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Compounding for Felines Veterinary Medicine Webinar A.J. Day, PharmD, RPh Manager of Pharmacy Consulting Chris Simmons, RPh VP Creative Development

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Compounding for Felines

Veterinary Medicine Webinar

A.J. Day, PharmD, RPhManager of Pharmacy Consulting

Chris Simmons, RPhVP Creative Development

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Disclosure

AJ Day, PharmD and Chris Simmons, RPh are employed by and have a financial interest with PCCA.

Goals & Objectives

• Explain basic terminology for the anatomy of felines.• Discuss common problems affecting felines including

hypertension, nutrition, thyroid disease, pain management, appetite and gastrointestinal issues and more.

• Evaluate feline case studies requiring pharmaceutical compounding.

• Describe unique compounding solutions for feline patients, including dosage forms, flavors, potential toxicities, salt forms of drugs, and QC/QA.

• Describe effective ways to market a compounding pharmacy practice to a veterinarian.

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Basic A & P

• Cats are– Carnivorous

• Don’t grind food – think of texture of solid dosage forms• Keen sense for rotting meat/nitrogens; will avoid

– Nocturnal• Administration time of meds, esp hormones?

– Nose-breathers• If panting at rest, they need to see a vet immediately• Think of particle size when compounding nebulized

medicines

Basic A & P

• Cats have– Acidic urine (pH 5 – 7)– Acidic GI tract (pH 1 – 2)

• Makes sense for digesting meats – Alkaline salivary pH (8 – 9)– A very rough tongue surface– Fast GI Transit Time (GITT) – relative to

humans

Unique Dosage Forms

• Transdermal• Oral Treat• Oral solution/Suspension

– Anhydrous (oil)– Aqueous

• Powder packets• Poloxamer Gel – make from scratch, do NOT

use pre-made gel• Paw Paste

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Potential ToxicitiesBenzoates (most common = metronidazole benzoate)

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Potential Toxicities• Metronidazole USP vs Metronidazole Benzoate BP

• Benzoate form tastes better• BUT…cats cannot metabolize this salt

– This becomes an issue with chronic administration accumulation

• Metronidazole Benzoate is generally OK to use in cats, provided they– Are not hepatically compromised– Do not have other organ failure (particularly kidneys)

• Discontinue use immediately if the cat shows signs/symptoms of CNS disturbances or marked behavioral changes

Potential Toxicities• Acetaminophen• Ethylene Glycol• Pyrethrins (dog products contain 40-60%

permethrin vs. cat products which contain 0.5% permethrin)

• Doxycycline– Solid dosage forms (which would include powders)

may cause severe, life-threatening esophageal erosions & strictures

– Use Fixed Oil Base for stability– Flush (have cat swallow) with at least 6 ml of non-

irritating liquid following Doxycycline administration

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Potential Toxicities• Enrofloxacin

– Fluoroquinolones as a class, potentially?– Blindness

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Flavoring for Animals

• Ask the owner – The owner has a better idea of what the animal likes/dislikes.

• Give a taste test – Let the animal decide if the flavor works

Flavoring for AnimalsLiquids

Oil Soluble/MiscibleGrape – NEW Cherry - NEWBeefBaconCaviar FishHam Chicken grilledLiverShrimpPizza

Water Soluble/MiscibleApple-adeBeef Liver Licorice Maple

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Flavoring for Animals• Powder FlavorsApplePassion fruitMangoTangerineSweetened Flavor Powder

MangoSweetened Flavor Powder

Passion FruitSweetened Flavor Powder

Tangerine

AlfalfaBeefChicken broth spray

driedLiver powderMolasses-ade

What Is the Ideal Flavor for Each Animal?

• Feline: Cats usually don’t like too much sweetness and hate bitter taste; animal treat; flavored paste to the paw as a alternative.

• Flavor: Fish, liver, tuna, cod liver oil, sardine, beef, chicken, cheese, bacon, molasses, peanut butter, shrimp, caviar, butter, marshmallow, etc

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Flavoring

Flavoring

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Flavoring

Flavoring

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1

Salt Conversions

• Chloramphenicol Palmitate USP vs. Chloramphenicol USP– Palmitate form tastes much better– 1.738 mg of the palmitate salt will give you 1

mg of base chloramphenicol– Both powders cost the same

Salt Conversions

• Metronidazole benzoate is virtually tasteless compared to metronidazole base.

• Doses listed in literature are for metronidazole base.

• No veterinary approved products

• Metronidazole 1 milligram is equivalent to Metronidazole benzoate 1.6 milligrams.

Commonly Requested Feline Compounds

• Enalapril– Indicated for hypertension– Pro-drug but still works as transdermal

• Cyclosporin– Indicated for immune-modulated conditions

• Typically for immunosuppressive, feline asthma, inflammatory bowel disease, keratoconjunctivitis sicca

• Itraconazole– Antifungal

• Interferon alpha– Stimulate immune system– Antiviral indicated for treatment of FIV– Roferon-A®, Intron-A®

• Ketorolac– NSAID

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Mirtazapine (Remeron®) • Mirtazapine (Remeron®)

– Developed for human use as an antidepressant for moderate to severe depression

– Off label treatment for use in dogs and cats as an appetite stimulant and to treat nausea.

• Doses– Dogs: 2.75mg/10lb orally once a day– Cats: 3.75mg orally every 48-72 hours

– In the event of liver disease or kidney disease, the clearance of this drug from the body is reduced byapproximately 30% so ideally the dose should be reduced.

Calcitriol (1,25-Dihydroxyvitamin D3)

• 60,000 ng/60ml in Almond Oil• Human Dialysis Patients• Feline dosing

– To suppress secondary Hyperparathyroidism in CRF: 1.65 – 3.63 ng/kg PO qd

– Less than 0.3 cents per nanogram– Less than 6 cents for average dose of 20 ng

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3

SAMe

• Trade name - Denosyl®– S-adenosylmethionine (SAMe)– Nutritional agent, Supports liver function (hepatic glutathione)

• Very unstable around air and moisture• Use Fixed Oil Base

Tramadol

• Analgesic, post-op especially common• Tastes horrible• Transdermal is a great, proven option!

– F 9764, Tramadol HCl 10 mg/0.12 mgLTopical Lipoderm [R] (AccuPen [TM]-15)

– Document 98036, 98037 = study in feline ear tissue that shows absorption

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Diltiazem

• Indicated for hypertension and myocardial ischemia

• Due to unique nature of feline GI tract, each product exhibits a unique pharmacokinetic profile– Particularly with extended release

• Cardizem CD® can have once daily dosing• Dilacor-XR® requires twice daily dosing

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Cisapride

• Gastrointestinal prokinetic agent• Indicated for GI stasis• Do NOT use in human population (FDA

negative list)– Potential for serious cardiac events

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Buprenorphine - TransmucosalAbsorption

• From April 2010 PCCA Apothagram• Basic chemistry can heal your patients!• Speakers William Howard, DVM, and Gigi Davidson, BSPh,

DICVP, discussed many important details for compounded drug delivery. One of the basic points to keep in mind is the relationship between pH of body fluids and pKa of the drug you need to deliver.

• For example, feline salivary pH is quite alkaline (pH 8-9) and the pKa of buprenorphine is around 8.3, which means that the cat’s saliva will not ionize the drug.

• This will increase lipophilicity, which translates to better transmucosal absorption. That is why buprenorphine is a great candidate for feline transmucosal administration, whereas other species (with less alkaline salivary pH) do not get the same benefits

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Methimazole

• Used to treat hyperthyroidism• Preferred > propylthiouracil due to side

effect profile

Methimazole

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Methimazole

Methimazole

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Start with a Plan

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Suggeted References• Plumb’s• The Feline Patient

The Answer:

Debbie just stopped by yesterday and showed me the AccuPen. I cannot wait to get it in and use it for my patients. I am especially looking forward to using for my feline patients and hospice. It's great that the caregiver doesn't have to come in contact with the medicine!!

The Result:

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November 1, 2009

Behaviors suggestive of postoperative pain in cats By Sheilah A. Robertson, BVMS (Hons), PhD, DACVA, DECVAA, CVA, MRCVS

In people, pain is what the patient says it is. But in animals, it's what we say it is. To better recognize acute pain in cats, observe patients for the behavioral changes described here.

In the United States, pet cats outnumber pet dogs, yet our understanding and treatment of pain in cats has lagged behind that in dogs. Veterinarians consider surgical procedures in dogs and cats to be equally painful

but treat cats perioperatively for pain less often than dogs.1 This undertreatment of pain results, in part, from the difficulty in recognizing and assessing pain in cats.

Various pain-scoring systems have been used to assess postoperative pain. These systems measure physiologic data (objective) or evaluate behavior (subjective) or do both. Algometers and pressure platform gait analysis are objective pain measuring tools, whereas the visual analog scale (VAS) is an example of a widely used subjective scoring system. The basic VAS used for assessing pain consists of a continuous line anchored at either end with a description of the scale's limits. For example, "no pain" would be at one end of the scale and "severe pain" would be at the other. The observer places a mark on the line that he or she thinks correlates to the animal's degree of pain. This mark is later converted to a number by measuring the distance of the mark from zero.

Each practice should choose or design a scoring system that meets its own specific needs; finding this system may require some trial and error. The system chosen should be user-friendly for veterinarians and team members. It should also be an integral part of an animal's postoperative evaluation. That is, after checking temperature, pulse, and respiration, you should assess the patient for pain—the fourth vital sign.

The scale choosen should include both noninteractive and interactive components and should rely heavily on changes in behavior. For example, with the dynamic and interactive visual analog scale (DIVAS)—an extension of the VAS—animals are first observed undisturbed from a distance and are then approached, handled, and encouraged to walk or move around. Finally, the surgical incision and surrounding area are palpated, and an overall assessment of pain is made.

BEHAVIORS CORRELATED WITH PAIN

To assess postoperative pain, evaluate a cat's posture and orientation and position in the cage, facial expression, loss of normal behaviors, and response to palpation.

Posture

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1. After surgery, this cat's posture—hunched with a lowered head—indicates pain.

2. This cat's posture and facial expression are consistent with abdominal pain.

3. A friendly cat that played at the front of its cage before surgery hides afterward.

4. Palpating a bone graft site to assess for pain.

A cat that adopts a hunched posture with its head hung low, sits quietly and seeks no attention, or resents being handled is likely experiencing pain (Figure 1). In one of the few studies in which detailed behavioral ethograms (quantitative descriptions of animal behavior) have been constructed, a hunched or tucked up posture appears to be correlated with acute pain in

cats after abdominal surgery.2 This observation has been corroborated by preliminary work at the University of Glasgow (Robertson SA, College of Veterinary Medicine, University of Florida. Unpublished data, 2007).

Orientation in cage

A cat experiencing postoperative pain will often sit in the back of its cage. This subtle sign of pain will remain unrecognized if the caregiver expects to see more active signs of pain, such as pacing, agitation, or vocalizing.

Facial expression

A head-down posture, with eyelids half-closed and eyes held in a slanted position may correlate with pain (Figure 2).

Loss of normal behaviors

The absence of normal behaviors in a specific patient (e.g. grooming or playing with string) should prompt you to assess that patient for pain. Many cats that are fearful or stressed will stay at the back of their cages and hunch themselves up, but if you observe these cats before and after surgery, you can detect subtle changes. For example, if pain relief is inadequate, a cat may be even more hunched than before. And instead of just being at the back of the cage, it may actively try to hide under things (Figure 3), and its facial expression will be different from that before surgery.

It is important to assess patients before and after surgery. Each cat is unique, and some will have altered behavior due to stress. The trick is to pick up small changes for that specific cat that can be attributed to pain. However, stress and fear are aversive emotions that can worsen pain, so they should not be dismissed. Instead, give some thought as to how to also relieve stress and fear, such as by providing a cat-only area, boxes for cats to hide in, and favorite toys and blankets from home or by using a synthetic feline pheromone (Feliway—Ceva Santé Animale).

Response to palpation

Wound palpation is an important component of pain assessment; you should be able to apply gentle pressure to a surgical wound without a cat's flinching or turning to bite (Figure 4). One of the many commonly reported

problems after onychectomy is excessive licking and chewing of the feet.3 Cats will often shake their paws and try to bite at their feet if bandages are placed on onychectomy wounds. These behaviors could indicate postoperative pain, pain from an incorrectly placed bandage, or a dislike of the bandage, so it is important to differentiate among these.

HOW OFTEN SHOULD PAIN BE ASSESSED?

The patient's health status, the extent of the surgery or injuries, and the anticipated duration of effect of the analgesic drugs administered determine the frequency and interval of evaluations. If a cat, for example, is resting comfortably (normal posture and facial expression) after postoperative buprenorphine administration, it may not need to be reevaluated for two to four hours. Allow

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animals to sleep after analgesic therapy. Vital signs can often be checked without unduly disturbing a sleeping animal. In general, do not wake an animal to check its pain status; however, the patient should still receive scheduled analgesics.

Continuous, undisturbed observations coupled with periodic interactive observations (e.g. palpating the wound) are likely to provide more information than occasionally observing the animal through the cage door. Unfortunately, continuous observations are not practical for most clinical situations. But the more frequent the observations, the more likely that subtle signs of pain will be detected.

Sheilah A. Robertson, BVMS (Hons), PhD, DACVA, DECVA, CVA, MRCVS Section of Anesthesia and Pain Management Department of Large Animal Clinical Sciences College of Veterinary Medicine University of Florida Gainesville, FL 32610

REFERENCES

1. Lascelles B, Capner C, Waterman-Pearson AE. A survey of current British veterinary attitudes to peri-operative analgesia for cats and small mammals. Vet Rec 1999;145:601-604.

2. Waran N, Best L, Williams V, et al. A preliminary study of behaviour-based indicators of pain in cats. Anim Welfare 2007; 16(S):105-108.

3. Patronek GJ, Assessment of claims of short- and long-term complications associated with onychectomy in cats. J Am Vet Med Assoc 2001;219(7):932-937.

1. After surgery, this cat's posture—hunched with a lowered head—indicates pain. 2. This cat's posture and facial expression are consistent with abdominal pain. 3. A friendly cat that played at the front of its cage before surgery hides afterward. 4. Palpating a bone graft site to assess for pain.

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A. J. Day

From: Fully Vetted [[email protected]]

Sent: Tuesday, October 05, 2010 12:17 AM

To: A. J. Day

Subject: Yeowch! Hissss! On the Hows, Whys and Stresses of Modern Feline Pain Control

Page 1 of 4PetMD Newsletter

10/5/2010

Are you having trouble viewing this e-mail? View it online: Click here | Unsubscribe

Yeowch! Hissss! On the Hows, Whys and Stresses of Modern Feline Pain Control

OCTOBER 05

Analgesia, we call it. It’s the absence of pain. The holy

grail for so many conditions. But it’s not enough not to

feel pain. It’s got to be safe, comfortable, appropriate,

reliable and effective. A tall order, especially for cats.

Why so? As far as drugs are concerned, cats have

historically been treated like small dogs. And dogs, in

turn, as small humans. Is it any wonder we’ve got so few

drugs that really work well for our feline companions?

Pain relief, in particular, is a surprisingly frustrating issue in feline medicine for a

couple of reasons:

1. Pain in cats is a tough thing to assess. Their silent stoicism, while admirable,

doesn’t exactly lend itself well to ready interpretation in the event of pain.

Even severe pain often goes undiagnosed in cats. How do we know? Good

question. Here’s an article that addresses the behavioral characteristics we’ve

now come to associate with post-operative pain in felids. We’re getting

smarter on this issue.

2. The presence of few reasonable alternatives to long term pain control in cats

typically means NO long term pain control in cats. So while severe acute or

post-op pain can be managed with heavy duty narcotics (think, strong opiates

like hydromorphone), there’s little available to treat long term illnesses

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(think, osteoarthritis, a very common condition in cats).

Still, I’m proud to report that pain relief in cats has come a long way over the last

couple of decades. Here’s an excerpt from a 2003 World Small Animal Veterinary

Association meeting lecture on the subject to illustrate the [newly enlightened]

motivation for feline analgesia:

Pain interferes with healing and can, in fact, make the disease process

more harmful. Hypotension, gastrointestinal injury, hypothermia and

immunosuppression may all occur as negative physiologic results of

pain. The body, in response to the trauma, releases all sorts of

leukotrienes: some of these are helpful, but many aggravate the

problem.

As a result, if a patient has, or is going to have tissue trauma, analgesic

therapy is required.

Makes lots of sense, right? It’s more than just the humane approach, it also happens

to be the more effective approach when it comes to healing.

Above all do no harm? It’s now clear that to deny a patient a pain control drug on

the basis of "safety" may not make so much sense if the patient’s pain score is

significant. The impact on the patient’s long term well being is now considered in a

more "holistic" manner. And that’s undoubtedly a good thing.

But the sad truth remains that few drugs are available for certain kinds of pain.

While opiates (morphine-like drugs) are eminently useful, they’re only helpful for

relatively short term pain control or hospice care. With some exceptions, cats are

just too whacked out by these meds to live normal lives.

As I said, there are some exceptions. Transdermal fentanyl patches, tramadol and,

butorphanol are all opiates that are used for acute and sub-acute pain control. (The

difference? Acute: think, post-op or trauma. Sub-acute: think, a flare-up of

arthritis.) For chronic pain control, these drugs are typically considered just too

drowse-inducing. But not for all. Sometimes it’s worth a try.

For dogs we’ve got lots of pain meds for long term pain. Osteoarthritic dogs are

living longer than ever before, now that they’ve got great drugs to control their

chronic discomfort. NSAIDs (non-steroidal anti-inflammatory drugs) are our go-to

meds for this purpose. And while they’ve got plenty of side-effects, the vast majority

of dogs will safely enjoy their benefits for years without them. No drowsiness. No

vomiting or diarrhea. No liver or kidney disease.

Not so with felines. Gastrointestinal and renal side effects (think, kidney failure) are

much more common with NSAIDs when used in cats. Though we will tap these meds

for their anti-inflammatory effects, we tend to do so only in well hydrated cats whose

renal status is demonstrably normal ... and only for one dose.

Metacam (meloxicam) is one such drug whose one-dose injectable formulation that

is approved by the FDA for use in cats. It’s great for spays and neuters and other

procedures we undertake in young, healthy cats …

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10/5/2010

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… not so much for those who suffer chronic pain, as in the case of arthritis, or slow-

moving cancers that require some anti-inflammatory palliation. In fact, a recent

FDA labeling advisory cautioned us strongly against the use of oral Metacam for

long-term care. It’s just too toxic to the kidneys.

Here are other NSAIDs that are sometimes used instead:

� Aspirin

� Ketoprofen

� Ketorolac tromethamine

� Carprofen (Rimadyl)

But I approach these with caution, and I suggest you do the same. Nonetheless, I’ve

used them all to great effect in cats. After all, there is no "one size fits all" in

medicine. Even less so when it comes to controlling pain, and nowhere is this more

true than when trying hard to control pain in cats. In the absence of approved drugs,

sometimes cautious creativity is the only key.

Dr. Patty Khuly

Pic of the day: "Cat on the water" by me and my CatPaint app

Page 3 of 4PetMD Newsletter

10/5/2010

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All opinions are welcome on FullyVetted. So bark away... I don't bite.

©1999-2010 PetMD Ventures, Ltd. All Rights Reserved | Unsubscribe | www.petmd.com

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10/5/2010

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Drug shortages and recalls –– How they may be compromising your pets’ care

NOV 03, 2010

I have four words for you: frustrating, confusing, scary, and stressful. That's what happens when the drugs you need aren’t available for your patients. And it’s been a big problem for the past few months as physicians and veterinarians struggle to make do without the crucial drugs that are used for anesthesia, seizure control, and pain management.

According to The Wall Street Journal, the trouble poses more than a mere challenge for the clinicians involved. According to a recent study, patient safety is clearly being compromised:

Pharmacists and other health-care practitioners say ongoing drug shortages are accompanied by difficulties including a lack of available information, trouble finding alternative medications, and deadly errors, according to a survey conducted by the nonprofit Institute for Safe Medication Practices.

And here are some of their findings:

A variety of difficulties associated with drug shortages, including a lack of information about a shortage’s duration (85% of respondents said this was frequently or always a problem during the past year), a lack of advanced warning from manufacturers or the FDA (84%), difficulty finding a good alternative (80%), internal hoarding (58%), and physician anger towards pharmacists, nurses or hospital in response to a shortage (55%).

Some 64% of respondents reported there was a risk of adverse patient

outcomes associated with a drug shortage, and one in three said their facility had a shortage-related "near miss." One in four reported errors, and one in five reported adverse patient outcomes.

Most of the drugs involved in the shortages are so-called "high alert

medications," which have the highest risk of injury if misused. Those

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include the blood thinner heparin, chemotherapy drugs, morphine, epinephrine and the neuromuscular blocking agents used in surgery.

Troublesome, right? To say the least. How scary is this? This scary: I believe it contributed to the death of one of my patients last week. Here’s the story … Floreana, Flor, is a toad huntress. I’ve told her stories here many times before. That’s partly because she has been our worst serial offender (you know, some dogs will learn to stay away from the creatures that do them wrong, while others — typically terriers — will keep going back for more), but it’s also because she was my parents’ dog. Last Thursday I received a call: Flor got another toad and this time it was very bad. The housekeeper had no car (my parents were out of the country), so I dropped everything and picked her up. She was seizuring on my lap as we drove to my place of work. At this point it was already on my mind: We have no propofol! And the last time she received such a big dose of toad toxin (secreted onto the skin), the only medication that had any ability to quiet her seizure activity was propofol (yes, the same drug that killed Michael Jackson). So when it became clear that the third dose of Valium and the second dose of phenobarbital were achieving a less-than-desired effect, I decided to wrap her up and take her to the specialty hospital for better drugs than I had on hand. By then it was too late. She vomited and subsequently suffered a respiratory arrest and profound bradycardia (very slow heart rate). CPR. Drugs. Oxygen. Recovery. And then a mad dash to the specialty hospital ensued … only to discover that they also didn't have propofol on hand. She continued to seizure through the night, developing aspiration pneumonia (after all that vomiting I knew it was coming) and severe arrhythmias (toad toxin is a powerful cardiotoxin, too), so that she'd have to spend the night in an oxygen cage with a continuous EKG and constant attention. Honestly, I considered euthanizing her at this point. My parents wouldn’t have blamed me, but the boyfriend urged me to give her a chance. And by the next morning she did look better. She even sat up when I tried to leave. But she was still horribly groggy from all the drugs. So it was that I took her home that following night, wobbly and urpy as she was. Thinking she was out of the woods and would be more comfy with me, I set her

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to sleep in a crate next to Slumdog — only a few short inches from my bed. At 3 a.m., Slumdog awoke me with his piteous whining. Flor’s breathing had become dangerously shallow. Though still curled into a comfy little ball, her pulses were imperceptible, her heart rate slow as a horse’s. She was dying. Right there and then I told her she would be OK, and that she was loved. And she went. Sure, the lack of propofol, which had helped her so quickly in the past, may not have had anything to do with it. Yet the fact that neither hospital had the drug available may well have been the deciding factor. In light of her previous successful recovery with the drug, can you blame me for wondering? Then there’s this less obvious, less personal issue to consider: Does the fact that physicians and veterinarians have to change their anesthetic and pain control protocols so suddenly factor into medical errors? Of course it does! Imagine your place of work suddenly altering its basic practices from one week to the next. Wouldn't some errors be expected? It’s no different in medicine, only the stakes are changed. Yet here’s the thing: Word of this problem has only recently started trickling down to patients and pet owners. Though it’s been frustrating for me, I haven’t thought about it in terms of my patients’ care until this episode. But as with so many profoundly important issues, sometimes things have to hit you broadside — and hard — before they make their true impact known.

Dr. Patty Khuly

http://www.petmd.com/blogs/fullyvetted/2010/nov/drug_shortages

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Finding the cure for drug delivery ills in veterinary medicine

NOV 12, 2010

Getting pets to pop their pills is a huge issue. So huge, in fact, that a drug's delivery method often informs veterinary decision making, sometimes more than the drug’s other properties. Side effects, for example, matter far less when the alternative is no treatment at all.

The "drug delivery" issue is getting more play recently, what with the growing list of drugs we're now prescribing for our patients. This, coupled with issues of accessibility, availability and price fuels a sizable niche industry created specifically to meet the needs of pets who won’t — or can’t — tolerate drugs and supplements designed to treat and/or prevent their ills. After all, pets can be picky about what we put in their mouths or mix into their meals. And you would be too if you didn’t understand why you needed to take that multivitamin, glucosamine, or fatty acid gelcap on a daily basis. This is why compounding pharmacies exist. For the modern veterinarian, being able to access our favorite compounding pharmacy’s expertise in the formulation of new versions of the same-old drugs that line our shelves is a boon to our profession. But few veterinary clients fully understand what it is our compounding pharmacies do for us. To help unmuddy the waters, here's a brief list of how these places help us bring better care to our patients: 1. Delivery, delivery, delivery As for the real estate and location truism, so too does the veterinary drug industry rely on the "D" word. As a pet owner, you know how it is. We try everything to get meds into our pets. Some of us hide our pets’ pills in foodstuffs or treats: cream cheese, peanut butter (chunky works best, IMO), ham, chicken breast, pill pockets, filet mignon … As veterinarians, we also do whatever it takes to get the meds into our patients. And, yes, sometimes it takes a lot of trial and error. More than anything else, what we all want is a cure that requires no daily discomfort, wriggling, stressing, in-the-towel-burrito-ing or the potential for biting, scratching or generalized inter-species strife. This is where the compounding pharmacy comes in with their ability to turn... a. chalky to chewy b. bitter to tasty c. oral to topical Yes, topical. So it is that sometimes compounding pharmacies can manage the seemingly impossible.

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2. Availability Is your drug on back-order? Discontinued? Supply chain hassles? Never fear. You don't have to compromise your pet's care if you can find a compounding pharmacy willing to make it for you. That’s what lots of veterinarians are doing now with drugs like ophthalmic cyclosporine. When the supply goes dry, compounding pharmacies' production ramps up. 3. Safety I'm not big on doing chemotherapy in-house. I'd always rather send my patients to the specialists where the required drugs are more safely housed. Yet I have plenty of clients who prefer that I administer these drugs personally, citing their pets' greater comfort in a place they already know well. This is where compounding pharmacies come in. They'll ship pre-measured doses to me, already in their syringes and ready to inject. Safer for me, my staff, and my patients. 4. Convenience Want your meds shipped directly to you? Your vet can arrange for that. Pharmacies will ship monthly, on cue, if that's what you need. It’s hard to quantify, but we suspect that non-compliance resulting from an inability to administer meds is among the biggest drivers of poor clinical outcomes in veterinary medicine (if not the biggest). Then there’s the issue of antibiotic resistance to deal with when antibiotics are started. The pill is found under the sofa … started again … spit out again … repeat … Given this setup, is it any wonder that compounding pharmacies are finding veterinary medicine a lucrative place to invest their time and money? But the take-home message here is not about building new businesses with our pet-dedicated dollars; it’s more about the willingness to meet our pets’ needs by making medications work through any means necessary. Trouble is, clients don’t always inform us when the meds aren’t going down the gullet. Not every pet owner is educated enough about drug choices to know they can ask us for alternatives. And, truth be told, we don’t always pointedly ask whether an unhappy outcome might be the result of poor drug compliance. (It just seems kind of rude to ask, you know?) However, now that you’ve read this, you know what you need to do. When you come across a tidy stack of tablets your dog has hidden under the bed, or your cat drools for hours after taking her pill, consider asking for another method. No one needs to suffer when so many other options are available.

Dr. Patty Khuly

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HOW COMPOUNDING PHARMACISTS CAN MAKE OUR JOB EASIER, IMPROVE CLIENT PERCEPTIONS AND THEREBY HELP OUR PATIENTS

Professor Richard Malik DVSc DipVetAn MVetClinStud PhD FACVSc FASM Post Graduate Foundation of Veterinary Science and Faculty of Veterinary Science, Building B22, The University of

Sydney, NSW 2006 Many years ago, I thought I had little need for compounding pharmacists. I had learned or learnt over the years how to cut

tablets into portions (with scalpel blades and pill cutters), use pill crushers, open capsules, reformulate them into size 00 gelatin capsules (often containing more than 1 drug) and present them for administration to my patients.

I had the time, and I also had the luxury of working in a Veterinary Teaching Hospital where (somewhat) willing helpers (students, nurses and even the odd resident) would help with this task. I was firmly of the view that nearly all owners could be taught how to successfully give capsules or tablets to their cat, without resorting to flavoured vehicles, while transdermal formulations held no great attraction for me, especially in relation to the management of hyperthyroidism (where I firmly believe radio-iodine is the way to go).

Over the last half dozen years, however, I have come to work more and more closely with compounding pharmacists, and the more I work with them, the more ways I can see that they greatly contribute to positive patient outcomes by improving the quality of veterinary care.

Many of the points I will make below will be compelling to the majority of readers. Some may take exception to the odd point, depending on their perspective, and experiences. Regulatory authorities may not be happy with all the suggestions I am about to make, but I am not afraid of providing a dissenting view. My brief is simple – I am an advocate for the client and their patients.

The points I will make, lend themselves to presentation as bullet points, using pertinent examples, to illustrate situations where compounders have something special to offer. In closing this introduction, I want to emphasise the value of developing a special relationship with one or two compounding pharmacists. They might be geographically convenient, or the least expensive, or appear to have the greatest interest in helping veterinary patients. But for whatever reason, if you forge a relationship with one or two pharmacies, you are likely to receive reliable, prompt, courteous and individual service, which will bode well for you and your clients.

1. Reformulating drugs (typically human drugs) into doses appropriate to smaller patients.

A common and important example is in relation to management of cats with hypertension with the human drug amlodipine, whose dose is typically somewhere between 1/8 to ¼ of a 2 mg tablet of Norvas® once or twice daily – this is hard to achieve (without losing quite a deal of an expensive drug), so getting the material in the correct dose into gelatin capsules is very helpful when treating renal hypertension in elderly cats. The gelatin capsule is helpful in itself, as the drug is bitter. As an aside, a small amount of butter or margarine helps gelatin capsules go down the throat of cats, and rub a bit on the end of their nose to make sure they keep swallowing.

In exotics practice (ferrets, birds and the like) – the reformulation of drugs is even more compelling, especially if they can be suspended in a tasty vehicles to improve compliance. For birds and ferrets, there are too many examples to list. Gels and suspensions both have their place.

In small animal oncology, there is a problem reformulating cytotoxic drugs in the practice because of O.H.S. issues, and also because these drugs are not evenly dispersed within coated tablets. Again, compounding pharmacists can come to the rescue, e.g. getting correct doses (typically 25-30 mg) of cyclophosphamide for treating small/thin cats with lymphoma (a 50 mg enteric coated tablet is generally suitable for cats weighing between 4 and 6 kg, as the dose is generally 10 mg/kg).

There is a long list of drugs that we routinely reformulate for feline practice including the anti-infectives moxifloxacin, clarithromycin, flucytosine, clofazimine and fluconazole. As well as likely improving compliance, without doubt there is an increase in the precision of dosing. The cost of having this done for a lengthy course of therapy is trivial.

Importantly, by providing a compounding pharmacist with a prescription for the drug and how it should be reformulated, the owner often gets the benefit of the cheaper wholesale rate available to pharmacists, and critically as most compounders work on MUCH SMALLER MARGINS than the average veterinary practice, the owner ends up paying far less. This might be perceived to be bad from your boss’s perspective, but it’s very good for the client, who can then pay for your expertise and not for maintaining your practice pharmacy with esoteric drugs with a finite limited shelf-life. And if your boss is smart, he/she will come around! Finally, compounders are usually fast and efficient. If you e-mail or FAX them a prescription, the drug is generally in the post on the way to the client within 24-48 hours. That’s good service!

2. Creating completely novel formulations for special purposes. For example, treating mycotic keratitis in horses can be problematic as the organisms involved may be resistant to many

available formulations, while certain human drugs e.g. natamycin ophthalmic suspension may be difficult to obtain because

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of regulatory authorities. Compounding pharmacists can extemporaneously make up ophthalmic formulation of drugs such as itraconazole, posaconazole, voriconazole and amphotericin B. That gives us quite a range of agents capable of being used in either ophthalmic drops or ointments. Dr Andrew Turner (and others) have used such formulations with great success in treating even advanced fungal infections of the equine cornea.

Some years ago I had a topical ointment made up consisting of petroleum jelly containing rifampicin and clofazimine for treating canine leproid granuloma lesions topically, without resorting to systemic therapy. It seemed to help in several refractory cases, although it was a messy formulation which stained the skin of both the patient and the client (who were therefore advised to wear gloves).

The emerging infectious disease feline trichomoniasis is best treated using a drug called ronidazole. Colleagues at North Carolina Sate University have suggested that the best way for this to be given, so as to minimise the possibility of neurotoxicity, is by purchasing analytically pure drug and formulating a specific colon-targeted delivery using a guar gum formulation. This can be arranged by diligent compounders.

No doubt you can think of a number of special situations where you would have liked to have a suitable formulation available, e.g. treating some nasty resistant ear infection in atopic dogs.

3. Getting drugs that are of proven benefit for treating companion animal diseases that have not yet become, or

will likely never become, commercially available in Australia. By far the best example of this scenario is the drug trilostane, which has a number of advantages over mitotane for

treating pituitary dependent hyperadrenocorticism. Compounding pharmacists are generally expert is locating RELIABLE manufactures of drugs like this, generally from China or India, from internationally accredited human laboratories. They are much better at filling in the appropriate paper work (import permits and the like), and further can EXACTLY tailor the dose of the agent for an individual patient.

Ironically, this has meant that trilostane for veterinary use in Australia is less expensive than in countries where it is commercially available. Certainly it has opened up this treatment option for a whole range of general veterinary practitioners and their clients that might not otherwise be able to afford treatment provided by a specialist referral centre. And after all, Cushing’s disease is as common as dirt, so it’s nice for us to all be able to effectively manage these cases.

Although there may be concerns about the quality and purity of drugs sourced in this manner, my experiences have been uniformly favourable, and in the case of trilostane, the effect of the drug is always TITRATRED for the individual patient using sequential Synactin response testing. If bioavailability is a bit different from the original manufacturer, it usually will just mean you will use a consistently different dose, with which you will rapidly become familiar as you treat more and more cases.

Another pertinent example is the oral hyperglycaemic drug diazoxide, which is of great benefit in the long term palliation of dogs and ferrets with metastatic insulinoma. This drug is very difficult to obtain (and very expensive) in its original formulation from its manufacturer, as it is not licensed for this indication in Australia. Compounders can generally obtain it, although there is often a wide variation in price according to where they source it from, how much they buy (much cheaper if they buy in large aliquots), and what their margin and handling costs are.

A further example is cisapride – a prokinetic agent thought to be useful in managing early cases of megacolon in cats and post-operative ileus in horses. It was taken off the human market as the result of a rare cardiac phenomenon, which has been encountered in veterinary patients. This drug is available and generally inexpensive from many compounders. Unfortunately it has not proven to be very helpful for most megacolon cats in my hands. Others may have different experiences.

A somewhat different situation is applicable to the drug phenytoin. The commercial formulation (Dilantin®) was shown many years ago to be ineffective for managing canine seizure disorders because of rapid metabolism through hepatic biotransformation. However, veterinarians in the Netherlands have developed sustained-release formulation of phenytoin that has shown to be of substantial efficacy in managing many types of canine seizure disorders. This type of formulation can be made up by switched on compounders in Australia like Bova Pharmacy1.

Occasionally, medications of proven benefit become temporarily unavailable in Australia due to changes in policy of national and multinational drug manufacturers. For example, the sedative/hypnotic/anaesthetic oxybarbiturate pentobarbitone, which had been available for many years as a solution in propylene glycol (Nembutal®), was discontinued by Abbotts who had originally manufactured the agent. Until a local manufacturer took up commercial production of pentobarbitone, it could be obtained by a single compounder (Stenlake Compounding) who had gone to some considerable trouble to ensure safe production of a sterile formulation for veterinary use (thereby circumventing the practice of diluting “euthanasia solution” to administer the agent for certain indications, e.g. treatment of 1080 poisoning in working dogs in the country).

1 BOVA CHEMIST, Shop 1 304-318 The Kingsway CARINGBAH NSW 2229 Ph: 02 9525 3044

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4. Obtaining generic drugs not currently available in Australia, except in their original (expensive) human

formulations. For example, in most situations the triazole drug fluconazole is the drug of choice for treating feline cryptococcosis,

being better tolerated than itraconazole (no hepatotoxicity) and somewhat more effective, based on the recent paper by Carolyn O’Brien et al in the Australian Veterinary Journal. However, the cost of treating an average cat with Diflucan®, the original formulation from Pfizer, is in excess of $120 per week wholesale (to the client without mark up).This is clearly beyond the reach of most clients, and accordingly for many years we advocated itraconazole as the drug-of-first-choice, largely on the basis of cost. It is now possible to get fluconazole manufactured in India (where it is used extensively in human patients) that permits cost effective treatment of virtually all cats with sinonasal cryptococcosis using fluconazole. We have measured blood concentrations in cats and dogs during treatment using the high performance liquid chromatography available at St Vincent’s hospital, and in all cases effective blood concentrations s were obtained using fluconazole sourced from reputable manufacturers in India. This is good news for cats and dogs with cryptococcosis! Indeed, it is likely that even if a veterinary manufacturer would take on licensing and marketing of this drug, it would not be available at the same excellent price as it is through reputable compounders.

Another pertinent example is ondansetron. This is one of a new highly effective class of centrally acting anti-emetic drugs, the central 5HT-3 (serotonin) receptor antagonists. The cost of this drug as sold by its original manufacturer is so expensive that its use is virtually precluded in small animal practice. The availability of compounded ondansetron capsules at a substantially reduced cost makes their routine use affordable in a variety of clinical situations – including pancreatitis cases (after the first day or so, when injectable Anzemet® is still a better option), Parvo virus enteritis, to prevent motion sickness when travelling and to prevent nausea, anorexia and vomiting associated with cytotoxic drugs such as carboplatinum and doxorubicin. Indeed, ondansetron is now so inexpensive that I believe it should be used routinely in all cats and dogs receiving chemotherapy for cancer, and you could make a case for its routine use in elective surgery cases to prevent nausea and vomiting in the post-operative period.

A further example is the immunomodulator cyclosporine. Although this is available as a veterinary formulation (Atopica®), the cost of this formulation is prohibitive for many owners. Utilisation of extemporaneously formulations individually made up for a given patient can provide a cost effective solution in many instances. Using this approach, it is prudent to use therapeutic monitoring of cyclosporine blood levels, to ensure bioavailability in individual patients is similar to the original formulation.

5. Obtaining drugs that are very difficult to obtain through regular channels. The drug clofazimine, for instance, is very difficult to get because the World Health Organisation. has attempted to

largely restrict its use to treatment of leprosy in developing nations. This makes it very difficult to obtain, which is unfortunate if you are trying to treat unusual mycobacterial infections in cats (mainly feline leprosy syndromes and the occasional refractory rapidly growing mycobacterium) where this drug is of proven efficacy and inexpensive. Again, compounders can really make a big difference here, although probably it is in everybody’s interest if one compounder supplies the drug, so they can buy it in large and therefore cost effective quantities, thereby maintaining low cost to all clients. This also circumvents the need for the veterinarian to prepare special submissions to the AVPMA, and allied administrative costs.

Similar considerations apply to the drug 5-flucytosine, a potent antifungal agent that is especially effective in the management of cryptococcosis in cats (and to a lesser extent dogs – due to a predictable drug eruption which limits its use in this species); this agent can be extremely difficult to obtain through regular channels, but at least one compounding pharmacist (Bova) has a reliable stockpile.

Another example is the drug thalidomide. This drug – which is both a potent tumour necrosis factor-alpha inhibitor and an inhibitor of angiogenesis, has an evidence-based role in the management of some inflammatory diseases of cats (lymphocytic plasmacytic gingivostomatitis and FIP) and the treatment of certain tumours.

A further example is the anti-viral agent trifluorothymidine. This agent is said my many veterinary authorities to be the most potent drug available for treatment of Herpes virus keratitis in cats, but is not commercially available and is made up contemporaneously by human eye hospitals on a need-by-need basis. The availability of sterile appropriately stabilised solutions of this agent are of great benefit in the timely management of rapidly- developing dendritic corneal ulcers in the cat.

6. Use of “polypills” i.e. fixed dose combinations of drugs used to treat a single disease condition. There are a number of situations in which optimal therapy for our patients involves the simultaneous administration of

several drugs concurrently. One example may be treatment of Helicobacter-related gastritis, when it is desirable to use a combination such as amoxicillin/metronidazole/bismuth or clarithrlomycin/omeprazole for several weeks to clear the

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infection. Another may be the treatment of certain refractory mycobacterial infections (M avium, M genavense, M ulcerans, feline leprosy syndromes) where two or three drug combinations e.g. rifampicin/clarithromycin/ moxifloxacin may be required for the initial period of therapy. In these instances, ESPECIALLY for feline patients, having all the medications in a single gelatin capsule is of GREAT BENEFIT!

A case in point which I am currently working on related to management of congestive heart failure due to mitral insufficiency. In my view, there is currently sufficient evidence that most dogs will benefit from the simultaneous administration of three or four drugs – the inodilator pimobendan, a long acting ACE inhibitor (e.g. enalopril), furosemide and spironolactone. Currently many clients are “forced” to choose between furosemide/pimobendan and furosemide/veterinary ACE inhibitor (typically Fortekor®) based on the high cost of drugs. However, as all the “best” drugs (except pimobendan) are out of patent, it is easy to come up with a fixed dose combination of FOUR drugs that can be given twice daily (on am empty stomach) to perhaps 70% of dogs with symptomatic mitral regurgitation. This should improve efficacy, compliance and reduce cost for many owners. Stated another way, the great majority of dogs may benefit from fixed dose combination marginally more expensive than pimobendan monotherapy and easy to give twice daily.

This article is really a work in progress. I am sure many readers will have different pertinent examples of how

Compounding Pharmacists can help them do a better job. I encourage them to SHARE THESE EXPERIENCES with me and your colleagues through forums such as the Control & Therapy Series of the Post Graduate Foundation, or by writing letters to the editor of The Veterinarian or Australian Veterinary Journal.

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Vet's view: Pet medications don't have to be a bitter pill

August 5, 2010 By Patty Khuly, Special for USA TODAY Never underestimate the gag reflex of a cat or the ability of a fleshy-faced dog to hide a pill deep within the cavernous folds of his oral cavity before spitting it out a few minutes after he's out of your sight. Pets are amazing that way — amazingly frustrating, that is.

Delivering drugs to pets is a huge issue in veterinary medicine. So big that it fuels a sizable niche industry created specifically to meet the needs of pets who can't or won't tolerate drugs and supplements designed to treat and/or prevent their ills. Which is why it's nearly every day we veterinarians access our favorite compounding pharmacy's expertise in the formulation of new versions of the same old drugs that line our shelves.

Yes, just like us (our kids, especially), pets can be picky about what we put in their mouths or mix into their meals. You would be, too, if you didn't understand why you needed to take that niacin, glucosamine or Centrum Silver on a daily basis.

I hate taking pills, too. The physical act of downing the trio of tablets I take every day is an uncomfortable, abhorrent one for reasons I can't even explain. I just don't enjoy downing a glug of chalky solids. So why would our pets?

Some of us hide our pets' pills in food or treats: cream cheese, peanut butter (chunky works best, IMO), ham, chicken breast, pill pockets, filet mignon. In vet school, I even spent time devising a protocol for getting fish to take an antibiotic called enrofloxacin (I soaked brine shrimp in 100mg/ml solution for three to five minutes before feeding them). As veterinarians, we do whatever it takes to get the meds into our patients. And, yes, sometimes it takes a lot of trial and error.

■ VIEWS FROM A VET

Patty Khuly, a small-animal veterinarian in Miami, is author of FullyVetted, a blog on pet

health at PetMD.com. She also writes weekly for the Miami Herald and monthly for Veterinary

Practice News. Her USA TODAY guest column appears each Friday.

Khuly lives in South Miami with her son, Max, dogs Vincent and Slumdog, goats Poppy and

Tulip, and a backyard flock of chickens.

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Others switch to liquid meds (readily available through compounding pharmacies) hoping these will make all the difference. And sometimes they do. But more than anything else, what we all want is a cure that requires no daily discomfort, wriggling, stressing, in-the-towel-burrito-ing or the potential for biting, scratching or generalized inter-species strife.

It's for this reason we seek drug delivery methods that require once-daily dosing instead of two to three doses per day. It's also why Pfizer's new injectable antibiotic, Convenia, makes us jump for joy (one painless subcutaneous shot equals two weeks of antibiotic coverage).

It's another reason we believe certain surgical or even radioactive treatments may best a lifetime of pills —— expensive and aggressive though we know them to be. It's why topical medications are so revered when they're found to work as effectively as the oral or injectable versions.

And it's what keeps compounding pharmacies in business. In case you've never heard of these places, these are pharmacies that serve the veterinary profession primarily by granting hard-to-administer drugs greater approachability. Yes, it's a niche industry. But it's one that (despite all the hand-wringing that goes on in the pharmacy industry) is highly profitable … and growing.

Why such a big deal?

It's hard to quantify, but we suspect that drug non-compliance as a result of an inability to administer meds is among the biggest drivers of poor clinical outcomes in veterinary medicine (if not the biggest). Then there's the issue of antibiotic resistance to deal with when antibiotics are started, found under the sofa, started again, spit out, repeat.

Given this setup, is it any wonder compounding pharmacies are finding veterinary medicine a lucrative place to invest their time and money?

But the take-home message here is not about building new businesses with our pet-dedicated dollars. It's more about meeting the needs of our pets with the willingness to make medications work through any means necessary.

Trouble is, clients don't always inform us when the meds aren't going down the gullet. Not every pet owner is educated enough about drug choices to know they can ask us for alternatives. And, truth be told, we don't always pointedly ask whether an unhappy outcome might be the result of poor drug compliance. (It just seems kind of rude to ask, you know?)

Now that you've read this, however, you know what you need to do. When your dog hides a tidy stack of tablets under the bed and your cat drools for hours after her pill, consider asking for another method. No one need suffer when so many other options are available.