1.

The ATC/DDD Methodology

Introduction

Drug Utilization Research (DUR) uses the Anatomical Therapeutic Chemical (ATC) as the classification system
and the Defined Daily Dose (DDD) as a unit of measure.
The ATC classification system groups the active medical substances according to the organ or system on which
they act and according to their therapeutic, pharmacologic and chemical properties. The DDD is a unit of
measurement and is linked to the ATC code. The definition of the DDD is: The assumed average maintenance
dose per day for a drug used for its main indication in adults.

The ATC/DDD methodology facilitates the presentation and comparison of drug consumption statistics at
international, national and regional levels despite differences in nomenclature (both branded and generic),
packing sizes, pricing and customary dosages. Such methodology is useful for valid presentation and
comparison of drug utilization within and across countries to support better outcomes and quality use of
medicines.

The methodology is endorsed by WHO and is recommended as the international standard for drug utilization
monitoring and research. The adoption of ATC/DDD by more users further facilitates the comparison of data at
an international level.

2. Anatomical Therapeutic Chemical (ATC) Classification

Structure

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.
ATC 1st level

The system has fourteen main anatomical or pharmacological groups (1st level). The ATC 1st levels are shown
in the figure.

ATC 2nd level

Pharmacological or Therapeutic subgroup

ATC 3rd& 4th levels

Chemical, Pharmacological or Therapeutic subgroup

ATC 5th level

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:

Thus, in the ATC system all plain metformin preparations are given the code A10BA02.
For the chemical substance, the International Nonproprietary Name (INN) is preferred. If INN names are not
assigned, USAN (United States Adopted Name) or BAN (British Approved Name) names are usually chosen.
The coding is important for obtaining accurate information in epidemiological studies. The five different levels
allow comparisons to be made at various levels according to the purpose of the study.

ATC/DDD History

How did ATC/DDD start?

The field of Drug Utilization Research (DUR) began attracting attention in the 1960’s. This followed the
publication of a breakthrough study on drug consumption from 1966-1967 (pioneered by the WHO Regional
Office for Europe) which further exemplified the importance and applicability of DUR (1). In addition, the WHO
symposium in 1969 highlighted the need for an internationally accepted classification system for drug
utilization studies. As a result the Drug Utilization Research Group (DURG) was established and entrusted with
the development of DUR methods. Inspired by this interest, the Anatomical Therapeutic Chemical (ATC)
classification was developed in Norway as a modification and extension of the European Pharmaceutical
Market Research Association (EPhMRA) classification system

In order to analyze drug use, it is essential to have both a classification system and a unit of measurement. To
address the drawbacks of traditional units of measurement, a technical unit of measurement called the
Defined Daily Dose (DDD) was developed for use in drug utilization studies.
International interests in the ATC/DDD methodology rapidly expanded, largely through the activity of the
DURG. In 1981, the WHO Regional Office for Europe formally recognized the ATC/DDD system for drug
utilization studies and recommended its use in Europe. In 1982 the WHO Collaborating Centre for Drug
Statistics Methodology was established and assigned the responsibility to coordinate the development and use
of the ATC/DDD methodology. In 1996, WHO recommended the global use of the ATC/DDD methodology.
Several decades of experience have demonstrated its suitability in drug utilization monitoring and research.
The increase in the number of users indicates the usefulness of the system.

1. Engel A, Siderius P. The consumption of drugs. Report on a study, 1966-1967. WHO Regional Office for
Europe, Copenhagen 1968 (EURO 3101).

3. Defined Daily Dose (DDD)

Definition and general considerations
Drug consumption can be expressed in cost, number of units, number of prescriptions or by
the physical quantity of drugs. However these variables can vary between regions and
countries over time. This limits comparisons of drug consumption at an international level.
To address this, a technical unit of measurement, the Defined Daily Dose (DDD) was created.

Defined Daily Dose (DDD): The assumed average maintenance dose per day for a drug used
for its main indication in adults.

DDDs are 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.

Principles for DDD Assignments

DDD Assignments
 DDDs are only assigned to drugs with ATC codes and a DDD will normally not be
assigned for a new substance before a product is approved and marketed in at least
one country.
 The basic principle is to assign only one DDD per route of administration within an
ATC code.
 DDDs for single substances are normally based on monotherapy. Exceptions to this
rule are given in the Guidelines for ATC classification and DDD assignment.
 For substances indicated for rare disorders with individual dosing, the Working Group
could decide not to assign a DDD.
 DDDs for herbal medicinal products are not included in the ATC index. They are
published in an ATC sorted list here.

When a new DDD is assigned for products with one single active ingredient, various
sources are used to get an overview of the actual or expected main use of a substance. The
assigned DDD is based on the following principles:

 The average adult dose used for the main indication as reflected by the ATC code.
When the recommended dose refers to body weight, an adult is considered to be a
person of 70 kg.
 The maintenance dose (long term therapeutic dose) is usually preferred when
establishing the DDD. The initial dose may differ from the maintenance dose but this
is not reflected in the DDD.
 The treatment dose is generally used. If, however, prophylaxis is the main indication,
this dose is used, for example antithrombotic agents in B01A.
 A DDD is usually expressed according to the declared content (strength) of the
product.
 The DDD is often identical for various dosage forms of the same drug. Different
DDDs may be established when the bioavailability is substantially different for
various routes of administration (e.g. oral and parenteral administration of morphine)
or if the dosage forms are used for different indications.

The DDDs assigned for combination products are based on the main principle of counting
the combination as one daily dose, regardless of the number of active ingredients included in
the combination. DDDs for combinations are normally expressed as number of single doses
used per day to obtain the desired therapeutic effect, following the same sources of
information as those used to establish the DDD for plain products.
If a treatment schedule for a patient includes several different products (e.g. two single
ingredient products) the utilization will be measured by counting the DDDs of each single
ingredient product separately and then summed together. If a treatment schedule includes a
combination product containing two active ingredients, the calculated utilization measured in
DDDs will normally be lower since the DDD for the combination will be counted.
Detailed principles for assigning DDDs to combination products are explained in the
Guidelines.

For all combination products where the DDD assigned deviates from the principles, a list of
DDDs are available here.

More about DDDs

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.

Estimating prevalence of drug use in children is not possible by using crude sales data
presented in DDDs owing to the variability of children’s doses. When undertaking DUR in a
population of children the prescribed daily dosages and indications in that population should
be obtained if available and compared with the DDD values. If these parameters in the
paediatric subgroup are difficult to identify, the general DDD can be used as a standardized
measuring tool for overall comparisons, with caveats or limitations associated with using an
adult based DDD.

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.

 Cumulative overview of DDD alterations

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 prescribed daily dose (PDD) is defined as the average dose prescribed according to a
representative sample of prescriptions. 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 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.

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4. DDD Indicators

Introduction to DDD Indicators

Drug Utilization figures expressed in DDDs are generally reported in units that control for
population size differences (such as 1000 persons). This provides a measure of exposure or
therapeutic intensity in a defined population, allowing comparisons across various time
periods and population groups.

Drug Utilization figures should ideally be presented using a relevant denominator for the
health context such as numbers of DDDs per 1000 inhabitants per day, DDD per inhabitant
per year, or as DDDs per 100 bed days.

DDD per 1000 inhabitants per day: Sales or prescription data presented in DDDs per 1000
inhabitants per day may provide a rough estimate of the proportion of the study population
treated daily with a particular drug or group of drugs. The figure 10 DDDs per 1000
inhabitants per day can be interpreted as follows: in a representative group of 1000
inhabitants, 10 DDDs of the drug are utilized on average, on any given day of the year
analysed. Alternatively this can be expressed as 10/1000 (1%) of the population are receiving
this drug each day in that year. This estimate is most useful for drugs used chronically and
when there is good agreement between the average prescribed daily dose (PDD) and the
DDD.

DDD per 100 bed days: The DDDs per 100 bed days may be applied when drug use by
inpatients is considered. The definition of a bed day may differ between hospitals or
countries. A common definition is: A bed day is a day during which a person is confined to a
bed and in which the patient stays overnight in a hospital. Day cases (patients admitted for a
medical procedure or surgery in the morning and released before the evening) are sometimes
included as one bed day and sometimes excluded. The same definition of bed days should
always be chosen when performing comparative studies. The figure 70 DDDs per 100 bed
days of hypnotics provides an estimate of the therapeutic intensity and estimates that 70% of
the inpatients receive one DDD of a hypnotic every day. This measure is applied in analyses
of in-hospital drug use. This indicator is quite useful for benchmarking in and between
hospitals.

DDD/patient: This indicator is often calculated in pharmacoepidemiological databases and

expresses the treatment intensity/total exposure according to a defined study period. If the
actual dose used is equivalent to the DDD, the DDD/patient would also express the number
of treatment days in a specific period.

Drug utilization data presented in DDDs give a rough estimate of consumption and not an
exact picture of the actual drug use, and the estimates described above are only true if there is
good agreement between the actually prescribed dose and the DDD.

Calculating DDD indicators

This section is a brief introduction on how to do calculations using the Defined Daily Dose
(DDD).

Utilization in DDD

DDD/1000 Inhabitants/day

DDD/100 bed days

DDD/patient
Utilization as a percentage

Utilization of a specific drug as a total percentage of its therapeutic class can be useful to
understand its representation. This can be calculated by:

When, for example, looking at the use of a specific antibiotic as a percentage of total
antibiotic use, this can be a useful indicator to look at the development of drug resistance in
antibiotics.

Expenditure per DDD

This indicator represents the actual cost paid by a health system for specific medicines. This
indicator provides information on the actual cost paid for a medicine and allows comparison
between countries (international differences in the expenditure for the same medicine). It also
allows comparison between medicines licensed with comparable clinical properties and
allows the calculation of exact differences within a country or between countries. This
indicator must be interpreted with caution if the indications for use differ and if the ratio
between the DDD and the prescribed daily dosage differ significantly within a drug group.

Expenditure indicators can be used to find various aspects such as:

 Pharmaceutical expenditure on total health expenditure

 Pharmaceutical expenditure per capita
 Expenditure on medicines on the essential medicines list versus expenditure on non
essential medicines
 Expenditure in specific monetary units (e.g. US dollars, euros) per DDD
 Expenditure for generics on total pharmaceutical expenditure
 Expenditure for new medicines on total pharmaceutical expenditure
 Top ten therapeutic or pharmacological classes by ATC levels
 Top ten ingredients by 5th level of ATC
 Quality indicators based on the ATC/DDD system
 With access to drug utilization statistics based on the ATC/DDD system, it is possible
to construct simple indicators reflecting the quality of prescribing or drug use.
Analogous to the examples above, the adherence to prescribing guidelines can be
 assessed using the percentage of use of the recommended drug of the total use of
drugs in a certain group


 The recommended drugs, as well as the drug group, can be defined using ATC codes.
Several disease and patient-specific factors may influence drug choice, and more
specifically not choosing the recommended drug in the individual case. Thus, the
indicator does not include patient specific factors such as indication, severity of
disease, lack of effect of first-line treatment, adverse effects or contraindications, and
this should be considered in the interpretation. Despite these limitations, simple
indicators have been useful to demonstrate potential quality problems and large
variations in prescribing and drug utilization.
 The Drug Utilization 90% (DU90%) indicator has been proposed as a means of
focusing on the most commonly used drugs (1). This indicator measures the number
of drugs accounting for 90% of the use in DDDs. Products are ranked in order of
DDDs and the number of drugs accounting for 90% of use is the DU90%. A good
way to represent this is by plotting the products in rank order of DDDs on the x-axis
against the number of defined daily doses of each product on the y-axis. The focus is
on the drugs that account for 90% of the volume and adherence to treatment
guidelines within this 90%. The adherence to guidelines can then be calculated as the
number of DDDs which are in the treatment guidelines over all DDDs within the
90%. Caution is needed when the ratio between the DDD and the prescribed daily
dose differ largely between the drugs included in the indicator.
 1. Bergman U1, Popa C, Tomson Y, Wettermark B, Einarson TR, Aberg H, Sjöqvist F.
Drug utilization 90%--a simple method for assessing the quality of drug prescribing.
Eur J Clin Pharmacol. 1998 Apr;54(2):113-8

5. Applications of the ATC/DDD

methodology

Where can we apply the ATC/DDD Methodology?

The purpose of the ATC/DDD methodology is to serve as a tool for producing good quality,
usable and comparable drug utilization statistics. The methodology can be used in:
- National Standard for Medicinal Products: The ATC classification has been adopted in
various countries as a national standard for classification of medicinal products. In addition,
many countries have established national product registries with ATC codes. ATC codes can
also be used consistently by producers, wholesalers, pharmacies and the regulatory
authorities to identify an active substance or a combination of active substances.

- International Classification: A drug classification system represents a common language

for describing the drugs available in a country or region and is a prerequisite for national and
international comparisons of drug use data.

- Health Policy: Drug utilization statistics is an important tool in the planning, monitoring
and evaluation of national drug policies. Availability of local or national data on drug use
represents the first step in improving the quality of drug use in the population.

- Pharmacoepidemiology/Drug Utilization Research: Follow trends and patterns in drug

use. Applications of a specific set of ATC codes and DDDs to drug use information over time
allow trends in drug utilization to be studied.

- Pharmacovigilance: The ATC classification can be used in the monitoring of Adverse

Drug Reactions (ADRs) as the system helps to link ADRs to drug classes. Moreover, since
DDDs can provide information on volume of medicines used, it can also help determine ADR
rates.

- Assisting procurement agencies and payer organizations: To ensure a better overview of

the availability of drugs. For example, identification of main drug costs to ensure no drug
shortages.

ATC codes are included in:

 A selection of international drug catalogues (e.g. Martindale)

 Several national catalogues
 WHO Model Lists of Essential Medicines
 WHO Drug Dictionary (WHO-DD): Which serves as a global coding, analysing and reporting
system of medical product information. Please note that many unofficial ATC codes are
used, but these are clearly marked.

 6. ATC/DDD for Drug Safety

Assessment

 Why apply ATC/DDD into Pharmacovigilance?


 In pharmacovigilance analyses using VigiBase® or other databases,
disproportionality analysis is an acknowledged tool to support signal detection.
Disproportionality metrics, e.g. the proportional reporting ratio (PRR), can be
calculated based on the ATC classification. When PRR is applied at the level of ATC
codes, the reporting rate of one specific event is calculated for a given ATC code and
compared to the reporting rate of the event in all ICSRs of the database except those
that contain one or more drugs from the ATC code of interest.

 7. Sources of Drug Utilization Data


 Data Sources
 Different types of drug use information are required depending on the problem being
examined.
 Data are collected, or are available, at national, regional and local health facility or
household level and may be derived from quantitative or qualitative studies.
Examples are as follows:


 - Sales data. Sales data may be obtained from drug importers, wholesalers or local
manufacturers at national, regional or local levels.



 - Dispensing data either comprehensive or sampled. Computerised pharmacies can
easily collect data on drugs dispensed. Alternatively, sample data can be collected
manually. Reimbursement systems, which operate in a number of countries at the
national level provide comprehensive dispensing data down to the individual
prescription level, as all prescriptions are submitted and recorded for reimbursement.
This is generally called “claims” data. Similar data are often available through health
 insurance or health maintenance organizations.
These databases can sometimes allow collection of demographic information on the
patients, and information on dose, duration of treatment and co-prescribing.


 - Patient encounter-based data. This is usually collected by specially designed
sampling studies such as those carried out by market research organizations.
However, increasing use of information technology at the medical practice level will
make such data available more widely in the near future. These methods have the
advantage of potentially providing accurate information on Prescribed Daily Doses,
patient demographics, duration of therapy, co-prescribing, indications, morbidity and
co-morbidity, and sometimes outcomes.


 - Patient survey data. Collection of data at the patient level can provide information
about actual drug consumption taking into account compliance in filling prescriptions
and taking medications as prescribed.



 - Health Facility data. Data on medication use at all the above levels is often
available in healthcare settings such as hospitals and health centres at regional,
district, or village level.
 More information is also available in the WHO publication "How to investigate drug
use in health facilities: selected drug use indicators ".

 8. Start using ATC/DDD


 How to start
 When the decision to introduce the ATC/DDD methodology is taken, it is essential to
realize that its proper use inevitably includes an important and time-consuming first
step:
 Each product has to be linked to the appropriate ATC code and DDD. For monitoring
and comparing drug use internationally, it is important to ensure that the retrieved
data are comparable, meaning that the ATC groups from different countries, regions
or health facilities do have the expected content.
 In order to achieve this, it is of vital importance that the officially correct ATC code is
assigned to each medicinal product package. If possible, this work should be done on
a national basis to secure consistent use of the methodology within a country. Many
countries have established systems of unique identifiers for drug products at the
package level. The number of DDDs per package should be calculated for each
medicinal product package and this information should be added to the medicinal
products registry. The national drug lists and ATC/DDDs should be linked at the level
 of the unique product identifier and this has to be done by persons with proper
knowledge of the methodology.


 A European Working Group made recommendations for setting up National Registers
of Medicinal Products with validated ATC codes and DDD values in 2004. The
document is available here .

 Users should be aware of the ATC/DDD system as a dynamic system to which

annual updates are made
 A few alterations in ATC codes and DDDs usually occur annually and new ATC
codes and DDDs are introduced every year. Thus it is necessary to check for updates
in the drug list regularly: updates of the ATC/DDD Index are issued in January each
year.
Historical sales data linked to specific packages no longer licensed or available should
be kept. It is important to update the ATC codes and DDD values of historical
utilization and expenditure data. Finally, when producing and presenting longitudinal
trends in utilization and expenditure data, it is important that the data for different
years are all presented using the latest ATC/DDD version.

9. How to set up a Drug Utilization Study

Setting up a Drug Utilization Study

When setting up a drug utilization study, the questions to be answered and the study
objectives should be defined. It is also important to decide whether the study will be a
onetime activity (research project) or an ongoing monitoring program.

Once it has been decided to perform a drug utilization study, it must be decided which data
source or sources to use. In many countries, the sources are limited and the question is;
Which sources do we have and how can they be used?

It is important to tailor the choice of data source to the question that needs to be answered.
Do we need to know:

 How much is used of certain drugs in a country, region, hospital or in a primary care
setting?
 What is the drug used for (indication)?
 How is it used (dose and duration of treatment)?
 Who are using it (age, gender)?
There are still many countries where drug utilization data are not easily available. But in
nearly all countries there will be systems and structures that can be used to set up a drug
utilization study.

Independent of the data source available, the steps for setting up a drug utilization study, or
rather; how to proceed to convert available drug data into drug utilization data is more or less
the same. The key issue of applying the ATC/DDD methodology is to transfer a list of
medicine packages into a structured list of ATC classified medicines, and the use/sales in a
respective number of packages into a number of DDDs.

Click here to check the different steps in setting up a DU

study!

Antimicrobial Consumption (AMC) Tool

A tool or programme to calculate antimicrobial consumption is available on the web, the
AMC Tool. This tool allows the calculation of consumption data from either health-care
settings or the community and uses two indicators to report antimicrobial consumption:
- DDD per 100 inhabitants per day
- DDD per 100 bed days

10. Training in the ATC/DDD methodology

Training Information
As a starting point the training course (face to face course) held by the WHO Collaborating
Centre for Drug Statistics Methodology is recommended. The courses are held annually in
Norway but may also be arranged on request in other countries. Further information on the
course can be found here

Course content
The course consists of lectures, discussions and hands-on training. The course is open to all
interested parties. However, basic knowledge of medical terminology is recommended. The
Centre may also arrange courses on request in other countries which plan to start using the
ATC/DDD methodology. Such courses have been arranged in several countries such as
Ecuador, India, Japan, Morocco and South-Africa.

The two-day course allows the individual to grasp the general and essential aspects of the
ATC/DDD methodology. The individual will learn by experts about:

 The ATC classification system and the concept of DDD (main principles)
 How to deal with combination products
 The different applications of the methodology
 The purpose of the ATC/DDD methodology in drug utilization statistics

Moreover working group sessions to solve ATC/DDD problems with guidance from experts
and example case studies will be presented and discussed. These sessions are important
elements of the course. Various ATC/DDD problems and points to consider related to the
application of the methodology in drug consumption statistics will be discussed.

It is recommended that individuals seeking to implement ATC/DDD should follow this

course (unless already an expert in the field) prior to implementation, in order to ensure the
key initial stages are completed correctly.

You can find the dates of the next training course and practical information of the training
course here

Practical information
The course will be carried out in English.
Registration form can be found here

Definition and general considerations

Definition and introduction
The basic definition of the defined daily dose (DDD) is:

The DDD is the assumed average maintenance dose per day for a drug used for its main
indication in adults.
The DDD is a unit of measurement and does not necessarily reflect the recommended or
Prescribed Daily Dose. 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.

Only one DDD is assigned per ATC code and route of administration (e.g. oral formulation).
The DDD is nearly always a compromise based on a review of available information
including doses used in various countries when this information is available. The DDD is
sometimes a “dose” that is rarely if ever prescribed, because it might be an average of two or
more commonly used doses.

Drug utilization data presented in DDDs only 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
consumption and to perform comparisons between population groups.

General principles for DDD assignment (to the top)

DDDs are only assigned to drugs with an ATC code and a DDD will normally not be
assigned for a substance before a product is approved and marketed in at least one country.

The basic principle is to assign only one DDD per route of administration within an ATC
code.

DDDs for single substances are normally based on monotherapy. Exceptions to this rule are
given in the guidelines of the relevant ATC groups.

For substances indicated for rare disorders with highly individual dosing schedules, the
Working Group could decide not to assign a DDD.

DDDs are not established for topical products, sera, vaccines, antineoplastic agents, allergen
extracts, general and local anesthetics and contrast media.

When a new DDD is assigned, various sources are used to get the best overview of the actual
or expected use of a substance. The assigned DDD is based on the following principles:

 The average adult dose recommended for the main indication as reflected by the ATC
code. When the recommended dose refers to body weight, an adult is considered to be
a person of 70 kg. It should be emphasised that even special pharmaceutical forms
mainly intended for children (e.g. mixtures, suppositories) are assigned the DDD used
for adults. Exceptions are made for some products only used by children, e.g. growth
hormones and fluoride tablets.

 The recommended maintenance dose (long term therapeutic dose) is usually preferred
when establishing the DDD. The initial dose may differ from the maintenance dose
but this is not reflected in the DDD. If the approved dose recommendation provides
limited information about maintenance dose, the DDD will usually be the average of
the maintenance dose range. Examples of interpretation of approved dose titration
recommendations:
o "Titrate up to a high dose if it is tolerated”: the high dose would normally be
chosen as the DDD.
 o “Consider to increase the dose only if efficacy is not satisfactory with initial
dose”: the DDD would normallybe based on the initial dose.

 For some groups of medicinal products specific principles for DDD assignment are
established (e.g. the DDDs for the selective serotonin agonists in the treatment of
migraine are based on the approved initial dose). These principles are given in the
guidelines for the relevant ATC groups.

 The treatment dose is generally used. If, however, prophylaxis is the main indication,
this dose is used, e.g. for fluoride tablets (A01AA01) and some antimalarials.

 A DDD is usually established according to the declared content (strength) of the

product. Various salts of a substance are usually not given different DDDs.
Exceptions are described in the guidelines for the relevant ATC groups. For
example, the DDDs for antimalarials are expressed as the base.

 Different stereoisomeric forms are normally assigned separate DDDs and ATC
codes. The DDDs for stereoisomeric forms are described in the respective ATC
groups.

 Prodrugs, which have not been given a separate ATC code, are normally not given a
separate DDD.

 The DDD is often identical for various dosage forms of the same drug. Different
DDDs can be established when the bioavailability is substantially different for various
routes of administration (e.g. oral and parenteral administration of morphine) or if the
dosage forms are used for different indications. When the use of parenteral
formulations represents only a minor fraction of the total use for a specific indication,
these products have normally not received a separate DDD even if the bioavailability
of the oral form is substantially different. This principle has not been strictly
followed in recent years. Parenteral antibacterials are for example mainly used in
hospitals and often for more severe infections than in primary care. The DDDs are
frequently used as indicators for antibacterial use in hospitals, and it has been decided
that assigning different DDDs for oral and parenteral formulations could be important
in some cases to improve the usefulness of the methodology in drug utilization
monitoring and research.

 Parenteral products with different routes of administration (e.g. i.v. and i.m.) have the
same DDD.

DDDs for combinations products (to the top)

The DDDs assigned for combination products are based on the main principle of counting the
combination as one daily dose, regardless of the number of active ingredients included in the
combination. If a treatment schedule for a patient includes e.g. two single ingredient
products, then the consumption will be measured by counting the DDDs of each single
ingredient product separately. If, however, a treatment schedule includes a combination
product containing two active ingredients, then the calculated consumption measured in
DDDs will normally be lower since the DDD for the combination will be counted.

Example I:
Treatment with two products, each containing one active ingredient:
Product A:
Tablets containing 20 mg of substance X (DDD = 20 mg)

Product B:
Tablets containing 25 mg of substance Y (DDD = 25 mg)

The dosing schedule 1 tablet of A plus 1 tablet of B daily will be calculated as a consumption
of 2 DDDs.

Example II:
Treatment with a combination product containing two active ingredients:

Product C:
Tablets containing 20 mg of substance X and 12.5 mg of substance Y. The DDD of the
combination products is assigned as 1 UD = 1 tablet.

The dosing schedule 1 tablet of C daily will be calculated as 1 DDD (even though it will be
equivalent to 1.5 DDD of the single active ingredients).

The following principles for assigning DDDs to combination products apply:

1. For combination products (other than the combination products used in

hypertension, see point 2 below) where the ATC code identifies the
main ingredient (i.e. for the 50- and 70-series combinations and for
some 4th level combinations), the DDD for the combination product
should be equal to the DDD for the main active ingredient.

2. For combination products used for treatment of hypertension (i.e. ATC

group C02, C03, C07, C08 and C09), DDDs are based on the average
number of dosing intervals per day. This means that: 1 tablet is the
DDD for combinations given once daily, whereas 2 tablets is the DDD
for combinations given twice daily and 3 tablets is the DDD for
combinations given three times daily etc. This principle means that the
assigned DDDs may differ from the DDD assigned for the main active
ingredient (according to ATC code).

For all combination products where the DDD assigned deviates from the principles given
above, a list of DDDs are available on this website List of DDDs combined products.

DDD alterations from 2005-2019

Cumulative overview of all DDD alterations performed in the period 2005-2019. The year
changed is when the alterations were implemented in the ATC/DDD Index. Please note that a
DDD may have changed more than once for some ATC codes. The ATC codes are current
codes. For substances where the DDD is changed twice the new DDD which is not according
to current value is marked with an asterix (*).

List of abbrevations
 Substance Previous DDD New DDD* Present Year
ATC codechanged
alosetron 2 mg O 1 mg O A03AE01 2005
amoxicillin and beta-lactamase 1 g O 1.5 g O J01CR02 2019
inhibitor
amoxicillin and enzyme inhibitor 1 g P 3 g P J01CR02 2005
amoxicillin 1 g O 1.5 g O J01CA04 2019
amoxicillin 1 g P 3 g P J01CA04 2019
3) 3)
ampicillin and enzyme inhibitor 2 g P 6 g P J01CR01 2017
ampicillin 2 g P 6 g P J01CA01 2019
amprenavir 2.4 g O 1.2 g O J05AE05 2006
apixaban 5 mg O 10 mg O B01AF02 2016
aprepitant 5) 95 mg P 150 mg P A04AD12 2019
aprepitant 95 mg O 165 mg O A04AD12 2019
atorvastatin 10 mg O 20 mg O C10AA05 2009
blood coagulation factors 1 deleted 2)B02BD 2017
calcium acetate 2 g O 6 g O V03AE07 2017
cefepime 2 g P 4 g P J01DE01 2019
ceftezole 6 g P 3 g P J01DB12 2008
ciprofloxacin 0.5 g P 0.8 g P J01MA02 2019
colistin 3 MU P 9 MU P J01XB01 2019
dabigatran etexilate 0.22g O 0.3 g O B01AE07 2016
daclizumab 0.35g P 5 mg P L04AC01 2018
1) 1)
desmopressin 0.36mg SL 0.24mg SL H01BA02 2009
esomeprazole 20 mg O 30 mg O A02BC05 2005
fentanyl 0.6 mg TD 1.2 mg TD N02AB03 2005
fluvastatin 40 mg O 60 mg O C10AA04 2009
gliclazide 0.16g O 60 mg O A10BB09 2011
glycopyrronium bromide 3 mg P 0.3 mg P A03AB02 2018
human menopausal gonadotrophin 30 U P 75 U P G03GA02 2016
ibrandronic acid 5 mg P 6 mg P M05BA06 2007
levetiracetam 2 g O 1.5 g O N03AX14 2005
lovastatin 30 mg O 45 mg O C10AA02 2009
meropenem 2 g P 3 g P J01DH02 2019
mifepristone 0.6 g O 0.2 g O G03XB01 2017
posaconazole 0.8 g O 0.3 g O J02AC04 2017
pravastatin 20 mg O 30 mg O C10AA03 2009
risperidone 1.8 mg P depot2.7 mg P depot N05AX08 2010
rivaroxaban 10 mg O 20 mg O B01AF01 2016
simvastatin 15 mg O 30 mg O C10AA01 2009
sirolimus 6 mg O 3 mg O L04AA10 2006
temocillin 2 g P 4 g P J01CA17 2019
thioctic acid 0.2 g O,P 0.6 g O,P A16AX01 2017
4) 4)
tiotropium bromide 18 mcg Inhal. 10 mcg Inhal. R03BB04 2017
powder powder
vasopressin (argipressin) 4 U P 40 U P H01BA01 2019
1) Base.
2) DDDs for the various blood coagulation factors in all ATC 5th level codes in B02BD are
deleted. No new DDDs will be established in B02BD Blood coagulation factors.
3) Refers to ampicillin.
4) The DDD for tiotropium bromide is unchanged but has been defined as the content of one
inhalation capsule (18 mcg) as tiotropium. Since there are different inhalation capsules on the
market containing different amounts of active substance, the DDD is now defined as the
delivered dose, which is the same (10 mcg) as tiotropium for all products.
5) Refers to fosaprepitant

Last updated: 2018-11-28

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 Created by Marta TERRON CUADRADO, last modified by Mathias GHYS on Jul 02, 2018

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 Main facts
 History and purpose
 Structure
 Nomenclature
 Inclusion of new entries and principles for classification
o Classification of combination products
  Brief insight into the DDDs
o Drug utilization studies and the ATC/DDD system
 Use and limitations of the ATC Classification system
 Other ATC Classification systems

Purpose

The purpose of this page is to provide basic information about the ATC Classification, one of
the underlying code systems of the eHDSI Master Value Sets Catalogue (MVC). Specifically,
the epSOSActiveIngredient Value Set contains the complete content of the ATC
Classification.

Relevant links and documents

 ATC/DDD Index (WHO Collaborating Centre for Drug Statistics Methodology, Oslo)
 Guidelines for ATC classification and DDD assignment | 2017. WHO Collaborating Centre for
Drug Statistics Methodology, Oslo
 Introduction to Drug Utilization Research 2003. WHO

More details on the update process of the ATC Classification here

Main facts
 The ATC/DDD system was developed as a tool for drug utilization research with the
aim of improving the quality of drug use.
 In the ATC Classification, drugs are divided into different groups in accordance with
the organ or system on which they act and their chemical, pharmacological, and
therapeutic properties.
 It contains five levels and drug consumption statistics can refer to each of these
levels: from a more general to the most specific, the fifth level.
 The complete ATC Index with DDDs (Defined Daily Doses) is published as a paper
copy or in electronic versions (English and Spanish) either in Excel or XML format.
Also a searchable version of the ATC Index with DDDs is available free of charge
from the WHO Collaborating Centre in Oslo.
 It is updated annually. The list of updates, which include new ATC/DDDs and
alterations, are available in the WHO Collaborating Centre web page.

History and purpose

The Anatomical Therapeutic Chemical (ATC) Classification system and the accompanying
Defined Daily Doses (DDD) - as measuring units - have their inception as a tool for drug
utilization studies in the 1960s. After the study of Engel and Siderius on the consumption of
drugs - showing great differences of drug consumption in six European countries during the
period 1966-1967 - and the symposium held in Oslo in 1969 'The Consumption if Drugs'
(organised by the WHO Regional Office for Europe) it was agreed that an internationally
agreed classification system for drug utilization studies was needed. Norwegian researchers
developed then the ATC classification system by modifying and extending the classification
system of the European Pharmaceutical Market Research Association. It was realised at that
time that both a classification system and a unit of measure were needed to measure drug use
and, subsequently, the DDD as technical unit of measure was developed.

In 1981, the WHO Regional Office for Europe recommended the ATC/DDD system for
international drug utilization studies. The WHO Collaborating Centre for Drug Statistics
methodology was established in Oslo as the central body responsible for coordinating the use
of the methodology for these studies. Subsequently, in 1996, WHO recognised the need to
foster the use if the ATC/DDD system as an international standard and the Centre was linked
directly to WHO Headquarters in Geneva instead to the WHO Regional Office. With this
approach, WHO intention was to allow a closer integration of international drug utilization
studies and other initiatives to achieve universal access to needed drugs and rational use of
drugs, especially in developing countries. It was recognized that 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.

Today, the main activities of the Collaborating Centre consist on the development and
maintenance of the ATC/DDD system, specifically: classifying drugs according to the ATC
system; establishing the DDD for those drugs which have been assigned an ATC code;
reviewing and revising as necessary the ATC classification system and DDDs; stimulating
and influencing the practical use of the ATC system by cooperating with researchers in the
drug utilization field; organising training courses in the ATC/DDD methodology and
lecturing in courses and seminars organized by others; and providing technical support to
countries in setting up their national medicines classification systems and build capacity in
the use of medicines consumption information.

"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".

(Guidelines for ATC classification and DDD assignment | 2017)

The ATC/DDD system facilitates the comparison of drug statistics at any level (institution,
local, regional, national, or international). By maintaining stable ATC codes and DDDs over
time - as aimed by the Centre in Oslo and the Working Group -, research of trends in drug
consumption can easily be performed. In fact, there is a strong reluctance to make changes to
the classification or the DDDs, where such changes are requested for reasons not directly
related to drug consumption studies.

It is emphasized that the classification of a substance in the ATC/DDD system is not a

recommendation for use, nor does it imply any judgement about efficacy or relative efficacy
of drugs and groups of drugs. Neither is it suitable for guiding decisions about
reimbursement, pricing, or therapeutic substitution.

Structure
An active substance is classified in the ATC system according to the organ or system on
which it acts and on its therapeutic, pharmacological, and chemical properties.

The structure has 5 levels; the first one allows active substances to be classified into 14 main
groups, which in turn are divided into pharmacological/therapeutic subgroups (2nd level).
The 3rd and 4th levels are chemical/pharmacological/therapeutic and the 5th is the chemical
substance.

The ATC System main groups or 1st level of the classification represent the organ or
system in the body on which the therapeutic effect is exerted:

A Alimentary tract and metabolism

B Blood and blood forming organs

C Cardiovascular system

D Dermatologicals

G Genito urinary system and sex hormones

Systemic hormonal preparations, excl. sex hormones and

H
insulins

J Antiinfectives for systemic use

L Antineoplastic and immunomodulating agents

M Musculo-skeletal system

N Nervous system

P Antiparasitic products, insecticides, and repellents

R Respiratory system

S Sensory organs

V Various

Example: complete classification of the commonly used analgesic ibuprofen, showing

the structure of the code
Nomenclature
The ATC System uses International non-proprietary names (INN); if INN names have not
being assigned, USAN (United States Adopted Name) or BAN (British Approved Name) are
usually chosen.The Biological Qualifier (BQ) is not part of the INN and the introduction of a
new BQ will not have any implication on the ATC code for the specific INN (the BQ is an
additional and independent element used in conjunction with the INN to uniquely identify a
biological substance to aid in the prescription and dispensing of medicines - further reading
on the Biological Qualifier is available here).

Inclusion of new entries and principles for

classification
The WHO Collaborating Centre in Oslo establishes new entries in the ATC classification on
requests from the users of the system. Not all substances have an ATC code assigned and the
reason might be that no requests has been received for them.

The criteria that active ingredients need to fulfil to be included in the ATC system are:

 Be a new chemical entity or biological proposed for licensing in at least one country
(normally a new entity is not included before an application for marketing authorisation is
submitted)
 Existing well defined chemical entities used in a number of countries. Preferably, an INN
should be established for the active ingredient, however other official names should be
available (e.g. USAN or BAN)
 herbal medicinal products assessed and approved by regulatory authorities based on
dossiers including efficacy, safety, and quality data (such as the procedure in place in the EU)
  Other medicinal products are considered on a case-by-case basis. Complementary,
homeopathic, and herbal traditional medicinal products are in general not included in the
ATC system

Medicinal products are classified according to the main therapeutic use of the main
active ingredient, on the basic principle of only one ATC code for each route of
administration, i.e. pharmaceutical forms with similar ingredients and strengths will have
the same ATC code. Likewise, immediate and slow release tablets will normally have the
same ATC code. Although, a medicinal product may be given more than one ATC code if it
is available in two or more strengths or routes of administration with clearly different
therapeutic uses.

e.g. Finasteride (a specific inhibitor of steroid Type II 5-alfa-reductase (intracellular

enzyme that converts testosterone into 5-alfa-dihydrotestosterone) is available in two
different strengths:

Low strength
tablet indicated
D11AX - Other
to treat male
dermatologicals
pattern
baldness

Higher strength tablet used to treat G04C - Drugs

benign prostatic hypertophy (BPH) used in BPH

In the same way, different pharmaceutical forms developed for various routes of
administration (topical or systemic use, for example) are given distinct ATC codes:

e.g. The corticosteroid drug prednisolone present in single ingredient products is given
different ATC codes depending on the therapeutic use and the corresponding
formulation:

Enemas Intestinal anti-

A07EA01
and foams inflammatory agents

Anti-hemorrhoidals
Suppositories C05AA04
for topical use

Creams, ointments Dermatological

D07AA03
and lotions preparations

Corticosteroids for
Tablets, injections H02AB06
systemic use

Nasal sprays, drops Nasal decongestants R01AD02

Eye drops Ophtalmologicals S01BA04

Ear drops Otologicals S02BA03

Finally, it may happen that a drug may be used for two or more equally important indications
and they are usually given only one ATC code. In such cases, the main indication is decided
based on the available literature and discussed in the WHO International Working Group for
Drug Statistics Methodology, where the final classification is decided.

Classification of combination products

It is interesting to know how medicinal products containing two or more active ingredients
are classified in the ATC system.

 Firstly, combination products are given different ATC codes versus the product with a single
component.
 Even though it may be difficult to decide where a certain combination product should be
placed, it is the main therapeutic use what influences how it is classified:
o e.g. a medicinal product containing an analgesic and a tranquilizer, which is used
primarily to ease pain, should be classified as an analgesic.
 In some ATC groups a ranking is introduced to help in the classification of combination
products (e.g. combinations of different antihypertensives or combinations of different
analgesics). This ranking shows which drug takes precedence over others when the
classification is decided and is detailed in the guidelines for the relevant groups.
 Specifically, combinations containing two or more active ingredients not belonging to the
same 4th level are classified using the 50-series:
o e.g. Paracetamol → N02BE01 vs paracetamol, combinations → N02BE51
 Different combination products sharing the same main ingredient are usually given the same
ATC code:
o e.g. Combinations of paracetamol + acetylsalicylic acid and paracetamol + caffeine
are classified under the same code N02BE51 paracetamol, combinations
 All the active ingredients of a combination are given in some ATC 5th levels → this principle
is more commonly used in recent years to give a better identification of the various
combinations.
o e.g.:
o M01AE02 naproxen
o M01AE52 naproxen and esomeprazole
o M01AE56 naproxen and misoprostol

Brief insight into the DDDs

Even though DDDs are not used in the eHDSI Project, it is worth knowing what they are and
their connection with the ATC codes.

The DDDs or Defined Daily Doses are the units of measure used in combination with the
ATC codes to perform consumption analysis. The DDD is the assumed average maintenance
does per day for a drug used for its main indication in adults.
As a unit of measure, a DDD should not be confused with the recommended or prescribed
daily dose; doses for individual patients, patients groups, other indications different to the
main one may differ from the DDD. Only one DDD is assigned to ach ATC code and route of
administration for analytical purposes.

DDDs provide a fixed unit of measure independent of price, currencies, package size and
strength, enabling researchers to assess trends in drug consumption and to perform
comparisons between population groups.

The basic principles for DDD assignment are:

 DDDs are only assigned to drugs with an ATC code and will normally not be assigned before
a product for the specific substance is approved and marketed in at least one country
 One DDD is assigned per route of administration within an ATC code:
o e.g. The DDD for the antibiotic ciprofloxacin given systemically (J01MA02) is 1g when
administered orally and 0.5g if administered via parenteral

 DDDs are not assigned to some groups of products: topical products, vaccines, antineoplastic
agents, allergen extracts, contrast media, and others.

Drug utilization studies and the ATC/DDD system

As explained above, the ATC/DDD system allows standardizing drug grouping and a stable
drug utilization metric for comparing drug use between countries, regions, and individual
healthcare institutions or settings, and for examining trends in drug use over time.

Drug consumption figures are usually presented as number of DDDs/1000 inhabitants/day or,
for hospital use, as DDDs per 100 bed days. Sales or prescription data presented as number of
DDDs/1000 inhabitants/day may provide a rough estimate of the proportion within a defined
area treated daily with certain drugs: a figure of 10 DDDs/1000 inhabitants/day indicates that
1% of the population on average receives that treatment daily.

Use and limitations of the ATC

Classification system
The development and decisions taken around the ATC system are based on its main purpose,
i.e. to serve as a tool for presenting drug utilization statistics with the final aim of improving
drug use. Consequently, using the system for other purposes may not be appropriate.
For its intended use, comparing drug utilization at international level for instance, it is
important that the data retrieved are comparable. For that, the ATC code and DDD should be
linked to each medicinal product at package level; sometimes it has been acknowledged by
WHO that the necessary skilled staff has not been allocated to this task. An additional issue
has been that some users were not aware of the dynamic nature of the classification and that
the annual updates may require the subsequent update of the national lists. Finally, there will
always exist medicinal products - either single or combination formulations- for which ATC
codes or DDDs are not available.

Finally, as already mentioned, the ATC classification does not reflect recommended
therapeutic use, neither does it imply any judgement about the efficacy of drugs or groups of
drugs.

In the eHDSI Project, the ATC classification is included as one of the code systems in which
the Master Value Sets Catalogue (MVC) is based, specifically as the way to represent:

 the active substance of medicinal products in ePrescriptions and

eDispensation documents
 the active substance of medicinal products in the Medication Summary
Section of the Patient Summary document
 the causative agent in the Allergies and Other Adverse Reactions Section
of the Patient Summary document when those reactions are due to drugs

It was evident that this choice was not the perfect solution to represent the active substance of
medication (see the document "The experience of selecting the code systems for the
development of the epSOS Master Value Catalogue (MVC)"), but it was also clear that it was
the only feasible one. In fact, the EU is currently working, as part of the global
implementation of the ISO IDMP Standards (Identification of Medicinal Products set of
standards), on a Substance Management System for the EU, which should be also compatible
internationally, according to the ISO IDMP Standard for substances. Therefore, we lack at
EU as well as at international level, a univocal way of identifying the substances of medicinal
products. And, as a consequence, the ATC classification continues as the most feasible means
to convey information about the active ingredients of medicinal products.

Already in EXPAND, a number of proposals were presented and agreed (Semantic

Maintenance Shop), later approved as CP-009 for the eHDSI Project, to overcome the
limitations of using the ATC classification: coded data for some active ingredients and
especially for combination medications are not available.


o e.g. there are many examples of widely used combined medications whose
ATC code does not include the exact active ingredients; also active ingredients
lack ATC code at the 5th level:

ATC code (5th

Example ATC description
level)

Amoxicillin + clavulanic acid amoxicillin and J01CR02

 (systemic use) enzyme inhibitor

Enalapril +
enalapril and diuretics C09BA02
hydrochlorothiazide

levonorgestrel and
Levonorgestrel + estradiol G03FA11
estrogen

Ferrimannitol ovoalbumin - -

It should be noted that, in recent years, the ATC classification is incorporating all active
ingredients in combination medications at the 5th level (see the examples earlier for naproxen
combinations or the extensively used combination of salbutamol and ipratropium bromide
used in inhalers, with ATC code R03AL02).

To overcome those issues, CP-009 (Formal approval of changes agreed in the EXPAND
project for the description of medication), gives solutions that allow the listing of the multiple
active ingredients that are present in combined medications as well as the communication of
active ingredients as text when structured and coded information for active ingredients is not
available.

Other ATC Classification systems

 ATCvet classification: Anatomical Therapeutic Chemical classification for veterinary
medicinal products. It is based on the same main principles as the ATC system for human
use; in fact, the ATCvet classification is kept as close to the human system as possible, only
introducing the necessary adaptations to make it suitable for the veterinary medicines.
 ATC herbal classification: provides a classification of herbal medicines by internationally
approved Latin binomial classification and common therapeutic use. Just as the ATC
classification, it allows capturing, grouping, and aggregating herbal remedies data at
different levels of granularity.

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