Major strides for cutaneous T-cell lymphoma

Transcription

AAD 2016 HIGHLIGHTS: Drug pricing, vitamin D, nutraceuticals, more pg.18
RURAL DERMATOLOGY Physician shares challenges and charms pg.72
Dermatology Times®
Clinical Analysis for Today’s Skincare Specialists
April 2016 | VOL. 37, NO. 4 |
April 2016
Major strides for cutaneous T-cell lymphoma
Volume 37 No. 4
Advances pave way for improved diagnosis, new therapies
Lisette Hilton | Senior Staff Correspondent
Clinical Analysis for Today’s Skincare Specialists
RESEARCHERS ARE making
important strides in better understanding the genetics of
CTCL
cutaneous T-cell lymmanifesting as
phoma (CTCL). This new
erythroderma
knowledge could have
with leukemic
major implications for
blood
improved diagnosis and,
involvement.
potentially, new targeted
Photo: Michael Girardi, M.D.,
Yale School of Medicine
CTCL therapies.
One such study by
Yale researchers describes 17 genes
in CTCL pathogenesis, including
genes involved in cell activation
and cell death.1
“We performed a systematic
analysis on the genetic basis
of CTCL using next generation
sequencing. We identified disease
promoting mutations in numerous putative oncogenes and tumor
suppressors that affect DNA damage repair, chromatin modification, and T-cell signaling,” says
the study’s lead author Jaehyuk
Choi, M.D., Ph.D., assistant professor of dermatology, biochemistry and molecular genetics at
Northwestern University Feinberg
School of Medicine, Chicago
DermatologyTimes.com
LATEST FDA APPROVALS
(formerly at Yale). “Specifically,
we identified novel oncogenic
mutations in CD28, a critical
T-cell costimulatory molecule. We
believe this genetic information
can be a useful tool for the diagnosis of this disease. Furthermore,
we believe these studies will catalyze the eventual development
CTCL see page 54
In This Issue
CLINICAL 37
Hidradenitis suppurativa
Often misdiagnosed and misunderstood, surprisingly clear Dx
COSMETIC 42
Fat melting
Lipo is only the beginning...learn
combo methods for optimal results
ONCOLOGY 53
Melanoma surgery
is not obsolete
Surgery is one component in rapidly
evolving world of management
BUSINESS 62
Your personality type
How it affects your practice
New options for rosacea and plaque psoriasis
Lisette Hilton | Senior Staff Correspondent
Promius Pharma announced FDA news for
two of the company’s dermatology drugs. The
FDA approved the prescription topical steroid
betamethasone dipropionate 0.05% (Sernivo
Spray) for the treatment of mild to moderate
plaque psoriasis in patients 18 years and older.
And, on Jan. 27, 2016, the FDA granted temporary
approval for doxycycline 40mg capsules (Zenavod) for the treatment of only inflammatory
papules and pustules in adult rosacea patients.
Susan Katz, M.D., says she sees a limited
According to the FDA: “The tentative apuse for the newly approved psoriasis
proval letter delays final approval of the
drug. Appropriate use is on skin
generic drug product until all patent or
READ
that is tougher (in other words, THE FULL
exclusivity issues have been resolved.
STORY:
avoiding face and intertriginous
A product that has tentative approval
bit.ly/DTLatest
FDAApprovals
areas), limited body surface area
cannot be marketed or sold in the
and for a limited time. With this
United States.” DT
type of use, potent topical steroids
Dr. Katz reports no relevant conflicts.
can bestow moderate improvement on
limited psoriasis, she says.
8
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is a private practitioner
is professor of pediatrics
of dermatologyust e,
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®
Oracea
(doxycycline, USP) 40 mg* Capsules
*30 mg Immediate Release & 10 mg Delayed Release beads
BRIEF SUMMARY
This summary contains important information about ORACEA (Or-RAY-sha). It is not
meant to take the place of your doctor’s instructions. Read this information carefully
before you start taking ORACEA. Ask your doctor or pharmacist if you do not understand
any of this information or if you want to know more about ORACEA. For full Prescribing
Information and Patient Information please see the package insert.
WHAT IS ORACEA?
ORACEA is a prescription medicine to treat only the pimples or bumps on the face caused
by a condition called rosacea. ORACEA is not an antibiotic dose of doxycycline and should
not be used for the treatment of infections. ORACEA did not lessen the facial redness caused
by rosacea. ORACEA has not been studied for the treatment of rosacea of the eyes or of
small blood vessels in the skin. It is not known if ORACEA is effective for use for longer
than 16 weeks and it is not known if ORACEA is safe for use longer than 9 months.
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ORACEA is for use in adults.
ORACEA should not be given to infants and children 8 years or younger because it may
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Also, do not take ORACEA if you are allergic to any medicine known as a tetracycline,
including doxycycline and minocycline. If you are not sure, talk to your doctor or pharmacist.
WHAT SHOULD I TELL MY DOCTOR BEFORE TAKING ORACEA?
Tell your doctor about all your health conditions, especially if you
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t TQFOEUJNFJOTVOMJHIUPSBSUJmDJBMTVOMJHIUTVDIBTBUBOOJOHCPPUIPSTVOMBNQ
Although sensitivity to sunlight has not been observed in controlled clinical studies of
ORACEA, tetracycline-class products can cause you to get severe sunburns.
Tell your doctor about all of the medicines you take, including prescription and
non-prescription medicines, vitamins, and herbal supplements.
ORACEA and other medicines can affect each other causing serious side effects.
Especially tell your doctor if you take
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TVDIBTXBSGBSJOPS$PVNBEJO®. Your doctor may need
to change your anticoagulant dose.
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PSQTPSJBTJT
t CJSUIDPOUSPMQJMMT5BMLUPZPVSEPDUPSBCPVUPUIFSNFUIPETPGCJSUIDPOUSPMCFDBVTFCJSUI
control pills may not work as well when you are taking ORACEA.
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aluminum.
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WHAT ARE THE MOST COMMON SIDE EFFECTS OF ORACEA?
Common side effects of ORACEA are soreness in the nose and throat, diarrhea, sinus
infection, high blood pressure, and increase in aspartate aminotransferase in the blood.
ORACEA may also cause
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the brain
ORACEA may cause serious side effects. Stop taking ORACEA and talk to your doctor right
away if you
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t I BWFBOBMMFSHJDSFBDUJPOXIJDINBZDBVTFBTLJOSBTITXFMMJOHEJGmDVMUZTXBMMPXJOH
or a feeling of tightness in your throat
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your body is attacking itself (autoimmune syndrome)
These are not all of the possible side effects of ORACEA. For more information, ask your
doctor or pharmacist.
You are encouraged to report negative side effects of prescription drugs to the FDA
at www.fda.gov/medwatch or call 1-800-FDA-1088. You may also contact GALDERMA
LABORATORIES, L.P. AT 1-866-735-4137.
HOW SHOULD I TAKE ORACEA?
t 5BLF03"$&"FYBDUMZBTQSFTDSJCFECZZPVSEPDUPS%POPUDIBOHFZPVSEPTFVOMFTT
told to do so by your doctor. Taking more than the prescribed dose may increase your
chance of having side effects.
t 5IFVTVBMEPTFPG03"$&"JTPOFDBQTVMFJOUIFNPSOJOHPOBOFNQUZTUPNBDI:PV
should take ORACEA at least one hour before or two hours after a meal.
t 5BLF03"$&"XJUIBGVMMHMBTTPGXBUFSXIJMFTJUUJOHPSTUBOEJOH5PQSFWFOUJSSJUBUJPOUP
your throat, do not lay down right after taking ORACEA.
t %P OPU UBLF 03"$&" XJUI PS SJHIU BGUFS UBLJOH BOUBDJET PS QSPEVDUT UIBU DPOUBJO
calcium, aluminum, magnesium, or iron. ORACEA may not work as well.
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regular time.
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WHERE SHOULD I GO FOR MORE INFORMATION ABOUT ORACEA?
t Talk to your doctor or pharmacist
t Go to www.oracea.com or call 1-866-735-4137
GALDERMA LABORATORIES, L.P., Fort Worth, Texas 76177 USA
Revised: February 2013
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WHAT SHOULD I AVOID WHILE TAKING ORACEA?
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booth or sunlamp. You could get a severe sunburn. Use sunscreen and wear clothes
that cover your skin if you have to be in sunlight.
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woman trying to have a baby.
Oracea and Galderma are registered trademarks.
©2016 Galderma Laboratories, L.P.
Galderma Laboratories, L.P.
14501 N. Freeway
Fort Worth, TX 76177
ORA-00032a
Printed in USA
01/16
References: 1. Data on file. Galderma Laboratories, L.P. 2. Del Rosso JQ,
Schlessinger J, Werschler P. Comparison of anti-inflammatory dose doxycycline
versus doxycycline 100 mg in the treatment of rosacea. J Drugs Dermatol.
2008;7(6):573-576. 3. Preshaw PM, Novak MJ, Mellonig J, et al. Modified-release
subantimicrobial dose doxycycline enhances scaling and root planing in subjects
with periodontal disease. J Periodontol. 2008;79(3):440-452.
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hcp.oracea.com
INTER
Resource Center s
CTIVE
For more information on specialized
areas of dermatology, related articles
and business resources, go to:
modernmedicine.com/ResourceCenters
bit.ly/plaquepsoriasis
Rosacea
resource center
Image appears with permission from VisualDx and Logical Images Inc.
Treatments
for plaque psoriasis
TEST YOURSELF AT
bit.ly/Aprilquiz
WHAT’S YOUR DIAGNOSIS?
A 52-YEAR-OLD WOMAN who spent much of her spare time gardening went to
bit.ly/roscearesourcenter
Therapeutic considerations
for psoriasis
the doctor after noticing a mottled blanching patch on the sides and front of
her neck and superior chest. She had noticed the rash months earlier, but it
had slowly gotten worse and she wanted to know if there was a treatment.
CHOOSE ONE:
Contact dermatitis
Poikiloderma of civatte
Photosensitive reaction
Dermatomyositis
Designing the optimum office space
bit.ly/considerationsforpsoriasis
Current and emerging
treatments for acne
bit.ly/designingtheoptimumofficespace
Following a decade
of medical school,
residencies, and fellowships,
dermatologists are primed
to deliver the best in patient
care. Often, though, the
spaces in which they provide
that care don’t measure up.
Inefficient offices can not
only impede efficiency, but
can actually be detrimental
to patient and practitioner
comfort, convenience,
and even safety. It seems
sensible, then, to invest time
and attention in creating and
maintaining a space that
works for a practice, not
against it.
BIZZARE ICD-10 CODES FOR DERMS
The 68,000 codes in the new ICD-10 system include
some real oddities. Plenty of weirdly specific codes are
getting attention in the medical press, like struck by
duck, struck by macaw, and struck by turtle.
Many skin-related ICD-10 codes will seem routine,
although there’s quite a bit of specificity compared
to the old ICD-9 codes. Here’s some advice.
bit.ly/emergingtx
bit.ly/BizzareICD10codesforderms
Getty Images/ BsWei
11
14
EDITORIAL ADVISORY
®
BOARD
Insight & Opinion From Our Advisory Board Leaders
Ronald G. Wheeland, M.D.,
in Tucson, Arizona
What is the future of dermatology?
omeone once said that if we don’t know the past, we are destined
to repeat it. As I have reached a certain age, I find that I’m more
interested in and aware of the past, so as to better try and accurately predict the future of dermatologic healthcare. Perhaps by
doing so dermatologists can be better prepared for the many unknowns that
the future is sure to bring. I have the luxury of not likely being around in 25
or 30 years to live up to any errors or mistakes I may make in this editorial,
which allows me the opportunity to make some pretty ridiculous predictions. I leave it to the readers to look back from the future to critique these
thoughts and determine how smart or wrong I’ve been. To try and cover this
topic methodically, I would like to begin with how I believe dermatology will
be practiced several decades from now.
S
THE PRACTITIONER OF THE FUTURE
With the multitude of major scientific
advances that have already occurred
in the diagnostic and therapeutic
areas in dermatology, my first (easy)
prediction is:
An enormous additional number
of scientific advances will continue to
occur in the future.
The sheer volume of this new knowledge in all areas of dermatology will add
to the complexity involved in the management of patients with skin diseases. While it is not impossible for a solo
practitioner to remain optimally well-informed as these advances occur and
still permit the delivery of the best possible care for all of his or her patients,
it will certainly become more difficult in
the future.
Because of this, I predict:
Solo dermatology practitioners will
cease to exist and subspecialty dermatologists will affiliate with one another to practice as a group.
Evidence that this trend has already
begun can be found from a recent
American Academy of Dermatology
practice survey, which shows a decline
over the past 10 years in the percentage of solo dermatologists practicing
in the United States. In 2007, 44% of
dermatologists were in solo practice,
but by 2014 that number had dropped
to 35%. Further, the percentage of
dermatologists in dermatology specialty group practices and multispecialty group practices averaged 50% to
60%. While there can be many explanations for this dramatic change, one
reason might be that providing the best
possible patient care requires a level
of knowledge most easily acquired by
subspecialists affiliating with one another rather than practicing alone. Further subspecialization in dermatology
will continue to deal with the scientific
advances that emerge in the future.
RESEARCH IN DERMATOLOGY
I believe the advances seen over the
past 10 years in biologic agents, monoclonal antibodies, cultured stem
cells, growth factors, laser and light
instruments, immunohistochemistry,
chemotherapy, wound healing, cosmetic surgery, and a host of others
will continue.
My biggest concern is whether there
still will be sufficient governmental and
private monetary support to permit the
unfettered pursuit of research under the
future healthcare delivery system, which
is likely to be single-payer in nature.
DERM SERVICE DEMAND
I believe the current high demand for
dermatologic services will continue
unabated in the future. While new university residency training programs in
dermatology may develop under some
new healthcare delivery system, current growth has been hampered by
federal budgetary shortfalls. To make up for what I believe will
be an overwhelming continued demand I believe more mid-level practitioners will be trained. These midlevel practitioners may practice alongside dermatologists or they may be
required to locate in underserved
rural or urban areas.
PRACTICE SETTING
The complexity of treating patients as
the new advances occur is not only
limited to diseases and treatments,
but added administrative requirements are likely to evolve as well.
Already, in today’s world it is often
more efficient and cost effective to divide responsibilities among a group of
non-physicians, like accountants, lawyers, human resource officers and other
trained individuals who can deal with
the current complex insurance company, licensing bodies and governmental regulations, including the Clinical
Laboratory Improvement Amendments
(CLIA), the Health Insurance Portability and Accountability Act (HIPPA), as
well as the use of the electronic medical
record (EMR).
As voice recognition programs continue to improve, I predict:
The future of the entire patient visit
will be electronically recorded and automatically added to the EMR.
Of course, given that the entire
healthcare delivery system is likely to
change as frequently as the political
tides, none of the current regulations
may even exist in the future. (I know, I
EDITORIAL see page 80
16
IRREGULAR
®
BORDER
Reena Rupani, M.D., F.A.A.D.
Center for Health and Healing
Mount Sinai Beth Israel
Oatmeal benefits certain skin disorders
A literature-based reference for guiding patients’ skincare regimens
H
ave you ever loved the taste of something so much that you wanted
to just….soak in it? That vintage
Barolo 1996, or perhaps a hand-churned
butter pecan ice cream, evoking memories
of tall grass and porch swings that never
were (née concrete-jungle child)?
If oatmeal’s warm internal hug has
ever inspired thoughts of pore-soaking
exhilaration, read on! Many of our patients with chronic inflammatory or pruritic skin disorders require guidance on
skincare regimens, and simple colloidal
oatmeal can be a soothing component.
Colloidal oatmeal (Avena sativa) is the
product of finely grinding the whole oat
grain (“groat”), until the majority of particles measure less than 75 micrometers.
Steel cut to rolled to instant to colloidal
— it’s a degree of processing from least
to most, respectively. Oats have long been used as medicinal aids in baths and applied compounds. Oats are approved by the German Commission E and are also covered
by the U.S. Food and Drug Administration Over-The-Counter skin protectant
monograph in the United States.1,2,3
WHAT MAKES IT SO SOOTHING?
Primary components include omega 3
and 6 fatty acids, polar lipids, and
beta-glucans, which combine with water
or emollients to form a gelatinous hydrocolloid, known as mucilage. Mucilage
generates a hydrating protective barrier and decreases transepidermal water
loss when applied to the skin.4 Other mucilage-containing herbs include heartsease (Viola tricolor), marshmallow (Althea
officinalis), fenugreek (Trigonella foenumgaecum), slippery elm (Ulmus fulva), and
flax (Linum usitatissimum). Oatmeal contains additional components that cleanse and protect irritated
skin, such as saponins for cleaning and
normalizing skin pH, antioxidants such
as vitamins A, B, and E, and polysaccha-
QUICK READ
Good for more than a morning
meal, oatmeal soothes angry skin,
relieves itching, and even has an
antimicrobial effect.
rides to maintain barrier integrity.5
In 2010, Rino and colleagues highlighted a nitrogen-containing phenolic
compound called avenanthramide, specific to oats, which directly inhibits nuclear factor kappa-beta (NF-kb).6 The
downstream effect is to decrease the
transcription of pro-inflammatory cytokines and exert additional anti-inflammatory benefits, such as reduced neutrophil chemotaxis and prostaglandin synthesis.7,8,9 Further molecular analysis has
also confirmed that avenanthramides inhibit IL-8 release in a dose-dependent
manner.10 Bottom line? It is very soothing.
AID FOR AD
Oatmeal is best known for use in
atopic dermatitis. Good skincare practices are part of the care process, helping to lessen itch and promote healing.
Running a warm bath, adding 10cc of
powdered colloidal oatmeal, and having
a 15-20 minute soak should be a twiceweekly component of the therapeutic regimen. Not only does this practice aid barrier repair, but it also eliminates the need
for additional soap (due to oatmeal’s natural saponins), thereby satisfying dermatologists’ typical advice to “soap less”
in atopic care. A recent study analyzed
four extracts of colloidal oats both at the
benchtop and the bedside, finding that
pro-inflammatory cytokines decreased in
vitro. Study subjects showed significant
clinical improvements in skin dryness,
scaling, roughness, and itch intensity.10
Lesser-known merits of oatmeal include antimicrobial properties, possibly due to inhibitory effects on eicosanoid formation, expression of cytosolic
phospholipase A2 (PLA2), and arachi-
donic acid mobilization in human keratinocytes.11
In one trial, patients with molluscum
contagiosum were successfully treated
with a combination zinc oxide and colloidal oatmeal cream.12
Could we then suggest oatmeal therapy for our patients with stubborn cold
sores? Not so fast. Oatmeal is a high arginine food, which is the amino acid
most used by herpes simplex viral particles for replication.
Another application might include
treatment for patients on multiple tyrosine
kinase inhibitors and epidermal growth
factor receptor inhibitors (such as cetuximab [Erbitux, Eli Lilly], erlotinib [Tarceva,
Genentech], panitumumab [Vecitbix,
Amgne], sorafenib [Nexavar, Bayer]) who
experience dose-limiting acneiform eruptions. A study by Alexandrescu, et al,
demonstrated partial-to-complete response in all assessable patients, thereby
suggesting an exciting potential resource
for mitigating a common and difficult
medication side effect, and increasing adherence to antineoplastic therapy.13
ADVERSE EFFECTS
Although allergic reactions to oatmealcontaining products are clinically rare,
one study demonstrated a higher-thanexpected sensitivity to oats in allergy
testing among atopic children, possibly
due to repeated applications on an impaired epidermal barrier.14
DIY SOOTHING
Oatmeal is commercially available in a variety of formulations: Cleansers, bath additives, emollients, sunscreens, and dry
shampoos. For your at-home DIY-ers:
Take a cup of steel-cut oats, run through a
very fine grinder six times (coffee or spice
will do), and then either add to the bath or
mix into your favorite emollient.DT
References online at bit.ly/DTOatmeal
18
AAD 2016
®
HIGHLIGHTS
AADA offers patient advocacy
assistance with drug costs
JOHN JESITUS | SENIOR STAFF CORRESPONDENT
Dermatologists can help ensure patients’ access to increasingly costly specialty drugs by getting involved at the
state, national and state-society levels,
according to experts who spoke at the
74th Annual Meeting of the American
Academy of Dermatology (AAD) in Washington D.C.
As insured patients’ copayments on
dermatology drugs have soared, says
Arianne Shadi Kourosh, M.D., many patients can no longer afford life-altering
treatments. This problem initially impacted biologic drugs primarily, she adds,
but during the past year, insurers have
QUICK READ
Getting involved with the AAD
Association and state medical
societies can help dermatologists
stay informed and advocate more
effectively for patients.
insurance providers have begun putting medicines into tiers based on the
medicine’s cost,” not its efficacy for a
given patient with a particular condition. “Insurance providers are interfering in the doctor-patient relationship
and creating a step-wise algorithm that
they think doctors should have to follow” before the insurers will cover specialty-tier drugs.
“I want to give the patient the drug that
they know works for them, and the
insurance company is demanding that
we go through this obstacle course of
drugs that they find acceptable.
In the meantime, patients are
suffering.”
Arianne Shadi Kourosh, M.D.
Harvard Medical School
increased copayments on many generic
drugs commonly used in dermatology —
most notably, antibiotics (such as doxycycline) and some topical steroids. She is
director of community health in the department of dermatology at Massachusetts General Hospital, and a faculty physician at Harvard Medical School.
As clinicians, “Our toolbox of medicines is suddenly narrowing immensely,
and we aren’t able to get our patients the
medications we’ve been able to get them
for years,” Dr. Kourosh says.
CALLING FOR REFORM
In response, the AAD Association (AADA)
is among several healthcare organizations supporting the Patients’ Access to
Care Act (PACA, H.R.1600), introduced
in March 2015 by cosponsors David
McKinley (R-WV) and Lois Capps (D-CA).
Dr. Kourosh clarifies the reason for
the bill: “This bill addresses the fact that
Of ten, pat ients who cha nge
insurance plans must re-tr y drugs
they’ve already failed, Dr. Kourosh says.
“I want to give the patient the drug that
they know works for them ... In the meantime, patients are suffering,” she explains
Additionally, Dr. Kourosh says, insurers
have proposed slashing the amount of coverage offered for higher-tier medications,
such as life-altering biologic drugs, by 25%
to 50%. With many biologics costing several thousand dollars per course, she says,
these cuts would put the drugs out of reach
for many who can get relief no other way.
“The PACA limits the insurance companies’ ability to decline coverage for
medicines in the way that they’ve been
doing, and calls from more accountability in coverage,” Dr. Kourosh adds.
Specifically, the PACA would amend the
Public Health Service Act by stating that
insurers using formularies or other tiered
cost-sharing structures shall not impose
cost-sharing requirements in a specialtydrug tier that exceed the amount of costsharing applicable to a non-preferred
branded drug tier.
ADVOCACY RESOURCES
To become better patient advocates, Dr.
Kourosh says, dermatologists can use resources including the AAD’s Drug Pricing
and Transparency Task Force (on which
she and session co-director Elise A. Olsen,
M.D., serve).
“Dermatologists can send questions and
tell us the experiences they’ve been having.
We’re gathering data to identify which drugs
are being the most affected,” she notes. The
task force also has formulated a position
statement that its members hope will guide
upcoming legislation.
“Another great resource is the AADA’s
Washington, D.C., office.” Here, she says,
AADA and legislative experts collaborate
with the AAD Drug Pricing and Transparency Task Force to provide current information that helps dermatologists understand the problem — and how they can
address it in Washington. Dr. Kourosh says,
“I encourage members to get involved with
the legislative process. That’s one of the
best ways to stay informed.”
Dr. Kourosh also encourages involvement with state medical societies. Many
medical issues, such as the tanning-bed
legislation the AADA has successfully
sponsored in many states, are legislated
at the state level, she notes.
Capitalizing on the AAD annual meeting’s Washington, D.C., location, Drs. Kourosh and Olsen invited representatives
from Congress (including Rep. McKinley)
and the Food and Drug Administration
to give AAD members a chance to voice
their concerns and obtain guidance from
lawmakers.
Dr. Kourosh says, “It’s about bringing
doctors and our government officials together to consult about these issues and
come up with solutions that people can
use in the short term, for daily patient care,
and long-term solutions we can work on
together from our different spheres to impact change on a macroscopic level.” DT
Disclosures: Dr. Kourosh reports no relevant
financial interests.
AAD 2016 HIGHLIGHTS
Research advances yield
new treatments for skin disease
JOHN JESITUS | SENIOR STAFF CORRESPONDENT
Genetic and pharmacogenomic research has resulted in targeted treatments for diseases affecting the skin,
ranging from Marfan syndrome to melanoma, according to Stephen I. Katz,
M.D., Ph.D., who spoke at the 74th Annual Meeting of the American Academy of Dermatology, in Washington
D.C., last month.
“In the area of pharmacogenomics,
we now know a lot about how one’s genetic makeup affects how we respond
to certain medications,” Dr. Katz says.
“The best example involves toxic epidermal necrolysis/Stevens-Johnson
syndrome (TEN/SJS): the Han Chinese
face a 1,000-fold to 10,000-fold greater
risk of developing TEN/SJS as a reaction
to certain medications if they have the
human leukocyte antigen allele HLAB*1502. “In some countries, regulators
have mandated that people must be
tested for this allele before taking certain drugs.” Dr. Katz is director of the
National Institutes of Health’s National
Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
Regarding rare diseases, he adds,
“It’s astounding — we never thought
we could biochemically influence some
diseases involving the skin structure.
Now we know what genes are involved
in Marfan syndrome, for example. A
mutation in the fibrillin-1 gene affects
the transforming growth factor beta
(TGF-β) pathway, making people much
more sensitive to the effects of TGF-β.
As a consequence, drugs that inhibit
TGF-β binding have been developed or
were already on the market. Angiotensin inhibitors have an effect on TGFβ and can prevent aortic dilatation,
which predisposes patients to aortic
coarctation.”
MICROBIAL INFLUENCE
Over the past decade, researchers also
have discovered how microbial flora in
the human microbiome impact health
and disease. “We’ve known for many
years that superinfection exacerbates
atopic dermatitis (AD). Investigators
QUICK READ
Genetic and pharmacogenomic
breakthroughs have led to improved
understanding of many diseases
that affect the skin.
are now studying how microbial flora
on the skin and in the gut may be affecting disease. Does the gut flora have
anything to do with AD expression? And
is there a way to replenish the normal
flora in AD?”
The microbiome also inf luences
hu m a n phy siolog y, deter m i n i ng
whether a person is fat or thin, Dr. Katz
says. It can also be manipulated to prevent or treat Clostridium difficile infections by performing fecal transplants
in patients with recalcitrant disease.
pharmaceutical companies to develop
highly specific drugs that are beneficial and, so far, relatively safe.” However, Dr. Katz says, one company had
to halt development of an antibody
that targeted the IL-17A pathway when
the company identified an association
with depression and suicide. This association is still being scrutinized, he
says.
“Five years ago,” he adds, “metastatic
melanoma was a death sentence. Nowadays, if we know the mutation in the
metastatic melanoma, there are currently three drugs on the market that
will interfere with certain transcriptional pathways such as the BRAF pathway and the MEK pathway. In addition,
we have checkpoint inhibitors, which
“Five years ago metastatic melanoma was
a death sentence. Nowadays, if we know
the mutation in the metastatic melanoma,
there are currently three drugs on
the market that will interfere with
certain transcriptional pathways.”
Stephen I. Katz, M.D.,Ph.D.
Director, NIAMS
Autoinflammatory diseases defined
by NIH experts in the past 15 years include familial Mediterranean fever
(FMF), neonatal-onset multi-system
inflammatory disease (NOMID), deficiency of the interleukin (IL)-1 receptor
antagonist (DIRA) and others.
“These diseases are characterized by
neutrophilic inflammatory infiltrates
in the skin. Not only have the genes
responsible for these diseases been
defined, but most have been shown to
involve the IL-1 pathway. We also have
treatments for many of these diseases.”
These treatments work by inhibiting
the IL-1β pathway, Dr. Katz says.
In psoriasis, elucidation of the IL-12
and -23 pathways has driven the development of several new biologic drugs.
“Understanding the inflammatory
and immunological pathways has led
are humanized monoclonal antibodies
used to enhance the immune response
to melanoma.”
Examples include anti-cytotoxic
T-lymphocyte associated protein 4
(CTLA4), which enhances the presentation of tumor-associated antigens to T
cells by dendritic cells. Similarly, antiprogrammed cell death protein 1 (PD1)
blocks the inhibition of T cells’ killing
of tumors, thereby enhancing the immune response, he says.
Thanks to combinations of drugs and
monoclonal antibodies, he says, “We in
medicine have been able to make outcomes for patients with melanoma a
little brighter. People are living significantly longer than the six to 10 months
that was previously typical after a diagnosis of metastatic melanoma.” DT
25
26
AAD 2016
®
HIGHLIGHTS
Off-label PDT protocols enhance
convenience, outcomes, applications
CHERYL GUTTMAN KRADER | STAFF CORRESPONDENT
Photodynamic therapy (PDT) with
20% aminolevulinic acid (ALA; Levulan
Kerastick, DUSA) and blue light (BLU-U,
DUSA) is a useful option for treating actinic keratoses (AK) of the face and scalp,
according to Maria M. Tsoukas, M.D., Ph.D.,
associate professor, department of dermatology, University of Illinois College of Medicine, Chicago. The
therapy provides high
clearance rates with
excellent cosmetic
outcomes when performedusingtheFDAapproved directions,
she told colleagues
PERCENT
during the 74th Annual Meeting of the
AK eradication
American Academy rate using a short
of Dermatology.
pre-treatment
Modified protocourse of
cols are being looked
topical 5-FU
at, however, and are
showing promise for
improving treatment convenience and reducing cost while maintaining or enhancing initial and longer-term outcomes, she
says.
The protocol for PDT that is approved
in the United States is a five-step process
that includes an ALA incubation period of
14 to 18 hours (although a shorter incubation time of two to three hours has showed
similar efficacy), and it often requires one
or two additional sessions performed at
intervals of three to four weeks to optimize the outcome, Dr. Tsoukas says.
95
PROTOCOL IN POINT
At the University of Illinois at Chicago, Dr.
Tsoukas and colleagues have implemented
a protocol that seems to reduce the need
for repeat sessions. It uses topical 5-fluorouracil (5-FU) as pretreatment, beginning
seven to 10 days prior to standard PDT.
“Results from several studies indicate that using the FDA-approved protocol, two or three serial PDT sessions are
needed to eradicate 70% to 95% of AKs,
and these serial PDT sessions have also
been shown to provide longer ‘lesionfree’ intervals than a single treatment,”
she says.
“Analyses of outcomes using our
QUICK READ
Modified PDT protocols prove
promising for AK treatment,
maintaining high clearance rates
while reducing cost, one expert says.
approach using a short pre-treatment
course of topical 5-FU indicate we are
achieving an AK eradication rate of up to
95% and better control of AK recurrences
with just a single PDT session.”
SIDE EFFECTS
Dr. Tsoukas adds that when the skin is
treated first with 5-FU, patients may develop a brisker local response with greater
discomfort likely during the light treatment
and increased redness and peeling after.
“Discomfort during the light treatment is
mostly dependent on the severity of actinic
damage and becomes manageable through
topical cooling with spray mist, handheld
mini fans, or iced towels. Care is needed to
avoid excessive cooling, however, because
that may decrease PDT efficacy,” she says,
adding that other protocols implement
local anesthetics or nerve blocks.
“Substituting the conventional light
irradiation with exposure to ambient
visible light, may provide a safe, effective, well-tolerated and cost-effective
method for medical and cosmetic dermatology PDT applications. By utilizing natural light, PDT may ultimately be used in
reversing photoaging,” Dr. Tsoukas says.
TIPS TO MINIMIZE RISK
“Of course to minimize risks, physicians
must carefully choose candidates who are
able to adhere exactly to protocols and
educate each patient thoroughly.”
Discussing other medical applications,
Dr. Tsoukas says PDT has been applied
extensively in Europe for the treatment of
superficial basal cell carcinomas (BCCs)
and nodular BCCs with good results.
“However, PDT is strictly contraindicated for micronodular invasive and morphea form BCCs as well as invasive squamous cell carcinomas (SCCs),” she adds.
“And hyperkeratotic and persistent lesions in patients at high risk for non-melanoma skin cancers must always be biopsied and examined histopathologically
“By utilizing natural light, PDT may
ultimately be used in reversing photoaging.”
Maria M. Tsoukas, M.D., Ph.D.
University of Illinois, Chicago
Other strategies that have been reported for enhancing the benefit of PDT
for treating AKs include:
\ Mild curettage of hyperkeratotic lesions
prior to treatment;
\ Occlusion during ALA incubation;
\ Application of heating, particularly
when treating AKs on the extremities;
\ Fract iona l laser resurfacing or
microneedling prior to PDT;
\ Application of longer and/or multiple
wavelengths during light exposure;
\ Fractionated PDT, and application of
other topical agents prior to PDT or for
a short course after, such as imiquimod, ingenol mebutate, diclofenac,
or retinoids.
In addition, daylight PDT is being
widely used in Europe and is beginning
to be adopted in the United States.
considering these individuals may rapidly develop poorly differentiated invasive SCCs.”
POTENTIAL IN ACNE VULGARIS TX
There is also good evidence showing that
PDT is a useful modality for treating inflammatory acne vulgaris. Dr. Tsoukas says
the protocol is similar in many ways to
the one used for AK treatment, albeit use
of a shorter incubation time and a longer
light wavelength for the illumination seem
to provide the best control of acne flares. “PDT can be used in conjunction with
long-term topical acne therapies, which
should be temporarily stopped during
PDT, and it may also be a suitable option
for patients with inflammatory acne who
cannot tolerate systemic therapies,” she
says. DT
AAD 2016 HIGHLIGHTS
Guidelines diverge around atopic
dermatitis management
Expert synthesizes dermatology, allergy specialty recommendations
Because many patients with atopic dermatitis (AD) may have already seen an
allergist, it is helpful for dermatologists to
understand there are some salient differences between AD management guidelines
issued by the American Academy of Dermatology (AAD) and those from the Joint Task
Force of the American College of Asthma,
Allergy and Immunology and the American Academy of Asthma, Allergy and Immunology (“JTF”).
Peter A. Lio, M.D., suggests that some
of the inconsistencies may be explained
by dissimilarity in focus of the two specialties — whereas allergists center more
on controlling allergic triggers as an underlying cause for AD, dermatologists are
more treatment-oriented and comfortable
using systemic medications when needed.
The difference, however, should not
be seen as a dividing point between dermatology and allergy, but rather as an opportunity for partnership to achieve the
common goal of delivering optimal patient care, says Dr. Lio, assistant professor of clinical dermatology and pediatrics,
Northwestern University Feinberg School
of Medicine, Chicago, Ill.
“For the dermatologist, collaboration
with an allergist can be especially valuable
in situations where allergy is suspected to
underlie AD, while allergists often turn
to dermatologists to help with patients in
need of aggressive therapy for controlling
more severe disease,” he says.
AREAS OF AGREEMENT
As a panel member on the JTF AD workgroup and co-author of the JTF guidelines,
Dr. Lio shares his insider’s perspective. He
notes that the AAD and JTF guidelines
agree on certain fundamental tenets for
AD management. According to both, topical corticosteroids, topical calcineurin inhibitors, and moisturizers are mainstays of
treatment; there is insufficient evidence to
recommend specialty moisturizers or prescription barrier creams; when AD is controlled, maintenance (proactive) therapy
is useful for preventing a flare; topical antihistamines have no role; and wet wraps
are helpful for managing a flare.
QUICK READ
AD management guidelines
among dermatology and allergy
specialties differ in important areas
but should be seen as opportunity
for the two specialties to partner
to achieve optimal patient care.
AREAS OF DISAGREEMENT
“However, there are a number of differences,
which is particularly interesting when considered from the perspective that both sets
of guidelines were developed based on review of the same evidence,” Dr. Lio says.
A role for vitamin D supplementation is
one topic on which the guidelines diverge.
Whereas the AAD guidelines say there is
not sufficient evidence to recommend its
ports laundering techniques that might
limit patient exposure to chemicals used
in clothing manufacturing and residuals
from laundry detergents.
A role of potential dietary triggers is another point on which the two guidelines
disagree. The AAD guideline supports a
diagnostic elimination diet only if there
seems to be a consistent correlation between symptoms and food intake. The
allergists are more amenable to this approach, stating evaluation of allergies to
milk, eggs, peanut, wheat, and soy could
be considered in children <5 years old with
persistent moderate-to-severe AD in spite
of optimized management and/or if the
child has a reliable history of an immediate reaction after ingesting a specific food.
“For the dermatologist, collaboration
with an allergist can be especially
valuable in situations where
allergy is suspected to underlie
atopic dermatitis.”
Peter Lio, M.D.
Chicago, Ill.
use, the JTF guideline states that patients
with AD may benefit from vitamin D supplementation.
Dr. Lio notes that his personal view is
consistent with the JTF guideline.
“The available evidence in this area
goes both ways, but one has to wonder if
the conflicting results can be explained by
differences in their enrolled populations
and if there may be a subgroup of patients
who are likely to benefit from vitamin D
supplementation and we don’t know yet
who they are,” he says.
“Vitamin D supplementation may be
worth a try considering it may do some
good, is inexpensive, and is unlikely to
cause harm,” he says.
The two sets of guidelines also differ in
their interpretations of evidence on controlling AD by choosing certain clothing
fabrics and laundering practices. The AAD
guidelines find evidence in these areas is
unclear whereas the JTF guideline sup-
A REFLECTION OF SPECIALTIES
Differences in treatment recommendations also reflect the unique expertise of
the two specialties. The AAD guideline say
injection immunotherapy cannot be routinely recommended whereas according
to the JTF, this modality can be considered in selected patients with aeroallergen sensitivity.
In the allergy guidelines a systemic
antihistamine is identified as potentially
beneficial for relieving itch associated with
AD in some patients, whereas the AAD
guideline concludes there is insufficient
evidence to recommend such use.
“The available evidence is pretty convincing that an antihistamine is not helpful for relieving itch in AD, and that is supported by my anecdotal experience discontinuing anthistamines in patients that
were using them on their own or based on
their allergist’s recommendation,” Dr. Lio
says. DT
29
2015 Leaders Society Members
L E A D E R S H I P
G I V I N G
F O R
A L L
O F
D E R M A T O L O G Y
The DF Board of Trustees greatly appreciates the vision, leadership and generosity
of the individuals listed here. Each member honored on these pages has made a strong commitment
to the advancement of dermatology that will benefit the field for many years to come.
A N N U A L
ALABAMA
Matthew K. Abele, M.D.
Melanie L. Appell, M.D.
Evans C. Bailey, M.D., Ph.D.
Elise P. Barnett, M.D.
Eric W. Baum, M.D.
Thomas W. Bender, III, M.D.
Retna A. Billano, M.D.
Janet J. Cash, M.D.
Robert A. Clark, M.D.
Jean-Pierre D. Donahue, M.D.
Craig A. Elmets, M.D.
Sharon F. Gardepe, M.D.
Robert D. Griffith, M.D.
Corey Hartman, M.D.
A. Michele Hill, M.D.
Dena J. Howell, M.D.
James M. Krell, M.D.
Gary D. Monheit, M.D.
John C. Romer, M.D.
Tonia Ruddock, M.D.
Sarah B. Sawyer, M.D.
Jenny O. Sobera, M.D.
Mark W. Teague, M.D.
Scott Van Loock, M.D.
Jeffery Weeks, M.D.
ALASKA
Robert F. Moreland, Jr., M.D.
ARIZONA
Lindsay Ackerman, M.D.
Senait Dyson, M.D.
Lora J. Plattner, M.D.
Henry H. Roenigk, Jr., M.D.
ARKANSAS
Cheryl Hull, M.D.
Stephen H. Mason, M.D.
CALIFORNIA
Fuad Abuabara, M.D.
Kenneth S. Alpern, M.D.
Susan Amaturo, M.D.
Sarah T. Arron, M.D., Ph.D.
Brooks A. Bahr, M.D.
Robert E. Beer, M.D.
Neal D. Bhatia, M.D.
Michael E. Borok, M.D.
Nina Botto, M.D.
Adrianna Browne, M.D.
Ivor Caro, M.D.
Howard Y. Chang, M.D., Ph.D.
Jeffrey B. Cheng, M.D., Ph.D.
Lisa K. Chipps, M.D.
Raymond J. Cho, M.D., Ph.D.
Holly L.F. Christman, M.D.
David H. Chu, M.D., Ph.D.
F. Landon Clark, M.D.
Michael W. Condie, M.D.
M. Kari Connolly, M.D.
Kelly M. Cordoro, M.D.
S U P P O R T
Jeffrey J. Crowley, M.D.
Lawrence F. Eichenfield, M.D.
Sabrina G. Fabi, M.D.
Rebecca L. Fitzgerald, M.D.
Lindy Fox, M.D.
Eric S. Fromer, M.D.
Edward Glassberg, M.D.
Linda M. Globerman, M.D.
Richard G. Glogau, M.D.
Peter M. Goldman, M.D.
Joseph H. Greenberg, M.D.
Robert G. Greenberg, M.D.
Anna D. Guanche, M.D.
Anna K. Haemel, M.D.
Robert Hartman, M.D.
R. Jeffrey Herten, M.D.
Lori M. Hobbs, M.D.
Renee M. Howard, M.D.
Tony Hsu, M.D.
Mohammed Kashani-Sabet, M.D.
Andrew J. Kaufman, M.D.
Amelia H. Kaymen, M.D.
Paul A. Klekotka, M.D., Ph.D.
Rachel I. Kornik, M.D.
Pui-Yan Kwok, M.D., Ph.D.
Nikolajs A. Lapins, M.D.
Delphine J. Lee, M.D., Ph.D.
Wennie C. Liao, M.D.
Janet Maldonado, M.D.
Erin F.D. Mathes, M.D.
Anubhav N. Mathur, M.D., Ph.D.
Theodora M. Mauro, M.D.
Andrew B. Menkes, M.D.
Robert L. Modlin, M.D.
Jenny Murase, M.D.
Haley B. Naik, M.D.
Isaac Neuhaus, M.D.
Binh Ngo, M.D.
F. Richard Noodleman, M.D.
Jeffrey North, M.D.
Susana M. Ortiz-Urda, M.D., Ph.D.
Daniel J. Piacquadio, M.D.
Jerome R. Potozkin, M.D.
Ronald E. Reece, M.D.
Vail C. Reese, M.D.
Jack S. Resneck, Jr., M.D.
Roberto R. Ricardo-Gonzalez, M.D., Ph.D.
Michael D. Rosenblum, M.D., Ph.D.
Beth S. Ruben, M.D.
Tiffany C. Scharschmidt, M.D.
Alan A. Semion, M.D.
Seth R. Stevens, M.D.
Gregory Van Dyke, M.D., Ph.D.
Jane S. Wada, M.D.
John W. Weiss, M.D.
Jashin Wu, M.D.
Paul S. Yamauchi, M.D., Ph.D.
An Yen, M.D.
Siegrid Yu, M.D.
COLORADO
April W. Armstrong, M.D., M.P.H.
Sylvia L. Brice, M.D.
Mariah C. Brown, M.D.
Anna L. Bruckner, M.D.
Robert P. Dellavalle, M.D., Ph.D.
Cory A. Dunnick, M.D.
John C. Fueston, M.D.
Loren E. Golitz, M.D.
James C. Huff, M.D.
Peggy B. Liao, M.D.
Theresa R. Pacheco, M.D.
Gregory G. Papadeas, D.O.
Kathleen Y. Sawada, M.D.
Brent C. Sigler, M.D.
Adrienne E. Stewart, M.D.
CONNECTICUT
Donna A.B. Aiudi, M.D.
Richard J. Antaya, M.D.
Sharon H. Barrett, M.D.
Laura G. Benedetto, D.O.
Christopher G. Bunick, M.D., Ph.D.
Sean R. Christensen, M.D., Ph.D.
Oscar R. Colegio, M.D., Ph.D.
Henry C. Gasiorowski, M.D.
Michele E. Gasiorowski, M.D.
Earl J. Glusac, M.D.
Peter W. Heald, M.D.
Christine J. Ko, M.D.
Lisa C. Kugelman, M.D.
Leon E. Luck, M.D.
Peggy S. Myung, M.D., Ph.D.
Sarika Ramachandran, M.D.
Ronald C. Savin, M.D.
Mary M. Tomayko, M.D., Ph.D.
Alicia D. Zalka, M.D.
Jonathan R. Zirn, M.D.
DELAWARE
Peter B. Panzer, M.D.
Scott M. Panzer, M.D.
DISTRICT OF COLUMBIA
Alison Ehrlich, M.D.
Susan T. Elliott, M.D.
Vincenzo Giannelli, M.D.
Rebat M. Halder, M.D.
O F
$ 1 , 5 0 0
Richard S. Greene, M.D.
Kathleen W. Judge, M.D.
Joely Kaufman, M.D.
Ronald C. Knipe, M.D.
Clifford W. Lober, M.D.
Stephen H. Mandy, M.D.⽧
Laertes A. Manuelidis, M.D.
John L. Meisenheimer, Jr., M.D.
Jeffrey G. Moskowitz, M.D.
Albert J. Nemeth, M.D.
Keyvan Nouri, M.D.
Marta I. Rendon, M.D.
Georgette Rodriguez-Vazquez, M.D.
Susan S. Roper, M.D.
Stanley V. Schwartz, M.D.
Steven D. Shapiro, M.D.
Anjali H. Singh, M.D.
Robert Snyder, M.D.
Cynthia R. Strohmeyer, M.D.
Scott D. Warren, M.D.
GEORGIA
Wayne L. Bakotic, D.O.
Garin D. Barth, M.D.
Linda M. Benedict, M.D.
Travis Blalock, M.D.
Elizabeth M. Burns, M.D.
Misty D. Caudell, M.D.
A. Damian Dhar, M.D.
Charles J. Douchy, M.D.
Virginia Rutledge Forney, M.D.
Leslie C. Gray, M.D.
Edmond I. Griffin, M.D.
Michelle L. Juneau, M.D.
John D. Kayal, M.D.
Jay A. Levin, M.D.
David J. Levine, M.D.
Damon V. Mauldin, M.D.
Brian P. Pollack, M.D., Ph.D.
Matthew J. Reschly, M.D.
Gabrielle M. Sabini, M.D.
Klaus Sellheyer, M.D.
Joel Stephen Shavin, M.D.
Carl V. Washington, Jr., M.D.
Jamie D. Weisman, M.D.
FLORIDA
HAWAII
David C. Adams, M.D.
Debra L. Bailey, M.D.
Keith Benbenisty, M.D.
Charles Camisa, M.D.
David Casper, M.D.
Attica C. Chang, M.D.
Arianne Chavez-Frazier, M.D.
Janet F. Cheng, M.D.
Armand B. Cognetta, Jr., M.D.
Scott E. Crater, M.D.
Peter Donelan, M.D.
Craig J. Eichler, M.D.
Neil A. Fenske, M.D.
Scott W. Fosko, M.D.
Theodore N. Fotopoulos, M.D.
Anthony F. Fransway, M.D.
Christopher A. Lum, M.D.
George M. Martin, M.D.
William K. Wong, M.D.
IDAHO
Brock A. Andersen, M.D.
Alisa Funke, M.D.
Ryan S. Owsley, M.D.
Earl R. Stoddard, M.D.
Gregory L. Wells, M.D.
ILLINOIS
Iris K. Aronson, M.D.
Bruce Bennin, M.D.
Kelle S. Berggren, M.D.
Michael Bukhalo, M.D.
I-Ja Chan, Ph.D.
Matthew P. Evans, M.D.
John H. Exner, M.D.
Lester J. Fahrner, M.D.
Michael Fretzin, M.D.
Scott D. Glazer, M.D.
Steven Goulder, M.D.
Kathleen J. Green, Ph.D.
Shelley J. Halper, M.D.
Mark D. Hoffman, M.D.
Meyer Horn, M.D.
Sharon L. Horton, M.D.
Carolyn I. Jacob, M.D.
Kastytis A.V. Jucas, M.D.
Jeffrey E. Karaban, M.D.
John T. Keane, M.D.
Judith P. Knox, M.D.
Patricia A. Ledwig, M.D.
Nancy C. Lichon, M.D.
Susan Liebovitz, M.D.
David A. Lorber, M.D.
Mary C. Massa, M.D.
Julie A. Moore, M.D.
Martin M. Okun, M.D., Ph.D.
Warren W. Piette, M.D.
Mark Romanelli, M.D.
Marjorie M. Rosenbaum, M.D.
Bethanee J. Schlosser, M.D., Ph.D.
Burton E. Silver, M.D.⽧
Amy F. Taub, M.D.
Carol K. Tharp, M.D.
Rebecca C. Tung, M.D.
Patricia P. Wyhinny, M.D.
Charles Zugerman, M.D.
Anonymous
INDIANA
Elliot J. Androphy, M.D.
Mitchell L. Bressack, M.D.
Gary P. Dillon, M.D.
Annette M. Dinneen, M.D.
Alexander A. Fondak, M.D.
Scott A. Fretzin, M.D.
A. David Gerstein, M.D.
Robert H. Huff, M.D.
Jane Dy Lim, M.D.
M. Kathleen McTigue, M.D.
Ginat W. Mirowski, D.M.D., M.D.
Jeffrey K. Moore, M.D.
Michael E. Murphy, M.D.
Keeter D. Sechrist, M.D.
Stephen J. Shideler, M.D.
Brian J. Williams, M.D.
IOWA
Timothy G. Abrahamson, M.D.
Richard T. Ameln, M.D.
Vincent L. Angeloni, M.D.
Thomas C. Boysen, M.D.
J. William Holtze, M.D.
David L. Knutson, II, M.D.
Jennifer A. Palmer, M.D.
Kristi J. Robson, M.D.
L E A D E R S H I P
A N N U A L
G I V I N G
S U P P O R T
Iowa (cont.)
Kimberly K. Schulz, M.D.
Marta J. Van Beek, M.D., M.P.H.
Susan D. Wall, M.D.
Hobart W. Walling, M.D.
Karolyn A. Wanat, M.D.
John H. Wollner, M.D.
F O R
O F
A L L
O F
$ 1 , 5 0 0
Angela R. Peterman, M.D.
Tara A. Rumbarger, M.D.
Eva F. Simmons-O’Brien, M.D.
Saif U. Syed, M.D.
Charles B. Toner, M.D.
Mark C. Udey, M.D., Ph.D.
Margaret A. Weiss, M.D.
KANSAS
MASSACHUSETTS
Martha Housholder, M.D.
David L. Kaplan, M.D.
Stephen R. Marshall, M.D.
Donald K. Tillman, Jr., D.O.
Kenneth A. Arndt, M.D.
Jeffrey D. Bernhard, M.D.
Mark A. Blumberg, M.D.
Kathryn E. Bowers, M.D.
Teresa M. DeGiacomo, M.D.
Eileen M. Deignan, M.D.
Erik Domingues, M.D.
Richard F. Eisen, M.D.
Daniel T. Finn, M.D.
David E. Fisher, M.D., Ph.D.
Samuel D. Goos, M.D.
Donald J. Grande, M.D.
Terry P. Hadley, M.D.
John E. Harris, M.D., Ph.D.
Christine M. Hayes, M.D.
Thomas D. Horn, M.D.
David A. Jones, M.D., Ph.D.
Kathleen M. Joyce, M.D.
Seth G. Kates, M.D.
Daniela Kroshinsky, M.D., M.P.H.
George Kroumpouzos, M.D., Ph.D.
Dennis Lee, M.D.
Ethan A. Lerner, M.D., Ph.D.
Mark A. Liska, M.D.
Merrill G. Liteplo, M.D.
Stephen R. Lyle, M.D., Ph.D.
Mary E. Maloney, M.D.
Claire P. Mansur, M.D.
Ronald S. Nadel, M.D.
Elizabeth H. Page, M.D.
Alexis Perkins, M.D.
Helen A. Raynham, M.D., Ph.D.
Thomas E. Rohrer, M.D.
Jeffrey M. Sobell, M.D.
Hensin Tsao, M.D., Ph.D.
Ruth Ann Vleugels, M.D., M.P.H.
Stephen G. Werth, M.D.
Karen Wiss, M.D.
KENTUCKY
Edwin M. Ahrens, M.D.
Tamella Buss Cassis, M.D.
Carol L. Kulp-Shorten, M.D.
Laurie G. Rendleman Massa, M.D.
Jeffrey B. Richardson, M.D.
George B. Sonnier, M.D.
James R. Wharton, M.D.
Janice W. Yusk, M.D.
Mark J. Zalla, M.D.
LOUISIANA
Robert W. Benson, M.D.
Anne Bishop Bryan, M.D.
Lori N. Byrd, M.D.
Julie G. Danna, M.D.
Mary L. Curry Dickerson, M.D.
Mary M. Dobson, M.D.
Kim Bui Drew, M.D.
Alexis R. Duke, M.D.
Brian P. Ford, M.D.
Josephine M. Futrell, M.D., Ph.D.
Michelle Smith Gerdes, M.D.
Kevin Guidry, M.D.
Laurie H. Harrington, M.D.
Mara A. Haseltine, M.D.
Sarah A. Haydel, M.D.
Steven C. Heard, M.D.
Sarah C. Jackson, M.D.
Stephen Klinger, M.D.
Robert A. Koppel, M.D.
Alan T. Lewis, M.D.
Dana A. Marshall, M.D.
Tom J. Meek, Jr., M.D.
Chad L. Prather, M.D.
Rachel Reina, M.D.
Frankie G. Rholdon, M.D.
Nicole E. Rogers, M.D.
Jason J. Romero, M.D.
Diane Loria Rose, M.D.
Amie Shannon, M.D.
Adrien A. Stewart, M.D.
Martha E. Stewart, M.D.
Laci Theunissen, M.D.
William A. Wesche, M.D.
MAINE
Peter H. Bouman, M.D.
Allen T. Bruce, M.D., Ph.D.
Orville Hartford, M.D.
MARYLAND
Lisa L. Anderson, M.D.
Krista K. Buckley, D.O.
Thomas J. Enelow, M.D.
Deborah A. Englert, M.D.
Juris Germanas, M.D., Ph.D.
Ronald Goldner, M.D.
Ali Hendi, M.D.
Teri A. Kahn, M.D., M.P.H.
Lisa C. Kates, M.D.
Stephen I. Katz, M.D., Ph.D.
Oanh Lauring, M.D.
Linda Lutz, M.D.
Barbara E. McAlpine, M.D.
Sean L. McCagh, M.D.
Monte S. Meltzer, M.D.
Diane Orlinsky, M.D.
(continued)
MICHIGAN
Ayad E. Abrou, M.D.
Thomas F. Anderson, M.D.
Peter J. Aronson, M.D.
Richard J. Ashack, M.D.
Barry I. Auster, M.D.
David A. Baird, M.D.
Walter Barkey, M.D.
Brent M. Boyce, M.D.
Julie A. Byrd, M.D.
Roger C. Byrd, D.O.
Amy B. Cardellio, D.O.
Karen L. Chapel, M.D.
Roxana L. Chapman, D.O.
Cynthia Tseng Chow, M.D.
Jenny Cotton, M.D., Ph.D.
Jack A. Dekkinga, M.D.
Michael A. Dorman, M.D.
Thomas F. Downham, II, M.D.
Lori Fedoronko, M.D.
Brian J. Gerondale, M.D.
Stuart R. Gildenberg, M.D.
Linda Stein Gold, M.D.
Iltefat H. Hamzavi, M.D.
Yolanda R. Helfrich, M.D.
Ann E. Hern, M.D.
Ronald D. Kerwin, M.D.
Kathrin Freitag Laing, M.D.
Judith T. Lipinski, M.D.
Lori Lowe, M.D.
Jeffrey L. Messenger, M.D.
Meena S. Moossavi, M.D.
Catherine A. Nordby, M.D.
Fred M. Novice, M.D.
John M. Pelachyk, M.D.
Michael J. Redmond, M.D.
Dana L. Sachs, M.D.
David C. Semler, M.D.
Steven Shumer, M.D.
Milton D. Soderberg, M.D.
Robert M. Soderstrom, M.D.
Marcy L. Street, M.D.
Kara Walton, M.D.
Yuelin Xu, M.D.
MINNESOTA
Robert C. Anderson, M.D.
Kathryn C. Barlow, M.D.
Bruce J. Bart, M.D.
Mitchell E. Bender, M.D.
Caleb Creswell, M.D.
Julie S. Cronk, M.D.
Heidi Foster, M.D.
Kathryn Gehrig, M.D.
Kristen P. Hook, M.D.
Lynda S. Kauls, M.D.
Nancy A. Leitch, M.D.
Sherri A. Long, M.D.
Paul B. Lundstrom, M.D.
Daniel D. Miller, M.D.
Erika J. Rabeni, M.D.
Hilary C. Reich, M.D.
Natalie S. Roholt, M.D.
Sarah Schram, M.D.
Cindy Firkins Smith, M.D.
Stephen R. Tan, M.D.
Megha M. Tollefson, M.D.
Whitney D. Tope, M.D.
Erin M. Warshaw, M.D.
MISSISSIPPI
Jeffrey C. Houin, Jr., M.D.
David B. Roy, D.O.
Misty T. Sharp, M.D.
Joseph P. Shrum, M.D.
Sam C. Tumminello, M.D.
Billy L. Walker, M.D.
William L. Waller, M.D.
Terry A. Westmoreland, M.D.
MISSOURI
Ramona Behshad, M.D.
Nicole Burkemper, M.D.
M. Laurin Council, M.D.
Karen E. Edison, M.D.
Erin S. Gardner, M.D.
Dee Anna Glaser, M.D.
Eva A. Hurst, M.D.
Charles Moon, M.D.
Lindall A. Perry, M.D.
Natalie Semchyshyn, M.D.
Viseslav Tonkovic-Capin, M.D.
Jaeyoung Yoon, M.D., Ph.D.
NEBRASKA
Susan H. Corey, M.D.
Mary T. Finnegan, M.D.
Jill S. Nelson, M.D.
Margaret Kontras Sutton, M.D.
NEVADA
Douglas Fife, M.D.
Gretchen E. Korver, M.D.
NEW HAMPSHIRE
James G. Dinulos, M.D.
E. William Frank, M.D.
Abel Jarell, M.D.
Andrea Pearson, M.D.
Faramarz H. Samie, M.D.
NEW JERSEY
Smita Agarwal, M.D.
Emily M. Altman, M.D.
Jerry Bagel, M.D.
Bruce J. Berger, M.D.
Meghan M.S. Caruso, D.O.
Adrian L. Connolly, M.D.
Booth H. Durham, M.D.
Herbert S. Feinberg, M.D.
Kenneth A. Grossman, M.D.
Daniel S. Kessel, M.D.
Sylvie D. Khorenian, M.D.
Carrie L. Kovarik, M.D.
Christopher B. Kruse, M.D.
Marc Meulener, M.D.
William B. O’Grady, M.D.
Daniel N. Sauder, M.D.
Diana E. Trusky, M.D.
Ingrid Warmuth, M.D.
NEW MEXICO
Sky Connolly, M.D.
NEW YORK
David J. Altman, M.D., Ph.D.
Snehal P. Amin, M.D.
Lisa A. Beck, M.D.
David S. Becker, M.D.
Michael Bobrow, M.D.
Gary J. Brauner, M.D.
Walter S. Brooks, M.D.
Laura Buccheri-Zappi, M.D.
J. Andrew Carlson, M.D.
Anne M. Chapas, M.D.
Chih-Shan Jason Chen, M.D., Ph.D.
Thomas C. Chin, M.D.
Paul Chu, M.D.
David H. Ciocon, M.D.
David E. Cohen, M.D., M.P.H.
Doris J. Day, M.D.
Liang Deng, M.D., Ph.D.
Tobechi Ebede, M.D.
Lydia M. Evans, M.D.
Michael Fisher, M.D.
David F. Frankel, M.D.
Linda K. Franks, M.D.
Peter C. Friedman, M.D.
Ellen C. Gendler, M.D.
Herbert P. Goodheart, M.D.
Marsha L. Gordon, M.D.
Emma Guttman-Yassky, M.D., Ph.D.
Elizabeth K. Hale, M.D.
Melville H.A. Hughes, M.D.
Francis W. Iacobellis, M.D.
Sherrif Ibrahim, M.D., Ph.D.
Yana Ignatovich, M.D.
Ali Jabbari, M.D., Ph.D.
Robert E. Kalb, M.D.
Sherri K. Kaplan, M.D.
Mark D. Kaufmann, M.D.
Alan R. Kling, M.D.
Jody W. Konstadt, M.D.
Michael A. Kurzman, M.D.
Jeffrey R. LaDuca, M.D., Ph.D.
Jo-Ann M. Latkowski, M.D.
Erica H. Lee, M.D.
Wei-Li S. Lee, Ph.D.
Pamela A. Leve, M.D.
Lawrence M. Lieblich, M.D.
Shari Lipner, M.D., Ph.D.
Cynthia A. Loomis, M.D., Ph.D.
Josephine McAllister, M.D.
Madhavi Menon, M.D.
Rhoda S. Narins, M.D.
Alice P. Pentland, M.D.
David Polsky, M.D., Ph.D.
Susan Haller Psaila, M.D.
Anthony M. Rossi, M.D.
Alan B. Schliftman, M.D.
Paul I. Schneiderman, M.D.
Robert A. Skrokov, M.D.
Nicholas A. Soter, M.D.
Jennifer A. Stein, M.D.
Ida M. Tiongco, M.D.
Eric S. Treiber, M.D.
Ruth K. Treiber, M.D.
Jeffrey M. Weinberg, M.D.
Michael B. Whitlow, M.D., Ph.D.
Cynthia B. Yalowitz, M.D.
Eugene G. Zappi, M.D.
Ross Zeltser, M.D.
Stuart M. Zweibel, M.D.
Anonymous
Anonymous
NORTH CAROLINA
John G. Albertini, M.D.
Claude S. Burton, III, M.D.
Donna A. Culton, M.D., Ph.D.
Luis A. Diaz, M.D.⽧
Russell P. Hall, III, M.D.
Suzanne P. Hess, M.D.
William D. Hoover, Jr., M.D.
Catherine M. Hren, M.D.
William W. Huang, M.D., M.P.H.
Aida M. Lugo-Somolinos, M.D.
Frederick A. Lupton, III, M.D.
Dean S. Morrell, M.D.
John C. Murray, M.D.
Adnan Nasir, M.D., Ph.D.
M. Joyce Rico, M.D.
Elizabeth Faircloth Rostan, M.D.
David S. Rubenstein, M.D., Ph.D.
Val Pierre Vallat, M.D.
Phillip M. Williford, M.D.
OHIO
John P. Anders, M.D.
Joshua Arbesman, M.D.
Jonathan Bass, M.D.
Jaye E. Benjamin, M.D.
Wilma F. Bergfeld, M.D.
Benjamin Bogucki, M.D.
Jeremy S. Bordeaux, M.D., M.P.H.
Michael L. Cairns, M.D.
Timothy Chang, M.D.
Maria Amer Charif, M.D.
Z. Charles Fixler, M.D.⽧
Valerie Fuller, D.O.
Meg R. Gerstenblith, M.D.
Hugh M. Gloster, Jr., M.D.
Jennifer W. Gould, M.D.
Scott C. Grevey, M.D.
Robert S. Haber, M.D.
Michelle A. Jahnke, M.D.
Christine Jaworsky, M.D.
William V. Krug, M.D.
Joyce A. Lender, M.D.
James F. Libecco, M.D.
Jenifer R. Lloyd, D.O.
Kurt Lu, M.D.
Anthony L. Mehle, M.D.
Beno Michel, M.D.
Brian C. Nash, M.D.
Susan T. Nedorost, M.D.
Lydia U. Parker, M.D.
Rafael A. Perez-Figaredo, M.D.
Jennifer L. Popovsky, M.D.
Arlene Rosenberg, M.D.
Donald R. Schermer, M.D.⽧
Guillermo R. Sicard, M.D.
Carol C. Slover, M.D.
Ursula Stanton-Hicks, M.D.
James S. Taylor, M.D.
OKLAHOMA
Mark D. Lehman, M.D.
OREGON
Michael J. Adler, M.D.
Scott A. B. Collins, M.D.
Eric Hester, M.D.
Kyle Horner, M.D.
J. David Igelman, M.D.
Paul A. Klas, M.D.
Maeran Chung Landers, M.D., Ph.D.
Sancy A. Leachman, M.D., Ph.D.
Debbie L. Miller, M.D.
Patricia L. Norris, M.D.
L E A D E R S H I P
A N N U A L
G I V I N G
S U P P O R T
Oregon (cont.)
Jay Y. Park, M.D.
Judith V. Redd, M.D.
Drew Reese, D.O.
Eric L. Simpson, M.D.
Bert G. Tavelli, M.D.
Curtis T. Thompson, M.D.
Dwight R. Tribelhorn, M.D.
PENNSYLVANIA
Brad Amos, M.D., Ph.D.
Mark A. Bechtel, M.D.
Ernest Benedetto, M.D.
Allison Britt Kimmins, M.D., M.P.H.
Brian C. Capell, M.D., Ph.D.
Christine Lynn Cassel, M.D.
Emily Y. Chu, M.D., Ph.D.
Christina L. Chung, M.D.
Carrie Ann R. Cusack, M.D.
Rosalie Elenitsas, M.D.
Tanya Ermolovich, D.O.
Richard G. Fried, M.D., Ph.D.
Joel M. Gelfand, M.D., M.S.C.E.
Lisa Goldberg, M.D.
Scott L. Gottlieb, M.D.
Charles H. Greenbaum, M.D.⽧
Thomas D. Griffin, M.D.
Richard J. Herschaft, M.D.
Jeffrey P. Hurley, M.D.
Young C. Kauh, M.D.
Matthew Keller, M.D.
Joslyn S. Kirby, M.D.
Caroline S. Koblenzer, M.D.
Stephanie A. Mackey, M.D.
Christopher J. Miller, M.D.
Suzan Obagi, M.D.
Steven K. Orman, M.D.
Herbert M. Parnes, M.D.
Aimee S. Payne, M.D., Ph.D.
Andrew K. Pollack, M.D.
Stephen M. Purcell, D.O.
Michael S. Rabkin, M.D.
Jennifer Ray Rajan, M.D.
Kimberly Anne Rau, M.D.
Paul J. Ruschak, M.D.
Joya Sahu, M.D.
John T. Seykora, M.D., Ph.D.
Stuart Daniel Shanler, M.D.
David L. Shupp, M.D.
Daniel Louis Shurman, M.D.
Joseph F. Sobanko, M.D.
Christine Stanko, M.D.
Robert M. Stiegel, M.D.
Junko Takeshita, M.D., Ph.D.
Justin Vujevich, M.D.
Marion M. Vujevich, M.D.
Joseph A. Witkowski, M.D.
Gil Yosipovitch, M.D.
Joseph J. Zaladonis, Jr., M.D.
RHODE ISLAND
Michael A. Bharier, M.D.
Robert Dyer, M.D.
H. William Higgins, II, M.D., M.B.E.
Charles J. McDonald, M.D.
Jason Randolph Michaels, M.D.
Leslie Robinson-Bostom, M.D.
SOUTH CAROLINA
Dirk M. Elston, M.D.
John C. Maize, Jr., M.D.
John C. Maize, Sr., M.D.
Long T. Quan, M.D., Ph.D.
Hudson C. Rogers, M.D.
Rebecca L. Smith, M.D.
Stephanie E. Smith-Phillips, M.D.
Sam Stafford, III, M.D.
F O R
A L L
O F
O F
(continued)
$ 1 , 5 0 0
Richard E. White, M.D.
Timothy G. Woodall, M.D.
SOUTH DAKOTA
Sarah K. Short Sarbacker, M.D.
TENNESSEE
Saundrett G. Arrindell, M.D.
Michael W. Bell, M.D.
Darrel L. Ellis, M.D.
Lloyd E. King, Jr., M.D., Ph.D.
Roy King, M.D.
Jami L. Miller, M.D.
Robert N. Page, M.D.
Kathryn Schwarzenberger, M.D.
Donald A. Sharp, M.D.
Kimberly D. Vincent, M.D.
Michael D. Zanolli, M.D.
John A. Zic, M.D.
TEXAS
William Abramovits, M.D.
Daniel S. Achtman, M.D.
Max F. Adler, M.D.
Kent S. Aftergut, M.D.
Linda J. Banta, M.D.
Chantal Barland, M.D.
Angela G. Bowers, M.D.
John Browning, M.D.
Suzanne Bruce, M.D.
David F. Butler, M.D.
Robert L. Chappell, Jr., M.D.
Melissa Chiang, M.D.
Justin W. Clark, M.D.
Brian M. Davis, M.D.
Steven A. Davis, M.D.
Seemal Desai, M.D.
Thushan DeSilva, M.D.
Dayna G. Diven, M.D.
Arturo R. Dominguez, M.D.
Kenneth E. Dorsey, M.D.
Susan E. Dozier, M.D.
Jeri Beth Foshee, M.D.
Matthew C. Fox, M.D.
R. John Fox, Jr., M.D.
Jan Fredric Fuerst, M.D.
Bonnie Baird Furner, M.D.
John J. Ghidoni, M.D.
Donald A. Glass, II, M.D., Ph.D.
Leonard H. Goldberg, M.D.
Adelaide A. Hebert, M.D.
David R. Hensley, M.D.
Peter D. Hino, M.D.
Alfred J. Hockley, III, M.D.
Gregory A. Hosler, M.D., Ph.D.
Kris L. Howard, M.D.
Mary E. Hurley, M.D.
Aaron K. Joseph, M.D.
Charles D. Kennard, M.D.
Mark D. Koone, M.D.
Catherine L. Kowalewski, D.O.
Jennifer Krejci-Manwaring, M.D.
Lu Q. Le, M.D., Ph.D.
Keagan H. Lee, M.D.
Moise L. Levy, M.D.
Lester F. Libow, M.D.
Rachel L. Limmer, M.D.
Jeffrey J. Meffert, M.D.
Denise W. Metry, M.D.
Vineet Mishra, M.D.
Gunjan Modi, M.D.
Anh V. Nguyen, M.D.
Janna Nunez-Gussman, M.D.
Robert L. Ochs, M.D.
Amit G. Pandya, M.D.
Isaac Perez, M.D.
Jennifer B. Perone, M.D.
Sharon S. Raimer, M.D.
Paras Ramolia, M.D.
Steven E. Rasmussen, M.D.
Christy Riddle, M.D.
Robin A. Roberts, M.D.
Howard A. Rubin, M.D.
Herman J. Schultz, M.D.
Keith E. Schulze, M.D.
Allison B. Friss Singer, M.D.
Jerald L. Sklar, M.D.
Michael Sorace, M.D.
Allison J. Stocker, M.D.
Mark D. Thieberg, M.D.
Charles S. Thurston, M.D.
John M. Tieman, M.D.
Jaime A. Tschen, M.D.
Travis W. Vandergriff, M.D.
Lisa C. Walker, M.D.
Mark S. Wallis, M.D.
Richard C. Wang, M.D., Ph.D.
T. Lynn Warthan, M.D.
Michael J. Wells, M.D.
Michael G. Wilkerson, M.D.
Daniel D. Witheiler, M.D.
John E. Wolf, Jr., M.D.
Amanda Wolthoff, M.D.
Priya S. Zeikus, M.D.
UTAH
Russell W. Eyre, M.D.
Douglas Grossman, M.D., Ph.D.
Brad Huber, M.D.
Joseph D. Jensen, M.D.
Kraig K. Jenson, M.D.
Julie Maughan, M.D.
Jacqueline Panko, M.D.
Douglas L. Powell, M.D.
Douglas M. Woseth, M.D.
VERMONT
Jamie A. Alpert, M.D.
Glenn D. Goldman, M.D.
Anita Goodrich Licata, M.D.
Steven R. Partilo, M.D., M.P.H.
Joseph C. Pierson, M.D.
WISCONSIN
William Aughenbaugh, M.D.
Daniel D. Bennett, M.D.
Lisa B. Campbell, M.D.
Alexandra Carley, M.D.
Yvonne E. Chiu, M.D.
David L. Crosby, M.D.
Beth A. Drolet, M.D.
Sheila S. Galbraith, M.D.
Molly A. Hinshaw, M.D.
Kristen E. Holland, M.D.
Kristina Kleven, M.D.
William P. LeFeber, M.D.
B. Jack Longley, M.D.
John W. Melski, M.D.
Elizabeth Nietert, M.D.
Edit Olasz, M.D.
Sun Young Ruggeri, M.D.
James P. Russell, M.D.
Thomas J. Russell, M.D.
Lawrence C. Scherrer, M.D., Ph.D.
Dawn H. Siegel, M.D.
Thorsteinn Skulason, M.D.
Ann Coleman Smith, M.D.
Kathleen S. Stokes, M.D.
Bradley T. Straka, M.D.
Michael J. White, M.D.
Gary S. Wood, M.D.
Yaohui Gloria Xu, M.D., Ph.D.
Gretchen M. Zirbel, M.D.
WYOMING
Larry E. Seitz, M.D.
IRELAND
C. Anthony Egan, M.B., M.R.C.P.
FROM THE PUBLIC
Jules T. Mitchel, Ph.D.
Thomas J. Stephens, Ph.D.
KEY
⽧ = LS Founder
Italics = LS Young Leader
VIRGINIA
Soni S. Carlton, M.D.
William L. Coker, Jr., M.D.
Allison K. Divers, M.D.
Lawrence J. Finkel, M.D.
Nicole Hayre, M.D.
Courtney R. Herbert, M.D., M.P.H.
Martin S. Horn, M.D.
Hazle S. Konerding, M.D.
Brett Krasner, M.D.
Rosemarie Liu, M.D.
Kappa P. Meadows, M.D.
Andrea Morris, M.D.
Alan N. Moshell, M.D.
Maithily A. Nandedkar, M.D.
Julia R. Nunley, M.D.
Steven M. Rotter, M.D.
Robert A. Silverman, M.D.
Carmen M. Williams, M.D.
WASHINGTON
Frank Baron, M.D.
James L. Brazil, M.D.
Elizabeth Dawson, M.D.
Daniel B. Dietzman, M.D.
Jennifer Gardner, M.D.
Brandith Irwin, M.D.
Sharon B. Kelly, M.D.
Paul Nghiem, M.D., Ph.D.
Michael W. Piepkorn, M.D.
Joy C. Wu, D.O.
To join, visit the DF Contribution Center at www.dermatologyfoundation.org
facebook.com/dermatologyfoundation
AAD 2016 HIGHLIGHTS
Vitamin D advice must weigh benefits, risks
Guidance for counseling patients on
Vitamin D supplementation may follow
the concept of “everything in moderation”,
Martin A. Weinstock, M.D., Ph.D., told colleagues recently at the 74th Annual meeting of the American Academy of Dermatology in Washington D.C.
“There has been a lot of publicity in the
lay press about the harms associated with
not getting enough vitamin D, but there
are also risks of getting too much,” says Dr.
Weinstock, professor, department of dermatology, Brown University, Providence,
R.I. Adequate levels of vitamin D are important for maintaining musculoskeletal health. There have also been studies
linking low levels of vitamin D to a variety of diseases, including cancer, cardiovascular disease, autoimmune disease,
and infection, although that work is controversial and does not necessarily imply
a causal relationship for vitamin D.
On the other hand, it is well-documented, based on outcomes of randomized controlled trials, that ingestion of
mega doses of vitamin D may adversely
affect musculoskeletal health and the
kidneys. Some data also suggest that
excessive vitamin D supplementation
increases risks of overall mortality, cancer, and cardiovascular disease, although
the evidence on those associations is not
definitive, Dr. Weinstock says.
SPECIFIC ADVICE
According to the Institute of Medicine, the
recommended dietary allowance for vitamin D is 600 IU/day for persons up to
age 70 and 800 IU/day for older individuals. These levels were developed based on
the assumption of minimal sun exposure.
“Many Americans do not achieve
the recommended intake of vitamin D
through diet alone, and use of a vitamin supplement containing the recommended dietary allowance is probably
reasonable for most people considering
that 4,000 IU/day is what the Institute of
Medicine recommends as the upper intake level for anyone aged 9 and older,”
Dr. Weinstock says.
“Individual recommendations, however, may vary depending on medical
considerations. Certain individuals may
need a higher intake of vitamin D while
600 to 800 IU/day may be too much for
some persons.”
ASSESSING VITAMIN D STATUS
The usual test for determining vitamin D
sufficiency is an assay of serum 25-hydroxyvitamin D, although the test is not
perfect and a low level may be misleading in some circumstances. For example,
patients with sarcoidosis may have a low
25-hydroxyvitamin D level but in fact have
adequate vitamin D stores. In addition, there
is racial variation in 25-hydroxy vitamin D
levels such that African Americans tend
to have lower levels which is explained by
their having lower levels of binding proteins
rather than a low level of vitamin D. DT
33
34
AAD 2016
®
HIGHLIGHTS
How nutrition influences skin health
QUICK READ
Patients are asking about dietary
guidelines. One expert shares how
our food source affects skin health
so you may better counsel patients.
Dermatologists are often asked by their
patients about eating for healthy skin. Zoe
D. Draelos, M.D., says that consumers need
to be aware of what they may be ingesting
inadvertently and what critical micronutrients may be lacking in their diets.
“Antioxidants are very important for
maintaining skin health and appearance.
Fruits and vegetables are a very good
source of the two most important antioxidant vitamins C and E. However, consumers should become label readers and take
care preparing the foods they eat, considering the possibility that pesticides and insecticides used in cultivating these crops
may have adverse effects relevant to the
skin,” says Dr. Draelos, consulting professor of dermatology, Duke University, Durham, N.C. She adds that “many people do
not realize that selenium is the third most
important dietary consumed antioxidant
after vitamin C and vitamin E.”
Cutting edge examination of how insecticides and pesticides used in agriculture affect human health points to the
possibility that, by acting as hormone
disruptors, these chemicals are contributing to obesity, female infertility, meta-
M E E T I N G
bolic syndrome, thyroid disease, and heart
disease. These potential consequences are
only now being appreciated based on findings of recent research with DDT in laboratory animals and observations of humans
inadvertently exposed to high levels of dioxin four decades ago.
“The original animal studies conducted
to examine the safety of DDT looked only
at the first generation of offspring. Now
there is evidence that the adverse consequences of exposure to these chemicals
may first manifest in later generations, perhaps the fourth or fifth,” Dr. Draelos says.
SKIN SENSITIVITIES
The dermatologic importance of this information relates to the numerous skin diseases
that are associated with obesity and diabetes and the potential for hormone disruptors
to be a causal factor in acne, although the
latter association requires more research.
With this information in mind, consumers should be careful to wash produce to re-
move chemical residues and pay attention
to where it was grown. “While DDT was
banned in the United States many years
ago, it is still used in other countries,” Dr.
Draelos says.
SELENIUM INTAKE
Selenium is a component of major antioxidant enzymes, glutathione peroxidase and
thioredoxin reductase, and it is also critical for overall health.
“Laboratory animals that are deficient
in selenium develop cancer and die prematurely, and selenium is an important micronutrient in hyperalimentation formulas and animal lab chow,” Dr. Draelos says.
While there is no test for measuring selenium levels in the blood, it is plausible
that Americans are becoming resistant
considering that selenium comes from eating food grown in selenium-rich soil, and
wheat grown in the Midwest has been a
major dietary source for this mineral. However, soil selenium content and therefore
the selenium content in wheat has dropped
as a result of changes in agriculture business practices.
She recommends consumers augment
their diets by choosing a supplement containing selenium. DT
T A K E A W A Y S
\ Dr. Martha L. Willson
\ Dr. Joel Spiro
\ Dr. Patria Ovalles
\ Robert Skaggs
British Columbia, Canada
Albany, N.Y.
Dominican Republic
Resident, University Louisville, Ky.
“I saw a really
interesting session
on the work-up and
management of
alopecia yesterday.”
“There are quite a
few lasers, and a lot
of interesting laser
therapies. It’s very
interesting and
something new
to learn.”
“The experience
with the teachers and
the speakers: I think
that is the oldest and
most important thing
that I can get from
The Academy.”
“The most interesting
thing that I saw was a
lecture on innovative
drug delivery by
Dr. Paller during
the plenary session.
I liked how it included
basic science, going to
clinical application.”
To view the complete video:
BIT.LY/WHATSINTERESTINGATAAD
FINACEA®
(azelaic acid) Foam, 15% for topical use
For Topical Use Only–Not for Oral, Ophthalmic or Intravaginal Use
Rx only
BRIEF SUMMARY
CONSULT PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION
1
INDICATIONS AND USAGE
Finacea (azelaic acid) Foam, 15% is indicated for topical treatment of the
inflammatory papules and pustules of mild to moderate rosacea.
5
WARNINGS AND PRECAUTIONS
5.1
Skin Reactions
There have been isolated reports of hypopigmentation after use of azelaic
acid. Because azelaic acid has not been well studied in patients with dark
complexion, monitor these patients for early signs of hypopigmentation.
5.2
Eye and Mucous Membranes Irritation
Azelaic acid has been reported to cause irritation of the eyes. Avoid contact
with the eyes, mouth and other mucous membranes. If Finacea Foam does
come in contact with the eyes, wash the eyes with large amounts of water
and consult a physician if eye irritation persists.
5.3
Flammability
The propellant in Finacea Foam is flammable. Instruct the patient to avoid
fire, flame, and smoking during and immediately following application. Do
not puncture and/or incinerate the containers. Do not expose containers to
heat and/or store at temperatures above 120°F (49°C).
6
ADVERSE REACTIONS
The following adverse reactions are described elsewhere in the prescribing
information:
t )ZQPQJHNFOUBUJPO[see Warnings and Precautions (5.1)].
t Eye and Mucous Membranes Irritation [see Warnings and Precautions
(5.2)].
6.1
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions,
adverse reaction rates observed in the clinical trials of a drug cannot be
directly compared to rates in the clinical trials of another drug and may not
reflect the rates observed in practice.
Finacea Foam was evaluated for the treatment of papulopustular rosacea
in two multicenter, randomized, double-blind, vehicle-controlled, 12-week
clinical trials involving a total of 1362 (Finacea Foam, 15%: 681; vehicle:
681) subjects. Overall, 95.7% of subjects were White, 73.4% were female,
and the mean age was 50.6 years.
Table 1: Adverse Reactions Occurring in ≥ 0.5% of Subjects Treated with
Finacea Foam Compared with Subjects Treated with Vehicle
System/Organ Class
Preferred
Finacea Foam,
15% (N=681)
n (%)
Vehicle
(N=681)
n (%)
General disorders and application site conditions
Application site pain*
Application site pruritus
Application site dryness
Application site erythema
42 (6.2%)
17 (2.5%)
5 (0.7%)
5 (0.7%)
10 (1.5%)
2 (0.3%)
5 (0.7%)
6 (0.9%)
* “Application site pain” is a term used to describe disagreeable skin
sensations, including burning, stinging, paraesthesia and tenderness.
6.2
Post-Marketing Experience
)ZQFSTFOTJUJWJUZSBTIBOEXPSTFOJOHPGBTUINBIBWFCFFOSFQPSUFEGSPN
the postmarketing experience of azelaic acid-containing formulations.
Because these reactions are reported voluntarily from a population of
uncertain size, it is not always possible to reliably estimate their frequency
or establish a causal relationship to drug exposure.
Local Tolerability Studies
In a 21-day cumulative irritation study under occlusive conditions, mildto-moderate irritation was observed for azelaic acid pre-foam emulsion. In
BIVNBOSFQFBUJOTVMUQBUDIUFTU)3*15
TUVEZOPTFOTJUJ[BUJPOQPUFOUJBM
was observed for azelaic acid pre-foam emulsion.
8
USE IN SPECIFIC POPULATIONS
8.1
Pregnancy
Teratogenic Effects: Pregnancy Category B
There are no adequate and well-controlled studies in pregnant women.
Therefore, Finacea Foam should be used during pregnancy only if the
potential benefit justifies the potential risk to the fetus.
Dermal embryofetal developmental toxicology studies have not been
performed with azelaic acid, 15% foam. Oral embryofetal developmental
studies were conducted with azelaic acid in rats, rabbits, and cynomolgus
monkeys. Azelaic acid was administered during the period of organogenesis
in all three animal species. Embryotoxicity was observed in rats, rabbits,
and monkeys at oral doses of azelaic acid that generated some maternal
toxicity. Embryotoxicity was observed in rats given 2500 mg/kg/day [162
UJNFTUIFNBYJNVNSFDPNNFOEFEIVNBOEPTF.3)%
CBTFEPOCPEZ
surface area (BSA)], rabbits given 150 or 500 mg/kg/day (19 or 65 times
UIF.3)%CBTFEPO#4"
BOEDZOPNPMHVTNPOLFZTHJWFONHLHEBZ
UJNFT UIF .3)% CBTFE PO #4"
B[FMBJD BDJE /P UFSBUPHFOJD FGGFDUT
were observed in the oral embryofetal developmental studies conducted in
rats, rabbits and cynomolgus monkeys.
An oral peri- and post-natal developmental study was conducted in rats.
Azelaic acid was administered from gestational day 15 through day 21
postpartum up to a dose level of 2500 mg/kg/day. Embryotoxicity was
PCTFSWFEJOSBUTBUBOPSBMEPTFPGNHLHEBZUJNFTUIF.3)%
based on BSA) that generated some maternal toxicity. In addition, slight
disturbances in the post-natal development of fetuses was noted in rats
at oral doses that generated some maternal toxicity (500 and 2500 mg/
LHEBZBOEUJNFTUIF.3)%CBTFEPO#4"
/PFGGFDUTPOTFYVBM
maturation of the fetuses were noted in this study.
8.3
Nursing Mothers
It is not known if azelaic acid is secreted into human milk in vivo/PXFMM
controlled studies of topically administered azelaic acid in nursing women
BSF BWBJMBCMF /FWFSUIFMFTT UIF EFDJTJPO UP EJTDPOUJOVF OVSTJOH PS UP
discontinue the drug should take into account the importance of the drug
to the mother.
8.4
Pediatric Use
The safety and efficacy of Finacea Foam in children below the age of 18
years have not been established.
8.5
Geriatric Use
Of the total number of subjects in clinical studies of Finacea Foam, 18.8
QFSDFOUXFSFBOEPWFSXIJMFQFSDFOUXFSFBOEPWFS/PPWFSBMM
differences in safety or effectiveness were observed between these subjects
and younger subjects, and other reported clinical experience has not
identified differences in responses between the elderly and younger patients,
but greater sensitivity of some older individuals cannot be ruled out.
17
PATIENT COUNSELING INFORMATION
Inform patients using Finacea Foam of the following information and
instructions:
t 'PSFYUFSOBMVTFPOMZ
t $MFBOTFBGGFDUFEBSFBT
XJUIBWFSZNJMETPBQPSBTPBQMFTTDMFBOTJOH
lotion and pat dry with a soft towel.
t 4IBLFXFMMCFGPSFVTF
t "WPJEVTFPGBMDPIPMJDDMFBOTFSTUJODUVSFTBOEBTUSJOHFOUTBCSBTJWFTBOE
peeling agents.
t "WPJE DPOUBDU XJUI UIF FZFT NPVUI BOE PUIFS NVDPVT NFNCSBOFT *G
Finacea Foam does come in contact with the eyes, wash the eyes with
large amounts of water and consult your physician if eye irritation
persists.
t *GBMMFSHJDSFBDUJPOTPDDVSEJTDPOUJOVFVTFBOEDPOTVMUZPVSQIZTJDJBO
t 8BTIIBOETJNNFEJBUFMZGPMMPXJOHBQQMJDBUJPOPG'JOBDFB'PBN
t $PTNFUJDTNBZCFBQQMJFEBGUFSUIFBQQMJDBUJPOPG'JOBDFB'PBNIBTESJFE
t "WPJEUIFVTFPGPDDMVTJWFESFTTJOHTBOEXSBQQJOHT
t 5PIFMQNBOBHFSPTBDFBBWPJEBOZUSJHHFSTUIBUNBZQSPWPLFFSZUIFNB
flushing, and blushing. These triggers can include spicy and thermally hot
food and drinks such as hot coffee, tea, or alcoholic beverages.
t 5IF QSPQFMMBOU JO 'JOBDFB 'PBN JT nBNNBCMF "WPJE mSF nBNF PS
smoking during and immediately following application.
t %JTDBSEQSPEVDUXFFLTBGUFSPQFOJOH
© #BZFS)FBMUI$BSF1IBSNBDFVUJDBMT*OD"MMSJHIUTSFTFSWFE
Manufactured for:
#BZFS)FBMUI$BSF1IBSNBDFVUJDBMT*OD
8IJQQBOZ/+
Manufactured in Switzerland
6798100BS
CLINICAL DERMATOLOGY
HS may be underdiagnosed
Experts discuss diagnostic criteria and evidence-based treatment guidelines
LISETTE HILTON | STAFF CORRESPONDENT
Misconceptions about hidradenitis
suppurativa (HS) prevent dermatologists and other clinicians from properly
diagnosing and treating what one expert says is a “crippling disease.”
One of t he misunderstandings
about HS is that it’s rare, according to
Gregor Jemec, M.D., D.M.Sc., professor
and chair of dermatology at Roskilde
Hospital, Health Sciences Faculty, University of Copenhagen, Denmark, who
chaired a section on hidradenitis suppurativa at the 2015 World Congress of
Dermatology in Vancouver, Canada. “U.S. registry studies suggest [it is
rare], while European population studies suggest it is not,” Dr. Jemec says.
“It is like looking in hospital records
for how many people suffer from the
common cold in November. You are
not likely to get the impression that it
is particularly common.”
HS prevalence in the Europe, including mild cases, is reported to be
between 1% and 2%. And most HS patients are young adults.
QUICK READ
Misconceptions about HS
include that the disease is rare
with few therapeutic options.
The disease is linked with family
history, smoking and obesity.
The true prevalence of HS is challenging to estimate because the disease is misunderstood and underdiagnosed, according to Iben Marie
Miller, M.D., Ph.D.,
a post doctorial scientist in the department of dermatology,
Rosk i lde Hospit a l,
Denmark. Dr. Miller,
who presented on HS
Dr. Miller
comorbidity and epidemiology at the World Congress, says
HS prevalence varies from 0.5% to 4.1%,
worldwide.
“Actually, Karl Marx was believed
to have [had] HS but was also misdiagnosed when alive,” Dr. Miller says.
Among the other important misconceptions among doctors about HS are
that it is a malodorous, or foul-smell-
DTExtra
Allergan announced in late February
that the FDA has approved its
topical dapsone gel, 7.5% (Aczone),
for treatment of acne vulgaris. The
newly formulated Aczone 7.5% gel can be
used once daily as opposed to the twicedaily dosing on the older formulation. The
prescription topical was approved for acne
in patients 12 years and older. The gel
will be available nationwide in May of 2016.
SOURCE: BIT.LY/DTACZONEAPPROVAL
ing, disease with very few therapeutic
options, according to Professor Errol
Prens, M.D., Ph.D., who presented on
immunological mechanisms underlying hidradenitis suppurativa at the
World Congress. Dr. Prens, a dermatologist-immunologist at Erasmus University Medical Center of Rotterdam,
The Netherlands, says it’s also a myth
that these patients often become resistant to therapy.
THE SCIENCE
While patients with HS often have a
family history of the disease, the much
stronger HS link is obesity, according
to Dr. Jemec. “There is no convincing data that the
quality of the diet plays a role, such as
specific foods, but quite strong data that
the quantity plays a role. Most patient
have a high BMI, prevalence and disease severity correlates with BMI and
BMI reduction appears to induce remission,” Dr. Jemec says.
Smoking seems highly associated
with the disease, according to Dr. Prens.
HIDRADENITIS SUPPURATIVA see page 38
Quotable
With the resurgent
interest for this often
crippling disease, a
number of new treatments are being developed in academia, as
well as by the industry.”
Gregor Jemec, M.D.
Copenhagen, Denmark
Insights into hidradenitis suppurativa
See story, this page
37
38
CLINICAL
®
DERMATOLOGY
HIDRADENITIS SUPPURATIVA:
Diagnostic criteria simplified, clarified from page 37
“Ninety percent [of HS patients] are
active smokers or past smokers,” Dr.
Prens says.
DIAGNOSING HS
The diagnostic criteria for HS have been
clarified and are not complex, according to Dr. Jemec. The first is the characteristic element of inflamed or non-inflamed nodules, tunnels, abscesses and
scars. The characteristic tomography of
HS is on the axilla, inflammatory skin
and groin. And the characteristic evolution of the disease, according to Dr.
Jemec, is that it recurs and progresses
to chronic disease.
An important clue as to whether a patient has HS, according to Dr. Prens, is
if the patient has had two episodes of
boils in the axillae or groins in the past
six months.
While the criteria may be simple, the
diagnosis often eludes dermatologists
and others, according to Dr. Miller. “A diagnostic delay of up to 12 years
has been reported, maybe due to a
mix of patients’ being reluctant to talk
“It is like looking in hospital records for
how many people suffer from the
common cold in November. You
are not likely to get the impression
that it is particularly common.”
Gregor Jemec, M.D.
University of Copenhagen, Denmark
about their symptoms, as they feel
embarrassed …, but also many doctors may not know the existence of this
disease and mistake it for a common infection,” Dr. Miller says.
EVIDENCE-BASED TREATMENT Two of the most important steps HS patients can take to treat the disease are to
stop smoking and lose weight.
The current treatment algorithm
for HS is in the European guidelines,
published online January 30, 2015 in
a supplement of the Journal of the European Academy of Dermatology and
Venereology.2
Risk factors, comorbidities
According to Dr. Miller, the main comorbidities and risk factors in HS are: Autoimmune diseases, such as Crohn’s disease
Diseases involving follicular occlusion, including acne Malignancies such as squamous cell carcinoma Psychological comorbidities, such as depression
Smoking
Metabolic syndrome, including obesity, hypertension, diabetes and dyslipidemia
“Both the metabolic syndrome and smoking constitute cardiovascular risk factors, which
is something HS has in common with psoriasis,” Dr. Miller says. “Preliminary data on body
composition was presented demonstrating that HS patients not only have higher body mass
index, but also higher fat percentage and lower muscle percentage compared to controls.
This may suggest fat maldistribution, or perhaps even an altered metabolism altogether
[may be a better description than BMI].”
For many of these comorbidities, studies suggest an HS association rather than a cause,
according to Dr. Miller. “The complexity of causality in many of these comorbidities are still to be explored. For
example, we still do not know whether the association with metabolic syndrome is caused
by HS or is due to confounders, such as lifestyle,” Dr. Miller says. “I also presented some
cutting-edge additional preliminary results from Danish studies on HS suggesting that
these patients may have a tendency of gallstones and renal hyperfiltration, which may be
a sign of early renal damage.”1 DT
“The European S1 HS guideline
suggests that the disease should be
treated based on its individual subjective impact and objective severity,”
according to the guidelines. “Locally
recurring lesions can be treated by
classical surgery or laser techniques,
whereas medical treatment either as
monotherapy or in combination with
radical surger y is more appropriate for widely spread lesions. Medical therapy may include antibiotics
(clindamycin plus [rifampicin], tetracyclines), acitretin [Soriatane, Stiefel
Laboratories] and biologics (adalimumab [Humira, AbbVie], infliximab
[Remicade, Janssen Biotech).”
According to Dr. Prens, dermatologists treating mild HS should consider
topical resorcinol 15% cream; topical
clindamycin or oral tetracyclines.
For moderate disease: topical resorcinol 15% cream; oral tetracyclines, rifampicin/clindamycin oral, acitretin
oral; and, in some cases, biologics and
surgical de-roofing. Severe disease
t reat ment s i nclude: r i fa mpici n/
clindamycin oral, acitretin oral; biologic medications adalimumab or infliximab; surgical de-roofing and en
bloc resection.
HS treatments that are supported
by the data, according to Dr. Jemec,
include topical clindamycin 0.1%
twice daily; tetracycline 500 mg twice
daily; Nd: YAG laser; infliximab; and
adalimumab. “Large cohorts further support the
use of rifampicin 300 mg BID given
with clindamycin 300mg BID, CO 2
laser evaporation, de-roofing and surgery,” Dr. Jemec says. “Incision and
drainage only works if fluctuating abscesses are found, which is not that
common. In general, the patients need
a broad approach combining medical
HIDRADENITIS SUPPURATIVA see page 41
CLINICAL DERMATOLOGY
HIDRADENITIS SUPPURATIVA:
Important patient self-management steps from page 38
and surgical therapy, pain management and appropriate bandages with
support for patient self-management.”
Adalimumab, the first and only drug
to have received FDA approval for the
treatment of adults with moderate-tosevere HS, is the most documented
drug for the disease, according to Dr.
Jemec.3
Two of the most
important steps HS
patients can take to
successfully treat
the disease are to
stop smoking and
lose weight.
2. Zouboulis CC, Desai N, Emtestam L, Hunger RE, Ioannides D,
Juhász I, Lapins J, Matusiak L, Prens EP, Revuz J, SchneiderBurrus S, Szepietowski JC, van der Zee HH, Jemec GB.
European S1 guideline for the treatment of hidradenitis suppurativa/acne inversa. J Eur Acad Dermatol Venereol. 2015
Apr;29(4):619-44.
Epub 2015 Jan 30. http://www.ncbi.nlm.nih.gov/
pubmed/25640693
3. http://abbvie.mediaroom.com/2015-09-10-AbbVies-HUMIRA-Adalimumab-Receives-First-and-Only-U-S-Food-andDrug-Administration-Approval-for-Moderate-to-SevereHidradenitis-Suppurativa
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“[Adalimumab] appears to have a
clinically significant effect in moderate-to-severe cases, when given in the
same dosage as used for the treatment
of Crohn’s disease,” Dr. Jemec says.
“With the resurgent interest for this
often crippling disease, a number of
new treatments are being developed
in academia, as well as by the industry. I am convinced that over the next
ten years our ability to help the many
patients more effectively will have improved greatly.” DT
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Come visit our ACMS booth for Exclusive Promotions at:
Booth #302, April 28-30, Orlanda, FL
Disclosures: Dr. Jemec: AbbVie, Actelion, AstraZeneca, Basilea, Celgene, Coloplast, Desitin, JannsenCilag, Leo Pharma, Michelson Diagnostics, MSD, Novartis, Roche. Dr. Miller: Recieved a Ph.D. grant from
The Danish Agency for Science, Technology and Innovation & LEO Pharma. Dr. Miller recieved lecture fees
from AbbVie and Galderma. Prof. Prens has received
honoraria from AbbVie, Amgen, Baxter, Celgene, Eli
Lilly, Galderma, Janssen-Cilag, Novartis and Pfizer
for participating as a speaker, or in advisory boards,
and he received investigator-initiated grants that were
paid to institution (Erasmus University Medical Center)
from AbbVie, AstraZeneca, Janssen, NTRC and Pfizer.
REFERENCES:
1. Miller IM, Carlson N, Mogensen UB, Ellervik C, Jemec
GB. A Population- and Hospital-based Cross-sectional Study of Renal Function in Hidradenitis Suppurativa. Acta Derm Venereol. 2015 Feb 24. www.ncbi.
nlm.nih.gov/pubmed/25710874
Strength in patient care.™
877-908-9609 | [email protected] | mti.net/derm
41
42
COSMETIC
®
DERMATOLOGY
Fat melting combinations that work
QUICK READ
Fat melting has become a melting pot
of procedures for many physicians experienced in the art and science of body
sculpting.
Beverly Hills, Calif., dermatologic
surgeon Jason Emer, M.D., says his
practice revolves around using combination therapies to define and enhance
patient bodies. And with a pallet of fat
melting and skin tightening options
available to enhance liposuction’s results, it’s rare that he’ll perform liposuction alone on a patient, he says.
Marie N. DiLauro, M.D., a cosmetic
surgeon and board-certified laser specialist who owns and operates a cos-
Two liposuction experts say they
rarely treat patients’ concerns
with liposuction only, and,
instead, use a combination
approach for body sculpting.
metic medical practice that specializes in liposuction and liposculpture
in Columbus, Ohio, also says it’s rare
that she’ll use liposuction alone.
“In the past, patients who were overweight or had an excess of fat in a few
areas wanted these areas of fat reduced
with liposuction. Today’s patients are
more health conscious, tend to exercise and work out more [and] may be
Today’s liposuction surgeons perform
detailed precision sculpting to accentuate
curves and muscle definition and, then, add
selective fat transfer as needed to create
a more curvaceous figure for a
woman, and a more muscular
chiseled look or physique for a man.
Marie N. DiLauro, M.D.
at their ideal weight but want to appear
healthy, fit and more muscular,” Dr. DiLauro says. “In the past decade, liposuction has evolved to address these patients’ needs and desires. Today’s liposuction surgeons perform detailed precision sculpting to accentuate curves
and muscle definition and, then, add selective fat transfer as needed to create
a more curvaceous figure for a woman,
and a more muscular chiseled look or
physique for a man.”
A CLOSER LOOK AT COMBOS
There are a lot of potential combinations,
including off-label combinations, aimed
at improving individual patient outcomes.
For patients with small irregularities
or others who want to fine-tune post-liposuction results, Dr. Emer often uses
Ultrashape (Syneron Candela). Surgeons can start Ultrashape treatments
almost immediately after liposuction,
although swelling from liposuction
takes three to six months to go away.
There is no inflammation or swelling
from the ultrasound technology, however, he says.
He adds that he uses ZWave (Eclipse
Aesthetics) shock therapy in all patients
post Cellfina (Ultherapy), or after leg
FAT MELTING see page 45
Columbus, Ohio
Quotable
DTExtra
In men, I now often
use the PowerX at the
end of the Tickle Lipo
procedure to
obtain increased
muscle definition in
the chest and
abdomen.”
Marie N. DiLauro, M.D.
Columbus, Ohio
Techniques for optimal fat melting
See story, this page
An expert panel convened during the Vegas
Cosmetic Surgery 2015 meeting share their
opinions about Thermage, Ultherapy and more.
View the entire video.
VIDEO
bit.ly/CSTSkinTightening
Eurax
®
(crotamiton, USP)
Lotion/Cream (10% w/w)
Rx only
FOR TOPICAL USE ONLY
NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE
DESCRIPTION
Eurax (crotamiton, USP) is a scabicidal and antipruritic agent available as a cream or lotion for topical use only. Eurax provides 10% (w/w) of the synthetic, crotamiton,
USP, in a vanishing-cream or emollient-lotion base containing: carbomer-934, cetyl alcohol, diazolidinylurea, dimethicone, fragrance, laureth-23, magnesium aluminum
silicate, magnesium nitrate, methylchloroisothiazolinone, methylisothiazolinone, petrolatum, propylene glycol, sodium hydroxide, steareth-2, and water. In addition, the
cream contains glyceryl stearate. Crotamiton is N-ethyl-N-(o-methylphenyl)-2-butenamide and its structural formula is:
Crotamiton, USP is a colorless to slightly yellowish oil, having a faint amine-like odor. It is miscible with alcohol and with methanol. Crotamiton is a mixture of the cis and
trans isomers. Its molecular weight is 203.28.
CLINICAL PHARMACOLOGY
Eurax has scabicidal and antipruritic actions. The mechanisms of these actions are not known. The pharmacokinetics of crotamiton and its degree of systemic absorption
following topical application have not been determined.
For eradication of scabies (Sarcoptes scabiei) and for symptomatic treatment of pruritic skin.
CONTRAINDICATIONS
Eurax should not be applied topically to patients who develop a sensitivity or are allergic to it or who manifest a primary irritation response to topical medications.
WARNINGS
If severe irritation or sensitization develops, treatment with this product should be discontinued and appropriate therapy instituted.
PRECAUTIONS
General
Eurax should not be applied in the eyes or mouth because it may cause irritation. It should not be applied to acutely inflamed skin or raw or weeping surfaces until the acute
inflammation has subsided.
Information for Patients
See DIRECTIONS FOR PATIENTS WITH SCABIES.
Drug Interactions
None known.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term carcinogenicity studies in animals have not been conducted.
Pregnancy (Category C)
Animal reproduction studies have not been conducted with Eurax. It is also not known whether Eurax can cause fetal harm when applied topically to a pregnant woman or
can affect reproduction capacity. Eurax should be given to a pregnant woman only if clearly needed.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
Clinical studies with Eurax (crotamiton, USP) Lotion/Cream did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond
differently than younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater
sensitivity of some older individuals cannot be ruled out.
ADVERSE REACTIONS
Primary irritation reactions, such as dermatitis, pruritus, and rash, and allergic sensitivity reactions have been reported in a few patients.
OVERDOSAGE
There is no specific information on the effect of overtreatment with repeated topical applications in humans. A death was reported but cause was not confirmed.
Accidental oral ingestion may be accompanied by burning sensation in the mouth, irritation of the buccal, esophageal and gastric mucosa, nausea, vomiting,
abdominal pain.
If accidental ingestion occurs, call your Poison Control Center.
DOSAGE AND ADMINISTRATION
In Scabies: Thoroughly massage into the skin of the whole body from the chin down, paying particular attention to all folds and creases. A second application is advisable
24 hours later. Clothing and bed linen should be changed the next morning. A cleansing bath should be taken 48 hours after the last application.
In Pruritus: Massage gently into affected areas until medication is completely absorbed. Repeat as needed.
LOTION: Shake well before using.
DIRECTIONS FOR PATIENTS WITH SCABIES:
1. Take a routine bath or shower. Thoroughly massage Eurax cream or lotion into the skin from the chin to the toes including folds and creases.
2. Put Eurax cream or lotion under fingernails after trimming the fingernails short, because scabies are very likely to remain there. A toothbrush can be used to apply the
Eurax cream or lotion under the fingernails. Immediately after use, the toothbrush should be wrapped in paper and thrown away. Use of the same brush in the mouth
could lead to poisoning.
3. A second application is advisable 24 hours later.
4. A 60 gram tube or bottle is sufficient for two applications.
5. Clothing and bed linen should be changed the next day. Contaminated clothing and bed linen may be drycleaned, or washed in the hot cycle of the washing machine.
6. A cleansing bath should be taken 48 hours after the last application.
HOW SUPPLIED
Eurax® (crotamiton, USP) Cream, 10% is a white to yellowish-white soft cream with a perfumed characteristic odor and supplied as:
60 g tube NDC 10631-091-60 (NSN 6505-00-116-0200)
Eurax® (crotamiton, USP) Lotion, 10% is a white to yellowish-white lotion having a characteristic perfumed odor and supplied as:
60 g (2 oz.) bottle
NDC 10631-092-60 (NSN 6505-01-153-4423)
454 g (16 oz.) bottle NDC 10631-092-16
SHAKE WELL before using.
Store at room temperature.
Keep out of reach of children.
To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Jacksonville, FL 32257 USA
129845
Revised September 2012
COSMETIC DERMATOLOGY
Female liposuction
patient shown
before and after
Power X alone.
Photos: Marie N. DiLauro,
M.D.
FAT MELTING:
Wind, fire, and ice: incorporating noninflammatory options from page 42
and arm liposuction. Doing so, he says,
helps prevent irregularities and further
improves the appearance of cellulite.
“If I have older patients who need
more skin tightening and do not want
skin surgery, such as a tummy tuck or
arm skin removal, I will do ThermiRF
[Thermi] to promote further skin tightening post-liposuction,” Dr. Emer says.
“I also do this for abdominal, shoulder
and arm etching. This allows me to get
very tight contours on muscles and give
definition like nobody has seen before.”
Dr. Emer says he gets amazing results
on the neck, inner thighs, knee and buttock roll with Kybella (deoxycholic acid,
Allergan), combined with ThermiRF,
Thermage (Valeant Pharmaceuticals
International) or Ultherapy (Ulthera).
And the dermatologic surgeon commonly combines treatments with noninflammatory options to improve outcomes, using such combinations as
“wind, fire and ice” treatment, which
is Ultrashape, Velashape (Velashape)
or Venus Legacy (Venus Concept) and
CoolSculpting (Zeltiq), he says. Dr.
Emer adds he is integrating the new
FDA-approved Sculpsure (Cynosure),
a fat-removal laser device that takes
about 25 minutes per treatment, into
this combination.
Dr. DiLauro says she added Tickle
Lipo (Euromi), which uses nutational
infrasonic energy to dissolve fat, to her
practice last year.
“The Tickle Lipo makes the infu-
sion of the tumescence and the aspiration phase more comfortable for the
patient. It also makes it much easier for
me to perform all phases of the procedure because the nutational motion of
the cannula gently separates the fat so
that much less force is required to move
the cannula through the tissue. Patients
also seem to recover more quickly after
the procedure when compared to other
methods of liposuction. Also the fat obtained with the Tickle Lipo is excellent
for fat transfer,” Dr. DiLauro says.
Patient results after Tickle Lipo are
similar to those that Dr. DiLauro says
she gets from using Vaser (Valeant Pharmaceuticals), ProLipo (Sciton) laser
lipo, and the PowerX (Valeant Pharmaceuticals) in combination.
“In men, I now often use the PowerX
at the end of the Tickle Lipo procedure
to obtain increased muscle definition in
the chest and abdomen,” she says.
Before purchasing Tickle Lipo, Dr.
DiLauro used the Vaser, traditional
cannulas and the PowerX separately
and in combination for body sculpting.
She says she often performed Vaser with
the PowerX, and utilized the PowerX,
alone, to perform medium- and highdefinition liposuction.
“For submental liposuction, I obtained excellent results using the following combinations: the Vaser with
the VentX (Vaser, Valeant Pharmaceuticals) cannula; Vaser with PowerX aspiration; and ProLipo with PowerX aspi-
ration. Now, I use the Tickle Lipo alone
for the submental area,” she says.
The Vaser is ideal when treating very
fibrous areas, areas that have been
treated with prior liposuction, and it
produces smooth viable fat for performing fat transfers, according to Dr.
DiLauro. The Prolipo laser works well
for cellulite and is useful for performing
liposuction of small areas and for treating small tissue irregularities that can
occur after abdominoplasty and prior
liposuction, she says.
For patients with very loose or lax
skin, Dr. DiLauro recommends one
Thermage radiofrequency treatment
before and after their procedure to improve skin tightening.
“We also recommend a series of Vaser
Shape and SkinTyte BBL [Sciton] treatments, if extra skin tightening is needed
after liposuction,” she says.
COMBOS FOR COMFORT
While most of the noninvasive options
have little patient comfort issues, technologies, such as CoolSculpting, can cause
inflammation, bruising and nerve sensations for weeks to months after the procedure, according to Dr. Emer.
“Lymphatic massage, hyperbaric oxygen treatment, oral [gabapentin] and
radiofrequency treatments really help,”
he says.
“Everyone gets radiofrequency treatments, like Venus Legacy or Velashape,
FAT MELTING see page 50
45
BOTOX® Cosmetic (onabotulinumtoxinA)
for injection
(Brief summary of full prescribing information)
Manufactured by: Allergan Pharmaceuticals Ireland
a subsidiary of: Allergan, 2525 Dupont Dr., Irvine, CA 92612
WARNING: DISTANT SPREAD OF TOXIN EFFECT
Postmarketing reports indicate that the effects of BOTOX® Cosmetic and all botulinum
toxin products may spread from the area of injection to produce symptoms consistent
with botulinum toxin effects. These may include asthenia, generalized muscle weakness,
diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing
difficulties. These symptoms have been reported hours to weeks after injection. Swallowing
and breathing difficulties can be life threatening and there have been reports of death.
The risk of symptoms is probably greatest in children treated for spasticity but symptoms
can also occur in adults treated for spasticity and other conditions, particularly in those
patients who have an underlying condition that would predispose them to these symptoms.
In unapproved uses, including spasticity in children, and in approved indications, cases
of spread of effect have been reported at doses comparable to those used to treat cervical
dystonia and upper limb spasticity and at lower doses.
BOTOX® Cosmetic for injection is indicated for the temporary improvement in the appearance of moderate
to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients.
BOTOX® Cosmetic is indicated for the temporary improvement in the appearance of moderate to
severe lateral canthal lines associated with orbicularis oculi activity in adult patients.
CONTRAINDICATIONS
BOTOX® Cosmetic is contraindicated in the presence of infection at the proposed injection site(s)
and in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the
components in the formulation.
Lack of Interchangeability between Botulinum Toxin Products
The potency Units of BOTOX® Cosmetic are specific to the preparation and assay method
utilized. They are not interchangeable with other preparations of botulinum toxin products
and, therefore, units of biological activity of BOTOX® Cosmetic cannot be compared to
nor converted into units of any other botulinum toxin products assessed with any other
specific assay method.
Spread of Toxin Effect
Postmarketing safety data from BOTOX® Cosmetic and other approved botulinum toxins suggest
that botulinum toxin effects may, in some cases, be observed beyond the site of local injection.
The symptoms are consistent with the mechanism of action of botulinum toxin and may include
asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary
incontinence, and breathing difficulties. These symptoms have been reported hours to weeks after
injection. Swallowing and breathing difficulties can be life threatening and there have been reports of
death related to spread of toxin effects. The risk of symptoms is probably greatest in children treated
for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, and
particularly in those patients who have an underlying condition that would predispose them to these
symptoms. In unapproved uses, including spasticity in children, and in approved indications, symptoms
consistent with spread of toxin effect have been reported at doses comparable to or lower than doses
used to treat cervical dystonia and upper limb spasticity. Patients or caregivers should be advised to
seek immediate medical care if swallowing, speech or respiratory disorders occur.
No definitive serious adverse event reports of distant spread of toxin effect associated with
dermatologic use of BOTOX®/BOTOX® Cosmetic at the labeled dose of 20 Units (for glabellar lines),
24 Units (for lateral canthal lines), 44 Units (for simultaneous treatment of lateral canthal lines and
glabellar lines), or 100 Units (for severe primary axillary hyperhidrosis) have been reported.
No definitive serious adverse event reports of distant spread of toxin effect associated with BOTOX®
for blepharospasm at the recommended dose (30 Units and below), strabismus, or chronic migraine at
the labeled doses have been reported.
Serious Adverse Reactions with Unapproved Use
Serious adverse reactions, including excessive weakness, dysphagia, and aspiration pneumonia, with
some adverse reactions associated with fatal outcomes, have been reported in patients who received
BOTOX® injections for unapproved uses. In these cases, the adverse reactions were not necessarily
related to distant spread of toxin, but may have resulted from the administration of BOTOX® to the site
of injection and/or adjacent structures. In several of the cases, patients had pre-existing dysphagia
or other significant disabilities. There is insufficient information to identify factors associated with
an increased risk for adverse reactions associated with the unapproved uses of BOTOX®. The safety
and effectiveness of BOTOX® for unapproved uses have not been established.
Hypersensitivity Reactions
Serious and/or immediate hypersensitivity reactions have been reported. These reactions include
anaphylaxis, serum sickness, urticaria, soft tissue edema, and dyspnea. If such a reaction occurs,
further injection of BOTOX® Cosmetic should be discontinued and appropriate medical therapy
immediately instituted. One fatal case of anaphylaxis has been reported in which lidocaine was used
as the diluent, and consequently the causal agent cannot be reliably determined.
Cardiovascular System
There have been reports following administration of BOTOX® of adverse events involving the
cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes.
Some of these patients had risk factors including pre-existing cardiovascular disease. Use caution
when administering to patients with pre-existing cardiovascular disease.
Pre-Existing Neuromuscular Disorders
Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular
junctional disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome) should be monitored when
given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically
significant effects including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria,
severe dysphagia and respiratory compromise from onabotulinumtoxinA (see Warnings and Precautions).
Dysphagia and Breathing Difficulties
Treatment with BOTOX® and other botulinum toxin products can result in swallowing or breathing
difficulties. Patients with pre-existing swallowing or breathing difficulties may be more susceptible
to these complications. In most cases, this is a consequence of weakening of muscles in the area of
injection that are involved in breathing or oropharyngeal muscles that control swallowing or breathing
(see Warnings and Precautions).
Deaths as a complication of severe dysphagia have been reported after treatment with botulinum toxin.
Dysphagia may persist for several months, and require use of a feeding tube to maintain adequate
nutrition and hydration. Aspiration may result from severe dysphagia and is a particular risk when
treating patients in whom swallowing or respiratory function is already compromised.
Treatment with botulinum toxins may weaken neck muscles that serve as accessory muscles of ventilation.
This may result in a critical loss of breathing capacity in patients with respiratory disorders who may have
become dependent upon these accessory muscles. There have been postmarketing reports of serious
breathing difficulties, including respiratory failure.
Patients with smaller neck muscle mass and patients who require bilateral injections into the
sternocleidomastoid muscle for the treatment of cervical dystonia have been reported to be at greater
risk for dysphagia. Limiting the dose injected into the sternocleidomastoid muscle may reduce the
occurrence of dysphagia. Injections into the levator scapulae may be associated with an increased
risk of upper respiratory infection and dysphagia.
Patients treated with botulinum toxin may require immediate medical attention should they develop
problems with swallowing, speech, or respiratory disorders. These reactions can occur within hours
to weeks after injection with botulinum toxin (see Warnings and Precautions).
Pre-existing Conditions at the Injection Site
Caution should be used when BOTOX® Cosmetic treatment is used in the presence of inflammation
at the proposed injection site(s), ptosis, or when excessive weakness or atrophy is present in the
targeted muscle(s).
Corneal Exposure and Ulceration in Patients Treated with BOTOX®
for Blepharospasm
Reduced blinking from BOTOX® Cosmetic injection of the orbicularis muscle can lead to corneal
exposure, persistent epithelial defect, and corneal ulceration, especially in patients with VII nerve
disorders. Vigorous treatment of any epithelial defect should be employed. This may require protective
drops, ointment, therapeutic soft contact lenses, or closure of the eye by patching or other means.
Spatial Disorientation, Double Vision or Past-pointing in Patients Treated
for Strabismus
Inducing paralysis in one or more extraocular muscles may produce spatial disorientation, double
vision or past pointing. Covering the affected eye may alleviate these symptoms.
Human Albumin and Transmission of Viral Diseases
This product contains albumin, a derivative of human blood. Based on effective donor screening and
product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases.
A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) also is considered extremely
remote. No cases of transmission of viral diseases or CJD have ever been reported for albumin.
ADVERSE REACTIONS
The following adverse reactions to BOTOX® Cosmetic (onabotulinumtoxinA) for injection are discussed
in greater detail in other sections of the labeling:
F &;=0,/:1':C49110.?>(see Warnings and Precautions)
F D;0=>09>4?4A4?D (see Contraindications and Warnings and Precautions)
F D>;3,24,,9/=0,?34924114.@7?40>(see Warnings and Precautions)
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, the adverse reaction rates
observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of
another drug and may not reflect the rates observed in clinical practice.
BOTOX® and BOTOX® Cosmetic contain the same active ingredient in the same formulation, but have
different labeled Indications and Usage. Therefore, adverse events observed with the use of BOTOX®
also have the potential to be observed with the use of BOTOX® Cosmetic.
In general, adverse reactions occur within the first week following injection of
BOTOX® Cosmetic and while generally transient, may have a duration of several months or longer.
Localized pain, infection, inflammation, tenderness, swelling, erythema, and/or bleeding/bruising
may be associated with the injection. Needle-related pain and/or anxiety may result in vasovagal
responses (including e.g., syncope, hypotension), which may require appropriate medical therapy.
Local weakness of the injected muscle(s) represents the expected pharmacological action of botulinum
?:C49:B0A0=B0,690>>:190,=-D8@>.70>8,D,7>::..@=/@0?:>;=0,/:1?:C49 (see Warnings
and Precautions).
Glabellar Lines
Table 2 lists selected adverse reactions reported by ≥1% of BOTOX® Cosmetic treated subjects (N=405)
aged 18 to 75 who were evaluated in the randomized, placebo-controlled clinical studies to assess
the use of BOTOX® Cosmetic in the improvement of the appearance of glabellar lines.
Table 2: Adverse Reactions Reported by ≥1% of the BOTOX® Cosmetic treated Patients
and More Frequent than in Placebo-treated Patients in Double-blind, Placebocontrolled Clinical Studies of Treatment of Glabellar Lines
Adverse Reactions by System
Organ Class
General Disorders and Administration
Site Conditions
Facial pain
Nervous System Disorders
Facial paresis
Eye Disorders
Eyelid ptosis
Musculoskeletal and Connective
Tissue Disorders
Muscular Weakness
BOTOX® Cosmetic
(N=405)
Placebo
(N=130)
6 (1%)
0 (0%)
5 (1%)
0 (0%)
13 (3%)
0 (0%)
6 (1%)
0 (0%)
Lateral Canthal Lines
Table 3 lists selected adverse reactions reported within 90 days following injection
by ≥1% of BOTOX® Cosmetic treated subjects (N=526) aged 18 to 75 who were evaluated in
two randomized, double-blind, placebo-controlled clinical studies to assess the use of
BOTOX® Cosmetic in the improvement of the appearance of lateral canthal lines alone.
Table 3: Adverse Reaction Reported by ≥1% of BOTOX® Cosmetic treated Patients
and More Frequent than in Placebo-treated Patients Within 90 Days, in Doubleblind, Placebo-controlled Clinical Studies of Treatment of Lateral Canthal Lines
Adverse Reactions by System
Organ Class
Eye disorders
Eyelid edema
BOTOX® Cosmetic
24 Units
(N=526)
Placebo
(N=530)
5 (1%)
0 (0%)
Immunogenicity
As with all therapeutic proteins, there is a potential for immunogenicity. Treatment with botulinum
toxins may result in the formation of neutralizing antibodies that may reduce the effectiveness of
subsequent treatments by inactivating biological activity of the toxin.
In three Lateral Canthal Line trials, 916 subjects (517 subjects at 24 Units and 399 subjects at
44 Units) treated with BOTOX® Cosmetic had specimens analyzed for antibody formation. Among
the 916 BOTOX® Cosmetic treated subjects, 14 subjects (1.5%) developed binding antibodies and no
subjects (0%) developed the presence of neutralizing antibodies.
The data reflect the subjects whose test results were considered positive or negative for neutralizing
activity to BOTOX® Cosmetic in a mouse protection assay. The results of these tests are highly
dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence
of antibody (including neutralizing antibody) positivity in an assay may be influenced by several
factors including assay methodology, sample handling, timing of sample collection, concomitant
medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to
BOTOX® Cosmetic with the incidence of antibodies to other products may be misleading.
The critical factors for neutralizing antibody formation have not been well characterized. The results
from some studies suggest that botulinum toxin injections at more frequent intervals or at higher
doses may lead to greater incidence of antibody formation. The potential for antibody formation
may be minimized by injecting with the lowest effective dose given at the longest feasible intervals
between injections.
Post-marketing Experience
Because these reactions are reported voluntarily from a population of uncertain size, it is not
always possible to reliably estimate their frequency or establish a causal relationship to
drug exposure.
There have been spontaneous reports of death, sometimes associated with dysphagia, pneumonia,
and/or other significant debility or anaphylaxis, after treatment with botulinum toxin (see Warnings
and Precautions).
There have also been reports of adverse events involving the cardiovascular system, including
arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk
factors including cardiovascular disease.
New onset or recurrent seizures have also been reported, typically in patients who are predisposed
to experiencing these events.
The following adverse reactions by System Organ Class have been identified during post-approval
use of BOTOX®/BOTOX® Cosmetic:
Ear and labyrinth disorders
D;:,.@>4>?4994?@>A0=?42:
Eye disorders
4;7:;4,7,2:;3?3,78:>>?=,-4>8@>A4>@,7/4>?@=-,9.0>A4>4:9-7@==0/
Gastrointestinal disorders
-/:849,7;,49/4,==30,/=D8:@?39,@>0,A:84?492
General disorders and administration site conditions
090=A,?4:98,7,4>0;D=0C4,
Metabolism and nutrition disorders
Anorexia
Musculoskeletal and connective tissue disorders
!@>.70,?=:;3D8D,724,
Nervous system disorders
=,.34,7;70C:;,?3D/D>,=?3=4,1,.4,7;,7>D3D;:,0>?30>4,7:.,74E0/9@8-90>>8D,>?3094,2=,A4>
;,=0>?30>4,;0=4;30=,790@=:;,?3D=,/4.@7:;,?3D>D9.:;0
Respiratory, thoracic and mediastinal disorders
>;4=,?4:9;90@8:94,/D>;90,=0>;4=,?:=D/0;=0>>4:9,9/:==0>;4=,?:=D1ailure
Skin and subcutaneous tissue disorders
7:;0.4,49.7@/4928,/,=:>4>3D;0=34/=:>4>;=@=4?@>>649=,>349.7@/4920=D?308,8@7?41:=80
dermatitis psoriasiform, and psoriasiform eruption)
DRUG INTERACTIONS
No formal drug interaction studies have been conducted with BOTOX® Cosmetic (onabotulinumtoxinA)
for injection.
Aminoglycosides and Other Agents Interfering with Neuromuscular Transmission
Co-administration of BOTOX® Cosmetic and aminoglycosides or other agents interfering with
neuromuscular transmission (e.g., curare-like compounds) should only be performed with caution as
the effect of the toxin may be potentiated.
Anticholinergic Drugs
Use of anticholinergic drugs after administration of BOTOX® Cosmetic may potentiate systemic
anticholinergic effects.
Other Botulinum Neurotoxin Products
The effect of administering different botulinum neurotoxin products at the same time or within
several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated
by administration of another botulinum toxin prior to the resolution of the effects of a previously
administered botulinum toxin.
Muscle Relaxants
Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after
administration of BOTOX® Cosmetic.
Pregnancy
Teratogenic Effects: Pregnancy Category C.
There are no adequate and well-controlled studies in pregnant women. BOTOX® Cosmetic should be
used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers
It is not known whether BOTOX® Cosmetic is excreted in human milk. Because many drugs are excreted
in human milk, caution should be exercised when BOTOX® Cosmetic is administered to a nursing woman.
Pediatric Use
Safety and effectiveness in patients below the age of 18 years have not been established.
Geriatric Use
Glabellar Lines
In the two initial glabellar lines clinical studies of BOTOX® Cosmetic, the responder rates appeared to
be higher for subjects younger than age 65 than for subjects 65 years or older (see Clinical Studies).
Lateral Canthal Lines
In the two lateral canthal lines clinical studies of BOTOX® Cosmetic, the responder rates appeared to
be higher for subjects younger than age 65 than for subjects 65 years or older.
OVERDOSAGE
Excessive doses of BOTOX® Cosmetic (onabotulinumtoxinA) for injection may be expected to produce
neuromuscular weakness with a variety of symptoms.
Symptoms of overdose are likely not to be present immediately following injection. Should accidental
injection or oral ingestion occur or overdose be suspected, these patients should be considered for
further medical evaluation and appropriate medical therapy immediately instituted, which may include
hospitalization. The person should be medically supervised for several weeks for signs and symptoms
of systemic muscular weakness which could be local, or distant from the site of injection (see Boxed
Warning and Warnings and Precautions).
If the musculature of the oropharynx and esophagus are affected, aspiration may occur which may lead
to development of aspiration pneumonia. If the respiratory muscles become paralyzed or sufficiently
weakened, intubation and assisted respiration may be necessary until recovery takes place. Supportive
care could involve the need for a tracheostomy and/or prolonged mechanical ventilation, in addition
to other general supportive care.
In the event of overdose, antitoxin raised against botulinum toxin is available from the Centers for
4>0,>0:9?=:7,9/$=0A09?4:949?7,9?,:B0A0=?30,9?4?:C49B4779:?=0A0=>0,9D
botulinum toxin-induced effects already apparent by the time of antitoxin administration. In the event
:1>@>;0.?0/:=,.?@,7.,>0>:1-:?@749@8?:C49;:4>:9492;70,>0.:9?,.?D:@=7:.,7:=>?,?00,7?3
Department to process a request for antitoxin through the CDC. If you do not receive a response within
30 minutes, please contact the CDC directly at 1-770-488-7100. More information can be obtained at
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5232a8.htm.
Manufactured by: Allergan Pharmaceuticals Ireland
a subsidiary of: Allergan.
2525 Dupont Dr.
Irvine, CA 92612
© 2015 Allergan. All rights reserved.
®
and ™ marks owned by Allergan.
Based on 71823US20
$'
50
COSMETIC
®
DERMATOLOGY
FAT MELTING:
Female patient
shown before
and one month
after Tickle Lipo.
Before and after results from page 45
post liposuction to improve swelling, decrease bruising and help tighten skin,”
Dr. Emer says. “We do this immediately,
especially after high definition liposuction, which [results in] very little swelling
to allow the skin to sculpt to the muscle
shape. We are currently testing the use
of Vanquish [BLT] to globally heat large
areas after liposuction to improve outcomes, as well. The combinations of possibilities are endless with all the new exciting technologies.”
Dr. DiLauro uses a combination approach to improve patient comfort during liposuction and to accelerate recovery after.
“After infusing the tumescent fluid,
I usually perform external ultrasound
with the Vaser Shape for about 15 minutes while the tumescence is taking effect…,” Dr. DiLauro says. “We have also
found that performing ultrasonic massage in a lymphatic drainage pattern with
the Vaser Shape or regular therapeutic ultrasound several times a week for the first
few weeks after the patient’s liposuction
procedure helps to reduce swelling and
accelerate healing.”
Photos: Marie N.
DiLauro, M.D.
Female patient
shown before
and three weeks
after Tickle Lipo.
Photos: Marie N.
DiLauro, M.D.
THE FUTURE
The future will tell whether and how combined therapies might give liposuctionlike results, according to Dr. Emer.
“…ultimately, you’ll get better results
than a single treatment alone; however,
you will never get high definition liposuction results without doing full contouring, harvesting fat and augmenting the
muscles like the buttocks, chest, shoulders. This gives permanent full fat reduction and new contour with etched and
defined lines that people would never
have had with standard noninvasive or
even the traditional tumescent approach
alone,” Dr. Emer says.
Dr. DiLauro says she doubts there will
be one technology that does it all anytime
soon.
For now, aesthetic physicians have the
options needed to offer patients much
more than fat removal, he says. DT
Disclosures: Dr. Emer is a consultant/luminary and performs clinical trials for Syneron/Candela, Venus, Thermi,
BLT and Valeant. Dr. DiLauro reports no relevant conflicts.
Female patient shown before and after submental lipo with the ProLipo followed by Power X.
Photos: Marie N. DiLauro, M.D.
DESONATE® (desonide) Gel 0.05%
For Topical Use Only
Rx Only
BRIEF SUMMARY
CONSULT PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION
1
Desonate is indicated for the treatment of mild to moderate atopic dermatitis in patients
3 months of age and older.
Patients should be instructed to use Desonate for the minimum amount of time as
necessary to achieve the desired results because of the potential for Desonate to suppress
the hypothalamic-pituitary-adrenal (HPA) axis [see Warnings and Precautions (5.1)].
Treatment should not exceed 4 consecutive weeks [see Dosage and Administration (2)].
4
CONTRAINDICATIONS
Desonate is contraindicated in those patients with a history of hypersensitivity to any of
the components of the preparation.
5
5.1 Effects on Endocrine System
Systemic absorption of topical corticosteroids can produce reversible hypothalamicpituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid
insufficiency. This may occur during treatment or upon withdrawal of the topical
corticosteroid.
The effect of Desonate on HPA axis function was investigated in pediatric subjects, 6
months to 6 years old, with atopic dermatitis covering at least 35% of their body, who
were treated with Desonate twice daily for 4 weeks. One of 37 subjects (3%) displayed
adrenal suppression after 4 weeks of use, based on the cosyntropin stimulation test.
As follow-up evaluation of the subject’s adrenal axis was not performed, it is unknown
whether the suppression was reversible [see Use In Specific Populations (8.4) and
Clinical Pharmacology (12.2)].
Pediatric patients may be more susceptible than adults to systemic toxicity from
equivalent doses of Desonate due to their larger skin surface-to-body mass ratios [see
Use In Specific Populations (8.4)].
Because of the potential for systemic absorption, use of topical corticosteroids may
require that patients be periodically evaluated for HPA axis suppression. Factors that
predispose a patient using a topical corticosteroid to HPA axis suppression include the
use of more potent steroids, use over large surface areas, use over prolonged periods,
use under occlusion, use on an altered skin barrier, and use in patients with liver failure.
An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression.
If HPA axis suppression is documented, an attempt should be made to gradually
withdraw the drug, to reduce the frequency of application, or to substitute a less potent
steroid. Manifestations of adrenal insufficiency may require supplemental systemic
corticosteroids. Recovery of HPA axis function is generally prompt and complete upon
discontinuation of topical corticosteroids.
Cushing’s syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also
result from systemic absorption of topical corticosteroids.
Use of more than one corticosteroid-containing product at the same time may increase
the total systemic corticosteroid exposure.
5.2 Local Adverse Reactions with Topical Corticosteroids
Local adverse reactions may be more likely to occur with occlusive use, prolonged use
or use of higher potency corticosteroids. Reactions may include skin atrophy, striae,
telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions,
hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection,
and miliaria. Some local adverse reactions may be irreversible.
5.3 Concomitant Skin Infections
If concomitant skin infections are present or develop during treatment, an appropriate
antifungal or antibacterial agent should be used. If a favorable response does not occur
promptly, use of Desonate should be discontinued until the infection is adequately
controlled.
5.4 Skin Irritation
If irritation develops, Desonate should be discontinued and appropriate therapy
instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by
observing failure to heal rather than noting a clinical exacerbation as with most topical
products not containing corticosteroids. Such an observation should be corroborated
with appropriate diagnostic patch testing.
6
ADVERSE REACTIONS
Because clinical trials are conducted under widely varying conditions, adverse reaction
rates observed in the clinical trials of a drug cannot be directly compared to rates in the
clinical trials of another drug and may not reflect the rates observed in practice.
In controlled clinical studies of 425 Desonate-treated subjects and 157 Vehicle-treated
subjects, adverse events occurred at the application site in 3% of subjects treated with
Desonate and the incidence rate was not higher compared with vehicle-treated subjects.
The most common local adverse events in Desonate treated subjects were application
site burning in 1% (4/425) and rash in 1% (3/425) followed by application site pruritus
in <1% (2/425).
Adverse events that resulted in premature discontinuation of study drug in Desonate
treated subjects were telangiectasia and worsening of atopic dermatitis in one subject
each. Additional adverse events observed during clinical trials for patients treated with
Desonate included headache in 2% (8/425) compared with 1% (2/157) in those treated
with vehicle.
The following additional local adverse reactions have been reported infrequently with
topical corticosteroids. They may occur more frequently with the use of occlusive dressings,
especially with higher potency corticosteroids. These reactions are listed in an approximate
decreasing order of occurrence: folliculitis, acneiform eruptions, hypopigmentation,
perioral dermatitis, secondary infection, skin atrophy, striae, and miliaria.
8
8.1 Pregnancy
Teratogenic effects: Pregnancy Category C:
There are no adequate and well-controlled studies in pregnant women. Therefore,
Desonate should be used during pregnancy only if the potential benefit justifies the
potential risk to the fetus.
Corticosteroids have been shown to be teratogenic in laboratory animals when
administered systemically at relatively low dosage levels. Some corticosteroids have
been shown to be teratogenic after dermal application in laboratory animals.
No reproductive studies in animals have been performed with Desonate. Dermal
embryofetal development studies were conducted in rats and rabbits with a desonide
cream, 0.05% formulation. Topical doses of 0.2, 0.6, and 2.0 g cream/kg/day of a
desonide cream, 0.05% formulation or 2.0 g/kg of the cream base were administered
topically to pregnant rats (gestational days 6-15) and pregnant rabbits (gestational
days 6-18). Maternal body weight loss was noted at all dose levels of the desonide
cream, 0.05% formulation in rats and rabbits. Teratogenic effects characteristic of
corticosteroids were noted in both species. The desonide cream, 0.05% formulation
was teratogenic in rats at topical doses of 0.6 and 2.0 g cream/kg/day and in rabbits at
a topical dose of 2.0 g cream/kg/day. No teratogenic effects were noted for the desonide
cream, 0.05% formulation at a topical dose of 0.2 g cream/kg/day in rats and 0.6 g
cream/kg/day in rabbits. These doses (0.2 g cream/kg/day and 0.6 g cream/kg/day)
are similar to the maximum recommended human dose based on body surface area
comparisons.
8.3 Nursing Mothers
Systemically administered corticosteroids appear in human milk and could suppress
growth, interfere with endogenous corticosteroid production, or cause other untoward
effects. It is not known whether topical administration of corticosteroids could result in
sufficient systemic absorption to produce detectable quantities in human milk. Because
many drugs are excreted in human milk, caution should be exercised when Desonate is
administered to a nursing woman.
8.4 Pediatric Use
Safety and effectiveness of Desonate in pediatric patients less than 3 months of age have
not been evaluated, and therefore its use in this age group is not recommended.
The effect of Desonate on HPA axis function was investigated in pediatric subjects, with
atopic dermatitis covering at least 35% of their body, who were treated with Desonate twice
daily for 4 weeks. One of 37 subjects (3%) displayed adrenal suppression after 4 weeks
of use, based on the cosyntropin stimulation test [see Warnings and Precautions (5.1)].
In controlled clinical studies in subjects 3 months to 18 years of age, 425 subjects were
treated with Desonate and 157 subjects were treated with vehicle [see Adverse Reactions
(6) and Clinical Studies (14)].
Because of a higher ratio of skin surface area to body mass, pediatric patients are at a
greater risk than adults of HPA axis suppression when they are treated with topical
corticosteroids. They are therefore also at greater risk of glucocorticosteroid insufficiency
after withdrawal of treatment and of Cushing’s syndrome while on treatment.
Adverse effects, including striae, have been reported with inappropriate use of topical
corticosteroids in infants and children. HPA axis suppression, Cushing’s syndrome,
linear growth retardation, delayed weight gain and intracranial hypertension have
been reported in children receiving topical corticosteroids. Manifestations of adrenal
suppression in children include low plasma cortisol levels and absence of response
to ACTH stimulation. Manifestations of intracranial hypertension include bulging
fontanelles, headaches, and bilateral papilledema.
8.5 Geriatric Use
Clinical studies of Desonate did not include patients aged 65 and older to determine
if they respond differently than younger patients. Treatment of this patient population
should reflect the greater frequency of decreased hepatic, renal, or cardiac function, and
of concomitant disease or other drug therapy.
17 PATIENT COUNSELING INFORMATION
Patients using topical corticosteroids should receive the following information and
instructions:
D This medication is to be used as directed by the physician. It is for external use only.
Avoid contact with the eyes.
D This medication should not be used for any disorder other than that for which it was
prescribed.
D Unless directed by the physician, the treated skin area should not be bandaged or
otherwise covered or wrapped so as to be occlusive.
D Unless directed by a physician, this medication should not be used on the underarm
or groin areas of pediatric patients.
D Parents of pediatric patients should be advised not to use Desonate in the treatment
of diaper dermatitis. Desonate should not be applied in the diaper area, as diapers or
plastic pants may constitute occlusive dressing [see Dosage and Administration (2)].
D Patients should report to their physician any signs of local adverse reactions.
D Other corticosteroid-containing products should not be used with Desonate without
first consulting with the physician.
D As with other corticosteroids, therapy should be discontinued when control is
achieved. If no improvement is seen within 4 weeks, contact the physician.
© 2014, Bayer HealthCare Pharmaceuticals Inc. All rights reserved.
Manufactured for:
Bayer HealthCare Pharmaceuticals Inc.
Whippany, NJ 07981
Manufactured in Canada
6706906BS3
Rev. July 2014
CUTANEOUS ONCOLOGY
Melanoma tx: Surgery not obsolete
LOUISE GAGNON | STAFF CORRESPONDENT
Surgery is not a treatment modality that is outdated in the management of advanced melanoma, despite
the existence of very effective novel
treatments, according to Vernon K.
Sondak, M.D., chair,
Department of Cutaneous Oncology, Moffitt Cancer Center, in
Tampa, Fla.
Speaking about the
role of surgery in the
Dr. Sondak
era of immunotherapy at the 10th annual Canadian melanoma conference, Dr. Sondak notes
that surgery remains a highly effective therapy for metastatic melanoma
and it is often an element in the overall treatment for patients with advanced melanoma.
“Surgery is not obsolete,” he says.
“We have to figure out how to use surgery as a component in this new and
rapidly evolving world (of metastatic
melanoma management).”
Unfortunately, even with more options for treatment, many patients
w ill not sur v ive metastatic mela-
QUICK READ
There have been significant strides in
the systemic treatment of metastatic
melanoma, but these advances do
not invalidate surgery as a valuable
part of disease management.
noma, Dr. Sondak stresses.
“There has been a revolution in the
management of (metastatic) melanoma,” he says. “The new drugs, however, are not curing everyone who
gets treated. Despite all the advances
(in systemic treatments), the majority of patients will end up dying of
their metastatic melanoma. A cure in
a majority of patients is still elusive.”
Surgery can be highly effective as a
sole modality, Dr. Sondak says, and he
points to five-year-old data that concluded that 89% of patients with metastatic melanoma achieve “complete
remission” (i.e., are rendered immediately disease-free) with surgery.
The study looked at 77 patients at
multiple sites who had Stage IV melanoma and were considered potential
candidates for surgery to remove all
known metastatic disease.1
“One thing that surgery does that
DTExtra
A median overall survival of longer than two
years was achieved in a group of patients with
metastatic melanoma assigned to treatment
with the combination of two MAPK inhibitors,
dabrafenib and trametinib. According to the
study, “Consistently, good prognostic features
at baseline were associated with both durable ongoing responses and prolonged overall survival and included normal LDH, earlierstage melanoma, and fewer metastatic sites.”
SOURCE: BIT.LY/MAPKINHIBITOR
no other treatment offers is complete
remission for about 90% of patients,”
Dr. Sondak says, adding that the approach to treatment in the metastatic
setting of melanoma is in constant
change.
“Ever y week, we spend time at
our tumor board discussing which
patients should or should not undergo surgery,” he says. “Years ago,
we would have just operated on these
patients and not given these cases a
second thought. The data are coming
fast, and clinical practice is changing. Our criteria (for surger y) are
evolving almost on a weekly basis.”
To date, there are no definitive predictors to know which patients will do
well on a systemic agent like ipilimumab (Yervoy, Bristol-Myers Squibb).
Given that unpredictability, a consensus does not exist about the place
of surgery in treatment, he says. DT
Disclosure: Dr. Sondak is a consultant to BMS,
Merck, GSK, Amgen, Provectus and Novartis.
Read full article and references:
bit.ly/MelanomaSurgeryNotObsolete
Quotable
If someone has late onset
eczema, psoriasis, contact
dermatitis, or other inflammatory entity, do not
hesitate to do a biopsy to
confirm your clinical
suspicion.”
Carrie Kovarik, M.D.
University of Pennsylvania
CTCL, best practices for a clever mimic
See story page 1
53
54
CUTANEOUS
®
ONCOLOGY
CTCL:
Tips for accurate diagnosis of clever mimic from page 1
of precision medicine for patients with
CTCL, [with] patients [receiving] the therapies that are most likely to help them.”
ANSWERS FOR A DIVERSE DISEASE
The genetic work helps to answer important questions about this diverse disease, according to study author Michael
Girardi, M.D., professor and vice chair of
dermatology at Yale School of Medicine.
“By examining the coding regions
of patients’ malignant cells, it was possible to identify the fuller spectrum of
mutations. The mutations that were
identified help explain why the CTCL
cells behave as they do; why they continue to resist cell death and are in a
state of perpetual activation; and why
they suppress the normal T cells,” Dr.
Girardi says.
In fact, several research groups,
including at Stanford, Vanderbilt and
the University of Pennsylvania, have
performed similar CTCL sequencing
studies on their patients. Together, these
studies are helping to complete a fuller
mapping of the genetic alterations possible in CTCL, according to Dr. Girardi.
“The number of genes that can
be affected is mind-boggling, so it is
great to see all this mutational mapping information now also coming out
QUICK READ
Researchers are making important
strides in better understanding
the genetics of cutaneous T
cell lymphoma (CTCL). This
new knowledge could have
major implications for improved
diagnosis and, potentially, new
targeted CTCL therapies.
from different research groups,” Dr.
Girardi says. “Also, recent work from the
Stanford and Harvard groups on high
throughput sequencing of the T-cell
receptor will surely also help enhance
the earlier diagnosis of CTCL, and better distinguish CTCL from inflammatory diseases of the skin.”
DIFFICULT DIAGNOSIS
CTCL can be a difficult diagnosis to
make, especially at the early stages,
according to Dr. Choi.
“Diagnosis takes careful consideration of both the clinical presentation
and the histopathology. CTCL has to be
considered especially for lesions that
appear in sun-protected areas such as
the buttocks,” he says.
According to Susan Thornton,
CEO of the Cutaneous Lymphoma
Foundation, the most challenging
Best practices for diagnosing
CTCL at various stages
Respect the full disease spectrum; the numerous clinical and histologic variants of CTCL
Recognize that CTCL may manifest as very subtle patches with a predilection for sun
protected areas, as follicular papules, as erythroderma and with many other possible
clinical presentations
Perform multiple biopsies at multiple times, to provide the pathologist with as much
information as possible
Perform immunohistochemistry and molecular analysis to try to help distinguish clonal
T cells from reactive T cells
Understand that any or all of the three major compartments of skin, blood and lymph
nodes may be involved
issue dermatologists have in diagnosing cutaneous lymphomas is knowing
when to look beyond what might look
like a typical case of eczema, psoriasis
or other more common skin rashes.
“The number of
genes that can be
affected is mindboggling, and so it
is great to see all
this mutational
mapping
information now
also coming out
from different
research groups.”
Michael Girardi, M.D.
Yale School of Medicine
“Cutaneous lymphomas, especially
mycosis fungoides, is a great mimicker
of other skin diseases. Even under the
microscope it can look like other more
benign skin conditions and be misdiagnosed for years, sometimes decades,”
Thornton tells Dermatology Times. “The
key is understanding the patient’s history, having cutaneous lymphoma as
a possible diagnosis in mind, doing a
punch biopsy of non-treated lesions and
sending to an experienced dermatopathologist for review. Even then, the
results may come back as inconclusive.
This is very frustrating for patients and
physicians as well, which is why it is
very important that patients be referred
to cutaneous lymphoma specialists if
this diagnosis is suspected for a second
opinion, diagnosis, proper disease staging and treatment recommendations.”
Check flow cytometry of the blood, especially in cases of erythroderma
BEST PRACTICES
Examine the lymph nodes and consider a PET/CT scan and lymph node biopsy
Most importantly, respect that CTCL is a diagnosis that may take time, repeated visits
and workups, and a full correlation of clinical, histologic and molecular analyses
Carrie Kovarik, M.D., associate professor, dermatology, dermatopathology,
and infectious diseases, University of
Pennsylvania, says that patients with
CTCL see page 61
CUTANEOUS ONCOLOGY
CTCL:
The future looks brighter from page 54
CTCL can go undiagnosed for many
years, due to initial lack of diagnostic
testing or non-specific biopsy results
in patients with early disease or erythroderma.
“If someone has late onset eczema,
psoriasis, contact dermatitis, or other
inflammatory entity, do not hesitate
to do a biopsy to confirm your clini-
cal suspicion. Doing biopsies from two
separate sites at once can increase your
diagnostic yield. In the setting of high
clinical suspicion, additional gene rearrangement studies from those two sites
can aid in confirming the diagnosis.”
CTCL care should involve collaborations among dermatologists, dermatopathologists, laboratory medicine, med-
Read more on this topic
\ CUTANEOUS LYMPHOMA FOUNDATION:
http://www.clfoundation.org
\ WHOLE-GENOME SEQUENCING REVEALS ONCOGENIC
MUTATIONS IN MYCOSIS FUNGOIDES:
McGirt LY, Jia P, Baerenwald DA, Duszynski RJ, Dahlman KB, Zic JA, Zwerner JP, Hucks D,
Dave U, Zhao Z, Eischen CM. Whole-genome sequencing reveals oncogenic mutations in mycosis fungoides. Blood. 2015 Jul 23;126(4):508-19.
http://bit.ly/mycosisfungoidesstudy
\ GENOMIC ANALYSES REVEAL RECURRENT MUTATIONS IN
EPIGENETIC MODIFIERS AND THE JAK-STAT PATHWAY INSÉZARY
SYNDROME:
Kiel MJ, Sahasrabuddhe AA, Rolland DC, Velusamy T, Chung F, Schaller M, Bailey NG, Betz
BL, Miranda RN, Porcu P, Byrd JC, Jeffrey Medeiros L, Kunkel SL, Bahler DW, Lim MS, Elenitoba-Johnson KS. Genomic analyses reveal recurrent mutations in epigenetic modifiers and
the JAK-STAT pathway in Sézary syndrome. Nat Commun. 2015 Sep 29;6:8470.
http://bit.ly/SezaryJAKStat
\ GENOMIC ANALYSIS OF MYCOSIS FUNGOIDES AND SÉZARY
SYNDROME IDENTIFIES RECURRENT ALTERATIONS IN TNFR2:
Ungewickell A, Bhaduri A, Rios E, Reuter J, Lee CS, Mah A, Zehnder A, Ohgami R, Kulkarni S,
Armstrong R, Weng WK, Gratzinger D, Tavallaee M, Rook A, Snyder M, Kim Y, Khavari PA. Genomic analysis of mycosis fungoides and Sézary syndrome identifies recurrent alterations in
TNFR2. Nat Genet. 2015 Sep;47(9):1056-60. Epub 2015 Aug 10.
http://bit.ly/TNFR2alterations
\ TCR SEQUENCING FACILITATES DIAGNOSIS AND IDENTIFIES
MATURE T CELLS AS THE CELL OF ORIGIN IN CTCL:
Kirsch IR, Watanabe R, O’Malley JT, Williamson DW, Scott LL, Elco CP, Teague JE, Gehad A,
Lowry EL, LeBoeuf NR, Krueger JG, Robins HS, Kupper TS, Clark RA. TCR sequencing facilitates diagnosis and identifies mature T cells as the cell of origin in CTCL. Sci Transl Med.
2015 Oct 7;7(308):308ra158.
http://bit.ly/TCRsequencing
ical oncology and radiation oncology,
according to Dr. Choi.
And when they don’t feel comfortable prescribing the medications used
to treat CTCL, dermatologists should
refer these patients, Dr. Choi says.
Dr. Girardi points out that “most dermatologists feel comfortable managing
stage 1A patients, with less than 10%
body surface area involvement. The
accessibility of specialized and multidisciplinary CTCL centers is a major
factor to consider for more advanced
disease, as these typically provide the
patient with a more comprehensive
evaluation of CTCL, the latest in diagnostic testing and access to cuttingedge clinical trials.”
The National Cancer Comprehensive
Network (NCCN) guidelines are a great
resource for various treatment modalities available to CTCL patients based
on their stage of disease, according to
Dr. Kovarik.
“Go to www.nccn.org, then guidelines
for non-hodgkins lymphoma,” she says.
A BRIGHTER, MORE TARGETED FUTURE
In as early as the next few years, next
generation sequencing will revolutionize the detection, treatment and management of CTCL, according to Dr. Choi.
“I don’t think it will be long before
every patient has their CTCLs sequenced
and this information is used to guide
treatment strategies,” Dr. Choi says. DT
Disclosures: Drs. Choi, Girardi, and Kovarik report
no relevant disclosures.
Reference:
1. Choi J, Goh G, Walradt T, Hong BS, Bunick CG,
Chen K, Bjornson RD, Maman Y, Wang T, Tordoff J,
Carlson K, Overton JD, Liu KJ, Lewis JM, Devine
L, Barbarotta L, Foss FM, Subtil A, Vonderheid EC,
Edelson RL, Schatz DG, Boggon TJ, Girardi M, Lifton RP. Genomic landscape of cutaneous T-cell
lymphoma. Nat Genet. 2015 Sep; 47(9):1011-9.
\ THE DIFFICULT-AND OFTEN DELAYED-DIAGNOSIS OF CTCL:
Weed J, Girardi M. The difficult-and often delayed-diagnosis of CTCL. Sci Transl Med. 2015
Oct 7;7(308):308fs41.
http://bit.ly/delayeddiagnosis
Questions? Comments?
Give Dermatology Times your
feedback by contacting us at
[email protected]
61
62
BUSINESS
®
OF DERMATOLOGY
THE DISRUPTIVE M.D.
74 DEFINING
Better communication equals healthy work
enviroments and increased effectiveness
FOR 2016 HIPAA AUDITS
78 TIPS
These 7 tips will help you prepare to pass
For more articles like this, see bit.ly/DermPulse
audits with flying colors
How personality type
impacts dermatology practice
ROBERT W. MCALPINE | CORRESPONDENT
Psychologist Carl Jung identified eight
mental processes that people use to acquire and evaluate information.
What’s interesting is that each of us
is more likely to use the processes that
come naturally to us and that we prefer.
We use the processes that don’t come as
naturally less consciously and often with
less control and skill; yet, to be most effective, we need to be able to use all the
processes effectively, calling on the one
that’s most needed in a particular situation, according to Robert W. McAlpine,
president of Type Resources, a company
that provides clients with the knowledge
they need to use personality type theory
successfully with individuals and teams.
UNDERSTAND YOUR PREFERENCES
The Myers-Briggs Type Indicator (MBTI)
is a tool that indicates which mental processes an individual is likely to prefer. Finding those preferences is the first step in
using personality types to one’s advantage.
“By understanding our ‘default’ processes, we can begin to identify blindspots in our ways of interacting with others,” Mr. McAlpine says.
INFORMATION INTAKE
McAlpine explained to Dermatology Times
each mental process, highlighting the ways
in which it might play out in a dermatologist’s interactions with patients, staff and
administrative responsibilities.
The first four mental processes focus
on information gathering.
Extraverted sensation. Extraverted
sensation helps to make one aware of
his or her current physical environment.
This process has a present time orientation, Mr. McAlpine says.
“It also draws one to engage with what
is providing the greatest attraction, and
to stay with that engagement until something more attractive enters the environment,” he adds. “With patients, this process is used to observe the condition of
the skin. With staff, it is used to notice
Quotable
PERSONALITY TYPE see page 66
DTExtra
“If you see recruiting
ads for certain states or
areas, it’s either saying
there’s a shortage or it’s
not a desirable location.
That can either be a good
thing or a bad thing.”
Neal Bhatia, M.D.
San Diego, Calif.
How do derms decide where to practice?
See story page 69
what staff members are doing, and how
they are doing what they are doing. From
a business perspective, it provides information about what competing practices
are doing and how patients are responding to how they are being treated.”
Introverted sensation. Individuals
with this preference verify what they
are experiencing or the information they
have received by checking with how well
it matches what they’ve experienced or
have been taught in the past. Unlike extraverted sensation, introverted sensation has a past time orientation.
With patients, this process is used to
compare what one is observing according to past observations, to identify similarities and differences, and to remember
what forms of treatment one has tried before on similar skin conditions, Mr. McAlpine explains, adding that “with the staff,
it is used to recognize changes in performance, allowing one to recognize improvements or make an intervention
if necessary. From a business perspec-
Medical associations and physicians have
expressed both optimism and concern regarding
the recent pledge by Centers for Medicare and
Medicaid Services (CMS) Acting Administrator
Andy Slavitt that the Meaningful Use program will
end in 2016 and be replaced by “something
better.” Questions range from what will replace
the current program to whether non-attesting
physicians will still be liable for penalties to
whether the EHR certification program will
continue in its current form.
READ THE FULL ARTICLE: BIT.LY/DTMEANINGFULUSE
BRIEF SUMMARY (see package insert for Full Prescribing Information)
®
(pimecrolimus) Cream 1%
Elidel
FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE. Rx Only.
See WARNINGS and boxed WARNING concerning long-term safety of topical
calcineurin inhibitors.
CONTRAINDICATIONS
ELIDEL (pimecrolimus) Cream 1% is contraindicated in individuals with a history of
hypersensitivity to pimecrolimus or any of the components of the cream.
WARNINGS
WARNING Long-term Safety of Topical Calcineurin Inhibitors Has Not Been Established
Although a causal relationship has not been established, rare cases of malignancy (e.g., skin and
lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including
ELIDEL Cream.
Therefore:
G ;:@5:A;A?8;:3@1>9A?1;2@;<5/-8/-8/5:1A>5:5:45.5@;>?5:/8A05:3>1-95:
any age group should be avoided, and application limited to areas of involvement with
atopic dermatitis.
G >1-95?:;@5:05/-@102;>A?15:/4580>1:81??@4-:E1->?;2-31
Prolonged systemic use of calcineurin inhibitors for sustained immunosuppression in animal
studies and transplant patients following systemic administration has been associated
with an increased risk of infections, lymphomas, and skin malignancies. These risks are
associated with the intensity and duration of immunosuppression.
Based on this information and the mechanism of action, there is a concern about a potential
risk with the use of topical calcineurin inhibitors, including ELIDEL Cream. While a causal
relationship has not been established, rare cases of skin malignancy and lymphoma have
been reported in patients treated with topical calcineurin inhibitors, including ELIDEL Cream.
Therefore:
G >1-9?4;A80:;@.1A?105:599A:;/;9<>;95?10-0A8@?-:0/4580>1:
G 2 ?53:? -:0 ?E9<@;9? ;2 -@;<5/ 01>9-@5@5? 0; :;@ 59<>;B1 C5@45: C117? <-@51:@?
should be re-examined by their healthcare provider and their diagnosis be confirmed
(see PRECAUTIONS).
G &41?-21@E;2>1-94-?:;@.11:[email protected]?410.1E;:0;:1E1->;2:;:/;:@5:A;A?
use. (See CLINICAL PHARMACOLOGY, WARNINGS, boxed WARNING, PRECAUTIONS,
INDICATIONS AND USAGE, and DOSAGE AND ADMINISTRATION.)
PRECAUTIONS
General: The use of ELIDEL Cream should be avoided on malignant or pre-malignant skin
conditions. Malignant or pre-malignant skin conditions, such as cutaneous T-cell lymphoma
(CTCL), can present as dermatitis. ELIDEL Cream should not be used in patients with
Netherton’s Syndrome or other skin diseases where there is the potential for increased
systemic absorption of pimecrolimus. The safety of ELIDEL Cream has not been established
in patients with generalized erythroderma. The use of ELIDEL Cream may cause local
symptoms such as skin burning (burning sensation, stinging, soreness) or pruritus. Localized
symptoms are most common during the first few days of ELIDEL Cream application and
typically improve as the lesions of atopic dermatitis resolve (see ADVERSE REACTIONS).
Bacterial and Viral Skin Infections: Before commencing treatment with ELIDEL Cream,
bacterial or viral infections at treatment sites should be resolved. Studies have not
evaluated the safety and efficacy of ELIDEL Cream in the treatment of clinically infected
atopic dermatitis. While patients with atopic dermatitis are predisposed to superficial
skin infections including eczema herpeticum (Kaposi’s varicelliform eruption), treatment
with ELIDEL Cream may be independently associated with an increased risk of varicella
zoster virus infection (chicken pox or shingles), herpes simplex virus infection, or eczema
herpeticum. In clinical studies, 15/1,544 (1%) cases of skin papilloma (warts) were observed
in patients using ELIDEL Cream. The youngest patient was age 2 and the oldest was age 12.
In cases where there is worsening of skin papillomas or they do not respond to conventional
therapy, discontinuation of ELIDEL Cream should be considered until complete resolution of
the warts is achieved.
Patients with Lymphadenopathy: In clinical studies, 14/1,544 (0.9%) cases
of lymphadenopathy were reported while using ELIDEL Cream. These cases of
lymphadenopathy were usually related to infections and noted to resolve upon appropriate
antibiotic therapy. Of these 14 cases, the majority had either a clear etiology or were known
to resolve. Patients who receive ELIDEL Cream and who develop lymphadenopathy should
have the etiology of their lymphadenopathy investigated. In the absence of a clear etiology
for the lymphadenopathy, or in the presence of acute infectious mononucleosis, ELIDEL
Cream should be discontinued. Patients who develop lymphadenopathy should be monitored
to ensure that the lymphadenopathy resolves.
Sun Exposure: During the course of treatment, it is prudent for patients to minimize or avoid
natural or artificial sunlight exposure, even while ELIDEL is not on the skin. The potential
effects of ELIDEL Cream on skin response to ultraviolet damage are not known.
Immunocompromised Patients: The safety and efficacy of ELIDEL Cream in
immunocompromised patients have not been studied.
Information for Patients (See Medication Guide.)
Drug Interactions: Potential interactions between ELIDEL and other drugs, including
immunizations, have not been systematically evaluated. Due to low blood levels of
pimecrolimus detected in some patients after topical application, systemic drug interactions
are not expected, but cannot be ruled out. The concomitant administration of known CYP3A
family of inhibitors in patients with widespread and/or erythrodermic disease should be done
with caution. Some examples of such drugs are erythromycin, itraconazole, ketoconazole,
fluconazole, calcium channel blockers and cimetidine.
Carcinogenesis, Mutagenesis, Impairment of Fertility: In a 2-year rat dermal
carcinogenicity study using ELIDEL Cream, a statistically significant increase in the
incidence of follicular cell adenoma of the thyroid was noted in low, mid and high dose male
animals compared to vehicle and saline control male animals. Follicular cell adenoma of the
thyroid was noted in the dermal rat carcinogenicity study at the lowest dose of 2 mg/kg/day
[0.2% pimecrolimus cream; 1.5× the Maximum Recommended Human Dose (MRHD) based
on AUC comparisons]. No increase in the incidence of follicular cell adenoma of the thyroid
C-?:;@105:@41;>-8/->/5:;31:5/5@E?@A0E5:9-81>-@?A<@;
93730-EI $
based on AUC comparisons). However, oral studies may not reflect continuous exposure or
the same metabolic profile as by the dermal route.
In a mouse dermal carcinogenicity study using pimecrolimus in an ethanolic solution, no
increase in incidence of neoplasms was observed in the skin or other organs up to the highest
dose of 4 mg/kg/day (0.32% pimecrolimus in ethanol) 27x MRHD based on AUC comparisons.
However, lymphoproliferative changes (including lymphoma) were noted in a 13 week repeat
dose dermal toxicity study conducted in mice using pimecrolimus in an ethanolic solution
at a dose of 25 mg/kg/day (47x MRHD based on AUC comparisons). No lymphoproliferative
changes were noted in this study at a dose of 10 mg/kg/day (17x MRHD based on AUC
comparison). However, the latency time to lymphoma formation was shortened to 8 weeks
after dermal administration of pimecrolimus dissolved in ethanol at a dose of 100 mg/kg/day
(179-217x MRHD based on AUC comparisons).
In a mouse oral (gavage) carcinogenicity study, a statistically significant increase in the
incidence of lymphoma was noted in high dose male and female animals compared to vehicle
control male and female animals. Lymphomas were noted in the oral mouse carcinogenicity
study at a dose of 45 mg/kg/day (258-340x MRHD based on AUC comparisons). No drugrelated tumors were noted in the mouse oral carcinogenicity study at a dose of 15 mg/kg/day
D $.-?10;:'/;9<->5?;:?:-:;>-83-B-31>-@/->/5:;31:5/5@E?@A0E
a statistically significant increase in the incidence of benign thymoma was noted in 10
mg/kg/day pimecrolimus treated male and female animals compared to vehicle control
treated male and female animals. In addition, a significant increase in the incidence of
benign thymoma was noted in another oral (gavage) rat carcinogenicity study in 5 mg/kg/day
pimecrolimus treated male animals compared to vehicle control treated male animals.
No drug-related tumors were noted in the rat based on AUC comparisons) and at a dose of
5 mg/kg/day for female animals (21x MRHD based on AUC comparisons). In a 52-week dermal
photo-carcinogenicity study, the median time to onset of skin tumor formation was decreased
in hairless mice following chronic topical dosing with concurrent exposure to UV radiation
(40 weeks of treatment followed by 12 weeks of observation) with the ELIDEL Cream vehicle
alone. No additional effect on tumor development beyond the vehicle effect was noted with the
addition of the active ingredient, pimecrolimus, to the vehicle cream.
A 39-week oral monkey toxicology study was conducted with pimecrolimus doses of 15, 45
and 120 mg/kg/day. A dose dependent increase in expression of immunosuppressive-related
lymphoproliferative disorder (IRLD) associated with lymphocryptovirus (a monkey strain of
virus related to human Epstein Barr virus) was observed. IRLD in monkeys mirrors what
has been noted in human transplant patients after chronic systemic immunosuppressive
therapy, post transplantation lymphoproliferative disease (PTLD), after treatment with
chronic systemic immunosuppressive therapy. Both IRLD and PTLD can progress to
lymphoma, which is dependent on the dose and duration of systemic immunosuppressive
therapy. A dose dependent increase in opportunistic infections (a signal of systemic
immunosuppression) was also noted in this monkey study.
An oral fertility and embryofetal developmental study in rats revealed estrus cycle
disturbances, post-implantation loss and reduction in litter size at the 45 mg/kg/day dose
(38× MRHD based on AUC comparisons). No effect on fertility in female rats was noted at
10 mg/kg/day (12× MRHD based on AUC comparisons). No effect on fertility in male rats
was noted at 45 mg/kg/day (23× MRHD based on AUC comparisons), which was the highest
dose tested in this study (see full Prescribing Information for additional Carcinogenesis,
Mutagenesis and Impairment of Fertility data).
Pregnancy Teratogenic Effects
Pregnancy Category C: There are no adequate and well-controlled studies of topically
administered pimecrolimus in pregnant women. The experience with ELIDEL Cream when
used by pregnant women is too limited to permit assessment of the safety of its use
during pregnancy. Pimecrolimus was transferred across the placenta in oral rat and rabbit
embryofetal developmental studies. There are, however, no adequate and well-controlled
studies in pregnant women. Because animal reproduction studies are not always predictive
of human response, this drug should be used only if clearly needed during pregnancy.
Nursing Mothers: It is not known whether this drug is excreted in human milk. Because of
the potential for serious adverse reactions in nursing infants from pimecrolimus, a decision
should be made whether to discontinue nursing or to discontinue the drug, taking into
account the importance of the drug to the mother.
Pediatric Use: ELIDEL Cream is not indicated for use in children less than 2 years of age.
The long-term safety and effects of ELIDEL Cream on the developing immune system are
unknown (see WARNINGS, boxed WARNING, and INDICATIONS AND USAGE).
Three Phase 3 pediatric studies were conducted involving 1,114 patients 2-17 years of
-31&C;?@A051?C1>1C117>-:0;95F10B145/81/;:@>;8810?@A051?C5@4-C117;<1:
label phase and one was a vehicle-controlled (up to 1 year) safety study with the option for
?1=A1:@5-8@;<5/-8/;>@5/;?@1>;50A?1"2@41?1<-@51:@?C1>1E1->?;2-31:
the short-term studies, 11% of ELIDEL patients did not complete these studies and 1.5% of
ELIDEL patients discontinued due to adverse events. In the one-year study, 32% of ELIDEL
patients did not complete this study and 3% of ELIDEL patients discontinued due to adverse
events. Most discontinuations were due to unsatisfactory therapeutic effect.
The most common local adverse event in the short-term studies of ELIDEL Cream in pediatric
patients ages 2-17 was application site burning (10% vs. 13% vehicle); the incidence in the
long-term study was 9% ELIDEL vs. 7% vehicle (see ADVERSE REACTIONS). Adverse events
that were more frequent (>5%) in patients treated with ELIDEL Cream compared to vehicle
C1>141-0-/41
B?5:@41?4;>@@1>9@>5-8!-?;<4->E:35@5?B?
5:KA1:F-
(13% vs. 4%), pharyngitis (8% vs. 3%), viral infection (7% vs. 1%), pyrexia (13% vs. 5%),
/;A34
B?
-:041-0-/41B?
C1>15:/>1-?10;B1>B145/815:@41
E1->
safety study (see ADVERSE REACTIONS). In 843 patients ages 2-17 years treated with ELIDEL
Cream, 9 (0.8%) developed eczema herpeticum (5 on ELIDEL Cream alone and 4 on ELIDEL
Cream used in sequence with corticosteroids). In 211 patients on vehicle alone, there were no
cases of eczema herpeticum. The majority of adverse events were mild to moderate in severity.
Two Phase 3 studies were conducted involving 436 infants age 3 months-23 months. One
6-week randomized vehicle-controlled study with a 20-week open-label phase and one
safety study, up to one year, were conducted. In the 6-week study, 11% of ELIDEL and 48%
of vehicle patients did not complete this study; no patient in either group discontinued due
to adverse events. Infants on ELIDEL Cream had an increased incidence of some adverse
events compared to vehicle. In the 6-week vehicle-controlled study these adverse events
included pyrexia (32% vs. 13% vehicle), URI (24% vs. 14%), nasopharyngitis (15% vs. 8%),
gastroenteritis (7% vs. 3%), otitis media (4% vs. 0%), and diarrhea (8% vs. 0%). In the
open-label phase of the study, for infants who switched to ELIDEL Cream from vehicle, the
incidence of the above-cited adverse events approached or equaled the incidence of those
patients who remained on ELIDEL Cream. In the 6 month safety data, 16% of ELIDEL and
35% of vehicle patients discontinued early and 1.5% of ELIDEL and 0% of vehicle patients
discontinued due to adverse events. Infants on ELIDEL Cream had a greater incidence
of some adverse events as compared to vehicle. These included pyrexia (30% vs. 20%),
URI (21% vs. 17%), cough (15% vs. 9%), hypersensitivity (8% vs. 2%), teething (27% vs. 22%),
vomiting (9% vs. 4%), rhinitis (13% vs. 9%), viral rash (4% vs. 0%), rhinorrhea (4% vs. 0%),
and wheezing (4% vs. 0%).
Geriatric Use: Nine (9) patients ≥65 years old received ELIDEL Cream in Phase 3 studies.
Clinical studies of ELIDEL did not include sufficient numbers of patients aged 65 and over to
assess efficacy and safety.
ADVERSE REACTIONS
No phototoxicity and no photoallergenicity were detected in clinical studies with 24 and
33 normal volunteers, respectively. In human dermal safety studies, ELIDEL (pimecrolimus)
Cream 1% did not induce contact sensitization or cumulative irritation.
In a one-year safety study in pediatric patients age 2-17 years old involving sequential
use of ELIDEL Cream and a topical corticosteroid, 43% of ELIDEL patients and 68% of
vehicle patients used corticosteroids during the study. Corticosteroids were used for
more than 7 days by 34% of ELIDEL patients and 54% of vehicle patients. An increased
incidence of impetigo, skin infection, superinfection (infected atopic dermatitis), rhinitis, and
urticaria were found in the patients that had used ELIDEL Cream and topical corticosteroid
sequentially as compared to ELIDEL Cream alone.
In 3 randomized, double-blind vehicle-controlled pediatric studies and one active-controlled
adult study, 843 and 328 patients respectively, were treated with ELIDEL Cream. In these
clinical trials, 48 (4%) of the 1,171 ELIDEL patients and 13 (3%) of 408 vehicle-treated
patients discontinued therapy due to adverse events. Discontinuations for AEs were primarily
due to application site reactions, and cutaneous infections. The most common application
site reaction was application site burning, which occurred in 8%-26% of patients treated
with ELIDEL Cream.
The following table depicts the incidence of adverse events pooled across the 2 identically
designed 6-week studies with their open label extensions and the 1-year safety study for
pediatric patients ages 2-17. Data from the adult active-controlled study is also included in
this table. Adverse events are listed regardless of relationship to study drug.
Two cases of septic arthritis have been reported in infants less than one year of age in
clinical trials conducted with ELIDEL Cream (n = 2,443). Causality has not been established.
Treatment Emergent Adverse Events ( ≥1%)
Pediatric
Pediatric Patients*
Patients*
Vehicle-Controlled
Open-Label
(20
(6 Weeks)
(1 Year)
Weeks)
Elidel
Elidel
Elidel
Elidel
Elidel
Cream
Cream
Cream
Cream
Cream
(N=267) (N=136) (N=335) (N=272)
(N=75)
%
%
%
%
%
At Least 1 AE
68
71
72
85
75
Infections and Infestations
Upper Respiratory
14
13
19
5
8
Tract Infection NOS
Nasopharyngitis
10
7
20
27
21
Skin Infection NOS
3
5
5
2
4
Influenza
3
1
7
13
4
Ear Infection NOS
3
5
5
2
4
Otitis Media
2
1
3
3
5
Impetigo
2
2
4
4
5
Bacterial Infection
2
2
1
1
0
Folliculitis
1
1
1
2
4
Sinusitis
1
1
3
2
1
Pneumonia NOS
1
1
2
0
1
Pharyngitis NOS
1
2
1
8
3
Pharyngitis
1
2
3
0
<1
Streptococcal
Molluscum
1
0
1
2
0
Contagiosum
Staphylococcal
<1
4
2
0
<1
Infection
Bronchitis NOS
<1
2
1
11
8
Herpes Simplex
<1
0
1
3
3
Tonsillitis NOS
<1
0
1
6
0
Viral Infection NOS
1
1
<1
7
1
Gastroenteritis NOS
0
2
1
7
3
Chickenpox
1
0
1
3
4
Skin Papilloma
<1
0
1
3
<1
Tonsillitis Acute NOS
0
0
0
3
0
Pediatric Patients*
Vehicle-Controlled
*Ages 2-17 years
Adult Active
Comparator
(1 Year)
Elidel
Cream
(N=328)
%
78
4
8
6
10
6
1
2
2
6
1
<1
1
0
0
1
2
4
1
0
2
<1
0
0
Upper Respiratory Tract
<1
0
1
Infection Viral NOS
Herpes Simplex
0
0
<1
Dermatitis
Bronchitis Acute NOS
0
0
0
Eye Infection NOS
0
0
0
General Disorders and Administration Site Conditions
Application Site
10
13
2
Burning
Pyrexia
8
9
12
Application Site
3
5
2
Reaction NOS
Application Site
3
6
1
Irritation
Influenza Like Illness
<1
0
1
Application Site
<1
0
0
Erythema
Application Site
1
2
1
Pruritus
Respiratory, Thoracic and Mediastinal Disorders
Cough
12
8
9
Nasal Congestion
3
2
2
Rhinorrhea
2
1
1
Asthma Aggravated
2
2
4
Sinus Congestion
1
1
1
Rhinitis
<1
0
2
Wheezing
<1
1
1
Asthma NOS
1
1
3
Epistaxis
0
1
0
Dyspnea NOS
0
0
0
Gastrointestinal Disorders
Abdominal Pain Upper
4
4
3
Sore Throat
3
4
5
Vomiting NOS
3
4
4
Diarrhea NOS
1
1
1
Nausea
<1
2
1
Abdominal Pain NOS
<1
1
2
Toothache
<1
1
1
Constipation
<1
0
1
Loose Stools
0
1
1
Reproductive System and Breast Disorders
Dysmenorrhea
1
0
2
Eye Disorders
Conjunctivitis NEC
1
1
2
Skin and Subcutaneous Tissue Disorders
Urticaria
1
0
<1
Acne NOS
0
1
<1
Immune System Disorders
Hypersensitivity NOS
4
4
5
Injury and Poisoning
Accident NOS
1
1
<1
Laceration
1
1
2
Musculoskeletal, Connective Tissue and Bone Disorders
Back Pain
<1
2
<1
Arthralgias
0
0
<1
Ear and Labyrinth Disorders
Earache
1
1
0
Nervous System Disorders
Headache
14
9
11
2
0
<1
2
0
1
2
1
0
<1
0
<1
9
7
26
13
5
1
3
3
15
<1
4
6
2
3
2
2
0
2
2
0
6
16
2
<1
1
<1
4
1
4
3
2
11
1
1
1
<1
7
<1
3
1
1
2
1
0
0
1
2
0
2
<1
1
6
8
7
8
4
4
3
4
<1
7
5
8
5
7
4
1
<1
<1
<1
4
1
2
2
<1
1
0
0
1
1
1
2
4
3
<1
2
<1
<1
1
2
5
1
3
<1
<1
1
<1
0
0
<1
1
0
1
2
2
3
3
0
25
16
7
*Ages 2-17 years
POST-MARKETING EVENTS
The following adverse reactions have been reported in patients using ELIDEL Cream. Because
these reactions are reported voluntarily from a population of uncertain size, it is not always
possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
General: Anaphylactic reactions, ocular irritation after application of the cream to the eye lids
or near the eyes, angioneurotic edema, facial edema, skin flushing associated with alcohol
use, skin discoloration
Hematology/Oncology: Lymphomas, basal cell carcinoma, malignant melanoma,
squamous cell carcinoma
OVERDOSAGE
There has been no experience of overdose with ELIDEL (pimecrolimus) Cream 1%. If oral
ingestion occurs, medical advice should be sought.
Manufactured by:
Novartis Pharma Produktions GmbH
Wehr, Germany
Distributed by:
Valeant Pharmaceuticals North America, LLC. Bridgewater, NJ 08807
REV. 02/2014 (based on #2079799 06/11)
DM/ELD/14/0010(1)
66
BUSINESS
®
OF DERMATOLOGY
PERSONALITY TYPE:
How yours affects your practice from page 62
tive, it allows one to coming a positive supportpare one’s current perforing relationship with all
mance with how one persuppliers, competitors
formed in the past. Some
and users of one’s serbusiness comparisons
vices, as one never knows
might be financial, supwhen one might need to
ply management, time
call their help.”
spent per patient or waitIntroverted feeling.
ing time per patient.”
This is a mental proExtraverted intucess that assesses how
ition. A mental process
well what one is doing
with a future orientation,
matches with one’s core
extraverted intuition
values.
identifies patterns within
“From a patient’s perthe experiences or inforspective it’s what needs
mation and explores posto be teased out of the
sibilities for using recogpatient so that the docnized patterns.
tor knows what is im“With patients this
portant to the patient.
would identify when skin
With the staff, the same
conditions are appearing
is true because it’s havacross the person’s body
ing an alignment beinstead of on just an isotween what is expected
lated area, or appearing
of a staff member, and
across patients instead
what is important to the
of (in) just one patient.
staff member that builds
These patterns might
commitment to the orbe used to recommend
ganization,” Mr. McAlchanges in one’s lifestyle We asked readers to select the personality style with which they most resonated. Above is how our derma- pine says. “It’s this protology population stacks up against the general United States. For a legend describing each individual
or to identify environ- personality style, see: bit.ly/MBTIdermstyles.
cess that gives the doctor
mental changes that are
input into whether one’s
putting the health of the
take, and the same is true from a busiinterventions are, or have
community at risk,” Mr. McAlpine says.
ness perspective.”
been, adequate, regardless of how the cli“With the staff, it could be used to discuss
The next four are decision-making
ent has responded or progressed. From
what improvements might be made in
mental processes.
a business perspective, it provides the
office procedures that would make work
“Just as we are all always gathering
incentive to find solutions to the probeasier and more patient-friendly. Similar
information, we are also always evallems the organization faces and to push
types of improvement discussion could
uating that information to make dethrough to success.”
be applied to multiple business aspects,
cisions. Remember, everyone uses all
Introverted thinking. It is through
as well.”
of these processes, but we all are more
introverted thinking’s use that desired
Introverted intuition. Introverted incomfortable using some versus others,”
goals or objectives are precisely develtuition is not impacted by time. Instead,
Mr. McAlpine says.
oped and stated along with everything
this mental process synthesizes what
Extraverted feeling. Used to assess
that is effected by achieving those goals
has been acquired through the previthe state of the relationship among peoor objectives.
ous three processes to arrive at one’s inple, extraverted feeling involves meeting
“It’s the process the doctor uses to
terpretation of the meaning of all of the
the patient in the patient’s psychologiknow what can be achieved and all of the
information.
cal space and interacting to establish a
ramifications of the treatment. It is then
“While this knowing may come impositive relationship with the patient, acused to explain the expected outcome to
mediately, it is most likely to take refleccording to Mr. McAlpine.
the patient,” Mr. McAlpine says. “With
tion time to allow the synthesis to occur
“It involves maintaining a posithe staff, it is used to define and clarify
and the knowing to form in one’s contive supportive relationship with the
expectations, and, from a business persciousness,” Mr. McAlpine says. “With
staff and among the staff members.
spective, it identifies the goals and obpatients, it is this knowing that guides
It also means having the staff interjectives the leadership seeks to achieve.”
the dermatologist in understanding the
acting with the patients in a way that
Extraverted thinking. This process
skin condition of the client and whether
has the patient feeling good about
is used to plan how to achieve a deit is unique to the client or a community
having selected this clinic,” he says.
sired goal or objective. It sequences all
issue. With the staff, it provides a sense
“In the business environment, it means
activitiesthatmustoccurandmonitorsthe
PERSONALITY TYPE see page 80
of knowing what actions to take or not
not burning bridges; instead, maintain-
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www.epiduoforte.com/hcp
BUSINESS OF DERMATOLOGY
Deciding where to practice?
These questions may help you think it through
Deciding where to practice and spend
your foreseeable future is a big deal
for young dermatologists. A few key
questions can help you determine the
practice destination that’s right for you.
As a rule of thumb, dermatologist
Neal Bhatia, M.D., advises new dermatologists to first consider what’s
important to them for the next five
to 10 years.
“For many younger derms, t he
first job is not their last,” says Dr.
Bhatia, director of clinical dermatology at Therapeutics Clinical Research, in San Diego, Calif. “What’s
important? And what are you willing
to trade off?”
Thinking five to 10 years out, these
key considerat ions t hat can help
dermatologists choose their perfect
practice location.
WHAT IS YOUR FOCUS?
Many dermatologists focus on where
they want to live, not on what they
want to practice. But type of practice
and location often go hand in hand,
according to Dr. Bhatia.
Dermatologists should do research
on the market before they open a
practice of their choice, to help ensure demand.
family are. It might also be where dermatologists have built-in referral bases
or community ties that lead to patients.
Sometimes, ‘home’ is where dermatologists trained. After completing Accreditation Council for Graduate Medical Education- (ACGME-) accosmetic practices in Bevcredited programs, 47.8% of
erly Hills, where there is a
physicians stayed or returned
dermatologist on every corto the state where they comner, might find themselves
pleted their most recent gradfighting for patients against
uate medical education, acdermatologists who either
cording to the Association of
already have an established
Medical Colleges 2011 State
base or an established legacy.
Physician Workforce Data
PERCENT
“Why would you want to
Book.
of physicians
But going home isn’t the
set yourself up for failure?
stayed or returned
best
idea if you think you
Or are you prepared to go
to the state where
can
rely
on the patronage
the long run in an environthey completed
their
most
recent
of
friends,
family and conment that you may not make
graduate
medical
tacts.
Dr.
Bhatia
says he went
overhead for some time?” Dr.
education
back
home
to
Milwaukee
and
Bhatia asks.
started
a
dermatology
pracDermatologists who want
tice with the advice of friends (includto practice medical dermatology gening friends he trained with in internal
erally have their pick of locations, acmedicine), as well as family.
cording to Dr. Bhatia.
“I opened in an area where there
“If you want to start on your own in
wasn’t a dermatologist for a couple
medical dermatology, the real trick is,
where can you really handle living?
of miles. I was near the hospital. On
Because the need for medical dermapaper, it made a lot of sense that this
tology is nationwide, and you can go
would be a good fit. What I didn’t know
almost anywhere in the rural part of
is that the market was in evolution and,
the country and not only make a dewithin a few years, I lost half of my recent income but have a really solid
ferral base because of the consolidation going on. I also had trouble maintaining status quo because of the way
insurances were changing,” Dr. Bhatia
says. He notes that “Milwaukee wasn’t
a big vanity market at the time. One
of the mistakes I made early was buying a laser … and the laser just ended
up sitting.”
QUICK READ
Making a decision where to open
or join a practice affects you, your
family, and your future. Experts say:
Consider the market and
your passions.
47.8
“If you see recruiting ads for certain
states or areas, it’s either saying there’s
a shortage or it’s not a desirable
location. That can either be a
good thing or a bad thing.”
WHAT IS YOUR PROFESSIONAL BLISS?
Neal Bhatia, M.D.
San Diego, Calif.
“New residents in training want to
open these big cosmetic practices in
big cities, where there’s no demand
[because the market is saturated].
They want to go to places that are
more where they want to live, rather
than where they want to work,” Dr.
Bhatia says.
Dermatologists who want to open
practice. It’s a little bit of a risk, and
it takes courage to make that decision,” Dr. Bhatia says.
WHERE ARE YOU IN YOUR LIFE?
Going home is a strong preference
for many dermatologists after their
residencies, according to Dr. Bhatia.
Home tends to be where friends and
Some go for the big job offer, which,
according to Dr. Bhatia, usually has
to be really good for someone to think
about moving to a brand new location.
Yet another preference is to go
where you’re needed, to serve communities in need of dermatologists,
or to go where you can learn from the
best — to an academic hub, for example.
WHERE TO PRACTICE see page 70
69
70
BUSINESS
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OF DERMATOLOGY
WHERE TO PRACTICE:
Follow your professional bliss from page 69
“If you’re from Southern California, there has to be a real draw for you
to want to go to North Dakota. But if
there’s big demand in North Dakota
and the job is really good, someone
might consider it,” Dr. Bhatia says.
Der m atolog i st L au ren E c ker t
Ploch, M.D., M.Ed.,
says she and her husband, a radiologist,
received an offer in
Aiken, S.C., that the
couple cou ldn’t ref use. “I’m ac t ua l ly
Dr. Ploch
going to be practicing primarily in Augusta, Georgia,
but will be living in Aiken. Both Aiken
and Augusta are relatively under-
served areas,” Dr. Ploch says, adding
that she thinks that “a big challenge
facing dermatologists is whether to
join a large group [or] hospital vs. a
small group vs. solo practice.”
According to Dr. Ploch, “Most dermatologists my age are intimidated
by the administrative demands of
private practice, so they prefer to join
a larger organization straight out of
residency. This may lead younger dermatologists to settle in cities where
these larger hospitals are located,
leaving rural areas and smaller towns
underserved. It seems like many people choose jobs based on opportunity
vs. what will make them happy in the
future.”
WHAT ARE THE LEAST AND MOST
DERM-DENSE AREAS?
Researchers published a study in 2010
in the Archives of Dermatology that
looked at areas in the United States
with the highest and lowest concentrations of dermatologists per capita.1
According to the study, the areas
with the highest derm density per
100,000 population are number one
Downtown Boston, Mass., followed
by Palo Alto, Calif., Manhattan, N.Y.,
and Santa Monica, Calif.
Among the least derm-dense areas:
Trenton, N.J., Lexington, Kentucky,
Mansfield, Ohio, and Chattanooga,
Tenn.
WHAT IS YOUR TARGET MARKET’S
DERM SATURATION?
Destination specialist weighs in
WHAT DOES A LOCATION EXPERT SAY?
Bert Sperling, founder of Sperling’s Best Places and www.bestplaces.net, makes his living helping
people find their best places to live, work and retire. He shares some of his tips for professionals with Dermatology Times:
Quality of life is high in the Pacific Northwest.
“People are making the choice to maybe not be in Boston or some other recognized center for practice because they want to have a ‘better’ lifestyle,” Mr.
Sperling says.
Some of the really hot cities for quality of life: Portland, Oregon, seems to
be on everybody’s short list, he says. Others are Asheville, N.C., and Austin,
Texas. Interestingly, Pittsburgh is very affordable and seems to be trending. The city is coming back
strong after a 100 years of decline, he notes. Minnesota is “hot” for a state, according to Mr. Sperling, because it’s striving to be a destination state for new residents. Minneapolis is regularly included as one of the top five livable cities in the United States.
Mr. Sperling
Urban living is trending.
“People seem to want to live more in towards the city and enjoy more city living as opposed to living
in the suburbs, like they used to 20 years ago. It seems like everybody wants to move in towards the
city, where things are happening,” he says.
What are the worst places?
Mr. Sperling says that it’s his feeling that there are no worst places to live.
“There are places that are struggling. There are places that are challenging. Cleveland, Detroit, Syracuse, places like that are having a tough time. They’re all tremendously affordable. As a result, the
housing stock is really inexpensive. For young people and for anyone willing to take a chance (people
with more energy than money), those places present an opportunity to do urban pioneering or urban
homesteading. You can stake a claim for not much money and help the city recover,” he says.
He adds that “I was talking to the Mayor of Rockford, Ill. Rockford is a place that has been struggling to remake itself after being home to manufacturing and industrial businesses — many of
which have moved off shore. He returned to his hometown and became mayor in his mid-thirties.
He says he could have stayed in Chicago and just been working with everybody else there, but by
coming back to Rockford, he’s making a real difference in what’s happening in the community.” DT
One way to find out how many dermatologists are in your immediate
area is to search your zip code, city
or town for how many dermatologists
are around.
Another tip, according to Dr. Bhatia, is to look at where the recruiters
are doing their recruiting.
“If you see recruiting ads for certain
states or areas, it’s either saying there’s
a shortage or it’s not a desirable location. That can either be a good thing
or a bad thing,” Dr. Bhatia says.
Dr. Bhatia notes that especially
aspiring cosmetic dermatologists
should consider looking beyond dermatologists as potential competition.
Medical spas, for example, offer esthetic services, including those traditionally offered by dermatologists
a nd cosmet ic su rgeons, in some
states.
WHAT DO YOU WANT IN A LOCATION?
Moving to a destination for its lifestyle
isn’t much fun if you’re working nonstop to start a new practice, according to Dr. Bhatia. “That’s a driver that
needs to be tempered with some reality. I think a reality that a lot of new
derms miss out on is, where is the best
opportunity to develop a practice and
grow?” Dr. Bhatia says.
Never t heless, you have to li ke
where you are. Definitely, spend time
in the location before moving there,
Dr. Bhatia says.
WHERE TO PRACTICE see page 76
72
BUSINESS
®
OF DERMATOLOGY
A rural dermatologist
tells his story
“Two roads diverged in a
wood… I took the one less
traveled by… And that has
made all the difference.”
– Robert Frost
Jeffrey M. Suchniak, M.D., a medical dermatologist at the Boice-Willis
Clinic in Rocky Mount, N.C., didn’t
transition to a rural practice; he decided to stay at a rural practice.
Di sc u s si ng h i s dec i sion w it h
Dermatolog y Times, Dr. Suchniak
says, “After residency, the person who
agreed to hire me in South Carolina
became injured and could not afford
to pay me what we agreed upon, so I
scrambled for a job in Rocky Mount.
My original intent was to only stay a
few years, until I knew exactly where
I wanted to raise my family and what
sort of practice I wanted to run. But as
time went on, I began to realize that
the patient base I had was exactly the
patient type I wanted to see.”
Today, his practice is nearly 100%
general adult and pediatric dermatology, with a focus on treating cancer.
Dr. Suchniak lived in Rocky Mount
for six years; then, moved 50 minutes
away to North Raleigh and has been
commuting to Rocky Mount for the
past nine years.
According to Dr. Suchniak, Rocky
Mount, like many of the nation’s rural
communities, is comprised of hardworking, salt-of-the-earth people —
many of whom are either farmers or
grew up on a farm.
“I see a large amount of patients (40
to 45 per day), 70- to 80- and 90-yearolds, who are just riddled with skin
cancers and pre-cancers,” he says,
adding that “in contrast, the city does
not retain a lot of people in their 20s
and 30s, which is the age range that
tends to use their expendable cash on
minor cosmetics.”
For a dermatologist who enjoys
treating skin cancers, a rural location has a seemingly endless supply of
patients. And the cases are often in-
teresting and unusual, according to
the dermatologist.
THE PROS
According to Dr. Suchniak, the pros of
practicing in a rural area include:
\ The flexibility to mold your practice
the way you want, as competition is usually minimal.
\ Medical dermatology is in demand
and can be lucrative, without the added
pressure to expand into cosmetics in
order to attract or to keep a steady patient base.
\ The patients are varied, with a wide
variety of skin conditions.
\ Dermatologists in rural America provide access. Patients sometimes travel for
hours to see rural dermatologists because
they’re closer than those in big cities.
\ “Another joy is that patients still respect
our opinion and very often leave decisions in our hands as they understand
that as trained physicians we honestly
do know how best to treat them, and not
‘Dr. Google,’” Dr. Suchniak says.
\ Dr. Suchniak says he actually gets to
sit down with patients, to educate and
explain things to them.
\ “Additionally, in very small communities the very people we treat are frequently people our children go to school
with, who we go to church with, and see
at the local sports games, which adds
a depth to the relationships we make.
Commutes to and from work are also
generally much easier and relaxing,
leaving much more time for your family and hobbies,” he says.
THE CONS
The very aspect of living and practicing
in a small town can be challenging, especially when it has been a long day and
you just need to pick up a few groceries, Dr. Suchniak says. That’s when Mrs.
Jones and three other patients stop you
to give you quick updates on their rash
and even to seek additional counseling,
while you are waiting for your cold cuts.
“Also, a certain level of familiarity
can lead to patients believing that they
should be treated differently than other
patients, which can be challenging,” he
says. “Other issues with rural living are
more obvious, such proximity to professional sports, good restaurants, unique
amenities and the airport, if you travel
a lot or have frequent guests.”
WORDS OF ADVICE
Do your homework on before you decide to move. The area should be able to
support the addition of a dermatologist.
The local population should be comprised of the age group and economic
caliber of patients you want to serve.
Consider how social a person you are.
As a dermatologist in a rural area, you
will be seeing your patients everywhere
you go in the town, and you will be engaged in friendly conversation constantly, even on days you would prefer
not to be, according to Dr. Suchniak. DT
74
BUSINESS
®
OF DERMATOLOGY
For more articles like this, see bit.ly/DermPulse
How to limit disruptive behavior
Experts highlight tactics to encourage open culture, accountability
RANDY DOTINGA | STAFF CORRESPONDENT
When a hospital’s top brass met recently to discuss how to cope with errors, the chief of surgery gathered her
courage and confessed a mistake she’d
made years earlier. While the surgeon’s
error wasn’t fatal, she’d still felt guilt
and shame.
“It had eaten away at her for years,
but she was finally willing to share to
make it easier for us to have that discussion,” recalls John Henry Pfifferling, Ph.D., who led the meeting. But
the response wasn’t what the surgeon
expected.
The other doctors criticized her and
even questioned whether she should
continue as chief of surgery. “She was
so vulnerable,” Dr. Pfifferling says,
“and they couldn’t stand it. She violated the code that said don’t be vulnerable, don’t share, don’t feel.”
Dr. Pfifferling, who’s spent decades
fighting the menace of the “disruptive physician,” was appalled. But
he wasn’t surprised. Too many physicians, he says, continue to isolate
themselves and either ignore or discount the views of their colleagues. In
a word, they disrupt.
But Dr. Pfifferling, director of The
Center for Professional Well-Being,
and others haven’t given up on their efforts. Prevention and communication,
they say, are crucial in every doctor’s
QUICK READ
A disruptive physician isn’t
necessarily aggressive in an obviously
obnoxious way. The disruption may
come from behaving in a way that
interferes with others’ work, not
communicating across specialties
or teams, or failing to give or receive
effective feedback. Here’s what you
can do to avoid a disrespectful and
non-professional environment.
office regardless of specialty or focus.
“No physician group is immune to
this,” says Charles Samenow, M.D.,
M.P.H., an assistant professor in the
department of psychiatry and behavioral sciences at George Washington
University, who recently gave a presentation on disruptive physicians to medical professionals in Montevideo, Uruguay. “We want to help folks learn skills
to improve the culture of medicine.”
WHO IS THE DISRUPTIVE PHYSICIAN?
The first step is to understand the lingo
of the doctor well-being movement. To
a large degree, “disruptive physician” is
a fancy term for a simple concept: The
doctor is being a jerk.
“It refers to somebody who is causing a problem in the workplace,” says
Michael F. Myers, M.D., professor of clinical psychiatry with the department
of psychiatry & behavioral sciences
at SUNY Downstate Medical Center.
“It usually means the doctor has acted
“At Vanderbilt, they call the disruptive
physician the ‘distressed’ physician to
focus on the problem of the physician as
opposed to the problems they cause. All
... have some sort of problem in terms of
work/life balance, burnout, family issues
or lack of interpersonal skills.”
Charles Samenow, M.D.
George Washington University
inappropriately in the eyes of co-workers, whether they’re other physicians or
trainees, nurses or secretaries.”
Dr. Samenow, who helped evaluate
the program for troubled physicians at
the Vanderbilt Center for Professional
Health, puts it this way: “At Vanderbilt,
they call the disruptive physician the ‘distressed’ physician to focus on the problem of the physician as opposed to the
problems they cause. All of the distressed
physicians they’ve worked with have
some sort of problem in terms of work/
life balance, burnout, family issues or
lack of interpersonal skills.”
Some types of behavior are obviously
disruptive, like swearing, throwing instruments or physically hurting someone
else. Just a few weeks ago, for example, Dr.
Pfifferling heard from a second-year neurosurgery resident who had to get stitches
after a surgeon kicked him under an operating table when he answered a question incorrectly.
But a disruptive physician isn’t necessarily aggressive in an obviously
obnoxious way. “Another type is the
person who is behaving in a passiveaggressive way,” Dr. Myers says. “He’s
a nice guy but he’s not showing up, we
can’t find them when he’s on call, he’s
slow to pick up his pager or return cell
phone calls, the nurses are getting upset
that things are being held up in the procedure room. He’s behaving in a way that’s
causing grief to other people as opposed
to the person who’s so obvious.”
DISMISSIVENESS IS A SYMPTOM TOO
What about the colleagues of the chief of
surgery who saw her vulnerability as an
opening to attack her? Dr. Pfifferling says
they’re disruptive physicians too. “She got
shamed and isolated,” he says. “Shaming
is just unacceptable.”
The severe isolation built into
medicine—even among dermatologists—contributes to this kind of
behavior, he says, adding that doctors
don’t communicate well with physicians
from other specialties, and physicians
as a whole don’t communicate well with
nurses, administrators and pharmacists.
DISRUPTIVE PHYSICIANS see page 76
76
BUSINESS
®
OF DERMATOLOGY
DISRUPTIVE PHYSICIANS:
Derms face unique challenges from page 74
“The silo mentality prevents true
teamwork,” says Dr. Pfifferling, and
it can lead to even more disruption
because people outside the bubble
feel as if they’re ignored. He adds,
“You don’t listen to people from other
tribes because they’re not acceptable
to you, and you never get a chance to
learn what they believe and give them
real legitimacy.”
Even those within a silo — fellow
dermatologists, for example — may
neglect each other. “Peers won’t listen
to peers because they’re competitors,”
he says. “You think they want to one-up
you so you don’t trust them.”
CHALLENGING THE SYSTEM,
CHALLENGING COLLEAGUES
Within recent years the world of medicine has begun to better understand
and combat the disruptive physician.
Medical systems are evolving to encourage better communication and require physicians to accept feedback
and criticism. Consultants from the
airline industry, for example, have spoken to medical teams about the importance of allowing lower-level employees like nurses and residents to challenge the decisions of their superiors.
“If you want to deal with disruptive
behavior, you have to change the entire
mindset of physicians,” Dr. Pfifferling
says. Starting at the very beginning,
in medical school, “you have learn to
give positive and critical feedback to
those around you.” In turn, those who
are challenged, like professors, must
be willing to accept criticism without
retaliation, he says.
UNIQUE ISSUES FOR DERMATOLOGISTS
Dr. Pfifferling has worked with dermatologists, and he says they face unique
challenges on two fronts.
Firstly, they may be perfectionists
who obsess about potentially missing
conditions like cancer. “They do such a
number on themselves that they’re exhausted,” he says.
In fact, he says, “control is a myth,”
and vulnerability about uncertainty
should be encouraged instead of dismissed. “Sometimes you have a patient
who dies,” he says, “and it is appropriate to go to a funeral because it tore your
heart out.”
Secondly, he says that dermatologists
may also feel as if doctors in other specialties dismiss them as inferior. This can
isolate these physicians from dermatologists and hurt patients by preventing
cross-talk between specialties, he says.
HOW TO DISRUPT THE DISRUPTIVE
What can physicians do to avoid a disrespectful and non-professional environment in their offices? Gerald B. Hickson, M.D., senior vice president for quality, safety and risk prevention at Vanderbilt University Medical Center, says
anyone running a practice should make it
clear that staff and patients should speak
up about problems. “I want everyone to feel free to tell
me when they see things that are disrespectful or not consistent with the
goals of our practice,” he says. “That’s
also good business practice.”
Dr. Hickson cautions, however, that
“we’re not seeking a culture of perfection.” Instead, the goal is an openness
and willingness to address the occasional human slip.
“At Vanderbilt, team members use
their eyes and ears and become our
surveillance system, Dr. Hickson says.
A total of 120 trained “peer messengers”
are available to share patient and staff
stories with those associated with behaviors that appears to be inappropriate.
“Within two days of when one of these
reports is submitted, 92% will be shared
by a peer in a respectful, non-judgmental way,” he says. “These conversations
take less than three minutes and occur
as close in time to the event as possible.”
This system also allows leaders to
identify those who are associated with
more than their fair share of events and
take action promoting accountability.
“Two percent of our professionals
account for half the staff complaints,
and 5% account for 35% of patient complaints,” Dr. Hickson says, adding that
“If someone is unwilling or unable to respond to these respectful communications by peers, then we have sufficient
reason to suspect that there’s an underlying problem. As fellow professionals, we
need to get them to the right services and,
if possible, appropriate remediation.”
If things go well, another silo —
another bubble, another cage — will
break down in favor of better communication and more well-being. DT
WHERE TO PRACTICE:
Corollary considerations from page 70
“Some places sound great until
you actually visit and spend time,”
Dr. Bhatia says.
D r. Plo c h s a y s t he p erk s of a
place a ren’t a lways ev ident u nt i l
you become more intimate w ith a
location.
For e x a mple, a lt houg h D r.
Ploch’s pay is similar in A iken to
what it was in New Orleans, where
she used to practice, the dollar goes
a lot further in Aiken.
“The gas is cheaper, and real estate in some areas is less expensive.
Stretching your dollar makes it much
easier to travel, retire or purchase a
home. It’s also better for work-life
balance for us. We’re much closer to
hiking and biking trails. It’s a golfer’s
paradise, if you like to golf. It’s also
much easier to travel from here…,”
Dr. Ploch says. “We’re only 2.5 hours
from t he At lantic coast (Charleston), three hours from Atlanta, and
two hours from Charlotte. New Orleans is pretty geographically isolated (six hours from Houston and
six to seven hours from Atlanta), so
weekend trips were difficult unless
we wanted to fly somewhere.” DT
RESOURCES:
1. Yoo JY, Rigel DS. Trends in dermatology: geographic
density of US dermatologists. Arch Dermatol. 2010
Jul;146(7):779. http://archderm.jamanetwork.com/
article.aspx?articleid=421611
78
BUSINESS
®
OF DERMATOLOGY
From the pages of
7 ways to prepare for 2016 HIPAA audits
RACHEL V. ROSE | STAFF CORRESPONDENT
Phase two of audits for the Health
Insurance Portability and Accountability Act (HIPAA) are coming this year as
the Office of Civil Rights (OCR) looks to
crack down on violations.
Why is there so much emphasis on
meeting standards that have been required for two decades in some instances? It’s due mainly to the increased
use of technology in healthcare and
accompanying cybersecurity risks. The
purpose of this article is to provide an
overview of the OCR audit program
(phase 2), identify key areas of risk and
provide suggestions on how to mitigate
adverse findings.
OCR AUDIT PROGRAM
In 2011, OCR launched the requisite OCR
Pilot Privacy, Security, and Breach Notification Audit Program. For the first phase,
only covered entities were audited. This
second phase includes business associates of covered entities.
Regardless of the type of entity, the
time frames for the audit are the same.
From the time the audit notification
letter is sent from OCR, organizations
should plan on a 30- to 90-day process.
Analogous to a Recovery Audit Contractor (RAC) audit, an entity has a certain
period of time to produce the requested
information. The information may be requested either on-site or as a desk audit,
which is described below.
Next, OCR reviews the information
provided and drafts a report. The entity
then has the opportunity to review and
respond to the draft report, after which
OCR finalizes the report.
The scope of the phase 1 audits was
limited to the federal Privacy, Security
and Breach Notification Rules. This does
not mean that a state law or international
law provision may have been violated —
it just was not addressed in phase 1
audits.
Phase 2 audits will be more robust, in
part due to a $4 million increase in OCR’s
2016 budget. Another area of difference
will be the number of on site versus desk
audits. During the phase 1 audits, covered entities were evaluated by a third
party, who visited them on-site. Phase 2
audits will include a greater number of
desk audits — entities responding to the
audits from their desks by providing policies and documentation of privacy policies and procedures to HHS.
This serves as a signal —a key administrative area that will be looked at during the audits are the adequacy of policies and procedures. Therefore, the
number of administrative and security
violations could increase significantly.
KEY AREAS OF RISK
A good place for practices to start is to
look at the findings from phase 1, as well
as recent penalties that were assessed by
HHS for HIPAA violations. Violations occurred in the administrative, technical
and physical realms. Primarily, policies
and procedures were found to be inadequate; encryption of USB drives, laptops
and email was found to be lacking; and
inadequate employee security awareness
and training were some of the major areas
of vulnerability.
MITIGATE ADVERSE FINDINGS
The most prudent approach is to be prepared ahead of time, much like an IRS or
Joint Commission audit. Whatever aspect of HIPAA compliance an organization is addressing, a good vantage point
from which to start is the patient information. Every action should take into account the confidentiality, integrity and
availability of the information. The way to
make employees and contractors aware
is through training. While the required
way to hold business associates and subcontractors accountable is through the
contractual obligations in a business associate agreement (BAA). Moreover, an
annual risk assessment is a must. And,
the HHS website is the ideal place to find
explanations of what is set out in the laws
and regulations.
Here are some tips to make sure that
the practice is HIPAA compliant and
avoid an adverse audit outcome.
Begin compliance efforts from the
➊
vantage point of the government,
who may “review pertinent policies,
procedures, or practices of the covered
entity or business associate and of the
circumstances regarding any alleged
violation.”
Read Section 164.316 for what is
required in relation to policies and
procedures from an administrative,
technical and physical aspect.
Curtail policies and procedures to
your individual practice.
Know where the external and internal sources of protected health
information are located.
Encrypt everything, both at rest
and in transit, and make sure that
the level of encryption utilized is adequate.
Train employees. Trustwave is a
reputable vendor that has online
training or various organizations offer
live courses.
Perform due diligence on various
third party risk assessors for expertise, price and quality.
OCR audits and HIPAA compliance
should not be taken lightly. RAC audits also started with a pilot program
more than a decade ago and now generate a substantial amount of revenue for
the government, as well as serving as a
check on providers’ claims submissions.
Those submissions, by the way, are also
required to be HIPAA-compliant.
➋
➌
➍
➎
➏
➐
CONCLUSION
The overall goal of the phase 2 audits is to
raise awareness and provide the opportunity for entities to correct their practices surrounding the creation, receipt,
transmission and maintenance of protected health information.
The flip side, however, is that OCR
may assess a penalty. Given that there
are going to be more on-site and business associate audits, the findings may
translate into increased scrutiny by OCR
on other fronts. Therefore, organizations
of all types should look at the OCR audit
like an IRS audit: A practice should be
prepared for an audit. Failure to do so
could be costly. DT
Read the full article:
bit.ly/DT7waysHIPAA
80
BUSINESS
®
OF DERMATOLOGY
EDITORIAL:
Optimism in the face of uncertainty from page 14
know, when did I bump my head?) On
the other hand, it could be even worse
with even more governmental intrusions.
THE HEALTHCARE SYSTEM
The options for future healthcare delivery systems are relatively few in
number, especially since I believe that
most current private health insurers will
cease to exist in the future as an effort
will be made to have all people covered
under one system that is managed and
paid for by the government.
During the current presidential
debates there have been discussions
on “single-payer” systems similar to
an expansion of our current Medicare
system or a “socialized medicine”
system similar to our current Veterans
Health Administration system where
the government pays the bills, employs the physicians and healthcare
providers and also owns the facilities.
My personal prediction is that the
most likely future healthcare system
will be of the single-payer type,
perhaps with some affiliation with a
small number of select private insurance companies.
CONCLUSION
In 2007, 44% of dermatologists were in
solo practice, but by 2014 that number had
dropped to 35%. Further, the percentage of
dermatologists in dermatology specialty
group practices and multispecialty group
practices averaged 50% to 60%.
No matter what happens over the next
several decades, I remain optimistic about the future of the specialty of
dermatology.
Certainly changes can be anticipated, but I believe our specialty has
worked very hard as a group to
scientifically advance the care of our
patients with skin disease and that
must never be allowed to diminish. DT
PERSONALITY TYPE:
How yours affects your practice from page 66
sequence to regulate activities, so that all
happens at the appropriate time.
“With regard to patients, it’s the process doctors use to explain how they plan
to conduct a procedure to the client. It lets
the client know what is going to happen
and how it will happen,” Mr. McAlpine
says. “When used with the staff, it aligns
performance activities with the goals
and objectives of the organization. From
a business perspective, it can be used to
ensure that all activities in the organization are contributing to the organization
achieving its goals and objectives.”
PUTTING KNOWLEDGE INTO PRACTICE
Now that you know the eight mental processes, how can you use them to your advantage? The answer, according to Mr.
McAlpine, is to recognize what each mental process provides, and its need in the
workplace.
“Then, a person can seek to become
self-aware as to which mental processes
one tends to use and which ones tend to
be overlooked or shortchanged,” he says.
“Another way is to take a moment to
focus on the task one is about to attempt
to accomplish, and assess what mental
processes are essential for that task, so
one can be more aware of the need to use
each mental process at the appropriate
time and in the appropriate way.”
REAL-LIFE EXAMPLES
Mr. McAlpine offers these real-life examples of how physicians he has encountered have used the mental processes.
1. About a month ago I had an accident
and had to go see a surgeon. When the
surgeon came into the exam room he
immediately focused on my injury and
started to examine the injury without
introducing himself. Couldn’t he have
taken a moment to introduce himself
and ask how I almost amputated my
finger? This is a definite example of a
failure to use Extraverted Feeling and
an over focus on Extraverted Sensation.
2. I had a dermatology appointment recently during which the dermatologist,
upon entering the room, immediately
noticed my finger and inquired about
how I hurt it and how it was healing.
He used both Extraverted Sensation
and Extraverted Feeling appropriately.
Later in the visit, he was examining a
place on my nose and recognized that
he had attempted to freeze the spot before, which is a great example of Introverted Sensation.
3. Several years ago when diagnosed with
colon cancer, the surgeon took the time
to explain all of the treatment options
and success rates to my wife and I. He
also described, from start to finish, how
each possible treatment would be performed. This was a great example of Extraverted Intuition, Introverted Thinking and Extraverted Thinking. He then
used Extraverted Feeling by leaving us
alone to discuss the options for about 10
minutes. [He returned] to answer our
questions, [then left] us alone, again. He
continued this process for approximately
two hours, while we worked our way to
a solution. When we told him our solution, he agreed with the decision. I have
never felt so supported than the way he
supported us through that process. DT
FOR MORE INFORMATION:
1. www.type-resources.com
2. http://www.myersbriggs.org/
my-mbti-personality-type/mbti-basics/
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85
86
Marketplace
Dermatology Times |
April 2016
CAREERS
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Contact Christie Knowles, (904) 354-4488 or
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DELAND, FLORIDA
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BOCA RATON, FLORIDA
Dermatology of Boca seeks an Associate/Partner
to join rapidly growing practice.
Please email CV to
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April 2016
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Marketplace
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87
88
Marketplace
Dermatology Times |
April 2016
CAREERS
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Part Time/Full Time Dermatologist for General/
Cosmetic/Surgical practice in Eugene, Oregon.
Dreyer Dermatology for 30 years has been setting the
standard for excellent patient care. Eugene is rich in both
outdoor sports but cultural offerings as well. Excellent
schools and access to world class healthcare provides
opportunities for great work-life balance.
Work-life benefits include:
r'MFYJCMFXPSLIPVSTr(FOFSPVT.BUFSOJUZMFBWF
r(VBSBOUFFE*ODPNF
Please forward cover letter and Resume to:
[email protected]
Seeking BC/BE Dermatologist in San Antonio, Texas
one of America’s fastest growing and most affordable cities
We need an exceptional dermatologist to join our busy, diverse practice, which includes adult and pediatric
derm/surg, cosmetic and laser treatments, and a full clinical research center.
t Full or part-time opportunity
t Diverse and friendly patient base
t Outstanding clinical and support staff
t Partnership track available
t Competitive compensation and benefits
In the heart of San Antonio’s South Texas Medical Center
Please send your CV & cover letter to [email protected]
Contact information:
Patricia Doucet, Practice Manager
7810 Louis Pasteur, STE 200 | San Antonio, TX 78229 | 210-614-3355
April 2016
|
Marketplace
CAREERS
TEXAS
Marketplace
Can Work For You!
★
Department of Medicine
Division of Dermatology &
Cutaneous Surgery
Reach highly-targeted,
market-specific business
professionals, industry
ACADEMIC DERMATOLOGIST POSITION
The Department of Medicine, Division of Dermatology and Cutaneous Surgery at The
University of Texas Health Science Center at San Antonio (UTHSCSA) is seeking a
full time Academic Dermatologist. The applicant should have an M.D. or D.O., and be
board certified (or board eligible) in Dermatology. The applicant should be motivated,
organized, and have the ability to perform in all areas of medical and surgical dermatology.
The applicant should be able to fulfill the dermatology support needed for the division as
well as provide instruction for our residents in our GME Dermatology residency program.
Cosmetic experience is also preferred.
The University of Texas Health Science Center at San Antonio is the largest medical
institute in South Texas, serving San Antonio and the 50,000 square-miles of South Texas
with a population of more than 4.2 million. The city of San Antonio, the seventh most
populated in the U.S. has a vibrant art community that reflects the rich history and culture
of the area with affordable housing, excellent schools, and a low crime rate. This unique
city offers some of the best cultural institutions, events, restaurants and friendly people
in South Texas.
Interested candidates should contact
Dr. Sandra Osswald at
email: [email protected]
The University of Texas Health Science Center at San Antonio is an Equal Employment
Opportunity/Affirmative Action Employer including protected veterans and persons with
disabilities. All faculty appointments are designated as security sensitive positions.
★
experts and prospects by
placing your ad here!
★
★
★
Call Joanna Shippoli
to place your
Recruitment ad
at 800.225.4569
ext. 2615
[email protected]
WASHINGTON
Physician - Dermatology
Virginia Mason Medical Center in Seattle, WA is recruiting Dermatologists for both the main campus and selected
surrounding regions. Our dermatologist provide medical dermatology and if desired, cosmetics. The Dermatology section
is recognized for high quality work and collegial environment. We have a very high volume of patients, many of whom also
receive both their primary and specialty care in our multispecialty clinic.
We have an excellent team of dermatopathologists who both support the clinical work and jointly share education and
quality initiatives. We have a dedicated Moh’s surgeon who is a member of the Dermatology section. We have a generous
compensation and benefits package.
Virginia Mason Medical Center is a multi-specialty clinic and 340 bed acute care hospital that stresses Team Medicine
for the ideal management of patients. We are a recognized leader in quality and safety. Our organization has received
numerous awards from organizations such as Healthgrades and Leap Frog. We are associated with an immunology focused
research institute. There are multiple opportunities for clinical research if desired.
Seattle is an exceptional place that combines the amenities of urban experience with proximity for many outdoor activities
such as skiing, boating, hiking, and innumerable sports. Seattle is a great place for family and children with excellent schools,
parks, music, and educational programs. It is considered one of America’s most livable cities.
Our ideal candidate is BE/BC in dermatology and prefers to work in a multi-specialty
clinic that is focused on maximizing the patient experience.
For more information and to apply online, please visit jobs.VirginiaMason.org. EOE.
RECRUITMENT
ADVERTISING
Can Work For You!
Reach highly-targeted,
market-specific
business professionals,
industry experts and
prospects by placing
your ad here!
Repeating an ad ENSURES it will be seen and remembered!
89
90
Marketplace
Dermatology Times |
April 2016
CAREERS
VERMONT
WISCONSIN
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Repeating an ad ENSURES it will be
seen and remembered!
EOE/AA/LEP
DERMATOLOGIST
Gundersen Health System in La Crosse,
Wisconsin, is seeking a BC/BE dermatologist
to work in our new state-of-the-art facility.
Your practice will consist of general
medical dermatology with opportunities
for dermatologic surgery (regular and
cosmetic), medical education and clinical
research within one of the nation’s largest
multi-specialty group practices. Services
currently offered include MOHS Surgery,
Photodynamic Therapy, PUVA, Broad and
Narrow Band UVB, Vascular Laser
Treatment and multiple IPLs.
Contact: Kalah Haug, Medical Staff
Recruitment, (608) 775-1005 or email
[email protected].
Visit: gundersenhealth.org/MedCareers
Visit us at
AAD Booth
#7348
Gundersen Lutheran Medical Center, Inc. | Gundersen Clinic, Ltd.
La Crosse, Wisconsin
RECRUITMENT ADVERTISING
Call Joanna Shippoli
to place your
Recruitment ad
at 800.225.4569 ext. 2615
[email protected]
92
LEGAL
®
EAGLE
David J. Goldberg, M.D., J.D.
is director of Skin Laser and Surgery
Specialists of New York and New
Jersey; director of laser research, Mount
Sinai School of Medicine; and adjunct
professor of law, Fordham Law School.
Can I charge more for some patients?
r. Cost has a large dermatology
practice in an urban Midwestern
community that over the last two
years has seen an increased number of
people without health insurance.
In fact, these uninsured patients have
presented him with a unique economic
opportunity: Dr. Cost charges his uninsured patients double what he bills to
contracted managed-care insured patients. He also aggressively pursues them
with collection agencies if they fail to pay.
Dr. Cost thinks of himself as a quality physician and a smart business man.
Much to Dr. Cost’s surprise, such an uninsured patient sues him over this dual
pricing scheme. Can Dr. Cost charge
higher fees for the uninsured as compared to the insured?
D
PRICING DISPARITY
In recent years, the United States has
seen countless stories like Dr. Cost’s, with
regard to physicians as well as hospitals.
Uninsured patients make up an ever increasing number of lower and middle income classes of Americans. Although patients with private or governmental insurance receive huge discounts for medical
care, uninsured patients pay higher prices
for the same medical care.
Apparently this pricing disparity has
gone on for years, but only recently has
been brought to the attention of the
American public. In a report from 2004,
it was estimated that uninsured patients
were charged 2.5 times more than a patient covered by one or more of the major
insurance companies. The disparity is
further accentuated by the fact that these
inflated charges are not a voluntarily
Dermatology Times (Print: ISSN 0196-6197, Digital ISSN 2150-6523) is
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QUICK READ
The legality of pricing disparity
between insured and uninsured
patients is decided on a stateby-state basis. Be aware that
differential billing policies
can violate state consumer
protection statutes.
assumed debt, but rather, one that often
cannot be avoided by the patient.
It is common knowledge that both notfor-profit and for-profit hospitals across
the United States have policies of charging uninsured patients more than insured
ones. Some physicians like Dr. Cost,
aware of this fact, have done the same.
Over the last several years uninsured patients have increasingly sued hospitals
for such policies. The claims have been
based on several theories, one of them
being that such differential billing policies
violate state consumer protection statutes. Such lawsuits are based on the theory that uninsured patients have been
subject to discrimination. The success of
these claims depends on the state statutes where the litigation has been filed.
PRECEDENT
In Morrell v. Wellstar Health System, a patient argued that the hospital violated the
Georgia Uniform Deceptive Trade Practices Act because it charged unreasonable rates and charged the uninsured
higher rates than insured patients. The
Georgia statute at issue prohibited fraudulent misrepresentation, false advertising,
or false and misleading statements. The
court found nothing illegal about the hospital’s policies because the hospital made
6013. Canadian G.S.T. number: R-124213133RT001.Publications Mail
Agreement Number 40612608. Return undeliverable Canadian addresses
to IMEX Global Solutions, P.O. Box 25542, London, ON, N6C 6B2,Canada.
Printed in the U.S.A.
© 2016 UBM. All rights reserved. No part of this publication may be
reproduced or transmitted in any form or by any means, electronic or
mechanical including by photocopy, recording, or information storage and
retrieval without permission in writing from the publisher. Authorization to
photocopy items for internal/educational or personal use, or the internal/
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Communications Inc. for libraries and other users registered with the
Copyright Clearance Center, 222 Rosewood Dr. Danvers, MA 01923, 978750-8400 fax 978-646-8700 or visit http://www.copyright.com online.
patients aware of its fees. Despite this,
and other similar decisions, some uninsured patients have been successful in
their consumer protection claims.
In Servedio v. Our Lady of the Resurrection Medical Center, a lawsuit
was brought by several uninsured patients who owed the hospital more than
$60,000. None of the patients were able
to pay for their medical services and the
hospital vigorously tried to collect the
debt, even bringing a lawsuit against one
of the patients. The patients claimed they
were charged inflated rates — double and
triple what an insured patient would pay.
They were not considered for charity care,
and excessive collection methods were
used in collecting their debt. In fact, Resurrection Medical Center had the highest
charge-to-cost ratio of any Chicago hospital. The Illinois court ruled that medical
services sold by a hospital were a form of
trade or commerce, and that the hospital’s conduct was immoral, unethical, oppressive, and clearly against public policy.
Litigation entitled In re. Sutter Health
Uninsured Pricing Cases involved a group
of uninsured patients at a California hospital who alleged that they were charged
unreasonable rates compared to the rates
charged to insured patients. The California Supreme Court noted that under the
California Unfair Competition Law, any
“unlawful, unfair, or fraudulent business
act or practice” was a violation. Ultimately
Sutter agreed to a policy that provided
discounts to uninsured patients.
Whether Dr. Cost loses his lawsuit will
be determined by his state statutes on unfair practices. He will likely need advice
from a health law attorney. DT
For uses beyond those listed above, please direct your written request to
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UBM Medica provides certain customer contact data (such as customer’s
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readers in reliance on such content.
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PRINTED IN
U.S.A.
SOOLANTRA®
(ivermectin) Cream, 1%
BRIEF SUMMARY
This summary contains important information about
SOOLANTRA (soo lan’ trah) Cream. Read this information carefully
before you prescribe SOOLANTRA Cream. For full Prescribing
Information and Patient Information please see the package insert.
WHAT IS SOOLANTRA CREAM?
SOOLANTRA Cream is a topical prescription medicine indicated for the
treatment of the inflammatory lesions of rosacea.
WHO IS SOOLANTRA CREAM FOR?
SOOLANTRA Cream is indicated for people with inflammatory lesions
of rosacea. It is not known if SOOLANTRA Cream is safe and effective
for children. Advise your patients to not use SOOLANTRA Cream for a
condition for which it was not prescribed and remind them to not give
SOOLANTRA Cream to other people, even if they have the same symptoms
as it may harm them.
WHAT SHOULD I ASK MY PATIENTS BEFORE PRESCRIBING
SOOLANTRA CREAM?
Before you prescribe SOOLANTRA Cream, ask your patients if they:
SOOLANTRA Cream is supplied in a child-resistant capped tube.
>!223)1+)17/<35)66(2:1217,)',-/(5)6-67%17'%3%1(7:-67 '2817)5'/2'.:-6)!2%92-(63-//-1+(2127648))=)7,)78&):,-/)
opening or closing.
>!2'/26)+)17/<35)66(2:1217,)',-/(5)6-67%17'%3%1(7:-67 clockwise.
WHAT ARE THE INGREDIENTS IN SOOLANTRA CREAM?
Active ingredient: ivermectin. Inactive ingredients: carbomer copolymer
type B, cetyl alcohol, citric acid monohydrate, dimethicone, edetate
disodium, glycerin, isopropyl palmitate, methylparaben, oleyl alcohol,
phenoxyethanol, polyoxyl 20 cetostearyl ether, propylene glycol,
propylparaben, purified water, sodium hydroxide, sorbitan monostearate,
and stearyl alcohol.
WHERE SHOULD I GO FOR MORE INFORMATION ABOUT
SOOLANTRA CREAM?
>!,-65-)* 800%5<6800%5-=)67,)0267-03257%17-1*250%7-21
about SOOLANTRA Cream. For full Prescribing Information and
Patient Information please see the package insert.
>272www.soolantra.com or call 1-866-735-4137
>,%9)%1<27,)50)(-'%/'21(-7-216
>%5)35)+1%17253/%11-1+72&)'20)35)+1%177-6127.12:1-*
SOOLANTRA Cream can harm an unborn baby.
>%5)&5)%67*))(-1+253/%172&5)%67*))(7-6127.12:1-*
SOOLANTRA Cream passes into breast milk and if it can harm a baby.
Trademarks are the property of their respective owners.
GALDERMA LABORATORIES, L.P., Fort Worth, Texas 76177 USA
Revised: December 2014
WHAT ARE THE MOST COMMON SIDE EFFECTS OF
SOOLANTRA CREAM?
The most commonly reported side effects when using SOOLANTRA Cream
include skin burning sensation and skin irritation. Remind your patients to
tell you if they have any side effect that bothers them or that does not go
away. These are not all of the possible side effects of SOOLANTRA Cream.
For more information, see the full Prescribing Information.
You are encouraged to report negative side effects of prescription drugs to
the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088. You may also
contact GALDERMA LABORATORIES, L.P. AT 1-866-735-4137.
HOW SHOULD PATIENTS USE SOOLANTRA CREAM?
> !5)%0-6*2586)217,)*%')21/<%1(6,28/(127&)86)(-1
the eyes, mouth, or vagina.
> !5)%06,28/(&)%33/-)(727,)%**)'7)(%5)%62*7,)*%')
once a day.
APPLYING SOOLANTRA CREAM:
>3)%6-=)(%028172* !5)%06,28/(&)%33/-)(72)%',
area of the face (forehead, chin, nose, each cheek) that is affected.
Avoid contact with the lips and eyes.
All trademarks are the property of their respective owners.
14501 N. Freeway
SOO-00071a Printed in USA 02/16
References: 1. Taieb A, Ortonne JP, Ruzicka T, et al;
Ivermectin Phase III Study Group. Superiority of
ivermectin 1% cream over metronidazole 0.75%
cream in treating inflammatory lesions of rosacea: a
randomized, investigator-blinded trial. Br J Dermatol.
2015;172(4):1103-1110. 2. Data on file. Galderma
Laboratories, L.P.

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