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 Prescription drugs must contain the label “Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.”

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