Fall 2012 Journal of Dermatology for Physician Assistants

VOLUME 6 NUMBER 4 FALL 2012

SDPA NEWS AND CURRENT AFFAIRS

DERMATOLOGY PA NEWS AND NOTES

CLINICAL DERMATOLOGY

SURGICAL DERMATOLOGY

COSMETIC DERMATOLOGY

PROFESSIONAL DEVELOPMENT

Official Journal of the Society of Dermatology Physician Assistants

5

th

Anniversary VOL. 6, NO. 4 FALL 2012 1 Year

FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE. Brief Summary Retin-A Micro® (tretinoin gel) microsphere, 0.1% and 0.04% is a formulation containing 0.1% or 0.04%, by weight, tretinoin for topical treatment of acne vulgaris. This formulation uses patented methyl methacrylate/glycol dimethacrylate crosspolymer porous microspheres (MICROSPONGE® System) to enable inclusion of the active ingredient, tretinoin, in an aqueous gel.

IMPORTANT NOTE: This information is a BRIEF SUMMARY of the complete prescribing information provided with the product and therefore should not be used as the basis for prescribing the product. This summary has been prepared by deleting information from the complete prescribing information such as certain text, tables, and references.

The physician should be thoroughly familiar with the complete prescribing information before prescribing the product.

INDICATIONS AND USAGE: Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%, is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the use of this product in the treatment of other disorders have not been established.

CONTRAINDICATIONS: This drug is contraindicated in individuals with a history of sensitivity reactions to any of its components. It should be discontinued if hypersensitivity to any of its ingredients is noted.

PRECAUTIONS: General: • The skin of certain individuals may become excessively dry, red, swollen, or blistered. If the degree of irritation warrants, patients should be directed to temporarily reduce the amount or frequency of application of the medication, discontinue use temporarily, or discontinue use all together. Efficacy at reduced frequencies of application has not been established.

If a reaction suggesting sensitivity occurs, use of the medication should be discontinued.

Excessive skin dryness may also be experienced; if so, use of an appropriate emollient during the day may be helpful.

• Unprotected exposure to sunlight, including sunlamps, should be minimized during the use of Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%, and patients with sunburn should be advised not to use the product until fully recovered because of heightened susceptibility to sunlight as a result of the use of tretinoin. Patients who may be required to have considerable sun exposure due to occupation and those with inherent sensitivity to the sun should exercise particular caution. Use of sunscreen products (SPF 15) and protective clothing over treated areas are recommended when exposure cannot be avoided.

• Weather extremes, such as wind or cold, also may be irritating to patients under treatment with tretinoin.

• Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%, should be kept away from the eyes, the mouth, paranasal creases of the nose, and mucous membranes.

• Tretinoin has been reported to cause severe irritation on eczematous skin and should be used with utmost caution in patients with this condition.

Information for Patients: A Patient Information Leaflet has been prepared and is included with each package of Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%.

Drug Interactions: Concomitant topical medication, medicated or abrasive soaps and cleansers, products that have a strong drying effect, products with high concentrations of alcohol, astringents, or spices should be used with caution because of possible interaction with tretinoin. Avoid contact with the peel of limes. Particular caution should be exercised with the concomitant use of topical over-the-counter acne preparations containing benzoyl peroxide, sulfur, resorcinol, or salicylic acid with Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%. It also is advisable to allow the effects of such preparations to subside before use of Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%, is begun.

Carcinogenesis, Mutagenesis, Impairment of Fertility: In a 91-week dermal study in which CD-1 mice were administered 0.017% and 0.035% formulations of tretinoin, cutaneous squamous cell carcinomas and papillomas in the treatment area were observed in some female mice. These concentrations are near the tretinoin concentration of these clinical formulations (0.04% and 0.1%). A dose-related incidence of liver tumors in male mice was observed at those same doses. The maximum systemic doses associated with the administered 0.017% and 0.035% formulations are 0.5 and 1.0 mg/kg/day, respectively. These doses are two and four times the maximum human systemic dose applied topically, when normalized for total body surface area. The biological significance of these findings is not clear because they occurred at doses that exceeded the dermal maximally tolerated dose (MTD) of tretinoin and because they were within the background natural occurrence rate for these tumors in this strain of mice. There was no evidence of carcinogenic potential when 0.025 mg/kg/day of tretinoin was administered topically to mice (0.1 times the maximum human systemic dose, normalized for total body surface area). For purposes of comparisons of the animal exposure to systemic human exposure, the maximum human systemic dose applied topically is defined as 1 gram of Retin-A Micro (tretinoin gel) microsphere, 0.1% applied daily to a 50 kg person (0.02 mg tretinoin/kg body weight).

Dermal carcinogenicity testing has not been performed with Retin-A Micro (tretinoin gel) microsphere, 0.04% or 0.1%.

Studies in hairless albino mice suggest that concurrent exposure to tretinoin may enhance the tumorigenic potential of carcinogenic doses of UVB and UVA light from a solar simulator. This effect has been confirmed in a later study in pigmented mice, and dark pigmentation did not overcome the enhancement of photocarcinogenesis by 0.05% tretinoin. Although the significance of these studies to humans is not clear, patients should minimize exposure to sunlight or artificial ultraviolet irradiation sources.

The mutagenic potential of tretinoin was evaluated in the Ames assay and in the in vivo mouse micronucleus assay, both of which were negative.

The components of the microspheres have shown potential for genetic toxicity and teratogenesis.

EGDMA, a component of the excipient acrylates copolymer, was positive for induction of structural chromosomal aberrations in the in vitro chromosomal aberration assay in mammalian cells in the absence of metabolic activation, and negative for genetic toxicity in the Ames assay, the HGPRT forward mutation assay, and the mouse micronucleus assay.

In dermal Segment I fertility studies of another tretinoin formulation in rats, slight (not statistically significant) decreases in sperm count and motility were seen at 0.5 mg/kg/day (4 times the maximum human systemic dose applied topically, and normalized for total body surface area), and slight (not statistically significant) increases in the number and percent of nonviable embryos in females treated with 0.25 mg/kg/day (2 times the maximum human systemic dose applied topically and normalized for total body surface area) and above were observed. In oral Segment I and Segment III studies in rats with tretinoin, decreased survival of neonates and growth retardation were observed at doses in excess of 2 mg/kg/day (17 times the human topical dose normalized for total body surface area).

Dermal fertility and perinatal development studies with Retin-A Micro (tretinoin gel) microsphere, 0.1% or 0.04%, have not been performed in any species.

Pregnancy: Teratogenic Effects: Pregnancy Category C. In a study of pregnant rats treated with topical application of Retin-A Micro (tretinoin gel) microsphere, 0.1%, at doses of 0.5 to 1 mg/kg/day on gestation days 6-15 (4 to 8 times the maximum human systemic dose of tretinoin normalized for total body surface area after topical administration of Retin-A Micro (tretinoin gel) microsphere, 0.1%) some alterations were seen in vertebrae and ribs of offspring. In another study, pregnant

New Zealand white rabbits were treated with Retin-A Micro (tretinoin gel) microsphere, 0.1%, at doses of 0.2, 0.5, and 1.0 mg/kg/day, administered topically for 24 hours a day while wearing Elizabethan collars to prevent ingestion of the drug. There appeared to be increased incidences of certain alterations, including domed head and hydrocephaly, typical of retinoid-induced fetal malformations in this species, at 0.5 and 1.0 mg/kg/day. Similar malformations were not observed at 0.2 mg/kg/day, 3 times the maximum human systemic dose of tretinoin after topical administration of Retin-A Micro (tretinoin gel) microsphere, 0.1%, normalized for total body surface area. In a repeat study of the highest topical dose (1.0 mg/kg/day) in pregnant rabbits, these effects were not seen, but a few alterations that may be associated with tretinoin exposure were seen. Other pregnant rabbits exposed topically for six hours to 0.5 or 0.1 mg/ kg/day tretinoin while restrained in stocks to prevent ingestion, did not show any teratogenic effects at doses up to 17 times (1.0 mg/kg/day) the maximum human systemic dose after topical administration of Retin-A Micro (tretinoin gel) microsphere, 0.1%, adjusted for total body surface area, but fetal resorptions were increased at 0.5 mg/kg. In addition, topical tretinoin in non Retin-A Micro (tretinoin gel) microsphere formulations was not teratogenic in rats and rabbits when given in doses of 42 and 27 times the maximum human systemic dose after topical administration of Retin-A Micro (tretinoin gel) microsphere, 0.1%, normalized for total body surface area, respectively, (assuming a 50 kg adult applied a daily dose of 1.0 g of 0.1% gel topically).

At these topical doses, however, delayed ossification of several bones occurred in rabbits. In rats, a dose-dependent increase of supernumerary ribs was observed.

Oral tretinoin has been shown to be teratogenic in rats, mice, rabbits, hamsters, and subhuman primates. Tretinoin was teratogenic in Wistar rats when given orally or topically in doses greater than 1 mg/kg/day (8 times the maximum human systemic dose normalized for total body surface area). However, variations in teratogenic doses among various strains of rats have been reported. In the cynomolgus monkey, which metabolically is more similar to humans than other species in its handling of tretinoin, fetal malformations were reported for doses of 10 mg/kg/day or greater, but none were observed at 5 mg/kg/day (83 times the maximum human systemic dose normalized for total body surface area), although increased skeletal variations were observed at all doses. Dose-related increases in embryolethality and abortion also were reported. Similar results have also been reported in pigtail macaques.

Topical tretinoin in animal teratogenicity tests has generated equivocal results. There is evidence for teratogenicity (shortened or kinked tail) of topical tretinoin in Wistar rats at doses greater than 1 mg/kg/day (8 times the maximum human systemic dose normalized for total body surface area). Anomalies (humerus: short 13%, bent 6%, os parietal incompletely ossified 14%) have also been reported when 10 mg/kg/day was topically applied. Supernumerary ribs have been a consistent finding in rats when dams were treated topically or orally with retinoids.

There are no adequate and well-controlled studies in pregnant women. Retin-A Micro should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

With widespread use of any drug, a small number of birth defect reports associated temporally with the administration of the drug would be expected by chance alone. Thirty human cases of temporally associated congenital malformations have been reported during two decades of clinical use of Retin-A. Although no definite pattern of teratogenicity and no causal association has been established from these cases, five of the reports describe the rare birth defect category holoprosencephaly (defects associated with incomplete midline development of the forebrain). The significance of these spontaneous reports in terms of risk to the fetus is not known.

Non-Teratogenic Effects: Topical tretinoin has been shown to be fetotoxic in rabbits when administered 0.5 mg/kg/day (8 times the maximum human systemic dose applied topically and normalized for total body surface area), resulting in fetal resorptions and variations in ossification. Oral tretinoin has been shown to be fetotoxic, resulting in skeletal variations and increased intrauterine death in rats when administered 2.5 mg/kg/day (21 times the maximum human systemic dose applied topically and normalized for total body surface area).

There are, however no adequate and well-controlled studies in pregnant women.

Animal Toxicity Studies: In male mice treated topically with Retin-A Micro (tretinoin gel) microsphere 0.1%, at 0.5, 2.0, or 5.0 mg/kg/day tretinoin (2, 8, or 21 times the maximum human systemic dose after topical administration of Retin-A Micro (tretinoin gel) microsphere, 0.1%, normalized for total body surface area) for 90 days, a reduction in testicular weight, but with no pathological changes were observed at the two highest doses. Similarly, in female mice there was a reduction in ovarian weights, but without any underlying pathological changes, at 5.0 mg/kg/day (21 times the maximum human dose). In this study there was a dose-related increase in the plasma concentration of tretinoin 4 hours after the first dose. A separate toxicokinetic study in mice indicates that systemic exposure is greater after topical application to unrestrained animals than to restrained animals, suggesting that the systemic toxicity observed is probably related to ingestion. Male and female dogs treated with Retin-A Micro (tretinoin gel) microsphere, 0.1%, at 0.2, 0.5, or 1.0 mg/kg/day tretinoin (5, 12, or 25 times the maximum human systemic dose after topical administration of Retin-A Micro (tretinoin gel) microsphere, 0.1%, normalized for total body surface area, respectively) for 90 days showed no evidence of reduced testicular or ovarian weights or pathological changes.

Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Retin-A Micro (tretinoin gel) microsphere, 0.1% or 0.04%, is administered to a nursing woman.

Pediatric Use: Safety and effectiveness in children below the age of 12 have not been established.

Geriatric Use: Safety and effectiveness in a geriatric population have not been established.

Clinical studies of Retin-A Micro did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

ADVERSE REACTIONS: The skin of certain sensitive individuals may become excessively red, edematous, blistered, or crusted. If these effects occur, the medication should either be discontinued until the integrity of the skin is restored, or the medication should be adjusted to a level the patient can tolerate.

However, efficacy has not been established for lower dosing frequencies.

True contact allergy to topical tretinoin is rarely encountered. Temporary hyper- or hypopigmentation has been reported with repeated application of tretinoin. Some individuals have been reported to have heightened susceptibility to sunlight while under treatment with tretinoin.

OVERDOSAGE: Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%, is intended for topical use only. If medication is applied excessively, no more rapid or better results will be obtained and marked redness, peeling, or discomfort may occur. Oral ingestion of large amounts of the drug may lead to the same side effects as those associated with excessive oral intake of Vitamin A. Rx only.

Distributed by: Ortho Dermatologics Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., Los Angeles, CA 90045 © OMP 2011 11DD0126 07/11 RETIN-A MICRO ® is a registered trademark of Ortho-McNeil Pharmaceutical, Inc. MICROSPONGE ® is a registered trademark of AMCOL International Corporation.

PUBLISHING STAFF

EDITORIAL BOARD

Travis Hayden, MPAS, PA-C, Editor in chief Joe R. Monroe, MPAS, PA-C Patricia Ferrer, MPAS, PA-C Gordon Day, R.Ph., PA-C Nancy Primo, MPAS, PA-C Lauren Zajac, MHS, PA-C Michelle DiBaise, MPAS, PA-C P. Eugene Jones, Ph.D., PA-C Mark Archambault, DHSc, PA-C Kristine Kucera, DHS, MPAS, PA-C Jennifer Winter, PA-C Mark Hyde, MMS, PA-C Jennifer Conner, MPAS, PA-C Jeffrey LaDuca, Ph.D., MD Alan Menter, MD

DEPARTMENT EDITORS

Clinical Department Editors Susan E. King-Barry, MPAS, PA-C Karen Graham, MPAS, PA-C Drugs in Dermatology Editor Stephen Wolverton, MD Surgical Department Editor Christy Kerr, MPAS, PA-C Cosmetic Department Editor Nancy Primo, MPAS, PA-C Prof Dev Department Editor Abby Jacobson, MS, PA-C

SDPA BOARD OF DIRECTORS

PRESIDENT John Notabartolo, MPAS, PA-C PRESIDENT-ELECT Jennifer Winter, PA-C IMMEDIATE PAST PRESIDENT Keri Holyoak, MPH, PA-C VICE PRESIDENT Jacki Kment, MPAS, PA-C SECRETARY / TREASURER Joleen Volz, MPAS, PA-C DIRECTORS AT LARGE Matthew Brunner, MHS, PA-C Greg Buttolph, MPAS, PA-C Jennifer Conner, MPAS, PA-C Vicki Roberts, MPAS, PA-C

Society of Dermatology Physician Assistants, Inc.

4111 W. Alameda Ave. Suite 412 Burbank, CA 91505 1-800-380-3992 SDPA@dermpa.org www.dermpa.org

Publisher Travis Hayden, MPAS, PA-C Managing Editor Jennifer M. Hayden, M.Ed Copy Editor Douglas Morris Art Director Angela Simiele Website Design Terry Scanlon

SALES OFFICE

Physician Assistant Communications, LLC P.O. Box 416, Manlius NY 13104-0416 Phone (315) 663-4147 PAC@pacommunications.org www.pacommunications.org EDITORIAL MISSION: The JDPA is the official clinical journal of the Society of Dermatology Physician Assistants. The mission of the JDPA is to improve dermatological patient care by publishing the most innovative, timely, practiceproven educational information available for the physician assistant profession.

PUBLISHED CONTENT IN THE JDPA: Statements and opinions expressed in the articles and communications herein are those of the authors and not necessarily those of the Publisher or the Society of Dermatology Physician Assistants (SDPA). The Publisher and the SDPA disclaim any responsibility or liability for such material, including but not limited to any losses or other damage incurred by readers in reliance on such content. Neither Publisher nor SDPA verify any claims or other information appearing in any of the advertisements contained in the publication and cannot take responsibility for any losses or other damage incurred by readers in reliance on thereon. Neither Publisher nor SDPA guarantees, warrants, or endorses any product or service advertised in this publication, nor do they guaranty any claim made by the manufacturer of such product or service.

THIS ISSUE: of JDPA includes articles that have been reviewed and approved for Category I (Preapproved) CME credit by the American Academy of Physician Assistants. Approval is valid for 1 year from the issue date, and participants may submit the self-assessment at any time during that period.

Category I CME articles included in JDPA are planned and developed in accordance with AAPA’s CME Standards for Journal Articles and for Commercial Support of Journal Articles.

Since its inception, the JDPA has utilized eco-friendly printing practices. The JDPA is printed on paper obtained from sustainable forests that meet strict environmental standards. Soy-based inks that have a low environmental impact are used during printing of the journal and the journal is printed using 100% renewable energy. SDPA members may join us in our efforts and opt to receive the JDPA in digital format.

JDPA/Journal of Dermatology for Physician Assistants (ISSN 1938-9574) is published quarterly (4 issues per volume, one volume per year) by Physician Assistant Communications, LLC, P.O. Box 416, Manlius NY 13104-0416. Volume 6, Number 4, Fall 2012. One year subscription rates: $40 in the United States and Possessions. Single copies (prepaid only): $10 in the United States (Include $6.50 per order plus $2 per additional copy for US postage and handling).

Periodicals postage rate paid at New York, NY 10001 and additional mailing offices. Š 2012 Physician Assistant Communications, LLC. 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 system, without permission in writing from the publisher.

POSTMASTER: Send address changes to Society of Dermatology Physician Assistants, Inc., 4111 W. Alameda Ave. Suite 412, Burbank, CA 91505, 1-800-380-3992.

THIS ISSUE IS SPONSORED BY

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Journal of Dermatology for Physician Assistants

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EDITOR’S MESSAGE

Journal of Dermatology for Physician Assistants

5

th

Anniversary Year

The Official Journal of the SDPA

Five Years of Extending Compassionate Care from Print to Practice

T

his issue marks the fifth year that the JDPA has been in publication.

In reflecting on the past five years, one comment in particular has continued to resonate with me; I feel it affirms what the JDPA has been striving to provide for the past five years. The comment was from the mother of a young girl suffering from eczema who, after reading the JDPA for the first time, shared with us her impression of our publication, “I love the human spin and the interest of what “eczema” or any illness is beyond the surface, which broadens the real picture. It is so much more than what it ever appears to be, both physically and emotionally. Congratulations on understanding people behind a diagnosis!”

Since its inaugural issue five years ago, the mission of the JDPA has remained the same: to improve dermatological patient care by publishing the most innovative, timely, practice-proven educational information available for the physician assistant profession. I thank everyone who has contributed throughout the past five years in helping us to accomplish this mission.

Through our published educational content, the professional and personal development of dermatology physician assistants is promoted, thereby improving our ability to practice a higher quality of care for the patients we serve. We are proud of how much the JDPA has contributed to improving dermatological care during the past five years and look forward to continuing this mission with all of you well into the future.

Throughout the past five years, I have had the privilege and honor of working with many talented and gifted individuals who truly comprehend the concept of, “…understanding people behind a diagnosis.” Through the hard work, dedication, and commitment to our profession by these volunteers (writers, editors, creative team members, and editorial board members), the JDPA has grown to be recognized as a trusted and respected resource for educating the dermatology physician assistant community. We are truly grateful and thankful for the remarkable contributions from our team of volunteers. Their combined efforts have helped to shape the JDPA and our profession by promoting the ideal of extending compassionate care from print to practice. J

Travis Hayden, MPAS, PA-C Editor in chief

VOL. 6, NO. 4 FALL 2012

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TABLE OF CONTENTS SDPA Members Only Content A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

17

Interpreting Dermoscopic Structures: Two-Step Algorithm

By Natalia Jaimes, MD and Ashfaq A. Marghoob, MD

CME

10 Derm PA News & Notes – part one

• SDPA State Affiliates Round Table Discussion - Steps to Becoming Affiliated with the SDPA • Certification Review - All Those Things Inside the Skin You Might Have Forgotten • Student Corner – Managed Care and Its Impact on Healthcare

17 Clinical Dermatology

• CME Article – Interpreting Dermoscopic Structures: Two-Step Algorithm • Clinical Snapshots - Dermatomyositis

Departments

04 Editorial Board 05 Editor’s Message 09 SDPA News & Current Affairs 10 Dermatology Market Watch 29 From The Patient’s Perspective 31 Dermoscopy Q&A 32 Clinical Snapshots 34 Surgical Wisdom 37 Cosmetic Pearls 48 Outside & Inside the 9 to 5...

49 Notes from your Office Manager 53 The Difference We Make 60 Dermatology in Art 61 JDPA Information for Authors 62 Professional Opportunities and Development

34 Surgical Dermatology

• Surgical Wisdom – Needle Stick Prevention

37 Cosmetic Dermatology • Cosmetic Pearls - Top Tips for Maintaining Smooth, Shiny Hair

42 Professional Development

• Is There a Glass Ceiling for PAs? Part 2 • Dermatology Billing & Coding – Suture Removal When You Can Charge and How • Judicial and Ethical Affairs – Case-Based Compliance Scenarios

50 Derm PA News & Notes – part two

Go Green - Read Online 6

Journal of Dermatology for Physician Assistants

• From the Desk of…

• Workplace Excellence – Embracing Conflict: Mastering the Art of Care-frontation • Supervising Physician Corner

dermPA.org

VOL. 6, NO. 4 FALL 2012

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Journal of Dermatology for Physician Assistants

Calendar

FROM THE SPDA News & Current Affairs

OF EVENTS

2012 OCTOBER/NOVEMBER SDPA 10th Annual Fall Conference October 31 - November 3, 2012 Caesars Palace Hotel Las Vegas, NV

2013 MARCH 71st AAD Annual Academy Meeting March 1 - 5, 2013 Miami, FL JUNE SDPA Summer Dermatology Conference June 27 - 30, 2013 Hyatt Regency at the Arch St. Louis, MO NOVEMBER SDPA 11th Annual Fall Conference November 13 - 16, 2013 InterContinental Buckhead Atlanta, GA

A Quadrennial Opportunity

I

’m tired of all the political advertisements on television, the radio, and my computer. Then there are mailings overflowing my mailbox daily, and let’s not even mention the half a dozen phone calls every night from 4-8pm. Yes, yet another Presidential election season is upon us, and although we may be quite fed up with the constant reminders, it is a great opportunity.

I have voted in every election since I turned 18. When I was living in Spain, my family would mail me hometown newspapers, and I had an absentee ballot, checking a box on only the elections and initiatives I was informed about. I am passionate about being a well informed member of our democracy and enjoy the ability to flex my power as an individual.

We have the chance to elect our leaders. By going to the polls on November 6th and casting our votes, we determine the course our nation takes over the next few years. No big deal you think? Try to tell that to the thousands of people who rebelled against the oppressive regimes throughout the Middle East this past year during the Arab Spring uprisings or to the Syrians who continue their own battle with a dictatorship.

Think this doesn’t apply to you or that you have no skin in the game?

How many of our loved ones are unemployed? Anyone you know lose their house in the past 6 years? What about healthcare? Have our practices taken a hit and are they rebounding? Are things bad and could they be worse? These are all questions (without getting partisan) that impact our day-to-day lives. These are reasons why every one of us should step up and vote.

Don’t vote ignorantly, become informed. Know where all the candidates stand on the issues that matter the most to you. Make the effort to become knowledgeable on how the candidates voted on important issues and how the outcomes of those votes affected our well-being.

I have never simply voted for a candidate; my vote is cast for an ideal.

I throw in my lot with the person who shares my vision of our future.

It’s not just about the here and now, it’s about how great we can be if we all do our part. VOTE! I’m President John Notabartolo and I approve this message. J

John Notabartolo, MPAS, PA-C SDPA President, Diplomate VOL. 6, NO. 4 FALL 2012

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DERMATOLOGY PA NEWS & NOTES

Dermatology Market Watch New Glytone Anti-aging Night Cream Revitalizes skin firmness and elasticity deep within the skin’s surface to visibly smooth the look of lines and wrinkles.

Formulated with a unique blend of Peptides and high concentrations of Vitamin E and Glycolic Acid as well as with Red Tea Flavonoids, this newest addition delivers antioxidant protection and anti-aging benefits.

Technical Information: • Peptides send signals to skin to make new collagen • Photo-stabilized Delta Tocopheryl Glucoside continuously delivers higher levels of Vitamin E to the skin than any other form of Tocopheryl for longer-lasting antioxidant protection and acts as a natural skin brightener • Red Tea Flavonoids (Rooibos) are proven to be 30% more effective than green tea as an antioxidant Benefits: • Proprietary blend of Antioxidants, natural Peptides and Glycolic Acid dramatically improves and helps delay the appearance of deep lines and wrinkles for noticeably younger-looking skin • Powerful age-fighting ingredients work synergistically to guard against environmental, photo, and free radical damage • Paraben-free

Contains: • 5.5% Glycolic Acid, known to reduce excess dead skin cell build-up and even out skin tone and texture • Photo-stabilized Vitamin E (Delta Tocopheryl Glucoside), a natural skin brightener, and Red Tea Flavonoids (Rooibos) for clinically-proven, powerful antioxidant protection shown to delay the visible signs of aging • Caprooyl Tetrapeptide-3, a tetrapeptide that reduces the appearance of wrinkles caused by repetitive facial expressions; works synergistically with Acetyl Tetrapeptide-2 by targeting the wrinkle from multiple angles • Acetyl Tetrapeptide-2, a tetrapeptide that strengthens the skin barrier function; helps stimulate the production of the proteins that preserve and strengthen the epidermal layers Direction for use: • Suitable for all skin types • Apply daily in the evening to entire face, neck, and décolleté or as directed by a physician

DexPak TaperPaks – Oral Steroid Therapy That Matches the Patients’ Needs The DexPak family of packaged oral steroids are designed to provide the healthcare provider with therapeutic options based on the disease state being treated, the expected duration of this disease state, and the severity of the associated symptoms. DexPak TaperPaks contain dexamethasone tablets, 1.5 mg. Dexamethasone is the preferred choice of many healthcare providers because of its absence of sodium retention properties and its long duration of action. The small tablets are also easy to swallow, a notable benefit to patients when a single dose may be comprised of several tablets.

Each DexPak TaperPak product delivers: • A sufficient initial dose to achieve rapid relief of symptoms • Appropriate dosing over the entire course of therapy to assure that symptoms do not reoccur • Appropriate tapering of the corticosteroid to avoid potential side-effects which may be associated with steroid withdrawal DexPak TaperPaks provide straightforward BID dosing in a concise, easy to understand format that enhances both dosing accuracy and patient compliance. The child resistant packaging provides an additional level of safety frequently not found with many pre-packaged oral steroid products. For more information, please contact ECR Pharmaceuticals or visit www.ecrpharma.com. J 10 Journal of Dermatology for Physician Assistants

CLODERM CREAM The difference is baked right in. ®

Cloderm Cream’s unique molecule, clocortolone pivalate, has no generic alternative • Provides Class IV efficacy with an excellent safety profile1-3 • The pivalate group enhances lipid solubility1 – Clocortolone pivalate is more lipophilic than other commonly used branded midpotent steroids4 • Statistically significant improvement of symptoms at day 43

Not a cookie-cutter corticosteroid

Make Cloderm Cream your 1st choice topical steroid • No age restriction • Available in 90 g tube and 75 g pump • To request samples or for further information, contact Promius Pharma at 888.384.6929 or visit www.Cloderm.com Indication and Important Safety Information Cloderm Cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. The most common adverse events with Cloderm Cream include burning, itching, irritation, dryness, and folliculitis. Cloderm Cream is contraindicated in patients who are hypersensitive to any of the ingredients of this product. As with all topical corticosteroids, systemic absorption can produce reversible HPA-axis suppression. See full prescribing information on reverse side. For more information see www.Cloderm.com.

References: 1. Bikowski J, Pillai R, Shroot B. The position not the presence of the halogen in corticosteroids influences potency and side effects. J Drugs Dermatol. 2006;5(2):125-130. 2. Del Rosso J, Friedlander SF. Corticosteroids: options in the era of steroid-sparing therapy. J Am Acad Dermatol. 2005; 53(1 Suppl 1):S50-58. 3. Data on file. Promius Pharma LLC. Bridgewater, NJ. 4. Royal Society of Chemistry Website. Chem Spider, the free chemical database. Available at http://www.chemspider.com. Accessed June 1, 2011.

Cloderm® is a trademark of Coria Laboratories, Ltd.

VOL. 6, NO. 4 FALL 2012 11

RxOnly

Laboratory Tests: The following tests may be helpful in evaluating the HPA axis suppression: Urinary free cortisol test ACTH stimulation test Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.

FOR TOPICAL DERMATOLOGIC USE ONLY– NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE. WARNING: KEEP OUT OF REACH OF CHILDREN

DESCRIPTION: Cloderm Cream 0.1% contains the medium potency topical corticosteroid, clocortolone pivalate, in a specially formulated water-washable emollient cream base consisting of purified water, white petrolatum, mineral oil, stearyl alcohol, polyoxyl 40 stearate, carbomer 934P, edetate disodium, sodium hydroxide, with methylparaben and propylparaben as preservatives.

Chemically, clocortolone pivalate is 9-chloro-6α-fluoro-11β, 21-dihydroxy-16α methylpregna-1, 4-diene-3, 20-dione 21-pivalate.

Its structure is as follows:

CLINICAL PHARMACOLOGY: Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions.

The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

Pharmacokinetics: The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.

Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses.

(See DOSAGE AND ADMINISTRATION).

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees.

Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

INDICATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.

Pregnancy Category C: Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

Nursing Mothers: It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

Pediatric Use: Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface area body weight ratio.

Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.

ADVERSE REACTIONS: The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: Burning, Itching, Irritation, Dryness, Folliculitis, Hypertrichosis, Acneiform eruptions, Hypopigmentation, Perioral dermatitis, Allergic contact dermatitis, Maceration of the skin, Secondary infection, Skin atrophy, Striae, Miliaria.

OVERDOSAGE: Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

DOSAGE AND ADMINISTRATION: Apply Cloderm (clocortolone pivalate) Cream 0.1% sparingly to the affected areas three times a day and rub in gently.

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

CONTRAINDICATIONS: Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

PRECAUTIONS: General: Systemic absorption of topical corticosteroids has produced reversible hypothalamicpituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.

Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings.

Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.

Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate anti-microbial therapy instituted.

HOW SUPPLIED: Cloderm (clocortolone pivalate) Cream 0.1% is supplied in 30 gram and 75 gram pump bottles, 45 gram and 90 gram tubes.

30 gram pump bottle 75 gram pump bottle 45 gram tube 90 gram tube

NDC-67857-804-30 NDC-67857-804-51 NDC-67857-804-45 NDC-67857-804-90

STORAGE: Store Cloderm Cream between 15° and 30° C (59° and 86° F).

Avoid freezing.

Distributed by:

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity.

(See PRECAUTIONS-Pediatric Use).

If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.

In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

Information for the Patient: Patients using topical corticosteroids should receive the following information and instructions: 1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.

2. Patients should be advised not to use this medication for any disorder other than for which it was prescribed.

3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.

4. Patients should report any signs of local adverse reactions especially under occlusive dressing.

5. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.

12 Journal of Dermatology for Physician Assistants

www.promiuspharma.com Promius Pharma, LLC 200 Somerset Corporate Blvd., Floor 7, Bridgewater, NJ 08807 Cloderm® is a trademark of Coria Laboratories, Ltd. Manufactured by: DPT LABORATORIES, LTD. San Antonio, Texas 78215

Issued 0711

004158

SDPA State Affiliates Round Table Discussion Steps to Becoming Affiliated with the SDPA

Joleen M Volz, MPAS, PA-C SDPA Secretary/Treasurer Former SDPA Constituent Relations Committee Chair

Matthew Brunner, MHS, PA-C

Vicki Roberts, MPAS, PA-C

Renata M. Block, MMS, PA-C

SDPA Director at Large Former President of the Georgia Dermatology Physician Assistants

SDPA Director at Large Former President of the South Carolina Society of Dermatology Physician Assistants

SDPA Constituent Relations Committee Chair President of the Illinois Society of Dermatology Physician Assistants

JOLEEN - After you formed your state chapter, what were your reasons to feel it beneficial to become affiliated with the SDPA? RENATA - Because of its national status, the SDPA is an integral part of the professional lives of dermatology PAs. It can provide support and networking opportunities for state chapters. Because of their not-forprofit statuses, state chapters can look to the SPDA to provide the forum for support of legislation that affects all states.

MATTHEW - At the time the GDPA became a formal non-profit, the SDPA was beginning to affiliate state chapters. We felt it was beneficial to become affiliated with the SDPA for several reasons. One of those advantages is that the SDPA provides tremendous benefits to affiliated state chapters. Most importantly though, the GDPA Board and members recognized that PAs have a stronger voice and a more unified front as a profession when we work together.

VICKI - My state chapter was already established for a couple of years before I became active. The local dermatology PAs were meeting on a regular basis discussing cases, reading and reviewing various dermatologic conditions, and having speaker dinners to help enhance their education. At the time, we were

not collecting dues and had very little funds. When the SDPA offered to help in the creation of a website, we decided that was an important reason to become affiliated. We soon learned that there were many other benefits as well.

JOLEEN - What was the process of becoming affiliated?

RENATA - The SDPA provides guidance in determining how a state chapter should review its goals, how to assess funding and liaison capabilities, and how a state chapter should be organized and governed.

MATTHEW - Becoming an affiliate chapter was an easy process. All applicants complete a simple application form, submit the names, addresses, titles, and terms of service of the members of the state chapter’s Board of Directors, and submit copies of the chapter bylaws for SDPA approval. Groups with Articles of Incorporation are requested to submit a copy of them. The GDPA then had a few follow-up emails with the SDPA to explain any questions they had about our bylaws and Board members.

VICKI - The actual process of becoming affiliated is pretty simple. Once you have all the requirements, it is a matter of filling out a form and sending it to the organization.

VOL. 6, NO. 4 FALL 2012 13

DERMATOLOGY PA NEWS & NOTES

The purpose of this SDPA State Affiliates round table discussion is to provide state chapters guidance in determining if they should become affiliated with the SDPA and insights about the process. Leading the discussion panel is Joleen M Volz, MPAS, PA-C, SDPA Secretary/Treasurer and former SDPA Constituent Relations Committee Chair.

She is joined at this round table by Matthew Brunner, MHS, PA-C, SDPA Director at Large and former President of Georgia Dermatology Physician Assistants (GDPA), Renata Block, MMS, PA-C, SDPA Constituent Relations Committee Chair and President of the Illinois Society of Dermatology Physician Assistants (ISDPA), and Vicki Roberts, MPAS, PA-C, SDPA Director at Large and former President of the South Carolina Society of Dermatology Physician Assistants (SCSDPA).

JOLEEN - How long does it take to become affiliated?

RENATA - If you have all criteria met, it should take about 5 - 7 days.

MATTHEW - Depending on how an affiliate chapter chooses to proceed, it may take a few weeks to a few months. For chapters that choose to incorporate and become recognized by the IRS as a non-profit, expect 6-12 months. For chapters that choose to stay as an organized group without incorporating, the process may only take a few weeks. Once a chapter has completed the initial formation steps, all that is left is to submit the affiliate application to the SDPA. The GDPA received affiliate status a few weeks after submitting its application to the SDPA.

DERMATOLOGY PA NEWS & NOTES

VICKI - Again, the form was very simple to fill out and send in. We were notified of our affiliation within a week.

JOLEEN - Are there any specific rules to becoming affiliated with the SDPA? RENATA - Yes. Each state should have a minimum of five board members who are all Fellow members of the SDPA. Each state affiliate must have a SDPA Liaison.

MATTHEW - Yes. It is helpful to review the rules prior to drafting your bylaws. Specifically, you must have at least five members serving on your chapter’s Board of Directors, and they must be Fellow members of the SDPA. Another requirement is that a chapter have a SDPA Liaison. In addition, an affiliate chapter must be in compliance with the SDPA vision and mission.

VICKI - Yes. There are certain requirements the SDPA requires to attain and maintain affiliate status.

There must be five officers who must also be SDPA Fellow members. The mission of the state affiliate should not contradict the mission of the SDPA. The bylaws the chapter uses must also clearly state the above rules. Each of these requirements needs to be met on a yearly basis.

JOLEEN - Where can I find information about the application process?

RENATA - There are great resources as well as a step-by-step guide available from the SDPA at www. dermpa.org. All you have to do is sign in, click “Members Only,” and look under “SDPA Document Library.”

Viola!

MATTHEW - The SDPA Document Library on www.dermpa.org provides the affiliate application and affiliate application policy. It also includes a guide for starting a state affiliate chapter.

14 Journal of Dermatology for Physician Assistants

VICKI - Forms and explanation of the process are located in the “Members Only” section of the SDPA website under the tab “SDPA Documents.”

JOLEEN - How did you go about creating your bylaws?

RENATA - Illinois utilized the SDPA bylaws as a guideline and tailored them specifically to what the state needed.

MATTHEW - The GDPA used the SDPA bylaws as a template for writing our own bylaws. We were able to adapt the SDPA bylaws to our chapter’s needs. The IRS also requested we include a ‘Conflict of Interest’ section that detailed how the Board of Directors would govern and handle such problems.

VICKI - We actually used the SDPA bylaws as a template to work from. We then discussed and voted on the details of each area with the members of the group until we ended up with a document that accurately reflected our state chapter.

JOLEEN - Can you give any specific circumstances where you have benefited from being affiliated with the SDPA? RENATA - Yes. A few years ago in Illinois, we had a physician who wrote a negative response about midlevel providers (specifically PAs) to a patient’s letter in a “Dear Annie” column. This was distributed in various newspapers. Not only was the Illinois Chapter able to respond as a group, but we also received immediate assistance and guidance from the SDPA. MATTHEW - A few years ago, a bill was proposed in Georgia that would have severely hampered PAs’ ability to treat patients with lasers. The SDPA worked with the GDPA, the AAPA, and the Georgia Association of Physician Assistants to amend the legislation to protect PAs’ abilities to practice.

VICKI - By far the biggest benefit we have received by being affiliated is the complimentary website design and maintenance. The website has been instrumental in keeping our members informed of upcoming events and has given our chapter a polished, professional look.

JOLEEN - Are you aware of the benefits to becoming affiliated with the SDPA? RENATA - Yes. With the SDPA having over 2,000 members, your state affiliate chapter is able to have a strong network, support, and recognition on a national level. The SDPA will be able to reach all your members regarding key legislation that concerns dermatology PAs within the state. Legislators want to hear from locals and having a state affiliate chapter will make you heard!

A state affiliate chapter also allows dermatology PAs to address local concerns and any issues that arise that are specifically targeted toward dermatology PAs.

MATTHEW - As I mentioned earlier, the SDPA offers a number of benefits to state affiliate chapters.

One of those benefits includes a meeting space at SDPA conferences where state affiliate chapters can host meetings and receptions. Also, the SDPA has a contract in place with Events Made Simple, the event planner for both the Summer and Fall SDPA Conferences. The SDPA agreement allows constituent affiliate chapters to contract with Events Made Simple to plan their own state conference. The GDPA has retained the services of Events Made Simple in planning our state conference called Dermatology PEARLS, for the past three years.

In addition, the GDPA utilizes the website services offered through Radar, the SDPA management and

website provider, to design and maintain our chapter’s website. The SDPA offers a free basic website through Radar for all constituent affiliate chapters. Most importantly though, the SDPA offers legislative support to affiliated state chapters.

VICKI - Again, website design and maintenance are a huge benefit for our group. Luckily, we have not had any legislative issues, but the SDPA would provide national support and advocacy if any legislative issues were to arise. Another benefit would be future industry support through the positive relationships already developed with the SDPA. J

Certification Review

All Those Things Inside the Skin You Might Have Forgotten

By James A. Van Rhee, MS, PA-C

Are you recertifying soon? Start your board review early. Each issue of the JDPA features one board question accompanied by a brief explanation of the answer along with any pertinent test taking tips. Best of luck!

A. Elevated plasma aldosterone and renin B. Elevated urine metanephrine and VMA C. Elevated plasma ACTH and negative cosyntropin stimulation test D. Elevated urine free cortisol and negative dexamethasone suppression test EXPLANATION: Addison’s disease is an autoimmune inflammation of the adrenal cortex. It may be secondary to tuberculosis or fungal infection of the adrenal glands. Patients present with weakness, fatigue, weight loss, and diarrhea. On physical examination

orthostatic hypotension, hyperpigmentation, and delayed deep tendon reflexes are noted. Laboratory studies reveal hyperkalemia and hypoglycemia. Further laboratory testing that can aid in the diagnosis includes an elevated ACTH level and negative cosyntropin stimulation test. Elevated plasma aldosterone and renin are noted in primary aldosteronism or Conn syndrome.

Elevated urine metanephrine and VMA are noted in pheochromocytoma. Elevated urine free cortisol and negative dexamethasone suppression test are noted in Cushing syndrome. J

The correct answer is C.

QUESTION: A 35 year-old female with a past medical history of tuberculosis presents with weakness, diarrhea, and weight loss. On physical examination, vital signs show a decreased blood pressure with orthostatic changes and hyperpigmentation of the skin is noted, along with delayed deep tendon reflexes. Laboratory studies reveal serum potassium of 5.8 mEq/L (normal range: 3.5-5.5 mEq/L) and a serum glucose of 60 mg/dl (normal range: 65-110 mg/dl). Which of the following laboratory results would be most helpful in confirming the most likely diagnosis for this patient?

James A. Van Rhee, MS, PA-C, is the Program Director for the Northwestern University Feinberg School of Medicine Department of Family Medicine Physician Assistant Program.

Mr. Van Rhee has been involved in physician assistant education for over 15 years. He has served as project director and test item writer for the Physician Assistant Education Association’s (PAEA) Physician Assistant Clinical Knowledge Rating Assessment Tool (PACKRAT) and is the author of the Physician Assistant: Certification and Re-certification Review Book, published

by Elsevier. For the last ten years he has been course director and presenter of the Physician Assistant Board Review, which is now being produced live online by Kaplan Medical.

VOL. 6, NO. 4 FALL 2012 15

DERMATOLOGY PA NEWS & NOTES

Future topics that may be discussed at the round table include keeping your state affiliate active and how to interact with your local state medical board. If you have any other topics that you would like to see covered, please feel free to share them with us.

Email editor@jdpa.org with any topic ideas or state affiliate questions.

Student Corner -

Managed Care and Its Impact on Healthcare

By Kruti Gandhi, MPH, PA-S

DERMATOLOGY PA NEWS & NOTES

D

uring my dermatology rotation I had encountered many patients with an insurance called AVMed/Medicare.

A problem arose since the doctor’s group practice would no longer accept this particular health insurance. Patients that had been coming for twenty plus years could no longer come to the practice under this insurance unless they wanted to pay out-of-pocket; this situation created anger and frustration for myself and these patients. With sky-rocketing out-of-pocket costs, I thought, “Why can’t the practice take that particular insurance so that the patient can get the care that he or she needs?”

The answer to my burning question was that even though the practice wants to take the insurance and provide continuity of care, the medical providers have little control over which insurances are accepted at the practice.

This particular insurance plan is now a capitated plan that limits which providers the patient can see, thereby affecting continuity of care. A significant proportion of the practice’s long time patients cannot be seen under

this insurance plan unless they pay out-of-pocket, which is costly. Through my rotation I realized that in order to overcome the barriers that I encountered here, I needed to remember, “I am here to help the patient.” It is not the medical providers who are dropping the patients; it is the insurance companies that are dropping providers and limiting whom patients can see. I suggested that the affected patients contact their insurance company and complain. In addition, I noted that the patients can change their insurance plan to continue the care with the provider. By providing patients with some knowledge and options regarding their healthcare coverage, I hope to improve the care I deliver. J Kruti Gandhi, MPH, PA-S is currently enrolled at the Barry University Physician Assistant Program in Miami, Florida. She currently is a volunteer member of the SDPA Student Affairs Committee serving as the Student Corner Leader. She will be graduating in December 2012 and plans to practice in dermatology.

ATTENTION Student Members of the SDPA! Publishing an article in a peer-reviewed journal is a great way to enhance your dermatology education, share knowledge with your peers, and improve upon your resume.

If you have written dermatology related papers and are interested in publishing your work, the JDPA staff is available to assist you through this process.

Please contact the JDPA at editor@jdpa.org.

16 Journal of Dermatology for Physician Assistants

CLINICAL DERMATOLOGY

Interpreting Dermoscopic Structures: Two-Step Algorithm

By Natalia Jaimes, MD and Ashfaq A. Marghoob, MD

SDPA Members Only Content A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

CME

This program has been reviewed and is approved for a maximum of .5 hours of AAPA Category I CME credit by the Physician Assistant Review Panel.

Approval is valid for 1 year from the issue date of OCTOBER 2012. Participants may submit the self-assessment exam at any time during that period.

This program was planned in accordance with AAPA’s CME Standards for Enduring Material Programs and for Commercial Support of Enduring Material Programs.

SDPA members may access the posttest at www.jdpa.org

Learning Objectives: 1. Review the basic concepts of the two-step algorithm of dermoscopy.

2. Understand the means of differentiating melanocytic from non-melanocytic lesions and benign from malignant neoplasms utilizing the two-step algorithm of dermoscopy.

3. Understand the utility of dermoscopy as a guide for management decisions.

VOL. 6, NO. 4 FALL 2012 17

Interpreting Dermoscopic Structures SDPA Members Only Content

CLINIC AL DERMATOLOGY

A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

18 Journal of Dermatology for Physician Assistants

Interpreting Dermoscopic Structures SDPA Members Only Content

CLINIC AL DERMATOLOGY

A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

VOL. 6, NO. 4 FALL 2012 19

Interpreting Dermoscopic Structures SDPA Members Only Content

CLINIC AL DERMATOLOGY

A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

20 Journal of Dermatology for Physician Assistants

Interpreting Dermoscopic Structures SDPA Members Only Content

CLINICAL DERMATOLOGY

A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

VOL. 6, NO. 4 FALL 2012 21

Interpreting Dermoscopic Structures SDPA Members Only Content

CLINIC AL DERMATOLOGY

A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

22 Journal of Dermatology for Physician Assistants

Interpreting Dermoscopic Structures SDPA Members Only Content

CLINIC AL DERMATOLOGY

A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

VOL. 6, NO. 4 FALL 2012 23

Interpreting Dermoscopic Structures SDPA Members Only Content

CLINIC AL DERMATOLOGY

A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

24 Journal of Dermatology for Physician Assistants

Interpreting Dermoscopic Structures SDPA Members Only Content

CLINIC AL DERMATOLOGY

A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

VOL. 6, NO. 4 FALL 2012 25

Interpreting Dermoscopic Structures SDPA Members Only Content

CLINIC AL DERMATOLOGY

A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

26 Journal of Dermatology for Physician Assistants

Interpreting Dermoscopic Structures SDPA Members Only Content

CLINIC AL DERMATOLOGY

A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

VOL. 6, NO. 4 FALL 2012 27

Interpreting Dermoscopic Structures SDPA Members Only Content

CLINIC AL DERMATOLOGY

A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

&

Dermoscopy Q A Question: What is it?

Under Dermoscopy

Answer on page 31 28 Journal of Dermatology for Physician Assistants

Natalia Jaimes, MD is a dermatologist from Medellín, Colombia. She received training in skin cancer management at the Memorial Sloan-Kettering Cancer Center, Department of Dermatology. Dr. Jaimes is an attending physician at Aurora Skin Cancer Center and Assistant Professor of Dermatology at the Universidad Pontificia Bolivariana in Medellín, Colombia. Her research interests are pigmented lesions, melanoma, and imaging diagnostic techniques including dermoscopy. She has indicated no relationships to disclose relating to the content of this article.

Ashfaq A. Marghoob, MD is a board-certified dermatologist specializing in the diagnosis and treatment of cancers of the skin. He is the Director of Memorial SloanKettering’s regional skin cancer clinic in Hauppauge, Long Island. Dr. Marghoob is active in clinical research and has published numerous papers on topics related to skin cancer with an emphasis on melanoma, atypical/dysplastic nevi, and congenital melanocytic nevi. His research interests are focused on the use of imaging instruments such as photography, dermoscopy, and confocal laser microscopy to study the in vivo biology of benign lesions and to elucidate features that can assist in the early detection of skin cancer.

He frequently lectures on these topics both nationally and internationally and was a member of the faculty at this year’s inaugural American Dermoscopy Meeting. He has indicated no relationships to disclose relating to the content of this article.

From The Patient’s Perspective

A Mother’s Wish for a Child with Eczema without being tormented by the Scratchy Monster and to not have her skin burn and itch, what it feels like to climb into the bath tub without asking, “Mommy, is this going to burn?” I wish I could trade places with her and take all this from her so she can be happy and carefree like children are supposed to be. This I wish for her.

A National Eczema Association member

Every morning, I try to start the day positively for my daughter’s sake regardless of how much sleep we didn’t get the night before. Today was no exception. I woke her up at 8:25, only three short hours after she finally fell asleep, after the usual night-long restless tossing and turning, scratching, crying, and scratching some more. We were already running late for her big day. Today, I took my 3-year-old daughter to her first day of preschool, telling myself, “She needs this, she will have fun.” My husband and I want her to have a ‘normal childhood’; we don’t want her to feel “different” from the other kids. Reality hit quickly as I watched in circle time: my daughter struggling not to scratch, then pulling her pant legs up and scratching her legs until one bled, and then scratching her back, her arms, the back of her neck as if bugs were crawling all over her skin. As the other children removed their long sleeve shirts/jackets/sweaters as it got warmer, my daughter stayed in hers. My heart sank as the other little girls ran to the playground in their sundresses and tank tops, bare legs, no redness, no flaking, no peeling, no rashes, no itching. I looked over at my daughter in her long sleeves and pants, still scratching, trying to scratch a spot on her back, as she watched the other kids run around, figuring out where she fits in in all this . . . and I know she’ll figure it out. She’s a smart kid—a sensitive one—and like most children, more resilient than we tend to give them credit for. As the school day came to an end for my daughter and we were getting ready to go home, we watched the other children getting ready for their nap time, eagerly pulling out their sleeping bags and pillows, arranging them on the floor next to their little friends. My daughter looked up at me and asked why she wasn’t taking a nap at school. I wondered to myself if my daughter would ever be able to take a carefree nap at preschool, or even at home, like the other kids. Probably not. I don’t wish for her to be the smartest kid, or the prettiest, or the fastest. I just wish so much and pray every day that just for one day and one night she can feel “normal”— she can know what it feels like not to itch incessantly, what it feels like to sleep through the night

All the pictures and words were collected at a National Eczema Association (NEA) conference where children could express themselves through artwork and answer important questions about how it feels to be affected by eczema (items with an “*” indicate comments said by many children)

HOW DO YOU SEE ECZEMA?

• A rash that never can be treated and sometimes sore • Unbearable • Painful • An everyday problem • Itchy, dry skin * • Red spots * • Evil • Special

HOW DOES ECZEMA MAKE YOU FEEL?

• Mad • Itchy * • Sad * • Upset * • Different * • Frustrated • Self conscious • Uncomfortable • Strong - I see my sister everyday and see how strong she is, it makes me stronger too

HOW DO PEOPLE WHO YOU MEET ON THE STREET SEE YOU? • They just see my rash.

• They think it is poison ivy * • Chicken pox * • Stare • Odd • Different • Normal * • Diseased • They see red

VOL. 6, NO. 4 FALL 2012 29

CLINIC AL DERMATOLOGY

Eczema from a Child’s Point of View

• Contagious, gross • They see me coming

HOW DO YOU THINK YOUR PARENTS SEE ECZEMA? • Terrible burden • A rash that is severe, leaving blood opened wounds that won’t heal until treated • Something that needs to be cured • A horrible and unbeatable disease * • Stop scratching, it will make it worse * • A really bad skin disease that has affected our lives • They would use scientific phrases

CLINIC AL DERMATOLOGY

HOW ABOUT YOUR TEACHERS, HOW DO THEY SEE ECZEMA?

• They think it is bad • They see a rash * • They feel sorry for me • Uncomfortable • My mom tells them • They feel bad, tell you not to scratch • I don’t think they know I have it *

...AND YOUR FRIENDS?

• They think it is “Pozin ivey” * • They feel bad for you • Not normal, odd • Like chicken pox * • Too bad you have eczema • They don’t know about it or think it’s just a rash

WHAT ARE SOME OF THE PROBLEMS KIDS FACE HAVING ECZEMA?

• Itching * • Sleeping a lot • Boo boos • Breaking out • Trying to stop scratching • Itches until it bleeds, get scabs • Getting up a lot at night and itching • Feeling left out • My brother’s friends desert him sometimes

WHO DO YOU FEEL THE MOST COMFORTABLE TALKING TO ABOUT ECZEMA? • Mom * • My family * • Parents * • Friends * • Specialists • No one

WHAT HELPS YOU DEAL WITH ECZEMA? • Medicine * • Lotion and cream * • Wrapped hands

30 Journal of Dermatology for Physician Assistants

• Something cold • A warm shower and a ton of cream • A book • Comics • Relaxing • Playing with my friends • Activities like video games • People not noticing it right away • My parents • Nothing really, I guess just knowing it will go away soon J The National Eczema Association offers patient education materials such as the following educational brochures: All About Atopic Dermatitis Atopic Dermatitis in Children Bathing & Moisturizing Hand Eczema Topical Corticosteroids: Myths & Facts Contact the National Eczema Association to learn more: info@nationaleczema.org, 415.499.3474, or nationaleczema.org

Take Home Points for Derm PAs:

By Steven K. Shama, MD, MPH

1. All clinicians who see children with eczema should read this short, heartfelt, innocent expression of a mother’s wish for her child. It takes a moment to read this mother’s words and to feel her heartbreak when she describes her child as different and her wish for her child to have a “normal childhood.”

2. I truly believe that it is every parents’ dream for their children that they have a normal life, that they fit in, and that their days can be play-filled days and that their nights be peace-filled nights.

Childhood eczema can take those dreams away.

3. We can become better clinicians knowing how parents may feel when they have a child with significant eczema. We need to read their words, open our hearts, and let these parents teach us how to care for their child. It goes well beyond our recommendations for soothing baths, emollients, and topical corticosteroids.

It is us caring enough to feel for these children, imagining what they must be thinking (see their comments and drawings), and having those conversations with our little patients and their parents to see if we can help with those tender emotional states as well as the physical. It is in caring about both states that we give the best and most satisfying medical care.

&

DermoscopyQ A SDPA Members Only Content

CLINIC AL DERMATOLOGY

A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

VOL. 6, NO. 4 FALL 2012 31

CLINICAL snapshots Dermatomyositis

By Larry Bishop, MD

SDPA Members Only Content A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

CLINIC AL DERMATOLOGY

Figure: Clinical view of Gottron’s papules

Larry Bishop, MD attended medical school at Wright State University, completed a surgical internship at the University of Pennsylvania, and completed his residency in dermatology at Wilford Hall Medical Center in San Antonio, TX. While at Wilford Hall, Dr. Bishop was able to serve as an exchange resident at the world’s oldest hospital dedicated to dermatology, Hospital Saint-Louis in Paris, France. Dr. Bishop currently practices at MIMA Dermatology in Melbourne, FL. His areas of special interest are cosmetic and surgical dermatology including Mohs Micrographic Surgery and nonsurgical rejuvenation of the face.

Dr. Bishop has created the Derm Challenge, an email based trivia game designed for PAs and NPs practicing in dermatology. Answers (along with the question or clinical image) from previous daily challenges can be found archived in a blog at www.dermchallenge.blogspot.com. To sign up for the Derm Challenge, forward your name, position, name of your dermatology practice, and email address to delsol321@cfl.rr.com. Dr. Bishop has indicated no conflicts of interest to disclose relating to the content of this article.

32 Journal of Dermatology for Physician Assistants

Announcing the next phase of high quality category 1 CME! Visit Dermpa.org/Diplomate to experience this innovative educational program developed by the SDPA. These new Distance Learning Initiative modules are available to ALL Society of Dermatology Physician Assistants members, including students and NPs.

5new_sign_JDPA_FullB.indd 1

VOL. 6, NO. 4 10/15/12 FALL 2012 33 12:15 PM

SURGICAL DERMATOLOGY

SURGICAL wisdom Needle Stick Prevention – Step 4: Evaluation SDPA Members Only Content A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

Figure: Campaign Process

For additional information on the campaign please visit the CDC website at www.cdc.gov/niosh/stopstick.

34 Journal of Dermatology for Physician Assistants

In the first-line treatment of external genital and perianal warts (EGW)…

Put patients in the clear.

VEREGEN® Delivers Complete Clearance With Low Recurrence*1 • 53.6% of patients demonstrated complete clearance1 —Only 6.8% of patients with complete clearance experienced recurrence at 12 weeks posttreatment1 • Sinecatechins Ointment, 15% is now included in the Centers for Disease Control and Prevention (CDC) Sexually Transmitted Diseases Treatment Guidelines2 —Listed as a patient-applied treatment option for EGW

• The most common adverse reactions were local skin and application site reactions1 *At 12 weeks posttreatment in the two phase 3 studies.

VEREGEN® is indicated for the topical treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older.

Important Selected Safety Information VEREGEN® has not been evaluated to treat urethral, intra-vaginal, cervical, rectal, or intra-anal human papilloma viral disease and should not be used to treat these conditions. Avoid use of VEREGEN® on open wounds.

Avoid exposure of VEREGEN®-treated areas to sun/UV-light because VEREGEN® has not been tested under these circumstances. Safety and efficacy of VEREGEN® have not been established in immunosuppressed patients or patients under 18 years of age, or The FIRST pregnant women, or for the treatment BOTANICAL DRUG of external genital and perianal warts approved for prescription use in the United States beyond 16 weeks or for multiple treatment courses.

The most common adverse reactions are local skin and application site reactions including (incidence ≥ 20%) erythema, pruritus, burning, pain/ discomfort, erosion/ulceration, edema, induration, and rash vesicular.

3

References: 1. VEREGEN® Ointment, 15% [Prescribing Information, 2011]. Melville, NY: PharmaDerm, a division of Fougera Pharmaceuticals Inc. 2. Workowski KA, Berman S; Centers for Disease Control and Prevention.

Sexually transmitted diseases treatment guidelines, 2010. MMWR Recomm Rep. 2010;59(RR-12):1-110. 3. Data on file, PharmaDerm.

Please see adjacent page for Brief Summary of full Prescribing Information.

VEREGEN is a registered trademark of MediGene AG, D-82152 Planegg/Martinsried, Germany. ©2012 PharmaDerm, a division of Fougera Pharmaceuticals Inc. Melville, NY 11747. All rights reserved. 98NVE030212

VOL. 6, NO. 4 FALL 2012 35

Brief Summary of Prescribing Information–See Package Insert for Full Prescribing Information at www.pharmaderm.com

Veregen

®

(sinecatechins)

Ointment, 15% Rx Only

For Topical Dermatologic Use Only

Nursing Mothers It is not known whether topically applied Veregen® is excreted in breast milk.

Pediatric Use Safety and effectiveness in pediatric patients have not been established.

Geriatric Use Seven patients (1.4%), older than 65 years of age were treated with Veregen® in clinical studies. This, however, is an insufficient number of subjects to determine whether they respond differently from younger subjects.

ADVERSE REACTIONS

INDICATIONS AND USAGE

Veregen® is a topical ointment indicated for the treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older.

Limitations of Use: Safety and effectiveness of Veregen® have not been established in immunosuppressed patients, in treatment of external genital and perianal warts beyond 16-weeks, or for multiple treatment courses.

CONTRAINDICATIONS None

CLINICAL STUDIES

Two randomized, double-blind, vehicle-controlled studies were performed to investigate the safety and efficacy of Veregen® in the treatment of immunocompetent patients 18 years of age and older with external genital and perianal warts. The subjects applied the ointment 3 times daily for up to 16 weeks or until complete clearance of all warts (baseline and new warts occurring during treatment).

Over both studies the median baseline wart area was 51 mm2 (range 12 to 585 mm2), and the median baseline number of warts was 6 (range 2 to 30).

The primary efficacy outcome measure was the response rate defined as the proportion of patients with complete clinical (visual) clearance of all external genital and perianal warts (baseline and new) by week 16, presented in Tables 1 and 2 for all randomized subjects dispensed medication.

Table 1: Efficacy by Region Complete Clearance All Countries (includes the United States) Veregen® 15% (N = 397) 213 (53.6%) Vehicle (N = 207) 73 (35.3%) United States Veregen® 15% (N = 21) 5 (23.8%) Vehicle (N = 9) 0 (0.0%) Table 2: Efficacy by Gender Complete Clearance Males Veregen® 15% (N = 205) 97 (47.3%) Vehicle (N = 118) 34 (28.8%) Females Veregen® 15% (N = 192) 116 (60.4%) Vehicle (N = 89) 39 (43.8%) Median time to complete wart clearance was 16 weeks and 10 weeks, respectively, in the two phase 3 clinical trials.

The rate of recurrence of external genital and perianal warts 12 weeks after completion of treatment in subjects with complete clearance is 6.8% (14/206) for those treated with Veregen® and 5.8% (4/69) for those treated with vehicle.

WARNINGS AND PRECAUTIONS

Veregen® should not be used to treat urethral, intra-vaginal, cervical, rectal, or intra-anal human papilloma viral disease.

Use of Veregen® on open wounds should be avoided.

Avoid exposure of Veregen® treated areas to sun/UV-light as Veregen® has not been tested under these circumstances.

USE IN SPECIFIC POPULATIONS

Pregnancy Pregnancy Category C: There are no adequate and well controlled studies in pregnant women. Veregen® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

36 Journal of Dermatology for Physician Assistants

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 Phase 3 clinical trials, a total of 397 subjects received Veregen® three times per day topical application for the treatment of external genital and perianal warts for up to 16 weeks.

Serious local adverse events of pain and inflammation were reported in two subjects (0.5%), both women.

In clinical trials, the incidence of patients with local adverse events leading to discontinuation or dose interruption (reduction) was 5% (19/397). These included the following events: application site reactions (local pain, erythema, vesicles, skin erosion/ulceration), phimosis, inguinal lymphadenitis, urethral meatal stenosis, dysuria, genital herpes simplex, vulvitis, hypersensitivity, pruritus, pyodermitis, skin ulcer, erosions in the urethral meatus, and superinfection of warts and ulcers.

Local and regional reactions (including adenopathy) occurring at >1% in the groups treated with Veregen® (N=397) or vehicle (N=207), respectively, were: erythema (70%, 32%), pruritus (69%, 45%), burning (67%, 31%), pain/discomfort (56%, 14%), erosion/ulceration (49%, 10%), edema (45%, 11%), induration (35%, 11%), rash vesicular (20%, 6%), regional lymphadenitis (3%, 1%), desquamation (5%, <1%), discharge (3%, <1%), bleeding (2%, <1%), reaction (2%, 0%), scar (1%, 0%), irritation (1%, 0%), and rash (1%, 0%).

A total of 266/397 (67%) of subjects in the Veregen® group had either a moderate or a severe reaction that was considered probably related to the drug, of which 120 (30%) subjects had a severe reaction. Severe reactions occurred in 37% (71/192) of women and in 24% (49/205) of men. The percentage of subjects with at least one severe, related adverse event was 26% (86/328) for subjects with genital warts only, 42% (19/45) in subjects with both genital and perianal warts and 48% (11/23) of subjects with perianal warts only.

Phimosis occurred in 3% of uncircumcised male subjects (5/174) treated with Veregen® and in 1% (1/99) in vehicle.

The maximum mean severity of erythema, erosion, edema, and induration was observed by week 2 of treatment.

Less common local adverse events included urethritis, perianal infection, pigmentation changes, dryness, eczema, hyperesthesia, necrosis, papules, and discoloration. Other less common adverse events included cervical dysplasia, pelvic pain, cutaneous facial rash, and staphylococcemia.

In a dermal sensitization study of Veregen® in healthy volunteers, hypersensitivity (type IV) was observed in 5 out of 209 subjects (2.4%) under occlusive conditions.

DOSAGE AND ADMINISTRATION

Veregen® is to be applied three times per day to all external genital and perianal warts.

Apply about an 0.5 cm strand of ointment to each wart using the finger(s), dabbing it on to ensure complete coverage and leaving a thin layer of the ointment on the warts.

Veregen® is not for ophthalmic, oral, intra-vaginal, or intra-anal use.

HOW SUPPLIED/STORAGE AND HANDLING

Veregen® is a brown ointment and is supplied in an aluminum tube containing 15 grams (NDC # 10337-450-15) of ointment per tube.

Prior to dispensing to the patient, store refrigerated 2°C to 8°C (36°F to 46°F).

After dispensing, store refrigerated or up to 25°C (77°F). Do not freeze.

Manufactured for:

Manufactured by: C.P.M. Contract Pharma GmbH & Co. KG Frühlingstrasse 7 D-83620 Feldkirchen-Westerham Germany U.S. Patent Nos. 5795911 and 5968973

98NVE060312

COSMETIC DERMATOLOGY

COSMETIC pearls Top Tips for Maintaining Smooth, Shiny Hair SDPA Members Only Content A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

VOL. 6, NO. 4 FALL 2012 37

NEW 2.5% PUMP!

ZYCLARAÂŽ (imiquimod) Cream, 2.5% and 3.75% are indicated for the topical treatment of clinically typical visible or palpable actinic keratoses (AK) of the full face or balding scalp in immunocompetent adults.

Avoid use in or on the lips and nostrils.

Do not use in or near the eyes.

Intense local skin reactions including skin weeping or erosion can occur after a few applications of ZYCLARA Cream and may require an interruption of dosing. Administration of ZYCLARA Cream is not recommended until the skin is healed from any previous drug or surgical treatment.

The safety and eďŹ&#x192;cacy of ZYCLARA Cream has not been established in the treatment of superficial basal cell carcinoma.

2.5% & 3.75%

See Important Safety Information and brief summary of Full Prescribing Information on the following pages.

Reference: ZYCLARA Cream Package Insert. Scottsdale, AZ: Medicis, the Dermatology Company; February 2012.

ZYCLARA is a registered trademark of Medicis Pharmaceutical Corporation. ZCL 12-046 03/31/13

38 Journal of Dermatology for Physician Assistants

Full face or balding scalp, we’ve got AKs covered FROM HERE

TO HERE

2.5% & 3.75% VOL. 6, NO. 4 FALL 2012 39

BRIEF SUMMARY (see package insert for Full Prescribing Information)

ZYCLARA

®

(imiquimod) Cream

Rx OnLY FOR TOPICAL USE OnLY nOT FOR ORAL, OPHTHALMIC, InTRA-AnAL OR InTRAVAGInAL USE InDICATIOnS AnD USAGE

Actinic Keratosis ZYCLARA Cream, 2.5% and 3.75% are indicated for the topical treatment of clinically typical visible or palpable, actinic keratoses (AK), of the full face or balding scalp in immunocompetent adults.

External Genital Warts ZYCLARA Cream, 3.75% is indicated for the treatment of external genital and perianal warts (EGW)/condyloma acuminata in patients 12 years or older.

Limitations of Use Imiquimod cream has been evaluated in children ages 2 to 12 years with molluscum contagiosum and these studies failed to demonstrate efficacy.

Treatment with ZYCLARA Cream has not been studied for prevention or transmission of HPV. Unevaluated Population The safety and efficacy of ZYCLARA Cream have not been established in the treatment of: • urethral, intra-vaginal, cervical, rectal or intra-anal human papilloma viral disease.

• actinic keratosis when treated with more than one 2-cycle treatment course in the same area.

• patients with xeroderma pigmentatosum.

• superficial basal cell carcinoma.

• immunosuppressed patients.

COnTRAInDICATIOnS None.

WARnInGS AnD PRECAUTIOnS

Local Skin Reactions Intense local skin reactions including skin weeping or erosion can occur after a few applications of ZYCLARA Cream and may require an interruption of dosing. ZYCLARA Cream has the potential to exacerbate inflammatory conditions of the skin, including chronic graft versus host disease.

Severe local inflammatory reactions of the female external genitalia can lead to severe vulvar swelling. Severe vulvar swelling can lead to urinary retention. Dosing should be interrupted or discontinued for severe vulvar swelling.

Administration of ZYCLARA Cream is not recommended until the skin is healed from any previous drug or surgical treatment.

Systemic Reactions Flu-like signs and symptoms may

accompany, or even precede, local skin reactions and may include fatigue, nausea, fever, myalgias, arthralgias, malaise and chills.

An interruption of dosing and an assessment of the patient should be considered.

Lymphadenopathy occurred in 2% of subjects with actinic keratosis treated with ZYCLARA Cream, 3.75% and in 3% of subjects treated with ZYCLARA Cream, 2.5%. This reaction resolved in all subjects by 4 weeks after completion of treatment.

Ultraviolet Light Exposure Risks Exposure to sunlight (including sunlamps) should be avoided or minimized during use of ZYCLARA Cream. Patients should be warned to use protective clothing (e.g., a hat) when using ZYCLARA Cream. Patients with sunburn should be advised not to use ZYCLARA Cream until fully recovered.

Patients who may have considerable sun exposure, e.g. due to their occupation, and those patients with inherent sensitivity to sunlight should exercise caution when using ZYCLARA Cream.

In an animal photo-carcinogenicity study, imiquimod cream shortened the time to skin tumor formation. The enhancement of ultraviolet carcinogenicity is not necessarily dependent on phototoxic mechanisms.

Therefore, patients should minimize or avoid natural or artificial sunlight exposure.

Increased Risk of Adverse Reactions with Concomitant Imiquimod Use Concomitant use of ZYCLARA and any other imiquimod products, in the same treatment area, should be avoided since they contain the same active ingredient (imiquimod) and may increase the risk for and severity of local skin reactions.

The safety of concomitant use of ZYCLARA Cream and any other Imiquimod products has not been established and should be avoided since they contain the same active ingredient (imiquimod) and may increase the risk for and severity of systemic reactions.

Immune Cell Activation in Autoimmune Disease ZYCLARA Cream should be used with caution in patients with pre-existing autoimmune conditions because imiquimod activates immune cells.

ADVERSE REACTIOnS

Clinical Trials Experience: Actinic Keratosis The data described below reflect exposure to ZYCLARA Cream or vehicle in 479 subjects enrolled in two double-blind, vehicle-controlled trials. Subjects applied up to two packets of ZYCLARA Cream or vehicle daily to the skin of the affected area (either entire face or balding scalp) for two 2-week treatment cycles separated by a 2-week no treatment period.

Local skin reactions were recorded as adverse reactions only if they extended beyond the treatment area, if they required any medical intervention, or they resulted in patient discontinuation from the study. The

40 Journal of Dermatology for Physician Assistants

Table 1: Selected Adverse Reactions Occurring in ≥ 2% of ZYCLARA-Treated Subjects and at a Greater Frequency than with Vehicle in the Combined Studies (AK) Adverse Reactions Headache Application site pruritus Fatigue Nausea Influenza like illness Application site irritation Pyrexia Anorexia Dizziness Herpes simplex Application site pain Lymphadenopathy Oral herpes Arthralgia Cheilitis Diarrhea

ZYCLARA Cream, 3.75% (N=160) 10 (6%)

ZYCLARA Cream, 2.5% (N=160) 3 (2%)

Vehicle (N=159) 5 (3%)

7 (4%)

6 (4%)

1 (<1%)

7 (4%) 6 (4%) 1 (<1%)

2 (1%) 1 (1%) 6 (4%)

0 2 (1%) 0

5 (3%)

4 (3%)

0

5 (3%) 4 (3%) 4 (3%) 4 (3%) 5 (3%) 3 (2%) 0 2 (1%) 0 3 (2%)

0 0 1 (<1%) 0 2 (1%) 4 (3%) 4 (3%) 4 (3%) 3 (2%) 2 (1%)

0 0 0 1 (<1%) 0 0 0 0 0 0

Table 2: Local Skin Reactions in the Treatment Area in ZYCLARA-Treated Subjects as Assessed by the Investigator (AK) ZYCLARA Cream, All Grades* (%) Severe 3.75% (N=160) Erythema 96% Severe erythema 25% 93% Scabbing/Crusting 14% Severe scabbing/ Crusting Edema 75% Severe edema 6% 62% Erosion/Ulceration 11% Severe erosion/ Ulceration Exudate 51% Severe exudate 6% 91% Flaking/Scaling/ Dryness 8% Severe flaking/ Scaling/Dryness * All Grades: mild, moderate or severe

ZYCLARA Cream, 2.5% (N=160) 96% 14% 84% 9%

Vehicle (N=159) 78% 0% 45% 0%

63% 4% 52% 9%

19% 0% 9% 0%

39% 1% 88%

4% 0% 77%

4%

1%

Table 3: Selected Adverse Reactions Occurring in ≥ 2% of ZYCLARA Treated Subjects and at a Greater Frequency than with Vehicle in the Combined Trials (EGW) ZYCLARA Cream, 3.75% Preferred Term (N=400) Vehicle Cream (N=202) Application site pain 28 (7%) 1 (<1%) Application site irritation 24 (6%) 2 (1%) Application site pruritus 11 (3%) 2 (1%) Vaginitis bacterial* 6 (3%) 2 (2%) Headache 6 (2%) 1 (<1%) * percentage based on female population of 6/216 for ZYCLARA Cream 3.75% and 2/106 for vehicle cream Table 4: Selected Local Skin Reactions in the Treatment Area Assessed by the Investigator (EGW) All Grades,* (%) Severe, (%) Erythema* Severe erythema Edema* Severe edema Erosion/ ulceration* Severe erosion/ ulceration Exudate* Severe exudate * Mild, Moderate, or Severe

ZYCLARA Cream, 3.75% (N=400) 70% 9% 41% 2% 36% 11%

Vehicle Cream (N=202) 27% <1% 8% 0% 4% <1%

34% 2%

2% 0%

incidence and severity of selected local skin reactions are shown in Table 2.

Overall, in the clinical trials, 11% (17/160) of subjects in the ZYCLARA Cream, 3.75% arm, 7% (11/160) of subjects in the ZYCLARA Cream, 2.5% arm, and 0% in the vehicle cream arm required rest periods due to adverse local skin reactions.

Other adverse reactions observed in subjects treated with ZYCLARA Cream include: application site bleeding, application site swelling, chills, dermatitis, herpes zoster, insomnia, lethargy, myalgia, pancytopenia, pruritus, squamous cell carcinoma, and vomiting.

Clinical Trials Experience: External Genital Warts In two double-blind, placebo-controlled studies 602 subjects applied up to one packet of ZYCLARA Cream or vehicle daily for up to 8 weeks.

The most frequently reported adverse reactions were application site reactions and local skin reactions. Selected adverse reactions are listed in Table 3.

Local skin reactions were recorded as adverse reactions only if they extended beyond the treatment area, if they required any medical intervention, or they resulted in patient discontinuation from the study. The incidence

and severity of selected local skin reactions are shown in Table 4.

The frequency and severity of local skin reactions were similar in both genders, with the following exceptions: a) flaking/scaling occurred in 40% of men and in 26% of women and b) scabbing/crusting occurred in 34% of men and in 18% of women.

In the clinical trials, 32% (126/400) of subjects who used ZYCLARA Cream and 2% (4/202) of subjects who used vehicle cream discontinued treatment temporarily (required rest periods) due to adverse local skin reactions, and 1% (3/400) of subjects who used ZYCLARA Cream discontinued treatment permanently due to local skin/ application site reactions.

Other adverse reactions reported in subjects treated with ZYCLARA Cream include: rash, back pain, application site rash, application site cellulitis, application site excoriation, application site bleeding, scrotal pain, scrotal erythema, scrotal ulcer, scrotal edema, sinusitis, nausea, pyrexia, and influenzalike symptoms.

Postmarketing Experience The following adverse reactions have been identified during post-approval use of imiquimod. 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.

Application Site Disorders: tingling at the application site Body as a Whole: angioedema Cardiovascular: capillary leak syndrome, cardiac failure, cardiomyopathy, pulmonary edema, arrhythmias (tachycardia, supraventricular tachycardia, atrial fibrillation, palpitations), chest pain, ischemia, myocardial infarction, syncope Endocrine: thyroiditis Gastro-Intestinal System Disorders: abdominal pain Hematological: decreases in red cell, white cell and platelet counts (including idiopathic thrombocytopenic purpura), lymphoma Hepatic: abnormal liver function Infections and Infestations: herpes simplex Musculo-Skeletal System Disorders: arthralgia Neuropsychiatric: agitation, cerebrovascular accident, convulsions (including febrile convulsions), depression, insomnia, multiple sclerosis aggravation,

paresis, suicide Respiratory: dyspnea Urinary System Disorders: proteinuria, urinary retention, dysuria Skin and Appendages: exfoliative dermatitis, erythema multiforme, hyperpigmentation, hypertrophic scar, hypopigmentation Vascular: Henoch-Schonlein purpura syndrome

OVERDOSAGE

Topical overdosing of ZYCLARA Cream could result in an increased incidence of severe local skin reactions and may increase the risk for systemic reactions.

Hypotension was reported in a clinical trial following multiple oral Imiquimod doses of >200 mg (equivalent to ingestion of the imiquimod content of more than 21 packets or pump actuations of ZYCLARA Cream, 3.75% or more than 32 packets or pump actuations of ZYCLARA Cream, 2.5%).

The hypotension resolved following oral or intravenous fluid administration.

Manufactured for: Medicis, The Dermatology Company Scottsdale, AZ 85256 April 2012 19110248

Important Safety Information for ZYCLARA Cream Intense local skin reactions including skin weeping or erosion can occur after a few applications of ZYCLARA Cream and may require an interruption of dosing. Administration of ZYCLARA Cream is not recommended until the skin is healed from any previous drug or surgical treatment.

Exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) should be avoided or minimized during use of ZYCLARA Cream. Patients should be advised to wear protective clothing (e.g., hat) when using ZYCLARA Cream.

Avoid concomitant use of ZYCLARA Cream and any Flu-like signs and symptoms may accompany, or even other imiquimod cream because of increased risk for precede, local skin reactions and may include fatigue, adverse events. nausea, fever, myalgias, arthralgias, malaise and chills.

In clinical studies, the most common adverse events involved skin reactions in the application ZYCLARA Cream should be used with caution in area including erythema, scabbing/crusting, patients with pre-existing autoimmune conditions flaking/scaling/dryness, edema, erosion/ulceration, because imiquimod activates immune cells. and exudate. Most skin reactions were rated as mild to moderate.

VOL. 6, NO. 4 FALL 2012 41

PROFESSIONAL DE VELOPMENT

Is There a Glass Ceiling for PAs? Part 2

By Kasey Drapeau-Dâ&#x20AC;&#x2122;Amato, MPAP, PA-C and Katherine Wilkens, MHIS, MPAP, PA-C

SDPA Members Only Content A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

42 Journal of Dermatology for Physician Assistants

A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

Kasey Drapeau-D’Amato, MPAP, PA-C is the President and founder of Certified Physician Assistant Consulting (www.certifiedpaconsulting.com). She received her Master’s degree in Physician Assistant Practice from the Keck School of Medicine’s Physician Assistant Program at the University of Southern California in 2003 and has been working as a Physician Assistant in Southern California since that time. She currently practices in one of the largest private practice dermatology groups in Los Angeles.

Kasey achieved the status of SDPA Diplomate in 2011 and is very active in the SDPA. She has written and contributed to multiple medical journal publications on the topics of the PA profession and compensation. She is also a regular contributor to the SDPA’s website public forum, where she provides guidance to her colleagues and peers.

Katherine Wilkens, MHIS, MPAP, PA-C is the Vice President of Certified Physician Assistant Consulting (www.certifiedpaconsulting.com). She received her first Master’s degree in medicine and Health Information Systems from Loma Linda University. She obtained her second Master’s degree from University of Southern California’s Keck School of Medicine’s Physician Assistant Program in 2003. Katherine currently practices dermatology in Northern California in a private practice setting.

She serves as the Clinical Administrative Manager for three separate offices. Katherine has maintained additional clinical skills by continuing to work in the ER. She has also been an employee of CEP, California Emergency Physicians, since 2003.

VOL. 6, NO. 4 FALL 2012 43

PROFESSIONAL DEVELOPMENT

SDPA Members Only Content

Dermatology Billing & Coding Suture Removal - When You Can Charge and How

By Inga Ellzey, MPA, RHIA, CDC

SDPA Members Only Content

PROFESSIONAL DEVELOPMENT

A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

44 Journal of Dermatology for Physician Assistants

SDPA Members Only Content

Ms. Ellzey, President/CEO of the Inga Ellzey Practice Group, Inc., in Casselberry, FL, is an expert on dermatology coding, documentation and reimbursement. She has more than 35 years of experience in the field of dermatology and is the CEO and founder of two nationwide dermatology billing services. You can reach her at the following number: (800) 318-3271, or email her at: inga@iepg.com.

Being a SDPA Diplomate has great benefits: 1. Earn 70* hours Catagory 1 CME 2. Online supports available 3. $50 discount on SDPA conferences 4. Private invite-only receptions 5. Personal recognition in medical journals such as the AADâ&#x20AC;&#x2122;s Dermatology World, Skin & Aging, and Practical Dermatology

6. Receive a SDPA Diplomate Certificate after completion of the DLI

*CME hours are approximate Benefits_sign_JDPA_HalfPage.indd 1

10/11/12 PM VOL. 6, NO. 4 FALL 201210:4945

PROFESSIONAL DEVELOPMENT

A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

Judicial and Ethical Affairs

Case-Based Compliance Scenarios

By Sarah Richardson, Chief Compliance Officer, Medicis Pharmaceutical Corporation

PROFESSIONAL DEVELOPMENT

SDPA Members Only Content A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

46 Journal of Dermatology for Physician Assistants

SDPA Members Only Content Sarah Richardson is the Chief Compliance Officer for Medicis Pharmaceutical Corporation and is responsible for overseeing the company’s corporate compliance program. Prior to joining Medicis, Mrs. Richardson was in private practice at Hunton & Williams, LLP and specialized in FDA regulatory law, healthcare fraud and abuse laws, and development of pharmaceutical/medical device company compliance programs. Mrs. Richardson is a graduate of Furman University, St. Andrews University, and Northwestern University School of Law.

Let them know they’re not alone...

Share a story with your patients.

Visit the Patient’s Perspective library of articles at www.jdpa.org/advocacy.html

If you know a patient who would like to share his/her story, please contact us at editor@jdpa.org

VOL. 6, NO. 4 FALL 2012 47

PROFESSIONAL DEVELOPMENT

A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

Outside & Inside the 9 to 5...

Marc Kawohl is a first year student at Nova Jacksonville Physician Assistant Program and the newly appointed SDPA Student Affairs Junior Student Coordinator. He was selected from over twenty applicants for the position.

The Junior Student Coordinator position is a 3-year commitment and includes responsibilities such as participating in monthly conference calls with the SDPA Board of Directors and Committee Chairs, attending annual SDPA conferences, and facilitating student involvement in the SDPA. Knowing how busy PA school can be, the Junior Student Coordinator, Senior Student Coordinator, and Recent Graduate Advisor all work together to ensure a proper balance of responsibilities.

PROFESSIONAL DEVELOPMENT

Marc received his undergraduate degree from the University of Central Florida in 2005, and shortly after he began teaching physical education. He chose to pursue the physician assistant career path because it encompasses many of his passions: educating, changing lives, and medicine. Marc shares with us his insights into how his previous experiences will help in his new position as Junior Student Coordinator and his thoughts for increasing student involvement with the SDPA.

I am looking forward to working with the SDPA as the new Junior Student Coordinator. I believe my leadership skills, approachability, and professionalism will be most beneficial to this position.

Leadership is the cornerstone in achieving goals in an ever-changing environment. As a public school teacher, I learned that the greatest leaders not only set examples, but they also listen to learn how to improve the overall performance of their teams. Throughout my six years of experience as an educator, I was nominated several times to be team leader because of my exceptional performance and my passion for achieving results.

Leadership should include being approachable.

Possessing this trait improves a leaderâ&#x20AC;&#x2122;s likelihood of getting a group to work as a unit. Open communication improves problem solving while giving rise to more effective solutions.

Being in any leadership position means the possibility of encountering diversity, challenges, and stressful situations. Knowing how to behave when these situations arise exemplifies professionalism. Gathering the best from each experience allows one to grow and overcome future tough moments.

I am confident that I can help to increase student involvement with the SDPA through communication. In order to promote student awareness, I plan on utilizing an outreach approach. Such an approach will include sending SDPA publications (e.g., SDPA Newsletter and JDPA) to PA programs; promoting the SDPA and its benefits at local PA program events (e.g., monthly dermatology speakers); and educating others about and encouraging new participation in the SDPA preceptorship program.

By giving students more information about the dermatology PA profession, we can offer students facts that will help with their career decisionmaking.

I appreciate the opportunity to lead my fellow students, assist my supervising SDPA Director at Large, and act as a liaison between the SDPA and SAAAPA. I am certain that my past work experience, my desire to be involved with the SDPA, and my passion for mentoring people will benefit the SDPA as I take on the Junior Student Coordinator position. J Marc Kawohl, PA-S1 SDPA Student Affairs Committee Junior Student Coordinator

To obtain an application for the next SDPA Junior Student Coordinator position as well as to learn more about the position, please visit the SDPAâ&#x20AC;&#x2122;s student website under the "How to Become the Student Coordinator of the SDPA" tab: www.dermpa. org/students/student-coordinator. If you have any questions, please contact Stephanie Cohen, PA-S, SDPA Student Affairs Committee Senior Student Coordinator at scohen@dermpa.org.

48 Journal of Dermatology for Physician Assistants

NOTES from your Office Manager

Six Ways to Grow Your Practice We would all like for our practice to be viewed as being outstanding. Below you will find some simple starting tips on how to begin to distinguish your practice as being one of the standouts within your community.

Include a question about how patients find your practice on your check-in/new patient forms or make it a part of the conversation at the front desk. If patients are referred from other practices make it a policy to send thank you notes. If the referrals are from other patients, make it a point to say thank you for the referrals. You can send HIPAA compliant thank you notes that simply say, “A new patient just joined our practice thanks to you.

Thank you for recommending us.”

➋ Become Visible on the Web Patients find dermatology practices by searching online. Go beyond just having a website. Meet with a local internet marketing firm to get a few suggestions on how to make your practice more visible in Google searches.

➌ Find Ways to Increase Patient Visits Send reminders to patients about preventive services and make sure you remind them that many health plans cover preventive checkups at 100%. Take steps to make sure your scheduled patients actually show up for their appointments. Use of automated phone and email reminders can significantly impact your no show percentage. Reducing your no show rates by several percentage points can have a significant impact on your revenue.

➍ Be Visible in Your Community By organizing an afternoon or even a Saturday morning free health screening event, you will make your practice visible to the community and have an opportunity to network with other organizations that are potential referral sources.

➎ Tell Your Patients “Thank You” When was the last time patients were thanked for coming to a dermatology office? Take the opportunity to differentiate your practice through a quick and easy email thanking patients for coming to your office and entrusting their care with you.

➏ Ask For an Assessment Include a survey with your thank you notes so that patients can give you an assessment of how they thought their visits went. This may give you tips for improvements you can make or key differentiators your patients experience at your practice that they may not get elsewhere. J

Dan Rodrigues, CEO of Kareo Kareo, Inc. 111 Academy Drive, Suite 250, Irvine, CA 92617 1-888-77-KAREO(2736) sales@kareo.com

VOL. 6, NO. 4 FALL 2012 49

PROFESSIONAL DEVELOPMENT

➊ Find Out How Patients Find You

DERMATOLOGY PA NEWS & NOTES

From the Desk of...

By Jane Mast, MPAS, PA-C

SDPA Legislative Affairs Committee Chair

Help the SDPA in the Fight Against Indoor Tanning “Never Believe that a few caring people can’t change the world. For, indeed, that’s all who ever have” – Margaret Mead As dermatology physician assistants we are aware of the dangers of indoor tanning beds. Roughly 76,250 new melanomas will be diagnosed this year.

Incidence rates for melanoma have been rising for at least thirty years. About 9,180 people are expected to die of melanoma this year. Melanoma is the leading cause of cancer deaths in women ages twenty-five to thrity and is second only to breast cancer in women ages thirty to thirty-four. Most of us are involved in the fight against melanoma every day. We diagnose and treat melanomas regularly. We do skin checks on our patients and teach them the ABCDE’s of moles. We teach them how to do monthly self-skin exams. We counsel them to avoid tanning of any sort, especially indoor tanning beds. Still there is more we can do.

The SDPA has worked hard over the last year to fight melanoma in a different way. Despite our efforts to educate our patients, most tanning bed users are not seeing dermatologists. Thirty million people currently use indoor tanning beds with 2.3 million of these customers being teenagers. Because of these startling statistics, we have teamed up with groups such as AIM at Melanoma to become advocates to ban tanning bed use for minors.

Since 2003 tanning bed legislation has become more common across the globe. Fifteen countries Jane Mast, MPAS, PA-C is a graduate of the University of Florida Physician Assistant Program and has practiced dermatology for ten years at Space Coast Dermatology in Merritt Island, Florida. Jane currently serves as the SDPA Legislative Affairs Committee Chair and has been active in working to help pass legislation against the use of indoor tanning beds.

50 Journal of Dermatology for Physician Assistants

worldwide and several jurisdictions in Canada currently ban minors who are under eighteen years of age from tanning beds. Iran and Brazil ban any use of tanning beds and New South Wales in Australia will impose a similar total ban in December 2014. Several countries are working on passing tanning bans for minors who are under eighteen years old, including Ireland, Sweden, and Demark.

In the United States during the 2011/2012 legislative sessions, twenty-four states including Washington, D.C. introduced legislation to restrict minors’ access to tanning beds. Approximately forty bills were introduced across the country related to indoor tanning of which more than twenty proposed banning tanning for minors under eighteen years old.

Thirty-three states currently have passed some sort of law restricting minors’ access to tanning beds. Only two states, California and Vermont, have a total ban on indoor tanning for minors under eighteen years old. Seventeen states have no restrictions at all.

The SDPA has supported key legislation that has passed this year. As of July 1, 2012 Vermont has banned all tanning for minors. On July 7, 2012 the Chicago city counsel passed an ordinance to ban tanning for minors. As of August 16, 2012, New York state banned minors under the age of seventeen from indoor tanning with parental consent required until age eighteen. This is the second most restrictive law in the country. Some important laws requiring parental consent were also passed this year. In May 2012, Utah prohibited anyone under the age of eighteen from using a tanning bed unless the minor has a written order from a healthcare provider or at time of each use is accompanied by a parent or legal guardian who must provide written consent.

Local jurisdictions throughout the country are deciding to take steps to protect minors from the dangers of UV radiation and tanning beds rather ...continued on page 52

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Trianex® 0.05% (Triamcinolone Acetonide Ointment) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.

IMPORTANT SAFETY INFORMATION Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients, including children.

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity. Occlusive dressings substantially increase the absorption of topical corticosteroids. Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen.

Local adverse reactions infrequently reported with topical corticosteroids include burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria. If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.

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For more information call 800-654-2299, or visit www.trianex-usl.com. ©2012 Upsher-Smith Laboratories, Inc., Maple Grove, MN 55369 1-800-654-2299

105942.01

VOL. 6, NO. 4 FALL 2012 51

Help the SDPA in the Fight Against Indoor Tanning ...continued from page 50

than waiting for their state government to take action. For example, after Chicago’s successful passage of their ordinance, Springfield, Illinois decided to address the issue as well.

DERMATOLOGY PA NEWS & NOTES

In June 2012, Rhode Island also passed a parental consent law. Any minor under eighteen is now prohibited from using a tanning facility unless the minor presents a written prescription by a licensed healthcare provider, or for every two visits, a parent/guardian signs a consent form stating that he/she has read and understands the risks involved.

This will go into effect January 1, 2013.

We are anticipating that many states where bills were previously introduced will again address this issue during the 2013 legislative session. We are also hoping that states where legislation has not been introduced will do so in 2013. Hopefully, many of these attempts will be successful.

Here are some ways you can help in the fight against the use of tanning beds: • Educate your patients, co-workers, family, and friends about the dangers of UV radiation and tanning beds and ask them to get involved.

• Contact your State Representative, State Senator, or local council member and ask them for their support concerning this issue.

• Write a letter to the editor of your local newspaper or contact other local media.

• Offer to testify at a hearing in the spring on Capitol Hill.

• Start a letter writing campaign.

• Offer to speak at a local high school in order to educate students and parents.

• Join the Legislative Affairs Committee of the SDPA by sending an e-mail to me at jmast@dermpa.org.

• Visit AIM at Melanoma’s website to see what your state has done this year at www.aimatmelanoma.org/en/aim-fora-cure/legislative-accomplishments-inmelanoma/2212.html. J

Trianex® 0.05% (Triamcinolone Acetonide Ointment) Rx Only INDICATIONS AND USAGE Trianex® 0.05% (Triamcinolone Acetonide Ointment) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.

CONTRAINDICATIONS Trianex® 0.05% (Triamcinolone Acetonide Ointment) is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

PRECAUTIONS General Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitaryadrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.

Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings.

Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.

Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug.

Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see PRECAUTIONS-Pediatric Use).

If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.

In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

Information for the Patient Patients using topical corticosteroids should receive the following information and instructions: 1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.

2. Patients should be advised not to use this medication for any disorder other than that for which it was prescribed.

3. The treated skin area should not be bandaged or otherwise covered or wrapped so as to be occlusive unless directed by the physician.

4. Patients should report any signs of local adverse reactions especially under occlusive dressing.

5. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.

Laboratory Tests The following tests may be helpful in evaluating the HPA axis suppression: Urinary free cortisol test ACTH stimulation test Carcinogenesis and Mutagenesis and Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.

Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.

Pregnancy Category C Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

Nursing Mothers It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

Pediatric Use Pediatric patients may demonstrate greater susceptibility to topical corticosteroidinduced HPA axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface area to body weight ratio.

Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.

ADVERSE REACTIONS The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: Burning, Itching, Irritation, Dryness, Folliculitis, Hypertrichosis, Acneiform eruptions, Hypopigmentation, Perioral dermatitis, Allergic contact dermatitis, Maceration of the skin, Secondary infection, Skin atrophy, Striae, Miliaria.

OVERDOSAGE Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

DOSAGE AND ADMINISTRATION Trianex® 0.05% (Triamcinolone Acetonide Ointment, USP) is generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition.

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

CAUTION: For external use only. Not for ophthalmic use.

Distributed by: UPSHER-SMITH LABORATORIES, INC. Minneapolis, MN 55447

104577-01

Revised: September 2010

52 Journal of Dermatology for Physician Assistants 104577_01_BS_HalfPageV_JDPA.indd 1

9/19/12 3:07 PM

The Difference We Make Clinician Burnout: A Hot Topic Clinician burnout has become a hot topic judging by the speed at which Shanafelt et al.’s study “Burnout and Satisfaction With Work-Life Balance Among US Physicians Relative to the General US Population” has seared through cyberspace. The problem of professional burnout seems to be resonating with large numbers of practicing clinicians, especially those who work in the front lines of primary care medicine.

Why the surge in interest? The problem appears to be widespread, perhaps much more so than anyone in the business of medicine realized and it seems to be most prevalent in specialties involving front line access to care.

According to the study, compared with a cohort of 3,442 US adult workers, doctors were more likely to manifest symptoms of burnout and to express dissatisfaction with work-life balance. Professional burnout negatively influences the quality of medical care and increases the likelihood for medical errors.

On a personal level burnout contributes to severed relationships, alcohol abuse, and thoughts of suicide. In addition, burned out clinicians are more likely to opt for early retirement.

In a career path that has the potential for meaningful and fulfilling work, why did nearly half of all physicians in the study report symptoms of burnout? Has this always been the case among medical professionals, or are these latest data just straws in the wind?

Perhaps a relative loss of autonomy might be a contributing factor. Fifty years ago most physicians set up private, solo practices. As individual entrepreneurs, they set their own hours, charged their own fees, and took no orders from third-party payers. All that has changed dramatically. Nowadays, the majority of physicians work as employees in hospitals, clinics, or large group practices. Administrators determine their salaries, daily patient load, hours worked, and benefits accrued. In short, modern clinicians have experienced a loss of autonomy, a factor which contributes to lack of work satisfaction.

There might be more to it than that. Physicians are highly educated workers. Yet when the study compared physicians to high school graduates, individuals with an MD or DO degree showed a greater risk for burnout.

Interestingly, individuals possessing undergraduate or graduate degrees (including doctorates), other than an MD or DO degree, are at lower risk for burnout. Perhaps the relative lack of respect afforded to doctors by society at large might be a contributing factor.

Lest you think this observation is a bit far-fetched, in my defense I offer a bumper sticker which I chanced to encounter just the other day, “Be Kind to a Nurse: After all, someone has to intervene on your behalf to make sure doctors don’t kill you!”

Most highly educated professionals are not employees in a service-based industry. Clinicians work in stressful environments, caring for folks who are vulnerable, sick, and depressed. When problems arise (as they inevitably do), clinicians are expected to take things in stride and roll with the punches. Many times they find themselves in precarious situations where the likelihood of getting sued is high. I don’t imagine that tenured university professors fall into the same category.

The more important question is about dealing with the problem of physician burnout. After all, the healthcare system itself stands to suffer immensely with the loss of significant numbers of practicing physicians already in short supply.

Richard Gunderman, MD, PhD offers some wise words to this end: “Only by keeping what matters most at the forefront can we reap a full harvest of professional fulfillment. Burnout is not a disease. It is a symptom. To combat it, we must focus primarily on what underlies it. And here the key is not eradicating the disease but promoting professional wholeness, which flows from a full understanding of the real sources of fulfillment.” Dr. Gunderman adds that, “Medicine represents one of life’s greatest opportunities to become fully human through service to others.”

On that score I think that William Osler and Albert Schweitzer would agree. J Brian T. Maurer has practiced pediatric medicine as a physician assistant for thirty years. Over the past two decades Mr. Maurer has explored the illness narrative as a tool to cultivate an appreciation for the delivery of humane medical care. He has published numerous vignettes, editorials, and essays in both national and international journals. Mr. Maurer has been a contributing author to the online open-access journal Dermanities (www.dermanities.com) since its inception. Readers can visit the author on the web at http:// briantmaurer.wordpress.com.

VOL. 6, NO. 4 FALL 2012 53

DERMATOLOGY PA NEWS & NOTES

By Brian T. Maurer, PA-C

Workplace Excellence

Embracing Conflict: Mastering the Art of Care-frontation

By Matthew Davidson, Ph.D.

DERMATOLOGY PA NEWS & NOTES

In my work as President of the Institute for Excellence & Ethics (IEE) I have had the opportunity to work with diverse individuals and organizations in their quest to achieve excellence. This column dedicated to workplace excellence explores the organizational, interpersonal, and ethical issues that contribute to (or detract from) individual or organizational excellence within the physician assistant profession. If you have any workplace topics you would like to see covered in the JDPA please feel free to share them with us. Email editor@jdpa.org with any topic ideas or questions concerning the workplace.

F

or weeks your office has been held hostage by a difficult and divisive colleague; for months the inappropriate language and humor being shared around the lunch table has made you uncomfortable; for as long as you can remember your colleague has been rude to patients; throughout this meeting or appointment some important truth has needed to be voiced - and yet, too often nothing is said. Well, maybe something is said later when the person or issue in question has moved on. Maybe a lot is said.

Maybe harsh words are uttered attacking the person or situation. Quite often conflicts ignored or avoided lead to griping and complaining, which precede anger, resentment, and cynicism.

Regardless of the organization we are serving, rarely if ever do we find an environment where individuals are living and working together in which some levels of conflict are not part of the reality; this includes humanistic, service, and religious organizations! The mission may be devoted to peace and love, but that doesn’t mean there is no conflict regarding goals and roles, personalities and politics.

Simply put: if you put people together and they attempt to do anything, conflict of some sort is inevitable. As much as we wish it would go away, as much as we hope that it will never happen, conflict is simply a part of the comingling of goal achievement and human interaction. Seem like a drastic conclusion? Think about it. Consider the labyrinth of needs, desires, values, abilities, and perspectives that accompany any human community engaged in any collective pursuit. Accept it; if you work and live with others you will encounter conflict. You may not need a professional arbitrator; it may not come to fisticuffs; you may be able to ignore or avoid, navigate or negotiate most interpersonal issues to avoid conflict

54 Journal of Dermatology for Physician Assistants

and maintain peace. But sooner or later conflict is inevitable.

Why does the conclusion, “conflict is inevitable”, seem so heavy and demoralizing? Why is conflict so often associated with something bad, something to be avoided, and something that is guaranteed to produce a net loss for the individual and the organization?

What if, in fact, we came to understand and accept that conflict is neutral, not necessarily bad or good, just a part of human functioning? In his book, Caring Enough to Confront, David Augsburger argues that when we see confrontation as rooted in caring, when we understand it as “care-frontation”, then we can begin to experience conflict as “natural, normal, neutral, and sometimes even delightful.”

How could conflict ever be delightful? This is possible when it removes from the confronter the acute pain, the recurring aggravations, the deep wounds, and the heavy burdens that fester and grow when suppressed; or, when it removes for the confronted the tangible tension and persistent awkwardness and provides them with new insights into how to coexist and work with one another.

Augsburger argues that “care-fronting unites love and power…concern for relationships with concern for goals.” Love and power, relationships and goals: I’m your boss, and I want you to be happy and successful here; you’re my patient, and I want you to be healthy. When confrontation is reframed as care-frontation it goes from something to be avoided - a win-lose, angry and argumentative, attack the person not problem reality - to something healthy and productive and worthy of the energy required.

Confrontation becomes care-frontation when we speak the truth in love, expressing our deepest beliefs and needs while still respecting the deepest beliefs

➌

Use I-statements that honestly and respectfully express your thoughts and feelings, are solutioncentered, and clarify the goal or expectation (e.g., I think ___because… I feel ___ because…

I intend to ___ because…). ➍ Avoid You-statements that blame, insult, and attack the personality and/or character of others.

You-statements divide, distract, and disrespect.

They sound like, “You never, you always, you should have, you won’t, and/or you don’t.” ➎ Seek win-win solutions by clearly expressing your needs (I want), their needs (you want), and working together to find creative solutions that satisfy both (we could). ➏ Accept that mistakes and missteps will happen; be ready to apologize, make up for, and move on.

Conflict is neither bad nor good, it simply is. Conflict simply is an essential part of goal achievement and human interaction. You simply cannot reach your full potential and deepest goals as an organization unless you accept and master the art of conflict. As you build an intentional culture of excellence in your office, I hope you can take some time to reframe confrontation into care-frontation and to work together to plan, practice, monitor, and improve your ability to speak the truth in love and to manage conflict with civility. J Matthew L. Davidson, Ph.D. is the Founder, President, and Director of Education for the Institute for Excellence & Ethics (IEE), a 501(c)3 nonprofit corporation dedicated to helping individuals and organizations achieve excellence. Previously he was the Research Director at the Center for Respect & Responsibility at the State University of New York College at Cortland. He has been on staff at the Family Life Development Center at Cornell University, the Values Program at LeMoyne College, and the Mendelson Center for Sport, Character, and Culture at the University of Notre Dame where he was also an Adjunct Professor of Education. He is a National Spokesperson for the Business Bureau National Center for Character Ethics. The IEE specializes in the development and dissemination of research-based tools for developing the culture and competencies of excellence and ethics in schools, athletics, the workplace, and the home; this is done through professional development workshops & academies, teaching & learning resources, assessment, and consulting services. He is a frequent national presenter and is available for keynote lectures, professional development, retreats, and organizational consulting. For additional information or to contact the IEE, please visit www.excellenceandethics.org.

VOL. 6, NO. 4 FALL 2012 55

DERMATOLOGY PA NEWS & NOTES

and needs of the other(s), holding self and others accountable out of mutual respect and for our mutual benefit.

When you assemble a team of individuals and put them into the day-to-day pressures of the work-aday world, managing conflict is an essential element of a positive and productive culture of excellence.

Too often, however, organizational approach to conflict is reactive, not proactive. We speak and operate in terms of conflict resolution, rather than conflict management. In the former, we seek to resolve it or make it go away. In the latter, we accept it and manage the type, nature, and net costs of this inevitable byproduct of human interaction.

Even in contexts where the goal is enjoyment and the relationships are familiar (e.g., friends or family gathering for food and fellowship), conflict doesn’t disappear - oh that it would! However, in contexts where our goals are challenging and our relationships are contingent, even utilitarian in nature (e.g., individuals with particular skills hired to help us thrive as an organization), then the nature, frequency, and intensity of conflicts are likely to increase. An intentional culture of excellence must proactively establish and develop the habits needed to efficiently and effectively navigate conflict or suffer the real costs to the individuals and the organization.

Care-fontation isn’t simply an emotional intelligence skill required for improved collegiality amongst professional colleagues; it is also an essential skill for effective patient care. “Speaking the truth in love” may be the simplest five word distillation of effective patient care. Put differently: effective patient care begins at the point of conflict; here is a problem we have to deal with. Much of the diagnosis of a problem points to the need for essential changes in behavior. Avoid the hard conversations, and the patient may like you but face dire future consequences; turn it into confrontation, and the patient is likely to turn resentful of the message along with the messenger and become entrenched in their harmful behaviors. Thus, developing productive habits for effective conflict is essential for all aspects of workplace excellence (it won’t hurt in our homes or in our other relationships outside of work either).

Here are some simple, though not necessarily easy, steps to transform confrontation into carefrontation: ➊ Attack the problem not the person. The goal isn’t to be right; the goal is to get it right. ➋ When in doubt, do it. Conflicts delayed and deferred make little things into big things.

Now achieve harmony in acne management

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56 Journal of Dermatology for Physician Assistants

Supervising Physician CORNER The AAD Medical Student Core Curriculum A Standardized Dermatology Curriculum An interview with Maj Patrick E. McCleskey, MD, FAAD

JDPA: How have things changed since you started teaching students compared to now?

Dr. McCleskey: The old school method of teaching was “top-down;” students showed up to a lecture, and we told them what we wanted them to learn. Newer approaches involve more active learning (e.g., problem based learning cases) and involve the learner’s needs and desires as well as the teacher’s. The reality is that dermatologists have less time to lecture students than they used to, and we have to be creative in how we deliver quality education without adding to the total number of hours of medical/PA school.

JDPA: We understand the need to be creative in delivering quality education, but why is there a need to agree on a standardized dermatology curriculum?

Dr. McCleskey: Our main goal is to promote better skin care for all patients, and the majority of skin care is delivered by providers other than dermatologists. Currently, there’s not enough dermatology being taught in medical schools; on average, students get fewer than ten hours of dermatology instruction throughout medical school. In addition, eight percent of medical schools require no dermatological instruction at all. You can graduate from medical school in the United States and learn virtually nothing about an entire organ system (the skin). That being said, there is little expectation of increased curriculum time; where dermatology is currently being taught, it is not standardized. Surveys of primary care doctors show us the learning gaps, and in some areas we are not meeting the needs of learners. By supporting this curriculum, the AAD is leading the way. This is not a “requirement,” just recommendations, especially for use in schools without a dermatology department or with limited resources or teaching time. The benefit is that it can be used in a flexible way by many types of teachers for many types of learners.

JDPA: What makes up the curriculum? Where is it housed?

Dr. McCleskey: The goals and objectives cover about 33 diagnoses/topics comprised of about 30 teaching modules and 10 videos that cover procedures such as how to perform a skin exam, a KOH prep, or shave and punch biopsies. There are user guides for learners and teachers as well as additional teaching tools. This curriculum is ready to be used “out-of-the-box” without additional planning. The curriculum can be found on the AAD website under Medical Student Core Curriculum. It is also the first page to come up on a Google search for “dermatology curriculum.”

JDPA: How do the modules work?

Dr. McCleskey: Each module teaches multiple goals/objectives through cases that demonstrate typical presentations of common skin conditions.

Questions are interspersed in the cases to engage the learner. Some modules teach from a diseasebased perspective (e.g., rosacea in the acne module), and some teach from a problem-based perspective (e.g., rosacea in the red face module). For educators, the modules can be given as a lecture or in a group discussion format. For learners, the modules can be reviewed at their own pace for self-directed learning. The case-based format puts skin conditions in clinical context. Each module takes about 20 to 40 minutes to complete, so it’s very reasonable to complete the entire curriculum during a dermatology rotation. The length also makes them perfect for onehour lecture timeslots, even if there is some audience interaction with the questions. One of the strengths of these modules, in addition to being evidencebased and extensively peer-reviewed, is that they can be used in many different learning environments, allowing flexibility for whatever the needs are at a given institution.

VOL. 6, NO. 4 FALL 2012 57

DERMATOLOGY PA NEWS & NOTES

Dr. Patrick E. McCleskey served as Vice Chair of the AAD work group that helped to create the AAD Medical Student Core Curriculum. He shares with us how the curriculum was designed, how it is intended to work, and other insights into the role the curriculum and modules will play in helping to educate physician assistant (PA) students and new PAs working in dermatology.

DERMATOLOGY PA NEWS & NOTES

JDPA: What is the evidence? How do we know it works?

Dr. McCleskey: Based on the UCSF study, students show statistically significant improvement over the course of two weeks when using 18 of the learning modules based on pre- and post-test comparisons. Students had very positive feedback about the learning modules and preferred the format over lectures. I conducted a study of military PA students and primary care residents (family medicine, internal medicine, and transitional year) that showed statistically significant improvement over the course of a two to four week clinical dermatology rotation.

Post-test scores were not influenced by year group (PGY1, PGY2, PGY3), or total number of half-days in clinic during the rotation. There was a statistically significant difference in post-test scores based on website activity. Residents who used the website more had higher post-test scores than those who used it very little. This suggests that the learning modules from the AAD Medical Student Core Curriculum, and not just time spent seeing patients (half-days in clinic), is associated with increased knowledge acquisition during the dermatology rotation. Because website activity was not randomized, there is a bias in this toward increasingly motivated learners gaining more knowledge, but that is the reality of adult learners. “You get out of it what you put into it.”

JDPA: What is the feedback from students in the studies?

Dr. McCleskey: The students in the study love it; feedback has been very positive. Students find the modules clear, concise, and worth their time. They prefer the curriculum to lectures and like the clinical cases.

JDPA: Why do this instead of lecture?

Dr. McCleskey: This is a good option if there is no time to lecture. It also works well with different learning styles and methods (active vs. passive). There is a great study by Dr. Chito Cruz showing that CD-ROM based learning was just as good as lecturebased learning. Students preferred the computerbased program to lectures, but attendance at lectures was still correlated with higher test scores, so lectures still have their place for many learners and teachers.

JDPA: How will this influence dermatology departments’ current curriculum? If the AAD recommends this curriculum, does it mean schools have to “standardize” their curriculum to fit?

Dr. McCleskey: No, this curriculum is not meant to serve as a mandate of any kind. It

58 Journal of Dermatology for Physician Assistants

should be viewed more as a toolbox full of tools for teaching. First, the diagnoses we cover are not controversial. We think students should learn to treat acne, warts, seborrheic dermatitis, and superficial dermatophytoses. No academic dermatologist would disagree. As a matter of fact, we asked academic dermatologists what should be taught in the needs assessment, and this was developed based on that assessment. Many programs may want to teach additional things, but our basic question was, given limited time, what should we teach? If they want to teach additional items, then great. So, no, this is not a requirement or meant to standardize teaching methods at institutions which already have robust dermatology teaching programs. It is meant to provide access to dermatological instruction to students who wouldn’t otherwise have access and to provide teaching platforms for dermatologists and other teachers of medical and mid-level students that is peer-reviewed and based on the best available evidence, without having to reinvent the wheel each time. Many dermatology departments now have mid-level providers, and this is an excellent way to orient them to dermatology when they first start in the practice.

JDPA: How can this be used by those who already teach students and residents?

Dr. McCleskey: This can be used during dermatology rotations or brief experiences in a dermatology office. If a student sees a patient in clinic and then learns from a case-based teaching module that afternoon or evening on the same topic, it will stick with him/her better. The teaching modules have high quality images that may be even more representative of the condition than the patient he/she saw during clinic. This kind of parallel learning is better than reading in a textbook because it reduplicates the clinical setting.

JDPA: How does this apply to those who don’t teach students and residents?

Dr. McCleskey: Dermatologists can use this to teach new mid-level providers or staff about particular conditions (e.g., a dermatologist might want to teach a new PA doing patch testing about allergic contact dermatitis). Referring providers in the community may find the curriculum helpful in response to your consults. Dermatology offices in the community (i.e., practices outside of academia) may have been reluctant to have students in their practice because they did not have the time or resources to create the “didactic” component of a school-based dermatology rotation. This curriculum satisfies that

need so essentially every community dermatology office, independent of their practice venue, can be a “teacher.”

JDPA: What do you see as the future of dermatology education?

Dr. McCleskey: In many medical schools and PA programs, teaching is now in small groups with “facilitators.” This curriculum is ideal for that format, even if the facilitator is not a dermatologist. Small group teaching is case-based, and these modules are all case-based.

Maj Patrick E. McCleskey, MD, FAAD, completed his undergraduate studies at The Johns Hopkins University. He went to medical school at Emory University School of Medicine and completed his dermatology residency with the Air Force at the San Antonio Uniformed Services Health Education Consortium. He has been practicing dermatology for eight years and is currently teaching and practicing at David Grant U.S. Air Force Medical Center at Travis Air Force Base, CA. The views expressed in this material are those of the author, and do not reflect the official policy or position of the U.S. Government, the Department of Defense or the Department of the Air Force.

DERMATOLOGY PA NEWS & NOTES

JDPA: Is there anything else you’d like dermatology providers to take away from this discussion?

Dr. McCleskey: I encourage them to go to the website and check it out. Share it with others in your practice, including other dermatologists, PAs, nurses, and your staff. There is a great need to provide clinical dermatology rotations for medical students, primary care residents, and physician assistant students. The AAD’s mission statement includes, “promoting excellence in patient care through education.” This is an effort to do just that. Part of being in a profession is volunteering some of our time to better the community, and if we can take the time to teach other providers about the basics of skin care, our patients are the ones who will benefit. J

© American Academy of Dermatology

The AAD Medical Student Core Curriculum was created by a work group of experienced dermatology educators based on the needs of today's learners. This curriculum demonstrates the dedication of the AAD and its members to education and patient care.

The curriculum guides provide direction about how one can best use this collection of learning modules, including the recommended order in which to review them. Each module has been peer-reviewed and is based on the best available evidence. Clinical vignettes and questions within each module provide a practical framework for learning. After completion of each module, students can test their knowledge with quiz questions.

The AAD encourages all students to participate in clinical dermatology rotations if possible. This curriculum is an excellent companion to the teaching offered in dermatology rotations, but it also may be used by students who are directing their own learning.

To learn more or to start using the AAD Medical Student Core Curriculum, please visit www.aad.org/ education-and-quality-care/medical-student-core-curriculum.

VOL. 6, NO. 4 FALL 2012 59

Dermatology in

By W. Stephen Steiner, PA-C

DERMATOLOGY PA NEWS & NOTES

Dr. Bernard Ackerman likened the study of dermatology to art history. The parallels between appreciation of art and the evaluation of skin are many. A neophyte describes a painting in regards to color, brushstroke, content, and structure. A skilled art historian assimilates these details unconsciously and may declare, “It looks like a Monet.” Each description is equally valid, and each serves a unique purpose. Similarly, one may describe the violaceous polygonal papules arising on the volar wrist; another may describe it simply as lichen planus. While blood work and biopsies are critical to our specialty, it is what we appreciate on the surface of the skin that largely influences decisions in clinical practice.

This series will explore the depictions of dermatologic conditions in classic artwork. The condition may be the focus of the painting, but often it is a quiet detail, only for the discerning and trained eye. If you have a piece of art that you would like to share with the JDPA readers, please contact us at editor@jdpa.org.

One of the best-known artists of the Northern Renaissance, Albrecht Durer (1471-1528) was famous as an engraver, painter, and mathematician. This artwork was produced in 1496 depicting syphilis.

In the text of the woodcut, Durer refers to this malady as the “French disease.”

Those in France called it the “Italian disease,” and those in Holland the “Spanish disease.” As an Italian sailing under the Spanish flag, Columbus arrived in America in 1492. Some theorize his crew contracted syphilis in the New World and brought the disease to Europe leading to the first major outbreak of syphilis in 1495. Perhaps syphilis could also be considered an “American disease.”

The astrological signs over the man suggest an event occurring in 1484 led to his ill-fated condition. Scorpio, traditionally associated with sexuality, is at the focal point of the globe, alluding to the likely origin of the malady.

He holds his body in a position of deference, as if the powers of the stars controlled his fate. The lesions depicted on the exposed areas of this individual are likely gummata, indicative of tertiary syphilis. Perhaps his mind is as affected as his skin.

Currently successfully managed with varying regimens of antibiotics, treatment of syphilis in the Renaissance consisted of ingestion or application of mercury as well as various herbs. Therapy for syphilis was very expensive, and cure was unlikely. J W. Stephen Steiner, PA-C is employed by Gwinnett Dermatology, PC and Gwinnett Clinical Research Center. He has worked in dermatology for the past twelve years. Outside of work, he enjoys woodworking and spending time with his wife and boys.

Write for the JDPA! Are you a PA who...

• Is interested in writing?

• Has a paper you want to get published?

Share your knowledge today. Contact editor@jdpa.org 60 Journal of Dermatology for Physician Assistants

JDPA INFORMATION FOR AUTHORS The Journal of Dermatology for Physician Assistants (JDPA) is a peer-reviewed publication that delivers innovative clinical, surgical, cosmetic, and professional content exclusively for dermatology PAs. Submissions to the JDPA are peer-reviewed by a panel of experienced dermatology PAs, educational PAs, and dermatologists before articles are accepted for publication.

Manuscripts submitted for publication will be reviewed with the understanding that they are original and have not been submitted elsewhere nor are being considered by other journals. Electronic submissions are accepted and should be sent to editor@jdpa.org.

The five main sections featured in each issue of the JDPA are listed below along with a brief description of the various topics that authors can contribute to. Regardless of the section, all articles must follow the following criteria: • Formatting - Times New Roman font, 12 point, double-spaced, left aligned.

• Article Order - Title, Author(s), Author bios (including disclosures), Text of Article, References, Tables, and Figures • Reference Citations - Utilize the AMA Manual of Style, 10th Edition.

DERMATOLOGY PA NEWS AND NOTES • Feature Articles

Write a review about a new or innovative dermatological procedure, device, and/or approach to patient care (500-1000 words).

• From The Desk Of…

Write an opinion essay sharing your insight regarding a current “hot item” issue (e.g., specialty PA credentialing, dermatology access to care, supervising physician relationships, etc.) or any other topic regarding the field of dermatology (250-1000 words).

CLINICAL DERMATOLOGY • CME articles

Content should be specific to the field of dermatology following any of the following formats: Study – Original research (clinical or basic science).

Professional issues or health policy papers.

Review – Scholarly review of a topic.

Content length: 6 pages (requires 4 self-assessment Q&A) = .5hr of Cat. I CME. 12 pages (requires 8 self-assessment Q&A) = 1hr of Cat. I CME. Article should include written learning objectives (3-4 required).

• Dermatology Case Report

Write a report and discuss a case(s) that illustrate an important or interesting observation (500-1500 words).

• Journal Club: Dermatology PA Perspectives

Write a review of an already published article from an established dermatology journal (e.g., JAAD, Cos Dermatol, Dermatol Surg, etc.), summarizing the practical thoughts and clinical issues (250-1000 words).

• From the Patient’s Perspective

Patients’ stories published in their own words. JDPA staff can even assist patients with writing their stories (250-1000 words).

• Clinical Snapshots

Write a brief written description and clinical facts about an interesting cutaneous anomaly (250-500 words).

• Drugs in Dermatology

Write about the current information regarding a particular dermatological medication, drug interaction, or medication side effect/adverse reaction (250-1000 words).

• Dermatology Evidence-Based Medicine (derm EBM)

Write a brief, evidence-based assessment of the one or two most relevant studies retrieved to answer a focused clinical question that may have arisen from a real-life situation. A derm EBM is not a comprehensive review of a subject or a synthesis of all the available knowledge (500–1500 words).

SURGICAL DERMATOLOGY • Feature Articles

Write a review about a new or innovative surgical procedure, device, and/or approach to patient care (500-1000 words).

• Surgical Wisdom

Write a brief article on a fact or pearl for the surgical setting (250-500 words).

• Surgical Dermatology Case Report

Write a report and discuss a case(s) that illustrate an important or interesting observation (500-1500 words).

• Journal Club: Dermatology PA Perspectives

Write a review of an already published article from an established dermatology journal (e.g., JAAD, Cos Dermatol, Dermatol Surg, etc.), summarizing the practical thoughts and clinical issues (250-1000 words).

COSMETIC DERMATOLOGY • Feature Articles

Write a review about a new or innovative cosmetic procedure, device, and/or approach to patient care (500-1000 words).

• Cosmetic Pearls

Write a brief article on a fact or pearl for the cosmetic setting (250-500 words).

• Cosmetic Dermatology Case Report Write a report and discuss a case(s) that illustrate an important or interesting observation (500-1500 words).

• Journal Club: Dermatology PA Perspectives Write a review of an already published article from an established dermatology journal (e.g., JAAD, Cos Dermatol, Dermatol Surg, etc.), summarizing the practical thoughts and clinical issues (250-1000 words).

PROFESSIONAL DEVELOPMENT • Feature Articles

Write an article that explores the professional issues dermatology PAs face such as reimbursement, education, medical trends, contracts, office management, etc. (500-1500 words).

• Outside & Inside the 9 to 5

Allow us to share your story of the good work that you do either outside or inside your practice of dermatology. You can write this article yourself or the JDPA staff can interview you to write the article (250-1000 words).

• Notes From Your Office Manager

Write a brief article on a fact or pearl for the office setting (250-500 words).

• Judicial and Ethical Affairs

Write an article that explores the complex or multifaceted ethical or judicial professional issues that affect the practice of dermatology for PAs (250-1000 words).

VOL. 6, NO. 4 FALL 2012 61

PROFESSIONAL OPPORTUNITIES AND DEVELOPMENT

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62 Journal of Dermatology for Physician Assistants

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Finacea

®

(azelaic acid) Gel,15% For Dermatologic Use Only–Not for Ophthalmic, Oral, or Intravaginal Use Rx only BRIEF SUMMARY CONSULT PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION INDICATIONS AND USAGE FINACEA Gel, 15%, is indicated for topical treatment of inflammatory papules and pustules of mild to moderate rosacea. Although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated. Patients should be instructed to avoid spicy foods, thermally hot foods and drinks, alcoholic beverages and to use only very mild soaps or soapless cleansing lotion for facial cleansing.

CONTRAINDICATIONS FINACEA Gel, 15%, is contraindicated in individuals with a history of hypersensitivity to propylene glycol or any other component of the formulation.

WARNINGS FINACEA Gel, 15%, is for dermatologic use only, and not for ophthalmic, oral or intravaginal use.

There have been isolated reports of hypopigmentation after use of azelaic acid. Since azelaic acid has not been well studied in patients with dark complexion, these patients should be monitored for early signs of hypopigmentation.

PRECAUTIONS General: Contact with the eyes should be avoided. If sensitivity or severe irritation develops with the use of FINACEA Gel, 15%, treatment should be discontinued and appropriate therapy instituted.

In a transgenic mouse study, chronic use of FINACEA Gel led to an increased number of animals with papillomas at the treatment site (see PRECAUTIONS: Carcinogenesis, Mutagenesis, and Impairment of Fertility). The clinical relevance of the findings in animal studies to humans is not clear.

Information for Patients: Patients using FINACEA Gel, 15%, should receive the following information and instructions: • FINACEA Gel, 15%, is to be used only as directed by the physician.

• FINACEA Gel, 15%, is for external use only. It is not to be used orally, intravaginally, or for the eyes.

• Cleanse affected area(s) with a very mild soap or a soapless cleansing lotion and pat dry with a soft towel before applying FINACEA Gel, 15%. Avoid alcoholic cleansers, tinctures and astringents, abrasives and peeling agents.

• Avoid contact of FINACEA Gel, 15%, with the mouth, eyes and other mucous membranes. If it does come in contact with the eyes, wash the eyes with large amounts of water and consult a physician if eye irritation persists.

• The hands should be washed following application of FINACEA Gel, 15%.

• Cosmetics may be applied after FINACEA Gel, 15%, has dried.

• Skin irritation (e.g., pruritus, burning, or stinging) may occur during use of FINACEA Gel, 15%, usually during the first few weeks of treatment. If irritation is excessive or persists, use of FINACEA Gel, 15%, should be discontinued, and patients should consult their physician (See ADVERSE REACTIONS).

• Avoid any foods and beverages that might provoke erythema, flushing, and blushing (including spicy food, alcoholic beverages, and thermally hot drinks, including hot coffee and tea).

• Patients should report abnormal changes in skin color to their physician.

• Avoid the use of occlusive dressings or wrappings.

Drug Interactions: There have been no formal studies of the interaction of FINACEA Gel, 15%, with other drugs.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Systemic long-term animal studies have not been performed to evaluate the carcinogenic potential of azelaic acid. In a 26-week dermal carcinogenicity study using transgenic (Tg.AC) mice, FINACEA Gel, 15%, and the gel vehicle, when applied once or twice daily, did not increase the number of female Tg.AC animals with papillomas at the treatment site. No statistically significant increase in the number of animals with papillomas at the treatment site was observed in male Tg.AC animals after once daily application. After twice daily application, FINACEA Gel, 15%, and the gel vehicle induced a statistically significant increase in the number of male animals with papillomas at the treatment site when compared to untreated males. This suggests that the positive effect may be associated with the vehicle application. The clinical relevance of the findings in animals to humans is not clear.

Azelaic acid was not mutagenic or clastogenic in a battery of in vitro (Ames assay, HGPRT in V79 cells {Chinese hamster lung cells}, and chromosomal aberration assay in human lymphocytes) and in vivo (dominant lethal assay in mice and mouse micronucleus assay) genotoxicity tests.

Oral administration of azelaic acid at dose levels up to 2500 mg/kg/day (162 times the maximum recommended human dose based on body surface area) did not affect fertility or reproductive performance in male or female rats.

Pregnancy: Teratogenic Effects: Pregnancy Category B There are no adequate and well-controlled studies of topically administered azelaic acid in pregnant women. The experience with FINACEA Gel, 15%, when used by pregnant women is too limited to permit assessment of the safety of its use during pregnancy.

Dermal embryofetal developmental toxicology studies have not been performed with azelaic acid, 15%, gel. 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 times the maximum recommended human dose based on body surface area), rabbits given 150 or 500 mg/kg/day (19 or 65 times the maximum recommended human dose based on body surface area) and cynomolgus monkeys given 500 mg/kg/day (65 times the maximum recommended human dose based on body surface area) azelaic acid. No teratogenic effects 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 observed in rats at an oral dose that generated some maternal toxicity (2500 mg/kg/day; 162 times the maximum recommended human dose based on body surface area). 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/kg/day; 32 and 162 times the maximum recommended human dose based on body surface area). No effects on sexual maturation of the fetuses were noted in this study.

Because animal reproduction studies are not always predictive of human response, this drug should be used only if clearly needed during pregnancy.

Nursing Mothers: Equilibrium dialysis was used to assess human milk partitioning in vitro. At an azelaic acid concentration of 25 µg/mL, the milk/plasma distribution coefficient was 0.7 and the milk/buffer distribution was 1.0, indicating that passage of drug into maternal milk may occur.

Since less than 4% of a topically applied dose of azelaic acid cream, 20%, is systemically absorbed, the uptake of azelaic acid into maternal milk is not expected to cause a significant change from baseline azelaic acid levels in the milk. However, caution should be exercised when FINACEA Gel, 15%, is administered to a nursing mother.

Pediatric Use: Safety and effectiveness of FINACEA Gel, 15%, in pediatric patients have not been established.

Geriatric: Clinical studies of FINACEA Gel, 15%, did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

ADVERSE REACTIONS Overall, treatment related adverse events, including burning, stinging/ tingling, dryness/tightness/ scaling, itching, and erythema/irritation/ redness, were 19.4% (24/124) for FINACEA Gel, 15%, and 7.1% (9/127) for the active comparator gel at 15 weeks.

In two vehicle controlled, and one active controlled U.S. clinical studies, treatment safety was monitored in 788 patients who used twice daily FINACEA Gel, 15%, for 12 weeks (N=333) or for 15 weeks (N=124), or the gel vehicle (N=331) for 12 weeks.

Table 3. Cutaneous Adverse Events Occurring in ≥1% of Subjects in the Rosacea Trials by Treatment Group and Maximum Intensity* FINACEA Gel, 15% N=457 (100%)

Vehicle N=331 (100%)

Mild n=99 (22%)

Moderate n=61 (13%)

Severe n=27 (6%)

Mild n=46 (14%)

Moderate n=30 (9%)

Severe n=5 (2%)

Burning/ stinging/ tingling

71 (16%)

42 (9%)

17 (4%)

8 (2%)

6 (2%)

2 (1%)

Pruritus

29 (6%)

18 (4%)

5 (1%)

9 (3%)

6 (2%)

0 (0%)

Scaling/dry skin/xerosis

21 (5%)

10 (2%)

5 (1%)

31 (9%)

14 (4%)

1 (<1%)

Erythema/ irritation

6 (1%)

7 (2%)

2 (<1%)

8 (2%)

4 (1%)

2 (1%)

Contact dermatitis

2 (<1%)

3 (1%)

0 (0%)

1 (<1%)

0 (0%)

0 (0%)

Edema

3 (1%)

2 (<1%)

0 (0%)

3 (1%)

0 (0%)

0 (0%)

Acne

3 (1%)

1 (<1%)

0 (0%)

1 (<1%)

0 (0%)

0 (0%)

*Subjects may have >1 cutaneous adverse event; thus, the sum of the frequencies of preferred terms may exceed the number of subjects with at least 1 cutaneous adverse event.

FINACEA Gel, 15%, and its vehicle caused irritant reactions at the application site in human dermal safety studies. FINACEA Gel, 15%, caused significantly more irritation than its vehicle in a cumulative irritation study. Some improvement in irritation was demonstrated over the course of the clinical studies, but this improvement might be attributed to subject dropouts. No phototoxicity or photoallergenicity were reported in human dermal safety studies.

In patients using azelaic acid formulations, the following additional adverse experiences have been reported rarely: worsening of asthma, vitiligo depigmentation, small depigmented spots, hypertrichosis, reddening (signs of keratosis pilaris), and exacerbation of recurrent herpes labialis.

Post-marketing safety-Skin: facial burning and irritation; Eyes: iridocyclitis on accidental exposure with FINACEA Gel, 15%, to the eye (see PRECAUTIONS).

Distributed under license; U.S. Patent No 6,534,070 www.myfinacea.com ©2010, Intendis, Inc. All rights reserved, July 2010 Manufactured by Intendis Manufacturing S.p.A., Segrate, Milan, Italy Distributed by: Morristown, NJ 07962 Intendis is part of the Bayer Group

6706803BS

VOL. 6, NO. 4 FALL 2012 63

For patients with mild to moderate rosacea,

Deliver a spectrum of benefits with

• The first and only gel approved to treat inflammatory papules, pustules, and associated erythema** (See Indication & Usage below) • 61% of patients achievedd treatment success in 12-week clinical studies1 • Helps maintain the stratuum corneum barrier function2 • #1 dermatologist-prescribed topical brand for mild to moderate rosacea3

INDICATION & USAGE FINACEA® (azelaic acid) Gel, 15% is indicated for topical treatment of inflammatory papules and pusstules of mild to moderate rosacea. *Although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated.

IMPORTANT SAFETY INFORMATION FINACEA Gel, 15% is contraindicated in individuals with a history of hypersensitivity to propylene glycol or any other components of the formulation. There have been isolated reports of hypopigmentation after use of azelaic acid. Since azelaic acid has not been well studied in patients with dark complexion, these patients should be monitored for early signs of hypopigmentation. FINACEA and its vehicle caused irritant reactions at the application site in human dermal safety studies. Skin irritation (e.g. pruritus, burning or stinging) may occur during use with FINACEA, usually during the first few weeks of treatment. If sensitivity or severe irritation develops and/or persists during use with FINACEA, discontinue use and institute appropriate therapy.

In clinical trials with FINACEA, the most common local adverse events (AE’s) (inclusive of mild, moderate and severe categories) were: burning/stinging/ tingling (29%), (29%) pruritus (11%) (11%), scaling/dry skin/xerosis (8%) and erythema/ irritation (4%). Contact dermatitis, edema and acne were observed at frequencies of 1% or less.

Rarely reported AE’s included: worsening of asthma, vitiligo depigmentation, small depigmented spots, hypertrichosis, reddening (signs of keratosis pilaris) and exacerbation of recurrent herpes labialis. Post-marketing safety information: Skin (facial burning and irritation); Eyes (iridocyclitis on accidental exposure with FINACEA to the eyes). To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare at 1-866-463-3634 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

FINACEA is for topical use only. It is not for ophthalmic, oral or intravaginal use. In case of accidental eye exposure, wash eyes with large amounts of water and consult a physician if eye irritation persists. Wash hands following application of FINACEA. See following page for Brief Summary of full Prescribing Information.

Model used for illustrative purposes only.

References: 1. FINACEA [package insert]. Morristown, NJ: Intendis, Inc; 2010. 2. Draelos ZD. Effects of azelaic acid 15% gel on skin barrier in rosacea. Cosmet Derm. 2008;21(5):259-261. 3. Wolters Kluwer Pharma Solutions, Source® Pharmaceutical Audit Suite, July 2010-December 2011. Based on TRx counts, dermatology specialty, inclusive of listed products/strengths only. Wolters Kluwer Health makes no representations regarding the adequacy of its data for the purpose of substantiating

any advertising and promotional claims made by Bayer. Bayer remains solely responsible for full compliance with any and all applicable advertising and marketing laws and regulations. Provision of approval for data release for publication is contingent upon Bayer’s acknowledgement of sole responsibility for accuracy of the claim made, as well as for compliance with any and all applicable marketing and advertising laws.

© 2012 Bayer HealthCare Inc. Bayer, the Bayer Cross and FINACEA are registered trademarks of Bayer HealthCare Inc. All rights reserved. FIN-10-0002-12 May 2012. Printed in USA.

64 Journal of Dermatology for Physician Assistants