EXPERIENCE WITH ANTIMICROBIAL DATA COLLECTION IN ANIMALS
17
NEED FOR HARMONISATION JAPAN EXPERIENCE EXPERIENCE WITH ANTIMICROBIAL DATA COLLECTION IN ANIMALS
Transcript of EXPERIENCE WITH ANTIMICROBIAL DATA COLLECTION IN ANIMALS
NEED FOR HARMONISATION
JAPAN EXPERIENCE
EXPERIENCE WITH ANTIMICROBIAL DATA
COLLECTION IN ANIMALS
Today’s Topics １. Regulation of Vet. Medicinal Products (VMPs) In Japan 2. Japanese Veterinary Antimicrobial Resistance Monitoring System (JVARM) 3. An overview of veterinary antimicrobial products in Japan
Reasonable and Safe Use of VMPs in Japan
Before Licensing Marketing
Approval System
- Prohibits distribution of unapproved drugs
At the retail level Veterinarian
- Must not prescribe without consultation
Prescription system
- Prohibits selling drugs without direction or prescription of vet.
Usage Restrictions on the usage
of vet. drugs
- Establishes usage standards
for vet. drugs
Distribution Restrictions on the
distribution of vet. drugs - Prohibits distribution without authorization
VMP Distribution
Distributor
Animal Owner
Veterinarian
Retailer
wholesaler
Distributor
Animal
×
Marketing Authorization
Holder
②Prescription
Indications
Dosage, administration, treatment period, withdrawal period others (public health concerns, technological concerns)
• Name of medicine
• Quantity
Information about treated animal
e.g.,) sex, age, identification number
Information about animal owner
Reasons for prescription
•Date of issue
•Information about veterinarian in charge
a set of 4 identical documents 1. For the veterinarian 2. For the regulating authority 3. For the distributor 4. For the animal owner
１）Regulation of Vet. Medicinal Products (VMPs) In Japan ２）JVARM ３）An overview of the availability of veterinary antimicrobial products in Japan used for therapy
General view of JVARM
１．Objective ・Nationwide monitoring of antimicrobial resistance ・Monitoring of veterinary antimicrobial use ２．Established in 1999
３．National Veterinary Assay Laboratory (NVAL) ４．Targeted bacterial species ・Indicator bacteria （E.coli & Enterococcus） ・food-borne pathogen （Salmonella & Campylobacter）
VMP Distribution
Distributor
Animal Owner
Veterinarian
Retailer pharmacy
wholesaler
Distributor
Animal
NVAL
report data annually
Monitoring of Antimicrobial Consumption
Pharmaceutical Affairs Law
Marketing Authorization Holder (MAH)
～2011 2012
Trade Name Trade NameSales amount
(￥1,000）
Sales amount
(￥1,000）
Volume of sales
（kg, L)
Volume of sales
（kg, L)
the names of antimicrobials the names of antimicrobials
Contents of the antimicrobials
The routes of administration The routes of administration
Target animal species Target animal species
Estimated Percentages of Sales
for Each Animals Species
Estimated Percentages of Sales
for Each Animals Species
The reported data from MAH
weight of the active ingredients
NVAL
Collates analyses and evaluates the data Publishes the data in a yearly report and posts it on the Web
http://www.maff.go.jp/nval/iyakutou/hanbaidaka/index.html
Sales Amount and Sales Volume of Antibiotics (2005)
Beef
Cattle
Dairy
cowPig Broiler Layer Dog/Cat
Tetracyclines Oxytetracycline oral 383,157 204154 1.8 1.3 84.5 8.1 4.3
injection 158,791 1162.7 11.6 5.6 82.5 0.07 0.07 0.09
total 541,948 205316.7
Doxycyclin HCl oral 520,321 23713.5 84.3 15.6
Estimated Percentages of Sales for Each Animal SpeciesAmount of
active
substance
(kg)
Sales
amount
(￥1000)
route of
administration
Active
substanceClass
１）Regulation of Vet. Medicinal Products (VMPs) In Japan ２）JVARM ３）An overview of the availability of veterinary antimicrobial products in Japan.
0,0
100,0
200,0
300,0
400,0
500,0
600,0
700,0
800,0
900,0
1000,0
2006 2007 2008 2009 2010 2011
Total
Tetracyclines
Sulfonamides
Macrolides
Penicillins
Aminoglycosides
Phenicols
Lyncomycin
Fluoroquinolones
Cephalosporins
Peptide
Quinolone
Nitrofran
Trends in veterinary antimicrobials sold in tonnes of active substance
0
100
200
300
400
500
600
BeefCattle DairyCow Horse Pig Broiler Layer Dog/Cat
200620072008200920102011
Sales of antimicrobial agents by target species, in tonnes of active substance, during 2006-11
0
50
100
150
200
250
300
350
400
450
200620072008200920102011
Sales of antimicrobial agents, in tonnes of active substance, during 2006-11
Trends in number of animals slaughtered in slaughterhouses and poultry slaughtering plants (1,000 heads/birds).
1
10
100
1 000
10 000
100 000
1 000 000
2006 2007 2008 2009 2010
Broiler
Fowl
Pig
Cattle
Horse
Calves
Conclusion
• JVARM is to monitor the consumption of veterinary antimicrobials from data released by Marketing Authorization Holder
• The data include weight in kilograms of the active ingredients
• Antimicrobials were most frequently used in pigs.
• Tetracycline had the highest sales volume.
Thank you very much for your
Attention
JVARM REPORT http://www.maff.go.jp/nval/tyosa_kenkyu/taiseiki/pdf/jvarm2000_2007_final_201005.pdf [email protected]
