WSVMA Survey on

Veterinary Compounding

WA Veterinarian Magazine

by WSVMA

Jan/Feb 2016

The WSVMA recently conducted a member survey to gather input on how compounded drugs are used in veterinary practice. The survey was intended to inform us as we communicate with both the Federal Drug Administration (FDA) and the Washington Pharmacy Quality Assurance Commission (PQAC) as both agencies are engaged in adopting new regulations for compounded drugs that could negatively affect veterinary medicine.

The FDA contends that compounding from bulk drug substances (i.e., active pharmaceutical ingredients) for animals has been and continues to be illegal. The AVMA has been in active discussions with the federal agency, soliciting input from members and submitting comments on Draft Guidance #230. Our compounding survey was useful in that it also provided crucial information that the WSVMA submitted to the FDA.

Prompted by the recent tragedies at compounding pharmacies in Massachusetts and Florida, the Washington legislature passed a bill requiring that conditions must meet minimum practice and quality standards known as USP 795 (non-sterile) and 797 (sterile) when compounding drugs. Washington Pharmacy Quality Assurance Commission is currently drafting rules to adhere to the new law, which could further affect how drugs are compounded in non-pharmacy or veterinary practice sites.

The WSVMA is actively engaged with PQAC on this issue, alerting them to compounding needs unique to veterinary practice, and the results of this survey is providing them critical information while they continue the rule-making process.

Survey results indicated that compounding is viewed as critical by a majority of veterinarians in Washington State. In fact, 93% of the 178 Washington veterinarians who responded to the survey indicated that having access to compounded medications was very important (83%) or important (10%) to their practice. Additionally, 76% of veterinarians surveyed stated it is very important (55%) or important (21%) to their patients’ health and medical outcomes to maintain office stock of compounded medications and 76% of veterinarians stated that a requirement for patient-specific prescriptions of compounded medication negatively (41%) or significantly negatively (35%) impacted their ability to practice.

Survey Facts: 76% of veterinarians who stated they would dispense a compounded medication from office stock daily/weekly if the law allowed.

Veterinarians in Washington State frequently prescribe compounded medications that are not available as FDA-approved medications for non-food animals and in some cases, humans. They rely on compounding for medications that are not commercially available, as well as to provide improved routes of administration and cost-effectiveness. Many of our patients, particularly small dogs, cats or exotic patients, will not tolerate medications as commercially available. Having the ability to compound in appropriate strengths and routes of administration (i.e. oral liquid suspensions, flavored chews, and/or transdermal solutions) is critical for our clients to safely and properly administer medications to their patients.

Some medications, such as Cisapride, which have been removed from the human market, significantly improve the quality of life of our patients and are only available via compounding routes. Emergency clinics face a particular challenge, with the need for in-stock compounded medications such as injectable Apomorphine for inducing nausea after toxin exposure or foreign body ingestion, Prazosin for urethral relaxation in emergency urethral obstruction in cats, Ursodiol for improving bile flow in cases of liver and gall bladder inflammation, and Fomepizole for Tylenol(Acetaminophen) toxicities.

Large animal veterinarians rely on compounded Ponazuril for deworming in non-food animals and compounded NSAIDs, such as Phenylbutazone, for equine patients. Many medications have been unavailable or on back-order in the recent past and having a compounded option, including for in-hospital use, is invaluable. Examples include Diazepam for seizuring pets, antibiotics such as Doxycycline for rickettsial infections or respiratory infections, analgesics, nebulization solutions, chemotherapeutics, and many other medications. We have attached a compiled survey-collected list of frequently-prescribed compounded medications, highlighting those which veterinarians feel should be allowed to be kept as office stock for urgent and emergent needs, as opposed to those for which a prescription could be provided.

Survey Facts: 55% of veterinarians who stated it is very important or important to maintain office stock of compounded medications.

As a result of these indications, 76% of Washington veterinarians surveyed stated that they would dispense a compounded medication from office stock daily or weekly if the law allowed. They do see the importance of regulated compounding pharmacies, however, and 52% are comfortable prescribing three days’ worth of medication from their office stock until the client can obtain a prescription from a compounding pharmacy, while 55% are comfortable prescribing five to seven days’ worth of medication. This time period varies pending a clinic’s location to a compounding pharmacy and taking into account preparation and shipping times, as well as weekends and holidays.

Because some veterinarians do not have ready access to compounding pharmacies and taking into account that USP standards are not feasible or practical for the majority of veterinarians, 64% of Washington veterinarians surveyed stated that they strongly agreed (45%) or moderately agreed (19%) that veterinarians and employees who compound for “their own use” administration for patients should be exempt from USP requirements.

With respect to bulk drugs, our veterinarians were not specifically surveyed, but separate discussion has indicated that many medications, such as Methimazole for hyperthyroidism, the antibiotic Marbofloxacin, and Cyclosporine ophthalmic solution for Dry Eye, cannot be produced from FDA-approved products without clients purchasing the product from a veterinarian and transporting it to the pharmacist themselves for compounding. This is time-cumbersome for clients; many small patients will not tolerate the palatability of such preparations, and many clients will not be able to financially afford the medication. Having to provide a justification on the prescription for use of bulk drugs is tedious and time-intensive, not to mention unclear as to what will classify as a “clinical difference.” Will inability to administer without aggression or inability for a client to financially afford medications compounded from FDA-approved products classify as a “clinical difference?” There is no precedence for this rule and human prescriptions are held by a different, but lesser standard. We would ask why the GFI has animal prescriptions held to an increased stringency compared to those of humans.

The following is a list of compounded drugs commonly used by Washington State veterinarians. According to our survey, the drugs underlined are compounded drugs that our members believe must be allowed to keep as office stock for use for urgent and emergent needs, as opposed to those for which a prescription could be provided.

Antibiotics: Minocycline, Doxycycline, Metronidazole, Enrofloxacin, Marbofloxacin, Azithromycin, Amoxicillin, Penicillin, Chloramphenicol, Sulfa-based antibiotics, Tylosin, Clindamycin, Dilution of injectable antibiotics with water, saline, or alcohol for aquatics

Analgesics: Tramadol, Buprenorphine (standard or sustained release), Gabapentin, Codeine

Anesthetics/Sedatives: Acepromazine, Ketamine, Xylazine, Reserpine (equine), Ketamine/Xylazine/Butorphanol (camelids)

Antitussive: Hydrocodone, Torbugesic elixir

Behavior/Psych: Clomipramine, Fluoxetine, Paroxetine, Amitryptiline

NSAIDS: Phenylbutazone, Meloxicam, Diclofenac(Surpass- equine)

Anticonvulsants: Potassium Bromide, Diazepam, Levetiracetam, Zonisamide, Phenobarbital (injectable)

Antifungals: Itraconazole, Fluconazole, Ketoconazole, Carbimazole, Famciclovir, Griseofulvin

Antihistamines: Hydroxyzine, Chlorpheniramine

Gastrointestinal: Famotidine, Omeprazole, Pantoprazole, Mirtazapine, Cisapride, Apomorphine, Cyproheptadine, Ondansetron, Amforal

Cardiac/Vascular: Enalapril, Benazepril, Amlodipine, Aspirin, Clopidogrel, Glycopyrrolate, Pimobendan, Atenolol,

Renal/Urinary: Prazosin, DES, Phenoxybenzamine, Aluminum Hydroxide, Calcitriol, Bethanechol, Tamsulosin, Losartan, Diethylstilbestrol(DES)

Steroids/Immunosuppressants: Prednisone(inj), Prednisone(oral), Prednisolone, Methylprednisolone, Triamcinolone, Cyclosporine (oral), Apoquel (generic), Budesonide, Mycophenolate, Stanozolol, Trichlormethiazide/Dexamethasone (Naquasone)

Chemotherapeutics: Lomustine, Cyclophosphamide, Chlorambucil, Melphalan, L-Asparaginase

Use in Toxicities: Calcium EDTA, DMSA (Succimer), Fomepizole

Respiratory: Sildenafil, Nebulization solutions (acetylcystine, terbutaline, dexamethasone), Theophylline

Ophthalmics: Tacrolimus, Cyclosporine, Diclofenac, Ofloxacin, Terramycin, Morphine, Chloramphenicol

Otics: Antibiotic/Antifungal/Steroid preparations

Other: Ursodiol, Methimazole, Trilostane, Anal gland infusion ointments, Potassium Phosphate for IV solution, Methocarbamol, SAM-E, Insulin, Chlorhexidine solutions, Avermectin, Ponazuril, Aminocaproic acid, Calcium gluconate, Pergolide, Coloring added to Formalin for external parasite treatment in aquatic