TESSy - The European
Surveillance System
Antimicrobial consumption (AMC)
reporting protocol 2019
European Surveillance of Antimicrobial Consumption Network
(ESAC-Net) surveillance data for 2018
March 2019
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Contents
Introduction ............................................................................................................... 4
ESAC-Net ........................................................................................................................... 4
AMC metadata changes 2019 ............................................................................................... 5
Summary of the TESSy AMC data upload and validation process ........................................... 5
Annual ESAC-Net data collection .......................................................................................... 6
Overview of AMC data collection and analysis ....................................................................... 6
How to use this document .................................................................................................... 8
Finding further information .................................................................................................... 8
Reporting to TESSy ................................................................................................... 9
Data collection schedule ....................................................................................................... 9
Preparing data ..................................................................................................................... 9
Checking metadata .............................................................................................................. 9
Checking data source profile ............................................................................................... 10
Submitting data .................................................................................................................. 10
Finalising submission ......................................................................................................... 10
TESSy HelpDesk ............................................................................................................... 11
Annex 1 Antimicrobial consumption (AMC) metadata .................................................. 12
ESAC-Net data .................................................................................................................. 12
ESAC-Net record types ................................................................................................. 12
Current record type versions .......................................................................................... 13
Metadata for antimicrobial consumption surveillance ............................................................ 13
Record type AMC - national registry data for all available antimicrobials ........................... 14
Record type AMC$PACKAGES - AMC data linked to the national registry ........................ 18
Record type AMCLIGHT - (aggregated number of DDDs reported) ................................... 20
Record type AMCDENOM - Denominator / Population under surveillance ......................... 24
Record type AMCDS - data source information for antimicrobial consumption data ............ 26
AMC metadata change history ............................................................................................ 36
Annex 2 Antimicrobial consumption (AMC) specific material ........................................ 37
Reporting ESAC-Net data ................................................................................................... 37
Reporting for different healthcare sectors ........................................................................ 37
Reporting the variables age class, gender and prescriber ................................................ 37
Reporting population (number of inhabitants) .................................................................. 38
Reporting historical data from the former ESAC project ................................................... 38
Reporting combined products ............................................................................................. 38
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Reporting liquid pharmaceutical form (variable SyrupForm) .................................................. 39
ATC and DDD updates ....................................................................................................... 39
ATC updates 2019 ........................................................................................................ 40
Defined daily doses for combined products, 2019 ............................................................ 42
Examples .......................................................................................................................... 49
How to report liquid medicinal products in vials or bottles ................................................. 49
How to report data coverage in the AMCDS record type .................................................. 50
How to report combined products ................................................................................... 52
Index ...................................................................................................................... 55
List of tables
Table 1: Implemented changes in record types for Antimicrobial Consumption (AMC) in 2019 ........... 5
Table 1: Accepted record types and record type versions .............................................................. 13
Table 2: Technical variables for AMC record type ......................................................................... 14
Table 3: Epidemiological variables for AMC record type ................................................................ 15
Table 4: Technical variables for AMC$PACKAGES record type ..................................................... 18
Table 5: Epidemiological variables for record type AMC$PACKAGES ............................................ 19
Table 6: Technical variables for record type AMCLIGHT ............................................................... 20
Table 8: Technical variables for record type AMCDENOM ............................................................. 24
Table 9: Epidemiological variables for AMCDENOM ..................................................................... 25
Table 10: Technical variables for record type AMCDS ................................................................... 26
Table 11: Epidemiological variables for record type AMCDS - community (primary care) data .......... 27
Table 12: Denominator data for the community (primary care) ....................................................... 29
Table 13: Epidemiological variables for record type AMCDS - Hospital care data ............................ 30
Table 14: Denominator data for the hospital sector ....................................................................... 32
Table 15: Epidemiological variables for record type AMCDS Total care data ................................... 32
Table 16: Denominator data for the total care sector ..................................................................... 34
Table 17: Summary variables ...................................................................................................... 35
Table 18: Implemented changes in record types for Antimicrobial Consumption (AMC) until 2018 .... 36
Table 19: New ATC codes ........................................................................................................... 40
Table 20: New DDD allocations .................................................................................................... 41
Table 21: DDD alterations ........................................................................................................... 41
Table 22: List of DDDs for all combined products in TESSy ............................................................ 42
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Introduction
ESAC-Net
The European Surveillance of Antimicrobial Consumption Network (ESAC-Net) is a Europe-wide
network of national surveillance systems, providing European reference data on antimicrobial
consumption. ESAC-Net col ects and analyses data on antimicrobial consumption from EU/EEA
countries, both in the community and in the hospital sector.
The specific objectives of ESAC-Net are:
•
To validate antimicrobial consumption data from the community (primary care) and the
hospital sector derived from national surveillance networks, including data from the
national drug registers;
•
To analyse trends in antimicrobial consumption overall and for different ATC groups, as
well as provide comparisons between countries and regions;
•
To make information on antimicrobial consumption in Europe publicly accessible through
ESAC-Net interactive database.
ESAC-Net covers all EU/EEA countries in agreement with Decision 1082/2013/EU of the European
Parliament and the Council of 22 October 2013 on serious cross-border threats to health.
Under ESAC-Net surveillance are the following antimicrobials:
Antibacterials for systemic use (ATC therapeutic subgroup J01);
Antimycotics for systemic use (ATC therapeutic subgroup J02);
Antifungals for systemic use (ATC chemical subgroup D01BA);
Drugs for treatment of tuberculosis (ATC pharmacological subgroup J04A);
Antivirals for systemic use (ATC therapeutic subgroup J05);
Nitroimidazole derivatives used orally and rectally as antiprotozoals (ATC chemical subgroup
P01AB);
Intestinal antiinfectives (ATC chemical subgroup A07AA)
(All ATC codes should be reported including vancomycin used orally as intestinal
antiinfectives).
Antimicrobial consumption (AMC) data sources are either national sales or reimbursement data,
including information from national drug registers. WHO Anatomical Therapeutic Chemical (ATC)
classification system is used for allocation of antimicrobials into groups. National reference data are
preferably collected at the medicinal product level. Preferred units of measurement are number of
DDDs. Main indicators describing antimicrobial consumption are number of DDDs per 1 000
inhabitants per day.
The technical platform for web-based data submission, data storage and dissemination is The
European Surveillance System (TESSy).
Data covering the period 1997-2009 were uploaded into TESSy after termination of the ESAC project
using the historical project database that was transferred from the University of Antwerp to ECDC.
This is reporting protocol for the 2019 data call for antimicrobial AMC surveillance data in 2018.
The Reporting Protocol is supplemented by the
Technical Annex at the TESSy homepage which
contains updated generic information for each data collection.
Because reporting countries’ data managers sometimes play multiple roles, in addition to AMC
metadata set displaye
d in Annex 1, subject-specific material is included in
Annex 2.
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AMC metadata changes 2019
Annual updates of the WHO Collaborating Centre for Drug Statistics Methodology (2019 ATC/DDD
index) are shown in Tables 19 to 22
(Annex 2).
The following metadata changes had been agreed with the ESAC-Net Disease Network Coordination
Committee and ESAC-Net members during the joint meeting of ARHAI networks in June 2018. They
were implemented following a consultation and approval by the ECDC National Focal Points for
Surveillance during the annual metadata revision process.
Table 1: Implemented changes in record types for Antimicrobial Consumption (AMC) in 2019
Variables
Description
AMC record type:
These variables were removed
DPPNational
The possibility to report nationally defined daily doses was important in
DDDNational
the early days of ESAC-Net when the WHO Collaborating Centre for
DDDNationalUnit
Drug Statistics Methodology had not yet allocated a DDD for all
antimicrobial agents.
These variables are now obsolete because nearly all antimicrobial
agents have been assigned a WHO DDD.
AMC record type:
These variables were removed
PackageContent;
The variables were originally created for internal validation purposes.
PackageContentUnit
However, they are now obsolete.
TESSy computes the package content from other existing variables:
the package size, strength and basic quantity ingredient.
AMC record type:
A validation rule was added to validate the correct uploading of the
Add validation rule for the
strength unit for combined products.
variable CombinedProduct
AMCLIGHT record type:
The variable was added as mandatory variable for the oral
SyrupForm
route of administration.
It will help assessing the paediatric consumption for all ESAC-Net
antimicrobial consumption (AMC) data. A similar variable exits in the
standard version of reporting ESAC-Net AMC data.
AMCLIGHT record type:
These variables were added as mandatory variables
Weight
WeightUnit
They will be used as indicator in the ECDC Atlas of Infectious Diseases
and are also required for the Joint Interagency Antimicrobial
Consumption and Resistance Analysis (JIACRA) Report (European
Commission request; comparison with the animal consumption).
Summary of the TESSy AMC data upload and validation process
1. The national data manager revises and compiles the data from national sales and/or
reimbursement databases.
2. The nominated national focal point for antimicrobial surveillance or the national operational
contact point with TESSy rights to upload and/or approve data uploads the compiled data into
TESSy. At the end of this process, the complete uploaded file is saved in a specific
environment which is different from the one used to generate the online reports.
3. TESSy provides a validation report to the country user for approval. This report shows the
correctness of the data uploaded based on the validation rules defined in the ESAC-Net
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metadata. At this stage, neither the calculation nor the volume of DDD reported is validated.
The country user checks the validation report and approves or rejects the uploaded file.
4. After approval by the country user, the file is automatically transferred into the TESSy data
warehouse where the number of DDDs per 1 000 inhabitants per day are calculated for each
ATC substance and each sector. At this stage the data are available in the TESSy online
reports for antimicrobial consumption and can be downloaded by the country user. These
online reports are automatically refreshed at least every hour. The outputs (maps, graphs
and tables) of TESSy online reports are produced with the same methods and programmes
used for the final reports and web application outputs.
5. The user should validate the figures shown in the TESSy online reports. The reports contain
detailed results for the country referring down to the ATC 5th level. Additionally, the contact
points who uploaded the data will receive via email a comparative summary of the data
including data from the previous six years.
6. It is important that the user informs the ESAC-Net experts at ECDC via email on the status of
the data to avoid ECDC using incorrect data.
7. In case mistakes are found or records must be updated the user should repeat all previous
reporting steps.
Annual ESAC-Net data collection
The complete calendar year is the temporal basis for data reporting and analysis.
The annual national consumption data derived from sales or reimbursement data can be reported:
Either using the record type AMC$PACKAGES with reporting of all consumed packages at the
product level based on the national registry data given in the parent record type AMC. The
number of DDDs will subsequently be calculated by TESSy. This is the preferred option,
or using the record type AMCLIGHT for reporting aggregated numbers of Defined Daily Doses
(DDDs) at the ATC substance level.
Denominator data (record type AMCDENOM) and information on the data source for antimicrobial
consumption data (record type AMCDS) must be reported whatever option is chosen to report
consumption data.
Overview of AMC data collection and analysis
Following data management at country level, antimicrobial consumption data from both healthcare
sectors (community and hospital) are uploaded in defined datasets as described in
Error! Reference
source not found..
The datasets to be uploaded comprise the three subjects AMC, AMCDENOM and AMCDS for each
healthcare sector.
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Figure 1: Overview of ESAC-Net metadata for each data source.
ESAC-Net Metadata Overview
Member States
TESSy
National Drug
Consumption:
Register
Number of
WHO
packages
AMC
DDD
AMC
AMC$PACKAGES
Consumption:
Consumption:
Number of DDD
Number of DDD
Number of packages
Number of packages
AMC
AMCLIGHT
Exposed population
AMCDENOM
AMCDENOM
AMCDENOM
Datasource description
AMCDS
AMCDS
AMCDS
Error! Reference source not found. illustrates that different datasets for the subjects AMC,
AMCDENOM and AMCDS must be uploaded from different data sources. For antimicrobial
consumption, the preferred option is to provide data at the medicinal product level (record types AMC
and AMC$PACKAGES), or alternatively aggregated data at the substance level (record type
AMCLIGHT). Data on the denominator/population (record type AMCDENOM) and on data sources
(record type AMCDS) must always be provided.
Denominator data (subject AMCDENOM with record type AMCDENOM) and description of the data
source (subject AMCDS with record type AMCDS) are essential to enable TESSy to calculate the
number of DDDs per 1 000 inhabitants per day and produce online reports. Uploading data only for
the subject AMC (record types AMC and AMC$PACKAGES, or record type AMCLIGHT) is not sufficient.
There are four possible situations depending on whether the country provides data at medicinal
product level (preferred option) or at the substance level, and on whether the country uses Eurostat
or its own population data:
•
Countries providing data at the medicinal product level and using Eurostat data must
provide three datasets (record types AMC, AMC$PACKAGES and AMCDS);
•
Countries providing data at the medicinal product level and using their own denominator
data must provide four datasets (record types AMC, AMC$PACKAGES, AMCDENOM and
AMCDS);
•
Countries providing data at the ATC substance level and using Eurostat data must provide
two datasets (record types AMCLIGHT and AMCDS);
•
Countries providing data directly at the ATC substance level and using their own
denominator data must provide three datasets (record types AMCLIGHT, AMCDENOM and
AMCDS).
TESSy will use the least level of detail common between AMC and AMCDENOM subjects for reporting.
For example, if consumption was reported by age and gender, but population was only reported
overall for the whole country, then TESSy will aggregate consumption data before reporting.
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Following successful upload of data, TESSy users have access to the TESSy online reports. Based on
these TESSy reports and following consultations with MS, ECDC publishes an annual chapter (HTML
report) on antimicrobial consumption in Europe in ECDC’s Annual Epidemiological Report.
How to use this document
This Reporting Protocol provides information for reporting countries’ data managers in three main
sections:
Reporting to TESSy – contains guidelines on how to prepare data for submission to TESSy,
deadlines, subject-specific information (e.g. new changes to metadata), and links to further
information.
Annex 1 – contains:
o The metadata set for the subject(s) covered by this Reporting Protocol.
o A history of previous AMC metadata changes.
Annex 2 – contains AMC-specific material relevant for distribution with the Reporting Protocol,
for example
o Reporting ESAC-Net data.
o Reporting combined products
o Reporting liquid pharmaceutical form
o ATC and DDD updates
o Examples.
Finding further information
Paragraphs denoted by the information icon tell where you can find further information.
Updated links to all the schedules, documentation and training materials mentioned in this Reporting
Protocol are included in the
Technical Annex, including:
Metadata sets and history.
Tutorials for data transformation using respectively Excel and Access.
TESSy user documentation.
CSV and XML transport protocols.
On country request, ECDC will offer webinars: ca 2hrs online teleseminars, and an individual
coaching how to upload data to TESSy, incl. latest metadata changes etc. The webinars can
be requested by the National focal points and will be available for the data managers in
charge of uploading national consumption data.
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Reporting to TESSy
This section provides an overview of the TESSy reporting process and tips on where you can find
useful information.
Important steps:
1.
Data collection schedule
2.
Prepare (export and transform) your data.
3.
Check that your data complies with the metadata.
4.
Check that your data source profile is up-to-date.
5.
Submit your file(s) to TESSy.
6.
Finalise and approve your submission.
Data collection schedule
National reference data for antimicrobial consumption can only be reported once for one year, using
AMC (preferred) or AMCLIGHT record type. Data from the community (primary care) and hospital
sector should be reported separately. Reporting total care data is acceptable only if the data cannot
be subdivided among sectors.
The collection of 2018 antimicrobial consumption data in TESSy starts in March 2019 and closes on 30
June 2019. After this date, the ECDC experts will subject the data to a final cleaning and validation
before analysing them. Data submitted after data collection closure are not guaranteed to be included
in the 2018 ESAC-Net data outputs on the occasion of the European Antibiotic Awareness Day (EAAD)
in November 2019 and in the HTML reports at the ECDC website summarising the 2018 ESAC-Net
data.
The uploaded 2018 ESAC-Net data will be released via the
ESAC-Net database at the ECDC website
on the occasion of the EAAD 2019.
An updated link to the current data collections schedule is provided in the
Technical Annex.
Preparing data
After you have exported the data from your national database, you need to ensure that the data are
in a format that TESSy can accept. This applies both to the type of file submitted to TESSy (only CSV
and XML files can be submitted) and to the format of the data in certain fields.
Tutorials covering how you can transform your data to the correct TESSy format using Excel or
Access are available on
the TESSy documents website. Information on the file formats is available in
the CSV Transport Protocol and XML Transport Protocol.
Checking metadata
TESSy metadata define the fields and data formats that are valid as input to TESSy for a given
subject.
As requirements to the data to be shared among TESSy users change, the data changes needed to
support the new requirements, identified and agreed upon between the National Surveillance Contact
Points, the Network Coordination Groups and ECDC’s Disease Experts, and then implemented as
changes to the TESSy metadata.
In order to ensure that your data can be saved correctly in TESSy, you therefore need to check that
your data are correctly formatted according to the most recent metadata set.
Changes to the metadata for the subject of this Reporting Protocol are described in:
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Changes to current metadata – changes since the last Reporting Protocol.
AMC metadata change history - all preceding changes.
It is especially important to focus on:
Field formats
Many fields require that data are formatted in a specific way. For example, dates must be in the
YYYY-MM-DD format; dates in the DD/MM/YYYY format will be rejected.
Coded values
Some fields only permit the use of specific values (coded values). For example,
M,
F,
UNK, or
Other are the
coded values for Gender and any other value in a Gender field will be rejected.
The metadata file contains all the definitions and rules you need to comply with to format your data
correctly for every subject (in this case the antimicrobial consumption). The file can be downloaded
as an Excel file from the TESSy documents website.
By filtering the fields in the file by subject, you can see the fields required for your subject and the
rules applying to these fields.
The
Technical Annex provides an overview of how you work with the metadata file, and the
TESSy user documentation provides in-depth details on metadata.
Checking data source profile
Before submitting your file(s), please review the profile for your data source(s) in TESSy (go to
Data
Sources), and update the information, if necessary.
Complete and up-to-date data source information for each subject is important for improving
interpretation of data each surveillance system has different features that need to be taken into
account when comparing data at an international level.
If your data source information is out-of-date and you do not have access rights to update it, please
request your National Focal Point for Surveillance or National Coordinator to do so.
In-depth information on the data source variables is available in the TESSy user documentation.
Submitting data
The data are submitted through the TESSy web interface (go to
Upload).
The
Technical Annex provides an overview of how you submit files to TESSy, and the TESSy user
documentation provides in-depth descriptions of all the upload methods.
Finalising submission
The compliance of your data with the validation rules in the metadata is checked automatically during
the data upload process.
The result of your upload – i.e. rejected or validated – is displayed immediately after the conclusion
of the check in the
Validation details webpage. Please review the result carefully:
If your file has been rejected, there will be a message explaining each instance of non-
compliance with the metadata that you need to correct.
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If your file has been validated, there might be warnings and remarks relating to possible data
quality issues or to potential overwriting of existing records that you should consider.
When your file has been validated and all necessary corrections with regard to the TESSy warnings
have been made, please ensure prompt approval –
unapproved uploads can block the approval
process for uploads of other countries.
The TESSy user documentation provides information on reviewing validation results and adjusting
reporting periods to avoid overwriting existing records.
TESSy HelpDesk
Email:
xxxxx@xxxx.xxxxxx.xx
Telephone number:
+46-(0)8-5860 1601
Availability: 9:00 – 16:00 Stockholm time, Monday to Friday (except ECDC Holidays)
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Annex 1 Antimicrobial consumption (AMC)
metadata
This section describes:
The antimicrobial consumption metadata
Changes to the antimicrobial consumption metadata
ESAC-Net data
Three subjects have been created to manage ESAC-Net data: AMC (to record antimicrobial
consumption data), AMCDENOM (to record denominator, i.e. population data) and AMCDS (to record
contextual data related to antimicrobial consumption, i.e. data source).
For these three subjects, five record types have been defined. Three record types relate to the AMC
subject:
•
AMC: single (individual antimicrobials at the product level (case-based);
•
AMC$PACKAGES: consumed packages at the product level (case-based);
•
AMCLIGHT: antimicrobial consumption expressed at the substance level (aggregate).
The aggregate AMCDENOM record type for recording population data relates to the AMCDENOM
subject. The AMCDS record type for recording contextual information relates to the AMCDS subject.
ESAC-Net record types
•
The record type
AMC contains the national registry data of all antimicrobials available in
the country, even if not used during the reporting year. It includes 8 technical and 12
epidemiological variables.
•
The record type
AMC$PACKAGES contains case-based antimicrobial consumption data
at the product level. It includes 3 technical and 7 epidemiological variables.
•
The record type
AMCLIGHT is an alternative for reporting the antimicrobial consumption
data and contains aggregated antimicrobial consumption data expressed in DDD at the
ATC substance level. It includes 6 technical and 12 epidemiological variables.
•
The record type
AMCDENOM contains denominator data; i.e. data on the population
under surveillance. It is mandatory only if the Member State is not using Eurostat data.
Additionally, data subdivided by sub-national area (NUTS classification), age class or
gender can be optionally reported. This record type includes 6 technical and 5
epidemiological variables.
The record type
AMCDS contains information on the antimicrobial consumption data
source. In particular, it includes information about whether the data represent national
reference data and which groups of antimicrobials are included. Finally, two variables
offer the possibility to share comments, either only with ECDC or publicly in the individual
country summary sheets. The record type AMCDS includes 7 technical variables, 10
epidemiological variables on consumption and 3 denominator variables for each sector.
Finally, it includes 5 summary variables on the inclusion of nursing homes, psychiatric
hospitals and day care centres. Data should be reported separately for the community
(primary care) and the hospital sector. If data cannot be subdivided between the
community and hospital sector, they can be reported for both sectors combined (total
care).
Descriptions of all the ESAC-Net metadata variables can be found in the TESSy system and in an
Excel file, which is provided with the invitation letter for the data call. Additionally, all variables,
including the respective coding and the associated validation rules, are described in
Metadata for
antimicrobial consumption surveillance on page
13.
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Current record type versions
Table 2 shows the record types and record type versions to be used when uploading 2018 AMC
surveillance data to TESSy.
Table 2: Accepted record types and record type versions
Subject
Record type
Description
version
AMC.5
National registry data of all
antimicrobials available.
Standard
(case-based)
AMC
AMC$PACKAGES.5 Antimicrobial consumption data linked
to the national registry.
Light
AMCLIGHT.3
(aggregated)
Consumption data (expressed DDD).
AMCDENOM
AMCDENOM.1
Denominator / population under
(aggregated)
surveillance.
AMCDS
AMCDS.3
Data source information for
(aggregated)
antimicrobial consumption data.
Metadata for antimicrobial consumption surveillance
The description of each variable used for reporting of the datasets of antimicrobial consumption data
is presented in the following tables.
Please note that validation rules only check data within one record type. For this reason, it is
theoretically possible to successfully upload data into TESSy, but no results are shown on the online
reports. The latter could happen if, for example, antimicrobial consumption data are reported with the
light version, but the healthcare sector or the denominator data are not reported accordingly in the
record types AMCDENOM or AMCDS. If this is the case, no calculation or data analysis will be
performed by TESSy.
In the tables, the following conventions are used:
VariableName
Literal name of a variable. Never contains spaces.
Upper/lower case is only used to improve readability.
Description
Description of a possible value for a specific variable.
Required
Whether it is mandatory
Data type
Textual, numeric, coded value
Code
Code as accepted by the system.
Validation rule
Function of validation rule (e.g., checking for the right format, checking for
coded values, “look up” validation rules, expected values based on other
rules).
Some variables are technically mandatory, i.e. TESSy will not accept the data submission unless the
corresponding fields have been completed.
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Record type AMC - national registry data for all available antimicrobials
Table 3: Technical variables for AMC record type
VariableName
1 - RecordID
Description
Unique identifier for the product in the reported year.
Possible format: ReportingCountry + Year + ProductId.
Required (what happens if not
Yes (Error)
submitted)
Data type
String (Text; max length: 80 characters)
Validation rule
-
VariableName
2 - RecordType
Description
Structure and format of the data (case based reporting or aggregate
reporting).
Required (what happens if not
Yes (Error)
submitted)
Data type
Coded Value
Code
AMC
Validation rule
-
VariableName
3 - RecordTypeVersion
Description
Indicates the version of the record type used in the reported batch. If
no record type version is provided in the batch, it is automatically set
with current version of the record type. The record type version is
required when no metadata set is provided at upload or when a record
type version, other than the current one, needs to be used.
Required (what happens if not
No
submitted)
Data type
Numeric
Code
See ESAC-Net metadata (e.g. 1)
Validation rule
-
VariableName
4 - Subject
Description
Subject of the data reported (see
Error! Reference source not
found. on page
Error! Bookmark not defined.).
Required (what happens if not
Yes (Error)
submitted)
Data type
Coded Value
Code
AMC
Validation rule
-
VariableName
5 - DataSource
Description
Data source (surveillance system) from which the record originates.
Required (what happens if not
Yes (Error)
submitted)
Data type
Coded Value
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Code
See ESAC-Net metadata
Validation rule
-
VariableName
6 - ReportingCountry
Description
Country reporting the record.
Required (what happens if not
Yes
submitted)
Data type
Coded Value
Code
See ESAC-Net metadata
Validation rule
-
VariableName
7 - DateUsedForStatistics
Description
Year of reporting.
Required (what happens if not
Yes (Error)
submitted)
Data type
Date
Code
Year (YYYY)
Validation rule
-
VariableName
8 - Status
Description
Status of reporting NEW/UPDATE or DELETE (inactivate). Default if left
out: NEW/UPDATE. If set to DELETE, the record with the given
RecordId will be deleted from the TESSy database (or better stated,
invalidated). If set to NEW/UPDATE or left empty, the record is newly
entered into the database.
Required (what happens if not
No
submitted)
Data type
Coded Value
Code
NEW/UPDATE, DELETE
Validation rule
-
Table 4: Epidemiological variables for AMC record type
VariableName
9 - ProductId
Description
Product identifier (previously Medicinal Product Package Code Value -
MPPCV). Must be a unique identifier of the medicinal product package
(MPP). Because it is a key value in many tables, it must not change
over time. Product identifiers that are no longer available on the
market or that are no longer registered still can be identified in the
TESSy database for historical purposes.
The product ID represents the variable ParentId of the record
type AMC&PACKAGES
Required (what happens if not
Yes
submitted)
Data type
String (Text; max length: 80 characters)
Validation rule
-
VariableName
10 - ProductLabel
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Description
The product label or medicinal product package label (e.g. Sovaldi®
400mg tablets
Required (what happens if not
Yes (Error)
submitted)
Data type
String (Text; max length: 80 characters)
Validation rule
-
VariableName
11 - PackageSize
Description
Package size or number of single items (e.g., tablets) in the package.
Do not provide the unit (e.g., not 60 tablets, it should be reported only
as 60). Note that e.g. vials are quantified in number of items and not
quantified by their volume (see
How to report medicinal products in
vials or syrup forms).
Required (what happens if not
No
submitted)
Data type
Numeric
Validation rule
-
VariableName
12 - PackageSizeUnit
Description
Unit of the size (number of items) of a package.
Required (what happens if not
Yes (Error)
submitted)
Data type
Coded value
Code
PCS=pieces,
Validation rule
-
VariableName
13 - Strength
Description
Quantity of the ingredient in each single item.
For multi-ingredient medicinal products, this field must contain the
ingredient strength in which the DDD is expressed (e.g.,
amoxicillin/clavulanic acid combinations: strength expresses the
strength of amoxicillin since DDD=1 g of amoxicillin).
For combined products where the DDD is expressed in Unit Dose (UD),
the strength should be reported in the number of UDs.
Required (what happens if not
Yes (Error)
submitted)
Data type
String (Text; max length: 80 characters)
Validation rule
Strength must be a positive integer or float (up to 3 decimals)
VariableName
14- StrengthUnit
Description
Unit of the strength reported.
Required (what happens if not
Yes (Error)
submitted)
Data type
Coded value
Code
G = Gram, MG = Milligram, IU = International unit, MU = Million units,
UD = Unit dose
Validation rule
If ATCCode is reported as A07AA02, A07AA05 or J01XB01, then
StrengthUnit must be reported as IU or MU.
If ATCCode is reported different than A07AA02, A07AA05, J01XB01
then StrengthUnit must be reported as G or MG.
If combined products are reported, then strength unit must be
reported as Unit Doses (UD) with the exception of ATC code J01CE30.
VariableName
15 - AntimicrobialRoute
Description
Route of administration of the substance.
Required (what happens if not
Yes (Error)
submitted)
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Data type
Coded value
Code
O = Oral, P = Parenteral, R = Rectal, I = Inhalation, M = Implant
Validation rules
1if Antimicrobial Route is reported as "I", then Inhalation Form should
be reported as IP or IS.
2. if Antimicrobial Route is reported different than "I", then Inhalation
Form should not be reported.
3. If ATCCode is reported as J01FA01 (erythromycin) and
AntimicrobialRoute is reported as O (oral), then Salt -if reported- can
only be reported as ESUC.
4. If ATCCode is reported as J01FA01 (erythromycin) and
AntimicrobialRoute is reported different than O(oral), then Salt must
not be reported.
5. If AntimicrobialRoute is reported different than "O" then SyrupForm
must be reported as NA.
6. If AntimicrobialRoute is reported as "O" then SyrupForm must be
reported as Y/N.
VariableName
16- SyrupForm
Description
All antimicrobials administered orally as a liquid (syrup, oral powder,
oral solution, oral suspension)
(The variable will be used for tracking paediatric consumption).
Required (what happens if not
Yes (Error)
submitted)
Data type
Coded value
Code
Y = Yes, N = No, NA = Not applicable
Validation rule
If AntimicrobialRoute is reported different than 'O', then SyrupForm
must be reported as NA.
If AntimicrobialRoute is reported as 'O', then SyrupForm must be
reported as Y/N.
VariableName
17- InhalationForm
Description
The galenic form of the drug for inhalation, i.e. inhalation powder or
inhalation solution
Required
No
Data type
Coded value
Code
IP = Inhalation powder, IS = Inhalation solution
Validation rule
If Route is reported as ’I’, InhalationForm should be reported as ’IP’ or
’IS’
If Route is reported as different from ’I’, InhalationForm should not be
reported
VariableName
18- ATCCode
Description
ATC code of the substance (ATC 5th level).
Required (what happens if not
Yes (Error)
submitted)
Data type
Coded value
Code
List of ATC codes (only ATC 5th level codes) - (See
Annual ESAC-Net
data collection)
Validation rule
-
VariableName
19- Salt
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Description
Salt associated with substance. Only used (required) for methenamine
and for erythromycin. For methenamine, the associated salt (hippurate
or mandelate) should be specified. For erythromycin, if the associated
salt is ethylsuccinate and the galenic form is tablet, then
ethylsuccinate must be specified. In all other cases (any other form
than tablet and even if ethylsuccinate), the variable ’Salt’ should be
left empty.
Required (what happens if not
No
submitted)
Data type
Coded value
Code
HIPP = Hippurate, MAND = Mandelate, ESUC = Ethylsuccinate,
NA = Not applicable
Validation rule
If ATCCode is reported as J01XX05 (methenamine), then Salt must be
reported as HIPP or MAND.
If ATCCode is reported as J01FA01 (erythromycin) and
AntimicrobialRoute is reported as O (oral), then Salt can only be
reported as ESUC.
If ATCCode is reported as J01FA01 (erythromycin) and
AntimicrobialRoute is reported different than O (oral), then Salt must
not be reported.
If ATCCode is reported different than J01XX05 (methenamine) or
J01FA01 (erythromycin), then Salt must not be reported.
VariableName
20 – CombinedProduct
Description
ATC code of the substance for combined products
Required (what happens if not
Yes (Error)
submitted)
Data type
Coded value
Code
List of ATC codes for combined products -
(Allocations of defined daily
doses for combined products in TESSy)
Validation rule
If ATCCode is not equal to the first 7 characters (before “_”) of the
code indicated in CombinedProduct.
Record type AMC$PACKAGES - AMC data linked to the national registry
Table 5: Technical variables for AMC$PACKAGES record type
VariableName
1 - RecordID
Description
Unique identifier for the product package consumption. Possible
format: ParentId + PlaceOfNotification + PlaceOfNotification +
AgeClass + Gender + Sector + Prescriber + Quarter.
Required (what happens if not
Yes (Error)
submitted)
Data type
String (Text; max length: 80 characters)
Validation rule
-
VariableName
2 - RecordType
Description
Structure and format of the data (case based reporting or aggregate
reporting).
Required (what happens if not
Yes (Error)
submitted)
Data type
Coded Value
Code
AMC$PACKAGES
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Validation rule
-
VariableName
3 - ParentId
Description
Unique identifier for the product in the year reported. Recommended
format: ReportingCountry + Year + ProductId.
ParentId represented by the corresponding variable ProductId exists in
the AMC record type.
Required (what happens if not
Yes (Error)
submitted)
Data type
String (Text; max length: 80 characters)
Validation rule
Table 6: Epidemiological variables for record type AMC$PACKAGES
VariableName
4 - PlaceOfNotification
Description
Sub-national area for which data are reported.
Select the most detailed NUTS level possible.
Leave empty for national data.
Required (what happens if not
No
submitted)
Data type
Coded value
Code
List of NUTS codes, country codes for non EU/EEA, UNK - Unknown
Validation rule
-
VariableName
5 - AgeClass
Description
Age class for which consumption data is reported. Leave empty if data
are not reported by age class.
Required (what happens if not
No
submitted)
Data type
Coded value
Code
See ESAC-Net metadata
Validation rule
AgeClass can only be reported for the community (primary care).
For community (primary care), please report age class, if possible
AgeClass can be reported only with a value from the following list: '00-
<01', '01-04', '05-09', '10-14', '15-19', '20-24', '25-29', '30-34', '35-39',
'40-44', '45-49', '50-54', '55-59', '60-64', '65-69', '70-74', '75-79', '80-
84', '85+' or 'UNK'.
VariableName
6 - Gender
Description
Gender of the reported data. Leave empty if data are not reported by
gender.
Required (what happens if not
No
submitted)
Data type
Coded value
Code
M=Male, F=Female, O=Other, UNK=Unknown
Validation rule
Gender can only be reported for the community (primary care).
For community (primary care), please report gender, if possible.
VariableName
7 - Sector
Description
Sector for which data are reported, i.e. community (primary care),
hospital sector, or both healthcare sectors combined (total care).
Required (what happens if not
Yes (Error)
submitted)
Data type
Coded value
© ECDC March 2019 All rights reserved.
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Code
AC = community (primary care), HC = Hospital sector, TC = Total care
Validation rule
-
VariableName
8 - Prescriber
Description
Category of physicians prescribing the antimicrobials.
Required (what happens if not
No
submitted)
Data type
Coded value
Code
GP = General Practitioners, SP = Specialists, GE = Geriatrics, DE =
Dentists, PE = Paediatricians, OTH = Other, UNK = Unknown - not
available.
Validation rule
Prescriber can only be reported only for the community (primary care).
For community (primary care), please report prescriber, if possible.
VariableName
9 - ReportQuarter
Description
Use only when reporting quarterly data. Leave empty for annual data.
Required (what happens if not
No
submitted)
Data type
Numeric
Validation rule
-
VariableName
10 - NumberOfPackages
Description
Number of packages consumed the reported sector and period.
Required (what happens if not
Yes (Error)
submitted)
Data type
Numeric
Validation rule
NumberOfPackages must be an integer or float (up to 3 decimals).
Record type AMCLIGHT - (aggregated number of DDDs reported)
Table 7: Technical variables for record type AMCLIGHT
VariableName
1 - RecordType
Description
Structure and format of the data (aggregate reporting).
Required (what happens if not
Yes (Error)
submitted)
Data type
Coded Value
Code
AMCLIGHT
Validation rule
-
VariableName
2 - RecordTypeVersion
Description
Indicates the version of the record type used in the reported batch. If
no record type version is provided in the batch, it is automatically set
with current version of the record type. The record type version is
required when no metadata set is provided at upload or when a record
type version, other than the current one, needs to be used.
Required (what happens if not
No
submitted)
Data type
Numeric
Code
See ESAC-Net metadata (e.g. 1)
Validation rule
-
VariableName
3 - Subject
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Description
Subject of the data reported (see
Error! Reference source not
found. on page
Error! Bookmark not defined.).
Required (what happens if not
Yes (Error)
submitted)
Data type
Coded Value
Code
AMC
Corresponding variable in the previous
(new variable)
ESAC project dataset (notes)
Validation rule
-
VariableName
4 - DataSource
Description
Data source (surveillance system) from which the record originates.
Required (what happens if not
Yes (Error)
submitted)
Data type
Coded Value
Code
See ESAC-Net metadata
Validation rule
-
VariableName
5 - ReportingCountry
Description
Country reporting the record.
Required (what happens if not
Yes
submitted)
Data type
Coded Value
Code
See ESAC-Net metadata
VariableName
6 - DateUsedForStatistics
Description
Year of reporting.
Required (what happens if not
Yes
submitted)
Data type
Date
Code
Year (YYYY, YYYY-Qq)
Table 7: Epidemiological variables for AMCLIGHT record type
VariableName
7 - PlaceOfNotification
Description
Sub-national area for which data are reported.
Select the most detailed NUTS level possible.
Leave empty for national data.
Required (what happens if not
No
submitted)
Data type
Coded value
Code
List of NUTS codes, country codes for non EU/EEA, UNK – Unknown.
Validation rule
-
VariableName
8 - AgeClass
Description
Age class for which consumption data is reported. Leave empty if data
are not reported by age class.
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Required (what happens if not
No
submitted)
Data type
Coded value
Code
See ESAC-Net metadata
Validation rule
AgeClass can only be reported for the community (primary care)
AgeClass can be reported only with a value from the following list: '00-
<01', '01-04', '05-09', '10-14', '15-19', '20-24', '25-29', '30-34', '35-39',
'40-44', '45-49', '50-54', '55-59', '60-64', '65-69', '70-74', '75-79', '80-
84', '85+' or 'UNK'.
VariableName
9 - Gender
Description
Gender of the reported data. Leave empty if data are not reported by
gender.
Required (what happens if not
No
submitted)
Data type
Coded value
Code
M=Male, F=Female, O=Other, UNK=Unknown
Validation rule
Gender can only be reported for the community (primary care).
VariableName
10 - Sector
Description
Sector for which data are reported, i.e. community (primary care),
hospital sector, or both healthcare sectors combined (total care).
Required (what happens if not
Yes (Error)
submitted)
Data type
Coded value
Code
AC = community (primary care), HC = Hospital sector, TC = Total care
Validation rule
-
VariableName
11 - Prescriber
Description
Category of physicians prescribing the antimicrobials.
Required (what happens if not
No
submitted)
Data type
Coded value
Code
GP = General Practitioners, SP = Specialists, GE = Geriatrics, DE =
Dentists, PE = Paediatricians, OTH = Other, UNK = Unknown - not
available.
Validation rule
Prescriber can only be reported for the community (primary care).
VariableName
12 - ATCCode
Description
ATC code of the substance (ATC 5th level).
Required (what happens if not
Yes (Error)
submitted)
Data type
Coded value
Code
List of ATC codes (only ATC 5th level codes). See
Annual ESAC-Net
data collection).
Validation rule
-
VariableName
13 - ATCName
Description
ATC name of the substance (ATC 5th level).
Required (what happens if not
No
submitted)
Data type
String (Text; max length: 80 characters)
Validation rule
-
© ECDC March 2019 All rights reserved.
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VariableName
14 - AntimicrobialRoute
Description
Route of administration of the substance.
Required (what happens if not
Yes (Error)
submitted)
Data type
Coded value
Code
O = Oral, P = Parenteral, R = Rectal, I = Inhalation, M = Implant
Validation rule
-
VariableName
15 - Salt
Description
Salt associated with substance. Only used (required) for methenamine
and for erythromycin. For methenamine, the associated salt (hippurate
or mandelate) should be specified. For erythromycin, if the associated
salt is ethylsuccinate and the galenic form is tablet, then
ethylsuccinate must be specified. In all other cases (any other form
than tablet and even if ethylsuccinate), the variable ’Salt’ should be
left empty.
Required (what happens if not
No
submitted)
Data type
Coded value
Code
HIPP = Hippurate, MAND = Mandelate, ESUC = Ethylsuccinate,
NA = Not applicable.
Validation rule
If ATCCode is reported as J01XX05 (methenamine), then Salt must be
reported as HIPP or MAND.
If ATCCode is reported as J01FA01 (erythromycin) and
AntimicrobialRoute is reported as O (oral), then Salt can only be
reported as ESUC.
If ATCCode is reported as J01FA01 (erythromycin) and
AntimicrobialRoute is reported different than O (oral), then Salt must
not be reported.
If ATCCode is reported different than J01XX05 (methenamine) or
J01FA01 (erythromycin), then Salt must not be reported.
VariableName
16 - NumberOfDDD
Description
Number of DDD used for the reported substance, healthcare sector
and period.
In the record type AMCDS (data source), specify whether
NumberOfDDD is reported as WHO DDDs or national Daily Doses.
Required (what happens if not
Yes (Error)
submitted)
Data type
String (Text; max length: 80 characters)
Validation rule
NumberOfDDD must be a integer or float (up to 3 decimals).
VariableName
17 - Weight
Description
Number of weight units (total weight corresponding to the reported
NumberOfDDD).
Required (what happens if not
Yes (Error)
submitted)
Data type
String (Text; max length: 80 characters)
Code
Validation rule
VariableName
18 - WeightUnit
Description
Unit of the weight.
Required (what happens if not
Yes (Error)
submitted)
Data type
Coded value
© ECDC March 2019 All rights reserved.
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Code
G = Gram; IU = International unit; MG = Milligram; MU = Million
units; UD = Unit dose
Validation rule
Record type AMCDENOM - Denominator / Population under surveillance
Table 8: Technical variables for record type AMCDENOM
VariableName
1 - RecordType
Description
Structure and format of the data (case based reporting or aggregate
reporting).
Required (what happens if not
Yes (Error)
submitted)
Data type
Coded Value
Code
AMCDENOM
Validation rule
-
VariableName
2 - RecordTypeVersion
Description
Indicates the version of the record type used in the reported batch. If
no record type version is provided in the batch, it is automatically set
with current version of the record type. The record type version is
required when no metadata set is provided at upload or when a record
type version, other than the current one, needs to be used.
Required (what happens if not
No
submitted)
Data type
Numeric
Code
See ESAC-Net metadata (e.g. 1)
Validation rule
-
VariableName
3 - Subject
Description
Subject of the data reported (see
Error! Reference source not
found. on page
Error! Bookmark not defined.).
Required (what happens if not
Yes (Error)
submitted)
Data type
Coded Value
Code
AMCDENOM
Validation rule
-
VariableName
4 - DataSource
Description
Data source (surveillance system) from which the record originates.
Required (what happens if not
Yes (Error)
submitted)
Data type
Coded Value
Code
See ESAC-Net metadata
Validation rule
-
VariableName
5 - ReportingCountry
Description
Country reporting the record.
Required (what happens if not
Yes
submitted)
Data type
Coded Value
Code
See ESAC-Net metadata
© ECDC March 2019 All rights reserved.
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Validation rule
-
VariableName
6 - DateUsedForStatistics
Description
Year of reporting.
Required (what happens if not
Yes
submitted)
Data type
Date
Code
Year (yyyy, yyyy-Qq)
Validation rule
-
Table 9: Epidemiological variables for AMCDENOM
VariableName
7 - PlaceOfNotification
Description
Sub-national area for which data are reported.
Select the most detailed NUTS level possible.
Leave empty for national data.
Required (what happens if not
No
submitted)
Data type
Coded value
Code
List of NUTS codes, country codes for non EU/EEA, UNK - Unknown
Validation rule
-
VariableName
8 - AgeClass
Description
Age class for which consumption data is reported. Leave empty if data
are not reported by age class.
Required (what happens if not
No
submitted)
Data type
Coded value
Code
See ESAC-Net metadata
Validation rule
AgeClass shall be reported only for the community (primary care)..
For community (primary care), please report age class, if possible.
AgeClass can be reported only with a value from the following list: '00-
<01', '01-04', '05-09', '10-14', '15-19', '20-24', '25-29', '30-34', '35-39',
'40-44', '45-49', '50-54', '55-59', '60-64', '65-69', '70-74', '75-79', '80-
84', '85+' or 'UNK'.
VariableName
9 - Gender
Description
Gender of the reported data. Leave empty if data are not reported by
gender.
Required (what happens if not
No
submitted)
Data type
Coded value
Code
M=Male, F=Female, O=Other, UNK=Unknown
Validation rule
Gender can only be reported for the community (primary care).
For community (primary care), please report gender, if possible.
VariableName
10 - Sector
Description
Sector for which data are reported, i.e. community (primary care),
hospital sector, or both healthcare sectors combined (total care).
Required (what happens if not
Yes (Error)
submitted)
Data type
Coded value
© ECDC March 2019 All rights reserved.
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Code
AC = community (primary care), HC = Hospital sector, TC = Total care
Validation rule
-
VariableName
11 - Denominator
Description
Number of individuals in place of notification.
Required (what happens if not
No
submitted)
Data type
Numeric
Validation rule
-
Record type AMCDS - data source information for antimicrobial
consumption data
Table 10: Technical variables for record type AMCDS
VariableName
1 - RecordType
Description
Structure and format of the data (case based reporting or aggregate
reporting).
Required (what happens if not
Yes (Error)
submitted)
Data type
Coded Value
Code
AMCDS
Validation rule
-
VariableName
2 - RecordTypeVersion
Description
Indicates the version of the record type used in the reported batch. If
no record type version is provided in the batch, it is automatically set
with current version of the record type. The record type version is
required when no metadata set is provided at upload or when a record
type version, other than the current one, needs to be used.
Required (what happens if not
No
submitted)
Data type
Numeric
Code
See ESAC-Net metadata (e.g. 1)
Validation rule
-
VariableName
3 - Subject
Description
Subject of the data reported.(see
Error! Reference source not
found. on page
Error! Bookmark not defined.)
Required (what happens if not
Yes (Error)
submitted)
Data type
Coded Value
Code
AMCDS
Validation rule
-
VariableName
4 – DataSource
Description
Data source (surveillance system) from which the record originates.
Required (what happens if not
Yes (Error)
submitted)
Data type
Coded Value
Code
See ESAC-Net metadata
© ECDC March 2019 All rights reserved.
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Validation rule
-
VariableName
5 - ReportingCountry
Description
Country reporting the record.
Required (what happens if not
Yes
submitted)
Data type
Coded Value
Code
See ESAC-Net metadata
Validation rule
-
VariableName
6 - DateUsedForStatistics
Description
Year of reporting.
Required (what happens if not
Yes
submitted)
Data type
Date
Code
Year (YYYY)
Validation rule
-
VariableName
7- NationalReferenceData
Description
Are data reported as national reference data?
If no, data reported shall provide additional information (e.g.,
reporting age class and gender from a different database than the
National reference data).
Required (what happens if not
Yes (Error)
submitted)
Data type
Coded value
Code
Y = Yes, N = No
Validation rule
-
Table 11: Epidemiological variables for record type AMCDS - community (primary care) data
VariableName
8 - DS_DataProviderAC
Description
Which authority/organisation/network was the provider for community
(primary care) data?
Required (what happens if not
No
submitted)
Data type
Coded Value
Code
MoH = Ministry of Health, HI = Health Insurance Company, CP =
Community Pharmacists, HN = Hospital Network, MR = Marketing
Research Company, MA = Medicines Agency, O = Other.
Validation rule
-
VariableName
9 - DS_TypeOfDataAC
Description
What is the type of community (primary care) data?
Required (what happens if not
No
submitted)
Data type
Coded value
Code
S = Sales, R = Reimbursement, B = Both
Validation rule
If DS_DataProviderAC is reported, then all the information for the
community (primary care), including DS_TypeOfDataAC, must be
reported.
VariableName
10 - DS_CoverageAC
© ECDC March 2019 All rights reserved.
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Description
What is the percentage of coverage of consumption data in the
community (primary care)? (See
How to report data coverage in the
AMCDS record type)
Required (what happens if not
Yes (Error)
submitted)
Data type
Numeric
Validation rule
If DS_DataProviderAC is reported, then all the information for the
community (primary care), including DS_CoverageAC, must be
reported.
VariableName
11 - DS_CoverageExtrapolatedAC
Description
Were the data extrapolated to obtain 100% coverage of the
community (primary care) in the country?
Required (what happens if not
Yes (Error)
submitted)
Data type
Coded value
Code
Y = Yes, N = No
Validation rule
If DS_DataProviderAC is reported, then all the information for the
community (primary care), including DS_CoverageExtrapolatedAC,
must be reported.
If DS_EurostatDataAC = Y and DS_CoverageAC is less than 100, then
DS_CoverageExtrapolatedAC must be reported as Y."
VariableName
12 - DS_ATCVersionAC
Description
Which version of the WHO ATC/DDD index was used for reporting
consumption data in the community (primary care?
Required (what happens if not
Yes (Error)
submitted)
Data type
Year
Code
YYYY
Validation rule
If DS_DataProviderAC is reported, then all the information for the
community (primary care) including DS_ATCVersionAC, must be
reported.
VariableName
13- DS_ATCVersionAlteratedAC
Description
Were other than official WHO ATC/DDD alterations applied?
Required (what happens if not
Yes (Error)
submitted)
Data type
Coded value
Code
Y = Yes, N = No
Validation rule
If DS_DataProviderAC is reported, then all the information for the
community (primary care), including DS_ATCVersionAlteratedAC, must
be reported.
VariableName
14 - DS_J01InclusionAC
Description
Is consumption of substances in ATC groups J01 + A07AA + P01AB
(i.e., antibacterials for systemic use + intestinal
antiinfectives/antibiotics + nitroimidazole derivatives) included in the
data reported for the community (primary care)?
Required (what happens if not
Yes (Error)
submitted)
Data type
Coded value
Code
Y = Yes, N = No
Validation rule
If DS_DataProviderAC is reported, then all the information for the
community (primary care), including DS_J01InclusionAC, must be
reported.
© ECDC March 2019 All rights reserved.
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VariableName
15 - DS_J02InclusionAC
Description
Is consumption of substances in ATC groups J02 + D01BA (i.e.,
antimycotics for systemic use + antifungals for systemic use) included
in the data reported for the community (primary care)?
Required (what happens if not
Yes (Error)
submitted)
Data type
Coded value
Code
Y = Yes, N = No
Validation rule
If DS_DataProviderAC is reported, then all the information for the
community (primary care), including DS_J02InclusionAC, must be
reported.
VariableName
16- DS_J04InclusionAC
Description
Is consumption of substances in ATC group J04A (drugs for the
treatment of tuberculosis) included in the data reported for the
community (primary care)?
Required (what happens if not
Yes (Error)
submitted)
Data type
Coded value
Code
Y = Yes, N = No
Validation rule
If DS_DataProviderAC is reported, then all the information for the
community (primary care), including DS_J04InclusionAC, must be
reported.
VariableName
17 - DS_J05InclusionAC
Description
Is consumption of substances in ATC group J05 (antivirals for systemic
use) included in the data reported for the community (primary care)?
Required (what happens if not
Yes (Error)
submitted)
Data type
Coded value
Code
Y = Yes, N = No
Validation rule
If DS_DataProviderAC is reported, then all the information for the
community (primary care), including DS_J05InclusionAC, must be
reported.
Table 12: Denominator data for the community (primary care)
VariableName
18- DS_EurostatDataAC
Description
Are the reported population data from Eurostat?
If no, national population data must be provided by the country.
Required (what happens if not
Yes (Warning)
submitted)
Data type
Coded value
Code
Y = Yes, N = No
Validation rule
If DS_EurostatDataAC = N, then DS_DataProviderDenomAC must be
reported
VariableName
19- DS_DataProviderDenomAC
Description
Which authority/organisation/network was the provider for population
data for the community (primary care)?
Required (what happens if not
No
submitted)
Data type
Coded value
Code
MoH = Ministry of Health, HI = Health Insurance Company, CP =
Community Pharmacists, HN = Hospital Network, MR = Marketing
Research Company, MA = Medicines Agency, O = Other.
© ECDC March 2019 All rights reserved.
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Validation rule
If DS_EurostatDataAC = N, then DS_DataProviderDenomAC must be
reported.
If DS_EurostatDataAC = Y, then DS_DataProviderDenomAC must not
be reported.
VariableName
20 - DS_TypeOfDataDenomAC
Description
What is the type of population data for the community (primary care)?
Required (what happens if not
No
submitted)
Data type
Coded value
Code
POP = Population, INS = Insured population.
Validation rule
If DS_EurostatDataAC = N, then DS_TypeOfDataDenomAC must be
reported.
If DS_EurostatDataAC = Y, then DS_TypeOfDataDenomAC must not
be reported.
Table 13: Epidemiological variables for record type AMCDS - Hospital care data
VariableName
21 - DS_DataProviderHC
Description
Which authority/organisation/network was the provider for hospital
sector data?
Required (what happens if not
No
submitted)
Data type
Coded Value
Code
MoH = Ministry of Health, HI = Health Insurance Company, NS =
National Statistics Agency, O = Other, NA = Not applicable
Validation rule
-
VariableName
22 - DS_TypeOfDataHC
Description
What is the type of hospital sector data?
Required (what happens if not
No
submitted)
Data type
Coded value
Code
S = Sales, R = Reimbursement, B = Both
Validation rule
If DS_DataProviderHC is reported, then all the information for the
hospital sector, including DS_TypeOfDataHC, must be reported.
VariableName
23 - DS_CoverageHC
Description
What is the percentage of coverage of consumption data in the
hospital sector?
Required (what happens if not
Yes (Error)
submitted)
Data type
Numeric
Validation rule
If DS_DataProviderHC is reported, then all the information for the
hospital sector, including DS_CoverageHC, must be reported.
VariableName
24 - DS_CoverageExtrapolatedHC
Description
Were the data extrapolated to obtain 100% coverage of the hospital
sector in the country?
Required (what happens if not
Yes (Error)
submitted)
Data type
Coded value
Code
Y = Yes, N = No
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Validation rule
If DS_DataProviderHC is reported, then all the information for the
hospital sector, including DS_CoverageExtrapolatedHC, must be
reported.
If DS_EurostatDataHC = Y and DS_CoverageHC is less than 100, then
DS_CoverageExtrapolatedHC must be reported as Y.
VariableName
25- DS_ATCVersionHC
Description
Which version of the WHO ATC/DDD index was used for reporting
consumption data in the hospital sector?
Required (what happens if not
Yes (Error)
submitted)
Data type
Date
Code
Year (YYYY)
Validation rule
If DS_DataProviderHC is reported, then all the information for the
hospital sector, including DS_ATCVersionHC, must be reported.
VariableName
26- DS_ATCVersionAlteratedHC
Description
Were other than official WHO ATC/DDD alterations used?
Required (what happens if not
Yes (Error)
submitted)
Data type
Coded value
Code
Y = Yes, N = No
Validation rule
If DS_DataProviderHC is reported, then all the information for the
hospital sector, including DS_ATCVersionAlteratedHC, must be
reported.
VariableName
27 - DS_J01InclusionHC
Description
Is consumption of substances in ATC groups J01 + A07AA + P01AB
(i.e., antibacterials for systemic use + intestinal
antiinfectives/antibiotics + nitroimidazole derivatives) included in the
data reported for the hospital sector?
Required (what happens if not
Yes (Error)
submitted)
Data type
Coded value
Code
Y = Yes, N = No
Validation rule
If DS_DataProviderHC is reported then all the information for the
hospital sector, including DS_J01InclusionHC, must be reported.
VariableName
28- DS_J02InclusionHC
Description
Is consumption of substances in ATC groups J02 + D01BA (i.e.,
antimycotics for systemic use + antifungals for systemic use) included
in the data reported for the hospital sector?
Required (what happens if not
Yes (Error)
submitted)
Data type
Coded value
Code
Y = Yes, N = No
Validation rule
If DS_DataProviderHC is reported then all the information for the
hospital sector, including DS_J02InclusionHC, must be reported.
VariableName
29 - DS_J04InclusionHC
Description
Is consumption of substances in ATC group J04A (drugs for the
treatment of tuberculosis) included in the data reported for the
hospital sector?
Required (what happens if not
Yes (Error)
submitted)
Data type
Coded value
Code
Y = Yes, N = No
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Validation rule
If DS_DataProviderHC is reported then all the information for the
hospital sector, including DS_J04InclusionHC, must be reported.
VariableName
30 - DS_J05InclusionHC
Description
Is consumption of substances in ATC group J05 (antivirals for systemic
use) included in the data reported for the hospital sector?
Required (what happens if not
Yes (Error)
submitted)
Data type
Coded value
Code
Y = Yes, N = No
Validation rule
If DS_DataProviderHC is reported then all the information for the
hospital sector, including DS_J05InclusionHC, must be reported.
Table 14: Denominator data for the hospital sector
VariableName
31 - DS_EurostatDataHC
Description
Are the reported population data from Eurostat? If no, national
population data must be provided by the country.
Required (what happens if not
Yes (Warning)
submitted)
Data type
Coded value
Code
Y = Yes, N = No
Validation rule
If DS_EurostatDataHC = N, then DS_DataProviderDenomHC must be
reported
VariableName
32 - DS_DataProviderDenomHC
Description
Which authority/organisation/network was the provider for population
data for the hospital sector?
Required (what happens if not
No
submitted)
Data type
Coded value
Code
MoH = Ministry of Health, HI = Health Insurance Company, NS =
National Statistics Agency, O = Other, NA = Not applicable
Validation rule
If DS_EurostatDataHC = N, then DS_DataProviderDenomHC must be
reported.
If DS_EurostatDataHC = Y, then DS_DataProviderDenomHC must not
be reported.
VariableName
33 - DS_TypeOfDataDenomHC
Description
What is the type of the population data for the hospital sector?
Required (what happens if not
No
submitted)
Data type
Coded value
Code
POP = Population, INS = Insured population.
Validation rule
If DS_EurostatDataHC = N, then DS_TypeOfDataDenomHC must be
reported.
If DS_EurostatDataHC = Y, then DS_TypeOfDataDenomHC must not
be reported.
Table 15: Epidemiological variables for record type AMCDS Total care data
VariableName
34- DS_DataProviderTC
Description
Which authority/organisation/network was the provider for ‘total
care’data?
Required (what happens if not
No
submitted)
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Data type
Coded Value
Code
MoH = Ministry of Health, HI = Health Insurance Company, CP =
Community Pharmacists, HN = Hospital Network, MR = Marketing
Research Company, MA = Medicines Agency, O = Other.
Validation rule
-
VariableName
35- DS_TypeOfDataTC
Description
What is the type of ‘total care’ data?
Required (what happens if not
No
submitted)
Data type
Coded value
Code
S = Sales, R = Reimbursement, B = Both
Validation rule
If DS_DataProviderTC is reported, then all the information for ’total
care’, including DS_TypeOfDataTC, must be reported.
VariableName
36 - DS_CoverageTC
Description
What is the percentage of coverage of consumption data for ‘total
care’?
Required (what happens if not
Yes (Error)
submitted)
Data type
Numeric
Validation rule
If DS_DataProviderTC is reported, then all the information for ‘total
care’, including DS_CoverageTC, must be reported.
VariableName
37- DS_CoverageExtrapolatedTC
Description
Were the data extrapolated to obtain 100% coverage of ‘total care’ in
the country?
Required (what happens if not
Yes (Error)
submitted)
Data type
Coded value
Code
Y = Yes, N = No
Validation rule
If DS_DataProviderTC is reported, then all the information for “total
care”, including DS_CoverageExtrapolatedTC, must be reported.
If DS_EurostatDataTC = Y and DS_CoverageTC is less than 100, then
DS_CoverageExtrapolatedTC must be reported as Y.
VariableName
38 - DS_ATCVersionTC
Description
Which version of the WHO ATC/DDD index was used for reporting
consumption data in ‘total care’?
Required (what happens if not
Yes (Error)
submitted)
Data type
Date
Code
Year (YYYY)
Validation rule
If DS_DataProviderTC is reported, then all the information for ‘total
care’, including DS_ATCVersionTC, must be reported.
VariableName
39- DS_ATCVersionAlteratedTC
Description
Were other than official WHO ATC/DDD alterations applied
Required (what happens if not
Yes (Error)
submitted)
Data type
Coded value
Code
Y = Yes, N = No
Validation rule
If DS_DataProviderTC is reported, then all the information ‘total care’,
including DS_ATCVersionAlteratedTC, must be reported.
VariableName
40 - DS_J01InclusionTC
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Description
Is consumption of substances in ATC groups J01 + A07AA + P01AB
(i.e., antibacterials for systemic use + intestinal
antiinfectives/antibiotics + nitroimidazole derivatives) included in the
data reported for ‘total care’?
Required (what happens if not
Yes (Error)
submitted)
Data type
Coded value
Code
Y = Yes, N = No
Validation rule
If DS_DataProviderTC is reported, then all the information for ‘total
care’, including DS_J01InclusionTC, must be reported.
VariableName
41 - DS_J02InclusionTC
Description
Is consumption of substances in ATC groups J02 + D01BA (i.e.,
antimycotics for systemic use + antifungals for systemic use) included
in the data reported for ‘total care’?
Required (what happens if not
Yes (Error)
submitted)
Data type
Coded value
Code
Y = Yes, N = No
Validation rule
If DS_DataProviderTC is reported, then all the information for ‘total
care’, including DS_J02InclusionTC, must be reported.
VariableName
42- DS_J04InclusionTC
Description
Is consumption of substances in ATC group J04A (drugs for the
treatment of tuberculosis) included in the data reported for ‘total
care’?
Required (what happens if not
Yes (Error)
submitted)
Data type
Coded value
Code
Y = Yes, N = No
Validation rule
If DS_DataProviderTC is reported, then all the information for ‘total
care’, including DS_J04InclusionTC, must be reported.
VariableName
43 - DS_J05InclusionTC
Description
Is consumption of substances in ATC group J05 (antivirals for systemic
use) included in the data reported for ‘total care’?
Required (what happens if not
Yes (Error)
submitted)
Data type
Coded value
Code
Y = Yes, N = No
Validation rule
If DS_DataProviderTC is reported, then all the information for ‘total
care’, including DS_J05InclusionTC, must be reported.
Table 16: Denominator data for the total care sector
VariableName
44- DS_EurostatDataTC
Description
Are the reported population data from Eurostat? If no, national
population data must be provided by the country.
Required (what happens if not
Yes (Warning)
submitted)
Data type
Coded value
Code
Y = Yes, N = No
Validation rule
If DS_EurostatDataTC = N, then DS_DataProviderDenomTC must be
reported
VariableName
45 - DS_DataProviderDenomTC
© ECDC March 2019 All rights reserved.
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Description
Which authority/organisation/network was the provider for the
population data for ‘total care’?
Required (what happens if not
No
submitted)
Data type
Coded value
Code
MoH = Ministry of Health, HI = Health Insurance Company, NS =
National Statistics Agency, O = Other, NA = Not applicable
Validation rule
If DS_EurostatDataTC = N, then DS_DataProviderDenomTC must be
reported.
If DS_EurostatDataTC = Y then DS_DataProviderDenomTC must not
be reported.
VariableName
46 - DS_TypeOfDataDenomTC
Description
What is the type of the population data for ‘total care’?
Required (what happens if not
No
submitted)
Data type
Coded value
Code
POP = Population, INS = Insured population.
Validation rule
If DS_EurostatDataTC = N, then DS_TypeOfDataDenomTC must be
reported.
If DS_EurostatDataTC = Y, then DS_TypeOfDataDenomTC must not
be reported.
Table 17: Summary variables
VariableName
47 - DS_PSYHOSP_Inclusion
Description
In which sector, i.e. community (primary care), hospital sector, or
both), are data from psychiatric hospitals reported?
Required (what happens if not
No
submitted)
Data type
Coded value
Code
AC = Community (primary care), HC = Hospital care, BOTH =
Community and hospital care, NONE = Not included.
Validation rule
-
VariableName
48 - DS_HALT_Inclusion
Description
In which sector, i.e. community (primary care), hospital sector, or
both, are data from nursing homes and other long-term care facilities
for the elderly reported?
Required (what happens if not
No
submitted)
Data type
Coded value
Code
AC = Community (primary care), HC = Hospital sector, BOTH =
Community and hospital care, NONE = Not included.
Validation rule
-
VariableName
49- DS_DayCare_Inclusion
Description
In which sector (AC and/or HC), data from day care centres (for young
children) are reported?
Required (what happens if not
No
submitted)
Data type
Coded value
Code
AC = Community (primary care), HC = Hospital sector, BOTH =
Community and hospital sector, NONE = Not included.
Validation rule
-
VariableName
50 - DS_CommentECDC
© ECDC March 2019 All rights reserved.
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Description
General comments for ECDC. Any information that is important or
useful when analysing the data, these comments will not be published.
Required (what happens if not
No
submitted)
Data type
String variable
Validation rule
-
VariableName
51 - DS_CommentPublic
Description
General comments for public display. Any remark that should be
included when presenting data.
Required (what happens if not
No
submitted)
Data type
String variable
Validation rule
-
AMC metadata change history
Table 18: Implemented changes in record types for Antimicrobial Consumption (AMC) until 2018
Year
Subject
Description
AMC
New variable CombinedProduct
AMCLIGHT
New variable CombinedProduct
AMCDS
Error message for:
-
DS_ATCVersionAC(HT,TC)
-
DS_ATCVersionAlteratedAC(HT,TC)
2016
-
DS_CoverageAC(HT,TC)
-
DS_J01InclusionAC(HT,TC)
-
DS_J02InclusionAC(HT,TC)
-
DS_J04InclusionAC(HT,TC)
-
DS_J05InclusionAC(HT,TC)
If DS_DataProviderAC(HT,TC) and one of the previous variables is not reported
Warning message if DS_EurostatDataAC(HT,TC)=N and
DS_DataProviderDenomAC(HT,TC) is not reported
Metadata changes prior to 2016 can be found on the TESSy documents website. There were no metadata
changes in 2017 and 2018.
© ECDC March 2019 All rights reserved.
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link to page 37 link to page 39 link to page 39 link to page 37
Annex 2 Antimicrobial consumption (AMC)
specific material
This section covers:
Reporting ESAC-Net data – tips for reporting for certain categories of data.
Reporting combined products
Reporting liquid pharmaceutical form
ATC and DDD updates.
Examples – examples of reporting data on the consumption of liquids, and on consumption
and population coverage
Reporting ESAC-Net data
As describe
d in Overview of AMC data collection and analysis, there are two options for reporting
ESAC-Net data:
The preferred standard version: Reporting national antimicrobial consumption data at the
medicinal product level, including national registry data, using the record types AMC and
AMCPACKAGES. If data are delivered with this preferred standard version:
o For erythromycin and methenamine, the associated salt must be provided (see ESAC-
Net metadata);
o For combined products, a variable, CombinedProducts, has to be reported to
distinguish and to define them. A detailed explanation is reporte
d in ATC code for
Combined products and a complete list of the products with DDDs can be found in
Table 22.
A light version: Reporting national antimicrobial consumption data at the ATC substance level
using the record type AMCLIGHT.
Reporting for different healthcare sectors
The preferred approach is to report national reference data of antimicrobial consumption separately
for each healthcare sector: community (primary care) and hospital sector. If the same data source is
used, it can be uploaded as one batch file (see
Error! Reference source not found. on page 7).
If otherwise not possible, the national reference data can be reported on both healthcare sectors
combined, i.e. total care (= community plus hospital sector).
When using the AMCLIGHT record type, data on the number of packages can be omitted for the
hospital sector.
Reporting the variables age class, gender and prescriber
If possible, ESAC-Net encourages reporting of community (primary care) antimicrobial consumption
data stratified by age class, gender and prescriber.
It is possible to report data for the variables age class, gender and prescriber using a data source
different from that of the main consumption data, thus allowing double reporting to TESSy. However,
only one data source can be assigned as being the national reference data, which is necessary to
ensure comparison of antimicrobial consumption between different Member States.
In cases where national reference data (without reporting for age class, gender and/or prescriber) are
reported in the preferred standard reporting (record types AMC, AMCPACKAGES) and additional data
for age class and gender are reported in the light version (record type AMCLIGHT), the reporting
country must create two TESSy data sources (one for the national reference data and another for the
© ECDC March 2019 All rights reserved.
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link to page 39
additional data) and refer to the correct data source in the record types. Otherwise, TESSy will not be
able to separate the data coming from the different sources and will provide wrong results.
Reporting population (number of inhabitants)
Eurostat population denominator data are preferred.
Available from:
http://ec.europa.eu/eurostat/data/database
TESSy maintains an up-to-date copy of the Eurostat population data in its own database.
•
If the surveillance coverage is compatible with Eurostat data, it is not necessary to submit
any population denominator data to TESSy via the record type AMCDS. By default, TESSy
uses Eurostat population data.
•
If the surveillance coverage is not compatible with Eurostat data or if data providers
disagree with TESSy using Eurostat data, it is necessary to provide denominator data at
the same level as the level of consumption data (healthcare sector, NUTS, age class and
gender). For more detailed information, please consult
Examples.
Reporting historical data from the former ESAC project
Data covering the period 1997-2009 were uploaded into TESSy after termination of the ESAC project
using the historical project database that was transferred from the University of Antwerp to ECDC.
If necessary, Member States can update these data in the same way that they have uploaded data
for the year 2010 and onward; however, in this case use TESSy’s
Replace function instead of its
Update function.
Reporting combined products
Products containing two or more active ingredients are regarded as combined products and their
DDDs are expressed in unit doses (UD). According to the
list of combined products from the WHO
Collaborating Centre for Drug Statistics Methodology, 2019, different combined products sharing the
same main active ingredients are usually given the same ATC code, though the active ingredients
might be in different quantities.
For example four different combinations of the active ingredients ampicillin and cloxacillin are
allocated to the same ATC code J01CR50:
a) J01CR50: ampicillin_0.25g – cloxacillin_0.25g Tablets
b) J01CR50: ampicillin_0.25g – cloxacilin_0.25g Powder for injection
c) J01CR50: ampicillin_0.5g – cloxacillin_0.5g Powder for injection
d) J01CR50: ampicillin_0.125g – cloxacillin_0.125g Tablets
Additionally, combinations of products of ampicillin with the active ingredients oxacillin or
flucloxacillin, which belong to the same 4th ATC group J01CF (beta-lactamase resistant penicillins)
like cloxacillin, are also allocated to the same ATC code J01CR50:
e) J01CR50: ampicillin_0.66g – oxacillin_0.33g Powder for injection
f) J01CR50: ampicillin_0.125g – oxacillin_0.125g Capsules
g) J01CR50: ampicillin_0.25g – flucloxacillin_0.25g Tablets
Different DDDs are assigned to each of the combined products a) - g). The impossibility to distinguish
them through the ATCCode, made it necessary to introduce a further variable in TESSy metadata.
Therefore the variable CombinedProduct was created. It is composed of the ATC code adding a
numerical element through the underscore symbol (_). The products of the previous example will be
classified with the following codes of the variable CombinedProduct:
a) J01CR50_1
b) J01CR50_5
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link to page 39 link to page 17 link to page 36
c) J01CR50_6
d) J01CR50_7
e) J01CR50_2
f) J01CR50_3
g) J01CR50_4
A list of all products that will report the new variable CombinedProduct can be found at the end of
Annex 2. Additionally
, a practical example how to report consumption for these combined products is
provided on page 50.
Reporting liquid pharmaceutical form (variable SyrupForm)
The variable SyrupForm is used for estimating paediatric consumption corresponding to all
antimicrobials that are taken orally as a liquid.
The variable
SyrupForm is used to track
all antimicrobials that are administered
orally as a
liquid. The variable SyrupForm does not correspond to the pharmaceutical form syrup only but to all
pharmaceutical forms that will produce a liquid and will be administered orally. Examples of
pharmaceutical forms that should be reported as ‘Y’ (yes) for SyrupForm are
syrup, oral powder,
oral solution and
oral suspension.
ATC and DDD updates
The ATC/DDD index 2019 should be used (http://www.whocc.no/atc_ddd_index).
The latest update of the ATC/DDD index can be found at:
http://www.whocc.no/atc_ddd_index/updates_included_in_the_atc_ddd_index/ New ATC codes, ATC changes, DDD updates and allocations of defined daily doses for combined
products in TESSy are provided in tables 19-22.
Updates for the past years can be looked up at the WHO CC webpages or in previous reporting
protocols (available for ESAC-Net network members at the ESAC-Net extranet.
The previous metadata changes are described in
AMC metadata change history.
Information on changes to the metadata for other subjects is available on the TESSy
documentation website.
© ECDC March 2019 All rights reserved.
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ATC updates 2019
Table 19: New ATC codes
Year
ATC Code
ATC Name (active substance; INN)
J01AA13
eravacycline
J01DD18
cefteram
J01DD64
cefpodoxime and beta-lactamase inhibitor
J01DH06
tebipenem pivoxil
J01DH52
meropenem and vaborbactam
J01MA22
tosufloxacin
J01MA23
delafloxacin
J04AM07
rifampicin, ethambutol and isoniazid
J04AM08
isoniazid, sulfamethoxazole, trimethoprim and pyridoxine
J05AG06
doravirine
2019
J05AH03
peramivir
J05AP57
glecaprevir and pibrentasvir
J05AR23
atazanavir and ritonavir
J05AR24
lamivudine, tenofovir disoproxil and doravirine
J05AX17
enisamium iodide
J05AX18
letermovir
J05AX19
tilorone
J05AX21
pentanedioic acid imidazolyl ethanamide
J05AX23
ibalizumab
© ECDC March 2019 All rights reserved.
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Table 200: New DDD allocations
(for products with one active ingredient; for combined products, see Table 22)
Year ATC code ATC Name (active substance; INN)
Route DDD value DDD unit
J01DB11
cefroxadine
O
2.1
g
J01DD18
cefteram
O
0.4
g
J01DD63
ceftriaxone and beta-lactamase inhibitor P
2
g
J01DH06
tebipenem pivoxil
O
0.56
g
J01DI03
faropenem
O
0.75
g
J01FA03
midecamycin
O
1.2
g
J01MA07
lomefloxacin
O
0.4
g
J01MA15
gemifloxacin
O
0.32
g
J01MA19
garenoxacin
O
0.4
g
J01MA22
tosufloxacin
O
0.45
g
2019 J01MA23 delafloxacin
O
0.9
g
J01MA23
delafloxacin
P
0.6
g
J04AK06
delamanid
O
0.2
g
J05AC02
rimantadine
O
0.2
g
J05AR23
atazanavir and ritonavir
O
0.3
g
J05AX17
enisamium iodide
O
1.5
g
J05AX18
letermovir
O, P
0.48
g
J05AX19
tilorone
O
0.125
g
J05AX21
pentanedioic acid imidazolyl ethanamide O
90
mg
Table 211: DDD alterations
Year ATC
ATC Name (active substance;
route Old
New
Code
INN)
DDD
DDD
J01XB01
colistin
P
3
9
MU
J01MA02
ciprofloxacin
P
0.5
0.8
g
J01DH02
meropenem
P
2
3
g
J01DE01
cefepime
P
2
4
g
2019 J01CR02
amoxicillin and beta-lactamase
O
1
1.5
g
inhibitor
J01CA17
temocillin
P
2
4
g
J01CA04
amoxicillin
P
1
3
g
J01CA04
amoxicillin
O
1
1.5
g
J01CA01
ampicillin
P
2
6
g
O: oral, P: parenteral, I: inhalation, IP: inhalation powder, IS: inhalation solution.
© ECDC March 2019 All rights reserved.
Page 41 of 55
Defined daily doses for combined products, 2019
Table 222: List of DDDs for all combined products in TESSy
(adapted from
WHO Collaboration Centre for Drug Statistics Methodology)
ATC
CombinedProduct Variable description in
Active ingredients per one
Dosage
No. of UD* per
Brand name
code
(variable to be
TESSy metadata
unit dose (UD)
form
one DDD
reported)
J01AA20
J01AA20_1
Tetracycline -
tetracycline 115.4 mg/
Tab
2 UD (=2 tab)
Deteclo
chlortetracycline -
chlortetracycline 115.4 mg/
demeclocycline
demeclocycline 69.2 mg
J01CA20
J01CA20_1
Pivampicillin_0.25g -
pivampicillin 0.25 g/
Tab
3 UD (=3 tab)
Miraxid
pivmecillinam_0.2g
pivmecillinam 0.2 g
J01CA20
J01CA20_2
Pivampicillin_0.125g -
pivampicillin 0.125 g/
Tab
6 UD (=6 tab)
Miraxid mite
pivmecillinam 0.1g
pivmecillinam 0.1 g
J01CE30
J01CE30_1
Benzylpenicillin/procain -
benzylpenicillin/procain-
Powder
3.6 g* expressed Bicillin C-R, Bicillin A-
benzylpenicillin/benzathine
benzylpenicillin/benzathine
for inj
as
P, Bicillin
benzylpenicillin
benzylpenicillin
benzylpenicillin
J01CR50
J01CR50_1
Ampicillin_0.25g -
ampicillin 0.25 g/
Tab
4 UD (=4 tab)
Ampiclox
cloxacillin_0.25g
cloxacillin 0.25 g
J01CR50
J01CR50_2
Ampicillin_0.66g -
ampicillin 0.66 g/
Powder
2 UD (= 2 g)
Ampoxium
oxacillin_0.33g
oxacillin 0.33 g
for inj
J01CR50
J01CR50_3
Ampicillin0.125g -
ampicillin 0.125g/
Caps
8 UD (= 8 caps)
Ampoxium
oxacillin_0.125g
oxacillin 0.125 g
J01CR50
J01CR50_4
Ampicillin_0.25g -
ampicillin 0.25 g/
Tab
4 UD (=4 tab)
Co-fluampicil
flucloxacillin_0.25g
flucloxacillin 0.25 g
J01CR50
J01CR50_5
Ampicillin_250mg -
ampicillin 250 mg/
Powder
4 UD (=2 grams
Viccillin-S
cloxacillin_250mg
cloxacillin 250 mg
for inj
of powder for
injection)
© ECDC March 2019 All rights reserved.
Page 42 of 55
ATC
CombinedProduct Variable description in
Active ingredients per one
Dosage
No. of UD* per
Brand name
code
(variable to be
TESSy metadata
unit dose (UD)
form
one DDD
reported)
J01CR50
J01CR50_6
Ampicillin_500mg -
ampicillin 500 mg/
Powder
2 UD (=2 grams
Viccillin-S
cloxacillin_500mg
cloxacillin 500 mg
for inj
of powder for
injection)
J01CR50
J01CR50_7
Ampicillin_125mg -
ampicillin 125 mg/
Tab
8 UD (=8 tab)
Viccillin-S
cloxacillin_125mg
cloxacillin 125 mg
J01EC20
J01EC20_1
Sulfacarbamide - sulfadiazine sulfacarbamide 0.167 g/
Tab
4 UD (=4 tab)
Trisulfamid
- sulfadimidine
sulfadiazine 0.167 g/
sulfadimidine 0.167 g
J01EE01
J01EE01_1
Sulfamethoxazole_80mg -
In 1mL:
Inf conc
20 UD (=20 ml)
Bactrim, Eusaprim,
trimethoprim_16mg
sulfamethoxazole 80 mg/
Trimetoprim-sulfa
trimethoprim 16 mg
J01EE01
J01EE01_2
Sulfamethoxazole_0.2g -
In 5 mL:
Mixt
8 UD (= 40 ml)
Bactrim, Eusaprim,
trimethoprim_40mg
sulfamethoxazole 0.2 g/
Trimetoprim-sulfa
trimethoprim 40 mg
J01EE01
J01EE01_3
Sulfamethoxazole_0.4g -
sulfamethoxazole 0.4 g/
Tab
4 UD (=4 tab)
Bactrim, Eusaprim
trimethoprim80mg
trimethoprim 80 mg
Trimetoprim-sulfa
J01EE02
J01EE02_1
Sulfadiazine_0.205g -
sulfadiazine 0.205 g/
Mixt
4 UD (=20 ml)
Triglobe, Trimin Sulfa
trimethoprim_45mg
trimethoprim 45 mg
J01EE02
J01EE02_2
Sulfadiazine_0.41g -
sulfadiazine 0.41 g/
Tab
2 UD (=2 tab)
Triglobe, Trimin Sulfa
trimethoprim_90mg
trimethoprim 90 mg
J01EE03
J01EE03_1
Sulfametrole_0.8g -
sulfametrole 0.8 g/
Tab
2 UD (=2 tab)
Lidaprim
trimethoprim_0.16g(tab)
trimethoprim 0.16 g
J01EE03
J01EE03_2
Sulfametrole0.8g -
sulfametrole 0.8 g/
Powder
2 UD (defined as Lidaprim
trimethoprim_0.16g(powd)
trimethoprim 0.16 g per vial
for inj
2 vials)
J01EE06
J01EE06_1
Sulfadiazin - tetroxoprim
sulfadiazin 0.25 g/
Tab
2 UD (=2 tab)
Sterinor
tetroxoprim 0.1 g
© ECDC March 2019 All rights reserved.
Page 43 of 55
ATC
CombinedProduct Variable description in
Active ingredients per one
Dosage
No. of UD* per
Brand name
code
(variable to be
TESSy metadata
unit dose (UD)
form
one DDD
reported)
J01EE07
J01EE07_1
Sulfamerazin - trimethoprim
sulfamerazin 0.12 g/
Tab
4 UD (=4 tab)
Berlocombin
trimethoprim 80 mg
J01RA04
J01RA04_1
spiramycin 1.5 MU/
Tab
3 UD (=3 tab)
Bidontogyl
metronidazole 250 mg
J01RA04
J01RA04_2
spiramycin 0.75 MU/
Tab
6 UD (=6 tab)
Orogyl
metronidazole 125 mg
J01RA05
J01RA05_1
levofloxacin_250mg -
levofloxacin 250 mg/
Tab
2 UD (=2 tab)
Duobact
ornidazole_500mg(tab)
ornidazole 500 mg
J01RA07
J01RA07_1
azithromycin_1000mg-
azithromycin 1000 mg
Tab
4 UD (=4 tab)
Safocid
fluconazole_150mg-
(1 tab)/
secnidazole_1000mg(tab)
fluconazole 150 mg (1 tab)/
secnidazole 1000 mg (2 tab)
(combination package)
J01RA09
J01RA09_1
ofloxacin_200mg -
ofloxacin 200 mg/
Tab
2 UD (=2 tab)
Oflox Oz
ornidazole_500mg(tab)
ornidazole 500 mg
J01RA10
J01RA10_1
ciprofloxacin_500mg -
ciprofloxacin 500 mg/
Tab
2 UD (=2 tab)
Cipramed
metronidazole_200mg(tab)
metronidazole 200 mg
J01RA11
J01RA11_1
ciprofloxacin_500mg -
ciprofloxacin 500 mg/
Tab
2 UD (=2 tab)
Ciprotini
tinidazole_300mg(tab)
tinidazole 600 mg
J01RA11
J01RA11_2
ciprofloxacin_250mg -
ciprofloxacin 250 mg/
Tab
4 UD (=4 tab)
Ciptin
tinidazole_300mg(tab)
tinidazole 300 mg
J01RA12
J01RA12_1
ciprofloxacin_500mg -
ciprofloxacin 500 mg/
Tab
2 UD (=2 tab)
Simprasole
ornidazole_500mg(tab)
ornidazole 500 mg
© ECDC March 2019 All rights reserved.
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ATC
CombinedProduct Variable description in
Active ingredients per one
Dosage
No. of UD* per
Brand name
code
(variable to be
TESSy metadata
unit dose (UD)
form
one DDD
reported)
J01RA13
J01RA13_1
norfloxacin 400 mg/
Tab
2 UD (=2 tab)
Actiflox-T
tinidazole 600 mg
J04AM02 J04AM02_1
Rifampicin_0.3g -
rifampicin 0.3 g/
Tab
2 UD (=2 tab)
Rifinah
isoniazid_0.15g
isoniazid 0.15 g
J04AM02 J04AM02_2
Rifampicin_0.15g -
rifampicin 0.15 g/
Tab
4 UD (=4 tab)
Rifinah
isoniazid_0.1g
isoniazid 0.1 g
J04AM02 J04AM02_3
Rifampicin_0.15g -
rifampicin 0.15 g/
Tab
4 UD (=4 tab)
Rimactazid
isoniazid_75mg
isoniazid 75 mg
J04AM05 J04AM05_1
Rifampicin_0.12g -
rifampicin 0.12 g/
Tab
6 UD (=6 tab)
Rifater
isoniazid_50mg -
isoniazid 50 mg/
pyrazinamide_0.3g
pyrazinamide 0.3 g
J04AM05 J04AM05_2
Rifampicin0.15g -
rifampicin 0.15 g/
Tab
4 UD (=4 tab)
Rimcure
isoniazid_75mg -
isoniazid 75 mg/
pyrazinamide_0.4g
pyrazinamide 0.4 g
J04AM05 J04AM05_3
rifampicin_225mg -
rifampicin 225 mg (1 tab)/
Tab
6 UD (=6 tab)
R-cinex
pyrazinamide_750mg -
pyrazinamide 750 mg
isoniazid_150mg(tab)
(1 tab)/ isoniazid 150 mg (1
tab) (combination package)
J04AM05 J04AM05_4
rifampicin_60mg -
rifampicin 60 mg/
Tab
10 UD (=10 tab)
RHZ 60
pyrazinamide_0.4g -
pyrazinamide 150 mg/
isoniazid_30mg(tab)
isoniazid 30 mg
J04AM06 J04AM06_1
Rifampicin - ethambutol -
rifampicin 0.15 g/
Tab
4 UD (=4 tab)
Rimstar
isoniazid - pyrazinamide
ethambutol 0.275 g/
isoniazid 75 mg/
pyrazinamide 0.4 g
© ECDC March 2019 All rights reserved.
Page 45 of 55
ATC
CombinedProduct Variable description
Active ingredients per one
Dosage No. of UD* per
Brand name
code
(variable to be
in TESSy metadata
unit dose (UD)
form
one DDD
reported)
J04AM06 J04AM06_2
rifamp._0.45g-
rifampicin 450 mg (1 tab)/
Tab
4 UD (=4 tab)
AK-4
pyrazin._0.75g-
pyrazinamide 750 mg
ethambutol_0.8g–
(2 tab)/ethambutol 800
isoniazid_0.3g
mg+isoniazid 300 mg (1 tab)
(combination package)
J04AM07 J04AM07_1
rifampicin_150mg -
rifampicin 150 mg/
Tab
4 UD (=4 tab)
3-FDC
ethambutol_275mg -
ethambutol 275 mg/
isoniazid_75mg(tab)
isoniazid 75 mg
J05AP51
J05AP51_1
sofosbuvir - ledipasvir
sofosbuvir 400 mg/
Tab
1 UD (=1 tab)
Harvoni
ledipasvir 90 mg
J05AP53
J05AP53_1
ombitasvir - paritaprevir ombitasvir 12.5 mg/
Tab
2 UD (=2 tab)
Technivie / Viekirax
ritonavir
paritaprevir 75 mg/
ritonavir 50 mg
J05AP54
J05AP54_1
elbasvir_50mg -
elbasvir 50 mg/
Tab
1 UD (=1 tab)
Zepatier
grazoprevir_100mg
grazoprevir 100 mg
J05AP55
J05AP55_1
sofosbuvir_400mg -
sofosbuvir 400 mg/
Tab
1 UD (=1 tab)
Epclusa
velpatasvir_100mg
velpatasvir 100 mg
J05AP56
J05AP56_1
sofosbuvir 400 mg/
Tab
1 UD (=1 tab)
Vosevi
velpatasvir 100 mg/
voxilaprevir 100 mg
J05AP57
J05AP57_1
glecaprevir_100mg -
glecaprevir 100 mg/
Tab
3 UD (=3 tab)
Maviret
pibrentasvir_40mg(tab) pibrentasvir 40 mg
J05AR01
J05AR01_1
Lamivudine -
lamivudine 0.15 g/
Tab
2 UD (=2 tab)
Combivir
zidovudine
zidovudine 0.3 g
J05AR02
J05AR02_1
Abacavir - lamivudine
abacavir 0.6 g/
Tab
1 UD (=1 tab)
Kivexa
lamivudine 0.3 g
© ECDC March 2019 All rights reserved.
Page 46 of 55
ATC
CombinedProduct Variable description
Active ingredients per one
Dosage No. of UD* per
Brand name
code
(variable to be
in TESSy metadata
unit dose (UD)
form
one DDD
reported)
J05AR03
J05AR03_1
Emtricitabine -
emtricitabine 0.2 g/
Tab
1 UD (=1 tab)
Truvada
tenofovir disoproxil
tenofovir disoproxil 0.245 g
J05AR04
J05AR04_1
Zidovudine - lamivudine zidovudine 0.3 g/
Tab
2 UD (=2 tab)
Trizivir
- bacavir
lamivudine 0.15 g/
abacavir 0.3 g
J05AR05
J05AR05_1
Lamivudine - nevirapine lamivudine 150 mg/
Tab
2 UD (=2 tab)
Lamivudine/Nevirapine/
- zidovudine
nevirapine 200 mg/
Zidovudine 150mg/200mg/
zidovudine 300 mg
300mg
J05AR06
J05AR06_1
Emtricitabine -
emtricitabine 0.2 g/
Tab
1 UD (=1 tab)
Atripla
tenofovir disoproxil -
tenofovir disoproxil 0.245 g/
efavirenz
efavirenz 0.6 g
J05AR08
J05AR08_1
Emtricitabine -
emtricitabine 0.2 g/
Tab
1 UD (=1 tab)
Eviplera, Complera
tenofovir disoproxil -
tenofovir disoproxil 0.245 g/
rilpivirine
rilpivirine 0.025 g
J05AR09
J05AR09_1
Emtricitabine -
emtricitabine 200 mg/
Tab
1 UD (=1 tab)
Stribild
tenofovir disoproxil -
tenofovir disoproxil 245 mg/
elvitegravir -cobicistat
elvitegravir 150 mg/
cobicistat 150 mg
J05AR011 J05AR011_1
lamivudine 300 mg/
Tab
1 UD (=1 tab)
Efavirenz/lamivudine/tenofovir
tenofovir disoproxil 300 mg
(fumarate)/
efavirenz 600 mg
J05AR012 J05AR012_1
lamivudine 300 mg/
Tab
1 UD (=1 tab)
Lamivudine and Tenofovir
tenofovir disoproxil 300 mg
(fumarate)
J05AR13
J05AR13_1
Lamivudine - abacavir - lamivudine 300 mg/
Tab
1 UD (=1 tab)
Triumeq
dolutegravir
abacavir 600 mg/
dolutegravir 50 mg
© ECDC March 2019 All rights reserved.
Page 47 of 55
ATC
CombinedProduct Variable description
Active ingredients per one
Dosage No. of UD* per
Brand name
code
(variable to be
in TESSy metadata
unit dose (UD)
form
one DDD
reported)
J05AR14
J05AR14_1
Darunavir -cobicistat
darunavir 800 mg/ cobicistat 150
Tab
1 UD (=1 tab)
Rezolsta/Prezcobix
J05AR15
J05AR15_1
Atazanavir -
atazanavir 0.3 g/ cobicistat 0.15 g Tab
1 UD (=1 tab)
Evotaz
cobicistat
J05AR17
J05AR17_1
Emtricitabine -
emtricitabine 200 mg/tenofovir
Tab
1 UD (=1 tab)
Descovy
tenofovir alafenamide
alafenamide 10 mg
J05AR17
J05AR17_2
Emtricitabine -
emtricitabine 200 mg /tenofovir
Tab
1 UD (=1 tab)
Descovy
tenofovir alafenamide
alafenamide 25 mg
J05AR18
J05AR18_1
Emtricitabine –
emtricitabine 200 mg/ tenofovir
Tab
1 UD (=1 tab)
Genvoya
tenofovir alafenamide - alafenamide 10 mg/ elvitegravir
elvitegravir - cobicistat
150 mg/ cobicistat 150 mg
J05AR19
J05AR19_1
Emtricitabin –
emtricitabine 200 mg/tenofovir
Tab
1 UD (=1 tab)
Odefsey
tenofovir alafenamide - alafenamide 25 mg/rilpivirine 25
rilpivirine
mg
J05AR20
J05AR20_1
Emtricitabine 200 mg/
Tab
1 UD (=1 tab)
Biktarvy
tenofovir alafenamide 25mg/
bictegravir 50 mg
J05AR21
J05AR21_1
Dolutegravir 50 mg/
Tab
1 UD (=1 tab)
Juluca
rilpivirine 25 mg
J05AR22
J05AR22_1
emtricitabine 200 mg/
Tab
1 UD (=1 tab)
Symtuza
tenofovir alafenamide 10 mg/
darunavir 800 mg/
cobicistat 150 mg
Tab: tablet, Powder for inj: powder for injection, Caps: capsule, Mixt: Mixture, Inf conc: Infusion concentrate
*: for J01CE30 the StrengthUnit is given in grams
2019 new DDD allocations for combined products are show in grey. No DDDs are assigned for the ATC codes J05AP52 and J05AR24.
© ECDC March 2019 All rights reserved.
Page 48 of 55
Examples
This section provides examples of reporting data on the consumption of liquids, on consumption and
population coverage and consumption of combined products.
How to report liquid medicinal products in vials or bottles
Liquid medicinal products in a vial or a bottle have either a strength expressed as a concentration (for
instance 250mg/5mL, 80mg/mL), or their content is expressed as the total amount (for instance
250mg/vial). TESSy cannot handle data for the variable Strength expressed as a concentration. Below
are provided instructions how to fill in the AMC record type for such products. Based on these data,
TESSy calculates the content of vials or bottles and allocates the correct DDD.
Variables to be reported for liquid medicinal products in both vials and bottles:
Variable
PackageSize:
Number of items in the box (either the number of vials or the number of
bottles of syrup)
Strength:
Total amount of active substance in one item (either a vial or a bottle of syrup)
StrengthUnit:
G/MG/IU/MU
SyrupForm:
Yes or No or NA
Two options for computing data for the variable Strength
•
Original strength (e.g. 500 mg per vial) expressed as the total amount of the active
substance in one item.
The strength to be reported is the original strength.
•
Original strength expressed as a concentration of an active substance per volume
(e.g. 100mg per 5 ml).
The strength to be reported is the result of the calculation of the numerator of the
original strength (e.g. 100 mg) divided by the denominator of the original strength
(e.g. 5 ml) and multiplied by the volume of the item (e.g. bottle or vial).
Based on this information, TESSy will compute the content of the active substance for a vial or syrup
bottle and allocate DDD accordingly.
Formula for computing the content of a medicinal product:
TESSy uses the following formula to compute a medicinal product’s active substance content:
Content = PackageSize x Strength
Three examples for computing the content of product A (vials) and products B and C
(bottles)
Example 1
The presentation of the product A is defined as 5 vials of 500 mg of amoxicillin each. For product A
the information to be provided is:
PackageSize:
5
Strength:
500
StrengthUnit:
MG
SyrupForm:
NA
Based on this information, TESSy will compute the following content of the active substance for
product A and allocate DDD:
© ECDC March 2019 All rights reserved.
Page 49 of 55
Content of product A = 5 PCS x 500 mg = 2500 mg (2.5 g)
Example 2
The presentation of the product B is defined as 1 bottle of syrup of 60mL of amoxicillin at a
concentration of 125mg/5mL. For product B the information to be provided is:
PackageSize:
1
Strength:
125/5x60=1500
StrengthUnit:
MG
SyrupForm:
Y
Based on this information, TESSy will compute the following content of the active substance for
product B and allocate DDD:
Content of product B = 1 PCS x 1500 mg = 1500 mg (1.5 g)
Example 3
The presentation of the product C is defined as 12 bottles of syrup each of 60mL of amoxicillin at a
concentration of 125mg/5mL. For product C the information to be provided is:
PackageSize:
12
Strength:
125/5x60=1500
StrengthUnit:
MG
SyrupForm:
Y
Based on this information, TESSy will compute the following content of the active substance for
product C and allocate DDD:
Content of product C = 12 PCS x 1500 mg = 18000 mg (18 g)
How to report data coverage in the AMCDS record type
TESSy calculates DDD per 1000 inhabitants per day. Therefore, TESSy has to divide the consumption
figures by the population figures. The figures provided for the consumption and for the population
should cover the same population. Some countries provide consumption figures for the whole
population, others provide them only for a sample. The information about the coverage for
consumption and population is stored in the record type AMCDS and should be provided for each
health sector for which data are delivered.
Examples of all possible cases are provided below. The examples provided show data reported to
TESSy for the sector community (primary care).
Country A reports data for the whole population from overall sales
The relevant variable names and the data reported in the record type AMCDS are as follows:
For the consumption data:
DS_CoverageAC:
100%
DS_CoverageExtrapolatedAC: No
The actual data coverage stored in TESSy is 100%.
For the population data:
Country A has the choice to use preferentially Eurostat data or its own national statistics database.
If country A chooses Eurostat data, TESSy will use Eurostat to retrieve the population figures. Country
A reports in the record type AMCDS as follow:
DS_EurostatDataAC:
Yes
© ECDC March 2019 All rights reserved.
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link to page 39
If country A chooses not to use Eurostat data, it reports in the record type AMCDS as follow:
DS_EurostatDataAC:
No
Additionally, it provides population data using the AMCDENOM record type.
Country B reports data extrapolated for the whole population from a sample representing
70% of the total population
Country B has collected data from a sample representing 70% of its total population. Then it has
extrapolated the data to 100% of the population. The relevant variable names and the data reported
in the record type AMCDS are as follows:
For the consumption data:
DS_CoverageAC:
70% (as its original data covered only 70% of the population)
DS_CoverageExtrapolatedAC: Yes
The actual data coverage in TESSy is 100% because Country B has extrapolated the data.
For the population data:
Country B, because it has extrapolated its original data to 100% of the population, can use
preferentially Eurostat data or its own national statistics database. See example of
country A for
details.
Country C reports data for a sample representing 70% of the total population without any
extrapolation
Country C has collected data from a sample representing 70% of its total population. It has not
extrapolated the data to 100% of the population like Country B. The relevant variable names and the
data reported in the record type AMCDS are as follows:
For the consumption data:
DS_CoverageAC:
70% (as its original data covered only 70% of the population)
DS_CoverageExtrapolatedAC: No
The actual data coverage in TESSy is 70% because Country C has not extrapolated the data.
For the population data:
Because the submitted consumption data represents only 70% of the total population, country C
cannot use Eurostat data. The relevant variable names and the data reported in the record type
AMCDS are as follows:
DS_EurostatDataAC:
No
Additionally, it provides population data corresponding to the sample using the record type
AMCDENOM.
Country D reports data from a sample of 80% from the insured population covering itself
90% of the total population
Country D receives the consumption data from an insurance company that collected data only in a
sample of the insured population representing only 80% of it. The insured population represents itself
90% of the total population. Country D has four different options to report the consumption data to
ECDC. The choice of the options is up to countries:
Option 1: the sample has been extrapolated to the whole insured population
Country D submits the data extrapolated to the insured population. The relevant variable names and
the data reported in the record type AMCDS are as follows:
© ECDC March 2019 All rights reserved.
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For the consumption data:
DS_Coverage:
90% (data extrapolated to the insured population)
DS_CoverageExtrapolated:
No
The actual data coverage in TESSy is 90% because Country D has not extrapolated the data to the
total population.
For the population data:
Country D with option 1 is in the same situation as Country C.
DS_EurostatDataAC:
No
Additionally, it provides population data corresponding to insured population using the record type
AMCDENOM.
Option 2: the sample has not been extrapolated to the whole insured population
Country D submits the original sample in the insured population without extrapolating to the total
insured population. The relevant variable names and the data reported in the record type AMCDS are
as follows:
For the consumption data:
DS_Coverage:
72% (data not extrapolated to the insured population, i.e. 80% of
90% = 72%)
DS_CoverageExtrapolated:
No
The actual data coverage in TESSy is 72% because Country D has not extrapolated the data to the
total population.
For the population data:
Country D with option 2 is in the same situation as Country C.
DS_EurostatDataAC:
No
Additionally, it provides population data corresponding to 80% of the insured population which finally
represents 72% of the total population using the record type AMCDENOM.
How to report combined products
From 2017, combined products under surveillance in ESAC-Net (as defined in the
list of the WHO
Collaborating Centre for Drug Statistics Methodology) reported for the antimicrobial consumption
have to contain the new variable CombinedProduct;
CombinedProduct: an additional code, based on the ATC classification and adjusted in order to
distinguish and precisely define one particular product.
The updated Table 22 contains the new variable assigned to all combined products under surveillance
in ESAC-Net and a description of the product details.
Variables to be reported for combined products in the record type ‘AMC’
(TESSy needs this information to calculate the number of DDD per package. Please, see also Tab. 22
Allocations of defined daily doses for combined products.)
ATCCode:
ATC code of the substances (5th level)
CombinedProduct: ATC code of the substances for the combined product
AntimicrobialRoute: Route of administration of the substance; e.g. oral or parenteral)
Package Size:
Number of items (e.g. tablets, bottles, ampules) in the package
Strength:
Quantity of the ingredient in each item (provided as the number of UDs)
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StrengthUnit:
Unit of the strength reported (UD)
ProductLabel:
The product label or medicinal product package label
Examples
The product A, B and C, all containing sulfamethoxazole and trimethoprim in different amounts were
previously reported with
ATCCode J01EE01.
Now for each of the products A, B and C it has to be reported, additional to the ATCCode, also the
CombinedProduct variable which makes them distinguishable.
Product A:
A package with 10 ampules of 1 ml infusion concentrates.
Each ml infusion concentrate contains ulfamethoxazole 80mg - trimethoprim 16mg. ml
(According to Tab. 22, 20 ml of an infusion concentrate with a combination of sulfamethoxazole 80mg
and trimethoprim 16mg per ml are equal to 20 UD = 1 DDD).
ATCCode: J01EE01
CombinedProduct: J01EE01_1
Antimicrobial route: Parenteral
PackageSize: 10
Strength; 1
StrengthUnit; UD
The content of a package of product A contains 10 UD and is equal to 0.5 DDD.
In the ESAC-Net metadata there are as well two other related variables. I.e. the variable
PackageContent (it has to be reported as 10) and the variable PackageContentUnit (it has to be
reported as UD).
Product B:
A package with 8 vials of 5 ml mixture containing each sulfamethoxazole 0.2 g and trimethoprim 40
mg.
(According to Tab. 22, 40 ml of mixture containing a combination of sulfamethoxazole_0.2 g -
trimethoprim_40 mg per 5 ml are equal to 8 UD = 1 DDD) .
ATCCode: J01EE01
CombinedProduct: J01EE01_2
Antimicrobial route: Parenteral
PackageSize: 8
Strength: 1
StrengthUnit: UD
The content of a package of product B contains 8 UD and is equal to 1 DDD.
In the ESAC-Net metadata there are as well two other related variables. I.e. the variable
PackageContent (it has to be reported as 8) and the variable PackageContentUnit (it has to be
reported as UD).
Product C:
A package with 8 tablets and each tablet containing sulfamethoxazole 0.4 g and trimethoprim 80 mg.
(According to Tab. 22, 4 tablets containing a combination of sulfamethoxazole_0.4 g -
trimethoprim_80 mg are equal to 4 UD = 1 DDD) .
ATCCode: J01EE01
CombinedProduct: J01EE01_3
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Antimicrobial route: Oral
PackageSize: 8
Strength: 1
StrengthUnit: UDThe content of a package of product C contains 8 UD and is equal to 2 DDD.
In the ESAC-Net metadata there are as well two other related variables. I.e. the variable
PackageContent (it has to be reported as 8) and the variable PackageContentUnit (it has to be
reported as UD).
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Index
ATC
Changes to, 36
Updates, 39
ESAC-Net, 13
Data call schedule, 6, 9
Metadata file, 10
Data collection
Record types, 12
Examples, 49
AMC, 14
Process overview, 6
AMC$PACKAGES, 18
Process summary, 5
AMCDENOM, 24
Reporting for different categories, 37
AMCDS, 26
DDD
AMCLIGHT, 20
For combined products in TESSy, 42
Overview, 12
Updates, 39
Versions, 13
Deadlines, 6, 9
Reporting
Helpdesk, 11
Examples, 49
Metadata
TESSy
AMC variables, 14
Reporting to, 9
AMC$PACKAGES variables, 18
TESSy HelpDesk, 11
AMCDENOM variables, 24
Variables
AMCDS variables, 26
Changes to, 36
AMCLIGHT variables, 20
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