JDPA Summer 2015 by Angela Simiele

DPA J

V o l u m e 9 • n u m b e r 3 • S UMMER 2 0 1 5 • www.jdpa.org

Journal of Dermatology for Physician Assistants

clinical dermatology

Dermatology Case Report 38 __________________________________

Surgical dermatology Surgical Wisdom

__________________________________

Cosmetic dermatology Fad Beauty Treatments - Is There Science Behind The Hype? 42 __________________________________

professional development Dermatology Billing & Coding Get Ready For ICD-10 47 __________________________________

dermatology Pa news & notes From the Desk of… Joe Monroe, MPAS, PA-C

›› Earn CME credit with this issue CME A Clinical Review of Tinea Capitis

Official Journal of the Society of Dermatology Physician Assistants

Volume 9 • number 3 • SUMMER 2015

SEE

ME MORE CLEARLY

PRESCRIBE COSENTYX®

THE FIRST AND ONLY IL-17A ANTAGONIST1 The clinical significance of the COSENTYX mechanism of action is unknown. Trial Designs: Trials 1 and 2 were multicenter, randomized, double-blind, placebo-controlled trials. Trial 1 evaluated 738 patients who received COSENTYX 300 mg (n=245), COSENTYX 150 mg (n=245), or placebo (n=248). Trial 2 evaluated 1306 patients who received COSENTYX 300 mg (n=327), COSENTYX 150 mg (n=327), placebo (n=326), or a biologic active control (n=323). All patients were adults with moderate to severe plaque psoriasis who had a BSA ≥10%, PASI score ≥12, an IGA mod 2011 score ≥3, and were candidates for systemic therapy or phototherapy. All patients were followed for up to 52 weeks. Coprimary end points were PASI 75 and IGA 0 or 1 (clear or almost clear) response at Week 12.

INDICATION COSENTYX® (secukinumab) is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS COSENTYX is contraindicated in patients with a previous serious hypersensitivity reaction to secukinumab or to any of the excipients. WARNINGS AND PRECAUTIONS Infections COSENTYX may increase the risk of infections. In clinical trials, a higher rate of infections was observed in COSENTYX-treated subjects compared to placebo-treated subjects. In placebo-controlled clinical trials, higher rates of common infections such as nasopharyngitis (11.4% versus 8.6%), upper respiratory tract infection (2.5% versus 0.7%), and mucocutaneous infections with candida (1.2% versus 0.3%) were observed with COSENTYX compared with placebo. The incidence of some types of infections appeared to be dose-dependent in clinical studies. 1

EMBRACE THE RESULTS At the 300-mg dose in Trial 11*† PASI 75 achieved in

Majority of patients achieved

of patients at 12 weeks

or almost clear skin at 12 weeks

PASI 75 sustained at

59% of patients achieved

in 81% of PASI 75 responders at 12 weeks‡

at 12 weeks

82%

1 YEAR

CLEAR

PASI 90

Recommended 300-mg dose = 2 subcutaneous 150-mg/mL injections. *In the COSENTYX 300-mg treatment arm of Trial 2, PASI 75 was achieved in 76% of patients at Week 12; IGA 0 or 1 was achieved by 62% of patients at Week 12; PASI 90 was achieved by 54% of patients at Week 12; and of patients who achieved PASI 75 at Week 12 (n=249), PASI 75 was sustained by 84% at 1 year. For some patients, a dose of 150 mg may be acceptable. In the COSENTYX 150-mg treatment arms, PASI 75 was achieved at Week 12 by 71% of patients in Trial 1 and 67% of patients in Trial 2; IGA 0 or 1 was achieved by 51% of patients at Week 12 in both Trials 1 and 2; PASI 90 was achieved at Week 12 by 39% of patients in Trial 1 and 42% of patients in Trial 2; and of patients who achieved PASI 75 at Week 12 (n=174 in Trial 1; n=219 in Trial 2), PASI 75 was sustained at 1 year by 72% of patients in Trial 1 and 82% of patients in Trial 2.

†

161/200 patients.

‡

IMPORTANT SAFETY INFORMATION (cont) Exercise caution when considering the use of COSENTYX in patients with a chronic infection or a history of recurrent infection. Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur. If a patient develops a serious infection, the patient should be closely monitored and COSENTYX should be discontinued until the infection resolves. Please see additional Important Safety Information on page 4. Please see Brief Summary of full Prescribing Information on following pages.

The Touch of a New Class 2

Volume 9 • number 3 • SUMMER 2015

MONTHLY MAINTENANCE DOSING WITH 300 MG1*†‡

A full 300-mg dose of COSENTYX requires 2 subcutaneous 150 mg/mL injections • COSENTYX is available in Sensoready® pens§ —each pen contains 150 mg/mL • Prefilled syringes§ are also available —each contains 150 mg/mL

The removable cap of the COSENTYX Sensoready pen and the prefilled syringe contains natural rubber latex and should not be handled by latexsensitive individuals. The safe use of the COSENTYX Sensoready pen or prefilled syringe in latex-sensitive individuals has not been studied.

ONCE A WEEK FOR 5 WEEKS ONCE A MONTH THEREAFTER1 *Monthly maintenance dose = 1 dose every 4 weeks. † The first self-injection should be performed under the supervision of a qualified healthcare professional. ‡ For some patients, a dose of 150 mg may be acceptable.

Journal of Dermatology for Physician Assistants

GET YOUR PATIENTS STARTED AT COSENTYXHCP.COM

IMPORTANT SAFETY INFORMATION (cont) Pre-treatment Evaluation for Tuberculosis Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with COSENTYX. Do not administer COSENTYX to patients with active TB infection. Initiate treatment of latent TB prior to administering COSENTYX. Consider anti-TB therapy prior to initiation of COSENTYX in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Patients receiving COSENTYX should be monitored closely for signs and symptoms of active TB during and after treatment. Exacerbations of Crohn’s Disease Exercise caution when prescribing COSENTYX to patients with active Crohn’s disease, as exacerbations of Crohn’s disease, in some cases serious, were observed in COSENTYX-treated patients during clinical trials. Patients who are treated with COSENTYX and have active Crohn’s disease should be monitored closely. Hypersensitivity Reactions Anaphylaxis and cases of urticaria occurred in COSENTYX-treated patients in the clinical trials. If an anaphylactic or other serious allergic reaction occurs, administration of COSENTYX should be discontinued immediately and appropriate therapy initiated. The removable cap of the COSENTYX Sensoready® pen and the COSENTYX prefilled syringe contains natural rubber latex which may cause an allergic reaction in latex-sensitive individuals. The safe use of the COSENTYX Sensoready pen or prefilled syringe in latex-sensitive individuals has not been studied. Vaccinations Prior to initiating therapy with COSENTYX, consider completion of all age appropriate immunizations according to current immunization guidelines. Patients treated with COSENTYX should not receive live vaccines. Non-live vaccinations received during a course of COSENTYX may not elicit an immune response sufficient to prevent disease. MOST COMMON ADVERSE REACTIONS Most common adverse reactions (>1%) are nasopharyngitis, diarrhea, and upper respiratory tract infection. Reference: 1. Cosentyx [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2015.

Please see additional Important Safety Information on pages 1 & 2. Please see Brief Summary of full Prescribing Information on following pages.

The Touch of a New Class 4

Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936-1080

6/15

COS-1316415

Volume 9 • number 3 • SUMMER 2015

COSENTYX™ (secukinumab) injection, for subcutaneous use COSENTYX™ (secukinumab) for injection, for subcutaneous use Initial U.S. Approval: 2015

A total of 3430 plaque psoriasis subjects were treated with COSENTYX in controlled and uncontrolled clinical trials. Of these, 1641 subjects were exposed for at least 1 year.

BRIEF SUMMARY: Please see package insert for full prescribing information.

Four placebo-controlled phase 3 trials in plaque psoriasis subjects were pooled to evaluate the safety of COSENTYX in comparison to placebo up to 12 weeks after treatment initiation, in Trials 1, 2, 3, and 4. In total, 2077 subjects were evaluated (691 to COSENTYX 300 mg group, 692 to COSENTYX 150 mg group, and 694 to placebo group) [see Clinical Studies (14) in the full prescribing information].

1 INDICATIONS AND USAGE COSENTYX™ is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. 4 CONTRAINDICATIONS COSENTYX is contraindicated in patients with a previous serious hypersensitivity reaction to secukinumab or to any of the excipients [see Warnings and Precautions (5.4)]. 5 WARNINGS AND PRECAUTIONS 5.1 Infections COSENTYX may increase the risk of infections. In clinical trials, a higher rate of infections was observed in COSENTYX-treated subjects compared to placebo-treated subjects. In placebo-controlled clinical trials, higher rates of common infections such as nasopharyngitis (11.4% versus 8.6%), upper respiratory tract infection (2.5% versus 0.7%) and mucocutaneous infections with candida (1.2% versus 0.3%) were observed with COSENTYX compared with placebo. The incidence of some types of infections appeared to be dose-dependent in clinical studies [see Adverse Reactions (6.1)]. Exercise caution when considering the use of COSENTYX in patients with a chronic infection or a history of recurrent infection. Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur. If a patient develops a serious infection, the patient should be closely monitored and COSENTYX should be discontinued until the infection resolves. 5.2 Pre-treatment Evaluation for Tuberculosis Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with COSENTYX. Do not administer COSENTYX to patients with active TB infection. Initiate treatment of latent TB prior to administering COSENTYX. Consider anti-TB therapy prior to initiation of COSENTYX in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Patients receiving COSENTYX should be monitored closely for signs and symptoms of active TB during and after treatment. 5.3 Exacerbations of Crohn’s Disease Exercise caution when prescribing COSENTYX to patients with active Crohn’s disease, as exacerbations of Crohn’s disease, in some cases serious, were observed in COSENTYX-treated patients during clinical trials. Patients who are treated with COSENTYX and have active Crohn’s disease should be monitored closely [see Adverse Reactions (6.1)]. 5.4 Hypersensitivity Reactions Anaphylaxis and cases of urticaria occurred in COSENTYX-treated patients in the clinical trials. If an anaphylactic or other serious allergic reaction occurs, administration of COSENTYX should be discontinued immediately and appropriate therapy initiated [see Adverse Reactions (6.1)]. 5.5 Risk of Hypersensitivity in Latex-sensitive Individuals The removable cap of the COSENTYX Sensoready pen and the COSENTYX prefilled syringe contains natural rubber latex which may cause an allergic reaction in latex-sensitive individuals. The safe use of COSENTYX Sensoready pen or prefilled syringe in latex-sensitive individuals has not been studied. 5.6 Vaccinations Prior to initiating therapy with COSENTYX, consider completion of all age appropriate immunizations according to current immunization guidelines. Patients treated with COSENTYX should not receive live vaccines. Non-live vaccinations received during a course of COSENTYX may not elicit an immune response sufficient to prevent disease. 6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail elsewhere in the labeling: • Infections [see Warnings and Precautions (5.1)] • Exacerbations of Crohn’s Disease [see Warnings and Precautions (5.3)] • Hypersensitivity Reactions [see Warnings and Precautions (5.4)] 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.

Journal of Dermatology for Physician Assistants

Table 1 summarizes the adverse reactions that occurred at a rate of at least 1% and at a higher rate in the COSENTYX groups than the placebo group during the 12-week placebo-controlled period of the placebocontrolled trials. Table 1 Adverse Reactions Reported by Greater Than 1% of Subjects with Plaque Psoriasis Through Week 12 in Trials 1, 2, 3, and 4 COSENTYX Adverse Reactions

300 mg (N=691) n (%)

150 mg (N=692) n (%)

Placebo (N=694) n (%)

Nasopharyngitis

79 (11.4)

85 (12.3)

60 (8.6)

Diarrhea

28 (4.1)

18 (2.6)

10 (1.4)

Upper respiratory tract infection

17 (2.5)

22 (3.2)

5 (0.7)

Rhinitis

10 (1.4)

5 (0.7)

Oral herpes

9 (1.3)

1 (0.1)

2 (0.3)

Pharyngitis

8 (1.2)

7 (1.0)

0 (0)

Urticaria

4 (0.6)

8 (1.2)

1 (0.1)

Rhinorrhea

8 (1.2)

2 (0.3)

1 (0.1)

Adverse reactions that occurred at rates less than 1% in the placebocontrolled period of Trials 1, 2, 3, and 4 through Week 12 included: sinusitis, tinea pedis, conjunctivitis, tonsillitis, oral candidiasis, impetigo, otitis media, otitis externa, inflammatory bowel disease, increased liver transaminases and neutropenia. Infections In the placebo-controlled period of the clinical trials in plaque psoriasis (a total of 1382 subjects treated with COSENTYX and 694 subjects treated with placebo up to 12 weeks), infections were reported in 28.7% of subjects treated with COSENTYX compared with 18.9% of subjects treated with placebo. Serious infections occurred in 0.14% of patients treated with COSENTYX and in 0.3% of patients treated with placebo [see Warnings and Precautions (5.1)]. Over the entire treatment period (a total of 3430 plaque psoriasis subjects treated with COSENTYX for up to 52 weeks for the majority of subjects), infections were reported in 47.5% of subjects treated with COSENTYX (0.9 per patient-year of follow-up). Serious infections were reported in 1.2% of subjects treated with COSENTYX (0.015 per patientyear of follow-up). Phase 3 data showed an increasing trend for some types of infection with increasing serum concentration of secukinumab. Candida infections, herpes viral infections, staphylococcal skin infections, and infections requiring treatment increased as serum concentration of secukinumab increased. Neutropenia was observed in clinical trials. Most cases of secukinumabassociated neutropenia were transient and reversible. No serious infections were associated with cases of neutropenia. Exacerbation of Crohn’s Disease Exacerbations of Crohn’s disease, in some cases serious, were observed in clinical trials in both COSENTYX and placebo treated patients. In the psoriasis program, with 3430 patients exposed to COSENTYX there were 3 cases of exacerbation of Crohn’s disease [see Warnings and Precautions (5.3)]. Hypersensitivity Reactions Anaphylaxis and cases of urticaria occurred in COSENTYX-treated patients in clinical trials [see Warnings and Precautions (5.4)]. 6.2 Immunogenicity As with all therapeutic proteins, there is the potential for immunogenicity. The immunogenicity of COSENTYX was evaluated using an electrochemiluminescence-based bridging immunoassay. Less than 1% of subjects treated with COSENTYX developed antibodies to secukinumab in up to 52 weeks of treatment. However, this assay

has limitations in detecting anti-secukinumab antibodies in the presence of secukinumab; therefore the incidence of antibody development might not have been reliably determined. Of the subjects who developed antidrug antibodies, approximately one-half had antibodies that were classified as neutralizing. Neutralizing antibodies were not associated with loss of efficacy.

An embryofetal development study was performed in cynomolgus monkeys with secukinumab. No malformations or embryofetal toxicity were observed in fetuses from pregnant monkeys that were administered secukinumab weekly by the subcutaneous route during the period of organogenesis at doses up to 30 times the maximum recommended human dose (MRHD; on a mg/kg basis at a maternal dose of 150 mg/kg).

The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of incidence of antibodies to COSENTYX with the incidences of antibodies to other products may be misleading.

A pre- and postnatal development toxicity study was performed in mice with a murine analog of secukinumab. No treatment related effects on functional, morphological or immunological development were observed in fetuses from pregnant mice that were administered the murine analog of secukinumab on gestation days 6, 11, and 17 and on postpartum days 4, 10, and 16 at doses up to 150 mg/kg/dose.

7 DRUG INTERACTIONS Drug interaction trials have not been conducted with COSENTYX. 7.1 Live Vaccines Patients treated with COSENTYX may not receive live vaccinations [see Warnings and Precautions (5.6)]. 7.2 Non-Live Vaccines Patients treated with COSENTYX may receive non-live vaccinations. Healthy individuals who received a single 150 mg dose of COSENTYX 2 weeks prior to vaccination with a non-U.S. approved group C meningococcal polysaccharide conjugate vaccine and a non-U.S. approved inactivated seasonal influenza vaccine had similar antibody responses compared to individuals who did not receive COSENTYX prior to vaccination. The clinical effectiveness of meningococcal and influenza vaccines has not been assessed in patients undergoing treatment with COSENTYX [see Warnings and Precautions (5.6)]. 7.3 CYP450 Substrates A role for IL-17A in the regulation of CYP450 enzymes has not been reported. The formation of CYP450 enzymes can be altered by increased levels of certain cytokines (e.g., IL-1, IL-6, IL-10, TNFα, IFN) during chronic inflammation. Thus, COSENTYX, an antagonist of IL-17A, could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of COSENTYX in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect (e.g., for warfarin) or drug concentration (e.g., for cyclosporine) and consider dosage modification of the CYP450 substrate. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category B There are no adequate and well controlled trials of COSENTYX in pregnant women. Developmental toxicity studies conducted with monkeys found no evidence of harm to the fetus due to secukinumab. COSENTYX should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

8.3 Nursing Mothers It is not known whether secukinumab is excreted in human milk or absorbed systemically after ingestion. Because many drugs are excreted in human milk, caution should be exercised when COSENTYX is administered to a nursing woman. 8.4 Pediatric Use Safety and effectiveness of COSENTYX in pediatric patients have not been evaluated. 8.5 Geriatric Use Of the 3430 plaque psoriasis subjects exposed to COSENTYX in clinical trials, a total of 230 were 65 years or older, and 32 subjects were 75 years or older. Although no differences in safety or efficacy were observed between older and younger subjects, the number of subjects aged 65 years and older was not sufficient to determine whether they responded differently from younger subjects. 10 OVERDOSAGE Doses up to 30 mg/kg intravenously (i.e., approximately 2000 to 3000 mg) have been administered in clinical trials without dose-limiting toxicity. In the event of overdosage, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted immediately. Manufactured by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936 US License No. 1244 © Novartis T2015-07 January 2015

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Volume 9 • number 3 • SUMMER 2015

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, PhD, 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

2015-16 SDPA Board of Directors PRESIDENT Matthew Brunner, MHS, PA-C PRESIDENT-ELECT Jennifer Conner, MPAS, PA-C IMMEDIATE PAST PRESIDENT Vicki Roberts, MPAS, PA-C VICE PRESIDENT Jacki Kment, MPAS, PA-C SECRETARY / TREASURER Joleen Volz, MPAS, PA-C DIRECTORS AT LARGE Jane Mast, PA-C Matt Dohlman, PA-C Gina Mangin, MPAS, PA-C Mark Hyde, MMS, 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 AAPA’s CME Standards for Journal Articles and for Commercial Support of Journal Articles. going green: Since its inception, the JDPA has utilized eco-friendly printing practices. The JDPA is printed on paper obtained from sustainable forests that meet strict environmental standards. Soy-based inks that have a low environmental impact are used during printing of the journal and the journal is printed using 100% renewable energy. SDPA members may join us in our efforts and opt to receive the JDPA in digital format.

Publishing Staff 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 To read the JDPA publication’s Ethics and Malpractice Statement, please visit www.jdpa.org/write.html. 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 9, Number 3, Summer 2015. 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. © 2015 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., 8400 Westpark Drive, 2nd Floor, McLean, VA 22102 1-800-380-3992., email SDPA@dermpa.org, www.dermpa.org. THIS ISSUE IS SPONSORED BY

Journal of Dermatology for Physician Assistants

Editor’s Message

very summer the SDPA leadership gathers for their annual leadership retreat. This is a time to meet new leaders and staff, organize within each committee, reflect on the past year’s accomplishments, and set goals for the new leadership year ahead. This is also one of those unique times that the entire group of SDPA volunteer leaders are able to meet face to face. Serving as Chair for the Publications and Communications Committee for the past ten years, I always leave this annual retreat feeling recharged and invigorated about both the mission and new goals we set for our organization. The goals we set consist of motivating words that are both spoken and written. What makes these goals successful is acting on them and carrying them out. If these goals were left untouched for the next year, what kind of leader would I be? Since our annual retreat I have spent quite a bit of time reflecting on what qualities make for great leadership. This issue’s JDPA Workplace Excellence article touches on the role of using both words and actions in order to have successful leadership. I believe this not only holds true for the elected and volunteer SDPA leadership but for us as dermatology PAs as well. I believe there is great value in volunteering for the SDPA and putting our time and energy into improving our profession. I also believe that it is equally important that we strive to be great leaders and make a difference in our day-to-day lives as dermatology PAs. We can do so by continuing to stay current on state and national legislation items relating to our profession, keeping up to date with current treatment therapies, and volunteering locally and/or abroad to provide excellent care to patients in need. As great PA leaders we can bring this information to our supervising physicians and staff to keep them informed of opportunities we wish to take the initiative on, with both our words and actions. As always I encourage anyone interested in becoming involved and being a great leader with the SDPA to do so. I also encourage all of our members to not only talk about being great dermatology PA leaders, but to take action and be great leaders within your own communities. J

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

Volume 9 • number 3 • SUMMER 2015

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.

A Clinical Review of Tinea Capitis By Abby Marie Alvarez, MPA, PA-C and Stevie Redmond, MPA, PA-C

›› CME 14 Derm PA News & Notes – part one • Certification Review • Student Corner – The SDPA Interactive Dermatology PA Resume Tool • American Academy of Dermatology Asks, ‘Who’s Got Your Back?’ - Find a Partner for Skin Cancer Prevention, Detection

23 Clinical Dermatology • CME Article – A Clinical Review of Tinea Capitis • Dermoscopy – Dermoscopic Notes from the 2014 American Dermoscopy Meeting • Dermatology Case Report – Sneddon-Wilkinson Disease

Departments 08 Editorial Board 09 Editor’s Message 13 SDPA News & Current Affairs 14 Dermatology Market Watch 28 From The Patient’s Perspective 32 Clinical Snapshots 41 Surgical Wisdom 44 Cosmetic Pearls 51 Notes from your Office Manager 55 The Difference We Make 64 Now Showing on Dermcast.tv 65 JDPA Information for Authors 66 Professional Opportunities and Development

40 Surgical Dermatology • Journal Club: Practice Changing Articles for Dermatology

42 Cosmetic Dermatology • Fad Beauty Treatments – Is There Science Behind The Hype?

47 Professional Development • Dermatology Billing & Coding - Get Ready For ICD-10 • Outside & Inside the 9 to 5… Reviving Her Passion to Heal

55 Derm PA News & Notes – part two

Go Green & Read On the Go 10 Journal of Dermatology for Physician Assistants

• Workplace Excellence • From the Desk of… • Supervising Physician Corner – An Interview with Sharon Jacob, MD

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 9 • number 3 • SUMMER 2015 11

12 Journal of Dermatology for Physician Assistants

FROM THE SDPA

News & Current Affairs Greetings Colleagues,

CALENDAR OF EVENTS AUGUST AAD Summer Academy Meeting August 19 – 23, 2015 New York, NY

2015

NOVEMBER SDPA 13th Annual Fall Dermatology Conference November 12 – 15, 2015 Loews Portofino Bay Hotel Orlando, FL

2016 March 74th AAD Annual Academy Meeting March 4 – 8, 2016 Washington, DC JUNE SDPA Summer Dermatology Conference June 1 – 5, 2016 JW Marriott Hotel Austin, TX

July 1st of each year always marks a momentous time for the SDPA as we transition our leadership team. During this period, our newly appointed committee chairs and elected officers meet with those leaders who will be continuing in a leadership role, and we begin the process of planning for the year ahead. As we begin this transitional time, I want to acknowledge all of those leaders who are stepping away from their current roles and thank them for all they have done to make the SDPA a great organization. It is an exciting time for the SDPA as it is always a time filled with hope and new potential for growing our professional organization. This correlates well with one of my personal annual goals to make room for self-improvement. One of the best ways we can improve ourselves professionally is to attain a new set of knowledge or skills or to take on a new challenge at work or in our community. Fifteen years ago next month I graduated from my PA training program full of excitement for my new profession and eager to start caring for patients. It would be nearly two years before I had the chance to attend my first CME conference due to the events of 9/11, but that same sense of excitement and feeling of determination returns and reinvigorates me with each CME conference I attend. It has become very clear to me that the more knowledge we PAs attain, the more skills we master, and the more certifications we earn the better care we provide to our patients. This has been the guiding point of my career and one of the reasons I am so passionate about making sure the SDPA offers each of you the best educational tools we can find. If you have completed the SDPA’s Distance Learning Initiative (DLI) and have become an SDPA Diplomate, I congratulate you on your accomplishment! As a reminder, all PAs who became SDPA Diplomates prior to January 1, 2015 must complete modules 001 - 005 prior to February 29th, 2016 in order to remain grandfathered in as we transition from the current DLI program in 2016. For those of you who initiated the DLI but have not yet completed it, I encourage you to find the time to complete this worthy and challenging course prior to February 29th, 2016. In addition, all current modules will cease to be sold as of December 31st, 2015, and all modules must be completed by February 29th, 2016. For those who have not yet started, I encourage you to consider completing the current program if time will allow. If you find you won’t have the time for whatever reason, don’t fret because we are planning to launch an entirely new DLI in the second half of 2016. We will release details to the SDPA membership as we get closer to launch time and the details become finalized. All SDPA Diplomates, whether current or new, must adhere to the DLI maintenance requirements that are outlined on our website www.dermpa.org. Lastly, I want to close by saying thank you for electing me to serve as President of our Society. It is an honor and a challenge that I welcome! My hope is that each of you will take the challenge to make room for self-improvement and better yourself as well! J Best Wishes,

Matthew Brunner, MHS, PA-C SDPA President, Diplomate

Volume 9 • number 3 • SUMMER 2015 13

Dermatology PA news & notes

Dermatology Market Watch Canfield’s VECTRA® XT - Now with 360⁰ Body Imaging Canfield Scientific, the world leader in 2D and 3D clinical p h o t o g r a p h y, introduced the latest groundbreaking capability of 360⁰ body imaging in high VECTRA® XT stitched 360⁰ image resolution 3D, at with contour lighting. the annual meeting of the American Society of Aesthetic Plastic Surgeons (ASAPS) in Montreal, Canada. With this new feature, a front and back view of the patient is automatically stitched together into a single, seamless wraparound image, giving the healthcare provider and patient an unprecedented understanding of the structural and aesthetic appearance of a patient’s body. Consultations about the back-side of the anatomy can

be difficult and often require the use of multiple mirrors or flat, 2D pictures. Now, with VECTRA’s 360⁰ body imaging, the patients can see all of the shapes, curves, and folds on their bodies, as well as the proportional impact of various procedures. All of the simulation tools in VECTRA’s Body Sculptor® software module can now be used on a 360⁰ image to view body contouring procedures such as abdominoplasty, liposuction, and buttock augmentation. VECTRA® XT 360⁰ body imaging is now a standard feature in software Version 5.6. This version is included with all new systems and is provided as a free upgrade to customers with current Canfield Care™ Support & Upgrade agreements. For more information contact Canfield Scientific at 800-815-4330 or by email at info@CanfieldSci.com. You can learn more about this and all of Canfield’s leading edge imaging solutions at CanfieldSci.com. J

Novartis Oncology Announces FDA Approval of Odomzo® Novartis recently announced that the US Food and Drug Administration (FDA) has approved Odomzo® (sonidegib, formerly LDE225) 200mg capsules for the treatment of adult patients with locally advanced basal cell carcinoma (laBCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy. The Odomzo approval was based on the demonstration of a durable objective response rate (ORR) in an international, multi-center, double-blind, randomized, two-arm, non-comparative trial in patients with laBCC not amenable to local therapy or metastatic basal cell carcinoma (mBCC). Patients with laBCC treated with Odomzo 200mg (n=66) were followed for at least 12 months unless discontinued earlier. The ORR was 58% (95% confidence interval: 45, 70), consisting of 5% (n=3) complete responses (CR) and 53% (n=35) partial responses (PR). A pre-specified sensitivity analysis using an alternative definition for CR, defined as at least a PR according to MRI and/or photography and no evidence of tumor on 14 Journal of Dermatology for Physician Assistants

biopsy of residual lesion, yielded a CR rate of 20%. Among the 38 patients with an objective response, 31 patients (82%) have ongoing responses ranging from at least 1.9 to 18.6 months and the median duration of response has not been reached. The most serious risks of Odomzo are embryofetal toxicity and musculoskeletal adverse reactions including rhabdomyolysis. Musculoskeletal adverse reactions, which may be accompanied by serum creatine kinase (CK) elevations, may occur with Odomzo and other drugs which inhibit the hedgehog pathway. The incidence of musculoskeletal adverse reactions in patients with laBCC treated with Odomzo 200mg was 68%, with 9% reported as grade 3 or 4. Adverse reactions occurring in more than 10% of patients treated with Odomzo 200mg were muscle spasms, alopecia, dysgeusia, fatigue, nausea, musculoskeletal pain, diarrhea, decreased weight, decreased appetite, myalgia, abdominal pain, headache, pain, vomiting, and pruritus. The most frequent grade 3 and 4 laboratory abnormalities occurring in at least 5% of patients were serum creatine kinase (CK) elevation and lipase elevation. J ...continued on page 17

Cloderm® (clocortolone pivalate) Cream, 0.1%, and Clocortolone Pivalate Cream, 0.1%

FOR YOUR PATIENTS WITH ACUTE, LOCALIZED DERMATOSES

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Cloderm Indication and Important Safety Information Cloderm® Cream and Clocortolone Pivalate Cream, 0.1%, are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. The most common adverse events with Cloderm® Cream and Clocortolone Pivalate Cream, 0.1%, include burning, itching, irritation, dryness, and folliculitis. Cloderm® Cream and Clocortolone Pivalate Cream, 0.1%, are contraindicated in patients who are hypersensitive to any of the ingredients of these products. As with all topical corticosteroids, systemic absorption can produce reversible HPA-axis suppression. Please See Accompanying Full Prescribing Information.

Volume 9 • number 3 • SUMMER 2015 15

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

DESCRIPTION: Cloderm Cream 0.1% contains the medium potency topical corticosteroid, clocortolone pivalate, in a specially formulated water-washable emollient cream base consisting of purified water, white petrolatum, mineral oil, stearyl alcohol, polyoxyl 40 stearate, carbomer 934P, edetate disodium, sodium hydroxide, with methylparaben and propylparaben as preservatives. Chemically, clocortolone pivalate is 9-chloro-6α-fluoro-11β, 21-dihydroxy-16α methylpregna-1, 4-diene-3, 20-dione 21-pivalate. Its structure is as follows:

CLINICAL PHARMACOLOGY: Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man. Pharmacokinetics: The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses. (See DOSAGE AND ADMINISTRATION). Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile. INDICATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. 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.

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. Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results. Pregnancy Category C: Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time. Nursing Mothers: It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman. Pediatric Use: Pediatric patients may demonstrate greater susceptibility to topical 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.

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.

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

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.

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

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).

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

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

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.

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

2. Patients should be advised not to use this medication for any disorder other than for which it was prescribed. 3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician. 4. Patients should report any signs of local adverse reactions especially under occlusive dressing.

16 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!

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 almost 20 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 fifteen years he has been course director and presenter of the Physician Assistant Board Review, which is now being produced live online by Kaplan Medical.

Dermatology Market Watch ...continued from page 14 Melanoma Research Foundation Launches New Educational Program Certified Melanoma Educators (CME)

The Melanoma Research Foundation (MRF) is excited by the launch of a new program called Certified Melanoma Educators (CME). This program is an online training program that provides volunteers with a solid foundation in speaking about melanoma. Becoming a CME is simple: go through the web-based material, take a free online test, and receive your CME certificate - valid for one year! With this training, CME volunteers will be able to speak, write, or interview about melanoma with confidence that they have a solid grasp of the latest and best information. For the experienced dermatology PA this is review

with updated statistics and takes less than an hour. The certificate can be added to your resume and offered to your employer as evidence of going above and beyond as well as your willingness to take on the education of the melanoma patients your practice manages. Taking a special interest in education on a subject such as this puts you in a position of value to your practice and as always, benefits the patients. The MRF has always been a grassroots organization, celebrating the power of many voices. I hope you will add your voice to the cause by becoming a Certified Melanoma Educator. Please visit http://mrf.mindflash. com/PublicCoursePage.aspx?c=1188187434 to begin your training today! J Volume 9 • number 3 • SUMMER 2015 17

DERmatology pa news & notes

EXPLANATION: Meniere’s disease is due to malfunction of the endolymphatic sac in the inner ear and presents with episodic, severe vertigo, sensorineural hearing loss, and tinnitus. Vestibular neuritis (labyrinthitis) typically presents following a recent upper respiratory tract infection. Symptoms include vertigo, nausea, vomiting, and nystagmus. No tinnitus or

hearing loss is noted. Vertebrobasilar vertigo is typically seen in older patients and no tinnitus or hearing loss is noted. Acoustic neuroma is a tumor of cranial nerve VIII. Patients preset with tinnitus, sensorineural hearing loss, and vertigo (described as an unsteadiness and not a true spinning vertigo). Benign paroxysmal positional vertigo presents with brief episodes of vertigo precipitated by head movement; the Dix-Hallpike test would be positive. J The correct answer is E

QUESTION: A 35-year-old male presents with vertigo. The patient states the vertigo is episodic and feels like a spinning sensation. The episodes last about thirty minutes. He also notes a ringing in his ears, but denies nausea and vomiting. Physical examination is normal, except for signs of sensorineural hearing loss. The DixHallpike test is negative. Which of the following is the most likely diagnosis? A. Benign paroxysmal positional vertigo B. Vertebrobasilar TIA C. Vestibular neuritis D. Acoustic neuroma E. Meniere’s disease

Go to enstilarcomingsoon.com

18 Journal of Dermatology for Physician Assistants

Student Corner

The SDPA Interactive Dermatology PA Resume Tool A Useful Resume Building Tool for Aspiring Dermatology PAs By Maria Kelly, PA-S2

The SDPA Student Affairs Committee is reminding recent graduates of our 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 seasoned 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 assist members in becoming more involved with their profession and creating additional items that they may wish to consider highlighting on their resume. For example, the link to the AAPA website can help members stay in tune with national changes, acquire CME credits, or view the 2013-2014 AAPA Salary Report. For additional CME opportunities, members can also click on the links for the SDPA Distant Learning Initiative (DLI) or the 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, and 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. Lastly, when building your resume do not forget to showcase your commitment to dermatology education. Members who wish to share their knowledge of dermatology and submit items for possible publication in the SDPA’s official journal can click on the Journal of Dermatology for Physician Assistants (JDPA) interactive link. With the new mock resume tool, you will not only be building your resume, but also your knowledge and your future. Of course, we cannot guarantee a job, but we hope this resource can assist you along your way! J

Introducing the ALL NEW Dermcast.tv The Official Media Resource of the SDPA

Featuring: • Fresh New Design • Dedicated PRO section • Now Optimized for Mobile

www.dermcast.tv Volume 9 • number 3 • SUMMER 2015 19

DERmatology pa news & notes

SDPA Student Affairs Committee Senior Student Coordinator

American Academy of Dermatology Asks, ‘Who’s Got Your Back?’

DERmatology pa news & notes

Find a Partner for Skin Cancer Prevention, Detection

When it comes to skin cancer prevention and “Since applying sunscreen to your own back can be detection, your back should be at the front of your difficult, it’s best to ask for someone else’s help.” mind. While it’s a hard area of the body to protect with According to the survey, men are twice as likely as sunscreen, it’s also an important one, as the back is the women to report that they wouldn’t feel comfortable most common location for melanoma, the deadliest form asking anyone to apply sunscreen to their back (10 of skin cancer. Research also has shown that thicker percent versus 5 percent, respectively). If no one else were melanomas, which can require around to provide help with more advanced treatment, are sunscreen, 14 percent of survey more frequently found on parts respondents would not take any of the body that can’t easily be action, like seeking shade or self-inspected, like the back. wearing protective clothing, to In recognition of shield their back from the sun. Melanoma/Skin Cancer “Exposure to ultraviolet Detection and Prevention (UV) radiation is the most Month® in May and Melanoma preventable risk factor for all Monday®, observed on May forms of skin cancer, including 4th this year, the American Think applying sunscreen to your own back is easy? In melanoma, so don’t leave your the video the AAD uses an ultraviolet (UV) camera to Academy of Dermatology back unprotected against the show just how hard it is to cover your own back with (AAD) is asking the public sun’s harmful UV rays,” Dr. sunscreen. As people attempt to apply sunscreen to to consider “Who’s Got their own backs – the UV camera quickly reveals all the Lebwohl says. “Find someone Your Back?” when it comes spots they miss, underscoring the importance of asking you’re comfortable with — friends or loved ones for help. To watch the full video, to applying sunscreen and like a significant other, friend please visit https://www.aad.org/spot-skin-cancer/ examining skin for suspicious or relative — and ask them to community-programs-events/melanoma-monday/ spots. whos-got-your-back. apply sunscreen to your back. Or even better, stay in the PREVENTION  shade and wear clothing that According to a 2015 online survey conducted by covers your back.” To emphasize the importance of sun the AAD, 37 percent of people rarely or never apply protection on the back, the AAD released a “Who’s sunscreen to their back when it’s exposed to the sun, and Got Your Back?” video in conjunction with Melanoma 43 percent rarely or never ask someone else to help them Monday®. apply sunscreen to their back. Men are more likely than women to rarely or never apply sunscreen to their back DETECTION  (40 percent versus 33 percent, respectively) and to rarely Once people have found a partner for skin cancer or never ask someone else for help (47 percent versus 40 prevention, it’s time to consider who’s got their back percent, respectively). when it comes to skin cancer detection. Skin cancer is “Before you head outside, it’s important to apply a highly curable when detected early and treated properly, water-resistant, broad-spectrum sunscreen with a Sun so it’s important to check skin for suspicious spots. Protection Factor of 30 or higher to all exposed skin, According to the AAD’s survey, 51 percent of including the back,” says board-certified dermatologist men and 35 percent of women don’t know how to Mark Lebwohl, MD, FAAD, President of the AAD. 20 Journal of Dermatology for Physician Assistants

BY THE NUMBERS

According to an American Academy of Dermatology survey: • 37% of people rarely or never apply sunscreen to their back. • 43% of people rarely or never ask someone else to help them apply sunscreen to their back. • Only 36% of people examine their back for signs of skin cancer at least once a year. • Only 35% of people ask someone else to help them examine hard-to-see areas of their skin for signs of skin cancer. About the AAD’s Survey  – The survey was conducted by Relevant Research Inc. of Chicago from January 12 to 15, 2015. A total of 1,019 respondents completed the online survey. Data were weighted by sex, age, race/ethnicity, and income according to the 2013 U.S. Census Bureau’s American Community Survey for adults ages 18-64. The margin of sampling error at the 95 percent confidence level is ± 3.1 percent.

Show us #whosgotyourback Who has your back when it comes to skin cancer prevention and detection? Is it a friend? Relative? Significant other? Let us know by posting a photo of that person on social media using the hashtag #whosgotyourback. Sample Tweet: My husband, John, has my back when it comes to skin cancer prevention and detection. #whosgotyourback

@AADskin

AADskin

The back is the most common location for melanoma, the deadliest form of skin cancer For more information about skin cancer prevention and detection, check out the “Who’s Got Your Back?” infographic on the following page. This infographic explains why it is so important to find someone who “has your back” when it comes to skin cancer prevention and detection. J Mark Lebwohl, MD, FAAD, is President of the American Academy of Dermatology. He earned his medical degree from Harvard Medical School in Boston and completed residencies in dermatology and internal medicine at the Mount Sinai Medical Center in New York, where he is currently a professor and chairman in dermatology. Dr. Lebwohl has chaired numerous symposia and written or edited several books. He also has authored or co-authored more than 500 publications, including articles, chapters, and abstracts. Reprinted with permission from the American Academy of Dermatology

Volume 9 • number 3 • SUMMER 2015 21

DERmatology pa news & notes

examine their skin for signs of skin cancer. Only half of respondents said they perform skin self-exams at least once a year. “Everyone should regularly examine their skin for signs of skin cancer,” Dr. Lebwohl says. “If you notice any spots that are different from the others, or anything that’s changing, itching or bleeding, make an appointment with a board-certified dermatologist.” The survey indicates that people are less vigilant about checking their back than the rest of their skin. Just 36 percent of survey respondents said they examine their back for signs of skin cancer at least once a year, and only 35 percent ask someone else to help them inspect hard-to-see areas. “When you perform a skin self-exam, it’s important to check your entire body, including your back,” Dr. Lebwohl says. “It can be difficult to examine certain areas by yourself, including the back, so ask someone you trust, like a spouse or family member, to help you.” For our patients, more information about how to prevent and detect skin cancer, including instructions on how to perform a skin self-exam, can be found at the AAD website SpotSkinCancer.org. There, patients can download a body mole map for tracking changes in their skin and find free SPOTme® skin cancer screenings in their areas. SPOT Skin Cancer™ is the AAD’s campaign to create a world without skin cancer through public awareness, community outreach programs and services, and advocacy that promote the prevention, detection, and care of skin cancer.

THE BACK IS THE MOST COMMON SITE FOR MELANOMA, THE DEADLIEST FORM OF SKIN CANCER.

PREVENTION

DETECTION

Adequately applying sunscreen to your own back can be a difficult task. Find a family member or friend who “has your back” when applying sunscreen.

It’s been reported that about 16% of melanomas are found by spouses.

Only 36% of people examine their back for signs of skin cancer at least once a year.*

43% SUN SCREEN

of people rarely or never ask someone else to apply sunscreen to their back.*

37%

Only 35% of people ask someone else to help them examine hard-to-see areas for signs of skin cancer.*

rarely or never apply sunscreen to their back.*

Apply a broad-spectrum, water-resistant, SPF 30+ sunscreen.

Check your skin regularly and ask a partner to help check the hard-to-see areas.

When spotted early and treated properly, skin cancer, including melanoma, has a high cure rate.

In addition, seek shade and wear protective clothing to protect your skin whenever possible.

If you notice anything changing, itching or bleeding on your skin, make an appointment to see a board-certified dermatologist.

*Results from a 2015 survey conducted by the American Academy of Dermatology.

The American Academy of Dermatology has your back. To find a free SPOTme® skin cancer screening or a board-certified dermatologist, visit SpotSkinCancer.org.

#whosgotyourback 22 Journal of Dermatology for Physician Assistants

Clinic al Dermatology

A Clinical Review of Tinea Capitis By Abby Marie Alvarez, MPA, PA-C and Stevie Redmond, MPA, PA-C

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

›› CME

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

Approval is valid for 1 year from the issue date of July 2015. 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. Discuss the various presentations of tinea capitis. 2. Provide an overview of diagnostic techniques to assess for tinea capitis. 3. Become familiar with the most up-to-date recommendations on treatment of tinea capitis. Volume 9 • number 3 • SUMMER 2015 23

A Clinical Review of Tinea Capitis SDPA Members Only Content

CLINIC AL Dermatology

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

24 Journal of Dermatology for Physician Assistants

A Clinical Review of Tinea Capitis 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 9 • number 3 • SUMMER 2015 25

A Clinical Review of Tinea Capitis SDPA Members Only Content

CLINIC AL Dermatology

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

26 Journal of Dermatology for Physician Assistants

A Clinical Review of Tinea Capitis

Stevie Redmond, MPA, PA-C completed her undergraduate degree at Mercer University in Macon, GA. She then went on to complete her Master’s degree in Physician Assistant studies at Georgia Regents University (formerly Medical College of Georgia). She is an assistant professor in the Physician Assistant Department at Georgia Regents University and works clinically in vascular surgery. Stevie is a member of the Georgia Association of Physician Assistant (GAPA) and the American Academy of Physician Assistants. She has indicated no relationships to disclose relating to the content of this article.

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Empower. Educate. Advance.

CLINIC AL Dermatology

Abby Alvarez, MPA, PA-C completed her undergraduate degree at the University of Kentucky and then her Master’s degree in Physician Assistant studies at Georgia Regents University (formerly Medical College of Georgia). She currently works in thoracic surgery at the Ohio State University. Abby is a member of the American Academy of Physician Assistants and the Ohio Association of Physician Assistants (OAPA). She has indicated no relationships to disclose relating to the content of this article.

From The Patient’s Perspective How Did I End Up With Stage T2bN0? By Lisa

I CLINIC AL Dermatology

have always been a very outdoorsy person - hunting, fishing, hiking, camping, but I have never worshiped the sun like my sisters. Actually, I used to hide from the sun. So finding out I had melanoma was an incredible shock to me! I am a blonde-haired, blue-eyed, pale, Irish/German girl. Which means that I have a lot of moles, freckles, and red spots on my skin. However, I did have one mole that didn't look like the rest. It was a strange mole on my left inner leg by my knee that I had noticed about two years ago. It was blue/brown/black in color, oddly shaped, and had various levels of elevation.

The Melanoma Research Foundation (MRF) is the largest independent organization devoted to melanoma. The MRF is a 501(c)(3) nonprofit organization. Committed to the support of medical research in finding effective treatments and eventually a cure for melanoma, the MRF also educates patients, caregivers, and physicians about the prevention, diagnosis, and treatment of melanoma. The MRF's website is the premier source for melanoma information seekers. The MRF is also an active advocate for the melanoma community, helping to raise awareness of this disease and the need for a cure. Its online forum - the Melanoma Patients Information Page (MPIP) - is the oldest and largest community of people affected by melanoma and is hosted through the MRF. It is designed to provide support and information to caregivers, patients, family, and friends.

Melanoma Research Foundation Contact Information: www.melanoma.org 1411 K Street, NW Suite 800, Washington, DC 20005 MRF Blog: www.melanoma.org/about-us/newspress-room/blog Phone: (800) 673-1290 28 Journal of Dermatology for Physician Assistants

During one of my annual physicals in December 2014, I asked my primary care provider (PCP) to look at this suspicious mole. My PCP said it was nothing to worry about and that it was just a nevus on top of a mole. I wasn't real happy with this response, so I decided to get a second opinion. I saw a dermatologist on May 13th, 2015 and the nurse practitioner there agreed that it looked suspicious and did a shave biopsy of it and sent it off to pathology. I really never thought about it for a second after that shave biopsy because I really was one to protect myself from the sun. I figured that it would come back basal cell carcinoma or just noting at all.

“I have always been an outdoorsy person, but never worshiped the sun like my sisters. I actually used to hide from the sun. So, how did I end up with Stage T2bN0?” However, six days later, the dermatologist called me and said that I had malignant melanoma and that I needed to see a surgical oncologist due to the pathology report. I was just like, "ok," and scheduled an appointment with a surgical oncologist two days later and that was that. It still really didn't hit me. I didn't know much about melanoma, so I didn't know how bad it could be. The next day, I picked up my pathology report and read it: 1.2mm Breslow’s thickness, ulcerated, non-brisk TILs, 2-4 mitoses per mm2. I immediately went online and did some research. I should add that I am a nurse and very well educated. I know how to navigate around all of the garbage on the Internet and find the actual appropriate facts. After educating myself on all things melanoma, it got real. It finally hit me! I had no clue that melanoma could be so bad. I had no clue that it could

go internal with metastases to the liver, lungs, and brain! I always thought it was just some epidermal lesion you had removed and you just had to watch your moles after that. So, now I was concerned, nervous, anxious, angry, sad, and annoyed. I was in an incredible place in my life! I had just married the most amazing man ever! We had just bought our dream home. I had just switched jobs and was working at an incredible hospital with incredible people. I was so happy and so pleased with my life. I did not want anything threatening it! Anyway, I met with the surgical oncologist on May 21st, 2015 and he told me I would need a wide local excision of the primary tumor site (left inner leg by my knee), and that I would need to have a sentinel lymph node biopsy to make sure the cancer did not go out of the primary area. Surgery was scheduled for June 19th.

What the heck!? One month of waiting – ugh! I was angry. I did not want to wait a month. I wanted this crap out of me! On my surgery day June 19th, 2015, I first had to go to nuclear medicine to have a dye injected in the primary tumor site to see what lymph node could be affected. That burned and hurt something awful! Then I was off to the operating room. I woke up with quite a bit of pain. My left knee/leg was wrapped. The surgeon told my husband that he had to remove a large chunk from my left inner leg by my knee and that he had to cut through the vein so that there would be a lot of swelling and a lot of pain. He also told him that he removed one lymph node from my left groin. I went home and rested and took a lot of Norco. I was in a lot pain... like A LOT! But each day got better... got easier... the pain subsided. ...continued on page 31

By Steven K. Shama, MD, MPH, FAAD 1. As I read this young lady’s essay I think of my own daughter or son who could have been writing the same thoughts. They are all young, in the prime of their lives, have good jobs, and a loving spouse. Life couldn’t be more perfect until something happens that they would have never thought of… in this case a melanoma, which could threaten it all. When we educate our patients and the general public about melanoma, we should be talking not only in a scientific way about the strange new irregularly shaped mole, the variable colors, and the size and perhaps elevation, but to a human being whose lovely and loving life can be changed dramatically by a simple spot. For us, this is a great responsibility and we should not take it lightly. So when you educate, wrap your thoughts around a person who has a beautiful story to tell, a life full of hope. 2. We also have a significant responsibility to educate clinicians outside of our specialty about what melanomas look like when they are most “innocent” in appearance. As we educate our patients so should we educate our colleagues with the same reverence towards a melanoma and we should make ourselves available when someone calls because of a concern regarding a changing mole. We are not told why there was a delay between December 2014 and May of 2015 for Lisa’s mole evaluation, since apparently she

was concerned enough to seek another opinion. Hopefully, it was not the typical large city long wait time for a dermatology appointment. My office staff has for many years always accommodated a concerned patient for an evaluation about a mole within one week of the phone call or sooner if the patient is really concerned. Regarding delays, I wondered why there was a one-month wait for Lisa’s lesion to be totally excised. While there was probably no negative consequence because of this delay, think of yourself knowing that you have some malignant lesion on your skin and living your life for one month until the surgery. If you are the clinician who makes the diagnosis, do everything you can for a rapid surgical excision. 3. Happily, the lesion was no deeper than 1.2mm with negative lymph nodes. As with any melanoma, no matter how thin it is, one has to be humbled by the fact that regular checkups are needed to monitor for recurrences. What we in the medical profession should set as our goal is this: that this young lady is the last patient who we will ever see with a melanoma. Let us educate with a heart about melanomas… let us support research… and let us make ourselves available whenever our patients are worried. J

Volume 9 • number 3 • SUMMER 2015 29

CLINIC AL Dermatology

Take Home Points for Derm PAs:

Dermoscopy Dermoscopic Notes from the 2014 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.

Figure 1: The diagram's arrows point both away from the circle and towards the center; the circle represents the central tumor body. Circled in the dermoscopy photograph of a pigmented basal cell carcinoma are radial structures whose globules are oriented both away from the center of the tumor and towards it.

Figure 2: The diagramâ&#x20AC;&#x2122;s arrows represent radial structures and the circle the tumor body. Arrows in the dermoscopy photograph highlight radial structures of a melanoma; note that none of the radial structures extend toward the tumor body.

30 Journal of Dermatology for Physician Assistants

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 in 2008 and is a Diplomate of the SDPA. He presently resides in Vancouver, Washington where he works in dermatology at the Vancouver Clinic with Graham Clark, MD. He has indicated no relationships to disclose relating to the content of this article.

From The Patient’s Perspective ...continued from page 29 How Did I End Up With Stage T2bN0? I was a bit shocked when I removed the dressing and took a shower for the first time (three days post-op). I had a fairly large chunk missing from my leg. It looked like a baby shark bite! Haha. But I didn't care. As long as my surgeon got all of the cancer out, I didn't care how much of my leg he took. I had my post-op appointment on June 25th, 2015 and I was very, very, VERY pleased to find out that my lymph node was clear! No spread of the cancer! This was literally the best news of my life! The surgeon did say that there was some residual cancer that was left over from the original biopsy, which was why he had to take such a large amount of tissue during the surgery, but that the margins were clear. So I was upgraded to a Stage T2bN0. I was fine with this staging, because it said N0! :)

I have lost all sensation between my knee and my ankle on my left leg. I also have decreased range of motion and decreased strength in that leg now. I do have to start physical therapy for this. They are unsure at this point whether I will get that sensation/strength/range of motion back or not. If I don't get it back, that is totally fine! I don't really care, because all that really matters is the fact that I am now cancer free! I had a lot of people praying for me. I truly do believe in the power of prayer. I hope that other people have their prayers answered too, and I am very happy to pray for anyone that would like me to. God bless everyone and keep your chin up! It is one hell of a rollercoaster, but eventually the ride stops and you can breathe again. J

Volume 9 • number 3 • SUMMER 2015 31

CLINIC AL Dermatology

Figure 3: The diagram picture contains milia-like cysts marked by arrows that correspond to the milia-like cysts contained in the basal cell carcinoma shown in the dermoscopy photograph on the right.

Clinical snapshots Scombroid Poisoning By Harpartap S. Sandu, MD and Matthew P. Hansen, BS, EMT

SDPA Members Only Content

CLINIC AL Dermatology

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

Figure 3 - After treatment.

Figures 1 and 2 - Upon arrival and prior to treatment.

Harpartap S. Sandu, MD completed his medical school at the Government Medical College in Amritsar, India. He has since completed an internal medicine residency at University of Missouri-Columbia and an emergency medicine residency at Washington University in St. Louis. He is a Fellow of the American Academy of Emergency Physicians. He is currently an emergency department physician at Enloe Medical Center in Chico, CA. He has no relationships to disclose relating to the content of this article. Matthew P. Hansen, BS, EMT completed his undergraduate degree in dietetics at California State University, Chico. He currently works as an emergency department technician at Enloe Medical Center in Chico, CA and has returned to school to pursue a career as a physician assistant. He is a member of the American Academy of Physician Assistants. He has no relationships to disclose relating to the content of this article.

32 Journal of Dermatology for Physician Assistants

Volume 9 • number 3 • SUMMER 2015 33

34 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 with or without MTX. 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 9 • number 3 • SUMMER 2015 35

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

9 2 1 – 1 –

8 3 2 3 – –

16 19 5 4 4 1

16 13 5 2 2 1

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

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

Enbrela (N = 876)

Reaction

Percent of Patients

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

28 14

27 12

2 1 2 – – 1

3 1 1 1 1 –

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

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

36 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. 55 3/2015 US License Number 1132 © 1998 – 2015 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 © 2015 Amgen Inc., Thousand Oaks, CA 91320 All rights reserved.

USA-EDRM-105992 USA-916-104255

PIV55

Truth

Tanning

Your natural skin color is great the way it is!

“I have to get a tan to look good.”

Fine Lines and Wrinkles Sagging Skin

“Only old people get cancer.”

You should know your skin will pay a price! Cataracts Brown Spots

Every time you tan, you increase your risk of melanoma.

Young women are getting skin cancer more often. The risk is real! Melanoma—the deadliest kind—is the third most common cancer in people from 15 to 39. You can get melanoma in your eyes.

SPF

“Having a good ‘base tan’ will protect my skin from the sun.”

A tan is a sign of damaged skin.

“Tanning beds are a good way to get vitamin D.” Tanning beds are risky, and most people get enough vitamin D from food and sunlight during daily activities.

You can get more than a tan from a tanning bed. If the tanning bed isn't clean, you could pick up a serious skin infection with symptoms like: ҈ Genital warts ҈ Skin rashes ҈ Skin warts ҈ Flaky, discolored patches on your skin

National Center for Chronic Disease Prevention and Health Promotion Division of Cancer Prevention and Control

Volume 9 • number 3 • SUMMER 2015 37

Dermatology Case Report Sneddon-Wilkinson Disease By Sara Velky, MPAS, PA-C, Rebecca Rote, MPAS, PA-C, and Michael Graves, MD

SDPA Members Only Content

CLINIC AL Dermatology

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

Figure 1

Erythematous plaques with overlying flaccid pustules on the chest and abdomen in SneddonWilkinson disease.

Figure 2

Subcorneal accumulation of neutrophils in Sneddon-Wilkinson disease (H&E original magnification 100x).

38 Journal of Dermatology for Physician Assistants

Figure 3

Subcorneal accumulation of neutrophils with prominent single keratinocytes with vesiculated nuclei in Sneddon-Wilkinson disease (H&E original magnification 400x).

Figures 4 & 5

Sara Kennedy Velky, MPAS, PA-C is a 2014 graduate of the Physician Assistant Program at Georgia Regents University in Augusta, GA (formerly the Medical College of Georgia). She is currently working in family medicine in Greenville, South Carolina. She has indicated no relationships to disclose relating to the content of this article. Rebecca B. Rote, MPAS, PA-C is an Associate Professor at the Georgia Regents University Physician Assistant Program in Augusta, GA, where she teaches courses in emergency medicine, rhythm and 12 lead EKG interpretation, advanced airway and basic cardiac life support, and advanced cardiac life support. She received her Master’s degree from Georgia Regents University (formerly the Medical College of Georgia) Physician Assistant Program in Augusta, GA. She has indicated no relationships to disclose relating to the content of this article. Michael Graves, MD is a fellow in micrographic surgery and cutaneous oncology at Scripps Clinic in La Jolla, CA. He received his MD from the University of Texas Southwestern Medical Center at Dallas and completed his dermatology residency at the Medical College of Georgia at Georgia Regents University. He has indicated no relationships to disclose relating to the content of this article.

Volume 9 • number 3 • SUMMER 2015 39

CLINIC AL Dermatology

Hyperpigmentation after resolution of pustules following months of dapsone, prednisone, and hydroxyurea therapy in Sneddon-Wilkinson disease.

SURGIC AL Dermatology Journal Club: Practice Changing Articles for Dermatology PAs

Minimal-Scar Segmental Extraction of Lipomas: Study of 122 Consecutive Procedures. Dermatol Surg. 2005 Jan;31(1):59-63; discussion 63-4.

Chandawarkar RY1, Rodriguez P, Roussalis J, Tantri MD 1Division of Plastic Surgery, University of Connecticut School of Medicine, Farmington, CT.

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.

40 Journal of Dermatology for Physician Assistants

SURGICAL wisdom Skin Cancer and Surgical Treatment Pearls Dermcast.tv Live Blog Jaeyoung Yoon, MD, PhD Lecturing at the 2013 SDPA Annual Summer Dermatology Conference in St. Louis, Missouri

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.

Image by Tudor

This Dermcast.tv live blog was recorded at the 2013 SDPA Annual Summer Dermatology Conference in St. Louis, Missouri and was posted online July 2015. It is available at www.dermcast.tv/live-blog-skin-cancer-and-surgicaltreatment-pearls. Dermcast.tv is the official online media resource of the SDPA. We are very proud that Dermcast is the #1 iTunes Podcast in dermatology. Dermcast.tv 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 2015 SDPA 13th Annual Fall Dermatology Conference in Orlando, Florida please visit the Dermcast.tv website at www.dermcast.tv.

Volume 9 â&#x20AC;˘ number 3 â&#x20AC;˘ SUMMER 2015 41

SURGIC AL Dermatology

SDPA Members Only Content

COSMETIC deRMATOLOGY

Fad Beauty Treatments

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

42 Journal of Dermatology for Physician Assistants

SDPA Members Only Content

Joshua Zeichner, MD, FAAD, is the director of Cosmetic and Clinical Research and an assistant professor of Dermatology at Mount Sinai Hospital in New York. He is actively engaged in clinical research, and his work has been published in the top peer-reviewed dermatology journals. As an educator, Dr. Zeichner trains residents and medical students and regularly lectures to international audiences at the major dermatology meetings.

What Do You Want To Read About In The JDPA? We’re interested in knowing what kind of articles SDPA members would be interested in reading more about in order to help improve their practice of dermatology. Share your content ideas today. Email them to editor@jdpa.org

JDPA Journal of Dermatology for Physician Assistants

Volume 9 • number 3 • SUMMER 2015 43

COSMETIC Dermatology

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

Cosmetic pearls Tips For Reducing Scars 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.

These tips are demonstrated in “Proper Wound Care: How to Minimize a Scar,” a video posted to the Academy website and the Academy’s YouTube channel. This video is part of the Dermatology A to Z: Video Series, which offers videos demonstrating tips people can use to properly care for their skin, hair, and nails. A new video in the series posts to the Academy’s website and YouTube channel each month.

Ellen Marmur, MD, FAAD, is an associate clinical professor in both the Department of Dermatology and the Department of Genetics & Genomic Research at Mount Sinai Hospital. Dr. Marmur earned her medical degree at Albert Einstein College of Medicine, and she trained in internal medicine at the Icahn School of Medicine at Mount Sinai and dermatology at the New YorkPresbyterian Weill Cornell Hospital.

44 Journal of Dermatology for Physician Assistants

HELP YOUR PATIENTS

FIGHT

Acne

– with –

Once-daily treatment of comedonal & inflammatory acne lesions Visit ONEXTON.com to help patients save with a $0 copay* *Offer valid for commercially insured patients only. See savings card for full eligibility Terms and Conditions.

INDICATION

ONEXTON (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/3.75% is indicated for the topical treatment of acne vulgaris in patients 12 years of age or older.

IMPORTANT SAFETY INFORMATION

• ONEXTON Gel is contraindicated in patients with a known hypersensitivity to clindamycin, benzoyl peroxide, any component of the formulation, or lincomycin. • ONEXTON Gel is contraindicated in patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis. • Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin. ONEXTON Gel should be discontinued if significant diarrhea occurs. • Orally and parenterally administered clindamycin has been associated with severe colitis, which may result in death. • Anaphylaxis, as well as other allergic reactions leading to hospitalizations, has been reported in postmarketing use of products containing clindamycin/benzoyl peroxide. If a patient develops symptoms

•

• •

of an allergic reaction such as swelling and shortness of breath, they should be instructed to discontinue use and contact a physician immediately. The most common local adverse reactions experienced by patients in clinical trials were mild and moderate erythema, scaling, itching, burning and stinging. ONEXTON Gel should not be used in combination with erythromycin-containing products because of its clindamycin component. ONEXTON Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. A decision should be made whether to use ONEXTON Gel while nursing, taking into account the importance of the drug to the mother. Patients should be advised to avoid contact with the eyes or mucous membranes. Patients should minimize exposure to natural and avoid artificial sunlight (tanning beds or UVA/B treatment) while using ONEXTON Gel. To minimize exposure to sunlight, protective clothing should be worn and a sunscreen with SPF 15 rating or higher should be used.

Please see Brief Summary of Prescribing Information on the following page. /TMs are trademarks of Valeant Pharmaceuticals International, Inc. or its affiliates. Any other product or brand names and logos are the property of their respective owners. © 2015 Valeant Pharmaceuticals North America LLC. DM/ONX/15/0036(1)

Volume 9 • number 3 • SUMMER 2015 45

BRIEF SUMMARY OF FULL PRESCRIBING INFORMATION

Neuromuscular Blocking Agents

This Brief Summary does not include all the information needed to use ONEXTON Gel safely and effectively. See full prescribing information for ONEXTON Gel.

Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. ONEXTON Gel should be used with caution in patients receiving such agents.

ONEXTONâ&#x201E;˘ (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/3.75%, for topical use Initial U.S. Approval: 2000 CONTRAINDICATIONS Hypersensitivity ONEXTON Gel is contraindicated in those individuals who have shown hypersensitivity to clindamycin, benzoyl peroxide, any components of the formulation, or lincomycin. Anaphylaxis, as well as allergic reactions leading to hospitalization, has been reported in postmarketing use with ONEXTON Gel [see Adverse Reactions] WARNINGS AND PRECAUTIONS Colitis/Enteritis Systemic absorption of clindamycin has been demonstrated following topical use of clindamycin. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin. If significant diarrhea occurs, ONEXTON Gel should be discontinued. Severe colitis has occurred following oral and parenteral administration of clindamycin with an onset of up to several weeks following cessation of therapy. Antiperistaltic agents such as opiates and diphenoxylate with atropine may prolong and/or worsen severe colitis. Severe colitis may result in death. Studies indicate toxin(s) produced by Clostridia is one primary cause of antibiotic-associated colitis. The colitis is usually characterized by severe persistent diarrhea and severe abdominal cramps and may be associated with the passage of blood and mucus. Stool cultures for Clostridium difficile and stool assay for C. difficile toxin may be helpful diagnostically. Ultraviolet Light and Environmental Exposure Minimize sun exposure (including use of tanning beds or sun lamps) following drug application [see Nonclinical Toxicology]. ADVERSE REACTIONS The following adverse reaction is described in more detail in the Warnings and Precautions section of the label: Colitis [see Warnings and Precautions]. Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates observed in the clinical trials of another drug and may not reflect the rates observed in clinical practice. These adverse reactions occurred in less than 0.5% of subjects treated with ONEXTON Gel: burning sensation (0.4%); contact dermatitis (0.4%); pruritus (0.4%); and rash (0.4%). During the clinical trial, subjects were assessed for local cutaneous signs and symptoms of erythema, scaling, itching, burning and stinging. Most local skin reactions either were the same as baseline or increased and peaked around week 4 and were near or improved from baseline levels by week 12. The percentage of subjects that had symptoms present before treatment (at baseline), during treatment, and the percent with symptoms present at week 12 are shown in Table 1. Table 1: Local Skin Reactions - Percent of Subjects with Symptoms Present. Results from the Phase 3 Trial of ONEXTON Gel 1.2%/3.75% (N = 243) Before Treatment (Baseline)

Maximum During Treatment

End of Treatment (Week 12)

Mild Mod.* Severe

Erythema

Scaling

Itching

Burning

Stinging

*Mod. = Moderate

Postmarketing Experience Because postmarketing adverse 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. Anaphylaxis, as well as allergic reactions leading to hospitalizations, has been reported in postmarketing use of products containing clindamycin phosphate/benzoyl peroxide. DRUG INTERACTIONS Erythromycin Avoid using ONEXTON Gel in combination with topical or oral erythromycincontaining products due to its clindamycin component. In vitro studies have shown antagonism between erythromycin and clindamycin. The clinical significance of this in vitro antagonism is not known. Concomitant Topical Medications Concomitant topical acne therapy should be used with caution since a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents. If irritancy or dermatitis occurs, reduce frequency of application or temporarily interrupt treatment and resume once the irritation subsides. Treatment should be discontinued if the irritation persists.

46 Journal of Dermatology for Physician Assistants

USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women treated with ONEXTON Gel. ONEXTON Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal reproductive/developmental toxicity studies have not been conducted with ONEXTON Gel or benzoyl peroxide. Developmental toxicity studies of clindamycin performed in rats and mice using oral doses of up to 600 mg/kg/day (240 and 120 times amount of clindamycin in the highest recommended adult human dose based on mg/m2, respectively) or subcutaneous doses of up to 200 mg/kg/day (80 and 40 times the amount of clindamycin in the highest recommended adult human dose based on mg/m2, respectively) revealed no evidence of teratogenicity. Nursing Mothers It is not known whether clindamycin is excreted in human milk after topical application of ONEXTON Gel. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to use ONEXTON Gel while nursing, taking into account the importance of the drug to the mother. Pediatric Use Safety and effectiveness of ONEXTON Gel in pediatric patients under the age of 12 have not been evaluated. Geriatric Use Clinical trials of ONEXTON Gel did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects. NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity, mutagenicity and impairment of fertility testing of ONEXTON Gel have not been performed. Benzoyl peroxide has been shown to be a tumor promoter and progression agent in a number of animal studies. Benzoyl peroxide in acetone at doses of 5 and 10 mg administered topically twice per week for 20 weeks induced skin tumors in transgenic Tg.AC mice. The clinical significance of this is unknown. Carcinogenicity studies have been conducted with a gel formulation containing 1% clindamycin and 5% benzoyl peroxide. In a 2-year dermal carcinogenicity study in mice, treatment with the gel formulation at doses of 900, 2700, and 15000 mg/kg/day (1.8, 5.4, and 30 times amount of clindamycin and 2.4, 7.2, and 40 times amount of benzoyl peroxide in the highest recommended adult human dose of 2.5 g ONEXTON Gel based on mg/m2, respectively) did not cause any increase in tumors. However, topical treatment with a different gel formulation containing 1% clindamycin and 5% benzoyl peroxide at doses of 100, 500, and 2000 mg/kg/day caused a dose-dependent increase in the incidence of keratoacanthoma at the treated skin site of male rats in a 2-year dermal carcinogenicity study in rats. In an oral (gavage) carcinogenicity study in rats, treatment with the gel formulation at doses of 300, 900 and 3000 mg/kg/day (1.2, 3.6, and 12 times amount of clindamycin and 1.6, 4.8, and 16 times amount of benzoyl peroxide in the highest recommended adult human dose of 2.5 g ONEXTON Gel based on mg/ m2, respectively) for up to 97 weeks did not cause any increase in tumors. In a 52-week dermal photocarcinogenicity study in hairless mice, (40 weeks of treatment followed by 12 weeks of observation), the median time to onset of skin tumor formation decreased and the number of tumors per mouse increased relative to controls following chronic concurrent topical administration of the higher concentration benzoyl peroxide formulation (5000 and 10000 mg/kg/day, 5 days/week) and exposure to ultraviolet radiation. Clindamycin phosphate was not genotoxic in the human lymphocyte chromosome aberration assay. Benzoyl peroxide has been found to cause DNA strand breaks in a variety of mammalian cell types, to be mutagenic in S. typhimurium tests by some but not all investigators, and to cause sister chromatid exchanges in Chinese hamster ovary cells. Fertility studies have not been performed with ONEXTON Gel or benzoyl peroxide, but fertility and mating ability have been studied with clindamycin. Fertility studies in rats treated orally with up to 300 mg/kg/day of clindamycin (approximately 120 times the amount of clindamycin in the highest recommended adult human dose of 2.5 g ONEXTON Gel, based on mg/m2) revealed no effects on fertility or mating ability. PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information).

Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 Manufactured by: Contract Pharmaceuticals Limited Mississauga, Ontario, Canada L5N 6L6 U.S. Patents 5,733,886 and 8,288,434 Issued 11/2014 9389300 DM/ONX/14/0031(1)

Professional development

Dermatology Billing & Coding Get Ready For ICD-10

CMS and AMA Announce Efforts to Help Providers

Volume 9 • number 3 • SUMMER 2015 47

ICD-10 October 1, 2015 To learn more, see the CMS ICD-10 Quick Start Guide and more free resources at cms.gov/ICD10.

Get Ready Now!

ICD-10 DEADLINE

OCT 1, 2015 professional development

About ICD-10

Online

1 SDPA Members Only Content Practice You can download the 2016 Code Tables and Index at cms.gov/ICD10

Management Systems

Make a Plan | Obtain Access to ICD-10 Codes Electronic Health Record Products

Print and Electronic

A complimentary subscription to the JDPA is provided to the Available many sources, in many formats members of from the SDPA. Please visit www.dermpa.org today to join the SDPATrain Your Staff | Get Up 2 toandSpeed gain full access to the valuable content of the JDPA. Coding/ Administrative

Clinical

Focus on documentation, new clinical concepts captured in ICD-10

Focus on ICD-10 fundamentals

Identify top codes and code current cases in ICD-10

Update Your Processes | Get Your Forms Ready

CMS 1500 Forms

Superbills

Be sure you have the 2012 version if you use paper claims

Replace ICD-9 diagnosis codes with ICD-10

Update hard-copy and electronic forms Software System Vendors Call right away to confirm your systems are ready

Talk to Your Vendors and Health Plans | Confirm Systems Are Ready Clearinghouses Billing Services

Health Plans

Ask about their readiness and testing opportunities

5 Business Trading Partners Test with health plans, clearinghouses, vendors

Test Your Systems and Processes | Verify You Can Generate Claims New Software/ Systems Make sure you can generate ICD-10 claims

Get More Info Visit the CMS website at cms.gov/ICD10

Test inside your practice and with trading partners

ICD-10 | October 1, 2015 Official CMS Industry Resources for the ICD-10 Transition

www.cms.gov/ICD10

48 Journal of Dermatology for Physician Assistants

Get Ready Now

WTF?

DO YOUR PATIENTS HAVE ATHLETE’S FOOT BETWEEN THE TOES?

What the Foot? For tinea pedis due to Trichophyton rubrum and Epidermophyton floccosum in adult patients

for more information, go to LuzuRx.com.

LUZU has the strength to clear fungus and relieve signs and symptoms of interdigital tinea pedis.* LUZU is the only topical azole antifungal approved to treat interdigital tinea pedis with once-daily, 2-week dosing. Efficacy demonstrated at 4 weeks post-treatment. Treat it fast with LUZU. The complete clearance rates (primary efficacy outcome) in the two trials, assessed at 4 weeks post-treatment following two weeks of double-blind once-daily treatment, were 26% vs 2% (N=209) and 14% vs 3% (N=214) for LUZU vs vehicle, respectively. Complete clearance was defined as achieving both clinical cure (absence of erythema, scaling, and pruritus) and mycological cure (negative KOH and negative fungal culture).

If your patients are asking WTF? What the Foot? Tell them about LUZU. Visit LuzuRx.com for more information. Indication LUZU (luliconazole) Cream, 1% is indicated for the topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the or ganisms Trichophy ton 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 Brief Summary of Prescribing Information for LUZU on next page. Reference: 1. LUZU [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals; 2014. ®/TMs are trademarks of Valeant Pharmaceuticals International, Inc. or its affiliates. Any other product or brand names and logos are the property of their respective owners. ©2015 Valeant Pharmaceuticals North America LLC DM/LUZ/14/0116c(1)

Volume 9 • number 3 • SUMMER 2015 49

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.

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).

LUZU (luliconazole) Cream, 1% for topical use Initial U.S. Approval: 2013

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).

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. 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 postmarketing 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. 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 of the prescribing information. 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) to pregnant female rats. No treatment related effects on maternal toxicity or malformations were

50 Journal of Dermatology for Physician Assistants

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

Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215 Product of Japan Issued: 8/2014 9386401 DM/LUZ/15/0007

Notes from your Office Manager

Right Staff At The Right Time Staffing For Workflow

“Am I overstaffed?” I hear this question over and over. Generally what I find are appropriate staffing levels but misappropriate timing! In other words, over the course of a week, the right staff is in place, but on a given hour of the day it is not.

Do you even know how many calls come into the service during the lunch hour? How much business is going elsewhere? Even the smallest practice can stagger lunch hours so that someone can answer phones during the entire day.

Think about the workflow in a practice. Even without consideration for specialty type, every medical office will tell you that the phones are busier on Monday mornings than any other time of the week. Yet, we often have the same staff phone support on Monday mornings that we have on Thursday afternoons – does that make sense?

What time does your practice open in the morning? Is the first patient scheduled at 8:30 AM? Your door should be unlocked and open by 8 AM. That means you need to staff a receptionist at 8 AM. However, you do not need your checkout/cashier or referral scheduler starting at 8 AM. It is impossible to have a patient ready for checkout or referral/surgery scheduling before 8:45 AM when the first appointment is at 8:30 AM. Why not stagger staff start times so that those positions are available at the end of the day for those later appointments and to reduce overtime? That also means the receptionist hours end earlier than check-out staff; after all, the last appointment is typically checked in and roomed by 4:45 PM, so that function is complete for the day. Watch your own workflow and stagger staff hours by position – it just makes sense! J

The phone workflow is often overlooked when we think of staffing to support it effectively. Every practice can do a simple study of their incoming phone volume by making tick marks for every incoming call on a per hour basis to track calls for appointments, prescription refills, nurse/provider call backs, diagnostic test results, billing, or other. The volumes that trend over the course of the week are good indicators for staffing levels required on the phones (if you think you didn’t get a typical week, try it for two or three weeks). For example, a triage nurse can typically support about sixty-five calls per day. All too often we don’t staff a phone nurse, but we try to return calls in between patient visits, when we get a patient no-show for an appointment, or even during our lunch break, all of which create additional problems in the practice (delays and repeat calls from patients, staff burn out and turnover, and poor patient satisfaction ratings reported to insurance companies).

Rosemarie Nelson is a principal with the MGMA healthcare consulting group. She conducts educational seminars and provides keynote speeches on a variety of healthcare-technology and operational topics. Drawing upon her diverse experience, Nelson provides practical solutions to help medical groups succeed in their practices. She may be reached via physicianspractice@cmpmedica.com.

Workflow doesn’t stop during the lunch hour in a medical practice, yet all too often I see practices close operations for lunch. Patients may only have their own lunch hour to make personal calls, and if your phones are on service, they can’t access you.

Volume 9 • number 3 • SUMMER 2015 51

professional development

By Rosemarie Nelson, MS

Outside & Inside the 9 to 5... Reviving Her Passion to Heal

professional development

Discovering Purpose Through a Medical Volunteer Trip to Rural India In Free The Children communities, we’ve seen inspiring advancements in basic health care. Specialized care, however, remains out of reach for many of our rural community members. Without expertise in dermatology, healthcare providers struggle to treat and diagnose skin conditions, which are widespread across many rural communities; a 1999 study found that 32% of children screened in rural Kenya suffered from skin disease. Through Passion to HealSM, an initiative of Valeant Pharmaceuticals NA LLC (VPNA), Free The Children has developed a comprehensive program for advanced diagnosis and treatment of skin conditions in rural Kenya and India through medical volunteer trips. In collaboration with Free The Children’s implementation partner, Me to We Trips, the Passion to HealSM initiative funds the cost of the medical volunteer trips. This provides American healthcare providers who specialize in dermatology the opportunity to travel free of charge to help treat and educate community members, and train local clinicians to create sustainable solutions. SDPA member Kim Guthke, PA-C shares with our readers her reflection about her recent medical volunteer trip to India with Passion to HealSM. expect was a personal reawakening. As a traveller, experiencing a new culture is exciting and overwhelming “The experience revived - unfamiliar sounds, captivating sights, medicine for me; it reminded me and sometimes pungent aromas. As of the reason why I went into the a medical provider, the experience is field, which is to serve people,” amplified while trying to understand Guthke explained. “I really felt I had a different kind of medical system, a purpose in trying to alleviate a assess patients who often don’t speak little bit of suffering for the people I the same language, and provide the met. It was incredibly refreshing and best possible care in a completely burned away everything that wasn’t different environment. important in life.” This was the challenge Kim Guthke, Through the Passion to HealSM PA-C was up for when she travelled program, she traveled to India to India with Passion to HealSM, a and visited a rural community in medical volunteer program through Kim Guthke, PA-C Rajasthan, far from a city center the international development and in need of care for people with charity Free The Children. It provides American varying skin diseases. One 10-year-old girl Guthke dermatologists and dermatology PAs and NPs the met had a severe spinal deformity but came to the opportunity to travel to help treat and educate dermatology clinic seeking help. community members as well as train local clinicians “There was nothing we could really do for her to create sustainable solutions. Since the program’s at our clinic, so we referred her to an orthopedic inception in 2012, Passion to HealSM has served clinic,” she added. “She was so lovely and really over 7,000 patients and has seen 200 healthcare touched me because she was so trusting and open providers volunteering their time in Kenya, India, in letting us assess her and try to get her care.” and Ecuador. Another patient, a young boy with a scalp Ms. Guthke, a PA at the Boulder Medical Center infection, was terrified when he visited the clinic. Dermatology Department in Boulder, Colorado, “We had to drain the infection and administer was intrigued by the chance to combine her medicine to him,” said Guthke. “His mother and professional work with one of her other passions, grandmother were on hand to comfort him, and travel. Her intention was to help as many people their trust in us really speaks to the program and the with skin conditions as possible, but what she didn’t relationship already established in the community.” 52 Journal of Dermatology for Physician Assistants

“The community members I met changed me forever,” she said. “Living in western culture, you realize how lucky you are to have access to medical care. I have such wonderful memories and will always feel connected to India.”

Free The Children is part of a family of organizations including Me to We and We Day that has a shared goal: to empower a generation to shift the world from ‘me’ to ‘we’ through how we act, how we give, the choices we make on what to buy and what to wear, the media we consume, and the experiences with which we choose to engage. Together, we are an international charity and educational partner, a social enterprise, a series of youth empowerment events that celebrate active citizenship, and a year-round program that educates and engages young people to take action on social issues. Over the years, we’ve learned that the shift to ‘we’ will happen when we empower young people to fulfill their potential as agents of positive change. To achieve this goal, we create and provide all the resources they need to become active local and global citizens. We also work alongside educators, families, and companies to equip them with the tools to inspire a generation of caring and compassionate young leaders. J

Volume 9 • number 3 • SUMMER 2015 53

professional development

Free The Children’s long-standing partnerships with India’s rural communities allows practitioners to be part of the bigger picture, not only doing work on the ground, but also contributing to a holistic model that continues even when they return home. “In such a short period, I made a deep connection to these people, and I think about them at least once a week now in my daily life,” said Guthke. “You don’t feel, ‘Oh no, what will happen when I leave?’ because the work continues and more volunteers will get to experience what I have.” Having built such a strong connection with the charity Free The Children through her work with Passion To HealSM, Guthke has gone on to inspire many other healthcare providers in her network to sign up for the program. Ms. Guthke will be acting as an ambassador for the program this fall when she will be travelling to Kenya to once again help change the lives of countless patients while also inspiring her colleagues and reviving their own passions to heal.

If you have any questions about the program or are interested in learning more about a potential volunteer opportunity in 2015, please email passiontoheal@ freethechildren.com. The medical volunteer trips are free of charge for trip participants; costs are covered by the generous support of VPNA. Change others’ lives and your own by traveling to Kenya or India this year. Trip dates are as follows: Kenya: August 16–24; October 4–12 India: August 9–17; November 22–30

Finacea Foam will be in the picture ÂŽ

(azelaic acid) Foam,15% www.finaceafoam.com

54 Journal of Dermatology for Physician Assistants

Dermatology PA news & notes

The Difference We Make Brokenness and Healing

By Brian T. Maurer, PA-C

Recently I returned from a medical conference at McGill University in Montreal, Canada. The title of the conference was “In Osler’s Footsteps.” I had been invited to give an oral presentation entitled, “Brokenness and Healing.” For me it was quite an honor to be asked to give a talk in the Osler Library of the History of Medicine, a mere stone’s throw from the resting place of the great physician’s ashes. During my weekend in Montreal I stayed at a bed and breakfast run by a woman in her mid-fifties named Michelle. The morning of my departure, I took a photograph of Michelle seated on the sofa in her parlor. On the wall behind the sofa where she sits there hangs a large abstract painting. Michelle was the artist. Several of her other paintings hang on the walls of her home; some abstract, some more traditional. Michelle studied art history as an undergraduate, and later completed a Master’s equivalency in fine arts. The painting that hangs on the wall above the sofa in her parlor was one of the last paintings Michelle did. That was back in 1985. Michelle no longer paints, because she is blind. Michelle suffers from a medical condition known as retinitis pigmentosa. This condition is transmitted genetically. If you happen to be the unlucky recipient of this gene, you too will go blind one day. Michelle told me that seventeen members of her extended family have been affected by retinitis pigmentosa. Although never formally diagnosed, her own father was blind when he died. Michelle has two children of her own,

a son and a daughter. The son has retinitis pigmentosa. So far her daughter and two grandchildren show no signs of the disease. When I told Michelle that I had come to Montreal to deliver a presentation on brokenness and healing, she stopped rocking in the chair and sat forward, seemingly intrigued by my words. We are all broken in some way, I told Michelle; yet we do have the capacity within ourselves to experience substantial healing. Slowly, Michelle nodded her head. “En français on dit la résilience,” she said. “Oui,” I replied, “la résilience. C’est la même chose.” Resilience - it’s the same in any language. At one time or another we are all broken individuals, and those of us who are healers become wounded healers. We may not realize this fully at first, yet we can find strength in our woundedness to minister to those suffering individuals who cross our paths every day. J Brian T. Maurer has practiced pediatric medicine as a physician assistant for thirty-six years. Over the past two decades Mr. Maurer has explored the illness narrative as a tool to cultivate an appreciation for the delivery of humane medical care. He has published numerous vignettes, editorials, and essays in both national and international journals. Mr. Maurer has been a contributing author to the online openaccess journal Dermanities (www.dermanities.com) since its inception. Readers can visit the author on the web at http://briantmaurer. wordpress.com. This article was reprinted with permission from the author and the Online Journal of Community and Person-Centered Dermatology (OJCPCD). The OJCPCD is a free, full text, open-access, online publication that addresses all aspects of skin disease that concern patients, their families, and practitioners. All posts can be viewed at www.ojcpcd.com.

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

JDPA Journal of Dermatology for Physician Assistants

Volume 9 • number 3 • SUMMER 2015 55

Workplace Excellence Why Leading by Example Isn’t Enough 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.

Okay, I’ll admit it. I’m not a huge fan of

mimes. It’s not that I don’t respect the talent that it takes to pull off this ancient performance art involving acting through body motions without use of speech. I guess I just find them to be an unusual version of their close cousin the clown. Maybe too, it’s because I feel like they’re such strong artistic performers that it makes me wonder what other abilities (or inabilities) that they are not showing us and why. This brings me to another strong belief of mine: that leading by example isn’t enough and that those who profess to lead by example (by which they are often mean, “I don’t express my leadership intuitions and convictions with my voice, but just by my actions,”) aren’t yet ready to really be called leaders or to show true leadership. I know that this is a strong statement. I know that we can all cite examples of quiet leaders, of leaders who inspired others by their example. I also know that leaders who talk a good game but don’t back it up with their actions are not truly leaders. I know that many would cite Rosa Parks as a leader who inspired others through her actions, which will never be forgotten and not by her words, which few could recall at all. However, would anybody argue that Rosa Parks was a greater civil rights leader than Dr. Martin Luther King, Jr.? With both his words and actions, many would point out that he was one of the greatest civil rights leaders of all times! When we talk about leadership we must 56 Journal of Dermatology for Physician Assistants

consider it on a scale and distinguish it by degrees between good, better, and best. If we’re striving to develop world class leaders and if we’re striving to build and become great leaders, then we must acknowledge the need for great leaders to practice what they preach, and also preach what they practice. We want to develop leaders capable of motivating, empowering, and persuading others. Great leadership requires both words and action. A leader must motivate, empower, and persuade others through words and works. In other words, by definition I am arguing that you can’t be a “leadership mime.” You must invite others into your vision and give them a chance to contribute to it. There is a Ted Talk video online by Derek Severs, which is a simple but powerful example about leaders and followers that shows why it is critically important for great leaders to motivate, empower, and persuade. To view the video visit www.ted.com/talks/derek_sivers_how_ to_start_a_movement.html. What I am trying to do is to simply define a leadership continuum of leaders, participants, and detractors, and highlight what leading behaviors look like in their presence and in their absence. A leader is a performance leader (works hard, effectively executes), but also demonstrates responsibility for self and others. He/she is willing and able to motivate, empower, and persuade others through word and works. At the other end of the spectrum a detractor uses his/her poor performance and his/her leadership potential to

So what about participants? They are literally in the middle. They may fulfill their performance requirements, but they may do so inconsistently or in an uninspired way, a way that would not lead others to want to follow them. They may follow the leaders one day and in one way, and then follow the detractors another day and in other ways. Participants are leadership mimes; they perform (like an actor). Leadership habits are something they’re still trying on like a costume, but it’s not the core of who they are. Healthcare providers can make these ideas their own by working with staff to define specific behaviors and expectations at each point in the continuum (and in every context in the life of the practice). For example, what does it look like, sound like, and feel like to be a leader: • In the practice and with coworkers? • In the exam room during patient appointments? • When you are behind several patients during a busy clinic day?

What does a detractor’s voice sound like? How is it different from the sound of a leader’s voice? Finally, does a participant fit into a practice and how can you encourage participants to become leaders? Defining these points along the continuum doesn’t mean they won’t ever show up, but it does mean you’ll improve your intentionality, and over time with enough intensity these will become shared norms and individual habits. When someone says, “I lead by example” it’s not so much a description of what they do as leaders as much as it is a clear statement of what they are not willing or able to do as leaders. World-class leadership is the goal, not “leadership mimes.” J Matthew L. Davidson, Ph.D. is the Founder, President, and Director of Education for the Institute for Excellence & Ethics (IEE), a 501(c)3 nonprofit corporation dedicated to helping individuals and organizations achieve excellence. 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.

Let them know they’re not alone... Share a story with your patients. Visit the Patient’s Perspective library of articles at www.jdpa.org/advocacy.html If you know a patient who would like to share his/her story, please contact us at editor@jdpa.org Volume 9 • number 3 • SUMMER 2015 57

DERmatology pa news & notes

lead others away from the shared vision of the team and toward his/her own selfish, competing goals. A detractor is a leader for ill. For example, a provider/ staff member who through their actions basically says, “This rule, this habit, this way of doing things that the practice/hospital is advocating for, I disagree with. I think there’s another way, a different way, an easier way. Follow me, not them.” Get a team full of leaders, excellence and execution will follow; get a team full of detractors and mutiny will follow.

58 Journal of Dermatology for Physician Assistants

From the Desk of... Joe Monroe, MPAS, PA

I’ve discovered many uses for the cell phone a good mechanism to review the case with others camera, which are listed below. The sheer portability – colleagues, supervising physicians (SP), etc. – to of this device makes it easy to take from room to solicit their opinions. This is especially useful in cases room, a sharp distinction from the old days when my deemed not serious enough to require summoning the macro camera (which cost thousands of dollars and SP, but unusual enough to benefit from sharing. weighed over six pounds) had to be sent for and set 6) I also use the camera to capture lesions that I up just to take a simple photo. I have a Samsung S4, plan to send for Mohs. After the pathology is obtained, which is perfectly fine for my purposes. Here are just I review the case (and photo) with the surgeon so proper a few uses I’ve discovered: staging is done to facilitate appropriate scheduling. 1) Diseases such as acne can be tracked with This also gives me the chance to go back to the patient serial photographs and progress shown to the patient to tell them how the surgery will be done and how and family. much time it might take. Most of these cases don’t require the 2) Photos of back (or actual presence of the surgeon at other hard to see areas) lesions the time of biopsy, but showing can be taken and shown to the them a photo of the lesion is the patient to go over key features next best thing. of the lesion; this is a terrific teaching tool for recognition of 7) For those using melanoma, including features EMRs, these photos can of benign lesions like SKs. be downloaded from the cell Figure: Cell phone photogragh of Don’t forget to take some shots phone to the medical record, to microspcopy results revealing a bed bug with the patient’s camera so document what was seen. The (Cimex lectularius) they can take the image home cameras on most cell phones are and teach others what’s good or bad about the lesion. often superior to those found on tablets with far better If necessary, you can save that image for the medical resolution and color saturation. Manipulation of cell record to compare to future images. phone camera images is far more flexible than those taken with a tablet. 3) Photos of interesting cases/lesions can be reviewed by the provider later, affording them an 8) For those who teach dermatology, (or those opportunity to appreciate features not seen live. I’ve who would like to) photos of your real cases are ideal had my differential expanded many times by rematerial to use in case based presentations. I also use viewing such photos long after the fact. One such these photos for articles I write and publish. At the case I had recently caused me to question my original very least, if you capture these cases, you can present diagnosis (eczema) and re-biopsy the patient who them to any audience, even to colleagues in local turned out to have cutaneous T-cell lymphoma! meetings. If you don’t want to keep a written log of photos, just photograph the patient’s name and clinic 4) Capturing photo images can be a good way number (from the chart) in the frame after the photo, to trigger reading about the diagnosis later. Once to keep track of who is in each picture. Some providers the patient is gone, unless you keep a running log of write the patient’s information on a piece of tape stuck diagnoses, it’s “out of sight, out of mind” for most on the patient’s skin at the time of the photo. of us. Reviewing the photos, then reading about the diagnoses reinforces your understanding of the 9) Carrying your cell phone from room to diseases, making it more likely you’ll recognize them room has other advantages unrelated to the camera the next time. function. Medical information (Epocrates, PDR, Google, etc.) is readily available along with many 5) Capturing cases on the camera can also be

Volume 9 • number 3 • SUMMER 2015 59

DERmatology pa news & notes

Uses for Cell Phone Cameras in Medicine

DERmatology pa news & notes

other useful programs and apps. For example, I use the flashlight app to examine hard-to-see areas such as the inside of the mouth, the calculator to calculate dosages of medications, and the camera function to review photos of a particular case. I have the names and phone numbers of most specialists we refer to available to look up (under contacts) and give to the patient. An entire article could be written about all the apps one could use in the clinic. 10) For me the most exciting use for cell phones I’ve discovered is taking photos directly through the eyepiece of my microscope. It takes a bit of practice, but I take photos of microspcopy results and then show the patient the scabies or fungal elements to help “sell” the diagnosis (see Figure). These are often patients who have been misdiagnosed and mistreated by so many different providers that they find it hard to trust us. But once we show them “their” actual scabies organism or eggs, they become believers and are more likely to comply with treatment advice because the diagnosis becomes real, almost palpable. I can also

use these photos (once I’ve cropped them, effectively enlarging the image) in PowerPoint lectures and in articles. To take the photographs, just hold the camera over the eyepiece and look through the viewfinder as you move closer to the actual eyepiece. Soon an entire image will appear which can be photographed and enlarged. I use an app called Snapseed to process the image in terms of cropping, color, contrast, and so on. With that app, you can crop a cropped image several times to effectively enlarge it and then save the processed image to use as desired. J Joe Monroe, MPAS, PA, practices dermatology in private practice with Carlos Garcia, MD. He also writes and lectures on skin disease and related topics. He is the founder and former president of the SDPA.

P R E V E N T. D E T E C T. L I V E

P R E V E N T. D E T E C T. L I V E . No matter what sport you play, the type of gear you wear is important.

No matter what sport you play, the type of gear you wear is important. Next you out head out to play, don’t the mostpiece important of gear — sunscreen. Next timetime you head to play, don’t forget the forget most important of gear —piece sunscreen.

Learn at www.SpotSkinCancer.org Learn moremore at www.SpotSkinCancer.org © 2012 American Academy of Dermatology. Use of this poster does not imply product or service endorsement by the American Academy of Dermatology.

60 Journal of Dermatology for Physician Assistants

Get Ready for Grand Rounds in Orlando! Have an interesting case to share? The Conference Education Planning Committee invites you to submit difficult and interesting cases for the Grand Rounds lecture in Orlando. Submit your cases to GrandRounds@dermpa.org for the Fall Conference!

Volume 9 â&#x20AC;˘ number 3 â&#x20AC;˘ SUMMER 2015 61

Supervising Physician CORNER An Interview with Sharon Jacob, MD By J. Margaret Casey

DERmatology pa news & notes

Sharon Jacob, MD has been a thought leader in the field of dermatology. In her career she has authored one hundred and ninety-seven peer-reviewed publications, ten chapters, and one book. She currently works as an Associate Clinical professor of dermatology at Loma Linda University (LLU) and is the Director of the Contact Dermatitis Clinic at LLU. For the last decade has devoted her time to exploring the field of pediatric contact dermatitis. She is part of the dermatology team at LLU that has launched the Pediatric Contact Dermatitis Registry. The JDPA had the opportunity to interview Dr. Jacob and learn more about the Pediatric Contact Dermatitis Registry and how dermatology PAs can become involved with it.

most pediatricians or pediatric dermatologists might be JDPA: What was the motivation for developing the expected to see in a given week. Pediatric Contact Dermatitis Registry? In November 2014, the Loma Linda University Dr. Jacob: Allergens causing clinically relevant (LLU) Dermatology team allergic contact dermatitis in launched an initiative named adults in the US also affect â&#x20AC;&#x153;Dermatology PAs and SDPA the Pediatric Contact Dermatitis children as well. Notably, there is a significant lack of published members are vital parts of the Registry to reach out to as many of the states as possible studies concerning contact pediatric contact dermatitis and determine whether patch dermatitis and its effects on US children. In the last decade, evaluation and management testing on children was being performed, at what volume, and pediatric contact dermatitis workforce that need to be by whom (demographically). By has become increasingly more the end of February 2015, there recognized. Prevalence estimates recognized.â&#x20AC;? were 169 responding providers of contact allergy are reported (representing 48 states and the in the range of 41% to 77% in District of Columbia) who had participated in a brief those referred for patch testing. The year 2008 marked eleven question survey and identified themselves as the first reported patch test studies on affected children providing patch test services to children. Notably, there in the US; these studies confirmed the safety and efficacy were only three PAs (accounting for 1.8% of providers). of patch testing for afflicted children and showed that US adults and children had similar rates of positive JDPA: Have you found that PAs are participating testing for contact dermatitis. in the voluntary reporting for the registry? The big question that remains, however, is the Dr. Jacob: In our initial findings, we found that true prevalence of the disease. This is a rather difficult PAs, who we believe make up a significant proportion of question to answer since the majority of reported the workforce, were drastically underreported. With the pediatric patch test cases come from tertiary care centers help of SDPA leadership an outreach to the SDPA began. for patients referred by dermatologists and allergists As of July 10, 2015 there are 240 registered providers in while a significant number of pediatricians, family the current Pediatric Contact Dermatitis Registry. North practitioners, and dermatologists routinely treat children Dakota and Delaware remain the two states where a with this affliction and do not report those cases. In provider has yet to be identified. Thirty-nine (16%) of a presentation at the American Contact Dermatitis the registered providers are PAs! Dermatology PAs and Society on March 19, 2015, Golbenberg et al. discussed SDPA members are vital parts of the pediatric contact that combining the data from the three largest (multidermatitis evaluation and management workforce that centered) North American studies (Hoegling, 2008; need to be recognized. Jacob, 2008; and Zug, 2008) summed to a total of 592 The Pediatric Contact Dermatitis Registry has two affected children being tested by a total of 19 patch specific components: 1) link registry and 2) optional testers over an average of 5.3 years. This translates to case reporting. Thus far the registry has identified that an average of only 6 pediatric patients patch tested a minimum of 1,372 pediatric patients are patch tested each year per provider, which is much less than what 62 Journal of Dermatology for Physician Assistants

Pediatric Contact Dermatitis Registry Link To register and take the survey please visit: http://lomalindahealth.org/medical-center/ our-services/dermatology/for-health-careprofessionals/practitioner-database-registrationform.pag Sharon Jacob, MD is an Associate Clinical Professor of Dermatology at Loma Linda University. She earned her medical degree from the Temple University, and completed dermatology training at the University of Miami and advanced contact dermatitis training at New York University (NYU). She has been board certified in dermatology. Dr. Jacob's clinical interests include atopic and contact dermatitis and education. She is considered a national expert on chemical sensitivities in the skin and has published more than 195 journal articles, book chapters and abstracts on this topic. In 2005, Dr. Jacob was the first to present contact dermatitis data on U.S. pediatric patients to the American Contact Dermatitis Society (ACDS). She has received an excellence in teaching award from the University of Miami Dermatology, an ACDS Clinical Research Award and an ACDS mid-career development award for information technology and research design training for her work in development of the Pediatric Contact Dermatitis Registry Project. The Pediatric Contact Dermatitis Registry Project was funded in part by a Society for Pediatric Dermatology Pilot Project Grant. Dr. Jacob enjoys taking care of children and their families and is an advocate for children’s dermatologic health.

Volume 9 • number 3 • SUMMER 2015 63

DERmatology pa news & notes

in the US each year. This number is estimated by the lower range number providers report testing each year. For example, if a provider tests 9 patients, they would indicate 1-10 patients per year. This provider would then be assigned a ‘1’ to report the minimum tested per year. The Pediatric Contact Dermatitis Registry is continuing to enroll providers. We are asking all dermatology PAs who provide patch testing services to children to participate in this brief eleven question (30 second) survey today. The provider registry/survey records the demographics of the clinical provider offering patch testing services to children. Accurately representing the key role of PAs involved with providing patch testing services is paramount. JDPA: What happens after a PA/provider registers? Dr. Jacob: Once providers register and complete the survey they are entered on the US map and their demographic data (e.g., years in practice, association affiliations, etc.) are registered. Upon registration providers are then invited to log their de-identified cases into a centralized database. As of July 2015, 506 cases have been logged into the database. In this entirely optional case log component, any registered provider can voluntarily enter his/her cases into the database on the provided short 30 second reporting form. The case registry portion has the potential to provide objective numbers of US cases of allergic contact dermatitis, their linked allergens, and any co-morbidities as well as the demographics of the patients. This study is IRB approved. Final protocol and approval letter is available on request: please contact Pedcontactdermreg@contactderm.net. Please note that before entering your own cases, please review your institution's IRB policies regarding data sharing. JDPA: What are the main purposes of collecting this data? Dr. Jacob: The purposes of collecting this data are to: 1) Increase the number of verified cases of allergic contact dermatitis in children ages 0-18 years in the US. 2) Promote awareness of allergic contact dermatitis in pediatric populations. 3) Shed light on the demographics of providers offering pediatric patch test services. 4) Help highlight regional disparities in access to patch test care and evaluation for children. Furthermore, it could potentially act as key evidence and a catalyst for governmental policy changes regarding common and currently unregulated allergens and ultimately improve the quality of life of children suffering from allergic contact dermatitis. J

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Dermcast.tv is the official online media resource of the SDPA. We are very proud that Dermcast is the #1 iTunes Podcast in dermatology. Dermcast.tv 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!

DERmatology pa news & notes

Melanoma Rates Continue to Rise for Children, Adolescents, and Young Adults

Through an analysis of Surveillance, Epidemiology, and End Results (SEER) data from the National Cancer Institute, researchers at Roswell Park Cancer Institute (RPCI) determined that the number of cases of melanoma diagnosed in children, adolescents, and young adults increased by 253% from 1973 to 2011. Read More: http://bit.ly/mel_children

Researchers Identify a New Weapon to Suppress the Spread of Melanoma A potent new weapon in the fight against melanoma was discovered in what is believed to be the largest epigenetic analysis to date of cell-signaling molecules in early-stage melanoma.