Guidelines for Guidelines for ATC and DDD ATC Guidelines for ATC classifi cation and DDD assignment 2011 2011 WHO Collaborating Centre for Drug Statistics Methodology Visiting address: Norwegian Institute of Public Health Marcus Thranes gate 6, 0473 Oslo, Norway P.O.Box 4404 Nydalen Tel: + 47 21 07 81 60 WHO Collaborating Centre for 0403 Oslo Fax: + 47 21 07 81 46 Drug Statistics Methodology Norway E-mail: [email protected] Guidelines for ATC classification and DDD assignment 2011 ISSN 1726-4898 ISBN 978-82-8082-438-7 Suggested citation: WHO Collaborating Centre for Drug Statistics Methodology, Guidelines for ATC classification and DDD assignment 2011. Oslo, 2010. © Copyright 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 14th edition WHO Collaborating Centre for Drug Statistics Methodology Norwegian Institute of Public Health P.O.Box 4404 Nydalen N-0403 Oslo Norway Telephone: (47) 21078160 Telefax: (47) 21078146 E-mail: [email protected] 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 1) A co-publication between the WHO Collaborating Centre for Drug Statistics Methodology and the Nordic Council on Medicines PREFACE 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 now widely used internationally and the number of users is gradually increasing. The purpose of preparing guidelines is to make information about the ATC classification system and the DDD methodology 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 14th edition of the Guidelines for ATC classification and DDD assignment is based on the ATC classification index with DDDs valid from January 2011. The ATC index with DDDs, which is important for the understanding of these guidelines, is available on request from the WHO Collaborating Centre for Drug Statistics Methodology (order form, see Annex II). A searchable version of the index is available on our website www.whocc.no. The ATC index with DDDs is updated annually. Please be aware that Spanish versions of the ATC/DDD publications also are available. An integrated version of the Guidelines for ATC classification and DDD assignment and ATC classification index with DDDs is available on internet. For further information, please see our website: www.whocc.no. All comments connected to the assignment of DDDs are given in shadowed boxes in the various chapters to each ATC group. 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 2010 Hanne Strøm Director 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 Solveig Sakshaug, MScPharm Hanne Strøm, 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 7 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 ............................................. 45 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 8 ATC system main groups.................................................................................. 48 A Alimentary tract and metabolism ...........................................................