2/21/2017. Doctor of Veterinary Medicine (DVM) Veterinary Medical Doctorate (VMD) Board Specialties. Technicians

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1 We agree that we have no conflicts of interest in this presentation. We also agree that there is no commercial bias related to this continuing education course. Discuss the role of veterinarians, their education, their terminology, and their patients. Identify common commercial and compounded medications and dosage forms utilized by veterinarians. Discuss federal and state regulations that affect both veterinary medicine and pharmacy. Identify resources and references for pharmacists and pharmacy technicians to use in their practice. A veterinarian diagnosed an older dog with epilepsy and prescribed 15mg of phenobarbital twice daily. When the client arrived at the pharmacy to pick up the prescription, the pharmacist told her that the dosage was too high and that she should reduce it in half. With the sub therapeutic treatment, the dog continued to suffer from seizures, until several weeks later when the veterinarian discovered the problem upon recheck. The dog was euthanized. A pharmacist suggested that a client purchase Rogaine to treat her dog s alopecia. Minoxidil is the active ingredient in Rogaine and can cause cardiomyopathy in dogs, something the pharmacist did not know. A dog with autoimmune disease was to treated with azathioprine. Instead the retail pharmacist dispensed azithromycin. The patient relapsed and had to be euthanized. 1

2 The American Pharmacists Association states: APhA encourages pharmacists and student pharmacists to become more knowledgeable about veterinary drugs and their usage. The American Association of Colleges of Pharmacy s Professional Affairs Committee issued a draft report titled: Producing Practice Ready Pharmacy Graduates in the Era of Value Based Healthcare. The reports reads in part: Veterinary pharmacy services are increasing in the United States across all practice settings, and the knowledge and skills necessary to treat our animal patients may be another opportunity for academic and clinical partnerships. National Association of Boards of Pharmacy Veterinary Pharmacy Education (Resolution ) NAPB Model State Pharmacy Act and Rules Be it further resolved that pharmacists dispensing medications for veterinary patients possess the competence and have access to resources necessary to appropriately dispense and provide care. Each pharmacy shall have ready access to references, to include at least one current reference in each other following categories, if applicable to services provided: State and Federal laws, pharmacology, dosage & toxicology, veterinary drugs, and general. Doctor of Veterinary Medicine (DVM) This is the degree awarded by all but one accredited veterinary school, and is therefore the degree most commonly held by veterinarians practicing in the US. Guinea Pigs Rabbits Chimpanzees Ducks Tapirs Lions Penguins Veterinary Medical Doctorate (VMD) This is a doctoral degree just like the DVM, but it comes from the Univerisity of Pennsylvania. Monitor Lizards Ferrets Chickens Pigs Board Specialties Board certified specialists such as; Veterinary Dermatology, Veterinary Ophthalmology, Zoological Medicine, and Internal Medicine to name a few. Equine Cows K9 Geese Technicians Certified Veterinary Technician (CVT), Registered Veterinary Technician (RVT), and Licensed Veterinary Technician (LVT). Feline Veterinarians Goats Patient the animal or pet being treated. Client the owner of the animal or pet being treated. FS Female Spayed MN Male Neutered TD Transdermal Mg/kg usually pronounced mig per kig And the granddaddy of them all sid this translates to once daily, or in Latin semel in die Most Veterinarians not only prescribe, but they dispense. Sales from the average Veterinarian s office amount to about ½ or their total revenue. Some Veterinarians have DEA numbers, some do not. Always check for controlled substance precriptions. Veterinarians normally DO NOT have NPI numbers. There is not a need, they don t bill insurance. 2

3 Pack Animals Ext. Release Drugs Problem Dogs Humans Part of Pack Canines rapidly absorb xylitol in their GI Tract Insulin Response Hypoglycemia GI Tract is short Gorgers Spend 60% of life asleep Nocturnal NSAIDS Ibuprofen, naproxen, and acetaminophen Causes gastrointestinal ulceration and renal lesions in doses that are safe in humans. May Adopt Humans Jacobson s Organ Methylxanthines Caffeine, chocolate, theophylline all have longer half lives in dogs than in humans. Has stimulatory effects on the CNS and cardiovascular tissue. The half life in dogs is more than twice what it is in humans. Solitary Animals Cats Meticulous Groomers Drug/Excipient/Food Species Affected Toxicity Alcohols Dogs, cats, birds Central nervous system toxicity Acetaminophen & NSAIDS These require conjugation by glucuronide to avoid formation of toxic metabolites. Once this pathway is saturated in cats (almost immediately), alternative pathways take over and toxic metabolites may be generated. There are no safe dosages of these in cats, as almost all NSAIDS can cause renal damage. Avocado Birds Pulmonary congestion, nonsuppurative inflammation of the liver, kidney, pancreas, skin, and proventriculus Benzocaine, benzoic acid derivatives Cats Red blood cell oxidative injury, hemolytic anemia Chocolate a Dogs, birds Cardiovascular and central nervous system stimulation Diazepam Cats have a somewhat limited ability to demethylate drugs. This is the pathway used to clear diazepam, thus it can sometimes cause irreversible, fatal, hepatocellular necrosis. Cremophor Dogs Histamine release, anaphylaxis Fat, fatty foods Dogs Increased risk of pancreatitis Doxycycline Solid dosage forms can become lodged in the esophagus and cause esophageal erosions and life threatening strictures. These dosage forms should always be followed by at least 6ml of a non irritating liquid. The liquid form is apple raspberry flavored which is totally unpalatable to cats. It will often cause profuse salivation, vomiting, and resistance to administration. Garlic, onions a Dogs, cats Hemolytic anemia Grapes, raisins a Dogs Renal toxicity Macadamia nuts a Dogs Lethargy, hyperthermia, ataxia, vomiting Pennyroyal Cats Hepatotoxicity Polysorbate 80 Dogs Histamine release, anaphylaxis Raw yeast dough Dogs Alcohol poisoning, gastrointestinal dilatation and volvulus Xylitol Dogs, birds Profound hypoglycemia and hepatocellular necrosis United States Pharmacopeial Convention, USP Pharmacists' Pharmacopeia: 3 Supplement ( ). 2nd ed. 3

4 Buprenorphine used in cats and dogs for relief of pain. Diethylstilbestrol used in spayed female dogs for incontinence, and in male dogs for BPH. Methimazole used in cats for hyperthyroidism Bromides used in dogs for seizure disorders Cisapride used in cats for treatment of constipation and megacolon Fluoxetine used in dogs for aggression, in cats for inappropriate elimination, in both for anxiety Transdermals Passage of therapeutic quantities of drug through the skin and into general circulation for systemic effects Non invasive, convenient external application Can be used in either cats or dogs. Especially effective in cats Used for difficult to medicate patients and chronic diseases Allows for caregiver safety Pluronic (Poloxomer) Gel Odorless and tasteless Good solubilizing capability with low toxicity good medium for drug delivery Transforms from low viscosity to solid gel on heating to body temperature When applied forms a solid barrier and sustained release drug depot Can be used topically or in hard to reach application sites Client education is necessary Chew Treats 4

5 A solid dosage form that is intended to be chewed and is easily swallowed Meant to increase the palatability and acceptance of medications and improve compliance Can be used in either dogs or cats. Especially effective in dogs A variety of flavors can be used Client education, especially regarding keeping out of the reach of children Oral Solutions and Suspensions Meant to increase the palatability and acceptance of medications and improve compliance Can be used in either dogs or cats. A variety of flavors can be used Client education on use of the oral dosage syringe Who is the patient Ease of administration for the client Storage requirements Beyond use date Cost Availability of active ingredient Availability of commercial product Client education And FLAVOR Species Cat Dog Bird Rabbit Ferret Reptiles Preference Meat, organ meat, fish Meat, salty, sweet Dietary dependent Herb, vegetable, sweet Meat, fish, sweet Dietary dependent 5

6 FDA CVM DOJ DEA USDA CVB Mark Papich Saunders Handbook of Veterinary Drugs Donald Plumb Plumb s Veterinary Drug Handbook James Carpenter Exotic Animal Formulary Susan Wynn & Steve Marsden Manual of Natural Veterinary Medicine Approved Animal Drug Products (Green Book) edanimaldrugproducts/default.htm Compendium of Veterinary Products Merck Veterinary Manual Cornell University College of Veterinary Medicine Howard Ansel Pharmaceutical Calculations US Pharmacopeial Convention healthcareprofessionals/compounding Lawrence Trissel Trissel s Stability of Compounded Formulations Pet Poison Helpline or or The American Society for the Prevention of Cruelty to Animals (ASPCA) or care/animal poisoncontrol Pet Poison Control FDA CVM, Form FDA 1932a ManualsForms/Forms/AnimalDrugForms/uc m pdf USDA CVB, Adverse Event Reporting Worksheets ealth/veterinary biologics/adverse eventreporting/ct_vb_adverse_event_forms 6

7 International Academy of Compounding Pharmacists American College of Veterinary Pharmacists Society of Veterinary Hospital Pharmacists American Veterinary Medical Association Michigan Veterinary Medical Assocation Michigan Administrative Code R The sale of prescription drugs for human use by a licensed pharmacist is exempt from tax. To qualify for this exemption, the pharmacist shall have a specific prescription as prescribed by a physician or other licensed practitioner of the healing arts. In short, prescriptions for non human use are taxable. Must be dispensed on the receipt of a valid prescription If compounding in advance of a prescription: Max inventory on hand may not exceed a quantity dispensed in any 14 day period over the last 6 months Cannot be used in food producing animals Finished compound must be labeled Not for use in food producing animals Applies to all cattle, swine, chicken, turkey, sheep, goats, bees and non ornamental fish are always considered to be food producing animals. Compounds using bulk powder API s RX must be documented as to the reason for compounding. Drugs must have a USP or NF monograph Bulk API s must be purchased from FDA approved manufacturers If an adverse event occurs, you must use FDA form 1932a This is different than reporting human adverse events! Compounded Drugs cannot be provided to offices for the purpose of resale! Mostly the same as human prescriptions EXCEPT: The name of the treated animal must be listed The species of the treated animal must be listed The owner of the animal must be listed For Controlled Substances: Must send the name of the owner and their information to MAPS. DUR and Consulting requirements have same legal force as for humans. You are also required by the Public Health Code to: Accurately interpret and evaluate the prescription Select the appropriate drug product Advise the prescriber and the patient as required as to contents, therapeutic action, utilization, and possible adverse reactions or interactions of drugs. Compound, dispense, and store drugs in a safe manner. 7

8 Pharmacists CANNOT counsel patients on OTC therapy using human meds for animals without a prescription from a veterinarian. WHY? 21 CFR Any human drug safe for use in animals is considered extralabel use An order from a veterinarian is required Requires a valid patient veterinarian relationship Recommend a drug labelled for an animal for animal use with out a veterinarian order. You can IF AND ONLY IF the drug is labelled and approved by the FDA Not all animal drugs have FDA approval Nor are they required to be in order to be sold! In these cases a pharmacy will be required to have an RX for these items! Use Dailymed to look for FDA approval. An NDC does not indicate FDA approval. Found under Ingredients and Appearance Can a doctor prescribe medications for any animal. NO! This is considered to be outside their scope of practice. A valid veterinarian client relationship does not exist as required under federal law. FDA form 1932a: manualsforms/forms/animaldrugforms/uc m pdf Legal Reference: 21 CFR Part 530 deals with human drugs for animal use The Michigan Board of Pharmacy provisions on animal drugs are in the General Rules and Controlled Substance Rules. 8

9 Which of the following should never be used in dogs? A) Tramadol B) Fluoxetine C) Xylitol D) DES Which of the following should never be used in dogs? A) Tramadol B) Fluoxetine C) Xylitol D) DES Xylitol is absorbed from the GI tract in dogs. It acts like glucose to stimulate the release of insulin causing rapid decline in blood glucose. Dogs become extremely hypoglycemic and may die. Chronic exposure also results in hepatic necrosis. Which of the following in NOT a consideration when compounding medication for a pet? A) Availability of a commercial product B) Flavor C) Beyond use date D) Color Which of the following in NOT a consideration when compounding medication for a pet? A) Availability of a commercial product B) Flavor C) Beyond use date D) Color All the others are among the list of compounding considerations. 9