VETERINARY DRUG USE AND PRESCRIBING Chapter 5

1. VETERINARY DRUG USE AND PRESCRIBINGChapter 5 Dr. DipaBrahmbhatt VMD MpHdbrahmbhatt@vettechinstitute.edu

2. Brand Name (®) or Not? • All drugs have 3 names • Chemical name • Generic (nonproprietary) name (active ingredient) • Trade (proprietary) name

3. Brand Name (®) or Not? • TRADE NAME: • Benadryl • CHEMICAL NAME: • 2(Diphenylmethoxy)-N,N-dimethylethylamine hydrochloride • CHEMICAL STRUCTURE: • GENERIC NAME: • diphenhydramine hydrochloride

4. Brand Name (®) or Not?

5. Chemical Name • Provides scientific and technical information • Is a precise description of the substance • Example: 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one

6. Generic NameNonpropriety • Official identifying name of the drug (assigned by USAN the U.S. Adopted Names Council) • Describes the active ingredient • Written using lowercase letters • Example: diazepam

7. Do you know the generic name? • TYLENOL • acetaminophen • ADVIL • ibuprofen • CLARITIN • loratadine

8. Trade NamePropriety/ Brand • Establishes legal proprietary recognition for the corporation that developed the drug • Registered with the U.S. Patent Office, only by the company that registered the drug (approved by FDA) • Written in capital letters or begins with a capital letter and has a circled, superscript R (registered) or TM (not registered). Example: Valium

9. Xylazine/Rompun®

10. Trade name? • Pseudoephedrine • Sudafed • Chlorpheniramine • Chlor-trimeton • Famotidine • Pepcid

11. Generic • Expiry of patent – 17 yrs. • Than other drugs can market drug: own trademark name or generic name of drug (trademark law: can’t look the same) • They must be bioequivalent (produce similar blood levels as patent) • Can have different pharmacological effects (vet needs to assess this) • Generic drugs are usually cheaper

12. Compounding • Is the preparation, mixing assembling, packaging, and/ or labeling of a drug based on a prescription drug order from a licensed practitioner for an individual patient • Occurs when health professionals prepare a specialized drug product to fill an individual patient’s needs when an approved drug is not available

13. Suspensions: “Shake Well”

14. Compounding • Uses of compounding • Creating discontinued drugs (cisapride cats megacolon) • Creating dosages and strength specific to a patient’s weight and health • Creating alternative dose forms such as liquids, ointments, or chewable tablets (Phenobarb elixir) • Adding flavoring to drugs to make them more appealing to animals • Customizing formulas that combine multiple drugs for one dose administration

16. Compounding • Concerns • Changes may turn an FDA approved drug into an unapproved drug • Compounded drugs are made without FDA oversight and may pose a risk to the patient • Compounded drugs may not be sterile • Errors may result in disease or death in patients who use them • Public health concerns • Food animals: drug residue, withdrawal time, reaction to drug/inactive forms

17. Compounding • 1996: Taskforce (vets, pharmacists and regulators): Compliance Policy Guide (CPG) for FDA-CVM • discusses that food-producing animals should not receive drugs that are labeled for humans • No regulatory action if • A legitimate medicinal need ID • Appropriate dose regimen for specific species, size, age, or medical condition • No marketed approved animal drug that can treat condition http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm117042.htm

18. Sources of Drug Information • United States Pharmacopoeia (USP) • Publication that is the legally recognized drug standard of the United States • Describes the source, appearance, properties, standards of purity, and other requirements of the most important pure drugs • The FDA requires that all drugs meet USP standards of purity, quality, and uniformity • FDA adherence to drug standard and regulation • All drugs must meet USP standards, be correctly labeled, identifying the manufacturer and the directions for use. All advertisements must be true and correct

19. Sources of Drug Information • FDA requires that a drug label state: indications for use, species to be used in, route of administration, dose, length of treatment • Drug label must contain: • Drug names (generic and trade) • Drug concentration and quantity • Name and address of manufacturer • Manufacturer’s control or lot number • Expiration date of drug • Withdrawal time (if warranted) • Controlled substance status of drug (if warranted)

21. Sources of Drug Information • Package insert • Provided with drugs to meet regulatory requirements • Registered trade name, generic name, controlled substance notation if warranted • Description or composition statement • Clinical pharmacology, actions, or mode of action • Indications and usage • Contraindications • Precautions • Warnings • Adverse reactions or side effects • Overdosage information • Dosage administration • Storage • How supplied

23. Sources of Drug Information • Drug References • Bound book of information on package inserts • Physician’s Desk Reference (PDR): human-approved drugs. Plumbs veterinary Drug book • Veterinary Pharmaceuticals and Biologicals (VPB) • Compendium of Veterinary Products (CVP)

24. Expiration Dates • The date before which a drug meets all specifications and after which the drug can no longer be used • Based on the stability of or experience with the drug • Drugs that are mixed in the clinic vary depending on the reconstitution and refrigeration status of the drugs

25. Dispensing vs. Prescribing • Veterinary drugs are those approved only for use in animals • Certain indication • Certain species • Certain route of administration • Certain dose • Certain length of time • Human drugs are approved by the FDA, in food-producing animals: CPG

26. Prescription • Veterinary prescription drugs are labeled for use only by or on the order of a licensed veterinarian • Veterinary prescription drugs must be properly labeled before being dispensed • A veterinary/client/patient relationship (VCPR) exists • Dispensing and treatment records must be maintained • Drugs should be dispensed only in quantities required for the treatment of the animals

27. VCPR

28. Abbreviation for documentation

29. Abbreviation for documentation

30. Prescriptions • A prescription is an order to a pharmacist, written by a licensed veterinarian, to prepare the prescribed medicine, to affix the directions, and to sell the preparation to the client

31. The Prescription • The name and address of the dispenser • Controlled substances, need DEA # 2. The client’s name and address, patient: species, name 3. The drug name, strength, and quantity

32. The Prescription 4. Sig: Instructions • Amount to be given • Administration route/ frequency and duration 5. # refills permitted 6. Veterinarian's signature 7. Date of prescription NB: +/- cautionary statement

33. Prescription

35. Label on the Prescription • The label on the prescription should be complete and contain: • The name and address of the dispenser • The client’s name (+/- address) • The animal’s name and species • The drug name, strength, and quantity • The date of the order • Directions for use • Any refill information (if warranted)

36. DRUG LABEL ON PRESCRIPTION BOTTLE

37. Dispensing Drugs • Prescription drugs may be dispensed by pharmacists / trained veterinary staff • Veterinary prescription drugs should be properly labeled when dispensed • Veterinary staff members cannot refill or dispense medications without vet approval • Medications dispensed in childproof containers • Expiry date • Light sensitive: Amber colored bottles • Write a zero before any decimal point

38. Electronic and Paperless Record Keeping • Vets write the medication order in a paper file or type it into an electronic record • Medical record with the date, time, and the initials of the person giving the drug • Vets using completely paperless electronic medical record system is increasing

39. Electronic and Paperless Record Keeping • Avoidance of errors • Prompts for patients with allergic reactions • Information on drug interactions • Identification of clients with special considerations • Automated input • Laboratory data automatically transfers into patient record • Prescription instructions can be entered into the computer in advance

40. Pharmacy Economics • Inventory and Control Maintenance • Time invested in maintenance of appropriate stock levels benefits the overall business health of the veterinary practice • The goal is to stock quantities of each item as low as possible to reduce overhead and inventory costs, but now low enough to have a shortage • The longer inventory sits on the shelf: hidden costs • Too much inventory ties up money • 80/20 rule: 20% drugs stocked , 80% of annual exp. Turnover rate = Yearly inventory expense/ Avg. cost of inventory on hand • 4 (drug replaced 4 times/year) • Goal: 12

41. Pharmacy Economics • Inventory Purchasing • Direct marketing is when a drug is purchased directly from the company that manufacturers it • Distributors or wholesalers are agencies that purchase the drug from the manufacturers and resell it to the veterinarians • Generic drugs: Submit Abbreviated New Drug Application (ANAD) • Other sources of drugs include veterinary practices, buying groups of several veterinary practices, and pharmacies

42. Pharmacy Economics • Inventory Management • Managing pharmaceuticals includes • Maintaining an adequate stock • Organizing so items are easy to locate • Identifying products that need to be reordered • Receiving and inspecting shipments • Rotating stock and monitoring expiration dates