Transcript VFD
VFD – Trying To Sort It Out DEC 3, 2016 BOB EBBESMEYER, D.V.M. (GERMAN VALLEY, IL) ALAN WHITMAN, D,V.M. (PIPER CITY, IL) What Is a VFD (Veterinary Feed Directive)? Written statement provided by a veterinarian (licensed in the state where the animals reside) in the presence of a VCPR (Veterinarian-Client-Patient Relationship) that authorizes a client to use a VFD drug in an animal feed in accordance with approved use One drug for one group of animals belonging to one producer for a specific disease state for a specified time with feed purchased from one distributor It is NOT a prescription; it is much more specific than a prescription What Is a VFD? VFD is not a new concept - we have had several VFD antibiotics for more than 10 years Most commonly used: Pulmotil in swine and beef feedlot cattle Others: Tilmovet, Kavault, Aivlosin What is the new concept for 2017? Almost all feed grade animal antibiotics will be VFD January 1 What Drugs Require a VFD? January 1, 2017: All Medically Important (MI) drugs used in feed are considered VFD drugs, and any use of them, starting January 1, 2017, requires a valid VFD Medically Important (MI) is defined as any antibiotic belonging to a class of drugs used commonly in human medicine Includes: Chlortetracycline, oxytetracycline, tylosin, sulfamethazine, neomycin, lincomycin, penicillin, virginiamycin, avilamycin, florfenicol, tilmicosin, tylvalosin What Drugs Do NOT Require a VFD? Drugs NOT Considered Medically Important (NCMI): Ionophores Carbadox Tiamulin (Bovatec, Rumensin) (Mecadox) (Denagard) Bacitracin (BMD) Bambermycin (Flavomycin) Anthelmentics (dewormers), Beta agonists, anticoccidials What About Drug Combinations? Just to make sure we do not make this all too simple: NOT Considered Medically Important (NCMI) drugs must be listed on VFD if given in combination with any drug on VFD list, AND the combination must be an approved combination What is a VCPR? Veterinarians are only allowed to write a VFD for a client when there is a VCPR Veterinarian-Client-Patient Relationship What is a VCPR? Defined in Veterinary Medicine and Surgery Practice Act of 2004 (225 ILCS 115/) (1) The veterinarian has assumed the responsibility for making clinical judgments regarding the health of an animal and the need for medical treatment and the client, owner, or other caretaker has agreed to follow the instructions of the veterinarian; What is a VCPR? (2) There is sufficient knowledge of an animal by the veterinarian to initiate at least a general or preliminary diagnosis of the medical condition of the animal. This means that the veterinarian has recently seen and is personally acquainted with the keeping and care of the animal by virtue of an examination of the animal or by medically appropriate and timely visits to the premises where the animal is kept, or the veterinarian has access to the animal patient's records and has been designated by the veterinarian with the prior relationship to provide reasonable and appropriate medical care if he or she is unavailable; and What is a VCPR? (3) The practicing veterinarian is readily available for follow-up in case of adverse reactions or failure of the treatment regimen or, if unavailable, has designated another available veterinarian who has access to the animal patient's records to provide reasonable and appropriate medical care. What is NOT a VCPR? "Veterinarian-client-patient relationship" does not mean a relationship solely based on telephonic or other electronic communications. Why Did FDA create this regulation? “To promote the judicious use of antimicrobials in food-producing animals…bring the use of these drugs under veterinary supervision so they are used only when necessary for assuring animal health.” (www.fda.gov) Basically, to fight the development of antimicrobial resistance Why Did FDA create this regulation? Antibiotic resistance leads to estimated 2 million infections and 23,000 deaths annually in U.S. (CDC) Websites and social media share and spread data very easily: Human Food antibiotics sold annually: 8 million pounds animal antibiotics sold annually: 29 million pounds Indirect pressure: large companies going “Antibiotic Free” (McDonalds, Subway, Tyson) Why Did FDA create this regulation? 29 million pounds of livestock feed: 8 million pounds – ionophores (NCMI: not considered medically important to humans) 21 million pounds of MI (medically important) antibiotics used annually 97% of these MI antibiotics were used OTC (over the counter = no/minimal veterinary oversight) Is the FDA cause valid? Yes…and No…and Maybe… Perhaps Yes: There is evidence that bacteria can develop resistance and transfer antibiotic resistance to other bacteria when antibiotics are used Is the FDA cause valid? Yes…and No…and Maybe… Perhaps No: Antibiotic use is often reported in pounds; does one gram of chlortetracycline equal one gram of ciprofloxacin? No, not even close. Variable evidence from countries (i.e., Denmark), even with severely limited use of feed-grade antibiotics, that resistance has significantly decreased Is the FDA cause valid? Yes…and No…and Maybe… Annually, approximately 262 million prescriptions are written for outpatient antibiotic use (Center for Disease Control, CDC) - 8 million pounds of human antibiotics annually Estimated 30-50% of these prescriptions inappropriate (CDC, various studies) Azithromycin (Z-Pack) is the most commonly prescribed antibiotic (ironically, it is most often prescribed for bronchitis, which is usually viral, so antibiotics are innappropriate) Is the FDA cause valid? Yes…and No…and Maybe… Drug companies are quite reluctant to spend billions to develop new antibiotics: Cost of drug; use may be limited to specific situations They are looking to create drugs for chronic conditions that get used much more often Ultimately, human AND animal medical fields must have a change in mindset about antibiotics use Will Antibiotics Still Be Used on Feed? Yes…But… Feed grade antibiotics can ONLY be used according to specified and approved label indications: Specified dose (either dose/animal or concentration to be mixed in feed) Specified species Specified disease states, for prevention, control or Specified treatment length (days) treatment Will Antibiotics Still Be Used on Feed? Yes…But… Cannot be used for “increased rate of gain” This has been voluntarily removed from the label of all feed grade antibiotics by the manufacturers No extra-label use of feed antibiotics Only etc for approved species, time, dose, indication, What Is Included in a VFD? Must be written (electronic or paper, which can be faxed if necessary) Triplicate; veterinarian keeps original, distributor and produce each get copy Cannot be done via telephone call Requires a good working relationship between the producer, the veterinarian, and the distributor What Is Included in a VFD? One veterinarian (not a clinic) One person responsible for care and feeding of animals One animal production site, can be more if same owner and a common health plan can be justified One VFD medication (or approved combination) can be listed on each VFD What Is Listed/Required on a VFD? 1. Client 2. Animal location(s) 3. Species 4. Number of head to be fed (over life of the VFD, maximum six months) 5. VFD medication What Is Listed/Required on a VFD? 6. Production class (specified option are on each drug’s label) 7. Indication (must be specifically listed on drug label) 8. Expiration of VFD – typically can be maximum of six months, but some are less if specified on drug label) 9. Dosage and duration 10. Feed concentration (if not indicated in dosage) What Is Listed/Required on a VFD? 11. Cautionary statements 12. Specific instructions 13. Withdrawal time for slaughter 14. VFD statement 15. Any allowed approved combination drugs VFD Limitations Very Important: No “Extra-Label Use” of any feed antibiotics is allowed Only for approved species, dose, time, indication, etc What about “minor species” sheep and goats???? Cannot be used after expiration – if needed after the six month (or less) expiration, another VFD must be written Blue Bird Labels: http://www.fda.gov/AnimalVeterinary/Products/AnimalFoodFeeds /MedicatedFeed/BlueBirdLabels/default.htm What Is Best: Paper or Electronic? FDA anticipates 750,000 VFD’s written annually, therefore FDA would prefer electronic records Advantages of electronic: Should be readily available anytime/anywhere Digitally stored so cannot be lost Electronic filled out forms should allow the VFD to be properly Electronic VFD’s (ie, GlobalVetLINK) Allows proper VFD creation (species, indication, dose, combinations, etc) Electronically signed and stored VFD’s are emailed to distributor and producer so they can have access anytime/anywhere Emails can be sent to notify veterinarian, distributor, and producer as expiration date is approaching What About Antibiotics in Water? As of January 1, 2017, all water-based antibiotics are prescription drugs. They do NOT require a VFD. Cannot be bought without veterinary approval, similar to the purchase of a prescription of an injectable drug They will not be available from feed distributors unless a pharmacist is on staff What About Injectable Antibiotics? There has been no change in injectable antibiotic regulations. Current OTC (over the counter) injectables are still available (penicillin, oxytetracyclene, etc) Anticipate that injectable antibiotics will become more regulated in future years Will There Be FDA Inspections? Yes, but unknown level of inspection 2017 anticipated to be a teaching year Random inspections checking to see that steps are were done appropriately Veterinarian: Distributor: valid VCPR, properly filled out VFD filled request properly, appropriate quantities Producer: fed to proper animals for proper time, dose and duration (best to have a written record of when/where fed) All records must be kept for two years (paper or electronically) Issues and Concerns Barriers to getting antibiotics Timeliness of animal treatment Added paperwork and record keeping Lack of veterinary availability in some places Potential audits/inspections Inaccurate VFD’s causing delays Extra veterinary costs Final Thought If we want to protect and preserve the use of antibiotics in food-producing animals, we are going to have to jump through VFD hoops www.ilfb.org/vfd http://feedstuffs.com/vfd.aspx https://www.isvma.org/vfd-resources/ QUESTIONS???