1.  Generic and trade names  Drug concentration and quantity  Name and address of manufacturer  Controlled substance status  Manufacturer’s lot number  Expiration date

2.  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

3.  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.

4.  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.

5.  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)

6.  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

7.  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)

8.  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.”

9.  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

10.  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

11.  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.

12.  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

13.  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

14.  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