Veterinary Compounding

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

2. 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

3. 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.

4. 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.

5. 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

6. 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.

7. 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.

8. 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

9. 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.

10. 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).

11. 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.

12. 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

13. 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.

14. 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

15. 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 .

16. 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.

17. 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

18. 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,

19. 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

20. 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

21. The Patients/Clients • Compounded Companion Animal Dosage Forms • Tablet Triturates • Flavored Liquids • Treats • Transdermals • Flavored pastes • Capsules

22. 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)

23. The Training/Equipment/Chemicals/ Formulae • Equipment • Professional Compounding Centers of America • Septrum • Galipot • Hawkins • Medisca

24. The Training/Equipment/Chemicals/ Formulae • Chemicals • Professional Compounding Centers of America • Septrum • Galipot • Hawkins • Medisca

25. 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.

26. 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

27. 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.

28. 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.