VETERINARY DRUG USE AND PRESCRIBING Chapter 5

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VETERINARY DRUG USE AND PRESCRIBINGChapter 5

• Dr. Dipa Brahmbhatt VMD MpHdbrahmbhatt_at_vettechins
  titute.edu

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Brand Name () or Not?

• All drugs have 3 names
• Chemical name
• Generic (nonproprietary) name (active ingredient)
• Trade (proprietary) name

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Brand Name () or Not?

• TRADE NAME
• Benadryl
• CHEMICAL NAME
• 2(Diphenylmethoxy)-N,N-dimethylethylamine
  hydrochloride
• CHEMICAL STRUCTURE
• GENERIC NAME
• diphenhydramine hydrochloride

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Brand Name () or Not?
CHEMICAL NAME NONPROPRIETARY NAME/ GENERIC NAME Active 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-dimethylcyclopropanecarboxylate)) Permethrin insecticide Atroban Defend Flysect
Dl 2-(o-chlorophenyl)-2-(methylamino) cyclohexanone hydrochloride Ketamine hydrochloride Ketasat Vetalar
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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

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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

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Do you know the generic name?

• TYLENOL
• acetaminophen
• ADVIL
• ibuprofen
• CLARITIN
• loratadine

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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?

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Xylazine/Rompun
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Trade name?

• Pseudoephedrine
• Sudafed
• Chlorpheniramine
• Chlor-trimeton
• Famotidine
• Pepcid

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Generic

• Expiry of patent 17 yrs.
• Than other drugs can market drug
• own trademark name or generic
• name of drug (trademark law cant 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

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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
  patients needs when an approved drug is not
  available

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Suspensions Shake Well
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Compounding

• Uses of compounding
• Creating discontinued drugs
• (cisapride cats megacolon)
• Creating dosages and strength specific to a
  patients 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

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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

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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/Complia
  ncePolicyGuidanceManual/ucm117042.htm

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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

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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
• Manufacturers control or lot number
• Expiration date of drug
• Withdrawal time (if warranted)
• Controlled substance status of drug (if
  warranted)

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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

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Sources of Drug Information

• Drug References
• Bound book of information on package inserts
• Physicians Desk Reference (PDR) human-approved
  drugs. Plumbs veterinary Drug book
• Veterinary Pharmaceuticals and Biologicals (VPB)
• Compendium of Veterinary Products (CVP)

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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

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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

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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

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VCPR
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Abbreviation for documentation
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Abbreviation for documentation
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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

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The Prescription

• The name and address of the dispenser
• Controlled substances, need DEA
• 2. The clients name and address, patient
  species, name
• 3. The drug name, strength, and quantity

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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

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Prescription
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Label on the Prescription

• The label on the prescription should be complete
  and contain
• The name and address of the dispenser
• The clients name (/- address)
• The animals name and species
• The drug name, strength, and quantity
• The date of the order
• Directions for use
• Any refill information (if warranted)

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DRUG LABEL ON PRESCRIPTION BOTTLE
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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

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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

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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

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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

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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

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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