Transcript A prescription drug is

 Generic and trade names
 Drug concentration and quantity
 Name and address of manufacturer
 Controlled substance status
 Manufacturer’s lot number
 Expiration date
 Also called “off-label use”
 Using a medication in a manner that is not listed as approved by FDA
 Different species, indication, dosage, frequency, route, withdrawal time
 Necessary in veterinary medicine
 AMDUCA gave veterinarians the authority to use approved animal drugs in an extra-label manner if “the
health of the animal is threatened, or suffering or death may result from failure to treat.”
 Only allowed when:
 There is no approved drug to treat the animal's condition or the approved drug's dosage is not effective.
 A careful diagnosis has been made and a valid VCPR exists.
 The identity of the animal being treated is carefully maintained
 The withdrawal time is extended
 The drug is properly labeled with the following to ensure safety:
 Veterinarian’s name and address
 Active ingredients
 Animal that med is prescribed to
 Dosage, frequency, route of administration, duration of therapy
 Cautionary statements
 Withdrawal/discard time
 Products derived from treated animals
 A valid VCPR is required before a drug can be prescribed to a patient.
 The veterinarian assumes responsibility for making decisions regarding the patient’s health.
 The client agrees to follow the veterinarian’s instructions.
 The veterinarian knows enough about the patient to make a preliminary diagnosis.
 They have examined the patient or the operation where the patient is managed.
 The veterinarian is available for follow-up care or has arranged for emergency care.
 The veterinarian oversees treatment, compliance, and outcome.
 Patient records are maintained.
 The veterinary profession is regulated by the DEA, FDA, USDA, and EPA.
 The FDA determines whether a drug will be Rx or OTC
 Decision is based on toxicity of drug, method of use, and how well directions can be written for drug’s
usage
 A prescription drug is: determined to be toxic, potentially toxic if misused, or too readily misused
 An over-the-counter drug is: If a drug is considered safe for the animal, the person administering
the medication, people who come into contact with the animal, the human food chain, and the
environment
 Some drugs are OTC in certain dose forms or concentrations and Rx in others
“Caution: Federal law restricts this drug
to use by or on the order of a licensed veterinarian.”
 Prescription drugs must contain the label
 Although LVTs cannot prescribe medications, they can fill drug orders and dispense
medications under the direction of a licensed veterinarian.
 Do not automatically refill medications without the permission of the prescribing veterinarian.
 It is illegal to fill a prescription from another veterinary practice.
 Name of prescribing veterinarian
 Name, address, and phone number of clinic
 Name of patient or ID of patient with and
client’s last name
 Drug name, concentration, and number of
units dispensed
 Date
 Refills
 Dose, frequency, route of administration,
duration of treatment
 Cautionary statements
 Withdrawal or discard times (food animals)
 Childproof containers vs. pill envelopes
 Temperature of storage environment
 Cold: not exceeding 46 degrees
 Cool: 46-59 degrees
 Room Temp: 59-86 degrees
 Warm: 86-104 degrees
 Excessive Heat: greater than 104 degrees
 Amber bottles
 Silica packets
 Reconstituted meds and bacterial growth
 A substance that has the potential for physical addiction, psychological addiction, and/or
abuse
 C-I: extreme potential for abuse, no approved veterinary purpose (heroin, LSD, marijuana)
 C-II: high potential for abuse/dependence (opium, morphine, pentobarbital)
 C-III: some potential for abuse/low moderate dependence (ketamine, Tylenol with codeine)
 C-IV: low potential for abuse/limited dependence (butorphanol, Valium)
 C-V: lowest potential for abuse. Antitussives and antidiarrheal (Lomotil, Robitussin AC)
 The Controlled Substances Act of 1970 states regulations for prescribing, handling, and
storing of controlled substances. This is enforced by the DEA.
 A veterinarian must be registered with the DEA to purchase, dispense, or prescribe controlled
substances.
 The registration number must be on all controlled substance prescriptions and order forms.
 Registration is valid for three years
 Some states (Texas included) allows veterinarians without DEA numbers to administer or dispense
controlled substances if they are employed by a registered veterinarian. However, they cannot
purchase them or write a prescription for them.
 C-I drugs cannot be prescribed to animals
 C-II drugs must have written prescriptions and cannot be refilled
 C-II, C-III, C-IV drugs must be dispensed in childproof containers and its label must state:
Caution: Federal law prohibits the transfer of this drug to any person other than the patient
for whom it was prescribed.”
 Must be stored in a locked cabinet of
substantial construction
 Glass front, lightweight portable safes, and
locked tackle boxes are not sufficient
 Farm-call vehicles may have a steel toolbox
attached to the vehicle
 Log of ordering, receiving, and dispensing
must be kept for 2 years
 Bound pages that are sequentially numbered
 Write in ink
 Take inventory every two years
 Computer records must not allow much
editing
 Cytotoxic drugs- drugs that are poisonous to mammalian cells
 Antineoplastic and antifungal agents
 Could potentially be teratogenic or carcinogenic
 Teratogenic/mutagenic agents- drugs that cause birth defects (not only in
the patient, but also in the person dispensing the drug)
 Carcinogenic agents- drugs that cause cancer or preneoplastic changes
 OSHA has guidelines for the safe use, storage, and disposal of these drugs
 Absorption through the skin when drug spills/drips
 Inhalation of aerosolized drug when needle is removed from pressurized bottle, when dug is
being crushed/broken, or when ampules are broken.
 Ingestion of food contaminated with the drug
 REMEMBER:
 Store your lunch in a refrigerator that food is in!
 Don‘t place lunch on a counter where meds are placed.
 Wash your hands!
 Every hazardous material should have a MSDS, package insert, and a hospital policy
procedure sheet for spills and disposal of equipment.
 Store cytotoxic drugs separately from other drugs and clearly label them.
 Prepare the drug just prior to administration in a low traffic, well-ventilated area.
 Wear protective gear: mask (not surgical), gloves (multiple pairs if latex), gown with long sleeves
and cuffs, goggles.
 Use screw-on syringes and IV lines.
 Recheck calculations.
 Insure catheter placement is correct.
 Place all equipment in sealable plastic bags immediately after use and into a leak and puncture
proof hazardous waste container.
 Clean up properly after use. Do not allow maintenance staff to handle cleaning
 Chemotherapy spill kits are available
 DEFINITION: Any manipulation to produce a dose form of a drug in any
form other than what is approved by the FDA
 Examples:
 Flavoring to improve palatability
 Formulating drugs into different forms that are no longer available to ease
administration
 Formulating a raw chemical into a dose form for administration to animals
 NOTE: anesthetic cocktails, diluting drugs with saline, crushing a tablet
into a liquid to make a suspension, and mixing drugs together in a syringe
are all examples of compounding
 Must be made and dispensed by a veterinarian or pharmacist
 Unacceptable if causes drug residues in food animals or puts the general public at risk
 Cannot be made for anyone outside the practice
 A valid client patient relationship must exist
 Cannot violate any drug residue, safety, or efficacy rules
 Must maintain records
 Labels must include:
 Veterinarian’s name and address
 Date drug is dispensed and date of expiration
 Medically active ingredients
 ID of animal
 Directions
 Cautionary statements
 Withdrawal times if needed
 Condition/disease