When the Veterinary Feed Directive (VFD) Final Rule was announced earlier this month by FDA, the accompanying press release called it a ‘major step towards judicious antibiotic use’ in veterinary medicine [1].
There are several elements which look good, at least on paper:
- As prescribers of any and all antibiotics it puts veterinarians in the role of gatekeepers. They have to fill out a form documenting a veterinarian-client-patient relationship (VCPR).
- Manufacturers will have to change product labels removing claims of ‘growth promotion’.
- Veterinarians will be allowed to prescribe antibiotics for ‘animal health reasons’ only.
- Most importantly, the veterinary oversight is being phased in as OTC antibiotics change their marketing status to become VFD drugs.
DEFINITIONS:
OTC Drug = Over-The-Counter approved animal drug available without a prescription or Veterinary Feed Directive
VFD Drug = a drug approved for use in animal feed …under the professional supervision of a licensed veterinarian
The last point is most important as almost all current antibiotic use in veterinary medicine is OTC which by definition means dispensation without supervision.
The other ingredients of the Final Rule are of uncertain value. There is no great expectations that veterinarians will be better gatekeepers than they were in the past. Or other doctors who keep prescribing antibiotics for the common cold. But US veterinarians have the benefit of learning from their European colleagues who have shown that less is better. Education and awareness campaigns and data driven guidance from professional organizations may affect a gradual change.
For now, the use of antibiotics for ‘infection prevention’ leaves the door wide open for those who want to continue current practices.
FDA has built in some enforcement measures and will monitor adherence. However, the ultimate proof that this legislation really made a difference will only come some years from now. After 2016 we would like to see a consistent gradual decrease in all the following areas:
- overall antibiotic consumption for veterinary use,
- the manufacture of antibiotics for US veterinary use, AND
- the rate of MDR pathogens (Salmonella, E.coli, Campylobacter) in cultures from animals and farm products.
There is a National Antimicrobial Resistance Monitoring System (NARMS) already in place to provide relevant surveillance data. Its khaki logo looks appropriately militaristic for this new “War on Bugs”. As a joint venture of CDC, FDA and USDA, this surveillance system collects relevant resistance information from human, food, and animals sources. NARMS also provides yearly update reports.
With VFD legislation taking effect in 2016, and given the lag time related to the roll-out of the new measures, it is unlikely we will see the effect of this Final Rule before the 2020 NARMS report. Let’s keep fingers crossed!
Here some background facts about antibiotics in current veterinary use [2]:
- Total antibiotic Sales (US) 2013 in kg – 14,788,555 (approx. 15,000 tons)
Tetracyclines – 44% Ionophores – 30% - From Medically Important Drug Classes – 9,196,803 kg
Of which 28% used for therapeutic indications (and not for growth promotion) - In 2013, 98% of 9,196,803 kg were OTC, 1% were VFD drugs
- Sales increases from 2009 to 2013:
Tetracyclines – 24%
Lincosamines – 153%
Cephalosporins – 41%
Aminoglycosides – 21%
Penicillins – 20% - Sales decrease from 2009 to 2013:
Sulfonamides – -24%
- Antibiotics are added in feed (70%) or water (24%). Injection and topical use is minimal.
References:
[1] http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm448446.htm
[2] 2013 Summary Report on Antimicrobial Sold or Distributed for Use in Food-Producing Animals
