Download Rediscovering Compounding Pharmacies

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.
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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.
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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.
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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
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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.
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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.
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