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

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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.

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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.

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Introduction

• The fundamental relationship in veterinary
  compounding pharmacy is the Patient-Physician-Phar
  macist 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.

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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
  465003(7).

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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.

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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

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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.

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Interaction with Vets

• You are the drug experts!
• Logic Disconnect Who knows?
• You dont know everything, get a book
• Just because you can do it, doesnt mean you
  should.
• Vets are really nice people

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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 arent .

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Interaction with Vets

• Clients are the owners, patients are the animals
• SID means once a day, dont argue you wont win.
• The pharmacological argument. Win, lose or draw.
• Dont mess it up for the rest of us
• Just say No.

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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

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The Patients/Clients

• Companion Animals
• You wouldnt believe what some people have as
  pets. Aardvarks to zebras, really.
• Gerbils, turtles, snakes, butterflies, lizards,
  large predator cats, elephants, ennuis, swans,
  storks, flamingoes, fish, frogs, goats, pigs,
  foxes, hedgehogs, wolves, foxes,

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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

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The Patients/Clients

• Feline
• Cats are finicky, prissy, compulsive, passive
  aggressive.
• Pilling cats aint fun
• You can trick them a couple of times, but plan on
  them catching on.
• Mega colon
• Hyperthyroidism
• Hypertensive
• Psychotic

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The Patients/Clients

• Compounded Companion Animal Dosage Forms
• Tablet Triturates
• Flavored Liquids
• Treats
• Transdermals
• Flavored pastes
• Capsules

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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)

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The Training/Equipment/Chemicals/ Formulae

• Equipment
• Professional Compounding Centers of America
• Septrum
• Galipot
• Hawkins
• Medisca

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The Training/Equipment/Chemicals/ Formulae

• Chemicals
• Professional Compounding Centers of America
• Septrum
• Galipot
• Hawkins
• Medisca

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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.

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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/
• Plumbs
• This is the ubiquitous green book. (although its
  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

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Resources and References

• Mc Gavins
• 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.

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Resources and References

• American College of Veterinary PharmacistsResearc
  h and Education Resource Center2830 Summer Oaks
  DriveBartlett, TN 38134-3811
• Phone 877-VETMEDS Fax[phone]
• Email acvp_at_vetmeds.org
• Your Local Veterinary Society.