Regulations you need to know: Pharmacy (Part 1) (Proceedings)

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Regulations you need to know: Pharmacy (Part 1) (Proceedings)

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Aug 01, 2010

Veterinarians and the State Board of Pharmacy

The Board of Veterinary Medicine regulates and licenses people practicing veterinary medicine in the State. Although there are professional standards defining

"veterinary-client-patient relationship" and proper prescribing of medications, it falls to the Board of Pharmacy in the state to regulate how prescription medications are dispensed to the general public. To simplify, the Board of Veterinary Medicine controls the professional PRESCRIBING of prescription medications and the Board of Pharmacy regulates the DISPENSING process for prescription medications. Veterinary practices must follow the regulations of both agencies.

Since veterinary practices are not licensed as retail pharmacies, it is normally against state pharmacy regulations to fill a prescription for a legend (prescription) drug that was written in (or phoned in from) outside the practice. In-house veterinary pharmacies are allowed to dispense prescription medication only to current patients of that practice when ordered by a veterinarian in that practice.

Dispensing Prescription Medications

Veterinarians may only dispense or administer a prescription drug (one that is labeled for use by or on the order of a veterinarian or physician) when he or she has a working knowledge of the conditions and treatment regimes of a particular patient and client. This is known as the veterinarian-client-patient relationship. This relationship is built on a simple foundation: the physical examination. Without the examination, the veterinarian-patient-client relationship does not exist.

In the food animal industry, it is customary to treat patients as groups in certain instances. The same relationship must still exist, but the examination can be of a herd or flock instead of a particular animal. Food animal veterinarians should be especially cautious of dispensing medications to clients who may not have a thorough understanding of the problem and the treatment protocol.

Clear directions including the drug name and quantity dispensed, dosage, route and frequency of administration must be written in the medical record or treatment sheet for all prescription drugs dispensed. The client should be especially cautioned (and it should appear on the prescription label) about the necessity for withholding milk or meat from treated animals in cases where residues of the drug may contaminate the product.

Packaging & Labeling

Prescription medications MUST be dispensed only in child-proof containers, even small quantity prescriptions such as a single tapeworm tablet, unless the client requests otherwise. Envelopes, baggies, or other similar containers can only be used to comply with the client's expressed verbal or written wishes for non-child-proof containers. The client may be asked if he or she would prefer an envelope or non-child-proof container BEFORE it is dispensed. When the client requests or approves of other dispensing containers, a note to that effect should be made on the medical record or treatment sheet. Although this is not mandated, medications that are pre-packaged for dispensing to clients, such as ophthalmic drops and ointments, fit nicely into a plastic pill vial. This practice gives the proper impression to the client (prescription medicine rather than an over-the-counter product) and provides an ideal place to adhere the prescription label.

Every container of prescription medication dispensed from a veterinary practice must comply with the labeling requirements of the Food and Drug Administration (FDA). At a minimum, the following information must be clearly printed or typed on a label affixed to the dispensing container:
     • Identification of the hospital - including street address, city, state and phone number,
     • Name of the prescribing veterinarian,
     • The current date,
     • The name of the patient - for veterinary prescriptions, the name of the animal and the last name of the owner are acceptable,
     • The name, strength and quantity of the drug,
     • Clear directions for use,
     • Expiration date if the supply being dispensed will not be used up during the current treatment period (e.g., more than a month's supply),
     • The number of authorized refills (optional, but printing NO REFILLS on the label is a good method to keep clients from calling back several months later and wanting "more of the stuff we had before"),
     • Any special precautions (e.g., keep refrigerated, or shake well before use),
     • The phrase "For veterinary use only" is recommended when the drug is one approved for use on animals only (Note: this phrase is routinely printed on all prescription labels from veterinary hospitals because it's easier than trying to decide which ones to label and which ones to omit).
     • The phrase "Keep out of the reach of children" is also recommended and routinely used on all veterinary prescriptions.

Most labels are placed directly on the vial and clear tape is placed over the writing to prevent alterations or smudging. For the times when the directions are going to be lengthy (as in the initial steroid therapy) the label can contain all the regular information with a statement saying "See enclosed directions." The specific, detailed directions can then be rolled up and placed on the inside of the vial with the tablets. Directions such as "Give as directed" are very vague and should be avoided.