VETERINARY DRUG USE AND PRESCRIBING
Chapter 5
Dr. Dipa Brahmbhatt VMD MpHDr. Dipa Brahmbhatt VMD [email protected]@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