I. INTRODUCTION.
It is important for the practitioner to be aware of the rules, regulations, and standards that impact how they dispense, prescribe, or administer medications. While the objective of this chapter is to present an overview of these topics, it is beyond the scope of this chapter to include every regulation; therefore, the appropriate agency should be consulted for further explanation and completeness if necessary.
II. REGULATORY AGENCIES.
There are both state and federal agencies, which govern how drugs are used in veterinary medicine.
A. Federal agencies
1. Food and Drug Administration (FDA). An agency of the United States Department of Health and Human Services. The 1938 Federal Foods, Drugs and Cosmetics Act (and subsequent amendments) gives the FDA the authority and responsibility for regulating a wide range of products to insure the safety and efficacy of foods, drugs, and cosmetics in the United States.
2. Center for Veterinary Medicine (CVM). A subdivision of the FDA which is responsible for regulating the drugs, devices, and food additives administered to animals.
3. Drug Enforcement Agency (DEA). A division of the United States Department of Justice which is responsible for the enforcement of the Controlled Substance Act (CSA) of 1970.
B. State agencies
1. Board of Veterinary Medicine (BVM). It protects the health and safety of the public and animals through the regulation of the practice of veterinary medicine as expressed in the state’s veterinary practice act. A state’s BVM contact information can be found at www.aavsb.org under “Boards and Agencies.”
2. Board of Pharmacy (BOP). It regulates the wholesale and the pharmacy distribution of pharmaceutical products (including veterinary drugs). The BOP also regulates licensed veterinarians engaged in the prescribing and distribution of controlled substances used in veterinary practice. A state’s BOP contact information can be found at www.nabp.net under “Boards of Pharmacy.”
III. PRESCRIPTION WRITING.
Definitions are as follows:
A. Prescription. An order for a medication (or device) issued by a licensed medical practitioner. The prescription is a legal document.
B. Prescription blanks. Printed forms on which the prescription is written. Prescription blanks are often preprinted with the name, address, and telephone number of the clinician or clinic. Some states require specialized prescription blanks for controlled substances.
C. Prescription drug. A drug or device that is required by state or federal law to be dispensed on prescription only, or is restricted to use by a practitioner only. Such products are identified by one of the following statements or legends appearing on the manufacturer’s label.
1. “Rx Only.”
2. “Caution: Federal law prohibits dispensing without a prescription.”
3. “Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.”
D. Prescription drugs are sometimes called legend drugs because of these statements. A prescription, however, can also be written for nonprescription drugs (over-the-counter or OTC drugs) by the clinician.
E. Required information on a prescription
1. Date
2. Owner’s name, address, and animal species or identification
3. Name, strength, and quantity of drug/device prescribed
4. Directions for use
5. Name, address, and signature of the prescriber
6. DEA number if a controlled drug is ordered
7. Refill information (how many times the prescription can be refilled) is optional, however, if not indicated the prescription cannot be refilled
F. Medication error prevention. A medication error, defined by the American Society of Health System Pharmacists, is “any preventable event that may cause or lead to inappropriate medication use or patient harm, while the medication is in the control of the healthcare professional, patient, or consumer. These events can be related to professional practice, health care products, procedures and systems, including prescribing, order communication, product labeling, packaging, nomenclature, compounding, dispensing, distribution, education, monitoring, and use.” Prescribing and dispensing are two of the most common sources of a medication error.
G. Prescribing errors can be categorized as errors of omission or errors of commission.
1. Errors of omission are caused by missing or incomplete information, examples include:
a. Failure to specify the quantity to dispense or the duration of therapy.
b. Failure to specify the dose or dosage regimen.
c. Failure to write legibly.
d. Failure to provide all legally required information (example: DEA number for controlled substance).
e. Incomplete specification of dosage form or strength or the specification of an unavailable dosage form or strength.
2. Errors of commission are caused by incorrect information, examples include:
a. Incorrect dose or regimen.
b. Incorrect drug or indication for use.
c. Incorrect dosage form.
d. Incorrect quantity or duration of therapy.
e. Therapeutic duplication.
f. Incorrect patient name on the prescription.
g. Use of outdated references.
h. Drug interactions or contraindications.
H. Dispensing errors include the errors of commission listed above as well as errors of omission.
1. Failure to counsel the owner about the medication prescribed.
I. Medication error prevention in prescription writing
1. When specifying a strength or dose, use a zero before the decimal point for an amount less than a whole unit (i.e., 0.1 mg, not a .1 mg); do not use trailing zeros after the decimal point for whole numbers (i.e., 1 mg, not 1.0 mg). The use of a “naked decimal” (.1 mg and 1.0 mg) could cause misinterpretation of the intended amount by a factor of ten (1 mg and 10 mg).
2. Many drug names (brand and generic names) look alike or sound alike; care should be taken to insure the correct drug is selected (i.e., hydralazine vs. hydroxyzine, Celebrex® vs. Celexa®).
3. The prescription information must be legible; poor or illegible handwriting can be misinterpreted and be a source of a medication error.
4. The metric system should be used to express strengths and quantities (i.e., Phenobarbital 30 mg); the use of outdated weight and measures should not be used (i.e., Phenobarbital ½ grain).
5. Vague directions for use (i.e., “take as directed”) should be avoided; the directions should be concise and include what the medication is used for infection, cough, and so forth, and for nonmaintenance drugs, the length of the treatment 1 week, 10 days, and so forth.
6. The use of abbreviations should be minimized or eliminated in prescription writing. Abbreviations can be misinterpreted, especially if penmanship is poor, leading to a medication error. Some abbreviations have been banned from use in human hospitals because they have frequently been the source of medication errors. (For a complete list of hazardous abbreviations and explanations refer to the Error-Prone Abbreviation List at the Institute for Safe Medication Practices’ website www.ismp.org.)
a. For example, both abbreviations “QOD” (every other day) and “QD” (daily) have been mistaken for the abbreviation “QID” (four times daily).
b. Veterinarians should avoid using nonstandardized abbreviations when writing a prescription to be taken to a human pharmacy. The abbreviation “SID” (once daily) is only used in veterinary medicine veterinarians—it is not used by any other healthcare profession. As a result, it has been mistaken for “QID” (four times daily) and “BID” (twice daily) by community pharmacists.
J. Issuance of the prescription. The information on a prescription can generally be communicated to a pharmacy by any of the three methods: written, oral, or electronic format.
1. Written format. The prescription information is written on a prescription blank and then is given to the animal’s owner to present to a pharmacy.
a. The prescription should always be written in ink or printed via computer; never written with a pencil.
b. Alterations and changes should be avoided; rewrite on new prescription blank if necessary.
2. Oral format. The prescription is telephoned to the pharmacy by the veterinarian or their agent and the information is recorded on a prescription blank by a pharmacist. Prescriptions for C-II drugs (next section) cannot be given over the phone.
3. Electronic format. Requirements and restrictions for this format may vary from state to state; the veterinarian should check with their state’s BOP before using this format.
a. Facsimile transmission: written information is faxed to the pharmacy and the information is processed the same as a written or oral prescription.
b. Computer to computer and handheld devices: prescription information is communicated electronically to the pharmacy’s computer system.
IV. CONTROLLED SUBSTANCES.1
Controlled substances are drugs (legal and illegal) and chemicals under the jurisdiction of the federal Controlled Substance Act (CSA) which regulates the manufacture, distribution, and dispensing of controlled substances. The Drug Enforcement Administration (125) enforces the CSA through the regulations found in Title 21, Code of Federal Regulations (CFR), Parts 1300-end. A Practitioner’s Manual is available on the DEA website (www.deadiversion.usdoj.gov) under “publications” to assist the practitioner in their understanding of the CSA and CFR; the manual summarizes the requirements for prescribing, administering, and prescribing controlled substances.
FIGURE 20-1. Depiction of page 1 of DEA Form-222. U.S. official order form—Schedules I and II.
A. Registration requirements for controlled substances
1. Registration with both the DEA and the state BOP is a requirement for any practitioner that will dispense, administer, or prescribe any controlled drug.
a. DEA (federal) registration needs renewal every 3 years; refer to the Practitioner’s Manual for the registration process.
b. State registration forms are available from the state’s BOP. The renewal period may vary from state to state.
2. Registration certificates must be maintained at the registered location in a readily retrievable manner.
3. Separate registration is required for each principal business or practice where controlled substances are dispensed, administered or stored; separate registration is not required for locations where controlled substances are prescribed but not dispensed, administered, or stored.
4. The practitioner must notify both the DEA and the state’s BOP if there is a change in their practice or business address.
B. Schedules of controlled substances. The drugs and chemicals that are considered controlled substances are divided into five schedules based on abuse potential, safety, and accepted medical use in the United States.
1. Schedule I. These substances have no current accepted medical use in the United States, have a lack of accepted safety when used, and have a high abuse potential. Examples: heroin, methamphetamine, LDS, and marijuana.
2. Schedule II. These substances have a high abuse potential and an accepted medical use in the United States. This schedule includes narcotics, depressants, and stimulants.
a. Examples used in veterinary medicine: morphine, dihydomorphone, fentanyl, and pentobarbital.
3. Schedule III. These substances have an accepted medical use in the United States and less abuse potential than Schedule I and II.
a. Examples used in veterinary medicine: ketamine, boldenone, buprenorphine, and hydrocodone with homatropine.
4. Schedule IV. These substances have a lower potential for abuse relative to the Schedule III substances.
a. Examples used in veterinary medicine: butorphanol, diazepam, and phenobarbital.
5. Schedule V. These substances have the lowest abuse potential of the controlled substances.
a. Examples used in veterinary medicine: phenylpropanolamine.
6. The amount of the controlled substance in a product also may influence into which schedule it fit; also, the combination of a controlled substance with a noncontrolled substance may affect the scheduling.
a. Example: codeine 30 mg tablets are Schedule II, codeine 30 mg/acetaminophen 325 g tablets are Schedule III, products with codeine 200 mg or less per 100 mL or 100 g are Schedule V.
7. The term “class” which is symbolized by the letter “C” is used interchangeably with “Schedule”; for example, a Schedule II drug and a C-II drug represent the same classification. Manufacturers use the “C” symbol on their label to identify the product as a controlled substance.
C. Controlled substance recordkeeping. The CSA created a closed distribution system in which all legitimate handlers of controlled substances: researchers, manufacturers, distributors, practitioners, pharmacies, with the exception of the ultimate user, must be registered. Under this distribution system, strict recordkeeping for accountability of all controlled substance transactions must be maintained.
1. Recordkeeping
a. All controlled substance records must be maintained in a readily retrievable manner separate from other business records.
b. All controlled substance records must be kept available for inspection for a minimum of 2 years. This includes invoices, credit memos, dispensing transactions, and administration records.
c. All Schedule II records must be kept separate from Schedule III to V records.
d. A practitioner that dispenses or administers controlled substances must take a beginning controlled substance inventory on the date they initially start to dispense or administer and take a new inventory every 2 years from when the beginning inventory was taken (a biennial inventory).
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