Winter 2013 Journal of Dermatology for Physician Assistants

DPA J

V O L U M E 7 • N U M B E R 1 • W I N T E R 2 0 1 3 • www.jdpa.org

Journal of Dermatology for Physician Assistants

DERMATOLOGY PA NEWS & NOTES

SDPA State Round Table 13 __________________________________

CLINICAL DERMATOLOGY What's New in Dermoscopy 23 __________________________________

SURGICAL DERMATOLOGY Journal Club

31

_________________________________

COSMETIC DERMATOLOGY Cosmetic Pearls

34

_____________________________ PROFESSIONAL DEVELOPMENT Dermatology Billing & Coding

›› Earn CME credit with this issue CME A Review of Herpes Simplex Type 2

18

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Official Journal of the Society of Dermatology Physician Assistants

VOLUME 7 • NUMBER 1 • WINTER 2013

1

THE SKIN BARRIER OF ROSACEA PATIENTS IS COMPROMISED

CHOOSE THE ONE VEHICLE THAT PROTECTS WHILE IT PERFORMS1,2*

METROGEL® (metronidazole) Gel, 1% FEATURES A SOPHISTICATED FORMULATION FOR POWERFUL EFFICACY AND TOLERABILITY

• The only ONE with niacinamide that helps protect the skin barrier and facilitate drug delivery1,3

• ONE with powerful QD efficacy: 71% median reduction in inflammatory lesion count at week 10 (P =.0005 vs vehicle)2

• ONE with a tolerable formulation: mild-tomoderate local skin irritation (ie, dryness and scaling) reported in clinical trials2

• Now the only ONE in a pump • Rosacea sufferers surveyed prefer the2 pump over the tube (69% vs 31%; N=207) †

MetroGel® (metronidazole) Gel, 1% is indicated for the topical treatment of inflammatory lesions of rosacea.

Important Safety Information The following adverse experiences have been reported with the topical use of metronidazole: nasopharyngitis, upper respiratory tract infections and headache.

Patients may also experience local burning, skin irritation, dryness and transient redness. Although rare, patients may also experience metallic taste, numbness or paresthesia of the extremities and nausea with use of MetroGel® 1%, and peripheral neuropathy has been reported with use of metronidazole. MetroGel® 1% therapy should be reevaluated if these symptoms occur. Caution should be used when prescribing metronidazole products for patients with blood dyscrasia, and patients using blood thinning agents such as coumarin or warfarin may experience prolonged prothrombin times. MetroGel® 1% is contraindicated in patients with a history of hypersensitivity to metronidazole or any other ingredient in the formulation.

Please see next page for brief summary of full Prescribing Information. *MetroGel® 1% does not further damage the already compromised skin barrier of rosacea patients. † Claims are based on a Consumer Packaging Preference Study of 207 physician-diagnosed, male and female rosacea patients aged 25 to 65 years. Patients were asked to complete a self-administered Internet survey following video presentations highlighting the steps involved when applying medication from a pump and a tube.

References: 1. Bissett D. Topical niacinamide and barrier enhancement. Cutis. 2002;70(suppl 6):8-12.

2. Data on file. Galderma Laboratories, L.P. 3. Dow G, Basu S. A novel aqueous metronidazole 1% gel with hydrosolubilizing agents (HSA-3). Cutis. 2006;77(suppl 4):18-26.

NOW AVAILABLE

IN A PUMP Distinguished delivery.

Powerful results.

MetroGel and Galderma are registered trademarks. ©2011 Galderma Laboratories, L.P. Galderma Laboratories, L.P. 14501 N. Freeway Fort Worth, TX 76177 MET-949 Printed in USA 11/11

www.metrogel.com

METROGEL® (metronidazole) Gel, 1% Rx Only For topical use only.

Not for oral, ophthalmic or intravaginal use.

Talk to your doctor or pharmacist to learn more about METROGEL. You can also learn more at www.metrogel.com.

BRIEF SUMMARY INDICATIONS AND USAGE METROGEL® (metronidazole) Gel, 1% is a nitroimidazole indicated for the topical treatment of inflammatory lesions of rosacea.

CONTRAINDICATIONS METROGEL is contraindicated in those patients with a history of hypersensitivity to metronidazole or to any other ingredient in this formulation.

WARNINGS AND PRECAUTIONS • Peripheral neuropathy, characterized by numbness or paresthesia of an extremity has been reported in patients treated with systemic metronidazole. Although not evident in clinical trials for topical metronidazole, peripheral neuropathy has been reported with the post approval use. The appearance of abnormal neurologic signs should prompt immediate reevaluation of METROGEL therapy.

• Metronidazole is a nitroimidazole and should be used with care in patients with evidence of, or history of, blood dyscrasia.

• If dermatitis occurs, patients may need to discontinue use.

• Topical metronidazole has been reported to cause tearing of the eyes. Therefore, contact with the eyes should be avoided.

ADVERSE REACTIONS Most common adverse reactions (incidence >2%) are nasopharyngitis, upper respiratory tract infection, and headache.

In a controlled clinical trial, 557 patients used metronidazole gel, 1% and 189 patients used the gel vehicle once daily for up to 10 weeks. The following table summarizes selected adverse reactions that occurred at a rate of ≥1%: Table 1: Adverse Reactions That Occurred at a Rate of ≥1% System Organ Class/Preferred Term Metronidazole Gel Gel, 1% Vehicle N=557 N=189 Patients with at least one AE Number (%) of Patients 186 (33.4) 51 (27.0) Infections and infestations 76 (13.6) 28 (14.8) Bronchitis 6 (1.1) 3 (1.6) Influenza 8 (1.4) 1 (0.5) Nasopharyngitis 17 (3.1) 8 (4.2) Sinusitis 8 (1.4) 3 (1.6) Upper respiratory tract infection 14 (2.5) 4 (2.1) Urinary tract infection 6 (1.1) 1 (0.5) Vaginal mycosis 1 (0.2) 2 (1.1) Musculoskeletal and connective tissue disorders 19 (3.4) 5 (2.6) Back pain 3 (0.5) 2 (1.1) Neoplasms 4 (0.7) 2 (1.1) Basal cell carcinoma 1 (0.2) 2 (1.1) Nervous system disorders 18 (3.2) 3 (1.6) Headache 12 (2.2) 1 (0.5) Respiratory, thoracic and mediastinal disorders 22 (3.9) 5 (2.6) Nasal congestion 6 (1.1) 3 (1.6) Skin and subcutaneous tissue disorders 36 (6.5) 12 (6.3) Contact dermatitis 7 (1.3) 1 (0.5) Dry Skin 6 (1.1) 3 (1.6) Vascular disorders 8 (1.4) 1 (0.5) Hypertension 6 (1.1) 1 (0.5) Table 2: Local Cutaneous Signs and Symptoms of Irritation That Were Worse Than Baseline Metronidazole Gel, 1% Gel Vehicle Sign/Symptom N=544 N=184 Dryness 138 (25.4) 63 (34.2) Mild 93 (17.1) 41 (22.3) Moderate 42 (7.7) 20 (10.9) Severe 3 (0.6) 2 (1.1) Scaling 134 (24.6) 60 (32.6) Mild 88 (16.2) 32 (17.4) Moderate 43 (7.9) 27 (14.7) Severe 3 (0.6) 1 (0.5) Pruritus 86 (15.8) 35 (19.0) Mild 53 (9.7) 21 (11.4) Moderate 27 (5.0) 13 (7.1) Severe 6 (1.1) 1 (0.5) Stinging/burning 56 (10.3) 28 (15.2) Mild 39 (7.2) 18 (9.8) Moderate 7 (1.3) 9 (4.9) Severe 10 (1.8) 1 (0.5)

The following additional adverse experiences have been reported with the topical use of metronidazole: skin irritation, transient redness, metallic taste, tingling or numbness of extremities, and nausea.

Post Marketing Experience The following adverse reaction has been identified during post approval use of topical metronidazole: peripheral neuropathy. Because this reaction is reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.

DRUG INTERACTIONS Oral metronidazole has been reported to potentiate the anticoagulant effect of coumarin and warfarin, resulting in a prolongation of prothrombin time. Drug interactions should be kept in mind when METROGEL is prescribed for patients who are receiving anticoagulant treatment, although they are less likely to occur with topical metronidazole administration because of low absorption.

USE IN SPECIFIC POPULATIONS Pregnancy: Teratogenic Effects: Pregnancy Category B. There are no adequate and well-controlled studies with the use of METROGEL in pregnant women. Metronidazole crosses the placental barrier and enters the fetal circulation rapidly. No fetotoxicity was observed after oral administration of metronidazole in rats or mice at 200 and 20 times, respectively, the expected clinical dose. However, oral metronidazole has shown carcinogenic activity in rodents. Because animal reproduction studies are not always predictive of human response, METROGEL should be used during pregnancy only if clearly needed.

Nursing Mothers After oral administration, metronidazole is secreted in breast milk in concentrations similar to those found in the plasma. Even though blood levels taken after topical metronidazole application are significantly lower than those achieved after oral metronidazole a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother and the risk to the infant.

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

Geriatric Use Sixty-six subjects aged 65 years and older were treated with metronidazole gel, 1% in the clinical study. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Carcinogenesis, Mutagenesis, Impairment of Fertility Metronidazole has shown evidence of carcinogenic activity in a number of studies involving chronic, oral administration in mice and rats, but not in studies involving hamsters.

In several long-term studies in mice, oral doses of approximately 225 mg/m2/day or greater (approximately 37 times the human topical dose on a mg/m2 basis) were associated with an increase in pulmonary tumors and lymphomas. Several long-term oral studies in the rat have shown statistically significant increases in mammary and hepatic tumors at doses >885 mg/m2/day (144 times the human dose).

Metronidazole has shown evidence of mutagenic activity in several in vitro bacterial assay systems. In addition, a dose-related increase in the frequency of micronuclei was observed in mice after intraperitoneal injections. An increase in chromosomal aberrations in peripheral blood lymphocytes was reported in patients with Crohn’s disease who were treated with 200 to 1200 mg/day of metronidazole for 1 to 24 months. However, in another study, no increase in chromosomal aberrations in circulating lymphocytes was observed in patients with Crohn’s disease treated with the drug for 8 months.

In one published study, using albino hairless mice, intraperitoneal administration of metronidazole at a dose of 45 mg/m2/day (approximately 7 times the human topical dose on a mg/m2 basis) was associated with an increase in ultraviolet radiationinduced skin carcinogenesis. Neither dermal carcinogenicity nor photocarcinogenicity studies have been performed with METROGEL or any marketed metronidazole formulations.

PATIENT COUNSELING INFORMATION Patients using METROGEL should receive the following information and instructions: 1. This medication is to be used as directed.

2. It is for external use only.

3. Avoid contact with the eyes.

4. Cleanse affected area(s) before applying METROGEL. 5. This medication should not be used for any condition other than that for which it is prescribed.

6. Keep out of reach of children.

7. Patients should report any adverse reaction to their physicians.

US Patent No. 6,881,726 and 7,348,317

Marketed by: Galderma Laboratories, L.P. Fort Worth, Texas 76177 USA P50742-3-BS Revised: November 2011

Manufactured by: G Production Inc. Baie d’Urfé, QC, H9X 3S4 Canada Made in Canada.

Journal of Dermatology for Physician Assistants

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 Dermoscopy Q&A Editor John Burns, 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

PUBLISHING STAFF 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: The 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.

GOING GREEN: 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.

KEEP CURRENT:

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 7, Number 1, Winter 2013. 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 2013 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., email SDPA@dermpa.org, www.dermpa.org.

THIS ISSUE IS SPONSORED BY

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Journal of Dermatology for Physician Assistants

EDITOR’S MESSAGE

I

nspiration presents itself in many different forms. As human beings, we continually seek to be inspired by the thoughts, people, and experiences in our lives. I am a firm believer that it is important to slow down in our daily routines and take notice of the many different sources of inspiration that surround us. These may include our neighbors who have served in the military to protect our freedoms, the grieving patient who lost his/her spouse but still takes the time to volunteer in our local community, the parents who rise above the difficulties of raising children with special needs, or these children themselves who forge successfully through life believing in their own abilities and imaginations, refusing to be bound by any limitations.

As PAs working in dermatology, we have the opportunity to be inspired by patients who struggle to manage and overcome various skin conditions. I am often compelled to ask my patients where they find their own inspiration. What gets them through the difficulties of their own diagnoses? What I learn from their insights is invaluable and can even be life changing.

On the flip side, how are we going to be inspirational to others? Many of us serve as PA student preceptors. When we are teaching PA students, are we so focused on the medical component of their education that we forget to incorporate the importance of having a good bedside manner?

Remember to inspire our students with the good example of listening to and talking with patients. We should let what first inspired us to become a PA to shine through in both our work and our teaching.

Inspiration is all around us. In this new year ahead, take time to be open to the inspiration that surrounds us daily as we interact with people.

This inspiration will help us to become better providers, will give us insight into how people feel when facing various medical conditions, and will ultimately help us to provide better care for all of our patients. If we are able to find and embrace the many sources of inspiration in our lives, we will be much more capable of sharing these with others. J

Travis Hayden, MPAS, PA-C JDPA Editor in Chief editor@jdpa.org

VOLUME 7 • NUMBER 1 • WINTER 2013

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TABLE OF CONTENTS SDPA Members Only Content

18 A Review of Herpes Simplex Type 2

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.

By Lindsay Hayler, MPH, MPAS, PA-C

›› CME

10 DERM PA NEWS & NOTES – part one • SDPA State Affiliates Round Table Discussion • Certification Review • Student Corner

18 CLINICAL DERMATOLOGY • CME Article – A Review of Herpes Simplex Type 2 • What’s New in Dermoscopy

DEPARTMENTS

04 Editorial Board 05 Editor’s Message 09 SDPA News & Current Affairs 10 Dermatology Market Watch 17 Now Showing on Dermcast.tv 25 From The Patient’s Perspective 27 Dermoscopy Q&A 30 Clinical Snapshots 32 Surgical Wisdom 34 Cosmetic Pearls 41 Notes from your Office Manager 42 Outside & Inside the 9 to 5...

46 The Difference We Make 52 Dermatology in Art 53 JDPA Information for Authors 54 Professional Opportunities and Development

31 SURGICAL DERMATOLOGY • Journal Club: Practice Changing Articles for Dermatology PAs

33 COSMETIC DERMATOLOGY • Journal Club: Practice Changing Articles for Dermatology PAs

37 PROFESSIONAL DEVELOPMENT • Dermatology Billing & Coding • Judicial and Ethical Affairs – Case-Based Compliance Scenarios

45 DERM PA NEWS & NOTES – part two

Go Green - Read Online 6

Journal of Dermatology for Physician Assistants

• From the Desk of…

• Workplace Excellence • Supervising Physician Corner

dermpa.org

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Indication: Kenalog® Spray (triamcinolone acetonide topical aerosol, USP) is indicated for 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.

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.

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

You are encouraged to report negative side effects of prescription drugs to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch For topical use only. Please see adjacent page for full prescribing information.

For more information, visit www.kenalogspray.com Reference: 1. Data on file. Ranbaxy Laboratories, Inc. Princeton, NJ. * After spraying, the nonvolatile vehicle remaining on the skin contains approximately 0.2% triamcinolone acetonide. Each gram of spray provides 0.147 mg triamcinolone acetonide in a vehicle of isopropyl palmitate, dehydrated alcohol (10.3%), and isobutane propellant.

KENALOG® is a licensed trademark of Bristol-Myers Squibb Company.

KS 1212

VOLUME 7 • NUMBER 1 • WINTER 2013

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Journal of Dermatology for Physician Assistants

FROM THE SDPA

NEWS & CURRENT AFFAIRS

CALENDAR OF EVENTS 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 JULY/AUGUST AAD Summer Academy Meeting July 31 – August 4, 2013 Hilton New York New York, NY NOVEMBER SDPA 11th Annual Fall Conference November 13 - 16, 2013 InterContinental Buckhead Atlanta, GA

Wishes for the New Year

I

have resolved to spend more time reviewing studies and data and taking a more evidence based approach. You know, making time to get through that stack of articles that most of us have sitting on our desk or nightstand. It is part of my effort to provide the best possible care to my patients. We PAs are unique in our recertification requirements, and it can spur us to be more current in treating our patients; this is something to use to our advantage. Another part of this is getting to know patients’ insurance formularies a bit better, which will help cut down on frustration from both my patients and my staff. If my staff spends fewer hours changing prescriptions and answering pharmacy questions, they will get more time to focus on important care issues.

The good news is that there are many avenues available to aid me in keeping my resolution. The most obvious is our own peer-reviewed journal, the Journal of Dermatology for Physician Assistants. As a SDPA member I also receive the Journal of the American Academy of Dermatology, The Dermatologist (formerly Skin & Aging), and several other useful journals. In this age of technology we have access to Dermcast.tv audio and video podcasts as well as the Epocrates free prescribing reference through which we can download our local insurers’ formularies.

If you are like me you think that no matter how knowledgeable you are, you can always learn more. There are many wonderful resources that are already in our hands and others that are just a download away.

Here’s my wish for 2013: that we all continue to excel in providing our patients with the best healthcare we can. J

John Notabartolo, MPAS, PA-C SDPA President, Diplomate

VOLUME 7 • NUMBER 1 • WINTER 2013

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DERMATOLOGY PA NEWS & NOTES

Dermatology Market Watch Ranbaxy Launches AbsoricaTM (isotretinoin) Capsules Ranbaxy Laboratories, Inc. announced the sales and promotion launch of Absorica (Isotretinoin) Capsules. Absorica is indicated for the treatment of severe recalcitrant nodular acne in patients 12 years of age and older.

Due to its high lipophilicity, oral absorption of isotretinoin is enhanced when given with a high-fat meal, however, Absorica, which is formulated using patented Lidose® technology, can be given without regards to meals. The fasted AUC0-t of Absorica is approximately 83% greater than that of Accutane, while both products are bioequivalent under fed conditions. Absorica is therefore not interchangeable and not substitutable with generic products of Accutane®. Absorica, NDA, was approved based on a large pivotal clinical trial enrolling 925 patients.

Exciting New Dermatology PA Video Although the physician assistant profession has been around for over 40 years, many patients are still “PA-naïve.” In an effort to increase patient awareness, the SDPA recently released the highly anticipated “What is a Dermatology PA” video.

Please take a few minutes to view the video (http://vimeo. com/dermpa/pavideo). This would be a great resource to post on your practice’s website, use in your waiting room, or post on your Facebook page. J

Being a SDPA Diplomate has great benefits: 1. Earn 70* hours Category 1 CME 2. Online support available 3. $50 Discount on SDPA conferences 4. Private invite-only receptions 5. Personal recognition in medical journals such as the AAD’s Dermatology World, Skin & Aging, and Practical Dermatology 6. Receive a SDPA Diplomate Certificate after completion of the DLI

*CME hours are approximate 10 Benefits_sign_JDPA_HalfPage.indd Journal of Dermatology1for Physician Assistants

10/12/12 9:46 AM

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.

VOLUME 7 • NUMBER 1 • WINTER 2013 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 The purpose of this SDPA State Affiliates round table discussion is to provide state chapters guidance in ways they can keep their state chapters active. 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 Michael Overcash, MPAS, PA-C, President of the South Carolina Society of Dermatology Physician Assistants (SCSDPA).

Joleen M Volz, MPAS, PA-C

Matthew Brunner, MHS, PA-C

Michael D. Overcash, MPAS, PA-C

Renata M. Block, MMS, PA-C

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

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 - In what ways does your state chapter communicate with its members?

JOLEEN - Do you utilize the pharmaceutical industry to assist your state chapter in any way and if so, how?

RENATA - As president of the ISDPA, I send out monthly updates to all members. We send out email blasts regarding events, job opportunities, and important legislation news.

RENATA - Yes, the pharmaceutical representatives are instrumental in passing information to fellow members via fliers and emails. They provide grant support so that we can hold meetings.

MATTHEW - Initially, the GDPA had very little funding and we used our leaders’ personal email accounts.

Over time, we have been able to adapt and use email services that offer more options. GDPA currently uses an email service called Constant Contact that allows our members to add, remove, and update their email subscriptions on their own. What we particularly like about this service is that it lets our members RSVP for events, register for CME events, and pay any registration fees if applicable. The service also helps reduce emails from ending up in spam folders of our members. The service is very easy to use and offers discounts for non-profit corporations.

MATTHEW - We hold monthly and sometimes semi-monthly dinner programs that are sponsored by industry. The meetings help our members network and gain valuable knowledge about the conditions we treat as well as the medications we prescribe to our patients. We also have a southeastern regional CME conference called, “Dermatology PEARLS” each spring that is sponsored by pharmaceutical, medical device, and lab/pathology industry partners through a combination of educational grants, product theaters, and exhibits.

MICHAEL - Our state is divided into three regions, each with its own representative. Those representatives manage a schedule of events/meetings (dinners mostly) and communicate with those in their area via email. Our state chapter has a website as well, scdermpa.org. The website posts announcements, hosts survey data, and accepts new member registrations. The website also has a forum, but it has not seen a lot of participation yet.

MICHAEL - So far the pharmaceutical companies are sponsoring frequent speaker events (dinners) that are generally well attended, especially in the Low Country (south coastal region) of our state.

JOLEEN - Does your state chapter have a website, and if so, do you feel it is an asset?

RENATA - Yes, we have educational information for the public about what a dermatology physician assistant does. We also have events and job opportunities (only available to members) posted on the website.

VOLUME 7 • NUMBER 1 • WINTER 2013 13

DERMATOLOGY PA NEWS & NOTES

SDPA Secretary/Treasurer Former SDPA Constituent Relations Committee Chair

DERMATOLOGY PA NEWS & NOTES

MATTHEW - Yes. A website is an essential way to communicate and recruit new members. We continue to grow as a constituent chapter through the recruitment of new members. Most of our members communicate and join through our website.

MICHAEL - Yes. Absolutely, I receive communication from students, PAs practicing in South Carolina, and outof-state parties interested in our state chapter, as well as membership inquiries.

JOLEEN - Do you have state CME events and if so, how often? Do you think this is beneficial to your state since the SDPA has two national events each year?

RENATA - We did have one CME event a year until the SDPA added their summer conference. We now strongly encourage our members to attend the SDPA conferences and explain the importance of doing so.

MATTHEW - For the past 5 years, the GDPA has hosted a large CME event in the spring where we offer over 20 hours of Category I CME credit. This past year, we also started hosting mini CME days at a dermatopathology lab where attendees can earn up to 5 Category I CME hours.

We find these events to be well attended with over 100 attendees at our annual conference, and we sell out of the limited space at our mini CME events. We do find it to be beneficial to offer this in addition to the two conferences hosted by the SDPA. Most of our members attend both a SDPA or other out-of-state event in addition to our state

CME conference.

MICHAEL - Every spring there is a state dermatologists’ meeting (SCDA), and we have a coinciding state dermatology PA meeting each year. The SCDA provides eight hours of CME. It is certainly beneficial to connect and discuss issues, but it is definitely no substitute for the SDPA events.

JOLEEN – Would it be beneficial if the SDPA involved state chapters when they are having a CME event within the chapters’ state?

RENATA - Absolutely, especially if they are affiliated with the SDPA. This will only add another perk for affiliation and allow other states to share information on what makes them successful.

MATTHEW - I absolutely think this is a great opportunity for the SDPA to work with the constituent chapters. Many opportunities exist to help coordinate speakers and outreach events such as the Miles for Melanoma run that was recently hosted at the conference in Seattle. I also think that the current SDPA initiative to add more local speakers from the host state is helping to bring more diversity to our education process and improving the quality in the process.

MICHAEL - Yes. At least have a time and place for state members to connect. The state organizations can organize this and have done so. J

The topic that will be discussed at the next round table is how to interact with your local state medical board. If you have any future 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.

PLEASE JOIN US FOR THE

2013 SUMMER

DERMATOLOGY CONFERENCE IN BEAUTIFUL

St.Louis

missouri

HYATT REGENCY AT THE ARCH

JUNE 27-30 - 2013

For More Info Visit Dermpa.org

14 Journal of Dermatology for Physician Assistants STD_StLouis_02.indd 1

1/10/13 2:30 PM

Certification Review

All Those Things Inside the Skin You Might Have Forgotten

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

EXPLANATION: Giardiasis is a protozoal infection due to the flagellate Giardia lamblia (also called Giardia duodenalis). Patients present with profuse, watery, nonbloody, diarrhea after exposure to the organism via fecal contamination of water or food, person-to-person contact, or by anal-oral sexual contact. Physical examination is unremarkable or may show signs of dehydration. Diagnosis is typically made by examining the stool and noting Giardia trophozoites or cysts. The photograph above shows a Giardia trophozoite to the right and a cyst to the left.

Amebiasis is caused by the amoeba Entamoeba histolytica.

Patients present with abdominal pain and bloody diarrhea.

Onchocerciasis is the cause of river blindness and is a microfilariae disease due to the Onchocerca volvulus.

Patients present with a papular, pruritic rash and later have involvement of the eye. Cryptosporidiosis is caused

by Cryptosporidium parvum. The infection is typically noted in immunocompromised patients and presents with abdominal pain and watery diarrhea. The oocysts in cryptosporidiosis are much smaller than the cysts noted in giardiasis and require special staining (acid-fast stain) to be detected in the stool. J The correct answer is A.

QUESTION: A 30 year-old male presents with a five-day history of profuse, watery diarrhea. The patient denies any abdominal pain or tenesmus. On physical examination, vital signs are normal and abdominal exam is unremarkable. Stool is negative for occult blood. Results of the microscopic examination of the stool are noted in the photograph below.

Which of the following is the most likely diagnosis?

A. Giardiasis B. Amebiasis C. Onchocerciasis D. Cryptosporidiosis

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 16 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 and on-demand by Kaplan Medical.

Photo Credit: Waterborne Disease Prevention Branch, CDC

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

Journal of Dermatology for Physician Assistants

If you know a patient who would like to share his/her story, please contact us at editor@jdpa.org VOLUME 7 • NUMBER 1 • WINTER 2013 15

DERMATOLOGY PA NEWS & NOTES

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!

Student Corner

First Foundations - Self Assessment

DERMATOLOGY PA NEWS & NOTES

By Emily Massey, PA-C

For continual development, each of us should reflect on our job performance and who we are as professionals.

Even in your first year as a dermatology physician assistant, self assessment should be performed. Here is a starting point for creating goals and assessing your performance in your first year. Additional items may be added to suit your specific needs.

Professional Acumen and Performance: Does your supervising physician believe that your medical knowledge and performance meet expectations based on your responsibilities? If not, what areas need attention and how/when will they be addressed?

Does your supervising physician agree with your time frame and plan?

Professional Relationships: Do you have good working relationships with supervisors, patients, office staff, and peers? How could those relationships be improved? How would you know they are improving?

Administration: Have goals with realistic time frames been set? Has your job contract been updated and renewed? Do you need more money for CME, professional society memberships, or licensing? Is your workspace including phone, computer, and exam tools adequate for top performance?

Compensation: How will you know when it is time to request a raise? Are you receiving quarterly reports on billings and collections? Are the reports correct?

Does your incentive pay match what was agreed upon in your job contract?

Medical Community: What leadership opportunities will you seek in the dermatology PA community and in the general medical community? Have you done so?

Community Service: How will you “give back” in appreciation to those who gave time/money/effort to you to make you a fabulous dermatology PA? Have you done so?

Included in this process should be an official meeting with your supervising physician to discuss your self-assessment, evaluate your performance from his/her point of view, and agree on upcoming goals. Some PAs may choose to qualitatively or quantitatively survey patients, peers, and staff to assess performance and relationships.

There are a variety of detailed evaluation techniques that track progress and facilitate clear communication with your office staff and supervising physician. Choose one technique that is right for you and start the discipline of self-assessment during your first year of professional life. J Emily Massey, PA-C is a graduate of the Medical University of South Carolina and has practiced in dermatology for 2.5 years. She enjoys helping new PAs transition into their careers in dermatology. Please feel free to provide feedback (ah-ha moments, challenges, helpful hints, etc.) on your first year in dermatology to emily.massey@alumni. musc.edu

What Do You Want To Read About In The JDPA? We’re interested in knowing what kind of articles SDPA members would be interested in reading more about in order to help improve their practice of dermatology.

Share your content ideas today.

Email them to editor@jdpa.org Journal of Dermatology for Physician Assistants

16 Journal of Dermatology for Physician Assistants

Now Showing on Dermcast.tv

The Official Online Media Resource of the SDPA Updated weekly, Dermcast.tv is your source for audio podcasts, the most current dermatology news and research, procedural videos, conference highlights, and much, much more. Best of all, as members of the SDPA, everything on Dermcast.tv is not only tailored precisely for you and your needs, it is available to you FREE.

SPECIFIC URL: http://dermcast. tv/federal-ehremrincentives-pasmaking-argumentmeaningful-use Image by: Ludovic Bertron

SPECIFIC URL: www.dermcast. tv/medicis-chiefcompliance-officersarah-richardson

SPECIFIC URL: http://dermcast.tv/demandphysician-assistantsexpected-skyrocket-comingyears Image by: Steve Jurvetson

Skin Cancer Prevention Goes Mobile with UMSkinCheck App The phrase “there’s an app for that” now applies to athome skin cancer detection. UMSkinCheck, a free iPhone and iPad application from the University of Michigan is designed to help people conduct their own skin checks and keep track of suspicious moles or spots. The application, released this summer, is being touted as a cost-effective and easy to use alternative to professional whole body photography.

Federal EHR/EMR Incentives for PAs? Making the Argument for “Meaningful Use” The government is providing financial compensation to most healthcare professionals who adopt EHR technology. However, there is one group of healthcare professionals who have been left out in the cold: physician assistants.

Compliance and Ethical Issues

Sarah Richardson, Medicis Chief Compliance Officer, explains the laws, regulations, and industry standards that govern relationships between pharmaceutical companies and HCPs and provides insights into compliance and ethical issues that may be encountered in your day-to-day activities.

Demand for Physician Assistants Expected to Skyrocket in Coming Years According to the U.S. Department of Labor, the demand for physician assistants is expected to grow by 30 percent within the next 20 years. Forbes magazine also rated physician assistant programs as the top Master’s degree for long-term employment.

VOLUME 7 • NUMBER 1 • WINTER 2013 17

DERMATOLOGY PA NEWS & NOTES

SPECIFIC URL: http://dermcast.tv/skincancer-prevention-goesmobile-umskincheck-app

CLINICAL DERMATOLOGY

A Review of Herpes Simplex Type 2

By Lindsay Hayler, MPH, MPAS, 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.

›› 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 January 2013. 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. Identify the clinical presentation of HSV-2.

2. Review the best methods for diagnosing HSV-2.

3.

Understand the risks associated with HSV-2 acquisition and transmission.

4. Review the current therapeutic options used in the treatment of HSV-2.

5. Understand both the impact HSV-2 has on the patient and the public health implications of this virus.

18 Journal of Dermatology for Physician Assistants

A Review of Herpes Simplex Type 2 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.

VOLUME 7 • NUMBER 1 • WINTER 2013 19

A Review of Herpes Simplex Type 2 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

A Review of Herpes Simplex Type 2 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.

VOLUME 7 • NUMBER 1 • WINTER 2013 21

A Review of Herpes Simplex Type 2 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.

Lindsay Hayler, MPH, MPAS, PA-C has practiced dermatology for four years with Dr. Shelley Sekula-Gibbs in Houston, TX. She received her first Master’s degree from the University of Texas Medical Branch in Physician Assistant Studies and obtained her second Master’s degree in Public Heath from the University of Texas at Houston School of Public Health. She has indicated no relationships to disclose relating to the content of this article.

22 Journal of Dermatology for Physician Assistants

What’s New in Dermocopy A PA’s Perspective of the Inaugural American Dermoscopy Meeting

By John Burns, PA-C

What’s New in Dermoscopy “What’s new in dermoscopy” provides an opportunity to catch up on dermoscopic articles/publications attendees may have missed during the past year or to provide a different perspective on those that we read. This meeting focused on the contributions made possible by using dermoscopy in the study of the life cycle of nevi and melanoma.

The steering committee for the inaugural American Dermoscopy Meeting couldn’t have selected a more geographically diverse location to complement its dermoscopic message. From the Snake River, which we will describe as a serpiginous vessel, to the Pierones Mountains, which we will designate as clods, Jackson Hole, Wyoming provided an unparalleled locale for a dermoscopy conference. Horseback riding, white water rafting, fishing, hiking, and touring of Yellowstone were all at one’s fingertips, but let’s not forget the dermoscopy.

Having been to several dermoscopy conferences, foreign and domestic, the format of the meeting was standard and the speakers were familiar including Doctors Ashfaq Marghoob, Ralph Braun, and Harold Rabinovitz and Margaret Oliviero, NP. The syllabus for the meeting held a little something for everyone including an introduction to the two step format for diagnosing skin lesions, identification of the various dermoscopic findings for general skin lesions and special sites, two break-out sessions, and a general update on “what’s new in dermoscopy.” The sessions were kept on time and were not too long, though I felt the opportunity for questions was limited. Interactive audience break-out sessions were abruptly consolidated from four to two. This decreased the odds for an individual to interact with a presenter, and I feel it is this interaction that benefits attendees most at a dermoscopy conference. The format of the meeting could have been improved by using a self-assessment of dermoscopic skill to separate attendees in preparation for the interactive audience break-out sessions; this would allow beginners to focus on morphology while leaving more advanced clinicians to focus on difficult to diagnose skin tumors. “What’s new in dermoscopy” is one of my favorite parts of any dermoscopy course, and I will devote the rest of this article to this topic, along with a synopsis of pearls I gleaned from this year’s course.

1. When evaluating a lesion for the presence of crystalline structures, make sure to rotate your dermatoscope 360 degrees.1 Termed “dynamic polarized dermoscopy,” Marghoob et al feel it is likely a lack of regularly oriented collagen which produces crystalline structures and necessitates this technique (A.F. Marghoob, oral communication, June 2012).1 2. Black globules on the ridges of the palms and soles following trauma, known clinically as “black heel” or dermoscopically as “pebbles on a ridge,” are the manifestation of blood being extruded through the eccrine ducts (R.P Braun, oral communication, June 2012).2 3. Nodular melanoma rarely contains superficial dermoscopic structures including reticular lines, a pitfall in misclassifying such lesions as nonmelanocytic and misdiagnosis. This is because the lesion lies primarily in the dermis (A.F. Marghoob, oral communication, June 2012).

4. Follow-up is not typically needed for diagnosing pigmented lesions involving the nail apparatus. This is because the complete fingernail plate has about a 4-6 month regeneration time and the toenail 8-12 months. Therefore, what you have on the day of clinical presentation is already a few months worth of data. (R.P Braun, oral communication, June 2012).3 Predicting the type of nevi an individual will develop may be possible with dermoscopy. By evaluating with dermoscopy the normal-appearing skin of 443 children, Scope et al were able to discern globular structures in 17% and a reticular pattern in 24%; no histology of these structures was obtained.4 In six adult patients, similar findings surrounding “suspicious lesions” were found and histologically examined. Four of these specimens had a globular pattern whereas three had a reticular pattern.

The four with a globular pattern demonstrated nesting of VOLUME 7 • NUMBER 1 • WINTER 2013 23

CLINIC AL DERMATOLOGY

Inaugural American Dermoscopy Meeting Pearls

TABLE: Prospective evaluation of 10,073 melanocytic neoplasms for crystalline structures.6 Type of Melanocytic Neoplasm

Clark’s nevus

# of Lesions Without Crystalline Structures

9,770

1

9,769

91

0

91

Blue nevus

15

0

15

Intradermal nevus

178

2

176

Congenital melanocytic nevus

CLINIC AL DERMATOLOGY

# of Lesions # of Lesions Studied With Crystalline Structures

Conference in 2007 reported using dermoscopy in their practice and had gained understanding of the technique through attendance of a seminar, reading a book, or spending time with another more experienced dermatologist.9 I had a great time at the inaugural American Dermoscopy Meeting and learned a lot. I hope to see more fellow SDPA members at the next meeting to be held August 1517, 2013 at Glacier National Park in Montana. J

REFERENCES: 1. Marghoob, AA, Cowell, L, Kopf, AW, Scope, A. Observation of chrysalis structures in polarized dermoscopy. Arch Dermatol. 2009;145(5):618.

Spitz nevus 3 3 0 2. Marghoob, AA, Braun RP, Kopf AW. Atlas of Dermoscopy. London ; New York: Taylor & Francis; 2005.

Invasive melanoma 13 11 2 3. Rich P, Scher RK. An Atlas of Diseases of the Nail. New York, New York: The Melanoma in-situ 3 0 3 Parthenon Publishing Group; 2003.

Total 10,073 17 10,056 4. Scope A, Marghoob AA, Chen CS, Lieb JA, Weinstock MA, Halpern AC. Dermoscopic patterns and subclinical melanocytic nests in normal-appearing melanocytes, as expected by dermoscopic examination, but skin. Br J Dermatol 2009;160:1318-1321. the specimens with reticular patterns had no increase in 5. Stefani AD, Campell TM, Malvehy J, Massone C, Soyer HP, Wellenhof RH. Shiny white melanocytes. Scope et al hypothesize that these subclinical streaks: An additional dermoscopic finding in melanomas viewed using contact polarized collections of melanocytes may be the precursor for future dermoscopy. Aust J Dermatol. 2010;51:295-298.

4 globular nevi.

6. Balagula Y, Braun RP, Rabinovitz HS, Dusza SW, Scope A, Liebman TN, MordenteI, Siamas K, Marghoob AA. The significance of crystalline/chrysalis structures in the diagnosis of “Chrysalis structures, crystalline structures, or shiny melanocytic and nonmelanocytic lesions. J Am Acad Dermatol. 2012;67:194-8. white streaks,” are seen in a variety of skin tumors, but 7. Engasser HC, Warshaw EM. Dermatoscopy use by US dermatologists: A cross-sectional in melanocytic processes appear to be largely confined Survey. J Am Acad Dermatol. 2010;63(3):412-419.

5,6 to melanoma and Spitz nevi. The Table above contains 8. Australian Cancer Network Melanoma Guidelines Revision Working Party. Clinical Practice a tally of 10,073 clinically and histologically diagnosed Guidelines for the Management of Melanoma in Australia and New Zealand. Cancer Council melanocytic neoplasms studied in a prospective fashion for Australia and Australian Cancer Network, Sydney and New Zealand Guidelines Group, the presence of crystalline structures.6 Only 1 out of 9,770 Wellington (2008).

Clark’s nevi demonstrated this finding and almost all of 9. Noor O, Nanda A, Rao BK. A dermoscopy survey to assess who is using it and why it is or is the invasive melanoma and Spitz nevi demonstrated this not being used. Int J Dermatol. 2009;48(9): 951-2.

finding.6 Despite the small number of melanoma and Spitz nevi, these findings are a cautionary tale; if one observes crystalline structures in a skin tumor thought to be a melanocytic process, the diagnosis of melanoma or Spitz nevus should be considered (See Table).6 Crystalline structures may also represent an indicator for thicker melanomas. Retrospective analysis of 229 melanoma, 110 invasive melanoma, and 119 insitu melanoma demonstrated that 41% of the invasive melanoma had crystalline structures while only 17% of the in-situ melanoma had them.6 What crystalline structures represent remains a matter of debate. Marghoob et al contribute this dermoscopic finding to collagen formation.

Stefani et al were unable to corroborate this and suggest that crystalline structures represent irregular acanthosis or an aberration of polarized light.5,6

John Burns, PA-C is a graduate of the Physician Assistant Program at Louisiana State University Health Science Center Shreveport, Louisiana. He is a Diplomate of the Society of Dermatology Physician Assistants. He presently resides in Frisco, Texas where he works in dermatology with Dr. Eric Weisberg.

&

Dermoscopy Q A Question: What is it?

Conclusion Dermoscopy usage appears to be increasing in the United States and in some parts of the world is the standard of care for individuals regularly evaluating pigmented skin lesions.7,8 After using the technique now for almost ten years I recommend that all dermatology physician assistants take time to learn this technique through self study, attendance at dermoscopy conferences, and working with individuals already familiar with it. In 2009, 41 of 63 dermatologists attending the American Academy of Dermatology Summer 24 Journal of Dermatology for Physician Assistants

Under Dermoscopy

Answer on page 27

From The Patient’s Perspective My CTCL Journey

It was a chilly morning in late October 2009. I had "You will die with it but probably not from it." I wasn't just arrived at the office of Doctor Williams, a local sure that helped to calm my concern. He explained that dermatologist. This was my first visit to a dermatologist, it looked like I had cutaneous T-cell lymphoma, known and I wasn't sure where this visit was going to take me. as CTCL. The lymphoma word didn't sound good.

He would need to take a biopsy to be sure. Looking The wait was short, and I was soon in an examination around my body again, he chose an older patch on my room ready to see the doctor. I looked around the lower back. He stated that this disease is often hard examination room at the pictures to identify and that future on the walls showing various biopsies might be needed. skin issues. Would this He told me I would be “After a few minutes, he stepped doctor be able to help with hearing back from his office my problem? I thought about back and said, ‘I know what you within the week. the red patches on my body and the years of applying Several days later, I have, and you will die with it.‘ ” received creams to clear them up. The a call and was first patch on the inside of my informed that my situation left knee had appeared at least had been referred to the five years ago. Previous doctors assured me it was only Huntsman Cancer Institute and that they would be eczema and that softer soaps and ointments would take contacting me for an appointment. Within a very short care of the problem. I now had many red patches that time, I was sitting in another examination room waiting extended from my knees to my shoulders, and some were to see Doctor Glen Bowen. I now realize, as I reflect back on my upper arms. to that day, that it was a turning point for several aspects of my life.

I remembered a time in early 2005 when I had a three-month work assignment in Sydney, Australia.

I had spent time researching CTCL on the Internet Because I had few distractions during that time, I was and saw pictures of patches like mine. Some of the stories able to consistently apply an eczema ointment every day were not very encouraging and I wondered what the and night. The few patches became softer, and at times future would bring. Just then, Doctor Bowen entered the the red color would be lighter, but it didn't seem to make room bringing a great amount of energy with him. He a long-term difference. I began to accept these patches as welcomed me and made me feel good to be there. He things that were going to stay around. They didn't seem looked me over and then started to explain about this to itch or hurt most of the time. They would occasionally disease. He used some images and related descriptions get scaly, and I would apply some hand lotion for a few that helped me to calm my concerns, to better days. comprehend what was going on, and to understand how we could treat this disease in the near term. I left feeling I had recently changed my primary care physician encouraged to fight the battle. and made a visit to get an annual physical examination.

He asked about the patches. I told him they were part The battle has not always been easy. Ultraviolet light of my life and that they didn't seem to go away so I just treatments began in mid December 2009. I made the accepted them. He suggested I have a dermatologist look at them to ensure they were not a concern. He recommended Doctor Williams and here I sat waiting for his opinion.

I was brought back to the present as the doctor entered the room, and we exchanged greetings. He The mission of the Cutaneous Lymphoma Foundation is looked at the red patches and asked a few questions about to support every person with cutaneous lymphoma by how long they had been there. After a few minutes, he promoting awareness and education, advancing patient care, stepped back and said, "I know what you have, and you and facilitating research. will die with it."

Contact information: www.clfoundation.org (248) 644-9014 info@clfoundation.org I wasn't quite sure I heard him right. I must have had PO Box 374, Birmingham, MI 48012 a puzzled look on my face because he explained further, VOLUME 7 • NUMBER 1 • WINTER 2013 25

CLINIC AL DERMATOLOGY

By Gary C. Robinson

CLINIC AL DERMATOLOGY

From The Patient’s Perspective trek to the clinic three times each week for two months.

In the early stages, my skin would be on the edge of a sunburn and painful to the touch. Then the itching would wake me up at night. The frequent visits for light therapy and the tired feeling that followed were impacting my work ability. I had launched my own business while this was happening; it did give me some schedule flexibility, but productivity was impacted. The patches initially got redder, and the itching was unbearable. I wondered if the time and effort were really going to be worth it. My wife was my biggest supporter during this period; she gave me daily encouragement and was there when I needed her.

After the initial two months, I had a nice tan and the itching was greatly minimized. The patches had faded away. My February 2010 visit with Doctor Bowen revealed that the light treatments were working, and I could begin a slow decrease in the frequency. It was now a time to look towards the future and to ensure my daily efforts matched my health desires. I had become involved in a CTCL support group, which met monthly to help educate other people like me. Participation in this group helped to lift my spirits, to educate me on the possibilities, and to identify those areas of my life where I could make changes to improve my overall health and well-being.

These monthly meetings have brought the support and encouragement of Mark Hyde, PA-C (who works with Doctor Bowen) and Kellie Custen (a patient and family support specialist). I have been able to meet and associate with other CTCL patients and learn how they are dealing with this disease. The monthly support group meeting agenda includes topics on mindfulness meditation, proper diet, and physical exercise programs.

These have helped me focus on my health improvement objectives. My CTCL diagnosis and the treatment journey since then have instilled in me an awareness of my overall health and the improvements I can make now to ensure a healthier future.

The journey is not over. I continue with light treatments every five weeks to maintain this disease.

The patches are gone for now. The itching and the slight sunburn pain still follow each treatment. Continual watching and caring by my wife identified some spots on my face, which were identified as basal cell carcinoma and have been removed. My family health history shows other potential concerns for the future so my wife and I have made diet changes and increased our exercise efforts so that we can enjoy a future retirement in the years to come.

This refocus on what is most important is the result of a short statement from a dermatologist who said I will die with this CTCL disease but not from it. I am trying to do what I can to make that a very long time from now.

The continued support of my wife and my CTCL team 26 Journal of Dermatology for Physician Assistants

at Huntsman Cancer Institute help make this journey possible and enjoyable. J Gary Robinson of Saratoga Spring, UT was diagnosed with CTCL in late 2009.

He runs an elearning development company with his wife to help small businesses migrate their training effort to the online world and is expanding to provide self-improvement and leadership skill content for individuals and companies. Volunteer service with the Boy Scouts of America continues to be a focus and Gary is preparing to serve as the president of a local Rotary Club.

Take Home Points for Derm PAs:

By Steven K. Shama, MD, MPH 1. How do we deliver bad news? Bad news can be any health related news given to a patient that negatively affects how the person views his/her future, and it is often in the “eye of the beholder.”

While it is often said about CTCL that you will "most likely die with it than from it," this statement can sound rather callous when it is the first piece of diagnostic information a patient receives from the clinician. The word lymphoma also suggests a bad diagnosis. We as clinicians understand why CTCL is labeled as such, but we must be sensitive to what patients hear and interpret. Notice the difference between saying “most likely you will die with it, than from it” vs. “I truly believe that you will live a healthy life despite this diagnosis?” We need to be gentle with our first words, since they may never be forgotten.

2. Who delivers the bad news? When this patient was called on the phone and was told that his “situation has been referred to the Huntsman Cancer Institute,” one wonders how he felt when he heard the word “cancer?” It seems to me that the clinician should have been involved with delivering this news and should have reiterated that more likely than not, the patient would live a healthy life despite the CTCL diagnosis.

3. How do you deal with patients with a chronic disease? I noticed that the patient recalled that Dr. Bowen, the CTCL specialist, made him feel good about seeing him. Dr. Bowen educated him, both visually and verbally, helped calm him down, and no doubt helped with the patient’s compliance over many months of treatment. The main themes in dealing with patients who have a chronic disease are to educate the patient and to be honest, caring, and available. I have used this expression before in this journal, but it is worth repeating, “To cure sometimes, to relieve often, to comfort always.”

&

DermoscopyQ A

Dermatoscopic Pattern of a Spiradenoma

By Philipp Tschandl, MD

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.

...Editor’s note on page 30 Philipp Tschandl, MD works at the Department of Dermatology, Division of General Dermatology, Medical University of Vienna, Austria. He has indicated no conflicts of interest to disclose relating to the content of this article.

This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author (©2012 Tschandl) and source (Dermatoscopic pattern of spiradenoma. Dermatol Pract Conc. 2012;2(4)9) are credited.

VOLUME 7 • NUMBER 1 • WINTER 2013 27

28 Journal of Dermatology for Physician Assistants

VOLUME 7 • NUMBER 1 • WINTER 2013 29

CLINICAL snapshots Syringomas

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 Syringomas

Larry Bishop, MD completed his residency in dermatology at Wilford Hall Medical Center in San Antonio, TX. While at Wilford Hall, Dr. Bishop served 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 indicated no conflicts of interest to disclose relating to the content of this article.

...continued from page 27

Notes for Dermascopic Pattern of a Spirademoma

By John Burns. PA-C

JDPA Dermosopy Q&A Editor

In Figure 2: Orangle clods are circled; thin-black

arrows note shiny white structures; yellow arrows mark arborizing blood vessels; and the large solidblack arrow denotes the blue globule.

If you have a particular dermascopic topic you would like to see covered in the JDPA, please email topic ideas to editor@JDPA.org.

30 Journal of Dermatology for Physician Assistants

SURGICAL DERMATOLOGY Journal Club: Practice Changing Articles for Dermatology PAs Efficacy of Mohs Micrographic Surgery for the Treatment of Dermatofibrosarcoma Protuberans: Systematic Review.

Arch Dermatol. 2012; 148(9):1055-63.

Foroozan M, Sei JF, Amini M, Beauchet A, Saiag P. Department of Dermatology and Research Unit EA 4339 “Skin, Environment, and Cancer” Ambroise Paré University Hospital, France.

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.

Journal clubs are a great way to review and critically evaluate the most current literature impacting the practice of dermatology. For physician assistants who are new to the practice of dermatology, journal clubs can assist them to become more familiar with advanced medical literature and improve their understanding of current issues within the field. The articles selected for the JDPA Journal Club are meant to be shared and discussed with your colleagues, peers, and supervising physicians. If you have any articles to recommend for the JDPA Journal Club, please email them to editor@jdpa.org.

Are You Treating Medicare Patients with Melanoma and Billing Under Your Own NPI #?

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VOLUME 7 • NUMBER 1 • WINTER 2013 31

SURGICAL wisdom Advice for PAs Interested in Surgical Dermatology SDPA Members Only Content

SURGIC 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.

Dermcast.tv is the official online media resource of the SDPA. Updated weekly, it is your source for audio podcasts, the most current dermatology news and research, procedural videos, conference highlights, and much, much more. Best of all, as members of the SDPA everything on Dermcast.tv is not only tailored precisely for you and your needs, it is available to you free!

32 Journal of Dermatology for Physician Assistants

COSMETIC DERMATOLOGY Journal Club: Practice Changing Articles for Dermatology PAs Optimal Tattoo Removal in a Single Laser Session Based on the Method of Repeated Exposures.

J Am Acad Dermatol. 2012 Feb; 66(2):271-7.

Kossida T, Rigopoulos D, Katsambas A, Anderson RR. 1st Department of Dermatology, Andreas Sygros Hospital, National and Kapodistrian University of Athens Medical School, Athens, Greece.

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.

Journal clubs are a great way to review and critically evaluate the most current literature impacting the practice of dermatology. For physician assistants who are new to the practice of dermatology, journal clubs can assist them to become more familiar with advanced medical literature and improve their understanding of current issues within the field. The articles selected for the JDPA Journal Club are meant to be shared and discussed with your colleagues, peers, and supervising physicians. If you have any articles to recommend for the JDPA Journal Club, please email them to editor@jdpa.org.

S D PA

ERSH B M E M

IP

RECEIVE A $20 AMAZON GIFT CARD FOR EVERY PERSON YOU REFER TO BECOME A MEMBER OF THE SDPA.

Please note: Each referral will be counted only after the new member pays his/her dues and lists the referring member’s name on the application. Referral of supervising physicians will NOT qualify for this campaign, but is certainly encouraged.

VOLUME 7 • NUMBER 1 • WINTER 2013 33 RAMC_3.25x4.75.indd 1

1/31/13 12:49 PM

COSMETIC pearls Utilizing Inbound Marketing to Capture Potential Cosmetic Patients By Risha Bellomo, MPAS, 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.

COSMETIC DERMATOLOGY

Risha Bellomo, MPAS, PA-C has practiced dermatology for 12 years and currently works at Advanced Dermatology & Cosmetic Surgery in Orlando, Florida. She has been their Director of PA/NP Cosmetic Training for the last 6 years and is also the founder and CEO of Bellomo Consulting, Inc. and Practical Medical Solutions, LLC. Risha's passion is educating and creating awareness to healthcare providers and the community She has indicated no relationships to disclose relating to the content of this article.

34 Journal of Dermatology for Physician Assistants

For the early treatment of recurrent herpes labialis to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time.

The only FDA-approved agent proven to help prevent cold sore progression1 In a controlled clinical trial:

• 42% of patients treated with XERESE® did not progress to the ulcerative stage vs vehicle (26%) (p<0.0001)2 • 50% smaller lesion area vs vehicle (p<0.0001); 1.6 days faster healing vs vehicle (p=0.0001)1-3 • Combines antiviral acyclovir with antiinflammatory hydrocortisone

WHEN A COLD SORE STARTS

STOP IT BEFORE IT GETS UGLY

Indication and Important Safety Information: XERESE (acyclovir and hydrocortisone) Cream 5%/1% is indicated for the early treatment of recurrent herpes labialis (cold sores) to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time in adults and adolescents (12 years of age and older).

XERESE Cream is intended for cutaneous use only, on the lips and around the mouth. XERESE should not be used in the eye, inside the mouth or nose, or on the genitals. Patients should be encouraged to seek medical advice when a cold sore fails to heal within 2 weeks. The effect of XERESE Cream has not been sufficiently established in immunocompromised patients. XERESE Cream has a potential for irritation and contact sensitization. In clinical trials, the most common adverse reactions in the area of the application site included drying or flaking of the skin; burning or tingling following application; erythema; pigmentation changes; application site reaction including signs and symptoms of inflammation. Each event occurred in less than 1% of patients.

Please see brief summary of Prescribing Information on adjacent page.

References: 1. XERESE [package insert]. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC; 2012.

2. Hull CM, Harmenberg J, Arlander E, et al. Early treatment of cold sores with topical ME-609 decreases the frequency of ulcerative lesions: a randomized, double-blind, placebo-controlled, patient-initiated clinical trial. J Am Acad Dermatol.

2011;64(4):696.e1-11. 3. Data on file, Valeant Dermatology. © 2012 Valeant Dermatology, a division of Valeant Pharmaceuticals North America LLC XER1260312

Learn more at www.XERESE.com

XPERTISE in action VOLUME 7 • NUMBER 1 • WINTER 2013 35

BRIEF SUMMARY OF PRESCRIBING INFORMATION XERESE®

USE IN SPECIFIC POPULATIONS Pregnancy Category B

(acyclovir and hydrocortisone) Cream 5%/1% for topical use

Teratogenic Effects

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.

Acyclovir was not teratogenic in the mouse, rabbit or rat at exposures greatly in excess of human exposure. There are no adequate and well-controlled studies of systemic acyclovir in pregnant women. A prospective epidemiologic registry of acyclovir use during pregnancy between 1984 and 1999 followed 749 pregnancies in women exposed to systemic acyclovir during the first trimester of pregnancy resulting in 756 outcomes. The occurrence rate of birth defects approximated that found in the general population. However, the size of the registry was insufficient to evaluate the risk for less common defects or to permit reliable or definitive conclusions regarding the safety of acyclovir in pregnant women and their developing fetuses.

New Valeant Xerese

INDICATIONS AND USAGE XERESE is indicated for the early treatment of recurrent herpes labialis (cold sores) to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time in adults and adolescents (12 years of age and older).

CONTRAINDICATIONS None.

WARNINGS AND PRECAUTIONS General XERESE is intended for cutaneous use only for herpes labialis of the lips and around the mouth. XERESE should not be used in the eye, inside the mouth or nose, or on the genitals.

There are other orofacial lesions, including bacterial and fungal infections, which may be difficult to distinguish from a cold sore. Patients should be encouraged to seek medical advice when a cold sore fails to heal within 2 weeks.

XERESE has a potential for irritation and contact sensitization (see Adverse Reactions).

ADVERSE REACTIONS Overall Adverse Reaction Profile The safety data derived from XERESE clinical studies reflect exposure to XERESE in 1002 subjects with recurrent herpes labialis treated 5 times daily for 5 days. The majority of the adverse reactions were local skin reactions and occurred in the area of the application site.

Adverse Reactions in Clinical Studies Because clinical studies are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other clinical studies and may not reflect the rates observed in clinical practice.

The majority of the adverse reactions were local and occurred in the area of the application site.

Skin and Subcutaneous Tissue Disorders The following most common adverse reactions (< 1%) were local skin reactions, and occurred in the area of the application site: — Drying or flaking of the skin; burning or tingling following application; erythema; pigmentation changes; application site reaction including signs and symptoms of inflammation.

Contact dermatitis following application has been observed when applied under occlusion in dermal safety studies. Where contact sensitivity tests have been conducted, the reactive substances were hydrocortisone or a component of the cream base.

A study enrolling 225 healthy adults was conducted to evaluate the contact sensitization potential of XERESE using repeat insult patch testing methodology. Of 205 evaluable subjects, one confirmed case (0.5%) of sensitization to hydrocortisone and 2 additional cases (1.0%) of possible sensitization to the XERESE base were identified. Additionally, one subject developed a contact allergy in the photosafety study to propylene glycol, one of the inactive ingredients of the cream base.

Dermal tolerance was assessed in a 21-day cumulative irritation study in 36 healthy subjects. XERESE, its cream base and Zovirax® (acyclovir) Cream 5% all showed a high and cumulative irritation potential under occlusive and semiocclusive conditions.

Photoallergic potential and phototoxicity were assessed in two studies in 50 and 30 healthy volunteers, respectively. No photoallergic or phototoxicity potential was identified for XERESE. DRUG INTERACTIONS No drug interaction studies have been performed with XERESE.

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. Animal reproduction studies have not been conducted with XERESE. No studies have been performed in pregnant women. Systemic exposure of acyclovir and hydrocortisone following topical administration of XERESE is minimal.

Nursing Mothers It is not known whether topically applied acyclovir or hydrocortisone is excreted in breast milk. Systemic exposure following topical administration of either drug is expected to be below detection limits. Because many drugs are excreted in human milk, caution should be exercised when XERESE is administered to a nursing woman.

Pediatric Use Safety and effectiveness in pediatric subjects less than 12 years of age have not been established.

Geriatric Use In clinical studies, there were insufficient subjects above 65 years of age to reach a firm conclusion regarding safety and efficacy of XERESE in this group, although the available results were similar to lower age subjects.

Immunocompromised Subjects Even though the safety of XERESE has been studied in immunocompromised subjects, data are insufficient to support use in this population. Immunocompromised subjects should be encouraged to consult a physician concerning the treatment of any infection.

Benefit has not been adequately assessed in immunocompromised patients. A randomized, double-blind study was conducted in 107 immunocompromised subjects with stable HIV infection and recurrent herpes labialis. Subjects had on average 3.7 episodes of herpes labialis in the previous 12 months. The median age was 30 years (range 19 to 64 years), 46% were female, and all Caucasian. Median CD4+ T-cell count at screening was 344/mm3 (range 100-500/mm3). Subjects were treated with XERESE or 5% acyclovir in XERESE vehicle. The primary objective was to exclude a doubling of the healing time in either treatment arm. The mean healing time for cold sores was similar between the two treatment groups: 6.6 days for XERESE and 6.9 days for 5% acyclovir in XERESE vehicle.

HOW SUPPLIED XERESE is supplied in a plastic-laminated aluminum tube containing 5 gm of XERESE. NDC 0187-5104-01: 5 gm tubes Revised: 01/2012 Manufactured for: Valeant Pharmaceuticals North America LLC Bridgewater NJ 08807 Produced under license MEDA Pharma SARL, Luxembourg, by Valeant International (Barbados) SRL, Barbados, West Indies Made in Canada

XERESE is a registered trademark of Meda Pharma SARL under license by Valeant.

U.S. Patents RE39,264 and 7,223,387 Part No. 2005525

36 Journal of Dermatology for Physician Assistants

Manufactured by: Contract Pharmaceuticals Limited (CPL) 7600 Danbro Crescent Mississauga, Ontario Canada L5N 6L6

XER1250312

PROFESSIONAL DE VELOPMENT

Dermatology Billing & Coding

Audits Rampant: Modifier 25 a Target of Audits

By Inga Ellzey, MPA, RHIA, CDC

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.

VOLUME 7 • NUMBER 1 • WINTER 2013 37

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.

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.

38 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. VOLUME 7 â&#x20AC;˘ NUMBER 1 â&#x20AC;˘ WINTER 2013 39

Judicial and Ethical Affairs

Case-Based Compliance Scenarios

By Sarah Richardson, Chief Compliance Officer, Medicis Pharmaceutical Corporation

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.

40 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.

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.

NOTES from your Office Manager Maintaining Patient Confidentiality 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.

These Risk Management Tips have been reprinted with permission from: MLMIC Dateline, published by Medical Liability Mutual Insurance Company, 2 Park Avenue, Room 2500, New York, NY 10016. Copyright ©2010 by Medical Liability Mutual Insurance Company. All Rights Reserved. No part of this article may be reproduced or transmitted in any form or by any means, electronic, photocopying, or otherwise, without the written permission of MLMIC. VOLUME 7 • NUMBER 1 • WINTER 2013 41

PROFESSIONAL DEVELOPMENT

SDPA Members Only Content

Outside & Inside the 9 to 5...

Amy Gouley, PA-C is a SDPA member and founder of Project Happy Face, a nonprofit corporation (501c3) dedicated to treating disadvantaged teens with acne. Free acne treatments and medications are provided to elevate self-esteem and confidence in developing young adults. The JDPA had an opportunity to discuss the program in further detail with Ms. Gouley.

PROFESSIONAL DEVELOPMENT

JDPA: Can you tell us how Project Happy Face got started?

spreads the word about small town values. Community involvement at an early age is incredibly valuable. The kids who are enrolled and participating in Project Happy Face inspire me to keep the program going.

Ms. Gouley: The project came from an idea I had after moving to California for school. I grew up in a small town in Idaho, and the sense of community that existed there was not present in JDPA: What states currently have Project California. I wanted to do something Happy Face chapters? to bring the community together. I feel Ms. Gouley: We are currently up that there are so many distractions for and running in California, where I lived teenagers, particularly in California. There the past eleven years. I just moved to isnâ&#x20AC;&#x2122;t the same value system that existed in Amy Gouley, PA-C Washington state four months ago my small Idaho town. I grew up knowing and we are accepting new student the importance of giving back to your community. applications. I am also working on opening a chapter As a physician assistant, I loved seeing teenagers as in my hometown, Hailey, Idaho, in the near future. patients. I decided that I could use my treatment of JDPA: What are the criteria for patients to enroll in acne as leverage to get the kids into the office, so I the program? could mentor them in regards to the importance of good grades, going to college, obtaining a career, Ms. Gouley: The program is for junior and senior and giving back to their community once they were high school students who are disadvantaged. established (with a job/career).

Disadvantaged students include those with parents who are divorced, low income, no health insurance, JDPA: What has influenced you the most? or have suffered abuse. Every teenager deserves free Ms. Gouley: I grew up in a small town in Idaho, acne treatment, but I especially wanted to include a really tight knit community. My parents taught those students who will most likely give back to me from an early age the their communities later in importance of being involved life. I decided that college in my community. In addition bound students with a GPA to being a registered nurse, of 3.0 or greater would most my mother volunteered for likely choose careers that will the March of Dimes and give them outstanding jobs; served as a member of the in turn they will be more school board. My father likely to give back to their also participated in the communities and continue community and volunteered to spread acts of civility. with the Department of Applicants must also sign a Fish and Game. I graduated contract to smile at strangers from high school with five and spread acts of kindness in their communities. scholarships, many of them were community JDPA: What kind of outcomes have you seen since based. I thought it was awesome that I could attend the start of the program? college because of my community involvement and support from the community. So, I always Ms. Gouley: The students are so grateful and intended to give back once I was established in happy to participate in the program. I love hearing my career. My plan was to develop a program that them express their gratitude. As their acne begins to 42 Journal of Dermatology for Physician Assistants

JDPA: How do you connect with the students?

Ms. Gouley: Each time a student is seen in the office, I ask them how things are going. I talk to them about how their college applications are coming along and how their preparation for their SATs is going.

I know all of the important dates for these high school students (I get them from their high school guidance counselors) such as when financial aid forms are due and when the PSAT/SAT is. I am one more voice telling them how to get their ducks in a row and how to get themselves ready for college.

JDPA: Do Project Happy Face participants do any activities as a group?

Ms. Gouley: Yes, we absolutely do group activities, field trips, and volunteer work together.

For our last outing we took the train to downtown Los Angeles and then a taxi drive through the skid row section where homeless people and families live. This particular trip was an eye opener for the teenagers. It really served as one more reinforcement for them to stay in school and get an education so they can contribute their energy back into their communities.

JDPA: Any advice for PAs who are interested in helping to be a positive influence for their patients?

Ms. Gouley: PAs can obtain school calendars from local high schools through the schools’ guidance counselors. PAs should pay attention to local high school events that matter to these

patients (e.g., high school athletic games and dances). Connections can be made by simply asking them, “How was the volleyball game last week?

Studying for any exams? What are your favorite classes?”

JDPA: How does participation in this program work in regards to the PA/supervising physician (SP) relationship?

Ms. Gouley: Physician assistants (and nurse practitioners) who are interested in joining Project Happy Face need to make arrangements with their SPs and agree about program involvement and the use of office time. Providers could propose to see the Project Happy Face patients during their lunch breaks or after hours so as to not disrupt the normal flow of the clinic.

JDPA: What are your future goals for Project Happy Face?

Ms. Gouley: I want Project Happy Face to become a nationwide program. I would love to see more PAs/NPs join the project and volunteer their time. Providers can take on as many patients as they are comfortable with. It would be great if someday Project Happy Face could provide college scholarships as well.

JDPA: Any other thoughts or ideas you would like to share with our readers?

Ms. Gouley: So many of us went into medicine for a reason; it is so much more than a 9 to 5 job. There are so many places and areas in the community where providers can help out. There are a variety of ways to give back; our options are endless. I conduct free skin screenings for local ski patrols, fire fighters, and police departments as well. We must continue to do what we love and contribute our energies, efforts, and knowledge to better our community.

Providers have the greatest opportunity to make a difference and bring humanity back to medicine.

If you are interested in learning more about Project Happy Face and reading testimonials from participating students, please visit their website at www.projecthappyface.org. Providers who are interested in starting a chapter in their state, can email Amy Gouley, PA-C at amy@ J projecthappyface.org. J

VOLUME 7 • NUMBER 1 • WINTER 2013 43

PROFESSIONAL DEVELOPMENT

diminish, I can see a difference in these teenagers’ confidence and self-esteem. They are totally jazzed, ready to roll, go to college, and take on the world.

Once they have clear skin, their attitudes change, and they become bright shining stars. They are elated to leave for college and they are so thrilled to update me on their progress with school, grades, sports, etc. Every senior who has left for college stays in touch with me. I receive regular emails, text messages, and postcards. I also offer one free office visit while they are in college, mostly to keep in touch, continue encouragement, and share in their excitement about their future endeavors. The program is absolutely working.

Students are seeking volunteer opportunities and spreading acts of civility.

DO YOU KNOW A SDPA DIPLOMATE? The SDPA wishes to congratulate all of our Physician Assistant members who have completed the rigorous Distance Learning Initiative.

For more information on achieving DIPLOMATE status in your state, visit Dermpa.org/DIPLOMATE 44 Journal of Dermatology for Physician Assistants Current list of diplomates effective as of 11/2012

DERMATOLOGY PA NEWS & NOTES

From the Desk of...

The New SDPA Philanthropy Task Force Your SDPA Directors at Large are proud to be heading up a new task force that will engage the SDPA in future philanthropic endeavors. This concept stemmed from the inaugural Miles for Melanoma 5K Run/1 Mile Walk held in Seattle at our 2012 Summer Dermatology Conference.

Through organizing this race and involving the local community, we were able to raise nearly $4,000 for the Melanoma Research Foundation.

Our next Miles for Melanoma event will take place at our 11th Annual Fall Conference in Atlanta, GA, November 13-16, 2013.

The potential growth of this program has led us to begin investigating other ways the SDPA can give back to local communities and organizations

that serve our patients and profession. A few ideas that have been discussed, in addition to 5K races, are donations to charitable organizations or activities (such as Camp Discovery) and/or joining the AAD with their philanthropic projects.

We are in the early stages of development with an important opportunity to create a valuable philanthropic branch of the SDPA and, as always, welcome the input of our members as we move forward with these ideas. Please contact the Philanthropic Task Force at philanthropy@ dermpa.org with suggestions or if you are interested in being part of the development of this team. J

Matthew Brunner, MHS, PA-C

Jennifer Conner, MPAS, PA-C

SDPA Director at Large

SDPA Director at Large

Greg Buttolph, MPAS, PA-C

Vicki Roberts, MPAS, PA-C

SDPA Director at Large

SDPA Director at Large

VOLUME 7 â&#x20AC;˘ NUMBER 1 â&#x20AC;˘ WINTER 2013 45

The Difference We Make

A Life Lesson My Chief Resident Taught Me A Tale Of Gratefulness

DERMATOLOGY PA NEWS & NOTES

By Steven K. Shama, MD, MPH It has been thirty years since the story that I am about to tell you occurred. But to me, it’s as if it happened yesterday evening. The events took place within a broader context than dermatology, changed my life as a dermatologist, and made my career even sweeter than I could have imagined.

Joe was my chief resident during my three-year residency in dermatology. He was a great teacher and quiet spoken. You could see that he really cared about all of us first year residents.

He really wanted us to “get it,” to deeply understand the wonder of our new specialty that we were just beginning to explore and that he loved so much.

You could see it on his face, always a smile, nothing too much, but just enough that everyone knew he was a happy guy, content with life, and grateful for his special blessing of dermatology. He never specifically said anything like that. You just knew when you were around him that that’s the way he felt.

And as far as teaching us dermatology, Joe seemed to know everything about dermatology; if he didn’t, he would look it up in front of us. He was humble and an inspiration to us all. But some lessons can’t be taught. They need to be personally experienced and that is what this story is all about.

In our program, we were on call every sixth night. We had to be physically in the hospital until 9 PM. My story begins on the twenty-third day of my first year of residency. For the first thirty days of our first year, we had the luxury of having one of the second or third year residents physically with us for night call.

On this particular evening, Joe was assigned as my backup resident, my pair of experienced eyes. The night was quiet and Joe and I were chatting about something when my beeper went off. It was the ER asking for a dermatology consult. I thought that it could be a serious problem since they wouldn’t call for a simple rash, would they? But I had Joe, so I knew that I was safe.

When I told Joe that we had a consult, he told me that I should go alone to see the patient, generate a differential diagnosis, come to a specific diagnosis and treatment plan, and then call him. I should let him know my thoughts, and then he would see the patient in the ER. Together we would write our official note. That was the plan, and that is the way we learned in those days.

I must admit that it was with some trepidation that I left the safety of the on-call room and made my way to the ER. I had never been in this ER before. As I began to hear sounds of commotion in the ER, I was no longer filled with trepidation; it was real fear that enveloped me. After all, what did I know about dermatology that I should be sent alone to an ER to see a patient? I had done well in all my schooling from high school through medical school, but this was the real thing. I was going to show the world what I had learned in the first twentythree days of my training, and hopefully make my residency program proud of me. I was the dermatologist, beginning my career. I took a long breath, found a proud smile from deep within me.

46 Journal of Dermatology for Physician Assistants

The ER was mobbed. It seemed like real chaos. I tried to figure out how to find someone to announce my arrival, but everyone seemed to be too busy. Then I saw a young woman in pressed blue scrubs coming through the crowd of people making her way towards me. She came right up to me and said, “You must be the dermatologist.” It was not a question; it was statement! Somehow she knew. Clearly she had never seen me before; and in the midst of all the craziness of the ER, she spotted me. So I asked the obvious question, “How did you know that I was from dermatology?” She didn’t hesitate for even a moment and said, “’Cause you’re the only one smiling around here!”

I got it. I realized that others knew what we dermatologists were like. Smiling doctors. I never forgot that moment. I never forgot what she said and how she said it. A humble smile crossed my face when she said what she said. That smile was never to leave.

The ER patient clearly had pityriasis rosea. I called Joe and described what I saw. He came down, agreed, and we informed the intern and resident in the ER about what was going on. They briefly smiled as we told them that the patient could be discharged. I truly believe their smiles were because the patient could be discharged, one less worry for them.

Joe and I walked back to the on-call room to gather our coats and go home for the night. Before I said good night, I told Joe about the ER nurse recognizing me. He, of course, being the seasoned dermatologist that he was, knew immediately what I was talking about. “Steve,” he said to me, “Welcome to dermatology, my friend. It is a great specialty. You will get a solid education in our program. You will do good work. You will make good diagnoses and treat people well. Be kind and compassionate to everyone, and always remember you are in service to your colleagues. Always believe that you are a proud member of the medical team. Be grateful that you have found a home in medicine. Give away some of that gratefulness by sharing a proud, humble smile on your face with others.

People will know that they can talk to you and be happy to see you. And when you look in the mirror, you will see what they are seeing, a grateful guy who has been blessed with this great specialty.”

I have never forgotten Joe’s words that night and have never forgotten my smile. And to all of us who are privileged to be in dermatology, let us all wear that special smile of gratefulness and share it with others. Thanks Joe for being you, one smiling guy. J Dr. Steve Shama was practicing general dermatology for 30 years in Boston, Massachusetts until last year. He retired at that time but continues in a 20 year career as a professional speaker and enjoys speaking on topics such as, “Dealing With Difficult People and Looking Forward To It!” and “Rediscovering The Joys of Medicine and of Life.” He gives these talks at medical meetings, in private practices, and to general audiences and youth throughout the country. You can reach Dr. Shama at www. steveshama.com.

Workplace Excellence

Caring For Those You Struggle to Like

By Matthew Davidson, Ph.D.

D

anger! Unlikeable person ahead. May impair listening and thinking. This is how a helpful reminder might read for all of us dealing with other human beings at least, according to Harvard Medical School Professor, Dr. Jerome Groopman, in his book, How Doctors Think. Dr. Groopman candidly describes his struggles to provide care for a patient “with seemingly endless complaints whose voice sounded to me like a nail scratching a blackboard.” After enduring one such complaint, he quickly diagnosed the patient with minor gastric trouble, prescribed antacids, and ignored the patient’s subsequent complaints that the problem was getting worse. He ignored her complaints until he was later called to the ER to find the woman dying from a heart aneurism. The unforgettable lesson he took from this experience: “Emotion can blur a doctor’s ability to listen and think.” His caution seems accurate, but it is particularly striking when you consider that he isn’t referencing a high pressure, high trauma, triage experience where pressure, time, fatigue, and fear comingle in a powerful emotional state that blurs thinking. He’s talking about emotion of a much simpler, but seemingly much more common and profoundly human kind; he argues that when providers struggle to like a patient they are prone to cut the patient off, ignore his/her complaints, or foreclose on snap judgments just to avoid having to deal with the patient.

What a powerful nugget of truth to reflect upon: “Emotion impacts the ability to think and listen.” This is not simply true of the provider-patient relationship, but a truth of the human experience, both in our personal and professional relationships.

The stakes may be higher in patient care where the net

effect may indeed lead to death or dire consequences for the patient and the practice, but the dangerous impact on our ability to think and listen is no less real in our professional or personal relationships.

Unfortunately, human emotions are an unavoidable danger of working with humans. Whether it’s an emotional state (I’m sad or mad right now because of these circumstances) or an emotional trait (I am by temperament impatient, volatile, and anxious), emotions impact our ability to think and listen.

If this is an accurate and stable observation of the human condition, then what are we to do with it? For starters, like so many problems, the solution begins with awareness and acceptance.

When you’re tired, angry, sad, or mad and when you’re having a hard time relating to or at some level liking the person you’re interacting with (be it patient, colleague, child, or spouse), you must be aware of and accept the very real possibility that your ability to think and listen may be impaired. What next? I can be aware that the person across from me is making my blood boil and that I am having irrational desires to turn my ears off, to think awful thoughts about them, and to do anything whatsoever to remove myself from their presence, but awareness and acceptance won’t change the situation.

There may be times where avoidance is a feasible (and even desirable) response. In the case of patient care, it may be a prudent course of action to try and find somebody else to stand in when you realize that your negative thoughts about the person may be getting in the way. Finding someone with a fresh perspective and an openness to the person or situation can help ensure a positive result for the patient and

VOLUME 7 • NUMBER 1 • WINTER 2013 47

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.

DERMATOLOGY PA NEWS & NOTES

prevent you from spreading your negative affect from this patient to others like an office germ. But often avoidance isn’t possible; therefore awareness, acceptance, and change of action are required.

So what can we do when our emotions are triggered, and we want to ensure that we’re still thinking and listening? Abraham Lincoln famously said, “I do not like that man. I must get to know him better.” It reflects a profound human insight; we often don’t like those we don’t know, but when we get to know a person, even just a little, we can often find a connection or an insight to this person. Whereas negative emotions get in the way of thinking and listening, positive emotional connections tend to increase thinking and listening. Thus, getting to know a person is an essential building block for empathy or at least sympathy.

Empathy is the capacity to not only recognize the feelings of another person, but at some level to mutually experience the feeling. Whereas, sympathy is a feeling of care and understanding for the experience of another. So, for example, empathy sounds like, “I know it’s not easy to lose weight, stop smoking, exercise regularly, or suffer with pain because I personally have experience with this; I have been in or can put myself in your shoes.” Sympathy is a feeling of caring and understanding for the suffering of others.

Sympathy sounds like, “I acknowledge that you’re struggling and I feel badly for you and would like to comfort you.” Sometimes we experience empathy or sympathy naturally or spontaneously; sometimes we have to work to find that human connection.

In our Excellence & Ethics Tools we highlight two fundamentals for making a connection to practically anyone anywhere. Making a human connection takes courage and curiosity, especially if that person is new, different, difficult, or if on the surface we don’t feel or see a connection. Human beings are funny creatures. Making connections for most of us isn’t easy. We are often suspicious and territorial: do they look like me, dress like me, talk like me? Basically, if they’re like me, I’ll like them. It takes courage to break through our fears. It also takes curiosity. We have to be interested in the other person and in finding a connection. Not surprisingly, one of Stephen Covey’s 7 Habits of Highly Successful People is to “seek first to understand, then be understood.”

When we don’t like a person, it isn’t natural to want to work to get to know them. We would rather be Judge Judy than Larry King. The Judge Judy

approach: inquisitor not interviewer, judge and jury, case closed. We have decided what their story is. We have put them into a box that we do not intend to let them out of. The Larry King approach: relaxed, open, JOB#: 08031A PROOF#: 1 comfortable, interested. The show was named for him CLIENT: Galderma but it wasn’t about him; it was aboutDESC: whomever A-size JournalAd he was Color: 4C interviewing. He asked simple questions and let the AD: NTomasweska person share. He was interested. He didn’t TRAFFIC: AGriffin presume OPERATOR: rs to know them, put them into a box, or answer the GALLEY#: 1 DATE: 6/24/10 - 3:58 PM questions for his guests. So, when emotions are CREATED: 6/15/10 - 11:19 AM running high, when you’re struggling to like a person, FONTS: MetaPlusBold- Italic, Helvetica NeueJudge LT Std 67 Medium model behavior similar to Larry King not Judy.

Condensed, Helvetica Neue LT Std This is no doubt a case of easier said than done.

47 Light Condensed, Helvetica 47 Light Condensed Like any habit, we have to practiceNeue it LTtoStdbecome good Oblique, ITC Avant Garde Gothic Std Medium,we’re ITC Avanttired Garde or at it. We have to work harder at it when Gothic Std Bold Condensed, ITC under pressure, angry or frustrated.

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Gothic Std Demi Condensed Remember also that it takes curiosity: leads IMAGES: curiosity Restoraderm_RRR_4C. Icon.eps, to questions; questions literally get eps, our08031A mind thinking NationaleczemaAssoc_4C. and engages our listening skills; eps, questions help us Galderma_Committed_4C. eps, 08031_A_JA_restoraderm_ to move from surface to substance.

Courage and lines_fn.tif curiosity leads to thinking and listening COLORS: C=98preventing M=24 Y=1 K=3, M=88 Y=0 K=5, C=56 M=0 us from being close-minded - C=100 intellectually and Y=100 K=0 NOTES: emotionally. J DOC PATH:

Mac:Users:somrakr:Desktop:GAL_ REFERENCE: CET_Q08031A_JA_D01.indd SIZE: 11.25” X 16.25” Jerome G. How doctors think. Boston: HoughtonDOC Mifflin; 2007:24-25.

PRINT SCALE: 100%

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. 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.

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Cosmos Communications 718

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48 Journal of Dermatology for Physician Assistants

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VOLUME 7 • NUMBER 1 • WINTER 2013 49

Supervising Physician CORNER The Camp Horizon Experience

An interview with Howard Pride, FAAD, MD Camp Horizon, a camp affiliated with the AAD’s Camp Discovery program, offers children with chronic dermatologic conditions the opportunity to experience summer camp and support each other in a setting of acceptance, love, and fun. Located in Millville, Pennsylvania, Camp Horizon was established in 1994. In the summer of 1995, the Camp Horizon hosted its first campers with 18 children and a staff of about 15 volunteers for a four-day camp experience. Since that time, the camp has expanded to a full week and has grown to over 80 campers and a staff of more than 65 volunteers. Dr. Howard Pride was part of the team that helped found the camp in 1994 and continues to serve as the Director of Camp Horizon.

DERMATOLOGY PA NEWS & NOTES

We had an opportunity to interview Dr. Pride and learn more about his experience with Camp Horizon as well as how PAs who are interested in volunteering can get involved.

JDPA: When did you decide to specialize in pediatric dermatology?

Dr. Pride: When I did my training, my residency was in internal medicine and pediatrics. I found dermatology to be fun with very visual problems that were focused and treatable. It really is a fascinating field with the complex medical problems, surgeries, and pathologies.

JDPA: How did you become involved with Camp Horizon?

Dr. Pride: In 1993 Dr. Linda Rabinowitz, the medical director of the AAD’s first summer camp, spoke at the summer Society for Pediatric Dermatology conference about Camp Knutson in Minnesota. In the summer of 1994, I volunteered as a dermatologist at Camp Knutson.

The same summer that I went to Minnesota, the Camp Victory campsite in Millville, Pennsylvania became available; it was a local camp that was created for those needing medical staff on hand. I presented my experience at Camp Knutson and the idea for creating a similar camp at the newly available Camp Victory campsite to my whole department at Geisinger Medical Center and there was a ground swell of support. Camp Horizon came into being in August 1995. There were eighteen campers that first year, and it was a huge success. By 1996, there were close to fifty campers.

JDPA: What first inspired/motivated you to begin Camp Horizon?

Dr. Pride: There wasn’t just one person who championed the idea. It was truly a group effort comprised of physicians, nursing staff, and administrative staff.

JDPA: What has been your proudest accomplishment(s) since Camp Horizon’s inception?

Dr. Pride: We started with a broad base, lots of energy, ideas, and a division of labor. Without this type of broad base, it would have been easy to become frozen into inaction and think about things that could go wrong instead of focusing on what could go right. There is so 50 Journal of Dermatology for Physician Assistants

much enthusiasm amongst those behind the scenes. The first camp session we had was more like a long weekend; campers came from Thursday through Sunday. Those campers participating at that point were all within driveable distances. The following year is when we saw a major shift. The AAD camp in Minnesota had an overflow of campers, so we had approximately eight campers flown in by the AAD to attend our camp. We really started our relationship with the AAD in 1996 by having them pay for flights and scholarships for campers.

JDPA: Do you have a favorite or most memorable camp experience?

Dr. Pride: There are so many. If I had to choose, I would say when kids do something for the first time in their lives at camp, which happens quite often. It can be flying on a plane for the first time to get to camp, participating in archery, or even being away from home for the first time.

JDPA: What do you think campers look forward to most?

Dr. Pride: Campers look forward to being around others who are dealing with skin conditions and to being accepted. Many campers have devastating skin conditions that are underappreciated, even amongst dermatologists.

We had one camper who had epidermolysis bullosa and really wanted to make it up the climbing wall. The group worked together to make this happen by fashioning a harness to help reduce the friction so the camper could comfortably make it up the wall.

JDPA: What are your goals/vision for Camp Horizon in the years to come?

Dr. Pride: I would like to see continued progression towards more global outreach verses just local; I would love to see more kids participate in the camp experience.

This type of expansion could include smaller camps that serve their local communities rather than one larger camp.

This has started to some extent with new Camp Discovery

camps in Connecticut, Texas, and Washington state. It would be good to expand to other places with populations that need such camps. While it is not required, it is helpful to have a dermatology physician who is an AAD member to begin the introduction of new camps. Groups can step forward and present a proposed camp location and staffing.

JDPA: Do you have many PAs volunteer at Camp Horizon?

Dr. Pride: PAs are involved in many different roles at the camp. Having a medical background does not mean that you will be volunteering in a medical capacity. The ideal volunteer is someone who can spend the entire week at camp and is willing to do whatever needs to be done without any strings attached. The medical staff doesn’t turn over much, and our medical director and nurses come back on a regular basis.

Volunteers are a vital part of Camp Horizon. Each year, over 1,000 wonderful people volunteer their time and talents in many different ways…from being a counselor, painting cabins, baking pies, and building shelves. The volunteer opportunities are many and varied. Volunteering at Camp Horizon makes a real difference in the lives of our special campers! Please call 570-271-8050 or emailhpride@ geisinger.edu to find out how you can help.

For additional information about Camp Horizon please visit www.campdiscovery.org Howard Pride, FAAD, MD, completed medical school at the University of Vermont, College of Medicine and completed his dermatology residency with Geisinger Medical Center in 1993.

He has been practicing pediatric dermatology for twenty years and is currently practicing at Geisinger Medical Center in Danville, PA. Dr. Pride has been involved with Camp Horizon since its inception in 1994 and is currently serving as the camp’s Director.

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.

VOLUME 7 • NUMBER 1 • WINTER 2013 51

DERMATOLOGY PA NEWS & NOTES

JDPA: Any suggestions or advice for PAs who are considering volunteering or may want to refer patients to Camp Horizon?

Dr. Pride: Those wishing to volunteer should get their applications in early. We tend to get far more applications than the actual number of volunteer spots we have available, which is a good problem to have. PAs who are referring patients should keep in mind that children do not have to have devastating skin conditions in order to participate in the camp experience. For volunteers and campers alike, this experience can be life changing. J

Interested in volunteering at the camp?

Dermatology in ART

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 explores 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 know of a piece of art that you would like to share with the JDPA readers, please contact us at editor@jdpa.org.

This depiction comes from the Italian philosopher Giovanni Battista della Porta’s (1538-1615) historic text De Humana Physiognomonia, published in 1586.

He was a proponent of physiognomy, a field that explores a relationship between an individual’s facial features and his/her intellect and temperament. In this artwork we can see the similarities between the human and the lion. Battista della Porta would likely read into the thickened furrows of the person’s brows and predict personality traits; however, the dermatology professional recognizes that the animalistic appearance may not be due to personality but to skin pathology.

Leonine facies tend to be a relatively late finding, with a less than optimistic prognosis; the differential includes mycosis fungoides, lepromatous leprosy, Paget’s disease of bone, and actinic reticuloid.

It is easy to disregard the field of physiognomy as a peculiarity of ancient medicine. However, the similar discipline of phrenology, in which an individual’s personality is linked to the shape of his/her skull, was practiced as recently as the early twentieth century. 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 Journal of Dermatology for Physician Assistants

52 Journal of Dermatology for Physician Assistants

Journal of Dermatology for Physician Assistants INFORMATION FOR AUTHORS – The 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 (250500 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).

VOLUME 7 • NUMBER 1 • WINTER 2013 53

PROFESSIONAL OPPORTUNITIES AND DEVELOPMENT

A DV ER T ISER INDE X Galderma – Metrogel 1%...................... Pages 2, 3 Ranbaxy – Kenalog Spray.......................Pages 7, 8 Promius – Cloderm............................Pages 11, 12 Ferndale – Heliocare..................................Page 28 Ferndale – DerMend.................................Page 29 Valeant – Xerese................................ Pages 35 - 36 Galderma – Cetaphil Restoraderm.............Page 49 Bayer HealthCare – Finacea...............Pages 55, 56 For more information on advertising opportunities in the JDPA, please log on to www.jdpa.org

ATTENTION PATIENTS, CAREGIVERS, AND MEDICAL PROFESSINALS:

TIONS A L U T A R G N CO bers! m e M t n e d Stu

You’re invited to the International Pemphigus & Pemphigoid Foundation’s

PEMPHIGUS & PEMPHIGOID 16th Annual Patient Conference!

APRIL 26-28, 2013 San Francisco, CA at the Hilton SFO Bayfront in Burlingame, CA

If you are graduating within your paid student membership year, the SDPA would like to offer you a gift by upgrading you to a full membership for the remainder of the year.*

FEATURING BULLOUS DISEASE EXPERT talks on skin, dental, and psychological issues!

*category of membership will be dependent on employment.

Early Bird Registration is just $150 per person. Save BIG when you come as a group - only $100 per person! Fee includes all meeting material, Friday night Reception, breakfast Saturday and Sunday, Saturday lunch, and more!

FOR MORE INFORMATION OR TO REGISTER VISIT

To apply, please send proof of graduation to sdpa@dermpa.org.

www.pemphigus.org/2013sf or call (855) 4-PEMPHIGUS

54 Journal of Dermatology for Physician Assistants Grad_Promo.indd 1

1/24/13 1:56 PM

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

VOLUME 7 • NUMBER 1 • WINTER 2013 55

CONTINUING TO SUPPORT YOUR PATIENTS WITH COPAY SAVINGS

For mild to moderate rosacea

The first and only gel approved to treat all 3 symptoms INFLAMMAT

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f papules and pustules

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.

3 Symptoms, 1 Medicine

for clearer-looking skin • 61% of patients achieved treatment success in 12-week clinical studies1

INDICATION & USAGE

FINACEA (azelaic acid) 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. ®

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%), pruritus (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 adjacent page for Brief Summary of full Prescribing Information.

Model used for illustrative purposes only.

Reference: 1. FINACEA [package insert]. Morristown, NJ: Intendis, Inc; 2010.

© 2012 Bayer HealthCare Inc. Bayer and the Bayer Cross are registered trademarks of Bayer. FINACEA is a registered trademark of Intendis GmbH. All rights reserved. FIN-10-0003-12 November 2012 Printed in USA.

56 Journal of Dermatology for Physician Assistants