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V o l u m e 8 • n u m b e r 2 • S P R I N G 2 0 1 4 • www.jdpa.org

Journal of Dermatology for Physician Assistants

dermatology Pa news & notes

SDPA State Affiliates 17 __________________________________

clinical dermatology JDPA Grand Rounds 29 __________________________________

›› Earn CME credit with this issue

Surgical dermatology Journal Club

39

_________________________________

Cosmetic dermatology Cosmetic Pearls

47

_____________________________ professional development JudicIal and Ethical Affairs

CME Understanding Rosacea: Current Theories on Pathophysiology and the Role of Emerging New Therapies for the Management of Erythematotelangiectatic Rosacea 18

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Official Journal of the Society of Dermatology Physician Assistants

Volume 8 • number 2 • SPRING 2014

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We are pleased to announce that as of January 1, 2014 all DLI modules are now AAPA approved to be used for the new “self assessment” category I CME requirement. Visit the AAPA or NCCPA websites for complete details on the new CME requirements being implemented in 2014.

AAPA • www.aapa.org • 703.836.2272 NCCPA • www.nccpa.net • 678-417-8100


NOW AVAILABLE FROM VALEANT DERMATOLOGY: BENSAL HP®

Indications and Usage

An external treatment for the inflammation and irritation associated with many common forms of dermatitis, including certain eczematoid conditions. These conditions include complications associated with pyodermas. Indicated also in the treatment of insect bites, burns, and fungal infections.

Important Safety Information

• BENSAL HP is contraindicated for use in those patients who are hypersensitive to topical polyethylene glycols. • BENSAL HP is for external use only. Not to be used in eyes. • It is not known if BENSAL HP interacts with other topical medications applied to the treatment area. Use with other topical agents has not been studied. • A small percentage of patients may experience a temporary burning sensation upon application of the ointment. • Safety and effectiveness in pediatric patients has not been established. Please see full Prescribing Information on the following page. Reference: Bensal HP [prescribing information]. Easley, SC: 7 Oaks Pharmaceutical Corp; 2010. Bensal HP is a trademark of 7 Oaks Pharmaceutical Corporation used under license.  Except as otherwise indicated, all other product names, slogans, and other marks are trademarks of the Valeant family of companies. © 2014 Valeant Pharmaceuticals North America, LLC. DM/BHP/14/0003 Printed in USA.

Volume 8 • number 2 • SPRING 2014

3


Rx Only Prescribing Information DESCRIPTION: Bensal HP ® ointment contains 30 mg salicylic acid per gram in a base containing: Benzoic acid, polyethylene glycol 400, polyethylene glycol 3350 and oak bark extract (QRB-7). CLINICAL PHARMACOLOGY: The mechanism of action of Bensal HP ® is not known. W hile the following animal data are available, their clinical significance is unknown. It has been demonstrated that Bensal HP ® significantly reduces methicillin-resistant Staphylococcus aureus (MRSA) protected by biofilms in wounds using porcine models. In addition, Bensal HP ® stimulates re-epithelialization of second-degree burns in porcine models. CLINICAL STUDIES: A randomized, double-blind, placebo-controlled study evaluated the rate of wound re-epithelialization. Four partial-thickness wounds (2x2 cm & 0.2 mm deep) were created under local anesthesia on the thighs of 13 normal, healthy, male volunteers with an electrokeratome. Bensal HP ® substantially increased the rate of re-epithelialization by 63% over the vehicle alone (p<0.01) and 77% over untreated control (p<0.005). INDICATIONS AND USAGE: An external treatment for the inflammation and irritation associated with many common forms of dermatitis, including certain eczematoid conditions. These conditions include complications associated with pyodermas. Indicated also in the treatment of insect bites, burns and fungal infections. CONTRAINDICATIONS: Bensal HP ® is contraindicated for use in those patients who are hypersensitive to topical polyethylene glycols. PRECAUTIONS: For external use only. Not to be used in eyes. DRUG INTERACTIONS: It is not known if Bensal HP ® interacts with other topical medications applied to the treatment area. The use of Bensal HP ® with other topical drugs has not been studied. ADVERSE REACTIONS: Bensal HP ® is generally well tolerated and non-irritating. A small percentage of patients may experience a temporary burning sensation upon application of the ointment. DOSAGE AND ADMINISTRATION: Patients should be advised to follow these step-by-step instructions for application of Bensal HP ® Ointment:

Hands should be washed thoroughly. W hen using tubes, the tip of the tube should not come into contact with the area to be treated; the tube should be recapped tightly after each application. If applying with a cotton-tipped applicator, which is recommended, use once and discard. Bensal HP ® Ointment should be applied twice a day for best results. Gently rinse the area to be treated with saline or water and then pat dry. Bensal HP ® Ointment can be applied directly to the wound or placed on dry gauze and then placed on the wound. Wet-Packs or Wet-To-Dry Dressings are not recommended since they will dilute the ointment and decrease its effectiveness. Bensal HP ® is designed to provide moisture to the wound. Spread a generous quantity of Bensal HP ® Ointment evenly over the desired area to yield a thin continuous layer of approximately 1/8 of an inch of thickness. There may be a mild warming sensation, or slight burning, to the treated area for 3-5 minutes after application. If irritation occurs or symptoms persist after 10 days, discontinue use and consult your physician. Try to keep the area being treated clean and exposed to air when possible. Apply an appropriate dressing to shield the area from clothes or exposure to water or dirt. If there is no improvement in the wound within 7 days, consult your physician for further evaluation of the wound. If there is no response to the ointment at all, then the wound should be re-evaluated for other contributing factors to the wound healing process. PEDIATRIC USE: Safety and effectiveness in pediatric patients has not been established. HOW SUPPLIED: 15 g tube .................................. NDC 63801 - 0107 - 09 30 g tube .................................. NDC 63801 - 0107 - 01 4 g tube .................................. NDC 63801 - 0107 - 12 2 g sample packet .................................. NDC 63801 - 0107 - 13 10 count 2 g sample packet carton .................................. NDC 63801 - 0107 - 10 Store at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted between 15ºC and 30ºC (between 59ºF and 86ºF). Brief exposure to temperatures up to 40ºC (104ºF) may be tolerated provided the mean kinetic temperature does not exceed 25ºC (77ºF); however, such exposure should be minimized.

Bensal HP ® inhibited all tested microbial strains, both Gram negative and Gram positive, in a Minimum Inhibitory Concentration (MIC) test against the following 49 select pathogens. Minimum Inhibitory Concentration Testing of QRB-7 The minimum inhibitory concentrations (MIC) of QRB-7 are listed below in parts per million (PPM)* . Microorganism Microorganism

QRB-7

Microorganism

QRB-7

Parts Per Million

Microorganism

Parts Per Million

Staphylococcus aureus, ATCC 6538 Salmonella choleraesuis, ATCC 10708 * Enterococcus faecalis, ATCC 19433 Pseudomonas cepacia, ATCC 10856 Staphylococcus epidermidis, ATCC 17917 Alcaligenes faecalis, ATCC 8750 Streptococcus uberis ATCC 27958 Escherichia coli, ATC 25922 Klebsiella pneumoniae, ATCC 13883 Pseudomonas aeruginosa, ATCC 10145 Shigella flexneri type 1A ATTC 9199 Pseudomonas paucimobilis, ATCC 29837 Streptococcus sanguis, ATCC 10556 Acinetobacter lewoffii, ATCC 9957 Pseudomonas putida, HTB Isolate Aeromonas sobria, ATCC 9071 Staphylococcus hominus, ATCC 27844 Staphylococcus haemolyticus, ATCC 29970 Staphylococcus saprophyticus, ATCC 15305 Staphylococcus simulans, ATCC 27848 Micrococcus lylae, ATCC 27566 Streptococcus agalactiae ATCC 13813 Streptococcus equisimilis ATCC 9542 Pseudomonas alcaligenes, ATCC 14909 Klebsiella oxytoca, ATCC 15764

25,000 25,000 50,000 3,125 12,500 25,000 12,500 25,000 25,000 25,000 12,500 1,563 12,500 25,000 6,250 25,000 12,500 25,000 25,000 25,000 50,000 12,500 12,500 25,000 12,500

Pseudomonas stutzeri, ATCC 17588 Salmonella typhi, ATCC 6539 Enterobacter aerogenes, ATCC 15038 Group D enterococcus Trichophyton mentagrophytes CDC y68+ Rhodotorula rubra HTB Isolate Enterobacter cloacae, Hosp/Envi isolate Escherichia coli, Hosp/Envi isolate Pseudomonas cepacia, Hosp/Envi isolate Klebsiella pneumoniae, Hosp/Envi isolate Staphylococcus aureus, Hosp/Envi isolate Acinetobacter calcoaceticus, ATCC 17961 Alcaligenes faecalis, ATCC 337 Enterobacter cloacae, ATCC 23355 Achromobacter xylosoxidans, HTB isolate Salmonella typhi, ATCC 19430 Listeria monocytogenes, ATCC 15313 Serratia marcesans, ATCC 14756 Serratia marcesans, ATCC 13880 Candida albicans, ATCC 10231 Serratia marcensans, Hosp/Envi isolate Salmonella enteritidis, ATCC 13076 Escherichia coli, ATCC 11229 Proteus mirabilis, ATCC 9240

50,000 12,500 25,000 50,000 50,000 50,000 25,000 25,000 25,000 25,000 50,000 25,000 25,000 25,000 25,000 25,000 12,500 25,000 25,000 12,500 25,000 25,000 25,000 25,000

* Data on file: 7 Oaks Pharmaceutical Corp., Easley, SC

Manufactured by: Sonar Products Inc. • Carlstadt, NJ For: 7 Oaks Pharmaceutical Corp.

• Easley, SC

© 2010 7 Oaks Pharmaceuticals Corp.

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Journal of Dermatology for Physician Assistants

• 877.723.6725 BHP-PI TD 1012


S D PA M

P I H S R EMBE

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

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

RAMC_6.75x4.75.indd 1

1/31/13 12:49 PM

SDPA 2014 SUMMER DERMATOLOGY CONFERENCE

INDIANAPOLIS, INDIANA

MAY 29th - JUNE 1st REGISTER TODAY!

Free Registration for the First 10 SDPA Student Members Volume 8 • number 2 • SPRING 2014

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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 Dermatology Grand Rounds Editor Cynthia F. Griffith, 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, MSPAS, 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 with the SDPA:

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 8, Number 2, Spring 2014. One year subscription rates: $40 in the United States and Possessions. Single copies (prepaid only): $10 in the United States (Include $6.50 per order plus $2 per additional copy for US postage and handling). Periodicals postage rate paid at New York, NY 10001 and additional mailing offices. Š 2014 Physician Assistant Communications, LLC. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including by photocopy, recording, or information storage and retrieval system, without permission in writing from the publisher. Postmaster: Send address changes to Society of Dermatology Physician Assistants, Inc., 4111 W. Alameda Ave. Suite 412, Burbank, CA 91505, 1-800-380-3992., email SDPA@dermpa.org, www.dermpa.org. THIS ISSUE IS SPONSORED BY

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Journal of Dermatology for Physician Assistants


Editor’s Message

Spring Songs

I

recently heard a news story on the radio that discussed the presence of repetition within music. It turns out that we as humans have the tendency to enjoy listening to music that has within its structure repeating notes, chords, and/or melodies. Through repetition, a familiarity is developed with the music, thus affording us the opportunity to shift our attention away from the music itself and towards other thoughts or feelings we may be experiencing; adjusting our reality so to say. This power of repeated exposure is not limited to music alone. As we go about our daily clinical routines, we have a certain level of comfort and familiarity with cases that we tend to treat frequently (acne, warts, and eczema for example). We know almost instantly what type of treatment plans to discuss with patients and what the expected outcomes for each condition will be (with minor adjustments made along the way given each individual patient’s specific needs). In the midst of seeing the same diagnosis several times a day, the security in knowing what to do allows us the freedom to shift our attention and perhaps step outside of our routines. We can then adjust our focus from the diagnosis at hand to the individual in front of us. What have they been up to lately? What’s going on in their lives right now with school, sports, family, work, travel, etc.? Making those deeper connections with our patients oftentimes leads to learning something new that can assist us in the management of their diagnoses. For example, we know that each spring tulips will bloom, robins will sing, and new patient appointments with high school juniors and seniors with acne will increase. Prom season is upon us. While we are certain in our diagnosis of their acne, how we choose to manage it can change. While we cannot speed up the healing hands of time, we can suggest things that may help to improve their appearance, discuss with them the dangers of indoor tanning, and perhaps, for peace of mind, schedule their follow-up visits sooner rather than later. It is when we are most comfortable in dealing with these familiar concerns that we are able to adjust our focus from the diagnoses themselves. Patients appreciate a level of care that goes beyond treating their particular skin concerns to caring for the individual as a whole. So while our patients and their concerns certainly aren’t music in the true sense of the word, the continued exposure and repetition of certain cases can make us better able to handle our patients’ overall concerns. It affords us an opportunity to adjust our reality and provide even better care for our patients. J

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

Volume 8 • number 2 • SPRING 2014

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

18 Understanding Rosacea: Current Theories on Pathophysiology and the Role of Emerging New Therapies for the Management of Erythematotelangiectatic Rosacea By Susan E. King-Barry, MPAS, PA-C, Priscilla Rajan, PA-C, Mary Showstark, MPAS, PA-C, and Jeffrey M. Weinberg, MD

›› CME 12 Derm PA News & Notes – part one • Student Corner • Certification Review & Maintenance • SDPA State Affiliates

18 Clinical Dermatology • CME Article – Understanding Rosacea: Current Theories on Pathophysiology and the Role of Emerging New Therapies for the Management of Erythematotelangiectatic Rosacea • JDPA Grand Rounds

Departments

06 Editorial Board 07 Editor’s Message 11 SDPA News & Current Affairs 16 Dermatology Market Watch 22 From The Patient’s Perspective 27 Dermoscopy 32 Clinical Snapshots 40 Surgical Wisdom 47 Cosmetic Pearls 51 Outside & Inside the 9 to 5… 53 Notes from your Office Manager 54 Camp Discovery 2014 59 The Difference We Make 66 JDPA Information for Authors 67 Professional Opportunities and Development

39 Surgical Dermatology • Journal Club: Practice Changing Articles for

Dermatology

43 Cosmetic Dermatology • Selecting the Right Patient for a Cosmetic Procedure

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

54 Derm PA News & Notes – part two

Go Green - Read Online 8

Journal of Dermatology for Physician Assistants

• From the Desk of… • Workplace Excellence • Supervising Physician Corner

dermpa.org


HALOG Cream and Ointment are designed for a difference your patients can truly feel. BIPHASIC CREAM for sustained relief.1,2 PLASTIBASE® OINTMENT for enhanced spreadability and appeal.3

INDICATIONS AND USAGE: HALOG (Halcinonide, USP) 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. For topical use only. For Important Safety Information, please see Brief Summary on reverse. For full Prescribing Information see Product Package Insert at HalogRx.com REFERENCES: 1. Blecker, J. Double-blind comparison between two new topical steroids, halcinonide 0.1% and clobetasol propionate cream 0.05%. Curr Med Res Opin. 1975;3:225-228. 2. Bagatell FK. Halcinonide: a new potent anti-inflammatory drug. Cutis. 1974:14:459-462. 3. Thau P, Fox C. A new procedure for the preparation of polyethylenemineral oil gels. J Soc Cosmet Chem. 1965;16:359-363.

HALOG ® is a registered trademark of Ranbaxy Laboratories Inc. All other trademarks are property of their respective owners. HLGJI1Ba 01/14

Volume 8 • number 2 • SPRING 2014

9


10 Journal of Dermatology for Physician Assistants


FROM THE SDPA

News & Current Affairs

CALENDAR OF EVENTS 2014

MAY/JUNE SDPA Summer Dermatology Conference May 28 – June 1, 2014 Marriott Downtown Indianapolis, IN AUGUST AAD Summer Academy Meeting August 6 - 10, 2014 Chicago, IL NOVEMBER SDPA 12th Annual Fall Dermatology Conference November 12 - 15, 2014 Manchester Grand Hyatt San Diego, CA

2015

MARCH 73rd AAD Annual Academy Meeting March 20 - 24, 2015 San Francisco, CA

T

he mission statement of the SDPA reads in part: “Advance the utilization and team concept of Physician Assistants in the practice of dermatology in a supervised relationship with physicians.” To that end, some of your SDPA Board members met recently with members of the AAD Board of Directors and other AAD representatives in Denver at the AAD Annual Meeting. We meet at least yearly and discuss how we can work together to advance our common goals. Each year the meeting consists of both new and familiar faces. Our goal is to help educate AAD leaders regarding PAs in dermatology so they in turn can educate their members. This is sometimes difficult to do since AAD members may have preconceived notions about how we practice, or may be basing their opinions on information that seems to suggest one thing but is more complex. Periodically an issue is brought to our attention by an SDPA member who sees an article referring to PAs in a negative way or hears a speaker make comments that demonstrate a lack of knowledge regarding our education or role in the practice of dermatology. Other misconceptions included physicians concerned about PAs attending a bridge program and becoming physicians in six months, PAs working entirely without supervision because data shows that PAs are billing Medicare directly rather than incident-to, and PAs claiming to be board certified in dermatology. We have sought to correct the misinformation. We researched and responded to each of these misconceptions. The SDPA members who bring these issues to our attention are often justifiably upset. Some have written letters or demanded that we respond to such misinformation or negative portrayal. The SDPA considers each and every request as they come in. We are developing a more formal way of responding so that our message is consistent, professional, and never antagonistic. We must first seek to understand and then to be understood. If we can determine where the misinformation came from, we can correct it. Responding with anger only serves to reinforce the negative opinion we are trying to correct. We must never stop educating both physicians and the public about our role in the care of patients and in the delivery of quality dermatological and surgical care to our patients. Our message of education should be delivered as carefully as our medical care is. It is rarely effective to confront someone about an issue when you are upset. The frustration is the only message that gets heard. While I want every PA to help us educate, the message should be well considered and never hasty. I encourage all SDPA members to bring the SDPA Board of Director’s attention anything they feel is worthy of a response. We can review it rationally using our combined years of experience handling these situations and decide the best way to approach it. Thank you all for keeping your ears and eyes open for the benefit and continued growth of our profession. J

Jennifer Winter, MSPAS, PA-C SDPA President, Diplomate

Volume 8 • number 2 • SPRING 2014 11


Dermatology PA news & notes

Student Corner

Introducing the SDPA’s First Ever Interactive Mock Resume The perfect resume-building tool to assist the aspiring dermatology PA The SDPA Student Affairs Committee is excited to announce our brand new, interactive mock resume. This new resource can be found on the SDPA student website and is intended to serve as a guide for SDPA Student members who are interested in beginning a career in dermatology or for those SDPA Associate members looking to transition into a career in dermatology. We have incorporated several interactive links into the mock resume. These interactive links will not only serve as a guide when building a resume, but will also help members become more involved with their profession and help them to create additional items to highligh on their resumes. For example, the mock resume link to the AAPA website can help members stay in tune with national changes to the profession, view the 2013-2014 AAPA Salary Report, or acquire CME credits. For additional CME opportunities, members can also click on the links for the SDPA Distant Learning Initiative (DLI) or the

Available Now! The SDPA’s First Ever Interactive Derm PA Resume

AAD Medical Student Core Curriculum. How do you get involved or make a difference in your state? Simply click on the SDPA link in the mock resume. Some states have local SDPA Affiliate chapters where you can build relationships, educate one another, or collaborate on state affairs. If your state does not have an SDPA Affiliate chapter, you can create one yourself and help make a difference in your state. Finally, when building your resume do not forget to showcase your commitment to dermatology education. Members who wish to share their knowledge of dermatology by submitting articles for potential publication in the SDPA’s official journal can click on the Journal of Dermatology for Physician Assistants (JDPA) interactive link in the mock resume. With the new mock resume tool, you will not only be building your resume, but will also increase your dermatological knowledge and enhance your employment opportunities in dermatology. Of course we cannot guarantee a job, but we hope this resource will assist you along your way! J

Write for the JDPA!

Are you a PA or a PA student who... • Is interested in writing? • Has a paper you want to get published?

The perfect resume building tool to assist the aspiring dermatology PA.

www.dermpa.org

|

1-800-380-3922

12 Journal of Dermatology for Physician Assistants

Share your knowledge today. Contact editor@jdpa.org

JDPA 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 8 • number 2 • SPRING 2014 13


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.

14 Journal of Dermatology for Physician Assistants

Issued 0711

004158


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! AOM, there are three main bacterial causes: Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. Alloiococcus otitidis is a rare cause of AOM, Neisseria meningitides is a cause of meningitis, Staphylococcus aureus is both a common cause of skin infections and a cause of AOM in neonates, and Mucor indicus is a cause of mucomycosis, which is an infection in the sinuses, brain, or lungs, and is typically noted in immunocompromised patients. J James A. Van Rhee, MS, PA-C, is the Program Director for the Yale University School of Medicine Physician Associate Program. Mr. Van Rhee has been involved in physician assistant education for over 17 years. He has served as project director and test item writer for the Physician Assistant Education Association’s (PAEA) Physician Assistant Clinical Knowledge Rating Assessment Tool (PACKRAT) and is the author of the Physician Assistant: Certification and Re-certification Review Book, published by Elsevier. For the last ten years he has been course director and presenter of the Physician Assistant Board Review, which is now being produced live online by Kaplan Medical.

Certification Maintenance - Frequently Asked Questions The year 2014 marks the beginning of the physician assistant profession's transition to a 10-year certification maintenance process. Physician assistants who pass PANCE, regain certification, or wrap up a sixyear certification maintenance cycle in 2014 will be the first to begin the new 10-year process. SDPA members can log into their NCCPA accounts and review their dashboards to confirm when they will move into this new 10-year cycle. This new process requires new types of CME activities; self-assessment (SA) and performance improvement (PI) CME. To learn more about the new requirements, SDPA members are encouraged to visit www.nccpa.net/CertMain. Below are some of the most frequently asked questions by SDPA members pertaining to these new changes in certification maintenance. Q: I recently saw that as of this year, 2014, the SDPA DLI program has been approved by the AAPA for the new self-assessment CME credit. As an SDPA member,

can I claim this self-assessment CME credit even if I completed the DLI program prior to January 1st, 2014? A: Physician assistants cannot earn and complete self-assessment (SA) or performance improvement (PI) CME credits until they have transitioned to the new 10year certification maintenance cycle. Physician assistants should check with NCCPA to determine when they will transition to the new 10-year certification maintenance cycle. If PAs participate in SA or PI CME activities prior to transitioning to the new 10-year certification maintenance cycle, the CME credits may be claimed as regular Category 1 CME credit, and may only be claimed during the 2 year CME cycle in which the credit was awarded. Q: If I took PANRE a year early in 2013 but my sixth year is 2014, will I recertify again in 6 years or 10 years? A. Taking PANRE a year early doesn't change your certification maintenance cycle, so you would transition to the 10-year cycle once your certification is updated in 2014 and would be due to pass PANRE again in 2024. J Volume 8 • number 2 • SPRING 2014 15

DERmatology pa news & notes

The correct answer is D

QUESTION: An 18-month-old child presents with fever. The mother states the fever started about 12 hours ago, and at that time the infant became fussy and started crying. The infant’s past medical history is unremarkable. On physical examination, the throat is clear without exudates, clear drainage is noted from both nares, and the right tympanic membrane is clear while the left is bulging and erythematous. The neck is supple without rigidity and the lungs are clear to auscultation. Which of the following is the most likely bacterial etiology for the infection in this patient? A. Alloiococcus otitidis B. Neisseria meningitidis C. Staphylococcus aureus D. Haemophilus influenzae E. Mucor indicus EXPLANATION: This patient has a classic presentation of acute otitis media (AOM) including history of acute onset of symptoms, presence of a middle ear effusion, and signs and symptoms of middle ear inflammation. While viral agents are a common cause of


Dermatology Market Watch

DERmatology pa news & notes

AAD Aims to Educate the Public about Skin Cancer The American Academy of Dermatology (AAD) is committed to leading the charge to reduce mortality from and the incidence of skin cancer in the next 10 to 30 years. The Academy’s SPOT Skin Cancer™ initiative aims to educate the public about skin cancer and motivate individuals to make positive behavior changes to prevent and detect skin cancer. One of the free resources available to dermatology PAs is intended to help educate children about sun safety. Gigi the Giraffe™ is the fictional character who will help to teach children about the importance of sun protection. There are free activities and facts sheets available to download at www.aad.org/spot-skin-cancer/ understanding-skin-cancer/kids-and-sun-safety/kidsand-sun-safety. Dermatology providers can print the activity sheets and have them available for scheduled pediatric patients and for patients who bring in children with them to their appointments or have children or grandchildren at home. There are also free downloads available to be used by providers who wish to educate children outside of the clinical setting. Sharing this information at a local elementary school as part of a health fair or at a public library can help educate youth about the importance of skin protection and will help them form healthy, lifelong habits. It is important to teach children about the dangers of too much sun on their skin. Teaching children important habits now such as seeking shade, applying

sunscreen, and wearing protective clothing can ensure that these habits become routine as they grow older. Please join in the effort to better educate children and help them to form healthy skin care habits now. J

AAD Spot Skin Cancer Resources Available for Children, Parents, and Teachers. Children's Resources • Gigi's facts about sun safety: Gigi answers some of the most frequently asked questions about sun safety. • Gigi sun safe poster: Print and hang this flyer of Gigi showing all the ways you can stay safe in the sun. • Gigi's activity sheet: Kids can have fun completing a maze, word find, crossword puzzle, and more while learning about sun safety. • Gigi's coloring sheets: Kids can color in Gigi while exploring how she remains sun safe everywhere she goes.

Tools for Parents and Teachers • Children's educational toolkit: This fun and interactive toolkit featuring Gigi the Giraffe™ is filled with activities and lessons to help teach children about sun safety. 16 Journal of Dermatology for Physician Assistants

• Children's sun safety flyer: Learn ways to incorporate sunsafety awareness into everyday life at home and at school. • Gigi the Giraffe™ stickers: Download and print these Gigi the Giraffe™ stickers on your home computer using AVERY Template 8293/Round Label/20 per sheet. • Children's educational presentation (Grades K-2): Download this sun-safety educational PowerPoint presentation featuring Gigi the Giraffe™, which is written for children in kindergarten to second grade. • Children's educational presentation (Grades 3-5): Download this sun-safety educational PowerPoint presentation featuring Gigi the Giraffe™, which is written for children in third to fifth grade.


SDPA State Affiliates

Indiana and the SDPA 20th Anniversary Celebration

We started the St. Louis/Missouri chapter. The SDPA is excited to have their 20th Anniversary Celebration and Annual Summer Dermatology Conference in Indianapolis this May! Since there currently is not an Indiana SDPA State Affiliate chapter, I thought I could share some insights with you in regards to the dermatology PAs who practice within the “Hoosier State.” There are currently eighteen dermatology PAs practicing within the state of Indiana who are SDPA members, and the number continues to grow. As I mentioned, there is no SDPA Affiliate currently established in Indiana. The SDPA does encourage PAs in all states to establish an Affiliate chapter due to the varying individual state laws concerning PA practice, the chance to be a member of a strong networking body, and the opportunity to have a strong voice for their profession within their respective states. In Indiana, one supervising physician can supervise two PAs, and charts must be reviewed within seventytwo hours after the patient has been seen by a PA. The supervising physician does not have to be present at the site of the patient/PA encounter, but this was a recent change to the law. The AAPA does have an Indiana state affiliate, which strongly encourages Indiana dermatology PAs to be active in and help to bridge a network with the Indiana Academy of Physician Assistants (IAPA). Some exciting news is that the Indiana state legislature recently passed bill SB 50 Minors and Tanning Devices on January 23rd, 2014. It is important that dermatology PAs play an integral part in these significant legislative changes that need to be made.

As an example of why we need SDPA State Affiliates, Indiana in 2007 was the last state to allow PAs prescriptive authority, which authorized PAs to only prescribe medications that have been approved by their supervising physicians. Also, prescriptions written for more than thirty days can only be written by supervising physicians. An Indiana SDPA State Affiliate could work to improve upon these existing laws. The SDPA Constituent Relations Committee is encouraging PAs in Indiana and other states to start a State Affiliate chapter with the SDPA. I will be holding a meeting for those interested in forming a State Affiliate on Friday, May 30th at the SDPA Annual Summer Dermatology Conference and hope to see you there. In the meantime, please contact me at rblock@dermpa.org with any questions on how to get started. For PAs in Indiana, please check out the Indiana Academy of Physician Assistants (IAPA) at indianapas.org. J The SDPA currently has 17 State Affiliate chapters. We continue to grow and would love to have all 50 states participating! It takes teamwork and a strong commitment. For anyone who is interested in starting an SDPA State Affiliate chapter or if you have a state chapter and need some advice about becoming affiliated with the SDPA, please contact me at rblock@dermpa.org. I am here to help you!

Volume 8 • number 2 • SPRING 2014 17

DERmatology pa news & notes

By Renata M. Block, MMS, PA-C SDPA Constituent Relations Committee Chair


Clinic al Dermatology

Understanding Rosacea: Current Theories on Pathophysiology and the Role of Emerging New Therapies for the Management of Erythematotelangiectatic Rosacea By Susan E. King-Barry, MPAS, PA-C, Priscilla Rajan, PA-C, Mary Showstark, MPAS, PA-C, and Jeffrey M. Weinberg, MD

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

›› CME

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

Approval is valid for 1 year from the issue date of April 2014. Participants may submit the self-assessment exam at any time during that period. This program was planned in accordance with AAPA’s CME Standards for Enduring Material Programs and for Commercial Support of Enduring Material Programs.

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

Learning Objectives: 1. Identify current theories explaining the pathophysiological etiology of rosacea. 2. Understand the complex dysregulation of the inflammatory, vascular, and neuronal mediators involved in rosacea. 3. Describe the current management strategies for erythematotelangiectatic rosacea. 4. Recognize new emerging therapies for the management of erythematotelangiectatic rosacea. 18 Journal of Dermatology for Physician Assistants


Understanding Rosacea 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 8 • number 2 • SPRING 2014 19


Understanding Rosacea 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


Understanding Rosacea 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.

Priscilla Rajan, PA-C is a recent graduate of Touro College, School of Health Sciences, Physician Assistant Program in New York, NY. She has indicated no relationships to disclose relating to the content of this article. Mary Showstark, MPAS, PA-C is a physician assistant who graduated with a Master’s Degree, in 2004 from the University of Florida. She has worked in trauma surgery, emergency medicine, urgent care, and for the federal government: DMAT. She currently works as an instructor and clinical coordinator for the Touro College, School of Health Sciences, Physician Assistant Program in New York, NY. She has indicated no relationships to disclose relating to the content of this article. Jeffrey M. Weinberg, MD, is an associate clinical professor of dermatology at Mount Sinai School of Medicine in New York City. In addition, he is acting director of the Division of Dermatology at Jamaica Hospital Medical Center, also in New York City. Dr. Weinberg graduated from the University of Pennsylvania School of Medicine in Philadelphia and completed an internship in medicine at Columbia-Presbyterian Medical Center in New York City. He then completed a residency in dermatology at the University of Pennsylvania School of Medicine. Dr. Weinberg is a Fellow of the American Academy of Dermatology, where he has served on several committees, and a member of the Dermatology Foundation. He is a Diplomate of the American Board of Dermatology. He has indicated no relationships to disclose relating to the content of this article.

Volume 8 • number 2 • SPRING 2014 21

CLINIC AL Dermatology

Susan E. King-Barry, MPAS, PA-C is an Associate professor at Western Michigan University, Physician Assistant Program, where she teaches courses in pathophysiology and dermatology, endocrinology, pulmonary, psychiatry and infectious disease. She received her Master’s degree from the University of Nebraska in Physician Assistant Studies. She has indicated no relationships to disclose relating to the content of this article.


From The Patient’s Perspective One Camper’s Journey of Discovery By Allyson Taubenheim

Y DEM OF D CA E

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When I got off the bus at Camp Discovery as a ten year old, I had no idea that when I A left a week later my life would be changed forever. I can still remember my first day at Camp Discovery. I was nervous and excited. During that first week I met SS ES LA people that were like me, and even people KE, MINN who were worse off than me. I began to realize my disease didn’t define me, and my selfconfidence grew. It was an amazing experience.

IG P B TR

CLINIC AL Dermatology

I was lucky enough to attend Camp Discovery for seven years. After that, my time as a camper was up, but I wasn’t ready to leave. That’s when I started as a volunteer counselor at Camp Discovery. I was ready to step up and be a great role model for kids like me. Eight years later I continue to volunteer at Camp Discovery. My time at the camp in Crosslake, Minnesota, is the most significant thing in my life. It has taught me to be grateful, confident, compassionate, and happy. I love working with all these special kids and amazing people, and I can’t imagine my life any other way. J

Allyson Taubenheim (front row, farthest right) with campers and counselors at Camp Discovery’s Camp Big Trout in Crosslake, Minnesota.

Camp Discovery offers kids living with skin disease a one-of-a-kind experience. Every summer, the AAD sponsors six weeks of camp in five locations where everyone can experience activities such as fishing, swimming, archery, horseback riding, nature trails, and just plain fun! Contact Information: www.aad.org/dermatology-a-to-z/for-kids/campdiscovery For additional information regarding Camp Discovery, please contact Janine Mueller at the AAD at: 
 Phone: (847) 240-1737 
 E-mail: jmueller@aad.org 22 Journal of Dermatology for Physician Assistants


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

2. I truly believe that campers meeting others with similar skin disorders is a major factor in their transformation over this short period of time. They form a community that is not based on their outward appearances but on their life experiences and hopes for the future. The power of Camp Discovery comes from the mutual acceptance between participants and

the nonjudgmental atmosphere, which creates true compassion among campers. 3. Camp Discovery turned a ten year old girl from a child being defined by her skin disease into a self-confident teacher of others. Allyson was taught gratefulness, confidence, and compassion, which led to increased happiness. Can you imagine if you were able to do this with the patients you serve? Don't miss out on the Camp Discovery experience. I agree with Allyson when she said it changed her life. After I spent two weeks during two seasons at Camp Discovery fifteen years ago, it changed my life. I have never forgotten that precious time with the campers. To this day, it is difficult for me to talk about the experience without tears. Won't you join us at camp this year?

The Harborside Hotel Bar Harbor, Maine June 17-19, 2014

To register, visit americandermoscopy.com

Volume 8 • number 2 • SPRING 2014 23

CLINIC AL Dermatology

1. Allyson’s story of her experience at Camp Discovery was touching, inspiring, and powerful. It reminds me of all the patients with significant skin diseases that I cared for over many years. Could I have achieved in one week the same positive effects that Camp Discovery did for these campers in the same amount of time? Humbly submitted, I don't believe I could have. It is a very special place.


PROVEN

EFFICACY

CUSTOMIZED, WITH WEIGHT-BASED1,2

DOSING

• Significant reduction in inflammatory lesions at ~1 mg/kg/day in SOLODYN®-treated patients1,2 – In a dose-ranging study, a 56.8% reduction from baseline vs placebo (39.4%)* – In 2 phase 3 trials, mean percent improvement from baseline was 43% and 46% vs placebo (32% and 31%, respectively)† • Once-daily dosing, with or without food1 • No generic equivalent *Phase 2 study; N=233 subjects. † N=924 subjects.

Indication and Usage SOLODYN is indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. Important Safety Information for SOLODYN Tablets use of tetracyclines with oral life-threatening; therefore, it • The most commonly observed contraceptives may render oral adverse reactions are headache, is important to consider this contraceptives less effective diagnosis in patients who fatigue, dizziness, and pruritus present with diarrhea subsequent • This drug is contraindicated in • Minocycline like other to the administration of persons who have shown tetracycline-class drugs antibacterial agents hypersensitivity to any of the can cause fetal harm when tetracyclines • Central nervous system side administered to a effects, including lightpregnant woman • Safety beyond 12 weeks of use headedness, dizziness, and has not been established • Tetracycline drugs should not be vertigo, have been reported used during tooth development • Cases of anaphylaxis, serious with minocycline therapy (last half of pregnancy and up to skin reactions, erythema 8 years of age) as they may cause • In rare cases, photosensitivity multiforme, and drug rash with has been reported permanent discoloration of teeth eosinophilia and systemic symptoms have been reported • Pseudomembranous colitis has • Should not be used during pregnancy or by individuals of postmarketing with minocycline been reported with nearly all either gender who are attempting use. Discontinue SOLODYN antibacterial agents and may to conceive a child; concurrent immediately if symptoms occur range from mild to Please see Brief Summary of full Prescribing Information on the following pages. References: 1. SOLODYN Tablets Package Insert. Scottsdale, AZ: Valeant Dermatology; February 2012. 2. Data on file, Valeant Pharmaceuticals.

Except as otherwise indicated, all product names, slogans and other marks are trademarks of the Valeant family of companies. ©2014 Valeant Pharmaceuticals North America LLC. DM/SDN/14/0005

24 Journal of Dermatology for Physician Assistants


BRIEF SUMMARY (see package insert for full prescribing information) SOLODYN® (minocycline HCl, USP) Extended Release Tablets Rx Only KEEP OUT OF REACH OF CHILDREN INDICATIONS AND USAGE Indication SOLODYN is indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. Limitations of Use SOLODYN did not demonstrate any effect on non-inflammatory acne lesions. Safety of SOLODYN has not been established beyond 12 weeks of use. This formulation of minocycline has not been evaluated in the treatment of infections.

animals treated early in pregnancy (see Use in Specific Populations). Pseudomembranous Colitis Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of “antibiotic-associated colitis”.

After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to discontinuation of To reduce the development of drugthe drug alone. In moderate to severe resistant bacteria as well as to maintain the cases, consideration should be given to effectiveness of other antibacterial drugs, management with fluids and electrolytes, SOLODYN should be used only as indicated protein supplementation, and treatment (see Warnings and Precautions). with an antibacterial drug clinically effective against Clostridium difficile colitis. CONTRAINDICATIONS This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines. WARNINGS AND PRECAUTIONS Teratogenic Effects A. MINOCYCLINE, LIKE OTHER TETRACYCLINE-CLASS DRUGS, CAN CAUSE FETAL HARM WHEN ADMINISTERED TO A PREGNANT WOMAN. IF ANY TETRACYCLINE IS USED DURING PREGNANCY OR IF THE PATIENT BECOMES PREGNANT WHILE TAKING THESE DRUGS, THE PATIENT SHOULD BE APPRISED OF THE POTENTIAL HAZARD TO THE FETUS. SOLODYN should not be used during pregnancy or by individuals of either gender who are attempting to conceive a child (see Nonclinical Toxicology & Use in Specific Populations). B. THE USE OF DRUGS OF THE TETRACYCLINE CLASS DURING TOOTH DEVELOPMENT (LAST HALF OF PREGNANCY, INFANCY, AND CHILDHOOD UP TO THE AGE OF 8 YEARS) MAY CAUSE PERMANENT DISCOLORATION OF THE TEETH (YELLOW-GRAY-BROWN). This adverse reaction is more common during long-term use of the drug but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. TETRACYCLINE DRUGS, THEREFORE, SHOULD NOT BE USED DURING TOOTH DEVELOPMENT. C. All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in fibula growth rate has been observed in premature human infants given oral tetracycline in doses of 25 mg/kg every 6 hours. This reaction was shown to be reversible when the drug was discontinued. Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can cause retardation of skeletal development on the developing fetus. Evidence of embryotoxicity has been noted in

Hepatotoxicity Post-marketing cases of serious liver injury, including irreversible drug-induced hepatitis and fulminant hepatic failure (sometimes fatal) have been reported with minocycline use in the treatment of acne. Metabolic Effects The anti-anabolic action of the tetracyclines may cause an increase in BUN. While this is not a problem in those with normal renal function, in patients with significantly impaired function, higher serum levels of tetracycline-class drugs may lead to azotemia, hyperphosphatemia, and acidosis. If renal impairment exists, even usual oral or parenteral doses may lead to excessive systemic accumulations of the drug and possible liver toxicity. Under such conditions, lower than usual total doses are indicated, and if therapy is prolonged, serum level determinations of the drug may be advisable. Central Nervous System Effects Central nervous system side effects including light-headedness, dizziness or vertigo have been reported with minocycline therapy. Patients who experience these symptoms should be cautioned about driving vehicles or using hazardous machinery while on minocycline therapy. These symptoms may disappear during therapy and usually rapidly disappear when the drug is discontinued. Benign Intracranial Hypertension Pseudotumor cerebri (benign intracranial hypertension) in adults and adolescents has been associated with the use of tetracyclines. Minocycline has been reported to cause or precipitate pseudotumor cerebri, the hallmark of which is papilledema. Clinical manifestations include headache and blurred vision. Bulging fontanels have been associated with the use of tetracyclines in infants. Although signs and symptoms of pseudotumor cerebri resolve after discontinuation of treatment, the possibility for permanent sequelae such as visual loss that may be permanent or severe exists. Patients should be questioned for visual

disturbances prior to initiation of treatment with tetracyclines. If visual disturbance occurs during treatment, patients should be checked for papilledema. Concomitant use of isotretinoin and minocycline should be avoided because isotretinoin, a systemic retinoid, is also known to cause pseudotumor cerebri.

drug-resistant bacteria to develop during the use of SOLODYN, it should be used only as indicated.

Superinfection As with other antibiotic preparations, use of SOLODYN may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, SOLODYN Autoimmune Syndromes should be discontinued and appropriate Tetracyclines have been associated with the therapy instituted. development of autoimmune syndromes. Laboratory Monitoring The long-term use of minocycline in the Periodic laboratory evaluations of organ treatment of acne has been associated systems, including hematopoietic, renal with drug-induced lupus-like syndrome, and hepatic studies should be performed. autoimmune hepatitis and vasculitis. Appropriate tests for autoimmune syndromes Sporadic cases of serum sickness have should be performed as indicated. presented shortly after minocycline ADVERSE REACTIONS use. Symptoms may be manifested by fever, rash, arthralgia, and malaise. In Clinical Trial Experience symptomatic patients, liver function tests, Because clinical trials are conducted under ANA, CBC, and other appropriate tests prescribed conditions, adverse reaction should be performed to evaluate the rates observed in the clinical trial may not patients. Use of all tetracycline-class drugs reflect the rates observed in practice. should be discontinued immediately. The following table summarizes selected Photosensitivity adverse reactions reported in clinical trials Photosensitivity manifested by an at a rate of ≥1% for SOLODYN. exaggerated sunburn reaction has been Selected Treatment-Emergent Adverse observed in some individuals taking Reactions in at least 1% of Clinical tetracyclines. This has been reported Trial Subjects rarely with minocycline. Patients should Adverse Reactions SOLODYN PLACEBO minimize or avoid exposure to natural or (1 mg/kg) N=364 artificial sunlight (tanning beds or UVA/B N=674 (%) (%) treatment) while using minocycline. If At least one treatment- 379 (56) 197 (54) patients need to be outdoors while using minocycline, they should wear loose-fitting emergent event 152 (23) 83 (23) clothes that protect skin from sun exposure Headache 62 (9) 24 (7) and discuss other sun protection measures Fatigue Dizziness 59 (9) 17 (5) with their physician. Pruritus 31 (5) 16 (4) Serious Skin/Hypersensitivity Malaise 26 (4) 9 (3) Reaction Mood alteration 17 (3) 9 (3) Cases of anaphylaxis, serious skin reactions 13 (2) 3 (1) (e.g. Stevens Johnson syndrome), erythema Somnolence 10 (2) 1 (0) multiforme, and drug rash with eosinophilia Urticaria 10 (2) 5 (1) and systemic symptoms (DRESS) syndrome Tinnitus Arthralgia 9 (1) 2 (0) have been reported postmarketing with Vertigo 8 (1) 3 (1) minocycline use in patients with acne. Dry mouth 7 (1) 5 (1) DRESS syndrome consists of cutaneous Myalgia 7 (1) 4 (1) reaction (such as rash or exfoliative dermatitis), eosinophilia, and one or more Postmarketing Experience of the following visceral complications Adverse reactions that have been reported such as: hepatitis, pneumonitis, nephritis, with minocycline hydrochloride use in a myocarditis, and pericarditis. Fever and variety of indications include: lymphadenopathy may be present. In some Skin and hypersensitivity reactions: cases, death has been reported. If this fixed drug eruptions, balanitis, erythema syndrome is recognized, the drug should be multiforme, Stevens-Johnson syndrome, discontinued immediately. anaphylactoid purpura, photosensitivity, Tissue Hyperpigmentation pigmentation of skin and mucous Tetracycline-class antibiotics are known membranes, hypersensitivity reactions, to cause hyperpigmentation. Tetracycline angioneurotic edema, anaphylaxis, DRESS therapy may induce hyperpigmentation in syndrome (see Warnings and Precautions). many organs, including nails, bone, skin, Autoimmune conditions: polyarthralgia, eyes, thyroid, visceral tissue, oral cavity pericarditis, exacerbation of systemic lupus, (teeth, mucosa, alveolar bone), sclerae and pulmonary infiltrates with eosinophilia, heart valves. Skin and oral pigmentation transient lupus-like syndrome. has been reported to occur independently Central nervous system: pseudotumor of time or amount of drug administration, cerebri, bulging fontanels in infants, whereas other tissue pigmentation has decreased hearing. been reported to occur upon prolonged administration. Skin pigmentation includes Endocrine: brown-black microscopic thyroid diffuse pigmentation as well as over sites discoloration, abnormal thyroid function. of scars or injury. Oncology: thyroid cancer. Development of Drug Resistant Oral: glossitis, dysphagia, tooth Bacteria discoloration. Bacterial resistance to the tetracyclines may develop in patients using SOLODYN, Gastrointestinal: enterocolitis, pancreatitis, therefore, the susceptibility of bacteria hepatitis, liver failure. associated with infection should be Renal: reversible acute renal failure. considered in selecting antimicrobial Hematology: hemolytic anemia, therapy. Because of the potential for thrombocytopenia, eosinophilia.

Volume 8 • number 2 • SPRING 2014 25


Preliminary studies suggest that use of minocycline may have deleterious effects on human spermatogenesis (see Nonclinical Toxicology). DRUG INTERACTIONS Anticoagulants Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.

systemic exposure to minocycline observed in patients as a result of use of SOLODYN). Reduced mean fetal body weight was observed in studies in which minocycline was administered to pregnant rats at a dose of 10 mg/kg/day (which resulted in approximately the same level of systemic exposure to minocycline as that observed in patients who use SOLODYN).

Minocycline was assessed for effects on peri- and post-natal development of rats in a study that involved oral administration to Penicillin pregnant rats from day 6 of gestation Since bacteriostatic drugs may interfere through the period of lactation (postpartum with the bactericidal action of penicillin, it is day 20), at dosages of 5, 10, or 50 advisable to avoid giving tetracycline-class mg/kg/day. In this study, body weight gain drugs in conjunction with penicillin. was significantly reduced in pregnant females that received 50 mg/kg/day Methoxyflurane (resulting in approximately 2.5 times the The concurrent use of tetracycline and methoxyflurane has been reported to result systemic exposure to minocycline observed in patients as a result of use of SOLODYN). in fatal renal toxicity. No effects of treatment on the duration of Antacids and Iron Preparations the gestation period or the number of live Absorption of tetracyclines is impaired by pups born per litter were observed. Gross antacids containing aluminum, calcium external anomalies observed in F1 pups or magnesium and iron-containing (offspring of animals that received preparations. minocycline) included reduced body size, improperly rotated forelimbs, and reduced Low Dose Oral Contraceptives size of extremities. No effects were In a multi-center study to evaluate the observed on the physical development, effect of SOLODYN on low dose oral behavior, learning ability, or reproduction contraceptives, hormone levels over one of F1 pups, and there was no effect on menstrual cycle with and without gross appearance of F2 pups (offspring SOLODYN 1 mg/kg once-daily were of F1 animals). measured. Based on the results of this trial, minocycline-related changes in Nursing Mothers estradiol, progestinic hormone, FSH and Tetracycline-class antibiotics are excreted LH plasma levels, of breakthrough in human milk. Because of the potential for bleeding, or of contraceptive failure, serious adverse effects on bone and tooth cannot be ruled out. To avoid contraceptive development in nursing infants from the failure, female patients are advised to use tetracycline-class antibiotics, a decision a second form of contraceptive during should be made whether to discontinue treatment with minocycline. nursing or discontinue the drug, taking into account the importance of the drug to the Drug/Laboratory Test Interactions mother (see Warnings and Precautions). False elevations of urinary catecholamine levels may occur due to interference with Pediatric Use the fluorescence test. SOLODYN is indicated to treat only inflammatory lesions of non-nodular USE IN SPECIFIC POPULATIONS moderate to severe acne vulgaris Pregnancy in patients 12 years and older. Teratogenic Effects: Pregnancy category D Safety and effectiveness in pediatric (see Warnings and Precautions) patients below the age of 12 has not been established. SOLODYN should not be used during pregnancy. If the patient becomes pregnant Use of tetracycline-class antibiotics below while taking this drug, the patient should be the age of 8 is not recommended due to apprised of the potential hazard to the fetus the potential for tooth discoloration (see and stop treatment immediately. Warnings and Precautions). There are no adequate and well-controlled Geriatric Use studies on the use of minocycline in Clinical studies of SOLODYN did not pregnant women. Minocycline, like other include sufficient numbers of subjects aged tetracycline-class drugs, crosses the 65 and over to determine whether they placenta and may cause fetal harm when respond differently from younger subjects. administered to a pregnant woman. Other reported clinical experience has not

NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility

contains minocycline hydrochloride equivalent to 80 mg minocycline, supplied as follows:

Carcinogenesis—Long-term animal studies have not been performed to evaluate the carcinogenic potential of minocycline. A structurally related compound, oxytetracycline, was found to produce adrenal and pituitary tumors in rats.

NDC 99207-466-30

Mutagenesis—Minocycline was not mutagenic in vitro in a bacterial reverse mutation assay (Ames test) or CHO/HGPRT mammalian cell assay in the presence or absence of metabolic activation. Minocycline was not clastogenic in vitro using human peripheral blood lymphocytes or in vivo in a mouse micronucleus test. Impairment of Fertility—Male and female reproductive performance in rats was unaffected by oral doses of minocycline of up to 300 mg/kg/day (which resulted in up to approximately 40 times the level of systemic exposure to minocycline observed in patients as a result of use of SOLODYN). However, oral administration of 100 or 300 mg/kg/day of minocycline to male rats (resulting in approximately 15 to 40 times the level of systemic exposure to minocycline observed in patients as a result of use of SOLODYN) adversely affected spermatogenesis. Effects observed at 300 mg/kg/day included a reduced number of sperm cells per gram of epididymis, an apparent reduction in the percentage of sperm that were motile, and (at 100 and 300 mg/kg/day) increased numbers of morphologically abnormal sperm cells. Morphological abnormalities observed in sperm samples included absent heads, misshapen heads, and abnormal flagella. Limited human studies suggest that minocycline may have a deleterious effect on spermatogenesis. SOLODYN should not be used by individuals of either gender who are attempting to conceive a child. HOW SUPPLIED/STORAGE AND HANDLING How Supplied SOLODYN (minocycline HCl, USP) Extended Release Tablets are supplied as aqueous film coated tablets containing minocycline hydrochloride equivalent to 55 mg, 65 mg, 80 mg, 105 mg or 115 mg minocycline, are supplied as follows.

The 55 mg extended release tablets are pink, unscored, coated, and debossed with “DYN-055” on one side. Each tablet contains minocycline hydrochloride equivalent to 55 mg minocycline, supplied identified differences in responses between as follows: Rare spontaneous reports of congenital the elderly and younger patients. In general, anomalies including limb reduction have Bottle of 30 dose selection for an elderly patient should NDC 99207-465-30 been reported with minocycline use in be cautious, usually starting at the low end The 65 mg extended release tablets are pregnancy in post-marketing experience. of the dosing range, reflecting the greater Only limited information is available blue, unscored, coated, and debossed frequency of decreased hepatic, renal, or regarding these reports; therefore, no with “DYN-065” on one side. Each tablet cardiac function, and concomitant disease contains minocycline hydrochloride conclusion on causal association can or other drug therapy. be established. equivalent to 65 mg minocycline, supplied as follows: Minocycline induced skeletal malformations OVERDOSAGE (bent limb bones) in fetuses when In case of overdosage, discontinue NDC 99207-463-30 Bottle of 30 administered to pregnant rats and rabbits in medication, treat symptomatically and The 80 mg extended release tablets are doses of 30 mg/kg/day and 100 mg/kg/day, institute supportive measures. Minocycline dark gray, unscored, coated, and debossed respectively, (resulting in approximately is not removed in significant quantities by with “DYN-080” on one side. Each tablet 3 times and 2 times, respectively, the hemodialysis or peritoneal dialysis.

26 Journal of Dermatology for Physician Assistants

Bottle of 30

The 105 mg extended release tablets are purple, unscored, coated, and debossed with “DYN-105” on one side. Each tablet contains minocycline hydrochloride equivalent to 105 mg minocycline, supplied as follows: NDC 99207-467-30

Bottle of 30

The 115 mg extended release tablets are green, unscored, coated, and debossed with “DYN-115” on one side. Each tablet contains minocycline hydrochloride equivalent to 115 mg minocycline, supplied as follows: NDC 99207-464-30

Bottle of 30

Storage Store at 25ºC (77ºF); excursions are permitted to 15º-30ºC (59º-86ºF) [See USP Controlled Room Temperature]. Handling Keep out of reach of children Protect from light, moisture, and excessive heat. Dispense in tight, light-resistant container with child-resistant closure. U.S. Patents 5,908,838; 7,790,705; 7,919,483; and Patents Pending* *90 mg is also covered by U.S. Patents 7,541,347 and 7,544,373 Manufactured for: Medicis, The Dermatology Company Scottsdale, AZ 85256 02/2012 17110264


Dermoscopy Dermoscopic Notes from the 2013 American Dermoscopy Meeting 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.

(continuted on pg. 28) Volume 8 • number 2 • SPRING 2014 27


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.

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 Vancouver, Washington where he works in dermatology at the Vancouver Clinic with Dr. Benjamin Vazquez. He has indicated no relationships to disclose relating to the content of this article.

Join Us for our 20th Anniversary Gala! In Indianapolis – Marriott Downtown. SAVE THE DATE

Who: Indianapolis Conference registrants When: 7:00pm on Friday, May 30th, 2014 The evening will include dinner, live music and a special guest speaker. Attire is Semi-Formal, suggestions include: Women – Cocktail Dress (mid length) or Dressy Pants and Blouse Men – Dark Business Suit

28 Journal of Dermatology for Physician Assistants


JDPA Grand Rounds

Painful Pink Plaques on the Back and Flank By Cynthia Faires Griffith, MPAS, PA-C, and Donald Alexander Glass II, MD, PhD

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 8 • number 2 • SPRING 2014 29


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

CLINIC AL Dermatology

Figure 1

Figure 2

Figure 3

30 Journal of Dermatology for Physician Assistants


SDPA Members Only Content

Cynthia Faires Griffith, MPAS, PA-C, is a 2011 graduate of UT Southwestern Medical Center Physician Assistant Program. She received her Bachelor of Science Degree in Psychology from John Brown University. She practices in the Department of Dermatology at the University of Texas Southwestern Medical Center with four other great physician assistants and nineteen wonderful physicians in Dallas, Texas. She has indicated no relationships to disclose relating to the content of this article. Donald A Glass II, MD, PhD is a graduate of the University of Pennsylvania with a BA in Chemistry, and received both his MD and PhD from Baylor College of Medicine. He did his transitional year internship at Cambridge Hospital in Massachusetts in 2008 and completed his residency in dermatology at UT Southwestern Medical Center in 2011. He is a board-certified dermatologist and an Assistant Professor in the Department of Dermatology at the University of Texas Southwestern Medical Center in Dallas, TX. As a physician scientist, Dr. Glass’ research interest focuses on the impact of genetics on complex diseases such as keloid formation, as well as on monogenic Mendelian disorders. In addition, he maintains an academic general dermatology clinic. He has indicated no relationships to disclose relating to the content of this article.

Volume 8 • number 2 • SPRING 2014 31

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.


Clinical snapshots Granular Parakeratosis By Gina Mangin, MPAS, PA-C and Christopher P. Crotty, MD

SDPA Members Only Content

Figures - Clinical view of granular parakeratosis.

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.

Gina Mangin, MPAS, PA-C has been a practicing physician assistant for 13 years. She completed her undergraduate degree at the University of North Carolina at Wilmington and then her Physician Assistant studies at East Carolina University. She then went on to complete her Masters degree in Physician Assistant Studies at the University of Nebraska. She has been practicing dermatology for 6 years and currently works at Sand Lake Dermatology Center in Orlando, FL. Gina has been active in the SDPA, holding a committee member position in the Distance Learning Committee and is a Diplomate of the SDPA. She currently is the President of the Florida Society of Dermatology Physician Assistants (FSDPA) and has held previous positions of Secretary and Director at Large. She has indicated no relationships to disclose relating to the content of this article. Christopher P. Crotty, MD completed his undergraduate studies at Notre Dame University and attended the University of Nebraska School of Medicine. After medical school he completed a residency in internal medicine at Denverâ&#x20AC;&#x2122;s Presbyterian Medical Center. He then completed a dermatology residency at the Mayo Graduate School of Medicine in Minnesota. While at Mayo Clinic, he studied under Dr. Fred Mohs to learn the Mohs micrographic surgical technique. Awarded the prestigious Osborne Fellowship, he continued his studies in dermatopathology at New York University. After six years of practicing dermatology and dermatopathology in Omaha, Nebraska, and teaching as an assistant clinical professor at the University of Nebraska Medical Center and at Creighton University, Dr. Crotty moved to Orlando, establishing Sand Lake Dermatology Center in 1988. He has indicated no relationships to disclose relating to the content of this article.

32 Journal of Dermatology for Physician Assistants


On behalf of Amgen

Thank you for a decade of ongoing partnership in serving patients

• 10 years of postmarketing experience in plaque PsO with ENBREL1 • Evaluated in clinical studies over the past 20 years in rheumatoid arthritis (RA), with over 15 years of postmarketing experience in moderate to severe RA2,3* • Over 35,000 patient-years of therapy in clinical studies4

Turn page to learn more.

ENBREL is indicated for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. ENBREL is indicated for reducing signs and symptoms, 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. Prescription ENBREL is administered by injection. Selected Safety Information: ENBREL suppresses the immune system and has been associated with serious and sometimes fatal infections, including TB and other opportunistic infections. Other serious and sometimes fatal adverse events including malignancies, neurologic events, hematologic events, congestive heart failure, hepatitis B reactivation, allergic reactions, lupus-like syndrome and autoimmune hepatitis have also been reported. ENBREL is contraindicated in patients with sepsis. Please see Important Safety Information on the following pages and the Brief Summary of the Prescribing Information at the end of this multi-page advertisement. *Initial clinical trials in RA began in 1993.

Volume 8 • number 2 • SPRING 2014 33


When choosing a biologic for adult chronic moderate to severe plaque psoriasis

ENBREL is a Biological Place to Start

In moderate to severe plaque psoriasis (PsO):

Experience

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.

• Evaluated in clinical studies over the past 20 years in rheumatoid arthritis (RA)2* - Over 15 years of postmarketing experience since approval for moderate to severe RA in 19983 - 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

Efficacy • Efficacy established through 24 weeks in a worldwide pivotal trial5 - 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 months5,6

Established safety profile • Safety data from 7 PsO trials that included 4,410 patients7-14 • Consistent adverse event rates through 3 years of treatment in over 1,100 patients in clinical trials15-19

34 Journal of Dermatology for Physician Assistants

10 years of postmarketing experience since approval for moderate to severe plaque PsO in 20041 *Initial clinical research in RA patients began in 1993.

www.enbrel.com


Turn page to learn more.

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

MALIGNANCIES

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

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

Volume 8 â&#x20AC;˘ number 2 â&#x20AC;˘ SPRING 2014 35


IMPORTANT SAFETY INFORMATION SERIOUS INFECTIONS Patients treated with ENBREL are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids or were predisposed to infection because of their underlying disease. ENBREL should not be initiated in the presence of sepsis, active infections, or allergy to ENBREL or its components. ENBREL should be discontinued if a patient develops a serious infection or sepsis. Reported infections include: 1) Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent TB before ENBREL use and periodically during therapy. Treatment for latent infection should be initiated prior to ENBREL use, 2) Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric antifungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness, and 3) Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria. The risks and benefits of treatment with ENBREL should be carefully considered prior to initiating therapy in patients 1) with chronic or recurrent infection, 2) who have been exposed to TB, 3) who have resided or traveled in areas of endemic TB or endemic mycoses, or 4) with underlying conditions that may predispose them to infections such as advanced or poorly controlled diabetes. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with ENBREL, including the possible development of TB in patients who tested negative for latent TB prior to initiating therapy.

MALIGNANCIES Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including ENBREL. In adult clinical trials of all TNF blockers, more cases of lymphoma were seen compared to control patients. The risk of lymphoma may be up to several-fold higher in RA and psoriasis patients. The role of TNF blocker therapy in the development of malignancies is unknown. Cases of acute and chronic leukemia have been reported in association with postmarketing TNF blocker use in RA and other indications. The risk of leukemia may be higher in patients with RA (approximately 2-fold) than the general population. Melanoma and non-melanoma skin cancer (NMSC) have been reported in patients treated with TNF blockers, including ENBREL. Periodic skin examinations should be considered for all patients at increased risk for skin cancer.

Pediatric Patients In patients who initiated therapy at ≤ 18 years of age, approximately half of the reported malignancies were lymphomas (Hodgkin’s and non-Hodgkin’s lymphoma). Other cases included rare malignancies usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. Most of the patients were receiving concomitant immunosuppressants.

NEUROLOGIC EVENTS Treatment with TNF-blocking agents, including ENBREL, has been associated with rare (< 0.1%) cases of new onset or exacerbation of central nervous system demyelinating disorders, some presenting with mental status changes and some associated with permanent disability, and with peripheral nervous system demyelinating disorders. Cases of transverse myelitis, optic neuritis, multiple sclerosis, Guillain-Barré syndromes, other peripheral demyelinating neuropathies, and new onset or exacerbation of seizure disorders have been reported in postmarketing experience with ENBREL therapy. Prescribers should exercise caution in considering the use of ENBREL in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders.

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

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.

78372-R1-V3

36 Journal of Dermatology for Physician Assistants


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

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

patient-years of therapy, the observed rate of NMSC was 3.54 cases per 100 patient-years vs 1.28 cases per 100 patient-years among 720 control-treated patients representing 156 patient-years. Postmarketing cases of Merkel cell carcinoma have been reported very infrequently in patients treated with Enbrel. Periodic skin examinations should be considered for all patients at increased risk for skin cancer. Pediatric Patients Malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with TNF-blocking agents (initiation of therapy at ≤ 18 years of age), including Enbrel. Approximately half the cases were lymphomas, including Hodgkin’s and non-Hodgkin’s lymphoma. The other cases represented a variety of different malignancies and included rare malignancies usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. The malignancies occurred after a median of 30 months of therapy (range 1 to 84 months). Most of the patients were receiving concomitant immunosuppressants. These cases were reported postmarketing and are derived from a variety of sources, including registries and spontaneous postmarketing reports. In clinical trials of 1140 pediatric patients representing 1927.2 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 Reactivation Reactivation of hepatitis B in patients who were previously infected with the hepatitis B virus (HBV) and had received concomitant TNF-blocking agents, including very rare cases (< 0.01%) with Enbrel, has been reported. In some instances, hepatitis B 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 hepatitis B 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 in patients previously infected with 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 previously infected with HBV and require treatment with Enbrel should be closely monitored for clinical and laboratory signs of active HBV infection throughout therapy and for several months following termination of therapy. In patients who develop HBV reactivation, consideration should be given to stopping Enbrel and initiating anti-viral therapy with appropriate supportive treatment. The safety of resuming Enbrel therapy after HBV reactivation is controlled is not known. Therefore, prescribers should weigh the risks and benefits when considering resumption of therapy in this situation. Allergic Reactions Allergic reactions associated with administration of Enbrel during clinical trials have been reported in < 2% of patients. If an anaphylactic reaction or other serious allergic reaction occurs, administration of Enbrel should be discontinued immediately and appropriate therapy initiated. Caution: The following components contain dry natural rubber (a derivative of latex), which may cause allergic reactions in individuals sensitive to latex: the needle cover of the prefilled syringe and the needle cover within the needle cap of the SureClick® autoinjector. Immunizations Live vaccines should not be given concurrently with Enbrel. It is recommended that pediatric patients, if possible, be brought up-to-date with all immunizations in agreement with current immunization guidelines prior to initiating Enbrel therapy [see Drug Interactions]. Autoimmunity Treatment with Enbrel may result in the formation of autoantibodies [see Adverse Reactions] and, rarely (< 0.1%), in the development of a lupus-like syndrome or autoimmune hepatitis [see Adverse Reactions], which may resolve following withdrawal of Enbrel. If a patient develops symptoms and findings suggestive of a lupus-like syndrome or autoimmune hepatitis following treatment with Enbrel, treatment should be discontinued and the patient should be carefully evaluated. Immunosuppression TNF mediates inflammation and modulates cellular immune responses. TNFblocking agents, including Enbrel, affect host defenses against infections. The effect of TNF inhibition on the development and course of malignancies is not fully understood. In a study of 49 patients with RA treated with Enbrel, there was no evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector cell populations [see Adverse Reactions]. Use in Wegener’s Granulomatosis Patients The use of Enbrel in patients with Wegener’s granulomatosis receiving

Volume 8 • number 2 • SPRING 2014 37


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

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

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

Placebo Controlleda (Studies I, II, and a Phase 2 Study) Placebo (N = 152) Reaction Infectiond (total) Upper Respiratory Infectionse Non-upper Respiratory Infections Injection Site Reactions Diarrhea Rash Pruritus Pyrexia Urticaria Hypersensitivity

Enbrelc (N = 349)

Percent of Patients

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

Enbrelc (N = 415)

Percent of Patients 81 65

39 30

50 38

86 70

15

21

59

54

11

37

18

43

9 2 1 – 1 –

8 3 2 3 – –

16 19 5 4 4 1

16 13 5 2 2 1

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

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) Placebo (N = 359)

Enbrela (N = 876)

Reaction

Percent of Patients

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

28 14

27 12

17

17

6

15

2 1 2 – – 1

3 1 1 1 1 –

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

b

Adverse Reactions in Pediatric Patients In general, the adverse reactions in pediatric patients were similar in frequency and type as those seen in adult patients [see Warnings and Precautions]. The types of infections reported in pediatric patients were generally mild and consistent with those commonly seen in the general pediatric population. Two JIA patients developed varicella infection and signs and symptoms of aseptic meningitis, which resolved without sequelae. In open-label clinical studies of children with JIA, adverse reactions reported in those ages 2 to 4 years were similar to adverse reactions reported in older children. Postmarketing Experience Adverse reactions have been reported during post approval use of Enbrel in adults and pediatric patients. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to Enbrel exposure. Adverse reactions are listed by body system below: Blood and lymphatic pancytopenia, anemia, leukopenia, neutropenia, system disorders: thrombocytopenia, lymphadenopathy, aplastic anemia [see Warnings and Precautions] Cardiac disorders: congestive heart failure [see Warnings and Precautions] Gastrointestinal disorders: inflammatory bowel disease (IBD) General disorders: angioedema, chest pain Hepatobiliary disorders: autoimmune hepatitis, elevated transaminases, hepatitis B reactivation Immune disorders: macrophage activation syndrome, systemic vasculitis Musculoskeletal and lupus-like syndrome connective tissue disorders: Neoplasms benign, melanoma and non-melanoma skin cancers, malignant, and unspecified: merkel cell carcinoma [see Warnings and Precautions] Nervous system disorders: convulsions, multiple sclerosis, demyelination, optic neuritis, transverse myelitis, paresthesias [see Warnings and Precautions] Ocular disorders: uveitis, scleritis Respiratory, thoracic interstitial lung disease and mediastinal disorders:

38 Journal of Dermatology for Physician Assistants

Skin and subcutaneous tissue disorders:

cutaneous lupus erythematous, cutaneous vasculitis (including leukocytoclastic vasculitis), erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, subcutaneous nodule, new or worsening psoriasis (all sub-types including pustular and palmoplantar) Opportunistic infections, including atypical mycobacterial infection, herpes zoster, aspergillosis and Pneumocystis jiroveci pneumonia, and protozoal infections have also been reported in postmarketing use. DRUG INTERACTIONS Specific drug interaction studies have not been conducted with Enbrel. Vaccines Most PsA patients receiving Enbrel were able to mount effective B-cell immune responses to pneumococcal polysaccharide vaccine, but titers in aggregate were moderately lower and fewer patients had 2-fold rises in titers compared to patients not receiving Enbrel. The clinical significance of this is unknown. Patients receiving Enbrel may receive concurrent vaccinations, except for live vaccines. No data are available on the secondary transmission of infection by live vaccines in patients receiving Enbrel. Patients with a significant exposure to varicella virus should temporarily discontinue Enbrel therapy and be considered for prophylactic treatment with varicella zoster immune globulin [see Warnings and Precautions]. Immune-Modulating Biologic Products In a study in which patients with active RA were treated for up to 24 weeks with concurrent Enbrel and anakinra therapy, a 7% rate of serious infections was observed, which was higher than that observed with Enbrel alone (0%) [see Warnings and Precautions] and did not result in higher ACR response rates compared to Enbrel alone. The most common infections consisted of bacterial pneumonia (4 cases) and cellulitis (4 cases). One patient with pulmonary fibrosis and pneumonia died due to respiratory failure. Two percent of patients treated concurrently with Enbrel and anakinra developed neutropenia (ANC < 1 x 10 9/L). In clinical studies, concurrent administration of abatacept and Enbrel resulted in increased incidences of serious adverse events, including infections, and did not demonstrate increased clinical benefit [see Warnings and Precautions]. Cyclophosphamide The use of Enbrel in patients receiving concurrent cyclophosphamide therapy is not recommended [see Warnings and Precautions]. Sulfasalazine Patients in a clinical study who were on established therapy with sulfasalazine, to which Enbrel was added, were noted to develop a mild decrease in mean neutrophil counts in comparison to groups treated with either Enbrel or sulfasalazine alone. The clinical significance of this observation is unknown. USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category B Pregnancy Surveillance Program There is a Pregnancy Surveillance Program that monitors outcomes in women exposed to Enbrel during pregnancy. Women who become pregnant during Enbrel treatment are encouraged to enroll. Patients or their physicians should call 1-800-77-AMGEN (1-800-772-6436) to enroll. Risk Summary There are no adequate and well controlled studies in pregnant women. Based on limited data, etanercept concentration in cord blood at the time of delivery showed that etanercept crossed the placenta in small amounts. 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. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Human Data Three case reports showed that cord blood levels of etanercept at delivery in infants, born to mothers administered etanercept during pregnancy, were between 3 and 32% of the maternal serum level. Nursing Mothers Limited data from published literature show that etanercept is present in low levels in human milk and minimally absorbed by a breastfed infant. Caution should be exercised when Enbrel is administered to a nursing woman. The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for Enbrel and any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition. 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 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 (6.2)]. The clinical significance of infant exposure to Enbrel in utero is unknown. The safety of administering live or live-attenuated vaccines in exposed infants is unknown. Risks and benefits should be considered prior to administering live or live-attenuated vaccines to exposed infants. 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.53: 11/2013 US License Number 1132 © 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 © 2013 Amgen Inc., Thousand Oaks, CA 91320 All rights reserved.

60077-R5-V1

PMV53


SURGIC AL Dermatology Journal Club: Practice Changing Articles for Dermatology PAs Adverse events associated with mohs micrographic surgery: Multicenter prospective cohort study of 20,821 cases at 23 centers JAMA Dermatol. 2013 Dec;149(12):1378-85. doi: 10.1001/jamadermatol.2013.6255. Alam M, Ibrahim O, Nodzenski M, et al.

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

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

Volume 8 â&#x20AC;˘ number 2 â&#x20AC;˘ SPRING 2014 39


SURGICAL wisdom Preventing Wrong-Site Surgery By Travis Hayden, MPAS, PA-C

SDPA Members Only Content

SURGIC AL Dermatology

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

Travis Hayden, MPAS, PA-C practices dermatology with Lesley Loss, MD and John Tu, MD at Dermatology Associates of Rochester, New York. He has indicated no relationships to disclose relating to the content of this article.

Let them know theyâ&#x20AC;&#x2122;re not alone... Share a story with your patients. Visit the Patientâ&#x20AC;&#x2122;s Perspective library of articles at www.jdpa.org/advocacy.html

JDPA Journal of Dermatology for Physician Assistants

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40 Journal of Dermatology for Physician Assistants


Finacea® (azelaic acid) Gel, 15% is a topical prescription medication used to treat inflammatory papules and pustules of mild to moderate rosacea.

Rosacea is with her wherever she goes . So is Finacea . It’s true. Rosacea is complex and it’s with them for life. Finacea® treats the papules and pustules with associated erythema 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. You have made Finacea® the #1 Dermatologist-prescribed topical rosacea brand.1

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 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 persists during use with Finacea®, discontinue use and institute appropriate therapy. 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, monitor these patients for early signs of hypopigmentation. Avoid contact with the eyes, mouth, and other mucous membranes. In case of eye exposure, wash eyes with large amounts of water. Wash hands immediately following application of Finacea®. Avoid use of alcoholic cleansers, tinctures and astringents, abrasives and peeling agents. Avoid the use of occlusive dressings or wrappings. In clinical trials with Finacea®, the most common treatment-related adverse events (AE’s) 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. Finacea® is for topical use only. It is not for ophthalmic, oral or intravaginal use. Patients should be reassessed if no improvement is observed upon completing 12 weeks of therapy. Please see Brief Summary of full Prescribing Information on adjacent page. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

1. According to IMS NPATM (National Prescription Audit) July 2010-October 2013 © 2014 Bayer HealthCare Pharmaceuticals. Bayer, the Bayer Cross, Finacea and the Finacea logo are registered trademarks of Bayer. All rights reserved. FIN-10-0001-14 | February 2014

Volume 8 • number 2 • SPRING 2014 41

SURGIC AL Dermatology

®


6.2 Post-Marketing Experience The following adverse reactions have been identified post approval of FINACEA Gel. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure: Eyes: iridocyclitis upon accidental exposure of the eyes to FINACEA Gel

Finacea (azelaic acid) Gel,15% ®

7 DRUG INTERACTIONS There have been no formal studies of the interaction of FINACEA Gel with other drugs.

For Dermatologic Use Only–Not for Ophthalmic, Oral, or Intravaginal Use Rx only BRIEF SUMMARY CONSULT PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE FINACEA® Gel is indicated for topical treatment of the 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. 5 WARNINGS AND PRECAUTIONS 5.1 Skin Reactions Skin irritation (i.e. pruritus, burning or stinging) may occur during use of FINACEA Gel, usually during the first few weeks of treatment. If sensitivity or severe irritation develops and persists, discontinue treatment and institute appropriate therapy. 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, monitor these patients for early signs of hypopigmentation. 5.2 Eye and Mucous Membranes Irritation Avoid contact with the eyes, mouth and other mucous membranes. If FINACEA Gel does come in contact with the eyes, wash the eyes with large amounts of water and consult a physician if eye irritation persists [see Adverse Reactions (6.2)]. 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In two vehicle-controlled and one active-controlled U.S. clinical trials, treatment safety was monitored in 788 subjects who used twice-daily FINACEA Gel for 12 weeks (N=333) or 15 weeks (N=124), or the gel vehicle (N=331) for 12 weeks. In all three trials, the most common treatment-related adverse events were: burning/stinging/tingling (29%), pruritus (11%), scaling/dry skin/xerosis (8%) and erythema/irritation (4%). In the active-controlled trial, overall adverse reactions (including burning, stinging/tingling, dryness/tightness/ scaling, itching, and erythema/irritation/redness) were 19.4% (24/124) for FINACEA Gel compared to 7.1% (9/127) for the active comparator gel at 15 weeks. Table 1: Adverse Events Occurring in ≥1% of Subjects in the Rosacea Trials by Treatment Group and Maximum Intensity*

Burning/ stinging/ tingling Pruritus Scaling/ dry skin/ xerosis Erythema/ irritation Contact dermatitis Edema Acne

FINACEA Gel, 15% N=457 (100%) Mild Moderate Severe n=99 n=61 n=27 (22%) (13%) (6%) 71 (16%) 42 (9%) 17 (4%)

Vehicle N=331 (100%) Mild Moderate Severe n=46 n=30 n=5 (14%) (9%) (2%) 8 (2%) 6 (2%) 2 (1%)

29 (6%) 21 (5%)

18 (4%) 10 (2%)

5 (1%) 5 (1%)

9 (3%) 31 (9%)

6 (2%) 14 (4%)

0 (0%) 1 (<1%)

6 (1%)

7 (2%)

2 (<1%)

8 (2%)

4 (1%)

2 (1%)

2 (<1%)

3 (1%)

0 (0%)

1 (<1%)

0 (0%)

0 (0%)

3 (1%) 3 (1%)

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

0 (0%) 0 (0%)

3 (1%) 1 (<1%)

0 (0%) 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. In patients using azelaic acid formulations, the following adverse events have been reported: worsening of asthma, vitiligo, depigmentation, small depigmented spots, hypertrichosis, reddening (signs of keratosis pilaris) and exacerbation of recurrent herpes labialis. Local Tolerability Studies FINACEA Gel and its vehicle caused irritant reactions at the application site in human dermal safety studies. FINACEA Gel caused significantly more irritation than its vehicle in a cumulative irritation study. Some improvement in irritation was demonstrated over the course of the clinical trials, but this improvement might be attributed to subject dropouts. No phototoxicity or photoallergenicity were reported in human dermal safety studies.

42 Journal of Dermatology for Physician Assistants

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Teratogenic Effects: Pregnancy Category B There are no adequate and well-controlled studies in pregnant women. Therefore, FINACEA Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Dermal embryofetal developmental toxicology studies have not been performed with azelaic acid, 15% 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 (MRHD) based on body surface area (BSA)], rabbits given 150 or 500 mg/kg/day (19 or 65 times the MRHD based on BSA) and cynomolgus monkeys given 500 mg/kg/day (65 times the MRHD based on BSA) 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 of 2500 mg/kg/day (162 times the MRHD based on BSA) that generated some maternal toxicity. In addition, slight disturbances in the post-natal development of fetuses was noted in rats at oral doses that generated some maternal toxicity (500 and 2500 mg/kg/day; 32 and 162 times the MRHD based on BSA). No effects on sexual maturation of the fetuses were noted in this study. 8.3 Nursing Mothers It is not known whether azelaic acid is excreted in human milk; however, in vitro studies using equilibrium dialysis were conducted to assess the potential for human milk partitioning. The studies demonstrated that, 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. These data indicate that passage of drug into maternal milk may occur. Since less than 4% of a topically applied dose of 20% azelaic acid cream 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. Nevertheless, a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. 8.4 Pediatric Use Safety and effectiveness of FINACEAGelin pediatric patients have not been established. 8.5 Geriatric Use Clinical studies of FINACEA Gel did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. 17 PATIENT COUNSELING INFORMATION Inform patients using FINACEA Gel of the following information and instructions: Use only as directed by your physician. •For external use only. •Before applying FINACEA Gel, cleanse affected area(s) with a very mild soap or a soapless cleansing lotion and pat dry with a soft towel. •Avoid use of alcoholic cleansers, tinctures and astringents, abrasives and peeling agents. •Avoid contact with the eyes, mouth and other mucous membranes. If FINACEA Gel does come in contact with the eyes, wash the eyes with large amounts of water and consult your physician if eye irritation persists. •Wash hands immediately following application of FINACEA Gel. •Cosmetics may be applied after the application of FINACEA Gel has dried. •Avoid the use of occlusive dressings or wrappings. •Skin irritation (e.g., pruritus, burning, or stinging) may occur during use of FINACEA Gel, usually during the first few weeks of treatment. If irritation is excessive or persists, discontinue use and consult your physician. •Report abnormal changes in skin color to your physician. •To help manage rosacea, avoid any triggers that may provoke erythema, flushing, and blushing. These triggers can include spicy and thermally hot food and drinks such as hot coffee, tea, or alcoholic beverages. © 2012, Bayer HealthCare Pharmaceuticals Inc. All rights reserved.

Manufactured for:

Bayer HealthCare Pharmaceuticals Inc. Wayne, NJ 07470

Manufactured in Italy 6706805BS


COSMETIC deRMATOLOGY

Selecting the Right Patient for a Cosmetic Procedure Dermcast.tv Live Blog Martha Sikes, MS, RPh, PA-C Lecturing at the SDPA 11th Annual Fall Dermatology Conference in Atlanta, Georgia

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

Volume 8 • number 2 • SPRING 2014 43


SDPA Members Only Content

COSMETIC Dermatology

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

Martha Sikes, MS, RPh, PA-C received her Bachelor of Science degree in Pharmacy from Purdue University in 1997. Feeling the need to provide more comprehensive patient care, she attended Georgia Regents University (formerly known as the Medical College of Georgia) where she graduated with a Bachelor of Science degree in Physician Assistant Studies in 2002. She received her Masters of Science degree from A.T. Still University in 2012. Martha began her career as a physician assistant in dermatology, and has been a guest lecturer in dermatology at Mercer University Physician Assistant Program since its inception. She became course director of pharmacology and pharmacotherapy courses in 2011, and accepted a full-time faculty appointment in 2012. She is a member of the Society of Dermatology Physician Assistants, Georgia Dermatology Physician Assistants, Georgia Association of Physician Assistants, the American Academy of Physician Assistants, and was recently appointed to the Ex-Officio position on the Georgia Composite Medical Board. She has indicated no relationships to disclose relating to the content of this article.

This Dermcast.tv live blog was recorded at the SDPA 11th Annual Fall Dermatology Conference 2013 in Atlanta, GA and was posted online November 13th, 2013. It is available at http:// dermcast.tv/live-blog-selecting-right-patientcosmetic-procedure. Dermcast.tv is the official online media resource of the SDPA. It is your source for audio podcasts, the most current dermatology news and research, procedural videos, conference highlights, and much, much more. 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! To read more SDPA live blogs and/or to follow the next live blog from the SDPA Annual Summer Dermatology Conference 2014 in Indianapolis, please visit the Dermcast.tv website at www. dermcast.tv. 44 Journal of Dermatology for Physician Assistants


Full Field Coverage with a Flexible Treatment Duration: 1, 2, or up to 4 Weeks

Important Safety Information · Carac is contraindicated in women who are nursing, pregnant or may become pregnant as fluorouracil may cause fetal harm. · Carac should not be used in patients with dihydropyrimidine dehydrogenase (DPD) enzyme deficiency. · Rarely, unexpected, systemic toxicity (e.g., stomatitis, diarrhea, neutropenia, and neurotoxicity) associated with parenteral administration of fluorouracil has been attributed to deficiency of dihydropyrimidine dehydrogenase “DPD” activity. Symptoms included severe abdominal pain, bloody diarrhea, vomiting, fever, and chills. · Carac should be discontinued if severe abdominal pain, bloody diarrhea, vomiting, fever, or chills develop when using the product. · In clinical trials, the most common drug-related adverse events were facial irritation (application site reactions) (94.6%), which included: erythema, dryness, burning, erosion, pain, and edema, and eye irritation (5.4%). · Patients using Carac should avoid prolonged exposure to sunlight or other forms of ultraviolet irradiation during treatment, as the intensity of the reaction may be increased. Please see Brief Summary of Full Prescribing Information on adjacent page. References: 1. CARAC® (fluorouracil cream 0.5%) [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals LLC; 2012. Except as where otherwise indicated, all product names, slogans, and other marks are trademarks of the Valeant family of companies. ©2013 Valeant Pharmaceuticals North America LLC. DM/CRC/13/0004

Volume 8 • number 2 • SPRING 2014 45


Carac® Cream, 0.5% Rx Only (fluorouracil cream) BRIEF SUMMARY IMPORTANT NOTE: This information is a BRIEF SUMMARY of the complete prescribing information. FOR TOPICAL DERMATOLOGICAL USE ONLY (NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE) CONTRAINDICATIONS Fluorouracil may cause fetal harm when administered to a pregnant woman. Fluorouracil is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. No adequate and well-controlled studies have been conducted in pregnant women with either topical or parenteral forms of fluorouracil. One birth defect (ventricular septal defect) and cases of miscarriage have been reported when fluorouracil was applied to mucous membrane areas. Multiple birth defects have been reported in the fetus of a patient treated with intravenous fluorouracil. Animal reproduction studies have not been conducted with Carac. Fluorouracil, the active ingredient, has been shown to be teratogenic in mice, rats, and hamsters when administered parenterally at doses greater than or equal to 10, 15 and 33 mg/kg/day, respectively, [4X, 11X and 20X, respectively, the Maximum Recommended Human Dose (MRHD) based on body surface area (BSA)]. Fluorouracil was administered during the period of organogenesis for each species. Embryolethal effects occurred in monkeys at parenteral doses greater than 40 mg/kg/ day (65X the MRHD based on BSA) administered during the period of organogenesis. Carac should not be used in patients with dihydropyrimidine dehydrogenase (DPD) enzyme deficiency. A large percentage of fluorouracil is catabolized by the enzyme dihydropyrimidine dehydrogenase (DPD). DPD enzyme defi ciency can result in shunting of fluorouracil to the anabolic pathway, leading to cytotoxic activity and potential toxicities. Carac is contraindicated in patients with known hypersensitivity to any of its components. WARNINGS The potential for a delayed hypersensitivity reaction to fluorouracil exists. Patch testing to prove hypersensitivity may be inconclusive. Patients should discontinue therapy with Carac if symptoms of DPD enzyme deficiency develop. Rarely, unexpected, systemic toxicity (e.g. stomatitis, diarrhea, neutropenia, and neurotoxicity) associated with parenteral administration of fluorouracil has been attributed to deficiency of dihydropyrimidine dehydrogenase “DPD” activity. One case of life threatening systemic toxicity has been reported with the topical use of 5% fluorouracil in a patient with a complete absence of DPD enzyme activity. Symptoms included severe abdominal pain, bloody diarrhea, vomiting, fever, and chills. Physical examination revealed stomatitis, erythematous skin rash, neutropenia, thrombocytopenia, inflammation of the esophagus, stomach, and small bowel. Although this case was observed with 5% fluorouracil cream, it is unknown whether patients with profound DPD enzyme deficiency would develop systemic toxicity with lower concentrations of topically applied fluorouracil. Applications to mucous membranes should be avoided due to the possibility of local inflammation and ulceration. PRECAUTIONS General There is a possibility of increased absorption through ulcerated or inflamed skin. Information for the Patient Patients using Carac should receive the following information and instructions: 1. This medication is to be used as directed. 2. This medication should not be used for any disorder other than that for which it was prescribed. 3. It is for external use only. 4. Avoid contact with the eyes, eyelids, nostrils, and mouth. 5. Cleanse affected area and wait 10 minutes before applying Carac. 6. Wash hands immediately after applying Carac. 7. Avoid prolonged exposure to sunlight or other forms of ultraviolet irradiation during treatment, as the intensity of the reaction may be increased. 8. Most patients using Carac get skin reactions where the medicine is used. These reactions include redness, dryness, burning, pain, erosion (loss of the upper layer of skin), and swelling. Irritation at the application site may persist for two or more weeks after therapy is discontinued. Treated areas may be unsightly during and after therapy. 9. If you develop abdominal pain, bloody diarrhea, vomiting, fever, or chills while on Carac therapy, stop the medication and contact your physician and/or pharmacist. 10. Report any side effects to the physician and/or pharmacist. Laboratory Tests To rule out the presence of a frank neoplasm, a biopsy may be considered for those areas failing to respond to treatment or recurring after treatment. Carcinogenesis, Mutagenesis and Impairment of Fertility Adequate long-term studies in animals to evaluate carcinogenic potential have not been conducted with fluorouracil. Studies with the active ingredient of Carac, fluorouracil, have shown positive effects in in vitro and in vivo tests for mutagenicity and on impairment of fertility in in vivo animal studies. Fluorouracil produced morphological transformation of cells in in vitro cell transformation assays. Morphological transformation was also produced in an in vitro assay by a metabolite of fluorouracil, and the transformed cells produced malignant tumors when injected into immunosuppressed syngeneic mice. Fluorouracil has been shown to exert mutagenic activity in yeast cells, Bacillus subtilis, and Drosophila assays. In addition, fluorouracil has produced chromosome damage at concentrations of 1.0 and 2.0 mcg/mL in an in vitro hamster fibroblast assay, was positive in a microwell mouse lymphoma assay, and was positive in in vivo micronucleus assays in rats and mice following intraperitoneal administration. Some patients receiving cumulative doses of 0.24 to 1.0 g of fluorouracil parenterally have shown an increase in numerical and structural chromosome aberrations in peripheral blood lymphocytes. Fluorouracil has been shown to impair fertility after parenteral administration in rats. Fluorouracil administered at intraperitoneal doses of 125 and 250 mg/kg has been shown to induce chromosomal aberrations and changes in chromosome organization of spermatogonia in rats. In mice, single-dose intravenous and intraperitoneal injections of fluorouracil have been reported to kill differentiated spermatogonia and spermatocytes at a dose of 500 mg/kg and produce abnormalities in spermatids at 50 mg/kg.

46 Journal of Dermatology for Physician Assistants

Pediatric Use Actinic keratosis is not a condition seen within the pediatric population, except in association with rare genetic diseases. Carac should not be used in children. The safety and effectiveness of Carac have not been established in patients less than 18 years old. Geriatric Use No significant differences in safety and efficacy measures were demonstrated in patients age 65 and older compared to all other patients. Pregnancy Teratogenic Effects: Pregnancy Category X See CONTRAINDICATIONS Nursing Women It is not known whether fluorouracil is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from fluorouracil, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. ADVERSE REACTIONS The following were adverse events considered to be drug-related and occurring with a frequency of ≥1% with Carac: application site reaction (94.6%), and eye irritation (5.4%). The signs and symptoms of facial irritation (application site reaction) are presented below. Summary of Facial Irritation Signs and Symptoms – Pooled Phase 3 Studies

During clinical trials, irritation generally began on day 4 and persisted for the remainder of treatment. Severity of facial irritation at the last treatment visit was slightly below baseline for the vehicle group, mild to moderate for the 1 week active treatment group, and moderate for the 2 and 4 week active treatment groups. Mean severity declined rapidly for each active group after completion of treatment and was below baseline for each group at the week 2 post-treatment follow-up visit. Thirty-one patients (12% of those treated with Carac in the Phase 3 clinical studies) discontinued study treatment early due to facial irritation. Except for three patients, discontinuation of treatment occurred on or after day 11 of treatment. Eye irritation adverse events, described as mild to moderate in intensity, were characterized as burning, watering, sensitivity, stinging and itching. These adverse events occurred across all treatment arms in one of the two Phase 3 studies. Summary of All Adverse Events Reported in ≥ 1% of Patients in the Combined Active Treatment and Vehicle Groups – Pooled Phase 3 Studies

Adverse Experiences Reported by Body System In the Phase 3 studies, no serious adverse event was considered related to study drug. A total of five patients, three in the active treatment groups and two in the vehicle group, experienced at least one serious adverse event. Three patients died as a result of adverse event(s) considered unrelated to study drug (stomach cancer, myocardial infarction and cardiac failure). Post-treatment clinical laboratory tests other than pregnancy tests were not performed during the Phase 3 clinical studies. Clinical laboratory tests were performed during conduct of a Phase 2 study of 104 patients and 21 patients in a Phase 1 study. No abnormal serum chemistry, hematology, or urinalysis results in these studies were considered clinically significant. OVERDOSE Ordinarily, topical overdosage will not cause acute problems. If Carac is accidentally ingested, induce emesis and gastric lavage. Administer symptomatic and supportive care as needed. If contact is made with the eye, flush with copious amounts of water. Keep out of the reach of children. Dermik Laboratories a business of sanofi-aventis U.S. LLC Bridgewater, NJ 08807 ©2009 sanofi-aventis U.S. LLC DM/CRC/13/0010


Cosmetic pearls Picosecond Lasers

Hard-to-treat tattoo colors are no match for newest laser SDPA Members Only Content

M. Christine Lee, MD, FAAD, is an assistant clinical professor of dermatologic surgery at the University of California, San Francisco and director of a private practice in Walnut Creek, California. Reprinted with permission from the American Academy of Dermatology

Volume 8 â&#x20AC;˘ number 2 â&#x20AC;˘ SPRING 2014 47

COSMETIC Dermatology

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


Professional development

Dermatology Billing & Coding ICD-10: What you Need to Know

Important Resources Now Available From the AAD 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.

ATTENTION Student Members of the SDPA! Publishing an article in a peer-reviewed journal is a great way to enhance your dermatology education, share knowledge with your peers, and improve upon your resume. If you have written dermatology related papers and are interested in publishing your work, the JDPA staff is available to assist you through this process. Please contact the JDPA at editor@jdpa.org.

48 Journal of Dermatology for Physician Assistants


Judicial and Ethical Affairs E-professionalism

By Karen Scully, MD, FRCPC, MA Ethics

The study of ethics has given me the opportunity to examine our day-to-day practice of dermatology with a critical lens. Issues such as informed consent, conflicts of interest, relations with pharmaceutical companies, research ethics, and ethical treatment of research subjects are some of the ethical matters I would like to address in this and upcoming issues of the JDPA. My aim is not to suggest what is right or wrong, but rather to raise awareness of ethical issues so that we can, to the best of our abilities, make sound decisions in caring for our patients. In this first column I present a brief overview of ethical principles and then look at the subject of informed consent.

professional development

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Volume 8 â&#x20AC;˘ number 2 â&#x20AC;˘ SPRING 2014 49


SDPA Members Only Content

professional development

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

Karen Scully is a board-certified dermatologist in the United States and Canada. She had a private practice in the Toronto area for many years and then accepted a teaching position at the Johns Hopkins Medical Institutions where she practiced and taught dermatology residents and medical students. More recently she moved to Charlotte, North Carolina and completed a Masterâ&#x20AC;&#x2122;s Degree in Ethics and Applied Philosophy at the University North Carolina at Charlotte.

The SDPA is celebrating 20 years! As part of the celebration, we will be making a 20th Anniversary photo and video montage that will play at our 2014 Summer Conference in Indianapolis. Please upload any photos or videos you have from SDPA Conferences & related events (i.e. Miles for Melanoma 5K, Diplomate Receptions, etc.). To get started, go to MEDIACOURIER.COM and type in sdpa20years as the password. Learn more about uploading here! http://bit.ly/1eDFv1B

50 Journal of Dermatology for Physician Assistants


Outside & Inside the 9 to 5...

JDPA: What inspired you to dedicate your athletic endeavors to raise funds for charity? Michelle: A few years back, a coworker of mine passed away suddenly from an unfortunate asthma attack. I ran 55 kilometers in 4 hours and 20 minutes and raised nearly $6,000 in her honor and promoted awareness of asthma. From that moment on, I decided that each year my athletic endeavors should have meaning beyond simply doing them for myself. Last year I dedicated my efforts to multiple sclerosis. I have dedicated 2014 to raising awareness of and money for melanoma education. I have been overwhelmed thus far by the support from the community who have assisted with fund raising (including my workplace, Dermatology & Skin Health). I am incredibly honored to have been selected to run with the Running for Cover team in support of the Melanoma Foundation of New England.

to reduce the chances of developing melanoma. I wanted to put more action into my words. Running the Boston Marathon for the Melanoma Foundation of New England seemed to be a perfect fit for getting the message out there not only to my patients, but also to so many others. Michelle Roy, PA-C

JDPA: Why did you become involved with raising funds to promote awareness of melanoma? Michelle: Skin cancer education, prevention, and detection have always been a mainstay of my practice. I have spent a great deal of time, as do many PAs, educating patients regarding the significance of skin cancer and the risk factors that can be mitigated

I have always loved endurance activities and have run numerous marathons. I had planned to run the Boston Marathon in 2013, but deferred due to having a busy racing schedule for my cycling team. So, after the cycling season was over in 2013, I started training for Boston. It has been very exciting and the entire office has become involved. We committed to raising $20,000 for the Melanoma Foundation of New England, and we have officially exceeded it! We hosted a great party, Martinis for Melanoma, and raised $12,000. The entire community supported this event with free donations of music, food, and items for an auction. It was really heartwarming to have the support of the community at large.

JDPA: What can you tell us about the money raised for the Melanoma Foundation of New England? Michelle: When people make a donation to my webpage (www.crowdrise.com/mfneboston2014/ fundraiser/michelleroyhttp://www.crowdrise.com/ mfneboston2014/fundraiser/michelleroy), the Volume 8 â&#x20AC;˘ number 2 â&#x20AC;˘ SPRING 2014 51

professional development

Michelle Roy, PA-C is a physician assistant with nearly twenty years of clinical experience, of which fourteen years have been in dermatology. Mrs. Roy is a graduate of the Duke University Physician Assistant Program. She has practiced in the metro DC and Boston areas before moving back to the seacoast of New Hampshire. She is an active member of the SDPA and the AAPA. Her clinical interests include treating pediatric and adult skin disorders, cosmeceuticals, and the use of emerging technologies in cosmetic dermatology. She lives with her husband in the Hampton, NH area. Michelle is an avid endurance athlete who enjoys running, cycling, and swimming. On April 21st, 2014, she ran the 118th Boston Marathon as a member of team Running for Cover, a group of runners raising funds for the Melanoma Foundation of New England and promoting melanoma awareness. The JDPA had an opportunity to interview Michelle and learn more about her experiences with fund raising for charities as well as her work with the Melanoma Foundation of New England.


professional development

Melanoma Foundation of New England uses the money for developing educational programs. One such program is â&#x20AC;&#x153;Skinny on Skin,â&#x20AC;? an important program designed to educate salon and medispa professionals regarding spotting melanomas. SDPA members can check out this great program at www.mfne. org/prevent-melanoma/theskinny-on-skin/. The money donated also goes directly to melanoma patients in the New England area to help with a variety of things including cost of treatment, copays not covered by traditional insurance, the cost of parking at hospitals, and assistance with transportation. While some of these things may seem small, they can actually be huge when someone is going through treatment. Additional information about the Foundation can be found at www.mfne.org.

Michelle: Melanoma awareness will always be near and dear to me. My supervising physician has had melanoma twice. As an office, we have all become very involved in fund raising for this great organization. We have developed some deep ties with the Melanoma Foundation of New England and hope to make it an annual event for the office. Who knows, maybe even some office staff will join me next year in the run. JDPA: Any final thoughts or information you would like to share with our readers? Michelle: Put your words into action, develop deeper ties with the community that you live and work in, and represent our profession with pride. J

JDPA: What are some of the ways you have helped to promote awareness about melanoma? Michelle: My practice has featured blog entries on its website as well as posting informative tidbits regarding the most deadly form of skin cancer, melanoma, as a way of increasing public awareness of this killer. To see portions of my blog and additional information, people can visit www.dermskinhealth. com/running-for-cover. We have always been very involved with community events such as free skin cancer screenings, educating school nurses regarding sun safety, and speaking to local groups about skin cancer. JDPA: What advice or tips would you offer to your fellow SDPA members who are considering raising money and awareness for a cause through participation in an athletic event? Michelle: Just do it. It can be life changing for both you and the community that you live in. Start small and then go big! JDPA: What does the future hold for you? Will you continue to participate in events to raise awareness for melanoma or choose a new cause for each athletic event?

52 Journal of Dermatology for Physician Assistants

"We hosted a great party, Martinis for Melanoma, and raised $12,000."


Notes from your Office Manager Failure or Malfunction of Office Equipment can lead to Patient, Staff , or Provider Injury SDPA Members Only Content

professional development

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

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 8 • number 2 • SPRING 2014 53


Dermatology PA news & notes

Camp Discovery 2014

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June 22 – 27, Camp Little Pine in Crosslake, Minnesota (ages 10 – 14) ● June 23 – 27, Camp Reflection in Carnation, Washington (ages 8 – 16) ● July 6 – 11, Camp Big Trout in Crosslake, Minnesota (ages 14 – 16) ● August 10 – 16, Camp Liberty in Hebron, Connecticut (ages 8-16) ● August 10 – 15, Camp Dermadillo, in Burton, Texas (ages 9 – 15) ● August 9 – 15, Camp Horizon, in Millville, Pennsylvania (ages 8 – 13)

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Camp Discovery was founded in 1993 and offers a summer camp experience like no other. Every summer, the American Academy of Dermatology sponsors six weeks of camp in five locations where everyone can experience activities such as fishing, swimming, archery, horseback riding, nature trails, and just plain fun! Under the expert care of dermatologists and dermatology healthcare professionals, Camp Discovery offers campers the opportunity to spend a week among other young people who have similar skin conditions. Many of the counselors have chronic skin conditions as well, and can provide support and advice to campers. There is no fee for camp. All costs, including transportation, are provided by the American Academy of Dermatology through generous donations from its members, other organizations, and individuals. The American Academy of Dermatology is proud to offer this experience to about 380 children each year.

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For more information about attending or volunteering, please visit the Camp Discovery website at www.aad.org/dermatology-ato-z/for-kids/camp-discovery/about-camp-discovery or contact Janine Mueller at (847) 240-1737 or jmueller@aad.org.

54 Journal of Dermatology for Physician Assistants


FOR INTERDIGITAL TINEA PEDIS DUE TO TRICHOPHYTON RUBRUM AND EPIDERMOPHYTON FLOCCOSUM IN ADULT PATIENTS

INTRODUCING LUZU L U ZU FA S T: 2 W E EK S, 14 DOS E S Efficacy demonstrated at 4 weeks post-treatment The only topical azole antifungal approved to treat interdigital tinea pedis with once-daily dosing over a 2-week period

Indications and Usage LUZU (luliconazole) Cream, 1% is indicated for the topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum and Epidermophyton floccosum in patients 18 years of age and older. Important Safety Information • LUZU is indicated for topical use only and is not indicated for ophthalmic, oral or intravaginal use. • LUZU should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when LUZU is prescribed for nursing mothers.

• The most common adverse reactions in clinical

trials were application site reactions, which occurred in less than 1% of subjects in both LUZU and vehicle arms. Most adverse reactions were mild in severity.

Please see full Brief Summary of Prescribing Information on adjacent page. Reference: LUZU [prescribing information]. Bridgewater, NJ: Medicis, a division of Valeant Pharmaceuticals; 2013.

Except as otherwise indicated, all product names, slogans, and other marks are trademarks of the Valeant family of companies. © 2014 Valeant Pharmaceuticals North America LLC.

DM/LUZ/13/0004

Volume 8 • number 2 • SPRING 2014 55


S:7â&#x20AC;?

BRIEF SUMMARY OF FULL PRESCRIBING INFORMATION FOR LUZU (luliconazole) This Brief Summary does not include all the information needed to use LUZU safely and effectively. See full Prescribing Information for LUZU. LUZU (luliconazole) Cream, 1% for topical use Initial U.S. Approval: 2013 Rx Only INDICATIONS LUZU (luliconazole) Cream, 1% is an azole antifungal indicated for the topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum and Epidermophyton floccosum, in patients 18 years of age and older. DOSAGE AND ADMINISTRATION For topical use only. LUZU Cream, 1% is not for ophthalmic, oral, or intravaginal use. When treating interdigital tinea pedis, a thin layer of LUZU Cream, 1% should be applied to the affected area and approximately 1 inch of the immediate surrounding area(s) once daily for two (2) weeks. When treating tinea cruris or tinea corporis, LUZU Cream, 1% should be applied to the affected area and approximately 1 inch of the immediate surrounding area(s) once daily for one (1) week. CONTRAINDICATIONS None ADVERSE REACTIONS

Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug, and may not reflect the rates observed in practice. In three Phase 3 clinical trials, 616 subjects were exposed to LUZU Cream, 1%: 305 with interdigital tinea pedis and 311 subjects with tinea cruris. Subjects with interdigital tinea pedis or tinea cruris applied LUZU Cream, 1% or vehicle cream once daily for 14 days or 7 days, respectively, to affected and adjacent areas. During clinical trials with LUZU Cream, 1% the most common adverse reactions were application site reactions which occurred in less than 1% of subjects in both the LUZU and vehicle arms. Most adverse reactions were mild in severity. Post-Marketing Experience The following adverse reactions have been identified during post-marketing use of luliconazole cream, 1%: contact dermatitis and cellulitis. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. DRUG INTERACTIONS The potential of luliconazole to inhibit cytochrome P-450 (CYP) enzymes 1A2, 2C9, 2C19, 2D6, and 3A4 was evaluated in vitro. Based on in vitro assessment, luliconazole at therapeutic doses, particularly when applied to patients with moderate to severe tinea cruris, may inhibit the activity of CYP2C19 and CYP3A4. However, no in vivo drug interaction trials have been conducted to evaluate the effect of luliconazole on other drugs that are substrates of CYP2C19 and CYP3A4. Luliconazole is not expected to inhibit CYPs 1A2, 2C9 and 2D6 based on in vitro assessment. The induction potential of luliconazole on CYP enzymes has not been evaluated. USE IN SPECIFIC POPULATIONS

Pregnancy: Pregnancy Category C.

to pregnant female rats. No treatment related effects on maternal toxicity or malformations were noted at 25 mg/kg/day (3 times the MRHD based on BSA comparisons). Increased incidences of skeletal variation (14th rib) were noted at 25 mg/kg/day. No treatment related effects on skeletal variation were noted at 5 mg/kg/day (0.6 times the MRHD based on BSA comparisons). Subcutaneous doses of 4, 20 and 100 mg/kg/day luliconazole were administered during the period of organogenesis (gestational days 6-18) to pregnant female rabbits. No treatment related effects on maternal toxicity, embryofetal toxicity or malformations were noted at 100 mg/kg/day (24 times the MRHD based on BSA comparisons). In a pre- and post-natal development study in rats, subcutaneous doses of 1, 5 and 25 mg/kg/day luliconazole were administered from the beginning of organogenesis (gestation day 7) through the end of lactation (lactation day 20). In the presence of maternal toxicity, embryofetal toxicity (increased prenatal pup mortality, reduced live litter sizes and increased postnatal pup mortality) was noted at 25 mg/kg/day. No embryofetal toxicity was noted at 5 mg/kg/day (0.6 times the MRHD based on BSA comparisons). No treatment effects on postnatal development were noted at 25 mg/kg/day (3 times the MRHD based on BSA comparisons). Nursing Mothers It is not known whether luliconazole is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when LUZU Cream, 1% is administered to women who are breastfeeding. Pediatric Use The safety and effectiveness of LUZU Cream, 1% in pediatric patients have not been established. The number of pediatric patients â&#x2030;Ľ12 years of age were too small to adequately assess safety and efficacy. Geriatric Use Of the total number of subjects in clinical studies of LUZU Cream, 1%, 8 percent were 65 and over, while 1.4 percent were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. NONCLINICAL TOXICOLOGY

Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies to evaluate the carcinogenic potential of LUZU Cream, 1% have not been conducted. Luliconazole revealed no evidence of mutagenic or clastogenic potential based on the results of two in vitro genotoxicity tests (Ames assay and Chinese hamster lung cell chromosomal aberration assay) and one in vivo genotoxicity test (mouse bone marrow micronucleus test). In a fertility study in rats, subcutaneous doses of 1, 5 and 25 mg/kg/day luliconazole were administered prior to and during mating and through early pregnancy. Treatment related effects on reproductive function were noted in females (decreased live embryos and decreased corpus luteum) at 5 and 25 mg/kg/day and males (decreased sperm counts) at 25 mg/kg/day. No treatment related effects on fertility or reproductive function were noted at 1 mg/kg/day (0.1X MRHD based on BSA comparisons). PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information) Inform patients that LUZU Cream, 1% is for topical use only. LUZU Cream, 1% is not intended for intravaginal or ophthalmic use. Manufactured for: Medicis, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807

There are no adequate and well-controlled studies of LUZU Cream, 1% in pregnant women. LUZU Cream, 1% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The animal multiples of human exposure calculations were based on daily dose body surface area (BSA) comparisons (mg/m2) for the reproductive toxicology studies described in this section and in Section 13.1. The Maximum Recommended Human Dose (MRHD) was set at 8 g 1% cream per day (1.33 mg/kg/day for a 60 kg individual which is equivalent to 49.2 mg/m2/day). Systemic embryofetal development studies were conducted in rats and rabbits. Subcutaneous doses of 1, 5 and 25 mg/kg/day luliconazole were administered during the period of organogenesis (gestational days 7-17)

56 Journal of Dermatology for Physician Assistants

Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215 Product of Japan Issued: 11/2013 140127 DM/LUZ/13/0005(1)


From the Desk of... Two thousand and fourteen is off to a busy start in the legislative corner. We continue to support tanning bed legislative reform throughout the country. We have become active in oral parity legislation this year on both the state and federal levels. Finally, we have focused our energy on getting practice reform for PAs in the state of Ohio. Many states continue to introduce legislation to prohibit tanning bed use by minors. The SDPA has partnered with various state organizations to support bills that prohibit minors under the age of 18 from using tanning beds. Melanoma rates continue to rise, and there is still a continued use of tanning beds by minors. One example of this year’s SDPA partnership has been in the state of Maryland where we have joined organizations including the AAD and The American Cancer Society to try to get tanning bed use banned for minors (see Figure, pg. 58). A new area of legislation the SDPA has been involved with this year is the issue of oral parity. Twenty-five percent of all cancer drugs under development are oral treatments. Many patients prefer oral medications as opposed to IV medications since they are less invasive and require fewer trips to the doctor’s office or hospital. The problem with oral chemotherapy options is that they are typically not covered in the same manner as IV chemotherapy medications. Oral medications are typically covered as a pharmacy benefit, and therefore a patient’s cost burden for these drugs can be much greater. Many states have passed oral parity legislation that helps make oral chemo more affordable and accessible; these include New York, Colorado, Hawaii, Indiana, Iowa, Kansas, Minnesota, Oregon, Texas, Vermont, Nebraska, and the District of Columbia. There are also federal efforts under way to pass oral parity reform. Although we may not deal with this issue on a daily basis in dermatology, it certainly can affect the lives of our patients. This is why the SDPA has become more involved at supporting such legislation going forward. Getting practice reform for PAs in the state of Ohio has been a challenge for many years. As it stands, Ohio legislation addressing the scope of practice for

physician assistants is very antiquated when compared to most other states. This restricts the ability of Ohio PAs to practice as healthcare providers and denies supervising physicians the ability to use their PAs to the best of their medical training and professional capabilities. Not only does the current legislation discourage Ohio physicians from hiring PAs, but it also hinders their practices from providing superior patient care to more patients on a daily basis. The SDPA in partnership with the AAPA and the Ohio Association of Physician Assistants (OAPA) is supporting a bill (HB 412) that would reform PA practice rules in the state of Ohio. This bill was introduced January 29th and addresses several problems with current laws. The bill removes the approval process by the Ohio State Medical Board of physicians’ supervision agreements, which will allow PAs to begin practicing immediately; in the past, the approval process could take up to 3 months. The bill creates one process for applications for licensure to practice and prescribe instead of the current three application processes. The Bill removes the travel time requirement for the doctor and allows PAs to delegate to MAs. Most importantly, the bill removes the restrictive list of procedures a PA may perform and allows the supervising physician to delegate duties within his or her scope of practice. The bill increases the number of PAs a doctor may supervise at one time from two to five. The SDPA is strongly supporting the bill going forward. Getting involved with legislative efforts such as these is an important service SDPA members can provide for their patients and profession. If you or someone you know is interested in getting involved with the SDPA Legislative Affairs Committee or with any of the issues I have highlighted here, please contact me at jmast@dermpa.org. J Jane Mast, MPAS, PA-C is a graduate of the University of Florida Physician Assistant Program and has practiced dermatology for ten years at Space Coast Dermatology in Merritt Island, Florida. Jane currently serves as the SDPA Legislative Affairs Committee Chair and has been active in working to help pass legislation against the use of indoor tanning beds.

Volume 8 • number 2 • SPRING 2014 57

DERmatology pa news & notes

Jane Mast, MPAS, PA-C SDPA Legislative Affairs Committee Chair


Figure: Newspaper advertisement endorsed by the SDPA, AAD, and several other prominent dermatology organizations that has been printed in various leading newspapers in Maryland.

DERmatology pa news & notes

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Real Risks: People who use tanning beds before the age of 35 increase their lifetime risk of melanoma by 59 percent.

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Real Deaths: Every hour, one person in America dies from melanoma. Real Action: Support legislation in Maryland restricting minors under 18 from indooor tanning.

Copyright Š 2014 American Academy of Dermatology. All rights reserved.

58 Journal of Dermatology for Physician Assistants

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The Difference We Make A Place Called Home

Everyone needs a place called “home.” Does your office inspire those same feelings? I suggest that it should for you to be most effective as a clinician. A place called home is where you feel surrounded by friendly people, cared about and cared for, secure, satisfied, trusted, and embraced, and where you receive hope and self-esteem. It is a place where you can say anything and it will be heard, and where you can be listened to and believed. Some people don't have such feelings about the home where they grew up, but most people, I would suggest, do have “places” they call “home” and that embody many of these same qualities. These alternative homes may be the homes of friends and/or relatives or the home of a special professional such as a teacher or religious leader. When you are anxious and perhaps even frightened, or when you doubt yourself and/or others, you need to go to some special, safe place for thoughtful reflection. I believe that our offices should reflect this home away from home atmosphere. If you look around your own office, what aspects have you specifically created or exist, seemingly by chance that give your patients, your staff, and even yourself a feeling of being taken care of and cared about? Perhaps it's the people that you hire. I remember telling a staff member that I hire for a few essential qualities, and then I look for other qualifications. I told him that I hire for kindness above all. I don't care what degrees the professionals in my office have, I need to know that above all their default position is always that of kindness. Compassion and caring about people would be the 2nd and 3rd qualities on that same list. After that I wonder what professional experience they will bring to my office. I want my staff to have a positive view of people, to be understanding of others, and to look for the best in people rather than the reverse. If a patient is late for an appointment, I would hope that we would assume that the patient did the best they could to be on time and circumstances simply got in the way. I hasten to say that some people do need boundaries; therefore, if a patient is habitually late, we will ultimately let them know in a supportive way that tardiness cannot be accepted. We will tell them that we know they are doing their best, but they need to try even harder.

Besides my staff having a positive attitude and a welcoming smile, I hope the office’s physical appearance reflects the same positive outlook and expresses a bit of who we are as medical providers. The walls of my office are painted with bright shades of yellow or pink, the patient reception areas look like an inviting living room, and the exam rooms reflect the same warmth. Colorful pieces of art are located throughout the office including photographs, paintings, and sculptures. This art reflects the interests and values of myself and my staff as well as displaying simple decorations. People can get to know us and our beliefs through our created office environment. I suggest that providers have an objective, qualified person evaluate their office’s physical environment and assist their staff in creating a positive, endearing, and supportive office climate for their patients. Ask someone who you admire for their loving yet evaluative qualities to comment on your office’s appearance and on your staff’s interactions with patients. Notice that I've not mentioned the quality of the dermatologic service that you provide. I'm assuming that you are all good at what you do and that you provide these services in a competent, professional manner. What I am talking about is the rest of what we do including the atmosphere that we create for ourselves, our staff, and our patients who put their faith in us. Part of what we “sell” our patients is a diagnosis and a treatment plan and part is a sense of trust in us. I suggest that you look around at the walls of your office, observe your staff, and even look at yourself in the mirror. Have you created that place called home? Think about creating that sacred space that you call “home” so that others can share with you that same embracing feeling. 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 8 • number 2 • SPRING 2014 59

DERmatology pa news & notes

By Steven K. Shama, MD, MPH, FAAD


Workplace Excellence

ICD-10: You can’t get out of it, so get into it! 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.

“I

f you can’t get out of it, then get into it;” this quote, made famous through the Outward Bound Experiential Education Program, is one my favorite parenting mantras. It’s a pithy nugget of truth simultaneously conveying tough love and wise counsel. “But Dad, I don’t want to go to school, practice piano, do my chores, etc.” “Well, you can’t get out of it, so get into it!” It is definitely tough love. The standard is unwavering, immovable, and non-negotiable. It’s because I love you; I believe in you; this is important for you; and you’re worthy and capable of this. I am not ranting and raving or telling them how weak, lazy, or ungrateful they are, how much harder I had it than them, or all that I do for them. There’s a reality that you have to face, and I am going to help you face it and get through it. How many times in life do we face something that we can’t get out of, and yet we fail to accept that reality? We whine, complain, make excuses, and look for ways to get around it or out of it altogether. All the while we waste precious time and energy and create an emotionally toxic environment for ourselves and those around us. If you can’t get out of it, get into it! I thought of this mantra recently when I considered the challenges associated with the transition from ICD-9 to ICD-10. For starters, so far as I can tell, it doesn’t look like you can get out of it, so probably it is best to find a way to get into it, or at least get through it! Strange as it seems, understanding and accepting this reality may actually bring a measure of closure and even peace. After all of the years and months leading up to this point, after all the rumors of the difficulties, and after all the ranting and resisting, we know that it

60 Journal of Dermatology for Physician Assistants

will happen. So then, how do we prepare ourselves for optimal performance given this reality? Switching over from the familiarity of the ICD9 is in many ways a technical challenge: new codes must be learned and applied; new procedures must be followed and mastered. However, apart from preparing for the technical changes, what’s at the core of this switch is really the changing of a habit. Changing habits is something that we spend a great deal of time on at the Institute for Excellence & Ethics, both individual habits and organizational habits (i.e., culture). Here’s the bottom line: making habits and breaking habits takes energy, often lots of energy! It’s hard work, and empirical research and life experience indicate that, in spite of all the energy it takes, we’re frequently unsuccessful in making a new habit or breaking an old one. A habit becomes a habit when it becomes automated, second nature, like breathing. We’re tired out when we begin a new job, start a new routine, or try to form a new habit because it literally takes energy. Nothing is natural or easy. We must concentrate on the task at hand, which requires cognitive, affective, and behavioral energy. Because we’re doing something new, it’s not easy, and we’re not good at it; this leads to more energy loss as we try to keep our emotions in check, remain positive, and hone our skills. Think about riding a bike: it took a lot energy and focus. You weren’t thinking about much else besides the knowledge and strength needed to stay upright. Then as you became good at it, you thought very little, if at all, about that bike. Now that your habit or skill of riding a bike is


At work our habits are essential to efficiency and consistency. We depend on our work habits even though we often are bored by the daily routine and tired of the daily grind. It’s those very routines and habits that reduce our stress and allow us to fly on autopilot. For most the switchover from ICD version 9 to 10 will mean the interruption of something so familiar that it is done with automaticity, with little effort, energy, or even thought. For a period of time you’ll be riding the bike and thinking about how to ride the bike at the same time, and that will feel difficult and will take some extra energy. In his book, Making Habits, Breaking Habits, author Jeremy Dean cites research indicating that on average (depending on the complexity of the task and other factors) it takes about 65 days for habit formation to occur. Figure on about 20 days to form a habit like drinking more water or knocking off your pushups and sit-ups before bedtime, but for most complex habits, 2-3 months is probably a good bet.) Does it really take 2-3 months for habits to change? Is this good news? It depends. If you’re the optimist who keeps telling everybody this will be easy-peasy, then this is probably not good news. If you’re the pessimist who keeps telling yourself and everybody else that we’ll never be able make the switch, this is also probably not what you want to hear. So, that’s according to the optimist and the pessimist, what about the realist? Yes. It’s the realist who we want to focus on. The realist has an understanding of what we describe at IEE as “Optimal Performance.” Optimal performance avoids the deficiencies or excesses that are simply inadequate for the goals and expectations (too much time, too much focus and effort; too little time, too little focus and effort = inadequate). Optimal performance realizes that this change will take place amid real-world circumstances, and will be carried out by individuals with different sensibilities and capabilities. Optimal performance, requires the following: 1. ACCEPT that this switch will happen and that for a while it’s going to take some extra focus and energy, but that with steady EFFORT, positive ATTITUDE, and PATIENCE, a new habit will be formed.

2. Define in concrete terms what you really want to AVOID and ACHIEVE as you make this change of habit. Remember, we’re looking for ideal or optimal, not perfect. Jot down the worst-case scenarios and the bestcase scenarios. Avoid the former; pursue the latter. 3. CREATE CHECKLISTS, standards, and simple reminders regarding your organization as guides in the formation of your new habits. Remember, culture (a shared way of doing things) is best done intentionally and proactively, not reactively! 4. For the first 60-90 days make regular time for ACTION & REFLECTION. What’s our plan? How’s it working for us? What can we change or modify to make things MORE OPTIMAL tomorrow? We cannot get out of this; we’re not going backwards, so how can we move from inadequate to more ideal? As a Kansas football coach I know liked to say, “Just get a little better each day.” Making and breaking habits takes energy. However, the pursuit of optimal performance balances clear goals and expectations for diverse capabilities within real-world circumstances. J REFERENCE: 1. Dean, J. Making habits, breaking habits: Why we do things, why we don’t, and how to make any change stick, Da Capo Press. 2013. Matthew L. Davidson, Ph.D. is the Founder, President, and Director of Education for the Institute for Excellence & Ethics (IEE), a 501(c)3 nonprofit corporation dedicated to helping individuals and organizations achieve excellence. He is a National Spokesperson for the Business Bureau National Center for Character Ethics. The IEE specializes in the development and dissemination of research-based tools for developing the culture and competencies of excellence and ethics in schools, athletics, the workplace, and the home; this is done through professional development workshops & academies, teaching & learning resources, assessment, and consulting services. He is a frequent national presenter and is available for keynote lectures, professional development, retreats, and organizational consulting. 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 8 • number 2 • SPRING 2014 61

DERmatology pa news & notes

mastered, your mind is free to look around and to think about things from the past or things in the future. You can now ride largely unaware of the bike or the knowledge and skill riding it requires.


Supervising Physician CORNER Taking Dermatology Grand Rounds Global An interview with Howard Green, MD, FACP, FAAD, FACMS By J. Margaret Casey

DERmatology pa news & notes

Derm Grand Rounds (dermgrandrounds.com) is an application that utilizes the collective intelligence of a professional board of advisors to identify skin photos submitted exclusively by dermatologists, dermatology residents, and dermatology physician assistants. The application is considered to be the world’s first professional-guided search engine. After an anomyzed photograph has been submitted, Derm Grand Rounds will return the top two names of what the majority of the professional board of advisors believes best identifies that skin photo. The goal of Derm Grand Rounds is to enhance the efficiency and proficiency of education and information gathering by dermatologists, dermatology residents, dermatology physician assistants and nurse practitioners by identifying their submitted photographs of skin promptly and precisely using the accuracy of group or crowd-based photo identification. We had an opportunity to interview Dr. Green and learn more about the program and his experiences as founder of DGR Education, LLC.

JDPA: How do you view your new role with the SDPA? Dr. Green: I was attending a board recertification review course sponsored by the AAD in Orlando, Florida. At the course we had to vote to identify photos of skin using a clicker or transponder. I discovered that if you put a group of dermatologists in a room, the majority vote always identifies a skin photo correctly. Overall, I was very disappointed with the course for several reasons. The course was expensive and I was away from my home and family. In addition, there was little or no discussion offered in the room after each vote. I knew there had to be a better way to educate and encourage dermatologists to interact with their peers without the geographic restrictions or costs of rote regional meetings or review courses. I thought that instead of using a transponder or clicker to identify a skin photo in a conference room, why not use a smart phone, a tablet, or a computer mouse? Instead of using a geographically restricted, stuffy conference room to vote on the identity of skin photos, why not use the entire world via Internet? Why not invite discussions from around the globe in real time regarding the identity of the uploaded photos and other pertinent dermatologic subjects? Why not make a rewarding game of the process with cash rewards for voting in concurrence with the majority, using acumen, and sharing knowledge and skills? That’s how DermGrandRounds was born. It is the first “gamified,” professionally guided search engine for dermatology providers. JDPA: What is the mission of Derm Grand Rounds? Dr. Green: The aim of DermGrandRounds is to make a rewarding game of the collective knowledge of dermatology professionals around the globe in order to enhance the efficiency and proficiency of educating and informing dermatology professionals. 62 Journal of Dermatology for Physician Assistants

JDPA: What has the response been like from dermatology PAs? Dr. Green: Dermatology PAs upload extraordinary skin photobooks, edit the wiki, and vote to identify photos every day. We are seeing dermatology PA participation rates that are similar to that of dermatologists and dermatology residents. JDPA: What is unique about the Derm Grand Rounds experience? Dr. Green: In addition to being the world’s first web and mobile-based, professionally guided search engine for dermatology professionals, we are the first mobile-based app, which has “gamified” the process of skin photo identification and dermatology education. Twice weekly, dermatology physicians, residents, physician assistants, and nurse practitioners compete to receive cash rewards based on competence, acumen, and sharing their skills and knowledge in this novel “gamified” process of collectivecrowd intelligence. Rewards in each dermatology training category are distributed twice weekly among the top point earners who accumulate points for identifying uploaded photos concurrent with the majority, sharing knowledge by editing the wikiskinatlas, and uploading anonymous photos. Any dermatology professional, including residents, physician assistants, and nurse practitioners may qualify to be the grand winner. This top winner may also designate an additional reward honorarium for his or her academic institution of choice. We have also created the world’s first wiki skin textbook (wikiskinatlas) in which our credentialed dermatology professionals who register for Derm Grand Rounds may update the content of the wiki in real time using theirs and others’ knowledge and skills.


JDPA: How is Derm Grand Rounds similar or dissimilar to the grand rounds held in academia? Dr. Green: By academia I assume you mean a conference room in a university setting. First of all, we are not geographically restricted. Secondly, our photo identification process and associated forum and discussions are similar to the certification preparatory courses and examinations which board-certified dermatologists and dermatology residents must pass for certification and recertification by the American Board of Dermatology. The Derm Grand Rounds process of group voting and discussion resembles academic dermatology rounds and regional dermatology meetings and sponsored educational conferences which all use crowd intelligence. JDPA: How large of an audience does Derm Grand Rounds reach? Dr. Green: A few months ago we launched the first professionally guided web and mobile app exclusively for the world’s 25,000 dermatology professionals. The website and mobile app and all of its functions have proven extremely popular with dermatology providers. Our rankings have soared and we currently have participants from over 60 nations. Each week hundreds of skin photos are uploaded from around the world, thousands of votes

are cast to identify those photos, thousands of wiki entries are written, and thousands of dollars in prizes are awarded. JDPA: With this extensive reach, what does “collectivecrowd” intelligence lend to the project? Dr. Green: It just amazes me to see anonymous pictures uploaded from dermatology professionals from every part of the globe. Skin types and diseases vary in their frequency and presentation in other countries from what we in the United States are used to seeing. From all over the world, the around-the-clock votes we use to identify these skin photos have a strong concurrence. Thomas Friedman was correct; in dermatology, the world is now flat! JDPA: What do you foresee as the future of Derm Grand Rounds? Dr. Green: Our white board of “future ideas” wraps twice around the room. Stay tuned! JDPA: Any additional facts or information you would like to share with our audience? Dr. Green: As an Internet start-up, we are moving as fast as we can to engineer our Derm Grand Rounds app and all its future functions for the myriad of mobile devices around the world. We thank you all for your continued participation. Log on, vote, discuss, compete, earn, educate yourself and others, and have fun! J Dr. Green graduated from the George Washington University and obtained his medical degree from the Boston University School of Medicine. He completed a residency in internal medicine at Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, and is certified by the American Board of Internal Medicine. Dr. Green was one of the youngest physicians elected to Fellowship in the American College of Physicians. He completed four years of residency training in dermatology at Harvard Medical School. Upon completion of his training at Harvard, Dr. Green was certified and has been recertified twice by the American Board of Dermatology. Dr. Green also completed an American College of Mohs surgery specialty fellowship in Mohs skin cancer and dermatologic surgery at the Boston University Medical Center. Dr. Green has published numerous scientific papers on mutagenesis, ultraviolet radiation, skin cancer, lasers, burns and wound healing. Dr. Green has several medical patents. For the last 17 years, Dr. Green has been selected by his peers and Castle Connolly Medical, LTD as one of America's Top Doctors. Dr. Green Founded DGR Education, LLC, which is the world’s only professionally guided and gamified search app for medicine and more. Dr. Green is also the managing partner of Dermatology Associates, of the Palm Beaches.

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DERmatology pa news & notes

JDPA: Can you tell us more about the wikiskinatlas? Dr. Green: The emergence of the Internet and the recent developments in online collaborative technologies have provided new tools with which to find, use, share, and expand dermatology knowledge. Our wikiskinatlas challenges the traditional notions of authorship, editing, and publishing and has the potential to change how we construct knowledge repositories and collaborate on the web. Anonymous photographs are submitted to the wikiskinatlas via the Derm Grand Rounds website and mobile app. These photos are categorized into wikiarticles according to majority-voted, identified names. Only dermatology professionals who have credentialed to participate on the Derm Grand Rounds website may access to edit the wikiskinatlas. The wikiskinatlas is available for free to all users of the Derm Grand Rounds website and mobile app and to the general public via the web. In contrast to conventional static publications, our dynamic publication in the wiki model has no final version or definite date of publication and will continuously integrate and synthesize new findings and insights. We have the potential to develop a dynamic, collaborative, dermatologic knowledge base using wiki technology that provides referenced authors with due credit and that can evolve via continual revision and integration of more traditional peer review models into a rigorous clinical, educational, and research tool.


I KNEW IT WAS A BAD SPOT, BUT NOT THIS BAD I WASN’T PREPARED FOR HOW DIFFICULT THIS WOULD BECOME Although basal cell carcinoma (BCC) is a common and treatable skin cancer, a few patients may progress to a more challenging form of disease—advanced BCC.1 One of the characteristics of advanced BCC is development in locations such as the eyelid, nose, or ear, which may become difficult to treat. In these areas, BCC can spread to critical underlying structures, and the risk to vision and other vital functions can increase.1-5

HOW DOES ADVANCED BCC APPEAR IN YOUR PRACTICE?

References: 1. Walling HW, Fosko SW, Geraminejad PA, Whitaker DC, Arpey CJ. Cancer Metastasis Rev. 2004;23:389-402. 2. Randle HW. Dermatol Surg. 1996;22:255-261. 3. Chew R. Optometry. 2007;78:344-351. 4. Leibovitch I, McNab A, Sullivan T, Davis G, Selva D. Ophthalmology. 2005;112:717-723. 5. Carucci JA, Leffell DJ. Fitzpatrick’s Dermatology in General Medicine. 7th ed. 2007.

To learn more about advanced BCC, visit www.LearnaboutaBCC.com At Genentech, we are passionate about dermatology. © 2012 Genentech USA, Inc. All rights reserved. HED0001489200 Printed in USA.

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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).

66 Journal of Dermatology for Physician Assistants

Surgical Dermatology Feature Articles

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

Surgical Wisdom

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

Surgical Dermatology Case Report

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

Journal Club: Dermatology PA Perspectives

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

Cosmetic Dermatology Feature Articles

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

Cosmetic Pearls

Write a brief article on a fact or pearl for the cosmetic setting (250500 words).

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

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

Professional Development Feature Articles

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

Outside & Inside the 9 to 5

Allow us to share your story of the good work that you do either outside or inside your practice of dermatology. You can write this article yourself or the JDPA staff can interview you to write the article (250-1000 words). Notes From Your Office Manager Write a brief article on a fact or pearl for the office setting (250-500 words).

Judicial and Ethical Affairs

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


Professional Opportunities and Development

A dver t iser INDE X • Valeant - Bensal HP........................... Pages 3, 4 • Ranbaxy - Halog................................Pages 9, 10 • Promius - Cloderm..........................Pages 13, 14 • Valeant – Solodyn.......................... Pages 24 - 26 • Amgen - Enbrel............................. Pages 33 - 38 • Bayer HealthCare – Finacea ...........Pages 41, 42 • Valeant – Carac...............................Pages 45, 46 • Valeant – Luzu ...............................Pages 55, 56 • Genentech – Erivedge..................... Pages 64, 65 For more information on advertising opportunities in the JDPA, please log on to www.jdpa.org

CONGRESS ON CANCERS OF THE SKIN XV WORLD

®

www.wccs2014.org This is a major opportunity to interact with an international faculty of the highest caliber. Hear about the latest exciting and rapid advances in the prevention, diagnosis, and particularly treatment of all types of skin cancer. Officially supported by

SkinCancer.org

BRITISH ASSOCIATION OF DERMATOLOGISTS

EXPAND YOUR PSORIASIS KNOWLEDGE SUMMIT HIGHLIGHTS: • latest treatments • psoriasis comorbidities • interactive environment

• cancer and psoriasis • complex case studies and more

May 28, 2014 • Indianapolis, IN This program has been reviewed and is approved for a maxium of 7.00 hours of AAPA Category 1 CME credit by the Physician Assistant Review Panel. Physician assistants should claim only those hours actually spent participating in the CME activity.

THE INTERNATIONAL LEAGUE OF DERMATOLOGICAL SOCIETIES

Edinburgh International Congress Centre (EICC)

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

Learn more at psoriasis.org/pa-summit

THE EUROPEAN ACADEMY OF DERMATOLOGY & VENEREOLOGY

Volume 8 • number 2 • SPRING 2014 67


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

For For more more information information on achieving on achieving DIPLOMATE DIPLOMATE status status in in your s dermpa.org/diplomate yourvisit state, visit dermpa.org/diplomate Current diplomates effective as of 20132013 Current listlist ofofdiplomates effective asDec of Dec 68 Journal of Dermatology for Physician Assistants


JDPA Spring 2014