AMC Tool User Manual

Arno Muller version 1.9 AMC Tool Manual

This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.

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Table of Contents Overall description...... 5 The WHO ATC/DDD index...... 5 User interface...... 6 The WHO ATC/DDD index and AMC Tool database window...... 6 The ATC classification page...... 6 The AMC Tool routes of administration page...... 7 The AMC Tool salts page...... 7 The ATC/DDD index for combined products page...... 7 The AMC Tool measurement units and conversion factors page...... 7 The AMC Tool internal database page...... 8 The consumption calculation component...... 8 The data entry page...... 8 The list of products...... 10 The product editor...... 10 Importing product data...... 11 Exporting product data...... 12 The DDD calculation results page...... 12 The DDD results...... 13 The denominator editor...... 13 Export of the DDD results...... 14 Data entry...... 14 The product record...... 14 Name of the product...... 14 Package Size...... 14 Strength...... 15 ATC substance...... 15 Route of administration...... 15 Salt...... 15 Combination...... 16 Manual data entry...... 16 Automatic data entry...... 16 AMC Tool standardised csv file for product data...... 17 Examples...... 18 Basic examples...... 18 Example 1...... 18 Manual data entry...... 18 Automated data entry...... 18 Example 2...... 18 Manual data entry...... 18 Automated data entry...... 19 Example 3...... 19 Manual data entry...... 19 Automated data entry...... 19

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Advanced examples...... 19 Example 4...... 19 Manual data entry...... 20 Automated data entry...... 20 Example 5...... 20 Manual data entry...... 20 Automated data entry...... 21 Example 6...... 21 Manual data entry...... 21 Automated data entry...... 21

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Overall description AMC Tool is programme designed for the calculation of antimicrobial consumption. It takes, as input, data expressed in number of packages and produces, as output, data expressed in Defined Daily Doses (DDD) at the substance level. The WHO ATC/DDD index The Anatomical Therapeutic Chemical (ATC) classification is a system to classify active medical substances according to defined standards. The active medical substances are divided into different groups according to the target organ or system and their therapeutic, pharmacological and chemical properties. The classification is organised following a hierarchical structure composed of 5 levels: 1. anatomical main group 2. therapeutic subgroup 3. pharmacological subgroup 4. chemical subgroup 5. chemical substance

The ATC classification has 14 anatomical main groups.

The Defined Daily Dose (DDD) is a unit of measurement for drug consumption. Importantly, the DDD is a technical unit and may not necessarily reflect the recommended or prescribed daily dose.

The DDD is the assumed average maintenance dose per day for a drug used for its main indication in adults.

The DDD is defined for active medical substance that have already been assigned an ATC. The DDD is defined by active substance and sometimes by active substance and route of administration or pharmaceutical form. Exceptionaly, the DDD is defined by active substance and associated salt.

The ATC/DDD system is a tool for drug utilization research in order to improve the quality of the use of medicines. The ATC/DDD system is a standard for international drug utilization research allowing exchanging and comparing data on use of medicines at international, national or local levels.

The ATC/DDD system is maintained by the WHO Collaborating Centre (CC) for Drug Statistics Methodology in Oslo, Norway (website: http://whocc.no).

The WHO CC releases every year a new version of the ATC/DDD system called the ATC/DDD index. Although the WHO CC aims at keeping the ATC/DDD system stable, it is updated every year. Thus it is important to report the version of the ATC/DDD index used when reporting figures on the use of medicines.

5 AMC Tool Manual User interface The interface of the programme is split into two main windows: • the ATC/DDD index window • the consumption calculation window The WHO ATC/DDD index and AMC Tool database window The window provides four types of information about: 1. the range of groups of the WHO ATC classification included in AMC Tool. AMC Tool does not cover all ATC groups. 2. the codes used by AMC Tool to represent the routes of administration, the salts and units of measurement. 3. the combined products included in AMC Toool. 4. the version of the internal database included in AMC Tool.

To select this window, click on the “WHO ATC/DDD” entry of the top menu.

The ATC classification page To access the ATC classification page, click on the “ATC classification” menu entry.

The page displays the range of ATC groups, subgroups and substances that are included in AMC Tool. AMC Tool includes the following ATC groups: • A07AA: Antibiotics as intestinal antiinfective • D01BA: Antifungals for systemic use • J01: Antibacterials for systemic use • J02A: Antimycotics for systemic use • J04: Antimycobacterials • J05: Antivirals for systemic use • P01AB: Nitroimidazole derivatives as antiparasitic products • P01B: Antimalarials

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Any other groups or substances not belonging to the previous list will be rejected by AMC Tool and the program will display an error message that the ATC code is not valid.

The AMC Tool routes of administration page To access the AMC Tool routes of administration page, click on the “Routes of administration” menu entry.

The page displays a list of routes of administration including their code, name and corresponding official ATC/DDD index codes if different.

During data entry, the user must use these AMC Tool codes otherwise the program will generate an error message that the route of administration is not valid.

The AMC Tool salts page To access the AMC Tool salts page, click on the “Salts” menu entry.

The page displays a list of salts included their code, name and corresponding ATC/DDD index codes. AMC Tool defines a list of salts and for each of them the corresponding ATC/DDD codes. During data entry, the user must use the AMC Tool codes otherwise the program will generate an error message that the salt is not valid. AMC Tool defines a default salt 'XXXX'. If no salt is provided during data entry, internally AMC Tool will affect the XXXX salt.

The ATC/DDD index for combined products page To access the DDDs for combined products, click on the “Combined products” menu entry.

The page displays the list of DDDs for combined proudcts defined by the WHO ATC/DDD CC. The WHO ATC/DDD CC, in addition to assigning DDD for single substances, also defines DDD for combined products. It maintains a list of DDD for a limited number of combined products (http://www.whocc.no/ddd/list_of_ddds_combined_products/). The AMC Tool programme has included these DDDs for combined products. In order to uniquely identify these DDDs for combined products, the program has assigned a unique code to each of the combined products, these codes are not official codes assigned by the WHO ATC/DDD CC.

The AMC Tool measurement units and conversion factors page To access the AMC Tool measurement units and conversion factor page, click on the “Measurement units and conversion factors” menu entry.

The page displays a list of measurement units and conversation factors used by AMC Tool.

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AMC Tool manages automatically calculation with different units of measurement, for instance, from gram to milligram.

The AMC Tool internal database page To access the AMC Tool internal database page, click on the “DB information” menu entry.

The page displays basic information about the internal database used by the program. AMC Tool stored the information about the ATC/DDD index and its own codes for route of administration and salt and measurement units into an internal database. The page provides information such as the version of the ATC/DDD index included in the program and the date the internal database was created.

The consumption calculation component This component provides the functionality for processing the antimicrobial consumption data. This component contains two pages: • the data entry page • the DDD results page

The data entry page To access the data entry page, click on the “Package data entry” entry.

The data entry page is split into two parts: • on the top the list of already entered package data • on the bottom, the editor for package data

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The list of products The list of products table displays the recorded products data as a table, one line corresponding to one product. It is possible to modify a product of the list by double clicking on it.

The product editor The bottom part of the page is the editor used to add a new product, to modify or delete a existing record. To add a new product, click on the “New button”, it will activate the fields of the editor. Fill in the different information and then click on the “Save” button. If there is no error, the new product will be added to the list of products in the top table. If any error occurred, a red asterisk will be displayed in front of the corresponding field. When no DDD exists for the combination of ATC substance, route of administration and salt, a message will be displayed that no DDD calculation will be performed, still AMC Tool will accept the product. In the table, in the column “DDD”, no DDD will be displayed for the product.

To modify or delete a recorded product, double click on the corresponding row in the table. The editor will be filled in with the data of the product. After the changes have been made, click on the “Save” button to save the changes. You can reset the product to its original data by clicking on the “Reset” button. To delete the product, click on the “Delete” button.

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Importing product data AMC Tool can import product data from a csv file. The csv file must be in the correct standardised format (see chapter on data entry).

Reading csv data To import the data, click on the File menu and select “Load package data (.csv)”.

A dialog will open asking for the file, the format of the csv file, either English (field separator ',' and decimal separator '.') or non-english (field separator ';' and decimal separator ','). Additionally, the dialog asks for if data previously entered either manually or imported should be kept or deleted before the new data are imported.

Data import During the import of the data, AMC Tool validates each row of the file. After that step, AMC Tool will display the result of the data import in a new panel. The panel displays on the top the name of the csv file and if any general error occurred (e.g. incorrect format...). In the centre, the results of each row is displayed as a table. The value for each column is displayed and in addition, the line number and the status of the row (OK: no error, INFO: useful information but no problem, ERROR: the row contains error). The corresponding cell is also highlighted and if the cursor is moved over the status cell, a tool tip explaining the issue is displayed. The result of the validation can be exported into a csv file by clicking on the “Export processing results” button. If no error occurred during the reading of the csv file, data can be imported by clicking on the “Record data” button. The DDD calculation results page is displayed with the imported data. You can go back to the data entry page to add new or modify existing records.

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Exporting product data AMC Tool can export product data in a csv file. The data are exported according to the standardised format (see chapter on data entry).

Writing csv data To export the data, click on the File menu and select “Save package data (.csv)”.

A dialog will open asking for the file, the format of the csv file, either English (field separator ',' and decimal separator '.') or non-english (field separator ';' and decimal separator ',').

The DDD calculation results page To access the DDD calculation results page, click on the “DDD results” entry.

The DDD calculation results page is split into two parts: • on the top the results of the DDD calculation by ATC groups and routes displayed as a tree. • on the bottom, the editor for denominator data

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The DDD results The DDD results are shown as a hierarchical tree based on the ATC/DDD index. To expand the nodes, click on the box in front of the ATC groups.

The denominator editor AMC Tool can manage two denominators: a number of bed-days (preferred indicator used in hospital settings) and a number of inhabitants per day (preferred indicator used in the community). To enter a denominator, select the type of denominator by clicking on the respective tab, either “Bed-days” or “Population”. For the “Bed-days” editor, it is possible to enter directly the number of bed-days in the corresponding field or to enter the number of beds, days and occupancy rate (between 0 and 1) and AMC Tool will calculate the number of bed-days. For the “Population” editor, it is possible to enter directly the number of inhabitants per day in the corresponding field or to enter the number of inhabitants and days and AMC Tool will calculate the number of inhabitants per day.

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When clicking on the “Apply denominator” button, AMC Tool will compute either DDD per 100 bed-days or DDD per 1000 inhabitants per day depending of the selected denominator.

Export of the DDD results To export the DDD results, click on the file menu and select the “Save DDD data” entry. Provide a filename to record the data and AMC Tool will save the data into the corresponding csv file. The newly created file can be open in any spreadsheet application.

Data entry Data entry consists in providing product data to AMC Tool. AMC Tool provides two means to provide product data. First, data can be entered manually using the product editor, second data can be recorded in a standardised csv file, AMC Tool can read this file and automatically populate the table of products with the file's data. The product record The product data contains the following field: • the name of the product • the package size of the product, either the number of items or of millilitres in one package • the strength, either as content of one item or concentration • the ATC substance • the route of administration • the associated salt (only relevant for erythromycin and methenamine as defined in the ATC/DDD index) • the combination code (only relevant for combined products with a DDD as defined in the ATC/DDD index) • the volume (number of packages used during the reporting period)

Name of the product The name of the product as free text.

Package Size The size of the product's package as measurement units. The package size can be expressed as item or millilitre.

The item (i) corresponds to one item in the package and could be one tablet, one capsule, one vial... For instance: • a box containing 10 tablets will be reported with a package size of 10i (10 items) • a box containing 1 vial will be reported with a package of 1i (1 item)

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The millilitre (ml) is used when the strength of a product is expressed as a concentration (e.g. g/ml). For instance: • a box containing 1 bottle of 60 ml and with a strength expressed as 75mg/5ml will be reported with a package size of 60ml (60 millilitres)

Strength The content of substance of one item when the package size is expressed in items or the concentration of substance when the package size is expressed in millilitres.

The strength as content can be expressed using two families of unit: • the gram, including gram (g) and milligram (mg) • the international unit, including international unit (IU) and millions of international units (MU). For instance: • a box of tablets with each individual tablet containing 1.5 g of active substance will be reported as 1.5g (1.5 gram) • a box of capsules with each individual capsules containing 3 MU will be reported as 3MU (3 millions of international units)

The strength as concentration uses the same units as as content for the numerator and the millilitre as unit for the denominator. For instance: • a bottle having a strength expressed as 75mg/5ml will be reported as 75mg/5ml • a bottle having a strength expressed as 100000IU/ml will be reported as 100000IU/1ml

ATC substance The ATC substance of the product. The ATC substance can be inputted either using the code or the name of the ATC sustance. AMC Tool can find the list of ATC substances when a subset of the code or name is given.

Route of administration The route of administration of the product. The route of administration can be inputted either using the code or name of the route.

Salt The salt of the product. In order to assign the correct DDD for erythromycin and methenamin, the salt has to be provided as the DDD is based on the salt.

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The salt field will be activited only when erythromycin or methenamin are selected with the corresponding route of administration. For all other substances, the salt should not be taken into account.

Combination The combination code of the product. In order to assign the correct DDD for combination products, the combination code should be provided as the DDD is based on the combination. The combination field will be activited only when the substance/ATC for a combination is selected with the corresponding route of administration.

Manual data entry Refer to the product editor paragraph of the user interface chapter.

Automatic data entry AMC Tool can read a standardised csv file containing product data and load the products (see table next page).

16 AMC Tool standardised csv file for product data The format of the csv file is derived from the structure of the product data.

Table 1: AMC Tool standardised csv product data format

Field Description Type Value Example PRODUCT_NAME Name of the product Text Free text PACK_SIZE_VALUE Value of the package size Number positive number If the package size is 5i, then report 5 PACK_SIZE_UNIT Unit of the package size Coded value list g, mg, IU, MU or ml If the package size is 5i, then report i STRENGTH_NUM_VALUE Value of strength as content or value of the Number positive number If the strength is 2g, then report 2 numerator as concentration If the strength is 1.25MU/5ml, then report 1.25 STRENGTH_NUM_UNIT Unit of the strength as content or unit of the Coded value list g, mg, IU, MU If the strength is 2g, then report g. numerator as concentration If the strength is 1.25MU/5ml, then report MU STRENGTH_DENOM_VALUE Value of of the denominator as Number positive number If the strength is 1.25MU/5ml, then report concentration 5 STRENGTH_DENOM_UNIT Unit of the denominator as concentration Coded value list ml If the strength is 1.25MU/5ml, then report ml ATC5 Code of the substance in the ATC/DDD index Coded value list Valid ATC code at 5th level If the substance is amoxicillin, then report (substance level) J01CA04. Refer to the ATC/DDD index for code assignment. ROUTE Route of administration Coded value list Valid AMC Tool codes for If the route of administration is inhalation route of administration powder, then report IP SALT Salt associated with the active substance. Coded value list Valid AMC Tool codes for If the substance is methenamine and the Only refer to erythromycin and methenamin salts associated salt is hippurate, then report (see ATC/DDD index) HIPP COMBINATION Combination code of the fixed dose Coded value list Valid AMC Tool codes for If the product is a combination of combination product combinations sulfamethoxazole (400mg) and trimethoprim (80mg) in tablet, then report J01EE01_3 VOLUME Number of packages to be reported for the Integer Positive integer If the number of packages used is 5789, product then report 5789 Examples

Basic examples

Example 1 Product: Amoxicillin 250mg 10 tablets Consumption: 3127 packages

Manual data entry Name: Amoxicillin 250mg 10 tablets Pack size: 10i Strength: 250mg ATC substance: J01CA04 – amoxicillin Route of administration: O – oral Number of packages: 3127

Automated data entry PRODUCT_NAME: Amoxicillin 250mg 10 tablets STRENGTH_DENOM_UNIT: empty PACK_SIZE_VALUE: 10 ATC5: J01CA04 PACK_SIZE_UNIT: i ROUTE: O STRENGTH_NUM_VALUE: 250 SALT: empty STRENGTH_NUM_UNIT: mg COMBINATION: empty STRENGTH_DENOM_VALUE: empty VOLUME: 3127

Example 2 Product: Gentamycin 80mg 1 vial Consumption: 475 packages of 1 vial each

Manual data entry Name: Gentamycin 80mg 1 vial Pack size: 1i Strength: 80mg ATC substance: J01GB03 - gentamicin Route of administration: P – parenteral Number of packages: 475 AMC Tool Manual

Automated data entry PRODUCT_NAME: Gentamycin 80mg 1 vial STRENGTH_DENOM_UNIT: empty PACK_SIZE_VALUE: 1 ATC5: J01GB03 PACK_SIZE_UNIT: i ROUTE: P STRENGTH_NUM_VALUE: 80 SALT: empty STRENGTH_NUM_UNIT: mg COMBINATION: empty STRENGTH_DENOM_VALUE: empty VOLUME: 475

Example 3 Product: Clarithromycin 125 mg/5ml suspension 60ml Consumption: 1091 packages corresponding to 1 reconstitued bottle of 60ml each

Manual data entry Name: Clarithromycin 125 mg/5ml suspension 60ml Pack size: 60ml Strength: 125mg/5ml ATC substance: J01FA09 - clarithromycin Route of administration: O – oral Number of packages: 1091

Automated data entry PRODUCT_NAME: Clarithromycin 125 mg/5ml STRENGTH_DENOM_UNIT: ml suspension 60ml ATC5: J01FA09 PACK_SIZE_VALUE: 60 ROUTE: O PACK_SIZE_UNIT: ml SALT: empty STRENGTH_NUM_VALUE: 125 COMBINATION: empty STRENGTH_NUM_UNIT: mg VOLUME: 1091 STRENGTH_DENOM_VALUE: 5

Advanced examples

Example 4 Product: Amoxcillin+Clavulanic Acid 1000 mg (875/125) 8 coated tablets Consumption: 3468 packages

According to the ATC/DDD index, for J01CR01, J01CR02, J01CR03 and J01CR05, the DDD refers to the dose of the antibiotic only and the dose of the inhibitor must be excluded. In this example of a product containing amoxicillin and clavulanic with a respective dosing of 875mg and 125mg, the strength to report is 875mg and not 1g.

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Manual data entry Name: Amoxcillin+Clavulanic Acid 1000 mg (875/125) 8 coated tablets Pack size: 8i Strength: 875mg ATC substance: J01CR02 - amoxicillin and beta-lactamase inhibitor Route of administration: O – oral Number of packages: 3468

Automated data entry PRODUCT_NAME: Amoxcillin+Clavulanic Acid STRENGTH_DENOM_UNIT: empty 1000 mg (875/125) 8 coated tablets ATC5: J01CR02 PACK_SIZE_VALUE: 8 ROUTE: O PACK_SIZE_UNIT: i SALT: empty STRENGTH_NUM_VALUE: 875 COMBINATION: empty STRENGTH_NUM_UNIT: mg VOLUME: 3468 STRENGTH_DENOM_VALUE: empty

Example 5 Product: Sulfamethoxazole and trimethoprim 400+80 mg 5 tablets Consumption: 679 packages

Sulfamethoxazole and trimethoprim 400+80 is a fixed dose combination. There are DDD for combined products for that combination. Sulfamethoxazole and trimethoprim has 3 combination codes. J01EE01_1 for infusion, J01EE01_2 for mixture and J01EE01_3 for tablets. The corresponding combination code is J01EE01_3. For this combination, the unit dose is 400+80mg. As this product is dosed at the same 400+80mg, the strength of the product is 1 UD (unit dose). Manual data entry Name: Sulfamethoxazole and trimethoprim 400+80 mg 5 tablets Pack size: 5i Strength: 1UD ATC substance: J01EE01 - sulfamethoxazole and trimethoprim Combination: J01EE01_3 Route of administration: O – oral Number of packages: 679

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Automated data entry PRODUCT_NAME: Sulfamethoxazole and STRENGTH_DENOM_UNIT: empty trimethoprim 400+80 mg 5 tablets ATC5: J01EE01 PACK_SIZE_VALUE: 5 ROUTE: O PACK_SIZE_UNIT: i SALT: empty STRENGTH_NUM_VALUE: 1 COMBINATION: J01EE01_3 STRENGTH_NUM_UNIT: UD VOLUME: 679 STRENGTH_DENOM_VALUE: empty

Example 6 Product: Sulfamethoxazole and trimethoprim 800+160 mg 7 capsules Consumption: 1021 packages

Sulfamethoxazole and trimethoprim 800+160 is a fixed dose combination. There are DDD for combined products for that combination. Sulfamethoxazole and trimethoprim has 3 combination codes. J01EE01_1 for infusion, J01EE01_2 for mixture and J01EE01_3 for tablets. The corresponding combination code is J01EE01_3. For this combination, the unit dose is 400+80mg. As this product is dosed at 800+160mg (doubled of the unit dose), the strength of the product is 2 UD (unit dose). Manual data entry Name: Sulfamethoxazole and trimethoprim 800+160 mg 7 capsules Pack size: 7i Strength: 2UD ATC substance: J01EE01 - sulfamethoxazole and trimethoprim Combination: J01EE01_3 Route of administration: O – oral Number of packages: 1021

Automated data entry PRODUCT_NAME: Sulfamethoxazole and STRENGTH_DENOM_UNIT: empty trimethoprim 800+160 mg 7 capsules ATC5: J01EE01 PACK_SIZE_VALUE: 7 ROUTE: O PACK_SIZE_UNIT: i SALT: empty STRENGTH_NUM_VALUE: 2 COMBINATION: J01EE01_3 STRENGTH_NUM_UNIT: UD VOLUME: 1021 STRENGTH_DENOM_VALUE: empty