Veterinary prescription drugs are medications that veterinarians prescribe for treating, preventing, or diagnosing animal diseases. These drugs are restricted by federal law to use by or on the order of a licensed veterinarian (Section 503(f) Food, Drug, and Cosmetic Act). Proper dispensing practices are essential for the safe and effective use of veterinary prescription drugs. These practices involve various factors, such as effective client counseling, appropriate storage, proper labeling, and accurate prescription writing. Veterinarians who adhere to these guidelines can mitigate the likelihood of adverse drug reactions, medication errors, and drug abuse.
Failure to comply with prescription medicine dispensing legislation and ethical standards can have serious legal and ethical consequences. Veterinarians may face disciplinary action by their state veterinary board, civil lawsuits, or even criminal prosecution. Furthermore, improper dispensing practices may damage a veterinarian’s reputation and undermine public trust.
Related: Dispensing Veterinary Prescription Drugs: An Overview
Legal framework for dispensing veterinary prescription drugs
The distribution of veterinary prescription medications is governed by an intricate network of federal and state rules and regulations. Understanding these standards is essential for veterinarians to ensure compliance and protect public health.
Controlled Substances Act (CSA)
The Controlled Substances Act (CSA) is a federal law that regulates the manufacture, distribution, dispensing, and use of controlled substances. According to the United States Drug Enforcement Association (US-DEA), “the CSA places all substances which were in some manner regulated under existing federal law into one of five schedules.
This placement is based upon the substance’s medical use, potential for abuse, and safety or dependence liability.” Veterinary clinics must comply with specific regulations for handling and dispensing controlled substances, including:
- Registration: Veterinarians must register with the Drug Enforcement Administration (DEA) to dispense controlled substances.
- Record-keeping: Detailed records must be maintained for all controlled substances, including purchases, sales, and inventory.
- Security: Controlled substances must be stored securely to prevent theft and diversion.
- Prescriptions: Prescriptions for controlled substances must be written in accordance with DEA regulations.
Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA)
The Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) permits veterinarians to prescribe extra-label uses of certain approved new animal drugs and approved human drugs for animals under certain conditions.
Extra-label use refers to the use of a drug in a manner not specified on the drug label. While AMDUCA allows for extra-label drug use under certain conditions, it is important to note that veterinarians must still adhere to federal and state regulations, as well as veterinary medical standards.
State regulations
Federal laws establish a general framework for dispensing veterinary prescription drugs, but state regulations can differ significantly. Veterinarians must understand the specific laws and regulations in the state where they practice.
State veterinary boards are empowered to establish regulations that oversee the practice of veterinary medicine within their states. These regulations may address issues such as:
- Prescription drug dispensing: Some states may have specific requirements for prescription drug labels, record-keeping, and client counseling.
- Controlled substances: State regulations may impose additional restrictions on the handling and dispensing of controlled substances, such as mandatory electronic prescribing or specific storage requirements.
- Extra-label drug use: State boards may have guidelines or restrictions on the extra-label use of drugs.
What is the role of state veterinary boards?
State veterinary boards are essential in overseeing and regulating the practice of veterinary medicine. Their responsibilities include:
- Licensing veterinarians and ensuring that they meet the required qualifications and standards of practice.
- Enforcing regulations in relation to state veterinary practice acts and regulations, including those related to prescription drug dispensing.
- Investigating complaints against veterinarians and may impose disciplinary actions, such as suspending or revoking licenses.
- Guiding veterinarians on ethical and legal issues, including those related to prescription drug dispensing.
Ethical considerations in prescription drug dispensing
Educating clients on the proper administration of drugs and the potential adverse effects is one of the most important ethical responsibilities of veterinarians. By providing comprehensive client education, veterinarians can help to improve medication compliance, reduce the risk of adverse drug reactions, and enhance the overall health and well-being of animals.
Instructions provided must be clear and concise and must include how to administer the medication, including dosage, frequency, and duration of treatment. The potential side effects must be clearly discussed, and how to recognize and respond to them. Emphasizing the importance of complying with the prescribed treatment plan helps to ensure optimal outcomes.
Drug safety and efficacy
It is the ethical obligation of veterinarians to ensure the safety and efficacy of the medications they prescribe. This involves choosing medications appropriate for the specific condition being treated, considering several important factors such as the patient’s age, weight, and overall health. Calculating and prescribing accurate dosages can help minimize the risk of adverse effects. Monitoring the patient’s response to treatment and adjusting as needed is also essential.
Controlled substances
The dispensing of controlled substances by veterinarians carries additional ethical responsibilities, including:
- Secure storage of controlled substances to prevent theft and diversion.
- Maintaining accurate records of all controlled substances dispensed, including patient information, drug quantity, and prescriber’s information.
- Client education on the potential risks and benefits of controlled substances, as well as proper storage and disposal.
Practical guidelines for dispensing veterinary prescription drugs
The AVMA’s Principles of Veterinary Medical Ethics require a veterinarian-client-patient relationship (VCPR) before a veterinarian can write a prescription for an animal patient. Each state’s veterinary medical board outlines specific regulations for prescription writing, including the mandatory information that must be included on the prescription.
The AVMA recommends that the following information be clearly included on the label:
1. Date
2. Veterinarian’s information
- Name
- Address
- Phone number
- DEA number (if applicable)
- License number
3. Client information
- Client’s name
- Identification of animal(s) treated, species and numbers of animals treated, when possible
4. Drug information
- Drug name, active ingredient, and quantity of the drug (or drug preparation) to be prescribed or dispensed
- Drug strength (if more than one strength available)
- Quantity to dispense
- Dosage instructions (e.g., quantity per dose, frequency of administration, route of administration, duration of treatment)
- Number of refills
- Cautionary statements, as needed
- Expiration date, if applicable
- Slaughter withdrawal and/or milk withholding times, if applicable
5. Veterinarian’s signature
Drug labeling
Accurate and legible drug labels are important for several reasons:
- Clear labels guide clients in administering medications correctly, reducing the risk of errors and promoting client safety.
- Accurate labeling also informs clients about potential side effects and contraindications, allowing them to monitor their animals for adverse reactions.
- Proper labeling also ensures compliance with federal and state regulations, which is essential for maintaining professional and ethical veterinary practice.
The medication container must clearly display the veterinarian’s name and address, the drug’s name (including the active ingredient), the specific animal(s) it’s intended for, detailed instructions for proper use, and precautions. This information may be found on the manufacturer’s label or a separate label attached to the product by the veterinarian.
Other essential information that should be on the drug label includes:
- Expiration date
- Storage instructions
- Prescription number
- Date of dispensing
Record keeping
Keeping accurate records of prescription drug dispensing is essential for several reasons:
- Legal compliance calls for the maintenance of accurate records to adhere to federal and state regulations, particularly those concerning controlled substances.
- Patient safety: Accurate records allow for tracking medication history, identifying potential drug interactions, and monitoring adverse reactions.
- Professional accountability: Detailed records document veterinary care and can serve as evidence to defend against malpractice claims.
- Inventory control involves maintaining records to monitor medication inventory levels, thereby ensuring adequate supply while preventing drug shortages.
Specific requirements for controlled substances
The use and prescribing of controlled substances are regulated by the U.S. Drug Enforcement Administration (DEA) and state-controlled substance authorities. Here’s what veterinarians need to know in order to comply with the law.
Client counseling
Effective client communication is essential for ensuring proper medication use and achieving optimal treatment outcomes. Here are strategies that can enhance client understanding and medication adherence, ultimately improving patient outcomes.
- Veterinarians should use plain language, avoiding medical jargon, to explain concepts clearly and understandably. Active listening is essential to understanding clients’ questions and concerns, which should then be addressed thoroughly.
- Visual aids, such as diagrams, illustrations, or videos, can enhance understanding by demonstrating drug administration techniques. Providing concise written instructions alongside verbal explanations reinforces the information and serves as a valuable reference for clients.
- Emphasizing the importance of following the prescribed treatment plan and explaining the potential consequences of non-compliance fosters client understanding and cooperation.
- Providing clear contact information for the veterinary clinic allows clients to seek further clarification or address concerns after their visit.
Dispensing veterinary prescription drugs is an essential component of veterinary practice that calls for an in-depth understanding of legal, ethical, and practical considerations.
Veterinarians must keep updated on current developments in veterinary medicine, which include changes in laws, regulations, and ethical standards. Continuous professional development is essential for maintaining a high standard of care and ensuring the best possible outcomes for animal patients.
References
- Use of prescription drugs in veterinary medicine. (n.d.). American Veterinary Medical Association. https://www.avma.org/resources-tools/avma-policies/use-prescription-drugs-veterinary-medicine
- U.S. Food and Drug Administration (FDA). (2023, October 26). Animal Medicinal Drug Use Clarification Act (AMDUCA). https://www.avma.org/resources-tools/animal-health-and-welfare/animal-health/amduca
Prescriptions and pharmacies: FAQs for veterinarians. (n.d.). American Veterinary Medical Association. https://www.avma.org/resources-tools/animal-health-and-welfare/animal-health/pharmacy/prescriptions-and-pharmacies-faqs-veterinarians
