Mitigating Pain in Livestock: What Options are Available
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1 Mitigating Pain in Livestock: What Options are Available NIAA 2014 Annual Conference Omaha, Nebraska April 2, 2014 Craig A. Lewis, DVM, MPH, DACVPM Center for Veterinary Medicine U.S. Food and Drug Administration,
2 Mitigating Pain in Livestock: What (Legal) Options are Available NIAA 2014 Annual Conference Omaha, Nebraska April 2, 2014 Craig A. Lewis, DVM, MPH, DACVPM Center for Veterinary Medicine U.S. Food and Drug Administration,
3 Outline Background Drugs (approved, unapproved, compounded) Extralabel Drug Use Pain Mitigation from the Literature (Status) Questions Under AMDUCA is extra-label use of analgesics and anesthetics permitted? Is extra-label use of products restricted only to those products that have been approved by FDA and have an NADA or NDA number? 2
4 Pain Mitigation Disease pain Cutaneous Visceral (serosa, distention, swelling) Musculoskeletal (bone, joint, muscle) (Inflammatory) Surgical pain General Localized 3
5 NSAIDs Aspirin Sodium salicylate Flunixin Ketoprofen Diclofenac Phenylbutazone Meloxicam Carprofen Pain Mitigation (from the literature) 4
6 Local anesthetics Lidocaine Mepivacine Bupivacaine Pain Mitigation (from the literature) 5
7 Barbiturates Pentobarbital Thiopental Acepromazine Benzodiasepines Diazepam Midazolam Azaperone Xylazine Pain Mitigation (from the literature) 6
8 Pain Mitigation (from the literature) Butorphanol Medetomidine Ketamine Tiletamine-zolazepam (Telazol) Guaifenesin Tramadol Yohimbine 7
9 Halothane Isoflurane Propofol Guaifenesin Tramadol Pain Mitigation (from the literature) 8
10 Approved Animal Drugs To be legally marketed, an animal drug must be the subject of an approved new animal drug application (NADA) an approved generic application [abbreviated new animal drug] application] (ANADA) a conditional approval an index listing 9
11 Approved Human Drugs To be legally marketed, a human drug must be the subject of an approved new drug application (NDA) an approved generic application [abbreviated new drug application] (ANDA) An OTC Drug Monograph 10
12 Unapproved Animal Drugs No pre-approval review No post-approval monitoring May unfairly compete against approved products Reduces the availability of legal, reviewed, tested and monitored drug products 11
13 Unapproved Animal Drugs Animal drugs illegally marketed in the United States that have not been approved by the Food and Drug Administration (FDA) Unapproved animal drugs have not been reviewed under FDA's legal review processes 12
14 Compounded Animal Drugs If compounded from approved drugs (as starting ingredients) MAY be legal under ELU regulations If compounded from bulk ingredients IS considered an unapproved animal drug Zero tolerance for compounding from bulk ingredients for food-producing animals 13
15 Compounded Animal Drugs Unknown quality control/manufacturing standards Unknown assurance of purity, potency, or stability Potential animal safety and efficacy issues Potential for unknown or unsafe residues Difficult to monitor No reporting requirements (even less than for other unapproved animal drugs) 14
16 Extralabel Drug Use Extralabel is the use of an approved drug in a manner that is not in accordance with the approved label directions. e.g. indication, species, dosage level, frequency, route of administration Allows veterinarians to prescribe extralabel uses of certain approved animal drugs and approved human drugs 15
17 Extralabel Drug Use Such use is limited to treatment modalities when the health of an animal is threatened or suffering or death may result from failure to treat. 16
18 Extralabel Drug Use Must be by or on the order of a veterinarian within the context of a valid veterinarian-client-patient relationship Must not result in violative residues Must be in conformance with all other parts of extralabel drug use regulation (21 CFR Part 530) Must not use drugs prohibited from extralabel use 17
19 Extralabel Drug Use Establish a substantially extended withdrawal period prior to marketing of milk, meat, eggs, or other edible products supported by appropriate scientific information. 18
20 Extralabel Drug Use Take appropriate measures to assure that assigned timeframes for withdrawal are met and no illegal drug residues occur in any food-producing animal subjected to extralabel treatment. 19
21 Extralabel Drug Use Approved animal drugs Approved human drugs Conditionally approved animal drugs Indexed animal drugs Medicated feeds VFD drugs (veterinary feed directive) Human OTC monographed drugs Unapproved animal drugs Drugs compounded from approved drugs Drugs compounded from bulk ingredients 20
22 Extralabel Drug Use Approved animal drugs (Rx or OTC) Approved human drugs Conditionally approved animal drugs Indexed animal drugs Medicated feeds VFD drugs (veterinary feed directive) Human OTC monographed drugs Unapproved animal drugs Drugs compounded from approved drugs Drugs compounded from bulk ingredients 21
23 Extralabel Drug Use Approved animal drugs (Rx or OTC) Approved human drugs Conditionally approved animal drugs Indexed animal drugs Medicated feeds VFD drugs (veterinary feed directive) Human OTC monographed drugs Unapproved animal drugs Drugs compounded from approved drugs Drugs compounded from bulk ingredients 22
24 Extralabel Drug Use Approved animal drugs (Rx or OTC) Approved human drugs Conditionally approved animal drugs Indexed animal drugs Medicated feeds VFD drugs (veterinary feed directive) Human OTC monographed drugs Unapproved animal drugs Drugs compounded from approved drugs Drugs compounded from bulk ingredients 23
25 Extralabel Drug Use Approved animal drugs (Rx or OTC) Approved human drugs Conditionally approved animal drugs Indexed animal drugs Medicated feeds VFD drugs (veterinary feed directive) Human OTC monographed drugs Unapproved animal drugs Drugs compounded from approved drugs Drugs compounded from bulk ingredients 24
26 Extralabel Drug Use Approved animal drugs (Rx or OTC) Approved human drugs Conditionally approved animal drugs Indexed animal drugs Medicated feeds VFD drugs (veterinary feed directive) Human OTC monographed drugs Unapproved animal drugs Drugs compounded from approved drugs Drugs compounded from bulk ingredients 25
27 Extralabel Drug Use Approved animal drugs (Rx or OTC) Approved human drugs Conditionally approved animal drugs Indexed animal drugs Medicated feeds VFD drugs (veterinary feed directive) Human OTC monographed drugs Unapproved animal drugs Drugs compounded from approved drugs Drugs compounded from bulk ingredients 26
28 Extralabel Drug Use Approved animal drugs (Rx or OTC) Approved human drugs Conditionally approved animal drugs Indexed animal drugs Medicated feeds VFD drugs (veterinary feed directive) Human OTC monographed drugs Unapproved animal drugs Drugs compounded from approved drugs Drugs compounded from bulk ingredients 27
29 Extralabel Drug Use Approved animal drugs (Rx or OTC) Approved human drugs Conditionally approved animal drugs Indexed animal drugs Medicated feeds VFD drugs (veterinary feed directive) Human OTC monographed drugs Unapproved animal drugs Drugs compounded from approved drugs Drugs compounded from bulk ingredients 28
30 Extralabel Drug Use Approved animal drugs (Rx or OTC) Approved human drugs Conditionally approved animal drugs Indexed animal drugs Medicated feeds VFD drugs (veterinary feed directive) Human OTC monographed drugs Unapproved animal drugs Drugs compounded from approved drugs Drugs compounded from bulk ingredients 29
31 Extralabel Drug Use Approved animal drugs (Rx or OTC) Approved human drugs Conditionally approved animal drugs Indexed animal drugs Medicated feeds VFD drugs (veterinary feed directive) Human OTC monographed drugs Unapproved animal drugs Drugs compounded from approved drugs Drugs compounded from bulk ingredients 30
32 NSAIDs Aspirin Sodium salicylate Flunixin Ketoprofen Diclofenac Phenylbutazone Meloxicam Carprofen Pain Mitigation (from the literature) 31
33 Pain Mitigation (from the literature) NSAIDs Aspirin Unapproved animal cattle, swine, sheep, poultry (marketed) OTC monograph human (marketed) Sodium salicylate Flunixin Ketoprofen Diclofenac Phenylbutazone Meloxicam Carprofen 32
34 Pain Mitigation (from the literature) NSAIDs Aspirin Sodium salicylate Unapproved animal cattle, swine, poultry (marketed) Flunixin Ketoprofen Diclofenac Phenylbutazone Meloxicam Carprofen 33
35 Pain Mitigation (from the literature) NSAIDs Aspirin Sodium salicylate Flunixin Approved animal horses, cattle, swine (marketed) Ketoprofen Diclofenac Phenylbutazone Meloxicam Carprofen 34
36 Pain Mitigation (from the literature) NSAIDs Aspirin Sodium salicylate Flunixin Ketoprofen Approved animal horses (marketed) Diclofenac Phenylbutazone Meloxicam Carprofen 35
37 Pain Mitigation (from the literature) NSAIDs Aspirin Sodium salicylate Flunixin Ketoprofen Diclofenac Phenylbutazone Approved animal horses (marketed) Meloxicam Carprofen 36
38 Local anesthetics Lidocaine Mepivacine Bupivacaine Pain Mitigation (from the literature) 37
39 Local anesthetics Lidocaine Pain Mitigation (from the literature) Unapproved animal, injectable cattle (marketed) Unapproved animal, topical (marketed) Mepivacine Bupivacaine 38
40 Barbiturates Pentobarbital Thiopental Acepromazine Benzodiazepines Diazepam Midazolam Azaperone Xylazine Pain Mitigation (from the literature) 39
41 Pain Mitigation (from the literature) Barbiturates Pentobarbital Thiopental Approved animal dog, cats (not marketed) Acepromazine Benzodiazepines Diazepam Midazolam Azaperone Xylazine 40
42 Pain Mitigation (from the literature) Barbiturates Pentobarbital Thiopental Acepromazine Benzodiazepines Diazepam Approved animal dogs (not marketed) Midazolam Azaperone Xylazine 41
43 Pain Mitigation (from the literature) Barbiturates Pentobarbital Thiopental Acepromazine Benzodiazepines Diazepam Midazolam No approved/marketed animal products Azaperone Xylazine 42
44 Pain Mitigation (from the literature) Barbiturates Pentobarbital Thiopental Acepromazine Benzodiazepines Diazepam Midazolam Azaperone Approved animal swine (not marketed) Xylazine 43
45 Pain Mitigation (from the literature) Barbiturates Pentobarbital Thiopental Acepromazine Benzodiazepines Diazepam Midazolam Azaperone Xylazine Approved animal drug cats, dogs, horses, deer (marketed) 44
46 Pain Mitigation (from the literature) Butorphanol Medetomidine Ketamine Tiletamine-zolazepam (Telazol) Guaifenesin Tramadol Yohimbine 45
47 Pain Mitigation (from the literature) Butorphanol Approved animal dogs, cats, horses (marketed) Medetomidine Ketamine Tiletamine-zolazepam (Telazol) Guaifenesin Tramadol Yohimbine 46
48 Pain Mitigation (from the literature) Butorphanol Medetomidine Approved animal dogs, cats (marketed) Ketamine Tiletamine-zolazepam (Telazol) Guaifenesin Tramadol Yohimbine 47
49 Pain Mitigation (from the literature) Butorphanol Medetomidine Ketamine Approved animal cats, primates (marketed) Tiletamine-zolazepam (Telazol) Guaifenesin Tramadol Yohimbine 48
50 Halothane Isoflurane Propofol Guaifenesin Tramadol Pain Mitigation (from the literature) 49
51 Halothane Isoflurane Pain Mitigation (from the literature) Approved animal dogs, horses (marketed) Propofol Guaifenesin Tramadol 50
52 Under AMDUCA is extra-label use of analgesics and anesthetics permitted? 51
53 Under AMDUCA is extra-label use of analgesics and anesthetics permitted? Yes 52
54 Is extra-label use of products restricted only to those products that have been approved by FDA and have an NADA or NDA number? 53
55 Is extra-label use of products restricted only to those products that have been approved by FDA and have an NADA or NDA number? Yes 54
56 Is extra-label use of products restricted only to those products that have been approved by FDA and have an NADA or NDA number? Yes (for the most part) 55
57 56
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