JDPA Fall 2013 by Angela Simiele

DPA J

V o l u m e 7 • n u m b e r 4 • f a l l 2 0 1 3 • www.jdpa.org

Journal of Dermatology for Physician Assistants

dermatology Pa news & notes

Certification Review 14 __________________________________

clinical dermatology Drugs in Dermatology 28 __________________________________

Surgical dermatology Dermatology Case Report

_________________________________

Cosmetic dermatology Journal Club

_____________________________ professional development Judicial and Ethical Affairs

›› Earn CME credit with this issue CME Overview of Noninfectious Vuvlar Dematoses in Adult Females 18

Official Journal of the Society of Dermatology Physician Assistants

Volume 7 • number 4 • FALL 2013

Locoid is the MOST PRESCRIBED mid-potency steroid brand*

DUAL ACTION ATOPIC DERMATITIS RELIEF

Locoid Lotion offers the strength of a mid-potency steroid with essential lipids to replenish and restore the skin barrier. Locoid Lotion (hydrocortisone butyrate 0.1%) is indicated for the topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older. Safety and effectiveness in pediatric patients below 3 months of age have not been established. Reversible HPA axis suppression may occur, with the potential for corticosteroid insufficiency. Consider periodic evaluations for HPA axis suppression if applied to large surface areas or used under occlusion. Systemic effects of topical corticosteroids may also include manifestations of Cushingâ&#x20AC;&#x2122;s syndrome, hyperglycemia, and glucosuria. Pediatric patients may be more susceptible to systemic toxicity due to their large skin surface-to-body mass ratios. Initiate appropriate therapy if concomitant skin infection develops. Discontinue use if irritation develops. Please see Brief Summary of Prescribing Information. www.locoidlotion.com Locoid is a registered trademark of Astellas Pharma Europe BV licensed to Onset Dermatologics, LLC. *IMS National Prescription Audit August 2013 LOC AD JDPA 11/13

Locoid® Lotion (hydrocortisone butyrate 0.1%) Rx Only BRIEF SUMMARY

1 INDICATIONS AND USAGE Locoid Lotion is a corticosteroid indicated for the topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older.

4 CONTRAINDICATIONS None.

clinical trials involving pediatric subjects 3 months to 18 years of age and adult subjects 18 years and older with mild to moderate atopic dermatitis. Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in clinical practice. Adverse reactions shown in the tables below include those for which there is some basis to believe there is a causal relationship to Locoid Lotion. Although the rates of application site reactions in the vehicle group were greater than those in the Locoid group in both studies, these rates are included in the tables (Table 1 and Table 2) because skin irritation is a known adverse reaction of topical corticosteroids. TABLE 1. Frequency of adverse reactions in pediatric subjects with mild to moderate atopic dermatitis

5 WARNINGS AND PRECAUTIONS 5.1 Hypothalamic-pituitary-adrenal (HPA) Axis Suppression Systemic effects of topical corticosteroids may include reversible HPA axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria. Studies conducted in pediatric subjects demonstrated reversible HPA axis suppression after use of Locoid Lotion. Pediatric patients may be more susceptible than adults to systemic toxicity from equivalent doses of Locoid Lotion due to their larger skin surface-to-body-mass ratios [see Use in Specific Populations (8.4)]. Patients applying a topical corticosteroid to a large surface area or to areas under occlusion should be considered for periodic evaluation of the HPA axis. This may be done by using cosyntropin (ACTH1-24) stimulation testing (CST). If HPA axis suppression is noted, the frequency of application should be reduced or the drug should be withdrawn, or a less potent corticosteroid should be substituted. Signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids. 5.2 Concomitant Skin Infections If skin infections are present or develop, an appropriate antifungal, antibacterial or antiviral agent should be used. If a favorable response does not occur promptly, use of Locoid Lotion should be discontinued until the infection has been adequately controlled. 5.3 Skin Irritation Locoid Lotion may cause local skin adverse reactions [see Adverse Reactions (6)]. If irritation develops, Locoid Lotion should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noticing a clinical exacerbation. Such an observation should be corroborated with appropriate patch testing.

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: • HPA axis suppression. This has been observed in pediatric subjects using Locoid Lotion [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)] • Concomitant skin infections [see Warnings and Precautions (5.2)] • Skin irritation [see Warnings and Precautions (5.3)] 6.1 Clinical Trials Experience The safety data derived from Locoid Lotion clinical trials reflect exposure to Locoid Lotion twice daily for up to four weeks in separate

Locoid Lotion (n=139) n (%)

Vehicle (n=145) n (%)

Application site reactions, including application site burning, pruritus, dermatitis, erythema, eczema, inflammation, or irritation

2 (1)

20 (14)

Infantile acne

1 (1)

0 (0)

Skin depigmentation

1 (1)

0 (0)

17 PATIENT COUNSELING INFORMATION

TABLE 2. Frequency of adverse reactions in adult subjects with mild to moderate atopic dermatitis

Application site reactions, including application site burning, dermatitis, eczema, erythema, or pruritus

There are no adequate and well-controlled studies in pregnant women. Therefore, Locoid Lotion should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 8.3 Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Locoid Lotion is administered to a nursing woman. 8.4 Pediatric Use Safety and efficacy in pediatric patients below 3 months of age have not been established. Because of higher skin surface-to-body-mass ratios, pediatric patients are at a greater risk than adults of HPA axis suppression when they are treated with topical corticosteroids. They are therefore also at a greater risk of glucocorticosteroid insufficiency after withdrawal of treatment and of Cushing’s syndrome while on treatment. 8.5 Geriatric Use Clinical studies of Locoid Lotion did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Locoid Lotion (n=151) n (%)

Vehicle (n=150) n (%)

5 (3)

7 (5)

Patients using Locoid Lotion should receive the following information and instructions: • Apply a thin layer to the affected skin two times daily. • Rub in gently. • Discontinue Locoid Lotion when control is achieved. • Do not use for longer than 4 weeks. • Avoid contact with the eyes. • Do not bandage, otherwise cover, or wrap the affected skin area so as to be occlusive unless directed by your physician. • Do not use Locoid Lotion in the diaper area, as diapers or plastic pants may constitute occlusive dressings. • Do not use Locoid Lotion on the face, underarms, or groin areas unless directed by your physician. • If no improvement is seen within 2 weeks, contact your physician. • Do not use other corticosteroid-containing products while using Locoid Lotion without first consulting your physician.

The following additional local adverse reactions have been reported infrequently with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions included: irritation, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact Manufactured for: dermatitis, secondary infection, skin atrophy, striae, miliaria and telangiectasia.

7 DRUG INTERACTIONS There are no known drug interactions with Locoid Lotion.

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category C. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.

Onset Dermatologics, LLC Cumberland, RI 02864 by Ferndale Laboratories, Inc. Ferndale, MI 48220 www.locoidlotion.com Locoid® is a registered trademark of Astellas Pharma Europe B.V. licensed to Onset Dermatologics, LLC BS-LOL Rev 09/12

locoid_jdpa_half horizontal.indd 1

ATTEND & SCORE A WILD DISCOUNT FOR NEXT SUMMER’S CONFERENCE*

*FOR ATLANTA ATTENDEES ONLY MUST REGISTER ONSITE IN ATLANTA

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ATLANTA FALL 2013 CONFERENCE

Intercontinental Buckhead November 13-16, 2013

For more information visit dermpa.org

Volume 7 • number 4 • FALL 2013

Journal of Dermatology for Physician Assistants

EDITORIAL BOARD

Travis Hayden, MPAS, PA-C, Editor in Chief Joe R. Monroe, MPAS, PA 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, PhD, 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, PhD, MD Alan Menter, MD

DEPARTMENT EDITORS

Clinical Department Editors Susan E. King-Barry, MPAS, PA-C Karen Graham, MPAS, PA-C Dermoscopy Editor John Burns, MSPA, 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 Jennifer Winter, PA-C PRESIDENT-ELECT Vicki Roberts, MPAS, PA-C IMMEDIATE PAST PRESIDENT John Notabartolo, MPAS, PA-C VICE PRESIDENT Jacki Kment, MPAS, PA-C SECRETARY / TREASURER Joleen Volz, MPAS, PA-C DIRECTORS AT LARGE Matthew Brunner, MHS, PA-C Jennifer Conner, MPAS, PA-C Jang Mi Johnson, PA-C Scott B. Ahrndt, MPAS, PA-C

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 AAPAâ&#x20AC;&#x2122;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. 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 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 4, Fall 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. ÂŠ 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

Journal of Dermatology for Physician Assistants

Editor’s Message “Coming together is a beginning; keeping together is progress; working together is success.” - Henry Ford

or the past nearly twenty years, the SDPA has proven its ability to come together, work hard, and persist even in the face of challenges. During this journey, our Society has promoted the importance and value of the role of physician assistants within the field of dermatology. We have seen great progress with more and more PAs being welcomed and utilized by dermatologists within our field as well as a growing acceptance of our presence at the annual AAD educational conferences. This acceptance was not easily earned. Our Society’s ability to stay unified and work towards goals such as being allowed to attend the AAD Annual Meetings with our supervising physicians has paved the way for this most recent achievement. You will find within the pages of this issue of the JDPA an advertisement for the upcoming 72nd AAD Annual Meeting in Denver, Colorado. To my knowledge, this is the first time our membership has ever been openly invited and encouraged by the AAD to attend. For those new to our profession, this may not seem to be anything extraordinary; however, to those who have worked hard over the years to forge a place for our members at the AAD Annual Meetings, this is a huge milestone. We have reached this milestone together as a unified Society. I truly believe it speaks to the notion of working together as being a definition of success. Please join me in applauding our SDPA leaders, both past and present, for the years of hard work they have put into promoting our profession. We came together, we stayed together, and now we have an invitation encouraging us to be educated along with our supervising physicians at the AAD Annual Meetings. As a Society and with our supervising physicians, we will continue to work together and achieve great success in improving patient care. J

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

Volume 7 • number 4 • FALL 2013

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

18 Overview of Noninfectious Vuvlar Dematoses in Adult Females By Jennifer McCarren, MPA, PA-C and Frances T. Florentino, MD

›› CME 10 Derm PA News & Notes – part one • Certification Review • SDPA State Affiliates • Student Corner

18 Clinical Dermatology

Departments

04 Editorial Board 05 Editor’s Message 09 SDPA News & Current Affairs 10 Dermatology Market Watch 24 From The Patient’s Perspective 27 Dermatopathology Q & A 29 Clinical Snapshots 30 Surgical Wisdom 43 Cosmetic Pearls 46 Outside & Inside the 9 to 5… 48 Notes from your Office Manager 55 The Difference We Make 60 Dermatology in Art 61 JDPA Information for Authors 62 Professional Opportunities and Development

• CME Article – Overview of Noninfectious Vuvlar Dematoses in Adult Females • Drugs in Dermatology

30 Surgical Dermatology • Dermatology Case Report

42 Cosmetic Dermatology • Journal Club: Practice Changing Articles for

Dermatology PAs

44 Professional Development • Dermatology Billing & Coding • Judicial and Ethical Affairs

54 Derm PA News & Notes – part two • From the Desk of… • Workplace Excellence • Supervising Physician Corner

On the Cover: This image is the property of the ASCCP & ISSVD Image Data Bank and is reprinted with their permission. ©American Society for Colposcopy and Cervical Pathology 2012. No copies of the image shall be made without the prior written consent of ASCCP.

Go Green - Read Online 6

Journal of Dermatology for Physician Assistants

dermpa.org

your patients’

problems are

NO-TOUCH RELIEF The Only Mid-Potency Topical Steroid Aerosol Spray 1

INDICATIONS AND USAGE: Kenalog® Spray (Triamcinolone Acetonide Topical Aerosol, USP) is indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. CONTRAINDICATIONS: Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations. For external use only. Please see full Prescribing Information on reverse and also at KenalogSpray.com. REFERENCE: 1. Fowler J, Fowler L. Physician and patient assessment of triamcinolone acetonide spray for steroid-responsive dermatoses. J Clin Aesthet Dermatol. 2010;3:27-31. Kenalog® is a licensed trademark of Bristol-Myers Squibb Company. KNGJI1 09/13

Volume 7 • number 4 • FALL 2013

KENALOG® SPRAY

Rx only

Triamcinolone Acetonide Topical Aerosol, USP (0.147 mg/g) For dermatologic use only Not for ophthalmic use

DESCRIPTION The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone acetonide is designated chemically as 9-fluoro-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17- acetal with acetone. The structural formula is:

C24H31FO6, MW 434.50 A two-second application, which covers an area approximately the size of the hand, delivers an amount of triamcinolone acetonide not exceeding 0.2 mg. 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. 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. 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 Kenalog Spray (Triamcinolone Acetonide Topical Aerosol, USP) is indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. CONTRAINDICATIONS Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations. 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 any 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, and for impairment of thermal homeostasis. If HPA axis suppression or elevation of the body temperature occurs, an attempt should be made to withdraw the drug, to reduce the frequency of application, substitute a less potent steroid, or use a sequential approach. Recovery of HPA axis function and thermal homeostasis are generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see PRECAUTIONS, Pediatric Use). If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled. Information for the Patient Patients using Kenalog Spray 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 and inhalation of the spray. 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. 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. 6. Do not use Kenalog Spray on the underarms or groin areas unless directed by your physician. 7. If no improvement is seen within 2 weeks, contact your physician. 8. Do not use other corticosteroid-containing products while using Kenalog Spray without first

consulting your physician. 9. Kenalog Spray is flammable. Avoid heat, flames or smoking when applying Kenalog Spray. Laboratory Tests A urinary free cortisol test and ACTH stimulation test may be helpful in evaluating HPA axis suppression. Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. Studies to determine mutagenicity with prednisolone and hydrocortisone showed negative results. Pregnancy: Teratogenic Effects 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 wellcontrolled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time. Nursing Mothers It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman. Pediatric Use Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface area to body weight ratio. 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 (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, and miliaria. OVERDOSAGE Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS, General). DOSAGE AND ADMINISTRATION Directions for use of the spray can are provided on the label. The preparation may be applied to any area of the body, but when it is sprayed about the face, care should be taken to see that the eyes are covered, and that inhalation of the spray is avoided. Spray is flammable; avoid heat, flame or smoking when using this product. Three or four applications daily of Kenalog Spray (Triamcinolone Acetonide Topical Aerosol) are generally adequate. HOW SUPPLIED Kenalog Spray (Triamcinolone Acetonide Topical Aerosol, USP) 63 g (NDC 10631-093-62) aerosol can. 100 g (NDC 10631-093-07) aerosol can. Storage and Handling Store at room temperature; avoid excessive heat. Contents under pressure; do not puncture or incinerate. Keep out of reach of children. To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. RANBAXY Jacksonville, FL 32257 USA

Revised August 2011

©Ranbaxy Pharmaceuticals, Inc.

Journal of Dermatology for Physician Assistants

Printed in the USA

DERM-3567-1212

FROM THE SDPA

News & Current Affairs

CALENDAR OF EVENTS 2013 NOVEMBER SDPA 11th Annual Fall Conference November 13 - 16, 2013 InterContinental Buckhead Atlanta, GA

2014

march 72nd AAD Annual Academy Meeting March 21 - 25, 2014 Denver, CO

MAY/JUNE SDPA Summer Dermatology Conference May 28 – June 1, 2014 Marriott Downtown Indianapolis, IN NOVEMBER SDPA 12th Annual Fall Conference November 12 - 15, 2014 Manchester Grand Hyatt San Diego, CA

eriodically the SDPA Board of Directors is asked to respond to an article that contains inaccurate or incomplete information that is unfavorable toward PAs. Usually it is brought to our attention by a SDPA member who is understandably upset about the way PAs have been portrayed. We take the role of education seriously whether for the public or other health care providers. When it comes to the response, how something is said is as important as what is said. We strive to be professional and rational in our responses; this can be difficult to do when frustrated or upset. I generally write the response and then sit on it for a day or two before rereading it to see if it could be said better. Recently an article was published by Health Magazine titled, “Are You Getting a Good Skin Cancer Check?” This article had generally great information except for the part where the author related the AAD’s stance that any new patients should be seen by a dermatologist and not a “nonphysician.” The author did not go so far as to say patients should not see a PA or NP at all. Nevertheless, we know that most of us see new patients and have the experience to do so. As President of the SDPA, I responded and chose to focus on those points. There were other issues that I could have addressed such as the high percentage of providers who do not examine the skin of the genitalia or feet. Those providers include dermatologists. The article published by Health Magazine can be found at www.health. com/health/article/0,,20723697,00.html. I encourage all SDPA members to respond with a thoughtful letter to the editor via a link at the bottom of the page that the article is featured on. Those of you who wish to see more about my response, please visit dermcast.tv at www.dermcast.tv/ sdpa-letter-editor-responds-healthcoms-%E2%80%9Care-you-gettinggood-skin-cancer-check%E2%80%9D. Please check back periodically on dermcast.tv as I will be sure to share any responses or feedback that we may receive from the Health Magazine staff. J

Jennifer Winter, PA-C

SDPA President, Diplomate

Volume 7 • number 4 • FALL 2013

Dermatology PA news & notes

Dermatology Market Watch Galderma Receives FDA Approval of Mirvaso®: The First and Only FDA-Approved Topical Treatment Specifically Developed and Indicated for the Facial Erythema of Rosacea Galderma Laboratories, L.P. has announced that the U.S. Food and Drug Administration (FDA) has approved Mirvaso® (brimonidine) topical gel, 0.33%* for the topical treatment of the facial erythema (redness) of rosacea in adults 18 years of age or older. Applied once daily, Mirvaso works quickly to reduce the redness of rosacea and lasts up to 12 hours. The approval of Mirvaso was based on data collected from more than 550 patients enrolled in two phase 3 clinical studies of one-month duration. The results from both studies showed that adults who used Mirvaso demonstrated significantly greater improvement in the facial redness of rosacea than vehicle gel. In addition, a long-term study in 276 subjects who used Mirvaso for up to 12-months was also conducted. Mirvaso is a topical gel that may work by constricting the dilated facial blood vessels to reduce the redness of rosacea. Mirvaso should be applied in a pea-sized amount, once daily to each of the five regions of the face: the forehead, chin, nose and each cheek. Mirvaso is a well-tolerated alpha-2 adrenergic agonist indicated for the topical treatment of persistent (nontransient) facial erythema of rosacea in adults 18 years of age or older. In clinical trials, the most common adverse reactions (≥1%) included erythema, flushing, skin-burning sensation and contact dermatitis. In the long-term study, the most common adverse events (≥ 4% of subjects) included flushing (10%), erythema (8%), rosacea (5%), nasopharyngitis (5%), skin burning sensation (4%), increased intraocular pressure (4%), and headache (4%). *Each gram of gel contains 5 mg of brimonidine tartrate, equivalent to 3.3 mg of brimonidine free base 10 Journal of Dermatology for Physician Assistants

CLODERM CREAM

Not a cookie-cutter corticosteroid. Unique clocortolone pivalate molecule enhances lipid solubility.1,2

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. Siddiqui O, Roberts MS, Polack AE. Percutaneous absorption of steroids: relative contributions of epidermal penetration and dermal clearance. J Pharmacokinet Biopharm. 1989;17(4):405-424. 2. Royal Society of Chemistry website. Chem Spider, the free chemical database. Available at http://www.chemspider.com. Accessed June 6, 2011. Cloderm® is a trademark of Coria Laboratories, Ltd. ©2013 Promius Pharma, LLC. All rights reserved.

CDM-0413-071

Volume 7 • number 4 • FALL 2013 11

RxOnly

5. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings. Laboratory Tests: The following tests may be helpful in evaluating the HPA axis suppression: Urinary free cortisol test ACTH stimulation test

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

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.

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.

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.

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. 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 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. Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity. (See PRECAUTIONS-Pediatric Use). If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled. Information for the Patient: Patients using topical corticosteroids should receive the following information and instructions: 1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes. 2. Patients should be advised not to use this medication for any disorder other than for which it was prescribed.

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

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

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

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.

12 Journal of Dermatology for Physician Assistants

Issued 0711

004158

Dermatology Market Watch ...continued Managing the Frustrations of Nail Dystrophy By Risha Bellomo, MPAS, PA-C

misshapen, damaged, infected, or discolored nail unit that may affect fingernails, toenails, or both. Presentations of nail dystrophy include onycholysis, onychorrhexis, onychoschizia, and onychauxis.1 When a patient presents with onychodystrophy, it is both frustrating for the patient and the healthcare provider. In the past, there have been limited therapies for onychodystrophy and little hope of improving the disrupted nail plate. Recently the FDA has approved the use of topical poly-ureaurethane, 16% (Nuvail, Innocutis) for dystrophic nails (i.e., nails affected by trauma, onychomycosis, psoriasis, brittle nails, and lichen planus). This topical nail solution protects the nail from further insult including dermatophyte and/or environmental factors and manages the signs of dystrophy.2,3 Topical poly-ureaurethane, 16% manages the signs and symptoms of nail dystrophy for intact or damaged nails by coating and adhering to the nail surface preventing direct abrasion and friction on the nail plate while providing protection against adverse effects of moisture. This ideal therapy for onychodystrophy allows for a strong adherence to the nail plate and penetration of the intercellular space of the nail surface allowing a flexible plus strong mechanical support to the nail plate. Topical poly-ureaurethane, 16% allows for adequate oxygen transfer across the nail plate and waterproofing to deter drying, which is necessary for proper nail growth. A healthy nail must have a coherent nail plate, proper organization of keratin filaments, and optimal moisture balance. Nails are much more permeable to water than skin, and the wetting/drying effect on nails is a critical issue.4 The most common nail disorder seen in clinical practice is onychomycosis, accounting for more than 50% of all nail disorders. Dr. Bradley Bakotic stated, “The first event in the development of the majority of onychomycosis cases is the induction of pathologic nail bed keratinization. This breaks down the integrity of the nail unit, providing a portal of entry for the infectious elements…In rethinking our approach to the management of nail unit dystrophy, we have to accept that there might be and usually is more going on within a dystrophic nail unit than simply a fungal infection.”1 Dr. Bakotic made a good point, and for years many of us have been guilty of just treating the infection and not the dystrophy. Our patients are most concerned about the appearance of their nails, and if we exclude treatment for onychodystrophy, we are decreasing patient satisfaction and outcomes.

Figure Baseline

3 months using Nuvail

12 months (6 mos. after disconuation of therapy)

In clinical studies where poly-ureaurethane, 16% was used to address nail dystrophy caused by dermatophyte infection, poly-ureaurethane, 16% demonstrated an overall 60% improvement of the appearance of the nail; characteristics assessed were color, nail involvement, onycholysis, thickness of the nail plate, and subungual hyperkeratosis. In addition to the appearance of the nail there were also mycological cure rates with monotherapy poly-ureaurethane, 16%. In just three months, there was a 36% mycological cure rate, and by six months there was a 62% mycological cure rate, looking at both KOH as well as culture results. This study gives insight into the dystrophic nail in onychomycosis and how it may be a pre-curser and portal for entry of the infection. In no way is polyureaureathane, 16% an anti-fungal agent, but this does prove that by treating the underlying dystrophy we improve not only the health of the nail but also improve cure rates associated with dermatophyte infection.2,3 Traditional treatment options for onychomycosis such as topical and oral antifungal medication have been successful in many cases, but there seems to be a high recurrence rate of infection. In a study presented at the 70th Annual Meeting of the American Academy of Dermatology (AAD), it was found that up to 47% of patients had a relapse of onychomycosis after long-term oral therapy.5 These treatments may in fact rid the nail of the causative agent, but the nail dystrophy remains if left untreated, which may aid in the high recurrence rates since a portal of entry still remains. A twelve-month study was performed to Volume 7 • number 4 • FALL 2013 13

DERmatology pa news & notes

Onychodystrophy manifests as a poorly formed,

REFERENCES:

1. Bakotic, B. A guide to detecting nail pathology. www.podiatry.com: 19 (Sept 2006). Continuing Education Course 145. 2. Tracey C. Vlahovic, DPM, Associate Professor and J. Stanley and Pearl Landau Faculty Fellow. The use of poly-ureaurethane, 16% for dystrophic nails. Temple University School of Podiatric Medicine. 3. Vlahovic TC and Schleicher SM. “Nail Disorders” in Skin Disease of the Lower Extremities: A Photographic Guide, HMP Communications, 2012, pp 19-20. 4. Nuvail Version III Speaker Slide deck (2013). 5. Schierszer, John. Study Suggests High Relapse Rate of Dermatophyte Toenail Onychomycosis After Long-Term Oral Therapy: Presented at AAD. Abstract 5643. Source: DGNews. March 21, 2012. 6. Santamaria, Greg and Vlahovic, Tracey. Clinical Evaluation of Topical Poly UreaUrethane, 16% Polymer in Dystrophic Nails: A Review. APMA Poster. 2013. Risha Bellomo, MPAS, PA-C has practiced dermatology for 13 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 8 years and is also the founder and CEO of Bellomo Consulting, Inc. and BCI Management & Communications, LLC. Risha's passion is educating and creating awareness to healthcare providers and the community. Mrs. Bellomo is a paid consultant and speaker for Innocutis Dermatology.

Certification Review

All Those Things Inside the Skin You Might Have Forgotten By James A. Van Rhee, MS, PA-C

Are you recertifying soon? Start your board review early. Each issue of the JDPA features one board question accompanied by a brief explanation of the answer along with any pertinent test taking tips. Best of luck! QUESTION: A two month-old male presents with a history of vomiting. The mother states the child has had projectile vomiting after eating for the past three weeks. She states the child is hungry immediately after the vomiting episodes. Poor weight gain has also been noted over this time period. On physical examination, vital signs are normal and an abdominal exam reveals a 2cm, non-tender, oval mass in the epigastric region. Which of the following diagnostic test results would most likely be noted in this patient? A. Presence of ectopic acid-secreting cells on 99mTe pertechnetate scan B. Coiled spring appearance of the intestine on contrast enema C. Hypokalemic, hypochloremic metabolic alkalosis D. Segmental narrowing of the ileum EXPLANATION: Pyloric stenosis presents in infants during the first two to three months of life. It is more common in males and is an important cause of gastric outlet obstruction. The typical presentation is projectile nonbilious vomiting, possible dehydration, and poor weight gain. On physical examination, an olive-sized, non-tender 14 Journal of Dermatology for Physician Assistants

mass is noted in the epigastric region. Visible peristaltic waves may be noted. Typical diagnostic test findings include hypokalemic, hypochloremic metabolic alkalosis, hypertrophic pylorus on ultrasound, and string sign in the pyloric region on upper GI study. Segmental narrowing (“string sign”) of the ileum is noted in Crohn’s disease. Coiled spring appearance on contrast enema is noted in intussusception. The presence of ectopic acid-secreting cells on 99mTe pertechnetate (Meckel) scan is noted in Meckel diverticulum. J The correct answer is C.

DERmatology pa news & notes

evaluate recurrence rates in the 62% of patients who were dermatophyte negative at the end of the six-month study of the clinical effects of poly-ureaurethane, 16%. These patients were asked to discontinue poly-ureaurethane, 16% from the six to twelve month period, and of the subjects that returned, 19 of 25 had no recurrence and were still dermatophyte negative. Even with six months of no additional therapy 76% of subjects had no relapse. This supports the theory that the best defense against infection or reinfection is a strong and healthy nail (see Figure).6 Poly-ureaurethane, 16% is a polymeric suspension that forms a uniform film when applied nightly to the nail. The polymer product is dispersed in organic solvents that vaporize rapidly upon application, which allows the suspended polymer to adhere to the contours of the nail to form a flexible, waterproof barrier over the nail. The film is colorless and transparent, and possesses good moisture vapor permeability. These properties of poly-ureaurethane, 16% ensure protection and optimal moisture balance that are the initial steps to patient satisfaction and to stronger, healthier nails.2,3 J

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.

DO YOU KNOW A SDPA DIPLOMATE? The SDPA wishes to congratulate all of our Physician Assitant members who have completed the rigorous Distance Learning Initiative. 6 6

2 4

3 1

2 1

11 3

2 12

10 16

For more information on achieving DIPLOMATE status in your state, visit dermpa.org/diplomate Current list of diplomates effective as of 5/2013

Volume 7 â&#x20AC;˘ number 4 â&#x20AC;˘ FALL 2013 15

SDPA State Affiliates

The Georgia Dermatology Physician Assistants By Renata M. Block, MMS, PA-C SDPA Constituent Relations Committee Chair

The SDPA is looking forward to holding its 11th Annual Fall Conference in Atlanta, Georgia this November 13th-16th. As Georgia will be the host state for the event, I thought it would be a great opportunity to interview the Executive Director and CME Planner of the Georgia Dermatology Physician Assistants (GDPA), Matthew Brunner, MHS, PA-C, to find out more information about this particular SDPA State Affiliate. We look forward to seeing everyone this November in the â&#x20AC;&#x153;Peach State!â&#x20AC;?

DERmatology pa news & notes

RENATA - When did your State Affiliate become established and for what reason? MATTHEW - The GDPA was the first state chapter of dermatology PAs in the country as well as the first specialty group of PAs in Georgia. The GDPA was formed after a group of Atlanta area dermatology PAs determined a need for a statewide chapter to support the increasing number of PAs practicing in the specialty of dermatology in the state of Georgia. Our first meeting was held in April 2002, during which those present elected Douglas DiRuggiero, PA-C as our first President. Douglas went on to lead our organization during our early formative years and helped to establish our Annual Supervising Physician Appreciation Dinner and Annual Supervising Physician of the Year award. RENATA - How many members do you have and how often do you meet? MATTHEW - We currently have seventy-three Fellow members, eighteen Affiliate members, three Associate members, two Physician members, and thirteen Student members for a total of one hundred and nine members. The GDPA usually meets once a month but on occasion we meet more often. We host our Annual Conference in the Spring of each year in Atlanta.

16 Journal of Dermatology for Physician Assistants

RENATA - What type of topics do you discuss? MATTHEW - Our monthly dinner programs are usually industry sponsored product specific talks but also include dermatopathology lectures, as well as healthcare reform discussions. RENATA - Do you have a Tax ID and are you registered as a notfor-profit organization (e.g., 501(c)(3) or 501 (c) (6))? MATTHEW - The GDPA has a tax ID and has been recognized by the IRS as a 501(c)3 corporation since 2010. RENATA - Are you in contact with your AAPA State Chapter? MATTHEW - The GDPA started as an Affiliate Chapter of the Georgia Association of Physician Assistants and later switched to become an Affiliate Chapter of the SDPA in 2010 when the SDPA began to affiliate state chapters. We maintain a Board Liaison, our Director At Large, who is responsible for coordinating our activities with both SDPA and our AAPA State Chapters. RENATA - When did you become a SDPA State Affiliate chapter and for what reason? MATTHEW - The GDPA was recognized as a SDPA State Affiliate on March 14, 2010. The GDPA elected to become a State Affiliate of the SDPA once the option became available in order to better meet the needs

RENATA - How can anyone contact you if they are interested in joining your State Affiliate chapter? Do you have yearly dues? MATTHEW - Any PA interested in joining the GDPA can do so by navigating to our website, www. GaDermPA.org, and clicking on Join GDPA. We began to charge dues two years ago and they are $25 per year. RENATA - What makes your State Affiliate chapter so successful? MATTHEW - Three things have contributed to the success of the GDPA: individual PA leaders who stepped forward and made a commitment to the organization; a strong base of membership in the metropolitan Atlanta area also ensured that we had enough members to make our meetings continue to receive support from the pharmaceutical industry; and finally our annual CME Conference, Dermatology PEARLS, has cemented the GDPA as an important resource to support our members’ professional practices.

RENATA - What future plans do you have for your State Affiliate chapter? MATTHEW - The GDPA is currently beginning a partnership with Principal Financial that will provide another resource for our members to draw from as they transition from students to professional practice. This relationship will provide our members with financial education, discounted rates for life and disability insurance, as well as free financial planning advice. We also are continuing to develop mini half-day CME meetings to expand educational offerings throughout the year. J The SDPA currently has 17 State Affiliate chapters. We continue to grow and would love to have all 50 states participating! It takes teamwork and a strong commitment. For anyone who is interested in starting a SDPA State Affiliate chapter or if you have a state chapter and need some advice about becoming affiliated with the SDPA, please contact me at rblock@dermpa.org. I am here to help you!

Student Corner

First Foundations - Professional Notebook As a PA, you receive licenses, certifications, and agreements from many different organizations. Is all of this important paperwork handy should you need to quickly find it? Collecting all of these documents and keeping them in an easily accessible notebook is something I highly recommend to PAs who are just beginning their careers. Here is a list to help you start organizing your own professional notebook: ● Physician assistant diploma ● NCCPA certification ● State license(s) ● State specific licensing information/agreements ● DEA license and state specific prescribing

licenses ● Job contract ● Professional goals for the next 3, 6, 12 months (agreed upon with you and your supervising physician)

● Photograph of yourself (professional headshots are

a good idea)

● CME documentation (as you might be audited

by NCCPA) ● Malpractice insurance information ● Professional society membership credentials ● Hospital credentialling ● Other medical certifications (CPR, ACLS, etc.) This paperwork can easily go with you should you change jobs, work in multiple locations, or take professional leave. In addition, scan these documents into your computer to provide an electronic back-up. J Emily Massey, PA-C is a graduate of the Medical University of South Carolina and has practiced in dermatology for three 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. Volume 7 • number 4 • FALL 2013 17

DERmatology pa news & notes

of our membership. The SDPA is better positioned to provide assistance to our constituents with their specific needs in the field of dermatology.

Clinic al Dermatology

Overview of Noninfectious Vuvlar Dematoses in Adult Females By Jennifer McCarren, MPA, PA-C and Frances T. Florentino, MD

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

›› CME

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

Approval is valid for 1 year from the issue date of October 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: • Become familiar with clinical presentations of common vulvar dermatoses in adult females • Review of the current therapeutic options used in the management of vulvar dermatoses • Understand the impact that vulvar dermatoses cause as a significant source of morbidity in women 18 Journal of Dermatology for Physician Assistants

Overview of Noninfectious Vuvlar Dematoses in Adult Females 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 4 • FALL 2013 19

Overview of Noninfectious Vuvlar Dematoses in Adult Females 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

Overview of Noninfectious Vuvlar Dematoses in Adult Females 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 4 • FALL 2013 21

Overview of Noninfectious Vuvlar Dematoses in Adult Females SDPA Members Only Content

CLINIC AL Dermatology

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

22 Journal of Dermatology for Physician Assistants

Overview of Noninfectious Vuvlar Dematoses in Adult Females SDPA Members Only Content

Jennifer McCarren, MPA, PA-C has been practicing dermatology since receiving her Master’s degree from Duquesne University in 2001. She presently resides in Georgia where she works with Dr. Frances T. Florentino at Evans Dermatology. She has indicated no relationships to disclose relating to the content of this article. Frances T. Florentino, MD graduated from Georgetown University in Washington, DC and completed a residency in dermatology at Henry Ford Hospital Health Systems in Detroit, Michigan. Dr. Florentino is a Fellow of the American Academy of Dermatology and is a Diplomate of the American Board of Dermatology. She has indicated no relationships to disclose relating to the content of this article.

Dermatopathology Q A Q: What is your diagnosis?

Answer on page 27 Volume 7 • number 4 • FALL 2013 23

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.

From The Patient’s Perspective All in Good Time

CLINIC AL Dermatology

By Maria Beckett

What a difference thirty-five years can make! That’s learning to arrive at meetings early to get the best seat in the how long I have had alopecia areata, and that is nearly how conference room. This was the seat that backed up to a wall long it has taken me to not only accept that I have it, but to and not to a window. Why, you may ask? Well, the exterior also talk openly with others about it as well. My first sign of light from the window would reveal the bald spots that were hair loss occurred while I was in grade school. My mother creatively camouflaged by my remaining, very thin hair. uncovered a small bald patch on the back of my head while Outside of the workplace, baseball caps were my head cover combing my hair. Upon its discovery, she immediately of choice. I have quite a collection. began implementing “home-grown” treatments (vigorous Over the years I underwent many types of treatments, scalp massages, tar-based shampoo, medicated scalp some that yielded moderate results and many that didn’t. ointment), which over time appeared to have resolved the Additional scalp biopsies were taken. I tried topical problem. steroids, more cortisone When I was fourteen shots, minoxidil, anthralin, “My affiliation with NAAF has and just entering high school, and diphencyprone. I even I began losing my hair once provided me with the courage to be attempted a few holistic more. It started with a small treatments including open about my diagnosis and to patch about the size of a quarter natural vinegar. While I did on the right side of my head just experience a mild amount of encourage and enlighten others.” above my ear. Unfortunately, hair regrowth over those years, the methods from several years the largest bald patches have back did not seem to do the been persistent and continue to trick this time. The quarter-sized patch grew to the size of prevent me from wearing my hair in a manner that would my palm. Another patch formed on the back of my head, be considered socially “normal.” I also lost my eyelashes and another inconveniently arrived on the top of my head along the way as well the hair in my nose, ears, and the hair where I would often part my hair. Our family doctor told on my arms and legs. Since my early twenties, I have been us it was alopecia areata. He may have mentioned that it was fighting a persistent battle with eczema, which I am told is an autoimmune disease, though I don’t remember. What I not uncommon for people with alopecia areata. do remember was the plug of skin taken from my scalp and So needless to say, I have seen my share of dermatologists. the unsuccessful treatments we tried including prednisone I have even seen rheumatologists on two separate occasions pills and cortisone shots. when it was suspected that I might have lupus. I don’t. From the vantage point of a fourteen year-old, I was Irrespective of the outcome of the treatments they provided, a mess! I wanted desperately to be “normal” again and to my experiences with these doctors, while mainly positive, have a full head of hair like “normal” people do. After all, no one else I knew of had this silly disease. So there I was, a teenager, losing my hair and trying not to let anyone find out. And as I sit here now some thirty-five years later, I realize that I spent a significant part of my adolescent and adult life trying to hide my condition so that those around me would not perceive me as different. I actually wore a scarf on my head all through high school and most of college to protect The National Alopecia Areata Foundation (NAAF) supports from that unexpected gust of wind (something with which research to find a cure or acceptable treatment for alopecia many alopecians are all too familiar). I gave up swimming, areata, supports those with the disease, and educates the which was one of my favorite activities. I even gave up the public about alopecia areata. notion of attending the Air Force Academy because I was Contact Information: www.naaf.org afraid I would not be able to style my hair in a way that 14 Mitchell Boulevard San Rafael, CA 94903  would conform to the school regulations. Phone: (415) 472-3780  Fax: (415) 472-5343  In my professional life, I taught myself several alopecia E-mail: info@naaf.org areata survival tactics for the workplace. My favorite was 24 Journal of Dermatology for Physician Assistants

From The Patient’s Perspective It was at this conference that my life and my outlook about this disease changed. I connected with many patients, young and old, and learned first-hand that I am not alone, and my experience is neither unique nor weird. I met courageous women who choose not to wear a hairpiece and are eager to educate others about alopecia areata. Incredibly, during that first conference I gained a sense of strength that I had not known before. My affiliation with NAAF has provided me with the courage to be open about my diagnosis and to encourage and enlighten others. So here I am, thirty-five years later. I have alopecia areata, and I am still OK. Oh yeah, I finally bought those wigs, and as quiet as it’s kept, I’m having fun! J Maria Beckett, a former business owner, is a member of the National Alopecia Areata Foundation (NAAF) Board of Directors. As an individual who was first diagnosed with alopecia areata as a teenager, Maria has an acute appreciation for the importance an organization like NAAF means to patients and their loved ones. Maria serves as a Patient Representative with the US Food and Drug Administration (FDA), providing the FDA with the unique perspective of patients and family members directly affected by a serious or life-threatening disease. Along with her husband John, Maria loves to travel, golf, and ski. She gets great enjoyment from family life, which includes three wonderful adult children, Keyia, Christopher, and Nathan.

Take Home Points for Derm PAs: By Steven K. Shama, MD, MPH 1. Maria took half her life, nearly thirty-five years, to come to terms with her hair loss. The next time you as a clinician see a young person with alopecia areata and knowing that there is no absolute cure, will you start the many treatments and send the patient off or will you offer yourself, your availability, and your heart to this person whose precious self-esteem may rest in your hands? 2. I might have titled this Perspective, “The Courage to Be Open,” since it took Maria over thirty years to make connections with the National Alopecia Areata Foundation in order for her to realize that her experience was not unique nor was she alone. These same thoughts should be those that we express to patients with

alopecia areata whom we are seeing for the first time. We should make sure that we always leave them with hope and worth. 3. As with any chronic disease without a cure, empathy is probably our best prescription. We do not have to experience all the diseases our patients have to express empathy. It takes being in that moment with them and truly listening to how their disease has changed their lives for us to find the words that will comfort them. I am always reminded of that beautiful thoughtful medical expression, “To cure sometimes, to relieve often, to comfort always.” I have written of this before in the JDPA, and I feel that it should be repeated as a mantra by us on a daily basis.

Volume 7 • number 4 • FALL 2013 25

CLINIC AL Dermatology

have been mixed. I have seen several dermatologists who were especially rigorous in their approaches to effectively treat my hair loss. One doctor I saw in the early nineties was impressively knowledgeable of the disease and genuinely seemed to want my hair to regrow just as much as I did. On the other hand, another doctor (head of dermatology at a prestigious medical university) did not seem to appreciate the fact that my hair loss was not a cosmetic issue. My hair was a part of me and, at the time, my self-esteem. I wanted it back. I was not ready to give up treatment, but after running through the prescribed checklist of treatments (scalp biopsy, cortisone shots, and anthralin), he metaphorically patted me on my head by literally telling me there was nothing more he could do and to “buy wigs” and “have fun with it.” I was shocked and disappointed, but I didn’t give up hope. Although that was the last time I saw a physician to treat my alopecia areata, I did not give up searching for answers. Sometime later I discovered the National Alopecia Areata Foundation (NAAF), a national patient advocacy group committed to identifying a cure and suitable treatments for alopecia areata. For years I followed NAAF, scouring the organization’s website and reviewing posts on the online bulletin board. I even attended local support group meetings in Towson, Maryland. I made modest donations and for years kept track of where and when the next annual conference would be. Not until 2010, when my husband purchased our plane tickets to fly to the conference in Indianapolis, did I actually attend.

26 Journal of Dermatology for Physician Assistants

Dermatopathology Q A SDPA Members Only Content

CLINIC AL Dermatology

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

Volume 7 • number 4 • FALL 2013 27

Drugs in Dermatology

Drug Induced Onycholysis and Photo-onycholysis By Leigh A. Ruelo, MPAS, PA-C

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.

Table: Drug Induced Onycholysis2 Acebutol

Cloxacillin

Hydroxyurea

Metoprolol

Piroxicam

+ Adalimumab

Demeclocycline

Ibuprofen

**+Minocycline

Propranolol

Allopurinol

Diflunisal

*Indapamide

+Mycophenolate

*+Psoralens

Atenolol

Docetaxel

Indomethacin

Nadolol

*Quinine

Bleomycin

Doxorubicin

Irinotecan

Nitrofurantoin

Roxithromycin

Capecitabine

**+ Doxycycline Isoniazid

*Norfloxacin

Sparfloxacin

Captopril

Estrogens

+Isotretinoin

*Ofloxacin

Tasonermin

*Chloramphenicol

Etoposide

Ketoprofen

Oral Contraceptive **+Tetracycline

Clofazimine

Fluorouracil

+Methotrexate

Paclitaxel

*Clorazepate

Gold

*+Methoxsalen Pindolol

Timolol *+Trioxsalen

*= Photo-onycholysis specifically **= Can cause both onycholysis and photo-onycholysis + = Medications frequently prescribed in dermatology

Figure: Photo-onycholysis from doxycycline

© DermNetNZ REFERENCES: 1. Litt JZ. Litt’s D.E.R.M. Drug Eruptions & Reactions Manual. 17th ed, London: Informa Healthcare; 2011:753-754. 2. James WD, Berger TG, Elston DM. Andrews’ Diseases of the Skin; Clinical Dermatology. 9th ed. Philadelphia, Pa: Elsevier Inc; 2000:985-986. 3. Baran R, de Berker D, Holzberg M, Thomas L, eds. Baran & Dawber’s Diseases of the Nails and their Management. Hoboken, Nj: John Wiley & Sons, Ltd; 2012:73. Leigh A. Ruelo, MPAS, PA-C received her Master’s degree from the Philadelphia College of Osteopathic Medicine in 2006 and practices dermatology in the northwest suburbs of Chicago.

28 Journal of Dermatology for Physician Assistants

Clinical snapshots Figure 1

CLINIC AL Dermatology

Figure 2

Images and content reprinted with permission from Medscape Reference (http:// emedicine.medscape.com/), 2013, available at: http://reference.medscape.com/ features/slideshow/acutepoisonings.

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Volume 7 • number 4 • FALL 2013 29

SURGIC AL Dermatology

SURGICAL wisdom American Academy of Dermatology Launches Mobile App To Help Dermatology Providers Identify Best Candidates For Mohs Surgery 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.

The AUC for Mohs surgery was co-published as a manuscript in the Journal of the American Academy of Dermatology (JAAD) and Dermatologic Surgery. The Mohs AUC represents a collaborative initiative by the AAD, American College of Mohs Surgery (ACMS), the American Society for Dermatologic Surgery Association (ASDSA), and the American Society for Mohs Surgery (ASMS). 30 Journal of Dermatology for Physician Assistants

When choosing a biologic for adult chronic moderate to severe plaque psoriasis or psoriatic arthritis, Enbrel (etanercept) is a Biological Place to Start ®

Turn page to learn more.

ENBREL is indicated for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. ENBREL is indicated for reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with psoriatic arthritis. ENBREL can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone. Important Safety Considerations: ENBREL has been associated with serious and sometimes fatal infections, including opportunistic infections and TB. Malignancies, neurologic events, hematologic events, hepatitis B reactivation, and serious allergic reactions have also been reported. Common adverse reactions: headache, infection, and injection site reaction. ENBREL is contraindicated in patients with sepsis. Please see additional Important Safety Information on the following pages and the Brief Summary of the Prescribing Information at the end of this multi-page advertisement. Prescription ENBREL is administered by injection. Volume 7 • number 4 • FALL 2013 31

When choosing a biologic for adult chron

ENBREL IS A BIOLOGI

In moderate to severe plaque psoriasis (PsO): ENBREL is indicated for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Efficacy Efficacy established through 24 weeks in a worldwide pivotal trial1 • In medical studies, nearly half of patients saw 75% skin clearance in their moderate to severe plaque psoriasis in 3 months with ENBREL. Overall, 3 out of 4 patients saw 50% skin clearance in 3 months1,2

Safety profile Safety data from 7 PsO trials that included 4,410 patients3-10 Consistent adverse event rates through 3 years of treatment in over 1,100 patients in clinical trials11-15 32 Journal of Dermatology for Physician Assistants

Experience Evaluated in clinical studies over the past 20 years in rheumatoid arthritis (RA)16* • Nearly 15 years of postmarketing experience since approval for moderate to severe RA in 199817 • ENBREL is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis. ENBREL can be initiated in combination with methotrexate (MTX) or used alone > 9 years of postmarketing experience since approval for moderate to severe PsO in 200418 *Initial clinical research in RA patients began in 1993.

www.enbrel.com

nic moderate to severe plaque psoriasis

ICAL PLACE TO START

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IMPORTANT SAFETY CONSIDERATIONS SERIOUS INFECTIONS Patients treated with ENBREL are at an increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. ENBREL should be discontinued if a patient develops a serious infection or sepsis during treatment. Perform test for latent TB; if positive, start treatment for TB prior to starting ENBREL. Monitor all patients for active TB during treatment, even if initial latent TB test is negative.

MALIGNANCIES Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including ENBREL. In adult clinical trials of all TNF blockers, more cases of lymphoma were seen compared to control patients. The risk of lymphoma may

be up to several-fold higher in RA and psoriasis patients. The role of TNF blocker therapy in the development of malignancies is unknown. Cases of acute and chronic leukemia have been reported in association with postmarketing TNF blocker use in RA and other indications. The risk of leukemia may be higher in patients with RA (approximately 2-fold) than the general population. Melanoma and non-melanoma skin cancer (NMSC) have been reported in patients treated with TNF blockers, including ENBREL. Periodic skin examinations should be considered for all patients at increased risk for skin cancer. Please see additional Important Safety Information on the following pages and Brief Summary of the Prescribing Information at the end of this advertisement. Volume 7 â&#x20AC;˘ number 4 â&#x20AC;˘ FALL 2013 33

When Whendiagnosed diagnosedwith withpsoriatic psoriatica

ENBREL ENBRELWAS WASAABIOLOGICAL BIOLOGICALP

Phil Mickelson Champion golfer Psoriatic arthritis patient ENBREL user

In psoriatic arthritis (PsA): ENBREL is indicated for reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with psoriatic arthritis. ENBREL can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone. Phil experienced skin symptoms, then joint symptoms, prior to his PsA diagnosis Phil experienced skin symptoms of PsA prior to experiencing joint symptoms Over time, Phil developed intense pain in some of his joints and tendons Phil’s joint symptoms got progressively worse and he went to see his doctor www.enbrel.com 34 Journal of Dermatology for Physician Assistants

Following his joint symptoms, Phil’s doctor diagnosed him with PsA and they started with ENBREL After starting ENBREL, Phil began to notice improvement in his joint and skin symptoms*† Today, Phil continues to take ENBREL to manage his psoriatic arthritis and is able to continue doing many of the things he loves *In a medical study, ENBREL was shown to be effective in improving joint symptoms in about half of psoriatic arthritis patients who used it at 6 months. Clinical responses were apparent at the time of the first visit (4 weeks) and were maintained through 6 months of therapy.2 †Results may vary.

Seek out signs and symptoms of psoriatic arthritis in patients with psoriasis symptoms “PsA can be a very severe disease with significant functional impairment....Therefore, we strongly encourage dermatologists to actively seek signs and symptoms of PsA at every patient visit.”19

—American Academy of Dermatology; 2008 Psoriatic Arthritis Guidelines

carthritis, arthritis,Phil Philand andhishisdoctor doctoragreed agreed

PLACE PLACETO TOSTART STARTFOR FORPHIL PHIL

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be up to several-fold higher in RA and psoriasis patients. The role of TNF blocker therapy in the development of malignancies is unknown. Cases of acute and chronic leukemia have been reported in association with postmarketing TNF blocker use in RA and other indications. The risk of leukemia may be higher in patients with RA (approximately 2-fold) than the general population. Melanoma and non-melanoma skin cancer (NMSC) have been reported in patients treated with TNF blockers, including ENBREL. Periodic skin examinations should be considered for all patients at increased risk for skin cancer. Please see additional Important Safety Information on the following page and Brief Summary of the Prescribing Information at the end of this advertisement. Volume 7 â&#x20AC;˘ number 4 â&#x20AC;˘ FALL 2013 35

IMPORTANT SAFETY INFORMATION SERIOUS INFECTIONS Patients treated with Enbrel® (etanercept) are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids or were predisposed to infection because of their underlying disease. ENBREL should not be initiated in the presence of sepsis, active infections, or allergy to ENBREL or its components. ENBREL should be discontinued if a patient develops a serious infection or sepsis. Reported infections include: 1) Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent TB before ENBREL use and periodically during therapy. Treatment for latent infection should be initiated prior to ENBREL use, 2) Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric antifungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness, and 3) Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria. The risks and benefits of treatment with ENBREL should be carefully considered prior to initiating therapy in patients 1) with chronic or recurrent infection, 2) who have been exposed to TB, 3) who have resided or traveled in areas of endemic TB or endemic mycoses, or 4) with underlying conditions that may predispose them to infections such as advanced or poorly controlled diabetes. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with ENBREL, including the possible development of TB in patients who tested negative for latent TB prior to initiating therapy. MALIGNANCIES Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including ENBREL. In adult clinical trials of all TNF blockers, more cases of lymphoma were seen compared to control patients. The risk of lymphoma may be up to several-fold higher in RA and psoriasis patients. The role of TNF blocker therapy in the development of malignancies is unknown. Cases of acute and chronic leukemia have been reported in association with postmarketing TNF blocker use in RA and other indications. The risk of leukemia may be higher in patients with RA (approximately 2-fold) than the general population. Melanoma and non-melanoma skin cancer (NMSC) have been reported in patients treated with TNF blockers, including ENBREL. Periodic skin examinations should be considered for all patients at increased risk for skin cancer. Pediatric Patients In patients who initiated therapy at ≤ 18 years of age, approximately half of the reported malignancies were lymphomas (Hodgkin’s and non-Hodgkin’s lymphoma). Other cases included rare malignancies usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. Most of the patients were receiving concomitant immunosuppressants. NEUROLOGIC EVENTS Treatment with TNF-blocking agents, including ENBREL, has been associated with rare (< 0.1%) cases of new onset or exacerbation of central nervous system demyelinating disorders, some presenting with mental status changes and some associated with permanent disability, and with peripheral nervous system demyelinating disorders. Cases of transverse myelitis, optic neuritis, multiple sclerosis, Guillain-Barré syndromes, other peripheral demyelinating neuropathies, and new onset or exacerbation of seizure disorders have been reported in postmarketing experience with ENBREL therapy. Prescribers should exercise caution in considering the use of ENBREL in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders. CONGESTIVE HEART FAILURE Cases of worsening congestive heart failure (CHF) and, rarely, new-onset cases have been reported in patients taking ENBREL. Caution should be used when using ENBREL in patients with CHF. These patients should be carefully monitored.

36 Journal of Dermatology for Physician Assistants

HEMATOLOGIC EVENTS Rare cases of pancytopenia, including aplastic anemia, some fatal, have been reported. The causal relationship to ENBREL therapy remains unclear. Exercise caution when considering ENBREL in patients who have a previous history of significant hematologic abnormalities. Advise patients to seek immediate medical attention if they develop signs or symptoms of blood dyscrasias or infection. Consider discontinuing ENBREL if significant hematologic abnormalities are confirmed. HEPATITIS B VIRUS REACTIVATION Use of TNF blockers, including ENBREL, has been associated with reactivation of hepatitis B virus (HBV) in chronic carriers of this virus. The majority of these reports occurred in patients on concomitant immunosuppressive agents, which may also contribute to HBV reactivation. Exercise caution when considering ENBREL in patients identified as carriers of HBV. ALLERGIC REACTIONS Allergic reactions associated with administration of ENBREL during clinical trials have been reported in < 2% of patients. If an anaphylactic reaction or other serious allergic reaction occurs, administration of ENBREL should be discontinued immediately and appropriate therapy initiated. IMMUNIZATIONS Live vaccines should not be administered to patients on ENBREL. JIA patients, if possible, should be brought up to date with all immunizations prior to initiating ENBREL. In patients with exposure to varicella virus, consider temporary discontinuation of ENBREL and prophylactic treatment with Varicella Zoster Immune Globulin. AUTOIMMUNITY Autoantibodies may develop with ENBREL, and rarely lupus-like syndrome or autoimmune hepatitis may occur. These may resolve upon withdrawal of ENBREL. Stop ENBREL if lupus-like syndrome or autoimmune hepatitis develops. WEGENER’S GRANULOMATOSIS PATIENTS The use of ENBREL in patients with Wegener’s granulomatosis receiving immunosuppressive agents (eg, cyclophosphamide) is not recommended. MODERATE TO SEVERE ALCOHOLIC HEPATITIS Based on a study of patients treated for alcoholic hepatitis, exercise caution when using ENBREL in patients with moderate to severe alcoholic hepatitis. ADVERSE EVENTS The most commonly reported adverse events in RA clinical trials were injection site reaction, infection, and headache. In clinical trials of all other adult indications, adverse events were similar to those reported in RA clinical trials. DRUG INTERACTIONS The use of ENBREL in patients receiving concurrent cyclophosphamide therapy is not recommended. The risk of serious infection may increase with concomitant use of abatacept therapy. Concurrent therapy with ENBREL and anakinra is not recommended. Hypoglycemia has been reported following initiation of ENBREL therapy in patients receiving medication for diabetes, necessitating a reduction in anti-diabetic medication in some of these patients. References: 1. Data on file, Amgen; 1642 Subanalysis: May 31, 2007. 2. Enbrel® (etanercept) Prescribing Information, Immunex Corporation, Thousand Oaks, Calif. June 2013. 3. Data on file, Amgen; CSR1632: April 7, 2003. 4. Data on file, Amgen; CSR1642: October 8, 2003. 5. Data on file, Amgen; CSR1639: October 8, 2003. 6. Data on file, Amgen; CSR117: February 24, 2006. 7. Data on file, Amgen; CSR20030190: November 18, 2005. 8. Data on file, Amgen; CSR115: November 28, 2005. 9. Data on file, Amgen; CSR20040216: March 6, 2008. 10. Pariser DM, Leonardi CL, Gordon K, et al. Integrated safety analysis: short- and long-term safety profiles of etanercept in patients with psoriasis. J Am Acad Dermatol. 2012;67:245-256. 11. Data on file, Amgen; Exposure-adjusted Rate of OI. 12. Data on file, Amgen; IPoD Safety Analysis of Malignancy: October 23, 2009. 13. Data on file, Amgen; Year 1 Summary of Adverse Events: October 14, 2010. 14. Data on file, Amgen; Year 2 Summary of Adverse Events: October 14, 2010. 15. Data on file, Amgen; Year 3 Summary of Adverse Events: October 14, 2010. 16. Data on file, Amgen; Enbrel RA Clinical Trials Experience: June 1, 2013. 17. Data on file, Amgen; RA Approval Letter: November 2, 1998. 18. Data on file, Amgen; PsO Approval Letter: April 30, 2004. 19. Gottlieb A, Korman NJ, Gordan KB, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section II: psoriatic arthritis: overview and guidelines of care for treatment with an emphasis on the biologics. J Am Acad Dermatol. 2008;58:851-864.

Please see Brief Summary of Prescribing Information on following pages.

75651-RI-V1

Enbrel® (etanercept) Brief Summary SEE PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION WARNINGS SERIOUS INFECTIONS AND MALIGNANCIES Patients treated with Enbrel are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions and Adverse Reactions]. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Enbrel should be discontinued if a patient develops a serious infection or sepsis. Reported infections include: • Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before Enbrel use and during therapy. Treatment for latent infection should be initiated prior to Enbrel use. • Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness. • Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria. The risks and benefits of treatment with Enbrel should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with Enbrel, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy. MALIGNANCIES Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including Enbrel. INDICATIONS AND USAGE Rheumatoid Arthritis Enbrel is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis (RA). Enbrel can be initiated in combination with methotrexate (MTX) or used alone. Polyarticular Juvenile Idiopathic Arthritis Enbrel is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients ages 2 and older. Psoriatic Arthritis Enbrel is indicated for reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with psoriatic arthritis (PsA). Enbrel can be used in combination with methotrexate (MTX) in patients who do not respond adequately to MTX alone. Ankylosing Spondylitis Enbrel is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis (AS). Plaque Psoriasis Enbrel is indicated for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy. CONTRAINDICATIONS Enbrel should not be administered to patients with sepsis. WARNINGS AND PRECAUTIONS Serious Infections Patients treated with Enbrel are at increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death. Opportunistic infections due to bacterial, mycobacterial, invasive fungal, viral, parasitic, or other opportunistic pathogens including aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, histoplasmosis, legionellosis, listeriosis, pneumocystosis, and tuberculosis have been reported with TNF blockers. Patients have frequently presented with disseminated rather than localized disease. Treatment with Enbrel should not be initiated in patients with an active infection, including clinically important localized infections. Patients greater than 65 years of age, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants (such as corticosteroids or methotrexate), may be at greater risk of infection. The risks and benefits of treatment should be considered prior to initiating therapy in patients: with chronic or recurrent infection; who have been exposed to tuberculosis; with a history of an opportunistic infection; who have resided or traveled in areas of endemic tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis; or with underlying conditions that may predispose them to infection, such as advanced or poorly controlled diabetes [see Adverse Reactions]. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with Enbrel. Enbrel should be discontinued if a patient develops a serious infection or sepsis. A patient who develops a new infection during treatment with Enbrel should be closely monitored, undergo a prompt and complete diagnostic workup appropriate for an immunocompromised patient, and appropriate antimicrobial therapy should be initiated. Tuberculosis Cases of reactivation of tuberculosis or new tuberculosis infections have been observed in patients receiving Enbrel, including patients who have previously received treatment for latent or active tuberculosis. Data from clinical trials and preclinical studies suggest that the risk of reactivation of latent tuberculosis infection is lower with Enbrel than with TNF-blocking monoclonal antibodies. Nonetheless, postmarketing cases of tuberculosis reactivation have been reported for TNF blockers, including Enbrel. Tuberculosis has developed in patients who tested negative for latent tuberculosis prior to

initiation of therapy. Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating Enbrel and periodically during therapy. Tests for latent tuberculosis infection may be falsely negative while on therapy with Enbrel. Treatment of latent tuberculosis infection prior to therapy with TNF-blocking agents has been shown to reduce the risk of tuberculosis reactivation during therapy. Induration of 5 mm or greater with tuberculin skin testing should be considered a positive test result when assessing if treatment for latent tuberculosis is needed prior to initiating Enbrel, even for patients previously vaccinated with Bacille Calmette-Guerin (BCG). Anti-tuberculosis therapy should also be considered prior to initiation of Enbrel in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent tuberculosis but having risk factors for tuberculosis infection. Consultation with a physician with expertise in the treatment of tuberculosis is recommended to aid in the decision whether initiating antituberculosis therapy is appropriate for an individual patient. Tuberculosis should be strongly considered in patients who develop a new infection during Enbrel treatment, especially in patients who have previously or recently traveled to countries with a high prevalence of tuberculosis, or who have had close contact with a person with active tuberculosis. Invasive Fungal Infections Cases of serious and sometimes fatal fungal infections, including histoplasmosis, have been reported with TNF blockers, including Enbrel. For patients who reside or travel in regions where mycoses are endemic, invasive fungal infection should be suspected if they develop a serious systemic illness. Appropriate empiric antifungal therapy should be considered while a diagnostic workup is being performed. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. When feasible, the decision to administer empiric antifungal therapy in these patients should be made in consultation with a physician with expertise in the diagnosis and treatment of invasive fungal infections and should take into account both the risk for severe fungal infection and the risks of antifungal therapy. In 38 Enbrel clinical trials and 4 cohort studies in all approved indications representing 27,169 patient-years of exposure (17,696 patients) from the United States and Canada, no histoplasmosis infections were reported among patients treated with Enbrel. Neurologic Events Treatment with TNF-blocking agents, including Enbrel, has been associated with rare (< 0.1%) cases of new onset or exacerbation of central nervous system demyelinating disorders, some presenting with mental status changes and some associated with permanent disability. Cases of transverse myelitis, optic neuritis, multiple sclerosis, Guillain-Barré syndromes, other peripheral demyelinating neuropathies, and new onset or exacerbation of seizure disorders have been reported in postmarketing experience with Enbrel therapy. Prescribers should exercise caution in considering the use of Enbrel in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders [see Adverse Reactions]. Malignancies Lymphomas In the controlled portions of clinical trials of TNF-blocking agents, more cases of lymphoma have been observed among patients receiving a TNF blocker compared to control patients. During the controlled portions of Enbrel trials in adult patients with RA, AS, and PsA, 2 lymphomas were observed among 3306 Enbrel-treated patients versus 0 among 1521 control patients (duration of controlled treatment ranged from 3 to 36 months). Among 6543 adult rheumatology (RA, PsA, AS) patients treated with Enbrel in controlled and uncontrolled portions of clinical trials, representing approximately 12,845 patient-years of therapy, the observed rate of lymphoma was 0.10 cases per 100 patient-years. This was 3-fold higher than the rate of lymphoma expected in the general US population based on the Surveillance, Epidemiology, and End Results (SEER) Database. An increased rate of lymphoma up to several-fold has been reported in the RA patient population, and may be further increased in patients with more severe disease activity. Among 4410 adult PsO patients treated with Enbrel in clinical trials up to 36 months, representing approximately 4278 patient-years of therapy, the observed rate of lymphoma was 0.05 cases per 100 patient-years, which is comparable to the rate in the general population. No cases were observed in Enbrel- or placebo-treated patients during the controlled portions of these trials. Leukemia Cases of acute and chronic leukemia have been reported in association with postmarketing TNF-blocker use in rheumatoid arthritis and other indications. Even in the absence of TNF-blocker therapy, patients with rheumatoid arthritis may be at higher risk (approximately 2-fold) than the general population for the development of leukemia. During the controlled portions of Enbrel trials, 2 cases of leukemia were observed among 5445 (0.06 cases per 100 patient-years) Enbrel-treated patients versus 0 among 2890 (0%) control patients (duration of controlled treatment ranged from 3 to 48 months). Among 15,401 patients treated with Enbrel in controlled and open portions of clinical trials representing approximately 23,325 patient-years of therapy, the observed rate of leukemia was 0.03 cases per 100 patient-years. Other Malignancies Information is available from 10,953 adult patients with 17,123 patient-years and 696 pediatric patients with 1282 patient-years of experience across 45 Enbrel clinical studies. For malignancies other than lymphoma and non-melanoma skin cancer, there was no difference in exposure-adjusted rates between the Enbrel and control arms in the controlled portions of clinical studies for all indications. Analysis of the malignancy rate in combined controlled and uncontrolled portions of studies has demonstrated that types and rates are similar to what is expected in the general US population based on the SEER database and suggests no increase in rates over time. Whether treatment with Enbrel might influence the development and course of malignancies in adults is unknown. Melanoma and Non-melanoma skin cancer (NMSC) Melanoma and non-melanoma skin cancer has been reported in patients treated with TNF antagonists including etanercept. Among 15,401 patients treated with Enbrel in controlled and open portions of clinical trials representing approximately 23,325 patient-years of therapy, the observed rate of melanoma was 0.043 cases per 100 patient-years. Among 3306 adult rheumatology (RA, PsA, AS) patients treated with Enbrel in controlled clinical trials representing approximately 2669 patient-years of therapy, the observed rate of NMSC was 0.41 cases per 100 patient-years vs 0.37 cases per 100 patient-years among 1521 control-treated patients representing 1077 patient-years. Among 1245 adult psoriasis patients treated with Enbrel in controlled clinical trials, representing approximately 283

patient-years of therapy, the observed rate of NMSC was 3.54 cases per 100 patient-years vs 1.28 cases per 100 patient-years among 720 control-treated patients representing 156 patient-years. Postmarketing cases of Merkel cell carcinoma have been reported very infrequently in patients treated with Enbrel. Periodic skin examinations should be considered for all patients at increased risk for skin cancer. Pediatric Patients Malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with TNF-blocking agents (initiation of therapy at ≤ 18 years of age), including Enbrel. Approximately half the cases were lymphomas, including Hodgkin’s and non-Hodgkin’s lymphoma. The other cases represented a variety of different malignancies and included rare malignancies usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. The malignancies occurred after a median of 30 months of therapy (range 1 to 84 months). Most of the patients were receiving concomitant immunosuppressants. These cases were reported postmarketing and are derived from a variety of sources, including registries and spontaneous postmarketing reports. In clinical trials of 696 patients representing 1282 patient-years of therapy, no malignancies, including lymphoma or NMSC, have been reported. Postmarketing Use In global postmarketing adult and pediatric use, lymphoma and other malignancies have been reported. Patients With Heart Failure Two clinical trials evaluating the use of Enbrel in the treatment of heart failure were terminated early due to lack of efficacy. One of these studies suggested higher mortality in Enbrel-treated patients compared to placebo [see Adverse Reactions]. There have been postmarketing reports of worsening of congestive heart failure (CHF), with and without identifiable precipitating factors, in patients taking Enbrel. There have also been rare (< 0.1%) reports of new onset CHF, including CHF in patients without known preexisting cardiovascular disease. Some of these patients have been under 50 years of age. Physicians should exercise caution when using Enbrel in patients who also have heart failure, and monitor patients carefully. Hematologic Events Rare (< 0.1%) reports of pancytopenia, including very rare (< 0.01%) reports of aplastic anemia, some with a fatal outcome, have been reported in patients treated with Enbrel. The causal relationship to Enbrel therapy remains unclear. Although no high-risk group has been identified, caution should be exercised in patients being treated with Enbrel who have a previous history of significant hematologic abnormalities. All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (eg, persistent fever, bruising, bleeding, pallor) while on Enbrel. Discontinuation of Enbrel therapy should be considered in patients with confirmed significant hematologic abnormalities. Two percent of patients treated concurrently with Enbrel and anakinra developed neutropenia (ANC < 1 x 10 9/L). While neutropenic, one patient developed cellulitis that resolved with antibiotic therapy. Hepatitis B Virus Reactivation Use of TNF-blocking agents has been associated with reactivation of hepatitis B virus (HBV), including very rare cases (< 0.01%) with Enbrel, in patients who are chronic carriers of this virus. In some instances, HBV reactivation occurring in conjunction with TNF-blocker therapy has been fatal. The majority of these reports have occurred in patients concomitantly receiving other medications that suppress the immune system, which may also contribute to HBV reactivation. Patients at risk for HBV infection should be evaluated for prior evidence of HBV infection before initiating TNF-blocker therapy. Prescribers should exercise caution in prescribing TNF blockers for patients identified as carriers of HBV. Adequate data are not available on the safety or efficacy of treating patients who are carriers of HBV with anti viral therapy in conjunction with TNF-blocker therapy to prevent HBV reactivation. Patients who are carriers of HBV and require treatment with Enbrel should be closely monitored for clinical and laboratory signs of active HBV infection throughout therapy and for several months following termination of therapy. In patients who develop HBV reactivation, consideration should be given to stopping Enbrel and initiating anti viral therapy with appropriate supportive treatment. The safety of resuming Enbrel therapy after HBV reactivation is controlled is not known. Therefore, prescribers should weigh the risks and benefits when considering resumption of therapy in this situation. Allergic Reactions Allergic reactions associated with administration of Enbrel during clinical trials have been reported in < 2% of patients. If an anaphylactic reaction or other serious allergic reaction occurs, administration of Enbrel should be discontinued immediately and appropriate therapy initiated. Caution: The following components contain dry natural rubber (a derivative of latex), which may cause allergic reactions in individuals sensitive to latex: the needle cover of the prefilled syringe and the needle cover within the needle cap of the SureClick® autoinjector. Immunizations Live vaccines should not be given concurrently with Enbrel. It is recommended that pediatric patients, if possible, be brought up-to-date with all immunizations in agreement with current immunization guidelines prior to initiating Enbrel therapy [see Drug Interactions]. Autoimmunity Treatment with Enbrel may result in the formation of autoantibodies [see Adverse Reactions] and, rarely (< 0.1%), in the development of a lupus-like syndrome or autoimmune hepatitis [see Adverse Reactions], which may resolve following withdrawal of Enbrel. If a patient develops symptoms and findings suggestive of a lupus-like syndrome or autoimmune hepatitis following treatment with Enbrel, treatment should be discontinued and the patient should be carefully evaluated. Immunosuppression TNF mediates inflammation and modulates cellular immune responses. TNFblocking agents, including Enbrel, affect host defenses against infections. The effect of TNF inhibition on the development and course of malignancies is not fully understood. In a study of 49 patients with RA treated with Enbrel, there was no evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector cell populations [see Adverse Reactions]. Use in Wegener’s Granulomatosis Patients The use of Enbrel in patients with Wegener’s granulomatosis receiving

Volume 7 • number 4 • FALL 2013 37

immunosuppressive agents is not recommended. In a study of patients with Wegener’s granulomatosis, the addition of Enbrel to standard therapy (including cyclophosphamide) was associated with a higher incidence of non cutaneous solid malignancies and was not associated with improved clinical outcomes when compared with standard therapy alone [see Drug Interactions]. Use with Anakinra or Abatacept Use of Enbrel with anakinra or abatacept is not recommended [see Drug Interactions].

compared to placebo-treated patients. In RA Study III, no pattern of increased autoantibody development was seen in Enbrel patients compared to MTX patients [see Warnings and Precautions]. Other Adverse Reactions Table 3 summarizes adverse reactions reported in adult RA patients. The types of adverse reactions seen in patients with PsA or AS were similar to the types of adverse reactions seen in patients with RA. Table 3. Percent of Adult RA Patients Experiencing Adverse Reactions in Controlled Clinical Trials

Use in Patients with Moderate to Severe Alcoholic Hepatitis In a study of 48 hospitalized patients treated with Enbrel or placebo for moderate to severe alcoholic hepatitis, the mortality rate in patients treated with Enbrel was similar to patients treated with placebo at 1 month but significantly higher after 6 months. Physicians should use caution when using Enbrel in patients with moderate to severe alcoholic hepatitis. ADVERSE REACTIONS Across clinical studies and postmarketing experience, the most serious adverse reactions with Enbrel were infections, neurologic events, CHF, and hematologic events [see Warnings and Precautions]. The most common adverse reactions with Enbrel were infections and injection site reactions. Clinical Studies Experience Adverse Reactions in Adult Patients With Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, or Plaque Psoriasis The data described below reflect exposure to Enbrel in 2219 adult patients with RA followed for up to 80 months, in 182 patients with PsA for up to 24 months, in 138 patients with AS for up to 6 months, and in 1204 adult patients with PsO for up to 18 months. In controlled trials, the proportion of Enbrel-treated patients who discontinued treatment due to adverse events was approximately 4% in the indications studied. Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not predict the rates observed in clinical practice. Infections Infections, including viral, bacterial, and fungal infections, have been observed in adult and pediatric patients. Infections have been noted in all body systems and have been reported in patients receiving Enbrel alone or in combination with other immunosuppressive agents. In controlled portions of trials, the types and severity of infection were similar between Enbrel and the respective control group (placebo or MTX for RA and PsA patients) in RA, PsA, AS and PsO patients. Rates of infections in RA and PsO patients are provided in Table 3 and Table 4, respectively. Infections consisted primarily of upper respiratory tract infection, sinusitis and influenza. In controlled portions of trials in RA, PsA, AS and PsO, the rates of serious infection were similar (0.8% in placebo, 3.6% in MTX, and 1.4% in Enbrel/ Enbrel + MTX-treated groups). In clinical trials in rheumatologic indications, serious infections experienced by patients have included, but are not limited to, pneumonia, cellulitis, septic arthritis, bronchitis, gastroenteritis, pyelonephritis, sepsis, abscess and osteomyelitis. In clinical trials in PsO, serious infections experienced by patients have included, but are not limited to, pneumonia, cellulitis, gastroenteritis, abscess and osteomyelitis. The rate of serious infections was not increased in open-label extension trials and was similar to that observed in Enbrel- and placebo-treated patients from controlled trials. In 66 global clinical trials of 17,505 patients (21,015 patient-years of therapy), tuberculosis was observed in approximately 0.02% of patients. In 17,696 patients (27,169 patient-years of therapy) from 38 clinical trials and 4 cohort studies in the US and Canada, tuberculosis was observed in approximately 0.006% of patients. These studies include reports of pulmonary and extrapulmonary tuberculosis [see Warnings and Precautions]. Injection Site Reactions In placebo-controlled trials in rheumatologic indications, approximately 37% of patients treated with Enbrel developed injection site reactions. In controlled trials in patients with PsO, 15% of patients treated with Enbrel developed injection site reactions during the first 3 months of treatment. All injection site reactions were described as mild to moderate (erythema, itching, pain, swelling, bleeding, bruising) and generally did not necessitate drug discontinuation. Injection site reactions generally occurred in the first month and subsequently decreased in frequency. The mean duration of injection site reactions was 3 to 5 days. Seven percent of patients experienced redness at a previous injection site when subsequent injections were given. Immunogenicity Patients with RA, PsA, AS or PsO were tested at multiple time points for antibodies to etanercept. Antibodies to the TNF receptor portion or other protein components of the Enbrel drug product were detected at least once in sera of approximately 6% of adult patients with RA, PsA, AS or PsO. These antibodies were all non-neutralizing. Results from JIA patients were similar to those seen in adult RA patients treated with Enbrel. In PsO studies that evaluated the exposure of etanercept for up to 120 weeks, the percentage of patients testing positive at the assessed time points of 24, 48, 72 and 96 weeks ranged from 3.6%–8.7% and were all non-neutralizing. The percentage of patients testing positive increased with an increase in the duration of study; however, the clinical significance of this finding is unknown. No apparent correlation of antibody development to clinical response or adverse events was observed. The immunogenicity data of Enbrel beyond 120 weeks of exposure are unknown. The data reflect the percentage of patients whose test results were considered positive for antibodies to etanercept in an ELISA assay, and are highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of any antibody positivity in an assay is highly dependent on several factors, including assay sensitivity and specificity, assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to etanercept with the incidence of antibodies to other products may be misleading. Autoantibodies Patients with RA had serum samples tested for autoantibodies at multiple time points. In RA Studies I and II, the percentage of patients evaluated for antinuclear antibodies (ANA) who developed new positive ANA (titer ≥ 1:40) was higher in patients treated with Enbrel (11%) than in placebo-treated patients (5%). The percentage of patients who developed new positive antidouble-stranded DNA antibodies was also higher by radioimmunoassay (15% of patients treated with Enbrel compared to 4% of placebo-treated patients) and by Crithidia luciliae assay (3% of patients treated with Enbrel compared to none of placebo-treated patients). The proportion of patients treated with Enbrel who developed anticardiolipin antibodies was similarly increased

Placebo Controlleda (Studies I, II, and a Phase 2 Study) Placebo (N = 152) Reaction

Enbrelc (N = 349)

Percent of Patients

Infectiond (total) Upper Respiratory Infectionse Non-upper Respiratory Infections Injection Site Reactions Diarrhea Rash Pruritus Pyrexia Urticaria Hypersensitivity

Active Controlledb (Study III) MTX (N = 217)

Enbrelc (N = 415)

Percent of Patients

39 30

50 38

86 70

81 65

9 2 1 – 1 –

8 3 2 3 – –

16 19 5 4 4 1

16 13 5 2 2 1

Includes data from the 6-month study in which patients received concurrent MTX therapy in both arms. Study duration of 2 years. c Any dose. d Includes bacterial, viral, and fungal infections. e Most frequent Upper Respiratory Infections were upper respiratory tract infection, sinusitis, and influenza. a

In placebo-controlled PsO trials, the percentages of patients reporting adverse reactions in the 50 mg twice a week dose group were similar to those observed in the 25 mg twice a week dose group or placebo group. Table 4 summarizes adverse reactions reported in adult PsO patients from Studies I and II. Table 4. Percent of Adult PsO Patients Experiencing Adverse Reactions in Placebo-Controlled Portions of Clinical Trials (Studies I & II) Placebo (N = 359)

Enbrela (N = 876)

Reaction

Percent of Patients

Infectionb (total) Non-upper Respiratory Infections Upper Respiratory Infectionsc Injection Site Reactions Diarrhea Rash Pruritus Urticaria Hypersensitivity Pyrexia

28 14

27 12

2 1 2 – – 1

3 1 1 1 1 –

Includes 25 mg SC QW, 25 mg SC BIW, 50 mg SC QW, and 50 mg SC BIW doses. Includes bacterial, viral and fungal infections. c Most frequent Upper Respiratory Infections were upper respiratory tract infection, nasopharyngitis and sinusitis. a

Adverse Reactions in Pediatric Patients In general, the adverse reactions in pediatric patients were similar in frequency and type as those seen in adult patients [see Warnings and Precautions]. The types of infections reported in pediatric patients were generally mild and consistent with those commonly seen in the general pediatric population. Two JIA patients developed varicella infection and signs and symptoms of aseptic meningitis, which resolved without sequelae. In open-label clinical studies of children with JIA, adverse reactions reported in those ages 2 to 4 years were similar to adverse reactions reported in older children. Postmarketing Experience Adverse reactions have been reported during post approval use of Enbrel in adults and pediatric patients. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to Enbrel exposure. Adverse reactions are listed by body system below: Blood and lymphatic system disorders: Cardiac disorders: Gastrointestinal disorders: General disorders: Hepatobiliary disorders: Immune disorders: Musculoskeletal and connective tissue disorders: Neoplasms benign, malignant, and unspecified: Nervous system disorders:

Ocular disorders: Respiratory, thoracic and mediastinal disorders:

38 Journal of Dermatology for Physician Assistants

pancytopenia, anemia, leukopenia, neutropenia, thrombocytopenia, lymphadenopathy, aplastic anemia [see Warnings and Precautions] congestive heart failure [see Warnings and Precautions] inflammatory bowel disease (IBD) angioedema, chest pain autoimmune hepatitis, elevated transaminases macrophage activation syndrome, systemic vasculitis lupus-like syndrome melanoma and non-melanoma skin cancers, merkel cell carcinoma [see Warnings and Precautions] convulsions, multiple sclerosis, demyelination, optic neuritis, transverse myelitis, paresthesias [see Warnings and Precautions] uveitis, scleritis interstitial lung disease

Skin and subcutaneous tissue disorders:

cutaneous lupus erythematous, cutaneous vasculitis (including leukocytoclastic vasculitis), erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, subcutaneous nodule, new or worsening psoriasis (all sub-types including pustular and palmoplantar) Opportunistic infections, including atypical mycobacterial infection, herpes zoster, aspergillosis and Pneumocystis jiroveci pneumonia, and protozoal infections have also been reported in postmarketing use. DRUG INTERACTIONS Specific drug interaction studies have not been conducted with Enbrel. Vaccines Most PsA patients receiving Enbrel were able to mount effective B-cell immune responses to pneumococcal polysaccharide vaccine, but titers in aggregate were moderately lower and fewer patients had 2-fold rises in titers compared to patients not receiving Enbrel. The clinical significance of this is unknown. Patients receiving Enbrel may receive concurrent vaccinations, except for live vaccines. No data are available on the secondary transmission of infection by live vaccines in patients receiving Enbrel. Patients with a significant exposure to varicella virus should temporarily discontinue Enbrel therapy and be considered for prophylactic treatment with varicella zoster immune globulin [see Warnings and Precautions]. Immune-Modulating Biologic Products In a study in which patients with active RA were treated for up to 24 weeks with concurrent Enbrel and anakinra therapy, a 7% rate of serious infections was observed, which was higher than that observed with Enbrel alone (0%) [see Warnings and Precautions] and did not result in higher ACR response rates compared to Enbrel alone. The most common infections consisted of bacterial pneumonia (4 cases) and cellulitis (4 cases). One patient with pulmonary fibrosis and pneumonia died due to respiratory failure. Two percent of patients treated concurrently with Enbrel and anakinra developed neutropenia (ANC < 1 x 10 9/L). In clinical studies, concurrent administration of abatacept and Enbrel resulted in increased incidences of serious adverse events, including infections, and did not demonstrate increased clinical benefit [see Warnings and Precautions]. Cyclophosphamide The use of Enbrel in patients receiving concurrent cyclophosphamide therapy is not recommended [see Warnings and Precautions]. Sulfasalazine Patients in a clinical study who were on established therapy with sulfasalazine, to which Enbrel was added, were noted to develop a mild decrease in mean neutrophil counts in comparison to groups treated with either Enbrel or sulfasalazine alone. The clinical significance of this observation is unknown. USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category B. Developmental toxicity studies have been performed in rats and rabbits at doses ranging from 60- to 100-fold higher than the human dose and have revealed no evidence of harm to the fetus due to Enbrel. There are, however, no studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Women who become pregnant during Enbrel treatment are encouraged to enroll in Amgen’s Pregnancy Surveillance Program. Patients or their physicians should call 1-800-77-AMGEN (1-800-772-6436) to enroll. Nursing Mothers It is not known whether Enbrel is excreted in human milk or absorbed systemically after ingestion. Because many drugs and immunoglobulins are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from Enbrel, a decision should be made whether to discontinue nursing or to discontinue the drug. Women who choose to continue Enbrel treatment while nursing are encouraged to enroll in Amgen’s Lactation Surveillance Program. Patients or their physicians should call 1-800-77-AMGEN (1-800-772-6436) to enroll. Pediatric Use Enbrel is indicated for treatment of polyarticular JIA in patients ages 2 years and older [see Indications and Usage, Warnings and Precautions, Adverse Reactions]. Enbrel has not been studied in children < 2 years of age with JIA. The safety and efficacy of Enbrel in pediatric patients with PsO have not been studied. Rare (<0.1%) cases of IBD have been reported in JIA patients receiving Enbrel, which is not effective for the treatment of IBD [see Adverse Reactions]. Geriatric Use A total of 480 RA patients ages 65 years or older have been studied in clinical trials. In PsO randomized clinical trials, a total of 138 out of 1965 subjects treated with Enbrel or placebo were age 65 or older. No overall differences in safety or effectiveness were observed between these patients and younger patients, but the number of geriatric PsO subjects is too small to determine whether they respond differently from younger subjects. Because there is a higher incidence of infections in the elderly population in general, caution should be used in treating the elderly. Use in Diabetics There have been reports of hypoglycemia following initiation of Enbrel therapy in patients receiving medication for diabetes, necessitating a reduction in anti-diabetic medication in some of these patients. Rx Only. This brief summary is based on ENBREL prescribing information v. 51: 06/2013 Manufactured by: Immunex Corporation Thousand Oaks, CA 91320-1799 US License Number 1132 Marketed by Amgen Inc. © 1998 – 2013 Immunex Corporation. All rights reserved. US Patent Nos. 7,915,225; 5,605,690; Re. 36,755. For more information please call 1-888-436-2735 or visit www.enbrel.com

60077-R3-V4

Dermatology Case Report A Novel Use of an Old Technique: Curettage & Electrodessication for Profound Sebaceous Hyperplasia By Richard Callahan, MSPA, PA-C and Glenn Goldman, MD

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.

Volume 7 • number 4 • FALL 2013 39

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.

Rich Callahan MSPA, PA-C graduated from the University of New England, College of Health Professions, Physician Assistant Program in 2005. He works for the Department of Dermatology at Fletcher Allen Health Care, in Burlington, Vermont. He is also a clinical instructor for the University of Vermont College of Medicine and the Fletcher Allen Health Care Family Practice Residency Program. He has indicated no relationships to disclose relating to the content of this article. Glenn Goldman, MD is Professor and Chief of Dermatology at Fletcher Allen Health Care/University of Vermont College of Medicine. He has indicated no relationships to disclose relating to the content of this article.

40 Journal of Dermatology for Physician Assistants

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

JDPA

SURGIC AL Dermatology

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

S D PA M

HI S R E B EM

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.

RAMC_6.75x4.75.indd 1

1/31/13 12:49 PM Volume 7 • number 4 • FALL 2013 41

COSMETIC deRMATOLOGY Journal Club: Practice Changing Articles for Dermatology PAs Sunscreen and Prevention of Skin Aging: A Randomized Trial Ann Intern Med. 2013; 158(11):781-790. Hughes MB, Williams GM, Baker P, Green AC Queensland Institute of Medical Research and University of Queensland, School of Population Health, Queensland, Australia, and University of Manchester, Manchester Academic Health Sciences Centre, Manchester, United Kingdom.

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.

42 Journal of Dermatology for Physician Assistants

Cosmetic pearls How To Maximize Results From Anti-Aging Skin Care Products SDPA Members Only Content

Moisturizer is one of the best anti-aging skin care products you can buy.

Volume 7 • number 4 • FALL 2013 43

COSMETIC 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.

Professional development

Dermatology Billing & Coding Modifier 25 Fact Sheet By Inga Ellzey, MPA, RHIA, CDC

professional development

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.

44 Journal of Dermatology for Physician Assistants

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.

Volume 7 â&#x20AC;˘ number 4 â&#x20AC;˘ FALL 2013 45

Outside & Inside the 9 to 5...

Heather Olivieri, MPAS, PA-C graduated cum laude from the University of Massachusetts Amherst with a Bachelor of Science in Biology and went onto receive her Master’s of Science Degree in Physician Assistant Studies from the Massachusetts College of Pharmacy and Health Sciences. Ms. Olivieri has been a practicing physician assistant in dermatology for ten years and in addition to medical dermatology she enjoys the business aspect of medicine. One year ago she became the proud owner of her own dermatology medical practice, Westford Dermatology & Cosmetic Center. The JDPA had an opportunity to interview Ms. Olivieri and learn about her experiences regarding her role as a physician assistant owner of a dermatology medical practice.

professional development

JDPA: Do you consider your current working situation to be unique? Ms. Olivieri: On one hand, I do consider my current working situation to be unique. There are not many PAs who own their own medical practice. I believe I am the only PA in Massachusetts who is the primary owner of a medical practice. On the other hand, I am doing exactly what all PAs do. I am practicing medicine within the scope of the profession and within my practice guidelines. I have a supervising physician whom I rely on. The way I practice has not changed from when I worked for a physician owned practice, and this is very important to me.

1. It was difficult to find a bank willing to give a loan for a medical practice start-up that was not primarily owned by a physician. 2. When some of the local specialty physicians learned of my goal, they tried to stop me. I received phone calls that proved to be false interest. 3. I had difficulty finding a supervising physician who was both qualified and willing to take on the role. Based on this obstacle alone, I almost shut down the practice before I opened.

Heather Olivieri, MPAS, PA-C

JDPA: What inspired and/or motivated you to pursue owning your own medical practice? Ms. Olivieri: As I gained more experience in dermatology, I had a dream of being more involved in the business aspect of medicine. I wanted the opportunity to make the business decisions and to be responsible for the success of the practice. My experience at different practices proved to me that there were things that I desired to change in order to create a better environment for both patients and staff. JDPA: What challenges or obstacles did you meet along your path to pursuing ownership? Ms. Olivieri: There are too many challenges to list them all in detail here. When I started pursuing my goal of practice ownership, I did not fully realize what I would be up against. Here is a list of just a few challenges I faced: 46 Journal of Dermatology for Physician Assistants

4. My previous practice was angry that I left (I had been there for over eight years). Their subsequent punitive actions cost me a lot of time and resulted in large legal fees.

JDPA: Do you advertise or educate potential patients any differently than traditional physician owned practices might? Ms. Olivieri: In the beginning, I tried to “lay low” and keep my ownership of the practice discreet. Even now, I don’t advertise that I am the owner. If a patient asks me, I do answer truthfully. I am always thankful when their responses are full of both encouragement and praise. JDPA: What do you consider to be the advantages to owning your own medical practice? Are there any advantages for the patients? Ms. Olivieri: The advantages are the same advantages that any business owner may have. I have the ability to hire the staff who I wish to work with, work the hours I want, control the aesthetics of the practice, implement business protocols, and decide how the business functions.

JDPA: Any words of advice to fellow PAs who are considering pursuing a similar path? Ms. Olivieri: The first step is to do a lot of research. Each state has different laws regarding PA practice ownership. Sometimes these laws are very difficult to interpret. The first thing I did was hire a lawyer and a business consultant. I also relied a lot on advice from the AAPA. I had them review my scope of practice guidelines and consulted them on various issues. I would also suggest taking business classes.

JDPA: Where do you see the future of the dermatology PA profession in 10 years? Ms. Olivieri: I think that some things will change while the essence of our profession will remain the same. The core of our profession revolves around excellent patient care. We are known for this. This will remain the same. I don’t see the requirement of a supervising physician changing nor do I think that it should. I am lucky to have an excellent supervising physician, who is invaluable in his experience and knowledge. I do think that the profession is changing. In the future, more PAs will pursue practice ownership. I would like to think that PAs will break new ground in areas that we have not even considered.

Ultimately I hope that PAs will be more accepted as competent In addition, practice medical providers ownership is not for by the community every PA, just like and other medical working in a specific The wating room at Westford Dermatology & professionals. This field is not for every Cosmetic Center. has been happening PA. While practice gradually since I began practicing ten years ago. ownership will not be the goal of every PA, all PAs I hope that the public will become more fully should strive to be the best healthcare provider educated regarding our profession. I think that no matter what field we are in. success in achieving these goals is up to us as PAs JDPA: How do you think PA owned practices are and what we are willing to do to achieve them. received in the physician community? JDPA: Any final thoughts you care to share with Ms. Olivieri: Well, I think it varies by state and our readers? maybe even by town. In my situation, I believe that Ms. Olivieri: My practice just celebrated there were some physicians in the dermatology our one-year anniversary in August. I am so specialty who felt threatened by my ownership. pleased that we have reached this milestone. They were worried that PA ownership might be Although people give me a lot of credit as “contagious” and take away from their bottom the owner, it is obvious to me that I would not line. Now that I am up and running, I think they have made it this far without an outstanding know that my practice is no more a threat than staff and supervising physician as well as a very any other new dermatology medical practice that supportive family. Without them, my dream of opens. On the other hand, the local primary care practice ownership would not have become physicians were very encouraging. They were a reality. J already accustomed to referring patients to me prior to my ownership of the practice and they continue to do so now.

Volume 7 • number 4 • FALL 2013 47

professional development

For the patients, I don’t see an advantage or disadvantage. They will receive the same care and treatment whether I am the owner or not. Perhaps they view me as more accessible, but I think PAs in general are more accessible.

Notes from your Office Manager Reliably Communicating and Acting on Critical Test Results SDPA Members Only Content

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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.

48 Journal of Dermatology for Physician Assistants

SDPA Members Only Content

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.

Expand your Expertise…

at the largest dermatology event of the year! The AAD’s 72nd Annual Meeting offers Physician Assistants: • Full access to over 325 educational sessions covering a wide variety of topics

Registration begins Wednesday, December 4th 12 p.m. (CT).

• A look at the latest products and services from hundreds of exhibitors • A variety of networking events to help build professional relationships Don’t miss your chance to attend! For information regarding registration requirements for Physician Assistants, please visit www.aad.org/AM14/nonmembers

Visit www.aad.org/meetings for more information

13-785_Physician_Assist_Journal_Ad_cmyk.indd 1

Volume 7 • number 49/17/2013 • FALL9:10:10 2013AM 49

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.

Simulated image based on patient with locally advanced BCC at Week 24.

BOXED WARNING AND ADDITIONAL IMPORTANT SAFETY INFORMATION Embryo-Fetal Death and Severe Birth Defects • Erivedge capsule can cause fetal harm when administered to a pregnant woman based on its mechanism of action • Verify pregnancy status prior to the initiation of Erivedge. Advise male and female patients of these risks. Advise female patients of the need for contraception during and after treatment and advise male patients of the potential risk of Erivedge exposure through semen • Advise patients to contact their healthcare provider immediately if they suspect they (or, for males, their female partner) may be pregnant 50 Journal of Dermatology for Physician Assistants

• Immediately report exposure to Erivedge during pregnancy and encourage women who may have been exposed to Erivedge during pregnancy, either directly or through seminal ﬂuid, to participate in the Erivedge pregnancy pharmacovigilance program by contacting the Genentech Adverse Event Line at (888) 835-2555 Blood Donation • Advise patients not to donate blood or blood products while receiving Erivedge and for at least 7 months after the last dose of Erivedge Nursing Mothers • Inform female patients of the potential for serious adverse reactions in nursing infants from Erivedge, taking into account the importance of the drug to the mother

TRANSFORM THE TREATMENT OF DIFFICULT ADVANCED BASAL CELL CARCINOMA (aBCC) ERIVEDGE IS A UNIQUE ORAL THERAPY E (Not act actual ctual ual size size))

• Due to the nature of aBCC and its clinical factors (ie, lesion recurrence, location/size, and invasiveness) some patients may not be candidates for surgery or radiation1,2 • Erivedge is an oral treatment option dosed as a 150-mg capsule once daily until disease progression or unacceptable toxicity3 • Erivedge reduced lesions in patients with aBCC1,3 Objective response rates (ORR) by IR from ERIVANCE1,3* laBCC (n=63)

mBCC (n=33)

43% (n=27) (30.5-56.0)

30% (n=10) (15.6-48.2)

Complete response

21% (n=13)

Partial response

22% (n=14)

30% (n=10)

7.6 (5.7-9.7)

7.6 (5.6-NE)

ORR (95% CI)

Median duration of response (months) (95% CI)

Indication Erivedge® (vismodegib) capsule is a hedgehog pathway inhibitor indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation. *Patients received at least 1 dose of Erivedge with independent pathologist-conﬁrmed diagnosis of BCC. Response in laBCC: absence of disease progression and either ≥30% reduction in lesion size (sum of the longest diameter) from baseline in target lesions by radiography or in externally visible dimension (including scar tissue); or complete resolution of ulceration in all target lesions. Complete responders also had no residual BCC on sampling biopsy and partial responders had residual BCC on sampling biopsy. Response in mBCC: assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. IR=Independent Review; laBCC=locally advanced BCC; ORR=objective response rate; CI=conﬁdence interval; NE=not estimable; mBCC=metastatic BCC.

Adverse Reactions • The most common adverse reactions (≥10%) were muscle spasms, alopecia, dysgeusia, weight loss, fatigue, nausea, diarrhea, decreased appetite, constipation, arthralgias, vomiting, and ageusia • In clinical trials, a total of 3 of 10 premenopausal women developed amenorrhea while receiving Erivedge • Treatment-emergent grade 3 laboratory abnormalities observed in clinical trials were hyponatremia in 6 patients (4%), hypokalemia in 2 patients (1%), and azotemia in 3 patients (2%) You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555. Please see Brief Summary of Prescribing Information on following page.

See what you can offer your patients with aBCC at www.Erivedge.com References: 1. Sekulic A, Migden MR, Oro AE, et al. N Engl J Med. 2012;366:2171-2179. 2. Walling HW, et al. Cancer Metastasis Rev. 2004;23:389-402. 3. Erivedge® (vismodegib) capsule Prescribing Information. Genentech, Inc. January 2012. © 2013 Genentech USA, Inc. All rights reserved. HED0001655400 Printed in USA.

Volume 7 • number 4 • FALL 2013 51

Table 1: Adverse Reactions Occurring in ≥ 10% of Advanced BCC Patients (cont) All aBCC Patients (N = 138) Grade 3 Grade 4 All Grades 3 (%) (%) (%) 1

MedDRA Preferred Term2 Metabolism and nutrition disorders Decreased appetite Musculoskeletal and connective tissue disorders Muscle spasms Arthralgias Nervous system disorders Dysgeusia Ageusia Skin and subcutaneous tissue disorders Alopecia

ERIVEDGE (vismodegib) capsule Initial U.S. Approval: 2012 This is a brief summary of information about ERIVEDGE. Before prescribing, please see full prescribing information. WARNING: EMBRYO-FETAL DEATH AND SEVERE BIRTH DEFECTS ERIVEDGE (vismodegib) capsule can result in embryo-fetal death or severe birth defects. ERIVEDGE is embryotoxic and teratogenic in animals. Teratogenic effects included severe midline defects, missing digits, and other irreversible malformations. Verify pregnancy status prior to the initiation of ERIVEDGE. Advise male and female patients of these risks. Advise female patients of the need for contraception and advise male patients of the potential risk of ERIVEDGE exposure through semen [see Warnings and Precautions (5.1), Use in Specific Populations (8.1, 8.6)]. 1 INDICATIONS AND USAGE ERIVEDGE capsule is indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation. 2 DOSAGE AND ADMINISTRATION The recommended dose of ERIVEDGE is 150 mg taken orally once daily until disease progression or until unacceptable toxicity [see Clinical Studies (14)]. ERIVEDGE may be taken with or without food. Swallow capsules whole. Do not open or crush capsules. If a dose of ERIVEDGE is missed, do not make up that dose; resume dosing with the next scheduled dose. 4 CONTRAINDICATIONS None. 5 WARNINGS AND PRECAUTIONS 5.1 Embryo-Fetal Death and Severe Birth Defects ERIVEDGE capsules can cause fetal harm when administered to a pregnant woman based on its mechanism of action. Vismodegib is teratogenic, embryotoxic, and fetotoxic in rats at maternal exposures lower than the human exposures at the recommended dose of 150 mg/day. In rats, malformations included craniofacial anomalies, open perineum, and absent or fused digits. Fetal retardations and variations were also observed. Verify pregnancy status prior to the initiation of ERIVEDGE. Advise male and female patients of the risks of embryo-fetal death and severe birth defects and the need for contraception during and after treatment. Advise patients to contact their healthcare provider immediately if they suspect they (or, for males, their female partner) may be pregnant. Female and male patients of reproductive potential should be counseled regarding pregnancy prevention and planning. If ERIVEDGE is used during pregnancy or if a patient becomes pregnant while taking (or for a male patient, if his female partner is exposed to) ERIVEDGE, the patient should be apprised of the potential hazard to the fetus. Report immediately exposure to ERIVEDGE during pregnancy to the Genentech Adverse Event Line at 1-888-835-2555. Encourage women who may have been exposed to ERIVEDGE during pregnancy, either directly or through seminal fluid, to participate in the ERIVEDGE pregnancy pharmacovigilance program by contacting the Genentech Adverse Event Line at 1-888-835-2555 [see Boxed Warning, Use in Specific Populations (8.1, 8.6)]. 5.2 Blood Donation Advise patients not to donate blood or blood products while receiving ERIVEDGE and for at least 7 months after the last dose of ERIVEDGE. 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. ERIVEDGE capsule was administered as monotherapy at doses ≥ 150 mg orally daily in four open-label, uncontrolled, dose-ranging or fixed single dose clinical trials enrolling a total of 138 patients with advanced basal cell carcinoma (BCC). The median age of these patients was 61 years (range 21 to 101), 100% were White (including Hispanics), and 64% were male. The median duration of treatment was approximately 10 months (305 days; range 0.7 to 36 months); 111 patients received ERIVEDGE for 6 months or longer. The most common adverse reactions (≥ 10%) were muscle spasms, alopecia, dysgeusia, weight loss, fatigue, nausea, diarrhea, decreased appetite, constipation, arthralgias, vomiting, and ageusia (Table 1). Table 1: Adverse Reactions Occurring in ≥ 10% of Advanced BCC Patients All aBCC1 Patients (N = 138) MedDRA Preferred Term2 Gastrointestinal disorders Nausea Diarrhea Constipation Vomiting General disorders and administration site conditions Fatigue Investigations Weight loss

All Grades 3 (%)

Grade 3 (%)

Grade 4 (%)

42 (30.4%) 40 (29.0%) 29 (21.0%) 19 (13.8%)

1 (0.7%) 1 (0.7%) -

55 (39.9%)

7 (5.1%)

1 (0.7%)

62 (44.9%)

10 (7.2%)

35 (25.4%)

3 (2.2%)

99 (71.7%) 22 (15.9%)

5 (3.6%) 1 (0.7%)

76 (55.1%) 15 (10.9%)

88 (63.8%)

aBCC = Advanced Basal Cell Carcinoma. MedDRA = Medical Dictionary for Regulatory Activities. 3 Grading according to NCI-CTCAE v3.0. Amenorrhea: In clinical trials, a total of 3 of 10 pre-menopausal women developed amenorrhea while receiving ERIVEDGE [see Non-Clinical Toxicology (13.1)]. Laboratory Abnormalities: Treatment-emergent Grade 3 laboratory abnormalities observed in clinical trials were hyponatremia in 6 patients (4%), hypokalemia in 2 patients (1%), and azotemia in 3 patients (2%). 1 2

7 DRUG INTERACTIONS 7.1 Effects of Other Drugs on Vismodegib Drugs that Inhibit or Induce Drug Metabolizing Enzymes Vismodegib elimination involves multiple pathways. Vismodegib is predominantly excreted as an unchanged drug. Several minor metabolites are produced by multiple CYP enzymes. Although vismodegib is a substrate of CYP2C9 and CYP3A4 in vitro, CYP inhibition is not predicted to alter vismodegib systemic exposure since similar steady-state plasma vismodegib concentrations were observed in patients in clinical trials concomitantly treated with CYP3A4 inducers (i.e., carbamazepine, modafinil, phenobarbital) and those concomitantly treated with CYP3A4 inhibitors (i.e., erythromycin, fluconazole). Drugs that Inhibit Drug Transport Systems In vitro studies indicate that vismodegib is a substrate of the efflux transporter P-glycoprotein (P-gp). When ERIVEDGE is coadministered with drugs that inhibit P-gp (e.g. clarithromycin, erythromycin, azithromycin), systemic exposure of vismodegib and incidence of adverse events of ERIVEDGE may be increased. Drugs that Affect Gastric pH Drugs that alter the pH of the upper GI tract (e.g. proton pump inhibitors, H2-receptor antagonists, and antacids) may alter the solubility of vismodegib and reduce its bioavailability. However, no formal clinical study has been conducted to evaluate the effect of gastric pH altering agents on the systemic exposure of vismodegib. Increasing the dose of ERIVEDGE when coadministered with such agents is not likely to compensate for the loss of exposure. When ERIVEDGE is coadministered with a proton pump inhibitor, H2-receptor antagonist or antacid, systemic exposure of vismodegib may be decreased and the effect on efficacy of ERIVEDGE is unknown. 7.2 Effects of Vismodegib on Other Drugs Results of a drug-drug interaction study conducted in cancer patients demonstrated that the systemic exposure of rosiglitazone (a CYP2C8 substrate) or oral contraceptives (ethinyl estradiol and norethindrone) is not altered when either drug is co-administered with vismodegib. In vitro studies indicate that vismodegib is an inhibitor of CYP2C8, CYP2C9, CYP2C19 and the transporter BCRP. Vismodegib does not induce CYP1A2, CYP2B6, or CYP3A4/5 in human hepatocytes. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category D ERIVEDGE capsule can cause fetal harm when administered to a pregnant female based on its mechanism of action. Vismodegib is teratogenic in rats at doses corresponding to an exposure of 20% of the exposure at the recommended human dose (estimated AUC 0-24hr steady-state exposure). In rats, malformations included craniofacial anomalies, open perineum, and absent or fused digits. Fetal retardations and variations were also observed. Vismodegib is embryolethal in rats at exposures within the range achieved at the recommended human dose. If ERIVEDGE is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the embryo or fetus. Report immediately exposure to ERIVEDGE during pregnancy to the Genentech Adverse Event Line at 1-888-835-2555. Encourage women who may have been exposed to ERIVEDGE during pregnancy, either directly or through seminal fluid, to participate in the ERIVEDGE pregnancy pharmacovigilance program by contacting the Genentech Adverse Event Line at 1-888-835-2555 [see Boxed Warning, Warnings and Precautions (5.1)]. In an embryo-fetal developmental toxicity study, pregnant rats were administered oral vismodegib at doses of 10, 60, or 300 mg/kg/day during the period of organogenesis. Pre- and post-implantation loss were increased at doses of ≥ 60 mg/kg/day (approximately ≥ 2 times the systemic exposure (AUC) in patients at the recommended human dose), which included early resorption of 100% of the fetuses. A dose of 10 mg/kg/day (approximately 0.2 times the AUC in patients at the recommended dose) resulted in malformations (including missing and/or fused digits, open perineum and craniofacial anomalies) and retardations or variations (including dilated renal pelvis, dilated ureter, and incompletely or unossified sternal elements, centra of vertebrae, or proximal phalanges and claws). 8.3 Nursing Mothers It is not known whether vismodegib is excreted in human breast milk. Because many drugs are excreted in human milk and because

52 Journal of Dermatology for Physician Assistants

of the potential for serious adverse reactions in nursing infants from ERIVEDGE, 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. 8.4 Pediatric Use The safety and effectiveness of ERIVEDGE capsule have not been established in pediatric patients. In repeat-dose toxicology studies in rats, administration of oral vismodegib resulted in toxicities in bone and teeth. Effects on bone consisted of closure of the epiphyseal growth plate when oral vismodegib was administered for 26 weeks at ≥ 50 mg/kg/day (approximately ≥ 0.4 times the systemic exposure (AUC) in patients at the recommended human dose). Abnormalities in growing incisor teeth (including degeneration/ necrosis of odontoblasts, formation of fluid-filled cysts in the dental pulp, ossification of the root canal, and hemorrhage resulting in breakage or loss of teeth) were observed after administration of oral vismodegib at ≥ 15 mg/kg/day (approximately ≥ 0.2 times the AUC in patients at the recommended human dose). 8.5 Geriatric Use Clinical studies of ERIVEDGE capsule did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. 8.6 Females of Reproductive Potential and Males ERIVEDGE capsule can cause harm to the embryo or fetus when administered during pregnancy. Counsel female and male patients regarding pregnancy prevention and planning. Advise patients to contact their healthcare provider immediately if they suspect they (or, for males, their female partner) may be pregnant [see Boxed Warning, Warnings and Precautions (5.1), Use in Specific Populations (8.1)] Female patients Determine pregnancy status within 7 days prior to initiation of treatment in females of reproductive potential. For females with a negative pregnancy test, initiate a highly effective form of contraception (failure rate of less than 1%) prior to the first dose. Continue highly effective contraception during therapy and for 7 months after the last dose of ERIVEDGE. If a patient becomes pregnant while taking ERIVEDGE, or during the 7 months after the last dose of treatment, report the pregnancy to the Genentech Adverse Event Line at 1-888-835-2555. Encourage pregnant females to participate in the ERIVEDGE pregnancy pharmacovigilance program by calling the Genentech Adverse Event Line at 1-888-835-2555. Counsel pregnant females about the teratogenic risk to the fetus. Amenorrhea has been observed in clinical trials in females of reproductive potential. Reversibility of amenorrhea is unknown [see Adverse Reactions (6), Nonclinical Toxicology (13.1)]. Male patients Male patients should use condoms with spermicide, even after a vasectomy, during sexual intercourse with female partners while being treated with ERIVEDGE capsule and for 2 months after the last dose to avoid exposing an embryo or fetus to vismodegib. 8.7 Hepatic Impairment The safety and effectiveness of ERIVEDGE capsule have not been established in patients with hepatic impairment [see Clinical Pharmacology (12.3)]. 8.8 Renal Impairment The safety and effectiveness of ERIVEDGE capsule have not been established in patients with renal impairment [see Clinical Pharmacology (12.3)]. 10 OVERDOSAGE There is no information on overdosage in humans. In clinical trials, ERIVEDGE capsule was administered at 540 mg orally once daily; exposure did not increase between 150 mg and 540 mg daily. 17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Medication Guide). t "EWJTF QBUJFOUT UIBU &3*7&%(& FYQPTVSF EVSJOH QSFHOBODZ DBO cause embryo-fetal death or severe birth defects. t *OTUSVDU GFNBMF QBUJFOUT PG SFQSPEVDUJWF QPUFOUJBM UP VTF B IJHIMZ effective form of contraception (failure rate of less than 1%) while taking ERIVEDGE and for at least 7 months after the last dose of ERIVEDGE. t *OTUSVDU BMM NBMF QBUJFOUT FWFO UIPTF XJUI QSJPS WBTFDUPNZ UP VTF condoms with spermicide, during sexual intercourse with female partners while taking ERIVEDGE and for at least 2 months after the last dose of ERIVEDGE. t *OTUSVDU QBUJFOUT UP JNNFEJBUFMZ DPOUBDU UIFJS IFBMUIDBSF QSPWJEFS if they (or, for males, their female partner) become pregnant or if pregnancy is suspected following exposure to ERIVEDGE. t *OTUSVDU QBUJFOUT UP JNNFEJBUFMZ SFQPSU BOZ QSFHOBODZ FYQPTVSF UP ERIVEDGE and encourage participation in the ERIVEDGE pregnancy pharmacovigilance program by calling the Genentech Adverse Event Line at 1-888-835-2555. t *OGPSN GFNBMF QBUJFOUT PG UIF QPUFOUJBM GPS TFSJPVT BEWFSTF reactions in nursing infants from ERIVEDGE, taking into account the importance of the drug to the mother. t "EWJTF QBUJFOUT OPU UP EPOBUF CMPPE PS CMPPE QSPEVDUT XIJMF UBLJOH ERIVEDGE and for at least 7 months after the last dose of ERIVEDGE. t "EWJTF QBUJFOUT UP TXBMMPX &3*7&%(& DBQTVMFT XIPMF BOE OPU UP crush or open the capsules.

ERIVEDGE ® [vismodegib] capsule Manufactured by: Patheon, Inc. Mississauga, Canada Distributed by: Genentech USA, Inc. ERIVEDGE is a registered trademark A Member of the Roche Group of Genentech, Inc. © 2013 2012 Genentech, Inc. 1 DNA Way South San Francisco, CA 94080-4990 1013 5 4 9 3 HED0000832301

Judicial and Ethical Affairs

The Ethical Challenges of Online Review By Karen Scully, MD, FRCPC, MA Ethics

The study of ethics has given me the opportunity to examine our day-to-day practice of dermatology with a critical lens. My aim is not to suggest what is right or wrong, but rather to raise awareness of ethical issues so that we can, to the best of our abilities, make sound decisions in caring for our patients. If you have any ethical 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 ethical questions.

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Karen Scully is a board-certified dermatologist in the United States and Canada. She had a private practice in the Toronto area for many years and then accepted a teaching position at the Johns Hopkins Medical Institutions where she practiced and taught dermatology residents and medical students. More recently she moved to Charlotte, North Carolina and completed a Master’s Degree in Ethics and Applied Philosophy at the University North Carolina at Charlotte.

Volume 7 • number 4 • FALL 2013 53

Dermatology PA news & notes

From the Desk of... By Cathleen Y. Chidester, MPAS, PAC

As healthcare professionals, specifically in dermatology, we see multiple patients with many different skin diseases, but none so devastating as melanoma. When we must call and give the pathology results to a patient or his/her family members, it can be heartbreaking for the provider as well as for the patient and family. What is the best approach for discussing the diagnosis? Which support groups should we recommend? Where can the most up-to-date information on diagnosis, treatments, and clinical trials be found? How can we get involved in fundraising activities or legislative action for prevention? All this and more can be found on the AIM at Melanoma website. This site is equally beneficial for patients, their family members, caregivers, and providers. The following is a brief overview of the many advantages of this site. The creation of AIM at Melanoma was inspired by two melanoma patients who lost their battle to this disease. Charlie Guild was diagnosed with stage IV melanoma at the young age of twenty-five. She had intended to go to medical school after graduation from Brown University. However, she never achieved that aspiration. She felt that there was a purpose for her having melanoma, and she wanted to make a difference in the lives of other melanoma patients. Sadly, she died on November 24, 2003, nine months after her diagnosis. Charlieâ&#x20AC;&#x2122;s parents founded the Charlie Guild Melanoma Foundation in her memory. Jim Schlipmann was diagnosed with stage I melanoma at the age of twenty-nine. He was a loving husband and father who cared deeply for family, friends, and golf. Fifteen years after his initial melanoma he was diagnosed with stage IV melanoma and died seven months later on December 12, 2002. The day after his funeral, his wife established the James A Schlipmann Melanoma Cancer Foundation. These two foundations merged to form AIM at Melanoma. There are three main sections on the AIM at Melanoma website. The first is AIM for Answers. This section provides information about melanoma and other lesions, risk factors, prevention, early detection, path to getting a diagnosis, dealing with the diagnosis, stages and treatment of melanoma, patient and caregiver support, and moving on after treatment. This section provides easily understood information that patients, family members, and friends can access to help them cope with the diagnosis, learn about new treatment options and support groups, and follow up on recommendations. The second section, AIM for Action, contains information on melanoma discussion groups, patient and caregiver symposiums, survivor stories, getting involved, fundraiser participation, a memorial wall, and a newsletter archive. The melanoma discussion forum provides an online melanoma support group for anyone who has been touched by melanoma such as the patient, caregivers, and family members. AIM at Melanoma hosts educational symposiums around the country at world-renowned melanoma centers. There is an area for survivors to share their stories. Another area provides information on how 54 Journal of Dermatology for Physician Assistants

to become a volunteer, participate in or start your own fundraiser, how to be active in public policy, and ways that you can support the efforts of AIM at Melanoma through education and research. Family and friends can honor and celebrate the life of their loved ones by posting memories, photographs, stories, and other remembrances on the Memorial Wall. There is also an experienced nurse available online at all times to answer any questions or concerns. AIM for Cure is the third section, which covers melanoma in the news, developing research, current legislation, and screening and prevention programs. The most up-to-date news articles are presented, which include links to information on melanoma research and treatments, indoor tanning legislation, and other related issues. There is information on the melanoma tissue bank, how it differs from other tissue banks, goals for research, and utilization of funds. Legislation regarding indoor tanning is presented with a link to information about current laws for each state. The AIM at Melanoma website provides a wealth of information that can be utilized by patients, caregivers, and providers. I have already directed several of my patients with melanoma and their relatives to this site when discussing a diagnosis or ongoing management of melanoma. It provides the patients with a sense of control because they can access the information online and make better informed decisions regarding their treatment. This sense of empowerment helps these patients to deal with their illness in a more positive way and assists the provider in discussing treatment options, availability of clinical trials, and support options for the patient and caregivers in a more effective and efficient manner. It is certainly worth taking the time to check out this website when counseling your patients with melanoma as it will benefit both the providers and the patients. J Cathleen Y. Chidester, MPAS, PA-C is a graduate of the Physician Assistant Program at the University of Texas Medical Branch at Galveston. She completed her fellowship training in dermatology at Scott and White Dermatology Clinic, which is a Texas A&M residency training program. She is currently employed at Saginaw Bay Dermatology Clinic in Bay City, Michigan.

The Difference We Make The Surge

The problems are three in number. Two are skin deep; the third lies deeper. This teenager shows me the rash around her right wrist. She’s had it since Christmas, she says. Little red bumps that itch. Several are grouped into small clusters. Ringworm, the school nurse said. Better go see your doctor and have it checked out. I turn her hand over, rotating the wrist to study the eruption, all the while conjuring up mental images of skin lesions that I have seen in the past. This rash doesn’t fit the criteria for ringworm, yet I am at a loss to explain it. “She also needs this form filled out to exempt her from swimming class,” the mother explains, handing me a paper. “She’s sensitive to the chlorine, breaks out in rash from head to toe if she gets in the pool. It’s just like the metal allergy she’s got.” “Metal allergy?” I ask. “Yes, she breaks out when metal touches her skin. Belt buckles, cheap earrings and such.”   “It looks like some sort of contact dermatitis,” I muse, still studying the eruption. The mother opens her purse and pulls out a shiny bracelet. “She got this for Christmas—from her brother,” she says. I reach for the bracelet and run it through my fingers. “You’ve been wearing this bracelet on that wrist?” I ask. The girl nods her head. “Metal allergy,” I say, this time as a pronouncement, not as a question. “I’ll give you a prescription for an ointment to use.”  “Then there’s the pain in her stomach,” the mother says.  “Tell me about it,” I say to the girl.  “Not much to tell,” she says. “It hurts right here in the middle.” She points to the pit of her stomach. “Anytime I eat something, it sets it off.”  “How long does it last?”  “A couple of hours, then it goes away.”  I pose a few more questions and ask the girl to lie down on the exam table. I listen to her abdomen, feel her belly, ask her to take a deep breath while I push in with my hand.  “Any stomach problems in the family?”  “I had ulcers when I was young,” the mother says.  “I’m not convinced

it’s an ulcer, but I do think she’s got some hyperacidity. I’ll prescribe a pill for you to take every morning before breakfast. Let’s see if that doesn’t help.”  I write out the prescriptions, explaining the directions as I do so. I sign the form to exempt her from swimming class. “Has she been under any duress lately?” I ask, as I hand the papers to the mother.  “Lots of stress,” the girl answers. “Mid-term exams....”  “And my son,” the mother says.  “Your son? How so?”  “He was in the Marines, over in Iraq. He came home with PTSD. He yells a lot. It bothers her—and me.”  “Is he getting some help?”  “He goes to see somebody. The state pays for some of his care. But he can’t hold a job.”  “How long has he been home?” I ask.  “Two years—” she says in a halting voice. “He came back when he was twenty-two, and he’s twenty-four years old now.” Her face turns red, her eyes well up with tears; yet she continues to smile. “I tell my daughter it’s just how things are right now with our family. This is our life now together.”   I offer her a tissue. She dabs the tears on her cheeks. For the moment, the surge has settled.  “Thank you for seeing my daughter.” The mother shakes my hand and turns to go.  This family—a mother, a daughter, a son. The problems are three in number. Two are skin deep; the third lies much deeper. J Brian T. Maurer has practiced pediatric medicine as a physician assistant for thirty years. Over the past two decades Mr. Maurer has explored the illness narrative as a tool to cultivate an appreciation for the delivery of humane medical care. He has published numerous vignettes, editorials, and essays in both national and international journals. Mr. Maurer has been a contributing author to the online open-access journal Dermanities (www.dermanities.com) since its inception. Readers can visit the author on the web at http://briantmaurer.wordpress.com. This article was reprinted with permission from the author. Originally published in Dermanities: October 7th, 2008; 5(3).

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

JDPA Journal of Dermatology for Physician Assistants

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DERmatology pa news & notes

By Brian T. Maurer, PA-C

Workplace Excellence

What’s Your Mindset: Set In Stone Or Ready To Grow? By Matthew Davidson, PhD

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.

n our office we recently introduced new software designed to monitor our time allocation on projects. It was an undertaking that I fully supported. Our team did some excellent research to ensure that we had the right software, which met our short and long term needs, was not too expensive, and was not too complicated. In other words, this was the right move, done the right way, for the right reasons. So, in theory I should have welcomed its arrival, right? When the day arrived to begin implementing the software, I could feel the resistance welling up in me as soon as I received the email asking me to sign up and create a login. I ignored the email for a few days looking for just the right time in a week when there really wasn’t a good time to focus on this important task amid all the urgent demands on my time and attention. One afternoon I finally decided to just get the darn thing loaded onto my computer. I closed out of one of the ten or so documents and windows open on my computer and tried to quickly login, skipping the directions that had been sent to me by my colleagues. I got halfway through the login, got frustrated, and aborted the mission. I wasn’t frustrated with the undertaking or my colleagues, just with myself. Why can’t I be better at these kinds of tasks? Why am I not more like my two colleagues who thrive at these kinds of tasks? Why does everything take longer than you think, even this darn software designed to track and analyze time, for goodness sake? An autopsy of this failed learning experience begins with some pretty obvious contributing factors: I was annoyed and tired at the outset, it was late in the afternoon, I had been multi-tasking, and I was feeling rushed. Add to those the fact that this type of challenge isn’t my strength or joy. The bottom line is that wrong context + wrong mindset = no learning! In 56 Journal of Dermatology for Physician Assistants

fact, context and mindset are two of the foundational factors in creating the conditions for ideal performance. Thinking about the context and mindset for learning is essential for workplace excellence because the highest performing organizations are learning organizations, ones that change, grow, innovate, and improve. Change is inevitable and essential; however, as a mentor of mine liked to say, “Aside from babies, nobody really likes to be changed.” We tend to prefer to stay with what we know, where we’re comfortable, and with what we’ve always done. Context and mindset are essential for individuals and organizations committed to learning, growing, changing, and improving. In her seminal work, Mindset, Carol Dweck explores the thinking and motivational dispositions of those who are able to achieve performance mastery that is marked by confidence and peace, rather than frustration and anxiety. Her research describes two basic learner frameworks or mindsets, that she calls “fixed mindset” and “growth mindset.” A fixed mindset operates according to the belief that you’re either naturally good at something or you’re not; therefore your ability is “fixed,” preset, and predetermined. If you believe your potential is finite or fixed, then you tend to put very little stock in the importance of experience, guided practice, persistence, and effort. In a fixed mindset we tend to worry more about the outcome achieved than the learning and growth acquired. In a fixed mindset we worry about how we compare and what others think, and we tend to fill our minds with a toxic stream of self-rejection, guilt, and anxiety (I’m terrible at this. They’re going to see that I’m not smart or competent. I’m the only one who doesn’t know this or can’t do this. I’m going to get fired). To make matters worse, in a fixed mindset we tend to isolate ourselves and avoid asking for help.

to learning? Are you willing to work on things you don’t like or aren’t naturally good at? This is the place for you! If you’re afraid of change, done learning, and unwilling to grow, this probably isn’t the place for you. 3. Make it safe to ask for help. We often suffer in silence because we don’t want to ask for help, which we fear makes us look dumb or incompetent. Creating a norm where asking for help is valued and regarded as strength, not weakness, is essential. 4. Provide regular teaching and learning opportunities. Everyone in the organization should have opportunities to be both teacher and student, everybody. Professional development opportunities and conferences are obviously valuable; equally important are chances for internal teaching and learning around the organization’s core tasks: how to make the most of the phone or computer system, how to best call or sign somebody in, how to read a chart, how to make a great cup of coffee. Think, learn, reflect, and grow together. How do we do it best, why do we do it that way, how could we do it better? A growth mindset is an intellectual habit formed through repeated practice so that eventually it becomes the way you think and operate. 5. Encourage innovation; reward growth and improvement. Change and improvement doesn’t occur in an atmosphere of fear. William Butler Yeats said, “We are happy when we are growing.” Developing the context and mindset for growth in your organization will contribute to workplace excellence and quite possibly workplace happiness! J REFERENCES: 1. Dweck, C. Mindset: The New Psychology of Success: How we can learn to fulfill our potential. New York, Ballantine Books. 2006. Matthew L. Davidson, PhD 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. He has indicated no relationships to disclose relating to the content of this article. For additional information or to contact the IEE, please visit www.excellenceandethics.org.

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By comparison, the mindset that Dweck describes as contributing to mastery performance and psychological thriving is the “growth mindset.” A growth mindset is one that embraces challenges and change as opportunities to stretch and grow oneself, not as something to be avoided, anxious about, or scared of. In a growth mindset mistakes and failures are simply viewed as opportunities to learn and grow, not a reason for self-rejection, shame, or embarrassment. A growth mindset actually looks for ways to target areas of weakness for development (like strength and conditioning for an area of weakness). Finally, the growth mindset understands, embraces, and seeks out the encouragement, accountability and expertise of others, rather than attempting to conceal its weaknesses. When it comes to mindset, we all have the capacity for a growth mindset; in fact, most of us probably demonstrate both at certain times. Take this comparison of fixed versus growth mindset into your workplace, consider for a moment your own experiences, and consider a time recently when your mind was fixed. A new hotshot comes into your workplace, and you start to feel old and ignorant; it seems like everybody is comfortable with the new computers, phones, or filing system; a new certification is required, and it feels like you’re a freshman at college again. Bam! I feel ignorant, I feel old, and I’m afraid to ask. I’m frustrated, anxious, and cranky! However, think about those times when you tackled a new challenge, learned or developed a new skill, or mastered some new technology; you felt powerful, capable, young, and confident. As Henry Ford famously observed, “Anyone who stops learning is old, whether at twenty or eighty. Anyone who keeps learning stays young.” Young people are not immune to having a fixed mindset; in education and athletic settings a fixed mindset is a major obstacle to the development of human potential. A growth mindset is simply a belief that learning is part of life and that changes and challenges merely require openness to the learning process. We all have the capacity for a growth mindset, but it must be developed and nurtured as part of a safe and supportive workplace culture. Here are some initial steps for creating a context in your organization that will contribute to growth mindset development: 1. Make time for learning. Time is our most precious commodity. Devoting time to learning is the first step to reinforcing its organizational priority. Hurrying to install a new computer, phone, filing system, or set of procedures without proper learning time will inevitably contribute to anxiety, frustration, and fixed mindset reactions. 2. Recruit and develop growth-minded people. Do you like challenges? Are you committed

Supervising Physician CORNER The National Alopecia Areata Registry, Biobank & Clinical Trials Network An interview with Maria Hordinsky, MD

DERmatology pa news & notes

By J. Margaret Casey

Have your patients ever asked, “Who gets alopecia areata?” “How did I get it when no one in my family has it?” “Is it related to another disease?” “What are the chances my children will get it?” “What is the chance that my alopecia areata patchy will worsen to alopecia areata totalis or alopecia areata universalis?” The Alopecia Areata Registry, Biobank, and Clinical Trials Network (Registry) is important because it is designed to answer those types of questions. The more people who participate in the Registry, the more questions can be answered and the more resources can be provided for researchers and pharmaceutical companies to advance studies and possibly find a long-lasting, effective treatment for this disease. Whatever form or stage of alopecia areata your patient has, the National Alopecia Areata Foundation (NAAF) encourages them to register. Everyone, from someone who just found their first patch to the person who has been living with alopecia universalis for years, has valuable data to contribute to our understanding of this disease. The Registry needs as many patients as possible for it to continue being the most comprehensive and validated resource for scientists to use in making new discoveries about alopecia areata. This Registry will be the base for many future clinical trials to develop a treatment for alopecia areata. Dr. Hordinsky, Chair of NAAF’s Scientific Advisory Council and Registry Investigator at the University of Minnesota, has provided for us the following information regarding the Registry. The items below can assist you in explaining to your patients the benefits of their participation in the Registry and how they can begin to get involved with it. How was this registry created? Initially funded since 2000 by The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), one of the institutes in the National Institutes of Health (NIH), the government provided over six million dollars to establish the Registry and gather initial information and samples. The project described was supported by Award Number HHSN268200682279C from NIAMS/NIH. Federal funding for the Registry concluded on March 31, 2012, at which time NAAF took on sole responsibility to manage and fund the Registry. In helping to establish the Registry, NIAMS indicated its strong commitment to alopecia areata research for which we will always be grateful. The Registry has created an enormous opportunity to advance basic, clinical, and translational studies in alopecia areata. It also provides an essential resource for all investigators interested in studying alopecia areata and stimulates opportunities for additional 58 Journal of Dermatology for Physician Assistants

research support from federal and private sources. How does the Alopecia Areata Registry, Biobank & Clinical Trials Network work? The Alopecia Areata Registry, Biobank & Clinical Trials Network is located at five sites across the United States where patients are examined and registered, and blood and tissue samples are taken when appropriate. The samples and data are sent to MD Anderson in Houston, Texas, where they are collected and stored in a biobank by the Principal Investigator. A Steering Committee made up of key members of the Registry and NAAF staff members oversees the functions of the Registry and determines the distribution of material to appropriate investigators. Upon request by credible investigators with well-conceived research, samples or data are distributed. So far, these well-qualified samples have provided the basis for a groundbreaking study that found genetic similarities between alopecia areata and other autoimmune diseases and a biomarker study that is still underway. Where can patients be seen? The sites of the registry and the senior investigators at each site are as follows: 1. University of Texas, Houston, Texas, MD Anderson Cancer Center Madeleine Duvic, M.D., Principal Investigator 2. University of Colorado Health Sciences Center, Denver, Colorado David Norris, M.D., Investigator 3. Columbia University, New York, New York Angela Christiano, Ph.D., Investigator 4. University of Minnesota, Minneapolis, Minnesota Maria Hordinsky, M.D., Investigator 5. University of California, San Francisco, California Vera Price, M.D., Investigator How does the Registry facilitate research in alopecia areata? A well-organized and well-run Registry facilitates research in alopecia areata and maximizes the effectiveness of investigation by assuring that: 1. Uniform diagnostic and classification criteria are applied to patients studied. 2. Fair access to patients and tissues are provided to all credible investigators with well-conceived projects, without regard to possible scientific overlap among projects. 3. Standardized and uniform information are available on each patient (i.e., everything is coded so participant identity is never revealed).

One part of the Short Form that can be confusing for participants is the question asking about the “proband” in the patient’s family. The proband refers to the first affected person in their family who registered. If they are the first or only person registering, they will automatically become the proband and do not need to complete that question. We connect families in the computer database by information gathered from this question. However, it is important for patients to list any proband if they know that someone in their family has registered before them. The second part of the Registry is optional. It involves completing a longer questionnaire called the Long Form, traveling to one of the participating sites (Houston, Denver, Minneapolis, New York, or San Francisco), having a brief skin exam, and donating blood for genetic and other research. The Registry cannot pay for any travel expenses, but there is no charge for going to one of the sites and participating in the second part of the Registry. Participants can also be assessed to see if they are eligible to provide a scalp biopsy specimen for studies on the local genetic and immunologic environment of the scalp and hair follicle. This biopsy procedure is also optional. J Maria K. Hordinsky, MD is Professor and Chair of the Department of Dermatology at the University of Minnesota, Minneapolis. She is recognized for her clinical expertise and research in hair diseases and neurodermatology. Dr. Hordinsky is Chair of the Scientific Advisory Council of the National Alopecia Areata Foundation and is a member of the Scientific Advisory Council of the Cicatricial Alopecia Research Foundation. In addition to her clinical and research interests, she has been Chair of the Department of Dermatology for over 10 years and is an active participant in medical school and practice plan activities including the Risk Management/Compliance Committee and the Clinical Sciences Council. Dr. Hordinsky is passionate about graduate medical education and is the current President of the Association of Professors of Dermatology as well as the Association’s representative to the Council of Academic Societies of the AAMC. She is the current Secretary Treasurer of the North American Hair Research Society and is the Section Editor for hair diseases in UpToDate. Dr. Hordinsky is a past recipient of the Leonard Tow Humanism in Medicine Award and has been a mentor to many medical students and visiting residents who have come to spend time with her to learn about hair diseases and neurodermatology.

Now Showing on Dermcast.tv

The Official Online Media Resource of the SDPA 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!

Alopecia 101 - Maria Hordinsky MD Maria Hordinsky, MD, Chair of the National Alopecia Areata Foundation (NAAF) Scientific Advisory Council and Alopecia Areata Registry, Biobank, and Clinical Trials Network Investigator at the University of Minnesota, reviews the diagnosis and current management strategies for alopecia areata. For additional information on the NAAF and alopecia areata, watch Dr. Hordinsky’s interview, recorded at the SDPA Summer 2013 Dermatology Conference in St. Louis, MO, on Dermcast.tv at: http://www.dermcast.tv/alopecia-101-maria-hordinsky-md.

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DERmatology pa news & notes

4. Patient studies are coordinated with studies in known animal models, which greatly enhances the effectiveness of the overall research effort in alopecia areata. What type of research in alopecia areata is facilitated by this registry? Material collected by the Registry greatly facilitates studies of the genetic basis of alopecia areata, the immunologic mechanisms of alopecia areata, basic hair biology related to alopecia areata progression and response to treatment, as well as the role of nerves and blood vessels in alopecia areata. Clinical trials and better understanding of disease subsets are also expected outcomes of the Registry. How can patients participate in the Registry? Patients can register online at www.NAAF.org/Registry_ Shortform or at any of the five registry sites. The registration process is simple. Patients complete a screening questionnaire called the Short Form, which provides the Registry with both epidemiological and statistical information about alopecia areata. They can complete this form directly online or download the form and mail it in to the address that is right on the form. We also encourage every patient to complete a Quality of Life questionnaire. The Registry personnel know that this life-altering disease can affect patients as deeply as a life-threatening disease. The intent of collecting quality of life data is to provide evidence that alopecia areata must be taken seriously both by research funding agencies as well as by health insurance companies in their coverage of treatments. Keeping in mind that quality of life information is personally sensitive, we ensure that your patient’s name and identifying information will be securely protected. In order to have a Short Form and Quality of Life questionnaire mailed to you or your patients, please contact NAAF at info@naaf.org or (415) 472-3780. Then mail or fax the forms back (the proper addresses and contact numbers are right on the Short Form). It is important to answer all of the questions, including those about other diseases, and to state whether affected family members are on the patient’s mother’s side or on the father’s side of the family.

Dermatology in Art By W. Stephen Steiner, PA-C

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.

DERmatology pa news & notes

This portrait of Porcupina Van Allen was painted in the 1830s, most likely by folk painter John Usher Parsons. Parsons had a relatively brief career as an artist, painting for less than five years. From her surname, we can presume the subject (or at least her husband) hailed from northern Europe, a common link for many with rosacea. Porcupina has fair skin and blue eyes, which allows the rosiness to be readily apparent. Parsons beautifully captures her malar erythema; no papules nor pustules are to be found. A touch of redness is seen on her chin. When I look at her, my differential includes erythematotelangiectatic rosacea and seborrhea; lupus and flushing syndromes run through the back of my mind as well. Would she have any scaling behind her ears? Would she complain of dandruff or itching in her scalp? Such findings may change my impression and/or treatment plan. Azelaic acid, metronidazole, and sulfa compounds are topical therapies often used for erythematotelangiectatic rosacea; all have fallen short of panacea status in my opinion. Laser and intense pulsed light (IPL) treatments would likely offer her the best reduction in erythema. J

Portrait of Porcupina Van Allen, oil on canvas, attributed to John Usher Parsons, (1806-1874).

W. Stephen Steiner, PA-C is employed by Marietta Dermatology Associates. He has worked in dermatology for the past twelve years. Outside of work, he enjoys woodworking and spending time with his wife and boys.

Write for the JDPA! Are you a PA who... • Is interested in writing? • Has a paper you want to get published? Share your knowledge today. Contact editor@jdpa.org 60 Journal of Dermatology for Physician Assistants

JDPA 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

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

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 4 • FALL 2013 61

Professional Opportunities and Development

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For more information on advertising opportunities in the JDPA, please log on to www.jdpa.org

We’re Celebrating 20 Years of the SDPA at the Annual Summer Dermatology Conference, May 29 - June 1, 2014 in Indianapolis.

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62 Journal of Dermatology for Physician Assistants

TOPICORT® (desoximetasone) Topical Spray, 0.25% Rx Only BRIEF SUMMARY 1 INDICATIONS AND USAGE Topicort® Topical Spray is a corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age or older. 4 CONTRAINDICATIONS None 5 WARNINGS AND PRECAUTIONS 5.1 Effect on Endocrine System Topicort® Topical Spray is a topical corticosteroid that has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Systemic absorption of topical corticosteroids can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid. In a study including 21 evaluable subjects 18 years of age or older with moderate to severe plaque psoriasis, adrenal suppression was identified in 1 out of 12 subjects having involvement of 10-15% of body surface area (BSA) and 2 out of 9 subjects having involvement of >15% of BSA after treatment with Topicort® Topical Spray twice a day for 28 days. [see Clinical Pharmacology (12.2)] Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of high potency steroids, larger treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure and young age. An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression. If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids. Cushing’s syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids. Use of more than one corticosteroid-containing product at the same time may increase the total systemic corticosteroid exposure. Pediatric patients may be more susceptible to systemic toxicity from use of topical corticosteroids. [see Use in Specific Populations (8.4)] 5.2 Local Adverse Reactions with Topical Corticosteroids Local adverse reactions may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Reactions may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. Some local adverse reactions may be irreversible. 5.3 Allergic Contact Dermatitis with Topical Corticosteroids Allergic contact dermatitis to any component of topical corticosteroids is usually diagnosed by a failure to heal rather than a clinical exacerbation. Clinical diagnosis of allergic contact dermatitis can be confirmed by patch testing. 5.4 Concomitant Skin Infections Concomitant skin infections should be treated with an appropriate antimicrobial agent. If the infection persists, Topicort® Topical Spray should be discontinued until the infection has been adequately treated. 5.5 Flammable Contents Topicort® Topical Spray is flammable; keep away from heat or flame. ADVERSE REACTIONS 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In randomized, multicenter, prospective vehicle-controlled clinical trials, subjects with moderate to severe plaque psoriasis of the body applied Topicort® Topical Spray or vehicle spray twice daily for 4 weeks. A total of 149 subjects applied Topicort® Topical Spray. Adverse reactions that occurred in ≥ 1% of subjects treated with Topicort® Topical Spray were application site dryness (2.7%), application site irritation (2.7%) and application site pruritus (2.0%). Another less common adverse reaction (<1% but >0.1%) was folliculitis.

Table 1. Number (%) of Subjects with Adverse Reactions Occurring in ≥ 1%

Number of Subjects with Adverse Reactions

Topicort® Topical Spray, 0.25% b.i.d. (N = 149)

Vehicle spray b.i.d. (N = 135)

13 (8.7%)

18 (13.3%)

Application site dryness

4 (2.7%)

7 (5.2%)

Application site irritation

4 (2.7%)

5 (3.7%)

Application site pruritus

3 (2.0%)

5 (3.7%)

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Teratogenic Effects: Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. Topicort® Topical Spray should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Desoximetasone has been shown to be teratogenic and embryotoxic in mice, rats, and rabbits when given by subcutaneous or dermal routes of administration at doses 3 to 30 times the human dose of Topicort® Topical Spray based on a body surface area comparison. 8.3 Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Because many drugs are excreted in human milk, caution should be exercised when Topicort® Topical Spray is administered to a nursing woman. If used during lactation, Topicort® Topical Spray should not be applied on the chest to avoid accidental ingestion by the infant. 8.4 Pediatric Use Safety and effectiveness of Topicort® Topical Spray in patients younger than 18 years of age have not been studied; therefore use in pediatric patients is not recommended. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing’s syndrome when they are treated with topical corticosteroids. They are therefore at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children. [see Warnings and Precautions (5.1)] HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. [see Warnings and Precautions (5.1)] 8.5 Geriatric Use Clinical studies of Topicort® Topical Spray did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. 10 OVERDOSAGE Topicort® Topical Spray can be absorbed in sufficient amounts to produce systemic effects. [see Warnings and Precautions (5.1)] 17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information and Instructions for Use) Inform patients of the following: • Use this medication as directed by the physician. • Topicort® Topical Spray is for external use only. Avoid use on the face, axilla or groin. • Do not use this medication for any disorder other than that for which it was prescribed. • Do not bandage or otherwise cover or wrap the treated skin so as to be occlusive. • Report any signs of local or systemic adverse reactions to the physician. • Do not use other corticosteroid-containing products with Topicort® Topical Spray without first consulting with the physician. • Discontinue therapy when control is achieved. If no improvement is seen within 4 weeks, contact the physician. • This medication is flammable; avoid heat, flame, or smoking when applying this product. • Discard this product 30 days after dispensed by pharmacist. Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1 Dist. by: TaroPharma® a division of Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532 Revised: April 2013 AD100-0030

Volume 7 • number 4 • FALL 2013 63

A CLASS 1, SUPER-POTENT SPRAY For plaque psoriasis

Important Safety Information • Topicort® Topical Spray is a topical corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age or older. • Topicort® Topical Spray is a topical corticosteroid that has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis. • Systemic absorption of topical corticosteroids can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid. • Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. • Local adverse reactions may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Reactions may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. Some local reactions may be irreversible. • Safety and effectiveness of Topicort® Topical Spray in patients younger than 18 years of age have not been studied; therefore use in pediatric patients is not recommended. ®

64 Journal of Dermatology for Physician Assistants

AD100-0033

July 2013