JDPA Fall 2016 by Angela Simiele

DPA J

V o l u m e 1 0 • n u m b e r 4 • F A LL 2 0 1 6 • www.jdpa.org

Journal of Dermatology for Physician Assistants

Dermatology PA News & Notes SDPA State Affiliates 16 __________________________________

CLINIcal dermatology Clinical Snapshots

__________________________________

surgical dermatology Surgical Wisdom 28 _________________________________

cosmetic dermatology Journal Club 31 __________________________________

professional development Outside & Inside the 9 to 5

›› Earn CME credit with this issue CME The Role of the Registry in Dermatologic Disease Burden and Research

Official Journal of the Society of Dermatology Physician Assistants

Volume 10 • number 4 • FALL 2016

80 mg/mL

START YOUR PATIENTS TODAY Taltz is a targeted interleukin-17A (IL-17A) antagonist indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Taltz can provide high levels of clearance—even complete resolution of plaques (PASI 100) is possible1 TRIAL 2: EFFICACY AT 12 WEEKS

90% 71% 40% PASI 75 vs 2 %

PASI 90 vs 1%

PASI 100 vs 1%

Taltz 80 mg every 2 weeks (n=351)

83%

achieved clear or almost clear skin (sPGA 0,1)

vs 2 %

Placebo (n=168) For all comparisons, P<.001 vs placebo.

ADDITIONAL RESULTS

In Trials 1 and 3, Taltz patients achieved similar results: 89% and 87% of Taltz patients achieved PASI 75 vs 4% and 7% for placebo. Additionally, 71% and 68% of Taltz patients achieved PASI 90 vs 1% and 3% for placebo, and 35% and 38% achieved PASI 100 vs 0% and 0% for placebo. Also, 82% and 81% achieved sPGA 0,1 vs 3% and 7% for placebo.

Taltz is the only approved treatment for moderate to severe plaque psoriasis that includes PASI 100 results in the Prescribing Information1 TRIAL DESIGN The Taltz clinical program included 3 randomized, double-blind, placebo-controlled trials to evaluate the efcacy and safety of Taltz. All patients were ≥18 years of age and had plaque psoriasis with a body surface area involvement of ≥10%, a static Physician’s Global Assessment (sPGA) score ≥3, and a Psoriasis Area Severity Index (PASI) score ≥12, and were candidates for phototherapy or systemic therapy. Participants were randomized to receive placebo or Taltz 80 mg every 2 weeks following a 160 mg starting dose. In Trials 2 and 3, an additional arm of US-approved etanercept (50 mg twice weekly) was included. Co-primary efcacy endpoints were proportion of patients with an sPGA 0,1 and at least a 2-point improvement from baseline and proportion of patients achieving PASI 75 (at least a 75% reduction in the PASI composite score) at week 12. Nonresponder imputation (NRI) methods were used for categorical efcacy analyses. Taltz® is a registered trademark of Eli Lilly and Company. PP-IX-US-0722 08/2016 ©LILLY USA, LLC, 2016. ALL RIGHTS RESERVED.

Download savings cards for your patients at taltz.com/hcp IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Taltz is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients. WARNINGS AND PRECAUTIONS Infections Taltz may increase the risk of infection. The Taltz group had a higher rate of infections than the placebo group (27% vs 23%). Serious infections have occurred. Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a serious infection develops, discontinue Taltz until the infection resolves. Pre-Treatment Evaluation for Tuberculosis Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with Taltz. Do not administer to patients with active TB infection. Initiate treatment of latent TB prior to administering Taltz. Patients receiving Taltz should be monitored closely for signs and symptoms of active TB during and after treatment. Hypersensitivity Serious hypersensitivity reactions, including angioedema and urticaria (each ≤0.1%), occurred in the Taltz group in clinical trials. If a serious hypersensitivity reaction occurs, discontinue Taltz immediately and initiate appropriate therapy. Inammatory Bowel Disease Crohn’s disease and ulcerative colitis, including exacerbations, occurred at a greater frequency in the Taltz group (Crohn’s disease 0.1%, ulcerative colitis 0.2%) than in the placebo group (0%) during clinical trials. During Taltz treatment, monitor patients for onset or exacerbations of inammatory bowel disease. Immunizations Prior to initiating therapy with Taltz, consider completion of all age-appropriate immunizations according to current immunization guidelines. Live vaccines should not be given with Taltz. ADVERSE REACTIONS Most common adverse reactions (≥1%) associated with Taltz treatment are injection site reactions, upper respiratory tract infections, nausea, and tinea infections. IX HCP ISI 22MAR2016

Please see Brief Summary of Prescribing Information on the following pages. Please see Instructions for Use included with the device.

Call The Lilly Answers Center at 1-800-LillyRx (1-800-545-5979) or visit taltz.com for more information about Taltz. Reference: 1. Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2016.

Volume 10 • number 4 • FALL 2016

Taltz® (ixekizumab) injection Brief Summary: Consult the package insert for complete prescribing information. INDICATIONS AND USAGE Taltz is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. CONTRAINDICATIONS Taltz is contraindicated in patients with a previous serious hypersensitivity reaction such as anaphylaxis to ixekizumab or to any of the excipients. WARNINGS AND PRECAUTIONS Infections—Taltz may increase the risk of infection. In clinical trials, the Taltz group had a higher rate of infections than the placebo group (27% vs 23%). Upper respiratory tract infection, oral candidiasis, conjunctivitis and tinea infections occurred more frequently in the Taltz group than in the placebo group (Adverse Reactions). Instruct patients treated with Taltz to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a serious infection or is not responding to standard therapy, monitor the patient closely and discontinue Taltz until the infection resolves. Pre-treatment Evaluation for Tuberculosis—Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with Taltz. Do not administer to patients with active TB infection. Initiate treatment of latent TB prior to administering Taltz. Consider anti-TB therapy prior to initiating Taltz in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Patients receiving Taltz should be monitored closely for signs and symptoms of active TB during and after treatment. Hypersensitivity—Serious hypersensitivity reactions, including angioedema and urticaria (each ≤0.1%), occurred in the Taltz group. If a serious hypersensitivity reaction occurs, discontinue Taltz immediately and initiate appropriate therapy. Inflammatory Bowel Disease—Crohn’s disease and ulcerative colitis, including exacerbations, occurred at a greater frequency in the Taltz group (Crohn’s disease 0.1%, ulcerative colitis 0.2%) than in the placebo group (0%) during the 12-week, placebo- controlled period. During Taltz treatment, monitor for onset or exacerbation of inflammatory bowel disease. Immunizations—Prior to initiating therapy with Taltz, consider completion of all age- appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with Taltz. No data are available on the response to live or inactive vaccines. ADVERSE REACTIONS The following adverse drug reactions are discussed in greater detail in other sections of the label: • Infections (Warnings and Precautions) • Hypersensitivity Reactions (Contraindications and Warnings and Precautions) • Inflammatory Bowel Disease (Warnings and Precautions) Clinical Trials Experience—Because clinical trials are conducted under widely varying and controlled 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. Weeks 0 to 12: Three placebo-controlled trials in subjects with plaque psoriasis were integrated to evaluate the safety of Taltz compared to placebo for up to 12 weeks. A total of 1167 subjects (mean age 45 years; 66% men; 94% White) with plaque psoriasis received Taltz (160 mg at Week 0, 80 mg every two weeks [Q2W] for 12 weeks) subcutaneously. In two of the trials, the safety of Taltz (use up to 12 weeks) was also compared with an active comparator, U.S. approved etanercept. In the 12-week, placebo-controlled period, adverse events occurred in 58% of the Taltz Q2W group (2.5 per subject-year of follow- up) compared with 47% of the placebo group (2.1 per subject-year of follow- up). Serious adverse events occurred in 2% of the Taltz group (0.07 per subject-year of follow-up), and in 2% of the placebo group (0.07 per subject-year of follow-up). Table 1 summarizes the adverse reactions that occurred at a rate of at least 1% and at a higher rate in the Taltz group than the placebo group during the 12-week placebo- controlled period of the pooled clinical trials. Table 1: Adverse Reactions Occurring in ≥1% of the Taltz Group and More Frequently than in the Placebo Group in the Plaque Psoriasis Clinical Trials through Week 12 Adverse Reactions

Taltz 80 mg Q2W (N=1167) (n%)

Etanercept b (N=287) (n%)

Placebo (N=791) (n%)

196 (17)

32 (11)

26 (3)

163 (14)

23 (8)

101 (13)

Injection site reactions Upper respiratory tract infectionsa Taltz® (ixekizumab) injection

IX HCP BS 22MAR2016

Table 1: Adverse Reactions Occurring in ≥1% of the Taltz Group and More Frequently than in the Placebo Group in the Plaque Psoriasis Clinical Trials through Week 12 (Cont.) Placebo Adverse Reactions Taltz 80 mg Q2W Etanercept b (N=287) (n%) (N=791) (n%) (N=1167) (n%) Nausea 23 (2) 1 (<1) 5 (1) Tinea infections 17 (2) 0 1 (<1) Upper respiratory tract infections cluster includes nasopharyngitis and rhinovirus infection. b U.S. approved etanercept. a

Adverse reactions that occurred at rates less than 1% in the Taltz group and more frequently than in the placebo group during the 12-week induction period included rhinitis, oral candidiasis, urticaria, influenza, conjunctivitis, inflammatory bowel disease, and angioedema. Weeks 13 to 60: A total of 332 subjects received the recommended maintenance regimen of Taltz 80 mg dosed every 4 weeks. During the maintenance period (Weeks 13 to 60), adverse events occurred in 80% of subjects treated with Taltz (1.0 per subject-year of follow-up) compared to 58% of subjects treated with placebo (1.1 per subject-year of follow-up). Serious adverse events were reported in 4% of subjects treated with Taltz (0.05 per subject-year of follow-up) and none in the subjects treated with placebo. Weeks 0 to 60: Over the entire treatment period (Weeks 0 to 60), adverse events were reported in 67% of subjects treated with Taltz (1.4 per subject- year of followup) compared to 48% of subjects treated with placebo (2.0 per subject-year of follow-up). Serious adverse events were reported in 3% of subjects treated with Taltz (0.06 per subject-year of follow-up), and in 2% of subjects treated with placebo (0.06 per subject-year of follow-up). Specific Adverse Drug Reactions: Injection Site Reactions The most frequent injection site reactions were erythema and pain. Most injection site reactions were mild-to-moderate in severity and did not lead to discontinuation of Taltz. Infections In the 12-week, placebo-controlled period of the clinical trials in plaque psoriasis, infections occurred in 27% of subjects treated with Taltz (1.2 per subject-year of follow-up) compared to 23% of subjects treated with placebo (1.0 per subject-year of follow-up). Serious infections occurred in 0.4% of subjects treated with Taltz (0.02 per subject-year of follow-up) and in 0.4% of subjects treated with placebo (0.02 per subject-year of follow-up) [see Warnings and Precautions (5.1)]. During the maintenance treatment period (Weeks 13 to 60), infections occurred in 57% of subjects treated with Taltz (0.70 per subject- year of followup) compared to 32% of subjects treated with placebo (0.61 per subject-year of follow-up). Serious infections occurred in 0.9% of subjects treated with Taltz (0.01 per subject-year of follow-up) and none in the subjects treated with placebo. Over the entire treatment period (Weeks 0 to 60), infections were reported in 38% of subjects treated with Taltz (0.83 per subject- year of follow-up) compared to 23% of subjects treated with placebo (1.0 per subject-year of follow-up). Serious infections occurred in 0.7% of subjects treated with Taltz (0.02 per subject-year of follow-up), and in 0.4% of subject treated with placebo (0.02 per subject-year of follow-up). Laboratory Assessment of Cytopenia Neutropenia—Over the entire treatment period (Weeks 0 to 60), neutropenia occurred in 11% of subjects treated with Taltz (0.24 per subject-year of follow-up) compared to 3% of subjects treated with placebo (0.14 per subject-year of followup). In subjects treated with Taltz, the incidence rate of neutropenia during Weeks 13 to 60 was lower than the incidence rate during Weeks 0 to 12. In the 12-week, placebo-controlled period, neutropenia ≥ Grade 3 (<1,000 cells/ mm3) occurred in 0.2% of the Taltz group (0.007 per subject- year of follow-up) compared to 0.1% of the placebo group (0.006 per subject-year of follow-up). The majority of cases of neutropenia were either Grade 2 (2% for Taltz 80 mg Q2W versus 0.3% for placebo; ≥1,000 to <1,500 cells/mm3) or Grade 1 (7% for Taltz 80 mg Q2W versus 3% for placebo; ≥1,500 cells/mm3 to <2,000 cells/ mm3). Neutropenia in the Taltz group was not associated with an increased rate of infection compared to the placebo group. Thrombocytopenia—Ninety eight percent of cases of thrombocytopenia were Grade 1 (3% for Taltz 80 mg Q2W versus 1% for placebo; ≥75,000 cells/mm3 to <150,000 cells/mm3). Thrombocytopenia in subjects treated with Taltz was not associated with an increased rate of bleeding compared to subjects treated with placebo. Taltz® (ixekizumab) injection IX HCP BS 22MAR2016

Active Comparator Trials—In the two clinical trials that included an active comparator, the rate of serious adverse events during weeks zero to twelve was 0.7% for U.S.-approved etanercept and 2% for Taltz 80 mg Q2W, and the rate of discontinuation from adverse events was 0.7% for U.S. approved etanercept and 2% for Taltz 80 mg Q2W. The incidence of infections was 18% for U.S. approved etanercept and 26% for Taltz 80 mg Q2W. The rate of serious infections was 0.3% for both Taltz 80 mg Q2W and U.S. approved etanercept. Immunogenicity—As with all therapeutic proteins there is the potential for immunogenicity with Taltz. By Week 12, approximately 9% of subjects treated with Taltz every 2 weeks developed antibodies to ixekizumab. Approximately 22% of subjects treated with Taltz at the recommended dosing regimen developed antibodies to ixekizumab during the 60-week treatment period. The clinical effects of antibodies to ixekizumab are dependent on the antibody titer; higher antibody titers were associated with decreasing drug concentration and clinical response. Of the subjects who developed antibodies to ixekizumab during the 60-week treatment period, approximately 10%, which equates to 2% of subjects treated with Taltz at the recommended dosing regimen, had antibodies that were classified as neutralizing. Neutralizing antibodies were associated with reduced drug concentrations and loss of efficacy. However, the assay to test for neutralizing antibodies has limitations detecting neutralizing antibodies in the presence of ixekizumab; therefore, the incidence of neutralizing antibodies development could be underestimated. 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 Taltz with the incidences of antibodies to other products may be misleading. DRUG INTERACTIONS Live Vaccinations—Avoid use of live vaccines in patients treated with Taltz (Warnings and Precautions). Cytochrome P450 Substrates—The formation of CYP450 enzymes can be altered by increased levels of certain cytokines (e.g., IL-1, IL-6, IL-10, TNF_, IFN) during chronic inflammation. Thus, Taltz, an antagonist of IL-17A, could normalize the formation of CYP450 enzymes. Therefore, upon initiation or discontinuation of Taltz in patients who are receiving concomitant drugs which are CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for effect (e.g., for warfarin) or drug concentration (e.g., for cyclosporine) and consider dosage modification of the CYP450 substrate. USE IN SPECIFIC POPULATIONS Pregnancy Risk Summary—There are no available data on Taltz use in pregnant women to inform any drug associated risks. Human IgG is known to cross the placental barrier; therefore, Taltz may be transmitted from the mother to the developing fetus. An embryofetal development study conducted in pregnant monkeys at doses up to 19 times the maximum recommended human dose (MRHD) revealed no evidence of harm to the developing fetus. When dosing was continued until parturition, neonatal deaths were observed at 1.9 times the MRHD [see Data]. The clinical significance of these nonclinical findings is unknown. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data—An embryofetal development study was conducted in cynomolgus monkeys administered ixekizumab. No malformations or embryofetal toxicity were observed in fetuses from pregnant monkeys administered ixekizumab weekly by subcutaneous injection during organogenesis to near parturition at doses up to 19 times the MRHD (on a mg/kg basis of 50 mg/kg/week). Ixekizumab crossed the placenta in monkeys. In a pre- and post-natal development toxicity study, pregnant cynomolgus monkeys were administered weekly subcutaneous doses of ixekizumab up to 19 times the MRHD from the beginning of organogenesis to parturition. Neonatal deaths occurred in the offspring of two monkeys administered ixekizumab at 1.9 times the MRHD (on a mg/kg basis of 5 mg/kg/week) and two monkeys administered ixekizumab at 19 times the MRHD (on a mg/kg basis of 50 mg/kg/week). These neonatal deaths were attributed to early delivery, trauma, or congenital defect. The clinical significance of these findings is unknown. No ixekizumab-related effects on functional or Taltz® (ixekizumab) injection IX HCP BS 22MAR2016

immunological development were observed in the infants from birth through 6 months of age. Lactation Risk Summary—There are no data on the presence of ixekizumab in human milk, the effects on the breastfed infant, or the effects on milk production. Ixekizumab was detected in the milk of lactating cynomolgus monkeys. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Taltz and any potential adverse effects on the breastfed infant from Taltz or from the underlying maternal condition Pediatric Use—The safety and effectiveness of Taltz in pediatric patients (<18 years of age) have not been evaluated. Geriatric Use—Of the 4204 psoriasis subjects exposed to Taltz, a total of 301 were 65 years or older, and 36 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 and over is not sufficient to determine whether they respond differently from younger subjects. OVERDOSAGE—In the event of an overdosage, monitor the patient for any signs or symptoms of adverse reactions and institute appropriate symptomatic treatment immediately. PATIENT COUNSELING INFORMATION—Advise the patient/caregiver to read the FDA- approved patient labeling (Medication Guide and Instructions for Use) before the patient starts using Taltz and each time the prescription is renewed, as there may be new information they need to know. Instructions on Self-Administration-Provide guidance to patients and caregivers on proper subcutaneous injection technique, including aseptic technique, and how to use the autoinjector or prefilled syringe correctly (Instructions for Use). Infection: Inform patients that Taltz may lower the ability of their immune system to fight infections. Instruct patients of the importance of communicating any history of infections to the healthcare provider, and contacting their healthcare provider if they develop any symptoms of infection. (Warnings and Precautions). Allergic Reactions: Advise patients to seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions. (Warnings and Precautions). Additional information can be found at www.Taltz.com.

IX HCP BS 22MAR2016

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 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 Travis Hayden, MPAS, PA-C Prof Dev Department Editor Abby Jacobson, MS, PA-C

2016-17 SDPA Board of Directors PRESIDENT Jennifer Conner, MPAS, PA-C PRESIDENT-ELECT Jane Mast, MPAS, PA-C IMMEDIATE PAST PRESIDENT Matthew Brunner, MHS, PA-C VICE PRESIDENT Jacki Kment, MPAS, PA-C SECRETARY / TREASURER Joleen Volz, MPAS, PA-C DIRECTORS AT LARGE Matt Dohlman, MHS, PA-C Gina Mangin, MPAS, PA-C Mark Hyde, MMS, PA-C Archana Sangha, 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 10, Number 4, Fall 2016. 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. © 2016 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.

Journal of Dermatology for Physician Assistants

Editor’s Message

As the holiday season comes and goes, we often reflect on resolutions, goals, and plans of action for the upcoming New Year. This is also a good time to look back and reflect on progress and achievements made in the previous year. When considering the achievements of the SDPA in this past year I am drawn to thinking about the role the Dermatology PA Foundation (DPAF) has naturally taken within our Society. The DPAF and its mission is one that I am proud of, excited about, and truly inspired by. We are so often referred to as the premier specialty Society and that is great. However, I think the addition of the DPAF further propels the SDPA into the forefront of cutting edge societies. The philanthropic and educational projects that the DPAF will focus on and promote highlights the level to which the SDPA values education as well as charitable giving to our patients and other worthy causes. The DPAF inspires me and reminds us that even within a great society there is still room for continued growth in the name of promoting philanthropy. This holds true in our own day-to-day practices. We can be excellent PAs, but there is always room for improvement. In the year ahead I would encourage all of us to find our own “DPAFs” within our clinical settings. Reflect on the excellent patient care you provide: the time, attention, and details you pour into each and every patient encounter. After your reflection, pick an area you wish to focus on that you feel may be able to be improved upon a bit more. Make your practice as a dermatology PA this year even better than the last; I am sure your patients will be eternally grateful for it! J

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

Volume 10 • number 4 • FALL 2016

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.

The Role of the Registry in Dermatologic Disease Burden and Research By Margit Juhász, MSc, Justin Love, PA-C, and Sharon Jacob, MD

›› CME 13 Derm PA News & Notes – part one • Certification Review • SDPA State Affiliates

18 Clinical Dermatology • CME Article – Role of the Registry in Dermatologic Disease Burden and Research

Departments 06 Editorial Board 07 Editor’s Message 10 SDPA News & Current Affairs 13 Dermatology Market Watch 17 DPAF News 23 From The Patient’s Perspective 25 Clinical Snapshots 28 Surgical Wisdom 32 Cosmetic Pearls 37 Notes from your Office Manager 42 AAD Camp Discovery 50 Professional Opportunities and Development

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

31 Cosmetic Dermatology • Journal Club: Practice Changing Articles for Dermatology

37 Professional Development • Outside & Inside the 9 to 5…

40 Derm PA News & Notes – part two

Go Green & Read On the Go 8

Journal of Dermatology for Physician Assistants

• Workplace Excellence • From the Desk of… • Supervising Physician Corner: An Interview with Suneel Chilukuri, MD

dermpa.org

Available Now! The SDPA’s First Ever Interactive Derm PA Resume The perfect resume building tool to assist the aspiring dermatology PA. www.dermpa.org

| 1-800-380-3922 Volume 10 • number 4 • FALL 2016

FROM THE SDPA

News & Current Affairs

CALENDAR OF EVENTS 2017 March 75th AAD Annual Academy Meeting March 3 – 7, 2016 Orlando, FL JUNE SDPA Summer Dermatology Conference June 1 – 4, 2017 Manchester Grand Hyatt San Diego, CA JUNE AAD Summer Meeting July 27 – 30, 2017 New York City, NY NOVEMBER SDPA 15th Annual Fall Dermatology Conference November 8 – 11, 2017 Caribe Hilton San Juan Puerto Rico

Two years ago, the SDPA celebrated its 20th anniversary. We are now in our 22nd year of existence and have experienced exponential growth since the first meeting of SDPA founders over pizza in 1994. Through the tireless efforts of many leaders, we have grown into the largest and most advanced PA specialty organization in the nation. One thing that has remained constant throughout our years of growth and success is the driving factor behind all that we do: our members. We continue to advance the profession through our premiere conference educational programs and are in the midst of developing a robust Diplomate Fellowship program to satisfy the need for standardized training for dermatology PAs. Education is obviously vital to our organization, but is only one part of the vast array of work the SDPA does to empower our members and advance the profession. Your SDPA leaders are consistently working to improve the perception of and opportunities for PAs in the field of dermatology. We provide a voice for issues affecting the PA profession at large, our patients, and legislative issues with potential impact on your ability to practice. The SDPA provides you with publications and communications designed by and for dermatology PAs. Our recently launched Dermatology PA Foundation (DPAF) allows SDPA members to give back to patients and our profession through research, education, and philanthropic endeavors. The overall value of your SDPA membership is immeasurable and I thank you for your dedication to our profession and the patients we serve. When you have the opportunity, please take the time to show your appreciation for current and past SDPA leaders who have given so much to make our organization what it is today. J

Jennifer Conner, MPAS, PA-C SDPA President, Diplomate

10 Journal of Dermatology for Physician Assistants

TREATMENT WITH A WHOLE NEW FORMULATION SERNIVO. A UNIQUE FORMULATION FOR MILD-TO-MODERATE PLAQUE PSORIASIS. • The Sernivo formulation features a new, versatile oil-in-water emulsion1 • Effectively treats extensive moderate plaque psoriasis1 Learn more and register for updates at sernivo.com

INDICATION AND USAGE SERNIVO Spray is indicated for the treatment of mild–to–moderate plaque psoriasis in patients 18 years of age or older. IMPORTANT SAFETY INFORMATION SERNIVO Spray can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. Systemic effects of topical corticosteroids may also manifest as Cushing’s syndrome, hyperglycemia or unmasking of latent diabetes mellitus, and glucosuria. These events are rare and generally occur after prolonged exposure to larger than recommended doses, particularly with high-potency topical corticosteroids. Do not use if atrophy is present at the treatment site. Do not use with occlusive dressings. Avoid use on the face, scalp, axilla, groin or other intertriginous areas. Use of SERNIVO Spray is not recommended in pediatric patients as they are more susceptible to systemic toxicity. Allergic contact dermatitis may occur. The most common adverse reactions (≥ 1%) were application site pruritus, burning and/or stinging, pain, and atrophy. Local reactions and skin atrophy are more likely to occur with occlusive use, prolonged use, or use of higher potency corticosteroids. These are not all the possible side effects of SERNIVO Spray. Please see brief summary of the Full Prescribing Information on the reverse side. To report SUSPECTED SIDE EFFECTS, call Promius Pharma at 1-888-966-8766 or contact the FDA at 1-800-FDA-1088. Reference: 1. Sernivo Prescribing Information. Promius Pharma, LLC. Princeton, NJ. February 2016. Sernivo™ is a trademark of Promius Pharma, LLC. ©2016 Promius Pharma, LLC. All rights reserved.

Volume 10 • number 4 • FALL 2016 11

Minimize the unwanted risks from endocrine effects by mitigating the risk factors favoring increased systemic bioavailability and by using the product as recommended [see Dosage and Administration]. Rx Only BRIEF SUMMARY OF PRESCRIBING INFORMATION INDICATIONS AND USAGE SERNIVO Spray is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. DOSAGE AND ADMINISTRATION Apply SERNIVO Spray to the affected skin areas twice daily and rub in gently. Use SERNIVO Spray for up to 4 weeks of treatment. Treatment beyond 4 weeks is not recommended. Avoid use on the face, scalp, axilla, groin, or other intertriginous areas. SERNIVO Spray is for topical use only. It is not for oral, ophthalmic, or intravaginal use. CONTRAINDICATIONS None. WARNINGS AND PRECAUTIONS Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression and Other Unwanted Systemic Glucocorticoid Effects SERNIVO Spray can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during or after withdrawal of treatment. Factors that predispose to HPA axis suppression include the use of high-potency corticosteroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age. Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test. In a study including 48 evaluable subjects 18 years of age or older with moderate to severe plaque psoriasis, abnormal ACTH stimulation test results suggestive of adrenal suppression were identified in 5 out of 24 (20.8%) subjects after treatment with SERNIVO Spray twice daily for 15 days. No subject (0 out of 24) had abnormal ACTH stimulation test results after treatment with SERNIVO Spray twice daily for 29 days [see Clinical Pharmacology]. If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid. If signs and symptoms of steroid withdrawal occur, supplemental systemic corticosteroids may be required. Systemic effects of topical corticosteroids may also manifest as Cushing’s syndrome, hyperglycemia, and glucosuria. These events are rare and generally occur after prolonged exposure to larger than recommended doses, particularly with high-potency topical corticosteroids.

Pediatric patients may be more susceptible to systemic toxicity due to their larger skin surface to body mass ratios. Use of SERNIVO Spray is not recommended in pediatric patients [see Use in Specific Populations]. Allergic Contact Dermatitis Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation. Corroborate such an observation with appropriate diagnostic patch testing. If irritation develops, discontinue the topical corticosteroid and institute appropriate therapy. 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 clinical practice. In two randomized, multicenter, prospective vehicle-controlled clinical trials, subjects with moderate plaque psoriasis of the body applied SERNIVO Spray or vehicle spray twice daily for 4 weeks. A total of 352 subjects applied SERNIVO Spray and 180 subjects applied vehicle spray. Adverse reactions that occurred in at least 1% of subjects treated with SERNIVO Spray for up to 28 days are presented in Table 1. Table 1: Adverse Reactions Occurring in ≥1% of Subjects Treated with SERNIVO Spray for up to Four Weeks SERNIVO Spray b.i.d. (N=352)

Vehicle Spray b.i.d (N=180)

Application site pruritus

6.0%

9.4%

Application site burning and/or stinging

4.5%

10.0%

Application site pain

2.3%

3.9%

Application site atrophy

1.1%

1.7%

Less common adverse reactions (with occurrence lower than 1% but higher than 0.1%) in subjects treated with SERNIVO spray were application site reactions including telangiectasia, dermatitis, discoloration, folliculitis and skin rash, in addition to dysgeusia and hyperglycemia. These adverse reactions were not observed in subjects treated with vehicle. Postmarketing Experience Because 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.

12 Journal of Dermatology for Physician Assistants

Postmarketing reports for local adverse reactions to topical corticosteroids have also included striae, irritation, dryness, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, hypertrichosis, and miliaria. USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. SERNIVO Spray should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Betamethasone dipropionate has been shown to be teratogenic in rabbits when given by the intramuscular route at doses of 0.05 mg/kg. The abnormalities observed included umbilical hernias, cephalocele, and cleft palate. Nursing Mothers Systemically administered corticosteroids appear in human milk and can suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids can result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when SERNIVO Spray is administered to a nursing woman. Pediatric Use Safety and effectiveness of SERNIVO Spray in patients younger than 18 years of age have not been studied; therefore use in pediatric patients is not recommended. Because of a higher ratio of skin surface area to body mass, pediatric patients are at greater risk of systemic toxicity, including HPA axis suppression and adrenal insufficiency, when treated with topical drugs. [see Warnings and Precautions] Rare systemic effects such as Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients, especially those with prolonged exposure to large doses of high potency topical corticosteroids. Local adverse reactions including skin atrophy have also been reported with use of topical corticosteroids in pediatric patients. Geriatric Use Clinical studies of SERNIVO Spray did not include sufficient numbers of subjects who were 65 years of age or older to determine whether they respond differently from younger subjects.

Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215 Distributed by: Promius Pharma, LLC., Princeton, NJ 08540 Sernivo is a trademark of Promius Pharma, LLC. Issued: 02/2016

Dermatology PA news & notes

Dermatology Market Watch

Changes to the iPLEDGE Non-Compliance Action Policy On November 1, 2016 the iPLEDGE Program Non-Compliance Action Policy (NCAP) went into effect for the iPLEDGE Program in order to strengthen the Program’s ongoing non-compliance efforts. The NCAP is consistently re-evaluated, and several changes have been made based on lessons learned since the NCAP was implemented. The changes are highlighted here and the full document is available online at www.ipledgeprogram.com/documents/NonCompliance%20Action%20Policy.pdf. Version 7 of the NCAP includes changes to Section 9, Table 2 (additions and modifications to typical stakeholder Non-Compliance activities): Prescriber Warning • Section 9.A.2.xii. Prescriber’s designee performed activities in the iPLEDGE Program system that indicate lack of training and/or supervision (at the sponsors’ discretion repeated acts of Non-Compliance will result in Permanent Deactivation). Permanent Deactivation • Section 9.A.4.viii. Repeated acts of NonCompliance where prescriber’s designee(s) performed activities in the iPLEDGE Program system that indicate systemic lack of training and/ or supervision. • Section 9.A.4.ix. Prescriber fails to implement Corrective Action or the iPLEDGE Program sponsors determine that no future program compliance can be expected (e.g., refusal to provide requested documentation for an investigation). Designee Permanent Deactivation • Section 9.B.4.vi. Designee fails to implement Corrective Action or the iPLEDGE Program

sponsors determine that no future program compliance can be expected (e.g., refusal to provide requested documentation for an investigation). Pharmacy Permanent Deactivation • Section 9.C.4.vii. Pharmacy fails to imple– ment Corrective Action or the iPLEDGE Program sponsors determine that no future program compliance can be expected (e.g., refusal to provide requested documentation for an investigation). Wholesaler Permanent Deactivation • Section 9.D.2.viii. Wholesaler fails to implement Corrective Action or the iPLEDGE Program sponsors determine that no future program compliance can be expected (e.g., refusal to provide requested documentation for an investigation). In summary, remember, the iPLEDGE Risk Evaluation Mitigation Strategy (REMS) Program designed to support the public health goals that no woman who is already pregnant will initiate isotretinoin therapy and that no woman will become pregnant while on isotretinoin therapy for one month prior to, during, and for thirty days after the course of treatment. Compliance with the requirements of the iPLEDGE Program is necessary to achieve this public health goal, and potential fetal exposure is paramount when considering actions taken against a non-compliant stakeholder in the iPLEDGE Program. Any questions about the non-compliance policy or iPLEDGE in general can be directed to the ipledge program at 1-866-495-0654 or to Abby Jacobson, MS, PA-C at AbbyJPA@gmail.com or (215) 681-0672. J ...continued on page 14 Volume 10 • number 4 • FALL 2016 13

Dermatology Market Watch ...continued from page 13 Free CME from the National Psoriasis Foundation

Mental Health Considerations

Released Wednesday, November 30, 2016

Biosimilar Updates

Released Thursday, December 8, 2016

Updates in Pediatric Psoriasis The National Psoriasis Foundation (NPF) has recently released new CME webinars at no cost to you. Dermatology PAs can access any of the five new CME webinars offered by the NPF and earn up to 1.0 AMA PRA Category 1 Credit(s)TM per webinar. If you were unable to attend a webinar during the specified time - donâ&#x20AC;&#x2122;t worry, we record it! All webinars will be posted for a period of two years following its live session, and you will still be eligible to earn 1.0 AMA PRA Category 1 Credit(s) TM per webinar. Please access all webinar registrations and program information at https://cme.psoriasis.org/courses. J

Phototherapy and Psoriasis

Scheduled for Tuesday, January 10, 2017 8:30 a.m. Pacific / 10:30 a.m. Central / 11:30 a.m. Eastern

Navigating Insurance

Scheduled for Tuesday, January 17, 2017 8:30 a.m. Pacific / 10:30 a.m. Central / 11:30 a.m. Eastern

Certification Review

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

Are you recertifying soon? Start your board review early. Each issue of the JDPA features one board question accompanied by a brief explanation of the answer along with any pertinent test taking tips. Best of luck! QUESTION: A 20-year-old male presents with an ulcer on the shaft of his penis. The patient states he had a new sexual contact about two weeks ago. On physical examination, a painless, 1-2 centimeter ulcer, with raised indurated margins, is noted on the anterior aspect of the shaft of his penis. Bilateral inguinal lymphadenopathy is noted. Which of the following is the diagnostic test of choice for this patient? A. Wet prep for trichomoniasis B. PCR test for Haemophilus ducreyi C. DNA probe for Neisseria gonorrhoeae D. Treponema pallidum enzyme immunoassay E. Nucleic acid amplification for Chlamydia trachomatis EXPLANATION: This patient presents with the classic presentation of primary syphilis, which is secondary to infection with Treponema pallidum. Screening for syphilis is routinely accomplished with non-treponemal tests, such as the RPR (Rapid Plasma Reagin). The diagnosis is confirmed with the use of a treponemal test, such as T. pallidum enzyme immunoassay. Haemophilus ducreyi 14 Journal of Dermatology for Physician Assistants

causes chancroid, which presents with a painful ulceration. Diagnosis is made with PCR testing. Neisseria gonorrhoeae presents with profuse urethral discharge and diagnosed via Gram stain, culture, or nucleic acid amplification testing. Trichomoniasis presentation is typically asymptomatic and diagnosis is made by wet examination of urethral secretions. Chlamydia trachomatis presents with watery urethral discharge and is diagnosed by nucleic acid amplification testing. J The correct answer is D.

DERmatology pa news & notes

Released Monday, December 12, 2016

James A. Van Rhee, MS, PA-C, is the Program Director for the Yale University School of Medicine Physician Assistant Program. Mr. Van Rhee has been involved in physician assistant education for over 20 years. He has served as project director and test item writer for the Physician Assistant Education Associationâ&#x20AC;&#x2122;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 pa news & notes Volume 10 • number 4 • FALL 2016 15

SDPA State Affiliates

Vegas Baby! SDPA 14th Annual Fall Dermatology Conference Review

DERmatology pa news & notes

One thing’s for sure… all of the learning that took place at this year’s Fall conference is definitely not staying in Vegas. The SDPA’s 14th Annual Fall Dermatology Conference was held November 2 – 6, 2016 at the exciting Caesars Palace in Las Vegas, Nevada. The conference kicked off with the “Fundamentals of Dermatologic Surgery: A Progressive Approach from Basic to Advanced Skills” pre-conference program on Wednesday, November 2nd. This program was attended by over one-hundred individuals, and was led by Lisa Chipps, MD and David Carr, MD. That evening, Taro Pharmaceuticals sponsored a fun and entertaining official Arrival Reception for attendees. For the next three and half days, the conference was packed-full of the latest tips and tricks, case studies, new pearls, professional development, and activities designed to connect attendees with colleagues from across the country. Topics ranged from “Surgical Anatomy” to “Wound Healing and Scar Management,” to “Acne, Rosacea: Trends, Updates and Strategies” to “Dermatoses of Pregnancy.” Each session was led by leading physicians, PAs, and thought-leaders within the field of dermatology. In addition to the Arrival Reception, other exciting activities included the “Viva Las Vegas! Welcome Event,” sponsored in part by Amgen, which included live music and a visit by two authentic Vegas show girls and Elvis as well as the VIP Reception at the famed Mob Museum. Saturday morning included the 5th Annual Miles for Melanoma 5k Run/Walk in which thirty-four dedicated conference attendees got up very early Saturday morning to participate. Several sessions were highlighted in conference “Live Blogs,” and in the daily recap emails, one of which is reprinted in this issue’s Clinical Dermatology section. All of the conference “Live Blogs” are available on Dermcast.TV; be sure to check them out, and make plans now to join us for next year’s conferences! The Summer 2017 conference will be held in San Diego, California and the Fall conference will be held in San Juan, Puerto Rico. The SDPAconferences.org website will be updated regularly with the latest information, so check back often and keep an eye out for email announcements in your inbox. If you were not able to attend the Fall conference, don’t worry… you can purchase conference CME packages through the SDPA’s Learning Center! (Please note, you must log-in to view the content; if you have trouble logging-in, please contact admin@dermpa.org). J 16 Journal of Dermatology for Physician Assistants

The Dermatology PA Foundation (DPAF) is the philanthropic arm of the SDPA. In our inaugural year, we have been able to accomplish and support our community of dermatology PAs and our patients. We've made amazing strides in our first year, but we don't plan on stopping here. As we look ahead to 2017 and plan our future programs and missions, you can still help to support us with a year-end contribution. We are asking you, our SDPA community members, to each contribute $10 towards the DPAF. This is your Foundation and even a small contribution of $10 can help us to support the charitable goals of dermatology PAs and improve the lives of our patients. This year, through our Miles for Melanoma program, race participants walked/ran to raise funds to contribute to the Melanoma Research Foundation's (MRF) goal to find a cure for melanoma. Due to the importance of this issue to our constituents, the DPAF will contribute $7,500 towards MRF regardless of our runners and walkers not meeting our match. In hosting our first ever DPAF Silent Auction, we raised over $9,000 towards our

$20,000 fundraising goal to send children with serious skin disease to summer camp and dermatology PAs to staff the camps as volunteers. The DPAF will contribute the remaining funds to meet our $20,000 contribution promise. This year we will be supporting Camp Wonder in California. Camp Wonder takes in children who are often considered too ill for other specialized summer camps and require around the clock care. In Austin, Texas during the SDPA's Annual Summer Dermatology Conference in June we raised over $18,000 and added 18 new Founding Circle Donors towards the DPAF's mission and goals. During the summer of 2016 we had two new corporate supporters join us in our mission to better the lives of dermatology patients and further the philanthropic goals of the Foundation. In 2017 we plan to begin exploring possibilities for expanding our programs into new arenas such as research and educational scholarships, providing education content and sessions, and more. If each SDPA member contributes just $10 before the end of the year, we could raise over $27,000 to put towards our programs! J

Volume 10 â&#x20AC;˘ number 4 â&#x20AC;˘ FALL 2016 17

DERmatology pa news & notes

Help the DPAF Reach Our Year End Goal!

Clinic al Dermatology

The Role of the Registry in Dermatologic Disease Burden and Research By Margit Juhász, MSc, Justin Love, PA-C, and Sharon Jacob, MD

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

›› CME

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

Approval is valid for 1 year from the issue date of December 2016. Participants may submit the selfassessment 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:

• Understand the multifactorial nature of the so-called “burden” of dermatologic disease on the medical community. • Describe the advantages of the registry system in research methodology. • Outline the role of the registry in current dermatologic research. 18 Journal of Dermatology for Physician Assistants

The Role of the Registry in Dermatologic Disease Burden and Research

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 10 â&#x20AC;˘ number 4 â&#x20AC;˘ FALL 2016 19

The Role of the Registry in Dermatologic Disease Burden and Research

SDPA Members Only Content

CLINIC AL Dermatology

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

20 Journal of Dermatology for Physician Assistants

The Role of the Registry in Dermatologic Disease Burden and Research

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 10 â&#x20AC;˘ number 4 â&#x20AC;˘ FALL 2016 21

The Role of the Registry in Dermatologic Disease Burden and Research

CLINIC AL Dermatology

Margit Juhász is a recent MD graduate from the Icahn School of Medicine at Mount Sinai in Manhattan, NY and is currently a preliminary internal medicine resident at St. Mary Medical Center – UCLA in Long Beach, CA. She has indicated no relationships to disclose relating to the content of this article. Justin Love, PA-C works at the Loma Linda University, Department of Dermatology. He has indicated no relationships to disclose relating to the content of this article. Sharon Jacob, MD, is a Professor of Dermatology at the Loma Linda University School of Medicine, Department of Dermatology. She has indicated no relationships to disclose relating to the content of this article.

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 22 Journal of Dermatology for Physician Assistants

From The Patient’s Perspective Oliver’s Story By Lisa W.

Society for Pediatric Dermatology Contact Information: www.pedsderm.net 8365 Keystone Crossing, Suite 107, Indianapolis, IN 46240 Email: info@pedsderm.net Phone: (317) 202-0224 Allergens causing clinically relevant allergic contact dermatitis in adults in the US are important in children as well. Notably, there is a significant lack of published studies performed on US children. That is why the Society for Pediatric Dermatology is supporting the Loma Linda University launch of its "Pediatric Contact Dermatitis Registry" initiative, which has two specific components: 1) A brief 'click through' provider registry/survey, which records the demographics of the clinical provider offering patch test services to children, available at: http://lomalindahealth.org/medical-center/ourservices/dermatology/for-health-care-professionals/ practitioner-database-registration-form.page 2) An entirely optional case log component, which any registered provider can voluntarily record his/her cases on a provided short reporting form into the database. The purpose of collecting this data is to: • Increase the number of verified cases of contact dermatitis in children ages 0-18 years in the US.  • Promote awareness of contact dermatitis in pediatric populations. • Shed light on the demographics of providers offering pediatric patch test services. • Help to highlight regional disparities in access to patch test care and evaluation for children. Accurately representing the key role of PAs involved with providing patch testing services is paramount. Please help and take the brief survey today. Thank you.

Corn is in almost everything (food, health/ beauty aids, adhesives, preservatives, etc.) or used in the packaging of many things. As an example, the plastic coating on cheese is often dusted with corn starch to keep cheese from sticking to the plastic. Since Oliver reacts differently to pure corn and its 110+ names (preservatives/derivatives), we blamed all skin/eczema issues on corn for the first 3-4 years of his life. Granted, corn allergy was still rare 10 years ago and is still not a common food allergy, though it is gaining momentum quickly. Getting the corn allergy diagnosis was difficult enough without adding contact dermatitis to his on-going list of medical concerns. Our first allergist kept saying he only had eczema because “textbook” hives don’t manifest with any of Oliver’s food allergies unless he eats/touches pure corn meal. His corn rashes were simply odd. We finally found one of only three allergists in the St. Louis, Missouri area with experience in corn allergy, allowing us to move on to deciphering numerous skin issues which didn’t go away after removing hidden corn from his diet/personal care items. The learning curve was tremendous. It took almost 3 years because corn is used literally everywhere. Gradually, we slowly learned all Oliver’s corn exposure variations. Some derivatives only cause a certain type of rash. Some make him hurt all over, in addition to showing the rash. Some cause severe itching but no rash. Some cause full-blown hives. Some cause blisters upon contact. Some are GI/intestinal/skin-rash all at once. He never had “textbook” eczema, for which I’m grateful, though it would have made things easier for diagnosing purposes. Again, the reason I provide so much food-allergy information above is because many food-allergic children also have skin problems. However, many kids with eczema can eat anything with no skin manifestations, thus giving rise to much confusion and frustration. There is a great deal of misinformation available referencing the overlap of food Volume 10 • number 4 • FALL 2016 23

CLINIC AL Dermatology

The Society for Pediatric Dermatology’s (SPD) objective is to promote, develop, and advance education, research, and care of skin disease in all pediatric age groups. The organization holds meetings twice a year to educate physicians about advances in pediatric dermatology, help them support children with dermatological diseases, and improve the care of these children.

My name is Lisa. As a sufferer of contact dermatitis (triggers still unknown) and the mother of a child with contact dermatitis (confirmed by patch testing), I’m a strong proponent of thorough, accurate patch testing available to all. First, as a preface, my 9 year-old son (Oliver), is allergic to corn by both ingestion and upon contact. He has been since birth, though the contact part began later at age three and a half. I feel it necessary to mention, in addition to and in reference to the discussion of contact dermatitis, because many food-allergic children also have contact dermatitis and eczema problems. Additionally, the corn allergy has and still makes deciphering his skin issues complicated.

test results were given to me, I remember being shocked it was only six positive patches. Why weren’t there more to Our problem is some of these weird rashes were on explain all of his strange rashes? Then I read where those Oliver’s face, hands, and bottom. Some of these were six occur - nickel is very common. However, he wore active noticeable and led to other kids teasing or asking about pants most days instead of jeans, thus we rarely saw rashes his face and hands. Or that low on his torso. it hurt, as was the Then I learned the two case with his bottom, “In retrospect, we both think his face was glucosides are common whenever it touched a in almost every soap/ struggling to heal because we were constantly toilet seat. The raised s h a m p o o /p e r s o n a l rash that itched on care product I had in putting his allergens on it three times a day.” his bottom would my home. The two often burn, and it was parabens are common always where the ring in many lotions, even the lotion our dermatologist had of the toilet seat touched his skin. What pushed us over prescribed for us to use on his face while it was so dry/ the edge was at age 8 (March of 2015), Oliver developed cracked from the perioral dermatitis occurrence/treatment perioral dermatitis on his face. This condition is unusual period. She felt horrible about that, as it had to have slowed except in 20 year-old-ish girls or pre-pubescent boys (with the healing process, possibly even exacerbating the problem. or without other skin issues). The usual medications didn’t In retrospect, we both think his face was struggling to heal help though. Certain medications actually made it worse. because we were constantly putting his allergens on it three Others made it burn, dry, or crack. Nothing made sense or times a day. cleared it completely for months.

CLINIC AL Dermatology

allergy and contact dermatitis.

We finally got lucky with a third attempted antibiotic, plus two topical medications, though it was still a very slow process of healing. However, we are lucky enough our dermatologist is located in one of only two to three practices in St. Louis to offer detailed patch testing. Once we cleared Oliver’s face (a process taking 4 months, forcing him to go to school regardless of how bad it looked), our dermatologist and I agreed he’d had too many strange rashes to keep thinking that everything was corn-related. She also thought he’d dealt with enough in his young life and wanted him to avoid more heartache, as she was suspecting more would pop up if we didn’t investigate further. Luckily, during this mess, Oliver had a long virus & missed seven days of school. While out of school, his dry, cracked hands (which had come and went all winter) healed completely. However, after just one day back at school the redness, dryness, and burning returned. This told me the school soap had to be a trigger. His dermatologist already knew about his hand problem from one of our two-week checkups for his perioral dermatitis treatment, so we immediately scheduled patch testing, knowing we had another piece of his personal skin puzzle. I do not have the chemical names of all six allergens he tested positive to, but two of them are in the glucoside family, and two of them are in the paraben group. He also is allergic to two metals: nickel and copper. At the time the

Fast forward one month. We switched all products to those known to be allergen-free for Oliver. He took his own soap to school in a pocket each day. He used his own soap at home, and we even cleaned his bathroom with safe products that wouldn’t irritate his bottom. We have a strict rule in our house now about what to use to clean toilet seats! After all this was done, our dermatologist said Oliver changed the way she views contact dermatitis and eczema, especially non-textbook, strange manifestations of eczema. She said part of the problem is there are 200+ rashes considered “eczema.” It’s not just one thing and it is often a “catch-all” term for the unknown rashes.

Therefore, she now thinks every child with any atopy (allergy) issues and combined skin problems of any sort, or contact dermatitis, and/or even “textbook” eczema (because of the food allergy overlap) should be patch tested to see if the products being used to supposedly treat the skin are actually making it worse. Even if there is no history of food allergy or contact allergy, she thinks patch testing could provide knowledge of skin allergens parents would have no way of knowing might be making matters worse. This tailors the treatment to each child’s personal skin/atopy profile. It’s very likely some day-to-day products could be causing the weird rashes that aren’t consistent between children, as skin problems are extremely individual. In summary, thorough patch testing could provide answers many of us have been seeking for years. J

Reprinted with permission from Dermatitis Academy. Lisa W. (mother to 9 year-old Oliver) had originally posted this blog on the Dermatitis Academy Blog on March 27, 2016 in the Parents Speak Out About Allergic Contact Dermatitis (ACD) section. Parents Speak Out About Allergic Contact Dermatitis (ACD) is a special category in the Dermatitis Academy Blog where passionate parents reveal a personal look into their family’s journey in dealing with allergic contact dermatitis and the important role that patch testing has in helping to manage this condition. Please visit the Dermatitis Academy home page at www.dermatitisacademy.com for more information on allergic contact dermatitis and patch testing. Please also consider sharing this blog post in order to help create awareness for this seldom considered, but highly relevant disease process. 24 Journal of Dermatology for Physician Assistants

Clinical snapshots Dermcast.tv Live Blog from the SDPA 14th Annual Fall Dermatology Conference Shifting the Paradigm of Actinic Keratoses By Sarah Patton, MSHS, 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.

SDPA 14th Annual Fall Dermatology Conference Live Blog Dermcast.tv Live Blog Post: November 6, 2016 If you were not able to attend Dr. Martin’s “Shifting the Paradigm of Actinic Keratoses” presentation at the Fall conference, don’t worry… you can now purchase conference CME packages through the SDPA’s Learning Center (please note, you must log-in to view the content; if you have trouble logging-in, please contact admin@dermpa.org). More SDPA 14th Annual Fall Dermatology Conference Live Blogs, as well as the weekly Dermcast.tv blogs, are available at Dermcast.tv.

Volume 10 • number 4 • FALL 2016 25

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

Dysplastic Nevi with Severe Atypia: Long-term Outcomes in Patients With and Without Re-excision J Am Acad Dermatol. 2016 Nov 9 [Epub ahead of print]. Engeln K1, Peters K 2, Ho J3, Jedrych J3, Winger D4, Ferris LK 2, Patton T5 Scripps Mercy Hospital, Pittsburgh, Pennsylvania. Department of Dermatology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. 3 Department of Dermatopathology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. 4 Clinical and Translational Science Institute, Pittsburgh, Pennsylvania. 5 Department of Dermatology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. 1 2

26 Journal of Dermatology for Physician Assistants

GOING 80 MPH DOWNHILL -

EXTREME? NOT WEARING SUNSCREEN,

NOW THAT’S CRAZY

I’m Julia Mancuso, Olympic medalist and professional skier, and I apply sunscreen every day. I’m wearing orange to help put a spotlight on skin cancer.

Did you know snow reflects and intensifies the damaging rays of the sun? Sun exposure is the most preventable risk factor for skin cancer. To protect your skin apply sunscreen, seek shade, and wear protective clothing. Visit SpotSkinCancer.org.

SURGICAL wisdom FDA Finalizes a Rule to Ban Powdered Gloves in Medicine By J. Margaret Casey

SDPA Members Only Content

Image: Wikimedia Commons

SURGIC AL Dermatology

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

J. Margaret Casey is a freelance writer for the JDPA. She has indicated no relationships to disclose relating to the content of this article.

28 Journal of Dermatology for Physician Assistants

CLASS 1 STRENGTH WITH A WELL-TOLERATED SPRAY FORMULATION1,2 Topicort® Topical Spray is a topical corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age or older. Important Safety Information • Topicort® Topical Spray is a topical corticosteroid that has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis. • Systemic absorption of topical corticosteroids can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid. • Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression.

• Local adverse reactions may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Reactions may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. Some local reactions may be irreversible. • Safety and effectiveness of Topicort® Topical Spray in patients younger than 18 years of age have not been studied; therefore use in pediatric patients is not recommended.

References: 1. National Psoriasis Foundation. Topical Steroids Potency Chart. https://www.psoriasis.org/sublearn03_mild_ potency. Accessed on 9/1/15. 2. Topicort® Topical Spray Prescribing Information. Taro Pharmaceuticals U.S.A., Inc. See brief summary of Prescribing Information on reverse side. © 2016 Taro Pharmaceuticals U.S.A., Inc. TaroPharma® and Topicort® are registered trademarks of Taro Pharmaceuticals U.S.A., Inc. AD1000047M August 2016

Volume 10 • number 4 • FALL 2016 29

TOPICORT® (desoximetasone) Topical Spray, 0.25% Rx Only

Table 1. Number (%) of Subjects with Adverse Reactions Occurring in ≥ 1% Topicort® Topical Spray, 0.25% b.i.d. (N = 149)

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

Number of Subjects with Adverse Reactions

13 (8.7%)

18 (13.3%)

4 CONTRAINDICATIONS None

Application site dryness

4 (2.7%)

7 (5.2%)

Application site irritation

4 (2.7%)

5 (3.7%)

5 WARNINGS AND PRECAUTIONS 5.1 Effect on Endocrine System Topicort® Topical Spray is a topical corticosteroid that has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis.

Application site pruritus

3 (2.0%)

5 (3.7%)

BRIEF SUMMARY 1 INDICATIONS AND USAGE Topicort® Topical Spray is a corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age or older.

Systemic absorption of topical corticosteroids can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid.

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Teratogenic Effects: Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. Topicort® Topical Spray should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

In a study including 21 evaluable subjects 18 years of age or older with moderate to severe plaque psoriasis, adrenal suppression was identified in 1 out of 12 subjects having involvement of 10-15% of body surface area (BSA) and 2 out of 9 subjects having involvement of >15% of BSA after treatment with Topicort® Topical Spray twice a day for 28 days. [see Clinical Pharmacology (12.2)]

Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels.

Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of high potency steroids, larger treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure and young age.

8.3 Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Because many drugs are excreted in human milk, caution should be exercised when Topicort® Topical Spray is administered to a nursing woman.

An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression. If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids. Cushing’s syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids. Use of more than one corticosteroid-containing product at the same time may increase the total systemic corticosteroid exposure. Pediatric patients may be more susceptible to systemic toxicity from use of topical corticosteroids. [see Use in Specific Populations (8.4)] 5.2 Local Adverse Reactions with Topical Corticosteroids Local adverse reactions may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Reactions may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. Some local adverse reactions may be irreversible. 5.3 Allergic Contact Dermatitis with Topical Corticosteroids Allergic contact dermatitis to any component of topical corticosteroids is usually diagnosed by a failure to heal rather than a clinical exacerbation. Clinical diagnosis of allergic contact dermatitis can be confirmed by patch testing. 5.4 Concomitant Skin Infections Concomitant skin infections should be treated with an appropriate antimicrobial agent. If the infection persists, Topicort® Topical Spray should be discontinued until the infection has been adequately treated. 5.5 Flammable Contents Topicort® Topical Spray is flammable; keep away from heat or flame. ADVERSE REACTIONS 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In randomized, multicenter, prospective vehicle-controlled clinical trials, subjects with moderate to severe plaque psoriasis of the body applied Topicort® Topical Spray or vehicle spray twice daily for 4 weeks. A total of 149 subjects applied Topicort® Topical Spray. Adverse reactions that occurred in ≥ 1% of subjects treated with Topicort® Topical Spray were application site dryness (2.7%), application site irritation (2.7%) and application site pruritus (2.0%). Another less common adverse reaction (<1% but >0.1%) was folliculitis.

Desoximetasone has been shown to be teratogenic and embryotoxic in mice, rats, and rabbits when given by subcutaneous or dermal routes of administration at doses 3 to 30 times the human dose of Topicort® Topical Spray based on a body surface area comparison.

If used during lactation, Topicort® Topical Spray should not be applied on the chest to avoid accidental ingestion by the infant. 8.4 Pediatric Use Safety and effectiveness of Topicort® Topical Spray in patients younger than 18 years of age have not been studied; therefore use in pediatric patients is not recommended. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing’s syndrome when they are treated with topical corticosteroids. They are therefore at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children. [see Warnings and Precautions (5.1)] HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. [see Warnings and Precautions (5.1)] 8.5 Geriatric Use Clinical studies of Topicort® Topical Spray did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. 10 OVERDOSAGE Topicort® Topical Spray can be absorbed in sufficient amounts to produce systemic effects. [see Warnings and Precautions (5.1)] 17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information and Instructions for Use) Inform patients of the following: • Use this medication as directed by the physician. • Topicort® Topical Spray is for external use only. Avoid use on the face, axilla or groin. • Do not use this medication for any disorder other than that for which it was prescribed. • Do not bandage or otherwise cover or wrap the treated skin so as to be occlusive. • Report any signs of local or systemic adverse reactions to the physician. • Do not use other corticosteroid-containing products with Topicort® Topical Spray without first consulting with the physician. • Discontinue therapy when control is achieved. If no improvement is seen within 4 weeks, contact the physician. • This medication is flammable; avoid heat, flame, or smoking when applying this product. • Discard this product 30 days after dispensed by pharmacist. Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1 Dist. by: TaroPharma® a division of Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532 Revised: April 2013 AD100-0030

30 Journal of Dermatology for Physician Assistants

COSMETIC Dermatology Journal Club: Practice Changing Articles for Dermatology PAs Laser Treatment for Darker Skin: Best Practices and Tips Dermcast.tv Blog By Martha L. Sikes, MS, RPh, PA-C

Image: Dermnet New Zealand

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. From Dermcast.tv Blog Post: November 21, 2016 Source: Cutis Adapted from the original article. 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 blogs and/or to follow the next live blog from the next SDPA dermatology conference, please visit the Dermcast.tv website at www.dermcast.tv.

Volume 10 â&#x20AC;˘ number 4 â&#x20AC;˘ FALL 2016 31

Cosmetic pearls Hair Loss After Having A Baby: What To Expect 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 “Hair Loss in New Moms,” a video posted to the AAD website and YouTube channel. This video is part of the AAD’s “Video of the Month” series, which offers tips people can use to properly care for their skin, hair, and nails. A new video in the series posts to the AAD website and YouTube channel each month.

Reprinted with permission from the American Academy of Dermatology

32 Journal of Dermatology for Physician Assistants

ADVERTORIAL

PERSPECTIVES ON OTEZLA® (apremilast) IS YOUR PATIENT READY FOR SYSTEMICS? An oral, non-biologic option for patients with moderate to severe plaque psoriasis INDICATIONS Otezla® (apremilast) 30-mg tablets is indicated for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Otezla is also indicated for the treatment of adult patients with active psoriatic arthritis.

DESPITE VARIOUS OPTIONS AVAILABLE TO TREAT MODERATE TO SEVERE PLAQUE PSORIASIS, MANY PATIENTS REMAIN UNTREATED OR UNDERTREATED1,a According to the Multinational Assessment of Psoriasis and Psoriatic Arthritis, or MAPP, survey—a large, population- and telephone-based survey, more than 87% of patients with moderate or severe psoriasis received no treatment or topical therapy alone.1,a Although physicians note concerns with topical treatment, many patients and healthcare providers hesitate to move to systemic therapy.1,2 A need exists for additional systemic treatments for patients with plaque psoriasis.2 “The moderate patients have too often been left out; they need more than topicals, but some patients may be unwilling to change to certain conventional systemics or biologics.”

— Ronald B. Prussick, MD, FRCPC; Rockville, MD*

a The Multinational Assessment of Psoriasis and Psoriatic Arthritis survey is the first multinational, large-scale probability survey of psoriasis and psoriatic arthritis based on national samplings of households in North America and Europe. A total of 3426 patients and 781 physicians completed the survey via telephone in 2012.1

OTEZLA IS AN ORAL, NON-BIOLOGIC TREATMENT3 Otezla is the first FDA-approved oral option in over 15 years indicated for patients with moderate to severe plaque psoriasis.3-6 Otezla works differently from other systemic medications.3 Both extracellular and intracellular inflammatory pathways may be targeted to modulate inflammation in patients with psoriasis.7-9 Inflammatory cytokines, including tumor necrosis factor–α (TNF-α) and interleukin (IL)-12/23 and -17, are examples of extracellular molecules targeted by biologics, or injectable, therapies.7,10-12 Phosphodiesterase 4 (PDE4) is an intracellular target that exerts its effects early in the inflammatory cascade by degrading cyclic adenosine monophosphate (cAMP) into AMP and lowering concentrations of intracellular cAMP (Figure 1).8,13 Based on preclinical data, when intracellular cAMP concentration is low, inflammatory signaling is increased.13 Conversely, when intracellular cAMP concentration is high, inflammatory signaling is dampened. Therefore, it is thought that cAMP signaling, as mediated through PDE4, balances the immune system by modulating the production of both pro- and anti-inflammatory mediators.13

Intracellular Pathways

Extracellular Pathways

PDE4 degrades cAMP to AMP

Target

cAMP

cAMP cAMP

TNF-

IL-12/23

Target

PDE4 AMP

IL-17

AMP

Inflammatory Cell

AMP

Inflammatory Cell

Target

cAMP signaling is thought to balance the immune system via the production of inflammatory mediators

Visual representation based on preclinical data. Figure 1: Both extracellular and intracellular inflammatory pathways may be targeted to modulate inflammation associated with psoriasis.7-9 Based on preclinical evidence, PDE4 is an intracellular target that affects the levels of cAMP in a cell, which is thought to indirectly impact the production of inflammatory mediators.8,9,13

Otezla is an oral, non-biologic PDE4 inhibitor.3,8,9 Based on preclinical evidence, Otezla works intracellularly, has anti-inflammatory properties, and is thought to indirectly modulate production of both pro- and anti-inflammatory mediators through its effect on cAMP concentrations and signaling (Figure 2).8,9 The specific mechanism by which Otezla exerts its therapeutic action is not well defined.3 Apremilast PDE4

Inhibits

Apremilast

cAMP

cAMP PDE4 AMP PDE4 AMP

AMP

Inflammatory Cell Visual representation based on preclinical data. Figure 2: Otezla inhibits intracellular PDE4, resulting in increased levels of cAMP.3,8,9

*Serves as a consultant to Celgene.

IMPORTANT SAFETY INFORMATION Contraindications Otezla® (apremilast) is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation. Warnings and Precautions Depression: Carefully weigh the risks and benefits of treatment with Otezla for patients with a history of depression and/or suicidal thoughts/behavior, or in patients who develop such symptoms while on Otezla. Patients, caregivers, and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes, and they should contact their healthcare provider if such changes occur. Treatment with Otezla is associated with an increase in adverse reactions of depression. During clinical trials, 1.3% (12/920) of patients treated with Otezla reported depression compared to 0.4% (2/506) on placebo; 0.1% (1/1308) of Otezla patients discontinued treatment due to depression compared with none on placebo (0/506). Depression was reported as serious in 0.1% (1/1308) of patients exposed to Otezla, compared to none in placebo-treated patients (0/506). Suicidal behavior was observed in 0.1% (1/1308) of patients on Otezla, compared to 0.2% (1/506) on placebo. One patient treated with Otezla attempted suicide; one patient on placebo committed suicide. Please see Important Safety Information presented throughout and Brief Summary of Full Prescribing Information on adjacent page.

Volume 10 • number 4 • FALL 2016 33

ADVERTORIAL

Otezla was evaluated in 2 multicenter, double-blind, placebo-controlled trials of similar design (ESTEEM 1 and 2). Patients with moderate to severe plaque psoriasis (N=1257) were randomized 2:1 to Otezla 30 mg twice daily or placebo for 16 weeks after a 5-day titration.3,14,15 At Week 16, all patients originally assigned to placebo were transitioned to receive Otezla 30 mg twice daily (BID). At Week 32, some patients originally randomized to the Otezla arm were, based on clinical response, re-randomized to receive Otezla 30 mg twice daily or placebo; those re-randomized to placebo restarted Otezla 30 mg twice daily at loss of response, but no later than Week 52. Select inclusion criteria were: age ≥18 years, body surface area (BSA) involvement ≥10%, static Physician Global Assessment (sPGA) ≥3, Psoriasis Area Severity Index (PASI) score ≥12, and candidates for phototherapy or systemic therapy. The primary endpoint was the proportion of patients achieving PASI-75 at Week 16. Patients entering the long-term extension phase could be treated through 5 years.14,15 In ESTEEM 1, the primary endpoint of PASI-75 at Week 16 was successfully reached. In the Otezla-treated group, 33% of patients achieved PASI-75 at Week 16 (Figure 3, 6).3,14 These results were consistent between ESTEEM 1 and ESTEEM 2.3,15 Patients Achieving a PASI-75 Response (%) a-c

Placebo P<0.0001

40 30

Placebo Otezla 30 mg BID

P<0.0001

47%

40 30 20

18%

10 n=189

n=374

Figure 5: Patients achieving an ScPGA score of 0 (clear) or 1 (minimal) at Week 16.14 Results were consistent between ESTEEM 1 and ESTEEM 2; bFAS; LOCF; Week 16: prespecified exploratory endpoint. In the planned hierarchical statistical testing sequence for ESTEEM, efficacy analyses preceding ScPGA were statistically significant, allowing for control of the overall type I error rate at 0.05 significance level in analysis of ScPGA; dBaseline ScPGA ≥3. Adapted with permission from Papp K, et al. J Am Acad Dermatol. 2015;73(1):37-49. a

33.1%

5.3%

n=282

n=562

19.4

18.7

Actual Otezla Patients Baseline

a Results were consistent between ESTEEM 1 and ESTEEM 2; bLast observation carried forward (LOCF), full analysis set (FAS) population; cNumber of randomized patients.

In an exploratory analysis, Otezla demonstrated an improvement in mean percent change in PASI score vs placebo at Week 16, -55% vs -18% (Figure 4).14 These results were consistent between ESTEEM 1 and ESTEEM 2.14,15 60

Week 16

A: PASI-85

Figure 3: Percentage of patients achieving the primary endpoint of a PASI-75 response at Week 16.3,14

55%

50 40 30

Placebo

Otezla 30 mg BID

18%

Crossover to Otezla 30 mg BID

10 0 2 (n=282) (n=562)

16 (n=247) (n=501)

B: PASI-69

Mean Changes in PASI (%) a-f

0 Mean Baseline PASI

0 Week

Otezla 30 mg BID

Among patients in ESTEEM 1 with moderate to very severe scalp psoriasis at baseline (Scalp Physician Global Assessment [ScPGA] ≥3), 47% of patients treated with Otezla had clear or minimal scalp involvement (ScPGA ≤1) at Week 16, compared with 18% of placebo patients (Figure 5, 6).14 Scalp response at Week 16 was a prespecified exploratory efficacy endpoint. In the planned hierarchical statistical testing sequence for ESTEEM, efficacy analyses preceding ScPGA were statistically significant, allowing for control of the overall type I error rate at 0.05 significance level in analysis of ScPGA. These results were consistent between ESTEEM 1 and ESTEEM 2.14,15 Patients Achieving an ScPGA Score of 0 or 1 (%) a-d

WHAT IS THE EFFICACY OF OTEZLA® (apremilast) IN PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS?

32 (n=216) (n=425)

a Exploratory analyses; data as observed; bResults were consistent between ESTEEM 1 and ESTEEM 2; cWeek 16: secondary endpoint; all other timepoints: exploratory endpoint; d Baseline mean PASI scores: placebo, 19; Otezla, 19; total, 19; eDuring Weeks 16 through 32 (maintenance phase), all patients received Otezla; fCauses of patient dropout include adverse events, lack of efficacy, and patient withdrawal; g95% confidence interval. Adapted with permission from Papp K, et al. J Am Acad Dermatol. 2015;73(1):37-49.

“Scalp psoriasis is particularly troublesome for patients and clinicians, especially when trying to manage it exclusively with topical therapies. Fortunately, patients have newer non-topical options. Otezla has offered my patients a welcome oral approach.”

− Melodie Young, A/GNP-C; Dallas, TX*

*Serves as a consultant to Celgene.

C: PASI-63

Figure 4: Mean percent change in PASI score over 32 weeks.14

Figure 6: (A) 85% improvement in PASI score. (B) 69% improvement in PASI score. (C) 63% improvement in PASI score. Individual results may vary.

IMPORTANT SAFETY INFORMATION Weight Decrease: Monitor body weight regularly; evaluate unexplained or clinically significant weight loss, and consider discontinuation of Otezla. Body weight loss of 5-10% occurred in 12% (96/784) of patients treated with Otezla and in 5% (19/382) of patients treated with placebo. Body weight loss of ≥10% occurred in 2% (16/784) of patients treated with Otezla compared to 1% (3/382) of patients treated with placebo. Please see Important Safety Information presented throughout and Brief Summary of Full Prescribing Information on adjacent page.

34 Journal of Dermatology for Physician Assistants

ADVERTORIAL WHAT IS THE SAFETY PROFILE OF OTEZLA® (apremilast)? In the ESTEEM trials, the most common adverse reactions that occurred

within the 2 groups of patients were diarrhea, nausea, upper respiratory tract infection, tension headache, and headache (Table 1).3 The majority of patients who reported nausea or diarrhea did so within the first 2 weeks of therapy. But as dosing continued, these events tended to resolve over time.16 Table 1: Adverse Reactions Reported in ≥1% of Patients With Psoriasis on Otezla and With Greater Frequency Than in Patients on Placebo for Up to Week 163

Adverse Reactions Diarrhea Nausea Upper respiratory tract infection Tension headache Headache Abdominal paina Vomiting Fatigue Dyspepsia Decreased appetite Insomnia Back pain Migraine Frequent bowel movements Depression Bronchitis Tooth abscess Folliculitis Sinus headache

Placebo (N=506) n (%)

Otezla 30 mg BID (N=920) n (%)

32 (6) 35 (7) 31 (6) 21 (4) 19 (4) 11 (2) 8 (2) 9 (2) 6 (1) 5 (1) 4 (1) 4 (1) 5 (1) 1 (0) 2 (0) 2 (0) 0 (0) 0 (0) 0 (0)

160 (17) 155 (17) 84 (9) 75 (8) 55 (6) 39 (4) 35 (4) 29 (3) 29 (3) 26 (3) 21 (2) 20 (2) 19 (2) 17 (2) 12 (1) 12 (1) 10 (1) 9 (1) 9 (1)

Two patients treated with Otezla experienced serious adverse reaction of abdominal pain.

“My patients are reassured knowing that the most frequent side effects typically emerge in the first 2 weeks and tend to resolve over time with continued dosing.”

− A. Matthew Brunner, PA-C; Macon, GA*

THE OTEZLA PRESCRIBING INFORMATION HAS NO REQUIREMENT FOR ROUTINE LAB MONITORING3 Overall, the proportion of patients who discontinued treatment because of any adverse reaction was 6.1% for Otezla-treated patients and 4.1% for placebo patients.3 The common adverse reactions that led to discontinuation were nausea (1.6%), diarrhea (1.0%), and headache (0.8%).3,16 “Otezla is working well for my patients with moderate to severe plaque psoriasis who have been on topicals previously and need a different therapy, prefer an oral option, and are concerned about routine lab monitoring during treatment.”

— J. Mark Jackson, MD; Louisville, KY*

THE LONG-TERM SAFETY PROFILE OF OTEZLA THROUGH 3 YEARS WAS GENERALLY SIMILAR TO THAT OBSERVED WITH OTEZLA THROUGH 16 WEEKS16 WHO MAY BE AN APPROPRIATE CANDIDATE FOR OTEZLA? Patients with moderate to severe plaque psoriasis who: • Have been on topicals previously and need a different therapy • Prefer an oral option • Are comfortable with the safety and efficacy data for Otezla • Are unable or unwilling to participate in routine laboratory monitoring during treatment Otezla is also indicated for adult patients with active psoriatic arthritis *Serves as a consultant to Celgene.

IMPORTANT SAFETY INFORMATION Drug Interactions: Apremilast exposure was decreased when Otezla was co-administered with rifampin, a strong CYP450 enzyme inducer; loss of Otezla efficacy may occur. Concomitant use of Otezla with CYP450 enzyme inducers (eg, rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended. Adverse Reactions Adverse reactions reported in ≥5% of patients were (Otezla%, placebo%): diarrhea (17, 6), nausea (17, 7), upper respiratory tract infection (9, 6), tension headache (8, 4), and headache (6, 4). Use in Specific Populations Pregnancy and Nursing Mothers: Otezla is Pregnancy Category C; it has not been studied in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether apremilast or its metabolites are present in human milk. Caution should be exercised when Otezla is administered to a nursing woman. Renal Impairment: Otezla dosage should be reduced in patients with severe renal impairment (creatinine clearance less than 30 mL/min); for details, see Dosage and Administration, Section 2, in the Full Prescribing Information. Please see Important Safety Information presented throughout and Brief Summary of Full Prescribing Information on adjacent page. References: 1. Lebwohl MG, et al. J Am Acad Dermatol. 2014;70(5):871-881.e30; 2. Van de Kerkhof PCM, et al. J Eur Acad Dermatol Venereol. 2015:29(10):2002-2010; 3. Otezla [prescribing information]. Summit, NJ: Celgene Corporation; 2015; 4. National Psoriasis Foundation. www.psoriasis.org/about-psoriasis/treatments/systemics. Accessed February 20, 2015; 5. US Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/19821-S001_Soritane.pdf. Accessed February 20, 2015; 6. US Food and Drug Administration. http://www. accessdata. fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory#apphist. Accessed February 20, 2015; 7. Nestle F, et al. N Engl J Med. 2009;361(5):496-509; 8. Schafer P. Biochem Pharmacol. 2012;83(12):1583-1590; 9. Schett G, et al. Ther Adv Musculoskelet Dis. 2010;2(5):271-278; 10. Cosentyx [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2016; 11. Taltz [prescribing information]. Indianapolis, IN: Eli Lilly and Company; 2016; 12. Chimenti SC, et al. Autoimmun Rev. 2013;12:599-606; 13. Schafer PH, et al. Cell Signal. 2014;26:2016-2029; 14. Papp K, et al. J Am Acad Dermatol. 2015;73(1):37-49; 15. Paul C, et al. Br J Dermatol. 2015;173(6):1387-1399; 16. Data on file, Celgene Corporation. Otezla® is a registered trademark of Celgene Corporation. © 2016 Celgene Corporation 08/16 USII-APR160234a

Volume 10 • number 4 • FALL 2016 35

36 Journal of Dermatology for Physician Assistants

Professional development

Notes from your Office Manager Treating Patients with Whom You Have a Close Relationship The Risk: Healthcare providers are often asked by close friends, relatives, or colleagues for medical advice, treatment, or prescriptions both inside and outside of the office. At times, these individuals may be seen at no charge as a courtesy. Although the American Medical Association advises providers not to treat immediate family members except in cases of emergency or when no one else is available, this practice continues to exist. Unfortunately, over the years, we have seen a number of lawsuits filed against providers by close friends, colleagues, and even their own family members because of care provided by our insureds. The defense of these suits is frequently hampered by the fact that there are often sparse or entirely non-existent medical records for the patient. The failure to maintain a medical record for every patient is defined as professional medical misconduct in Education Law § 6530(32). Providing care under these circumstances may pose unique risks. Recommendations: 1. Always create a medical record for friends, relatives, and colleagues for whom you provide care of any kind. 2. All patient encounters must be documented in the medical record, including those that occur outside the medical office.

3. A thorough medication history should be obtained to avoid potential drug interactions and identify any contraindications. 4. Take a complete history when seeing friends, relatives, or colleagues as patients. If indicated, this should include issues that may be uncomfortable to discuss such as the use of psychotropic medications and sexual history. 5. Perform a thorough physical examination. Sensitive portions of a physical examination should not be deferred when pertinent to the patient’s complaints. These may include a breast, pelvic, or rectal examination. A chaperone may be necessary for those portions of the exam. 6. Do not write prescriptions for individuals with whom you do not have an established professional relationship and always document the reasons for prescribing the medication and dose. If narcotics are prescribed, the Prescription Monitoring Program (I-STOP) must be checked. 7. If a surgical procedure is to be performed, a signed informed consent must be present in the record, with accompanying documentation that the requisite risks, benefits, and alternatives to the treatment have been discussed with the patient. J

These Risk Management Tips have been reprinted with permission from: MLMIC Dateline, published by Medical Liability Mutual Insurance Company, 2 Park Avenue, Room 2500, New York, NY 10016. Copyright ©2016 by Medical Liability Mutual Insurance Company. All Rights Reserved. No part of this article may be reproduced or transmitted in any form or by any means, electronic, photocopying, or otherwise, without the written permission of MLMIC.

Volume 10 • number 4 • FALL 2016 37

professional development

Outside & Inside the 9 to 5... The Airelle® Skincare Story On the surface, it seems unlikely that the grandeur and fantasy of Hollywood could unite in perfect harmony with the discipline and science of dermatology. Yet that’s precisely how Airelle® Skincare was born. This unexpected collaboration began when Stephen D’Amato, First Kasey DrapeauD’Amato, MPAP, PA-C Assistant Director on some of primetime TV's hottest shows, sought the expertise of his wife, Kasey Drapeau-D’Amato, an aesthetic dermatology PA with more than ten years of experience. The pair joined forces in an effort to fill a void in the skincare and anti-aging regimens of many of Hollywood’s top actors, actresses, models, aestheticians and makeup artists.

In addition, Stephen knew makeup alone would no longer be enough to mask skin imperfections when placed under the microscope of ultra-high definition televisions and movie screens. Therefore, Stephen sought the expertise of his wife, Kasey, a dermatology PA, with the goal of developing a skincare line unlike anything on the market. “Stephen and I worked diligently to develop a line of natural products capable of helping people achieve their true skin potential, while also helping protect skin from environmental damage and the various signs of aging,” Kasey explains. “We knew the end result had to create beautiful skin, capable of withstanding the critical eye of the modern HDTVs.”

The Challenge Stephen repeatedly observed the new challenges posed to makeup artists and lighting technicians due to the transition to High Definition Cameras. “Although Hi-Def cameras deliver vivid clarity and resolution to the images they capture, they also bring out the imperfections which were never quite as noticeable; specifically imperfections in the skin.” During lengthy film shoots, Stephen observed some recurring issues. Actors were spending more time in the makeup chair; Directors of Photography were spending more time lighting the actors; and makeup artists were seeking more effective skincare products. “Hollywood demands natural skincare products that work quickly – almost instantly – and they expect those products to deliver noticeable, lasting results,” Stephen explains. “Actors’ hectic schedules make it difficult to schedule in-office procedures, so they rely on skincare products to maintain their beautiful, youthful complexions.” 38 Journal of Dermatology for Physician Assistants

Stephen D’Amato and Kasey Drapeau-D’Amato, MPAP, PA-C

The Solution Together, Stephen and Kasey began scouring the globe in search of the most innovative and effective natural ingredients. In addition, they resolved to recruit a team of the world’s leading dermatological scientists and formulators. Their mission was to develop a line of anti-aging skincare products that work fast, help improve the appearance of fine lines and wrinkles, and protect the skin to help prevent wrinkles from forming.

Realizing a Dream In 2014, Airelle® Skincare was officially launched to the physician market. Through the launch, Stephen and Kasey fulfilled their goal of bringing to market a natural line of anti-aging products developed to improve the appearance of fine lines and wrinkles in less than twenty-eight days, and to protect collagen in an effort to prevent future wrinkles from forming. J

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“I believe that being proactive and protecting the collagen is the key to maintaining healthy, vibrant, youthful-looking skin,” says Kasey. “Environmental damage is a leading cause of skin damage and collagen breakdown. If we can develop a product line that protects collagen, we can revolutionize the way the world thinks about skincare.” Stephen and Kasey collaborated with top European dermatology experts, many of whom are heralded as leaders in the field of photoaging science, as well as leading U.S.-based cosmetic chemists and formulators. In addition, the duo partnered with expharmaceutical sales and marketing experts to help develop and refine their vision.

Dermatology PA news & notes

Workplace Excellence Rediscovering The Adversity Advantage By Matthew Davidson, PhD 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.

he holiday season is upon us once again. It’s that time of year when we come together with family and give thanks for our many blessings. Thanksgiving in particular is a wonderful example of how shared beliefs and values manifest themselves in shared rituals or traditions, which in turn reinforce our shared beliefs and values in a circular relationship. These practices and traditions of Thanksgiving can also be applied to the workplace, with staff members, as well as with patients. The earliest tradition of Thanksgiving was based on belief in the importance of giving thanks for the bountiful harvest. The tradition was thus born of values such as wisdom, gratitude, and humility. Those values took shape in the form of a feast centering on food, faith, and friendship. In time the tradition of Thanksgiving served to remind and reinforce those animating values behind the ritual. And the tradition has certainly evolved, right? I mean wouldn’t the Pilgrims be surprised at how football and parades and Black Friday have become part and parcel of the Thanksgiving tradition? That’s not a commentary on the lost purity of Thanksgiving. The tradition was initiated by a unique group of human beings to serve their unique needs; it continues to evolve and change and manifest in countless different ways depending on geography, race, religion, and family norms. Traditions and rituals, our cultural norms, are neither bad nor good in and of themselves; but they do shape and reinforce a set of values - either by accident or by design. So it’s important to continuously reflect on what we do and why we do it “our way.” For my family, Thanksgiving means a big family gathering (I mean big, too!). It’s about kids playing together, it’s about telling (and retelling) old stories and bad jokes; it’s about sitting around a fire (a “bomb” fire as one niece described it) 40 Journal of Dermatology for Physician Assistants

and talking and laughing and reconnecting. Some years back we had started a tradition of going around and having each person say what they were thankful for (not sure who or how it started, but seems like something I may have been crazy and goofy enough to propose). It was pretty cool. It was at times touching and other times tedious (think big group, young kids, and the “my family” response showing up a few times). But I truly believe that we all felt that we had tapped into some deeper part of Thanksgiving. We deepened the tradition, we tapped into some of the deeper values behind the day. In my opinion, there’s something about Thanksgiving that is very simple: we eat and we relax. I don’t think we should (or could) infringe upon that core piece of Thanksgiving for our family. But, there’s also something deeper, something that begs for reflection on the important things in life. But, unless you have a routine that makes space and provides a format it simply doesn’t happen (or may end up taking the form of Uncle Al getting drunk and telling everybody what’s important - at the top of his lungs from the front lawn. Note: I do not have an Uncle Al; Al is not a pseudonym for a real uncle either; just an example, I swear). Well, like lots of traditions, at some point our “what we’re thankful for” tradition fell off. Not sure why. No official proclamation. We just probably forgot, missed it one year, and then never reestablished it. But I think we lost a little something. So it got me to thinking about some new ideas for going after the deeper part of Thanksgiving. For what it’s worth, here’s one to consider adapting or adopting. This example can certainly be applied at your next family holiday meal or at the next office staff meeting. It might be helpful in maintaining the implementation of this in the workplace by knowing you will do this every year as part of the holiday season.

What are the advantages of the Belief Box activity? First, it’s intentional. You’re doing this with a specific intent. If you’re lucky your group may accidentally fall on something like this, but if you think it’s important you want to ensure that it happens by design, not hope it happens by chance. Second, it’s consistent. This helps to ensure that it goes well and as you hoped (note how these questions pull for deep thinking but give a person plenty of safety and choice about what to share and how to share it). It’s structured and simple enough to do in almost any time block you have. Finally, it taps into the deeper values behind the tradition of the holidays providing a simple but powerful way to connect (and reconnect) to one another and to reconnect to our shared beliefs, experiences, and values. Questions and reflections can be tailored to discuss office dynamics and allow staff members an opportunity to get to know one another and perhaps even develop a better sense of understanding with each other too. As you reflect on your own holiday traditions and rituals what are the defining aspects of the experience for your family and/or workplace staff? What makes it unique to your family and/or workplace? What traditions have you lost or forgotten or ruined (that happens too!)? What if you are tired of the same old conversations, the same old routines, the same predictable patterns; what if you don’t like what it has become, if you want something deeper or just something different? Don’t worry. You made them. You can change them. Changing your traditions is as easy as intentionally shaping some new norms, new ways of doing things. What if you’re not ready for something as “nutty” as the Belief Box? No worries. Maybe just find one place in your day where you can more intentionally shape how you will be together to better reflect your deepest hopes and intentions for the wonderful tradition that is, the holidays. 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.

Volume 10 • number 4 • FALL 2016 41

DERmatology pa news & notes

Perhaps hold a staff meeting prior to everyone leaving the office to head home for the holidays and celebrate with their respective families and friends. The idea is this, I call it a Belief Box. It is a tool my company, IEE, has used to create a process by which individuals have a chance to stand up on the box and share their beliefs, ideas, and inspirations openly with a group. We has used this tool with individuals from all age levels and in many different settings and I thought it would be a good tool to adapt for a new family holiday ritual. Here’s one version of how to use this tool: • A set of questions is generated that are meant to be thought provoking and to probe for guiding philosophy and beliefs. • Each person has the chance to “stand on the box” - in some contexts, that just means it’s their turn (no standing at all). In other instances, people have literally created a box, or a spot for each person to stand before the group to receive questions and share their response. • Each person has the right to pass on any question that is too personal, too difficult, or to which they simply don’t have a response. • Figure out how many people you will have participating, and how much total time you have. Then appoint a time-keeper to make sure each person is given equal time (better to go for something doable the first time and have them wanting to do a second round, then push your luck and cause mayhem and revolt - but maybe I’m projecting based on my family!). Here are some sample questions drawn from our version of the Belief Box activity: • Explain what you believe is more important, fitting in or standing out. • What’s the best advice anybody has ever given you? • What advice would you offer somebody your age to help them make the most of their life? • What is the secret to finding happiness? • What’s one sure way to be unhappy? • What things in life are more important than money? • If you only had a month to live, how would you spend your time? • What does it mean to “live a life of purpose?” • What is something you feel you absolutely must accomplish before you die? You can have each person answer them all in a rapidfire style. Or, you can have the group pick and choose which questions to ask. There are really an unlimited number of questions and processes to follow.

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Camp Discovery was founded in 1993 and offers a summer camp experience like no other. Every summer, the American Academy of Dermatology sponsors six weeks of camp in five locations where everyone can experience activities such as fishing, swimming, archery, horseback riding, nature trails, and just plain fun! Under the expert care of dermatologists and dermatology healthcare professionals, Camp Discovery offers campers the opportunity to spend a week among other young people who have similar skin conditions. Many of the counselors have chronic skin conditions as well, and can provide support and advice to campers. There is no fee for camp. All costs, including transportation, are provided by the American Academy of Dermatology through generous donations from its members, other organizations, and individuals. The American Academy of Dermatology is proud to offer this experience to about 380 children each year. The success of AAD's Camp Discovery depends on dedicated dermatology healthcare providers and counselors who volunteer their time to ensure that the medical needs of each camper are met. • Volunteers can select the week that is most convenient for them. • There is no cost for volunteers to attend. All fees, including transportation, are provided by the American Academy of Dermatology. • Each location accepts a number of cabin counselors and medical staff.

42 Journal of Dermatology for Physician Assistants

For your patients with corticosteroid-responsive dermatoses...

D A T E H R E P S

Provide relief with Topicort 0.05% 1,2 • • • • • •

Group C molecule3 Low allergenic potential4-6 Available in cream and ointment3,7 Paraben-free1,2 Propylene glycol-free1,2 Fragrance-free

Topicort® (desoximetasone cream USP) 0.05% and Topicort® (desoximetasone ointment USP) 0.05% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Topicort® (desoximetasone cream USP) 0.05% and Topicort® (desoximetasone ointment USP) 0.05% are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. IMPORTANT SAFETY INFORMATION 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, and miliaria. Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression.

Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface area to body weight ratio.

Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of pediatric patients. Before prescribing, please see brief Prescribing Information on reverse side. References: 1. Topicort® Cream 0.05% Prescribing Information. Taro Pharmaceuticals U.S.A., Inc. 2. Topicort® Ointment 0.05% Prescribing Information. Taro Pharmaceuticals U.S.A., Inc. 3. Jacob SE, Steele T. Corticosteroid classes: A quick reference guide including patch test substances and cross-reactivity. J Am Acad Dermatol. 2006;54:723-727. 4. National Psoriasis Foundation. Topical Steroids Potency Chart. https://www.psoriasis.org/page.aspx?pid=469. Accessed 9/3/15. 5. Baeck M, Chemelle J-A, Rasse C, Terreux R, Goossens A. et al. C16-methyl corticosteroids are far less allergenic than the non-methylated molecules. Contact Dermatitis. 2011;64:305-312. 6. Scheuer E, Warshaw E. Allergy to corticosteroids: Updated and review of epidemiology, clinical characteristics, and structural cross-reactivity. Am J Contact Derm. 2003;14(4):179-187. ©2016 Taro Pharmaceuticals U.S.A., Inc. TaroPharma® and Topicort® are registered trademarks of Taro Pharmaceuticals U.S.A., Inc. AD1000055D August 2016

Volume 10 • number 4 • FALL 2016 43

RxRx only only RxRx only only

AsAs with with other other corticosteroids, corticosteroids, therapy therapy should should bebe discontinued discontinued when when control control is is achieved. achieved. If no If no improvement improvement is seen is seen within within 4 weeks, 4 weeks, contact contact thethe physician. physician.

Brief Brief Summary Summary of Prescribing of Prescribing Information. Information. ForFor complete complete prescribing prescribing information information

Laboratory Laboratory Tests Tests The The following following tests tests may may bebe helpful helpful in in evaluating evaluating thethe hypothalamic-pituitaryhypothalamic-pituitaryadrenal adrenal (HPA) (HPA) axis axis suppression: suppression: Urinary Urinary free free cortisol cortisol test test ACTH ACTH stimulation stimulation test test

® ® Topicort Topicort (Desoximetasone (Desoximetasone Cream Cream USP) USP) 0.05% 0.05% ® ® Topicort Topicort (Desoximetasone (Desoximetasone Ointment Ointment USP) USP) 0.05% 0.05%

ForFor topical topical use use only. only. Not Not forfor oral, oral, ophthalmic, ophthalmic, or or intravaginal intravaginal use. use. INDICATIONS INDICATIONS AND AND USAGE USAGE ® ® ® ® Topicort Topicort (desoximetasone (desoximetasone cream cream USP) USP) 0.05% 0.05% and and Topicort Topicort (desoximetasone (desoximetasone manifestations manifestations of of corticosteroid-responsive corticosteroid-responsive dermatoses. dermatoses. CONTRAINDICATIONS CONTRAINDICATIONS Topical Topical corticosteroids corticosteroids areare contraindicated contraindicated in in those those patients patients with with a history a history of of hypersensitivity hypersensitivity to to anyany of of thethe components components of of thethe preparation. preparation. WARNINGS WARNINGS Keep Keep outout of of reach reach of of children. children. PRECAUTIONS PRECAUTIONS General General Systemic Systemicabsorption absorptionof oftopical topicalcorticosteroids corticosteroidscan canproduce producereversible reversible hypothalamic-pituitary-adrenal hypothalamic-pituitary-adrenal (HPA) (HPA) axis axis suppression suppression with with thethe potential potential forfor upon upon withdrawal withdrawal of of thethe topical topical corticosteroid. corticosteroid. Because Because of of thethe potential potential forfor systemic systemic absorption, absorption, useuse of of topical topical corticosteroids corticosteroids may may require require that that patients patients bebe periodically periodically evaluated evaluated forfor HPA HPA axis axis suppression. suppression. Factors Factors that that predispose predispose a patient a patient using using a topical a topical corticosteroid corticosteroid to to HPA HPA axis axis suppression suppression include include thethe useuse of of more more potent potent steroids, steroids, useuse over over large large surface surface areas, areas, useuse over over prolonged prolonged periods, periods, useuse under under occlusion, occlusion, useuse onon anan altered altered skin skin barrier, barrier, and and useuse in patients in patients with with liver liver failure. failure.

Carcinogenesis, Carcinogenesis, Mutagenesis, Mutagenesis, and and Impairment Impairment of of Fertility Fertility Long-term Long-term animal animal studies studies have have notnot been been performed performed to evaluate to evaluate thethe carcinogenic carcinogenic Desoximetasone Desoximetasone was was nonmutagenic nonmutagenic in the in the Ames Ames test. test. Corticosteroids Corticosteroids have have been been shown shown to to bebe teratogenic teratogenic in laboratory in laboratory animals animals when when administered systemically relatively dosage levels. Some corticosteroids administered systemically at at relatively lowlow dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. have been shown to be teratogenic after dermal application in laboratory animals. Desoximetasone been shown teratogenic and embryotoxic in mice, Desoximetasone hashas been shown to to bebe teratogenic and embryotoxic in mice, rats, and rabbits when given subcutaneous or dermal routes of administration rats, and rabbits when given byby subcutaneous or dermal routes of administration ® ® in doses 150 times human dose Topicort(desoximetasone in doses 1515 to to 150 times thethe human dose of of Topicort (desoximetasone cream cream ® ® USP) 0.05%, Topicort USP) 0.05%, or or Topicort (desoximetasone (desoximetasone ointment ointment USP) USP) 0.05%. 0.05%. There There areare nono adequate adequate and and well-controlled well-controlled studies studies in in pregnant pregnant women women onon ®

® ® (desoximetasone (desoximetasone cream cream USP) USP) 0.05% 0.05% or or Topicort Topicort (desoximetasone (desoximetasone ointment ointment

thethe potential potential riskrisk to the to the fetus. fetus. Drugs Drugs of this of this class class should should notnot bebe used used extensively extensively onon pregnant patients, in large amounts, or or forfor prolonged periods of time. pregnant patients, in large amounts, prolonged periods of time. Nursing Mothers Nursing Mothers It isIt not known whether topical administration of of corticosteroids could result in in is not known whether topical administration corticosteroids could result

AnAn ACTH ACTH stimulation stimulation test test may may bebe helpful helpful in in evaluating evaluating patients patients forfor HPA HPA axis axis suppression. suppression. If HPA If HPA axis axis suppression suppression is is documented, documented, anan attempt attempt should should bebe made made to to gradually gradually withdraw withdraw thethe drug, drug, to to reduce reduce thethe frequency frequency of of application, application, or or

Systemically Systemically administered administered corticosteroids corticosteroids areare secreted secreted intointo breast breast milk milk in quantities in quantities

require require supplemental supplemental systemic systemic corticosteroids. corticosteroids. Recovery Recovery of HPA of HPA axis axis function function is is generally generally prompt prompt and and complete complete upon upon discontinuation discontinuation of of topical topical corticosteroids. corticosteroids.

Pediatric Pediatric Use Use Pediatric Pediatricpatients patientsmay maydemonstrate demonstrategreater greatersusceptibility susceptibilityto totopical topical corticosteroid-induced HPA axis suppression and Cushing’s syndrome than corticosteroid-induced HPA axis suppression and Cushing’s syndrome than mature patients because a larger skin surface area body weight ratio. mature patients because of of a larger skin surface area to to body weight ratio. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, and intracranial hypertension have been reported in pediatric patients receiving and intracranial hypertension have been reported in pediatric patients receiving topicalcorticosteroids. corticosteroids.Manifestations Manifestationsof ofadrenal adrenalsuppression suppressionin inpediatric pediatric topical patients include linear growth retardation, delayed weight gain, plasma patients include linear growth retardation, delayed weight gain, lowlow plasma cortisol levels, and absence of response ACTH stimulation. Manifestations cortisol levels, and absence of response to to ACTH stimulation. Manifestations of of intracranial hypertension intracranial hypertension include bulging fontanelles, headaches, and bilateral include bulging fontanelles, headaches, and bilateral papilledema. papilledema. Administration topical corticosteroids pediatric patients should limited Administration of of topical corticosteroids to to pediatric patients should bebe limited

Cushing’s Cushing’s syndrome, syndrome, hyperglycemia, hyperglycemia, and and unmasking unmasking of latent of latent diabetes diabetes mellitus mellitus can can also also result result from from systemic systemic absorption absorption of of topical topical corticosteroids. corticosteroids. Use Use of of more more than than one one corticosteroid-containing corticosteroid-containing product product at at thethe same same time time may may increase increase thethe total total systemic systemic corticosteroid corticosteroid exposure. exposure. Pediatric Pediatric patients patients may may bebe more more susceptible susceptible to to systemic systemic toxicity toxicity from from useuse of of topical topical corticosteroids. corticosteroids. Local Local Adverse Adverse Reactions Reactions with with Topical Topical Corticosteroids Corticosteroids Local Local adverse adverse reactions reactions may may bebe more more likely likely to occur to occur with with occlusive occlusive use, use, prolonged prolonged useuse or use or use of higher of higher potency potency corticosteroids. corticosteroids. Reactions Reactions may may include include atrophy, atrophy, striae, striae, telangiectasias, telangiectasias, burning, burning, itching, itching, irritation, irritation, dryness, dryness, folliculitis, folliculitis, acneiform acneiform eruptions, eruptions, hypopigmentation, hypopigmentation,perioral perioraldermatitis, dermatitis,allergic allergiccontact contactdermatitis, dermatitis,secondary secondary infection, infection, and and miliaria. miliaria. Some Some local local adverse adverse reactions reactions may may bebe irreversible. irreversible. Allergic Allergic Contact Contact Dermatitis Dermatitis with with Topical Topical Corticosteroids Corticosteroids Allergic Allergic contact contact dermatitis dermatitis to to anyany component component of of topical topical corticosteroids corticosteroids is is usually usually diagnosed diagnosed byby a failure a failure to to heal heal rather rather than than a clinical a clinical exacerbation. exacerbation. Clinical Clinical Concomitant Concomitant Skin Skin Infections Infections Concomitant Concomitant skin skin infections infections should should bebe treated treated with with anan appropriate appropriate antimicrobial antimicrobial ® ® agent. agent. If the If the infection infection persists, persists, Topicort Topicort (desoximetasone (desoximetasone cream cream USP) USP) 0.05% 0.05% ® ® or or Topicort Topicort (desoximetasone (desoximetasone ointment ointment USP) USP) 0.05% 0.05% should should bebe discontinued discontinued until until thethe infection infection hashas been been adequately adequately treated. treated. Information Information forfor thethe Patient Patient Patients Patients using using topical topical corticosteroids corticosteroids should should receive receive thethe following following information information and and instructions: instructions: 1. 1. This This medication medication is to is to bebe used used as as directed directed byby thethe physician. physician. It isIt for is for external external useuse only. only. Avoid Avoid contact contact with with thethe eyes. eyes. 2. 2. Patients Patients should should bebe advised advised notnot to to useuse thisthis medication medication forfor anyany disorder disorder other other than than forfor which which it was it was prescribed. prescribed. 3. 3. The The treated treated skin skin area area should should notnot bebe bandaged bandaged or or otherwise otherwise covered covered or or wrapped wrapped as as to to bebe occlusive occlusive unless unless directed directed byby thethe physician. physician. 4. 4. Patients Patients should should report report anyany signs signs of of local local adverse adverse reactions, reactions, especially especially under under occlusive occlusive dressings. dressings. ® ® 5. 5. Other Other corticosteroid-containing corticosteroid-containing products products should should notnot bebe used used with with Topicort Topicort ® ® (desoximetasone (desoximetasone cream cream USP) USP) 0.05% 0.05% or Topicort or Topicort (desoximetasone (desoximetasone ointment ointment Issued: Issued: April April 2014 2014

44 Journal of Dermatology for Physician Assistants

bebe exercised exercised when when topical topical corticosteroids corticosteroids areare administered administered to a tonursing a nursing woman. woman.

corticosteroid corticosteroid therapy therapy may may interfere interfere with with thethe growth growth and and development development of of pediatric patients. pediatric patients. ADVERSE REACTIONS ADVERSE REACTIONS The following local adverse reactions reported infrequently with topical The following local adverse reactions areare reported infrequently with topical corticosteroids, may occur more frequently with occlusive corticosteroids, butbut may occur more frequently with thethe useuse of of occlusive dressings. These reactions listed approximate decreasing order dressings. These reactions areare listed in in anan approximate decreasing order of of occurrence: occurrence: Burning,itching, itching,irritation, irritation,dryness, dryness,folliculitis, folliculitis,hypertrichosis, hypertrichosis,acneiform acneiform Burning, eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration skin, secondary infection, skin atrophy, striae, and miliaria. maceration of of thethe skin, secondary infection, skin atrophy, striae, and miliaria. In controlled clinical studies incidence adverse reactions were 0.8% In controlled clinical studies thethe incidence of of adverse reactions were lowlow 0.8% ® ® Topicort forfor Topicort (desoximetasone (desoximetasone cream cream USP) USP) 0.05% 0.05% and and included included pruritus, pruritus, erythema, vesiculation, and burning sensation.The The incidence erythema, vesiculation, and burning sensation. incidence of of adverse adverse ® ® reactions was lowlow (0.2%) forfor Topicort reactions was (0.2%) Topicort (desoximetasone (desoximetasone ointment ointment USP) USP) 0.05% 0.05% and included mild burning sensation application. and included mild burning sensation at at thethe sitesite of of application. OVERDOSAGE OVERDOSAGE PRECAUTIONS). PRECAUTIONS). Mfd. Mfd. by:by: Taro Taro Pharmaceuticals Pharmaceuticals Inc., Inc., Brampton, Brampton, Ontario, Ontario, Canada Canada L6T L6T 1C1 1C1 Dist. Dist. by:by: TaroPharma TaroPharma a division a division of of Taro Taro Pharmaceuticals Pharmaceuticals U.S.A., U.S.A., Inc., Inc., Hawthorne, Hawthorne, 10532 NYNY 10532 ® ® ® ® Topicort Topicort and and TaroPharma TaroPharma areare registered registered trademarks trademarks of of Taro Taro Pharmaceuticals Pharmaceuticals

FDA. FDA. Visit Visit www.fda.gove/Safery/MedWatch/default.htm, www.fda.gove/Safery/MedWatch/default.htm, or call or call 1-800-FDA-1088. 1-800-FDA-1088.

From the Desk of...

The Society of Dermatology Physician Assistants (SDPA) Board of Directors with much thought and consideration fully endorses the American Academy of Physician Assistants (AAPA) proposed policy on Full Practice Authority and Responsibility (FPAR). The proposed FPAR policy includes the following actions with SDPA suggested edits in BOLD CAPS: ● Emphasize our profession’s continued commitment to team-based practice RATHER THAN AUTONOMOUS CARE. ● Support the elimination of provisions in laws and regulations that require a PA to have and/or report a supervisory, collaborating or other specific relationship with a physician in order to practice. ● Advocate for the establishment of autonomous state regulatory boards, with a voting membership comprised of a majority of PAs, to license, regulate, and discipline PAs. ● Ensure that PAs are eligible to be reimbursed directly by public and private insurances. The SDPA believes that PAs demonstrate a mastery of both skill proficiency and medical knowledge that negates the need for individual PAs to have their licenses subjugated to that of another member of the healthcare team. We assert that individual PAs recognize the limits of their knowledge and skills, and will consult appropriate members of the healthcare team in order to obtain optimal patient outcomes. The AAPA policy on FPAR proposes the elimination of provisions in laws and regulations that require a PA to have a supervisory, collaborating or other specific relationship with a physician in order to practice. The SDPA fully supports this decoupling of PA licensure from other healthcare team members as we believe this would afford PAs greater mobility within the healthcare system and improve patient access to care by allowing PAs the same opportunities for practice as other members of the healthcare team. Roadblocks to reimbursement also create difficulties for patients, healthcare systems, and the medical professionals who provide care to patients. The SDPA supports the proposal set forth by the FPAR policy that PAs be given the opportunity to be reimbursed directly by both public and private entities to ensure that all parties have a functioning and equitable healthcare system. Finally, the SDPA believes that PAs should be held to the same accountability as other members of the healthcare team for their professional practice decisions and actions. In order for this to occur, PA licensure and practice should be defined, disciplined, and regulated by a medical board comprised primarily of peer medical professionals, PAs. The SDPA supports the provision proposed by the AAPA policy on FPAR advocating for the establishment of autonomous state regulatory boards, with a voting membership comprised of a majority of PAs, that license, regulate, and discipline PAs as this model will allow PA practice to be governed in the same manner as other healthcare professionals. The SDPA considers the proposed policy changes to be a natural progression of the profession from a ‘dependent practice model’ to the current and modern ‘team based model of care’ that is the standard for healthcare provision across the United States. The SDPA fully endorses the AAPA’s policy on FPAR as these changes will strengthen our profession’s commitment to team based care and ultimately benefit the health of the nation. Sincerely, The SDPA Board of Directors ...continued on page 45 Volume 10 • number 4 • FALL 2016 45

DERmatology pa news & notes

SDPA Position Statement: AAPA’s Future of PA Practice Authority Proposal

The Joint Task Force on the Future of PA Practice Authority

DERmatology pa news & notes

REQUEST FOR FEEDBACK The Joint Task Force on the Future of PA Practice Authority has engaged in its preliminary deliberations, and seeks feedback from the PA community regarding its suggestions for AAPA policy. After 50 years, we believe that the PA profession has demonstrated a commitment to competent and quality care for our patients. It is natural for our profession to seek to define its future. After initial deliberations, the Task Force believes the profession should consider and commit to a process that gives PAs “Full Practice Authority and Responsibility”. In this process we seek to make the PA profession and individual PAs more accountable, preserve our positive relationship with physicians, and, by decreasing unnecessary administrative burdens on physicians, PAs and our employers, increase access to care for patients. In order to realize PA Full Practice Authority and Responsibility, AAPA would have to adopt policy changes and take action to: • Emphasize our profession’s continued commitment to team-based practice. • Support the elimination of provisions in laws and regulations that require a PA to have and/or report a supervisory, collaborating or other specific relationship with a physician in order to practice. • Advocate for the establishment of autonomous state boards, with a voting membership comprised of a majority PAs, to license, regulate, and discipline PAs. • Ensure that PAs are eligible to be reimbursed directly by public and private insurance.

What do we mean by Full Practice Authority and Responsibility? We mean that, collectively, PAs have the Authority and Responsibility, as a majority of the voting members of an autonomous state PA licensing board, to: • Define and regulate PA licensure • Define and regulate PA practice • Determine and enforce through disciplinary action PA practice standards We mean that, individually, every licensed PA has the Authority and Responsibility to: • Practice as a member of health care teams that include other PAs, physicians, NPs, nurses, pharmacists, physical therapists, social workers, and others • Practice to the top of their own education, training, experience and competency • Recognize the limits of their knowledge and abilities, and know when a patient’s condition requires consultation with and/or referral to other qualified healthcare providers • Adhere to the regulatory requirements of the PA board • Adhere to standards of care, document this care, prescribe and order appropriately, and complete and sign all documents required for patient care, disability, insurance, medical leave, and medical necessity • Accept liability for the care they provide • Bill public and private payers directly for the services they provide, as appropriate

How is Full Practice Authority and Responsibility different from “independent practice” or “autonomy”? As PAs, we remain committed to team-based care. We will continue to seek and participate in collaborative clinical relationships with other health care providers, including physicians, other PAs, NPs, nurses, physical therapists, pharmacists, social workers, and other health care professionals. We believe that every member of every patient care team should be respected for their education, experience and skills, for the role they play in patient care, for their contributions to patient health, and for the support and leadership they give to other members of the team. To be clear, just like physicians, NPs and other providers, PAs make and will continue to make autonomous clinical decisions every day. However, we believe that the terms “independent practice” and “autonomy” do not appropriately reflect our commitment to a team-based model of care. The use of these terms could suggest that 46 Journal of Dermatology for Physician Assistants

we do not seek or value our relationships with physicians, nurses, or other health care providers, or that we seek to practice “alone” with no accountability.

Can the profession embrace FPAR without changing its title? The task force recognized that changing the name of the profession is an important topic that could gain added urgency if Full Practice Authority and Responsibility becomes AAPA policy. However, while there is considerable dissatisfaction with the title of “Physician Assistant”, we recognize that no clear consensus on an alternate title has emerged. The task force believes that moving to FPAR is critical for the profession’s viability and should not be delayed by the issue of changing the profession’s title. Additionally, we agreed that tackling this topic is outside the scope of our charges. We believe that another group should be convened to undertake the research and PA community engagement on the topic of name change, and invite your feedback on that suggestion. In the interim, the Task Force intends to use the acronym “PA”, consistent with the current AAPA convention. It is clear that changing state and federal laws and regulations, as well as the policies and practices of employers and insurance companies, will be challenging and take time. The first step, however, is to reach agreement, as a profession, about the future that we will work to achieve. Just as PAs do in their everyday practice, the Joint Task Force on the Future of PA Practice Authority recognizes the limits of our collective and individual experiences. For that reason, we seek the feedback and input of our fellow PAs and the full range of AAPA constituent organizations. We hope that you will engage in dialogue with us and with each other through Huddle or through social media. We seek your views through email (fparfeedback@aapa. org) or letter. And we intend to send out a survey to individual PAs in early January. And we expect to discuss these important issues with you at the Leadership and Advocacy Summit (LAS) in early March. We plan to share all of your feedback – positive or negative – on an AAPA webpage devoted to this topic: www.aapa.org/fpar/. Once we hear from you, we will come together again to reconsider and, if necessary, revise our position. It is our expectation and intent to offer a resolution to the AAPA Board of Directors and the AAPA House of Delegates for their consideration in May 2017. J

Volume 10 • number 4 • FALL 2016 47

DERmatology pa news & notes

Initiating a Profession Wide Discussion: Next Steps

Supervising Physician CORNER An Interview with Suneel Chilukuri, MD By J. Margaret Casey

DERmatology pa news & notes

The JDPA recently had an opportunity to interview Suneel Chilukuri, MD discuss his role as the SDPA 14th Annual Fall Dermatology Conference Medical Director, and learn about his experiences in educating and working with dermatology PAs. JDPA: What about this role peaked your interest initially? Dr. Chilukuri: I saw the role as SDPA Conference Medical Director as an opportunity to help advance the education of PAs and bring it to an even higher level. In the past, I think speakers at PA conferences have felt they need to bring the level of education down a notch when they are presenting to the PA audience, and the truth is they don’t have to do this at all. I believe that dermatology PAs are the hungriest group of individuals when it comes to learning and obtaining new knowledge. This past summer I presented at my first SDPA conference, and I was one of the last speakers of the day. It was a beautiful day in Austin, and due to plane layovers and delays my lecture ended up being at 4:45pm. The conference was slated to conclude at 5pm. I apologized to my audience and gave attendees the out by stating that anyone who wanted to leave to spend time with family, enjoy the day, or be done with the conference was welcome to do so. I was blown away that what appeared to be 96% stayed for the entire lecture. They stayed because of this hunger and desire to learn. It really spoke to me about the commitment of PAs to their profession. JDPA: How do you view your role as SDPA Conference Medical Director? Dr. Chilukuri: I see myself as a liaison between PAs and physicians. I attend at least one conference a month. I pay close attention and watch to see who the best speakers are and who I learn the most from. I want to give these standout speakers an opportunity to share their knowledge and expertise with members of the SDPA at our conferences. I think it is vital that we continue to vary the content that we offer at SDPA conferences as well. JDPA: Do you perceive any challenges with this position? Dr. Chilukuri: I think physicians for the most part are excited to share information and education with PAs. Some of this will depend on their level of experience working with PAs. I need to help develop good working relationships with presenters to keep lectures and conference material content at a high level. JDPA: How would you define success in your role as SDPA Conference Medical Director? Dr. Chilukuri: I will consider my role a success if two 48 Journal of Dermatology for Physician Assistants

goals are met. The first goal is that I hope that all SDPA conference attendees will rate the conference content a 5 out of 5 for usefulness. I want content to be pertinent and have attendees feel as though it is information they can apply on a practical and daily basis in the clinic. I don’t find there is much practical use for esoteric topics or conditions that are not seen on a routine basis. The second goal that will make my role a success is if all conference topics and presentations are relevant to all attendees including beginner, intermediate, and advanced/veteran dermatology PAs. In the ideal scenario, all lectures would prove to be practical to all ranges of PAs no matter where they are in their careers. JDPA: What experiences or special skills do you have that you think will help you in this position? Dr. Chilukuri: I am very procedurally oriented in my practice of dermatology. Ninety-nine percent of my practice is spent on cosmetic and surgical dermatology. I rarely practice strictly medical dermatology. I hope to share with the SDPA audience my experience in using many cosmetic treatments and procedures for medical conditions. While my practice is primarily cosmetic dermatology, it is by no means only about making patients feel pretty. We are currently using radiofrequency microneedling to change people’s lives. We recently used this procedure to treat a patient’s hyperhidrosis and he told me it is life changing. For the first time in as long as he can remember he doesn’t need to change his shirt between business meetings. We are also more effectively treating active acne and acne scarring to help patients change how they feel about themselves. Utilizing cosmetic procedures and products to treat medical conditions is providing additional tools in our medical toolboxes. I still refer to other experts in the field when I have a need to use biologics or other treatment regimens that aren’t part of my day-to-day approach. JDPA: What has been your experience thus far in working with and/or educating dermatology PAs? Dr. Chilukuri: I have been working with PAs and NPs since 2003 and see them as a remarkable and integral part of our practice. In the past, I introduced five PAs into a practice with two physician partners who were not too keen on working with mid-level providers. These PAs are now an integral part of that practice. Many PAs

general dermatology providers as well as primary care physicians. JDPA: What advice would you share with fellow dermatologists who are considering volunteering their time to helping educate dermatology PAs? Dr. Chilukuri: I want my colleagues to know that PAs are remarkable resources. So often I hear physicians complaining that they can’t find associates or that they have no time because they are so busy. Meanwhile, the perfect resource is right in front of them – Physician Assistants. Utilizing PAs ultimately provides our patients with better access to healthcare. I would strongly recommend that physicians who hire a PA for the first time train the PA to treat patients the way they would like patients to be treated. Putting time into this training will help the PA truly serve as an extension of you. Take the time to work side by side with your newly hired PA before having him/her see patients on his/her own time. As I see it, there are two approaches: 1) Hire a PA and let him/her see patients on his/her own and go wild. 2) Take the time to train a new PA and he/she will function as a true extension of you and treat patients the way you would treat them. Patients will appreciate the continuity of care. Both approaches get work done, you just need to determine what outcome you would prefer. JDPA: Any additional information that you would like to share with the JDPA readers? Dr. Chilukuri: There are so many amazing online resources for the education of PAs. We become better providers when we utilize these resources. Next time you are waiting in a pickup line to get your children from school or riding the chairlift during a ski trip, take advantage of learning online. We don’t all need to be toting journals everywhere with us. We can be learning virtually anywhere and we should be. J Suneel Chilukuri, MD is an internationally recognized cosmetic surgeon specializing in the C¬-lift, a non-surgical facelift technique. He teaches this signature liquid facelift technique to his plastic surgery and dermatology colleagues throughout the world. In fact, he has been an invited lecturer at more than 200 national and international conferences spanning 6 continents over the past 17 years. Passionate about inventing and studying cutting edge procedures, Dr. Chilukuri performs clinical research for numerous devices and medications to continue advancing the field of aesthetic surgery. He has shared his knowledge and expertise by publishing more than 50 book chapters and manuscripts in peer-reviewed cosmetic surgery, dermatologic surgery, and dermatology journals and textbooks. While currently serving as a voluntary professor at the Baylor College of Medicine, Dr. Chilukuri has served as a faculty instructor and clinical professor for cosmetic, surgical, and reconstructive surgery at other renowned academic institutions including Yale University School of Medicine, Columbia University College of Physicians and Surgeons, and Albert Einstein Medical College. For the past 13 years, he has been an advanced national and international trainer for companies including Allergan Cosmetics, Galderma Cosmetics, Suneva Cosmetics, Skin Medica Cosmeceuticals, PCA Skin, Cynosure Lasers, and Theraclear Lasers. With the advent of new advances in technology, he is often able to provide non-invasive solutions for a variety of cosmetic concerns.

Volume 10 • number 4 • FALL 2016 49

DERmatology pa news & notes

become experts in the field, and dermatology accessibility is improving because of them. I currently have an NP working at my practice and am looking to hire a new PA. It has been my experience that NPs and PAs tend to be more eager and interested in learning than many dermatology residents. JDPA: What do you hope to gain from this experience? Dr. Chilukuri: I know I won’t be around forever, and realize that my legacy is the information that I am able to impart to the PAs who I educate. I dedicate one to two days a week to teaching in the community and truly consider teaching part of my contribution to the future of dermatology. JDPA: What contributions would you like to see come from members of the SDPA in regards to the conferences? Dr. Chilukuri: I encourage all SDPA members and conference attendees to be heard. Please share what you would love to learn more about. We typically hear from the same ten to fifteen voices, and would love to hear from each and every member. Providing this type of feedback will help us improve the education and ultimately benefit our patients. I think there would be great benefit to being able to have attendees send texts during conferences with their feedback. We all live such busy lives and are constantly moving all around, but having the ability to send a text right there at the conference would be a great way of capturing valuable feedback while it is fresh in the attendees’ minds. JDPA: Do you see the role of dermatology PAs changing in the future and if so how? Dr. Chilukuri: I believe the level of education continues to rise. Over the past decade and a half, I have noticed patient acceptance of PAs has increased. Patients are realizing that often times PAs are able to spend more time with them than their supervising physicians. My wife is a pediatric NP, and many patients prefer to see her instead of the physician; they will actually call and reschedule appointments to see her. This was not always the case. There was a time when patients would question why they had to see an NP or PA and why they weren’t seeing a physician. JDPA: What insights or words of wisdom would you share with a new dermatology PA who has just joined the field and the SDPA? Dr. Chilukuri: Every single veteran and newbie dermatology PA should be reading each and every journal they can get their hands on: including the JDPA, the AAD Blue Journal, JCC, JDD, and Dermatology Surgery. Having these journals accessible on your phone or tablet while you are on the go is such an important part of staying abreast of what is going on in the world of dermatology. It is important to share the latest trends, treatments, and information with our patients. I share pertinent articles I come across with my patients on a regular basis. I use these articles so my patients will have pertinent information for appointments with their

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OLYMPIC MEDALIST

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Did you know snow reflects and intensifies the damaging rays of the sun? Sun exposure is the most preventable risk factor for skin cancer. To protect your skin, apply sunscreen, seek shade and wear protective clothing. Visit SpotSkinCancer.org. © 2013 American Academy of Dermatology. Use of this poster does not imply product or service endorsement by the American Academy of Dermatology.

50 Journal of Dermatology for Physician Assistants

13-173-PP

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.

ONEXTON™ (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] Colitis/Enteritis ONEXTON Gel is contraindicated in patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis [see Warnings and Precautions] 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.

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 ONX.0088.USA.16

Volume 10 • number 4 • FALL 2016 51

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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

•

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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.

*This offer is only valid for patients with commercial insurance. Eligible uninsured patients will pay more. This offer is not valid for any person eligible for reimbursement of prescriptions, in whole or in part, by any federal, state, or other governmental programs, including, but not limited to, Medicare (including Medicare Advantage and Part A, B, and D plans), Medicaid, TRICARE, Veterans Administration or Department of Defense health coverage, CHAMPUS, the Puerto Rico Government Health Insurance Plan, or any other federal or state health care programs. This offer is good only in the U.S. at retail pharmacies owned and operated by Walgreen Co. (or its affiliates) or other participating independent retail pharmacies. This offer is not valid in Massachusetts or Minnesota or where otherwise prohibited, taxed or otherwise restricted. Visit www.valeantaccessprogram.com for full terms and conditions.

Please see Brief Summary of full Prescribing Information on the following page. ® /TMs are trademarks of Valeant Pharmaceuticals International, Inc. or its affiliates. All other product or brand names are trademarks of their respective owners. © 2016 Valeant Pharmaceuticals North America LLC. ONX.0075.USA.16 Printed in USA.

52 Journal of Dermatology for Physician Assistants