V eterinary Therapeutics November 2012 AMERICAN VETERINARY MEDICAL ASSOCIATION 1 THE VETERINARIAN-CLIENT-PATIENT RELATIONSHIP The veterinarian-client-patient relationship (VCPR) is the basis for interaction among veterinarians, their clients, and their patients. A VCPR exists when all of the following conditions have been met: The veterinarian has assumed responsibility for making clinical judgements regarding the health of the animal(s) and the need for medical treatment, and the client has agreed to follow the veterinarian’s instructions. The veterinarian has sufficient knowledge of the animal(s) to initiate at least a general or preliminary diagnosis of the medical condition of the animal(s). This means that the veterinarian has recently seen and is personally acquainted with the keeping and care of the animal(s) by virtue of an examination of the animal(s), or by medically appropriate and timely visits to the premises where the animal(s) are kept. 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. ADVERSE EVENT REPORTING (Approved by the AVMA Executive Board in March 2006; reaffirmed April 2011) Being committed to the continuing availability of medicinal products that are pure, safe, potent and efficacious for animals, the AVMA encourages continued development and strengthening of adverse event reporting systems. This includes continued collaboration with constituent professional organizations, industry organizations, government entities and other stakeholders. AMINOGLYCOSIDES (Approved by the AVMA House of Delegates in March 1998; reaffirmed March 2004 and November 2008) Until further scientific information becomes available, aminoglycoside antibiotics should not be used in cattle, except as specifically approved by the FDA. 2 USE OF AQUATIC ANIMAL THERAPEUTIC AGENTS (Approved by the AVMA Executive Board in June 2004; revised April 2007 and April 2012) The AVMA recognizes the need for sufficient approved therapeutics to facilitate safe and effective prevention, diagnosis, treatment and control of aquatic animal disease and: a) Supports the implementation of the Minor Use and Minor Species Animal Health Act of 2004; b) Cooperates with and, when appropriate, participate in realistic and responsible initiatives by other organizations to obtain the approval of new therapeutics for aquatic animals; c) Promotes the provision of educational information for veterinarians, producers and owners on relevant subjects related to aquatic animal therapeutics; and, d) Works with government agencies to develop appropriate policies and guidelines regarding the safe and effective use of aquatic animal therapeutics. e) Encourages a veterinarian-client-patient-relationship when drugs are used in all aquatic animals. The following points should be considered with respect to the use of therapeutics in aquatic animal disease: 1. Prescription and Veterinary Feed Directive drugs Veterinarians are solely responsible for writing prescriptions and Veterinary Feed Directives for animal (including aquatic animal) drug treatment; however, there are very few approved drugs for aquatic animals. Therefore, in addition to the overall actions listed above, the AVMA will work to address this situation by: a) Supporting and encouraging the responsible use of therapeutic agents in aquatic animals; and, b) Supporting the promulgation of regulations that permit the extra-label use of drugs and medicated feeds for aquatic animals. 2. Non-prescription (“Over the Counter”) drugs The AVMA encourages veterinarians and aquatic animal owners to work closely together in the selection and use of approved or indexed drugs, as identified by FDA CVM, to ensure that these are administered in a manner consistent with: a) The health needs of the aquatic animals; 3 b) The product label and drug pharmacological properties; c) Judicious use of antimicrobial drugs; d) The safety of the animal, the user, and the surrounding environment; and, e) Applicable regulations. 3. Unapproved Drugs The AVMA encourages appropriate action be taken to remove drugs that are being illegally marketed. 4. Veterinary Biologics The AVMA recognizes that infectious disease prevention can be achieved through the appropriate use of important health management alternatives to drugs, including veterinary biologics. The AVMA supports the central role that veterinarians play in the development, selection, administration and monitoring of veterinary biologics for aquatic animal disease prevention, diagnosis and control. The AVMA endorses the development and use of biologics and disease diagnostic tests for aquatic animals in accordance with USDA regulations for these products in other species. 5. Pesticides The AVMA recognizes that pesticides used to control life stages of parasites off the animal but in the environment are licensed through the Environmental Protection Agency and must be used in accordance with the label directions; that these products are often used without veterinary supervision; and that persons purchasing these products do not require a veterinary prescription. The AVMA encourages veterinarians and aquatic animal owners or production facility managers to work together to ensure the responsible use of approved pesticides as part of an integrated pest control program. The AVMA also recommends that non-veterinarians considering a pesticide treatment for an aquatic animal holding facility contact a veterinarian with experience in the management of aquatic animal diseases as an important step in the preparation of an appropriate integrated pest management plan. 4 USE OF BIOTECHNOLOGY IN DEVELOPMENT OF DRUGS AND VACCINES (Approved by the AVMA Executive Board in November 1986; reaffirmed November 1989; reviewed March 2004; reaffirmed April 2008; revised April 2010) The AVMA supports and encourages the ethical use of biotechnology in veterinary medicine to develop new or improved biologic and therapeutic agents. Such use may include but is not limited to: Internationally harmonized research, development, production, licensure/approval, sale, distribution, and use of safe and effective vaccines, pharmaceuticals, and other therapeutic products used in animal health. Science-based regulatory policies and procedures supporting pre and post-approval product evaluations. Development of innovative, useful (sensitive, specific, and robust) diagnostic and surveillance tools. AVMA GUIDELINES FOR COMPLEMENTARY AND ALTERNATIVE VETERINARY MEDICINE (Approved by the AVMA House of Delegates in 2001; revised April 2006 and November 2007) Introduction These guidelines are intended to help veterinarians make informed and judicious decisions regarding medical approaches known by several terms including "complementary," "alternative," and "integrative." Collectively, these approaches have been described as Complementary and Alternative Veterinary Medicine (CAVM). The AVMA recognizes the interest in and use of these modalities and is open to their consideration. The AVMA believes that all veterinary medicine, including CAVM, should be held to the same standards. Claims for safety and effectiveness ultimately should be proven by the scientific method. Circumstances commonly require that veterinarians extrapolate information when formulating a course of therapy. Veterinarians should exercise caution in such circumstances. Practices and philosophies that are ineffective or unsafe should be discarded. 5 Terminology The identification of standard and broadly accepted definitions applicable to CAVM, including the definition of CAVM itself, is challenging. These guidelines identify CAVM as a heterogeneous group of preventive, diagnostic, and therapeutic philosophies and practices. The theoretical bases and techniques of CAVM may diverge from veterinary medicine routinely taught in North American veterinary medical schools or may differ from current scientific knowledge, or both. It is not the intent of these guidelines to determine or describe the relative value of the individual modalities. The evidence pertaining to, and the practice of, individual CAVM modalities differ. Current examples of CAVM include, but are not limited to, aromatherapy; Bach flower remedy therapy; energy therapy; low-energy photon therapy; magnetic field therapy; orthomolecular therapy; veterinary acupuncture, acutherapy, and acupressure; veterinary homeopathy; veterinary manual or manipulative therapy (similar to osteopathy, chiropractic, or physical medicine and therapy); veterinary nutraceutical therapy; and veterinary phytotherapy. Education, training, and certification The AVMA believes veterinarians should ensure that they have the requisite skills and knowledge for any treatment modality they may consider using. The AVMA does not officially recognize diplomate-status or certificates other than those awarded by veterinary specialty organizations that are members of the AVMA American Board of Veterinary Specialties (ABVS), nor has it evaluated the training or education programs of other entities that provide such certificates. Recognition of a veterinary specialty organization by the AVMA requires demonstration of a substantial body of scientific knowledge. The AVMA encourages CAVM organizations to demonstrate such a body of knowledge. Recommendations for patient care The foremost objective in veterinary medicine is patient welfare. Ideally, sound veterinary medicine is effective, safe, proven, and holistic in that it considers all aspects of the animal patient in the context of its environment. Diagnosis should be based on sound, accepted principles of veterinary medicine. Proven treatment methods should be discussed with the owner or authorized agent when presenting the treatment options available. Owner consent should be obtained prior to initiating any treatment, including CAVM. 6 Clients usually choose a medical course of action on the advice of their veterinarian. Recommendations for effective and safe care should be based on available scientific knowledge and the medical judgment of the veterinarian. Responsibilities State statutes define and regulate the practice of veterinary medicine including many aspects of CAVM. These guidelines support the requisite interaction described in the definition of the veterinarian-client-patient relationship.1Accordingly, a veterinarian should examine an animal and establish a preliminary diagnosis before any treatment is initiated. The quality of studies and reports pertaining to CAVM varies; therefore, it is incumbent on a veterinarian to critically evaluate the literature and other sources of information. Veterinarians and organizations providing or promoting CAVM are encouraged to join with the AVMA in advocating sound research necessary to establish proof of safety and efficacy. Medical records should meet statutory requirements. Information should be clear and complete. Records should contain documentation of client communications and owner consent. In general, veterinarians should not use treatments that conflict with state or federal regulations. Veterinarians should be aware that animal nutritional supplements and botanicals typically are not subject to premarketing evaluation by the FDA for purity, safety, or efficacy and may contain active pharmacologic agents or unknown substances. Manufacturers of veterinary devices may not be required to obtain premarketing approval by the FDA for assurance of safety or efficacy. Data establishing the efficacy and safety of such products and devices should ultimately be demonstrated. To assure the safety of the food supply, veterinarians should be judicious in the use of products or devices for the treatment of food-producing animals. If a human health hazard is anticipated in the course of a disease or as a result of therapy, it should be made known to the client. References 1. Model Veterinary Practice Act, as published on the AVMA Website, www.avma.org 7 COMPOUNDING (Approved by the AVMA Executive Board in November 2000; revised April 2005 and April 2009) Compounding is the manipulation of a drug, other than in accordance with the FDA approved label, to make a different formulation of the drug to meet the needs of a specific patient. Veterinarians need to be aware that compounding, including formulation in a novel drug delivery system (e.g. transdermal), may impact the absorption and depletion of a drug. This may result in drug concentrations that are above or below the therapeutic range and lead to the development of an adverse drug event, including therapeutic failure. In order to minimize the risk of adverse events associated with compounded drugs, the following actions are recommended: 1. The decision to use a compounded drug should be veterinarian (not pharmacist) driven, based on a veterinarian-client-patient relationship. Whenever possible the veterinarian should make that decision utilizing evidence-based medicine. 2. Compounding must be implemented in compliance with the Animal Medicinal Drug Use Clarification Act (AMDUCA) and the FDA Compliance Policy Guide 608.400 titled Compounding of Drugs for Use in Animals. Use of compounded drugs in food animals is accompanied by food safety concerns that preclude their use unless information exists to assure avoidance of illegal tissue residues. 3. Use of a compounded drug should be limited to: a. Those drugs for which both safety and efficacy have been demonstrated in the compounded form in the target species; b. Disease conditions for which response to therapy or drug concentration can be monitored; or c. Those individual patients for which no other method or route of drug delivery is practical. 4. Use of a compounded drug should be accompanied by the same precautions followed when using an approved drug, including counseling of the client regarding potential adverse reactions and attention to the potential for unintended human or animal exposure to the drug. 8 One element in evaluating the quality of a compounding pharmacy is whether the pharmacy is accredited by an independent accreditation body. For example, the Pharmacy Compounding Accreditation Board (PCAB) offers accreditation to compounding pharmacies that meet high quality and practice standards. Further information and a listing of PCAB-accredited pharmacies are available at www.pcab.org. Be aware that independent accreditation is different from association or professional training center memberships that may lack quality assurance programs and inspections. COMPOUNDING FROM UNAPPROVED (BULK) SUBSTANCES (Approved by the AVMA Executive Board in April 2005; revised November 2009) Compounding of drugs from unapproved (bulk) substances for use in non-food animals is medically necessary in certain situations and should be allowed through enforcement discretion, if such compounded products are used under the conditions for extra-label use of approved drugs delineated in the regulations written to implement AMDUCA. Such compounding should be allowed only if effective regulatory mechanisms are in place and implemented to assure that such compounding is patient specific and is performed only in the context of a veterinarian-client-patient relationship. DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT OF 1994 (Approved by the AVMA Executive Board in April 2001, reaffirmed March 2006 and April 2011) The AVMA supports the Food and Drug Administration Center for Veterinary Medicine’s position that the Dietary Supplement Health and Education Act of 1994, which defines dietary supplements to be used in humans, does not apply to products intended for oral administration to animals. Additionally, the AVMA believes that the ACT should not be modified to include animals. DRUG LABELING (Approved by the AVMA Executive Board in April 2005, reaffirmed November 2009) Labels that accompany animal drugs should provide relevant pharmacokinetic and pharmacodynamic data necessary for the rational design of dosing regimens specific for the individual patient. 9 EXTRALABEL USE OF VETERINARY FEED DIRECTIVE DRUGS FOR MINOR SPECIES (Approved by the AVMA Executive Board in April 2005; revised November 2006; reaffirmed April 2011) The AVMA believes that veterinarians, their clients and patients would be well served should the FDA CVM either amend the Compliance Policy Guide 615.115 (Extralabel Use of Medicated Feeds for Minor Species) or the Veterinary Feed Directive regulations (21 CFR Part 558) to accommodate extralabel use of all medicated feeds for minor species. SALE OF HUMAN-LABEL DRUG PRODUCTS TO VETERINARIANS (Approved by the AVMA Executive Board in July 1993; revised April 2001, June 2006, and April 2011) 1. Because there are a limited number of drugs labeled for use in animals, veterinarians need to have access to human-labeled prescription drugs to effectively treat patients. As licensed health professionals, veterinarians must use them according to their best medical judgment in compliance with relevant laws and regulations. 2. The Food and Drug Administration has confirmed that veterinarians may legally obtain human-label prescription drugs; however, suppliers may not promote the sale of these products to veterinarians. 3. Veterinarians have the legal obligation to comply with AMDUCA regulations (21CFR530) when using any human or animal-labeled product for treatment of animals. INTERNET PHARMACIES (Approved by the AVMA Executive Board in April 2001; revised April 2005 and April 2009) The following recommendations are offered as a guide to prescribing and client purchases: 10