Glass Manual On The Management of Antimicrobial Consumption Data

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GLASS

Manual on the management of


antimicrobial consumption data

Global Antimicrobial Resistance and


Use Surveillance System (GLASS)
GLASS
Manual on the management of
antimicrobial consumption data

Global Antimicrobial Resistance and


Use Surveillance System (GLASS)
GLASS manual on the management of antimicrobial consumption data
ISBN 978-92-4-001019-2 (electronic version)
ISBN 978-92-4-001020-8 (print version)
© World Health Organization 2020
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Contents

Abbreviations iv 3.2.4. Step 1 – Filling in product and consumption


variables 38

1. Introduction 2 3.2.5 Step 2 – Assign calculated variables, and


validate and correct product information 46
3.3. Calculate and export consumption data 49
2. WHO methodology for AMC 4
3.4. Export data for WHO GLASS-AMC submission 51
2.1. AMC data components 4
2.1.1. AMC data 4
4. AMC data analysis using the exported
2.1.2. Denominator data 5 AMC Excel files 54
2.2. AMC reporting metrics and indicators 5 4.1. Prepare the data analysis file 54
2.3. ATC/DDD classification methodological 4.1.1. Select a workbook 55
considerations 5
4.1.2. Combine the data for the different
2.3.1. Nomenclature 5 antimicrobial classes and years 56
2.3.2. ATC code 5 4.1.3. Create ATC3 variable 57
2.3.3. DDDs 6 4.1.4. Create a substance variable 58
2.4. AMC variables 8 4.2. Generate tables and figures 62
2.4.1. Product data variables 8 4.2.1. Calculate DID from DDD 62
2.4.2. Consumption data 12 4.2.2. Present total AMC by year 62
2.4.3. Compiling antimicrobial product and 4.2.3. Present relative AMC in DID by ATC3
consumption data 13 and year 63
4.2.4. Present relative AMC by route of
3. GLASS-AMC Excel template 30 administration 66

3.1. Introduction to the tool 30 4.2.5. List the top 10 most used antibiotic
substances or DU75/DU90 by route of
3.2. Fill in the GLASS-AMC template 32 administration and by year 67
3.2.1. Enter availability data 32
3.2.2. Enter population data 33 5. Conclusion 72
3.2.3. Compile product and consumption data 35

iii
Abbreviations

AMC Antimicrobial consumption


AMR Antimicrobial resistance
ATC 
A natomical Therapeutic Chemical
DDD Defined Daily Dose
DID 
Defined Daily Doses/1000 inhabitants/day
DU75 
Drug Utilization 75
DU90 
Drug Utilization 90
GLASS 
Global Antimicrobial Resistance and
Use Surveillance System
INN 
International nonproprietary name
MPP Medicinal product package
WHO World Health Organization

iv
SECTION

01
GLASS Manual on the management of antimicrobial consumption data

1. Introduction

Antimicrobial resistance (AMR) is a significant threat to This manual mainly targets professionals from the
health and human development, affecting our ability to national AMC surveillance technical team responsible for
treat a range of infections. Use of antimicrobials is the managing the AMC surveillance database for the national
main driver for the development of AMR. To obtain a AMC surveillance programme and for submission of
thorough and comprehensive picture of AMR and to be data to GLASS-AMC, and for analysing AMC data for the
able to identify areas in which actions are needed, data national AMC report. The manual can also be shared with
from surveillance of AMR and antimicrobial consumption AMC data-source partners, in cases where these partners
(AMC) are essential. These data should be easily are asked to compile files of their AMC data.
compared and exchanged, and should be used locally,
This manual provides:
nationally and globally.
• an introduction to the GLASS-AMC methodology for
The World Health Organization (WHO) methodology for a
calculating data consumption using the Anatomical
global programme on surveillance of AMC is a component
Therapeutic Chemical/Defined Daily Dose (ATC/DDD)
of the Global Antimicrobial Resistance and Use Surveillance
approach;
System (GLASS)), the system for surveillance of AMR and
antimicrobial use, referred to here as GLASS-AMC. • instructions on how to use the GLASS-AMC Excel
template to organize AMC data, generate AMC
GLASS-AMC provides a common technical basis for setting
indicators and export data into the GLASS-AMC
up national surveillance systems on AMC that can produce
format;
reliable and comparable data at national and global levels.
The methodology can be used by all countries, regardless • instructions on how to use the AMC estimates
of the level of development of a country’s national AMC produced by the GLASS-AMC Excel template to
surveillance system. generate and display the most common AMC metrics
and indicators.
This manual summarizes the WHO methodology for a
global programme on surveillance of AMC. It is intended to The manual is based on the following WHO documents:
guide countries on how to: • WHO methodology for a global programme on
• use the GLASS-AMC Microsoft Excel template to surveillance of antimicrobial consumption 1
prepare the national AMC surveillance data according • the WHO ATC/DDD toolkit; 2 and
to the WHO methodology;
• the WHO GLASS-AMC Excel template.1
• produce national AMC data files to foster AMC data
analysis at national level; and
• facilitate the preparation of the AMC national data for
submission to GLASS-AMC.

1 See https://www.who.int/activities/facilitating-global-surveillance-of-antimicrobial-resistance
2 See https://www.who.int/medicines/regulation/medicines-safety/toolkit_content/en/

2
SECTION

02

3
GLASS Manual on the management of antimicrobial consumption data

2. WHO methodology for AMC

The WHO methodology defines consumption data as The ATC/DDD methodology is used to standardize the data
referring to estimates derived from sources of aggregated collection and reporting of AMC.
data, such as importers or wholesalers, hospitals or
WHO collects three data elements: AMC data, denominator
pharmacies, or health insurance companies.
data, and descriptive or contextual information.
AMC surveillance provides information on the types
This manual focuses on AMC data and the population data
and quantity of antimicrobials consumed. It provides an
(denominator) that are captured by the GLASS-AMC Excel
estimate of use of antimicrobials. Consumption data can
template. Contextual data may be relevant for interpreting
be presented as total consumption for a country, or can be
the calculated consumption estimates but are not needed
disaggregated by setting (community or hospital, public or
for estimating consumption.
private sectors).
To ensure the standardization and comparisons of AMC 2.1.1. AMC data
between health facilities, between countries and between AMC data are composed of product information and
regions, GLASS-AMC methodology uses the ATC system consumption data.
to classify antimicrobial substances and the number of
DDDs as a measurement metric. Product information

WHO has defined a core set of antimicrobials that all Countries should produce a list of all medicinal product
countries should include in their surveillance programme. packages (MPPs) for the antimicrobial agents with
In addition, the WHO surveillance programme includes an marketing authorization in the country. For each uniquely
optional list of antimicrobials that countries may include identified MPP, a range of information needs to be
in their surveillance programme, according to local needs systematically collected to calculate the quantity of the
and resources. The core and optional antimicrobials are active ingredient (substance) in a package and correctly
listed in Table 2.1. apply the ATC/DDD methodology to obtain the number of
DDD contained in one MPP:
2.1. AMC data components Number of DDDs = quantity of active substance
/ DDD value
AMC is defined as the quantities of antimicrobials used
in a specific health care sector (i.e., public, private, or Consumption data
public and private) and at a specific health care level (i.e.,
community, hospital, or community and hospital) during a For each MPP reported in the registry, consumption is
specific time period (e.g. days, months and years). expressed as the total number of packages imported,
sold or dispensed (depending on the data source used
For global reporting, national estimates of consumption to extract the consumption data) during the defined time
are reported for the calendar year (January to December). period, stratified (or not) by health care sector and level.

Table 2.1. Classes of antimicrobials listed as core or optional by the WHO surveillance programme

ANTIMICROBIAL CLASS ATC MONITORING


Antibacterials for systemic use J01 Core
Antibiotics for alimentary tract A07AA Core
Nitroimidazole derivatives for protozoal diseases P01AB Core
Antifungals J02 Optional
Antimycotics D01BA Optional
Antivirals J05 Optional
Antimycobacterials for treatment of tuberculosis J04A Optional
Antimalarials P01B Optional
ATC: Anatomical Therapeutic Chemical; WHO: World Health Organization

4
WHO methodology for AMC

2.1.2. Denominator data In this system, the active substances are divided into
different groups according to the organ or system on
The total numbers of DDDs derived as consumption
which they act and their therapeutic, pharmacological and
estimates should be adjusted for the population to which
chemical properties. There are five different levels of ATC
the data apply. For national estimates of consumption,
classification.
the appropriate population will be the total national
population (all age and gender groups combined). WHO DDDs provide a fixed unit of measurement that is
has standardized population estimates for all Member independent of price, currencies, package size and
States in the WHO Global Observatory.3 strength. They enable researchers to assess trends in drug
consumption and to compare population groups.
It is possible for a country to use other population
estimates. For example, if surveillance is in place only in The DDD is the assumed average maintenance dose per
a part of the country (e.g. half of the regions), only the day for a drug used for its main indication in an adult
population of the covered territory should be included. If (assuming a person of 70 kg). The DDDs for the anti-
the surveillance is based only on health insurance data, infectives are generally based on the use in infections of
only the people insured should be included. moderate severity. However, some anti-infectives are only
used in severe infections, and their DDDs are assigned
The denominator should not reflect the coverage of the data
accordingly.
sources. If the system collects data at the national level, but
only captures about 80% of the drugs on the market at the DDDs are only assigned to drugs with an ATC code;
national level (e.g. missing data from some wholesalers), normally, a DDD will not be assigned for a substance until a
the total national population should be used and the product is approved and marketed in at least one country.
consumption should be noted as being an underestimate The ATC/DDD system is maintained by the WHO
owing to missing data (e.g. estimated at 20%). Collaborating Centre for Drug Statistics Methodology, in
Oslo.4 ATC codes and DDDs are revised annually, with the
2.2. AMC reporting metrics and indicators aim of keeping them as stable as possible over time.
GLASS-AMC methodology presents the volume of A searchable version of the complete ATC index with
antimicrobials consumed using two metrics: DDD and the DDDs is available,5 as is a list of the DDDs of combined
weight of the antibiotic substances in metric tonnes (t). products.6 At national level, AMC surveillance officers may
The second metric can be used for comparison with AMC find substances with no ATC or DDD assigned. When this
in the animal sector. The total number of packages sold for occurs, the technical GLASS-AMC team can be consulted
a specific therapeutic group level may also be summed, to on how to proceed.7
give a total number of packages consumed.
To obtain correct consumption figures, it is vital to
This manual focuses only on the first metric, the number of correctly assign ATC and DDD, so that the amount of DDD
DDD, and on the following key indicators: in each MPP can be correctly attributed. To ensure that the
process is performed correctly, certain methodological
• quantity of antibiotics as DDD per 1000 inhabitants per
considerations on the ATC and DDD need to be considered,
day (DID) for total consumption and by pharmacological
as outlined below.
subgroup – DID = ( Total DDD x 1000) / (Population x
365); 2.3.1. Nomenclature
• relative consumption of antibiotics as a percentage of Each antimicrobial substance should be named, preferably
total consumption by route of administration (i.e., oral, using the international nonproprietary name (INN). If no
parenteral, rectal or inhaled); and INN name has been assigned, the usual approach is to
• list of the most frequently used antibiotic substances, choose a United States-adopted name (USAN) or a British-
making up 75% and 90% of the total consumption – approved name (BAN).
that is, Drug Utilization 75 (DU75) and Drug Utilization
2.3.2. ATC code
90 (DU90) – stratified by route of administration.
A medicinal substance can be given more than one
2.3. ATC/DDD classification ATC code if the substance is available in two or more
methodological considerations strengths or routes of administration with clearly different
therapeutic uses. In such cases, it is important to assign
The ATC classification system is the most commonly used the correct ATC5 based on the route of administration; for
method for aggregating medicines data, and it allows example, vancomycin is available for oral and parenteral
flexibility in reporting by medicine or groups of medicines. administration (oral: A07AA09 and parenteral: J01XA01),
as is metronidazole (oral: ‎ P01AB01 and parenteral:
J01XD01).
3 See https://apps.who.int/gho/data/node.main.POP107?lang=en
4 See https://www.whocc.no/
5 See https://www.whocc.no/atc_ddd_index/
6 See https://www.whocc.no/ddd/list_of_ddds_combined_products/
7 The team can be contacted by email at glass-amc@who.int

5
GLASS Manual on the management of antimicrobial consumption data

NOTE: To determine total use of each of these antimicrobials, 2.3.3. DDDs


it will be necessary to include the relevant ATC codes.
Considerations for DDDs are:
Pharmaceutical products containing two or more active
• route of administration – only one DDD is assigned
ingredients are defined as combinations; they are given
per ATC5 code and route of administration, since
different ATC codes from plain products containing one
the bioavailability may be substantially different for
active ingredient. For the J01 antimicrobial class:
various routes of administration or if the dosage forms
• combinations of antibacterials with other drugs, are used for different indications;
including local anaesthetics or vitamins, are classified
• salt – various salts of a substance are usually not
at a separate fifth level in the respective antibacterial
given different DDDs, but there are some exceptions,
group, by using the 50-series;
and in those cases the salt needs to be taken into
• combinations of two or more systemic antibacterials consideration to assign the correct DDD; and
from different third levels are classified in J01R, except
• some specific substances used in combination with
for combinations of sulfonamides and trimethoprim,
other non-antimicrobial substances – the DDD for
which are classified at a separate fourth level, J01EE.
antimicrobials and enzyme inhibitors is the same as
To illustrate this situation, Table 2.2. shows the ATC5 codes the DDD for the main active ingredient, and should
for metronidazole on its own and with other antibacterials. be based only on the strength of the main active
ingredient.
Examples of two situations with DDDs are shown in Table
2.3: the same antimicrobials but with a different DDD based
on administration route and salt, and antimicrobials and
enzyme inhibitors with a different ATC but the same DDD.8

Table 2.2. Example of metronidazole as plain substance and combined with other antibacterials

ATC5 DESCRIPTION
A01AB17 Alimentary tract and metabolism, anti-infectives and antiseptics for local oral treatment
D06BX01 Dermatologicals, other chemotherapeutics
G01AF01 Genitourinary system and sex hormones, imidazole derivatives
P01AB01 Antiparasitic products, insecticides and repellents, nitroimidazole derivatives
P01AB51 Antiparasitic products, insecticides and repellents, nitroimidazole derivatives, metronidazole
combinations
J01XD01 Anti-infectives for systemic use, imidazole derivatives
J01RA10 Anti-infectives for systemic use, imidazole derivatives, combinations of antibacterials, ciprofloxacin
and metronidazole

8 See https://www.whocc.no/atc_ddd_index/

6
WHO methodology for AMC

Table 2.3. Examples of DDDs for antimicrobials with different routes of administration or salts, and of different
substances with the same DDD

ADMINISTRATION UNIT OF NOTE


ATC CODE NAME DDD
ROUTE DDD
J01MA02 ciprofloxacin O 1 g
P 0.5 g
J01GB01 tobramycin Inhal. powder 0.112 g
Inhal. solution 0.3 g
P 0.24 g
P01AB01 metronidazole O 2 g
P01AB01 metronidazole R 2 g
J01XD01 metronidazole
P 1.5 g
J01FA01 erythromycin O 1 g
P 1 g
erythromycin
O 2 g
ethylsuccinate
J01XX05 methenamine hippurate O 2 g
methenamine mandelate O 3 g
J01CA04 amoxicillin O 1.5 g
P 3 g
J01CR02 amoxicillin and enzyme O 1.5 g
inhibitor P 3 g Refer to amoxicillin
ATC: Anatomical Therapeutic Chemical; DDD: Defined Daily Dose; Inhal: inhalation; O: oral; P: parenteral.

Table 2.4. Examples of DDDs for combined products

UNIT OF
ATC CODE DOSAGE FORM ACTIVE INGREDIENTS PER UD DDD
DDD
J01EE01 inf conc sulfamethoxazole 80 mg / trimethoprim 16 mg 20 UD
mixt sulfamethoxazole 0.2 g / trimethoprim 40 mg 8 UD
tab sulfamethoxazole 0.4 g / trimethoprim 80 mg 4 UD
ATC: Anatomical Therapeutic Chemical; DDD: Defined Daily Dose; UD: unit dose.

Table 2.5. Substances for which a factor needs to be applied to convert from million international units to grams

CONVERTING
ADMINISTRATION UNIT OF THE UNIT OF
ATC5 NAME FACTOR FROM MU
ROUTE STRENGTH OF THE DDD
TO G
J01CE01 benzylpenicillin P MU G 0.6
J01CE02 phenoxymethylpenicillin O MU G 0.625
J01CE08 benzathine P MU G 0.6
benzylpenicillin
J01CE09 procaine benzylpenicillin P MU G 1
J01FA02 spiramycin O MU G 0.3125
ATC: Anatomical Therapeutic Chemical; DDD: Defined Daily Dose; MU: million international units; O: oral; P: parenteral.

7
GLASS Manual on the management of antimicrobial consumption data

Combinations In Sections 3 and 4 of this document, a step-by-step


‘Combinations’ refers to a combination of multiple guide to use of the GLASS-AMC Excel template, using
antimicrobial substances in one product. When establishing 12 representative MPPs, illustrates how the data can be
DDDs for combination products, both components are taken compiled, calculated and displayed.
into consideration. The DDDs are given for fixed doses, 2.4.1. Product data variables
based on the proportion of the association and on the route
of administration. A list of DDDs for combination products is Product data variables are the variables that should
available,9 and examples of DDDs for combined products are compose the register of the antimicrobials MPP.
given in Table 2.4. Users need to be familiar with the information to be
Unit of the DDD collected and understand why this information is
necessary to generate quantitative estimates of AMC. The
The unit used for the DDD depends on whether the product information collected makes it possible to:
is plain or a combination
• uniquely identify each package;
• Plain products – as far as possible, the DDD for a plain
product is given in amount of active ingredients, using • classify it according to the ATC/DDD system;
the following units: g (gram), mg (milligram), mcg • calculate the total strength and the DDD of the active
(microgram), mL (millilitre), mmol (millimole), U (unit), substance per package; and
TU (thousand units) and MU (million units).
• characterize the package to better understand the
When the unit provided in the MPP differs from the unit dynamics of AMC in the country.
of the DDD, a converting factor needs to be applied to
the pack content before applying the DDD. The list of The variables reported in Table 2.6. are the same data
substances for which the converting factor is needed elements as are collected in the “Product data” worksheet
is given in Table 2.5. of the GLASS-AMC template; they are colour-coded as
follows:
• Combination products – the UD is used for combination
products because the DDD cannot be given in amount • light blue variables – product variables that are
of active ingredient. mandatory;
• brown variables – product variables automatically
2.4. AMC variables assigned by the system (assuming that the mandatory
variables have been correctly assigned); and
AMC variables fall into two main categories: product data
variables and consumption variables. This section describes • green variables – optional variables intended to
the variables that are the same as those collected or better characterize the MPPs, to allow for a better
automatically calculated by the GLASS-AMC Excel template. understanding of the AMC dynamic in the country.

9 See https://www.whocc.no/ddd/list_of_ddds_combined_products/

8
WHO methodology for AMC

Table 2.6. Product-level variables for the national antimicrobial register

PRODUCT_ID The national code of the MPP. If no code exists for an MPP, the country should provide one arbitrary
code that should uniquely identify each MPP.
The Product_ID should not change over time. When an MPP is no longer available on the market
or is no longer registered, its Product_ID should not be attributed to another MPP, to allow for
identification of the old MPP for historical purposes (prescription history).
LABEL The label of the medicinal product. If possible, the label should contain the name of the medicinal
product, package size, strength and pharmaceutical form.
PACKSIZE Size of the package. The package size includes information on
Mandatory the number of pieces (tablets, pills or vials)
Data type: number contained in one package. For syrup, the
Pack size unit of measurement. package size should be reported as ‘mL’ of the
PACKSIZE_UNIT final reconstituted product.
Mandatory
Data type: coded value
PCS Pieces
ML Millilitres
ROUTE_ADMIN Route of administration. This describes how the product is administered, and it is the basis for
assigning the right DDD value. This information is also used during the analysis, where it allows for
aggregation of consumption data by route of administration.
Mandatory
Data type: coded variable
O Oral
P Parenteral
R Rectal
IP Inhalation powder
IS Inhalation solution
STRENGTH The strength of the substance of each item as There are special cases to consider when
defined by PACKSIZE. assigning the strength to an MPP:
Mandatory 1) For some specific substances used in
Data type: Number combination with others, only the antimicrobial
Unit measurement of strength substance needs to be considered (e.g. amoxicillin
STRENGTH_UNIT 1 g/clavulanic acid 0.2 g, strength=1 G);
Mandatory
Data type: coded value 2) For products with multiple antimicrobial
MG Milligram substances, DDDs are given for fixed doses,
G Gram based on the proportion of the association and
IU International unit the route of administration.
MU Million international units The strength can be “grams”, “milligrams”,
UD Unit dose “international units”, “million international units”,
“unit doses”.
INBASQ Basic ingredient quantity These variables are only valid for oral solution
Mandatory if PACKSIZE_UNIT==ML (i.e. syrup).
Data type: Number They describe the ingredient base quantity and
Unit measurement of the basic ingredient quantity, its unit (i.e. mL), which are the denominators of
INBASQ_UNIT the strength.
which is always “ML”
Mandatory if PACKSIZE_UNIT==ML
Data type: coded value
ML Millilitres
ATC5 WHO ATC code at substance level (ATC5-level).
Mandatory
Coded value
The information can be retrieved from:
• the ATC/DDD website https://www.whocc.no/atc_ddd_index/
• the “ATC” worksheet of the GLASS-AMC Excel template

9
GLASS Manual on the management of antimicrobial consumption data

SALT The salt associated with erythromycin and methenamine.


WHO has defined a different DDD values according to the salt for erythromycin (ATC5-J01FA01) and
methenamine (ATC5-J01XX05)
Mandatory for ATC5 == J01FA01 or ATC5 == J01XX05
Data type: coded value
ESUC Ethylsuccinate
HIPP Hippurate
MAND Mandelate
COMBINATION The ATC5 COMB_CODE. This is a technical variable used in the GLASS-AMC Excel template to
univocally link the ATC5 of combined products to the correct DDD value, taking into consideration the
fixed dose and the administration route.
MANDATORY for combined products that have a DDD assigned in the list of DDDs for combined
products: https://www.whocc.no/ddd/list_of_ddds_combined_products/
Data type: CODED VALUE
Values are provided in the “DDD combination” worksheet of the GLASS-AMC Excel template
PAEDIATRICS_ This variable describes whether the MPP is a paediatric medicine product.
PRODUCT Optional variable
Data type: coded value
YES Yes
NO No
FORM Pharmaceutical formulation type. To allow for easier analysis of the data, countries may decide to
standardize the field and create a list of coded values.
Optional variable
Data type: free text
PRODUCT_NAME Medicinal product name. This text usually contains the brand name and strength. For combination
products, the strength is usually an addition of the individual ingredients (e.g. Fleming 457 for
amoxicillin sodium 400 mg and clavulanate potassium 57 mg).
Optional variable
Data type: free text
INGREDIENTS The name of the ingredients in the MPP INN name should be used. For combination INNs, names
should be separated by a semicolon (e.g. amoxicillin; clavulanic acid).
Optional variable
Data type: free text
PRODUCT_ORIGIN The source of the product; this can be imported, donation or locally produced in the country.
Optional variable
Data type: coded value
IMP Imported
DON Donation
LOC Locally produced in the country
MANUFACTURER_ Three-letter ISO code uniquely identifying the country of manufacture; it may provide interesting
COUNTRY information on the dynamics of AMC in the country.
Optional variable
Data type: coded value
List of country codes based on the ISO3166 alpha-3 country codes list can be found here:
https://en.wikipedia.org/wiki/ISO_3166–1_alpha-3
GENERIC This variable collects the information on whether the MPP is a generic.
Optional variable
Data type: coded value
YES Yes
NO No
YEAR_ Year of authorization on the product in the market.
AUTHORIZATION Optional variable
Data type: number
YEAR_ Year of withdrawal of the product from the market (if applicable). This information ONLY refers to the
WITHDRAWAL FINAL withdrawal. Temporary withdrawal MUST NOT be reported here.
Optional variable
Data type: Number

10
WHO methodology for AMC

CONV_FACTOR Transform strength expressed in IU into G, for situations where the DDD unit is G and the strength unit
is IU. In the GLASS-AMC Excel template this information is automatically filled in.
MANDATORY variable, automatically assigned
Data type: Number
PACKCONTENT Total amount of active substance in the MPP in G The formula to calculate the pack content is:
or IU. PACKSIZE ×(STRENGTH ÷ INBASQ) × CONV_
Mandatory variable, automatically calculated in FACTOR
the GLASS-AMC Excel template
Data type: Number Where the pack content is expressed in MG, this
Unit of the substance content. needs to be converted to G
PACKCONTENT_
UNIT Mandatory variable, automatically calculated
in the GLASS-AMC Excel template
Data type: coded value
G Gram
UD Unit dose
ARS ATC + ROUT_ADMIN + SALT
This is a technical variable that is automatically calculated in the GLASS-AMC Excel template. It is
needed for assigning the correct DDD to the MPP mandatory variable, automatically assigned in the
GLASS-AMC Excel template.
Data type: text
WHO_DDD The DDD as assigned by the WHO CC for the This information can be retrieved (together with
specific ATC5 code – route of administration – the ATC5) in the ATC/DDD official website:
salt and combination. https://www.whocc.no/atc_ddd_index/
Mandatory variable, automatically assigned in the https://www.whocc.no/ddd/list_of_ddds_
GLASS-AMC Excel template combined_products/
Data type: Number The same information is also provided in the
The measurement unit in which the WHO DDD of “DDD” or “DDD combination” worksheets of the
WHO_DDD_UNIT GLASS-AMC Excel template.
the MPP is expressed.
Data type: coded value
G Gram
UD Unit dose
DPP Number of DDD contained in one MPP.
DPP = PACKCONTENT/DDD
Mandatory variable, automatically assigned in the GLASS-AMC Excel template
Data type: Number
AMC: antimicrobial consumption; ATC: Anatomical Therapeutic Chemical; DDD: Defined Daily Dose; GLASS: Global Antimicrobial Resistance Surveillance
System; ID: identification; ISO: International Organization for Standardization; MPP: medicinal product package; WHO: World Health Organization.

11
GLASS Manual on the management of antimicrobial consumption data

2.4.2. Consumption data As shown in Table 2.7, consumption can be reported


by health care sector (e.g. public and private sector),
Consumption is expressed as the total numbers of packages
or disaggregated at hospital and community (primary
for each product included in the register of antimicrobial
care) level.
products that are imported, sold or dispensed during the
defined period; for GLASS-AMC this is set as one calendar
year (January–December).

Table 2.7. Consumption variables for the national antimicrobial register

COUNTRY Three-letter ISO code uniquely identifying the reporting country.


Mandatory variable
Data type: coded value
List of country codes based on the ISO3166 alpha-3 country codes list can be found here:
https://en.wikipedia.org/wiki/ISO_3166–1_alpha-3
PRODUCT_ID The national code of the MPP. If no code exists for an MPP, the country should provide one arbitrary
code that should uniquely identify each MPP. The Product_ID should not change over time. When
an MPP is no longer available on the market or is no longer registered, its Product_ID should not
be attributed to another MPP; this allows identification of the old MPP for historical purposes (i.e.
prescription history).
Mandatory
Data type: free text
YEAR The year the AMC data refer to.
Mandatory variable
Data type: numeric
SECTOR Whether the consumption data are from the public, private, or global (public + private) sector.
Mandatory variable
Data type: coded value
GLO Global
PUB Public
PRI Private
TOTAL_ The total number of packages of the MPP / Product_ID consumed.
PACKAGES Data type: number

COMMUNITY_ The number of packages of the MPP / Product_ID consumed for use in the community.
PACKAGES Data type: number

HOSPITAL_ The number of packages of the MPP / Product_ID consumed for hospital use.
PACKAGES Data type: number

AMC: antimicrobial consumption; ID: identification; ISO: International Organization for Standardization; MPP: medicinal product package.

12
WHO methodology for AMC

2.4.3. Compiling antimicrobial product and The tables below give the product and consumption
consumption data information for each of these 12 MPPs.

To obtain correct consumption figures, it is vital to correctly The 12 MPPs are:


fill in all the information that is used to calculate the content 1. REMOXIL 1 GR 16 TABLET
of the active substance in each MPP, and to correctly assign
ATCs and DDDs, so that the correct amount of DDD in each 2. AMOXICOR 250 MG 5 ML 100 ML SUSPENSION
MPP can be attributed. 3. AMOXYCLAV IV 1,2 GR 1 VIAL
We selected 12 MPPs, to provide a step-by-step guide to 4. BENZYLPENICILLIN 1 MU 1 VIAL
compiling the product and consumption information. In
5. HIPPURIN 1 GR 28 FILM TABLET
these examples you will manually fill in all the variables,
or you can use the GLASS-AMC Excel template, in which 6. BACTRIM, Film coated 400 mg/80 mg x 10
case, the brown variables will automatically be assigned
7. BACTRIM FORTE, film coated tablets x 800mg + 160 mg x 10
by the macros. These MPPs have been extracted from
the national AMC data from imaginary country AAA. 8. BACTRIM, 200 mg/40 mg per 5 mL oral, 80 mL suspension
Consumption data are provided for the core GLASS-AMC 9. VANCOCIN, capsule 250 mg, 20 pcs
antimicrobial classes (J01, A07AA and P01AB) for the
calendar years 2017 and 2018; the data are for the public 10. VANCOMYCIN, vial dry inf 1 g
sector only, but disaggregated for hospital and community 11. FLAGYL 500 MG CAPSULE, 20 pcs
use. The ATC/DDD version used for this exercise is the
2020 version.10 12. ANEROBIZOL INFU 500 mg/100 mL

1. REMOXIL 1 GR 16 TABLET, imported product, authorized in 1990, market holder is Company A

COUNTRY AAA PRODUCT INFORMATION MANDATORY


• Product_ID: No unique code is assigned in country
PRODUCT_ID P1 AAA. As this is the first product of the registry, we
assign the code P1
LABEL REMOXIL 1 GR 16 TABLET • Label: It should provide as many characteristics as
possible of the product, such as the name, package
PACKSIZE 16 size, strength and pharmaceutical form
• As described in the label, the pack size is 16 pieces
PACKSIZE_UNIT PCS • Route of administration is oral
• The strength is 1 and the strength unit is G
ROUTE_ADMIN O • Since it is not a syrup, there is no need to provide INBASQ
• The ATC5 is J01CA04. If the ATC5 is not indicated
STRENGTH 1
already, it can be retrieved from the WHO CC website:
https://www.whocc.no/atc_ddd_index/ or from the
STRENGTH_UNIT G
“ATC” worksheet of the GLASS-AMC Excel template
INBASQ • There is no need to fill in salt and combination

INBASQ_UNIT

ATC5 J01CA04

SALT

COMBINATION

10 See https://www.whocc.no/atc_ddd_index/

13
GLASS Manual on the management of antimicrobial consumption data

PAEDIATRIC_PRODUCT NO PRODUCT INFORMATION OPTIONAL


• This is not a paediatric product: NO
FORM tablet • It is marketed in the form of tablets
• The product name is “REMOXIL 1000”
PRODUCT_NAME REMOXIL 1000 • The INN name of the ingredient is “amoxicillin”
• It is an imported MPP manufactured in country “BBB”
INGREDIENTS amoxicillin and the market authorization holder is Company A.
• It is a GENERIC product
PRODUCT_ORIGIN IMP • Its use was first authorized in 1990 and it is still
authorized
MANUFACTURER_
BBB
COUNTRY

MARKET_AUTH_HOLDER COMP_A

GENERICS YES

YEAR_AUTHORIZATION 1990

YEAR_WITHDRAWAL

CONV_FACTOR PRODUCT INFORMATION CALCULATED


• No converting factor is needed because both the
PACKCONTENT 16 strength and the DDD are in G
• The pack content is: 1 g x 16 = 16 g
PACKCONTENT_UNIT G • For J01CA04 Oral, the DDD is 1.5 g (NOTE: the DDD for
the same antimicrobial, but for parenteral use, is 3 g)
ARS J01CA04_O amoxicillin DDD U Adm.R
ATC code 1.5 g O
WHO_DDD 1.5 J01CA04 3 g P
• The total DDD for the MPP is: 16 / 1.5 = 10.7
WHO_DDD_UNIT G

DPP 10.7

SECTOR PUB CONSUMPTION DATA


• Consumption data are available only for the public
2017 TOTAL_PACKAGES sector, stratified by hospital and community, for the
years 2017 and 2018
2017 COMMUNITY_
5000
PACKAGES

2017 HOSPITAL_
6500
PACKAGES

2018 TOTAL_PACKAGES

2018 COMMUNITY_
6170
PACKAGES

2018 HOSPITAL_
7670
PACKAGES

14
WHO methodology for AMC

2. A
 MOXICOR 250 MG 5 ML 100 ML SUSPENSION, imported product, first authorized in 1989, market holder is
Company A

COUNTRY AAA PRODUCT INFORMATION MANDATORY


• Product_ID: As this is the second product of the
PRODUCT_ID P2 registry, we assign the code P2
• Label: It should provide as many characteristics as
AMOXICOR 250 MG 5 ML possible of the product, such as the name, package
LABEL
100 ML SUSPENSION size, strength and pharmaceutical form
PACKSIZE 100 • As described in the label, the pack size is 100 ML (since
this is a syrup)
PACKSIZE_UNIT ML • Route of administration is oral
• The strength is 250 MG for each 5 (INBASQ) ML
ROUTE_ADMIN O (INBASQ_UNIT) (i.e. STRENGTH=250/5)
• The ATC5 is J01CA04
STRENGTH 250 • There is no need to fill in the salt and the combination
variables
STRENGTH_UNIT MG

INBASQ 5

INBASQ_UNIT ML

ATC5 J01CA04

SALT

COMBINATION

PAEDIATRIC_PRODUCT NO PRODUCT INFORMATION OPTIONAL


• This is not a paediatric product: NO
FORM syrup • It is marked in the form of syrup
• The product name is “Amoxicor 250”
PRODUCT_NAME Amoxicor 250 • The INN name of the ingredient is “amoxicillin”
• It is an imported MPP manufactured in country “CCC”
INGREDIENTS amoxicillin and the market authorization holder is Company A.
• It is not a GENERIC product
PRODUCT_ORIGIN IMP • Its use was first authorized in 1989 and it was
withdrawn
MANUFACTURER_ in January 2018
CCC
COUNTRY

MARKET_AUTH_HOLDER COMP_A

GENERICS YES

YEAR_AUTHORIZATION 1989

YEAR_WITHDRAWAL 2018

CONV_FACTOR PRODUCT INFORMATION CALCULATED


• No converting factor is needed since both the strength
PACKCONTENT 5 and the DDD are in G
• The pack content is:
PACKCONTENT_UNIT G ((250 mg / 5) x (100)) = 5000 mg = 5 g
• We already know that the DDD for J01CA04 Oral is 1.5 g
ARS J01CA04_O • The total DDD for the MPP is: 5 / 1.5 = 3.3 g

WHO_DDD 1.5

WHO_DDD_UNIT G

DPP 3.3

15
GLASS Manual on the management of antimicrobial consumption data

SECTOR PUB CONSUMPTION DATA


Consumption data are available only for the public sector,
2017 TOTAL_PACKAGES stratified by hospital and community, for the years 2017 and
2018. The MPP was withdrawn from the market on January
2017 COMMUNITY_ 2018, and this is why the number of packages used in 2018
5500
PACKAGES is much lower than those from 2017

2017 HOSPITAL_
7000
PACKAGES

2018 TOTAL_PACKAGES

2018 COMMUNITY_
100
PACKAGES

2018 HOSPITAL_
0
PACKAGES

3. AMOXYCLAV IV 1,2 GR 1 VIAL, imported product, authorized in 1988, market holder is Company A

COUNTRY AAA PRODUCT INFORMATION MANDATORY


• Product_ID: As this is the third product of the registry,
PRODUCT_ID P3 we assign the code P3
• Label: It should provide as many characteristics as
AMOXYCLAV IV 1,2 GR 1 possible of the product, such as the name, package
LABEL
VIAL size, strength and pharmaceutical form
PACKSIZE 1 • As described on the label, the pack size is 1 PCS
• Route of administration is parenteral (P)
PACKSIZE_UNIT PCS • The strength is 1 g. NOTE: only the strength of
amoxicillin (the main ingredient) needs to be
ROUTE_ADMIN P considered, as indicated in this extract from the ATC/
DDD index:
STRENGTH 1 amoxicillin and beta-lactamase inhibitor
ATC code DDD U Adm.R Note
STRENGTH_UNIT G J01CR02 1.5 g O Refers to amoxicillin
3 g P Refers to amoxicillin
INBASQ
• The ATC5 is J01CR02. It can be retrieved from the WHO
INBASQ_UNIT CC website: https://www.whocc.no/atc_ddd_index/
or from the “ATC” worksheet of the GLASS-AMC Excel
ATC5 J01CR02 template
• There is no need to fill in the salt and the combination
SALT
variables
COMBINATION

16
WHO methodology for AMC

PAEDIATRIC_PRODUCT NO PRODUCT INFORMATION OPTIONAL


• This is not a paediatric product: NO
Powder for Injection or • It is marked as powder for Injection or Infusion
FORM
Infusion • The product name is “AMOXYCLAV 1200”
• The INN name of the ingredient is “amoxicillin;
PRODUCT_NAME AMOXICLAV 1200
clavulanic acid”
INGREDIENTS amoxicillin; clavulanic acid • It is an imported MPP manufactured in country “ZZZ”
and the market authorization holder is Company A.
PRODUCT_ORIGIN IMP • It is not a GENERIC product: NO
• Its use was first authorized in 1988 and it is still
MANUFACTURER_ authorized
ZZZ
COUNTRY

MARKET_AUTH_HOLDER COMP_A

GENERICS NO

YEAR_AUTHORIZATION 1988

YEAR_WITHDRAWAL

CONV_FACTOR PRODUCT INFORMATION CALCULATED


• No converting factor is needed since both the strength
PACKCONTENT 1 and the DDD are in G
• The pack content is: 1 g x 1 = 1 g
PACKCONTENT_UNIT G • The DDD for parenteral administration is 3 g
• The total DDD for the MPP is: 1 / 3 = 0.33
ARS J01CR02_P

WHO_DDD 3

WHO_DDD_UNIT G

DPP 0.33

SECTOR PUB CONSUMPTION DATA


Consumption data are available only for the public sector,
2017 TOTAL_PACKAGES stratified by hospital and community, for the years 2017
and 2018
2017 COMMUNITY_
7000
PACKAGES

2017 HOSPITAL_
8500
PACKAGES

2018 TOTAL_PACKAGES

2018 COMMUNITY_
8170
PACKAGES

2018 HOSPITAL_
9670
PACKAGES

17
GLASS Manual on the management of antimicrobial consumption data

4. BENZYLPENICILLIN 1 MU 1 VIAL, import, authorized in 1989, market holder is Company A

COUNTRY AAA PRODUCT INFORMATION MANDATORY


• Assign a unique identifier. As this is the forth product of
PRODUCT_ID P4 the registry, we assign the code P4
• Label: It should provide as many characteristics as
BENZYLPENICILLIN 1 MU 1 possible of the product, such as the name, package
LABEL
VIAL size, strength and pharmaceutical form
PACKSIZE 1 • As described in the label, the pack size is 1 PCS
• Route of administration is parenteral
PACKSIZE_UNIT PCS • The strength is 1 and the unit is MU
• The ATC5 is J01CR02. ATC code can be retrieved from
ROUTE_ADMIN P the WHO CC website: https://www.whocc.no/atc_ddd_
index/ or in the “ATC” worksheet of the GLASS-AMC
STRENGTH 1 Excel template
• No need to fill in the salt and the combination variables
STRENGTH_UNIT MU

INBASQ

INBASQ_UNIT

ATC5 J01CE01

SALT

COMBINATION

PAEDIATRIC_PRODUCT NO PRODUCT INFORMATION OPTIONAL


• This is not a paediatric product: NO
Powder for Injection or • It is marked Powder for Injection or Infusion
FORM
Infusion • The product name is “BENZYLPENICILLIN 1 MU”
• The INN name of the ingredient is “benzylpenicillin”
PRODUCT_NAME BENZYLPENICILLIN 1
• It is an imported MPP manufactured in country “CCC”
INGREDIENTS benzylpenicillin and the market authorization holder is Company A.
• It is not a GENERIC product
PRODUCT_ORIGIN IMP • Its use was first authorized in 1989

MANUFACTURER_
CCC
COUNTRY

MARKET_AUTH_HOLDER COMP_A

GENERICS NO

YEAR_AUTHORIZATION 1989

YEAR_WITHDRAWAL

18
WHO methodology for AMC

PRODUCT INFORMATION CALCULATED


CONV_FACTOR 0.6 • NOTE: Since the strength is in IU and the DDD in G we
need to apply the converting factor: 1 MU = 0.6 G. In the
GLASS-AMC Excel template converting factors can be
PACKCONTENT 0.6 retrieved in the “Conversion” worksheet

PACKCONTENT_UNIT G

ARS J01CE01_P

WHO_DDD 3.6


WHO_DDD_UNIT G

• The pack content is: 1 MU x 0.6 = 0.6 g


DPP 0.17 • The DDD for parenteral administration is 3.6 g
• The total DDD for the MPP is: 0.6 / 3.6 = 0.17
SECTOR PUB CONSUMPTION DATA
Consumption data are available only for the public sector,
2017 TOTAL_PACKAGES stratified by hospital and community, for the year 2017 and 2018

2017 COMMUNITY_
800
PACKAGES

2017 HOSPITAL_
2300
PACKAGES

2018 TOTAL_PACKAGES

2018 COMMUNITY_
1970
PACKAGES

2018 HOSPITAL_
3470
PACKAGES

19
GLASS Manual on the management of antimicrobial consumption data

5. HIPPURIN 1 GR 28 FILM TABLET, imported, authorized in 1998, market holder is Company A

PRODUCT INFORMATION MANDATORY


COUNTRY AAA
• Product_ID: P5
• Label: It should provide as many characteristics as
PRODUCT_ID P5 possible of the product, such as the name, package
size, strength and pharmaceutical form
HIPPURIN 1 GR 28 FILM • As described in the label, the pack size is 28 PCS
LABEL
TABLET • Route of administration is oral
• The strength is 1 and the unit is G
PACKSIZE 28
• The ATC5 is J01XX05. ATC5 can be retrieved from the
WHO CC website: https://www.whocc.no/atc_ddd_
PACKSIZE_UNIT PCS index/ or in the “ATC” worksheet of the GLASS-AMC
Excel template
ROUTE_ADMIN O methenamine
ATC code DDD U Adm.R Note
J01XX05 2 g O hippurate
STRENGTH 1
3 g O hippurate

STRENGTH_UNIT G • NOTE: since DDD differ according to the associated


salt, it is important to specify the salt (HIPP).
INBASQ In the GLASS-AMC Excel manual, the code for the salt
can be retrieved in the “Salt” worksheet
INBASQ_UNIT

ATC5 J01XX05

SALT HIPP


COMBINATION

PAEDIATRIC_PRODUCT NO PRODUCT INFORMATION OPTIONAL


• This is not a paediatric product: NO
FORM TABLET • It is marketed as tablets
• The product name is “HIPPURIN 1000”
PRODUCT_NAME HIPPURIN 1000 • The INN name of the ingredient is “methenamine”
• It is an imported MPP manufactured in country “CCC”
INGREDIENTS methenamine and the market authorization holder is Company A.
• It is not a GENERIC product
PRODUCT_ORIGIN IMP • Its use was first authorized in 1998 and it is still
authorized
MANUFACTURER_
CCC
COUNTRY

MARKET_AUTH_HOLDER COMP_A

GENERICS NO

YEAR_AUTHORIZATION 1998

YEAR_WITHDRAWAL

20
WHO methodology for AMC

CONV_FACTOR PRODUCT INFORMATION CALCULATED


• No need for converting factor
PACKCONTENT 28 • The pack content is: 1 g x 28 = 28 g
• DDD for oral administration with hippurate is 2 g
PACKCONTENT_UNIT G • The total DDD for the MPP is: 28 / 2 = 14

ARS J01XX05_OHIPP

WHO_DDD 2

WHO_DDD_UNIT G

DPP 14

SECTOR PUB CONSUMPTION DATA


Consumption data are available only for the public sector,
2017 TOTAL_PACKAGES stratified by hospital and community, for the years 2017
and 2018
2017 COMMUNITY_
10000
PACKAGES

2017 HOSPITAL_
11500
PACKAGES

2018 TOTAL_PACKAGES

2018 COMMUNITY_
11170
PACKAGES

2018 HOSPITAL_
12670
PACKAGES

21
GLASS Manual on the management of antimicrobial consumption data

6. BACTRIM, Film coated 400 mg/80 mg x 10


7. BACTRIM FORTE, film coated tablets x 800mg + 160 mg x 10
8. BACTRIM, 200 mg/40 mg per 5 mL oral, 80 mL suspension
All MPPs are imported, all authorized in 1985, market holder is Company A

COUNTRY AAA AAA AAA

PRODUCT_ID P6 P7 P8
BACTRIM FORTE, Film BACTRIM, 200 mg/40 mg
BACTRIM, Film coated
LABEL coated tablets x 800mg + per
tablets 400 mg/80 mg x 10
160 mg x 10 5 mL oral, 80 mL syrup
PACKSIZE 10 10 80

PACKSIZE_UNIT PCS PCS ML

ROUTE_ADMIN O O O

STRENGTH 1 2 1

STRENGTH_UNIT UD UD UD

INBASQ 5

INBASQ_UNIT ML

ATC5 J01EE01 J01EE01 J01EE01

SALT

COMBINATION J01EE01_3 J01EE01_3 J01EE01_2

PAEDIATRIC_PRODUCT NO NO YES

FORM tablet tablet syrup

PRODUCT_NAME BACTRIM 480 BACTRIM 960 BACTRIM 240


Sulfamethoxazole; Sulfamethoxazole; Sulfamethoxazole;
INGREDIENTS
trimethoprim trimethoprim trimethoprim
PRODUCT_ORIGIN IMP IMP IMP

MANUFACTURER_
ZZZ ZZZ ZZZ
COUNTRY

MARKET_AUTH_HOLDER COMP_A COMP_A COMP_A

GENERICS NO NO NO

YEAR_AUTHORIZATION 1985 1985 1985

YEAR_WITHDRAWAL

22
WHO methodology for AMC

CONV_FACTOR

PACKCONTENT 10 20 20

PACKCONTENT_UNIT UD UD UD

ARS J01EE01_O J01EE01_O J01EE01_O

WHO_DDD 4 4 8

WHO_DDD_UNIT UD UD UD

DPP 2.5 5 2

SECTOR PUB PUB PUB

2017 TOTAL_PACKAGES

2017 COMMUNITY_
55555 40000 300
PACKAGES

2017 HOSPITAL_
57055 41500 1800
PACKAGES

2018 TOTAL_PACKAGES

2018 COMMUNITY_
56725 41170 1470
PACKAGES

2018 HOSPITAL_
58225 42670 2970
PACKAGES

Product information mandatory and calculated In the figure, sulfamethoxazole/trimethoprim (ATC5
variables for the Bactrim products J01EE01) is available in three different fixed doses
(lines 14–16):
• Product_ID are unique identifiers (e.g. P6, P7 and P8
codes). • MPP P6 – Film coated tablets 400 mg/80 mg x 10
corresponds exactly to the fixed dose reported in
• Assign labels that provide as many characteristics as
line 16; the strength will then be 1 UD, the COMB_
possible of the product, such as the name, package
CODE is J01EE01_3, the pack content is 1 UD x 10
size, strength and pharmaceutical form.
= 10 UD, the WHO_DDD is 4 UD and the PDD = 10
• PACKSIZE: 10 pieces, 10 pieces and 80 mL (the third UD / 4 UD = 2.5
MPP is a syrup), respectively.
• MPP P7 – BACTRIM FORTE, Film coated tablets
• Route of administration is oral for the three products. x 800mg + 160 mg x 10 corresponds to twice the
• STRENGTH: these three MPPs comprise a fixed dose reported in line 16; the strength is 2 UD,
combination of antimicrobial substances; namely, the COMB_CODE is J01EE01_3, the pack content
sulfamethoxazole and trimethoprim. The three MPPs is 2 UD x 10 = 20 UD, the WHO_DDD is 4 UD and
differ in the proportions of the two active substances. the PDD = 20 UD / 4 UD = 5
For products with multiple antimicrobial substances, • MPP P8 – BACTRIM, 200 mg/40 mg per 5 mL oral,
DDDs are given on fixed doses, based on the proportion 80 mL syrup is a combination that corresponds
of the association of the substances and on the route to the fixed dose reported in line 15; the strength
of administration. The strength is reported as number is 1 UD, INBASQ is 5 ML, the COMB_CODE is
of unit doses (UDs) of the corresponding fixed dose. J01EE01_2, the pack content is 1 UD / 5 x 80 = 16
The list of DDD for combined product is published by UD, the WHO_DDD is 8 UD and the PDD = 16 UD /
the WHO Collaborating Centre,11 or can be found in 8 UD = 2.
the “DDD Combination” worksheet of the GLASS-AMC
Excel tool. The illustration below is an extract from
this worksheet.

11 See https://www.whocc.no/ddd/list_of_ddds_combined_products/

23
GLASS Manual on the management of antimicrobial consumption data

Product information optional variables for the Consumption data variables for the Bactrim
Bactrim products products
Only the third of the three products is a paediatric product. Consumption data are available only for the public sector,
Product names and ingredients are reported in the table stratified by hospital and community, for the years 2017
above. All are imported MPP manufactured in country and 2018.
“CCC” and the market authorization holder is Company A.
None is a generic product, and all were authorized in 1985
and are still on the market.

9. VANCOCIN, capsule 250 mg, 20 pcs, imported, authorized in 1998, market holder is Company B
10. VANCOMYCIN, vial dry inf 1 g, locally produced, authorized in 2005, market holder Company B

COUNTRY AAA AAA PRODUCT INFORMATION MANDATORY


• Product_ID: P9 and P10
PRODUCT_ID P9 P10 • Label: It should provide at least the
product name, package size, strength and
VANCOCIN, pharmaceutical form
VANCOMYCIN, • Pack sizes are 20 PCS and 1 PCS,
LABEL capsule 250 mg,
vial dry inf 1 g respectively
20 pcs
• Route of administration is oral and
PACKSIZE 20 1 parenteral
• Strength is 250 MG and 1 G
PACKSIZE_UNIT PCS PCS • ATC5: vancomycin (WHO CC website or in
“ATC” worksheet of the GLASS-AMC Excel
ROUTE_ADMIN O P template) has three options. We disregard
the last one
STRENGTH 250 1 (“S” group includes topical formulations
approved for use in eye or ear).
STRENGTH_UNIT MG G The other two options are:
• A07AA09: an alimentary tract and
INBASQ metabolism antibiotic for oral
administration. This corresponds to the
INBASQ_UNIT MPP P9
• J01XA01: antibiotic for systemic, for
parenteral administration, corresponding
ATC5 A07AA09 J01XA01
to MPP P10

24
WHO methodology for AMC

ATC code DDD U Adm.R


SALT A07AA09 vancomycin 2 g O
J01XA01 vancomycin 2 g P
S01AA28 vancomycin

COMBINATION • No SALT and no COMBINATION information


is needed
PAEDIATRIC_PRODUCT NO NO PRODUCT INFORMATION OPTIONAL
• None is a paediatric product
Powder for • Form is tablet and powder for injection
FORM TABLET
Injection • Product name: “VANCOCIN 250”;
VANCOMYCIN “VANCOMYCIN 1000”
PRODUCT_NAME VANCOCIN 250 • The INN name for both is “vancomycin”
1000
• MPP P9 is imported and produced in country
INGREDIENTS vancomycin vancomycin ZZZ, while MPP10 is locally produced.
• The market authorization holder is Company B
PRODUCT_ORIGIN IMP LOC for both
• MPP P10 is a generic product
MANUFACTURER_ • Their use was authorized in 1998 and 2005,
ZZZ AAA
COUNTRY respectively
MARKET_AUTH_HOLDER COMP_B COMP_B

GENERICS NO YES

YEAR_AUTHORIZATION 1998 2005

YEAR_WITHDRAWAL

CONV_FACTOR PRODUCT INFORMATION CALCULATION


• MPP P9:
PACKCONTENT 5 1 • Pack content: 250 MG x 20 = 5000 MG
= 5 G;
PACKCONTENT_UNIT G G • DDD is 2 g; DPP= 5 / 2=2.5
• MPP P10:
ARS A07AA09_O J01XA01_P • Pack content: 1 G x 1 = 1 G;
• DDD is 2 g; DPP= 1 / 2=0.5
WHO_DDD 2 2

WHO_DDD_UNIT G G

DPP 2.5 0.5

SECTOR PUB PUB CONSUMPTION DATA


Consumption data are available only for
2017 TOTAL_PACKAGES the public sector, stratified by hospital and
community, for the years 2017 and 2018.
2017 COMMUNITY_
100 200
PACKAGES

2017 HOSPITAL_
2500 3500
PACKAGES

2018 TOTAL_PACKAGES

2018 COMMUNITY_
2170 3170
PACKAGES

2018 HOSPITAL_
3670 4670
PACKAGES

25
GLASS Manual on the management of antimicrobial consumption data

11. FLAGYL 500 MG CAPSULE, 20 pcs, imported, authorized in 1998, market holder is Company B
12. ANEROBIZOL INFU 500 mg/100 mL, imported, authorized in 1998, market holder is Company B

COUNTRY AAA AAA PRODUCT INFORMATION MANDATORY


• Product_ID: P11 and P12
PRODUCT_ID P11 P12 • Label: It should provide as many
characteristics as possible of the product,
ANEROBIZOL such as the name, package size, strength
FLAGYL 500 MG
LABEL INFU 500 mg/100 and pharmaceutical form
CAPSULE, 20 pcs
mL • Pack size is 20 PCS and 1 PCS, respectively
PACKSIZE 20 1 • Route of administration is oral and parenteral
• Strength is 500 MG for both
PACKSIZE_UNIT PCS PCS • ATC5: when we look for metronidazole in the
WHO CC website or in the “ATC” worksheet
ROUTE_ADMIN O P of the GLASS-AMC Excel template we will
have several options. We disregard the first
STRENGTH 500 500 three since they all relate to formulations for
topical use.
STRENGTH_UNIT MG MG The other two options are:
• J01XD01: antibiotic for systemic,
INBASQ for parenteral administration,
corresponding to MPP P12
INBASQ_UNIT • P01AB01: a nitroimidazole antiprotozoal
for oral or rectal use. This correspond
ATC5 P01AB01 J01XD01 to the MPP P11
ATC code DDD U Adm.R
SALT
A01AB17 metronidazole
D06BX01 metronidazole
G01AF01 metronidazole
J01XD01 metronidazole 1.5 g P
P01AB01 metronidazole 2 g O
COMBINATION
2 g R

• No SALT and no COMBINATION information
is needed
PAEDIATRIC_PRODUCT NO NO PRODUCT INFORMATION OPTIONAL
• None is a paediatric product
Powder for • Form is tablet and Powder for injection
FORM TABLET
Injection • Product name “FLAGYL” and “ANEROBIZOL”
• The INN name for both is “metronidazole”
PRODUCT_NAME FLAGYL ANEROBIZOL
• Both are imported and produced in country
INGREDIENTS metronidazole metronidazole ZZZ.
• The market authorization holder is Company B
PRODUCT_ORIGIN IMP IMP for both MPPs
• P12 is a generic product
MANUFACTURER_ • Their use was authorized in 1998
ZZZ ZZZ
COUNTRY

MARKET_AUTH_HOLDER COMP_B COMP_B

GENERICS NO YES

YEAR_AUTHORIZATION 1998 1998

YEAR_WITHDRAWAL

26
WHO methodology for AMC

CONV_FACTOR PRODUCT INFORMATION CALCULATED


• P11:
PACKCONTENT 10 0.5 • Pack content: 500 MG x 20 = 10000 MG =
10 G;
PACKCONTENT_UNIT G G • DDD is 2 g; DPP= 10/2 = 5
• P12:
ARS P01AB01_O J01XD01_P • Pack content: 500 MG x 1 = 500 MG =
0.5 G;
WHO_DDD 2 1.5 • DDD is 1.5 g; DPP= 0.5 / 1.5 =0.33

WHO_DDD_UNIT G G

DPP 5 0.33

SECTOR PUB PUB CONSUMPTION DATA


Consumption data are available only for
2017 TOTAL_PACKAGES the Public sector, stratified by hospital and
community, for the year 2017 and 2018
2017 COMMUNITY_
7000 7000
PACKAGES

2017 HOSPITAL_
8500 8500
PACKAGES

2018 TOTAL_PACKAGES

2018 COMMUNITY_
8170 8170
PACKAGES

2018 HOSPITAL_
9670 9670
PACKAGES

27
GLASS-AMC Excel template

SECTION

03

29
GLASS Manual on the management of antimicrobial consumption data

3. GLASS-AMC Excel template

WHO provides an Excel file for collecting AMC data on • automatically calculate and export data consumptions;
the eight antimicrobial categories targeted by the GLASS- and
AMC surveillance system. The tool is updated every
• automatically generate the WHO GLASS-AMC file.
year, to account for the latest version of the ATC/DDD
classification. This section first describes the structure of the template
and explains how to fill in various worksheets. It then
To ensure that you are using the latest version of the
explains how to use the macros to validate the data, to
GLASS-AMC data consumption template, verify the year in
calculate and export consumption data, and to generate
the top-left corner of the “Macro” worksheet, as shown in
the WHO GLASS-AMC file.
the illustration below.
Countries can use one WHO–AMC Excel template to 3.1. Introduction to the tool
collect AMC data from one year or several years, stratified
(or not) by health sectors and levels (public versus private, The Excel template for data collection has 13 worksheets.
and community versus hospital). “Macro” is the worksheet from which users can launch
the routines (macros) embedded in the template. To allow
With the GLASS-AMC Excel template, the user can: the system to calculate and export consumption data,
• systematically collect: users need to fill in three worksheets: “Product data”,
“Data availability” and “Population data”. The remaining
• MPP information and consumption data at product
worksheets (ATC, DDD, DDD Combination, Conversion,
level;
Units, RoAs [Routes of administration] and Sector) are in
• information on the population under surveillance; read-only mode; they are used by the macros, and they
provide information and codes needed for compiling the
• automatically perform some data validation steps and
“Product data” worksheet. Table 3.1. describes the content
consumption calculations at package level;
of each of the worksheets.

30
GLASS-AMC Excel template

Table 3.1. Contents of the worksheets in the GLASS-AMC Excel file

WORKSHEET FUNCTION
1. Macro To run macros: Four macros are embedded, to assist in data checking and to automatically fill in some
of the product variables, to calculate and export consumption, and to export the data for a selected
year into the GLASS-AMC file.
2. Availability To be filled in: Here, users must indicate – for each category of antimicrobials (A07AA, D01BA, J01,
data J02, J04, J05, P01AB, N04BB) and health care sector (public, private, global) and level (hospital,
community, total) – whether AMC data are provided for a specific year. Information provided should
match with those provided in the “Product data” sheets and those provided in the “Population” sheet.
This information is used internally by the macro for calculating consumption and exporting data.
3. Population To be filled in: Here, users are asked to provide the population figure. Denominator figures can be
Data disaggregated by class of antimicrobials (A07AA, D01BA, J01, J02, J04, J05, P01AB, N04BB), health
care sector and level, if the population differs according to those factors. The information is used as
the denominator to calculate the number of Defined Daily Doses/1000 inhabitants/day (DID)
4. Product Data To be filled in: This is the key worksheet for the collection of information on the medicinal product
package (MPP) and the quantity of packages consumed stratified (or not) by health sector (global,
public or private) and health level (hospital versus community, and public versus private).
5. ATC Provides information to fill in product data: Provides the list of medicines being monitored by GLASS-
AMC, with ATC code and ATC level for each medicine. The ATC/DDD classification is revised every year.
Here, users can find the ATC5 codes to fill in the “ATC” variable.
6. DDD Provides information to fill in product data: Provides the DDD assigned by the WHO Collaborating
Centre with units of measurement (e.g. g, mg, MU) for the plain products targeted by GLASS-AMC. The
ATC/DDD classification is revised every year. Users can consult this worksheet to identify special cases
that apply to the plain antimicrobial substance contained in the MPP that would need special attention
when filling in the product data (e.g. association with salt or association with other substances).
7. DDD Provides information to fill in product data: Medicinal products containing two or more active
combination ingredients are considered as combinations in the ATC system, and they have a different ATC code
to the single components. When establishing DDDs for combination products, both components are
taken into consideration – DDDs are given on fixed doses, based on the proportion of the association
and the route of administration. This worksheet provides the list of DDDs for the combination
medicines targeted by GLASS-AMC. The list is extracted from this
list of DDDs for combination products: https://www.whocc.no/ddd/list_of_ddds_combined_products/
Here, users can retrieve the combination code “COMB_CODE”, which they need to fill in in the
“COMBINATION” variable.
8. Conversion Provides information to fill in product data: This is the table of conversion factors from millions of
international units (MU) to grams. If the mandatory variables are provided correctly, the system will
automatically fill in the CONV_FACTOR variable for the MPP, for which the strength is provided in MU
and the DDD in G/
9. Units Provides information to fill in product data: Provides the code to fill in the UNIT variables; also
describes each variable and notes to which variable each unit applies. Here, users can find the coded
values to correctly fill in the PACKSIZE_UNITE, STRENGTH_UNIT and INBASQ_UNIT variables.
10. Salts Provides information to fill in product data: The specification of salts is only required for methanamine
(hippurate or mandelate) and where erythromycin data relate to the ethylsuccinate salt. Here, users can
find the coded values to correctly fill in the SALT variable.
11. RoAs Provides information to fill in product data: Here, users can retrieve the code to correctly fill in the ROUTE_
ADMIN variable.
12. Sectors Provides information to fill in product data: Here, users can retrieve the code to correctly fill in the
SECTOR variable.
13. Origins Provides information to fill in product data: Here, users can retrieve the code to correctly fill in the PRODUCT_
ORIGIN variable.

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GLASS Manual on the management of antimicrobial consumption data

3.2. Fill in the GLASS-AMC template 3.2.1. Enter availability data


This worksheet is designed to collect information on
This section uses a set of case studies to explain how to fill
the availability of consumption data for the 72 possible
in the GLASS-AMC template.
combinations (antimicrobial class – health care sector –
The case studies use AMC data from the years 2017 and health care level) by year of consumption.
2018 for country AAA. Data are only from the public sector
How to fill in the sheet
and are aggregated at the hospital and community levels.
The data reported include the three core GLASS-AMC The “Availability Data” worksheet, shown below, includes 72
antimicrobial classes; that is, antibacterials for systemic records that correspond to the 72 possible combinations.
use (J01), antibiotics for alimentary tract (A07AA) and The steps are:
nitroimidazole derivatives for protozoal diseases (P01AB). 1. 
Fill in the “COUNTRY” information for all 72 records
The population of country AAA is 13 million inhabitants. (using the relevant ISO 3166 alpha-3 country codes).
The use of the Excel tool can be split into five steps, 2. 
Indicate with a “YES” if consumption data have
summarized here and explained in detail below: been provided in the “Product data” sheet for the
1. Enter availability data. corresponding country, antimicrobial class, health care
sector, health care level and year. Indicate with a “NO” if
2. Enter population data.
consumption data have not been provided, or leave the
3. Compile product and consumption data. cell empty as this is considered to equate to NO.
4. Calculate and export consumption data. A set of years is proposed (i.e. from 2014 to 2019). However,
users can delete or add years as needed.
5. 
Export data into the format required for GLASS-AMC
submission for a given year.

12 See https://apps.who.int/gho/data/node.main.POP107?lang=en

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GLASS-AMC Excel template

3.2.2. Enter population data • SECTOR: health care sector to which the data refer
(GLO, PUB, PRI); and
This worksheet is designed to collect information on the
population to which the given consumption data apply, for • TOTAL, COMMUNITY, HOSPITAL: numeric integer
each antimicrobial class (A07AA, D01BA, J01, J02, J04, value of the population to which the AMC data refer.
J05, P01AB, N04BB), health care sector (GLOBAL, PUBLIC, How to fill in the sheet
PRIVATE) and level (TOTAL, COMMUNITY, HOSPITAL).
The information is used as the denominator to calculate As shown in the illustration below, the population data
the number of DDD/1000 inhabitants per day (i.e. the DID). worksheet initially presents as empty. Users are requested
to fill in all the variables for each “YEAR”. In cases where
WHO has standardized population estimates for all the population is the same across each “ANTIMICROBIAL
Member States, and the WHO estimate is the default value CLASS” and health “SECTOR”, these fields can be left
used for calculations. However, a country can use its own empty and the population provided will automatically
national population estimates if the WHO estimate is be applied to each available class. If consumption data
thought to be incorrect. National population estimates are are provided separately by hospital and community but
available from the WHO Global Observatory.12 the population targeted by the surveillance is the same,
The variables to be entered are: population size only needs to be reported once using the
“TOTAL” data field.
• COUNTRY: ISO 3166 alpha-3 country codes;
• YEAR: 4 digits for the YEAR;
• ANTIMICROBIAL CLASS: ATC code of the core and
optional antimicrobial classes targeted by GLASS-AMC
(J01, A07AA, P01AB, J02, D01BA, J05, J04A, P01B);

33
GLASS Manual on the management of antimicrobial consumption data

The three case studies below show how the data would differ the three regions where half of the country population live.
depending on where country AAA collects AMC data from. In this case, the population needs to be reported separately
for the private and the public sector using the “TOTAL” field.
Case study 1: In this example, country AAA collects AMC
data only from the public sector. Those data are reported Case study 3: In this example, country AAA collects AMC
separately for community and hospital. However, since the data without distinguishing between the public and private
population to which the data apply is the same, it is reported sector, but does separate community and hospital data.
only once using the “TOTAL” field. The surveillance of the hospitals covers only the three
regions where half of the population of the country lives.
Case study 2: In this example, country AAA collects AMC
In this case, the sector must be set as “GLOBAL” and the
data separately for the public and private sector, whereas
population must be provided separately for community
data for community and hospital use are combined.
and hospital.
However, AMC surveillance for the private sector targets only

34
GLASS-AMC Excel template

3.2.3. Compile product and consumption data data” worksheet and the macro “Validate Products”. The
process involves two steps, as shown below.
Two components of the worksheet allow the user to enter
and automatically compile and validate product and Step 1. Compile product information (mandatory and
consumption data; these components are the “Product optional) and consumption information.

35
GLASS Manual on the management of antimicrobial consumption data

Step 2. Assign calculated variables and validate product” The “Product data” worksheet collects products information
– use the “Validate products” routine to assign calculated and consumption data. It includes all the information
variables and validate the data, then correct the data detailed in Sections 2.4.1 and 2.4.2 plus two variables,
following ”STATUS MESSAGES” and again run the “Validate “Status” and “Status Message”, which report the results
products” routine. of the validation process used when running the “Validate
Products” macro. Table 3.2 shows the grouping of variables
in the product data worksheet.

36
GLASS-AMC Excel template

Table 3.2 Grouping of variables in the product data worksheet

VALIDATION STATUS, STATUS MESSAGES


OUTPUT Two variables are automatically populated when the macro “Validate Products” is run. They provide
the overall result of the validation check (ok, error, info), and the details of the error or errors
identified, to help the user to identify and correct them. More information is given in Section 3.4.2.
PRODUCT COUNTRY, PRODUCT_ID, LABEL, PACKSIZE, PACKSIZE_UNIT, ROUTE_ADMIN, STRENGTH,
INFORMATION STRENGTH_UNIT, INBASQ, INBASQ_UNIT, ATC5, SALT, COMBINATION
MANDATORY This information is needed to correctly assign the ATC5 level code, the route of administration and
the quantity of active substance present in the package for calculation of the DDD.
PRODUCT PAEDIATRICS_PRODUCT, FORM, PRODUCT_NAME, INGREDIENTS, PRODUCT_ORIGIN,
INFORMATION MANUFACTURER_COUNTRY, MANUFACTURER
OPTIONAL GENERIC, YEAR_AUTHORIZATION, YEAR_WITHDRAWAL
This additional product information can help in validating the data and interpreting consumption
figures (e.g. drop in consumption of a specific product because it has been withdrawn or increase
because it has been approved in the country).
PRODUCT CONV_FACTOR, PACKCONTENT, PACKCONTENT_UNIT, ARS, WHO_DDD, WHO_DDD_UNIT, PDD
INFORMATION This product information will automatically be populated when the macro “Validate Products” is run.
AUTOMATICALLY It allows the user to obtain the DDD by MPP unit, which, when multiplied by the number of packages,
CALCULATED provides the total DDD consumed for the specific MPP.
Note: Where inconsistency is identified, or an ATC code or DDD have not yet been assigned for a
product, these fields should be left empty (otherwise, the overall process will be affected).
CONSUMPTION SECTOR, TOTAL_PACKAGES, COMMUNITY_PACKAGES, HOSPITAL_PACKAGES
INFORMATION Here, users need to provide the number of packages consumed for each MPP, stratified (or not) by
health care sector and level. The worksheet suggests some years, but keeping the same structure
users can add one or more extra years, or delete some of the proposed years.

37
GLASS Manual on the management of antimicrobial consumption data

3.2.4. Step 1 – Filling in product and The same MPPs described in Section 2.4.3 are used to fill
consumption variables in the worksheet (see that section for a full explanation on
how to fill in MPP information).
Countries can input the product data in two ways:
Product information mandatory
a) In cases where a country has already prepared a list of
MPPs with the “Product information mandatory” and 1. COUNTRY
“Product information optional” variables compiled to ISO 3166 alpha-3 country codes. In the example, the country
match the order and codes of the variables as requested is AAA.
by the GLASS-AMC template, users can simply copy and
paste the data here. 2. PRODUCT ID

b) In cases where a country needs to build their MPPs This should be a unique code that has been assigned to this
registry from scratch, users can employ the worksheet product. No unique code existed for MPPs in country AAA;
to do this. therefore, an arbitrary code that uniquely identifies the MPP
is assigned.

38
GLASS-AMC Excel template

3. LABEL
This is label information as written on the package; for
example, product name, strength and number of tablets,
capsules or millilitres in the package. The label is an
important variable because it is the only mandatory variable
that allows an external reviewer to cross check the MPPs.
4. PACKSIZE and
5. PACKSIZE_UNIT
These variables contain information on the number of
tablets, pills or vials – that is, pieces (PCS) or millilitres
(ML) – contained in one package.
The information is used to calculate the PACKCONTENT
variable.
Note: The worksheet “Units” provides the codes for the
PACKSIZE_UNIT.
6. ROUTE_ADMIN
The route of administration needs to be correctly filled in
because it allows the user to select the correct ATC5 and
automatically assign the DDD.
Note: The worksheet “RoAs” provides the codes for the
ROUTE_ADMIN.

7. STRENGTH and
8. STRENGTH_UNIT
9. INBASQ and
10. INBASQ_UNIT
These variables collect the information to calculate the
strength of the substance or substances for each item
(e.g. tablet, vial, ampullas, sachets or mL) contained in the
MPP. INBASQ is the denominator of the strength in the
case of an oral solution. The strength is multiplied by the
PACKSIZE to automatically calculate the PACKCONTENT
and PACKCONTENT_UNIT variables.
Note: The worksheet “Units” provides the codes for the UNITS.

39
GLASS Manual on the management of antimicrobial consumption data

Specific substances used in combination with others Note: The worksheet “DDD combination” is where users can
For some specific substances used in combination with consult the DDD combinations list to identify the fixed dose
others (e.g. antimicrobials and enzyme inhibitor), only the (here called SUBSTANCES) and the “ROUTE” corresponding
antimicrobial substance needs to be considered. to the MPP, and assign the strength (and COMBINATION, as
explained below). This situation is illustrated below for MPP
Note: The worksheet “DDD” is where, after having P6 and MPP P7.
identified the ATC5 codes, users can verify whether the
antimicrobial substances fall into the specific case A. This • MPP P6: Bactrim Film coated tablets 400 mg/80 mg:
situation is specified under “NOTES” and is illustrated 1 UD
below for MPP P3. In the “DDD combination” worksheet, the fixed dose for
• MPP P3: Amoxiclav IV 1,2 gr 1 vial: 1 G “Oral (O) sulfamethoxazole 0.4 g/trimethoprim 80 mg”
that corresponds to the content of each tablet has a
Each vial contains amoxicillin 1 g and clavulanate 0.2 strength of 1 UD.
g (ATC5 J01CR02). For the strength, we must refer
only to amoxicillin, as indicated under “NOTES”. • MPP P7: Bactrim Film coated tablets 800 mg/160 mg:
2 UD
Products with multiple antimicrobial substances
This is the same fixed doses as the previous example,
For products with multiple antimicrobial substances, but each tablet contains twice the fixed dose, so the
DDDs are given in fixed doses, based on the proportion strength is 2 UD.
of the association of the substances and on the route of
administration. The strength is reported as number of UD of
the corresponding fixed dose.

40
GLASS-AMC Excel template

Oral solutions
For an oral solution, the strength corresponds to the
substance contained in the defined basic ingredient
quantity (INBASQ). In such cases, it is mandatory to
provide the information on the INBASQ and on INBASQ_
UNIT (which is always ML). This situation is illustrated
below for MPP P2 and MPP P8.
• MPP P2: Amoxicor 250 mg/5 ml: 250 MG 5 ML
• MPP P8: Bactrim 200 mg,40 mg/5 ml: 1 UD 5 ML
Worksheet “ATC”: here users can find the complete
11. ATC5 list of ATC codes for the GLASS-AMC core and optional
12. SALT antimicrobials.
13. COMBINATION Special case: antimicrobials substances with multiple ATCs.
These variables collect information to correctly classify the • MPP P9: VANCOCIN, capsule 250 mg, 20 pc: A07AA09
antimicrobial substance or substances included in the MPP • MPP P10: VANCOMYCIN VIAL DRY INF 1 G: J01XA01
and, in combination with the ROUTE_ADMIN, allow the user
to automatically assign numerical values to the following There are two options in the “ATC” worksheet for
variables: CONV_FACTOR, ARS, DDD and DDD_UNIT. vancomycin:

ATC5 • A07AA09: an alimentary tract and metabolism


antibiotic for oral administration. This corresponds
ATC5 is the WHO ATC code at substance level (ATC5-level). to the MPP P9.
A substance can be given more than one ATC code if it is
available in different strengths or routes of administration • J01XA01: antibiotic for systemic use, for parenteral
with clearly different therapeutic uses (e.g. vancomycin administration, corresponding to MPP P10.
and metronidazole).

41
GLASS Manual on the management of antimicrobial consumption data

Salt
Salt is the code of the salt associated with the antimicrobials;
it applies only for:
• J01FA01: erythromycin ethylsuccinate
• J01XX05: methenamine hippurate, mandelate
Worksheet “SALT”: Here, SALT codes are available
Worksheet “DDD”: Here, under “NOTES”, the worksheet
states whether the salt needs to be considered, as shown
below for hippurin. Worksheet “DDD combination”: Here, users can find the
“COMB_CODE” for the fixed doses of the GLASS-AMC core
• HIPPURIN 1 GR 28 FILM TABLET: J01XX05, HIPP and optional antimicrobials. This situation is illustrated
Contains methenamine hippurate, ATC5 code J01XX05. below for MPP P6 and MPP P8.
In the DDD worksheet, the DDD changes according to • MPP P6: Bactrim Film coated tablets 400 mg/80 mg:
the salt. We need to fill in HIPP as the SALT variable. J01EE01_3

Combination In the “DDD combination” worksheet, fixed dose for


“Oral (O) sulfamethoxazole 0.4 g/ trimethoprim 80
Combination is the code of the combined product mg” that corresponds to “COMB_CODE” J01EE01_3
(“COMBE_CODE”) from the “DDD combination” sheet.
• MPP P8: BACTRIM, 200 mg/40 mg per 5 mL oral, 80
For combinations, DDDs are given on fixed doses, based mL syrup: J01EE01_2
on the proportion of the substances and on the route of
administration. This combination corresponds to the fixed dose
corresponding to “COMB_CODE” J01EE01_2

42
GLASS-AMC Excel template

Product optional variables 19. MANUFACTURER_COUNTRY


14. PAEDIATRIC_PRODUCT This is the three-letter ISO code that uniquely identifies
This variable describes whether the MPP is a paediatric the country of manufacturing. It may provide interesting
medicine product (YES) or not (NO). information on the dynamic of AMC in the country.

15. FORM 20. MARKET_AUTH_HOLDER

This variable describes the pharmaceutical formulation This variable is the company owning the market authorization
type. It is a free text field, but countries may want to for the specific MPP.
standardize these fields by grouping different forms. 21. GENERICS
16. PRODUCT_NAME This variable collects information on whether the MPP is a
This text variable usually contains the brand name and generic product. It is a coded variable where the accepted
strength. For combination products, the strength is usually values are YES or NO.
the addition of the individual ingredients (e.g. Fleming 457 for 22. YEAR_AUTHORIZATION
amoxicillin sodium 400 mg; clavulanate potassium 57 mg).
This variable is the year of authorization of the product in the
17. INGREDIENTS market. It is four-digit integer.
This variable names the ingredients in the MPP. The INN 23. YEAR_WITHDRAWAL
name should be used, and for combination products the INN
This variable is the year of withdrawal of the product from the
names should be separated by a semicolon (e.g. amoxicillin;
market (if applicable). It is four-digit integer. This variable refers
clavulanic acid).
ONLY to the FINAL withdrawal; temporary withdrawal MUST
18. PRODUCT_ORIGIN NOT be reported here.
This is a coded variable, where the source of the product can
assume the following values: import (IMP), donation (DON) or
locally produced (LOC).

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GLASS Manual on the management of antimicrobial consumption data

AMC variables In the case study, Country AAA provides AMC data only
24. SECTOR for the public sector, and separated at community and
hospital level for the years 2017 and 2018.
This variable refers to the health care sector AMC data
apply. It is a coded variable, where the accepted codes are Note: Users can add or delete the AMC reporting year,
public (PUB), private (PRI) or global (GLO) (private + public). provided that the TOTAL_PACKAGE, COMMUNITY_
PACKAGE and HOSPITAL_PACKAGE structure is
Note: The worksheet “Sector” provides the coded values maintained, as shown below.
to fill in this variable.
Once all the mandatory and optional product information
25. YEAR_TOTAL_PACKAGES and the consumption information have been filled in, the
26. YEAR_COMMUNITY_PACKAGES “Product data” worksheet would appear as shown below
(the worksheet has been split into three pieces to fit onto
27. YEAR_HOSPITAL_PACKAGES the page). Note that all the cells where the information is
Consumption is expressed as the total number of packages automatically calculated are currently empty.
for each MPP that are imported, sold or dispensed during
one specific year in total care, in the community, or in the
hospital.

44
GLASS-AMC Excel template

45
GLASS Manual on the management of antimicrobial consumption data

3.2.5 Step 2 – Assign calculated variables, and valid combination code), but there is no DDD
and validate and correct product associated with the inputted data;
information – ERROR: if errors (e.g. invalid codes or missing data)
are found – depending on the error, all or part of the
This process includes the following steps:
information automatically calculated may not be
1. Run the “Validate products” routine in the “Macro” compiled and the PDD will be 0 or missing; and
worksheet – the STATUS will change into “Parsed and
• STATUS MESSAGES: provide useful information to
validated”.
identify and correct errors.
2. Go back to the “Product data” and check the status
Note: A status of “ERROR” or “INFO” will not block the
of the Product information, it should have been
Excel macros that calculate consumption and generate
calculated automatically (if this has not happened,
export data. However, no calculation will be performed on
correct the provided information).
the specific product.
3. Go back to the “Macro” worksheet and again run the
Note: If a product has no ATC code or DDD because these
“Validate products” routine.
have not yet been assigned to the specific antimicrobial,
The process can be repeated until the user considers that the raised error is not actually an error, it is simply a flag
the data has been fully validated and is of good quality. that no ATC/DDD has been assigned. The user must keep
the record (i.e. the line) in the list because an ATC/DDD may
The “Validate products” routine is as follows:
be assigned in later years, making it possible to assess the
• Parse the provided product variables and fill in the consumption of these MPP retrospectively.
product information automatically calculated (CONV_
Note: The macro function only checks for logical
FACTOR, PACKCONTENT, PACKCONTENT_UNIT,
inconsistencies (e.g. typos in coded variables, missing
ARS, WHO_DDD, WHO_DDD_UNIT, PDD).
information, or inclusion of ATC codes and route of
• Validate the logic and the correctness of the data administrations and salts that do not exist, and missing
provided, and provide feedback on the output of the correspondence among variables). Other errors may not
validation STATUS and STATUS MESSAGES: be detected; for example, pack size wrongly assigned,
• STATUS: wrong strength or strength unit (e.g. MG instead of G, MU
instead of IU), or wrong ATC5 code assigned. It is therefore
– OK: no inconsistency detected; important to also manually check for common mistakes,
– INFO: When all data inputted are correct (e.g. valid crosschecking the value assigned to the variables with the
ATC code, valid route of administration, valid salt information provided in the “LABEL”.

46
GLASS-AMC Excel template

The image below shows the previous “Product data” for example:
worksheet, after running the “Validate products”. The
• P2: the ATC5 of ampicillin was entered instead of that
worksheet includes various errors. Red squares signal
of amoxicillin;
inconsistencies that the system can detect (in the image
below, the expanded window showing the error message • P3: oral administration was entered instead of
variables gives an idea of the information provided by the parenteral, and the strength was entered as 1.2 G
system). Only a human process of data validation can instead of 1 G; and
address the inconsistency issues that the system cannot • P9: a pack size of 30 PCS was entered instead of 20,
detect (shown by the blue squares in the image below); and the strength was in G instead of MG.

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GLASS Manual on the management of antimicrobial consumption data

Users should go line by line through the worksheet and Note: even if errors remain for a few MPPs, the GLASS-
correct each error. Once all the mistakes have been AMC template will still calculate and export consumption
corrected, users should again run the “Validate product” for all the MPPs for which no error has been detected.
macro. Remember that not all errors are real errors (e.g.
Note: It is possible that there is no ATC code available or
where the ATC/DDD has not yet been assigned), so it is
there is no DDD assigned for product. In this case, users
possible to finalize the validation process and still have
should contact the GLASS-AMC team.13
errors flagged.
The image below shows how the “Product data” worksheet
appears once it has been filled in and validated, and no
errors have been detected.

13 The team can be contacted by email at glass-amc@who.int

48
GLASS-AMC Excel template

3.3. Calculate and export consumption


data
Once the data have been validated, users can run the
“Calculate consumption” and “Export consumption”
macros to generate consumption estimates in the DDD,
DID and export consumption worksheets.
Even if the data have been validated, users should always
run the macro functions in the following order:
1. Validate products If this happens, users need to:
2. Calculate consumption 1. Correct the data in the “Availability data” or in the
3. Export consumption “Population data” to ensure correspondence between
the information provided in the two worksheets.
The “Calculate consumption” macro performs all the
calculations in the background, so nothing will change in 2. Re-run the “Validate products” macro.
the “Product data” sheet itself. 3. Run the “Calculate consumption” macro.
Note: If a correspondence between “Population data” and If no inconsistencies are found, the consumption metrics
“Data availability data” is missing, the system will flag it are calculated and the “Status” will appear as “Consumption
with a message like the one in the image above. calculated”, as shown in the image below.

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GLASS Manual on the management of antimicrobial consumption data

The “Export consumption” macro generates two workbooks “Availability data” and “Population data” worksheets)
with the consumption estimates. has its own sheet.
• The first workbook (“Book 1”) contains the consumption • The second workbook (“Book 2”) contains the
estimates in DDD and DID at the substance level consumption estimates in DDD and number of packages
(ATC5), stratified by health care sector and level and (PKG) at the MPP level. In this workbook, all the products
by route of administration. Each of the ATC3 classes are provided in one sheet.
reported (according to the information provided in the
User can save these two files for future use (see Section 4).

”Book 1”: ”Book 2”:


1 ATC3 group per sheet Aggregated at ATC5 All ATC groups on one sheet at product level
substance level

50
GLASS-AMC Excel template

3.4. Export data for WHO GLASS-AMC 2. Calculate consumption


submission 3. Export for WHO GLASS-AMC submission
When clicking on the “Export for WHO GLASS-AMC
The export function generates a workbook with product submission” button, a box will open where users need to
and consumption data for one calendar year, in line with indicate the year of the data they want to export.
the format and file type required for submission to the
AMC module of the GLASS IT platform. A one-sheet file with tab-separated values (TSV) will be
generated, containing the product information (optional
Even if the data were previously validated and consumption and mandatory) and the consumption information for the
was calculated, users always need to run the macro specified year, organized as requested by the GLASS-AMC
functions in the following order: module of the GLASS-IT platform. The user should save
1. Validate products this file, making sure to not change the file type, which will
be “.tsv”.

51
GLASS-AMC Excel template

SECTION

04

53
GLASS Manual on the management of antimicrobial consumption data

4. AMC data analysis using


the exported AMC Excel files

This section explains how to use the workbooks produced depending on the user’s preferences. Thus, users can
by the GLASS-AMC Excel template (“Book 1” or “Book 2”, or employ some or all of the steps described in this manual.
both) to calculate and visualize the following AMC indicators:
4.1. Prepare the data analysis file
• quantity of antibiotics as DID for total consumption
and by pharmacological subgroup (ATC3 level) – DID In this step, the user will prepare a so-called “data analysis
= ( Total DDD x 1000) / (Population x 365); file”, to generate figures and tables. The data analysis file
• relative consumption of antibiotics as a percentage should include at least the following variables:
of total consumption by route of administration (oral, • Sector
parenteral, rectal or inhaled); and
• ATC5 code
• list of the most frequently used antibiotic substances
comprising the top 10 consumed antibiotics and • ATC3 class
75% and 90% of the total consumption (i.e. DU75 and • Substance name
DU90), stratified by route of administration.
• Route of administration
There are many ways of managing data and summarizing
the results in Excel. This manual demonstrates one way, but • Year
there are other possibilities that may be as or more efficient, • DID (or DDD)

54
AMC data analysis using the exported AMC Excel files

4.1.1. Select a workbook Here, we choose to use “Book 1” and DID estimates
because this metric accounts for the population size and
1. “Book 1” provides DDD and DID estimates aggregated
is the final metric that we are interested in.
at the ATC5 substance level, and by health care sector
and administration route. Data are split over different If there is a suspicion that the population to be used as
worksheets, with each one providing DDD or DID denominator differs from the population used to fill in the
estimates for each of the reported antimicrobials. GLASS-AMC Excel template, it may be better to generate
DID from the DDD estimates in the data analysis file.
2. “Book 2” provides DDD and number of packages by
MPP and by health care sector and administration
route for each year of data. These data are provided in
a single worksheet.

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GLASS Manual on the management of antimicrobial consumption data

4.1.2. Combine the data for the different The user should delete the repeated titles and the empty
antimicrobial classes and years variables, and reshape the database to allow the data to
be analysed by year. This is achieved by piling-up DID
“Book 1” provides consumption estimates in different
data from 2017 and 2018, creating the “YEAR” variable
sheets for the different classes of antimicrobials
and renaming the piled-up variable “DID”, as shown in the
reported. Users can create a new sheet with the data
image below.
from the different classes of antimicrobials included in
the surveillance. In the example below, the new sheet is
named “DID_all” – it includes all substances belonging to
A07AA, J01 and P01AB (antibacterials).

56
AMC data analysis using the exported AMC Excel files

4.1.3. Create ATC3 variable 1. Name the new variable ATC3.


To be able to analyse consumption data at the ATC3 level, 2. Use the LEFT function (by typing = LEFT) and select
we need to create a new variable for the ATC3 class for the ATC5 code.
each substance. To do this, we extract the first four digits
3. Take the first four characters (as shown in the example
from the ATC5 variable using the LEFT function in the
below).
Excel sheet:
4. Pull down the cursor to repeat the formula for all rows.

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GLASS Manual on the management of antimicrobial consumption data

4.1.4. Create a substance variable To better understand what the VLOOKUP function does,
more details can be found online or through the “Help”
The next step is to create a new variable containing the
section of Excel. Substeps 1–12, given below, explain how
substance name for each ATC5 code, using the VLOOKUP
to use that function.
function in the Excel sheet. That function helps to match
the ATC5 code to the correct ATC name. The INN name can 1. Make a copy of the ATC worksheet and add it to the
be retrieved from the ATC worksheet of the GLASS-AMC data analysis sheet “Book 1”, as shown in the example
Excel template. below.

GLASS-AMC excel template

Book 1

58
AMC data analysis using the exported AMC Excel files

2. Name the new variable SUBSTANCE. 5. Go to the ATC sheet and highlight all the text in the
sheet. The function automatically fills out the cells for
3. Use the VLOOKUP function by typing =VLOOKUP.
which the function should search for the particular
4. Select the ATC5 code and type “;” or “,” depending on ATC5 code.
your version of Excel.

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GLASS Manual on the management of antimicrobial consumption data

6. Type “;” or “,” depending on your version of Excel, type 7. To ensure that the range of cells for which the
“2” for the column number (since this is the column function searches for the matching ATC5 code does
with the value that we want to retrieve), type “;” or “,” not change when you repeat the function across the
and select or type “FALSE” for a direct match. Press rows, fix the range by adding $ in front of the cell
“ENTER”. You will be taken back to the sheet with your letters and numbers as shown in the image below
consumption estimates (“DID_all”) and the name of (underlined in red).
the substance that matches with the ATC5 code will
8. Pull down the cursor to repeat the formula for all rows.
automatically be filled in on the Excel template.

60
AMC data analysis using the exported AMC Excel files

To create the variable pharmaceutical substance, complete 11. Automatically, the first element of the formula will
substeps 9–12: change from B2 to C2 while the remaining part will
stay the same because you have used the “$” to block
9. Name the new variable PHARMACEUTICAL SUBSTANCE.
the cells delimiting the ATC range of data.
10. Repeat the VLOOKUP formula by dragging the cursor
12. Pull the cursor down to repeat the formula for all rows.
to the cell on the right.

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GLASS Manual on the management of antimicrobial consumption data

4.2. Generate tables and figures DID = ( Total DDD x 1000) / (Population x 365)
The population of country AAA in 2017 and 2018 was 100
The data analysis file now contains eight variables 981 437.
(SECTOR, ATC5, ATC3, SUBSTANCE, PHARMACEUTICAL
SUBSTANCE, ROUTE, YEAR and DID) and is ready for 1. Name the new variable DID.
analysis. 2. Create the function by typing =(H2*1000)/
Consumption data can be demonstrated in many different (100981437*365).
ways. This manual explains how to generate some of the 3. Pull down the cursor to repeat the formula for all rows.
most common results and tables and figures; showing
how to: 4.2.2. Present total AMC by year
• calculate DID from DDD; Next, we will use the “SUM” function to add up all DIDs
across the ATC5 groups for the years 2017 and 2018, as
• present total AMC by year; follows:
• present relative AMC in DID by pharmacological 1. Place the cursor in an empty cell and write the name
subgroup (ATC3) by year; of the indicator: DID_2017. In the cell below type
• present relative AMC by route of administration by year; “DID_2018”.
• list the top 10 most used antibiotic substances or 2. Go in the cell next to “DID_2017” and use the SUM
DU75/DU90 by route of administration and by year. function by typing “=SUM(“.

4.2.1. Calculate DID from DDD 3. Enter the range of the data to sum up. For 2017,
the range goes from H2 to H79 to give: DID_2017
In the dataset we prepared in Section 4.1., we used the =SUM(H2:H79).
DID estimates calculated by the GLASS-AMC template. In
this example the DDD is provided, and we will calculate 4. Use the same formula to calculate the sum for 2018
the DID for each substance using this formula: (from H80 to H157): DID_2018 =SUM(H80:H157).

62
AMC data analysis using the exported AMC Excel files

4.2.3. Present relative AMC in DID by ATC3 and year 2. Click on “PivotTable”. A dialogue box will open where
you need to:
The next step is to produce a summary table and
corresponding bar chart, where DID is shown by ATC3 a. Specify the table or range of your data: the system can
class and surveillance year. One of the quickest ways to propose the range or users can select the range of
collapse and summarize ATC5 substances into ATC3 preference.
classes is through a pivot table:
b. State where you want the pivot table to be displayed.
1. From the Insert tab on the toolbar at the top of Excel, In this case, select in a “New worksheet”.
select “PivotTable”, which is located under “Tables” in
c. Click “OK”.
the left-hand corner.

63
GLASS Manual on the management of antimicrobial consumption data

3. A new worksheet opens with an empty pivot table on 4. In the PivotTable fields, add the variable “ATC3” under
the left and the menu to compile the table on the right. “ROWS”, the variable “YEAR” under “COLUMNS” and
Rename the worksheet “Pivot DID”. the variable “DID” under “VALUES”. Ensure that the
option “Sum of DID” is selected.

Menu to build-up the table

Empty pivot table

64
AMC data analysis using the exported AMC Excel files

5. Create a figure from the pivot table. Several tutorials d. The system will automatically propose the figure
are available online showing how to create and modify shown below.
figures created in Excel. In the image below, the figure
It is possible to modify the figure; for example:
was created directly from the pivot table using the
following steps: a. 
Sort the antimicrobials from the largest number
consumed for the 2018 list.
a. Select “Row Labels” for the 2017 and 2018 columns
(avoiding selecting the totals). b. Insert an axis title (in this case an appropriate Y-axis
title would be “DDD/1000 inhabitants/day”).
b. Click on Insert.
c. Provide the title.
c. Select column 2D, the “Cluster” column.

65
GLASS Manual on the management of antimicrobial consumption data

4.2.4. Present relative AMC by route of 2. Select “Row Labels” for the 2017 and 2018 columns
administration (avoid selecting the totals).
1. Use the pivot table to create a table summarizing 3. Click on Insert.
AMC by route of administration for the year 2018. 4. Select column 2D, the “Cluster” column.
In the PivotTable Fields sidebar, add the variable
“YEAR” under “FILTERS” and select 2018, then add 5. The system will automatically propose the figure shown
the variable “ROUTE” under “ROWS”, and the variable below.
“DID” under “VALUES”. Ensure that the option “Sum of 6. Modify the figure, as appropriate.
DID” is selected.

66
AMC data analysis using the exported AMC Excel files

4.2.5. List the top 10 most used antibiotic substances 1. Create a pivot table summarizing AMC by substance and
or DU75/DU90 by route of administration and by year route of administration for the year 2018. In the PivotTable
Fields sidebar, add the variables “YEAR” and “ROUTE”
These tables demonstrate the most commonly used
under “FILTERS” and select 2018 and O, add the variable
antibiotic substances at the ATC5 level. As discussed
“SUBSTANCE” under “ROWS” and “DID” under “VALUES”.
earlier, DU75 ranks the antibiotic substances that make
Ensure that the option “Sum of DID” is selected.
up to 75% of the consumption and DU90 contains
the antibiotic substances that make up to 90% of the 2. Place the cursor on the “Sum of DID” cell and right
consumption. click, then select “Show values as”, and select “% of
column total”.

67
GLASS Manual on the management of antimicrobial consumption data

3. We now have a table where DID is summarized as • the cumulative percentage for the first substance
percentage over the total amount of DID consumed for on the list is equal to the “PERCENTAGE”;
the antimicrobials for oral use in 2018.
• the cumulative percentage for the next
4. The pivot table automatically orders the data in antimicrobials is to the cumulative percentage of
alphabetic order, based on the “Row Label” value. a substance, with the percentage of the substance
next in order.
5. The next step is to order the substances by “Sum of
DID”, from the largest to the smallest. Pull down the cursor to repeat the formula for all rows.
The cumulative percentage across all the substances
6. Next, create a new variable (e.g. called “CUMULATIVE
for a given route of administration should add up to
PERCENTAGE”) that adds up the percentages across
100.
the ATC5 substances by route of administration. As
shown in the illustration:

68
AMC data analysis using the exported AMC Excel files

7. We now have a table with antibiotic substances for 8. Changing the “Route” filter from “Oral” to “Parenteral”
oral administration ranked according to their 2018 provides a table with antibiotic substance for
consumption, in descending order. The results for parenteral administration ranked according to their
DU75 and DU90 are shown below. 2018 consumption in descending order. The results
for DU75 and DU90 are shown below.

DU75

DU90

DU75

DU90

69
SECTION

05
GLASS Manual on the management of antimicrobial consumption data

5. Conclusion

This manual provides detailed instructions on how to use the GLASS-AMC


Microsoft Excel template to prepare national AMC surveillance data according to
the WHO methodology. It also explains how to use these data to generate some
of the most common metrics and indicators for national AMC data analysis.
This type of information is valuable for countries to understand their patterns of
AMC and to identify areas for improvement. As an illustration, WHO’s first global
report on surveillance of AMC consumption provides information on the AMC
data collected during the WHO early implementation phase in 2016–2018.14
Finally, it is important to share these data with health professionals for further
analysis, scientific interpretation and actions to guide countries and WHO to
better use of antimicrobials.

14 W
 HO report on surveillance of antibiotic consumption: 2016–2018 early implementation
Geneva: World Health Organization; 2018 (https://www.who.int/medicines/areas/rational_
use/oms-amr-amc-report-2016-2018/en/).

72
World Health Organization ISBN 978-92-4-001019-2
20 avenue Appia
1211 Geneva 72 - Switzerland
https//www.who.int/health-topics/antimicrobial-resistance

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