Post on 24-Mar-2020
transcript
Gut Health Day Prepared by Jean Szkotnicki
February 18th, 2016
CANADIAN ANIMAL HEALTH INSTITUTE
u Trade Association representing manufacturers & distributors of animal medications
u Pioneer & generic companies
u Transnational & domestic companies
u Represent approximately 95% of sales
ANTIMICROBIAL RESISTANCE (AMR)
u Global Issue
u Canadian Antimicrobial Resistance and Use Action Plan
u VDD Regulatory & Policy Changes
u Impacts on Users of Antimicrobials in Agriculture
u Future Endeavours
AMR a Global Issue
u World Health Assembly resolution May 2014 called for global action to address AMR – Action Plan released May 2015
u World Organization for Animal Health (OIE) Resolution No. 26 on Combatting AMR – May 2015
u Food and Agricultural Organization (FAO): passed a resolution on AMR- June 2015
u “Berlin Declaration on AMR” by the G7 health ministers – Oct 2015
u President Obama’s executive order to combat AMR – Sept 2014
u Need for alignment with US FDA on AMR initiatives given the integrated nature of North American agri-food and pharmaceutical industry
Canadian Antimicrobial Resistance & Use Action Plan
u 3 Pillars u Surveillance – Canadian Integrated Program on AMR & Surveillance
(CIPARS)
u Stewardship
u Removal of growth promotion claims from medically important antimicrobials used in feed & water plus veterinary oversight of product
u Controls over Own Use Importation & Importation of Active
Pharmaceutical Ingredients
u Research
Veterinary Drugs Directorate, Health Canada Regulatory & Policy Changes
u Canadian Animal Health Institute (CAHI) approached VDD in March 2014 agreeing to voluntarily remove growth promotion claims from medically important antimicrobials (MIA) used in feed & water
u Also agreed to veterinary oversight of these same products
u Driving force – U.S. Food & Drug Administration move to remove growth promotion claims and have veterinary oversight of MIA used in feed & water by the end of 2016
ELANCO ANIMAL HEALTH
NEGATIVE OUTCOMES OF REMOVING SUBTHERAPEUTIC ANTIBIOTICS Ø increased incidence of enteric diseases in food-producing
animals Ø productivity and mortality losses Ø increased use of antibiotics for therapeutic purposes with
greater relevance to treatment of serious infection in humans (I, II).
Group Category I Category II Category III Total Growth promotion production claims removal
0 22 Erythromycin, Penicillin G, Streptomycin, Tylosin & Virginiamycin
36 Bacitracin , Chlortetracycline Neomycin, Oxytetracycline, & Sulfonamides
58
OTC to Pr 0 48 Erythromycin, Lincomycin, Penicillin G, Streptomycin, Tilimicosin, Tylosin & Virginiamycin
88 Apramycin, Bacitracin, Chlortetracycline, Neomycin, Novobiocin, Oxytetracycline, Spectiomycin, Sulfonamides & Tiamulin
136
WHAT ARE THE MEDICALLY IMPORTANT ANTIMICROBIALS (MIA)?
REGULATORY CHANGES THAT LIE AHEAD u By 2018…..
u Prohibition on Own Use Importation of Medically Important Antimicrobials
u Controls over Importation of Active Pharmaceutical Ingredients (API) u Veterinarian will be required to have a Establishment
License to import API & it must meet GMP for both commercially & non-commercially available product
u Pharmacists will be exempt from having to meet the above requirements for non-commercially available product
POLICY CHANGES THAT LIE AHEAD u Medically Important Antimicrobials used in feed and water to
move from being over the counter medications to being prescription only
u Feedmills will be able to manufacture feed in anticipation of a veterinary prescription if mixing on label as listed on the Medicating Ingredients Brochure
u Manufacture of Extra Label Drug Use of MIA products by Feedmills will still require a prescription
u Electronic veterinary signatures will be enabled on prescriptions
TIMEFRAME FOR CHANGES
Spring-Summer 2016
Canada Gazette I publication of new regulation for 75 day consultation. Followed by 6-18 months to review comments.
Spring, 2017
Canada Gazette II & subsequent transition period
Dec 2017
Coming into Force. Transition to new labels (AGP and Prescription) New MIA labels required for product distributed by manufacturers including therapeutic claims, duration of use & compatibities.
IMPACTS ON USERS OF MIA ANTIMICROBIALS USED IN FEED & WATER u Farmers – MIA Antimicrobials Used in Feed & Water will no
longer be available through Livestock Medicines Outlets but available through your veterinarian
u Veterinarians – Consideration being given to veterinarians being required to meet practice standards that address antimicrobial resistance
u Electronic signatures permitted on feed prescriptions
u Feedmills – Able to manufacture feed as per the Medicating Ingredients Brochure in anticipation of a prescription but only able to sell product pursuant to a prescription
FUTURE ENDEAVOURS u Farmers,…
u Expanding Quality Assurance Programs to address AMR e.g. Chicken Farmers of Canada Prohibiting Extra Label Drug Use of MIA Antimicrobials
u Looking at Production Practices to Help Limit Need for Antimicrobials in Production e.g. all in all out production systems, limiting animal exposure to disease challenges at auction sales, pre-conditioning of calves prior to moving into the feedlot
u Stronger relationship with your veterinarian
VETERINARIANS - STANDARDS AROUND AMR
RESEARCH
u Alternatives to Antimicrobials
Alternative tools to antibiotics
Alternatives Efficacy* Potential for development
Antibiotics +++++ 0
Zinc Oxide ++++ 0
Copper Sulphate +++ 0
Organic Acids + 0
Enzymes +++ +++
Pre-fermentation & Inoculation ? +
Probiotics + +
Fermentable Substrates (Prebiotics) ++ +++
Lactose ++ 0
Zeolites & Clay Minerals ? 0
Nutraceuticals (e.g. ginseng, oregano) ? +
Soya Isolates + +
Immunoglobulins ++ ?
Epidermal Growth Factors ? ?
Colostrally Derived Growth Factors ? ?
* Efficacy & development based on a subjective score 0 to ++++ (very high) or ? (unknown)
Husbandry /Management Techniques
Efficacy* Potential for Development*
All-in-All Production ++++ ++++
Hygiene ++++ +++
Later Weaning ? +
Outdoor Production ++ 0
Colostrum Quality & Intake +++ ++
Immunisation +++ ++
Drinking Water Quality & Provision ++ +++
Education – Owner & Stockperson ++++ ++++
* Efficacy & development based on a subjective score 0 to ++++ (very high) or ? (unknown)
Acknowledgements : Dr. Pinder Gill, Dr. Vernon Fowler, British Society of Animal Science, 2005
REGULATORY PATHWAYS TO SUPPORT COMMERCIALIZATION OF NEW PRODUCTS
u Regulatory Pathway in support of feed additives with physiological claims & health claims
PRESSURE TO DETERMINE USE OF ANTIMICROBIALS IN AGRICULTURE
u CAHI provides data to the Public Health Agency of Canada
CIPARS 2014 REPORT
1) The change nationally in the use of antibiotics was 4.74% for 2014 compared to 2013.
2) Companion animal represents under 1.0 % of the total kg active.
3) The largest antibiotic category continues to be tetracyclines followed by ionophore and chemical coccidiostats.
4) The classifications with the largest growth in 2014 compared with 2013 are: 1) chemical coccidiostats, 2) aminoglycosides, 3)macrolides.
5) The classification with the largest decline in 2014 compared with 2013 was tetracyclines.
6) Provincially, Quebec leads in the volume of total antibiotics used in animal medicine.
7) “ 3 company rule” is established to comply with the EU and US anti-competition regulations, and we added in some cases a “90% rule” on top to be sure not to infringe the regulations in the USA.
CIPARS 2014 REPORT
0
50,000
100,000
150,000
200,000
250,000
300,000
350,000
400,000
450,000
500,000
550,000
600,000
650,000
700,000
CHEMICAL COCCIDIOSTATS,
ARSENICALS
IONOPHORE COCCIDIOSTATS
AMINOGLYCOSIDES ß-LACTAMS / PENICILLIN
CEPHALOSPORINS FLUOROQUINOLONES LINCOSAMIDES MACROLIDES TETRACYCLINES SULPHONAMIDES OTHERS
Kilo
gram
s (K
G)
of A
ntib
ioti
cs
Antibiotic Class
Active Kilograms of Antibiotic Class of Veterinary Products in Canada Canadian Integrated Program for Antimicrobial Resistance Surveillance (C.I.P.A.R.S.)
KG Active 2014 KG Active 2013
Total 2014: 1,548,585 kg Total 2013: 1,478,492 kg
Difference: 4.7%
CIPARS 2014 REPORT
0.00
100,000.00
200,000.00
300,000.00
400,000.00
500,000.00
600,000.00
AB BC MB NB NF NS ON PEI QC SK
Kilo
gram
s (K
G)
of A
ntib
ioti
cs
Province
Active Kilograms of Antibiotic Class of Veterinary Products in Canada by Province Canadian Integrated Program for Antimicrobial Resistance Surveillance (C.I.P.A.R.S.)
KG Active 2014 KG Active 2013
Total 2014: 1,548,585 kg Total 2013: 1,478,492 kg
Difference: 4.7%
CIPARS 2014 Report
24
-200,000
0
200,000
400,000
600,000
800,000
1,000,000
1,200,000
1,400,000
2014 vs 2013 KG Active by Route of Administration
Chemical Coccidiostats, Arsenicals Ionophore Coccidiostats Aminoglycosides ß-Lactams / Penicillin
Cephalosporins Fluoroquinolones Lincosamides Macrolides
Tetracyclines Sulphonamides Others
CHALLENGE – MARKET PRESSURES & ACCUMULATING SCIENTIFIC EVIDENSE WILL CONSTRAIN THE SECTORS ACCESS TO ANTIMICROIBIALS
Source: Friends of the Earth 2015
IMPROVED UNDERSTANDING OF AMR u MANAGEMENT - Consider livestock production practices to reduce use &
potential impact on human medicine
u DEVELOPMENT OF ALTERNATIVES - Design/test therapeutic approaches against veterinary or zoonotic diseases
u SURVEILLANCE - Monitor the emergence of resistance (genes) & potential for transfer between livestock – the environment & consumer products
u RESEARCH -Study the kinds & flow ofresistance (genes) & zoonotic potential of microbes
QUESTIONS & DISCUSSION