Medication compounding and administration challenges in the chronic pain patient (Proceedings)

Chronic pain patients certainly present their own set of challenges beyond the obvious challenges around relieving their discomfort. We have to ensure that they eat enough, but not too much of the most appropriate nutrient profile. We need to make as specific a plan as possible for an appropriate level of activity and exercise. We need to build our multi-modal "pain management pyramid" with all its intricate and detailed layers. And then, once we have our medication and nutraceutical plan in place, we need to ensure that our clients can actually execute our plan. Medications can't help the patient unless they get INTO the patient!

And herein lay one of the biggest challenges of managing chronic pain patients (especially cats) — how do we make medication time equivalent to "treat time"?

Medication Compounding

(Many thanks to Dr. Dawn Boothe for her ongoing work to illuminate the details, concerns, and limitations of compounding within veterinary medicine)

According to the National Association of Boards of Pharmacy, compounding of medication is the preparation, mixing, assembling, packaging, or labeling of a drug or device as the result of a practitioner's prescription drug order, based on the practitioner, patient, pharmacist relationship. No one will argue that compounding is a critical component in veterinarians getting their patients the medications they need and deserve. In fact, veterinarians would be unable to practice whole disciplines, like oncology and pain management, were it not for the ability to have medications compounded.

That said, there are serious concerns around the issue of compounding that we as veterinarians have an obligation to understand and to take into account as we make our treatment plans for our patients. Having a medication compounded is NOT a decision that should be made lightly. In fact, the sole justification for ordering a compounded medication is that no commercially available product will meet the patient's needs. The dilemma surrounding compounding of mediation includes a complete lack of oversight on the part of either the state or federal government. Essentially, there is a complete lack of oversight of compounded products. Consequently, we are faced with a complete lack of assurance with respect to quality, safety, or efficacy of a compounded product. It is truly a case of "caveat emptor".

There are a few regulations that pertain to compounding pharmacists. For instance, if a drug exists in a tablet or capsule form, it cannot be re-formulated into a tablet or capsule form. It can, however, be made into a liquid. Also, in the case of "orphan" drugs, if the compounded form will be a strength or formulation that will likely not ever be produced for that drug, then the compounder is OK to make it. It is interesting to note that while there is a paucity of federal regulation over pharmaceutical compounding, the FDA has taken a position that it "frown on" compounding. In personal conversations with several compounding pharmacists, this appears almost to be a "non-position" position statement.

The potential for errors in compounding medications is multi-fold (remember the polo ponies who died in 2009 due to inappropriately compounded amino acids). There may be ingredient errors, mathematical errors (remember the polo ponies!), preparation errors, storage errors, and altered release.

In reality, if you are a registered pharmacist, you can compound medications. There is not OBLIGATION for special training. That said, there IS training available in the art and science of compounding. This includes instruction on compounding techniques, theory (e.g. emulsions, etc.), the use of bacteriostatics, flavorings, and then wet-lab instruction to gain hands-on practice. PCCA (Professional Compounding Pharmacies of America) and NPCA (National Community Pharmacists Association) offer compounding training and certification. In addition, the Pharmacy Compounding Accreditation Board (www.pcab.org) offers a program of training which allows pharmacists who successfully complete the program to demonstrate their success. This certification/accreditation is recognized by the American Animal Hospital Association as a step in the right direction for those of us seeking a reputable, reliable compounding pharmacy.

It is useful to remember that it is ultimately the veterinarian's (not the pharmacist's) responsibility to ensure efficacy of a compounded product!

Finally, it is notable that there is a complete lack of scientific evidence that trans-dermal gels are the least bit effective as a delivery system for medications in cats and dogs. And, in fact, there are several studies that confirm the complete failure of transdermal gels to provide even a blood level, let alone a therapeutic blood level, of medication. When studied, the gels demonstrated marked variability in their concentrations and their absorption. Recently there has been an increase in the number of reports of topical reactions to the transdermal gel preparation. For the most part, Dr. Boothe's work (and the work of other scientists evaluating this aspect of pharmaceutical compounding) has proven a true indictment of the veterinary profession's attachment to "ease of administration"

So, what are we to do? Well, we can ask to see the certifications and training of the compounding pharmacist we are thinking of using. We can ask if they are accredited by the PCAB. Ask if they have a pharmacist training in compounding, or just a pharmacy technician who is trained. Ask in as much detail as possible for what you want from the pharmacy. Ask what policies for cleanliness, handling of compounded medications, certifications/qualifications they have in place.

One final note on compounding — a human pharmacy is prohibited from taking a veterinary drug and compounding it for us. For this reason, it may be most useful to work with a veterinary exclusive compounding pharmacy. Any organization worth working with will be completely transparent with information that communicates their excellence and commitment to quality.

Let's turn our attention now to the dilemma of getting medications into the patient. In other words, we need to answer the question, "How can we make medication time into a treat time?"

Several obvious strategies include:

Use a "sexy and delicious" carrier like Pill Pockets® or other products like them. For the most part, with the various flavors that are available, we can find SOMETHING the pet wants. Be sure to prescribe a specific MAXIMUM number of these treats to be dispensed each day. Because they are so palatable, most pets will try to get MORE than their fair share of them!

Have the owner wrap the pill into a small piece of cheese, liver-sausage, or similar product for delivery. Here again we must provide very specific guidance to the client about acceptable versus unacceptable delivery options. Be mindful of dietary intolerances, sodium content, etc.

One of the "old stand-bys" in veterinary medicine is to cover the pill with peanut butter or cream cheese. Once again, please be mindful of any dietary considerations for the patient.

Crushing a pill or opening a capsule and mixing it into a small amount of liquid or canned food that will be immediately consumed. Liquids to consider might include tuna water, milk, oil from canned fish, etc.

There are flavoring systems whereby the owner has a liquid flavor at home which may be mixed with the single dose of medication for immediate delivery. DO NOT mix multiple doses of medication into flavoring systems! This is essentially mimicking the compounding process, and we have NO DATA about stability, efficacy, or safety when we do such a thing or when we advocate that our clients so. Our obligation is to the patient, and to ensure that we do no harm!

We must be sure that the delivery method we recommend will not interfere with the health of the animal — in other words, don't recommend a milk carrier to a cat with lactose intolerance. Be mindful of sodium content in your medication vehicle as well...

In certain cases, we may have to be creative as we think through how to medicate our patients. For instance, if we have a patient who will not take oral medications, or is anorectic and we need to be able to deliver food as well as meds, an esophagostomy tube is a relatively non-invasive way to get the job done. Dogs and cats both tolerate e-tubes VERY well, and they can be in place for a VERY long time. Likewise, some medications can be delivered across mucous membranes — buprenorphine absorbs reasonably well across the cheek membrane in cats and makes delivery fairly straightforward. Liquid morphine is another easy delivery.

As time passes, there will be more data about alternative dosing routes available.

One of the medication challenges unique to the chronic pain patient who is elderly is the issue of drug intolerance. If we have a patient in chronic renal disease, then NSAIDs are a poor choice for that patient and we need to create a pain plan that avoids them. The good news is that drugs and physical medicine techniques are available to help these patients. We need to expand our thinking to embrace the new to complement the old.