Summer 2013 Journal of Dermatology for Physician Assistants by Angela Simiele

DPA J

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

Journal of Dermatology for Physician Assistants

dermatology Pa news & notes

Student Corner 18 __________________________________

clinical dermatology Dermoscopy 28 __________________________________

Surgical dermatology Journal Club

_________________________________

Cosmetic dermatology Cosmetic Pearls

_____________________________ professional development

›› Earn CME credit with this issue CME Allergic Contact Dermatitis from Topical Corticosteroids 19

An Innovative Dermatology Education Tool for Physician Assistants 42

Official Journal of the Society of Dermatology Physician Assistants

Volume 7 • number 3 • Summer 2013

The need is great. The patient is waiting. Get involved. www.PassionToHeal.com

Passion to Heal is a registered servicemark of Medicis, a division of Valeant Pharmaceuticals SER 12-076B

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 3 • Summer 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 3, Summer 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

Made in the SDPA

s Americans, there is a certain pride in knowing that we are supporting our fellow citizens and their jobs when we purchase items that are “Made in the USA.” Upon leaving the most recent SDPA Summer Conference, I was once again reminded of how proud I am of being involved in such an outstanding organization. During my days spent working in clinic, I proudly wear my SDPA lapel pin. Occasionally, I have patients ask about its origins, and I am happy to explain to them what the SDPA is and share with them some of the great accomplishments that our Society has attained through the hard work and volunteer hours of so many of our members. Recently the SDPA leadership, in conjunction with the AAPA, put out a call to action regarding an AMA resolution that would have added language about surgery (including laser and cryotherapy) placing more restrictions on PAs than many current state laws. Thanks to the efforts of our SDPA Board of Directors who sent a letter to the Chairman of the AMA Board of Trustees and of our fellow members who sprang into action calling local AMA representatives, the AMA Board was convinced to remove all language restricting surgery from the resolution. The input from many PAs was cited as a key reason for the AMA’s reconsideration. It is with great appreciation that I say “thank you” to all who had a hand in bringing about this change. Working together as an organization, leadership and membership combined, we have the ability to continue to make great positive changes within the healthcare system as well as the field of dermatology. There will continue to be new issues that arise requiring us to work together in overcoming obstacles, improving our profession, and achieving our goals. I have no doubt that together, wearing our SDPA lapel pins with pride, we will continue to move our profession forward. J

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

Volume 7 • number 3 • Summer 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.

19 Allergic Contact Dermatitis from Topical Corticosteroids By Robin Person, MPAS, PA-C and Karen Graham, PhD, MPAS, PA-C

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

19 Clinical Dermatology

Departments

03 JDPA Information for Authors 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 34 Clinical Snapshots 37 Surgical Wisdom 41 Cosmetic Pearls 46 Outside & Inside the 9 to 5... 47 Notes from your Office Manager 51 The Difference We Make 54 Now Showing on Dermcast.tv 56 Dermatology in Art 58 Professional Opportunities and Development

• CME Article – Allergic Contact Dermatitis from Topical Corticosteroids • Dermoscopy

36 Surgical Dermatology • Journal Club: Practice Changing Articles for Dermatology PAs

40 Cosmetic Dermatology • Journal Club: Practice Changing Articles for Dermatology PAs

42 Professional Development • An Innovative Dermatology Education Tool for Physician Assistants • Dermatology Billing & Coding

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

On the Cover: Photograph by J. Desiree Douglas, MPA, PA-C for the JDPA

Go Green - Read Online 6

Journal of Dermatology for Physician Assistants

dermpa.org

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Indication: Kenalog® Spray (triamcinolone acetonide topical aerosol, USP) is indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Important Safety Information: Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients. Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see PRECAUTIONS, Pediatric Use). You are encouraged to report negative side effects of prescription drugs to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch For topical use only. Please see adjacent page for full prescribing information. For more information, visit www.kenalogspray.com Reference: 1. Data on file. Ranbaxy Laboratories, Inc. Princeton, NJ. * After spraying, the nonvolatile vehicle remaining on the skin contains approximately 0.2% triamcinolone acetonide. Each gram of spray provides 0.147 mg triamcinolone acetonide in a vehicle of isopropyl palmitate, dehydrated alcohol (10.3%), and isobutane propellant. KENALOG® is a licensed trademark of Bristol-Myers Squibb Company. KS 1212

Volume 7 • number 3 • Summer 2013

Journal of Dermatology for Physician Assistants

FROM THE SDPA

News & Current Affairs

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

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

just returned from the 2013 Summer SDPA Conference in St. Louis, MO. It was a very busy week, exhausting and energizing all at the same time. The Board members and Committee Chairs held a Leadership Summit to review what we have done and how we plan to take the SDPA into the future. We have a total of 13 standing committees, all working to educate our members, educate the public and physicians, keep track of legislative issues that may affect us or our patients, support the state societies that may be better able to respond to those same legislative issues, and so on. We are now the largest specialty constituent organization of the AAPA. If you communicate with a leader of the SDPA either at a conference or via email be sure to thank them. The Committee Chairs, especially, put a great deal of effort into the SDPA. Even better than just thanking them, consider volunteering to be a member of a committee. Time is consistently listed as the biggest barrier to volunteering, but a small investment of time by many will reduce the time requirements of a few. As a committee member, you can participate as much or as little as you are able. You can even do this without joining a specific committee. I first got involved by agreeing to spend a few hours in the SDPA public relations booth in the exhibit hall at the AAD meeting. It was a great way to meet people, and I had a kick doing so. I am a bit shy by nature, and it was much easier to have people coming to me rather than having to approach others. Some of the people I met were the leaders of the SDPA who were there networking and meeting with the Board of the AAD. This type of networking leads to opportunities. One such opportunity for me was that I became involved in writing. At first I contributed a paragraph or two for a press release, and it grew from there. I have now had the opportunity to be published in several places including JAAPA, the JDPA, Dermatology World, and soon Derm Perspectives. I was also involved in editing and question writing for our own Comprehensive Review Notes. It all started with baby steps. The quality of CME at the SDPA Summer Conference was topnotch as usual. I overheard one speaker comment that we had the best and brightest of St. Louis lecturing for us. That is what it is all about. Our Society exists to educate and support our members in order to improve the care of our patients. We want the best and brightest teaching us the latest and greatest. Kudos to the SDPA CME Committee for putting it all together. High quality CME benefits everyone. Our members get education and CME credit. Those who lecture see the quality of our meetings and that increases respect for dermatology PAs in general and SDPA members in particular. The pharmaceutical companies see the numbers of PAs drawn to our meetings and want to be involved with the conferences, which supports both the SDPA and the dermatology PA community at large. There is a place for all to play a role, large or small. In which part of the success of the SDPA do you want to be involved? J

Jennifer Winter, PA-C

SDPA President, Diplomate

Volume 7 • number 3 • Summer 2013

Dermatology PA news & notes

Dermatology Market Watch Two New GSK Oral Oncology Treatments Approved by FDA as Single-Agent Therapies Two new drugs have been approved by the US Food and Drug Administration (FDA) for use in certain patients with metastatic or unresectable melanoma, along with a diagnostic test to identify patients who are suitable for treatment. The new products, dabrafenib (Tafinalar) and trametinib (Mekinist), were both developed by GlaxoSmithKline (GSK). Both are orally available tablets, but they have slightly different mechanisms of action. Dabrafenib acts as a BRAF inhibitor and is approved for use in patients with melanoma whose tumors express the BRAF V600E gene mutation. It is seen as being a next-generation product but is in the same class as the first BRAF inhibitor to reach the market, vemurafenib (Zelboraf, Genentech). Trametinib has a related but slightly different mechanism and acts as a mitogen-activated, extracellular signal-regulated kinase inhibitor (MEK inhibitor). It is the first drug in this class to be approved and is indicated for use in patients with whose tumors express the BRAF V600E or V600K gene mutations. Approximately half of melanomas arising in the skin have a BRAF gene mutation, the FDA notes in its approval notice. Melanoma is the leading cause of death from skin disease, the FDA adds. The National Cancer Institute estimates 76,690 Americans will be diagnosed with melanoma and 9,480 will die from the disease in 2013. Dabrafenib and Trametinib Approved for Metastatic Melanoma. Medscape. May 29, 2013.

New AAD Dermatology A to Z App Skin health and beauty tips are now available at your fingertips with the new Dermatology A to Z mobile app from the American Academy of Dermatology (AAD). The app, available at no cost at www.dermapp.net, the Apple Store, and Google Play, also provides information on diseases and treatments. All content is reviewed and approved by board-certified dermatologists. Other features of the app include: • State-of-the-art real-time UV index based on the geographic location of the device (UV index also available by zip code search). • Find-a-dermatologist search tool based on the geographic location of the device or by city and state or zip code. • Feed of the Academy’s monthly Skin E-News to provide the latest news in skin care. More information on the Dermatology A to Z app is available at www.dermapp.net. 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 3 • Summer 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 Onychomycosis

Rediscovering Topical Antifungal Therapy By John V Notabartolo, MPAS, PA-C

The Development Of A New Topical Antifungal

Efinaconazole 10% solution is the first triazole antifungal specifically developed for topical treatment of mild to moderate distal lateral subungual onychomycosis (DLSO). It may be the first topical treatment for DLSO to be considered a viable alternative to oral treatment.9 Efinaconazole inhibits ergosterol biosynthesis, and has been shown to exhibit a similar or more potent in vitro antifungal activity compared to existing agents against a broad range of pathogens.10,11 The low surface tension of the alcohol-based formulation helps efinaconazole to penetrate through the nail plate, access the nail bed by wicking into the air gap, and spread over the site of infection.12

Assessing Efficacy In Onychomycosis

Mycologic cure (eradication of the causative organism) is the only consistently defined efficacy parameter in onychomycosis trials, and was the main treatment goal.13,14 Other efficacy parameters reported in trials include complete cure (0% clinical involvement of target toenail in addition to mycologic cure), and various levels of ‘treatment success’ ranging from 0-20% affected target toenail involvement. Baseline severity is also important; in a patient with moderate onychomycosis (40% affected target toenail at baseline) a 50% improvement may not record as a ‘treatment success’, but may be a very relevant outcome.

Onychomycosis often needs prolonged therapy to achieve resolution. Another limitation of many clinical studies could be the relatively short duration of treatment given, the slow growth of the toenail, and longer treatment or follow-up resulting in further improvement.15,16

Efinaconazole: Phase 2 Study

A multicenter, randomized, double-blind vehiclecontrolled study in 135 patients with mild to moderate DLSO. Subjects randomized (2:2:2:1 ratio) to receive efinaconazole 10% solution (with or without semiocclusion), efinaconazole 5% solution, or vehicle, once daily for 36 weeks, with one post-treatment follow-up (Week 40).17 Complete cure was numerically higher in all active groups (16-26%) versus vehicle (9%) at followup. Efinaconazole provided effective treatment for the majority of onychomycosis patients; mycologic cure ranged from 83-87%, and clinical efficacy and treatment effectiveness was significantly greater compared to vehicle. Adverse events were generally similar and mild. Local-site reactions were restricted to few patients, not differing meaningfully across groups.17

Efinaconazole 10% Solution: Phase 3 Studies

Two multicenter, randomized, double-blind vehiclecontrolled studies in 1,655 patients with mild to moderate DLSO were conducted. Patients were randomized (3:1 ratio) to receive efinaconazole 10% solution or vehicle, once daily for 48 weeks, with one post-treatment followup (Week 52).9 Mycologic cure rates were comparable to those reported for oral itraconazole. Over 56% of patients on efinaconazole 10% solution had mycologic cure at Week 52, compared to 16.6% on vehicle (P<.001), and 54% reported with oral itraconazole.17 Overall, 18.5% of patients on efinaconazole 10% solution had complete cure at Week 52 compared to 4.7% of subjects on vehicle (P<.001). Treatment benefit was statistically significant (P=0.021) from Week 36. Cure rate was better than reported for oral itraconazole (14%), and 2-3 orders of magnitude greater than reported with ciclopirox lacquer (7%).17,18 Clinical treatment success (≤10% affected toenail Volume 7 • number 3 • Summer 2013 13

DERmatology pa news & notes

Onychomycosis is the most common nail disorder in adults.1 It is a progressive disease, frequently affecting the toenails, and often involving several nails.2-4 Symptoms range from mild and superficial, causing discoloration of the nail plate, to severe, resulting in loss of the nail plate and deformity of affected areas. Onychomycosis should not be considered a cosmetic problem. Its impact on individuals can be significant.5 Many patients suffer from long-lasting disease that may be a source of more widespread fungal lesions, spreading to other nails, body areas, and even family members.6 Despite recent advances, it remains a difficult condition to treat successfully. Treatment options range from topical care without systemic side effects but decreased efficacy, to highly effective systemic treatments with side effect concerns.7,8

involvement) was seen in 47% of patients. Given that the majority of patients had ≥40% affected toenail involvement at baseline this represents a clinically meaningful improvement for many patients. As expected for a topical agent, efinaconazole 10% solution was found to be safe, with mild, transient irritation at the site of application reported as the most common adverse event in 2% of patients.9

DERmatology pa news & notes

Conclusion Toenail onychomycosis is challenging to treat, and most of the patients studied in the efinaconazole clinical trials had long-standing and widespread disease illustrated by the disease duration and number of nails involved. Oral antifungal agents are the most effective treatment options currently available.19,20 Efficacy with current topical treatment has been disappointing, advocating use in superficial white onychomycosis, and in very early cases of DSLO where infection is limited to the distal edge of the nail plate or where oral antifungal medication is contraindicated.21 Efinaconazole 10% solution provides the first viable alternative to oral therapy for onychomycosis. Mycologic cure rates are comparable to those seen with oral itraconazole, and 2-3 orders of magnitude greater than reported with ciclopirox lacquer. J REFERENCES: 1. Gupta AK, Jain HC, Lynde CW, et al. Prevalence and epidemiology of onychomycosis in patients visiting physicians’ offices: a multicenter canadian survey of 15,000 patients. J Am Acad Dermatol 2000; 43: 244-8. 2. Szepietowski JC, Reich A, Garlowska E, et al. Factors influencing coexistence of toenail onychomycosis with tinea pedis and other dermatomycoses: a survey of 2761 patients, Arch Dermatol, 2006;142:1279–84. 3. Roberts DT. Onychomycosis: current treatment and future challenges, Br J Dermatol, 1999;141(Suppl. 56):1–4. 4. Szepietowski JC. Selected clinical aspects of onychomycosis, Mikol Lek, 2004;11:119–28. 5. Scher RK. Onychomycosis: a significant medical disorder. J Am Acad Dermatol 1996;35(3 Pt 2):S2–5. 6. Seebacher C, Brasch J, Abeck D, et al. Onychomycosis. Mycoses 2007;50:321-7. 7. Jones ED. Onychomycosis: Current treatment options, J Am Acad Nurse Practictioners 2003;15(4):165-169. 8. Gunt HB, Kasting GB. Effect of hydration on the permeation of ketoconazole through human nail plate in vitro. Eu J Pharma Sci. 2007; 32: 254–260. 9. Elewski BE, Rich P, Pollak R, et al. Efinaconazole 10% solution in the treatment of toenail onychomycosis: two phase 3 multicenter, randomized, double-blind studies. J Am Acad Dermatol 2012. Published on line November 20, 2012. 10. Tasumi Y, Nagashima M, Shibanushi T, et al. Mechanism of antifungal action of efinaconazole, a novel triazole agent. In press. 11. Jo Siu WJ, Tatsumi Y, Senda H, et al. Comparison of in vitro antifungal activities of efinaconazole and currently available antifungal agents against a variety of pathogenic fungi associated with onychomycosis. In press. 12. Joseph WS, Vlahovic TC, Pillai R, et al. Efinaconazole 10% Solution in the Treatment of Onychomycosis of the Toenails. In press. 13. Werschler WP, Bondar G, Armstrong D. Assessing treatment outcomes in toenail onychomycosis clinical trials. Am J Clin Dermatol 2004;5:145-152. 14. Gupta AK. Treatment of dermatophyte toenail onychomycosis in the United States: a pharmacoeconomic analysis. J Am Podiatr Med Assoc 2002;92:272-286. 15. Epstein E. How often does oral treatment of toenail onychomycosis produce a 14 Journal of Dermatology for Physician Assistants

disease-free nail? An analysis of published data. Arch Dermatol 1998;134:15511554. 16. Sigurgeirsson B, Billstein S, Rantanen T, et al. LION Study: efficacy and tolerability of continuous terbinafine (Lamisil) compared to intermittent itraconazole in the treatment of toenail onychomycosis: Lamisil vs itraconazole in onychomycosis. Br J Dermatol 1999;141 (suppl):5-14. 17. Tschen EH, Bucko AD, Oizumi N, et al., Efinaconazole solution in the treatment of toenail onychomycosis: a phase 2, multicenter, randomized, double-blind study. J Drugs Dermatol, 2013;12(2):186-192. 18. Sporanox (itraconazole) [package insert]. Janssen Pharmaceuticals Inc, Titusville, NJ; 2012. 19. Gupta AK, Joseph WS. Ciclopirox 8% nail lacquer in the treatment of onychomycosis of the toenails in the United States. J Am Podiatr Med Assoc 2000; 90:495–501. 20. Elewski BE. Onychomycosis: treatment, quality of life, and economic issues. Am J Clin Dermatol. 2000;1:19–26. 21. Gupta AK, Tu LQ. Therapies for onychomycosis: a review. Dermatologic Clinics 2006;24:375–379. 22. Iorrizo M, Piraccini BM, Rech G, et al. Treatment of onychomycosis with oral antifungal agents. Expert Opinion on Drug Delivery 2005;2:435–440. John V Notabartolo, MPAS, PA-C graduated in 1998 from University of Nebraska through the first Interservice PA program at Fort Sam Houston TX, receiving his Master of PA Studies in 1999. He has practiced dermatology in Las Vegas, NV for over 12 years. Mr. Notabartolo has attended Advisory Boards with Valeant Dermatology. Acknowledgement: Brian Bulley, MSc (Inergy Limited, UK) assisted with the preparation of this manuscript. Medicis, a division of Valeant Pharmaceuticals, funded Inergy’s activities pertaining to this manuscript.

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!

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

*FOR ATLANTA ATTENDEES ONLY MUST REGISTER ONSITE IN ATLANTA

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.

Registration Now Open!

ATLANTA FALL 2013 CONFERENCE Intercontinental Buckhead November 13-16, 2013

For more information visit dermpa.org Volume 7 • number 3 • Summer 2013 15

DERmatology pa news & notes

EXPLANATION: Borderline personality disorder is characterized by instability of interpersonal relationships; marked impulsivity that is potentially self-damaging; inappropriate, intense anger or control of anger; recurrent suicidal attempts, gestures or threats; and identity disturbances. Generalized anxiety disorder is characterized by apprehension, worry, irritability, difficulty concentrating,

insomnia, and somatic complaints on most days for at least six months. Schizophreniform disorder symptoms are similar to schizophrenia: social withdrawal, massive disruption of thinking, mood, and overall behavior as well as poor filtering of stimuli; but the duration of symptoms is greater than a week and less than six months. Bipolar disorder presents with episodes of mania and depression. J The correct answer is A.

QUESTION: A 26 year-old woman presents with a three year history of sexual promiscuity and substance abuse. She frequently expresses anger when she feels abandoned and she can have difficulty controlling that anger. Her past relationships have been intense and short-lived. She has attempted suicide twice in the past two years. Which of the following is the most likely diagnosis? A. Borderline personality disorder B. Generalized anxiety disorder C. Schizophreniform disorder D. Bipolar disorder

SDPA State Affiliates Round Table Discussion Interacting with Your Local State Dermatology Medical Societies

DERmatology pa news & notes

The purpose of this SDPA State Affiliates round table discussion is to provide state chapters guidance in ways they can best interact with local state dermatology medical societies. Leading the discussion panel is Joleen M Volz, MPAS, PA-C, SDPA Secretary/Treasurer and former SDPA Constituent Relations Committee Chair. She is joined at this round table by Renata Block, MMS, PA-C, SDPA Constituent Relations Committee Chair and Immediate Past President of the Illinois Society of Dermatology Physician Assistants (ISDPA) and Jacki Kment, MPAS, PA-C, Founder and Immediate Past President of Nebraska Dermatology Physician Assistants.

Joleen M Volz, MPAS, PA-C

Jacki Kment, MPAS, PA-C

Renata M. Block, MMS, PA-C

SDPA Secretary/Treasurer SDPA Constituent Relations Committee Board Advisor

SDPA Vice President Founder and Immediate Past President of Nebraska Dermatology Physician Assistants

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

JOLEEN - Are PAs within your state allowed to attend local dermatology medical society meetings? RENATA - Yes. Within the past few years the Chicago Dermatological Society (CDS) has been slowly opening the doors and allowing dermatology PAs to attend some of their meetings. Diana Monaghan, the ISDPA PresidentElect for 2013, and her supervising physician made this happen, and we could not be more thankful. JACKI - PAs are not only allowed to attend the biannual meetings of the Nebraska Dermatology Society (NDS), but they are also invited to become members. Two years ago the NDS saw the need to add a mid-level practitioner to their Board of Directors, and I was honored to be the first mid-level practitioner appointed to this position. JOLEEN - Are PAs allowed to speak as lecturers at these events? RENATA - No. This is really disappointing. Illinois has such a strong nursing lobby, and many NPs and nurses are allowed to speak for the local dermatology chapter, but not PAs. I am hoping 2013 will be different as we continue to educate dermatologists regarding the benefits of dermatology PAs. JACKI - I have never been to an NDS meeting in which a PA has been the event speaker. Since the NDS only meets two times per year the speakers are generally out-of-state board-certified dermatologists who specialize in particular areas of interest. 16 Journal of Dermatology for Physician Assistants

JOLEEN - If your local dermatology medical society has a meeting, are you allowed to exhibit a booth and do you? RENATA - A few years ago, I met with the President of the CDS to introduce this concept. However, ironically, though a huge dermatology PA supporter herself, she thought it was "beneath" us to do so. Instead, we came up with a solution to have a power point presentation educating dermatologists about dermatology PAs. Excited, I put a presentation together, only to find out later that I could not present it as PAs are not allowed to speak at the meetings. This was very disappointing to me. However, it was the first time a President of the Society ever presented material on dermatology PAs. This was a huge step for us. JACKI - The Nebraska Dermatology Physician Assistants (NDPA) has never exhibited at a NDS meeting. The exhibitors are generally limited to pharmaceutical companies. JOLEEN - Could you use SDPA materials (pamphlets or media) to promote your state dermatology PA chapter? RENATA - SDPA materials are always wonderful, but I believe each state chapter should create their own. The ISDPA has made up an educational brochure to create awareness about dermatology PAs and educate the public in Illinois about skin cancer. It was wonderful because we received permission from the AAD to utilize their ABCDEs photos in the brochure. We handed out lip balms with SPF along with these brochures at various events we volunteered for, which helped increase awareness about the ISDPA. JACKI - The State of Nebraska is a very PA-friendly

JOLEEN – Has it been a challenge for your chapter to get the attention of your local dermatology medical society? If so, how did your chapter approach their resistance? RENATA - Yes. I feel there has been resistance, but it is slowly turning around. Developing a website for the ISDPA was key because it put us out there. It created a buzz and was noticed and praised by the local dermatology society. More and more dermatologists are seeking dermatology PAs and contact our chapter to ask questions about dermatology PAs and to post job opportunities on our website. JACKI - Fifteen years ago I became the first dermatology PA in Lincoln, Nebraska. At that time there were only three other dermatology PAs in the state (two in clinical practice and one in PA education). Therefore, this was a fairly new concept only fifteen years ago. However, in the past ten years our profession has grown by leaps and bounds, and dermatology PAs are now a norm in many dermatology practices throughout the state. In our practice alone we have five dermatology PAs and two dermatologists. Although there was some resistance early on, it has become less over the years with continued education and on-going excellent patient care by dermatology PAs within our state. The NDPA was founded in June 2010, and so we do not have a long history. It is amazing to see that fifteen years ago there were only four dermatology PAs in our state, and just three years ago a need arose for a statewide organization to support the increasing number of PAs practicing in the specialty of dermatology in the State of Nebraska. Amazing progress! J

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

*CME hours are approximate Benefits_sign_JDPA_HalfPage.indd 1

10/12/12 9:46 AM Volume 7 • number 3 • Summer 2013 17

DERmatology pa news & notes

state, and PAs have good relationships with most of the dermatologists within our state. This has been shown by the NDS adding a mid-level board member to their Board of Directors. However, SDPA promotional/educational materials would be useful for those who still have questions regarding the utilization of dermatology PAs and for those who wish to add a PA to their practice. JOLEEN – Are dermatology PAs allowed to volunteer at local dermatology medical society events? RENATA - Yes. The ISDPA was welcome to volunteer with the CDS at the AAD Skin Cancer Screening on North Avenue Beach in Chicago. Medicis was the sponsor of the event. I had personally met with the company’s representatives the year before to encourage them to support such an event because of their strong support of dermatology PAs. As the President of the ISDPA, I was interviewed at the event on one of the days that I volunteered, and the interview will be featured as part of the Medicis proactive approach to educating the community. JACKI - Nebraska dermatology PAs are allowed and strongly encouraged to participate in state dermatology medical society events such as skin cancer screenings and public awareness events. For instance, on February 8, 2013 the NDS sponsored an Advocacy Day at the Nebraska State Capitol, and dermatology PAs were highly encouraged to participate. The NDPA is also co-sponsoring an anti-tanning bill in our state legislature with the NDS this year. We have been actively involved in this legislation by participating on this project’s task force and providing support for such an important venture.

Student Corner

Call for SDPA Junior Student Coordinator Applicants

DERmatology pa news & notes

Here is your chance to become involved in the PA professional community. The SDPA is currently accepting applications for the Junior Student Coordinator position. The deadline is September 1, 2013. This position is a 3-year commitment. The selected applicant will spend his/her first year as Junior Student Coordinator (first year PA-S), then advance to Senior Student Coordinator (second year PA-S), and finish the commitment with a year serving as Recent Graduate Advisor.

Distance Learning Initiative, the job listings and resume posting services, as well as opportunities to become more involved in the leadership and direction of your chosen profession as PAs. The SDPA encourages everyone who is interested in dermatology to join as a student member for just $25, to receive all of the wonderful opportunities (join now at www. dermpa.org/members).

If you are interested in becoming involved in the SDPA as a Junior Student Coordiantor please visit the SDPA student website, and click on, “How to Some of the responsibilities of Become the Student Coordinator the position include participation Inaugural SDPA Student Affairs Committee. From left to right: Stephanie Cohen, MMS, PA-C; Marc Kawohl, PA-S; and of the SDPA” in order to in monthly conference calls with Sara Wilchowski, PA-C (former Recent Graduate Adviser). download the application (www. the SDPA Board of Directors dermpa.org/students/student-coordinator). If you have and other Committee Chairs, attending yearly SDPA any questions, please contact Marc Kawohl, PA-S, SDPA conferences, and facilitating student involvement in the Student Affairs Committee Senior Student Coordinator at SDPA. Considering how busy PA school can be, the Junior J mkawohl@dermpa.org. Student Coordinator, Senior Student Coordinator, and Recent Graduate Advisor all work together to ensure the proper balance of responsibilities.

Thank you,

Applicants interested in the Junior Student Coordinator position must be a SDPA student member. Some of the benefits of becoming a SDPA student member include having access to the Journal of Dermatology for Physician Assistants (the official and peer reviewed journal of the SDPA), access to the interactive online content through the

SDPA Student Affairs Committee Senior Student Coordinator

Marc Kawohl, PA-S Stephanie Cohen, MMS, PA-C SDPA Student Affairs Committee Recent Graduate Adviser

Jennifer Winter, PA-C SDPA President, Diplomate

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 18 Journal of Dermatology for Physician Assistants

JDPA Journal of Dermatology for Physician Assistants

Clinical Dermatology

Allergic Contact Dermatitis from Topical Corticosteroids By Robin Person, MPAS, PA-C and Karen Graham, PhD, MPAS, PA-C

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

›› CME

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

Approval is valid for 1 year from the issue date of July 2013. Participants may submit the self-assessment exam at any time during that period. This program was planned in accordance with AAPA’s CME Standards for Enduring Material Programs and for Commercial Support of Enduring Material Programs.

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

Learning Objectives: 1) Understand the risks of developing allergic contact dermatitis (ACD) to topical corticosteroids 2) Review the structural classification of corticosteroids 3) Discuss the pathogenesis of ACD and the process of patch testing 4) Identify the challenges of diagnosing ACD to topical corticosteroids utilizing patch testing Volume 7 • number 3 • Summer 2013 19

Allergic Contact Dermatitis from Topical Corticosteroids 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

Allergic Contact Dermatitis from Topical Corticosteroids 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 â&#x20AC;˘ number 3 â&#x20AC;˘ Summer 2013 21

Allergic Contact Dermatitis from Topical Corticosteroids 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

Allergic Contact Dermatitis from Topical Corticosteroids SDPA Members Only Content

Robin M Person, MPAS, PA-C has practiced dermatology for four years with Dr. Ronald L Smits at the North Texas VA in Bonham, Texas. She received her Bachelor’s degree from the University of Texas Health Science Center in Forth Worth in Physician Assistant Studies and obtained her Master’s degree in Physician Assistant Studies from the University of Nebraska. She also completed the Physician Assistant Fellowship Program in Dermatology through the University of Texas Southwestern Medical Center at Dallas and completed the dermatology Diplomate program through the Society of Dermatology Physician Assistants. She has indicated no relationships to disclose relating to the content of this article. Karen Graham, PhD, MPAS, PA-C is an associate clinical professor at the University of Wisconsin-La Crosse-GundersenMayo Physician Assistant Program, where she teaches courses in evidence-based medicine and clinical practice skills. She received her Master’s degree from the University of Iowa in Physician Assistant Studies and her PhD in Higher Education Administration from the University of Toledo. She has indicated no relationships to disclose relating to the content of this article.

Dermatopathology Q A By Dipti Anand, MD

Q: A 56 year-old male presents with scaly erythematous plaques involving his cheeks and ears. The clinical impression is seborrheic dermatitis versus lupus erythematosus. The histologic diagnosis is seborrheic dermatitis. Which one of the two histologic findings did the biopsy from his left cheek show?

B Under the microscope [H&E stain (400 x)]

Answer on page 27 Volume 7 • number 3 • Summer 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 A Son’s Words Shared

The Midwest Melanoma Partnership’s Inaugural Melanoma Symposium March 24, 2012

CLINIC AL Dermatology

By Scott Raecker Thank you Dr. Milhem and Dr. Weiner for the (ALD). As we watched the movie I thought about this invitation to say a few words today at the Midwest Melanoma symposium. The parents set out on a mission to find a Partnership’s first Melanoma Symposium. I am honored to treatment to save their child. Throughout their quest, they be invited. I have been thinking for months about what I clashed with doctors, scientists, and support groups, who wanted to say to you today, and it was not until yesterday were skeptical that anything could be done for ALD, much afternoon when I spoke with my mom that my thoughts less by laypeople. But the parents persisted, setting up came to mind. camp in medical libraries, reviewing animal experiments, badgering researchers, questioning top doctors all over the In July of 2008 my dad was diagnosed with Stage IV world, and even organizing an international symposium Melanoma with no external source point ever identified. It about the disease. was in that month that my father and our family met Dr. Milhem. My father was a man Despite dead ends of of science, an accomplished research, the horror of watching “(Dr. Milhem) has correlated my disease and recognized dentist, and their son's health decline, and a man of faith who believed to a runaway railroad train, racing for the being surrounded by skeptics, that “…God causes all things they persisted until they finally to work together for good to hit upon a therapy involving station. It can either crash at full speed or those who love Him, to those adding a certain kind of oil hopefully, be slowed for a more gentle who are called according to His (actually an oil containing two purpose.” I share this with you, specific long chain fatty acids), arrival - he is trying to slow the train.” because I remember the day both isolated from rapeseed that we sat with Dr. Milhem at oil and olive oil to their son's the University of Iowa Hospitals and Clinics and discussed diet. Miracle! Lorenzo’s Oil has extended thousands of lives the science of melanoma, the faith necessary to approach beyond expectations. The lessons I took away and the reason treatment, and the research necessary to find a cure. I I thought of you were two-fold. First, the researchers of that remember it like it was yesterday; in fact, it was Wednesday, time were in silos doing their work and lacked collaboration, July 30th 2008. Like my dad, I pay attention to details. innovation, creativity, and listening for the simple within the complex. Second, there is this great scene in the movie I remember our family talking about how unbelievable where the researchers at the symposium are visiting during it is that with all of the wonderful progress and awareness a social gathering and drawing rich discussion on the of so many cancers such as breast cancer and prostate connectivity between and among their efforts. cancer that there are still cancers such as melanoma and pancreatic cancer that we are still in the dark ages of I believe there may be two or three or four of you at this research with standard treatment protocols that are decades symposium who have never had the time to connect before. old. I remember when Dad asked Dr. Milhem, "Where do you go to meet your peers and learn about the most recent advances in research?" His answer, "We don't." In some small part, it is from that discussion that you are all here today. My father would believe that it is not happenstance, but for a purpose that you have been drawn together. I am not a man of science. I don’t understand the world you work in. I am a director of a non-profit organization, a state legislator, a husband, father, and son. In my worlds, I have come to understand and appreciate the essential necessities It is the mission of the Midwest  Melanoma Partnership to facilitate the sharing of ideas, clinical trials, and resources in an of collaboration and leverage to accomplish the tasks that effort to improve the diagnosis, treatment, and long- term care on the surface seem impossible. of melanoma patients. My son is taking advanced biology in high school Contact Information: www.midwestmelanoma.org and had a recent project that included watching the movie Anyone interested in becoming a member, making a donation, Lorenzo's Oil. I highly recommend it. If you don’t know or who has questions can contact the MMP Administrative the story, it is about a family’s unending quest to find an Coordinating center at rstmmpadmin@mayo.edu. answer for their son’s rare disease, adrenoleukodystrophy 24 Journal of Dermatology for Physician Assistants

Your lives are so full with the day-to-day demands on your time and the pressure of balancing the business of being a doctor and a researcher (let alone the compassion of caring for patients) that you have not had the time to share notes, to correlate data, or to learn from each other what may be the possible from the impossible. What may be possible from the impossible made me think of polio, Jonas Salk, and Albert Sabin. I believe that the Salks and Sabins of melanoma may be in this room. And if not, then the John Enders, Fredrick Robbins, and Thomas Wellers of melanoma research may be in this room. You know them of course. Years before Salk or Sabin, it was this group of three researchers who had a breakthrough in 1948 when they successfully cultivated the poliovirus in human tissue in the laboratory. In March 1948, Weller was attempting to grow varicella virus in embryonic lung tissue. He had inoculated the planned number of tubes when he noticed that there were a few unused tubes. He retrieved a sample of mouse brain infected with polio virus and added it to the remaining test tubes on the off chance that the virus might grow. The varicella cultures failed to grow, but the polio cultures were successful. This development greatly facilitated vaccine research and ultimately allowed for the development of vaccines against polio. Enders and his colleagues were recognized in 1954 for their labors with a Nobel Prize in Physiology or Medicine. I look out on this esteemed group, and I wonder to myself, “Which of you see yourself as Salk or Enders?” Who among you will it be? Then I think, “Maybe it will not be one among you, but two or a group of you who meet at this symposium, strike up a relationship, get each other’s cards, and make a commitment to connect.” Which of you are using the mouse brain, the rape seed, or the olive oil of today that will allow you to stumble upon the missing step that unlocks the new treatment that extends quality of life or provides the cure itself? Which of you will have grandchildren who will speak with pride of their grandfather or grandmother who won the Nobel Prize for finding the cure for melanoma? Is it you? I believe it is. And this is why. You are here. Each of you has a vision of that day or you would not be here, and this would not be your life’s work. So this is what I want to share with you. I want you to be inspired. I want you to be challenged. I want you to build bridges that break down barriers. I want you to work together. I want you to not be satisfied with the opportunity to extend the quality of life; I want you to hunger with an unquenching desire to save lives. I want you to wake every morning with words like determination, grit, perseverance, creativity, curiosity, drive, imagination, and courage as the starting point and guiding focus of your day. Towards the end of my dad’s eighteen-month battle he wrote this in an e-mail: “Dr. Milhem says, ‘Even though there is no reason for you to be alive, I did give you hair’ - he is funny. He has correlated my disease to a runaway

railroad train, racing for the station. It can either crash at full speed or hopefully, be slowed for a more gentle arrival - he is trying to slow the train.” Our family believes that Dr. Milhem gave our family a tremendous gift by extending my dad’s life beyond expectations and by bringing the train into the station as slowly as he could, and we are forever grateful. We are also inspired to ask you for more. How can you use the experiences of patients like my dad, not to slow or stop the train, but to get the train off the tracks in the first place? I want you to know that each one of you individually, working together collectively, has the capacity to change the world. As I said, I don’t comprehend the complexities of the science of melanoma. Another e-mail from my dad stated, “Dr. Milhem continues to believe ‘something’ is impacting the growth pattern - and he would like me to continue with the experimental chemo treatment. At this time that includes a combination of an HIV-inhibitor and an antirejection drug for organ transplants. And if nothing else, I believe my continued treatment may lead to advances that will help other people.” That was the day that Dr. Milhem told my dad he was a “hero.” That was also the day that Dad told Dr. Milhem that he would make him famous for helping him find the cure. Every person in this room is a hero, as was my father. I close today with words directly to you from my father, a portion of his final update to his family that was delivered by our family pastor after Dad had left this world for the next. “We have fought the good fight against cancer but we are losing. I have friends who are winning the race against cancer and for that I am grateful. I have also lost many friends to this disease. I have not been praying that cancer would leave my body; I have prayed to accept whatever happens. The time came when I knew I was not going to have a cure. I wanted instead to have the faith to accept all things with God at my side. I also prayed for Dr. Milhem at the University of Iowa as he is working on ways to cure melanoma so none of my children or grandchildren will go through what I have. I prayed that when my grandchildren are my age, cancer will be cured just as polio was conquered.” Thank you for this honor. J Scott Raecker sserves as Executive Director of Character Counts In Iowa (CCII) – a position he has held since the organization was founded in 1997. Scott’s commitment to positively impact Iowa was also reflected in his 14 years of public service as a member of the Iowa House of Representatives from 1999 through 2012. In the legislature, Scott served in numerous leadership roles including chair of the House Appropriations Committee, chair of the Ethics Committee, and chair of the Midwest Council of Government’s Legislative Leadership Institute. Scott and his wife, Martha, live in Urbandale, Iowa with their children, Emily, 20, and Max, 17. Volume 7 • number 3 • Summer 2013 25

CLINIC AL Dermatology

From The Patient’s Perspective

Take Home Points for Derm PAs: By Steven K. Shama, MD, MPH

1. How wonderful and refreshing it is for us as clinicians/researchers to hear the message of hope and inspiration sent from a patient or a family member of a patient. The next time we give hope to a patient, let us try to put ourselves on the same side of the table as the patient. Let’s see how really good it feels.

CLINIC AL Dermatology

2. Imagine someone believing that you are a hero with an unquenchable desire to extend life, to relieve pain, and to cure a deadly disease. 3. In creatively trying to problem solve, one of the most effective techniques is to brainstorm. This involves a number of people who bring their different perspectives and suggest many possible answers. Isn’t this collaboration? So why don’t we do it more often? How many cures for diseases could be discovered more quickly if we all came down from our silos (Ivory Towers) and met on ground level?

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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 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

26 Journal of Dermatology for Physician Assistants

Dermatopathology Q A By Dipti Anand, MD

SDPA Members Only Content

B Under the microscope [H&E stain (400 x)]

Dipti Anand, MD is a board-certified dermatopathologist specializing in the diagnosis of various inflammatory and neoplastic diseases of the skin. She is an associate dermatopathologist at SkinPath Solutions in Atlanta, Georgia. Dr. Anand received her medical degree from M.S. Ramaiah Medical College in India. She then successfully completed internships at Dr. Ram Manohar Lohia Hospital and Handa Medical Center and Diagnostic Laboratory in New Delhi. She then moved to Philadelphia, Pennsylvania in 2004 and completed an internship in internal medicine at Albert Einstein Medical Center and a pathology residency at the Hospital of University of Pennsylvania. She attended a fellowship in dermatopathology at the University of Texas Southwestern under the training of Clay Cockerell, MD. Dr. Anand is board certified in pathology as well as dermatopathology. She enjoys teaching dermatopathology to dermatologists, residents, and physician assistants. She is active in the education of residents at the Medical College of Georgia and Emory University Medical School. Dr. Anand is an active member of the Atlanta Dermatology and Dermatologic Surgery Society, the Georgia Society of Dermatology and Dermatologic Surgery, the American Academy of Dermatology, and the American Society of Dermatopathology. She has indicated no relationships to disclose relating to the content of this article.

Volume 7 â&#x20AC;˘ number 3 â&#x20AC;˘ Summer 2013 27

CLINIC AL Dermatology

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

Dermoscopy Dermoscopic Features of Skin Tumors and Their Clinical Counterparts By John Burns, MSPA, 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.

Figure 1

Figure 2

John Burns, MSPA, PA-C is a graduate of the Physician Assistant Program at Louisiana State University Health Science Center Shreveport, LA. He completed his fellowship training in dermatology at University of Texas Southwestern Medical Center, Dallas, TX from 2007 to 2008 and is a Diplomate of the SDPA. He presently resides in Frisco, TX where he works in dermatology with Dr. Eric Weisberg. 28 Journal of Dermatology for Physician Assistants

IMPORTANT SAFETY INFORMATION SERIOUS INFECTIONS

HEMATOLOGIC EVENTS

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.

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.

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.

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

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.

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.

Pediatric Patients

DRUG INTERACTIONS

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.

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.

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.

References: 1. Data on file, Amgen. 2. Enbrel® (etanercept) Prescribing Information, Immunex Corporation, Thousand Oaks, Calif. December 2012. 3. 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.

Please see Brief Summary of Prescribing Information on following pages.

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.

Volume 7 • number 3 • Summer 2013 29

When choosing a biologic for adult chronic

ENBREL IS A BIOLOGI

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 patients1,3 Consistent adverse event rates through 3 years of treatment in over 1,100 patients in clinical trials1 30 Journal of Dermatology for Physician Assistants

Experience Evaluated in clinical studies over the past 19 years in rheumatoid arthritis (RA)1* • > 14 years of postmarketing experience since approval for moderate to severe RA in 19981 • 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 > 8 years of postmarketing experience since approval for moderate to severe PsO in 20041

c moderate to severe plaque psoriasis (PsO)

ICA PLACE TO START ICAL

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. Prescription ENBREL is administered by injection. *Initial clinical research in RA patients began in 1993.

www.enbrel.com Please see Important Safety Information on previous page. Please see Brief Summary of Prescribing Information on following pages.

72675-R1-V1

Volume 7 â&#x20AC;˘ number 3 â&#x20AC;˘ Summer 2013 31

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: • A ctive 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. • B acterial, 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

32 Journal of Dermatology for Physician Assistants

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

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

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. b

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)

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. 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:

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:

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.

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.

Cardiac disorders:

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].

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.

Blood and lymphatic system disorders:

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).

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.

Enbrela (N = 876)

Reaction

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].

Placebo (N = 359)

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.

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

Skin and subcutaneous tissue disorders:

p ancytopenia, 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

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. 50: 12/2012 Manufactured by: Immunex Corporation Thousand Oaks, CA 91320-1799 US License Number 1132 Marketed by Amgen Inc. and Pfizer 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

Volume 7 • number 3 • Summer 2013 33

Clinical snapshots Clues on the Skin: Acute Poisonings By Jessica Bar, MD and Raffi Kapitanyan, MD

Figures:

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.

Jessica Bar, MD, Resident Department of Emergency Medicine  University of Medicine and Dentistry of New Jersey Robert Wood Johnson Medical School New Brunswick, New Jersey. Dr. Bar has indicated no conflicts of interest to disclose relating to the content of this article. Raffi Kapitanyan, MD, Assistant Professor Department of Emergency Medicine University of Medicine and Dentistry of New Jersey Robert Wood Johnson Medical School New Brunswick, New Jersey. Dr. Kapitanyan has indicated no conflicts of interest to disclose relating to the content of this article. Images and content reprinted with permission from Medscape Reference (http:// emedicine.medscape.com/), 2013, available at: http://reference.medscape.com/ features/slideshow/acutepoisonings.

34 Journal of Dermatology for Physician Assistants

Announcing the next phase of high quality category 1 CME! Visit Dermpa.org/Diplomate to experience this innovative educational program developed by the SDPA. These new Distance Learning Initiative modules are available to ALL Society of Dermatology Physician Assistants members, including students and NPs. Volume 7 â&#x20AC;˘ number 3 â&#x20AC;˘ Summer 2013 35

SURGICAL Dermatology Journal Club: Practice Changing Articles for Dermatology PAs Factors Predictive of Recurrence and Death From Cutaneous Squamous Cell Carcinoma: A 10-Year, Single-Institution Cohort Study JAMA Dermatol. 2013; 149(5):541-547. Schmults CD, Karia PS, Carter JB, Han J, Qureshi AA. Department of Dermatology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.

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.

36 Journal of Dermatology for Physician Assistants

SURGICAL wisdom The Surgical Checklist SDPA Members Only Content

a r e f Re

! R E B M HIP S E R E B M EM S D PA M

xtend o

to e excited e r a e W

ampaig

rC Membe a r e f e R

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

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

Volume 7 • number 3 • Summer 2013 37

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.

I DIDN’T THINK THAT IT COULD RECUR AGAIN I WASN’T PREPARED FOR MY BASAL CELL CARCINOMA TO BE ADVANCED Basal cell carcinoma (BCC) is the most common skin cancer in the United States. Although most BCC can be treated, a few patients develop a more challenging form of disease—advanced BCC.1 One of the characteristics of advanced BCC is multiple recurrence. Once a BCC has recurred, it is more likely to continue recurring, even when it seems the lesion has been cleared.1-3 When BCC advances in a cycle of recurrence, the complications can increase.2-4

HOW DOES ADVANCED BCC APPEAR IN YOUR PRACTICE?

Refere Ref ere r nce nces: s 1. Wa s: Walli lli l ngg HW, Fo Fosko sko k SW SW,, Gera Geramin mineja ejad d PA,W PA,Whit hitake akerr DC, DC, Arp Arpey ey CJ. C Can Cancer cer Me M tas tastas tasis i Rev is Rev. 20 2004; 04; 04;23: 4 23: 23:389 389 89-40 -4 -40 4 2. 2 2. 2 Fa F tta t h A, Poll Poll o ock oc J, J Ma Mahes hes e hwa hw r A, A, Britto Bri tto JA A. J Plas astt Reco econst nstrr Aest Aesthet het Su Surg. rg. 20 2010; 10;63: 63:e43 e43 33-e e441 1. 3. 3 Mo Morse rse s lli P, To Tosti sti A, Gu Guerr err r a L, L, et al. al. J Derm rm mato atoll Surgg On O col co . 19 1 93; 93;19 19: 19 99 917 17-92 17-92 922. 2 4. 2. 4 C Ch hew R. Optome Opt ometry ome try.. 2007 try 2007 007;78 ;78:34 ;78 :344-3 4-3 351.

38 Journal of Dermatology for Physician Assistants

Volume 7 • number 3 • Summer 2013 39

COSMETIC deRMATOLOGY Journal Club: Practice Changing Articles for Dermatology PAs Recommendations For a Screening Series For Allergic Contact Eyelid Dermatitis Dermatitis. 2012; 23(1):17-21. Herro EM, Elsaie ML, Nijhawan RI, Jacob SE Division of Dermatology, University of California-San Diego, CA. Reviewed by J. Desiree Douglas, MPA, PA-C

J. Desiree Douglas, MPA, PA-C graduated from Duquesne University in 2000. She began her career in emergency medicine and in 2007 transitioned into dermatology. She is currently working at the University of Pittsburgh Medical Centerâ&#x20AC;&#x2122;s (UPMC) Cutaneous Oncology Clinic as well as the Occupational and Contact Dermatitis Center. In 2009 she was promoted to Co-Director of the Occupational and Contact Dermatitis Center. She has indicated no relationships to disclose relating to the content of this article.

Cosmetic pearls Top Tips for Beautiful Nails SDPA Members Only Content

COSMETIC Dermatology

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Volume 7 • number 3 • Summer 2013 41

Professional development

An Innovative Dermatology Education Tool for Physician Assistants The Medical Student Core Curriculum By P. Eugene Jones, PhD, PA-C and Jennie A. Hocking, MPAS, PA-C

42 Journal of Dermatology for Physician Assistants

professional development P. Eugene Jones, PhD, PA-C is the Program Director and Jennie A. Hocking, MPAS, PA-C is the Associate Director of the UT Southwestern Medical Center Physician Assistant Program in Dallas, Texas. The authors have indicated no relationships to disclose relating to the content of this article.

Volume 7 â&#x20AC;˘ number 3 â&#x20AC;˘ Summer 2013 43

Professional development

Dermatology Billing & Coding Preventative Screening Codes 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

professional development Volume 7 â&#x20AC;˘ number 3 â&#x20AC;˘ Summer 2013 45

Outside & Inside the 9 to 5...

professional development

Utilizing telemedicine, Lauren Zajac, MHS, PA-C and Ashley Klinger, PA-C work hard to help bring dermatological care to underserved areas. For patients in rural areas the closest dermatology practice may be hundreds of miles away. This geographic obstacle causes some people to postpone seeking specialty care, which can lead to treatment delays that can put patients at increased risk. Geisinger Health System, an academic, vertically integrated tertiary care center in Northeastern and Central Pennsylvania, utilizes dermatology PAs Lauren Zajac and Ashley Klinger in teledermatology so that rural Pennsylvanians can have better access to dermatological care.

The term “teledermatology” was coined in 1995 and referred to using telecommunications to improve dermatological care in rural Oregon. The model that Zajac and Klinger practice is unique compared to how most of teledermatology is practiced nationwide. Their practice sites are located at Geisinger satellite clinics, which house full-time primary care providers and rotating specialists. Zajac practices Lauren Zajac, MHS, PA-C at clinics located in Lock Haven and Phillipsburg, and Klinger practices in Frackville. They take histories, perform examinations, and photograph every patient. When biopsies are needed, the PAs perform them. The clinical photos are attached to detailed notes that include treatment plans they have already initiated, thus reflecting a store-and-forward model, as opposed to live-action video conferencing. Via Geisinger’s robust electronic medical record system, their supervising physician, Dr. Victor John Marks, reviews chart notes and photos on large high-

definition computer screens in his office one to two hours away from Zajac and Klinger. Dr. Marks adds attestations to each note, commenting on diagnoses and treatment plans. The team uses various modes of communication throughout the day to enhance or modify diagnoses or management of the patients.

Ashley Klinger, PA-C

Lauren Zajac, MHS, PA-C utilizing digital photography for her clinic’s store-andforward teledermatology system.

46 Journal of Dermatology for Physician Assistants

“At anytime, we can pick up the phone or page Dr. Marks and he’s available,” says Klinger. “If he isn’t, whoever’s covering for him is, and we have a whole team of dermatology doctors at Danville available to consult.” Dr. Marks visits their sites each month, consulting on complicated patients whom Zajac and Klinger have scheduled specifically for those dates. It also gives him an opportunity to see how the clinic itself is operating and hear any concerns or needs they may have. The PAs return to their home base in Danville each month to see patients, participate in a journal book club, and attend grand rounds. Geisinger ensured Zajac and Klinger were well trained

“The training in Danville was excellent. We were well prepared for practicing in the teledermatology program,” says Zajac, who spent five years in general dermatology before her current position. Zajac and Klinger perform skin biopsies as well as some excisions of skin cancer and

dysplastic nevi in their clinics. They do not perform more complicated surgeries such as on the head and neck; they instead refer those patients to Geisinger’s dermatologic surgeons. Likewise, they refer occasional cases of complex or refractory skin conditions to dermatologists in Danville, Wilkes-Barre, and State College. All three clinics are booked for months, and Geisinger is hiring additional PAs for teledermatology soon. “[Teledermatology] is a new concept for patients and providers in our area, but everyone is very receptive to this revolutionary form of medicine. This process allows Geisinger dermatology to provide another avenue for rural patients to access healthcare,” says Klinger. J Reproduced with permission from the American Academy of Physician Assistants, April 17th, 2013.

Notes from your Office Manager Tracking Test Results SDPA Members Only Content A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

These Risk Management Tips have been reprinted with permission from: MLMIC Dateline, published by Medical Liability Mutual Insurance Company, 2 Park Avenue, Room 2500, New York, NY 10016. Copyright ©2010 by Medical Liability Mutual Insurance Company. All Rights Reserved. No part of this article may be reproduced or transmitted in any form or by any means, electronic, photocopying, or otherwise, without the written permission of MLMIC. Volume 7 • number 3 • Summer 2013 47

professional development

in the specialty before establishing their remote clinics. The two PAs spent six months at the Danville headquarters rotating among clinics in general, pediatric, and surgical dermatology. They participated in educational programs involving chapter assignments, clinical images, and journal reviews. Toward the end of their training period they were evaluated on clinical images, procedural dermatology, and clinical pharmacology and therapeutics.

Dermatology PA news & notes

From the Desk of... By John Burns, MSPA, PA-C

I attended the inaugural American Dermoscopy Meeting in Jackson Hole, Wyoming and wanted to share some words of advice for fellow dermatology physician assistants as they prepare to attend a dermoscopy conference. Below you will find my suggestions for the top five things to do prior to and during a dermoscopy conference. ➊ Take the dermoscopy pretest and make sure to write your answers down. All of the dermoscopy meetings I have attended contain this component, and every time I have looked around to see others not recording their answers. Dr. Philip Eichhorn, one of my favorite dermatology professors at University of Texas Southwestern and the best clinical dermatologist I have ever met, insisted on writing answers down stating, “If you didn’t write it down then it didn’t count. We all like to cheat a little bit, ‘oh I saw that’ or ‘oh I knew that,’ but to be honest with yourself is to write your answers down.” At the end of the course, the answers to the pretest are revealed along with a quick viewing of the test lesions. At this time make sure to keep track of which items you missed and why. This will allow for self-study and improvement in your dermoscopic skills. ➋ Write down any questions you have regarding a subject during the lectures, and save them for after the session. This is typically when you will have the greatest opportunity to ask them and to benefit from questions that others might have. ➌ Prior to attending a dermoscopy conference make sure to write down any questions you have regarding dermoscopy. This will be the chance to have those questions answered without a whole lot of work on your part. ➍ Use a tablet or laptop computer to bring dermoscopic photos that you have questions about. Most of the time lecturers are more than happy to take a look at them and answer any questions you might have. ➎ Actively participate in the meeting, especially the breakout sessions, as these interactions may be as close as one gets to formal instruction in dermoscopy.

48 Journal of Dermatology for Physician Assistants

Dermoscopy usage appears to be increasing in the United States and in some parts of the world is the standard of care for individuals regularly evaluating pigmented skin lesions.1,2 After using the technique now for almost ten years I recommend that all dermatology physician assistants take time to learn this technique through self study, attendance at dermoscopy conferences, and working with individuals already familiar with it. In 2009, 41 of 63 dermatologists attending the American Academy of Dermatology in the Summer of 2007 reported using dermoscopy in their practice and gained understanding of the technique through attendance of a seminar, reading a book, or spending time with another more experienced dermatologist.3 I had a great time at the inaugural American Dermoscopy Meeting and learned a lot. I hope to see more fellow SDPA members at the next meeting to be held August 15-17, 2013 at Glacier National Park in Montana. J REFERENCES: 1. Engasser HC, Warshaw EM. Dermatoscopy use by US dermatologists: A cross-sectional survey. J Am Acad Dermatol. 2010;63(3): 412-419. 2. Australian Cancer Network Melanoma Guidelines Revision Working Party. Clinical Practice Guidelines for the Managementt of Melanoma in Australia and New Zealand. Cancer Council Australia and Australian Cancer Network, Sydney and New Zealand Guidelines Group, Wellington (2008). 3. Noor O, Nanda A, Rao BK. A dermoscopy survey to assess who is using it and why it is or is not being used. Int J Dermatol. 2009;48(9): 951-2 John Burns, MSPA, PA-C is a graduate of the Physician Assistant Program at Louisiana State University Health Science Center Shreveport, LA. He completed his fellowship training in dermatology at University of Texas Southwestern Medical Center, Dallas, TX from 2007 to 2008 and is a Diplomate of the SDPA. He presently resides in Frisco, TX where he works in dermatology with Dr. Eric Weisberg.

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

Put patients in the clear.

VEREGEN® Delivers Complete Clearance With Low Recurrence*1 • 53.6% of patients demonstrated complete clearance1 — 6.8% of patients with complete clearance experienced recurrence at 12 weeks posttreatment1 • The most common adverse reactions were local skin and application site reactions1 *At 12 weeks posttreatment in the two phase 3 studies.

In two well-controlled studies where VEREGEN® was applied 3 times daily for up to 16 weeks, 53.6% of subjects experienced complete clinical (visual) clearance of all external genital and perianal warts (baseline and new); the rate of recurrence in subjects with complete clearance 12 weeks after completion of treatment was 6.8%. VEREGEN® is indicated for the topical treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older. Important Selected Safety Information VEREGEN® has not been evaluated to treat urethral, intra-vaginal, cervical, rectal, or intra-anal human papilloma viral disease and should not be used to treat these conditions. Avoid use of VEREGEN® on open wounds. Avoid exposure of VEREGEN®-treated areas to sun/UV-light because VEREGEN® has not been tested under these circumstances. Safety and efficacy of VEREGEN® have not been established in immunosuppressed patients or patients under 18 years of age, or pregnant women, or for the treatment of external genital and perianal warts beyond 16 weeks or for multiple treatment courses. The FIRST BOTANICAL DRUG The most common adverse reactions approved for prescription are local skin and application site use in the United States reactions including (incidence ≥ 20%) erythema, pruritus, burning, pain/ discomfort, erosion/ulceration, edema, induration, and rash vesicular. 2

References: 1. VEREGEN® Ointment, 15% [Prescribing Information, 2012]. Melville, NY: PharmaDerm, part of Fougera Pharmaceuticals Inc. 2. Data on file, PharmaDerm.

Please see adjacent page for Brief Summary of full Prescribing Information. Please see Package Insert for full Prescribing Information at www.pharmaderm.com. VEREGEN is a registered trademark of Medigene AG, D-82152 Planegg/Martinsried, Germany. ©2013 PharmaDerm, part of Fougera Pharmaceuticals Inc. Melville, NY 11747. All rights reserved. 98NVE040213

Volume 7 • number 3 • Summer 2013 49

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

Veregen

(sinecatechins)

Ointment, 15% Rx Only

For Topical Use Only

INDICATIONS AND USAGE

Veregen® is indicated for the topical treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older. The safety and effectiveness of Veregen® have not been established for treatment beyond 16-weeks or for multiple treatment courses. The safety and effectiveness of Veregen® in immunosuppressed patients have not been established.

DOSAGE AND ADMINISTRATION

Veregen® is to be applied three times per day to all external genital and perianal warts. Apply about an 0.5 cm strand of the Veregen® to each wart using the finger(s), dabbing it on to ensure complete coverage and leaving a thin layer of the ointment on the warts. Patients should wash their hands before and after application of Veregen®. It is not necessary to wash off the ointment from the treated area prior to the next application. Veregen® is not for ophthalmic, oral, intravaginal, or intra-anal use.

CONTRAINDICATIONS None

WARNINGS AND PRECAUTIONS

Veregen® has not been evaluated for the treatment of urethral, intra-vaginal, cervical, rectal, or intra-anal human papilloma viral disease and should not be used for the treatment of these conditions. Use of Veregen® on open wounds should be avoided. Patients should be advised to avoid exposure of the genital and perianal area to sun/UV-light as Veregen® has not been tested under these circumstances.

ADVERSE REACTIONS

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In Phase 3 clinical trials, a total of 397 subjects received Veregen® three times per day topical application for the treatment of external genital and perianal warts for up to 16 weeks. Serious local adverse events of pain and inflammation were reported in two subjects (0.5%), both women. In clinical trials, the incidence of patients with local adverse events leading to discontinuation or dose interruption (reduction) was 5% (19/397). These included the following events: application site reactions (local pain, erythema, vesicles, skin erosion/ulceration), phimosis, inguinal lymphadenitis, urethral meatal stenosis, dysuria, genital herpes simplex, vulvitis, hypersensitivity, pruritus, pyodermitis, skin ulcer, erosions in the urethral meatus, and superinfection of warts and ulcers. Local and regional reactions (including adenopathy) occurring at >1% in the groups treated with Veregen® (N=397) or vehicle (N=207), respectively, were: erythema (70%, 32%), pruritus (69%, 45%), burning (67%, 31%), pain/ discomfort (56%, 14%), erosion/ulceration (49%, 10%), edema (45%, 11%), induration (35%, 11%), rash vesicular (20%, 6%), regional lymphadenitis (3%, 1%), desquamation (5%, <1%), discharge (3%, <1%), bleeding (2%, <1%), reaction (2%, 0%), scar (1%, 0%), irritation (1%, 0%), and rash (1%, 0%). A total of 266/397 (67%) of subjects in the Veregen® group had either a moderate or a severe reaction that was considered probably related to the drug, of which 120 (30%) subjects had a severe reaction. Severe reactions occurred in 37% (71/192) of women and in 24% (49/205) of men. The percentage of subjects with at least one severe, related adverse event was 26% (86/328) for subjects with genital warts only, 42% (19/45) in subjects with both genital and perianal warts and 48% (11/23) of subjects with perianal warts only. Phimosis occurred in 3% of uncircumcised male subjects (5/174) treated with Veregen® and in 1% (1/99) in vehicle. The maximum mean severity of erythema, erosion, edema, and induration was observed by week 2 of treatment. Less common local adverse events included urethritis, perianal infection, pigmentation changes, dryness, eczema, hyperesthesia, necrosis, papules, and

50 Journal of Dermatology for Physician Assistants

discoloration. Other less common adverse events included cervical dysplasia, pelvic pain, cutaneous facial rash, and staphylococcemia. In a dermal sensitization study of Veregen® in healthy volunteers, hypersensitivity (type IV) was observed in 5 out of 209 subjects (2.4%) under occlusive conditions.

USE IN SPECIFIC POPULATIONS

Pregnancy Pregnancy Category C: There are no adequate and well controlled studies in pregnant women. Veregen® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers It is not known whether topically applied Veregen® is excreted in breast milk. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric Use Seven patients (1.4%), older than 65 years of age were treated with Veregen® in clinical studies. This, however, is an insufficient number of subjects to determine whether they respond differently from younger subjects.

CLINICAL STUDIES

Two randomized, double-blind, vehicle-controlled trials were performed to investigate the safety and efficacy of Veregen® in the treatment of immunocompetent subjects 18 years of age and older with external genital and perianal warts. The subjects applied the ointment 3 times daily for up to 16 weeks or until complete clearance of all warts (baseline and new warts occurring during treatment). Over both trials the median baseline wart area was 51 mm2 (range 12 to 585 mm2), and the median baseline number of warts was 6 (range 2 to 30). The primary efficacy outcome measure was the response rate defined as the proportion of subjects with complete clinical (visual) clearance of all external genital and perianal warts (baseline and new) by week 16, presented in Tables 1 and 2 for all randomized subjects dispensed medication. Table 1: Efficacy by Region Complete Clearance All Countries (includes the United States) Veregen® 15% (N = 397) 213 (53.6%) Vehicle (N = 207) 73 (35.3%) United States Veregen® 15% (N = 21) 5 (23.8%) Vehicle (N = 9) 0 (0.0%) Table 2: Efficacy by Gender Complete Clearance Males Veregen® 15% (N = 205) 97 (47.3%) Vehicle (N = 118) 34 (28.8%) Females Veregen® 15% (N = 192) 116 (60.4%) Vehicle (N = 89) 39 (43.8%) Median time to complete wart clearance was 16 weeks and 10 weeks, respectively, in the two phase 3 clinical trials. The rate of recurrence of external genital and perianal warts 12 weeks after completion of treatment in subjects with complete clearance is 6.8% (14/206) for those treated with Veregen® and 5.8% (4/69) for those treated with vehicle.

HOW SUPPLIED/STORAGE AND HANDLING

Veregen® is a brown ointment and is supplied in an aluminum tube containing 15 grams (NDC # 10337-450-15) of ointment per tube or 30 grams (NDC # 10337-450-03) of ointment per tube. Prior to dispensing to the patient, store refrigerated 2°C to 8°C (36°F to 46°F). After dispensing, store refrigerated or up to 25°C (77°F). Do not freeze. Keep out of reach of children. Manufactured by: C.P.M. Contract Pharma GmbH & Co. KG Frühlingstrasse 7 D-83620 Feldkirchen-Westerham Germany VEREGEN is a registered trademark of Medigene AG, Planegg/Martinsried, Germany. U.S. Patent Nos. 5795911 and 5968973

Manufactured for:

98NVE050213

The Difference We Make

On The Importance of “Selling” Trust in Medicine

I was recently at a conference of hundreds of professionals from different disciplines, all who are trying to make our city a better place to live. After looking thru the attendance list, it was clear that there were very few healthcare practitioners and none sitting at my table of 8. All my tablemates were in sales; two were in real estate sales, two in computers sales, and three in retail clothing sales. As a bonding exercise at the onset of the conference, we were all asked to engage in a table discussion to find similarities amongst all of us related to our professions. We all stated our professions and began the discussion. Sales was the first commonality that was brought up. I quickly brought up the fact that it was not a thread for ALL of us, since I was in medicine and NOT a salesperson. Somehow, this was not only a statement by me of fact but a proud affirmation that I do not sell anything to my patients. I was quickly reminded by one of my tablemates of a fact that I would never forget. “You are in sales, Steve Shama.” I initially protested until someone made it perfectly clear. “Steve Shama, deny what you may, but you very well may be the biggest salesman of us all! You sell trust.” I immediately realized that she was right. My effectiveness as a healthcare professional is based on my patients trusting me. In order for any healthcare practitioner to obtain a truly accurate history from our patients, we must first sell them that old adage: Trust me, I’m a doctor…Trust me, I’m a healthcare practitioner. For us to convince them that our diagnosis is correct and treatment is appropriate, we need to sell them trust. It is our first and foremost “product.” One of my tablemates mentioned a book he had just read by Dan Pink, To Sell Is Human, (Riverhead Books, New York, 2012). Pink is the author of five best selling books about the changing world of business, work, and management. Pink points out that, according to the Bureau of Labor Statistics, 1 in 9 Americans is involved in sales. Yet the main contention of Pink’s book is that the other 8 are also involved in sales but of a different type. As examples, Pink mentions entrepreneurs who sell others on new ideas, as well as parents who convince their children to live their lives with good morals and ethics. Teachers “sell” students on facts, knowledge, and wisdom. Like it or not, Pink says, “We are all in sales.” It was clear to me at that moment that my greatest tool and my most valuable product in my “persuasion tool box” was trust and that I subtlety but critically “sold” it everyday. If you look up the definition of trust you will find variations on the theme of “the reliance on the integrity, strength, ability, and surety of a person or thing.” We need trust in most activities of our lives. We need to inherently trust our public conveyances (planes, trains, buses, cars) that they are safe, and that the people who run them are well trained and responsible. In marriage the most important quality in our partner is trustworthiness, according to John Gottman, PhD, the nation’s foremost researcher of marriage and the family. And in medicine, should not the most important quality be trust? Is it not the foundation of our relationship with our patients? Trust can happen in a moment and has to be maintained. The greatest threat to trust and the biggest cause of

erosion of trust is betrayal. How well do you, as a healthcare practitioner radiate trust? What do you do to give others the feeling that you can be trusted? I truly believe that to be trusted by others you yourself have to believe that you can be trusted. There is a wonderful expression: The art of convincing someone of something is being convinced yourself. Some qualities that help instill in others a sense of trust in you include listening, valuing the other person, allowing for differences between you and them, having a nonjudgmental approach, being willing to say “I’m Sorry,” feeling ok when you say “I’m not sure about something but I’ll find out,” saying you are going to follow up and doing it, and truly caring about your patients so it is very clear to them that you really do care. Unfortunately, there is no prescription you can write for yourself or others that will help develop or express the essential quality of trust. If there were, it might look like this.

Trust Me Sig: Take liberally prn Disp: Unlimited quantity Refill: Forever No interchange. Trade name only So there was no question in my mind when I left that conference that I am in sales; I sell trust. There is no seasonal variation and no refrigeration needed. Happily I don’t need to keep records of this wonderful product I sell since I don’t have to pay taxes on it! However, the quality can vary, and let the buyer beware. How can one tell when you are getting the best quality trust? There is that special feeling, that intuitive moment, when that healthcare practitioner makes you feel safe, secure, and taken care of. If nothing more, developing a trusting relationship between us and our patients is good for “business,” but when we do it because it is the right thing to do and when we develop that very special “trusting” bond with our patients, it is the way we heal best. So here’s to a profitable year in your practice. May your sales grow and may you continue to become richer and richer. Take care of your production plant, your inner core of trust. Use only the finest ingredients with the most excellent quality control, all for the sake of your “customers” who believe in you and need to trust in you. J

Dr. Steve Shama was practicing general dermatology for 30 years in Boston, Massachusetts until last year. He retired at that time but continues in a 20 year career as a professional speaker and enjoys speaking on topics such as, “Dealing With Difficult People and Looking Forward To It!” and “Rediscovering The Joys of Medicine and of Life.” He gives these talks at medical meetings, in private practices, and to general audiences and youth throughout the country. You can reach Dr. Shama at www.steveshama.com. Volume 7 • number 3 • Summer 2013 51

DERmatology pa news & notes

By Steven K. Shama, MD, MPH

Workplace Excellence

Good Stress to Distress: Fighting the Burnout Battle 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.

Struggling to get motivated for another day at

work? Feeling like you just can’t get enough sleep or enough caffeine? Feeling cynical about and boxed in by work and life? It might just be a flat day or particularly difficult week. Or, you might be battling burnout, and you’re not alone in the battle! In a 2013 Medscape Survey on burnout, nearly 40% of physicians responding indicated that they were burned out, defined as “a loss of enthusiasm for work, feelings of cynicism, and a low sense of personal accomplishment.”1 In our own work with individuals and organizations, we find stress and burnout a very common occupational hazard and major preventer of workplace excellence. In almost every workplace setting, we see evidence of the destructive force of chronic stress, which erodes energy and enthusiasm, saps patience and civility, and generally undermines high performance. In his seminal work on stress, Hans Selye presents stress essentially as existing on a good stress to distress continuum.2 Good stress is natural, normal and actually improves focus, motivation, and endurance (like how the deadline for this article improved my motivation, focus, and endurance). However, there is a tipping point for each of us where the stressors in our life push us into distress, which triggers mental, physical, and emotional breakdown (like recently when my work was crazy coupled with my family’s schedule of games, concerts, school events, and other commitments to push me over my tipping point). A chronic state of distress leads to burnout, that place when everything you do 52 Journal of Dermatology for Physician Assistants

takes longer, where everything you do is a burden, where little things become big things, where life is a constant battle to muster the energy to do the things that you once did with ease and even enjoyment. Struggling with burnout can be especially difficult since the effects often seep into life outside of work creating a toxic state that leaves us with nowhere to escape. We’re miserable at work thinking we want to be at home, only to get home and be tired and cranky at home because of work! The more tired and stressed we get the poorer our decision-making becomes regarding things in our control that could help ease (or worsen) the burnout (e.g., decisions about food, sleep, exercise, and alcohol). As if that cycle of pain weren’t enough, the struggle with burnout is often accompanied by a code of silence. Once the conversation is started, the experience is quite common and fairly widespread, which can be very comforting. But until we name and confront the topic out in the open, silent suffering only serves to heighten the painful experience and our feelings of isolation and hopelessness. If, according to the research nearly half of us are experiencing burnout, then why can’t we address it in the open? There are obviously a host of reasons for this code of silence, but the following are a few to consider. Saying that you’re burned out may evoke fears of what others will think (“You’re burned out? Are you kidding me? I’ve got twice as much responsibility at home and at work as you!”). We often reject our feelings and experiences of being burned out (“I shouldn’t be feeling this. What’s

Sometimes burnout is the result of the accumulation of stress from negative things in life including sickness, death, financial problems, and a toxic work environment. But stress can also be the result of good things such as working hard and doing our best at home, work, and in our communities. A colleague of mine recently said, “Life balance is only possible if you either hate/neglect work or home; if you love and are dedicated to both, you’re in trouble.” So we get burnt out from trying to do too much, saying yes too often, and then running ourselves into an energy deficit where we neglect the life-renewing forces such as prayer and meditation, healthy diet, exercise, and good old-fashioned down time. A Neil Young lyric from his song My My, Hey Hey famously says, “It’s better to burn out than to fade away.” However, another line in that same song reads, “Once you’re gone, you can’t come back.” Chronic stress that leads to burnout can end a career and left unchecked can create unwanted health consequences. So, what can we do to ensure that we avoid letting the stressors build up, contribute to distress, and lead to burnout? In our stress management sessions we talk about three essentials: 1. Be aware. Look for patterns that indicate signs of burnout including high irritability, headaches, low energy, use of food, drugs, and alcohol to escape, and just an overall sense of dragging yourself through the day. It’s also easier to monitor yourself when the topic is open for discussion amongst your colleagues. So break the silence and share what you’re going through. 2. Choose your response. Risk factors accumulate; so do protective factors. A few drinks and mindless television

may be the right choice some nights, but likely not every night. Focus on how you care for yourself outside of work, and see how it changes your focus when you’re at work. Focusing on sleep, nutrition, exercise, and time with family will go a long way to restoring your approach at work. 3. Grow and let go. A major contributor to burnout is our mindset and how you approach work and life. Perfectionists are more susceptible to burnout than those who can find optimal more quickly; pessimists are more susceptible to burnout than optimists. Learning to see mistakes and challenges as opportunities to learn and grow is essential to managing stress and avoiding burnout. Strive to grow every day; stop worrying about tomorrow or complaining about yesterday; let go of all those things that are sapping your energy for work and life. Your work and life stressors may not change, but how you approach them can. As Victor Frankl said, “When we are no longer able to change a situation, we are challenged to change ourselves.” Burnout can be beat. Start today fighting your way back to being healthy, whole, and engaged. J REFERENCES: 1. Peckham, C. Physician lifestyles-linking to burnout. Medscape survey. 2013.Available at http://www.medscape.com/features/slideshow/lifestyle/2013/public. Accessed June 4, 2013. 2. Selye, H. Stress without distress. New York, NY: Signet. 1975. 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.

Volume 7 • number 3 • Summer 2013 53

DERmatology pa news & notes

wrong with me? I love my work and life, so why am I in this rut?”). Admitting to others that you’re burned out can create fears of what people will recommend to “fix us” (“Maybe you should lose weight, join my church or yoga class, or have fewer children!”). Finally, fear of admitting burnout can be based on supposed negative consequences regarding work evaluation, promotion, and related issues (“Maybe you should get another job if this one’s too much for you”). And so we try to hide it, and we suffer in silence, which often increases the duration and intensity of the experience.

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!

SPECIFIC URL: http://bit.ly/14djTDR

DERmatology pa news & notes

Image by webmonk

SPECIFIC URL: http://bit.ly/11TCkvE Image by Mulloy Morrow

SPECIFIC URL: http://bit.ly/1a0Nu9T Image by Mulloy Morrow

54 Journal of Dermatology for Physician Assistants

FDA Warns of Dangers of Henna Tattoos The main issues with henna have been introduced through â&#x20AC;&#x153;black henna.â&#x20AC;? This form of henna stains the skin quickly and creates a darker color. It often contains the chemical p-phenylenediamine, which can cause serious allergic reactions and even scarring. This can then lead into a life-long allergy triggered by other chemicals, especially those found in hair dye.

Linguistic Acculturation and the Trend of Skin Cancer among Hispanic Males This study considers linguistic acculturation among Hispanic males and how the behaviors they adapt from multiple cultures actually increases their risk of skin cancer.

Getting Lighter: Cyclosporine Responsiveness and Low-Caloric Diets for Psoriasis Patients This Italian study included people over the age of 18 with at least 10% of their body covered in active but clinically stable plaque psoriasis. Each patient had a Body Mass Index of 30 but less than 45. J

Supervising Physician CORNER Attributes of a Successful Working Relationship An Interview with Kenneth Ellner, MD and Mrs. Norma Gordon, PA-C By J. Margaret Casey

What are the most rewarding and most challenging Dr. Ellner, how long have you utilized a PA within aspects of working within the field of dermatology? your practice? What were you hoping a PA would bring to your practice? Mrs. Gordon: The most rewarding aspect of working in dermatology is the ability to Dr. Ellner: I have utilized a PA work independently and build since the time I started practicing your own practice. The reward twenty-four years ago. Having a comes in having patients and PA in the practice provides better their families return year after access to dermatologic medical year trusting you with their care for our patients. dermatologic care. The most What qualities contribute to challenging is always being on a successful supervising physician/ your game and trusting that you PA working relationship? are always delivering high quality Dr. Ellner: As in any care. relationship, honesty, integrity, open communication, and Dr. Ellner, what do you see intelligence are contributing as the future role of PAs within qualities to a successful the field of dermatology? supervising physician/PA working relationship. Dr. Ellner: As the population Mrs. Norma Gordon, PA-C and Kenneth Ellner, MD increases and more and more Mrs. Gordon: I believe people will be given heath care, PAs will help to allow for that a successful working relationship requires trust, better access to these increasing demands. communication, mutual respect, and an appreciation for each other’s skills. Mrs. Gordon, do you have any advice for new PAs as they begin interviewing with potential supervising Mrs. Gordon, please describe for us your current physicians? leadership position and any goals you would like to focus on while in this position. Mrs. Gordon: Find a good match, somebody you can really relate to with mutual respect for each other. You Mrs. Gordon: This year I accepted the role of spend as much time interacting with them as you do in a President of the Georgia Dermatology Physician Assistant marriage, so the teamwork needs to work! Society. I felt like it was a time in my life and career (my family is grown and I do not have any other serious Any additional interesting facts you would like to time commitments) when I could devote some time to share? giving back to the PA community. We have a very strong Mrs. Gordon: I have been a PA for thirty-seven years dermatology PA organization in Atlanta, and I would like and have a daughter who is starting her second year of PA to help the organization grow with even more opportunities school at Emory University. She wants to follow in my for CME, camaraderie, networking among our peers, and footsteps and practice dermatology. to help raise awareness of our profession to the community. Dr. Ellner: I was one of the first dermatologists to In what ways has Dr. Ellner encouraged or supported work with a dermatology physician assistant and have you in pursuing your current leadership position? never regretted it! J Mrs. Gordon: Dr. Ellner has always encouraged me to be the best that I can be. He sets an example by being involved and taking on leadership roles himself. Volume 7 • number 3 • Summer 2013 55

DERmatology pa news & notes

Dr. Kenneth Ellner, MD and Mrs. Norma Gordon, PA-C have been working together for fourteen years, with the past nine years at the Atlanta Center for Dermatologic Diseases and prior to that five years at Kaiser. We recently had an opportunity to interview them both about their supervising physician/PA relationship and what they believe makes it a success.

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

DERmatology pa news & notes

Dr. Bernard Ackerman likened the study of dermatology to art history. The parallels between appreciation of art and the evaluation of skin are many. A neophyte describes a painting in regards to color, brushstroke, content, and structure. A skilled art historian assimilates these details unconsciously and may declare, “It looks like a Monet.” Each description is equally valid, and each serves a unique purpose. Similarly, one may describe the violaceous polygonal papules arising on the volar wrist; another may describe it simply as lichen planus. While blood work and biopsies are critical to our specialty, it is what we appreciate on the surface of the skin that largely influences decisions in clinical practice. This series explores the depictions of dermatologic conditions in classic artwork. The condition may be the focus of the painting, but often it is a quiet detail, only for the discerning and trained eye. If you know of a piece of art that you would like to share with the JDPA readers, please contact us at editor@jdpa.org. Most disease states have associated social stigmata. A person suffering from an internal ailment can often easily hide his/her affliction; however, many skin conditions are difficult, if not impossible, to conceal. When people see the weeping crust of impetigo, the flaky scale of psoriasis, or the purulence of a ruptured cyst, they often fear contracting the illness by being in proximity of the affected individual. Vitiligo can be presumed to be no different. It is easy to scoff at those unlearned minds that could not recognize vitiligo as an autoimmune phenomenon. No dermatological condition has blurred the lines between races more significantly than vitiligo as evidenced by the story of John Boby. John Boby was born to slaves in Jamaica in the 18th century. Patches of depigmentation arose in his darkly pigmented skin, leading some to suppose that he came from an adulterous, interracial relationship. One can only imagine the taunting that he would have inevitably had to endure. Boby’s initial notoriety gave way to public curiosity; he was purchased by a showman in 1795 and exhibited for all to see his unique skin condition. Slavery is aborhant enough but to have bought an individual and placed him on display is even more reprehensible. Fortunately Boby was able to gain his freedom and later married an English woman. J 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.

Etching with engraving by unknown artist, 1803. Published by Alex Hogg, London, 1 Oct 1803.

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JDPA Journal of Dermatology for Physician Assistants

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Volume 7 â&#x20AC;˘ number 3 â&#x20AC;˘ Summer 2013 57

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for his dedication to caring for people with psoriasis

Join us October 26, 2013 Hilton Anatole Hotel Dallas, Texas Reception 6:30 p.m. Dinner 7:30 p.m. Entertainment Live Auction

Dr. Alan Menter is Chairman of the Division of Dermatology at Baylor University Dr. Alan Menter Medical Center in Dallas. He is the original founder of the International Psoriasis Council and the co-author of the first gene discovery for psoriasis in 1994.

Learn more www.psoriasis.org/gala All contributions support National Psoriasis Foundation programs that advance research, education and advocacy.

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National Psoriasis Foundation Honors

1/24/13 1:56 PM

Finacea

(azelaic acid) Gel,15% For Dermatologic Use Only–Not for Ophthalmic, Oral, or Intravaginal Use Rx only BRIEF SUMMARY CONSULT PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION INDICATIONS AND USAGE FINACEA Gel, 15%, is indicated for topical treatment of inflammatory papules and pustules of mild to moderate rosacea. Although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated. Patients should be instructed to avoid spicy foods, thermally hot foods and drinks, alcoholic beverages and to use only very mild soaps or soapless cleansing lotion for facial cleansing. CONTRAINDICATIONS FINACEA Gel, 15%, is contraindicated in individuals with a history of hypersensitivity to propylene glycol or any other component of the formulation. WARNINGS FINACEA Gel, 15%, is for dermatologic use only, and not for ophthalmic, oral or intravaginal use. There have been isolated reports of hypopigmentation after use of azelaic acid. Since azelaic acid has not been well studied in patients with dark complexion, these patients should be monitored for early signs of hypopigmentation. PRECAUTIONS General: Contact with the eyes should be avoided. If sensitivity or severe irritation develops with the use of FINACEA Gel, 15%, treatment should be discontinued and appropriate therapy instituted. In a transgenic mouse study, chronic use of FINACEA Gel led to an increased number of animals with papillomas at the treatment site [see PRECAUTIONS: Carcinogenesis, Mutagenesis, and Impairment of Fertility]. The clinical relevance of the findings in animal studies to humans is not clear. Information for Patients: Patients using FINACEA Gel, 15%, should receive the following information and instructions: • FINACEA Gel, 15%, is to be used only as directed by the physician. • FINACEA Gel, 15%, is for external use only. It is not to be used orally, intravaginally, or for the eyes. • Cleanse affected area(s) with a very mild soap or a soapless cleansing lotion and pat dry with a soft towel before applying FINACEA Gel, 15%. Avoid alcoholic cleansers, tinctures and astringents, abrasives and peeling agents. • Avoid contact of FINACEA Gel, 15%, with the mouth, eyes and other mucous membranes. If it does come in contact with the eyes, wash the eyes with large amounts of water and consult a physician if eye irritation persists. • The hands should be washed following application of FINACEA Gel, 15%. • Cosmetics may be applied after FINACEA Gel, 15%, has dried. • Skin irritation (e.g., pruritus, burning, or stinging) may occur during use of FINACEA Gel, 15%, usually during the first few weeks of treatment. If irritation is excessive or persists, use of FINACEA Gel, 15%, should be discontinued, and patients should consult their physician [See ADVERSE REACTIONS]. • Avoid any foods and beverages that might provoke erythema, flushing, and blushing (including spicy food, alcoholic beverages, and thermally hot drinks, including hot coffee and tea). • Patients should report abnormal changes in skin color to their physician. • Avoid the use of occlusive dressings or wrappings. Drug Interactions: There have been no formal studies of the interaction of FINACEA Gel, 15%, with other drugs. Carcinogenesis, Mutagenesis, Impairment of Fertility: Systemic long-term animal studies have not been performed to evaluate the carcinogenic potential of azelaic acid. In a 26-week dermal carcinogenicity study using transgenic (Tg.AC) mice, FINACEA Gel, 15%, and the gel vehicle, when applied once or twice daily, did not increase the number of female Tg.AC animals with papillomas at the treatment site. No statistically significant increase in the number of animals with papillomas at the treatment site was observed in male Tg.AC animals after once daily application. After twice daily application, FINACEA Gel, 15%, and the gel vehicle induced a statistically significant increase in the number of male animals with papillomas at the treatment site when compared to untreated males. This suggests that the positive effect may be associated with the vehicle application. The clinical relevance of the findings in animals to humans is not clear. Azelaic acid was not mutagenic or clastogenic in a battery of in vitro (Ames assay, HGPRT in V79 cells {Chinese hamster lung cells}, and chromosomal aberration assay in human lymphocytes) and in vivo (dominant lethal assay in mice and mouse micronucleus assay) genotoxicity tests. Oral administration of azelaic acid at dose levels up to 2500 mg/kg/day (162 times the maximum recommended human dose based on body surface area) did not affect fertility or reproductive performance in male or female rats. Pregnancy: Teratogenic Effects: Pregnancy Category B There are no adequate and well-controlled studies of topically administered azelaic acid in pregnant women. The experience with FINACEA Gel, 15%, when used by pregnant women is too limited to permit assessment of the safety of its use during pregnancy. Dermal embryofetal developmental toxicology studies have not been performed with azelaic acid, 15%, gel. Oral embryofetal developmental studies were conducted with azelaic

acid in rats, rabbits, and cynomolgus monkeys. Azelaic acid was administered during the period of organogenesis in all three animal species. Embryotoxicity was observed in rats, rabbits, and monkeys at oral doses of azelaic acid that generated some maternal toxicity. Embryotoxicity was observed in rats given 2500 mg/kg/day (162 times the maximum recommended human dose based on body surface area), rabbits given 150 or 500 mg/kg/day (19 or 65 times the maximum recommended human dose based on body surface area) and cynomolgus monkeys given 500 mg/kg/day (65 times the maximum recommended human dose based on body surface area) azelaic acid. No teratogenic effects were observed in the oral embryofetal developmental studies conducted in rats, rabbits and cynomolgus monkeys. An oral peri- and post-natal developmental study was conducted in rats. Azelaic acid was administered from gestational day 15 through day 21 postpartum up to a dose level of 2500 mg/kg/day. Embryotoxicity was observed in rats at an oral dose that generated some maternal toxicity (2500 mg/kg/day; 162 times the maximum recommended human dose based on body surface area). In addition, slight disturbances in the post-natal development of fetuses was noted in rats at oral doses that generated some maternal toxicity (500 and 2500 mg/kg/day; 32 and 162 times the maximum recommended human dose based on body surface area). No effects on sexual maturation of the fetuses were noted in this study. Because animal reproduction studies are not always predictive of human response, this drug should be used only if clearly needed during pregnancy. Nursing Mothers: Equilibrium dialysis was used to assess human milk partitioning in vitro. At an azelaic acid concentration of 25 µg/mL, the milk/plasma distribution coefficient was 0.7 and the milk/buffer distribution was 1.0, indicating that passage of drug into maternal milk may occur. Since less than 4% of a topically applied dose of azelaic acid cream, 20%, is systemically absorbed, the uptake of azelaic acid into maternal milk is not expected to cause a significant change from baseline azelaic acid levels in the milk. However, caution should be exercised when FINACEA Gel, 15%, is administered to a nursing mother. Pediatric Use: Safety and effectiveness of FINACEA Gel, 15%, in pediatric patients have not been established. Geriatric: Clinical studies of FINACEA Gel, 15%, did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. ADVERSE REACTIONS Overall, treatment related adverse events, including burning, stinging/tingling, dryness/ tightness/scaling, itching, and erythema/irritation/redness, were 19.4% (24/124) for FINACEA Gel, 15%, and 7.1% (9/127) for the active comparator gel at 15 weeks. In two vehicle controlled, and one active controlled U.S. clinical studies, treatment safety was monitored in 788 patients who used twice daily FINACEA Gel, 15%, for 12 weeks (N=333) or for 15 weeks (N=124), or the gel vehicle (N=331) for 12 weeks. Table 3. Cutaneous Adverse Events Occurring in ≥1% of Subjects in the Rosacea Trials by Treatment Group and Maximum Intensity* FINACEA Gel, 15% N=457 (100%) Mild Moderate Severe n=99 n=61 n=27 (22%) (13%) (6%) Burning/ stinging/ tingling Pruritus Scaling/dry skin/xerosis Erythema/ irritation Contact dermatitis Edema Acne

Vehicle N=331 (100%) Mild Moderate Severe n=46 n=30 n=5 (14%) (9%) (2%)

71 (16%) 29 (6%)

42 (9%) 18 (4%)

17 (4%) 5 (1%)

8 (2%) 9 (3%)

6 (2%) 6 (2%)

2 (1%) 0 (0%)

21 (5%)

10 (2%)

5 (1%)

31 (9%)

14 (4%)

1 (<1%)

6 (1%)

7 (2%)

2 (<1%)

8 (2%)

4 (1%)

2 (1%)

2 (<1%) 3 (1%) 3 (1%)

3 (1%) 2 (<1%) 1 (<1%)

0 (0%) 0 (0%) 0 (0%)

1 (<1%) 3 (1%) 1 (<1%)

0 (0%) 0 (0%) 0 (0%)

*Subjects may have >1 cutaneous adverse event; thus, the sum of the frequencies of preferred terms may exceed the number of subjects with at least 1 cutaneous adverse event. FINACEA Gel, 15%, and its vehicle caused irritant reactions at the application site in human dermal safety studies. FINACEA Gel, 15%, caused significantly more irritation than its vehicle in a cumulative irritation study. Some improvement in irritation was demonstrated over the course of the clinical studies, but this improvement might be attributed to subject dropouts. No phototoxicity or photoallergenicity were reported in human dermal safety studies. In patients using azelaic acid formulations, the following additional adverse experiences have been reported rarely: worsening of asthma, vitiligo depigmentation, small depigmented spots, hypertrichosis, reddening (signs of keratosis pilaris), and exacerbation of recurrent herpes labialis. Post-marketing safety-Skin: facial burning and irritation; Eyes: iridocyclitis on accidental exposure with FINACEA Gel, 15%, to the eye [see PRECAUTIONS]. ©2012, Bayer HealthCare Pharmaceuticals Inc. All rights reserved. Manufactured for:

Bayer HealthCare Pharmaceuticals Inc. Wayne, NJ 07470

Manufactured in Italy M 6706804BS Rev. May 2012

Volume 7 • number 3 • Summer 2013 59

CONTINUING TO SUPPORT YOUR PATIENTS WITH COPAY SAVINGS

For mild to moderate rosacea

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

ERY

ORY PA PULES

THE

INFLAM

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T PUS in the p

resence o

f papules and pustules

Although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated.

3 Symptoms, 1 Medicine

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

INDICATION & USAGE

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

IMPORTANT SAFETY INFORMATION

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

In clinical trials with FINACEA, the most common local adverse events (AE’s) (inclusive of mild, moderate and severe categories) were: burning/stinging/ tingling (29%), pruritus (11%), scaling/dry skin/xerosis (8%) and erythema/irritation (4%). Contact dermatitis, edema and acne were observed at frequencies of 1% or less. Rarely reported AE’s included: worsening of asthma, vitiligo depigmentation, small depigmented spots, hypertrichosis, reddening (signs of keratosis pilaris) and exacerbation of recurrent herpes labialis. Post-marketing safety information: Skin (facial burning and irritation); Eyes (iridocyclitis on accidental exposure with FINACEA to the eyes). To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare at 1-866-463-3634 or FDA at 1-800-FDA-1088 or www.fda.gov/ medwatch. FINACEA is for topical use only. It is not for ophthalmic, oral or intravaginal use. In case of accidental eye exposure, wash eyes with large amounts of water and consult a physician if eye irritation persists. Wash hands following application of FINACEA. See adjacent page for Brief Summary of full Prescribing Information. Model used for illustrative purposes only. Reference: 1. FINACEA [package insert]. Morristown, NJ: Intendis, Inc; 2010.

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

60 Journal of Dermatology for Physician Assistants