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Introduction to Veterinary Pharmacy Gigi Davidson

Clinical Pharmacy Services, College of Veterinary Medicine, North Carolina State University, Raleigh, NC, USA

Key Points

●● Several organizations exist that support vet- ●● Veterinary drug law is significantly differ- erinary pharmacy practice, including a train- ent from human drug law. For example, ing and credentialing process that culminates there is not currently a legal avenue for in the designation of Diplomate, International pharmacists to recommend human over‐ College of Veterinary Pharmacy (ICVP). the‐counter (OTC) drug products for veteri- ●● Veterinary pharmacists are uniquely trained nary patients. specialists that provide competent care and ●● Veterinary pharmacy residency training drug products to nonhuman species and programs have grown substantially since can be resources for community pharma- 1989. cists dispensing drugs to animals. ●● Core competencies for veterinary phar- ●● Veterinary pharmacotherapy is rapidly macy education must be standardized and entering the mainstream of pharmacy prac- uniformly implemented across pharmacy tice, despite the fact that most pharmacists school curricula. are not adequately trained in the field.

1.1 Introduction medicinal agents for animals were almost exclusively performed by veterinarians. In the Although the practice of providing medicinal late ­twentieth century, the practice of clinical therapy to animals dates back to the pharmacy for human medicine was estab­ Mesopotamian healer Urlugaledinna in 3000 lished, and veterinary professionals began to bce (Royal College COPYRIGHTEDof Veterinary Surgeons ­recognize MATERIAL the unique therapeutic contribu­ 2017), it took society nearly 5000 years to real­ tions made by clinically trained Doctors of ize that pharmacists were well‐placed medical Pharmacy. Veterinary pharmacy, which is professionals that could provide safe and practiced by pharmacists, is unique from the ­effective pharmacotherapy and monitoring to field of ­veterinary pharmacology, which is animal patients as well as to humans. In 1761, practiced by veterinarians, because it encom­ the first college of veterinary medicine was passes a three‐pronged approach that utilizes established in Lyon, France (Larkin 2010); and ­medicinal chemistry, pharmacology, and from that time until the mid‐twentieth century, ­species‐specific pharmacotherapeutics to eval­ the preparation, dispensing, and monitoring of uate the best action plan for a specific patient.

Pharmacotherapeutics for Veterinary Dispensing, First Edition. Edited by Katrina L. Mealey. © 2019 John Wiley & Sons, Inc. Published 2019 by John Wiley & Sons, Inc.

Chapter No.: 1 Title Name: 0004238187.INDD 0004238187.INDDComp. 1 by: RKarthikeyan Date: 25 Jan 2019 Time: 03:05:19 PM Stage: Printer WorkFlow:CSW Page Number:1/25/2019 1 3:05:19 PM 2 1 Introduction to Veterinary Pharmacy

“I promise to devote myself to a lifetime of service to others through the profession of pharmacy. In fulfilling this vow: • I will consider the welfare of humanity and relief of suffering my primary concerns. • I will apply my knowledge, experience, and skills to the best of my ability to assure optimal outcomes for my patients. • I will respect and protect all personal and health information entrusted to me. • I will accept the lifelong obligation to improve my professional knowledge and competence. • I will hold myself and my colleagues to the highest principles of our profession’s moral, ethical, and legal conduct. • I will embrace and advocate changes that improve patient care. • I will utilize my knowledge, skills, experiences, and values to prepare the next generation of pharmacists. I take these vows voluntarily with the full realization of the responsibility with which I am entrusted by the public.”

Figure 1.1 The pharmacist’s oath.

Beginning with a handful of pharmacists inter­ ­pharmacy, a US Food and Drug Administration ested in veterinary medicine, veterinary phar­ (FDA) guidance document released in 2015 macy has now evolved into a globally impactful estimated that 75 000 pharmacies fill 6 350 000 specialty area of pharmacy practice and resi­ compounded prescriptions for animal dency training programs and encompasses a patients annually (FDA 2015). It is important broad spectrum of practice settings, including to note that this estimate was only for com- veterinary teaching hospitals, veterinary medi­ pounded veterinary prescriptions and did not cal practices, community pharmacies, gov­ account for the number of all prescriptions ernmental agencies, and the pharmaceutical dispensed from pharmacies to animals. industry. Because most pharmacists have not received While most pharmacists are not trained as adequate training in comparative pharmacol­ veterinary pharmacy specialists, most com­ ogy and veterinary pharmacotherapeutics, munity pharmacists will encounter prescrip­ one would have to question whether pharma­ tions for nonhuman patients in their practice. cists are fulfilling the oath’s obligations when A survey of more than 13 000 licensed phar­ it comes to dispensing drugs to veterinary macists in North Carolina revealed that 77% patients. of respondents filled prescriptions for animal Drugs that achieve desired therapeutic patients in their practice (Sorah et al. 2015). A effects in humans do not always produce the similar survey of pharmacists in Oregon also same effects in nonhuman patients, and vice revealed that 77% of respondents filled pre­ versa. Using the wrong drug or the wrong scriptions for veterinary patients (Mingura dose of medications in animals can result in 2017). Pharmacists are the only healthcare therapeutic failure or serious adverse events. professionals expected by society – and legally In addition, statutes, regulations, rules, and permitted by regulatory authorities – to pro­ guidance for drug use in animals are signi­ vide pharmaceutical care and drug products ficantly different from those for humans, for all species. Yet despite this unique ­position, particularly with respect to animal species only 4% of pharmacy students who graduated whose tissues or milk may be consumed by in 2015 reported receiving any training in vet­ humans. Consequently, there is a critical erinary pharmacotherapy (Arnish et al. 2015). need for community pharmacists to under­ In fact, the pharmacy oath (Figure 1.1) does stand basic comparative pharmacology not distinguish between human patients ­principles, laws surrounding drug use in food and veterinary patients. Despite the lack animal species, and pharmacotherapy of of standardized education in veterinary common veterinary diseases in order to serve

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the needs of the pet‐owning public. There is Kernan remains an active and vital contribu­ an additional need for a designated veteri­ tor to veterinary pharmacy practice. Several nary pharmacy specialty to meet the unique other veterinary schools followed suit in hir­ needs of providing legally compliant phar­ ing pharmacists in the late 1970s and early maceutical products, compounds, coun­ 1980s, and today all but one of the veterinary seling, and monitoring of veterinary patients schools in the USA and Canada employ at on an in‐patient basis, as well as serving as a least one pharmacist in a faculty, administra­ resource for community pharmacists outside tive, or professional staff position. In 1982, of the veterinary practice setting. a group of veterinary pharmacists, includ­ ing Kernan, met in Lincoln, Nebraska, to 1.1.1 History ­establish the Society of Veterinary Hospital Pharmacists (SVHP), the first professional Historically, the role of pharmacists in veteri­ organization representing veterinary phar­ nary medicine was limited to incidental macists. The organization has steadily grown ­compounding of medications and dispensing and now hosts more than 165 veterinary human‐approved prescription drugs for pets pharmacist members practicing throughout within the community pharmacy practice. the world. In 1989, the Auburn University Veterinary pharmacy, as an exclusive prac­ College of Veterinary Medicine and College tice, originated in colleges of veterinary med­ of Pharmacy collaborated to create the first icine in North America. In 1965, Laurence veterinary pharmacy residency program, and Reed Enos, PharmD, became the first veteri­ selected Dr. Bobbi Anglin as the first veteri­ nary pharmacist when he was hired by nary pharmacy resident (Dr. Sue Duran, per­ the University of California (UC) Davis sonal communication, Auburn University School of Veterinary Medicine (Laurence College of Veterinary Medicine, March 19, Reed Enos, personal communication, May 9, 2017). Since then, UC Davis, North Carolina 2011; Jeanne Enos, personal communication, State University, Purdue University, and the June 13, 2016). Clinical pharmacy was just University of Wisconsin have all established beginning in human medicine at that time, veterinary pharmacy residency training pro­ and Dr. Enos was hired to serve a clinical role grams, producing many residency‐trained providing pharmaceutical care for veterinary veterinary pharmacists. Compared to their patients and to provide education in pharma­ humble beginnings in 1965, today’s veteri­ cotherapeutic principles to veterinary stu­ nary pharmacists provide a significant and dents. He held administrative, teaching, and positive impact on animal healthcare. service roles within both the School of Veterinary Medicine and the College of Pharmacy during his 37 years of practice 1.2 Veterinary Pharmacy there. His philosophy was to develop a strong Professional Organizations clinical program in veterinary pharmacy that emphasized teaching, research, and thera­ 1.2.1 Society of Veterinary peutics. In 1968, Faye Kernan, BSP, MTS, Hospital Pharmacists became Canada’s first veterinary pharmacist, hired by the Western College of Veterinary The SVHP is an organization of pharmacists Medicine at the University of Saskatchewan who work exclusively in the veterinary field, (Faye Kernan, personal communication, May primarily at veterinary teaching hospitals in 9, 2011). Like her US counterpart at UC colleges of veterinary medicine (see www. Davis, Ms. Kernan established a model for svhp.org). Membership is international; the veterinary pharmacy practice and earned USA, Canada, the Netherlands, Denmark, tremendous respect from her veterinarian South Africa, Australia, Spain, Austria, and pharmacist peers. Fifty years later, and New Zealand are currently represented.

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The SVHP membership meets annually to ACVP develops and disseminates ACPE‐ participate in the Accreditation Council for accredited educational materials, sponsors Pharmacy Education (ACPE) and accredited programs (including compounding and disease continuing education activities, and to state management courses), serves as an infor­ exchange ideas and information about mation resource, and works closely with allied ­veterinary pharmacy practice. While mem­ organizations to enhance the veterinary phar­ bership as an SVHP Fellow is restricted to macy care offered by pharmacy practitioners. licensed pharmacists who practice in ­nonprofit veterinary­ institutional settings providing professional service, teaching, or 1.3 Veterinary Organizations research (or some combination thereof), with Pharmacological Expertise associate membership is open to pharma­ cists, veterinarians, and other animal health 1.3.1 The American Academy professionals who have an interest in veteri­ of Veterinary Pharmacology nary pharmacy. The number of practicing and Therapeutics (AAVPT) veterinary hospital pharmacists continues to grow steadily. The AAVPT was founded in 1977 and consists of approximately 300 veterinary pharmacol­ ogy trained professionals from over 20 coun­ 1.2.2 International College tries. Members of AAVPT share a common of Veterinary Pharmacy interest in research and teaching in veterinary In 2000, the International College of pharmacology. The Academy’s stated objec­ Veterinary Pharmacy (ICVP) was estab­ tives are to support and promote education lished by the SVHP to develop a recognized and research in comparative pharmacology, specialty college and certification for veter­ clinical veterinary pharmacology, and other inary hospital pharmacy. Appropriately aspects of pharmacology of interest to the vet­ trained SVHP Fellows would qualify for erinary profession; to sponsor a journal pub­ specialty certification through an arduous lishing related pharmacology manuscripts; to credentialing process and would then be provide educational meetings and symposia in eligible to sit for a rigorous certification veterinary pharmacology and therapeutics; to examination. In 2001, the first 13 diplo­ enhance the exchange of educational materi­ mates of the ICVP were awarded the cre­ als and ideas among veterinary pharmacolo­ dentials of Diplomate, ICVP. Today, there gists; and to organize advisory committees of are 31 diplomates of ICVP, with approxi­ experts to address problems in veterinary mately 10 additional candidates undergoing therapeutics. The AAVPT has been very sup­ the certification process. portive to veterinary pharmacists since its inception and has welcomed many of them into its membership. 1.2.3 American College of Veterinary Pharmacists 1.3.2 The American College The American College of Veterinary of Veterinary Clinical Pharmacists (ACVP) is affiliated with the Pharmacology (ACVCP) American College of Apothecaries and was established to support the efforts of independ­ Similar to the relationship between the SVHP ent pharmacists in developing and strength­ and ICVP, the ACVCP originated from the ening the services they provide for animals AAVPT in 1990 as an AVMA‐recognized and strengthening the support services they board specialty in veterinary clinical pharma­ provide for veterinarians. Pharmacist mem­ cology. Veterinarians must complete a resi­ bership is open to any licensed pharmacist dency, board examinations, and graduate meeting ACVP Practice Standards. training in veterinary clinical pharmacology to

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achieve diplomate status. The logo of ACVCP determined that 87% of US pet owners sur­ demonstrates the college’s commitment to veyed consider their pets as family members. advancing the practice of clinical pharmacol­ Animals provide service, entertainment, pro­ ogy in veterinary medicine: “To cure with tection, food, and companionship, and even compassion, knowledge, and diligence.” More answer medical research questions for than 60 veterinary pharmacologists have humans in ways that greatly improve the achieved diplomate status in ACVCP, with quality and length of human life. Pharmacists many more pursuing certification. ACVCP‐ can play a major role in maintaining animal boarded veterinary pharmacologists often health, and by doing so also contributing to work collaboratively with veterinary pharma­ the health and well‐being of humans, whether cists in veterinary teaching hospitals, and by strengthening the human–animal bond, many routinely provide clinical pharmacology preventing the spread of zoonotic disease, or support to community veterinarians and preventing drug residues in human food. pharmacists seeking their expert knowledge of Veterinary pharmacists (those whose prac­ clinical veterinary therapeutic strategies. tice is limited to veterinary patients) may play a larger role in these efforts, but the role of community pharmacists in maintaining animal health continues to grow. 1.4 Impact of Veterinary The benefits that veterinary pharmacists Pharmacy Practice provide to veterinary teaching hospitals have been measured (Jinks and Paulsen Veterinary drug sales approximated $76.4 1982), demonstrating that in addition to billion in 2010 (Animal Health Institute positive effects on patient care, veterinary 2017). In 2010, approximately 31% of all dog pharmacists add value in areas of drug dis­ owners and 18% of cat owners received pre­ tribution, academic development, and clini­ scriptions for medication from their pet’s cal research. The impact of pharmacists veterinarian (American Veterinary Medical adequately trained in veterinary pharmacy Association 2010). It is unknown how many that are practicing in the community, of these prescriptions were dispensed by ­industrial, and governmental sectors has not pharmacists adequately trained in veterinary been measured, but predictably would reveal pharmacotherapy. Several recent reports equally valuable contributions. The scope of describe serious errors made by pharmacists veterinary pharmacy practice by veterinary when dispensing drugs to veterinary patients, pharmacists (those individuals who have some of which resulted in patient fatalities. deliberately chosen to limit their practice to The author is aware of legal action directed veterinary patients) also continues to expand at pharmacists because of dispensing errors. as pet owners and veterinarians recognize Adequate training of pharmacists in veteri­ the valuable contributions that veterinary nary pharmacotherapy as part of a core phar­ pharmacists make as part of the veterinary macy curriculum would prevent many healthcare team. dispensing errors. The pet‐owning public The role of community and even hospital demands and deserves high‐quality medical pharmacists in veterinary medicine contin- care for their animals that does not stop ues to expand regardless of whether or not an abruptly at the pharmacy when they encoun­ individual pharmacist intended to dispense ter a pharmacist not adequately trained in medications to veterinary patients. This is veterinary pharmacotherapy. the result of both state and federal legislation Although the impact of the human–animal (proposed and passed) that encourages or bond cannot be measured quantitatively, the mandates veterinarians to provide prescrip- benefit animals provide to human life is tions to pet owners instead of dispensing great. A Mintel Market Report on America’s medication directly from the veterinary pet owners (America’s Pet Owners US 2016) hospital.

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1.5 Scope of Pharmacist pharmacists when providing pharmaceutical Involvement in Veterinary care for all family members, human or other­ Medicine wise. As human reliance on animals increases (e.g. companionship, service, research, food, agribusiness, and entertainment), most phar­ The current scope of veterinary pharmacy macists will eventually find themselves pro­ practice includes, but is not limited to, veteri­ viding some degree of pharmaceutical care nary academia, veterinary specialty referral and drugs to a nonhuman patient. Many centers, community and online (Internet) pharmacists have devoted a large portion, if pharmacies that serve veterinary patients only, not all, of their professional practice to pro­ the pharmaceutical and agricultural industry, viding pharmaceutical expertise and special­ and governmental public health and regulatory ized skills to care for animals. Pharmacists ­sectors. The scope of pharmacy practice desiring to effectively participate in animal that incorporates both human and veterinary care have many career options, some of which patients includes community pharmacies are described throughout the remainder of (chain and independent) and sometimes hospi­ this section, starting with venues that require tal pharmacies. This section of the chapter greater veterinary pharmacy expertise and describes the various levels of involvement then discussing those that may require less pharmacists may have in veterinary medicine, veterinary pharmacy expertise. from roles that require postgraduate training and documentation that a certain level of exper­ tise has been acquired (Diplomates, ICVP) to 1.5.1 Veterinary Teaching Hospitals those that only occasionally fill prescriptions The most well‐established practice of veteri­ for veterinary patients. It is important to note nary pharmacy resides in veterinary academic that even the latter role requires a basic level of teaching hospitals (Figure 1.2) associated with understanding of comparative pharmacology Colleges of Veterinary Medicine (Appendix and veterinary drug law in order to fulfill the A). Pharmacists in these roles provide exper­ profession’s responsibility to patient care. tise in areas of service (drug selection, distri­ The desire, by veterinarians, to proactively bution, and control), teaching (didactic, involve pharmacists in veterinary medicine incidental exchanges, client counseling, in‐ was well documented over four decades ago. service education, and continuing education In 1977, a survey of veterinarians in Wyoming programs for pharmacists and veterinarians), demonstrated the need for pharmacist and research (clinical trial development and involvement in veterinary medicine and rec­ administration, compounded preparation ommended the establishment of a veterinary quality assurance, adverse drug reaction and pharmacy specialty that should require spe­ medication error reporting, publication of cialized education and examination for licen­ articles in scientific and professional journals, sure (Nelson 1977). Unfortunately, the Board and responding to drug information queries). of Pharmaceutical Specialties (BPS) still does not include veterinary pharmacy as a phar­ macy specialty practice. However, veterinary pharmacy certainly qualifies for considera­ tion in light of BPS’s overriding mission “to ensure that the public receives the level of pharmacy services that will improve a patient’s quality of life (Board of Pharmaceutical Specialties 2017). BPS’s stated mission does not characterize patients as being limited to the human species, nor does the pharmacist’s oath. The public expects competency from Figure 1.2

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A typical day for a veterinary teaching hospi­ in exclusively equine veterinary practices. tal pharmacist involves attending service A typical day for a veterinary pharmacist rounds with clinical veterinary faculty, house practicing in a specialty referral center officers, and students; preparing and deliver­ involves many of the distributive and consul­ ing lectures for veterinary, pharmacy, and tative duties that are performed by pharma­ ­veterinary technology students; providing cists at veterinary teaching hospitals but with drug utilization reviews and therapeutic less emphasis on teaching and research. interventions; maintaining hospital pharmacy ­operations (inpatient and outpatient drug dis­ 1.5.3 “Community” Veterinary tribution, preparing sterile and nonsterile Pharmacies compounds, and admixture of intravenous One of the most rapidly growing areas of vet­ and chemotherapeutic therapies); and engag­ erinary pharmacy practice is in the commu­ ing in a variety of incidental teaching and con­ nity pharmacy setting. When the Animal sultative activities with students, veterinary Medicinal Drug Use Clarification Act practitioners, and animal owners. Veterinary (AMDUCA) of 1996 codified the extra‐label pharmacists at teaching hospitals, and their use of human drugs in animals, veterinarians staff, are valuable resources for community began prescribing more and more human pharmacists. drugs for use in animal patients. As a result, 1.5.2 Veterinary Specialty pharmacists in chain and independent phar­ Referral Centers macies were presented with an unprece­ dented number of prescriptions for animals. Many pharmacists are not aware that The professional rewards of helping animals ­veterinary specialization exists. Specialty combined with the financial rewards of cash‐ training programs (generally three years) and paying customers (third‐party payment for ­certification examinations exist in veterinary veterinary patients is rare in the USA) caused ophthalmology, oncology, anesthesiology, retail pharmacy market analysts to set their cardiology, neurology, surgery, dentistry, and sights on the veterinary prescription market. so on. While veterinary teaching hospitals Independent pharmacies also began actively often employ many of these specialists, there collaborating with veterinarians to provide are an increasing number of large, private compounded preparations for animal veterinary hospitals that limit their practice patients, and large retail chains began allow­ to specialized veterinary medicine. These ing pets into the discounted generics plans are called referral hospitals or referral cent­ traditionally offered for human prescrip­ ers because the primary care veterinarian tions. The result has been the emergence of “refers” patients to these hospitals. Small‐ several veterinary‐only pharmacies catering animal (canine and feline) oncology, internal solely to animal patients, and most recently, medicine, cardiology, neurology, and oph­ veterinary‐only online pharmacies are thalmology are among the most common becoming more prevalent. In 2011, the specialties at these private veterinary hospitals.­ Fairness to Pet Owners Act was debated by Recently, veterinary specialty referral centers the US Congress, proposing legislation that are employing veterinary pharmacists. would force veterinarians to provide written Interventions by these pharmacists have a prescriptions to all pet owners, giving them direct and positive impact on patient care, the option to purchase prescription drugs patient well‐being, and practice revenue outside of the veterinary clinic. Failing to (Dorsey n.d.). Some veterinary pharmacists get out of committee in 2011, the bill was in these settings are species specialists and reintroduced in 2014 as HR4203. While the are noted for their expertise and skills in fate of the bill is not yet determined, dis­ ­providing pharmaceutical care for a single cussion did prompt the Federal Trade species, such as pharmacists caring for horses Commission to examine the portability of

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pet medications. This is anticipated to fur­ 1.5.5 Government Sectors (FDA, ther increase the flow of veterinary prescrip­ CDC, NIH, and Disaster Relief) tions into retail pharmacies. A critical point Veterinary pharmacists provide valuable that has not been part of the debate around ­services to governmental and regulatory sec­ the Fairness to Pet Owners Act is the lack of tors. The Center for Veterinary Medicine of competence of most pharmacists in veteri­ the US Food and Drug Administration (FDA nary pharmacology. Instead, the debate has CVM) employs many veterinary pharmacists been centered on potential cost savings for in areas of compliance, surveillance, adverse pet owners if drugs are purchased at chain event reporting, and medication error pre­ pharmacies rather than veterinary hospitals. vention. The Centers for Disease Control and For community pharmacists to provide the Prevention (CDC) also employ veterinary same level of expertise for veterinary patients pharmacists who are charged with overseeing as they do for human patients, additional the distribution and use of biological agents education is necessary. Optimally, veterinary and drugs used to prevent or treat rare dis­ pharmacotherapeutics would become a core eases that are zoonotic. The National curricular requirement in accredited US col­ Institutes of Health (NIH) employ a veteri­ leges of pharmacy. nary pharmacist responsible for providing conventionally manufactured drugs, com­ 1.5.4 Industry (Pharmaceutical pounds, and consultation for research animals and Agricultural) in NIH‐funded protocols. Among other responsibilities, pharmacists in this role may Pharmacists with veterinary expertise are focus their efforts on minimizing the stress valuable to the animal health industry. that drug administration can cause to research Because of their unique training that com­ animals, which involves developing combina­ bines pharmacological expertise, clinical tion drug dosage forms (to avoid multiple decision making, and marketing skills, phar­ administrations) and transmucosally absorbed macists with specialized veterinary training drugs for nasal and buccal administration. make excellent professional representatives Veterinary pharmacists may also serve on for the veterinary pharmaceutical industry. disaster relief teams. These specially trained They can easily explain the pharmacody­ pharmacists are parts of multidisciplinary namics and clinical advantages of new teams that also may include veterinarians drugs to veterinarians and can serve as con­ and veterinary technicians that are ready to sultants for adverse event monitoring and be deployed regionally. When called upon, ­reporting. Veterinary pharmacists also serve these teams of veterinary professionals are in research and development roles in the vet­ deployed to stricken areas to provide triage, erinary pharmaceutical industry by design­ medical care, and treatment for displaced ing and overseeing pre‐ and postmarketing and injured animals. One of the largest clinical trials for veterinary drugs. Veterinary deployments of a Veterinary Medical pharmacists with expertise in the livestock Assistance Team (VMAT) was during the or poultry industry are contracted by pro­ Hurricane Katrina recovery in 2005. Many ducers to consult in areas of medication veterinary pharmacists were involved in management, specialized compounding, and these efforts. avoidance of drug residues in the tissues of food‐producing animals. As pharmacists are 1.5.6 Animal Poison Prevention well trained in pharmacokinetic principles,­ and Consultation they are able to collaborate with producers to predict drug depletion profiles for thera­ Veterinary pharmacists may also serve as peutic agents used in food‐­producing poison control specialists at animal poison animals. control centers such as the Pet Poison

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Helpline (www.petpoisonhelpline.com). 1.6 Veterinary Pharmacy Pharmacists often are the last line of defense Practice Considerations in recognizing and preventing potential ­animal poisoning. Unfortunately, pharma­ 1.6.1 Basic Considerations cists traditionally are trained only in human toxicology, which can be vastly different The two most profound differences between from veterinary toxicology. In fact, canine human and animal patients are that animal toxicology can be vastly different from patients do not communicate using spoken feline ­toxicology, which can be vastly differ­ words, and animals and their byproducts are ent from equine toxicology. Factors that consumed as food by humans. These two dif­ affect the risk of toxicity vary greatly among ferences drive many of the rules and regula­ ­species; they include (but are not limited tions regarding drug use in animals. A to) differences in absorption, distribution, complete discussion on drug therapy in metabolism, and elimination; anatomical food‐producing animals is provided in characteristics, such as the ­inability to Chapter 22. vomit; the age and size of the animal; and To fully appreciate the differences in vet­ seasonal and environmental influences. erinary pharmacy practice as compared to Veterinary pharmacists possess a working human pharmacy practice, it is also impor­ knowledge of species‐specific susceptibili­ tant to consider the unintended impact of ties to toxins and can work with boarded human healthcare systems and human veterinary toxicologists (DVMs with spe­ behaviors on veterinary medicine. The com­ cialty training in veterinary toxicology) plex systems of private, and state or federally for more unusual toxic exposures. The mandated, third‐party payor programs are American Society for the Prevention of mostly unique to human medicine, and Cruelty to Animals reported that 16% of although private third‐party insurance is pet poisonings in 2015 were attributable available to animal owners, it is rarely to human drugs (American Society for encountered by pharmacists. Because most the Prevention of Cruelty to Animals payment for veterinary healthcare is out of 2017). Lack of knowledge on the part of pocket, animal owners must carefully con­ pet ­owners can result in inadvertent sider the expense of purchasing medications ­poisonings when pets are accidentally or for their animals. This consideration often intentionally exposed to drugs. In some drives them out of the veterinary practice to instances, pet owners attempt to treat large discount outlets or the Internet to find ­animals with human OTC products or the least expensive options for therapy. The their own prescription drugs; pharmacists lack of veterinary pharmacology knowledge who are ­adequate trained in veterinary and risk of poor‐quality drugs in some of ­pharmacology are ideally positioned to these outlets can result in disastrous conse­ intervene and provide valuable post‐ingestion quences for pet owners who are trying to consultation. save money. For example, purchasing a cheap or compounded version of the immunomod­ ulating therapy cyclosporine instead of the FDA‐approved version for a dog with life‐ Dramatic difference threatening immune‐mediated disease can It is important for community pharmacists result in subtherapeutic blood concentra­ to understand that emetics that are effec- tions or often therapeutic failure. As a result, tive for inducing vomiting in one species the pet owner is forced to spend considerably may not be effective for another species more money back at the veterinary clinic try­ (Chapter 6). ing to re‐stabilize the animal or is forced to opt for humane euthanasia. Unlike human

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medicine, veterinary practitioners and ani­ during and after natural disasters. However, mal owners have the option of humane human behavior also strongly influences the euthanasia to end suffering when circum­ availability of opioids. Because of the ram­ stances (financial or medical) necessitate. pant rise of human addiction to opioids, all State and federal third‐party payor systems 51 states and territories in the USA have for Medicare and Medicaid (Center for Prescription Drug Monitoring Programs Medicare and Medicaid Services [CMS]) also (PDMPs) that closely monitor and often strongly influence the human medical sys­ severely restrict the quantity of opioids that a tem through approved reimbursement for­ prescriber can give to a human for use out­ mularies and a mandate for pharmacists to side of a hospital admission. To decrease sup­ substitute generic drugs when filling pre­ plies of opioids, federal mandates have also scriptions for CMS patients. As a result, been issued to reduce manufacturing of opi­ human pharmacy software programs require oids. The unintended consequence for veteri­ a national prescriber identification number narians and animal patients is an increasing (NPI) that verifies that prescriber in the CMS difficulty in obtaining opioids to meet patient database before new prescriptions can be needs. In 16 of the states with PDMPs, veteri­ processed. Community pharmacists often narians have been specifically excluded from request NPI numbers from veterinarians and these restrictions, but community pharma­ find it difficult to proceed in the software cists often do not realize that opioid prescrip­ without this verification number. The alter­ tions for animals may be exempt from their native verification is through the prescriber’s state PDMP rules. It is critical that commu­ DEA [Drug Enforcement Administration] nity pharmacists remain current and number, but DEA has stated that it “strongly informed of all state and federal rules and opposes the use of a DEA registration num­ regulations that may affect animal patients. ber for any purpose other than the one for which it was intended, to provide certifica­ Key Points for Processing Veterinary tion of DEA registration in transactions Prescriptions involving controlled substances. The use of DEA registration numbers as an NPI is not 1) Instead of NPI or DEA numbers, identify an appropriate use and could lead to a weak­ an alternate prescriber verification num- ening of the registration system” (DEA n.d.). ber (e.g. the state veterinary license Veterinarians express significant frustration number). when asked for NPI or DEA numbers or 2) Do not substitute generically without when pharmacists automatically substitute the veterinarian’s authorization. generic medications even when the veteri­ 3) Only require DEA numbers for prescrip- narian has indicated that therapeutic substi­ tions for controlled substances. tution is not permitted. Community pharmacists should be prepared for a differ­ The third‐party payor system also heavily ent approach when filling prescriptions for influences the drug approval and marketing animals: (i) Instead of NPI or DEA numbers, process. The human pharmaceutical indus­ identify an alternate prescriber verification try (Pharmaceutical Researchers and number (e.g. the state veterinary license Manufacturers of America [PhRMA]) con­ number), (ii) do not substitute generically sistently ranks as the most profitable indus­ without the veterinarian’s authorization, and try in the USA, and was relatively resistant to (iii) only require DEA numbers for prescrip­ the economic crisis that affected the USA in tions for controlled substances. 2009. The insurance industry also remains As mentioned in this chapter, opioid short­ relatively lucrative (Kaiser Health News ages may occur due to manufacturing short­ 2009). Because third‐party payors almost ages or interruption of the supply chain always cover the costs of human drug ­therapy

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for their constituents, there is little incentive based on cohorts of several thousand to reduce the astronomical prices that are humans. Occasionally, a drug intended to be charged for new human drug therapies. marketed for humans is successful in Phase I Profits by the pharmaceutical industry are (animal) testing but is determined to be toxic used to subsidize drug approval fees for new to humans in Phase II or III (human) pre‐ submissions, and the approval system is marketing studies. To attempt to recoup largely subsidized by these profits. In 2017, some of the research and development there were more than 35 000 drugs approved investment for these drugs, they are some­ for humans, while only 1564 were approved times taken up by the animal pharmaceutical for use in animals. The FDA approved 45 industry (Animal Health Institute [AHI]) for new human drugs in 2015 and consistently development for animal use. Some examples averages about 28 new drug approvals annu­ of these drugs include flunixin meglumine, ally. In comparison, FDA CVM approved five enrofloxacin, and tilmicosin for which the new animal drugs in 2015 and was praised in FDA CVM approved labeling bears a strong the 2017 budget for “exceeding all perfor­ warning that these products are not for use mance goals” in 2015 (FDA 2017). Comparing in humans. It is important to note that these the 2015 FDA budgets for human and animal warnings or potential drug interactions with new drug approval, the human drug approval other drugs will not be included in any drug budget was almost eight times larger than interaction/pharmacy alert software. The that for animal drugs. Considering the vast vast number of species, breeds, and genetic number of species and diseases requiring polymorphisms encountered in veterinary new drug therapy in veterinary medicine, the pharmacotherapy have thus far prevented ratio of expenditure and drug availability for the development of any intelligent drug humans versus animals seems upside down. interaction software for animal patients. As The priority of human need over animal mentioned further in this chapter, commu­ need is also evident during shortages of nity pharmacists must become familiar with human drug supplies. Manufacturing prob­ the pharmacology and toxicity of veterinary‐ lems, mergers, and natural disasters all con­ only drugs and employ methods that will tribute to significant drug shortages, which prevent them from being erroneously dis­ grow steadily every year. When drug supplies pensed to humans. are short, many drug manufacturers and Finally, there are many sound‐alike drugs wholesalers operate in a distribution mode that can be problematic for community phar­ known as “allocation,” whereby human pro­ macists accepting verbal prescriptions from viders get top priority for receiving drugs, veterinarians. For example, Soloxine® (oral and amounts are based on the provider’s pur­ levothyroxine tablets) sounds identical to chasing history of the shorted item. During Ciloxan® (ciprofloxacin ophthalmic ointment shortages of intravenous fluids, electrolytes, or solution). Usually, the instructions would chemotherapy drugs, and opioids, many prompt a pharmacist to request clarification, ­veterinary providers are denied access to but if the veterinarian states “use as directed” drugs because their patients are not human. without distinction to route of administra­ Because community pharmacists are well tion, then dispensing errors may occur. positioned to serve all species of patients, Another common and more consequential they serve a valuable role in helping veteri­ mistake is when veterinarians are phoning in narians and pet owners identify affordable prescriptions for Hycodan® for cough sup­ and available drug therapy for their patients. pression in dogs, to be followed by a written Postmarketing adverse drug events are also or faxed prescription. Instead of Hycodan, more likely in animal patients, since cohorts the pharmacist thinks he hears the more of only 50–300 animals are required for ani­ commonly prescribed drug for humans, mal drug approval. Human drug approval is Vicodin®. Vicodin contains a fatal dose of

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acetaminophen for cats and a potentially regulated by the FDA under the Federal Food, fatal dose of acetaminophen for small dogs. Drug, and Cosmetic (FDC) Act. New animal Although the paper prescription would drugs must have an approved New Animal ­eventually alert the pharmacist to this error, Drug Application (NADA), similar to the severe morbidity or death could have likely New Drug Application (NDA) for human ensured in the few days between verbal and drugs. Animal drugs, like human drugs, must written orders. Community pharmacists are be shown to be safe and effective for their well advised to have veterinarians spell out intended uses. Generic copies of new animal drug names if there is any doubt at all as to drug products can be approved pursuant to what the veterinarian is prescribing. submission of an Abbreviated New Animal Drug Application (ANADA).

1.6.2 Veterinary Drug Law 1.6.3 Regulations for Drugs It is important for pharmacists to understand Intended for Food‐Producing that regulations for veterinary drug use are Animals different from those that apply to human drug use, but it is even more complicated Regulations for human and “food‐produc­ than that. There are a specific set of regula­ ing” animal drugs differ in important ways tions that apply to only some animals (food because humans may consume animal animal species) but not others. Detailed ­tissues and byproducts. The administration information about drug use in food animals of drugs to food‐producing animals (see is presented in Chapter 22, but a summary is Chapter 22 for additional information), in this chapter. All other veterinary drug including drugs in animal feed or water, has ­regulations apply to both food animals and the potential to generate residues of the par­ companion animals. ent drug or its metabolites that could be Veterinary pharmacists must work within consumed by (and pose health hazards to) the boundaries for drug use established by a humans. It is necessary to determine when it number of agencies at both the federal and is safe for the public to consume tissues state levels. These agencies include the FDA, from an animal that has been treated with a DEA, US Department of Agriculture (USDA), drug. This information is part of the FDA‐ and Environmental Protection Agency (EPA) mandated approval process for drugs labeled (see Table 1.1, “Classes of Veterinary Products for use in food ­animals. That is why there Approved by Agency”), in addition to the are major differences in regulations related state boards of pharmacy and veterinary to extra‐label use of drugs (i.e. use for an medicine. In the USA, regulations governing indication that has not received FDA veterinary drugs have much in common with approval) in food animals compared to the regulations that govern human drugs. For humans. After a drug is approved for human example, both human and animal drugs are use, the FDA does not limit or control how physicians prescribe medications. In con­ trast, extra‐label use of drugs in food animals­ Table 1.1 Classes of veterinary products approved is permitted only under limited conditions by agency. to ensure public safety. For some drugs, extra‐label use is expressly prohibited (see Agency Product class Chapter 22).

FDA Drugs 1.6.4 Regulations for Drug Use EPA Topically administered pesticides in Companion Animals USDA Biologics and vaccines In 1996, a milestone veterinary drug law, DEA Controlled substances AMDUCA, was enacted, permitting extra‐label

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use of many approved animal and human drugs product (e.g. strength, dosage form, and by or on the lawful order of a veterinarian ­formulation), and package size and type: within the context of an established set of They do not denote legal approval by the ­conditions known as a “veterinarian–client– FDA. Although categories of veterinary patient relationship” (VCPR; see Figure 1.3, drugs are similar to those for human drugs, “Elements of the Veterinarian–Client–Patient there are some notable differences in their Relationship”). Prior to AMDUCA, the law use. For example, megesterol acetate, a hor­ required veterinarians to use drugs exactly as monal agent, is used almost exclusively as an labeled for the approved indication, at the antineoplastic therapy in humans but is used approved dose, by the approved route, for the for behavior modification in animals. A approved duration, and only in the approved pharmacist receiving a prescription for species. This effectively rendered any other megesterol for a cat cannot assume that the drug use, including use of any human‐labeled cat has cancer. drug, illegal. Because AMDUCA grants veteri­ narians the ability to prescribe human‐labeled 1.6.4.1 Prescription Drugs drugs for use in animals, the need for pharma­ Prescription animal drugs (also known as cists trained in veterinary pharmacotherapy has legend drugs) are restricted by federal law to emerged as a needed discipline. The quality of use by or on the order of a licensed veterinar­ medical care for companion animals is substan­ ian, according to Section 503(f) of the FDC tially enhanced with access to human‐approved Act. The law requires that such drugs be drugs because there are so few approved veteri­ labeled with the statement “Caution: Federal nary drugs in comparison. law restricts this drug to use by or on the order Prescription and OTC drugs approved by of a licensed veterinarian” (see Figure 1.4) the FDA for use in animals are listed in the within the confines of a VCPR (see Figure Green Book, also known as Animal Drugs@ 1.3). The VCPR primarily evolved because FDA (http://www.fda.gov/animalveterinary). animal patients cannot communicate ver­ All drugs in the Green Book have an assigned bally with their healthcare providers. While a NADA number for new animal drugs or an human patient can phone a prescriber and ANADA number for generic animal drugs. If describe symptoms that can lead to a reason­ a “drug” cannot be located in the Green Book, able diagnosis, animal patients cannot. For it is not FDA approved for use in animals. this reason, veterinarians must have either National Drug Code (NDC) numbers for physically examined the animal or visited the drugs only identify the manufacturer, specific­ site where the animal is housed.

Elements of the Veterinarian–Client–Patient Relationship

A Veterinarian–Client–Patient relationship. A VCPR means that all of the following are required: a. The veterinarian has assumed the responsibility for making medical judgments regarding the health of the patient, and the client has agreed to follow the veterinarian’s instructions. b. The veterinarian has sufficient knowledge of the patient to initiate at least a general or preliminary diagnosis of the medical condition of the patient. This means that the veterinarian is personally acquainted with the keeping and care of the patient by virtue of: i. a timely examination of the patient by the veterinarian, or ii. medically appropriate and timely visits by the veterinarian to the operation where the patient is managed. c. The veterinarian is readily available for follow-up evaluation or has arranged for the following: i. veterinary emergency coverage, and ii. continuing care and treatment. d. The veterinarian provides oversight of treatment, compliance, and outcome. e. Patient records are maintained.

Figure 1.3

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of a human OTC drug in an animal unless such use is specifically pursuant to a pre- scription order by a licensed veterinarian within the context of a valid VCPR. This means that there is not currently a legal ave- nue for pharmacists to recommend human OTC drug products for veterinary patients. Hopefully, this can change as the pharmacy profession adopts veterinary pharmaco- therapeutics as a core competency.

Figure 1.4 1.6.5 Veterinary Drug Compounding All states except Alaska, Connecticut, Drug compounding is the process by which a Delaware, Maine, Washington, and the District veterinarian or pharmacist prepares a medi­ of Columbia currently have laws in place that cation in a manner not stipulated in the require a VCPR before a veterinarian can pre­ product labeling to create a compound spe­ scribe a drug for use in an animal (American cifically tailored to the needs of an individual Veterinary Medical Association 2017). Even if patient. Compared with the number of drugs a VCPR is not mandated at the state level, it is approved by the FDA for use in humans, required by federal law when drugs are pre­ the number of drugs approved for use in scribed for extra‐label use in animal patients ­veterinary species is low, so the need for (21 CFR 530.10), when veterinary feed direc­ compounded therapies to treat animals is tive drugs are used in animal patients [21 CFR consequently high. Even though current fed­ 558.6 (a)(2)], and when autologous biologics eral law permits veterinarians to use and pre­ are used in animal patients (9 CFR 113.113). scribe drugs that are FDA approved for 1.6.4.2 Over‐the‐Counter Drugs human use in an extra‐label fashion, many Unlike human OTC drugs, veterinary OTC human medications are only available in drugs undergo full approval by the FDA. The ­formulations impractical or unsafe for use FDA is responsible for determining whether in pets (e.g. the use of xylitol as an artifi­ an animal drug product will be available by cial sweetener). Compounding also allows prescription only or sold directly to layper­ access to medications that are not currently sons. OTC status hinges on whether it is pos­ commercially available, such as drugs dis­ sible to prepare “adequate directions for use” continued by pharmaceutical companies for under which a layperson can use the drug economic reasons or as a result of voluntarily safely and effectively. Safe use includes safety or federally mandated withdrawals (e.g. to the animal, safety of food products derived cisapride, potassium bromide, and diethyl­ from the animal, safety to persons adminis­ stilbestrol), and drugs unavailable for use due tering the drug or otherwise associated with to temporary shortages (e.g. electrolytes and the animal, and safety in terms of the drug’s fluids, and opioid injections). A comprehen­ impact on the environment. sive discussion on compounding is provided in Chapter 3. Dramatic difference 1.6.6 Veterinary Adverse Drug It is important for the pharmacist to under- Event Reporting stand that human OTC drugs are not labeled for use in any species­ other than humans. Recognizing and reporting adverse drug Consequently, federal law prohibits the use events (ADEs) in animal patients comprise an integral role for the veterinary pharmacist.

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While not mandated by regulation in hospitals, can enhance pharmacotherapy by the USA, the American Animal Hospital instituting an adverse event monitoring sys­ Association (AAHA) considers adverse drug tem. The primary purpose of instituting a experience reporting a standard for accredi­ monitoring system is to improve detection of tation. Responsibility for this important task ADEs (including lack of efficacy) associated could easily be assigned to the veterinary with the use of approved drugs in animals. pharmacist, who can develop, implement, Compared to human drugs, there is a greater and monitor systems for adverse drug expe­ need for an adverse event monitoring system rience surveillance. Community pharmacists because of the limited number of patients are often the first healthcare professional included in pre‐approval clinical trials (a few that pet owners reach out to regarding a sus­ dozen to a few hundred). Because only a lim­ pected ADE. Pharmacists lacking training in ited number of animals are exposed to the veterinary pharmacotherapy are not likely drug prior to its commercial release, ADEs familiar with recognizing adverse events in that are uncommon may not be discovered animals but can play a key role in referring until after the drug has been administered to the owner to seek immediate evaluation from a large number of animals. Additionally, vet­ their veterinarian when adverse events are erinary clinical trials do not include all breeds known or suspected. of a species, nor do they include animals An ADE is defined by the FDA CVM as receiving many concurrent drugs. Therefore, “any observation in animals, whether or not unexpected breed‐specific ADEs (Chapter 5) considered to be product‐related, that is and drug–drug interactions are likely to unfavorable and unintended and that occurs occur, even though they are not indicated on after any use of veterinary medical prod­ the label. Pharmacist‐driven adverse event ucts (off‐label and on‐label uses). Included monitoring systems can improve patient are events related to a suspected lack of care, educate the veterinary staff concerning expected efficacy according to approved ADEs, and provide drug regulatory agencies labeling or noxious reactions in humans with statistical information regarding the after being exposed to veterinary medical incidence, types, and impact of adverse drug product(s)” (FDA 2006). Monitoring for and experiences on patient outcomes. reporting ADEs comprise a multidiscipli­ For veterinary pharmacists interested in nary responsibility and are accomplished instituting an adverse event monitoring sys­ through a ­combined effort of veterinarians, tem, the type of information collected is crit­ pharmacists, veterinary technicians, and all ical. It is important that veterinarians and other members of the veterinary healthcare staff can easily access the reporting forms, team. Although not mandated by the FDC whether they are electronic or paper. While Act, monitoring and reporting of ADEs are forms may vary between hospitals, the data required by the Joint Commission for indicated in Table 1.2 are recommended. Accreditation of Healthcare Organizations, Once the ADE is submitted to the veteri­ the American Society of Health‐Systems nary pharmacist, formal acknowledgment of Pharmacists, and the American Animal receipt should be returned to the reporter. Hospital Association. Once the internal report is evaluated for ADEs in animals can be reported to the ­completeness, a notation should be made in manufacturer or through the FDA Adverse the patient’s permanent medical record and Drug Event Reporting Form 1932a (FDA appropriate reports on appropriate forms to 2017). ADE monitoring is required by the (i) the attending veterinarian, (ii) the FDA, FDA for all approved veterinary drugs. (iii) the drug manufacturer or compound­ Additionally, the manufacturer (sponsor) is ing pharmacy, and (iv) the institutional required to report ADEs to the FDA. Pharmacy and Therapeutics Committee or Pharmacists, particularly veterinary pharma­ equivalent. Note that reporting to FDA cists at teaching hospitals or specialty referral simultaneously ­accomplishes notifying the

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Table 1.2 Elements of a veterinary adverse to human medicine; however, ­significant event report. ­differences have developed between veterinary­ and human medical terminology. Chapter 25­ Patient signalment and Appendix B provide ­information about Time and date differences in anatomic terminology that are Identity of reporter necessary to describe species that walk on four Attending veterinarian legs compared to species that walk on two Diagnosis legs. There are other phrases, terminology, Organ system involvement/clinical signs and just plain “jargon” that are standard in a veterinary hospital but that most pharmacists Suspected drugs are not aware of. Until recently, veterinarians Concurrently administered drugs and therapies almost exclusively dispensed medications Relevant tests and laboratory data to pet owners themselves, so they had no need Date and time of onset to learn to write prescriptions properly. Treatment and follow‐up Consequently, many veterinary colleges did Previous reactions to similar agents not teach veterinary students how to write prescriptions using standard Latin abbrevia­ Instructions for where to send the completed form tions, so non‐veterinary‐trained pharmacists frequently misinterpret unknown veterinary abbreviations. This has resulted in disastrous drug ­manufacturer. ADEs associated with consequences. For example, “once daily” is biologicals and vaccines should be reported almost exclusively abbreviated as SID (semel to the US Department of Agriculture, Center in die) by veterinary prescribers,­ and pharma­ for Veterinary Biologics (USDA, CVB). cists have misinterpreted this abbreviation to ADEs caused by pesticides should be read TID, QID, and even 5/D, usually resulting reported to the EPA. Adverse events from in serious toxicity (even death). Table 1.4 lists products that are not approved by the abbreviations that might be encountered by FDA (e.g. grooming aids) should be reported community pharmacists filling prescriptions to the US Consumer Product Safety Com­ for veterinary patients. mission (CPSC). Links to these agencies are listed in Table 1.3. 1.6.8 Drug Administration

1.6.7 Veterinary Terminology As described in Chapter 25, there are major dif­ ferences in drug administration techniques Veterinary medical terminology is largely between human and veterinary patients as grounded in the same Latin system that applies well as between veterinary species.­ These

Table 1.3 Adverse event reporting by product category.

Product type Agency Link

Drugs FDA http://www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ ucm055305.htm Vaccines USDA www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary‐biologics/ adverse‐event‐reporting/ct_vb_adverse_event Pesticides EPA http://www.epa.gov/enforcement/report‐environmental‐violations Grooming aids CPSC http://www.cpsc.gov

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Table 1.4 Common veterinary abbreviations in prescription writing.

Common veterinary abbreviations in prescription writing

Term or abbreviation Translation

Bolus Large, solid, oral dosage form, usually for horses or livestock Divided BID The total daily dose is calculated and then administered over 2 equally divided doses 12 hours apart DLH Domestic Longhaired (cat) Drench Large volume of oral liquid administered as a single dose (usually livestock) DSH Domestic Shorthaired (cat) EOD Every other day Fe Feline or cat FS or F/S Female spayed Intact A non‐neutered animal K9 Canine or dog MC or M/C Male castrated MN or M/N Male neutered OD Once daily or right eye, depending on context Paste Viscous oral liquid dosage form (frequently for horses) Pinnae The inner, hairless part of an animal’s ears QOD Every other day SID Semel in die (once daily) TD Transdermal

­differences are based on the size of the animal, drug boluses (as the term is typically used in its temperament, anatomical differences, and human medicine) in dogs or cats. The phar­ others. A pharmacist’s knowledge of com­ macist should confirm with the veterinarian pounding (Chapter 3) can be lifesaving for what the intended route of administration is some veterinary patients by enabling an owner prior to dispensing. or veterinarian to treat a fractious, aggressive, or fearful animal. Examples of creative manipu­ 1.6.9 Veterinary‐Only Drugs lations that veterinary­ pharmacists use to allow drug delivery include enhancing palatability, Many drugs may be used legally in both formulating transmucosally or transdermally human and animal patients, including furo­ absorbed drugs, and creating combination semide, many beta lactam antimicrobials, therapy capsules. corticosteroids, and many others. Other Dosage forms and descriptive terminology drugs have unique human toxicities and are also vary for drugs administered to animals. approved for use only in animals or in some In veterinary medicine, “pastes,” “boluses,” cases only in one species. Some drugs were and “drenches” are exclusively intended for approved initially for use in humans but oral use when referring to horses, cattle, withdrawn after serious adverse effects sheep, goats, and/or pigs. Sometimes, the emerged (Table 1.5). In other cases, these term “bolus” is also intended for intravenous drugs were identified as toxic to humans

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Table 1.5 Veterinary indications for drugs withdrawn for humans for safety reasons.

Drug Human toxicity Indications for animal use

Potassium bromide Bromism – CNS toxicity Canine epilepsy Cisapride Fatal arrhythmias Prokinetic Diethylstilbestrol Carcinogenic in offspring of user Urinary incontinence Dipyrone Hepatotoxicity Antipyretic Phenylbutazone Nephrotoxicity Anti‐inflammatory Phenylpropanolamine Hypertensive crisis/stroke Urinary incontinence

Table 1.6 Therapeutic plasma concentrations of selected drugs by species.

Drug Species Therapeutic concentration

Bromides (potassium and sodium) Canine 1–3 mg/mL Cyclosporine Canine, feline 400–600 nanogram/mL (trough) Phenobarbital Canine, feline 15–45 microgram/mL Digoxin Canine, feline 0.8–1.2 nanogram/mL Theophylline Canine, feline 8–10 microgram/mL (trough)

early in development and never approved for must be able to advise human caregivers human use. about possible risks from exposure to veteri­ More than 1400 drugs are approved by the nary drugs. FDA CVM for use in animals. Veterinary pharmacists must possess a working knowl­ 1.6.10 Monitoring Veterinary Patients edge of the names, mechanisms of action, for Response to Drug Therapy indications, dosing, adverse effects, safety profiles, and counseling points for veteri­ Pharmacists who are well trained in phar­ nary‐only drugs that may belong to similar macokinetic/pharmacodynamic principles therapeutic classes as those used in humans and therapeutic drug monitoring can but may cause serious adverse effects if acci­ use those skills as veterinary pharmacists. dentally dispensed to a human. For example, Therapeutic drug monitoring in animals is enrofloxacin is a commonly prescribed performed for many reasons, including but ­veterinary‐only fluoroquinolone antibiotic not limited to determining if the current known to cause severe central nervous sys­ drug dose is achieving­ target therapeutic tem (CNS) disturbances (e.g. auditory and plasma concentrations. Therapeutic plasma visual hallucinations) in humans. To avoid concentrations of several drugs are well erroneous dispensing of veterinary‐only defined in dogs and cats (Table 1.6). For per­ drugs to humans, most retail pharmacies that formance animals (Chapter 24), plasma and stock veterinary‐only drugs segregate them urine samples are ­collected to screen for the from human drug inventory. Because medi­ presence of banned substances. Other sam­ cation administration to animals­ by necessity ples that may be collected include hair and involves a human, veterinary pharmacists saliva. Veterinary pharmacists should be

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familiar with sample collection and handling these subjects, the veterinary pharmacist methods and protocols. must be familiar with veterinary drug infor­ Veterinary pharmacists can help educate mation resources and connected to refer­ pet owners to monitor for drug efficacy and ences that ensure instant access to the most toxicity. Veterinary pharmacists should be current evidence or conventional wisdom on familiar with how to monitor vital signs in any given subject. Because every veterinary each veterinary species. For example, pulse species is unique and is accompanied with an rate may be a good indicator of drug efficacy intended use that may invoke specific regula­ or toxicity for many drugs (sympathomimet­ tory restrictions, veterinary pharmacists ics, tricyclic antidepressants, selective sero­ must also develop a personal algorithm to tonin reuptake inhibitors, beta adrenergic approach each prescription order individu­ receptor antagonists, etc.) and is best deter­ ally in a way that considers therapeutic man­ mined in cats by palpating the femoral artery agement of disease as well as intended use of in the inner thigh. That would definitely not the patient. At the very least, the competent be recommended for horses! The mandibu­ veterinary pharmacist knows that extrapola­ lar artery beneath the lower jawbone in tion directly from human pharmacology horses is a much safer location. Neither of is rarely appropriate and is frequently those are appropriate access points for moni­ dangerous. toring human pulse rate. The body tempera­ ture that constitutes a “fever” in humans may 1.7.1 Anatomy be quite normal or even hypothermic in ani­ mals, and a respiratory rate that is normal in Dosing of drugs in humans is, for the most humans may indicate tachypnea in horses. part, empirical and based on stage of life. Veterinary pharmacists should be familiar Pharmacists caring for humans are familiar with normal ranges for vital signs in most with typical “adult” doses and typical “pedi­ domestic species (Appendix C) and the atric” doses and process prescription orders implications for values that fall out of range. that are generally dosed in “units per human” instead of metrology based on body weight or surface area. The heterogeneity across vet­ 1.7 Species Specifics erinary species prohibits empiric dosing in most cases. Veterinary pharmacists must Competent veterinary pharmacists must be learn acceptable dosage ranges as applied to well versed in practice considerations that body weight and body surface area, and when are vastly different from those for human dosing by body surface area, the veterinary pharmacotherapy. As detailed in Chapter 4, pharmacist must choose the appropriate comprehensive knowledge of species anat­ body surface area calculation formula for a omy and physiology, species metabolic and given species. Veterinary patients are also toxicologic susceptibilities, and veterinary horizontally oriented, as opposed to humans medical terminology, as well as legal and who are vertically oriented. Solid dosage ­regulatory boundaries (Chapter 2), drug forms administered orally to animals do not depletion profiles for food‐producing ani­ have the benefit of gravity to move them to mals (Chapter 22), intended use of animals the stomach, so veterinary pharmacists must (Chapter 24), behavioral characteristics ensure that adequate measures are taken to (Chapter 16), dietary preferences, drug ensure that drugs do not become trapped on administration techniques (Chapter 25), and esophageal mucosa, where they may be ero­ drug‐monitoring techniques, will enable the sive. Humans also have a relatively homoge­ veterinary pharmacist to more accurately neous skin covering, whereas fur, feathers, predict drug disposition and effect in indi­ scales, and exoskeletons may prove to be tre­ vidual animals. In addition to a mastery of mendous barriers to drug administration in

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animal species. Digestive organs of many likely to vary with the temperature of the ani­ animal species are also vastly different from mal’s habitat. Veterinary pharmacists must those of humans. Although humans have a also consider other physiological variants simple, monogastric stomach, herbivorous such as normal body temperature or pre­ species require complex, microbe‐filled ferred body temperature range, respiratory digestive organs such as rumens and cecums and pulse range, glomerular filtration rate, to adequately convert cellulose fibers into intravascular blood volume, and cellular idi­ utilizable carbohydrate energy. Oral antibiot­ osyncrasies such as hemoglobin structure ics must be carefully selected to introduce when considering appropriate therapeutic into these complex microbe‐filled organs, or regimens for animals. else malabsorption and endotoxemia from bacterial overgrowth may occur. 1.7.3 Metabolic Capacity

1.7.2 Physiology In addition to the vast amount of drug metab­ olism knowledge that pharmacists must com­ Veterinary pharmacy also involves a working mit to memory for human therapeutics, knowledge of species’ physiological varia­ veterinary pharmacists must also master the tions. Not only do digestive organs impact metabolic capabilities, microsomal enzyme drug disposition across the species, but die­ systems, and p‐glycoprotein substrate inter­ tary habit also has significant impact. Animals actions for all veterinary species. As animal that are primarily carnivores may have a rela­ species have evolved differently from humans, tively more acidic gastrointestinal and uri­ so has their capacity to metabolize xenobiot­ nary pH than humans. Herbivores may have a ics. A drug substance such as acetaminophen relatively more basic gastrointestinal and uri­ may be safe and therapeutically effective in nary pH than humans. Both extremes will humans but is metabolized to lethal hemo­ cause variation on the intestinal absorption toxins and hepatotoxins in cats. and urinary reabsorption of weak acids and weak bases as compared to what occurs in 1.7.4 Pharmacogenomics humans. Many herbivorous species are physi­ ologically unable to vomit (e.g. horses and Pharmacogenomics are beginning to play a rabbits). For this reason, great care must be large role in human pharmacotherapy, but taken to prevent unintentional oral adminis­ genetic and cultural factors have always been tration of a potential toxin because induction considered significantly in veterinary phar­ of emesis is not likely to be effective. Animals macotherapy. Veterinary pharmacists must that are unable to vomit have also evolved carefully consider breed‐specific disease pre­ powerfully discerning olfactory senses that dispositions and drug tolerances in animal make forced oral drug administration very species. For example, many herding breeds difficult. The thermoregulatory capability of (e.g. Border Collies, Australian Shepherds, an animal species must also be considered. and Shetland Sheepdogs) lack the MDR1 Many animals cannot sweat efficiently (e.g. gene that prevents drugs from crossing the dogs and cats) and must therefore depend on blood–brain barrier and are very susceptible respiration and vasodilation for dissipation of to the adverse CNS effects of heartworm pre­ body heat. Drugs acting on these systems can ventatives and other anthelmintic drugs have dramatic and sometimes lethal effects (Washington State University College of on body temperature. Other animals (e.g. Veterinary Medicine Veterinary Clinical reptiles and fish) cannot voluntarily maintain Pharmacology Lab 2017). Veterinary phar­ a preferred body temperature (poikilotherms) macists must also consider an animal’s and are vulnerable to environmental condi­ behavior and habitat when providing drug tions. Drug metabolism in these species is therapy. Cats are notorious groomers of

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themselves and of other household cats. For number of animals). Pharmacists must appre­ this reason, a topically administered drug ciate these limitations when they evaluate will become systemically available not only in and/or participate in veterinary research. the cat to which it is applied, but also to any other household cat that helped groom the medication off the treated cat’s skin. Finally, 1.9 Veterinary Pharmacy animals housed exclusively outside are par­ Information Resources ticularly vulnerable to weather extremes, and drug therapy must be planned accordingly. Drug dosing in nonhuman patients is not as straightforward as it is in human patients. 1.8 Critical Evaluation of Dosing in animals often is species specific or indication specific. For example, the labeled Published Veterinary Literature dose of firocoxib, a veterinary‐only non­ steroidal anti‐inflammatory agent, for horses Given the relative shortage of approved is 0.1 mg/kg, while the labeled dose for dogs drugs for all needs in veterinary medicine is 5 mg/kg, a 50‐fold difference. The labeled compared to human medicine, veterinary dose of maropitant, an antiemetic veteri­ pharmacists frequently aid in evaluating nary‐only drug, is 2 mg/kg orally to prevent and providing novel drug therapies for ani­ vomiting in dogs, and 8 mg/kg orally to pre­ mal patients. Veterinary pharmacists should vent motion sickness in dogs. Consequently, be capable of reviewing and evaluating pub­ it is imperative that pharmacists are aware lished literature to support the use of novel of and have access to current and credible therapies in animals, rather than merely veterinary drug information resources. reading and accepting investigator conclu­ When consulting veterinary references, sions. Accordingly, veterinary pharmacists ­veterinary pharmacists determine the most possess a basic knowledge of study design recent publication date and consider the fre­ and should be able to determine if the meth­ quency with which the material is revised. ods employed in a particular study were Many new veterinary information reference appropriate. They should be familiar with books and databases are published each year. the intent and validity of statistical presen­ This section describes drug information tations, as well as possible sources of error resources that veterinary pharmacists most and limitations of the investigation. commonly use. It is important to note that many of the assumptions regarding the validity of human 1.9.1 Veterinary Drug trials – for example, rational selection of Information Reference Handbooks cohort size – do not necessarily apply to ani­ mal studies. Because animal subjects do not The resource known familiarly as “Plumb’s” “volunteer” for investigational studies as comprises two reference products: the print‐ humans do, Institutional Animal Care and version Plumb’s Veterinary Drug Handbook Use Committees (IACUCs) must ensure that and the electronic Plumb’s Veterinary Drugs. a sufficient number of animals is included to The author (Donald C. Plumb, PharmD) and accomplish investigator aims without using contributors all are well‐known authorities animals unnecessarily. This requires careful in the veterinary medical field, and this pub­ balancing of multiple considerations: rational lication is widely utilized as a formulary by selection of group size (e.g. for a pilot study or practicing veterinary pharmacists. power analysis), careful experimental design, The Saunders Handbook of Veterinary maximizing use of each animal, minimizing­ Drugs: Small and Large Animal is written loss of animals, and efficient statistical ­analysis by board‐certified veterinary pharmacology (maximum information from the minimum expert Mark G. Papich, DVM, PhD, Diplomate,

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American College of Veterinary Clinical that journal in 2013 and 2014). Impact factors Pharmacology. It currently is in its fourth edi­ were designed to indicate the quality of jour­ tion. This book is available in both traditional nals. For example, the New England Journal of print and e‐book formats. Medicine had an impact factor of 59.558 in The Exotic Animal Formulary, currently in 2015, considered to be the highest among its fourth edition, is the only drug formulary general medicine journals (New England that exclusively addresses drug treatment of Journal of Medicine 2017). exotic animals. It is written by clinical and Impact factors for human journals cannot research veterinarian James W. Carpenter, be applied comparably to veterinary journals. with contributions from more than 20 expert In 2015, the Journal of Veterinary Internal veterinary authors. Medicine (JVIM) – one of the most widely The Compendium of Veterinary Products read and respected veterinary journals – had (CVP) is a comprehensive collection of vet­ an impact factor of 1.821. While this pales in erinary product information, including FDA‐ comparison to the New England Journal of approved labeling for veterinary drugs. CVP Medicine, one must consider that JVIM pub­ is particularly helpful for pharmacists seek­ lishes a narrower scope of articles (no articles ing to associate brand names with generic on public health, policy, surgery, radiology, contents for veterinary drugs. etc.). Another reason for the relatively low The Food Animal Residue Avoidance impact factor of veterinary journals is the fact Databank (FARAD; www.farad.org) is of crit­ that human journals are focused on intensive ical importance to veterinary pharmacists research for specific diseases in a single spe­ who provide drug products and care for cies. Veterinary journals publish research for food‐producing animals. FARAD is a con­ hundreds of diseases in dozens of species, so gressionally mandated drug residue avoid­ multiple citations of any one article are less ance risk management program supported likely. To the point, an impact factor of 1.5–2 by the USDA. Its primary mission is to pro­ is excellent for a veterinary journal. vide scientifically based expert advice to help mitigate unsafe chemical residues (e.g. drugs, pesticides, and biotoxins) in products derived from food animals. FARAD is maintained by 1.10 Veterinary Pharmacy a consortium of universities, including the Educational Core University of California Davis, University of Florida, Kansas State University, and Although veterinary pharmacy is rapidly North Carolina State University. The pro­ moving into the mainstream of pharmacy gram employs veterinary pharmacologists practice, and related test questions are now and veterinary pharmacists to evaluate drug included in the national pharmacy licensure depletion profiles in edible animal products. examination (NABPLEX), veterinary phar­ macy education is lagging. At the time of 1.9.2 Veterinary Journals writing, only a handful of veterinary phar­ macy educational opportunities (didactic and As with human medicine, new and emerging experiential) are offered during the Doctor of information in veterinary medicine is pub­ Pharmacy program and only in a few schools lished in primary literature (i.e. journals). of pharmacy. Pharmacists wishing to provide Pharmacists likely are accustomed to seeing competent medical care for nonhuman impact factors reported for healthcare patients have largely had to acquire this ­journals. The impact factor reflects the knowledge through postgraduate continuing ­average number of citations received per education programs. Unfortunately, the qual­ paper published in that journal during the two ity of veterinary pharmacy continuing educa­ preceding years (e.g. a journal’s 2015 impact tion programs is heavily dependent on the factor is the average number of citations­ from credentials of the author/presenter, and while

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many of those individuals are interested in offered here for those institutions wishing to veterinary pharmacy topics, they possess no offer complete veterinary pharmacy educa­ specialty credentials and have no authentic tion in their programs: veterinary pharmacy experience. Pharmacists 1) Veterinary Drug Information Resources wishing to learn the principles of veterinary 2) Principles of Drug Disposition in pharmacy practice through continuing edu­ Nonhuman Species cation programs are well advised to inquire 3) Principles of Toxicology in Nonhuman about and confirm the qualifications of these Species authors/presenters. For authors who are 4) Veterinary Drug Law and Ethical pharmacists, diplomate status in ICVP is a Considerations good indicator, as well as employment in a 5) Species Specific Anatomical and Physio­ veterinary teaching hospital or veterinary‐ logical Considerations for Dogs, Cats, focused institution. Veterinarians who pro­ Horses, Food Animals, and Exotic Species vide continuing education to pharmacists 6) Species‐Specific Disease State Manage­ should ideally be diplomates of the American ment Principles College of Veterinary Clinical Pharmacology 7) Top 50 Veterinary‐Only Drugs Review or diplomates in another specialty college 8) Compounding Considerations for (e.g. American College of Veterinary Internal Nonhuman Species. Medicine or American College of Veterinary Ophthalmology). Content can also betray The primary purpose of this book is to pro­ lack of expertise. For example, veterinary vide colleges of pharmacy with a text that can pharmacy continuing educational programs be used to create a core course in veterinary that include information on how pharmacists pharmacy. can counsel pet owners in using human OTC products are clearly lacking an understanding of the legal restrictions placed on use of OTC 1.11 Summary drugs in animals. Similarly, content that pro­ vides only “recipes” for compounding veteri­ Pharmacists are the only healthcare profes­ nary products but does not provide evidence sionals who are legally allowed to and for efficacy of the compounded products in expected by society to provide competent veterinary species lacks an understanding of pharmaceutical care and products to all the importance of pharmacotherapeutics. species. However, most pharmacists have While some schools and colleges of phar­ not received formal training in comparative macy have been quick to offer veterinary pharmacology, veterinary pharmacother­ pharmacy electives, this material is not apy, or veterinary drug laws and regula­ offered in all pharmacy school curricula. For tions. Pharmacists specially trained in pharmacy schools to produce the most com­ veterinary pharmacotherapy can support petent practitioners, structured learning community pharmacists as well as veteri­ programs containing core principles of vet­ narians and their patients in many impor­ erinary pharmacy practice should be stand­ tant therapeutic aspects, including drug ardized with the goal of achieving uniform therapy selection, compounding, therapeu­ competency across pharmacy school gradu­ tic monitoring, counseling of pet owners, ates. The following outline for basic core drug information research, and adverse competencies in veterinary pharmacy is drug event reporting.

­References

American Society for the Prevention of Cruelty toxins of 2014. http://www.aspca.org/news/ to Animals. (2014). Ten most common pet ten‐most‐common‐pet‐toxins‐2014.

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American Veterinary Medical Association drugs for use in animals. Federal Register. (2010). US Pet Ownership and Demographics https://www.federalregister.gov/ Sourcebook. Schaumburg, IL: American articles/2015/05/19/2015‐11982/ Veterinary Medical Association. compounding‐animal‐drugs‐from‐bulk‐ American Veterinary Medical Association. drug‐substances‐draft‐guidance‐for‐ (2017). Does every state require a valid industry‐availability. VCPR to exist before a veterinarian can Food and Drug Administration (FDA). (2017). write a prescription? https://www.avma.org/ FDA budget. https://www.fda.gov/ Advocacy/StateAndLocal/Documents/ AboutFDA/ReportsManualsForms/Reports/ VCPR_state_chart.pdf. BudgetReports/ucm559364.htm. America’s Pet Owners US. (2016). Mintel Jinks, M.J. and Paulsen, L.M. (1982). market reports. http://www.store.mintel. Pharmaceutical services in a veterinary com/americas‐pet‐owners‐us‐august‐2016. hospital and clinic. Am. J. Hosp. Pharm. 39 Animal Health Institute (2017). Industry (4): 619–621. statistics. Washington, DC: Animal Health Kaiser Health News. (2009). Pharmaceutical Institute http://www.ahi.org/about‐animal‐ industry ranks as “Most Profitable” in medicines/industry‐statistics. “Fortune 500.” https://khn.org/morning‐ Arnish CE, Davidson GS, Royal K. (2015). breakout/dr00004161. Veterinary pharmacy education: prevalence Larkin M. (2010). Pioneering a profession. and perceptions. Poster presented at the JAVMA News. https://www.avma.org/ Society of Veterinary Hospital Pharmacists News/JAVMANews/Pages/110101a.aspx. 34th Annual Meeting, June 14–17, Mingura M. (2017). Community pharmacists Portland, ME. and veterinary prescriptions: an analysis Board of Pharmaceutical Specialties. (2017). of prevalence, type, training, and History [of the Board of Pharmaceutical knowledge retention. Poster presentation Specialties]. https://www.bpsweb.org/about‐ at the Society of Veterinary Hospital bps/history. Pharmacists 36th Annual Meeting, Dorsey M. (2001). Impact of a clinical Portland, OR, June 12–14. pharmacist on pain management in a Nelson, R.B. (1977). The role of the pharmacist veterinary specialty referral practice. Paper in drug information for the agricultural presented at the American Society of sector. Fed. Proc. 36 (1): 127–129. Health‐System Pharmacists (ASHP) 36th New England Journal of Medicine. (2017). Midyear Clinical Meeting, New Orleans, Media Center fact sheet. http://www.nejm. LA, December, abstr. no. p‐45d. org/page/media‐center/fact‐sheet. Drug Enforcement Agency (DEA). (N.d.). Royal College of Veterinary Surgeons. (2017). General requirements. In Practitioner’s History of the veterinary profession. https:// Manual, sect. II. https://www.deadiversion. knowledge.rcvs.org.uk/heritage‐and‐history/ usdoj.gov/pubs/manuals/pract/section2.htm. history‐of‐the‐veterinary‐profession. Food and Drug Administration (FDA). (2006). Sorah E, Davidson G. Royal K. (2015). Pharmacovigilance of veterinary medicinal Dispensing errors for non‐human patients products: management of adverse event in the community pharmacy setting: a reports (AERs) – VICH GL24. https://www. survey of pharmacists and veterinarians. fda.gov/downloads/AnimalVeterinary/ Poster presentation at the Society of GuidanceComplianceEnforcement/ Veterinary Hospital Pharmacists GuidanceforIndustry/UCM052657.pdf. 34th Annual Meeting, Portland, ME, Food and Drug Administration (FDA). (2015). June 14–17. Compounding animal drugs from bulk drug Washington State University College of substances; draft guidance for industry; Veterinary Medicine Veterinary Clinical availability; withdrawal of Compliance Policy Pharmacology Lab. (N.d.). Problem drugs. Guide; Section 608.400 Compounding of https://vcpl.vetmed.wsu.edu/problem‐drugs.

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