Guidelines For Atc Classification And Ddd Assignment 2013-Books Pdf

Guidelines for ATC classification and DDD assignment 2013

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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 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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