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Guide to Compounding Pharmacy in Veterinary Practice By Renee Lupo, R.Ph., F.A.C.A., A.C.V.P., Technical-Services Pharmacist and Philip A. Scully, R.Ph., Technical-Services Pharmacist Phil, Technical-Services Pharmacist and Ziggy ©2011 Wedgewood Pharmacy

Guide to Compounding Pharmacy in Veterinary Practice

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This ebook gives a general background on how custom compounded preparations fit into the practice of veterinary medicine.

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Page 1: Guide to Compounding Pharmacy in Veterinary Practice

Guide to Compounding Pharmacy in Veterinary PracticeBy Renee Lupo, R.Ph., F.A.C.A., A.C.V.P., Technical-Services Pharmacist and Philip A. Scully, R.Ph., Technical-Services Pharmacist

Phil,Technical-Services Pharmacistand Ziggy

©2011 Wedgewood Pharmacy

Page 2: Guide to Compounding Pharmacy in Veterinary Practice

ContentsABOUT THE AUTHORS.............................................................................................................................................3

Customer Care Specialists and pharmacists are available:Monday - Friday 8:00 a.m. to 8:00 p.m. EasternSaturday 9:00 a.m. to 5:00 p.m. Eastern800.331.8272 WedgewoodPetRx.com

Wedgewood Pharmacy405 Heron Drive, Suite 200Swedesboro NJ 08085-1749

CUSTOM-COMPOUNDED MEDICATIONS ARE IMPORTANT TO VETERINARIANS......................................................4WHEN VETERINARIANS TURN TO COMPOUNDED MEDICATIONS...........................................................................5 When the best therapy for a patient is not commercially available.........................................................5 When a manufactured drug is not available in the necessary strength, dosage form or flavor..............5 When a patient is sensitive or allergic to a non-active component of a manufactured product............5VETERINARY COMPOUNDED MEDICATIONS COMMONLY PRESCRIBED FOR COMPANION ANIMALS......................6VETERINARY COMPOUNDED MEDICATIONS COMMONLY PRESCRIBED FOR HORSES..............................................6THE SCIENCE OF COMPLIANCE: CUSTOMIZE DOSAGE-FORMS AND FLAVORS TO IMPROVE COMPLIANCE..............7 Oral suspensions, gels and solutions..........................................................................................................8 Capsules and tablets....................................................................................................................................8 Chewable soft treats....................................................................................................................................8 Sterile preparations.....................................................................................................................................8 Pre-filled syringes and biodegradable beads for oncology.........................................................................9 Gourmeds®..................................................................................................................................................9 Bitter-Block™...............................................................................................................................................9 Tiny Tabs®.................................................................................................................................................10 Twist-a-Dose®............................................................................................................................................10 Medi-Melts™..............................................................................................................................................10 Quad Tabs™...............................................................................................................................................11 Low-dust oral granules..............................................................................................................................11 Flavors.......................................................................................................................................................12HOW TO WRITE A PRESCRIPTION FOR A COMPOUNDED PREPARATION...............................................................13WHEN NOT TO PRESCRIBE A COMPOUNDED PREPARATION.................................................................................14 Compounding is only for non-food-producing animals..........................................................................14 Limitations of compounded preparations...............................................................................................14HOW TO CHOOSE A COMPOUNDING PHARMACY..................................................................................................15NEW JERSEY ADMINISTRATIVE CODES RELEVANT TO COMPOUNDING..................................................................17 TITLE 45. PROFESSIONS AND OCCUPATIONS, CHAPTER 14.PHARMACY PRACTICE ACT............................17

TITLE 45. PROFESSIONS AND OCCUPATIONS, CHAPTER 16. VETERINARY PRACTICE LAW........................17 TITLE 13. LAW AND PUBLIC SAFETY, CHAPTER 44. STATE BOARD OF VETERINARY MEDICAL EXAMINERS, SUBCHAPTER 4. GENERAL RULES OF PRACTICE...............................18

CONTINUED LEARNING ABOUT VETERINARY COMPOUNDING.............................................................................18

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Page 3: Guide to Compounding Pharmacy in Veterinary Practice

Renee LupoR.Ph., F.A.C.A., A.C.V.P., Technical-Services Pharmacist

Renee Lupo, R.Ph, F.A.C.A., F.A.C.V.P., technical-Services Pharmacist for Wedgewood Pharmacy, is the company’s lead technical/clinical pharmacist, working with prescribers and their staff to develop custom formulations. She also manages all technical training for the company’s pharmacy professionals and is a member of the Formula-Change Control Committee and Quality Review Board of the company. She has been in the

pharmacy profession since 1977 and has worked at Wedgewood since 1994.

Lupo is experienced in all aspects of the compounding pharmacy specialty and has developed unique expertise in sterile compounding and compounding formulations. Her focus on veterinary compounding includes specialization in veterinary medications and veterinary ophthalmology. She has attained certifications in Pharmaceutical Care and Compounds for Veterinary Patients; Advanced Canine and Advanced Feline Therapeutics; and Avian and Exotic Pet Pharmacotherapy. Previously, she was pharmacist-in-charge for an independent pharmacy.

Lupo is a member of the International Academy of Compounding Pharmacists; the New Jersey Academy of Compounding Pharmacists; and is a Fellow in the American College of Apothecaries; and the American College of Veterinary Pharmacists.

Lupo holds a B.S. degree in Pharmacy from the Philadelphia College of Pharmacy at the University of the Sciences in Philadelphia.

Customer Care Specialists and pharmacists are available:Monday - Friday 8:00 a.m. to 8:00 p.m. EasternSaturday 9:00 a.m. to 5:00 p.m. Eastern800.331.8272 WedgewoodPetRx.com

Philip A. ScullyR.Ph., Technical-Services Pharmacist

Philip A. Scully, R.Ph., technical-Services Pharmacist for Wedgewood Pharmacy, works with prescribers and their staff to develop custom formulations. He is a member of the Formula-Change Control Committee and Quality Review Board of the company and works closely with Research & Development.

Scully is experienced in all aspects of the compounding-pharmacy specialty and has developed unique expertise in compounding formulations, flavoring and oral dosage-forms. He has been in the pharmacy profession since 1993 and has worked at Wedgewood since 2003. He is a Registered Pharmacist in New Jersey and was a certified primary diabetes educator. Previously, he was director of Operations/pharmacist-in-charge for Winslow’s Pharmacy: An Omnicare Company (Vineland NJ); a consultant pharmacist with Cherry Hill Pharmacy LTC (Cherry Hill NJ) and was pharmacist-in-charge for an independent pharmacy.

He holds a B.S. degree in Pharmacy from the Philadelphia College of Pharmacy at the University of the Sciences in Philadelphia.

Wedgewood Pharmacy405 Heron Drive, Suite 200Swedesboro NJ 08085-1749 3

Page 4: Guide to Compounding Pharmacy in Veterinary Practice

CUSTOM-COMPOUNDED MEDICATIONS ARE IMPORTANT TO VETERINARIANS.In a nationwide study we conducted among veterinary practices, 99% said that “having access to compounded preparations from a pharmacy” is very or somewhat important to them. In fact, almost one-half of the practices we surveyed prescribe compounded medications at least once a week. Seven in ten practices prescribe compounded medications at least monthly and nearly two in ten do so every day.

The use of custom-compounded medication is woven into the weekly activities of most veterinary practices. With fewer pharmaceutical compounds manufactured for animal use and the widespread off-label use of drugs manufactured for human health, compounding is key to veterinarians, their clients and the animals in their care. Veterinarians told us that they choose the compounding pharmacies they trust carefully. A majority of practices do business with just two compounders and one in four prescribe from just one. They said that product consistency (89%) and a good reputation (81%) are most important to them in selecting a compounding partner. But no small number also said that other factors, too, are important to their choice. These include:

• Availabilityofdosage-forms/flavors:73% • Priorexperiencewiththepharmacy:73% • Deliveryspeed:72% • Knowledgeablecustomer-service:64% • Largeselection:58% • Easeofordering:56% • Professionalpackaging/labels:53% • Accesstopharmacists:52%

With a list dominated by quality, knowledge, selection and speed, only about one in four said that “the lowest price” is a key factor in selecting the compounding pharmacies with which they do business.

Customer Care Specialists and pharmacists are available:Monday - Friday 8:00 a.m. to 8:00 p.m. EasternSaturday 9:00 a.m. to 5:00 p.m. Eastern800.331.8272 WedgewoodPetRx.com

Guide to Compounding Pharmacy in Veterinary PracticeBy Renee Lupo, R.Ph., F.A.C.A., A.C.V.P., Technical-Services Pharmacist and Philip A. Scully, R.Ph., Technical-Services Pharmacist.

Wedgewood Pharmacy405 Heron Drive, Suite 200Swedesboro NJ 08085-1749 4

Page 5: Guide to Compounding Pharmacy in Veterinary Practice

WHEN VETERINARIANS TURN TO COMPOUNDED MEDICATIONSVeterinarians typically prescribe custom-compounded medication in three situations:

When the best therapy for a patient is not commercially availableDrugs can become unavailable for any number of reasons. The most common factors are manufacturer backorders, recalls and discontinuations (for reasons other than safety). Frequently, and at an increasingly regular pace, a pharmaceutical manufacturer may temporarily halt production. Manufacturers can experience interruptions in the supply of active pharmaceutical ingredients (API) and other components of the commercial medicines they make. When situations like these occur, veterinarians often turn to compounding pharmacies to assure continuation of critical therapies.

When a manufactured drug is not available in the necessary strength, dosage form or flavorIn a typical companion-animal practice, veterinarians treat all sizes and shapes of pets from many species. In a single day, a practice may see a chubby cat, a chatty cockatiel, a charming Chihuahua and a cantankerous Collie. The animals seen in daily veterinary practice vary greatly in weight and food preferences, creating unique challenges for dosing and compliance. For some disease states, getting the dose exactly right can make the difference between helping and hurting a patient. Because of these factors, veterinarians frequently need to depart from commercially available options to get the right strength, dosage form or flavor. In many cases, compounded preparations are prescribed instead of manufactured drugs because an animal, literally, won’t swallow it. A specialized compounding pharmacy can be a critical ally in patient care.

When a patient is sensitive or allergic to a non-active component of a manufactured productSome animals are allergic to components of manufactured medicines such as lactose, dyes, flavors, sweeteners and preservatives. Through custom compounding, veterinarians can finely tune not only the strength of the active pharmaceutical ingredients but also the other components of a medicine (for example, an ophthalmic can be changed from a corn oil base to an aqueous base to reduce irritation in the eye). Custom compounding can be a life-saving option when a pet can’t tolerate a drug component.

Customer Care Specialists and pharmacists are available:Monday - Friday 8:00 a.m. to 8:00 p.m. EasternSaturday 9:00 a.m. to 5:00 p.m. Eastern800.331.8272 WedgewoodPetRx.com

Guide to Compounding Pharmacy in Veterinary PracticeBy Renee Lupo, R.Ph., F.A.C.A., A.C.V.P., Technical-Services Pharmacist and Philip A. Scully, R.Ph., Technical-Services Pharmacist.

Wedgewood Pharmacy405 Heron Drive, Suite 200Swedesboro NJ 08085-1749 5

Page 6: Guide to Compounding Pharmacy in Veterinary Practice

VETERINARY COMPOUNDED MEDICATIONS COMMONLY PRESCRIBED FOR COMPANION ANIMALS

At Wedgewood Pharmacy, these are the most commonly prescribed compounded medications for use with companion animals. This list does change from time to time depending on current therapy recommendations and manufacturer backorders. Each item below is hyperlinked to a professional monograph or more information about the drug in the Learning Center at www.WedgewoodPetRx.com.

• Aminopentamide• Cisapride• Cyclosporine• Diethylstilbestrol• Methimazole• Metronidazole• Tacrolimus• Trilostane

VETERINARY COMPOUNDED MEDICATIONS COMMONLY PRESCRIBED FOR HORSES• Dexamethasone• Griseofulvin• Isoxsuprine• Pentosan• Pergolide• Phenylbutazone• Pyrimethamine/Sulfadiazine

These are the most common, but we work with more than 250 therapeutic agents in veterinary medicine. Search our website to see more compounded preparations.

Customer Care Specialists and pharmacists are available:Monday - Friday 8:00 a.m. to 8:00 p.m. EasternSaturday 9:00 a.m. to 5:00 p.m. Eastern800.331.8272 WedgewoodPetRx.com

Guide to Compounding Pharmacy in Veterinary PracticeBy Renee Lupo, R.Ph., F.A.C.A., A.C.V.P., Technical-Services Pharmacist and Philip A. Scully, R.Ph., Technical-Services Pharmacist.

Wedgewood Pharmacy405 Heron Drive, Suite 200Swedesboro NJ 08085-1749 6

Page 7: Guide to Compounding Pharmacy in Veterinary Practice

THE SCIENCE OF COMPLIANCE: CUSTOMIZE DOSAGE-FORMS AND FLAVORS TO IMPROVE COMPLIANCE.

Compliance is a real issue for far too many veterinarians and pet owners. Many pet owners don’t realize the risks and consequences of abandoning or interrupting treatment, and most are not aware of other options that could make administering medications more pleasant for them and their pets. When they become frustrated with administering medication, they may just decide to take their business elsewhere. When non-compliance results in unhappy clients, it could cost a veterinary practice in dollars and cents.

Several studies have been conducted recently regarding non-compliance among companion animals. Some of the findings may be surprising:

• Therateofcomplianceforchronicmedicationisjust76%.Thatmeansanastounding24%ofpetsaren’tbeing treated with the medications they need to live healthier lives — and in some cases, simply to live. • Petownerswhoareshownoneormorewaystoadministermedicationhadasignificantlyhigherrateof compliance (73% vs. 59% for those not shown). Yet, only 43% of practices show pet owners how to administer medication. • 60%ofownerswouldpaymoreformedicationthatispalatableoreasytoadminister. • 93%ofveterinarianssaythatcompliancemonitoringhasapositiveimpactontheirpractice. • 72%ofpetownerswouldliketoreceiveinformationinwritingabouttheirpets’medicationsotheycouldrefer back to it.1

Simply put, an animal can’t get well if it doesn’t accept its medicine. Improved compliance equals improved outcomes. Ease of compliance also is a key factor in client satisfaction.

Customer Care Specialists and pharmacists are available:Monday - Friday 8:00 a.m. to 8:00 p.m. EasternSaturday 9:00 a.m. to 5:00 p.m. Eastern800.331.8272 WedgewoodPetRx.com

Guide to Compounding Pharmacy in Veterinary PracticeBy Renee Lupo, R.Ph., F.A.C.A., A.C.V.P., Technical-Services Pharmacist and Philip A. Scully, R.Ph., Technical-Services Pharmacist.

Wedgewood Pharmacy405 Heron Drive, Suite 200Swedesboro NJ 08085-1749 7

1 All of the facts in this section are drawn from Albers J, DVM, Hardesty C. Compliance:Taking Quality Care to the Next Level. Lakewood, CO: AAHA Press; 2009:5.

Page 8: Guide to Compounding Pharmacy in Veterinary Practice

Since most veterinarians prescribe compounded medications, common dosage-forms and flavors available from compounding pharmacies are well-known. From creams and ointments, to pastes and powders, from alfalfa to watermelon, there are many options for customizing medications. In response to veterinarians’ needs, we’ve developed a few new options with which you may not be familiar. Here’s a brief review of compounding options.

Oral suspensions, gels and solutionsFlexible dosing, such as creating a more concentrated strength in a dosage volume that is higher than commercially •manufactured drugsAdding flavors to mask bitter drugs•

Capsules and tabletsOne of the most common dosage-forms•Convenient in most cases and familiar to just about everyone•

Chewable soft treatsFlavored chewable treats may improve compliance because the medicine is disguised as a treat for the animal•

Sterile preparationsDelivered intravenously, intramuscularly or intraocularly•Sterility is of the utmost importance•Requires a compounding pharmacy to have special facilities and its compounding technicians trained in aseptic techniques •When selecting a compounding pharmacy to compound sterile injectibles, look for a pharmacy that is compliant with USP •<797> for compounding sterile preparationsKnowwhat• questions to ask your compounding pharmacy using the guide located at WedgewoodPetRx.com or see page 15 of this guide.

Customer Care Specialists and pharmacists are available:Monday - Friday 8:00 a.m. to 8:00 p.m. EasternSaturday 9:00 a.m. to 5:00 p.m. Eastern800.331.8272 WedgewoodPetRx.com

Guide to Compounding Pharmacy in Veterinary PracticeBy Renee Lupo, R.Ph., F.A.C.A., A.C.V.P., Technical-Services Pharmacist and Philip A. Scully, R.Ph., Technical-Services Pharmacist.

Wedgewood Pharmacy405 Heron Drive, Suite 200Swedesboro NJ 08085-1749 8

Page 9: Guide to Compounding Pharmacy in Veterinary Practice

Since we folks at Wedgewood Pharmacy have written this handy guide to compounded medications, we hope you’ll excuse us for mentioning the unique dosage-forms that we developed and provide exclusively:

Pre-filled syringes and biodegrabable beads for oncologyPre-filled syringes are used to minimize exposure of these drugs to compounding technicians, veterinary staff and owners. •Biodegradable beads, for drugs like Cisplatin and Carboplatin, can be surgically implanted into a patient. •Capsules packaged individually also help reduce the risk of exposure to clients and staff •When selecting a compounding pharmacy to compound oncology medications, look for a pharmacy that is • NIOSH compliant

Gourmeds® • Flavoredchewabletablets• Economical• Easiertoadminister• Naturalchickenandfishflavorsforsmallanimals• Apple-molassesandpeppermintflavorsforhorses• Lesscustomizablethansomedosage-forms• Availableinmostcommonlyprescribedmedications

Bitter-Block™ • AvailableforcertainmedicationsintheGourmedsdosageform• Deliversalltheflavor—withoutthebite• Usingaproprietaryprocessandfood-gradematerials,each particle of medication is coated before it’s pressed into a tasty, chewable Gourmeds tablet• GourmedsareavailableinBitter-Blockformulasfor Amitriptyline, Clindamycin, Fluoxetine and Clomipramine

Customer Care Specialists and pharmacists are available:Monday - Friday 8:00 a.m. to 8:00 p.m. EasternSaturday 9:00 a.m. to 5:00 p.m. Eastern800.331.8272 WedgewoodPetRx.com

Guide to Compounding Pharmacy in Veterinary PracticeBy Renee Lupo, R.Ph., F.A.C.A., A.C.V.P., Technical-Services Pharmacist and Philip A. Scully, R.Ph., Technical-Services Pharmacist.

Wedgewood Pharmacy405 Heron Drive, Suite 200Swedesboro NJ 08085-1749 9

Page 10: Guide to Compounding Pharmacy in Veterinary Practice

Tiny Tabs®• SmallerthanaTic-Tac®(6.25mmindiameter)• Makepillingeasier• Perfectfordifficult-to-administerorbitter-tastingmedications• Pet-appropriatestrengths• Moreeconomicalthanotherdosage-forms

Twist-a-Dose® • Transdermalgelapplicator• Whenoralmedicationsarejustnotfeasible• Reducesownercontactwithmedication• Twotwistsdispensetherightamount,withnotinymarkingstoread• Twoeasysteps• Availableformorethan20transdermalmedications

Medi-Melts™• Themedicinestaysput• Forsickeranimals,thatmayhavedifficultyswallowing• Lookslikeastandardtablet• Lightlycompressedsotheydisintegraterapidlyonan animal’s tongue, creating a paste that can’t be rejected• Atastyflavormakesitseemlikeatreat

Customer Care Specialists and pharmacists are available:Monday - Friday 8:00 a.m. to 8:00 p.m. EasternSaturday 9:00 a.m. to 5:00 p.m. Eastern800.331.8272 WedgewoodPetRx.com

Guide to Compounding Pharmacy in Veterinary PracticeBy Renee Lupo, R.Ph., F.A.C.A., A.C.V.P., Technical-Services Pharmacist and Philip A. Scully, R.Ph., Technical-Services Pharmacist.

Wedgewood Pharmacy405 Heron Drive, Suite 200Swedesboro NJ 08085-1749 10

®

Page 11: Guide to Compounding Pharmacy in Veterinary Practice

Quad Tabs™• It’sasnap!• Tabletsarescoredtwiceformaximumflexibilityindispensinganddosing• Noneedtowaitforaspecialdosagesize

Low-dust oral granules• Whenpowder“dust”posesarisk• Granulesarelargerthan100microns,thelargestparticlesizethatcanbeinadvertentlyinhaled• Convenientdosingforhorses• Economical• Flavorsmayimprovecompliance

Customer Care Specialists and pharmacists are available:Monday - Friday 8:00 a.m. to 8:00 p.m. EasternSaturday 9:00 a.m. to 5:00 p.m. Eastern800.331.8272 WedgewoodPetRx.com

Guide to Compounding Pharmacy in Veterinary PracticeBy Renee Lupo, R.Ph., F.A.C.A., A.C.V.P., Technical-Services Pharmacist and Philip A. Scully, R.Ph., Technical-Services Pharmacist.

Wedgewood Pharmacy405 Heron Drive, Suite 200Swedesboro NJ 08085-1749 11

Granules

Page 12: Guide to Compounding Pharmacy in Veterinary Practice

FlavorsFlavoring medications is one of the most important choices in specifying a compounded preparation for a patient. Flavors can disguise bad-tasting drugs; this is where the art of compounding meets the science of compounding. Pharmacists use flavor strategically, by complementing the existing flavor of a medicine (for example, adding a fruit flavor to a sour-tasting medication), or by masking it altogether with a strong, pleasant taste that overshadows the flavor of the medicine. Some medications use a less bitter insoluble salt or use secondary flavors to mask bitter end-notes.

Additionally, enhancers like sweeteners and salt help mask bitterness. Other enhancers can also be used to improve the feel of the medication in the patient’s mouth. (Anything that can make a medication feel non-gritty, smooth or creamy can generally improve patient compliance.)

Many of the meat flavors used by Wedgewood Pharmacy use the actual proteins for each flavor, which is important to note if your patient has allergies to the flavor you specify. We also have synthetic flavors, like marshmallow, available in some dosage forms.

Pet owners may ask, “Why not just use foods as flavoring?” Foods typically are not used in compounding because they can spoil, significantly increase the volume that needs to be given because foods are less concentrated than most flavoring agents used and may interfere with the bioavailability or stability of the medication.

Customer Care Specialists and pharmacists are available:Monday - Friday 8:00 a.m. to 8:00 p.m. EasternSaturday 9:00 a.m. to 5:00 p.m. Eastern800.331.8272 WedgewoodPetRx.com

Guide to Compounding Pharmacy in Veterinary PracticeBy Renee Lupo, R.Ph., F.A.C.A., A.C.V.P., Technical-Services Pharmacist and Philip A. Scully, R.Ph., Technical-Services Pharmacist.

Wedgewood Pharmacy405 Heron Drive, Suite 200Swedesboro NJ 08085-1749 12

Page 13: Guide to Compounding Pharmacy in Veterinary Practice

HOW TO WRITE A PRESCRIPTION FOR A COMPOUNDED PREPARATIONWriting a prescription for a compounded preparation is much like writing a prescription for any other medication, and many of the same elements and shorthand apply. Each prescription for a compounded medication must contain: • Patientandownernamesandtheanimalspecies,breedand/orweight • Activeingredient:(e.g.Cyclosporine) • Strength:(e.g.2%) • Dosageform:(e.g.OphthalmicDrops) • Sig:(e.g.1GTTOUBIDRefills:2)

The veterinarian may make additional specifications such as indicating the vehicle (for the example above, corn oil or olive oil). The veterinarian is responsible for selecting an appropriate therapy, the pharmacist for accurately and appropriately compounding the medication. The compounding pharmacist will determine the appropriate inactives (filler/diluents) and packaging; formulations can differ from pharmacy to pharmacy.

Many states’ regulations allow for the veterinarian to order medication for use in their practice. You should familiarize yourself with the regulations in your state.

Customer Care Specialists and pharmacists are available:Monday - Friday 8:00 a.m. to 8:00 p.m. EasternSaturday 9:00 a.m. to 5:00 p.m. Eastern800.331.8272 WedgewoodPetRx.com

Guide to Compounding Pharmacy in Veterinary PracticeBy Renee Lupo, R.Ph., F.A.C.A., A.C.V.P., Technical-Services Pharmacist and Philip A. Scully, R.Ph., Technical-Services Pharmacist.

Wedgewood Pharmacy405 Heron Drive, Suite 200Swedesboro NJ 08085-1749 13

Page 14: Guide to Compounding Pharmacy in Veterinary Practice

WHEN NOT TO PRESCRIBE A COMPOUNDED PREPARATIONDo not specify a compounded preparation when a suitable FDA-approved product is commercially available. Compounding a copy of an available manufactured drug should not be done as a cost-savings measure. It is not appropriate to request a compounded preparation that would violate any existing drug patents, is a new molecule or a vaccine. Additionally, many pharmacists may decline to compound preparations that are dangerous for them or end users to handle.

Compounding is only for non-food-producing animals.Most compounding pharmacies compound every day for cats, dogs and horses. Many compound for exotics like ferrets, pocket pets, birds and lizards. Some compound for zoos and a select few compound for laboratory animal maintenance or for research studies. It is legal to prescribe a compounded preparation for just about any type of animal patient. Wedgewood Pharmacy does not compound for food-producing animals. Wedgewood Pharmacy, like most compounding pharmacies, has adopted the policy that any animal that will be used directly in the human food chain or produces milk or eggs that are used for human consumption may not receive compounded preparations.

Limitations of compounded preparationsThere are some limiting factors that may make it impossible to create certain compounded preparations. They include physical and chemical properties, such as the desired strength not being achievable or stability issues created by temperature and light factors. If facility capabilities are a problem, a good compounding pharmacy will know its limitations and decline to compound something it is not equipped to prepare.

Customer Care Specialists and pharmacists are available:Monday - Friday 8:00 a.m. to 8:00 p.m. EasternSaturday 9:00 a.m. to 5:00 p.m. Eastern800.331.8272 WedgewoodPetRx.com

Guide to Compounding Pharmacy in Veterinary PracticeBy Renee Lupo, R.Ph., F.A.C.A., A.C.V.P., Technical-Services Pharmacist and Philip A. Scully, R.Ph., Technical-Services Pharmacist.

Wedgewood Pharmacy405 Heron Drive, Suite 200Swedesboro NJ 08085-1749 14

Page 15: Guide to Compounding Pharmacy in Veterinary Practice

HOW TO CHOOSE A COMPOUNDING PHARMACYWhen you select a compounding pharmacy, be sure to ask questions like these:

• AreyoucommittedtocompliancewiththeUSP<797>guidelinesforsterilecompounding? Have you completed a <797> gap analysis? • Wouldyouknowifyouarehavingaproblemwithyourclean-roomoraseptic-compounding environment? (A pharmacy with a clean room should be able to tell you about its environmental monitoring program, which is designed as one means to assure sterility.) • Ifyouarecompoundingsterilepreparations,doyouconductweeklylab-testsofairand surface samples in your clean room and other controlled environments?

• IstheairqualityinyoursterilecompoundinglabengineeredforHEPAfiltrationto reduce particulates?

• Doyouobtainindependent,routinecertificationsofyourcleanroomsandlaminarairflow hoods?

• Doyouperformdailymonitoringanddocumentationofyourclean-roomtemperatureand humidity? • Isyourstaffproperlytrainedandevaluatedinasepticmanipulationskills,gowning technique and clean-room use?

• Doyoufilter(0.2micron)inaClass100(ISO5)laminarairflowhoodcontainedina Class 1000 (ISO 6) clean room, or autoclave where appropriate, to achieve sterility?

• DoyouperformsterilitytestingaccordingtoUSP<71>—SterilityTestsandUSP<85>— Bacterial Endotoxin (Pyrogen) Test?

• Doyouperformpost-filtrationfilter-integritytesting?

• Doyouhavesystemsinplaceforhandlingcomplaintsandinvestigatingsterilityfailures and adverse events?

Customer Care Specialists and pharmacists are available:Monday - Friday 8:00 a.m. to 8:00 p.m. EasternSaturday 9:00 a.m. to 5:00 p.m. Eastern800.331.8272 WedgewoodPetRx.com

Guide to Compounding Pharmacy in Veterinary PracticeBy Renee Lupo, R.Ph., F.A.C.A., A.C.V.P., Technical-Services Pharmacist and Philip A. Scully, R.Ph., Technical-Services Pharmacist.

Wedgewood Pharmacy405 Heron Drive, Suite 200Swedesboro NJ 08085-1749 15

Page 16: Guide to Compounding Pharmacy in Veterinary Practice

• Intheeventofasterilityfailure,complaintoradverseevent,doyouhaveaprocedure in place for determining and conducting a recall, if necessary?

• Doyoupurchasepharmaceutical-gradechemicals(USP,NFequivalent)fromFDA-registered suppliers?

• DoyouobtainCertificatesofAnalysesforallformulaingredients?

• Doyoumaintainbothmasterformulasandlot-specificworksheetsforallcompounded medications?

• Canyouimmediatelytraceaprescriptionbacktotheoriginalformulalog-sheetandthe source of ingredients? • Iseverystepofthecompoundingprocessfromprescribingtocompoundingandlabeling through dispensing reviewed and verified by a licensed pharmacist?

• Doyouverifythepotencyoffinishedcompoundedmedicationsthroughweight,volumeand yield checks?

• DoyouperformpHtestingoninjections,ophthalmicpreparationsandothercompounded medications?

• DoyouperformHPLCverificationonselectedformulations?

• Areyourpharmacists,technicalandcustomercarestaffdedicatedtocompounding?

• Doesthepharmacyhaveadequateliabilityinsurance?

• AreyouactivemembersoftheAmericanCollegeofApothecaries,theInternational Academy of Compounding Pharmacists and the American College of Veterinary Pharmacists?

Customer Care Specialists and pharmacists are available:Monday - Friday 8:00 a.m. to 8:00 p.m. EasternSaturday 9:00 a.m. to 5:00 p.m. Eastern800.331.8272 WedgewoodPetRx.com

Guide to Compounding Pharmacy in Veterinary PracticeBy Renee Lupo, R.Ph., F.A.C.A., A.C.V.P., Technical-Services Pharmacist and Philip A. Scully, R.Ph., Technical-Services Pharmacist.

Wedgewood Pharmacy405 Heron Drive, Suite 200Swedesboro NJ 08085-1749 16

Page 17: Guide to Compounding Pharmacy in Veterinary Practice

NEW JERSEY ADMINISTRATIVE CODES RELEVANT TO COMPOUNDINGEvery compounding pharmacy is governed by the board of pharmacy in the state in which it resides. In the case of Wedgewood Pharmacy, that is the New Jersey State Board of Pharmacy. The state of New Jersey has regulations in place with which compounding pharmacies operating within the state must comply. Prescribers should be familiar with the laws in the states in which they practice. Here, for example, are a few key provisions of New Jersey’s laws governing compounding pharmacies.

TITLE 45. PROFESSIONS AND OCCUPATIONS, CHAPTER 14.PHARMACY PRACTICE ACT45:14-2 a. As used in this act: “Compounding” means the preparation, mixing, assembling, packaging or labeling of a drug or device as the result of a practitioner’s prescription or initiative based on the relationship of the practitioner or patient with the pharmacist in the course of professional practice or for the purpose of, or incident to, research, teaching or chemical analysis and not for sale or dispensing. Compounding also includes the preparation of drugs or devices in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns.

10 c. Practitioners authorized under the laws of this State to compound drugs and to dispense drugs directly to their patients in the practice of their respective professions shall meet the standards established by their respective licensing boards with respect to storage, handling, security, counseling, labeling, packing and record keeping requirements for the dispensing of drugs, or if no such standards exist, the same storage, handling, security, counseling, labeling, packaging and record keeping requirements for the dispensing of drugs applicable to pharmacists.

TITLE 45. PROFESSIONS AND OCCUPATIONS, CHAPTER 16. VETERINARY PRACTICE LAW 45:16-15 a - e. 15. a. A licensed veterinarian may prescribe, sell, dispense, or distribute any prescription item, providing there is a bona fide veterinarian-client-patient relationship, and the prescription item is properly recorded in the medical record, but when a prescription is issued by a licensed veterinarian to a person, another licensed veterinarian may dispense prescription items to that person without a bona fide veterinarian-client-patient relationship.

Customer Care Specialists and pharmacists are available:Monday - Friday 8:00 a.m. to 8:00 p.m. EasternSaturday 9:00 a.m. to 5:00 p.m. Eastern800.331.8272 WedgewoodPetRx.com

Guide to Compounding Pharmacy in Veterinary PracticeBy Renee Lupo, R.Ph., F.A.C.A., A.C.V.P., Technical-Services Pharmacist and Philip A. Scully, R.Ph., Technical-Services Pharmacist.

Wedgewood Pharmacy405 Heron Drive, Suite 200Swedesboro NJ 08085-1749 17

Page 18: Guide to Compounding Pharmacy in Veterinary Practice

TITLE 13. LAW AND PUBLIC SAFETY, CHAPTER 44. STATE BOARD OF VETERINARY MEDICAL EXAMINERS, SUBCHAPTER 4. GENERAL RULES OF PRACTICE

13:44-4.1 Veterinary prescription items

(b) A licensed veterinarian may prescribe, sell, dispense, or distribute any prescription item, providing there is a bona fide veterinarian-client-patient relationship, and the prescription item is properly recorded in the medical record. For purposes of this section, a prescription is properly recorded when it contains the type of medication, the strength per unit, the number of units dispensed, the directions for use and the date dispensed.

CONTINUED LEARNING ABOUT VETERINARY COMPOUNDINGWedgewoodPetRx.com contains additional materials about compounding for veterinarians and information about compounded preparations. We recommended these topics: • Drug shortage and backorder alerts • List of more than 30 available flavors • Index of professional drug monographs • Request a free trial prescription of one of our unique dosage forms

Customer Care Specialists and pharmacists are available:Monday - Friday 8:00 a.m. to 8:00 p.m. EasternSaturday 9:00 a.m. to 5:00 p.m. Eastern800.331.8272 WedgewoodPetRx.com

Guide to Compounding Pharmacy in Veterinary PracticeBy Renee Lupo, R.Ph., F.A.C.A., A.C.V.P., Technical-Services Pharmacist and Philip A. Scully, R.Ph., Technical-Services Pharmacist.

Wedgewood Pharmacy405 Heron Drive, Suite 200Swedesboro NJ 08085-1749 18