Veterinary Pharmacy Issues

Transcription

1 KPhA s 133 rd Annual Meeting and Trade Show KPhA s 133 rd Annual Meeting and Trade Show Be the Critical Link DoubleTree by Hilton Hotel Overland Park, Kansas Veterinary Pharmacy Issues September 21, 2013 Shirley Arck, PharmD, FSVHP Disclosures I have no relevant financial relationships with commercial interests pertaining to the content presented in this program 1

2 Program Summary Pharmacists have long dispensed the occasional human drug for use in animals. Over the last few years the frequency of those prescriptions has increased. In addition, some veterinary labeled drugs have become available to be dispensed by a pharmacist. The goal of this presentation is to introduce applicable laws that apply to filling prescriptions for animals, identify useful references, and highlight select major differences in species response after drug administration. Learning Objectives Identify laws and regulatory bodies affecting veterinary medicine and pharmacy Identify veterinary pharmacy resources Describe the effect of a specific drug administered to an animal that differs from the effect usually seen in humans Agencies with oversight of products used in/on animals FDA FDA CVM USDA APHIS EPA State agencies 2

3 FDA Guidance, Compliance & Enforcement Food, Drug and Cosmetic Act AMDUCA Animal Medicinal Drug Use Clarification Act of 1994 Compliance Policy Guides Several CPG Sec Compounding of Drugs for Use in Animals AMDUCA Allows veterinarians to use most veterinary drugs and approved human drugs in an extralabel manner under certain conditions Extra-Label Use (ELDU) Actual use or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling AMDUCA Conditions Valid VCPR Veterinary-Client-Patient Relationship Defined in AMDUCA and Kansas law Health of animal is threatened. Suffering or death may result in failure to treat Many for food animals. 3

4 AMDUCA List of drugs prohibited from ELDU in foodproducing animals Most drugs on the list are rarely seen in human pharmacies, but does include fluoroquinolones AVMA ELDU algorithm AMDUCA Compounding Currently allowable only from finished products Approved animal drugs and human drugs Bulk chemicals not allowed Rarely, rarely OK to do for food animals Just say no CPG Compounding of Drugs for Use in Animals provides guidance to drug compounders, veterinarians, and the staff of the Food and Drug Administration (FDA) on how the Agency intends to address compounding of drugs intended for use in animals. This guidance describes FDA's current thinking on what types of compounding might be subject to enforcement action. cm htm 4

5 USDA Animal and Plant Health Inspection Service Animal Health USDA APHIS Veterinary Services protects and improves the health, quality, and marketability of our nation's animals, animal products and veterinary biologics by preventing, controlling and/or eliminating animal diseases, and monitoring and promoting animal health and productivity. Veterinary Biologics Vaccines Distemper, West Nile Antibodies Equine IgG Antitoxins Tetanus Antitoxin Toxoids Clostridium Biologic Diagnostic Tests Heartworm Antibody, Feline Leukemia USDA APHIS Animal Welfare Also enforces the Animal Welfare Acts 5

6 EPA Registers pesticides Some pesticides are used on animals Frontline Plus, Advantix Species Differences Cats bad at glucuronidation Acetaminophen, aspirin good at acetylation Diltiazem, hydralazine Some cats can t convert prednisone to prednisolone Dogs active at glucuronidation deficient in acetylation Sulonamides relatively toxic Species Differences Acetaminophen Dogs Do not metabolize as well as humans 10-15mg/kg po tid Never in cats Glucuronidation very slow Severe methemoglobinemia, hematuria, icterus If someone asks for Tylenol for their pet, just say no! 6

7 Species Differences Aspirin Human dose 5 to 10mg/kg po q4h Canine dose 10 to 40mg/kg po bid-tid Feline dose 10mg/kg po q48 hrs Cats lack glucoronyl transferase so slowly metabolize salicylate t1/2 elimination is 40 hours in cats vs 7.5 hours in dogs Species Differences Aspirin Cattle dose Yes, I said cattle Two to four 240 grain boluses PO 7

8 Other NSAIDs Small Animal Veterinary Labeled Oral Carprofen Propionic acid subgroup like ibuprofen Etodolac May be more selective for COX-2 than COX-1 in dogs Meloxicam 2.7 to 10x more selective for COX-2 than COX-1 in dogs Deracoxib 12 to 37x more selective in dogs Firocoxib 384x more selective in dogs Tepoxalin COX-LOX inhibitor in dogs as well as humans NSAIDs Ibuprofen Exquisitely toxic to dogs GI ulcers, bleeding, kidney failure Symptoms appear within 4 hours to days later Another one to just say no! 8

9 Species Differences Levothyroxine dose Canine 0.1mg to 0.8mg po bid Feline 0.05mg to 0.1mg po once daily Equine 10mg in 70ml corn syrup po once daily Birds 0.1mg tablet in 30ml to 120 ml water daily; stir water and offer for 15 minutes and then remove Breed Differences Ivermectin In most mammals P-Glycoprotein acts as a drugtransport pump at the blood-brain barrier transporting drugs from the brain back into the blood Collies do not have the PGP that is sensitive to ivermectin SE include seizures, salivation, disorientation, ataxia, trembling etc. Generally OK at labeled doses Oddities Guiafenesin Oral Expectorant Horses 3mg/kg PO Parenteral muscle relaxant Adjunctive to anesthesia Mostly used in horses ~100mg/kg IV No commercially available product currently 9

10 Oddities Grape and raisin toxicity in dogs Causes kidney failure Cause unclear maybe a mycotoxin 0.5 oz per pound of grapes 0.18 to 0.48 oz per pound of raisins Oddities Chocolate toxicity in dogs Theobromine Vomiting, diarrhea, panting, muscle spasms, potential cardiac arrest in older dogs As little as 1 oz baking chocolate or 8 oz of milk chocolate in a 50lb dog Oddities 10

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12 Resources Formularies Plumb s Veterinary Drug Handbook, 7 th ed. Donald Plumb, PharmD Boothe s Small Animal Formulary, 6 th ed. Dawn Boothe, DVM Exotic Animal Formulary, 4 th ed. James Carpenter, DVM Resources Pharmacology Texts Veterinary Pharmacology & Therapeutics, 9 th ed. Jim Reviere, DVM & Mark Papich, DVM Small Animal Clinical Pharmacology and Therapeutics, 2 nd ed. Dawn Boothe, DVM 12

13 Resources Other Merck Veterinary Manual Free FDA Green Book Search: Animal Compendium of Veterinary Products Bayer Healthcare CVP App - Free itunes, Google play, BlackBerry, Generic Mobile Edition Veterinary Health Center at Kansas State University Pharmacist vhc@vet.k-state.edu Courses University of Wisconsin Madison Extension Services in Pharmacy Veterinary Therapeutics, Veterinary Pharmacy Law Don Michalski, MS, RPh, Jim Budde, PharmD, Donald Plumb, PharmD University of Florida Continuing Pharmacy Education Certificate Course Veterinary Therapeutics for Practicing Pharmacists Elaine Blythe, PharmD Post-Test S.I.D means/is a. Sudden intense diarrhea b. Septal intestinal defect c. Systemic infectious disease d. Once a day 13

14 Post-Test Guaifenesin (glyceryl guiacolate): a. Is an expectorant b. Is available commercially in an FDA approved IV formulation c. Is used intravenously as a muscle relaxant in horses d. More than one, but not all of the above Post-Test Which of the following statements are true? a. Cats can safely take acetaminophen b. Dogs can safely take ibuprofen c. Raisins are toxic to dogs d. It is legal to give any drug to any animal if therapeutically indicated 14