Pharmacy Issues
The following article was printed in the CVMA Voice newsletter in the Winter 2005 issue.
Resource Materials for Veterinarians on Pharmacy Issuesfrom the CVMA Task Force on Pharmacy Issues
Background
CVMA members have expressed confusion and uncertainty in regard to pharmacy issues. In particular, questions have been raised about the time interval between patient examination and subsequent prescribing of medication, Internet pharmacies, and drug compounding and piracy. CVMA has developed the following resources to help answer these questions, and has identified other resources on the Internet for which links are provided. In particular, CVMA suggests visiting the AVMA Web site section on prescribing and dispensing at (
http://www.avma.org/prescribing/default.asp).
Interval between patient examination and subsequent prescribing of medicationCVMA members have asked whether the veterinarian-client-patient relationship (VCPR), as defined in the Colorado Veterinary Practice Act, should include a statement about the time interval between examining an animal patient and subsequently dispensing or refilling medications.
The CVMA Task Force on Pharmacy Issues reviewed VCPR definitions from a number of sources and found no instances where such an interval is specified in the definitions. The absence of a specific interval indicates that one solution does not necessarily fit all circumstances. Veterinarians must consider an array of factors to make a complex medical decision when prescribing medications. Dictating an interval might actually serve to diminish the importance of professional discretion.
CVMA encourages veterinarians to develop a hospital policy on dispensing and refilling medications, and to communicate this policy to clients. This policy should include elements such as:
a discussion with the client about the disease process, concurrent diseases, and other medications already being administered (if any),
- the appropriate number of refills (if any),
- a schedule for re-check examinations,
- consideration of the accelerated rate of animal aging compared to humans,
- an understanding of appropriate dose and dosing frequency, and
- potential adverse effects.
Internet pharmacies
A client's request for a written prescription to be filled elsewhere presents an educational opportunity. The discussion should review the medical, legal, and business aspects of complying with the client's request. To aid this discussion, CVMA has prepared a client education brochure on Internet pharmacies that can be downloaded at
www.colovma.com and duplicated in your practice. Veterinarians should be familiar with, and discuss with clients, the "red flags" and risks associated with Internet pharmacies as presented in the client education brochure.
In addition, the veterinarian should be aware of the following considerations:
- Consider asking the client if there is some concern or problem that can be addressed to the client's satisfaction. For example, an interest in perceived cost savings might be readily addressed by offering to match the Internet pharmacy's price (including the shipping and handling fees).
- Any medically indicated drug therapy should be initiated by the attending veterinarian in the context of a valid VCPR. It is within the veterinarian's purview, not the pharmacist's, to determine the medical criteria whereby a drug is indicated.
- Drugs may be prescribed rather than dispensed. The American Veterinary Medical Association and the Colorado State Board of Veterinary Medicine both recommend that veterinarians honor client requests to prescribe rather than dispense medications. In Colorado, prescriptions are considered to be part of the medical record to which the client has reasonable access.
- When honoring client requests to prescribe rather than dispense medications, veterinarians should provide a written prescription that the client can present to the pharmacy – rather than providing a voice or fax authorization directly to the pharmacy.
- A prescription must be written by the veterinarian who has most recently seen the animal for the medical condition necessitating that particular prescription, since prescriptions require a valid VCPR.
- Review appropriate dose, dosing frequency and number of refills with the client. Consider no refills to encourage client communication.
- As with any prescription, a written record should be maintained. Consider a prescription pad that provides a duplicate copy for the medical record.
- You should suggest the client verify that an Internet pharmacy is properly licensed with the Colorado Board of Pharmacy (go towww.dora.state.co.us/pharmacy/Index.htm and click on Automated License Verification).
- Advise the client if he or she purchases a whole bottle of a prescription medication to be sure that the original labeling is intact, including a NADA (New Animal Drug Approval) number.
- When honoring a client's request for a prescription, the fact that the prescription will be filled elsewhere does not relieve the prescribing veterinarian of the responsibility to discuss proper use, adverse effects, side effects, need for follow-up appointments or blood work, etc.
- Charging for writing a prescription is a gray zone. On one hand, writing a prescription takes time for which the veterinarian should be properly compensated. On the other hand, while Colorado law does not prohibit such a practice, the Colorado Veterinary Practice Act indicates that "obtaining fees for unnecessary services" can be considered unprofessional or unethical.
- If you have a concern about the activities of an Internet pharmacy, the AVMA has developed a complaint form (http://www.avma.org/prescribing/complaint_form.pdf) to convey concerns to the Food and Drug Administration and state authorities.
Other helpful resources:
Compounding
Compounding is defined as any manipulation to produce a dosage from a drug other than that manipulation provided for in the directions for use on the label of the approved drug product. A few examples include combining drug agents for anesthesia, incorporating a pill into liquid or capsule forms, or creating certain antidotes.
There is a legitimate need for compounding, which is governed by the Animal Medicinal Drug Use Clarification Act (AMDUCA) since compounding is an extralabel use. Legal compounding can only begin with FDA-approved drugs, yet veterinarians recognize rare instances where unapproved drugs are needed to treat specific non-food animal patients. An excellent brochure explaining veterinary compounding has been produced by AVMA, the Animal Health Institute, and the American Veterinary Distributors Association at
http://www.avma.org/compounding/brochures.asp.
Use of a compounded drug should be accompanied by the same precautions followed when using a drug in its original form, including counseling the client regarding potential adverse reactions, and the potential for unintended human or animal exposure to the drug.
Use of a compounded drug should be limited to:
- Those drugs for which safety and efficacy have been demonstrated in the compounded form on target species;
- Disease conditions for which response to therapy or drug concentrations can be monitored; or
- Those individual patients for which no other method or route of drug delivery is practical.
There are additional aspects to consider in using a compounded drug, including:
- The flavoring of FDA-approved drugs is acceptable.
- Obtaining or compounding a drug in a quantity for "in-office use" is unacceptable. (see page 10 for potential changes in Colorado)
- Re-labeling or re-selling compounded drugs is illegal.
Drug piracy
Drug piracy is essentially the wholesaling of unapproved drugs, which are often made from bulk ingredients that do not meet FDA guidelines and which are frequently from foreign sources. Such drugs circumvent the FDA drug approval and monitoring process. Often pirated drugs are mass-marketed products with little quality control. Pirated drugs mimic approved drugs, but they are not an FDA approved generic that ensures safety, efficacy, quality, stability, and accuracy in packaging and labeling. Some examples of approved drugs that are often pirated include omeprazole, enrofloxacin, praziquantel, and ivermectin formulations.
Why is drug piracy bad?
- It denies the patient treatment with a safe, effective, pure, potent and stable FDA approved drug.
- It exposes the patient to an unapproved drug that may be contaminated, sub- or super-potent, or unstable.
- It exposes all parties, especially the veterinarian, to unnecessary liability. (Even if the client signs a waiver you as veterinarian are still liable if problems arise from a pirated drug.)
- It undermines the incentive for research and development by the drug companies, potentially leading to fewer approved drugs. It takes an average of 8-10 years at a cost of $300 million to get a new drug approved. It costs $2-8 million to add a new species to a drug label. In short, if they can't sell it they won't make it!
- Veterinarians may have fewer approved drugs without a healthy animal pharmaceutical industry.
- Bulk ingredients often originate from developing countries that may lack a well-regulated chemical industry, so quality and purity can be questionable. The bulk ingredients may come from countries where there are real threats about bio-terrorism.
- It is illegal.
Remember, when prescribing compounded drugs, it is the veterinarian's responsibility to:
- Exercise due diligence by determining that the pharmacy is preferentially using FDA-approved products.
- Understand that the veterinarian incurs professional liability if pirated drugs are used in or dispensed from the veterinarian's practice.
- Inform the client it is never acceptable to use pirated drugs, even if the client desires to sign a waiver.
Other helpful resources:
No comments:
Post a Comment