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PHARMACEUTICALS AND PODIATRY Rediscovering Compounding Pharmacies Used correctly, these facilities can be a useful adjunct to your practice. BY ALEC O. HOCHSTEIN, DPM What Is Compounding? Compounding refers to customized preparation of a medication to fit the needs of one individual. The prescriber provides exact specifications, and the pharmacist compounds the medication for direct delivery to only that one patient or prescriber. Patients sometimes need drugs that are discontinued or in short supply, or an individual may be unable to tolerate the commercially available preparation. Compounded prescriptions can omit certain nonessential materials such as dye or gluten, in order to meet the medical needs or preferences of the patient. Pharmacists can precisely target dosages, flavoring, and form according to individual circumstances. If a patient cannot swallow capsules, for example, the prescription may be reformulated for a variety of delivery methods: lozenges and lollipops, lip balms, tinctures, suppositories and inserts, injections, creams and ointments, gels, transdermal patches, and more. General Benefits of Compounding When the form of a drug is changed, its effects on the patient can be manipulated. The human skin, our largest organ, readily absorbs substances (whether beneficial or toxic) that are applied to it. However, once absorbed, medications in topical form will affect only the local area, with minimal entry into the circulatory system. Patients are relieved from the chore of swallowing pills, and (because there is less systemic absorption) there is generally no concern regarding drug interactions. www.podiatrym.com As long as the patient isn’t allergic to the components of the topical preparation, side-effects are not likely. Furthermore, topical analgesics provide superior pain management because there is no possibility of patients becoming addicted to them. Specific Compounded Podiatry Treatments Using a compounding pharmacy to introduce medications in topical form opens up excellent new treatment options for podiatric patients. At the same time, the podiatrist is treatments. Below is an overview of some of the most common: Plantar Fasciitis This pathology includes a range of components, each of which calls for separate pharmaceutical treatment: inflammation, scarring, fibromatosis, compression or irritation of the nerves and tarsal tunnel, bursitis, and osseous inflammation. Plantar fasciitis can be addressed effectively with a compound that combines an NSAID such as ketoprofen or flurbiprofen with a topical anesthetic, and The individualized nature of compounding allows several medications to be combined in one single customized topical treatment. freed from safety concerns about adding new systemic drugs into the regimen of patients with multiple health problems. Patients are also more likely to be compliant with topical treatments, since they’re not being sent home with another bottle of pills, and they don’t have to face unpleasant injections. Also, the individualized nature of compounding allows several medications to be combined in one single customized topical treatment. Patients are spared the necessity of buying and keeping track of several different preparations, and their satisfaction with the entire experience is increased. Many podiatric conditions will benefit from topical compounded even a calcium channel blocker like verapamil. This topical medication is usually included as part of a larger care regimen. Diabetic Neuropathy Antidepressants and anti-seizure medications can be safely combined with opioid analgesics, alleviating neuropathy symptoms without the risk of adverse reactions. Even in patients who present with extensive systemic medical conditions, podiatrists can safely prescribe NSAIDs and other drug therapies in topical form, when drug interaction risks would preclude those same medications in oral form. Continued on page 116 JANUARY 2015 | PODIATRY MANAGEMENT 115 PHARMACEUTICALS AND PODIATRY Rediscovering (from page 115) Pain Management With the increasing number of cautionary rules about prescribing pain medications, topical preparations enable adequate pain management without the limits placed by worries about addictiveness or patient drug-seeking behaviors. Topical compounding allows high doses of analgesics directly to the affected area. Medication can be delivered locally at far higher levels than would be possible if taken orally. Research demonstrates that serum levels of topical medications remain at less than 5 percent of what they would be if the same quantity were delivered orally. 116 Wound Care Depending on the nature of the wound, many pharmaceutical approaches are available. A debriding agent such as collegenase can be mixed with nifedipine or pentoxifylline to increase vascular perfusion. An antiseptic or antibiotic can then be added, along with phenytoin to stimulate the growth of new cells. Phenytoin is a broadly effective drug used both systemically and topically to facilitate wound healing. It stimulates the production of fibroblasts and the deposit of collagen. It also has an antibacterial action, and it is widely used for pressure sores, burns, traumatic wounds and skin ulcers from all causes. Research shows that when phenytoin is added to a conventional antibiotic ointment, healing times were speeded up by over 60 percent. Furthermore, there was no detectable phenytoin in the blood serum when it was applied as a topical treatment, and no study reported any adverse effects. Hyperhidrosis This condition can be effectively addressed with topical compounds or with individualized preparations for iontophoresis and phonophoresis. These procedures use electronic or ultrasound transport methods to deliver drugs to targeted tissues below the skin, to treat pain and pathology directly. They still eliminate the risk of systemic drug reactions and they have been proven effective for alleviating plantar fasciitis and generalized heel pain. Fingernail Lichen Planus These are notoriously difficult to treat, but topical application of tazarotene gel and clobetasol gel have been found to produce good results with no side-effects. Also, researchers advocate “synergistic” compounds involving various drugs together with penetrant enhancers as an effective alternative to surgery. Onychomycosis Topical antifungals can be combined with penetrants and other was created by a coalition of eight nationwide professional and regulatory organizations. The purpose of this board is to develop and maintain the highest compounding standards among its participating members. Practitioners seeking a compounding pharmacy should make sure they choose one with PCAB certification, if possible. Other accreditation networks include the International Academy of Compounding Pharmacists (IACP) and PCCA. The process of earning ac- Practitioners seeking a compounding pharmacy should make sure they choose one with PCAB certification. medications to address various types of fungus. You may prescribe a blend of urea ointment, desiccating solutions, keratolytics, and vital dyes together with penetrants. The antifungal Butenafine and tea tree oil in a cream together have been demonstrated to be effective. Other problems that are well-addressed by compounded topical treatments include: • Achilles tendinopathy • tendonitis, including posterior tibial tendon disorder • interdigital neuroma • osteoarthritis • bursitis • plantar plate rupture • molluscum contagiosum • dorsal nerve entrapment syndromes • venous and arterial ulceration management What to Look for in a Compounding Pharmacy • Accreditation: It is important to examine the credentials of compounding pharmacies, since the market has recently been flooded with companies trying to capitalize on the high reimbursement levels from insurance companies. While the FDA maintains oversight over the integrity of the active components themselves, compounding pharmacies fall under the regulations of state pharmacy boards. In 2007, the Pharmacy Compounding Accreditation Board (PCAB) JANUARY 2015 | PODIATRY MANAGEMENT creditation with one of these companies involves extensive evaluation of equipment and procedures, and is not simply a matter of office personnel filling out paperwork. • Medicare acceptance: Many podiatric patients are covered by Medicare instead of (or in addition to) commercial payers. • Clinical pharmacist on the premises at all times: This is a baseline requirement for integrity and reliability, and is usually required by state law. Avoid any companies which allow staffing only by pharmacy technicians and assistants. • High-level customer service: Develop a relationship with your local pharmacies, and evaluate the quality of their customer service. What is their turn-around time? How well do they communicate with patients and doctors? Your patients rely on your referrals, and the quality of the pharmacy you send them to will affect their attitude about your professional expertise. A Brief History of Compounding Throughout history, healers and specialists have expanded the use of active elements in plants, minerals, animal products, fungus, and molds. Ancient civilizations compounded chemically powerful substances for grooming, wound care, treating the ill, and ritual burial preparations. In recent centuries, apothecaries continued the tradition of compounding Continued on page 117 www.podiatrym.com PHARMACEUTICALS AND PODIATRY Rediscovering (from page 116) medications to meet specific needs. As recently as the 1930s and 1940s, more than half of all medicines in the United States were compounded by the pharmacist. This tradition began to change significantly in the ‘50s and ‘60s, as more manufactured pharmaceuticals entered the marketplace. Increasingly, prescriptions were written for brand-name products, with pharmacists only repackaging them for individual use. New Frontiers Are Opening Up Recently, a new wave of awareness is bringing compounding pharmacies back into partnership with physicians across all the branches of medicine. Innovations in genetic testing have created simple saliva-swab DNA profiling to identify how rapidly a patient will metabolize a medication. The results of this testing allow for entirely new layers of prescription customization. www.podiatrym.com Approaching podiatric therapy in terms of process rather than product will result in greater integrity of care. As practitioners, it is far too easy for us to reach for a commercial product that partially meets a patient’s needs, rather than to write a specifically customized prescription. The resurgence of compounding pharmacies offers podiatrists a gateway for re-entry into the high levels of professional healing that we have all been trained to deliver. PM Resources http://www.pharmacist.com/frequently-asked-questions-about-pharmaceutical-compounding http://www.podiatrytoday.com/ blogged/how-topical-compounding-hasworked-my-patients http://www.compoundingcenter.com/ patients/podiatry/ http://www.compoundingcenter.com/ patients/podiatry/#9 http://www.ncbi.nlm.nih.gov/pubmed/10349289?dopt=Abstract http://www.ncbi.nlm.nih.gov/pub- med/9167809?dopt=Abstract http://www.ncbi.nlm.nih.gov/pubmed/10357864?dopt=Abstract http://www.lakerx.com/compounding. html http://phion.com.au/blog/index. php/2013/12/17/nutrient-absorptionthrough-the-skin-to-the-bloodstream/ http://www.pcab.org/prescribers http://www.iacprx.org/? http://www.pccarx.com/prescribers/ what-is-pcca-prescribers http://www.doh.wa.gov/Portals/1/ Documents/Pubs/690283.pdf http://www.keycompounding.com/ how-your-dna-affects-the-medicationsyou-take/ Dr. Hochstein is Medical Director of Wound Management Technologies. JANUARY 2015 | PODIATRY MANAGEMENT 117