelines for ATC classification and DDD assignment. 2000 Guidelines for ATC classification and DDD assignment. 2001 Guidelines for ATC classification and DDD assignment. 2002 Guidelines for ATC classification and DDD assignment. 2003 Guidelines for ATC classification and DDD assignment. 2004 Guidelines for ATC classification and DDD assignment. 2005 Guidelines for ATC classification and DDD assignment. 2006 Guidelines for ATC classification and DDD assignment. 2007 Guidelines for ATC classification and DDD assignment. 2008 Guidelines for ATC classification and DDD assignment. 2009 Guidelines for ATC classification and DDD assignment. 2010 Guidelines for ATC classification and DDD assignment. 2011 Guidelines for ATC classification and DDD assignment. 2012 Guidelines for ATC classification and DDD assignment. 1 A co publication between the WHO Collaborating Centre for Drug Statistics Methodology and the Nordic. Council on Medicines, The Anatomical Therapeutic Chemical ATC classification system and the Defined. Daily Dose DDD as a measuring unit are recommended by the WHO for drug. utilization studies The system is widely used internationally and the number of users. is increasing The purpose of preparing guidelines is to make information about the. ATC DDD system available to the users, The members of the WHO International Working Group for Drug Statistics. Methodology have given expert advice and comments on the work with these. guidelines, This edition of the Guidelines for ATC classification and DDD assignment is based. on the ATC classification index with DDDs valid from January 2013. The guidelines consist of a general part including information about the procedures. and data requirements for ATC DDD assignment and alterations The second part of. the publication the interpretative guidelines describes the different ATC levels down. to the 4th level These guidelines should be consulted whenever the ATC DDD. system is used for drug utilisation research They describe particular issues which. have been discussed and resolved by consensus of the Working Group. The Guidelines and the ATC index with DDDs are updated annually Both. publications can be ordered as paper copies English or Spanish versions from the. Centre order form see Annex II A searchable version of the ATC DDD index. linked to the text from the Guidelines is available on the website www whocc no. ATC DDD index, We hope this book will prove helpful to the users of the ATC DDD system. Suggested improvements can be addressed to the WHO Centre in Oslo. Oslo December 2012,Hanne Str m, WHO Collaborating Centre for Drug Statistics Methodology. Norwegian Institute of Public Health,Staff of the Centre. Christian Berg MScPharm MPH,Hege Salvesen Blix MScPharm PhD. Irene Litleskare MScPharm,Marit R nning MScPharm,Solveig Sakshaug MScPharm. Hanne Str m MScPharm,Tove Granum secretary,Siv Gald Ullereng secretary. TABLE OF CONTENTS,I Introduction 10,A History of the ATC DDD system 10. B Present Organisational responsibility for the ATC DDD system 11. 1 WHO Collaborating Centre for Drug Statistics Methodology 11. 2 WHO International Working Group for Drug Statistics. Methodology 12,C The purpose of the ATC DDD system 14. II The anatomical therapeutic chemical ATC classification system 15. A Structure and nomenclature 15,B Inclusion and exclusion criteria 16. C Principles for classification 16,1 General Principles 16. 2 Classification of plain products 18,3 Classification of combination products 19. D Principles for changes to ATC classification 20,E The EphMRA classification system 21. III DDD Defined Daily Dose 22,A Definition and general considerations 22. B Principles for DDD assignment 23,1 Plain products 23. 2 Combination products 25,3 Other factors 26,a Fixed dose groups 26. b Depot formulations 26,c Intermittent dosing 26,d Duration of treatment 27. 4 Selection of units 27,C Pediatric DDD 28,D Principles for reviewing and changing DDD 29. E Description of other drug utilization metrics 30. IV Use and misuse of the ATC DDD system 31,A Drug utilization 33. B Improving drug use 35,C Drug Safety Assessment 35. D Double medication and pseudo double medication 36. E Drug catalogues 36, F Drug costs pricing and reimbursement and cost containment 37. G Pharmaceutical marketing purposes 37, V Procedures and data requirements for ATC DDD assignment and. alterations 38,A Requests for ATC classification 38. 1 Procedures and timing 38,2 Data requirements for submission 40. B Requests for changes to ATC classifications 41,1 Procedures and timing 41. 2 Data requirements for submission 42,C Requests for DDD assignment 42. 1 Procedures and timing 42,2 Data requirements for submission 44. D Requests for changes to DDDs 44,1 Procedures and timing 44. 2 Data requirements for submission 44,VI Description of ATC index with DDDs 45. VII Other ATC classification systems 46,A ATCvet classification 46. B ATC herbal classification 46,VIII ATC DDD interpretative guidelines 47. ATC system main groups 48,A Alimentary tract and metabolism 49. B Blood and blood forming organs 83,C Cardiovascular system 95. D Dermatologicals 123,G Genito urinary system and sex hormones 141. H Systemic hormonal preparations excl Sex hormones and insulins 157. J Antiinfectives for systemic use 165,L Antineoplastic and immunomodulating agents 185. M Musculo skeletal system 193,N Nervous system 203. P Antiparasitic products insecticides and repellents 225. R Respiratory system 233,S Sensory organs 247,V Various 257. List of terms 273, Application form for new ATC codes and DDDs Annex I. Order form ATC DDD publications Annex II,I INTRODUCTION. A History of the ATC DDD system, The field of drug utilization research has attracted increasing interest since its. infancy in the 1960s The pioneering work was done by two consultants at the. WHO Regional Office for Europe Engel and Siderius The consumption of drugs. report of a study 1966 1967 WHO regional Office for Europe 1968 Their study. of drug consumption in six European countries during the period 1966 1967. showed great differences in drug utilization between population groups This study. was followed by a symposium in Oslo in 1969 entitled The Consumption of Drugs. organised by the WHO Regional Office for Europe It was agreed at this. symposium that an internationally accepted classification system for drug. consumption studies was needed It was also at this symposium that the Drug. Utilization Research Group DURG was established and tasked with the. development of internationally applicable methods for drug utilization research. By modifying and extending the European Pharmaceutical Market Research. Association EphMRA classification system Norwegian researchers developed a. system known as the Anatomical Therapeutic Chemical ATC classification. In order to measure drug use it is important to have both a classification system. and a unit of measurement To deal with the objections against traditional units of. measurement a technical unit of measurement called the Defined Daily Dose. DDD to be used in drug utilization studies was developed. The Nordic Council on Medicines NLN established in 1975 collaborated with. Norwegian researchers to further develop the ATC DDD system The NLN. published the Nordic Statistics on Medicines using the ATC DDD methodology for. the first time in 1976 Since then the interest in the ATC DDD system has. B Present Organisational responsibility for the ATC DDD. 1 WHO Collaborating Centre for Drug Statistics Methodology. In 1981 the WHO Regional Office for Europe recommended the ATC DDD. system for international drug utilization studies In connection with this and to. make the methodology more widely used there was a need for a central body. responsible for coordinating the use of the methodology The WHO Collaborating. Centre for Drug Statistics Methodology was accordingly established in Oslo in. 1982 The Centre was until 2001 situated at the Norwegian Medicinal Depot. NMD From January 2002 the Centre has been located at the Norwegian Institute. of Public Health The Centre is funded by the Norwegian government. In 1996 WHO recognized the need to develop use of the ATC DDD system as an. international standard for drug utilization studies The Centre was therefore linked. directly to WHO Headquarters in Geneva instead of the WHO Regional Office for. Europe in Copenhagen This was seen as important to allow close integration of. international drug utilization studies and WHO s initiatives to achieve universal. access to needed drugs and rational use of drugs particularly in developing. countries Access to standardised and validated information on drug use is essential. to allow audit of patterns of drug utilization identification of problems educational. or other interventions and monitoring of the outcomes of the interventions. The first agreement was drawn up by WHO Headquarters with the Government of. Norway in 1996 The latest redesignation of the Department of. Pharmacoepidemiology Norwegian Institute of Public Health as a WHO. Collaborating Centre for Drug Statistics Methodology was in May 2012. According to this Agreement all activities related to ATC DDD classification have. to be conducted in accordance with policies determined by WHO. The main activities of the Centre are development and maintenance of the. ATC DDD system including,To classify drugs according to the ATC system. To establish DDDs for drugs which have been assigned an ATC code. To review and revise as necessary the ATC classification system and DDDs. To stimulate and influence the practical use of the ATC system by cooperating. with researchers in the drug utilization field, To organize training courses in the ATC DDD methodology and to lecture such. courses and seminars organized by others, To provide technical support to countries in setting up their national medicines. classification systems and build capacity in the use of medicines consumption. information, 2 WHO International Working Group for Drug Statistics Methodology. In 1996 when the decision on globalizing the ATC DDD system was taken the. WHO Division of Drug Management and Policies established the WHO. International Working Group for Drug Statistics Methodology The International. Working Group comprises 12 members drawn from the WHO Expert Advisory. Panels for Drug Evaluation and for Drug Policies and Management The. International Working Group members are selected by WHO Headquarters to. represent a wide range of geographical and professional backgrounds including. clinical pharmacology clinical medicine international public health drug. utilization and drug regulation The members of the International Working Group. represent different users of the ATC DDD system and different nationalities as they. represent the 6 WHO global regions The WHO Collaborating Centre for Drug. Statistics Methodology receives expert advice from the Working Group. The main terms of reference of the Working Group are. To continue the scientific development of the ATC DDD system. To discuss and approve all new ATC codes DDD assignments and alterations to. existing ATC codes and DDDs, To develop further the use of the ATC DDD system as an international standard. for drug utilization studies, To revise as necessary the guidelines for assignment and change of ATC codes. To revise as necessary the procedures for applications for assignment of and. changes to ATC codes and DDDs to ensure they are consistent and transparent. To assess the sources and availability of statistics on drug use internationally and. to encourage the systematic collection of comprehensive drug use statistics in all. countries and regions using the ATC DDD system as the international standard. To develop methods manuals and guidelines for the practical application and. appropriate use of the ATC DDD system in drug utilization studies in a variety of. settings particularly those applicable to developing countries. To work with groups involved in rational drug use initiatives to integrate. methods for measurement of drug use in assessing needs and outcomes of. interventions with the aim of improving drug use, The International Working Group meets twice annually A teleconference may. replace one of the two annual meetings, Meetings of the International Working Group are private and members are required. to complete a WHO declaration of interest form before the meeting Observers. from the WHO Collaborating Centre for International Drug Monitoring the WHO. Collaborating Centre for Drug Utilization Research Clinical Pharmacological. Services and the International Federation of Pharmaceutical Manufacturers. Association are also invited to attend the meetings of the International Working. An open session is held prior to one of the meetings to which any interested party. can register see further information below Decision making parts of meetings of. the International Working Group will continue to be held in private. Decisions on ATC classification or DDD assignment are published on the website. of the WHO Collaborating Centre for Drug Statistics Methodology and in the. publication WHO Drug Information Any decision on a new or revised ATC. classification or DDD assignment is first published as temporary Any interested. party wishing to dispute this decision is invited to comment within a specified. deadline after its publication If there are no objections to a temporary decision. then it will be published as a final decision and implemented in the next issue of the. ATC classification index with DDDs If there is an objection then the decision will. be reconsidered at the next meeting of the International Working Group If a new. decision is taken at the second meeting the new decision will be published as. temporary and will be open to comments similar to the first decision WHO has the. final responsibility for any decisions to be taken and any dispute arising in the. course of this work must be referred to WHO for final resolution. Open Session, The open session is held once a year in connection with the meeting of the WHO. International Working Group for Drug Statistics Methodology It is held in the. interest of transparency and consists of one hour and a half prior to the closed. decision making session of the meeting, It is open to anyone with a legitimate interest in the Anatomical Therapeutic. Chemical ATC classification system and Defined Daily Dose DDD assignment. This includes regulatory authorities the pharmaceutical industry academia and. non governmental organisations, It provides an opportunity for these persons to present additional information to the. experts to assist them in their decision making, It provides an opportunity for the international experts of the Working Group to. exchange ideas and opinions with interested parties. It is not intended to be used as a mechanism to challenge the decision of the. Working Group The procedures for applying for and commenting on an ATC. classification or a DDD assignment are outlined in these Guidelines see section V. Interested parties are requested to register for this session to WHO Headquarter at. least 14 days in advance of the meeting and are requested to provide a relevant. reason for attending WHO Headquarter will restrict the time allowed for each. presentation in order to keep the duration of the open session within 1 5 hours. Information on these meetings will be made available on the WHO website at. www who int medicines,C The purpose of the ATC DDD system. The purpose of the ATC DDD system is to serve as a tool for drug utilization. research in order to improve quality of drug use One component of this is the. presentation and comparison of drug consumption statistics at international and. other levels, A major aim of the Centre and Working Group is to maintain stable ATC codes and. DDDs over time to allow trends in drug consumption to be studied without the. complication of frequent changes to the system There is a strong reluctance to. make changes to classifications or DDDs where such changes are requested for. reasons not directly related to drug consumption studies For this reason the. ATC DDD system by itself is not suitable for guiding decisions about. reimbursement pricing and therapeutic substitution. The classification of a substance in the ATC DDD system is not a. recommendation for use nor does it imply any judgements about efficacy or. relative efficacy of drugs and groups of drugs,II THE ANATOMICAL THERAPEUTIC CHEMICAL ATC. CLASSIFICATION SYSTEM,A Structure and nomenclature. In the Anatomical Therapeutic Chemical ATC classification system the active. substances are divided into different groups according to the organ or system on. which they act and their therapeutic pharmacological and chemical properties. Drugs are classified in groups at five different levels The drugs are divided into. fourteen main groups 1st level with pharmacological therapeutic subgroups 2nd. level The 3rd and 4th levels are chemical pharmacological therapeutic subgroups. and the 5th level is the chemical substance The 2nd 3rd and 4th levels are often. used to identify pharmacological subgroups when that is considered more. appropriate than therapeutic or chemical subgroups. The complete classification of metformin illustrates the structure of the code. A Alimentary tract and metabolism,1st level anatomical main group. A10 Drugs used in diabetes,2nd level therapeutic subgroup. A10B Blood glucose lowering drugs excl insulins,3rd level pharmacological subgroup. A10BA Biguanides,4th level chemical subgroup,A10BA02 metformin. 5th level chemical substance, Thus in the ATC system all plain metformin preparations are given the code. Nomenclature, International nonproprietary names INN are preferred If INN names are not. assigned USAN United States Adopted Name or BAN British Approved. Name names are usually chosen, WHO s list of drug terms Pharmacological action and therapeutic use of drugs. List of Terms is used when naming the different ATC levels.
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