VETERINARY DRUG USE AND PRESCRIBING

Chapter 5

Dr. Dipa Brahmbhatt VMD MpHDr. Dipa Brahmbhatt VMD MpHdbrahmbhatt@vettechinstitute.edudbrahmbhatt@vettechinstitute.edu

Brand Name (®) or Not?

– All drugs have 3 names • Chemical name• Generic (nonproprietary) name (active

ingredient)• Trade (proprietary) name

Brand Name (®) or Not?TRADE NAME:

– BenadrylCHEMICAL NAME:

– 2(Diphenylmethoxy)-N,N-dimethylethylamine hydrochloride

CHEMICAL STRUCTURE:

GENERIC NAME:– diphenhydramine hydrochloride

CHEMICAL NAME

NONPROPRIETARY NAME/

GENERIC NAMEActive ingredient

PROPRIETARY/TRADE NAME

D(-)-alpha-amino-p-hydroxybenzyl-penicillin

trihydrate

Amoxicillin Amoxi-Drop (Pfizer)Biomox (Virbac)Robamox-V (FD)

((3-phenoxyphenyl) methyl cis-trans-3-(2,2-

dichloroethenyl)-2,2-dimethylcyclopropanecarb

oxylate))

Permethrin insecticide AtrobanDefendFlysect

Dl 2-(o-chlorophenyl)-2-(methylamino) cyclohexanone hydrochloride

Ketamine hydrochloride KetasatVetalar

Brand Name (®) or Not?

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

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

Do you know the generic name?

TYLENOL– acetaminophen

ADVIL– ibuprofen

CLARITIN– loratadine

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

Xylazine/Rompun®

Trade name?

Pseudoephedrine – Sudafed

Chlorpheniramine – Chlor-trimeton

Famotidine– Pepcid

GenericExpiry 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

CompoundingIs 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

Suspensions: “Shake Well”

CompoundingUses 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

CompoundingConcerns

– 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

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

conditionhttp://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm117042.htm

Sources of Drug InformationUnited 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

Sources of Drug InformationFDA 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)

Sources of Drug InformationPackage 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

Sources of Drug InformationDrug 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)

Expiration DatesThe 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

Dispensing vs. PrescribingVeterinary 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

PrescriptionVeterinary prescription drugs are labeled for use

only by or on the order of a licensed veterinarianVeterinary prescription drugs must be properly

labeled before being dispensedA veterinary/client/patient relationship (VCPR)

existsDispensing and treatment records must be

maintainedDrugs should be dispensed only in quantities

required for the treatment of the animals

VCPR

Abbreviation for documentation

Abbreviation for documentation

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

The Prescription

1. 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

The Prescription 4. Sig: Instructions– Amount to be given– Administration route/ frequency and

duration5. # refills permitted6. Veterinarian's signature7. Date of prescription NB: +/- cautionary statement

Prescription

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)

DRUG LABEL ON PRESCRIPTION BOTTLE

Dispensing DrugsPrescription drugs may be dispensed by

pharmacists / trained veterinary staffVeterinary prescription drugs should be

properly labeled when dispensedVeterinary staff members cannot refill or

dispense medications without vet approvalMedications dispensed in childproof

containers Expiry dateLight sensitive: Amber colored bottlesWrite a zero before any decimal point

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

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

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

Pharmacy EconomicsInventory 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

Pharmacy EconomicsInventory 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