OUTLINE
Professional Veterinary Pharmacy Organizations
Important Veterinary Terminology
Dosage Forms Utilized in Animal Patients
Species Considerations in Drug Delivery
Algorithms for Filling Veterinary Prescriptions
I. INTRODUCTION
A pharmacist’s responsibility for providing patients with high-quality pharmaceutical care extends beyond the human species. While colleges of pharmacy and licensing boards have focused almost exclusively on human pharmacotherapy, society expects an equally competent quality of pharmaceutical care and products to be provided for nonhuman family members. It behooves all pharmacists to be equipped with a working knowledge of veterinary pharmacotherapy and to develop a clinically and legally sound algorithm for processing veterinary prescriptions. True mastery of veterinary pharmacotherapy is a lifelong learning process, but all pharmacists can acquire a functional understanding of providing drugs and care for animal patients by considering the information outlined in this chapter.
II. INFORMATION RESOURCES
Many veterinary-specific information resources are not presented during undergraduate pharmacy education. Some of the most useful resources are listed here.
A. Texts
1. Veterinary Drug Information Monographs: These monographs have been carefully prepared and approved by USP Committees of Experts for Veterinary Drugs, Veterinary Information and Pharmacy Compounding. All information presented is evidence-based and peer-reviewed.
a. Information monographs: Similar to the former USP-Dispensing Information monographs for human patients, these monographs include useful information such as indications, extra-label use, species and dosage forms, dosing, label and extra-label withdrawal times, and relevant human data. Unfortunately, they are no longer included in printed copies of USP/NF but are available free of charge at the following URL: http://www.usp.org/audiences/veterinary/monographs/main.html.
b. Substance monographs (e.g., Cisapride monohydrate)
c. Compounding formulation monographs (e.g., Sodium Bromide Injection)
2. USP Pharmacists’ Pharmacopoeia, beginning with 2nd edition, 2008 (1)
a. Veterinary drug monographs (information, substance, formulation)
b. Veterinary pharmacopeial stimuli articles
c. Veterinary drug regulations
(1) The Animal Medicinal Drug Use Clarification Act
(2) Extra-label use of drugs in food-producing animals
d. FDA Form 1932A for reporting adverse drug reactions, lack of efficacy or product defects, http://www.fda.gov/opacom/morechoices/fdaforms/FDA-1932a.pdf
e. Important veterinary contacts
f. List of potential food/drug/excipient toxins in animal species
3. Plumb’s Veterinary Drug Handbook, by Donald Plumb (2): AHFS-style comprehensive, referenced drug monographs and important veterinary reference information, companion veterinary patient education information literature (Veterinary Drug Handbook: Client Information Edition)
4. Saunders Handbook of Veterinary Drugs, by Mark Papich (3): condensed drug monographs with phonetic guide and accompanying patient educational information
5. Veterinary Herbal Medicine, by Susan Wynn (4): comprehensive description of herbal and alternative medicines used in animal patients
6. Veterinary Pharmacology and Therapeutics, by Mark Papich and Jim Riviere (5): comprehensive veterinary pharmacology text for all species
7. Small Animal Clinical Pharmacology and Therapeutics, by Dawn Merton Boothe (6): comprehensive, illustrated veterinary pharmacology text for dogs and cats
B. Free-access Internet sites
1. Food and Drug Administration Center for Veterinary Medicine, www.fda.gov/cvm
a. FDA Veterinarian, News and events in veterinary medicine: published bimonthly. Articles are free of copyright and may be reprinted. Editor Jon F. Scheid. Comments are invited: Phone 240-276-9110, fax 240-276-9115, or write to FDA Veterinarian, Center for Veterinary Medicine, Communications Staff (HFV-12), 7519 Standish Place, Rockville, MD 20855.
(1) Scientific news
(2) New drug approvals
(3) Drug approval withdrawals
b. Compliance Policy Guides (CPGs) for drug use in animals, http://www.fda.gov/ora/compliance_ref/cpg/cpgvet/default.htm: CPGs are printed guidance documents in an organized system for statements of FDA compliance policy, including those statements that contain regulatory action guidance information. These guides are internal guidance documents to assist FDA field inspectors during inspections. These CPGs do not create or confer any rights, privileges, or benefits on or for any private person but are intended for internal guidance.
c. Adverse Drug Event Reporting for animals, http://www.fda.gov/cvm/adereporting.htm: Veterinarians and animal owners may report adverse experiences with animal drugs, feeds, and devices to the FDA by completing the information listed at the link provided (FDA Form 1932A).
d. Green Book (FDA-approved veterinary drugs), http://www.fda.gov/cvm/Green_Book/elecgbook.html: The Green Book is a byproduct of The Generic Animal Drug and Patent Restoration Act (GADPTRA) enacted in 1988. The Green Book serves to fulfill the portion of the GADPTRA requiring that a list of all animal drug products approved for safety and effectiveness be made available to the public. The Green Book is updated in January of each calendar year. Pharmacists should consult the Green Book to determine approval status and availability of drug products used in animals.
e. Freedom of Information Summaries (FOIS) for Veterinary Approved Drugs, http://www.fda.gov/cvm/FOI/foidocs.htm: A Freedom of Information (FOI) Summary summarizes the safety and effectiveness information submitted by the drug manufacturer to support the approval of a new animal drug. FOIS summarize the indications for use, dosage form, route of administration, and the recommended dosage. Pivotal and supplementary studies supporting safety and effectiveness of the drug in the target animal as well as human food safety are also presented in the FOIS.
f. Information for Consumers, http://www.fda.gov/cvm/consumer.html: These PDF brochures are intended to answer frequently asked questions regarding use of veterinary drugs, devices, and feeds. This page was used recently to answer questions from consumers who were concerned about melamine-contaminated batches of pet food.
g. Good Manufacturing Practices: This document contains a comprehensive description of federal requirements for manufacturers of drug products.
h. Regulatory activity regarding veterinary medicine, http://www.fda.gov/foi/warning.htm: Warning letters issued to firms pursuant to an FDA inspection are listed on this site and are searchable by company, subject, FDA office, date, and responses. Veterinarians search this site when choosing a compounding pharmacist with whom to work.
2. American Veterinary Medical Association, www.avma.org
a. Guidance documents and position statements on veterinary issues
b. Veterinary scientific news
c. Peer-reviewed veterinary scientific articles
d. Animal and human public health issues
3. Veterinary Support Personnel Network, www.vspn.org
a. Veterinary continuing education
b. Veterinary discussion forums and chat rooms
c. Library holdings
C. Subscription services
1. Journals
a. The Journal of the American Veterinary Medical Association (JAVMA), http://www.avma.org/journals/javma/javma_about.asp
(1) Original peer-reviewed veterinary scientific research
(2) Current veterinary news and events
(3) Guidelines and position statements regarding animal health and welfare
(a) AVMA Position Statement on Compounding For Animals
(b) AVMA Guidelines on Euthanasia
(c) Compendium of Animal Rabies Prevention and Control
b. The International Journal of Pharmaceutical Compounding (IJPC), http://www.ijpc.com/
(1) Original research
(2) Feature articles on veterinary medicine
(3) Veterinary compounded preparation formulas
2. Forums
a. The Veterinary Information Network (VIN), www.vin.com
(1) Message boards for veterinary practitioners moderated by expert veterinary consultants
(2) Clinical rounds with continuing education credit
(3) Library holdings
(4) Scientific abstracts and manuscripts
(5) Client educational materials
(6) Scientific research forum proceedings
(7) User-friendly search engine
b. Veterinary Forum—Professional Compounding Centers of America
(1) Moderated discussion of contemporary pharmacy issues
(2) Focus on providing compounded preparations for animal patients
3. Listservs
a. American College of Veterinary Pharmacists, members@vetemeds.org
b. Society of Veterinary Hospital Pharmacists, svhp_l@listserv.uga.edu
c. International Journal of Pharmaceutical Compounding, NETWORK@LISTS.IJPC.COM
D. Veterinary colleges: directory of U.S. Colleges of Veterinary Medicine, academic pharmacists and pharmacologists for questions regarding veterinary pharmacotherapy, http://www.veterinaryschools.com/dvm-schools-colleges-programs.html
III. PROFESSIONAL VETERINARY PHARMACY ORGANIZATIONS
A. International College of Veterinary Pharmacists (ICVP), www.svhp.org
1. Board-certified veterinary academic teaching hospital pharmacists
2. Certification via credentialing, continuing education, and examination
B. American College of Veterinary Pharmacists (ACVP), www.vetmeds.org
Monthly newsletters for practicing veterinarians, pharmacists, and pet owners
C. Veterinary drug information hotline
Board-certified veterinary pharmacy specialist consultants
D. Veterinary Specialty Training programs to achieve certification
80+-hours Accreditation Council for Pharmacy Education (ACPE) approved continuing education credits annually
1. Annual conference: ~12 hours ACPE credits
2. Mid-year conference: ~12 hours ACPE credits
3. 40-hour ACPE certificate program in advanced canine and feline pharmacotherapy
4. 20-hour ACPE certificate program in advanced exotic animal species pharmacotherapy
5. 20-hour ACPE certificate program in advanced equine pharmacotherapy
6. Diplomate in Veterinary Pharmacy specialty certification program
E. Society of Veterinary Hospital Pharmacists (SVHP), www.svhp.org
1. Web site with current news, critical issues, and position statements
2. Newsletter: six issues annually
3. Annual conference: ~20 hours ACPE credits
4. Listserv
F. Professional Compounding Centers of America (PCCA), www.pccarx.com
1. ACPE-approved veterinary pharmacotherapy CE: ~40 hours
2. International Veterinary Symposium: ~20-hour ACPE credit
3. Online veterinary pharmacotherapy courses
a. Introduction to Veterinary Pharmacotherapy: 20 hours ACPE or 2-hour college credit
b. Advanced Veterinary Pharmacotherapy: 20 hours ACPE
4. Webinars
a. Introduction to Veterinary Pharmacotherapy
b. Veterinary Practice Builders: Small Animal Niches
c. Veterinary Practice Builders: Equine Niches
d. Providing Care and Compounds for Feline Patients
e. Providing Care and Compounds for Canine Patients
IV. LEGAL CONSIDERATIONS
A. Evolution of Animal Drug Law. Humans consume some animal species as food. Because it is currently legal in the United States for a human to consume any species except another human, drug use laws for animal species evolved quite differently from laws for drug use in the human species. The following is a brief outline of legislation critical to the use of drugs in animal species.
1. Food, Drug and Cosmetic Act, 1938
a. Mandated FDA approval for all drugs in the United States, except those qualifying for pharmacy practice exemption
b. Did not address drug use in animal patients
c. Did not create a veterinary practice exemption
2. Animal Drug Amendment, 1968a. From 1938 to 1968, there were increasing incidents of drugs accumulating in the human food chain through meat, milk, and eggs, causing human deaths and illnesses.
b. Legal definition of a food animal species is problematic as animal use is determined by individual human preference. For example, rabbits may be kept as pets, performance animals (e.g., rabbit hopping, which is essentially stadium jumping for rabbits), pelt animals, meat animals, or laboratory animals or may be raised to serve as food for other nonhuman species (e.g., reptiles and raptors). Therefore, any nonhuman animal is potentially a food-producing animal in the United States.
c. This Act codified restriction on drug use in nonhuman patients to only those products that were approved specifically for use in the target species. For example, amoxicillin labeled for humans could not be used in dogs, and antiinflammatory drugs labeled for dogs could not be used in cattle.
d. An unintended consequence of this law was that use of human-labeled drugs and compounded preparations in animal patients became technically illegal.
3. Animal Medicinal Drug Use Clarification Act, 1996 (AMDUCA), http://www.fda.gov/cvm/s340.htm
a. This Act codified extra-label use of drugs by veterinarians within the context of a valid veterinarian-client-patient relationship (VCPR) while avoiding drug residues in the food chain.
(1) VCPR is federally mandated and means as follows:
(a) The veterinarian has assumed the responsibility for making clinical judgments regarding the health of the animal and the need for medical treatment, and the client has agreed to follow the veterinarian’s instructions.
(b) The veterinarian has sufficient knowledge of the animal to initiate at least a general or preliminary diagnosis of the medical condition of the animal. This means that the veterinarian has recently seen and is personally acquainted with the keeping and care of the animal either by virtue of an examination of the animal or by medically appropriate and timely visits to the premises where the animal is kept.
(c) The veterinarian is readily available or has arranged for emergency coverage for follow-up evaluation in the event of adverse reactions or the failure of the treatment regimen.
(2) A valid VCPR must be present before a veterinarian can prescribe any of the following:
(a) Legend drugs
(b) Off-label use of over-the-counter drugs
(c) Compounded preparations
b. AMDUCA prohibited extra-label drug use that would result in drug residues in the human food chain. AMDUCA banned use of the following drugs or chemicals in food-producing animals (http://www.fda.gov/cvm/Documents/530_41.pdf):
(1) Chloramphenicol
(2) Clenbuterol
(3) Diethylstilbestrol (DES)
(4) Dimetridazole
(5) Furazolidone, nitrofurazone, other nitrofurans
(6) Fluoroquinolones
(7) Glycopeptide
(8) Ipronidazole
(9) Other nitroimidazoles
(10) Phenylbutazone animal and human drugs in female dairy cattle 20 months of age or older
(11) Sulfonamide drugs in lactating dairy cattle (except approved use of sulfadimethoxine, sulfabromomethazine, and sulfamethoxypyridazine)
c. AMDUCA codifies compounding for animal patients as long as starting ingredients are FDA-approved drugs.
d. Compliance Policy Guides are internal guidance documents for FDA inspectors that allow regulatory discretion in areas that are not provided for by law. Veterinary-related CPGs are continuously revised and posted at this link: http://www.fda.gov/ora/compliance_ref/cpg/cpgvet/default.htm.
B. Food animals: Defined as any animal patient, or a tissue or byproduct thereof, which can be consumed by humans.
1. Any nonhuman species can be legally consumed by humans1 in the United States.
2. Some typical food animal species are as follows:
a. Cattle
b. Poultry
c. Sheep
d. Goats
e. Pigs
f. Fish
g. Deer
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