1. CHAPTER 1 Dr. Dipa Brahmbhatt VMD MpH, MS dbrahmbh@yahoo.com

3. BOOKS

4. WHY ‘Veterinary Technician must understand why the diagnosis was made, why the surgery was performed, why the prognosis was rendered and why the treatment was prescribed’

5. Medication Error “Medication error as any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer” June 2010

6. Commonly Misinterpreted Abbreviations Abbreviation usedIntended asMisread as UUnits0 (zero) IUInternational UnitsIV (intravenously) mcg or µgMicrogrammg (milligram) SIDOnce daily BID (twice daily) and QID (four times daily) TIWThree times a weekThree times daily QhsAt bedtimeEvery hour

7. Iatrogenic?

8. ALL DRUGS ARE POISONS Safety and Efficacy is dependent on DOSE, MODE OF ADMINISTRATION and INDIVIDUAL patient characteristics – Tylenol (acetaminophen) safe for humans, tolerated in dogs and DEADLY IN CATS – Intranasal IBR given Subcutaneous – Underweight or dehydrated patients – Drug is a substance used to tx, prevent or dx. Dz. In animals

9. Top Pet Toxin of 2008: Medications In 2008, human medications like ibuprofen, acetaminophen, decongestants, cold medicines and anti-depressants topped the ASPCA's list of most common pet poisons ibuprofen, acetaminophen http://www.suite101.com/content/most-common-pet-poisons- according-to-aspca-a87882

10. DEFINITION Veterinary Pharmacology: ‘The STUDY and USE of drugs in animal healthcare Goal of veterinary clinical pharmacology is to optimize therapy (individual, herd, flock, etc )

11. BRIEF HISTORY 5000 B.C.: India hospital for horses and elephants 1700’s: Cattle epidemic in Europe 1760’s: France began opening veterinary colleges 1860’s: First veterinary school in Philadelphia

12. SOURCES OF DRUGS Drug SourceExample MineralsSulfur, iron, electrolytes Botanicals: Plants, Molds, BacteriaDigitalis, antibiotics AnimalInsulin, TH, Lanolin Synthetic (manmade/engineered) Laboratory via chemical reaction Greater purity Aspirin, steroids, procaine (novocain)

13. PHARMACOLOGY TERMS ‘Pharmaco’ Drug / Medicine ‘Pharmacotherapeutics’ Tx of disease with Medicine ‘Pharmacokinetics’ Study of absorption, Blood levels, distribution, Biotransformation, excretion ‘Pharmacodynamics’’ MOA of drug Effects: Biological and physiological

14. PHARMACOLOGY TERMS CHEMICAL NAME NONPROPRIETARY NAME/ GENERIC NAME Active ingredient PROPRIETARY/ TRADE NAME D(-)-alpha-amino-p- hydroxybenzyl-penicillin trihydrate AmoxicillinAmoxi-Drop (Pfizer) Biomox (Virbac) Robamox-V (FD) ((3-phenoxyphenyl) methyl cis-trans-3-(2,2- dichloroethenyl)-2,2- dimethylcyclopropanecarbox ylate)) Permethrin insecticideAtroban Defend Flysect Dl 2-(o-chlorophenyl)-2- (methylamino) cyclohexanone hydrochloride Ketamine hydrochlorideKetasat Vetalar

15. PHARMACOLOGY TERMS DOSAGE Amount given over time 10mg/kg (for 5 kg dog DOSE is 50 mg) Dosage regimen: 13.5mg/kg every 12 hours for 14 days (Clavamox) DOSE Amount of drug administered at one time to patient 1 ml 2 tablets

16. FDA http://www.fda.gov/default.htm Pre 1906: little regulation of drugs 1906: Federal Pure Food and Drug Act The FDA (Food and Drug Administration) created to enforce the Act Established standards for drug strength, purity, and guidelines for labeling 1906 – 1930’s FDA was small and their authority was limited Source of drugs was botanical: ergot, quinine, digitalis Dosing/toxicities as proper testing was not performed

17. SULFANILAMIDE ELIXER “Taste of raspberries… taste of death” " But to realize that six human beings, all of them my patients, one of them my best friend, are dead because they took medicine that I prescribed for them innocently, and to realize that that medicine which I had used for years in such cases suddenly had become a deadly poison in its newest and most modern form, as recommended by a great and reputable pharmaceutical firm in Tennessee: well, that realization has given me such days and nights of mental and spiritual agony as I did not believe a human being could undergo and survive. I have known hours when death for me would be a welcome relief from this agony." (Letter by Dr. A.S. Calhoun, October 22, 1937)

18. Regulation of Drug Products The Food and Drug Administration (FDA) became a government agency to enforce the federal Pure Food and Drug Act of 1906 – The Pure Food and Drug Act established standards for drug strength, purity, and guidelines for drug labeling Until the late 1930s, the FDA had little power to determine and enforce correct drug dosage information In 1938, Congress passed the federal Food, Drug, and Cosmetic Act (FDCA), which required that a drug be adequately tested to demonstrate its safety when used as its label directs In 1972, the FDCA was amended to include many more protections Copyright © 2011 Delmar, Cengage Learning

19. Regulation of Drug Products The FDA is headed by a commissioner and organized into a number of different centers The FDA’s Center for Veterinary Medicine (CVM) ensures that approved veterinary medicines will not harm animals The FDA-CVM prohibits the sale and use of a drug that would cause animals to suffer serious health problems The 1968 amendments to the FDCA made drug manufacturers specify drug withdrawal periods and detection methods for determining drug residues in animal foodstuffs Details: Figure 1-1 Copyright © 2011 Delmar, Cengage Learning

20. FDA http://www.fda.gov/downloads/AnimalVeterinary/NewsEvents/FDAVeterinarianNewsletter/UC M236854.pdf YESNOMAYBE SO Animal DrugsVaccines (USDA)Pharmacies Banned turtles under 4 inches Salmonella carriers Antibodies (USDA)Practice of Vet Med. Extra label use Animal Devices: if adulterated/ misbranded Toxoids (USDA) Flea and Tick products FDA/EPA Animal Feed: safe ingredients, human food safety NO REGULATION cat litter, pet accessories (toys, bed, crates), grooming aids FDA: milk, milk products (cheese, cream, and ice cream) and “Shell eggs” (eggs inside their shells) USDA: egg products meat, poultry, and catfish

21. OBTAIN DRUGS PrescriptionExtra - Label Controlled Substances Over the counter OTC: safe for animal, the person administering the medication, people coming into contact with the animal, the human food chain and the environment

22. OBTAIN DRUGS Prescription Drugs – Considered toxic, potentially toxic if misused or too readily misused – Regulated by the FDA and are limited to use under the supervision of a veterinarian or physician – Obtained through vet or prescription – VETERINARIAN/CLIENT/PATIENT RELATIONSHIP (VCPR) – “CAUTION: Federal law restricts the use of this drug to use by or on the order of a licensed veterinarian”

23. Prescription Drug label Vet techs cannot write prescriptions but can fill drug orders and dispense medication as instructed by vet

24. VCPR 1.Animal has been examined by a veterinarian who assumes responsibility for making judgments about the animal’s health and the need for treatment 2.Client agrees to follow the given Instructions 3. Veterinarian is available for follow-up 4. http://www.avma.org/animal_health/vcpr_poster.pdf Jane R. Shaw, DVM, PhD

25. OBTAIN DRUGS OFF-LABEL or EXTRA-LABEL – Vet discretion – Not indicated by labeling by FDA – ANIMAL MEDICINAL DRUG USE CLARIFICATION ACT (AMDUCA) - 1994 Extra label by OR order of licensed veterinarian VCPR NO DRUG RESIDUES IN FOOD ANIMAL Extra label not allowed in FEED ADDITIVES Code of Federal Regulations: DRUGS cannot be used http://cpharm.vetmed.vt.edu/vm8784/default.htm

27. AMDUCA American Medicinal Drug Use Clarification Act of 1994 Sec. 530.41. The following drugs are prohibited for extralabel animal and human drug uses in food-producing animals: (a______________________ ; (b) Clenbuterol; (c) Diethylstilbestrol (DES); (d) Dimetridazole; (e) Ipronidazole; (f) Other nitroimidazoles; (g) Furazolidone (except for approved topical use); (h) Nitrofurazone (except for approved topical use); and (i) Sulfonamide drugs in lactating dairy cattle (except approved use of sulfadimethoxine, sulfabromomethazine and sulfaethoxypyridazine). Dated: October 22, 1996. William B. Schultz, Deputy Commissioner for Policy. [FR Doc. 96-28662 Filed 11-6-96; 8:45 am] BILLING CODE 4160-01-F

28. AMDUCA Rimadyl in cats is used by a number of veterinarians. – However the U.S. label states: “WARNINGS: Keep out of reach of children. Not for human use. Consult a physician in cases of accidental human exposure. For use in dogs only. Do not use in cats.”

29. FARAD http://www.farad.org/ Food Animal Residue Avoidance Databank (FARAD) FARAD: University based computer-based system – Provide information on how to avoid drug, pesticide, and environmental contaminant residue problems – Current label information including withdrawal times of drugs, official tolerances, scientific articles, pharmacokinetics, and the fate of chemicals in food animals – List of drugs prohibited for use in livestock – Sponsored by USDA

30. CONTROLLED SUBSTANCES Drugs that are considered to be dangerous because of the potential for human misuse or abuse They are regulated by the DRUG ENFORCEMENT ADMINISTRATION (DEA) via the CONTROLLED SUBSTANCES ACT of 1970. Before this act, drug abuse was defined as the illicit use of an illegal drug or the improper use of a prescription drug. After 1970, controlled substances were classified into 5 schedules that are based on the potential for abuse. The higher the number (schedule), the lower the risk for abuse.

31. Vet Details

32. CONTROLLED SUBSTANCES FDA (DHHS) regulates the development and approval of drugs, DEA (Justice Dept.): regulates the laws and rules pertaining to the purchase, storage and use of controlled substances Vets need to register with the DEA annually Stored in locked cabinet / safe, records (file with DEA and log every 2 years) Any address changes are to be reported to the DEA.

34. Controlled substances Veterinary Technician Role – Order, keep records, maintain storage procedures – Cannot dispense

35. Controlled Substance Medication

36. Acetominophen Toxicity Cat Tylenol Toxicity Moonface

37. CHAPTER REVIEW ___ drugs that can be purchased without a prescriptionA) pharmacodynamics ___ drugs considered dangerous because of their potential forB) controlled substances Human abuseC) pharmacokinetics ___ drugs that can be obtained only through a veterinarian or D) over the counter drug Via a prescriptionE) pharmacotherapy ___ drugs used in a manner not specifically described on the F) prescription drugs FDA- approved labelG) extra-label drugs ___ study of a drug’s mechanism of action and its biological H) vet. pharmacology And physiological effectsI) FDA-CVM ___ study of the absorption, blood levels, distribution, metabolism, And excretion of drugsJ) Animal Medicinal Drug ___ the treatment of disease with medicinesUse Clarification Act of ___ the study and use of drugs in animal health care1994 ___ the law that allows extra-label use of a drug under certain Conditions ___ agency that ensures that approved veterinary medicines are Relatively safe for animals

38. CHAPTER REVIEW CONT’D 1)The FDA became a government agency after the passage of the a) Federal Food and Drug Act of 1906 b) Controlled Substances Act of 1970 c) Food, Drug, and Cosmetic Act of 1938 2)A person studying how the body absorbs, uses, and gets rid of codeine is engaged in the pharmacological specialty called a) pharmacotherapeutics b) pharmacodynamics c) pharmicokinetics

39. CHAPTER REVIEW 3) Controlled substances must a) be kept in a locked cabinet or safe b) have orders, receipts, uses, and thefts recorded c) be ordered by veterinarians who register annually with the DEA d) All of the above 4) The higher (larger) the schedule number of a controlled substance drug a) the higher the risk for human abuse potential b) the lower the risk for human abuse potential c) the less medical value it has

40. CHAPTER REVIEW TRUE OR FALSE 1)Prescription drugs are limited to use under the supervision of a veterinarian or physician. 2)The majority of veterinary drugs in use during the early 1900s were found naturally in plants 3)The major requirement of the Food, Drug, and Cosmetic Act of 1938 is the requirement of drug safety 4)Diazepam (Valium) is an example of a schedule I drug 5)Over the counter drugs are approved for human use only by the FDA

41. THE FOLLOWING IS THE PART OF THE PACKAGE INSERT FOR RIMADYL….. Can you identify which section refers to PHARMACODYNAMICS and which refers to PHARMACOKINETICS?

42. CLINICAL PHARMACOLOGY: Carprofen is a non-narcotic, non-steroidal anti-inflammatory agent with characteristic analgesic and antipyretic activity approximately equipotent to indomethacin in animal models. The mechanism of action of carprofen, like that of other NSAIDs, is believed to be associated with the inhibition of cyclooxygenase activity. Two unique cyclooxygenases have been described in mammals. The constitutive cyclooxygenase, COX-1, synthesizes prostaglandins necessary for normal gastrointestinal and renal function. The inducible cyclooxygenase, COX-2, generates prostaglandins involved in inflammation. Inhibition of COX-1 is thought to be associated with gastrointestinal and renal toxicity while inhibition of COX-2 provides anti-inflammatory activity. The specificity of a particular NSAID for COX-2 versus COX-1 may vary from species to species. In an in vitro study using canine cell cultures, carprofen demonstrated selective inhibition of COX-2 versus COX-1. Clinical relevance of these data has not been shown. Carprofen has also been shown to inhibit the release of several prostaglandins in two inflammatory cell systems: rat polymorphonuclear leukocytes (PMN) and human rheumatoid synovial cells, indicating inhibition of acute (PMN system) and chronic (synovial cell system) inflammatory reactions. Several studies have demonstrated that carprofen has modulatory effects on both humoral and cellular immune responses. Data also indicate that carprofen inhibits the production of osteoclast-activating factor (OAF), PGE1, and PGE2 by its inhibitory effect in prostaglandin biosynthesis. Based upon comparison with data obtained from intravenous administration, carprofen is rapidly and nearly completely absorbed (more than 90% bioavailable) when administered orally. Peak blood plasma concentrations are achieved in 1–3 hours after oral administration of 1, 5, and 25 mg/kg to dogs. The mean terminal half-life of carprofen is approximately 8 hours (range 4.5–9.8 hours) after single oral doses varying from 1–35 mg/kg of body weight. After a 100 mg single intravenous bolus dose, the mean elimination half-life was approximately 11.7 hours in the dog. Rimadyl is more than 99% bound to plasma protein and exhibits a very small volume of distribution. Carprofen is eliminated in the dog primarily by biotransformation in the liver followed by rapid excretion of the resulting metabolites (the ester glucuronide of carprofen and the ether glucuronides of 2 phenolic metabolites, 7-hydroxy carprofen and 8-hydroxy carprofen) in the feces (70– 80%) and urine (10–20%). Some enterohepatic circulation of the drug is observed.

43. Medical Calculation 1 Trade name: ‘Clavamox’ Generic: Amoxicillin-Clavulanic acid Broad spectrum bacterium DOSAGE: 13.75 mg/ kg BID PO X 14 days 1) How many tablets for a 15.5 lbs. dog per day Concentration: 62.5 mg, 125 mg, 250 mg, 400 mg tablets 2) How many total tablets dispensed to the owner

44. References Romich, J.A. Pharmacology for Veterinary Technicians, 2 nd edition. 2010. Bill, R.L. Clinical Pharmacology and Therapeutics for the Veterinary Technician, 3 rd edition. 2006. http://cpharm.vetmed.vt.edu/vm8784/default.htm http://cpharm.vetmed.vt.edu/vm8784/default.htm

45. References Dave Sobecki, Allan G. Bluman, Angela Schirck-Matthews. Math in our World. McGraw-Hill Companies,Inc. 2010 http://www.msnbc.msn.com/id/35286379/ns /health-pet_health/t/when-vets-make- mistakes-pets-pay-price/ http://www.msnbc.msn.com/id/35286379/ns /health-pet_health/t/when-vets-make- mistakes-pets-pay-price/ http://www.fda.gov/AnimalVeterinary/Resour cesforYou/ucm214772.htm