Working group session

Transcription

1 Working group session OIE Data Collection Improvement on the Possible Reporting Options Bangkok, March 2018

2 Reporting Options The sections of the OIE Template named Reporting Options 1, 2 and 3, collect the quantities of antimicrobial agents intended for use in animals. Baseline Information Reporting Option 1 Reporting Option 2 Reporting Option 3 Parts A + B : for all Member Countries to respond Part C : for the Member Countries choosing a Reporting Option Antimicrobial agents Type of use* Antimicrobial agents Type of use* Group of animals** Antimicrobial agents Type of use Group of Animals** Routes of administration * Type of use: therapeutic or growth promotion **For the purposes of the OIE database, animal groups means: terrestrial food-producing animals, aquatic food-producing animals or Companion animals

3 OIE Questionnaire: What changed? First year (2015) Second year (2016) Third year (2017)

4 Tools for using the OIE template 1. Guidance for completing the OIE template for the collection of data on antimicrobial agents intended for use in animals 2. Annex to the Guidance for Completing the OIE template for In case of questions contact the Antimicrobial Use Team by at

5 Guidance for completing the OIE template Baseline information Information that clarifies the reference points and provides the background for interpretation Baseline Information s part Member Countries who could not provide amounts of antimicrobials Member Countries who provided amounts of antimicrobials Part A. Contact Person for Antimicrobial Agents Use Data Collection Part B. General Information Part C. Data Collection on the Use of Antimicrobial Agents in Animals.

6 Guidance for completing the OIE template Baseline information Baseline Information s part Member Countries who could not provide amounts of antimicrobials Member Countries who provided amounts of antimicrobials Part A. Contact Person for Antimicrobial Agents Use Data Collection Who reported the data to the OIE we may need to clarify something

7 Updated New Guidance for completing the OIE template Baseline information Member Countries who Baseline Information s part could not provide amounts of antimicrobials Part B. General Information Member Countries who provided amounts of antimicrobials Are data on the amounts of antimicrobials available aims to encourage OIE MCs to collect what they already have and expand coverage to their whole country. If data are not available, OIE MCs can describe the barriers to provide such data Are Growth promoters allowed or used helps where only overall amounts are used List of allowed Growth promoters some substances are used for growth promotion and therapeutic use, the list helps tease out such dual use

8 New Guidance for completing the OIE template Baseline information Baseline Information s part Part C. Data Collection on the Use of Antimicrobial Agents in Animals. Member Countries who could not provide amounts of antimicrobials Member Countries who provided amounts of antimicrobials Year for which data are reported there may be reporting delays in some countries, plus we welcome a certain amount of historical data Time period helps OIE to understand if the data cover portion of a calendar year Data source we need to understand where the data are coming from; OIE MCs need to map the distribution system in their country to identify the most reliable source for complete and least potential for duplicate reporting

9 Guidance for completing the OIE template Baseline information Baseline Information s part Part C. Data Collection on the Use of Antimicrobial Agents in Animals. Member Countries who could not provide amounts of antimicrobials Member Countries who provided amounts of antimicrobials Estimated coverage of the data we need to know how much of the total sales in the OIE MC are reported and what is not included Is the information extrapolated from representative samples helps OIE to understand what are the data provided Explanations of estimate coverage and extrapolations carried out helps OIE to understand the reported information and to identify similar data sets Animal groups covered refers to the categories in the different reporting options and helps OIE identify like and like when only total amounts are reported

10 Guidance for completing the OIE template Baseline information Baseline Information s part Part C. Data Collection on the Use of Antimicrobial Agents in Animals. Member Countries who could not provide amounts of antimicrobials Member Countries who provided amounts of antimicrobials Animals raised in your country and considered as food-producing knowing differences in animals raised for food helps OIE to collate appropriate data National report available on the web? helps OIE to get an overview on the data available in an OIE MC

11 Annex to the Guidance for the Completion of the OIE template Explains the calculations necessary to provide the data required by the OIE template: Conversion of different weight units into kilograms Calculation of amounts to be reported o o o For active chemical substances as reported on the label For prodrugs and certain long-acting derivatives that require conversion into the active antimicrobial entity (moiety) From numbers of packs and content of antimicrobial agent per unit to kg Always contact the Antimicrobial Use Team(antimicrobialuse@oie.int) if conversion factors are missing

12 Working group session Practical exercise

13 Step 0 Fill the OIE template for your country Sheet: Baseline information (Parts A and B)

14 Step 0 Prepare a simplified mapping of the distribution system in your country.

15 Different possible sources of DATA Sales Purchase Import Veterinary Use at a farm level Others

16 Data Duplication It is consider to be a risk in the following situations: Import data of active ingredients or manufacturing data reported without taking into account exports Import data of veterinary products and also providing data on sales of veterinary products (domestic and imported) Import, sales or purchase data of veterinary products reported in addition to usage data at a farm level

17 Practical exercise (invented names and sales figures) Data Source Name of the Product Antimicrobial Class Sales of Veterinary Products Zolran Tetracyclines World Organisation for Animal Health Protecting animals, Preserving our future 17

18 Data needed?? Information on Veterinary Medicinal Products (VMP) Active substance(s) and Antimicrobial Class (Necessary) Strength and strength unit (Necessary) Content (Necessary) Route of administration (Desirable) Target species (Desirable) Sales figure for sale package for each VMP containing Antimicrobials Package size (Necessary) Number of package sales (Necessary)

19 Step 1 Create a table with necessary information to perform the calculations: World Organisation for Animal Health Protecting animals, Preserving our future 19

20 Step 2 Filling information on Zolran from the summary of Characteristics of the product on the label World Organisation for Animal Health Protecting animals, Preserving our future 20

21 Step 2: Necessary information for Zolran Information on VMP: Active substance: Doxycycline Strength: 100 mg/ml (as declared on the product label) Content: 100 ml Sales figure for sale package: Box: each box contains 50 bottles of 100 ml We will have two hypothetical cases: Hypothetical Case A The country sold boxes Hypothetical Case B The country sold bottles World Organisation for Animal Health Protecting animals, Preserving our future 21

22 Step 3: Calculations Step Hypothetical Case A (box) Hypothetical Case B (bottle) 1 Calculation on the content of doxycycline per bottle Product label = 100 mg/1 ml Presentation = 100 ml 100 mg Doxycycline x 100 ml = 1 ml = mg Doxycycline per bottle Product label = 100 mg/1 ml Presentation = 100 ml 100 mg Doxycycline x 100 ml = 1 ml = mg Doxycycline per bottle World Organisation for Animal Health Protecting animals, Preserving our future 22

23 Ste p Step 3: Calculations Hypothetical Case A (box) Hypothetical Case B (bottle) 2 Sum up the antimicrobial agent contained in all presentations and packages sold Product D contains mg of doxycycline per bottle The country sold boxes = mg of doxycycline x (4 800 x 50) = mg of doxycycline x ( ) = mg of doxycycline Product D contains mg of doxycycline per bottle The country sold bottles = mg of doxycycline x (4 800) = mg of doxycycline World Organisation for Animal Health Protecting animals, Preserving our future 23

24 Step 3: Calculations Ste p Hypothetical Case A (box) Hypothetical Case B (bottle) 3. Convert the total sum of antimicrobial agent to kg = mg = kg of doxycycline = mg = 48 kg of doxycycline As you notice there are difference in the results between the hypothetical cases A (box) and B (bottle). Even if the results are different, both cases are right on the calculations, the main difference lies in how the sold data was collected and/or reported. Data could be doubling if in hypothetical case A(box), at the end of step 3, we had multiplied kg of doxycycline by the number of bottles per box, as we have already considered this information in step 2. World Organisation for Animal Health Protecting animals, Preserving our future 24

25 International Units (IU) If the chemical compound as declared on the product label is in IU, please use the following conversion factors (Table 2 of the Annex to the guidance) World Organisation for Animal Health Protecting animals, Preserving our future 25

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