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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
ISSN 1726 4898ISBN 978 82 8082 525 4Suggested citation WHO Collaborating Centre for Drug Statistics MethodologyGuidelines for ATC classification and DDD assignment 2013 Oslo 2012WHO Collaborating Centre for Drug Statistics Methodology Oslo NorwayUse of all or parts of the material requires reference to the WHO CollaboratingCentre for Drug Statistics Methodology Copying and distribution for commercialpurposes is not allowed Changing or manipulating the material is not allowedGuidelines forATC classificationand DDD assignment16th editionWHO Collaborating Centre for Drug Statistics MethodologyNorwegian Institute of Public HealthP O Box 4404 NydalenN 0403 OsloTelephone 47 21078160Telefax 47 21078146E mail whocc fhi noWebsite www whocc noPrevious editions1990 Guidelines for ATC classification11991 Guidelines for DDD11993 Guidelines for ATC classification1993 Guidelines for DDD1996 Guidelines for ATC classification and DDD assignment1998 Guidelines for ATC classification and DDD assignment2000 Guidelines for ATC classification and DDD assignment2001 Guidelines for ATC classification and DDD assignment2002 Guidelines for ATC classification and DDD assignment2003 Guidelines for ATC classification and DDD assignment2004 Guidelines for ATC classification and DDD assignment2005 Guidelines for ATC classification and DDD assignment2006 Guidelines for ATC classification and DDD assignment2007 Guidelines for ATC classification and DDD assignment2008 Guidelines for ATC classification and DDD assignment2009 Guidelines for ATC classification and DDD assignment2010 Guidelines for ATC classification and DDD assignment2011 Guidelines for ATC classification and DDD assignment2012 Guidelines for ATC classification and DDD assignment1 A co publication between the WHO Collaborating Centre for Drug Statistics Methodology and the NordicCouncil on MedicinesThe Anatomical Therapeutic Chemical ATC classification system and the DefinedDaily Dose DDD as a measuring unit are recommended by the WHO for drugutilization studies The system is widely used internationally and the number of usersis increasing The purpose of preparing guidelines is to make information about theATC DDD system available to the usersThe members of the WHO International Working Group for Drug StatisticsMethodology have given expert advice and comments on the work with theseguidelinesThis edition of the Guidelines for ATC classification and DDD assignment is basedon the ATC classification index with DDDs valid from January 2013The guidelines consist of a general part including information about the proceduresand data requirements for ATC DDD assignment and alterations The second part ofthe publication the interpretative guidelines describes the different ATC levels downto the 4th level These guidelines should be consulted whenever the ATC DDDsystem is used for drug utilisation research They describe particular issues whichhave been discussed and resolved by consensus of the Working GroupThe Guidelines and the ATC index with DDDs are updated annually Bothpublications can be ordered as paper copies English or Spanish versions from theCentre order form see Annex II A searchable version of the ATC DDD indexlinked to the text from the Guidelines is available on the website www whocc noATC DDD indexWe hope this book will prove helpful to the users of the ATC DDD systemSuggested improvements can be addressed to the WHO Centre in OsloOslo December 2012Hanne Str mWHO Collaborating Centre for Drug Statistics MethodologyNorwegian Institute of Public HealthStaff of the CentreChristian Berg MScPharm MPHHege Salvesen Blix MScPharm PhDIrene Litleskare MScPharmMarit R nning MScPharmSolveig Sakshaug MScPharmHanne Str m MScPharmTove Granum secretarySiv Gald Ullereng secretaryTABLE OF CONTENTSI Introduction 10A History of the ATC DDD system 10B Present Organisational responsibility for the ATC DDD system 111 WHO Collaborating Centre for Drug Statistics Methodology 112 WHO International Working Group for Drug StatisticsMethodology 12C The purpose of the ATC DDD system 14II The anatomical therapeutic chemical ATC classification system 15A Structure and nomenclature 15B Inclusion and exclusion criteria 16C Principles for classification 161 General Principles 162 Classification of plain products 183 Classification of combination products 19D Principles for changes to ATC classification 20E The EphMRA classification system 21III DDD Defined Daily Dose 22A Definition and general considerations 22B Principles for DDD assignment 231 Plain products 232 Combination products 253 Other factors 26a Fixed dose groups 26b Depot formulations 26c Intermittent dosing 26d Duration of treatment 274 Selection of units 27C Pediatric DDD 28D Principles for reviewing and changing DDD 29E Description of other drug utilization metrics 30IV Use and misuse of the ATC DDD system 31A Drug utilization 33B Improving drug use 35C Drug Safety Assessment 35D Double medication and pseudo double medication 36E Drug catalogues 36F Drug costs pricing and reimbursement and cost containment 37G Pharmaceutical marketing purposes 37V Procedures and data requirements for ATC DDD assignment andalterations 38A Requests for ATC classification 381 Procedures and timing 382 Data requirements for submission 40B Requests for changes to ATC classifications 411 Procedures and timing 412 Data requirements for submission 42C Requests for DDD assignment 421 Procedures and timing 422 Data requirements for submission 44D Requests for changes to DDDs 441 Procedures and timing 442 Data requirements for submission 44VI Description of ATC index with DDDs 45VII Other ATC classification systems 46A ATCvet classification 46B ATC herbal classification 46VIII ATC DDD interpretative guidelines 47ATC system main groups 48A Alimentary tract and metabolism 49B Blood and blood forming organs 83C Cardiovascular system 95D Dermatologicals 123G Genito urinary system and sex hormones 141H Systemic hormonal preparations excl Sex hormones and insulins 157J Antiinfectives for systemic use 165L Antineoplastic and immunomodulating agents 185M Musculo skeletal system 193N Nervous system 203P Antiparasitic products insecticides and repellents 225R Respiratory system 233S Sensory organs 247V Various 257List of terms 273Application form for new ATC codes and DDDs Annex IOrder form ATC DDD publications Annex III INTRODUCTIONA History of the ATC DDD systemThe field of drug utilization research has attracted increasing interest since itsinfancy in the 1960s The pioneering work was done by two consultants at theWHO Regional Office for Europe Engel and Siderius The consumption of drugsreport of a study 1966 1967 WHO regional Office for Europe 1968 Their studyof drug consumption in six European countries during the period 1966 1967showed great differences in drug utilization between population groups This studywas followed by a symposium in Oslo in 1969 entitled The Consumption of Drugsorganised by the WHO Regional Office for Europe It was agreed at thissymposium that an internationally accepted classification system for drugconsumption studies was needed It was also at this symposium that the DrugUtilization Research Group DURG was established and tasked with thedevelopment of internationally applicable methods for drug utilization researchBy modifying and extending the European Pharmaceutical Market ResearchAssociation EphMRA classification system Norwegian researchers developed asystem known as the Anatomical Therapeutic Chemical ATC classificationIn order to measure drug use it is important to have both a classification systemand a unit of measurement To deal with the objections against traditional units ofmeasurement a technical unit of measurement called the Defined Daily DoseDDD to be used in drug utilization studies was developedThe Nordic Council on Medicines NLN established in 1975 collaborated withNorwegian researchers to further develop the ATC DDD system The NLNpublished the Nordic Statistics on Medicines using the ATC DDD methodology forthe first time in 1976 Since then the interest in the ATC DDD system hasB Present Organisational responsibility for the ATC DDD1 WHO Collaborating Centre for Drug Statistics MethodologyIn 1981 the WHO Regional Office for Europe recommended the ATC DDDsystem for international drug utilization studies In connection with this and tomake the methodology more widely used there was a need for a central bodyresponsible for coordinating the use of the methodology The WHO CollaboratingCentre for Drug Statistics Methodology was accordingly established in Oslo in1982 The Centre was until 2001 situated at the Norwegian Medicinal DepotNMD From January 2002 the Centre has been located at the Norwegian Instituteof Public Health The Centre is funded by the Norwegian governmentIn 1996 WHO recognized the need to develop use of the ATC DDD system as aninternational standard for drug utilization studies The Centre was therefore linkeddirectly to WHO Headquarters in Geneva instead of the WHO Regional Office forEurope in Copenhagen This was seen as important to allow close integration ofinternational drug utilization studies and WHO s initiatives to achieve universalaccess to needed drugs and rational use of drugs particularly in developingcountries Access to standardised and validated information on drug use is essentialto allow audit of patterns of drug utilization identification of problems educationalor other interventions and monitoring of the outcomes of the interventionsThe first agreement was drawn up by WHO Headquarters with the Government ofNorway in 1996 The latest redesignation of the Department ofPharmacoepidemiology Norwegian Institute of Public Health as a WHOCollaborating Centre for Drug Statistics Methodology was in May 2012According to this Agreement all activities related to ATC DDD classification haveto be conducted in accordance with policies determined by WHOThe main activities of the Centre are development and maintenance of theATC DDD system includingTo classify drugs according to the ATC systemTo establish DDDs for drugs which have been assigned an ATC codeTo review and revise as necessary the ATC classification system and DDDsTo stimulate and influence the practical use of the ATC system by cooperatingwith researchers in the drug utilization fieldTo organize training courses in the ATC DDD methodology and to lecture suchcourses and seminars organized by othersTo provide technical support to countries in setting up their national medicinesclassification systems and build capacity in the use of medicines consumptioninformation2 WHO International Working Group for Drug Statistics MethodologyIn 1996 when the decision on globalizing the ATC DDD system was taken theWHO Division of Drug Management and Policies established the WHOInternational Working Group for Drug Statistics Methodology The InternationalWorking Group comprises 12 members drawn from the WHO Expert AdvisoryPanels for Drug Evaluation and for Drug Policies and Management TheInternational Working Group members are selected by WHO Headquarters torepresent a wide range of geographical and professional backgrounds includingclinical pharmacology clinical medicine international public health drugutilization and drug regulation The members of the International Working Grouprepresent different users of the ATC DDD system and different nationalities as theyrepresent the 6 WHO global regions The WHO Collaborating Centre for DrugStatistics Methodology receives expert advice from the Working GroupThe main terms of reference of the Working Group areTo continue the scientific development of the ATC DDD systemTo discuss and approve all new ATC codes DDD assignments and alterations toexisting ATC codes and DDDsTo develop further the use of the ATC DDD system as an international standardfor drug utilization studiesTo revise as necessary the guidelines for assignment and change of ATC codesTo revise as necessary the procedures for applications for assignment of andchanges to ATC codes and DDDs to ensure they are consistent and transparentTo assess the sources and availability of statistics on drug use internationally andto encourage the systematic collection of comprehensive drug use statistics in allcountries and regions using the ATC DDD system as the international standardTo develop methods manuals and guidelines for the practical application andappropriate use of the ATC DDD system in drug utilization studies in a variety ofsettings particularly those applicable to developing countriesTo work with groups involved in rational drug use initiatives to integratemethods for measurement of drug use in assessing needs and outcomes ofinterventions with the aim of improving drug useThe International Working Group meets twice annually A teleconference mayreplace one of the two annual meetingsMeetings of the International Working Group are private and members are requiredto complete a WHO declaration of interest form before the meeting Observersfrom the WHO Collaborating Centre for International Drug Monitoring the WHOCollaborating Centre for Drug Utilization Research Clinical PharmacologicalServices and the International Federation of Pharmaceutical ManufacturersAssociation are also invited to attend the meetings of the International WorkingAn open session is held prior to one of the meetings to which any interested partycan register see further information below Decision making parts of meetings ofthe International Working Group will continue to be held in privateDecisions on ATC classification or DDD assignment are published on the websiteof the WHO Collaborating Centre for Drug Statistics Methodology and in thepublication WHO Drug Information Any decision on a new or revised ATCclassification or DDD assignment is first published as temporary Any interestedparty wishing to dispute this decision is invited to comment within a specifieddeadline after its publication If there are no objections to a temporary decisionthen it will be published as a final decision and implemented in the next issue of theATC classification index with DDDs If there is an objection then the decision willbe reconsidered at the next meeting of the International Working Group If a newdecision is taken at the second meeting the new decision will be published astemporary and will be open to comments similar to the first decision WHO has thefinal responsibility for any decisions to be taken and any dispute arising in thecourse of this work must be referred to WHO for final resolutionOpen SessionThe open session is held once a year in connection with the meeting of the WHOInternational Working Group for Drug Statistics Methodology It is held in theinterest of transparency and consists of one hour and a half prior to the closeddecision making session of the meetingIt is open to anyone with a legitimate interest in the Anatomical TherapeuticChemical ATC classification system and Defined Daily Dose DDD assignmentThis includes regulatory authorities the pharmaceutical industry academia andnon governmental organisationsIt provides an opportunity for these persons to present additional information to theexperts to assist them in their decision makingIt provides an opportunity for the international experts of the Working Group toexchange ideas and opinions with interested partiesIt is not intended to be used as a mechanism to challenge the decision of theWorking Group The procedures for applying for and commenting on an ATCclassification or a DDD assignment are outlined in these Guidelines see section VInterested parties are requested to register for this session to WHO Headquarter atleast 14 days in advance of the meeting and are requested to provide a relevantreason for attending WHO Headquarter will restrict the time allowed for eachpresentation in order to keep the duration of the open session within 1 5 hoursInformation on these meetings will be made available on the WHO website atwww who int medicinesC The purpose of the ATC DDD systemThe purpose of the ATC DDD system is to serve as a tool for drug utilizationresearch in order to improve quality of drug use One component of this is thepresentation and comparison of drug consumption statistics at international andother levelsA major aim of the Centre and Working Group is to maintain stable ATC codes andDDDs over time to allow trends in drug consumption to be studied without thecomplication of frequent changes to the system There is a strong reluctance tomake changes to classifications or DDDs where such changes are requested forreasons not directly related to drug consumption studies For this reason theATC DDD system by itself is not suitable for guiding decisions aboutreimbursement pricing and therapeutic substitutionThe classification of a substance in the ATC DDD system is not arecommendation for use nor does it imply any judgements about efficacy orrelative efficacy of drugs and groups of drugsII THE ANATOMICAL THERAPEUTIC CHEMICAL ATCCLASSIFICATION SYSTEMA Structure and nomenclatureIn the Anatomical Therapeutic Chemical ATC classification system the activesubstances are divided into different groups according to the organ or system onwhich they act and their therapeutic pharmacological and chemical propertiesDrugs are classified in groups at five different levels The drugs are divided intofourteen main groups 1st level with pharmacological therapeutic subgroups 2ndlevel The 3rd and 4th levels are chemical pharmacological therapeutic subgroupsand the 5th level is the chemical substance The 2nd 3rd and 4th levels are oftenused to identify pharmacological subgroups when that is considered moreappropriate than therapeutic or chemical subgroupsThe complete classification of metformin illustrates the structure of the codeA Alimentary tract and metabolism1st level anatomical main groupA10 Drugs used in diabetes2nd level therapeutic subgroupA10B Blood glucose lowering drugs excl insulins3rd level pharmacological subgroupA10BA Biguanides4th level chemical subgroupA10BA02 metformin5th level chemical substanceThus in the ATC system all plain metformin preparations are given the codeNomenclatureInternational nonproprietary names INN are preferred If INN names are notassigned USAN United States Adopted Name or BAN British ApprovedName names are usually chosenWHO s list of drug terms Pharmacological action and therapeutic use of drugsList of Terms is used when naming the different ATC levels
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