Veterinary Compounding

Skip Lenz, Pharm. D, F.A.C.V.P., F.A.S.C.P

Veterinary Compounding Introduction The Regulations The Interaction with Vets/Vet Techs/Receptionist and

Clients The Patients/Clients

Large Animal/Food Animals/Zoo animals Companion Animals

Canine Feline Exotics

The Training/Equipment/Chemicals Resources and References

Introduction

Compounding can be characterized as any manipulation to produce a dosage form other than manipulations that is provide for in the directions for use on the labeling of an approved drug product. This is to say that mixing a pediatric liquid antibiotic is not compounding, but making a sterile inject able from non-sterile materials is the most difficult form of compounding.

Introduction

Compounding should be the ultimate expression of Pharmaceutical Care. In order to practice good Veterinary Pharmaceutical Care the individual will have to broaden his/her skills beyond human pharmacology. The diversity of issues involved with the myriad of species requiring pharmaceutical interventions is legend.

Introduction

Using the ADME model in human patients requires the practitioner to investigate each step as a consequence of multiple pathologies, using the same model in the veterinary population requires an understanding of the species-specific anatomy, physiology, bio-chemistry, velocity of metabolism to name just a few confounds

Introduction

The office based vet is a recent phenomenon. Historically veterinarians necessarily dispensed medications from their own dispensary. Classically the vet traveled from farm to farm plying their skills which involved not only diagnostics but also creating dosage forms out of readily available materials. To this day the pharmaceutical industry pays vague lip-service to the veterinarian industry.

Introduction

The research and development costs involved with bringing a veterinary new drug to the market-place sometimes exceed the cost of bringing the very same drug to the human market-place. As a matter of course, there are several exotic species with no approved drug. This yields a very fertile field for cultivation by an appropriately trained pharmacist.

Introduction

The fundamental relationship in veterinary compounding pharmacy is the Patient-Physician-Pharmacist triad. The addition of the owner can complicate the triad or it can facilitate providing good Pharmaceutical Care. We have seen the complications that the inter-net has created in human medicine, one can expect the same uneducated and sometimes dangerous interventions in veterinary medicine. It is the responsibility of each of us to ensure that our patients will receive the best that our profession provides to the human population

The Regulations The Rules and Common Sense

Compounding can be characterized as any manipulation to produce a dosage form other than manipulations that is

provide for in the directions for use on the labeling of an approved drug product.

Florida Board of Pharmacy Chapter 465 59X-27.700 Definition of Compounding:

“Compounding is the professional act by a pharmacist or other practitioner authorized by law, employing the science or art of any branch of the profession of pharmacy, incorporating ingredients to create a finished product for dispensing to a patient or for administration by a practitioner or his agent; and shall specifically include the professional act of preparing a unique finished dosage form containing any ingredient or device by sections 465:003(7).

Florida Board of Pharmacy Chapter 465 59X-27.700 Definition of Compounding

Compounding includes: The preparation of drugs or devices in anticipation of

prescriptions based on routine, regularly observed prescribing patterns

The preparation pursuant to a prescription of drugs or devices which are not commercially available

The preparation of commercially available products from bulk when the prescribing practitioner has prescribed the compounded product on a per prescription basis and the patient has been made aware that the compounded product will be prepared by the pharmacist

The preparation of drugs or devices for sale or transfer to pharmacies, practitioners, or entities for purposes of dispensing or distribution is not compounding.

Florida Board of Pharmacy Chapter 465 59X-27.700 Definition of Compounding:

Animal Medicinal Drug use Clarification Act of 1994 (AMDUCA)

Extra label Drug Use (ELDU) is the actual or intended use of a drug in an animal that is not in accordance with the FDA- approved labeling. This includes any deviation from FDA- approval for

indications dosage levels frequencies. routes of administration species

Florida Board of Pharmacy Chapter 465 59X-27.700 Definition of Compounding

The Duck Rule of Compounding versus Manufacturing Volume Equipment Drug Pirates

Patient/Physician/Pharmacist Triad .Veterinary compounding DOES NOT excuse the

requirements of consulting. Internet prescribing is a No No.

Interaction with Vets

You are the drug experts! Logic Disconnect: Who knows?

You don’t know everything, get a book

Just because you can do it, doesn’t mean you should.

Vets are really nice people

Interaction with Vets

Vet Techs are the gate keeper. Vet techs can be your best friends. Vet techs can be your worst nightmare. Vet techs want to learn. Receptionists are not Vet Techs Some Vet techs are not Vet techs Some “nurses” are vet techs, some nurses are

nurses and some nurses aren’t .

Interaction with Vets

Clients are the owners, patients are the animals

SID means once a day, don’t argue you won’t win.

The pharmacological argument. Win, lose or draw.

Don’t mess it up for the rest of us

Just say No.

The Patients/Clients

The patient is the animal, the client is the owner/guardian.

Large Animals /Food Animals/ Zoo animals Probably not the best place to start.. Dr. Midnight Milk Cup The squirt gun approach

The Patients/Clients

Companion Animals

You wouldn’t believe what some people have as pets. Aardvarks to zebras, really.

Gerbils, turtles, snakes, butterflies, lizards, large predator cats, elephants, ennui’s, swans, storks, flamingoes, fish, frogs, goats, pigs, foxes, hedgehogs, wolves, foxes,

The Patients/Clients

Canine There are many breeds but they are all canines. There are many genetic specific predominant. The new pocket breeds are fraught with genetic

problems Dogs eat rocks Idiopathic Canine Epilepsy Thunderstorm Phobias Dry Eye Ear Grunge

The Patients/Clients

Feline Cats are finicky, prissy, compulsive, passive

aggressive. Pilling cats ain’t fun You can trick them a couple of times, but plan on

them catching on. Mega colon Hyperthyroidism Hypertensive Psychotic

The Patients/Clients

Compounded Companion Animal Dosage Forms

Tablet Triturates Flavored Liquids Treats Transdermals Flavored pastes Capsules

The Training/Equipment/Chemicals/ Formulae

Training

Professional Compounding Centers of America American College of Veterinary Pharmacist National Association of Compounding Pharmacist Septrum Creighton University School Of Pharmacy and Health

Professions. Medisca Gallipot (Secundum Artum)

The Training/Equipment/Chemicals/ Formulae

Equipment Professional Compounding Centers of America Septrum Galipot Hawkins Medisca

The Training/Equipment/Chemicals/ Formulae

Chemicals Professional Compounding Centers of America Septrum Galipot Hawkins Medisca

The Training/Equipment/Chemicals/ Formulae

Formulae

Professional Compounding Centers of America Septrum Galipot Hawkins Medisca Drug Topics Internal Journal of Compounding Pharmacy The internet, but be very careful.

Resources and References

Veterinary Information Network A great reference source and a place to interact with vets. You

will need to have a vet sponsor and probably will have to advertise.

http://vin.com/ Plumb’s This is the ubiquitous green book. (although it’s red now) This

is the definitive handbook on veterinary pharmaceutics. It can be accessed via VIN.

Plumb's Veterinary Drug Handbook, Fifth Edition, Donald C. Plumb

Resources and References

Mc Gavin’s This is the Depiro of veterinary pharmacology. Great basic

book. The fourth edition is current. Pathologic Basis of Veterinary Disease, Fourth Edition, Mc

Gavin, Donald etal. Moby. ACVP The pre-eminent society of Veterinary Pharmacists. The put

out a newsletter on a regular basis. They also have a Dear Doc letter that can be used in marketing your practice.

Resources and References

American College of Veterinary PharmacistsResearch and Education Resource Center2830 Summer Oaks DriveBartlett, TN 38134-3811

Phone: 877-VETMEDS Fax:901-383-8882 Email: acvp@vetmeds.org Your Local Veterinary Society.