Top 6 VFD Formatting Mistakes

Transcription

1 Top 6 VFD Formatting Mistakes R. TOM BASS, II, DVM, PHD RENAISSANCE NUTRITION, INC. More VFD stuff, again?!!?? You are legally responsible for only filling a VFD order that is COMPLETE AND CORRECT! Don t assume the veterinarian is doing it correctly! 45% of VFDs received as of Mar. 31 were incorrect!! 1

2 Distribution Limitations for VFD Feeds (from the Ren Distributor Acknowledgement Letter) (1) The distributor will not ship a VFD medication or feed to an animal production facility that does not have and has not provided said distributor with the required copy of a properly formulated, non expired VFD order; (2) The distributor will not ship a VFD medication or feed to another distributor without first receiving a written acknowledgement letter similar to this one; (3) The distributor will comply with all necessary VFD related record keeping; (4) The distributor has complied with the FDA s distributor notification requirements and forwarded a copy of their notification to Renaissance Nutrition (attn.: Caitlyn Massie); (5) The distributor has listened to one of the Pro Start sessions on VFD training on either 07/15/16 or 11/18/16. Information required on a VFD 1. Veterinarian s name, address, and telephone number; 2. Client s name, business or home address, and telephone number; 3. Premise(s) at which the animals specified in the VFD are located; 4. Date of VFD issuance (effective date); 5. Expiration date of the VFD; 6. Name of the VFD drug(s); 7. Species and production class of animals to be fed the VFD feed; 8. Approximate number of animals to be fed the VFD feed by the expiration date of the VFD; 9. Indication for which the VFD is issued; 10. Concentration of VFD drug in the feed (g/ton) and duration of use; 11. Withdrawal time, special instructions, and cautionary statements necessary for use of the drug in conformance with the approval; 12. Number of reorders (refills) authorized, if permitted by the drug approval, conditional approval, or index listing; 13. The statement Use of feed containing this Veterinary Feed Directive (VFD) drug in a manner other than as directed on the labeling (extra label use), is not permitted; 14. Affirmation of intent for combination VFD drugs as described in 21 CFR 558.6(b)(6); and 15. Veterinarian s electronic or written signature. 2

3 Top 6 VFD Formatting Errors: 1. Picking the wrong VFD form to use 2. Incorrect drug concentration 3. Incorrect feeding duration 4. Not including all the required information 5. Incorrect animal number 6. Allowing refills Try to avoid using generic VFD forms! 83% error rate!! Too much info that the vet has to look up. Filling in blanks vs. checking boxes. 3

4 Try to use sponsorgenerated forms Medication and species specific. Generated w/fda approval. Checking boxes vs. filling in blanks. Use sponsorgenerated forms 4

5 or e VFDs generated by electronic records management firms Only 27% submitted w errors Checking boxes vs. filling in blanks, w/even more guidance than the paper forms. Correct or Incorrect? 5

6 Let s do the N T math Assume the calves will weigh 100 lb. We need to provide 10 mg N T per pound of body weight. 10 mg/lb x 100 lb = 1000 mg N T per calf per day. Milk replacer at 3000 g/ton N T = 1500 mg/lb N T 1000 mg / 1500 mg/lb = 0.67 lb of milk replacer powder per head per day. Milk replacer at 1600 g/ton N T = 800 mg/lb N T 1000 mg / 800 mg/lb = 1.25 lb of milk replacer powder per head per day. What s the proper drug concentration to denote?? Must be denoted in grams/ton!! It should be the drug concentration in the final medicated feed that is fed to the animal. N T milk replacer: 1600 g/ton Do NOT denote a drug concentration of 20,000 g/ton if using #2927V Aureomycin 4 gram crumbles: 8,000 g/ton if top dressed A lower concentration if mixed into a grain mix or TMR Tylan: 8 10 g/ton 6

7 What s wrong? What s wrong? 7

8 Affirmation of intent statement is needed Anything else wrong?? 0.25 x 4.75 x 80 x 5 = 475 lb 8000 g/ton to provide 10 mg/lb. body wt. per day 500 Correct or Incorrect?? 8

9 INCORRECT Veterinarian s signature Statement: Use of feed containing this VFD drug Affirmation of intent What is the proper duration of treatment to denote? MUST DENOTE a finite number of days, NOT a range of days, within these guidelines: N T Milk Replacer in calves: 7 14 days Aureomycin (CTC) for bacterial enteritis and pneumonia treatment in cattle: up to 5 days Aureo S 700 in beef cattle: exactly 28 days CTC use in swine: not more than 14 days for control of lepto, or ileitis, or treatment of bacterial enteritis and pneumonia 9

10 Some label indications do not have a specified treatment duration For a few specific indications, treatment duration can be denoted as the full duration of the VFD, or some shorter period, as deemed appropriate by the veterinarian. Examples: Tylan for reduction of liver abscesses CTC for liver abscess reduction, respiratory disease control, and anaplasmosis control in cattle. CTC for reduction of vibrionic abortion in breeding sheep, and reduction in cervical lymphadenitis (jowl abscesses) in swine. **Expect these approvals to be revised to include a specified treatment duration in the future. Make sure all necessary information is provided!! 10

11 How many animals to treat?? Each animal can only be treated once per VFD. Repeat dosing of any treated animal is illegal without a new VFD. e.g. pulse dosing Aureomycin in dairy heifers Estimate the total number to be treated for the duration of the VFD, not the number in one of several recurring groups. e.g. Aureomycin treatment in 3 groups/cycles, each for 10 sick weaned heifers over the 6 month VFD duration. What does approximate number mean??? My estimation: a maximum of 5 10% more than the number denoted on the VFD. No refills or reorders are allowed for any of the currently approved VFD medications NOT an either/or selection! 11

12 No refills allowed!! How do you get an illegal VFD corrected? 1. Communicate w/the herd veterinarian ASAP Clearly identify and explain the errors, and specify the corrective action needed 2. Document the changes and void the original VFD (keep the old and the revised VFD stapled together) 3. Remember, you can t legally deliver a VFD product until you have a properly formatted VFD in your hand! 12

13 Remember your responsibilities 1. You can have VFD products in your inventory, but cannot sell and deliver them without receiving a copy of a valid VFD. 2. You can t legally deliver a VFD product to a farm until you have a properly formatted VFD in your hand! 3. You (and the vet) are responsible for ensuring that an appropriate amount of VFD product is sold and delivered to the farm. 4. VFD required to be sent with the order for all special mixes and direct drops. Send these VFDs to Sherri Dilling. 5. You MUST send a copy of the VFD(s) in to Renaissance with your applicable sales tickets. Send these VFDs to Trona Leaper. 6. The FDA is well aware of the Type A medicated article loophole and will be following up on those sales. Record Keeping VETERINARIAN Paper or electronic copy of the VFD kept for 2 years from the date of issuance DISTRIBUTOR (NUTRITIONIST, FEED STORE OR MILL) Paper or electronic copy of the VFD kept for 2 years from the date of issuance PRODUCER Paper or electronic copy of the VFD kept for 2 years from the date of issuance FDA can inspect or request VFD documentation from the veterinarian, distributor or producer at any time to verify compliance with VFD rules. You are legally obligated to produce records on demand. 13

14 The bottom line READ THE VFD, and MAKE SURE IT IS CORRECT BEFORE DELIVERING PRODUCT TO FARM 2. COMMUNICATE w/veterinarians ASAP TO CORRECT MISTAKES 3. DON T SHOOT THE MESSENGER!! QUESTIONS?? 14