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DEFINED DAILY DOSE

(DDD)
DEFINITION
DEFINED DAILY DOSE (DDD):

The assumed average maintenance dose per day for


a drug used for its main indication in adults.

 DDDs area only assigned for medicines given an ATC


codes. The DDDs are allocated to drugs by the WHO
Collaborating Centre in Oslo, working in close association
with the WHO International Working Group on Drug Statistics
Methodology.
 Only one DDD is assigned per ATC code and route of
administration (e.g. oral formulation). The DDD is sometimes a
dose that is rarely or never prescribed because it is an average
of two or more commonly used doses.

 DDDs are not established for all medicines with an ATC


code.

 Major drug groups without DDDs are topical products


(most products in ATC group D), sera (ATC group J06),
vaccines (ATC group J07), antineoplastic agents (ATC
group L01), general and local anesthetics (ATC
group N01), ophthalmologicals and otologicals (most
products in ATC group S), allergen extracts (ATC group
V01) and contrast media (ATC group V08).
 The DDD is a unit of measurement and does not necessarily
correspond to the recommended or Prescribed Daily Dose
(PDD).

 Therapeutic doses for individual patients and patient groups


will often differ from the DDD as they will be based on
individual characteristics such as age, weight, ethnic
differences, type and severity of disease, and pharmacokinetic
considerations.
 Drug utilization data presented in DDDs give a rough estimate
of consumption and not an exact picture of actual use.

DDDs provide a fixed unit of measurement independent of


price, currencies, package size and strength enabling the researcher
to assess trends in drug utilization and to perform comparisons
between population groups.
By applying DDD it is possible to:

 Examine changes in drug utilization over time


 Make international comparisons
 Evaluate the effect of an intervention on drug use
 Document the relative therapy intensity with various groups
of drugs
 Follow the changes in the use of a class of drugs
 Evaluate regulatory effects and effects of interventions
on prescribing patterns.
DDD for Children
• DDDs are normally assigned based on use in adults.

• For medical products approved for use in children, the


dose recommendations will differ based on age and body
weight.

•Many medical products used in children are not approved by


regulatory agencies for such use, and the usual documentation
used by the WHO Collaborating Centre regarding dose
regimens is not available.
• Paediatric DDDs are challenging to assign and problems
related to Drug Utilization Research (DUR) in children cannot
be solved by such means.
DDD Changes
DDDs sometimes need to be reviewed because dosages may
change over time, e.g. due to the introduction of new main
indications or new research making it necessary to change
the DDD.
Prescribed Daily Dose (PDD)
It is important to underline that the DDD is a technical unit
(fixed unit of measurement) and does not necessarily correspond
to the recommended or prescribed daily dose (PDD).
• The PDD can be determined from studies of prescriptions,
medical or pharmacy records, and it is important to relate the
PDD to the diagnosis on which the drug is used.

The prescribed daily dose (PDD) is defined as the average dose


prescribed according to a representative sample of
prescriptions.
The PDD will give the average daily amount of a drug that
is actually prescribed. When there is a substantial discrepancy
between the PDD and the DDD, it is important to take this into
consideration when evaluating and interpreting drug utilization
figures.

 For drugs where the recommended dosage differs for


different indications (e.g. antipsychotics) it is important
that diagnosis is linked to the prescribed daily dose given.
 Pharmacoepidemiological information (e.g. sex, age and
mono/combined therapy) is also important in order to interpret
a PDD.

 The PDD can vary according to both the illness treated


and national policies and practices.

 For example, the PDDs of anti-infectives may vary according


to the severity of the infection.

 There are also international differences between PDDs,


which can be up to four or five fold higher/lower. PDDs in
Asian populations are often lower than in Caucasian
populations.
Responsible Organizations of
ATC/DDD methodology
•Who is who?

•- The World Health Organization:

•The WHO endorsed the ATC/DDD methodology for


global use in 1996 as an international standard for drug
utilization studies in an effort to ensure universal access to
essential drugs and to stimulate rational use of drugs
particularly in middle/low income countries.
- The WHO Collaborating Centre for Drug Statistics
Methodology :

The central body responsible for the development and


maintenance of the ATC/DDD system.

This Centre is located at the Norwegian Institute of Public Health


(NIPH) and the main activities of the Centre are drawn up in an
agreement between the WHO Headquarters and the Government
of Norway.
These activities are:
oTo classify drugs according to the ATC system.
oTo establish DDDs for drugs which have been assigned an ATC
code.
oTo review and revise as necessary the ATC classification
system and DDDs.
oTo stimulate and influence the practical use of the ATC system
by
cooperating with researchers in the drug utilization field.
oTo organize training courses in the ATC/DDD methodology and
to lecture such courses and seminars organized by others.
oTo provide technical support to countries in setting up their
national medicines classification systems and build capacity in
the use of medicines consumption information.
WHO International Working Group for Drug Statistics
Methodology :
This body includes 12 expert members selected by WHO
Headquarters, who represent a wide range of geographical and
professional backgrounds.
All six WHO regions are represented in the group.
This body gives expert advice to the WHO Collaborating
Centre.
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 and DDDs.
 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.
Guidelines

• The ATC/DDD guidelines and the Index were both published for
the first time in the current format in 1990.
• The system has been in use for statistics since 1975.
• Both publications are updated annually and available
electronically and in hard copies.
• English and Spanish versions of the publications are available.
Guidelines for ATC Classification and DDD assignment

• A comprehensive guide regarding ATC and DDD can be found


here.

•The Guidelines includes information on the ATC


Classification system and general principles of DDDs
assignment.

• Information necessary for allocating ATC codes and DDDs at


a national or local level can be found in the Guidelines.

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