Download WHO Drug Dictionary User Guide - User Group Portal

WHO Drug Dictionary
User Guide
Limited for internal use
www.umc-products.com
WHO Drug Dictionary User Guide
2015
Page 1 (51)
Table of Contents
1. Getting Started .................................................................................................................... 4
1.1 Use of the Dictionary ..................................................................................................... 5
1.2 Different Uses – Clinical and Safety .............................................................................. 5
1.3 Different Software Solutions ......................................................................................... 5
1.4 Important Common Questions ..................................................................................... 6
1.5 Development Principles ................................................................................................ 7
2. The WHO Drug Dictionaries ................................................................................................ 9
2.1 The Content ................................................................................................................... 9
2.2 Types and Formats ...................................................................................................... 10
2.2.1 The Dictionary Types ............................................................................................ 11
2.2.2 Dictionary Formats ............................................................................................... 12
2.2.3 The benefits of the WHO Herbal Dictionary ........................................................ 13
2.2.4 About the Dictionary Formats .............................................................................. 15
2.2.5 The Information Levels in the C-format ............................................................... 16
2. 3 How to Identify Types of Entries ................................................................................ 19
3. Codes and IDs .................................................................................................................... 21
3.1 The Drug Code ............................................................................................................. 21
3.1.1 Drug Record Number ........................................................................................... 22
3.1.2 Sequence Number 1 ............................................................................................. 22
3.1.3 Sequence Number 2 ............................................................................................. 23
3.1.4 Multi-ingredient Products .................................................................................... 24
3.1.5 The use of Drug Code in the WHO Herbal Dictionary .......................................... 24
3.2 The Medicinal Product ID ............................................................................................ 25
3.2.1 The Medicinal Product ID ..................................................................................... 25
4. General Principles ............................................................................................................. 27
4.1 Non-Unique Names ..................................................................................................... 27
4.1.1 Non-unique names - Example .............................................................................. 28
4.2 Preferred vs. Generic Entries ...................................................................................... 28
www.umc-products.com
WHO Drug Dictionary User Guide
2015
Page 2 (51)
4.3 Old Form Entries .......................................................................................................... 29
5. Classifications .................................................................................................................... 30
5.1 Anatomical Therapeutic Chemical (ATC) ..................................................................... 30
5.1.2 What is an ATC Classification? ............................................................................. 31
5.1.3 ATC in the WHO Drug Dictionaries ....................................................................... 34
5.1.4 The Herbal ATC ..................................................................................................... 36
5.2 Standardized Drug Groupings (SDGs) .......................................................................... 37
5.2.1 Structure............................................................................................................... 37
6. Practical Issues .................................................................................................................. 38
6.1 The Data Files .............................................................................................................. 38
6.2 Downloading the data files ......................................................................................... 39
6.2.1 File and Zip Labels ................................................................................................ 39
6.3 Loading the Files .......................................................................................................... 41
6.4 Changes Files ............................................................................................................... 42
6.4.1 Cumulative Changes File ...................................................................................... 42
6.4.2 Changed Drug Name ............................................................................................ 43
6.4.3 Names of Changes Files ........................................................................................ 43
6.5 Migration from Old Version ........................................................................................ 45
6.6 How Changes to the Dictionaries are Prioritized and Decided ................................... 45
6.7 How Do I submit a Question or Report a Suspected Error? ........................................ 46
6.8 New Drug Requests ..................................................................................................... 47
6.8.1 WHO Drug Dictionary Enhanced Update Request ............................................... 47
6.9 CRO - Sponsor relationship ......................................................................................... 50
www.umc-products.com
WHO Drug Dictionary User Guide
2015
Page 3 (51)
1. Getting Started
This guide describes the WHO Drug Dictionary Enhanced, the WHO Drug Dictionary
Enhanced extended with the WHO Herbal Dictionary and the WHO Drug Dictionary –
together known as the WHO Drug Dictionaries.
As a user of the WHO Drug Dictionaries you will find that the basic principles of the
dictionaries are quite straight forward. You have a verbatim drug name in your clinical, or
safety data that you want to code, you find it in the dictionary which translates the name
into information such as active ingredients and therapeutic use.
The dictionary should be as comprehensive as possible with drugs from all regions where
you conduct trials and collect safety information from. The dictionaries should also be
accurate, up-to- date and contain features that facilitate coding and reporting.
However, you will find that there are cases when things aren't that straight forward - the
same name may be used for different products in different countries, products may have
changed their composition over the years without changing their names.
This guide will help you get started if you are a new user, or get a deeper understanding if
you are an experienced user. You will find that each chapter is divided into an introduction
and "read more" sections. Depending on your area of expertise you may look into all or
only a few of these sections.
You will also find a section about the practical aspects of being a dictionary subscriber how you can download the latest version of the data files, how you can submit a
suggestion etc.
A section called "Practices" contains descriptions about how you can use the dictionary in
different situations. This section will grow over time and there will be different Practices
for coders, analysts and for data maintenance staff.
We encourage you to read the texts and use the comment fields if you have any comments
or questions – your input can make the guide even more comprehensive and useful!
This Guide does not contain any descriptions of the data files in which the data is
distributed. If you are interested in the details or if you are a developer of a software
system in which the dictionary is a part you can enroll in the UMC Software Certification
Program.
www.umc-products.com
WHO Drug Dictionary User Guide
2015
Page 4 (51)
1.1 Use of the Dictionary
The main purpose of the dictionary is to identify concomitant medication and to use the
collected data in analysis, communication and other value added processes.
The front-end of the dictionary is basically just a list of trade names – when you find a
name that corresponds to the name mentioned in a verbatim you just select it.
Once you have a body of data, you can use the classifications included in the dictionary for
analysis. The selected drug names are translated into a code system which will give you
information about the patients or trial subjects that can give you an insight of how your
drug works under study.
Some data elements – beside the drug name – are useful when a drug entry is selected in
the coding. Sometimes the same name appears more than once and these data elements
are useful to make the correct assignments.
1.2 Different Uses – Clinical and Safety
The WHO Drug Dictionaries are used within two main areas – Pharmacovigilance and
clinical trials. There are many similarities in the use in these two areas – but there are also
differences.
The similarities are that the dictionary is used to identify and code concomitant medication
both in clinical trials and drug safety reporting. The differences are how the collected and
coded data is used, but the mode of coding is also often different; coding in clinical trials is
often done in group – using auto-encoders, whereas in Pharmacovigilance the process is
often manual.
In clinical trials a common use is to identify protocol violations, whereas the use in
Pharmacovigilance is to find signals – either interactions or co-suspects.
In Pharmacovigilance the main use of concomitant medication information is to identify
potential interactions or possible co-suspected drugs.
1.3 Different Software Solutions
This guide describes the WHO Drug Dictionaries in a general way, the features, codes and
nomenclature as provided by the Uppsala Monitoring Centre.
The dictionary data is distributed in a format that makes it possible to upload it to any
software system for coding, reporting or analysis – both home-built and commercial.
These software systems have different kinds of functionalities – some features in the
dictionary may not be included in the system you are using, or other nomenclature may be
used.
www.umc-products.com
WHO Drug Dictionary User Guide
2015
Page 5 (51)
In order to harmonize the implementation and use of the dictionaries – and to help
software developers get the most out of the dictionary – the UMC has set-up a Software
Certification Programme. Read more about the programme on www.umc-products.com
1.4 Important Common Questions
To fully appreciate the potential for data storage and analysis, it is important for the
users/you to know what kind of information can be captured, and how the linked
information and the hierarchies of a drug dictionary work.
To make an effective use of the WHO Drug Dictionaries, we recommend a discussion
involving all the stakeholders when making important decisions for your organization.
Stakeholders within an organisation who are involved in the management and the use of
drug dictionary information, we are referring to clinical data managers, IT/IS managers,
and data entry personnel representing primary users; biostatisticians, analysts and decision
makers representing the end-users.
Shared Decisions and Questions
A number of topics are covered in this guide but a few needs should be discussed by all
stakeholders. It is important that the end-users of the data know what the coders can
collect and enter into the clinical case or safety reports in order to fully understand the
data they analyze.
It is important that the clinical data managers knows how the statisticians are using the
data in order to prioritize the coding of items that are useful in an analysis.
Other important questions are more strategic such as: What dictionary type and dictionary
format should your Organization use?
There are a number of decisions that needs to be made to optimize the use of the
dictionaries within your organization. Here are some questions that should be discussed:
•
•
•
•
•
•
•
What Dictionary type should the organization subscribe to? The UMC provides
three dictionaries, which dictionary suits your company best?
The dictionaries are available in different Dictionary formats. Which dictionary
format should your company use? The C-format has a number of benefits – you
need to decide if and how to implement it.
The C-format contains two coding systems. Which one should be used?
Which of the dictionaries would you manage the best?
How should your organization use the ATC classification in an effective way?
You can suggest entries to the dictionary if something is missing. How should your
organisation best use the New Drug Request Service?
Should your organisation use the WHO Drug Dictionary Browser?
www.umc-products.com
WHO Drug Dictionary User Guide
2015
Page 6 (51)
1.5 Development Principles
This section describes important issues encountered by organizations that collect and
interpret information about concomitant medication in clinical trials – issues that have
been the guiding principles in the development of the WHO Drug Dictionary Enhanced.
Patients and clinical trial subjects often take other drugs apart from the trial substance.
This may confound the outcome of the study – and many organizations choose to exclude
subject that take certain drugs in their studies or exclude them from certain types of
analysis.
The information about the concomitant medication can be of high value – since this
information can be an important clue to how the trial substance will work once it is on the
market and both positive and negative interactions can be discovered.
Important Concerns
Global
The world is getting more and more integrated – people travel more than ever and
medicinal products are being sold over the internet without any geographical restrictions.
This is important to keep in mind when collecting information about concomitant
medication – drugs taken by the subjects may come from any country, not just the country
where the trial is conducted.
When a drug name is mentioned in a verbatim it is important to have a global source –
which makes it possible to distinguish which products are available in different markets.
Up-to-date
Many new drugs are launched every year and many drugs change their composition or
other important properties. Even if a drug name has been identified in a verbatim and it
has been found to contain a certain active ingredient this may not be true in the future.
The product may have other active ingredients – or the same trade name may have been
used for a completely different product in another country.
Organization without a comprehensive drug dictionary that make ad-hoc investigations
when drug names appear in concomitant medication verbatims may miss the fact that a
product has changed or that alternative products are available. When analyzing
concomitant medication it is important that the selected product is correct – that it reflects
the active ingredients taken by the trial subject.
www.umc-products.com
WHO Drug Dictionary User Guide
2015
Page 7 (51)
Harmonized
Clinical data is often shared between regions and organization. In order for all parties to
interpret the data in the same way the same dictionary should be used and the same
principles for classification should be used throughout the dictionary.
If an organization conducts a trial and later collaborates with – or even sells the product to
– another organization, the value of the clinical data will increase if internationally
accepted standards have been used.
Structured
The most important issue in the coding and interpretation of concomitant medication data
is that trade names are mapped to their active ingredients. It is also important that these
products and substances are placed in a hierarchical classification. This makes it possible to
select whole groups of products that should be avoided in a specific trial – so called
protocol violation lists. The hierarchies also make it possible to aggregate statistics in order
to analyze the data and find patterns.
The WHO Drug Dictionary Enhanced
The need for an international, structured dictionary for medicinal product information was
identified by the WHO in the 1960’s. The dictionary was first used in drug safety
monitoring, but it was soon accepted by the life sciences as an important tool in other
areas – especially clinical development. The WHO Drug Dictionary Enhanced is an
information service that is used for coding, communication and analysis of drug
information.
The dictionary is maintained by Uppsala Monitoring Centre (UMC), which is the field name
for the WHO Programme for International Drug Monitoring. The organization is in the
center of a network of regulatory agencies in over 100 countries. These regulatory
agencies provide the UMC with reliable sources with information about products available
in their countries. The UMC also collaborate with IMS Health that collect product
information from 63 countries - and other reliable sources are frequently used to find or to
verify information about medicinal products.
In order to optimise the dictionaries and to ensure that they meet the requirements from
new legislation or changing user needs. The development of the dictionary is driven by the
user community and new tools for analysis and classification are added. The UMC is also
active in relevant standardization organizations.
www.umc-products.com
WHO Drug Dictionary User Guide
2015
Page 8 (51)
2. The WHO Drug Dictionaries
The dictionaries contain information about medicinal products and there are a lot of data
elements that describe each entry – the most important are the drug name and the active
ingredient. Depending on your set-up you can access different data elements, but this
guide describes the dictionary from a general perspective.
The data elements can be divided into two categories; information that is useful in order to
select the right entry in the coding phase, and elements and classifications that can be
used in the analysis and interpretation of the collected data.
2.1 The Content
The UMC is collaborating with IMS Health. IMS Health is an organization that collects
global drug-utilization data, including product information and product names, active
ingredients, forms, strengths and classifications in over 100 countries. This product
information is the basis for new entries in WHO Drug Dictionary Enhanced and WHO
Herbal Dictionary.
All product information that is entered into the dictionaries is quality assured in a process
that includes verification in at least one additional data source. The additional data sources
are national drug information submitted by regulators that participate in the WHO
Programme for International Drug Monitoring, national drug compendia or other reliable
international sources.
All drugs in the WHO Drug Dictionary and the WHO Drug Dictionary Enhanced are classified
according to the Anatomical Therapeutic Chemical classification – ATC. Through this
hierarchical way of grouping, it is possible to analyze medicinal products and the data
according to therapeutic usage, to pharmacological sites of action and aspects of chemical
structure and/or some combination of those.
The type of Products in the WHO Drug Dictionary /WHO Drug Dictionary Enhanced
•
•
•
•
•
•
•
•
•
Medicinal product
Herbal remedy
Vaccine
Dietary supplement
Radio-pharmaceutical
Blood product
Diagnostic agent
Homeopatic remedy
Galenic drugs, ex tempore
www.umc-products.com
WHO Drug Dictionary User Guide
2015
Page 9 (51)
Only products intended for medical use on humans are entered into the dictionaries. Some
products may be classified as a medicinal product by one country but not by another, for
example biological products. These are entered according to their classification in the
national drug compendia.
Since 2005 all new herbs are only entered into the WHO Herbal Dictionary and herbal
remedies are the only product type in the WHO Herbal Dictionary.
2.2 Types and Formats
In this guide we frequently refer to ‘dictionary types’ and ‘dictionary formats’. It is
important that you don’t confuse the two concepts.
This guide describes the features of the WHO Drug Dictionaries and they sometimes refer
to features that are available in a particular dictionary format or dictionary type. Keep this
in mind – if a feature is described and you cannot access, the reason could be the set-up
chosen by your organization.
The dictionary is presented in different ways in different software systems, and the
terminology may differ from the official UMC terms.
The Dictionary Types
The difference between the dictionary types and dictionary formats is the drug entries that
are included – the type of drugs or the number of drugs.
The two dictionary types are the WHO Drug Dictionary Enhanced and the WHO Herbal
Dictionary, which is an extension of the WHO Drug Dictionary Enhanced.
The original WHO Drug Dictionary contains only a small subset/division of entries in the
other two dictionaries. The dictionary is only available for organizations that have not
upgraded to the WHO Drug Dictionary Enhanced and WHO Herbal dictionary, an
extension/addition to the WHO Drug Dictionary Enhanced.
The Dictionary Formats
The difference between the dictionary formats is the amount of information available per
drug - the level of detail in which it is described.
The WHO Drug Dictionaries are distributed in two dictionary formats, the B-format and the
C-format.
The dictionary formats represents the data differently by using different table structures
and different data fields. The different data fields make it possible to allow many entries to
be included in the C-format that cannot be included in the B-format.
www.umc-products.com
WHO Drug Dictionary User Guide
2015
Page 10 (51)
The C format contains additional data elements compared to the B-format – especially
elements that is useful in the selection of entries in the coding phase.
The dictionary formats are available to all customers.
2.2.1 The Dictionary Types
WHO Drug Dictionary Enhanced is the dictionary that contains conventional drugs, even if
some herbal products are included. A large part of the data is provided by IMS Health, and
it covers product names, active ingredients, forms, strengths and classifications for
products from over 100 countries.
IMS Health is an organisation that collects global drug-utilisation data, including product
information. The IMS Health data has been processed and put into the structure of the
WHO Drug Dictionaries and it has been coded with the dictionary’s codes and IDs as well as
the ATC classification.
The data from IMS Health also keep the dictionary up-to-date with new drug launches and
modifications to the existing drugs. The fast and frequent update of the dictionary ensures
that drugs are entered soon after (and sometimes before) their launch. This can be
compared with the original WHO Drug Dictionary which includes drugs when they have
appeared in ADR reports sent to the WHO ADR database.
The WHO Drug Dictionary Enhanced is coded with the Anatomical Therapeutic Chemical
classification (ATC).
The WHO Herbal Dictionary allows the correct coding, classification and analysis of herbal
products and their adverse drug reactions and interactions. The need has arisen out of the
growing popularity of drugs of natural origin – herbal remedies – and the increased risk of
serious interactions between conventional products and herbal products.
The WHO Herbal Dictionary is available as an extension of WHO Drug Dictionary Enhanced
in which the herbal and conventional drugs are seamlessly integrated. The herbal drugs are
classified according to the Herbal ATC classification which is built on the conventional ATC
classification. This makes it possible to analyse coded data using the combined ATC/Herbal
ATC without having to differentiate between the two product types.
This dictionary type makes coding easy since they together contain the highest proportion
of all drugs used in the world. This reduces the need for manual investigations, increases
the quality of the coded data and makes it possible to analyse all types of products using
the combined ATC/Herbal ATC.
The WHO Herbal Dictionary was introduced in 2005 in order to better represent drugs of
natural origin – herbals. The UMC has entered herbal products into the WHO Drug
www.umc-products.com
WHO Drug Dictionary User Guide
2015
Page 11 (51)
Dictionary for many years. The WHO Herbal Dictionary was introduced to allow better
coding of herbal information and thus better understand how these affect other medicinal
products.
The WHO Herbal Dictionary contains all the herbal entries that have been entered into
WHO Drug Dictionary over the years. From 2005 all herbals are included exclusively in the
WHO Herbal Dictionary.
The WHO Drug Dictionary was the only dictionary type available until 2005 when the WHO
Drug Dictionary Enhanced and WHO Herbal Dictionary were introduced.
The WHO Drug Dictionary is only available for customers that have subscribed to the
dictionary before 2005 and who have not yet upgraded to the WHO Drug Dictionary
Enhanced. All entries in the WHO Drug Dictionary are also included in WHO Drug
Dictionary Enhanced.
The WHO Drug Dictionary does not contain the data from IMS Health, but drugs from other
sources and drugs that have appeared in ADR reports from any of the countries in the
WHO Programme, will be added.
The WHO Drug Dictionary is coded with the Anatomical Therapeutic Chemical classification
(ATC).
To see the number of entries in the different dictionary types – please read the Dictionary
Type statistics page (updated quarterly)
New subscribers will automatically receive the WHO Drug Dictionary Enhanced. From
2005, WHO Drug Dictionary is available only to customers that have started their
subscription before 2005 and have not yet upgraded to WHO Drug Dictionary Enhanced.
2.2.2 Dictionary Formats
When the WHO Drug Dictionaries were created in the 1960’s they only contained the most
basic information about each product. In 2005 a new format was introduced which gives
you access to more information about the products in the dictionary – which will be useful
in the coding process and the analysis of the coded data. Both the old (B-format) and the
new (C-format) are available in parallel. All Dictionary types are available in both formats.
The B-format is a dictionary of drug names. A verbatim name can be compared to this list
of names – and the dictionary will return information that is useful for coding and analysis:
a unique code (The Drug Code), the active ingredient(s) and the Anatomical Therapeutic
Chemical class(es) that the drug belongs to. Unfortunately names that appear in verbatims
often refer to more than one entry in the B format – it can be available with different
ingredients in different countries, in different pharmaceutical forms etc. The fact that the
www.umc-products.com
WHO Drug Dictionary User Guide
2015
Page 12 (51)
same drug name can refer to different products with different active ingredients is known
as non-unique names. The C format was introduced to help coders and other users of the
dictionary to understand the difference between the non-unique names.
The more detailed information in the C-format is useful in the coding of medical data. The
additional information – such as country, pharmaceutical form and strength – is sometimes
important in order to chose the right entry and get the codes and classifications that best
represents the drug.
The C-format enables optimized coding and analysis of clinical and regulatory data by
distinguishing between products in different countries and in different dosage forms and
strengths. This may be of importance for an in-depth analysis of a safety problem. It is
possible to identify reactions that are caused by specific pharmaceutical forms or related
to the route of administration, and to compare them with other forms of the same product
or route of administration.
2.2.3 The benefits of the WHO Herbal Dictionary
In Germany more than 70% of the population uses natural medicines. For most of them
herbal medicinal products are first choices in treatment of minor diseases or disorders, e.g.
colds, headaches, sleeping disorders. (www.ifd-allensbach.de)
In USA the usage of herbal remedies increased by 380% between 1990 and 1997 (JAMA
1998)
A US survey showed that 18,4% of patients on regular prescription medication also use at
least one herbal or high-dose vitamin - 61,5% of these do not inform their physician.
(JAMA, 1998)
The growing popularity of drugs of natural origin – herbal remedies- is a challenge that can
no longer be ignored by the drug safety community, including the pharmaceutical industry.
The herbal remedies might cause adverse events by themselves, but they are also affecting
other medical treatments. In order to understand the effect of a medicinal product in the
general population the industry and regulators must fully understand the concomitant
medications used by their patients.
Although the therapeutic value of many herbals may be well recognized, herbal medicinal
products, with few exceptions, is not part of the same regulatory framework as
conventional medicinal products, and have not gone through the same rigorous scientific
testing for efficacy and safety. As there is a growing awareness that herbal products may
cause harm just like conventional medicinal products, there is a need for effective risk
management strategies to cover herbal products.
www.umc-products.com
WHO Drug Dictionary User Guide
2015
Page 13 (51)
Since herbal remedies are not always part of the regulatory framework it is especially
important that the pharmaceutical industry and the regulatory authorities monitor the
effect these products have on regulated medicinal products.
To enable herbal drug utilisation research and safety monitoring, the existing systems for
capture, storage and analysis of data need to be adapted to accommodate relevant
information on herbal products; the safety issues associated with the use of herbal
products and their public health impact have to be evaluated and communicated.
In order to address this issue UMC Products & Services produces a new unique
classification system – the Herbal Anatomical Therapeutic Chemical (H-ATC) classification and the WHO Herbal Dictionary with information about herbal products.
The WHO Herbal Dictionary is the first international dictionary of herbal products. The
dictionary is used for identifying the names of herbal products, their active ingredients and
therapeutic use, in the course of their drug safety surveillance. It translates a drug name to
useful information, which is used for coding and analysis of drug safety data – both preand post- marketing.
The WHO Herbal Dictionary will help you:
•
•
•
Find the trade names of herbal products and code them in your clinical data.
Translate the Trade Name into active ingredients – plants, parts of plants and
extraction types.
Analyse the coded data by using the new unique Herbal ATC classification.
And thereby help you to identify patterns, increase your understanding of how herbal
products may influence the action of your product and allow you to take necessary action.
St. John’s Wort
In 1998 and 1999 a number of suspected interactions between the commonly used antidepressant St. John’s Wort (Hypericum perforatum L.) and other drugs were identified. In
the years that followed a number of studies were conducted and adverse event reports
were analysed with the possible interaction with St. John’s Wort in mind.
•
•
A number of pregnancies were reported for women taking oral contraceptives and
products containing St. John’s Wort
St. John’s Wort has been shown to reduce the serum concentration of the anti-HIV
drug Inidavir (Crixivan). The suboptimal concentration may reduce the effect of the
drug, and even increase the risk of the development of resistance of the HIV virus
to Inidavir.
www.umc-products.com
WHO Drug Dictionary User Guide
2015
Page 14 (51)
•
•
A few cases indicate that the use of St. John’s Wort has reduced the effect of
Cyclosporin, which has caused rejection of transplanted hearts.
The herb has also been shown to reduce the serum concentrations of warfarin and
some statins (simvastatin and atorvastatin).
Most products affected have added precautions about concomitant use of St. John’s Wort
to the labelling and SPCs.
Many of these interactions are serious or potentially serious. Unless the interactions with
St. John’s Wort had been found other conclusions may have been drawn.
The St. John’s Wort incident illustrates the importance of knowing as much as possible
about the concomitant medications taken when adverse events are detected. The WHO
Drug Dictionary has been used for many years to help companies and regulators
understand the concomitant medication in studies and spontaneous reports. The new
WHO Herbal Dictionary will make the same kind of analysis possible for concomitant
medication of herbal remedies.
2.2.4 About the Dictionary Formats
All WHO Drug Dictionaries – the WHO Drug Dictionary, WHO Drug Dictionary Enhanced
and the WHO Drug Dictionary Enhanced extended with the WHO Herbal Dictionary – are
distributed in two dictionary formats. The dictionary formats are different ways of
representing the data – using different table structures and different data fields. The
different data fields makes it possible to allow many entries to be included in the C-format
that cannot be included in the B-format since the additional data fields allow individual
dictionary entries for specific form and strength variations of the drugs, and country
specific information.
All dictionary formats are available to all customers; even if your organization is using the
B-format you also have access to the C-format when you download your dictionary files.
You can also get access to all C-format features if you use the WHO Drug Dictionary
Browser
The A format (discontinued)
The dictionary format that was available between 1992 and 2002 is referred to as the A
format. It was a dictionary of drug names. It was used to find the active ingredients and
therapeutic use (through the ATC classification) of a given drug name.
The B-format
In 2002 some minor changes were made to the A format – and it was renamed the B
format. The unique identifier in the B-format (as well as in the A format) is the Drug Code.
www.umc-products.com
WHO Drug Dictionary User Guide
2015
Page 15 (51)
The B-format was made available in two versions – the B-1 and B-2 formats, with different
inclusion criteria. The B-2 format contains the same type of entries as the A format, and
the name and the Drug Code is always unique.
The B-1 format is discontinued since 2009. It had previously been used as a reference for
some users, but when the WHO Drug Dictionary Browser was introduced it replaced the
need for the B-1 format.
The B formats translate a drug name into more useful information – active ingredients,
Drug Codes, ATC codes etc.
The B-format is country independent and does not contain information about
pharmaceutical form or strength.
The C-format
In 2002 a new dictionary format was introduced – known as the C format.
The new dictionary format contains information about the drugs as they are marketed in
different countries and it also contains information about the pharmaceutical form.
The C-format contains many more entries than the B-format. One single drug name (one
entry in the B-format) is multiplied by the number of countries it is available in. For each
drug name there are entries for each pharmaceutical form, strength, and market
authorization (license) holder – and in some cases additional variants due to e.g. patient
group.
The unique identifier in the C-format is the Medicinal Product ID. The Drug Code system is
also included in the C-format.
The C-format makes it possible to code with different levels of precision – using a system
called information levels.
The added value of the C-format is that it helps the coders find the correct entry when the
drug name is available with different ingredients in different countries or in different
pharmaceutical forms.
The reason many organisations still use the B format is because many of the software
packages doesn’t support the C-format. The WHO Drug Dictionary Browser has been
developed to help users of the B-format access features of the C-format.
2.2.5 The Information Levels in the C-format
The C-format allows precise characterisation of medicinal products. However, when
concomitant medication is recorded in a case report detailed information is not always
available. Often only the name of the drug is given, but sometimes additional information,
www.umc-products.com
WHO Drug Dictionary User Guide
2015
Page 16 (51)
like country and pharmaceutical form are important to make sure that the right code is
used. Therefore a system of different levels of precision - information levels - is
implemented in the C format.
When an entry is made into the WHO Drug Dictionaries it contains information about the
drug name, active ingredients, pharmaceutical form, strength, country etc. Based on the
recorded data a number of additional entries are created – one where the information
about strength is set to unknown, one with the pharmaceutical form set to unknown etc.
The least specific entry includes only information about the drug name and the active
ingredients.
Info
level
Drug
Code
Name
Name
Specifi
er
Count
ry
MA
H
For
m
1
X
X
2
X
X
(X)
3
X
X
(X)
X
4
X
X
(X)
X
X
5
X
X
(X)
X
X
X
6
X
X
(X)
X
X
X
Strengt
h
X
Notice that the table above illustrates the most common information levels. A few entries
have other combinations of data fields.
The complete data entry contains the data in information level 6. Based on this entry a
number of less specific entries are generated automatically – levels 1, 3, 4 and 5.
Level 2 is often not generated since the name specifier is left empty in the levels where the
corresponding information (strength, pharmaceutical form or company) is no longer
included. E.g. a name specifier that refers to the pharmaceutical form will not be used in
levels 4 and below.
Not all products are available in all six information levels. Entries made before 2002 were
entered in levels 1-4.
www.umc-products.com
WHO Drug Dictionary User Guide
2015
Page 17 (51)
An example of a product that is available in different information levels:
MP ID
Drug Code Name
067763
00544101
003
123647
MAH
Country
Pharm Form
Bezalip
Not
Specified
Unspecified
Unspecified
00544101
003
Bezalip
Hoffmann
Canada
Unspecified
00544101
003
Bezalip
Canada
Coated
tablets
00544101
003
Bezalip
Canada
Coated
tablets
067762
00544101
003
Bezalip
Roche
Nederland
bv
Netherlands
Unspecified
069815
00544101
003
Bezalip
Retard
Roche
Nederland
bv
Netherlands
Coated
tablets
069814
00544101
003
Bezalip
Retard
Roche
Nederland
bv
Netherlands
Coated
tablets
123646
123645
Name
Specifi
er
Streng
th
-la Roche
limited
SR
Hoffmann
-la Roche
limited
SR
400MG
Hoffmann
-la Roche
limited
400
mg
400
mg
067763 is the least specific, information level 1.
123647 also contain information about country and MAH – this is information level 4.
123646, 069815 and 069815 are level 5.
123645 and 069814 contain all data – they are on information level 6.
www.umc-products.com
WHO Drug Dictionary User Guide
2015
Page 18 (51)
2. 3 How to Identify Types of Entries
Preffered names
The Drug Code is a three tier hierarchy which is an aggregation of Drug Record Number
(Drecno), Sequence Number 1 and Sequence Number 2.
The three tier hierarchy – which is described in more detail in the section ‘Drug Code’ –
guarantees that no trade name entry can exist without reference to its preferred name
entry and its preferred salt entry.
The preferred names in the WHO Drug Dictionaries are the names of the top level entries
in the Drug Code hierarchy.
The Preferred name entries are entries that have the value ‘001’ in the field Sequence
Number 2.
The preferred name entries can be subdivided into Preferred base entries – entries that
have the value ‘01’ in the field Sequence number 1, and Preferred Salt entries that have
values higher than 001 in the Sequence number 1.
Generic Names
In order to identify if an entry is generic or the B and the C formats have slightly different
approach. The B format has a fields called Designation which gives you information about if
an entry is generic and if it is a multi-ingredient entry.
Generic
Non-generic
Number of Ingredients = 1
N
T
Number of Ingredients > 1
X
M
The C-format has a field called Generic which can include the values Y (Yes) or N (No).
Example:
Drecno
Seq
1
Seq 2
Name
Generic
Designation
000200
01
001
Paracetamol
Y
N
000200
01
009
Acetaminophe
n
Y
N
000200
01
002
Dymadon
N
T
www.umc-products.com
WHO Drug Dictionary User Guide
2015
Page 19 (51)
Acetaminophen is a synonym to paracetamol. It is a generic name but it is not the
preferred name since it is not the name used in the INN standard which is the name
standard that is preferred in the WHO Drug Dictionary Enhanced. The acetaminophen
entry is therefore given a Seq 2 higher than 001.
•
•
•
Paracetamol is Generic and Preferred
Acetaminophen is Generic but not Preferred
Dymadon is neither Generic nor Preferred.
Multi-ingredient entries can also be both preferred and generic.
Drecno
Seq
1
Seq
2
Name
Generic
Designation
008926
01
001
Duocid
N
M
008926
01
002
Penactam
N
M
008926
01
007
Ampicillin
w/sulbactam
Y
X
In this multi-ingredient combination of active ingredients there exists an entry which refers
to the non-proprietary names.
•
•
•
Duocid is not Generic, but it is Preferred
Pentacam is neither Generic nor Preferred
Ampicillin w/sulbactam is Generic but not Preferred
Trade Names
Trade names can be seen as entries that are non-generic. To identify if a product is a trade
name you can use the opposite approach to when you identify a generic entry.
The B-format these entries have the values T or M in the Designation field. In the C format
they have the value N in the Generic field.
Umbrella Entries
Umbrella entries are referring to classes of drugs and can be used if a verbatim only
contains imprecise information about the concomitant medication – generally only the
class of drugs.
The Umbrella entries can be divided into two categories: therapeutic classes and substance
classes.
www.umc-products.com
WHO Drug Dictionary User Guide
2015
Page 20 (51)
The therapeutic classes are often based on an ATC class – e.g. Antacids
These entries can be identified by looking at the Drug Code – which starts with a 9.
The substance classes are used when the verbatim contains information about a family of
substances – e.g. Penicillin.
Both the name of these entries and their active ingredients contain the abbreviation NOS,
Not Otherwise Specified.
The substance with the NOS text can be identified – they have a code that starts with 81 in
the CAS field.
3. Codes and IDs
The WHO Drug Dictionaries contains a large number of data fields that contain information
about the Medicinal Products. This information is used to identify a product that should be
coded in a database, e.g. for clinical trial data or drug safety data.
The WHO Drug Dictionary contains two types of IDs that can be used as links between the
case reports in the Clinical trials database/Drug Safety database and the WHO Drug
Dictionaries. The Medicinal Product ID identifies an entry in the C format of the dictionary.
The Drug Code is the unique identifier in the B format and it is also included in the C
format.
3.1 The Drug Code
A Drug Code identifies a name, either a trade name or a generic name. The Drug Code is
the primary key in the B-2 format and it is used also in the C-format.
The Drug Code is a three tier hierarchy which is an aggregation of Drug Record Number
(Drecno), Sequence Number 1 and Sequence Number 2. The code is not only a unique
identifier of a name – it also gives information about the active ingredient(s) and salt/ester
form of the substance. In herbal products and insulin’s the Drug Code can identify other
sub-classification of the main ingredient.
The three tier hierarchy – which is described in more detail in the section ‘Drug Code’ –
guarantees that no trade name entry can exist without reference to its preferred name
entry and its sub-classification.
A Drug Code always consists of eleven figures.
The Preferred name entries are entries that have the value ‘001’ in the field Sequence
Number 2.
www.umc-products.com
WHO Drug Dictionary User Guide
2015
Page 21 (51)
The preferred name entries can be subdivided into Preferred base entries – entries that
have the value ‘01’ in the field Sequence number 1, and Preferred Salt entries that have
values higher than 001 in the Sequence number 1.
3.1.1 Drug Record Number
The Drug record numbers (drecno) is the primary part of the Drug Code classification. The
drecno refers to different types of information depending on the type of product – in
conventional drugs they refer to the active ingredient (molecule), in herbal products they
refer to the plant and in Insulins they refer to the origin of the insulin or the insulin
analogue – e.g. Insulin bovine, Insulin lispro.
Entries with the same drecno contain the same active ingredient or unique combination of
active ingredients etc.
Example
Drecno
Seq 1 Seq 2
Name
000005
01
001
Ampicillin
000200
01
001
Paracetamol
The two examples above have different Drug Record Numbers which means that they
contain different active ingredients – ampicillin and paracetamol.
All entries containing only ampicillin will have the same Drug Record Number – regardless
of the salts of the substance, different trade names and different countries.
3.1.2 Sequence Number 1
The Sequence Number 1 (Seq1) is the secondary classification in the Drug Code; it is used
to allow sub-classifications of the information – active ingredient etc – recorded in the
drecno. The Seq1 refers to different kinds of information depending on the type of product
– in conventional drugs they refer to salt or ester forms of the active ingredient, in herbal
products they refer to the plant part and extraction method and in insulin they refer to any
modification made to the base substance including substances which are described as
crystalline, amorphous or compound. Other biologicals have similar secondary
classifications.
Entries with the same Drecno and Seq1 contain the same active – salt/ester form of active
ingredient, part of planet etc.
www.umc-products.com
WHO Drug Dictionary User Guide
2015
Page 22 (51)
The value in the Seq1 can be 01 or higher. Entries with the value 01 identifies the entry
that refers to the active entity, if the value is higher it refers to a sub-class. In the name
field in the dictionary you will find the name of the primary or secondary active entity.
Example:
Drecno
Seq 1
Seq 2
Name
000005
01
001
Ampicillin
000005
02
001
Ampicillin sodium
000005
03
001
Ampicillin trihydrate
The three entries all have the same active ingredient – ampicillin, but in different salt
forms, sodium and trihydrate. They all have the same Drug Record Number - 000005.
All entries containing only ampicillin sodium will have the same Drug Record Number and
Sequence Number 1, regardless of the different trade names and different countries –
00000502.
Drug Record Numbers that identify multi-ingredient entries will have only one Sequence
Number 1 with value ‘01’.
3.1.3 Sequence Number 2
The Sequence Number 2 (Seq2) is the tertiary level in the Drug Code. It identifies if an
entry is a preferred name entry or a trade name entry and in some cases synonyms to
generic names, e.g. acetaminophen as a synonym to Paracetamol.
The entry with Sequence Number 2 value ‘001’ identifies the name of the preferred name
of the substance (Drug Record Number) or substance and salt (Drug Record Number and
Sequence Number 1).
•
•
In single ingredient Drug Record Numbers this will be the INN name for
conventional substances or accepted scientific name of herbal substances.
In multi ingredient Drug Record Numbers it will be the name of the first product
with the given combination that was entered into the dictionary, often a trade
name.
Example:
Drecno
Seq 1
www.umc-products.com
Seq 2
Name
WHO Drug Dictionary User Guide
2015
Page 23 (51)
000005
01
001
Ampicillin
000005
01
002
Ampicin
000005
01
003
Binotal
000005
02
001
Ampicillin sodium
000005
02
002
Binotal
000005
02
003
Polycillin-n
All entries in the example contain ampicillin. The first three entries contain ampicillin in its
base form but the following three contain ampicillin sodium.
3.1.4 Multi-ingredient Products
Multi ingredient products – products with more than one active ingredient- need to have a
separate coding principle. It is not always possible to include the names of all active
ingredients in the name field, so the first entry with the unique combination of ingredients
will be the preferred name even though it is not always a generic name.
Example:
MP ID
Drecno
Seq 1
Seq 2
Name
Generic
098204
001903
01
001
Ampiclox N
098205
001903
01
002
Sinteclox
N
The entries 098204 and 098205 are multi-ingredient products. The entry with seq 1 = 01
and seq 2 = 001 is the preferred name but it is not generic.
Read more in the section Preferred vs. Generic
3.1.5 The use of Drug Code in the WHO Herbal Dictionary
For conventional medicinal products the Drug Record Number identifies the active
ingredient, or unique combination of active ingredients, Sequence Number 1 identifies the
salt or the ester of the active ingredient and Sequence Number 2 identifies a specific drug
name.
Herbal products in WHO Herbal Dictionary, WHO Drug Dictionary and WHO Drug
Dictionary Enhanced use the fields in a corresponding way. The Drug Record Number is
www.umc-products.com
WHO Drug Dictionary User Guide
2015
Page 24 (51)
used to identify plants instead of the ingredients, and Sequence Number 1 is used to
identify plant parts or extractions instead of salts and esters.
This means that e.g. Atropa belladonna is given a Drug Record number – 015687, the ‘root
dry extract’ of Atropa belladonna is given the Drug Record Number 015687 and the
Sequence 1 is 03. In the example below Tremoforat is the trade name of a product that
contains the dry extract of the root of Atropa belladonna.
Drecno
Seq 1
Seq 2
Name
015687 01
001
ATROPA BELLADONNA
015687 03
001
ATROPA BELLADONNA ROOT DRY EXTRACT
015687 03
002
TREMOFORAT
3.2 The Medicinal Product ID
The Medicinal Product ID is unique for each entry in the C format. The ID is just a ‘numeric
name’ of the medicinal product and it has no intrinsic meaning.
When the Medicinal Product ID is used as a link between the dictionary and the case
reports it allows retrieval of all relevant information from the drug/herbal dictionary simply
by identifying the corresponding entry in the dictionary together with all its data elements
that can be used for classification, interpretation and analysis of the coded data.
3.2.1 The Medicinal Product ID
The Medicinal Product ID is unique for each entry in the C-format. The ID is just a ‘numeric
name’ of the medicinal product and it has no intrinsic meaning. The Medicinal Product ID
identifies a unique combination of the following information:
•
•
•
•
•
•
•
Medicinal Product Name
Name Specifier
Drug Code (Drug Record Number + Sequence 1 + Sequence 2)
Market Authorization Holder
Country
Pharmaceutical form, available as Sequence Number 3 and Pharmaceutical Form in
the Pharmaceutical Product table
Strength available, as Sequence Number 4 and quantity and unit of active
ingredient/s in the Ingredient table.
www.umc-products.com
WHO Drug Dictionary User Guide
2015
Page 25 (51)
This means that there cannot be two entries that are identical in all seven fields. If one of
them is different it counts as a new ‘Unique entry’.
•
•
•
•
•
The same name appears in several countries.
Within a country the Trade name is available in several pharmaceutical forms.
Each of the pharmaceutical forms is available in different strengths.
The product can be marketed by different market authorization (license) holders
(especially generics).
Sometimes there are special versions of the products that are available for
different patient groups etc.
Notice that all entries in the dictionary do not contain all the seven pieces of information.
The minimum information is Medicinal Product Name and Drug Code – the remaining
fields will be set to unspecified. The reason the Drug Code is listed is because the entries
with minimum of data and the name can appear in products with different ingredients.
Example:
MP ID
Drug Code
Name
Name
Specifier
MAH
Country
Pharm.
Form
Strength
(Seq 4)
(Seq 3)
067763 00544101003 Bezalip
Not
Specified
Unspecifie
d
Unspecified
123647 00544101003 Bezalip
Hoffmann
Canada
Unspecified
Canada
Coated
tablets
Canada
Coated
tablets
-la roche
limited
123646 00544101003 Bezalip
SR
Hoffmann
-la roche
limited
123645 00544101003 Bezalip
www.umc-products.com
SR
400MG
Hoffmann
-la roche
limited
WHO Drug Dictionary User Guide
2015
400 mg
Page 26 (51)
In the example several entries are available for the drug called Bezalip. The entry with
Medicinal Product ID 067763 holds only information about the name and the active
ingredient(s) – through the Drug Code. The Medicinal Product IDs,
123647
123646
123645
These Medicinal Product IDs identify related entries with increasing amount of data.
4. General Principles
In order for the dictionary to accurately describe the world of product information there
are a number of principles for how different situations are managed. This section describes
these different situations.
4.1 Non-Unique Names
Sometimes the same drug name is available with different active ingredients. Therefore,
additional information about the drug may be necessary in order to find the correct entry.
This is one of the reasons the C-format has been introduced - to help the users find the
correct entry by choosing the entry that contains the additional information, such as
country and pharmaceutical form.
These non-unique names are represented in different ways and in different software
systems. Systems that are based on the B-format often have the name followed by a code:
•
•
MENARIL
MENARIL
/00141802/
/ 00321701/
The Drug Name field is not always sufficient to identify a drug. If more than one entry have
the same Drug Name other data fields needs to be investigated. This can happen for the
following reasons:
1. The same drug name is used in different countries with different sets of
ingredients.
2. The same drug name is used in different pharmaceutical forms which contain
different sets of active ingredients.
3. A product has changed its composition without changing its trade name.
www.umc-products.com
WHO Drug Dictionary User Guide
2015
Page 27 (51)
4.1.1 Non-unique names - Example
The text ‘Menaril’ in a verbatim text does not return as a direct hit, if you query the Drug
Name field.
The WHO Drug Dictionary Browser returns the following entries in its Compare screen – in
which you can see the two alternatives – their active ingredients - ATC classes and the
countries where they are marketed etc.
•
•
•
If you know the country of origin it will be possible to select an entry
If you know the indication it may be possible to select an entry based on the ATC
classification
If you know the pharmaceutical form (or possibly the route of administration) you
may be able to select an entry
4.2 Preferred vs. Generic Entries
These two concepts are similar but not identical. In the WHO Drug Dictionaries the term
Preferred name is purely technical. It identifies the drug term – dictionary entry – that has
been entered as the ‘top’ entry for a specific active ingredient or combination of active
ingredients.
www.umc-products.com
WHO Drug Dictionary User Guide
2015
Page 28 (51)
A preferred name entry in a single ingredient entry corresponds to the name of the active
ingredient – substance name, plant name, insulin name or any sub-classification thereof.
That means in these cases the entries are both preferred and generic.
The name field is limited in length and cannot contain all names of active ingredients; we
are referring to multi-ingredient products, the names of the preferred entries.
The preferred name entry is the name of the first product entered with a specific
combination of active ingredients – often a trade name. If the preferred name is a trade
name it means that these entries are preferred but not generic.
The term ‘generic’ is a bit ambiguous. For the sake of this guide the term generic entry or
generic name refers to an entry – or the name of that entry – in the dictionary that refers
only to an active ingredient or a unique combination of active ingredients.
Sometimes there are different name standards for active ingredients – e.g. Acetaminophen
is a synonym to Paracetamol. These synonyms are often also included in the dictionaries –
and the synonyms are in other words generic but not preferred.
Notice that the UMC is investigating a new approach to the generic multi-ingredients. This
is part of a pilot project that was started in 2009.
Contact [email protected] to learn more.
4.3 Old Form Entries
In some coding situations it is useful to know if a product is on the market or not – for
example when a verbatim name appears in the dictionary in different compositions. In
these “non-unique name” situations the medicinal product may have changed its
composition – and the dictionary contains both the old and the new formula.
From 2010 a simplified way to identify old form entries will help you see if a drug entry is
flagged as old form – and if there are differences in different countries. The information is
released as a data file and is also available in the WHO Drug Dictionary Browser (if you
have access to the Comparison screen in Browser 2.0). The UMC has started a process in
which we will encourage the companies that develop coding software to include this
feature in the software interfaces.
The new table is distributed together with the dictionary files and identifies Drug Codes
that are flagged as old form in the data file OldForm DrugCode List.txt. This is available in
the same folder as the B-format in your downloaded data. Please review the file and let us
know if you have any questions.
www.umc-products.com
WHO Drug Dictionary User Guide
2015
Page 29 (51)
The information about if a product is on the market or not is country specific – if you have
set up your system to display country, form, strength etc (the C-Format) you will see which
products are flagged as old form and which are not. If you have set up your system to only
see product names (the B-Format) it is a little bit more complicated. OldForm DrugCode
List.txt therefore contains two types of Drug Codes – Drug Codes that are flagged as old
form in all countries and Drug Codes which are old form in some countries (these countries
are listed) but not all.
Notice that the entries that are flagged as old form remain in the dictionary for a reason. If
you have an old study – or an old case report – it is important that they point to the
products as they existed at the time.
You can read more about the file structure of OldForm DrugCode List.txt in the file
description document, also available in the B file folder in the downloaded data.
5. Classifications
All products in the dictionaries are classified according to their active ingredients and
therapeutic use. These classifications can be used to analyze the coded data and to
produce different types of tabulations.
Many products are also classified with the Standardized Drug Grouping (SDG) system. This
is a flexible way of classifying products that was introduced in 2010.
5.1 Anatomical Therapeutic Chemical (ATC)
In the ATC classification drugs are divided into different groups according to the organ or
system in which they act and their chemical, pharmacological and therapeutic properties.
The Anatomical Therapeutic Chemical (ATC) classification is an integrated part of the WHO
Drug Dictionaries. The ATC classification is maintained by the WHO Collaborating Centre
for Drug Statistics Methodology in Oslo, Norway.
•
•
•
Anatomical is the organ or system on which a drug acts.
Therapeutic (and Pharmacological) is Indication for typical use(s) Pharmacological
Form
Chemical is the Compound structure and properties.
The hierarchical classification makes it possible to aggregate statistics and to produce
queries on different levels as an alternative to analysis and querying on Drug Code level.
The UMC has developed a specific Herbal ATC which is used in the WHO Herbal Dictionary it follows the same principles as the conventional ATC classification.
www.umc-products.com
WHO Drug Dictionary User Guide
2015
Page 30 (51)
Read more about the Herbal ATC.
ATC Levels
1.
2.
3.
4.
5.
6.
The ATC classification hierarchical levels:
14 anatomical groups designated by the letters A – V.
Therapeutic main groups.
Therapeutic/pharmacological subdivision which is designated by letters.
Therapeutic/pharmacological/chemical subgroup which is designated by letters. In
this level the pharmacological properties and the chemical nature of the substance
are taken into account.
7. Individual substance designated by numbers. This level is not used in the WHO
Drug Dictionaries.
5.1.2 What is an ATC Classification?
The Anatomical Therapeutic Chemical (ATC) classification is an integrated part of the WHO
Drug Dictionaries. The ATC classification is maintained by the WHO Collaborating Centre
for Drug Statistics Methodology in Oslo, Norway. The UMC has developed a specific Herbal
ATC (H-ATC) which is used in the WHO Herbal Dictionary - it follows the same principles as
the conventional ATC classification. This chapter describes the ATC classification – as it is
developed and maintained by the WHO centre in Oslo – with only a few references to the
WHO Drug Dictionaries
In the Anatomical Therapeutic Chemical (ATC) classification system, the drugs are divided
into different groups according to the organ or system on which they act and their
chemical, pharmacological and therapeutic properties.
Drugs are classified in groups at five different levels. The drugs are divided into fourteen
main groups (1st level) similar to system organ class groups. The next level is the
pharmacological/therapeutic subgroup (2nd level) and the 3rd and 4th levels are
chemical/pharmacological/therapeutic subgroups. The 5th level is the chemical substance.
A
Alimentary tract and metabolism
B
Blood and blood forming organs
C
Cardiovascular system
D
Dermatologicals
G
Genito-urinary system and sex hormones
H
Systemic hormonal preparations, excluding sex hormones and
insulins
www.umc-products.com
WHO Drug Dictionary User Guide
2015
Page 31 (51)
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
The 1st level groups.
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
Oral blood glucose lowering drugs
(3rd level, pharmacological subgroup)
A10B A
Biguanides
(4th level, chemical subgroup)
A10B A02
Metformin
(5th level, chemical substance)
Thus, in the ATC system all single ingredient metformin preparations are given the code
A10B A02.
Nomenclature
International non-proprietary 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 is used when naming the different ATC levels.
•
www.umc-products.com
WHO Drug Dictionary User Guide
2015
Page 32 (51)
Inclusion and Exclusion Criteria
The WHO Collaborating Centre for Drug Statistics Methodology establishes new codes in
the ATC classification on request from the users of the system. These include
manufacturers, regulatory agencies and researchers. The coverage of the system is not
comprehensive: a major reason why a substance is not included is that no request has
been received.
The Centre gives priority to single ingredient preparations containing well-defined
substances which have an INN name and which are:
•
•
New Chemical Entities and biological proposed for licensing in a range of countries
Existing well-defined substances used in a variety of countries
Other medicines are considered on a case by case basis.
Official ATC codes for combined (multi ingredient) preparations are assigned only to a
limited extent. Combinations likely to be widely used internationally, however, are given
an ATC code (e.g. beta blockers and diuretics).
A new medicinal substance is normally not included in the ATC system before an
application for marketing authorisation is submitted in at least one country.
Complementary and traditional medicinal products are in general not included in the ATC
system.
Principles for Classification
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 pharmaceutical
formulation (i.e. similar ingredients, strength and pharmaceutical form).
A medicinal product can be given more than one ATC code if it is available in two or more
strengths or formulations with clearly different therapeutic uses.
A medicinal product may be used for two or more equally important indications, and the
main therapeutic use of a drug may differ from one country to another. This will often give
several classification alternatives. Such drugs are usually only given one code, the main
indication being decided on the basis of the available literature. Problems are discussed in
the WHO International Working Group for Drug Statistics Methodology where the final
classification is decided. Cross-references will be given in the guidelines to indicate the
various uses of such drugs.
www.umc-products.com
WHO Drug Dictionary User Guide
2015
Page 33 (51)
Example:
The substance Acetyl Salicylic acid can be coded with any of the following ATC codes:
•
•
•
A01AD
B01AC
N02BA
LOCAL ORAL TREATMENT
PLATELET AGGREGATION
ANALGESICS AND ANTIPYRETICS
The ATC system is not strictly a therapeutic classification system. At all ATC levels, ATC
codes can be assigned according to the pharmacology of the product. Subdivision on the
mechanism of action will, however, often be rather broad, since a too detailed
classification according to mode of action often will result in having one substance per
subgroup which as far as possible is avoided.
Some ATC groups are subdivided in both chemical and pharmacological groups. If a new
substance fits in both a chemical and pharmacological 4th level, the pharmacological group
is normally used.
Substances classified in the same ATC 4th level cannot be considered
pharmacotherapeutically equivalent since their mode of action, therapeutic effect, drug
interactions and adverse drug reaction profile may differ.
Principles for Changes to ATC Classification
As the drugs available and their uses are continually changing and expanding, regular
revisions of the ATC system will always be necessary.
Changes in the ATC classification are kept to a minimum. Before alterations are made,
difficulties arising for the users of the ATC system are considered and related to the
benefits achieved by the alteration.
Alterations in ATC classification are made when the main use of a drug has clearly changed,
and when new groups are required to accommodate new substances or to achieve better
specificity in the groupings.
5.1.3 ATC in the WHO Drug Dictionaries
All entries in the WHO Drug Dictionaries are assigned with ATC codes – either conventional
ATC or the Herbal ATC.
Official and Unofficial
The WHO Drug Dictionaries are assigned ATC codes based primarily on the guidelines of
ATC and the Herbal ATC.
Sometimes additional ATC assignments are made to describe other important uses of a
drug or a substance. These are flagged as ‘unofficial’ and should be seen as additional
possible indications.
www.umc-products.com
WHO Drug Dictionary User Guide
2015
Page 34 (51)
Multi-ingredient drugs are assigned ATC codes based on the guidelines but since the
guidelines rarely describes the exact combinations of substances these are flagged as
‘unofficial’.
Fourth Level Assignment
The ATC is a hierarchical terminology. The hierarchy has five levels, where the fifth level
identifies the substance names.
The WHO Drug Dictionaries are assigned on the fourth level – since the substance
information corresponds to the Drug Code system. Some entries in the dictionaries are
coded with other levels than the fourth – when no fourth level terms that can be used.
ATC and Herbal ATC
When the WHO Drug Dictionary Enhanced is extended with the WHO Herbal Dictionary
both conventional and herbal drugs will be integrated in the same system. The products
are coded with the classification relevant to each product. The two hierarchies are closely
related – and the Herbal ATC classification can be seen as additional branches on the ATC
hierarchy tree. Analysis of data based on the combined ATC/H-ATC is therefore possible
using the same methodology as the conventional ATC. The Herbal ATC is used for products
that only contain herbal substances.
V90
In the WHO Drug Dictionary Enhanced and WHO Drug Dictionary a number of herbals are
included. The reason for this is that they existed in the dictionary already when the WHO
Herbal Dictionary was developed and it is not possible to delete entries.
These entries are coded with the ATC code ‘V 90 – Unspecified Herbal‘. The V 90 code is
also used for entries in the WHO Herbal Dictionary that are under assessment.
Name and Substance Level Assignments
The ATC guidelines describe how a drug is assigned an ATC code.
The ATC classifies drugs according to the most common use – the ATC is not synonymous
to indication. The classification has been developed to allow different types of analysis on
drug utilization data, clinical and safety data. Depending on the use of the ATC
classification in the dictionary two ways of assigning ATC codes to drugs have been
developed. Sometimes it is important to know what the primary use of a specific medicinal
product is – and sometimes it is more important to know all potential uses (and effects) of
its active ingredients.
Name Level Assignment
www.umc-products.com
WHO Drug Dictionary User Guide
2015
Page 35 (51)
Until 2008 only the C format has had name level assignment – each drug entry has been
given a minimum of ATC codes, preferably only one. This use is most relevant when
individual cases are analyzed and when certain reports are produced (e.g. when the Class
fields in CDISC is populated).
From 2008 this assignment level is also available for users of the B format. An additional
table is available so that each Drug Code can be mapped to the ATC table with higher
precision.
Substance Level Assignment
When analyzing large data sets and when identifying protocol violations it is more
important to know all the ATC terms of the active ingredients of a drug.
Until 2008 only the B format has had name level assignment – all drugs with the same Drug
Record Number and Sequence 1 (active ingredient and salt) are assigned with all ATC codes
of the ingredient(s). From 2008 this assignment level is also available for users of the C
format. An additional table is available so that each Medicinal Product can be mapped to
all ATC codes assigned to its active ingredient(s).
ATC assignment in the WHO Drug Dictionary Browser
The WHO Drug Dictionary Browser is based on the C format and each product has the ATC
codes based on the name level assignment. However – in the product page it is possible to
access the preferred name entry, which is coded with the substance level assignment.
5.1.4 The Herbal ATC
Some herbal remedies have a longstanding use in conventional medicine and their actions
are well defined. Examples are Digitalis leaves, Opium, Ispaghula and Cascara. Such
remedies are already classified in the regular ATC system. For various reasons it has been
impractical to incorporate hundreds of herbal remedies in the regular ATC classification.
However, experiences from the ATC system - particularly in connection with the
monitoring of adverse effects of drugs - have shown that such a system is also suitable for
herbal remedies.
The Herbal ATC system (H-ATC) developed by the UMC provides a unique scientific
framework for a harmonized, global nomenclature and therapeutic classification of herbal
substances and combinations of them.
The Herbal ATC is an integrated part of the WHO Herbal Dictionary, in the same way as ATC
is a part of the WHO Drug Dictionary. The two dictionaries are seamlessly integrated and
the two classifications can be used together to analyze clinical data.
www.umc-products.com
WHO Drug Dictionary User Guide
2015
Page 36 (51)
It should be stressed that assignment of an H-ATC code to a herbal remedy is not an
indication that the remedy has been proven effective and safe. Assignment of an H-ATC
number indicates only that information about medical use has been found in the literature.
In both the ATC and the Herbal ATC systems remedies are divided into groups according to
their therapeutic use. The first level is 14 anatomical groups designed by the letters A – V,
these are the same in ATC and H-ATC. The following levels are the same in the two
classifications as far as possible, but in some cases additional categories are introduced in
the H-ATC for herbal specific groups.
The complete classification, in the Herbal ATC system, of preparations of Aloe ferox Mill,
dry leaf juice, which is used as a laxative, is A06AB5001:
•
•
•
•
•
A:An Alimentary Tract and Metabolism (1st level, Anatomical main group).
06: Herbal laxatives (2nd level group, therapeutic main group)
A: Laxatives (3d level group, therapeutic/ pharmacological subgroup)
B: Contact laxatives (4th level group, therapeutic/ pharmacological/chemical
subgroup) 5001
5001: Aloe ferox Mill., dry leaf juice (5th level group, individual crude drug).
5.2 Standardized Drug Groupings (SDGs)
The dictionaries contain a number of tools that can be used for analysis – the Drug Code
hierarchy and the ATC classification. Another tool is the Standardized Drug Groupings
(SDGs).
An SDG is any grouping of medicines having one or several properties in common. The
individual grouping can be based on indication, chemical properties, pharmacodynamic
properties and/or pharmacokinetic properties as well as any other property of interest.
The SDGs are developed by experts within the WHO Drug Dictionary user community in
collaboration with the UMC. The lists are often previously proprietary lists used for the
identification of drugs of interest in clinical trials or as signal detection. The lists are peer
reviewed by the expert working group and put in a uniform data format.
The lists can be used as they are or be a starting point for the development of lists of drugs
of special interest which can be used to identify protocol violations and to identify signals
and interactions.
Subscribers can contact us at [email protected] to receive the SDGs
5.2.1 Structure
Hierarchy/Subgroups
www.umc-products.com
WHO Drug Dictionary User Guide
2015
Page 37 (51)
Many of the SDGs are divided into subgroups to increase the flexibility for usage. The
subgroups may be based on chemical or therapeutic properties within the group. One
example is the Cytochrome P 450 (CYP)-SDGs where the user can look at all CYP interacting
substances or only the inducers, inhibitors or substrates individually. The creation of
subgroups is designed to increase the clinical usefulness of the SDG.
Narrow and Broad Scope
To further allow for flexible analysis some SDGs have a broad and a narrow scope. The
narrow scope generally represents the well known substances with an established use and
known chemical properties. The broad scope generally represents medicines with similar
effects or other properties that might be helpful in a broader analysis. The broad/narrow
search can have a variety of different uses and is stated in the definition of the individual
SDGs.
One example of the broad/narrow scope is estrogens: there are substances classified as
estrogens based on their therapeutic and chemical properties but there are also
substances having estrogen like effects that might be of interest to include in the search if
one wishes to search for menopausal women within a study population. Another example
of different scopes is the CYP SDG where clinically relevant substances are included in the
narrow scope and substances with no or unknown clinical relevance are included in the
broad search.
6. Practical Issues
This section describes some practical issues that can help you get the most out of your
subscription. It contains information about how you download the dictionary and how you
keep it up to date, about how the renewal process works and different channels you can
use to get in touch with the UMC.
6.1 The Data Files
The WHO Drug Dictionaries are information services – data that can be loaded into any
software for coding and analysis of clinical or drug safety data.
The data are distributed in ASCII text files, where the different data fields appear in given
fixed positions in order to make the dictionaries independent of all possible database
systems.
As a subscriber to the WHO Drug Dictionaries you will receive new versions either once,
twice or four times per year depending on your license. You will receive the full dictionary
each time, together with changes files describing the changes made to the data compared
to the previous versions. The changes files are divided into separate files for inserts,
www.umc-products.com
WHO Drug Dictionary User Guide
2015
Page 38 (51)
deletes and updates. There are also specific changes files for name changes, Drug Code
changes etc to facilitate the update process of your dictionary.
6.2 Downloading the data files
The WHO Drug Dictionary data is accessed by a password-protected internet connection.
Each user has a personal user account. User names are created by the UMC and cannot be
changed by the user.
The data files and the corresponding documents are published on the release dates in the
UMC Customer Area on the internet – http://www.umc-products.com/customerarea.
The same material is also available on request on CD. The CDs will be sent by mail on the
release date.
The WHO Drug Dictionaries are updated and maintained by the UMC and have scheduled
release dates.
1st of March (head release of the year)
1st of June
1st of September
1st of December
If the above date is on a weekend or Swedish national holiday the release will be the first
working day after that date.
6.2.1 File and Zip Labels
Label in Download Area
The dictionaries have the same name label every quarter.
Dictionaries;
•
•
•
•
•
•
•
Drug Dictionary month, 1 YYYY
Drug Dictionary Enhanced B2 month, 1 YYYY
Drug Dictionary Enhanced C month, 1 YYYY
Drug Dictionary Enhanced SDG month, 1 YYYY
Herbal Dictionary and Drug Dictionary Enhanced B2 month, 1 YYYY
Herbal Dictionary and Drug Dictionary Enhanced C month, 1 YYYY
Herbal Dictionary and Drug Dictionary Enhanced SDG month, 1 YYYY
ATC tool;
www.umc-products.com
WHO Drug Dictionary User Guide
2015
Page 39 (51)
•
•
•
Drug Dictionary ATC tool month, 1 YYYY
Drug Dictionary Enhanced ATC tool month, 1 YYYY
Herbal Dictionary and Drug Dictionary Enhanced ATC tool month, 1 YYYY
Examples:
•
•
Drug Dictionary Enhanced C March, 1 2009
Herbal Dictionary and Drug Dictionary Enhanced C September, 1 2010
Label for Patches
If a production error occurs that is detected after a dictionary release are the new files for
download relabelled with a patch ID (p1, p2,...) added to the end name as followed.
Example;
Drug Dictionary month, 1 YYYY Patch 1
Drug Dictionary Enhanced C month, 1 YYYY Patch 1
etc…
Released files are to be replaced on the UMC Customer Area with the corrected
files/patches and “Important messages” on the User Group Portal is updated with new
release information.
Label if files are split
Sometimes customers have problems downloading files due to their size. This can be
caused by temporary problems with data transfer speed and leads to a time-out.
When this happens some files may be split into several smaller packages and the new files
for download relabelled with a Part ID (part1, part2,...) added to the end name as followed.
Example;
Drug Dictionary month, 1 YYYY Part 1
Drug Dictionary Enhanced C month, 1 YYYY Part 1
etc…
Released files are to be replaced on the UMC Customer Area with the smaller packages
and “Important messages” on the User Group Portal is updated with new release
information.
If needed an e-mail is send to you about downloading problems and solutions.
Label Zip Files
The zip files have the same name label every quarter.
www.umc-products.com
WHO Drug Dictionary User Guide
2015
Page 40 (51)
Dictionaries;
•
•
•
•
•
•
who_dd_month_1_YYYY
who_dde_b2_month_1_YYYY
who_dde_c_ month_1_YYYY
who_dde_sdg_ month_1_YYYY
who_hd_dde_month_1_YYYY
who_hd_dde_sdg_ month_1_YYYY
ATC tool;
•
•
•
who_dd_atc_tool_month_1_YYYY
who_dde_atc_tool_month_1_YYYY
who_hd_dde_atc_tool_month_1_YYYY
Label for Patches
If a production error occurs that is detected after a dictionary release are the new files for
download relabelled with a patch ID (p1, p2,...) added to the end name as followed.
Example;
who_dd_month_1_YYYY_p1
who_dde_c_month_1_YYYY_p1
etc…
Released files are to be replaced on the UMC Customer Area with the corrected
files/patches and “Important messages” on the User Group Portal is updated with new
release information.
6.3 Loading the Files
Once you have downloaded the data files from the UMC you can load them into whatever
software you are using. The loading procedure is different from software to software –
contact your software provider or the UMC to learn more.
The system picks up the text files, identifies the data fields based on their fixed positions
and creates loading scripts which loads the data into the database.
The dictionary repository is often based on a database structure that reflects the structure
of the format your company is using – the B or the C-format.
If you are interested in more technical descriptions of the dictionaries – such as table
structures and file formats – please contact us and you will get the full Developer Package.
www.umc-products.com
WHO Drug Dictionary User Guide
2015
Page 41 (51)
6.4 Changes Files
The changes files make it possible for you to compare the version of the dictionary with
the previous quarter, two quarters back and one year back. You can identify all entries that
have been added, deleted or modified. If an entry has been deleted there is always a
replacement entry – and a reference is available in the files.
Changes files are stored in a subfolder for each format. They are divided into separate files
for inserts, deletes and updates. There are also specific changes lists for name changes,
drug code changes etc. The changes files can be found in a subfolder placed in each format
folder on the CD or in the zip files;
Examples
\B2\Changes
\C\Changes
6.4.1 Cumulative Changes File
The Cumulative changes table makes it possible for you to trace Drug Codes that have
been discontinued, and to identify the replacement Drug Code.
The first Drug Record Number, Sequence Number 1 and Sequence Number 2 lists all
discontinued Drug Codes.
Year, Quarter identifies when an ID as been discontinued.
The second Drug Record Number, Sequence Number 1 and Sequence Number 2 lists the
Drug Code to which a reference was made.
This replacement Drug Code may have been discontinued at a later stage, so please make
sure that you code the discontinued code with the latest replacement code.
Notice that the Cumulative changes table only dates back to 2004. If you identify
discontinued Drug Codes that you cannot find in the Cumulative changes table, please
submit them to the UMC and we will trace them for you using other tools.
Example:
0008890100304400586302003
In the example above you can see that the drug code 00088901003 was last used in the
December 1 release 2004 and that it was replaced by the code 00586302003
www.umc-products.com
WHO Drug Dictionary User Guide
2015
Page 42 (51)
6.4.2 Changed Drug Name
Sometimes names in the dictionary change. This happens when an erroneous name has
been corrected, or – in the B-format - when a code has been added to the name in order to
make the name unique.
If you are just replacing the old version of the dictionary with the new you would not need
to make any modifications. If you have separate tables that are used by auto-encoders you
may need to use the Changed DrugName.txt:
Drecno
Seq1
Seq2
New Drug Name
Old Drug Name
000002
02
002
ALUPENT
ALUPENT
/00000202/
000004
01
002
RESTAMIN
/00000401/
RESTAMIN
000010
02
013
MALAREX
MALAREX
/00001002/
1. Identify the entries affected by the change using the Drecno, seq1 and
Seq 2 (the Drug Code) or the ‘Old Drug Name’.
2. Replace the old drug name with the new.
6.4.3 Names of Changes Files
Changes Lists B-format
Main files
The changes lists for the main files have the same format and structure as the main table it
represent.
Examples
DD_ins.txt – inserted items for the DD table
DD _del.txt – deleted items from the DD table
DD _upd.txt – updated items in the DD table
DDA_ins.txt – inserted items for the DDA table
DDA _del.txt – deleted items from the DDA table
DDA _upd.txt – updated items in the DDA table
www.umc-products.com
WHO Drug Dictionary User Guide
2015
Page 43 (51)
ING_ins.txt – inserted items for the ING table
ING _del.txt – deleted items from the ING table
Subsidiary Files
The changes lists for the subsidiary files have the same format and structure as the table it
represent.
Examples
INA_ins.txt – inserted items for the INA table
INA _del.txt – deleted items from the INA table
INA _upd.txt – updated items in the INA table
Changes lists C-format
Main Files
The changes lists for the main files have the same format and structure as the main table it
represent.
Examples
MP_ins.txt – inserted items for the MP table
MP_del.txt – deleted items from the MP table
MP_upd.txt – updated items in the MP table
PP_ins.txt – inserted items for the PP table
PP_del.txt – deleted items from the PP table
PP_upd.txt – updated items in the PP table
ING_ins.txt – inserted items for the ING table
ING _del.txt – deleted items from the ING table
ING _upd.txt – updated items in the ING table
THG_ins.txt – inserted items for the THG table
THG _del.txt – deleted items from the THG table
THG _upd.txt – updated items in the THG table
Subsidiary Files
The changes lists for the subsidiary files have the same format and structure as the table it
represent.
Examples
www.umc-products.com
WHO Drug Dictionary User Guide
2015
Page 44 (51)
ATC_ins.txt – inserted items for the ATC table
ATC _del.txt – deleted items from the ATC table
ATC _upd.txt – updated items in the ATC tables
ORG_ins.txt – inserted items for the ORG table
ORG _del.txt – deleted items from the ORG table
ORG _upd.txt – updated items in the ORG tables
Additional Changes Lists
A number of additional lists have been developed to facilitate the update process based on
main files information;
MP ATC-changes.txt – lists ATC code changes per Medicinalprod_Id.
MP Changed DrugCode.txt – lists changed Drug Codes per Medicinalprod_Id.
MP Changed Name.txt – lists changed Drug Name for a Medicinalprod_Id.
MP Moved to MP with different DrugCode.txt – lists replaced Medicinalprod_Id where
Drug Code has been changed.
MP Moved to MP with same DrugCode.txt – lists replaced Medicinalprod_Id where Drug
Code is the same.
6.5 Migration from Old Version
The Changes files describe all data entries that have been added, changes or modified
since the previous quarter, two quarters back and a year back. Sometimes it is necessary to
update a system from old versions of the dictionary to the latest which means that another
approach is necessary.
It is important to identify the unique codes that have been used by the organization in any
clinical or safety data and to identify if the corresponding dictionary entries have been
affected by any reclassification or redirection in the dictionary during the time between
the two versions. The UMC has produced a Cumulative Changes file which can be used to
identify these entries.
When you have used the Cumulative Changes file to make sure that all codes are up to
date there are cases when an old drug code can’t be found neither in the cumulative
changes file nor in the latest dictionary.
Please, submit these codes to the UMC and we will assist you trace the correct
replacement entry.
6.6 How Changes to the Dictionaries are Prioritized and Decided
In order to optimize the dictionaries and to ensure that they meet the requirements from
new legislation or needs of new users; our aim at UMC is to continuing optimizing and
perfecting the dictionary.
www.umc-products.com
WHO Drug Dictionary User Guide
2015
Page 45 (51)
By doing so, suggestions are gathered from User Group meetings for further development
and we also collect questions and comments from users in the User Group Portal.
International harmonization work and technical developments are also monitored in order
to ensure that the dictionary is up-to-date.
The suggested modifications will be prioritized by the users. Modifications and other ideas
for new developments will be collected, investigated and implemented in time for the
following March 1 version.
Prior to implementing adaptations and new developments, suggestions will be made
available on the User Group Portal. These changes will also be discussed at the User Group
meetings the year prior to the implementation of the changes.
6.7 How Do I submit a Question or Report a Suspected Error?
If you have a question or if you suspect an error you may first look into the User Group
Portal to see if the issue has already been reported. Errors that are known and reported in
the latest version of the dictionaries will be listed.
If you want to submit a question or report an error, please e-mail us at:
[email protected] or call +46 18 65 60 60.
The WHO Drug Dictionary Browser has also a channel of communication through which
you can submit requests and trace the status of your request.
Our support team will respond within 3 business days. If further investigation is necessary
you will get a receipt from the UMC which includes an errand number and an estimated
time for the investigation. When the investigation is completed you will receive the full
answer which will include the errand number.
The UMC will grade the errand according to severity:
1. A show-stopping bug. Makes loading or use of the dictionary impossible/very
difficult
2. Minor error in a specific drug entry
3. Inconsistent coding
4. Suggested improvement
5. Unclear guideline.
Any show-stopping bugs will be dealt with immediately. A new version of the dictionary – a
patch will be posted on the Customer Area for downloading by the customers.
A message will be sent to all customers.
www.umc-products.com
WHO Drug Dictionary User Guide
2015
Page 46 (51)
An error may prevent some, but not all customers from loading or using the dictionary
depending on differences in the set-up of their dictionary management system. A new
version of the dictionary or of certain files will be sent to the reporters and will be available
on request. These issues will be listed on the User Group Portal.
Inconsistencies in coding will be put in a modification log which will be prioritized. The
modifications are made each year in the March 1 release. The modifications will be
presented on the User Group Portal in time before the March 1 release.
These changes can be of different kinds:
•
•
•
•
•
Changes in principles for how to use a field
General up-dates of inconsistent data
Changes in inclusion criteria for one of the formats
Additional columns in existing tables
Additional tables
Expanded Field Lengths
A reported issue may also be an ambiguity in the guidelines or a misunderstanding. These
issues will be logged and clarified in the coming versions of this guide.
6.8 New Drug Requests
If a Drug Name is missing – How can I add it to the Dictionary?
The WHO Drug Dictionaries are updated with new drugs and modifications to existing
drugs. However, some types of drugs can appear as concomitant medication in clinical data
before they appear in the dictionaries. If you find a drug name missing in the dictionaries –
please report it.
The UMC provides a service called ‘New Drug Request’ which makes it possible for
customers to propose new entries to the dictionary. The dictionaries – the WHO Drug
Dictionary Enhanced, WHO Drug Dictionary and WHO Herbal Dictionary – have slightly
different services for new drug request.
To submit a Request please, contact: [email protected]
6.8.1 WHO Drug Dictionary Enhanced Update Request
This service has two options - regular updates and expedited updates. To enter a drug in
the dictionary you need to provide us with some basic facts about the requested drug. If
you request a large number of entries you might prefer to enter the request in an
electronic format.
www.umc-products.com
WHO Drug Dictionary User Guide
2015
Page 47 (51)
An Excel form is available on the WHO Drug Dictionary User Group Portal:
http://usergroup.umc-products.com/.
To be certain that new drug entries are included in the following version of the dictionary
please submit your requests no later than six weeks before the distribution date (March 1,
June 1, September 1 or December 1).
After you have made a request you will get a reply telling you when you can expect the
entry to be added to the dictionary. If a request can’t be added because of incorrect
information, lack of adequate information sources or if it is already included in the
dictionary, you will be informed.
To make sure that the correct drug information is recorded in the dictionary, please
provide us with information about the country where the drug is marketed, and if possible
an information source where the drug is listed.
If you choose the expedited service, the UMC will enter the requested drug information
within three days and the data will be sent to you. The data will also appear in the next
quarterly release of the dictionary. For the expedited service we will charge you an hourly
fee.
When you make a request for an expedited service please enter as much information as
possible in the form. If you provide the country of origin and/or a reliable information
source it will be possible to give you a response within three days. If this data is not
available we may need to contact you to guarantee that we give you the relevant product
information.
General principle
On June 1, 2005 the first release of the new WHO Drug Dictionary Enhanced was
distributed to a number of customers. Since then, customers still using the WHO Drug
Dictionary and WHO Drug Dictionary Enhanced have been accessing different data sets.
This affected the New Drug Request service. The reason for this is that data entries cannot
be added into the WHO Drug Dictionary if it already exists in the WHO Drug Dictionary
Enhanced without creating duplicates and cause problems for customers that upgrade
from WHO Drug Dictionary to WHO Drug Dictionary Enhanced.
Exception
New Drug Requests can be of two types:
1. A product name that has been found as concomitant medication in a clinical trial
or spontaneous ADR report.
www.umc-products.com
WHO Drug Dictionary User Guide
2015
Page 48 (51)
2. The company’s own product that needs to be coded in the database to allow
analysis with the ATC classification and Drug Code.
Expedited New Drug Requests of the first type (1) are only available for WHO Drug
Dictionary Enhanced customers.
WHO Drug Dictionary customers may request New Drug Requests of the second type (2).
The result of these requests are provided in separate files containing the same formats as
the dictionary – B and C. Each request file will also contain the preferred name entry
related to the requested drug.
All files with requests are given a reference number and are also archived at the UMC.
Once per year the UMC will provide files describing the changes to a company’s requested
new drugs including re-assignments of ATC etc.
To be certain that new drug entries are included in the following version of the dictionary
please submit your requests no later than six weeks before the distribution date (March 1,
June 1, September 1 or December 1).
After you have made a request you will get a reply telling you when you can expect the
entry to be coded and when you can expect to get the files.. If a request can’t be added
because of incorrect information, lack of adequate sources or if it is already coded, you will
be informed.
Collaboration with CRO
If your company collaborates with a CRO you may give the CRO access to the New Drug
Request codes. The company/sponsor must contact the UMC to inform us about the
collaboration. The UMC will accept this and send the company’s new drugs requests and
the annual changes files to the CRO.
If a WHO Drug Dictionary customer upgrades to WHO Drug Dictionary Enhanced they will
find all requested entries in the WHO Drug Dictionary Enhanced.
WHO Herbal Dictionary Update Request
If you find an herbal product missing in the WHO Herbal Dictionary you can report it, just
like when you make update requests for the other dictionaries.
The entry of herbal product information is less straightforward than conventional
products. Sometimes an investigation needs to be done to identify the content of the
product, and sometimes new plant species need to be added. This process may take more
time than with conventional products. The expedited service is therefore not available for
www.umc-products.com
WHO Drug Dictionary User Guide
2015
Page 49 (51)
herbal products, but update requests are assessed and updates are made as fast as
possible.
6.9 CRO - Sponsor relationship
Before a clinical trial is started it is important to decide how to use the WHO Drug
Dictionaries. If the trial is conducted by a CRO it is also important that the sponsor and the
CRO have compatible subscriptions of the dictionaries, and that it is agreed how the coding
will be performed and what codes will be used. The following checklist is a suggested
starting point in the discussions.
1.
•
•
•
•
•
•
Type of dictionary:
WHO Drug Dictionary
WHO Drug Dictionary Enhanced
WHO Herbal Dictionary
WHO Drug Dictionary + WHO Herbal Dictionary
WHO Drug Dictionary Enhanced + WHO Herbal Dictionary
Additional New Drug Requests
2. Frequency:
The trial is conducted with a specific version of the dictionary, no updates.
• One per year
• Twice per year
• Four times per year
3. Format:
• B-format
• C-format
4.
•
•
•
•
•
Data entry precision level:
Medicinal Product ID
Drug Code
Verbatim text
ATC code – indication
Indication verbatim
www.umc-products.com
WHO Drug Dictionary User Guide
2015
Page 50 (51)
5.
•
•
•
•
•
•
What level of training is required from the coders?
UMC on-line training
Certification
Advanced certification
Annual accreditation
Internal training
None
Both parties shall make a validation of the other party’s license agreement.
www.umc-products.com
WHO Drug Dictionary User Guide
2015
Page 51 (51)