JDPA Winter2016 by Angela Simiele

DPA J

V o l u m e 1 0 • n u m b e r 1 • W I N T ER 2 0 1 6 • www.jdpa.org

Journal of Dermatology for Physician Assistants

Dermatology PA News & Notes SDPA State Affiliates 17 __________________________________

CLINIcal dermatology Clinical Case Report

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surgical dermatology Journal Club 31 _________________________________

cosmetic dermatology Cosmetic Pearls 38 __________________________________

professional development Judicial and Ethical Affairs – Defensive Medicine

›› Earn CME credit with this issue CME Clinical Research Trials in Dermatology – More Than Skin Deep - Part I

Official Journal of the Society of Dermatology Physician Assistants

Volume 10 • number 1 • WINTER 2016

Hong Hu, Research Advisor, Lilly Research Laboratories

It begins with a promise to discover medicines that make life better. Since 1876, we have worked tirelessly to develop and deliver trusted medicines that meet real needs, finding ways to come through no matter the odds. From the development of insulin to the discovery of new treatments for mental illness, we have pioneered breakthroughs against some of the most stubborn and devastating diseases. We bring this same determination to our work today, uniting our expertise with the creativity of research partners across the globe to keep finding ways to make life better. To find out more about our promise, visit www.lilly.com/about.

8th AnnuAl DermAtology

PeArlS Cme ConferenCe

MARCH 31st to APRil 2nd

2016

the Westin Buckhead Hotel

adjacent to lenox Mall - Atlanta, Georgia Featured lecturers and their topics: Difficult Pruritus: Scrotal, Vaginal, and Perianal presented by Matthew Zirwas, MD

Laser Science and Use In Dermatology presented by Suneel Chilukuri, MD

Obesity Exacerbated Dermatoses presented by Douglas DiRuggiero, MHS, PA-C

Nevi and Pigmented Neoplasms presented by Whitney High, MD

Dyschromias: Diagnosis and Management presented by Amy McMichael, MD

Challenging Psoriasis Cases presented by Abby Jacobson, MS, PA-C

Conference organizers plan to request 25 hours of Category i CME as well as 8.0 hours of Self-Assessment CME from AAPA. Provided by

Georgia Dermatology Physician Assistants Derm PEARLS: is a three day medical education program designed as a comprehensive training for Physician Assistants and Nurse Practitioners working in the dermatology speciality.

Volume 10 â&#x20AC;˘ number 1 â&#x20AC;˘ WINTER 2016 Registration Now open: www.GaDermPA.org

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

2015-16 SDPA Board of Directors PRESIDENT Matthew Brunner, MHS, PA-C PRESIDENT-ELECT Jennifer Conner, MPAS, PA-C IMMEDIATE PAST PRESIDENT Vicki Roberts, MPAS, PA-C VICE PRESIDENT Jacki Kment, MPAS, PA-C SECRETARY / TREASURER Joleen Volz, MPAS, PA-C DIRECTORS AT LARGE Jane Mast, PA-C Matt Dohlman, PA-C Gina Mangin, MPAS, PA-C Mark Hyde, MMS, PA-C

editorial missioN: The JDPA is the official clinical journal of the Society of Dermatology Physician Assistants. The mission of the JDPA is to improve dermatological patient care by publishing the most innovative, timely, practiceproven educational information available for the physician assistant profession. PUBLISHED CONTENT IN THE JDPA: Statements and opinions expressed in the articles and communications herein are those of the authors and not necessarily those of the Publisher or the Society of Dermatology Physician Assistants (SDPA). The Publisher and the SDPA disclaim any responsibility or liability for such material, including but not limited to any losses or other damage incurred by readers in reliance on such content. Neither Publisher nor SDPA verify any claims or other information appearing in any of the advertisements contained in the publication and cannot take responsibility for any losses or other damage incurred by readers in reliance on thereon. Neither Publisher nor SDPA guarantees, warrants, or endorses any product or service advertised in this publication, nor do they guaranty any claim made by the manufacturer of such product or service. This Issue: The JDPA includes articles that have been reviewed and approved for Category I (Preapproved) CME credit by the American Academy of Physician Assistants. Approval is valid for 1 year from the issue date, and participants may submit the self-assessment at any time during that period. Category I CME articles included in JDPA are planned and developed in accordance with AAPA’s CME Standards for Journal Articles and for Commercial Support of Journal Articles. going green: Since its inception, the JDPA has utilized eco-friendly printing practices. The JDPA is printed on paper obtained from sustainable forests that meet strict environmental standards. Soy-based inks that have a low environmental impact are used during printing of the journal and the journal is printed using 100% renewable energy. SDPA members may join us in our efforts and opt to receive the JDPA in digital format.

Publishing Staff Managing Editor Jennifer M. Hayden, M.Ed Copy Editor Douglas Morris Art Director Angela Simiele Website Design Terry Scanlon SALES Office Physician Assistant Communications, LLC P.O. Box 416, Manlius NY 13104-0416 Phone (315) 663-4147 PAC@pacommunications.org www.pacommunications.org To read the JDPA publication’s Ethics and Malpractice Statement, please visit www.jdpa.org/write.html. keep current with the SDPA:

JDPA/Journal of Dermatology for Physician Assistants (ISSN 1938-9574) is published quarterly (4 issues per volume, one volume per year) by Physician Assistant Communications, LLC, P.O. Box 416, Manlius NY 13104-0416. Volume 10, Number 1, Winter 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. THIS ISSUE IS SPONSORED BY

Journal of Dermatology for Physician Assistants

Editor’s Message

y oldest daughter recently participated in her school’s annual science fair. As with every science fair project she had to pick a topic she was interested in, formulate a hypothesis, design an experiment to test her hypothesis, and present the results to her classmates and teachers. To no ones surprise in our family she decided to test the effectiveness of different SPF sunscreens. As part of the school’s science fair, the students were expected to explain why they decided to pursue their various topics. What did surprise us was the fact that my daughter said she decided to pursue her SPF topic because she was inspired by the recent Dermatology PA Foundation (DPAF) Miles for Melanoma (M4M) Run/Walk that our family participated in at the SDPA Fall Dermatology Conference in Orlando. While at the run she had spoken to some of the Melanoma Research Foundation (MRF) volunteers, and they were eager and excited to provide her with information and resources for her research. As her next step, our daughter created a list of questions relating to sun protection and melanoma prevention and sent them via email to the MRF. Within a week the MRF Director of Education sent back a detailed response to every one of her questions as well as going out of her way to include a few links to kid friendly activities and informational websites. This meant the world to my daughter. Watching the whole process unfold brought to light the importance of taking every opportunity to share information with those we come in contact with. The willingness of the MRF volunteers to provide our daughter with information about melanoma prevention sparked a desire in her to not only research sun protection but to share her findings with her entire school community (no doubt sparking someone else’s interest in the subject). Because these volunteers decided to engage in a conversation with an inquisitive child about safe sun practices and melanoma prevention strategies, the message of the MRF continues to be shared with a much broader community. I hope we follow the lead of these volunteers and take advantage of every opportunity we have as dermatology PAs to educate those we come in contact with each day (e.g., our patients and their children, or friends, or family members who come with them to our offices). Planting the seeds of sun protection and melanoma prevention at a young age can result in valuable and positive outcomes for many people. J

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

Volume 10 • number 1 • WINTER 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.

Clinical Research Trials in Dermatology – More Than Skin Deep - Part I By Sandra Morris, PA-C

›› CME 10 Derm PA News & Notes – part one • Certification Review • Student Corner – Calling All PA Students! • SDPA State Affiliates – Things To Do in Austin, Texas…

18 Clinical Dermatology • CME Article –Clinical Research Trials in Dermatology – More Than Skin Deep - Part I • Dermatology Case Report – A Man With Pruritic Bumps Since Childhood

Departments 04 Editorial Board 05 Editor’s Message 09 SDPA News & Current Affairs 10 Dermatology Market Watch 24 From The Patient’s Perspective 26 Clinical Snapshots 32 Surgical Wisdom 38 Cosmetic Pearls 45 Notes from your Office Manager 50 The Difference We Make 55 Camp Discovery 2016 62 Professional Opportunities and Development

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

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

40 Professional Development • Judicial and Ethical Affairs – Defensive Medicine • Outside & Inside the 9 to 5… In Memory of Nancy Primo, MPAS, PA-C

50 Derm PA News & Notes – part two

Go Green & Read On the Go 6

Journal of Dermatology for Physician Assistants

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

dermpa.org

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

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

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

Volume 10 • number 1 • WINTER 2016

Journal of Dermatology for Physician Assistants

FROM THE SDPA

News & Current Affairs Greetings Colleagues,

CALENDAR OF EVENTS 2016 March 74th AAD Annual Academy Meeting March 4 – 8, 2016 Washington, DC JUNE SDPA Summer Dermatology Conference June 1 – 5, 2016 JW Marriott Hotel Austin, TX JULY AAD Summer Meeting July 28 – 31, 2016 Boston, MA NOVEMBER SDPA 14th Annual Fall Dermatology Conference November 3 – 6, 2016 Caesars Palace Las Vegas, NV

Recently, the NCCPA proposed a new model for the PANRE that would drastically change the way you and I maintain our certification. If you haven’t heard about this proposed change, I encourage you to become engaged in this discussion. The format currently favored by NCCPA would require PAs to ‘periodically’ take at home exams covering “a broad range of organ systems and task and skill areas.” In the final years of the ten-year cycle, each PA would take a timed exam in a testing center on one of 10-12 specialty exams selected by the PA. If a PA scores in the ‘exceptional’ range on the specialty exam, he/she would qualify for a Certificate of Added Qualification. This model poses a number of concerns to me as a practicing PA. I already spend a great deal of time and financial resources maintaining my required one hundred hours of CME during every two-year cycle. This is in addition to the time, money, and energy that go into preparing for a recertification exam every six years, now transitioning to every ten years. We also have new CME requirements of forty hours of Self Assessment and forty hours of Performance Improvement CME over the first eight years of the new ten-year cycle. Finally, the actual cost to PAs of this new model of recertification has not been determined. The SDPA has written a letter to the NCCPA asking them to not make additional changes to the recertification model while PAs adjust to the new tenyear cycle and the new Self Assessment and Performance Improvement CME requirements. The SDPA is also concerned that more testing will increase both the cost and the time that individual PAs spend on recertification. The NCCPA is right to point out that for forty years they have served the profession as our certification body. While that certification exists to serve the interests of patients and the public in providing confidence in the skills of individual PAs, the NCCPA also exists as a service to the PA professionals who hold that certification. The SDPA and the AAPA oppose Certificates of Added Qualification since they have the potential to limit PAs’ ability to move from specialty to specialty. This flexibility is particularly important for PAs since in most cases we are employees and not employers. It does not improve patient access if failure to have a Certificate of Added Qualification either prevents PAs from entering a specialty or being reimbursed by an insurer for their services. To learn more about the NCCPA’s proposed model visit: https://www. nccpa.net/panre-model. To submit questions or comments email: newpanre@ nccpa.net. I encourage you to take the time to become engaged in this important discussion. J In service to you,

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

Volume 10 • number 1 • WINTER 2016

Dermatology PA news & notes

Dermatology Market Watch Valeant Dermatology To Award Scholarships in 2016 to Students and Mothers Pursuing Undergraduate and Graduate Degrees Nine $10,000 Scholarships to be Awarded on July 1, 2016 Valeant Dermatology, a division of Valeant Pharmaceuticals North America LLC, recently announced the launch of the Valeant Dermatology ASPIRE HIGHER Scholarship Program that will award scholarships of up to $10,000 each to nine individual students who will be attending an undergraduate or graduate education program during the 2016 to 2017 school year. The scholarships recognize students who have been diagnosed and treated for a dermatologic condition and are pursuing a higher education degree. Applicants need not have used a Valeant dermatologic prescription medication to be eligible, and use of a Valeant product will not increase an applicant's chance of being awarded a scholarship. Three scholarships will be awarded in three different categories: • Undergraduate Scholar Awards - for students pursuing an undergraduate degree. • Graduate Scholar Awards - for students pursuing a graduate degree. • Today's Woman Scholar Awards - for students who are mothers pursuing either a graduate or undergraduate degree. "Since 2013 Valeant Dermatology has supported students in achieving their higher education goals through our scholarship programs. We understand the burden that a skin condition can inflict on patients and applaud their

aspirations and accomplishments," said Deb Jorn, Executive Vice President and Company Group Chairman of Valeant Dermatology. "We're particularly excited to be expanding our awards this year to honor graduate school students, as well as mothers who often face added challenges while pursuing their degrees." Applicants are required to submit a 500-word essay describing the impact their dermatologic condition has had on their life and the role their healthcare practitioner has played in helping treat their condition. Other application requirements include two letters of recommendation and information on their current school and community activities. Applications will be accepted from February 1, 2016 through April 30, 2016 and the winners will be named on July 1, 2016. To apply for a scholarship go to www.ValeantAspireHigher.com. Students eligible for the scholarship are those who have been diagnosed with a dermatologic condition at some point in their life, were under the care of a dermatologist, PA, or nurse practitioner and have used a prescription medication from any manufacturer as treatment. All applicants must have applied to, have been accepted to or are currently attending an accredited college, university or advanced vocational or technical school in 2016. Please visit the website at www. ValeantAspireHigher.com to learn more about the Valeant Scholarship Program. J

Glytone KP Kit While Keratosis Pilaris (KP) tends to get worse in the winter when skin is at its driest and humidity is low, it can be a year-round problem for those with allergies and/or allergy-prone skin. While there is no cure, your skin can look and feel noticeably smoother in two simple steps thanks to the highly effective Glytone KP Kit. Glytone puts together all the essentials to provide dry skin relief, effectively reducing the appearance of unsightly, red bumps and rough, dry patches: Glytone Exfoliating Body Wash, Glytone Body Lotion and a free body pouf. The convenient two-step body care system also retexturizes skin for renewed smoothness, hydration and suppleness. Each innovative formula in the kit contains a high 10 Journal of Dermatology for Physician Assistants

concentration of Glytone's Free Glycolic Acid, which offers superior penetration, allowing for highly effective enhanced exfoliation and retexturization. Glytone's pure Glycolic Acid works by dissolving the bonds between skin cells, which helps to increase the turnover of fresh, healthy cells. Infused with a fresh, clean scent, Glytone Exfoliating Body Wash with 8.8 Free Acid Value (Glycolic Acid) works beautifully with the soft nylon body pouf to efficiently slough off the buildup of dry, dead cells that can otherwise clog follicles, revealing smoother, fresher and more supple skin. Glytone Body Lotion with 17.5 Free Acid Value (Glycolic Acid) retexturizes treated areas, leaving skin smoother and silky soft. The body-smoothing formula is enhanced with Allantoin to soothe, Glycerin to hydrate and Tocopheryl Acetate for powerful antioxidant protection. The Glytone KP Kit provides the ultimate skin-smoothing trio for anyone who wants to get skin in show-off shape all through the last days of winter and beyond. Because everyone deserves the right to bare, beautiful, smooth arms and legs! J ...continued on page 13

only isotretinoin therapy supported with “The PROMISE” Living with severe recalcitrant nodular acne

is challenging enough. Let The Promius PromiseTM program help guide your patients through the requirements. ZenataneTM (Isotretinoin Capsules USP) is the only isotretinoin with The Promius Promise. Support to help your patients stay on track: • A live, US-based call center available weekdays 8AM-11PM ET and Saturdays 9AM-3PM ET • Answers to questions regarding requirements and insurance coverage • Automatic application of $0 co-pay or money-saving rebates for eligible patientsa • Facilitation of no-cost shipping anywhere patients are located in the contiguous United States

Please call 1-888-959-7600 for eligibility requirements.

Talk to your patients about ZENATANE with The Promius Promise Zenatane (Isotretinoin Capsules USP) 10 mg, 20 mg, 30 mg and 40 mg Capsules INDICATION Zenatane is indicated for the treatment of severe recalcitrant nodular acne. Because of significant adverse effects associated with its use, Zenatane should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. In addition, Zenatane is indicated only for those female patients who are not pregnant, because Zenatane can cause severe birth defects. CAUSES BIRTH DEFECTS

DO NOT GET PREGNANT CONTRAINDICATIONS AND WARNINGS Zenatane must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking Zenatane in any amount, even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining whether an exposed fetus has been affected. Birth defects which have been documented following Zenatane exposure include abnormalities of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands. Cases of IQ scores less than 85 with or without other abnormalities have been reported. There is an increased risk of spontaneous abortion, and premature births have been reported. Documented external abnormalities include: skull abnormality; ear abnormalities (including anotia, micropinna, small or absent external auditory canals); eye abnormalities (including microphthalmia); facial dysmorphia; cleft palate. Documented internal abnormalities include: CNS abnormalities (including cerebral abnormalities, cerebellar malformation, hydrocephalus, microcephaly, cranial nerve deficit); cardiovascular abnormalities; thymus gland abnormality; parathyroid hormone deficiency. In some cases death has occurred with certain of the abnormalities previously noted. If pregnancy does occur during treatment of a female patient who is taking Zenatane, Zenatane must be discontinued immediately and she should be referred to an Obstetrician-Gynecologist experienced in reproductive toxicity for further evaluation and counseling. Special Prescribing Requirements Because of Zenatane teratogenicity and to minimize fetal exposure, Zenatane is approved for marketing only under a special restricted distribution program approved by the Food and Drug Administration. This program is called iPLEDGE™. Zenatane must only be prescribed by prescribers who are registered and activated with the iPLEDGE program. Zenatane must only be dispensed by a pharmacy registered and activated with iPLEDGE, and must only be dispensed to patients who are registered and meet all the requirements of iPLEDGE (see PRECAUTIONS). Other serious side effects include depression, psychosis and rarely, suicidal ideation, suicide attempts and suicide, aggressive and/or violent behavior, pseudotumor cerebri, pancreatitis, hearing impairment, inflammatory bowel disease, skeletal changes, hyperostosis, premature epiphyseal closure, vision impairment, corneal opacities and decreased night vision. Please see adjacent page for Brief Summary of Prescribing Information or visit www.zenatane.com for Full Prescribing Information. iPLEDGETM is a trademark owned by McKesson Specialty Arizona Inc. Questions about iPLEDGE? Call 1.866.495.0654 or visit www.ipledgeprogram.com Copyright© 2015. Marketed by Promius Pharma, a wholly owned subsidiary of Dr. Reddy’s Laboratories, Inc. Princeton, NJ 08540 Based on PI: 150058463 Revised 11/2014. Printed in the U.S.A. ZNT-1015-139 11/15

Volume 10 • number 1 • WINTER 2016 11

BRIEF SUMMARY OF PRESCRIBING INFORMATION See package insert for Full Prescribing Information, Medication Guide and iPLEDGE R.E.M.S. information or visit www.zenatane.com. CAUSES BIRTH DEFECTS

DO NOT GET PREGNANT

CONTRAINDICATIONS AND WARNINGS Zenatane™ must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking Zenatane™ in any amount, even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining whether an exposed fetus has been affected. Birth defects which have been documented following Zenatane™ exposure include abnormalities of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands. Cases of IQ scores less than 85 with or without other abnormalities have been reported. There is an increased risk of spontaneous abortion and premature births have been reported. Documented external abnormalities include: skull abnormality; ear abnormalities (including anotia, micropinna, small or absent external auditory canals); eye abnormalities (including microphthalmia); facial dysmorphia; cleft palate. Documented internal abnormalities include: CNS abnormalities (including cerebral abnormalities, cerebellar malformation, hydrocephalus, microcephaly, cranial nerve deficit); cardiovascular abnormalities; thymus gland abnormality; parathyroid hormone deficiency. In some cases death has occurred with certain of the abnormalities previously noted. If pregnancy does occur during treatment of a female patient who is taking Zenatane™, Zenatane™ must be discontinued immediately and she should be referred to an Obstetrician-Gynecologist experienced in reproductive toxicity for further evaluation and counseling. Special Prescribing Requirements Because of Zenatane™ teratogenicity and to minimize fetal exposure, Zenatane™ is approved for marketing only under a special restricted distribution program approved by the Food and Drug Administration. This program is called iPLEDGE™.

Table 1 Monthly Required iPLEDGE Interactions Female Patients of Childbearing Potential

Male Patients, And Female Patients Not of Childbearing Potential

PRESCRIBER Confirms patient counseling

Enters the 2 contraception methods

Enters pregnancy test results

PATIENT Answers educational questions before every prescription

Enters 2 forms of contraception

PHARMACIST Contacts system to get an authorization

INDICATIONS AND USAGE Severe Recalcitrant Nodular Acne Zenatane™ is indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. “Severe,” by definition means “many” as opposed to “few or several” nodules. Because of significant adverse effects associated with its use, Zenatane™ should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. In addition, Zenatane™ is indicated only for those female patients who are not pregnant, because Zenatane™ can cause severe birth defects. CONTRAINDICATIONS Pregnancy: Category X. Allergic Reactions - Zenatane™ is contraindicated in patients who are hypersensitive to this medication or to any of its components. WARNINGS Psychiatric Disorders Zenatane™ may cause depression, psychosis and, rarely, suicidal ideation, suicide attempts, suicide, and aggressive and/or violent behaviors. No mechanism of action has been established for these events. Prescribers should read the brochure, Recognizing Psychiatric Disorders in Adolescents and Young Adults: A Guide for Prescribers of Isotretinoin. Prescribers should be alert to the warning signs of psychiatric disorders to guide patients to receive the help they need. Therefore, prior to initiation of Zenatane™ therapy, patients and family members should be asked about any history of psychiatric disorder, and at each visit during therapy patients should be assessed for symptoms of depression, mood disturbance, psychosis, or aggression to determine if further evaluation may be necessary. Patients should stop Zenatane™ and the patient or a family member should promptly contact their prescriber if the patient develops depression, mood disturbance, psychosis, or aggression, without waiting until the next visit. Discontinuation of Zenatane™ therapy may be insufficient; further evaluation may be necessary. A referral to a mental health professional may be necessary. The physician should consider

whether Zenatane™ therapy is appropriate in this setting; for some patients the risks may outweigh the benefits of Zenatane™ therapy. Pseudotumor Cerebri Zenatane™ use has been associated with a number of cases of pseudotumor cerebri (benign intracranial hypertension), some of which involved concomitant use of tetracyclines. Concomitant treatment with tetracyclines should therefore be avoided. Serious Skin Reactions There have been post-marketing reports of erythema multiforme and severe skin reactions [e.g., Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN)] associated with Zenatane™ use. Pancreatitis Acute pancreatitis has been reported in patients with either elevated or normal serum triglyceride levels. Lipids Elevations of serum triglycerides in excess of 800 mg/dL have been reported in patients treated with Zenatane™. Hearing Impairment Impaired hearing has been reported in patients taking Zenatane™. Hepatotoxicity Clinical hepatitis considered to be possibly or probably related to Zenatane™ therapy has been reported. Inflammatory Bowel Disease Zenatane™ has been associated with inflammatory bowel disease in patients without a prior history of intestinal disorders. Skeletal Bone Mineral Density Effects of multiple courses of Zenatane™ on the developing musculoskeletal system are unknown. There is some evidence that long-term, high-dose, or multiple courses of therapy with Zenatane™ have more of an effect than a single course of therapy on the musculoskeletal system. Hyperostosis A high prevalence of skeletal hyperostosis was noted in clinical trials for disorders of keratinization with a mean dose of 2.24 mg/kg/day. Additionally, skeletal hyperostosis was noted in six of eight patients in a prospective study of disorders of keratinization. Premature Epiphyseal Closure There are spontaneous reports of premature epiphyseal closure in acne patients receiving recommended doses of Zenatane™. Vision Impairment Visual problems should be carefully monitored. All Zenatane™ patients experiencing visual difficulties should discontinue Zenatane™ treatment and have an ophthalmological examination. Corneal Opacities Corneal opacities have occurred in patients receiving Zenatane™ for acne and more frequently when higher drug dosages were used in patients with disorders of keratinization. Decreased Night Vision Decreased night vision has been reported during Zenatane™ therapy and in some instances the event has persisted after therapy was discontinued. Because the onset in some patients was sudden, patients should be advised of this potential problem and warned to be cautious when driving or operating any vehicle at night. PRECAUTIONS Zenatane™ must only be prescribed by prescribers who are registered and activated with the iPLEDGE program. Zenatane™ must only be dispensed by a pharmacy registered and activated with iPLEDGE, and must only be dispensed to patients who are registered and meet all the requirements of iPLEDGE. Registered and activated pharmacies must receive Zenatane™ only from wholesalers registered with iPLEDGE. Prescribers To prescribe Zenatane™, the prescriber must be registered and activated with the pregnancy risk management program iPLEDGE. Prescribers can register by signing and returning the completed registration form. Prescribers can only activate their registration by affirming that they meet requirements and will comply with all iPLEDGE requirements. Isotretinoin must only be prescribed to female patients who are known not to be pregnant as confirmed by a negative CLIA-certified laboratory conducted pregnancy test.

soles, photoallergic/photosensitizing reactions, pruritus, pyogenic granuloma, rash (including facial erythema, seborrhea, and eczema), Stevens-Johnson syndrome, sunburn susceptibility increased, sweating, toxic epidermal necrolysis, urticaria, vasculitis (including Wegener’s granulomatosis), abnormal wound healing (delayed healing or exuberant granulation tissue with crusting). Special Senses Hearing: hearing impairment, tinnitus. Vision: corneal opacities, decreased night vision which may persist, cataracts, color vision disorder, conjunctivitis, dry eyes, eyelid inflammation, keratitis, optic neuritis, photophobia, visual disturbances. Urinary System: glomerulonephritis, nonspecific urogenital findings. Laboratory Elevation of plasma triglycerides, decrease in serum high-density lipoprotein (HDL) levels, elevations of serum cholesterol during treatment Increased alkaline phosphatase, SGOT (AST), SGPT (ALT), GGTP or LDH Elevation of fasting blood sugar, elevations of CPK, hyperuricemia Decreases in red blood cell parameters, decreases in white blood cell counts, elevated sedimentation rates, elevated platelet counts, thrombocytopenia White cells in the urine, proteinuria, microscopic or gross hematuria Drug Interactions • Vitamin A: Patients should be advised against taking vitamin supplements containing vitamin A to avoid additive toxic effects. • Tetracyclines: Concomitant treatment of tetracyclines should be avoided because Zenatane™ use has been associated with a number of cases of pseudotumor cerebri (benign intracranial hypertension). • Micro-dosed Progesterone Preparations: Micro-dosed progesterone preparations may be an inadequate method of contraception during Zenatane™ therapy. It is not known if hormonal contraceptives differ in their effectiveness when used with Zenatane™. Therefore, it is critically important for female patients of childbearing potential to select and commit to use two forms of effective contraception simultaneously, at least one of which must be a primary form. • Norethindrone/ethinyl estradiol: In a study of 31 premenopausal female patients with severe recalcitrant nodular acne receiving OrthoNovum® 7/7/7 Tablets as an oral contraceptive agent, Zenatane™ at the recommended dose of 1 mg/kg/day, did not induce clinically relevant changes in the pharmacokinetics of ethinyl estradiol and norethindrone and in the serum levels of progesterone, follicle-stimulating hormone (FSH) and luteinizing hormone (LH). • St. John’s Wort: Zenatane™ use is associated with depression in some patients. Patients should be prospectively cautioned not to self-medicate with the herbal supplement St. John’s Wort because a possible interaction has been suggested with hormonal contraceptives based on reports of breakthrough bleeding on oral contraceptives shortly after starting St. John’s Wort. Pregnancies have been reported by users of combined hormonal contraceptives who also used some form of St. John’s Wort. • Phenytoin: Zenatane™ has not been shown to alter the pharmacokinetics of phenytoin in a study in seven healthy volunteers. These results are consistent with the in vitro finding that neither isotretinoin nor its metabolites induce or inhibit the activity of the CYP 2C9 human hepatic P450 enzyme. Phenytoin is known to cause osteomalacia. No formal clinical studies have been conducted to assess if there is an interactive effect on bone loss between phenytoin and Zenatane™. Therefore, caution should be exercised when using these drugs together. • Systemic Corticosteroids: Systemic corticosteroids are known to cause osteoporosis. Therefore, caution should be exercised when using these drugs together. OVERDOSAGE In humans, overdosage has been associated with vomiting, facial flushing, cheilosis, abdominal pain, headache, dizziness, and ataxia. These symptoms quickly resolve without apparent residual effects. Zenatane™ causes serious birth defects at any dosage. Female patients of childbearing potential who present with isotretinoin overdose must be evaluated for pregnancy. Patients who are pregnant should receive counseling about the risks to the fetus. Nonpregnant patients must be warned to avoid pregnancy for at least one month and receive contraceptive counseling. Educational materials for such patients can be obtained by calling the manufacturer. Because an overdose would be expected to result in higher levels of isotretinoin in semen than found during a normal treatment course, male patients should use a condom, or avoid reproductive sexual activity with a female patient who is or might become pregnant, for one month after the overdose. All patients with isotretinoin overdose should not donate blood for at least one month.

Pharmacists Isotretinoin must only be dispensed by a pharmacy registered and activated with the pregnancy risk management program iPLEDGE and only when the registered patient meets all the requirements of the iPLEDGE program. The Responsible Site Pharmacist SPECIFIC POPULATIONS must register the pharmacy by signing and returning the completed registration form. Pregnancy: Category X. Nursing Mothers ADVERSE REACTIONS It is not known whether this drug is excreted in human milk. Nursing mothers should Clinical Trials and Post-marketing Surveillance not receive Zenatane™. The adverse reactions listed below reflect the experience from investigational studies Pediatric Use of Zenatane™ and the postmarketing experience. The relationship of some of these The use of Zenatane™ in pediatric patients less than 12 years of age has not been events to Zenatane™ therapy is unknown. studied. The use of Zenatane™ for the treatment of severe recalcitrant nodular Dose Relationship acne in pediatric patients ages 12 to 17 years should be given careful consideration, Cheilitis and hypertriglyceridemia are usually dose related. Most adverse reactions especially for those patients where a known metabolic or structural bone disease reported in clinical trials were reversible when therapy was discontinued; however, exists. some persisted after cessation of therapy. Geriatric Use Body as a Whole: allergic reactions, including vasculitis, systemic hypersensitivity, Clinical studies of isotretinoin did not include sufficient numbers of subjects aged edema, fatigue, lymphadenopathy, weight loss. 65 years and over. Cardiovascular: palpitation, tachycardia, vascular thrombotic disease, stroke. Endocrine/Metabolic: hypertriglyceridemia, alterations in blood sugar levels HOW SUPPLIED/STORAGE AND HANDLING Gastrointestinal: inflammatory bowel disease, hepatitis, pancreatitis, bleeding and Zenatane is supplied in 10 mg, 20 mg, 30 mg and 40 mg Capsules. inflammation of the gums, colitis, esophagitis/esophageal ulceration, ileitis, nausea, Store at 68° to 77°F (20° to 25°C). [See USP Controlled Room Temperature]. and other nonspecific gastrointestinal symptoms. Protect from light. Hematologic: allergic reactions, anemia, thrombocytopenia, neutropenia, rare reports of agranulocytosis. Please see www.zenatane.com for Full Prescribing Information. Musculoskeletal: skeletal hyperostosis, calcification of tendons and ligaments, premature epiphyseal closure, decreases in bone mineral density, musculoskeletal Rx Only symptoms (sometimes severe) including back pain, myalgia, and arthralgia, transient Manufactured by: pain in the chest, arthritis, tendonitis, other types of bone abnormalities, elevations Cipla Limited of CPK/rare reports of rhabdomyolysis. Kurkumbh Village Neurological: pseudotumor cerebri, dizziness, drowsiness, headache, insomnia, Pune – 413 802 INDIA lethargy, malaise, nervousness, paresthesias, seizures, stroke, syncope, weakness Manufactured for: Psychiatric: suicidal ideation, suicide attempts, suicide, depression, psychosis, Dr. Reddy’s Laboratories Limited aggression, violent behaviors, emotional instability. Bachupally– 500 090 INDIA Of the patients reporting depression, some reported that the depression subsided with discontinuation of therapy and recurred with reinstitution of therapy. OrthoNovum 7/7/7 is a registered trademark of Ortho-McNeil Pharmaceuticals, Inc. Reproductive System: abnormal menses. Respiratory: bronchospasms (with or without a history of asthma), respiratory iPLEDGE™ is a trademark owned by McKesson Specialty Arizona, Inc. infection, voice alteration. Questions about iPLEDGE? Call 1.866.495.0654 or visit www.ipledgeprogram.com Skin and Appendages: acne fulminans, alopecia (which in some cases persists), Copyright© 2015. Marketed by Promius Pharma, a wholly owned subsidiary of bruising, cheilitis (dry lips), dry mouth, dry nose, dry skin, epistaxis, eruptive Dr. Reddy’s Laboratories, Inc. Princeton, NJ 08540 xanthomas,erythema multiforme, flushing, fragility of skin, hair abnormalities, Based on PI: 150058463 Revised 11/2014. Printed in U.S.A. ZNT-1015-139. 11/15. hirsutism, hyperpigmentation and hypopigmentation, infections (including disseminated herpes simplex), nail dystrophy, paronychia, peeling of palms and

12 Journal of Dermatology for Physician Assistants

Certification Review

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

QUESTION: A 68-year-old male, with a history of hypertension and diabetes mellitus type II, presents to the office with palpitations. Patient denies shortness of breath, cough, or fever. Physical examination reveals blood pressure 164/88 mm Hg, pulse 110/minute, and respiratory rate 16/minute. Pulmonary exam is normal. Cardiac exam reveals tachycardia without murmur. The remainder of the exam is normal. EKG is noted below.

EXPLANATION: Atrial fibrillation is most commonly noted in elderly patients and presents with palpitations. Hypertensive heart disease and coronary heart disease are the most common underlying chronic disorders in patients with atrial fibrillation. EKG noted above reveals an irregularly irregular heart rate with no discernable p wave activity, consistent with atrial fibrillation. Patients with atrial fibrillation are at an increased risk for the development of arterial thromboembolism; the most clinically evident thromboembolic event is ischemic stroke.sudden stop inspiration when palpating the right upper quadrant; it is noted in cholecystitis. J The correct answer is A.

This patient is at a high risk for development of which of the following disorders? A. Arterial thromboembolism B. Tonic-clonic seizure C. Mitral regurgitation D. Aseptic pericarditis E. Thyrotoxicosis

James A. Van Rhee, MS, PA-C, is the Program Director for the Yale University School of Medicine Physician Associate Program. Mr. Van Rhee has been involved in physician assistant education for 20 years. He has served as project director and test item writer for the Physician Assistant Education Association’s (PAEA) Physician Assistant Clinical Knowledge Rating Assessment Tool (PACKRAT) and is the author of the Physician Assistant: Certification and Re-certification Review Book, published by Elsevier. For the last fifteen years he has been course director and presenter of the Physician Assistant Board Review, which is now being produced live online by Kaplan Medical.

Dermatology Market Watch ...continued from page 10 Leo Pharma Announced FDA Approval of Enstilar LEO Pharma Inc. announced in the Fall of 2015 that Enstilar® had been approved by the U.S. Food and Drug Administration (FDA) for the topical treatment of plaque psoriasis in adults 18 years of age and older. Enstilar® is a once-daily, alcohol free foam formulation in a pressurized spray can that allows application across large body areas of plaque psoriasis. In the pivotal Phase 3 clinical trial, over half of patients treated with Enstilar® were "Clear" or "Almost Clear" by Week 4 as assessed by the Investigator Global

Assessment (IGA) score of disease severity. Additionally, more than half of patients treated with Enstilar® achieved a 75% improvement in Psoriasis Area and Severity Index (PASI) score from baseline. Adverse reactions were reported in less than 1% of patients treated with Enstilar® and included application site irritation, application site pruritus, folliculitis, skin hypopigmentation, hypercalcemia, urticaria, and exacerabation of psoriasis. For more information, visit Enstilar.com. J

...continued on page 14 Volume 10 • number 1 • WINTER 2016 13

DERmatology pa news & notes

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!

Dermatology Market Watch ...continued from page 13 Update on Removal of Your Ability to Prescribe Isotretinoin By Abby A. Jacobson, MS, PA-C SDPA Representative to the iPLEDGE Program

DERmatology pa news & notes

Don't risk being removed/deactivated from the iPLEDGE system. A question I often get asked is if you have a non-compliant patient or have a patient become pregnant while enrolled in the iPLEDGE system, will you as the prescriber be deactivated from iPLEDGE? As long as you (and your designees) follow the iPLEDGE program requirements you will not be locked out. If you falsify something or try to get around the requirements of iPLEDGE, then you may face deactivation (even if your patient did not become pregnant!). The bottom line is even

when the program is frustrating or we are trying to help a patient avoid additional work (or expenses) we cannot take short cuts when it comes to iPLEDGE. Anything less then total compliance risks removal of this life changing drug from the market plus your own inability to write this medication for your patients. Don't put your reputation and access to this medication in jeopardy - follow every single iPLEDGE requirement. Make sure all of your offices’ staff and designees understand the program as well as ways to avoid intentional (or unintentional) falsification.

On September 14, 2012 the iPLEDGE Program Non-Compliance Action Policy (NCAP) went into effect for the iPLEDGE Program in order to codify the Program’s ongoing non-compliance efforts. As a part of the Sponsors’ efforts to further improve the effectiveness of the NCAP based on lessons learned since the NCAP was implemented, beginning on December 31, 2015 the Sponsors implemented a revision to the NCAP. iPLEDGE NCAP Version 6.0 can be viewed in its entirety at www.ipledgeprogram.com/ documents%5CNon-Compliance%20Action%20Policy.pdf. The following is an excerpt from Table 2 in NCAP Version 6.0, which includes all actions that may lead to the permanent deactivation of a prescriber or designee from the iPLEDGE Program: Prescribers: • Prescriber dispensed medication directly to patient, regardless of patient status • Intentional falsification of pregnancy test results (including incorrect sample collection date) • 2 Warnings in a 60-day period • Permanent Deactivation of two designees for the same prescriber within a rolling 12-month period • Intentional falsification of patient classification type determined to be an attempt to violate program requirements • Intentional falsification of contraception methods. Prescriber instructed patient to enter different contraception methods from what she was using in order to match the prescriber’s contraception choices thereby allowing her to complete her contraception comprehension exam and obtain drug • Intentional misuse of the Serious Medical Reasons Exemption process Designees: • Designee dispensed medication directly to patient, regardless of patient status • Intentional falsification of pregnancy test results (including incorrect sample collection date) • 2 Warnings in a 60-day period • Intentional falsification of patient classification type determined to be an attempt to violate program requirements • Intentional falsification of contraception methods. Designee instructed patient to enter different contraception methods from what she was using in order to match the designee’s contraception choices thereby allowing her to complete her contraception comprehension and obtain drug J If you have questions regarding this issue or any issue related to compliance with iPLEDGE please feel free to contact the SDPA’s representative to the iPLEDGE Program, Abby A. Jacobson, MS, PA-C at ajacobson@dermpa.org. 14 Journal of Dermatology for Physician Assistants

FEWER RECURRENCES

MORE FREEDOM TO GO WITH THE FLOW www.

.com

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SITAVIG safely and effectively. The physician should be thoroughly familiar with the complete Prescribing Information before prescribing the product. SITAVIG (acyclovir) buccal tablets Initial U.S. Approval: 1982

ADVERSE REACTIONS

INDICATIONS AND USAGE

DRUG INTERACTIONS

DOSAGE AND ADMINISTRATION

USE IN SPECIFIC POPULATIONS

SITAVIG is indicated for the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults. • Application of one SITAVIG 50mg buccal tablet as a single dose to the upper gum (canine fossa) region. • SITAVIG should be applied within one hour after the onset of prodromal symptoms and before the appearance of any signs of herpes labialis. • Do not crush, chew, suck or swallow tablets.

DOSAGE FORMS AND STRENGTHS 50mg buccal tablets.

CONTRAINDICATIONS

Known hypersensitivity to acyclovir, milk protein concentrate, or any other component of the product.

Most common adverse reactions (≥1%) are: headache and application site pain. To report SUSPECTED ADVERSE REACTIONS, contact Cipher Pharmaceuticals U.S. LLC at 1-800-499-4468 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Due to the low dose and minimal systemic absorption of SITAVIG, drug interactions are unlikely. Nursing Mothers: Caution should be exercised when administered to a nursing woman. Learn more at www.Sitavig.com Manufactured By: Farméa 10 rue Bouché Thomas ZAC d’orgemont 49 000 Angers - France

Distributed By: Cipher Pharmaceuticals U.S. LLC Charleston, SC 29401 1-800-499-4468 www.cipherpharma.com

Volume 10 • number 1 • WINTER 2016 15

DERmatology pa news & notes

Student Corner Calling All PA Students! The SDPA is holding its Annual Summer Dermatology Conference June 1 â&#x20AC;&#x201C; 5, 2016 at the JW Marriott Hotel in Austin, Texas. The SDPA Student Affairs Committee would be honored by your presence and participation at the conference. To help students attend the event, the SDPA is offering 10 free student registrations to the conference ($175 value!). To take advantage of this special offering, send a personal note to the SDPA Student Affairs Committee. Free student registrations are first come PA Students, SDPA Student Affairs Committee Members, AAPA first serve. Please visit www.dermpa.org past-President John McGinnity, MS, PA-C, and SDPA past-President Vicki Roberts, MPAS, PA-C in attendance at the 12th Annual Fall to become an SDPA student member. Dermatology Conference in San Diego, California in 2014. Sign up for the conference, view the conference program, and make a hotel reservation at www. sdpaconferences.org. Please join us for applicable learning opportunities through a variety of foundational speakers. Workshops are also available for hands-on skills used in the practice of dermatology. The SDPA Student Affairs Committee will be in full attendance, and we would love to have SDPA Student Affairs Committee Members and fellow PA Students in attendance at the you there! We encourage you 13th Annual Fall Dermatology Conference in Orlando, Florida in November 2015. to join us for our committee meeting to see what goes on behind the scenes, and of course for student-only activities! This is a great opportunity to connect with other students who are interested in becoming dermatology PAs, as well as to meet dermatology PAs currently in the workforce. Please contact Maria Kelly, PA-S2, at mkelly@dermpa.org for your unique conference registration code or if you have any additional questions. Thank you and we look forward to seeing you in Austin! J Sincerely, Maria Kelly, PA-S2 SDPA Student Affairs Committee Senior Student Coordinator

Brittney Franley, PA-S2

SDPA Student Affairs Committee Junior Student Coordinator

Stephanie Palazzolo, PA-C

SDPA Student Affairs Committee Recent Graduate Advisor 16 Journal of Dermatology for Physician Assistants

SDPA State Affiliates

Things To Do in Austin, Texas While Attending the SDPA Annual Summer Dermatology Conference

The SDPA is excited to hold their Annual Summer Dermatology Conference in Austin, Texas this June. The Constituent Relations Committee has contacted some SDPA members who are Austin residents in order to identify the “Best of Austin,” which should not be missed. Enjoy!

FOOD Asian Fusion/Sushi - Uchi Featured in GQ magazine as one of the top restaurants in the US! www.uchiaustin.com Doughnuts - Gourdough’s Doughnuts Visit the airstream trailer on South 1st Street or their brick and mortar on W 5th street and get ready to experience a REAL doughnut! The flying pig is our favorite! www.gourdoughs.com Pizza - Home Slice Enjoy a stroll down South Congress Ave while you explore the eclectic shops and Austin’s favorite pizza joint. Meatball is our favorite! www.homeslicepizza.com American/SoutHwestern - Ranch 616 By far one of our favorite spots in the city! It is the epitome of Texas with its charming decor and amazing cuisine. Try the pork chops, ranch water, and Mexican coffee. Be sure to call ahead for a reservation. www.theranch616.com Burgers - Hoppdoddys Care for local craft brews and farm to table burgers? Try this AMAZING place! Don’t worry about the line, you can have a drink while you wait. Their ahi tuna burger, truffle fries and Nutella and pretzel milkshakes are to die for! www.hopdoddy.com

BarbeCue - Franklin’s Barbecue If you are REALLY into BBQ, wake up early, pick up some breakfast tacos and head to Franklin’s to get in line. Make sure you are there by 9 AM. Prepare yourself for the BEST barbecue in the US, but you won’t be eating until around noon. Not to worry, they sell Shiner (local beer) to enjoy while waiting in line! www.franklinbarbecue.com Other Great Options - Jo’s coffee shop, South Congress Café, Sway, Garner, Swift’s attic, Moonshine, La Condessa, and Torchy’s tacos. The possibilities are endless.

ACTIVITIES SOCO shopping - Enjoy shops with local flare and some live music! Stand up Paddle Boarding & Kayaking If the weather is right, put on some shades and experience Austin from Lady Bird Lake! You can enjoy the sunshine and paddle with the local turtles and swans. Congress Avenue Bridge Bats - Care to see 750,000 bats flying at one time? Head to the South Congress Bridge at sundown and prepare to be amazed! www.austinot.com/guide-bat-season-in-austin Continental Club - For live music head to the historic Continental Club on South Congress. www.continentalclub.com/Austin.html Driskill Hotel - Visit the oldest operating hotel in Austin where President Lyndon B. Johnson took his wife on their first date. Their historic bar is a great place to meet or enjoy a cocktail. www.driskillhotel.com

TRANSPORTATION Ride in Style! Download Uber or Lyft and you’ll have a personal driver within minutes. So there it is SDPA members, right from our sources! You cannot get any better information than from the locals. For maps, events, restaurants, and everything else about Austin, please visit www.austintexas.org/visit/thingsto-do. Have fun and we’ll see you in Austin! J

Volume 10 • number 1 • WINTER 2016 17

DERmatology pa news & notes

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

Clinic al Dermatology

Clinical Research Trials in Dermatology – More Than Skin Deep - Part I By Sandra Morris, PA-C

›› 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 March 2016. Participants may submit the self-assessment exam at any time during that period. This program was planned in accordance with AAPA’s CME Standards for Enduring Material Programs and for Commercial Support of Enduring Material Programs.

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

Learning Objectives:

1. Understand what the term “informed consent” means. 2. Be able to identify the four phases of a clinical trial. 3. Understand the multi-factorial reasons for the high cost of new molecular entities. 4. Be able to discuss what Good Clinical Research Practice is and why it is so important to the validity of clinical trials. 5. Be able to identify the main documents associated with the development of an ethical clinical trial. 18 Journal of Dermatology for Physician Assistants

Clinical Research Trials in Dermatology – More Than Skin Deep - Part I

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 • number 1 • WINTER 2016 19

Clinical Research Trials in Dermatology â&#x20AC;&#x201C; More Than Skin Deep - Part I

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

Clinical Research Trials in Dermatology – More Than Skin Deep - Part I

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 • number 1 • WINTER 2016 21

Clinical Research Trials in Dermatology â&#x20AC;&#x201C; More Than Skin Deep - Part I

SDPA Members Only Content

CLINIC AL Dermatology

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

22 Journal of Dermatology for Physician Assistants

Clinical Research Trials in Dermatology – More Than Skin Deep - Part I

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.

Sandra Morris, PA-C completed her undergraduate degree in Medical Technology at the University of Southern Mississippi, a Master’s of Science degree in Microbiology and Immunology at the University of Tennessee, and a Master’s of Medical Science in Physician Assistant Studies at Emory University. She currently works at Newnan Dermatology. She has been involved in clinical trial research related to the development of systemic medications for psoriasis and psoriatic arthritis in conjunction with one of her supervising physicians, Dr. Mark Ling, who is owner of a dermatologic research company in Newnan, Georgia. She is currently a member of the American Academy of Physician Assistants, Georgia Association of Physician Assistants, Society of Dermatology Physician Assistants, and Georgia Dermatology Physician Assistants. She has indicated no relationships to disclose relating to the content of this article. Volume 10 • number 1 • WINTER 2016 23

From The Patient’s Perspective Caregiver Fatigue: How To Avoid Burning Out By Mary Antonucci Director of Advocacy & Volunteer Services Melanoma Research Foundation (MRF)

CLINIC AL Dermatology

The JDPA typically features articles written by patients with dermatological illnesses or skin conditions in this From the Patient’s Perspective section. In past issues, we have also highlighted articles written by patient’s caregivers. The article below covers the subject of avoiding burnout as a caregiver (and in particular for those caring for patients battling melanoma). We feel it is greatly valuable for our JDPA audience to read and share this information with patients and their respective caregivers.

Providing care to a sick loved one is a centuries-old act of kindness and loyalty. There is comfort in knowing that your loved one is receiving the best possible care and relationships are often strengthened by this new kind of intimacy. The benefits of caregiving are clear, but what about the toll it can take?

Caregiver Fatigue, or Caregiver Syndrome, as it’s increasingly being referred to by the medical community, is a result of not asking for help and consistently sacrificing yourself and your needs for the benefit of others. Feeling extreme stress over extended periods of time affects your health, motivation, attitude and mood, as well as your ability to cope with your daily responsibilities. Caregivers in poor health cannot provide optimal care for someone else.

AVOIDING BURNOUT

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

Melanoma Research Foundation Contact Information: www.melanoma.org 1411 K Street, NW Suite 800, Washington, DC 20005 MRF Blog: www.melanoma.org/about-us/newspress-room/blog Phone: (800) 673-1290 24 Journal of Dermatology for Physician Assistants

Take a break - Does leaving your loved one’s side make you nervous? Ask a trusted friend or family member to step in and take over for a few hours while you run errands or do something relaxing. Remember, you can’t do everything by yourself. Remember the fundamentals - Make sure you remember to eat and get enough sleep. Take short naps if you need to and talk to your healthcare provider if lack of sleep becomes a problem. Establish healthy boundaries - Well-meaning friends and family members may overwhelm you with phone calls and emails. Don’t feel guilty about not returning every call. Caring Bridge (www.caringbridge. org) is a free service that allows families to stay connected by providing free personalized patient websites. Updating your site and sharing the link is a great way to keep people informed. Ask for help - Accepting help from others isn’t always easy, but it’s important to remember that letting others help you will also help your loved one. People want to help, but may not know how to offer it. Ask for what you need and for those things that would be most helpful to you. Lotsa Helping Hands (www.lotsahelpinghands. com) is a free service that provides families with an organized means of answering the question, “What can I do to help?”

Avoid tunnel vision - Don’t let caregiving take over your entire life. It’s easier to accept a difficult situation if there are other things in your life you find rewarding. While it’s important not to over-commit yourself, be sure to set-aside time for things that give you meaning and purpose. Laugh - You might not feel like laughing right now, but having a good giggle can reduce stress hormones like cortisol. Watch a comedy or laugh with a friend over the absurdity of life. Caregiving may be the hardest job you’ll ever have. If you know the warning signs for burnout and can take steps to avoid it, caregiving may also be the most rewarding experience of your life. For additional information on caregiving, download the Melanoma Research Foundation’s Caregiver Support Guide, written for caregivers, by caregivers available at the MRF website (www.melanoma.org). J

Caregiver’s Bill of Rights I have the right to take care of myself. This is not an act of selfishness. It will give me the ability to take better care of my loved one. I have the right to seek help from others even though my loved one may object. I know the limits of my own endurance and strength. I have the right to maintain parts of my own life that do not include the person I care for just as if (s)he was healthy. I know that I do everything that I reasonably can do for this person. I have the right to do some things just for myself. I have the right to get angry, be depressed and express difficult feelings once in a while. I have the right to reject any attempt by my loved one to make me do things out of guilt or anger. I have the right to get considerations, affection, forgiveness and acceptance for what I do for my loved one, as I offer these in return. I have the right to take pride in what I’m doing. And I have the right to applaud the courage it has taken to meet the needs of my loved one. I have the right to protect my individuality. I also have the right to a life that will sustain me when my loved one no longer needs my full-time help. — Anonymous

Take Home Points for Derm PAs: By Steven K. Shama, MD, MPH, FAAD I would suggest that the readers check the link which leads to an article about Caregiver Fatigue (CF), defined as a debilitating condition brought on by unrelieved, constant caring for a person with a chronic illness, and associated with symptoms of depression, anxiety, and anger.

2. Using a non-traditional definition of CF, I can see CF affecting the person suffering from the chronic illness. After months and years of caring for themselves (along with a separate caregiver) they might develop symptoms of CF. We must ask our patients about this.

1. The first way of looking at the issue of CF is from the classic caregiver perspective, that is, from the perspective of the person who is caring for a loved one who has a chronic illness. It reminds me of the label compassion fatigue, the loss of compassion for the ill person after caring for someone long term. What a terrible feeling this must be to have, and what guilt the caregiver must be feeling. As clinicians, we must ask whether the caregiver may be suffering from CF and its associated pathology, including compassion fatigue and offer help.

3. I realize that we, as clinicians, are caregivers ourselves to our patients, and may suffer from CF. When we take care of someone, do we care “too much” about those patients who have a chronic condition? Might we get depressed, anxious, or angry when we see these patients? We need to recognize the syndrome in us and ask for the same help we recommend to others, for our own health and for the health of our patients. J

Volume 10 • number 1 • WINTER 2016 25

CLINIC AL Dermatology

Share your feelings - You’re probably experiencing a wide range of emotions right now. Give yourself a chance to understand and work through them. Confide in a close friend, a counselor or a support group. Lean on the MRF’s Melanoma Patients Information Page (MPIP) community members. Rest assured, everything you are feeling right now is normal.

Clinical snapshots A Changing Congenital Nevus - Is There Dysplasia? By Andrew Larsen, PA-C

SDPA Members Only Content Figure

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.

Andrew Larsen, PA-C is a graduate of Le Moyne College Physician Assistant Program. He is currently working at Albany ENT & Allergy. Mr. Larsen has indicated no conflicts of interest to disclose relating to the content of this article.

26 Journal of Dermatology for Physician Assistants

FOR CONTROL OF

ACNE

• Turn down inflammatory lesion counts*† — Week 12—ITT: –68.7% vs –39.2% for vehicle (P<.001); Severe: –74.4% vs –33.0% for vehicle (P<.001) • Local tolerability scores (erythema, dryness, scaling, stinging/burning) were assessed at each visit — Mean scores peaked at week 1 and decreased thereafter, and were mostly mild to moderate in severity (ITT, n=217) PRESCRIBE EPIDUO FORTE GEL FOR POWERFUL CONTROL OF MODERATE TO SEVERE ACNE Important Safety Information Indication: Epiduo® Forte (adapalene and benzoyl peroxide) Gel, 0.3%/2.5% is indicated for the topical treatment of acne vulgaris. Adverse Events: In the pivotal study, the most commonly reported adverse reactions (≥1%) in patients treated with Epiduo Forte Gel were skin irritation, eczema, atopic dermatitis and skin burning sensation. Warnings/Precautions: Patients using Epiduo Forte Gel should avoid exposure to sunlight and sunlamps and wear sunscreen when sun exposure cannot be avoided. Erythema, scaling, dryness, stinging/burning, irritant and allergic contact dermatitis may occur with use of Epiduo Forte Gel and may necessitate discontinuation. When applying Epiduo Forte Gel, care should be taken to avoid the eyes, lips and mucous membranes.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Please see brief summary of full Prescribing Information on next page. * A multicenter, randomized, double-blind, parallel-group, active- and vehicle-controlled, 12-week study comparing the efficacy and safety of once-daily adapalene 0.3%/BPO 2.5% fixed-dose combination gel relative to vehicle in subjects with moderate to severe acne vulgaris (N=503). At baseline, subjects had between 20 and 100 inflammatory lesions and 30 to 150 noninflammatory lesions. † Week 12 percentages based on multiple imputation. ITT=intent to treat.

Power up at www.epiduoforte.com/hcp

Volume 10 • number 1 • WINTER 2016 27

IMPORTANT INFORMATION ABOUT

EPIDUO® FORTE

(adapalene and benzoyl peroxide) GEL, 0.3% / 2.5% BRIEF SUMMARY This summary contains important information about EPIDUO FORTE (Ep-E-Do-Oh For-Tay) Gel. It is not meant to take the place of your doctor’s instructions. Read this information carefully before you start using EPIDUO FORTE Gel. Ask your doctor or pharmacist if you do not understand any of this information or if you want to know more about EPIDUO FORTE Gel. For full Prescribing Information and Patient Information, please see the package insert. WHAT IS EPIDUO FORTE GEL? EPIDUO FORTE Gel is a prescription medicine used on the skin (topical) to treat acne vulgaris. Acne vulgaris is a condition in which the skin has blackheads, whiteheads and pimples. WHO IS EPIDUO FORTE GEL FOR? EPIDUO FORTE Gel is for use in people 12 years of age and older. It is not known if EPIDUO FORTE Gel is safe and effective for children younger than 12 years old. Do not use EPIDUO FORTE Gel for a condition for which it was not prescribed. Do not give EPIDUO FORTE Gel to other people, even if they have the same symptoms you have. It may harm them. WHAT SHOULD I TELL MY DOCTOR BEFORE USING EPIDUO FORTE GEL? Before you use EPIDUO FORTE Gel, tell your doctor if you: • have other skin problems, including cuts or sunburn. • have any other medical conditions. • are pregnant or planning to become pregnant. It is not known if EPIDUO FORTE Gel can harm your unborn baby. Talk to your doctor if you are pregnant or planning to become pregnant. • are breastfeeding or plan to breastfeed. It is not known if EPIDUO FORTE Gel passes into your breast milk and if it can harm your baby. Talk to your doctor about the best way to feed your baby if you use EPIDUO FORTE Gel. Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Using other topical acne products may increase the irritation of your skin when used with EPIDUO FORTE Gel. WHAT SHOULD I AVOID WHILE USING EPIDUO FORTE GEL? • You should avoid spending time in sunlight or artificial sunlight, such as tanning beds or sunlamps. EPIDUO FORTE Gel can make your skin sensitive to sun and the light from tanning beds and sunlamps. You should use sunscreen and wear a hat and clothes that cover the areas treated with EPIDUO FORTE Gel if you have to be in the sunlight. • You should avoid weather extremes such as wind and cold as this may cause irritation to your skin. • You should avoid applying EPIDUO FORTE Gel to cuts, abrasions and sunburned skin. • You should avoid skin products that may dry or irritate your skin such as medicated or harsh soaps, astringents, cosmetics that have strong skin drying effects and products containing high levels of alcohol, spices or limes. • You should avoid the use of “waxing” as a hair removal method on skin treated with EPIDUO FORTE Gel. • EPIDUO FORTE Gel may bleach your clothes or hair. Allow EPIDUO FORTE Gel to dry completely before dressing to prevent bleaching of your clothes.

28 Journal of Dermatology for Physician Assistants

WHAT ARE THE MOST COMMON SIDE EFFECTS OF EPIDUO FORTE GEL? EPIDUO FORTE Gel may cause serious side effects including: • Local skin reactions. Local skin reactions are most likely to happen during the first 4 weeks of treatment and usually lessen with continued use of EPIDUO FORTE Gel. Signs and symptoms of local skin reaction include: • Redness • Dryness • Scaling • Stinging or burning Tell your doctor right away if these side effects continue for longer than 4 weeks or get worse; you may have to stop using EPIDUO FORTE Gel. These are not all of the possible side effects of EPIDUO FORTE Gel. For more information, ask your doctor or pharmacist. You are encouraged to report negative side effects of prescription drugs to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088. You may also contact GALDERMA LABORATORIES, L.P. at 1-866-735-4137. HOW SHOULD I USE EPIDUO FORTE GEL? • Use EPIDUO FORTE Gel exactly as your doctor tells you to use it. EPIDUO FORTE Gel is for use on the skin only (topical). Do not use EPIDUO FORTE Gel in or on your mouth, eyes or vagina. • Apply EPIDUO FORTE Gel 1 time a day. • Do not use more EPIDUO FORTE Gel than you need to cover the treatment area. Using too much EPIDUO FORTE Gel or using it more than 1 time a day may increase your chance of skin irritation. APPLYING EPIDUO FORTE GEL: • Wash the area where the Gel will be applied with a mild or soapless cleanser and pat dry. • EPIDUO FORTE Gel comes in a pump. Depress the pump to dispense a small amount (about the size of a pea) of EPIDUO FORTE Gel and spread a thin layer over the affected area. • Wash your hands after applying the Gel. WHERE SHOULD I GO FOR MORE INFORMATION ABOUT EPIDUO FORTE GEL? • Talk to your doctor or pharmacist. • Go to www.EPIDUOFORTE.com or call 1-866-735-4137. All trademarks are the property of their respective owners. GALDERMA LABORATORIES, L.P., Fort Worth, Texas 76177 USA Revised: July 2015 20089-0415-BS

Reference: 1. Epiduo Forte Clinical Study Report (SRE 18240). Data on file. Galderma Laboratories, L.P. ©2015 Galderma Laboratories, L.P. Galderma Laboratories, L.P. 14501 N. Freeway Fort Worth, TX 76177 EFO-00031 Printed in USA 01/16

www.epiduoforte.com/hcp

Dermatology Case Report A Man With Pruritic Bumps Since Childhood By Sara Wilchowski, MS, PA-C, Anne H. Hanson, DO, and Stuart R. Gildenberg, 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. Hyperkeratotic and verrucous papules on the left flank. Some of the individual papular lesions were spiny.

Figure 2

Multiple hyperkeratotic hyperpigmented papules and plaques on the anterior and posterior trunk. The lesions on the mid-upper back had a Blaschkoid distribution.

Volume 10 â&#x20AC;˘ number 1 â&#x20AC;˘ WINTER 2016 29

CLINIC AL Dermatology

Figure 1

Figure 3

CLINIC AL Dermatology

Biopsy from the back demonstrated prominent epidermal papillomatosis and overlying hyperorthokeratosis.

Figure 4

There was homogenous material in the papillary dermis beneath the hyperkeratotic and acanthotic epidermis. This eosinophilic amorphous fissured (homogenous) material was compatible with amyloid deposition. Sara M Wilchowski MS, PA-C is a graduate of Wayne State University PA program and a Diplomate of the Society of Dermatology Physician Assistants. She currently resides and practices medical dermatology in Warren, Michigan. She has indicated no relationships to disclose relating to the content of this article. Anne H. Hanson, DO is a graduate of Saint Joseph Mercy Heath System Dermatology Residency Program in Ann Arbor, Michigan. She currently resides in Colorado where she practices general dermatology with a group practice in Englewood, Colorado. She has indicated no relationships to disclose relating to the content of this article. Stuart R. Gildenberg, MD is a graduate of the University of Michiganâ&#x20AC;&#x2122;s Dermatology Residency Program. He is currently a member of the teaching faculty at Saint Joseph Mercy Health System Dermatology Residency Program. He is a past-President of the Michigan Dermatologic Society and has authored a variety of academic publications and presentations. He has indicated no relationships to disclose relating to the content of this article. 30 Journal of Dermatology for Physician Assistants

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

Maintaining Ear Aesthetics in Helical Rim Reconstruction Ann Plast Surg. 2014 Mar;72(3):318-22. Taylor JM1, Rajan R, Dickson JK, Mahajan AL. From the *Department of Plastic and Reconstructive Surgery, Royal Devon & Exeter Hospital, Exeter; †Department of Plastic and Reconstructive Surgery, Derriford Hospital, Plymouth; and ‡Department of Plastic and Reconstructive Surgery, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.

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

Volume 10 • number 1 • WINTER 2016 31

SURGICAL wisdom The following is a letter received in response to the article â&#x20AC;&#x2DC;Dermatology Case Report- How Should You Manage This Patient With facial Melanoma?â&#x20AC;&#x2122; published in the JDPA Fall 2015 issue. The JDPA appreciates and welcomes feedback from its readers and would like to share the letter with our audience. We feel that sharing opinions of other providers with our readers invites open dialogue, which we can all benefit and learn from.

SURGIC AL Dermatology

...continued on page 34

32 Journal of Dermatology for Physician Assistants

COMING SOON FROM ALLERGAN

ACZONE (dapsone) Gel 7.5% ®

• number 1 • WINTER 2016 33

...continued from page 32

SURGIC AL Dermatology

Jason D. Christian, PA-C enjoys working in dermatology at Cedar Dermatology in Cedar City, UT. He graduated from the Duke University Physician Assistant Program in 2009 after completing his Bachelor's Degree in 2006 at Southern Utah University. He has indicated no relationships to disclose relating to the content of this article.

SDPA MEMBERSHIP HAVE YOU TAKEN ADVANTAGE OF OUR REFER A MEMBER CAMPAIGN? RECEIVE A $20 AMAZON GIFT CARD For every Fellow, Associate or Affiliate* member you refer to become a member of the SDPA *Effective 10/1/15 - No award will be given for referring Student Members.

Please note: Each referral will be counted only after the new member pays his/her dues and lists the referring memberâ&#x20AC;&#x2122;s name on the application. Referral of supervising physicians and student members will NOT qualify for this campaign, but are certainly encouraged.

34 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. AD1000047-I Feb 2016

Volume 10 • number 1 • WINTER 2016 35

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

36 Journal of Dermatology for Physician Assistants

COSMETIC deRMATOLOGY Journal Club: Practice Changing Articles for Dermatology PAs

Protein Loss in Human Hair from Combination Straightening and Coloring Treatments J Cosmet Dermatol. 2015 Sep;14(3):204-8. França-Stefoni SA1, Dario MF1, Sá-Dias TC1, Bedin V2, de Almeida AJ2, Baby AR1, Velasco MV1. Faculty of Pharmaceutical Sciences of University of São Paulo, São Paulo, SP, Brazil. Healthy Skin Foundation and Hair and Skin Research and Treatment Institute, São Paulo, SP, Brazil.

1 2

Volume 10 • number 1 • WINTER 2016 37

Cosmetic pearls Beauty From the Inside Out: Improving Your Diet or Taking Supplements May Lead to Younger-Looking Skin 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.

38 Journal of Dermatology for Physician Assistants

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.

Patricia K. Farris, MD, FAAD is a clinical associate professor of dermatology at Tulane University School of Medicine in New Orleans. She is a well-recognized authority on cosmeceuticals and topical skin care, and has published material and lectured extensively on these subjects. Dr. Farris received her medical degree and completed her residency at Tulane University in New Orleans, where she served as chief resident.

Volume 10 â&#x20AC;˘ number 1 â&#x20AC;˘ WINTER 2016 39

Professional development

Judicial and Ethical Affairs Defensive Medicine By Natalie Zering, PA-S

As a PA student there are many things that I worry about, but the one thing that always lingers in the back of my head is the fear of a future malpractice suit. I have worked with providers who have been sued even though they practiced good medicine and used appropriate treatments. I have interacted with some providers who seem to share my fear of malpractice suits, and this fear seems to affect the way they choose to practice medicine. During my clinical rotations I have noticed some providers will perform extensive workups or order invasive procedures that in my humble opinion as a student are not medically necessary to make the diagnosis. I have also observed that some providers seem to avoid caring for more complex patients (even when within their scope of care) by referring them to another provider. These ways of practicing medicine are often referred to as “defensive medicine.” Defensive medicine is defined as “the ordering of treatments, tests, and procedures primarily to help protect the physician from liability rather than to substantially further the patient’s diagnosis or treatment.”1 This way of practicing medicine is problematic for a number of reasons. The amount of tests ordered by providers could potentially be contributing to excessive health care costs.1 The annual cost attributed to the overuse of medical services beyond evidence established levels was estimated by the Institute of Medicine to be 210 billion dollars in 2012.2 Studies have shown that many providers practice defensive medicine by ordering excessive diagnostic tests, hospitalizing low-risk patients, referring patients to specialists more than is necessary, and using invasive procedures that do not benefit patients and/or could even be detrimental in some cases of highrisk patients. Many of these providers shared the common fear of missing the diagnosis of cancer.1,3 There are patients who have been harmed by 40 Journal of Dermatology for Physician Assistants

a provider’s error or negligence, and these patients do deserve some sort of compensation. Research has shown that only around 15% of all malpractice lawsuits are related to actual acts of negligence by a provider, and the number of people injured due to provider negligence who actually sued was only 3%.4 Based on those statistics, it seems that the people who were actually injured due to provider negligence were not the ones benefitting from litigation. The cost of legal and administrative fees is so high that many plaintiffs do not receive much compensation.4 Our malpractice system is clearly very inefficient, and there is a need for tort reform to better serve the needs of both patients and providers. There are several alternative dispute resolution tactics that have been used with great success in avoiding litigation. The first one is early disclosure and apology, which is when both parties sit down, discuss the issue, and seek resolution. This tactic was implemented by the University of Michigan Health System in 2002, and it resulted in a reduction of malpractice claims from 262 claims and lawsuits in August 2001 to 82 claims and lawsuits in August of 2007.4,5 The second tactic is mediation, which is when a third-party mediator facilitates a negotiation between the two parties that is nonbinding and informal. Mediation allows for more creative solutions to resolve the dispute and is associated with higher satisfaction. Medical centers such as John Hopkins, University of Pittsburgh Medical Center, and Drexel have implemented mediation programs with great success. University of Pittsburgh Medical Center successfully used the mediation tactic to settle 24 of 27 cases in 2004 and they estimated that they saved around 1 million dollars in defense costs alone and they observed that the average mediated case was settled much quicker than a litigated case.4 The third tactic is arbitration, which is when

REFERENCES: 1. Hermer LD, Brody H. Defensive Medicine, Cost Containment, and Reform. Journal of General Internal Medicine. 2010; 25(5): 470-473. 2. Huff C. 4 Ethical Dilemmas facing physicians. Medical Economics. http:// medicaleconomics.modernmedicine.com/medical-economics/content/ modernmedicine/modern-medicine-feature-articles/4-ethicaldilemmas-facing August 7th, 2014. Accessed 10/29/15. 3. Studdert DM, Mello MM, Sage WM, et al. Defensive Medicine Among High-Risk Specialist Physicians in a Volatile Malpractice Environment. JAMA. 2005;293 (21): 2609-2617. 4. Sohn DH, Sonny Bal B. Medical Malpractice Reform: The Role of Alternative Dispute Resolution. Clinical Orthopedics and Related Research. 2012;470(5):1370-1378. 5. Sack K. Doctors Say, ‘I’m Sorry’ before ‘See You in Court.’ The New York Times. May 18, 2008. Natalie Zering, PA-S is a second year physician assistant student at the LeMoyne College Physician Assistant Program in Syracuse, NY. She attended Central Washington University and worked at Tacoma General Hospital and Marybridge Children’s Hospital as a CNA prior to PA school. Her interests include oncology and emergency medicine, snowboarding, showing/training dogs, and photography. 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

JDPA Journal of Dermatology for Physician Assistants

If you know a patient who would like to share his/her story, please contact us at editor@jdpa.org Volume 10 • number 1 • WINTER 2016 41

professional development

the parties are represented by attorneys who argue the case in the presence of an arbiter or arbitration panel. This method is the most formal option of the three, and the arbiter’s decision is binding. Some providers have chosen to have new patients sign a pretreatment arbitration agreement, which states that any dispute that arises will be handled by arbitration and not litigation. Providers are able to select arbiters who have a good knowledge of medical practices rather than a panel of jurors who may have little or no knowledge of such practices.4 It is my opinion that all diagnostic tests and procedures should be ordered with the purpose of furthering a patient’s health and not for the purpose of avoiding litigation. I also believe that providers who are negligent should be held accountable for their actions. I feel strongly that there is a better way to go about achieving accountability than the current methods. We are in great need of tort reform in this country and without changes in our malpractice system, defensive medicine will continue and could unfortunately become the new standard of care. J

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INDICATION AND USAGE Enstilar® (calcipotriene and betamethasone dipropionate) Foam is indicated for the topical treatment of plaque psoriasis in patients 18 years of age and older. Apply Enstilar® to affected areas once daily for up to 4 weeks. Patients should discontinue use when control is achieved. Instruct patients not to use more than 60 g every 4 days. IMPORTANT SAFETY INFORMATION For topical use only. Enstilar® is not for oral, ophthalmic, or intravaginal use. Instruct patients to avoid use on the face, groin, or axillae, or if atrophy is present at the treatment site, and not to use with occlusive dressings, unless directed by a physician. The propellants in Enstilar® are flammable. Instruct patients to avoid fire, flame, or smoking during and immediately after using this product. Hypercalcemia and hypercalciuria have been observed with use of Enstilar®. If hypercalcemia or hypercalciuria develop, patients should discontinue treatment until parameters of calcium metabolism have normalized. Topical corticosteroids can produce reversible hypothalamicpituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. Risk factors include use of high-potency topical corticosteroids, use over a large surface area or on areas under occlusion, prolonged use, altered skin barrier, liver failure, and use in pediatric patients. If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent steroid. Systemic effects of topical corticosteroids may also include Cushing’s syndrome, hyperglycemia, and glucosuria. Use of more than one corticosteroid-containing product at the same time may increase total systemic corticosteroid exposure. Adverse reactions reported in <1% of subjects treated with Enstilar® in clinical trials included application site irritation, application site pruritus, folliculitis, skin hypopigmentation, hypercalcemia, urticaria, and exacerbation of psoriasis. Patients who apply Enstilar® to exposed skin should avoid excessive exposure to either natural or artificial sunlight, including tanning booths, sun lamps, etc. You may wish to limit or avoid use of phototherapy in patients who use Enstilar®. There are no adequate and well-controlled studies of Enstilar® in pregnant women. Enstilar® should be used during pregnancy only if the potential benefit to the patient justifies the potential risk to the fetus. Because many drugs are excreted in human milk, caution should be exercised when Enstilar® is administered to a nursing woman. Do not use Enstilar® on the breast when nursing. The safety and effectiveness of Enstilar® in pediatric patients have not been studied. Please see Brief Summary on following page. *Must be 18 years of age or older to be eligible. For specific eligibility requirements and program restrictions, visit www.enstilar.com or call 1-855-772-7224. Reference: 1. Enstilar® [prescribing information]. Parsippany, NJ: LEO Pharma Inc.; October 2015.

42 Journal of Dermatology for Physician Assistants

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Volume 10 • number 1 • WINTER 2016 43

Enstilar ® (calcipotriene and betamethasone dipropionate) Foam, 0.005%/0.064% for topical use Initial U.S. Approval: 2006 BRIEF SUMMARY: Please see package insert for full Prescribing Information. INDICATIONS AND USAGE Enstilar ® (calcipotriene and betamethasone dipropionate) Foam is indicated for the topical treatment of plaque psoriasis in patients 18 years of age and older. CONTRAINDICATIONS None. WARNINGS AND PRECAUTIONS Flammability The propellants in Enstilar ® Foam are flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application. Hypercalcemia and Hypercalciuria Hypercalcemia and hypercalciuria have been observed with use of Enstilar ® Foam. If hypercalcemia or hypercalciuria develop, discontinue treatment until parameters of calcium metabolism have normalized. The incidence of hypercalcemia and hypercalciuria following Enstilar ® Foam treatment of more than 4 weeks has not been evaluated. Effects on Endocrine System Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid. Factors that predispose a patient to HPA axis suppression include the use of high-potency steroids, 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. If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid. Systemic effects of topical corticosteroids may also include Cushing’s syndrome, hyperglycemia, and glucosuria. Pediatric patients may be more susceptible to systemic toxicity due to their larger skin surface to body mass ratios. Use of more than one corticosteroid-containing product at the same time may increase total systemic corticosteroid exposure. Allergic Contact Dermatitis Allergic contact dermatitis has been observed with topical calcipotriene and topical corticosteroids. Allergic contact dermatitis to a topical corticosteroid is usually diagnosed by observing a failure to heal rather than a clinical exacerbation. Corroborate such an observation with appropriate diagnostic patch testing. Risks of Ultraviolet Light Exposures Patients who apply Enstilar ® Foam to exposed skin should avoid excessive exposure to either natural or artificial sunlight, including tanning booths, sun lamps, etc. Physicians may wish to limit or avoid use of phototherapy in patients who use Enstilar ® Foam. ADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The rates of adverse reactions given below were derived from three randomized, multicenter, prospective vehicle and/or active-controlled clinical trials in subjects with plaque psoriasis. Subjects applied study product once daily for 4 weeks, and the median weekly dose of Enstilar ® Foam was 24.8 g. Adverse reactions reported in <1% of subjects treated with Enstilar ® Foam included: application site irritation, application site pruritus, folliculitis, skin hypopigmentation, hypercalcemia, urticaria, and exacerbation of psoriasis. 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. Postmarketing reports for local adverse reactions to topical steroids include atrophy, striae, telangiectasia, dryness, perioral dermatitis, secondary infection, and miliaria.

44 Journal of Dermatology for Physician Assistants

USE IN SPECIFIC POPULATIONS Pregnancy Teratogenic Effects: Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. Pregnant women were excluded from the clinical studies conducted with Enstilar ® Foam. Enstilar ® Foam should be used during pregnancy only if the potential benefit to the patient justifies the potential risk to the fetus. Animal reproduction studies have not been conducted with Enstilar ® Foam. Enstilar ® Foam contains calcipotriene that has been shown to be fetotoxic and betamethasone dipropionate that has been shown to be teratogenic in animals when given systemically. 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 topically administered calcipotriene or corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Enstilar ® Foam is administered to a nursing woman. Instruct the patient not to use Enstilar ® Foam on the breast when nursing. Pediatric Use Safety and effectiveness of the use of Enstilar ® Foam in pediatric patients have not been studied. Because of a higher ratio of skin surface area to body mass, children under the age of 12 years are at particular risk of systemic adverse effects when they are treated with topical corticosteroids. They are, therefore, also at greater risk of HPA axis suppression and adrenal insufficiency with the use of topical corticosteroids. Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients treated with topical corticosteroids. Local adverse reactions including striae have been reported with use of topical corticosteroids in pediatric patients. Geriatric Use Of the total number of subjects in the controlled clinical studies of Enstilar ® Foam in plaque psoriasis, 97 were 65 years or older, while 21 were 75 years or older. No overall differences in safety or effectiveness of Enstilar ® Foam were observed between these subjects versus younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. PATIENT COUNSELING INFORMATION [Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions For Use)] Inform patients of the following: • Instruct patients to shake before use. • Instruct patients not to use more than 60 g every 4 days. • Discontinue therapy when control is achieved unless directed otherwise by the physician. • Avoid use of Enstilar ® Foam on the face, underarms, groin or eyes. If this medicine gets on face or in mouth or eyes, wash area right away. • Wash hands after application. • Do not occlude the treatment area with a bandage or other covering unless directed by the physician. Instruct the patients not to use other products containing calcipotriene or a corticosteroid with Enstilar ® Foam without first talking to the physician. • Instruct patients who use Enstilar ® Foam to avoid excessive exposure to either natural or artificial sunlight (including tanning booths, sun lamps, etc.). Physicians may wish to limit or avoid use of phototherapy in patients who use Enstilar ® Foam. • Enstilar ® Foam is flammable; avoid heat, flame, or smoking when applying this medication. •The foam can be sprayed holding the can in any orientation except horizontally. Manufactured by: Colep Laupheim GmbH & Co. KG Fockestraße 12 88471 Laupheim Germany (DE)

Distributed by: LEO Pharma Inc. 1 Sylvan Way, Parsippany, NJ 07054

Notes from your Office Manager

Service Animals in Healthcare Settings What You Need to Know The use of service animals by patients with disabilities is protected by the Americans with Disabilities Act (ADA) and the state Civil Rights and Human Rights Laws.1,2 Medical providers must be aware of not only the protections afforded to the use of service animals, but also the limitations on the use of such animals in healthcare settings. If a patient with a disability is asked to remove a service animal from the office, or if the patient believes that he/she is the object of discrimination, the patient may file a complaint with the United States Department of Justice or his/her respective state’s Division for Human Rights. When providers and staff are unaware of state and federal requirements, their actions can lead to the imposition of civil liability, as well as fines and penalties assessed by both state and federal agencies.3 Therefore, it is extremely important for providers to understand the rights of patients under these laws and regulations, and know exactly what they can and cannot ask the patient.

a disability.”8 State law requires that the dog be trained by a recognized or professional trainer, and that the dog is actually used to perform tasks for a patient.9 Some examples of such tasks include: guiding blind persons; alerting a deaf person to danger; pulling a wheelchair; alerting and protecting a person having a seizure; reminding a mentally ill patient to take medication; and calming a patient with Post Traumatic Stress Disorder during an anxiety attack.10 Service animals are permitted in waiting rooms, private offices, patient rooms, clinics, and nonsterile examination rooms. Service animals may be excluded from operating rooms, burn units, and other such areas where the presence of an animal might compromise a sterile environment.11 Within permissible areas, the service animal must be harnessed, leashed, or tethered, unless this interferes with its tasks or the person’s disability. In those limited instances, the dog’s owner must maintain control of the animal by using voice or other signals.12

Under federal law, “places of public accommodation” are required to permit service animals to accompany people with disabilities in all areas where members of the public are allowed.4 A private medical office or facility is considered a place of public accommodation subject to these requirements.5,6

When a patient comes to the office with a service animal, and it is not obvious what service it provides, staff may ask only two questions:13

Effective March 15, 2011, except as discussed later in this article, only dogs are recognized as service animals.7 The most recent federal definition of a service animal is a “dog individually trained to perform work or tasks for an individual with

Staff cannot request medical documentation of the disability, ask what the patient’s disability is, or request documentation of the training the dog has completed. Allergies and fear of dogs are not sufficient reasons for denial of access, or refusal of

1. Is the dog a service animal required due to a disability? 2. What work or task(s) has the dog has been trained to perform?

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By Donnaline Richman, Esq., Fager Amsler & Keller LLP, Counsel to Medical Liability Mutual Insurance Company

service, to persons with disabilities. Instead, both the fearful/allergic person and the disabled person with the animal must be accommodated.14

professional development

Unfortunately, some individuals who are not disabled have purchased vests and tags online for their pets claiming that the dog is being used for emotional support. They may demand to have the dog accompany them in permissible areas. However, “dogs that are not trained to perform tasks that mitigates the effects of a disability, including dogs that are used purely for emotional support, are not service animals” and, therefore, do not need to be accommodated.15 There are very few occasions where a service animal can be excluded from the premises. An animal cannot be excluded on the basis of speculation or stereotyping. However, the patient may be asked to remove the service animal if the animal is out of control and the handler does not act effectively to control it, or if the animal is not housebroken. In such situations, staff can request that the patient remove the dog from the premises, but must simultaneously offer to see and treat the patient without the dog present.16 Additionally, the patient is responsible for providing care and food for the animal, or making arrangements to do so.17 In 2009, the United States District Court, Oregon, found that a hospital appropriately prohibited a service dog from remaining with his owner because, on numerous admissions, the dog had a rancid odor, which permeated the entire inpatient unit and posed a risk of infection. The owner refused to have the dog bathed. Further, there was no one available to care for and walk the dog when the owner’s spouse was not present on the unit. The dog, a large St. Bernard, often growled at the nursing staff and impeded access to the patient’s bedside. Thus, because the facility showed definite proof that the dog posed a direct threat and actual risk to staff and other patients, the court found that exclusion was justified. The patient was allowed to be admitted to the hospital only without her service animal.18 In a 2013 United States District Court case in the Northern District of California, a patient with a disability who used a service dog for independence and mobility was admitted to a hospital psychiatric unit. She was denied the right to have her service dog accompany her. The Court found that the hospital violated the ADA due to its failure

46 Journal of Dermatology for Physician Assistants

to prove that the dog represented a direct threat to the health and safety of others, or that the presence of the dog would fundamentally alter the nature of the facility, and that the patient suffered irreparable harm when the hospital refused to allow the dog to accompany her.19 In 2011, a patient with a service animal charged a Florida physician with violation of the ADA.20 The patient complained that he was denied access to medical services solely because he was accompanied by his service animal. An investigation by the Department of Justice revealed that the physician’s staff had inappropriately questioned the patient, objected to the dog’s presence in the waiting room, and demanded written documentation of training and certification. After the charges against the physician were substantiated, he entered a settlement agreement with the U.S. Department of Justice. The key provisions of the signed consent order included: 1. Modification of the physician’s office policy to allow patients with service animals access to care; 2. Adoption of a written office policy about patients with service animals which complied with the ADA; 3. Provision of a copy of this policy to and training of all employees, staff, and contractors; 4. Posting a notice of welcome in his office to patients with service animals; and 5. Developing a policy to handle complaints involving service animals. Some patients with disabilities may prefer to use a miniature horse, particularly to pull a wheelchair. The 2010 revision of the ADA regulations includes a new, separate provision for miniature horses. A miniature horse is generally 24 to 34 inches tall and weighs between 70 and 100 pounds.21 This animal must have been trained to perform tasks for disabled patients. The new regulations set out four assessment factors designed to assist a place of public accommodation in determining whether or not a miniature horse can accompany a patient. The four assessment factors are:22 1. The horse must be housebroken. 2. The horse must be under the patient’s control.

In summary, you and your staff must be prepared when a patient with a disability is accompanied by a service animal to your office or facility. You should develop and comply with an office policy, which meets the requirements of the ADA and state Civil Rights Laws with respect to service animals. Staff must then be trained and reeducated annually about what they can and cannot do when a patient comes to your office with a service animal. J

5. 28 C.F.R. § 36.104. 6. Executive Law § 292 (9). 7. U.S. Department of Justice, Civil Rights Division. ADA 2010 Revised Requirements: Service Animals, supra, p. 1 (2011). State law defines a service dog as a dog that is properly harnessed and has been or is being trained by a qualified trainer. Civil Rights Law § 47-b (4). 8. U.S. Department of Justice, Civil Rights Division. ADA 2010 Revised Requirements: Service Animals, supra, p. 1 (2011). 9. Executive Law § 292 (33). 10. U.S. Department of Justice, Civil Rights Division. ADA 2010 Revised Requirements: Service Animals, supra, p. 1 (2011). 11. Id., p.2. 12. Id., p.2. 13. Id., p.2. 14. Id., p.2. 15. U.S. Department of Justice, Civil Rights Division. Fact Sheet: Highlights of the Final Rule to Amend the Department of Justice’s Regulation Implementing Title II of the ADA. Accessed on August 18, 2015 at http:// www. ada.gov/regs2010/factsheets/title2_factsheet. html. 16. U.S. Department of Justice, Civil Rights Division. ADA 2010 Revised Requirements: Service Animals, supra, p. 2 (2011). 17. Id., p. 2. 18. Roe v Providence Health System, 655 F. Supp 2d 1164, (D. Oregon, 2009). 19. Tamara v. El Camino Hosp., et. al., 964 F. Supp. 2d 1077 (N.D. California, 2013). 20. Settlement Agreement, United States of America v. Berenson, Complaint USAO No: 2011-VO-0468/DJ No. 202-18-267, August 1, 2012, pp. 2 – 9. Accessed on August 18, 2015 at http://www.ada.gov/ berenson_settle. htm. 21. U.S. Department of Justice, Civil Rights Division. ADA 2010 Revised Requirements: Service Animals, supra, p. 2 (2011). 22. Id., p.2

REFERENCES: 1. 42 U.S.C.A. § 12101 et. seq. 2. Civil Rights Law § 47 et. seq.; Executive Law § 292 (21). 3. Civil Rights Law § 47-c (2); 42 U.S.C.A. § 12188 (b)(2). 4. U.S. Department of Justice, Civil Rights Division. ADA 2010 Revised Requirements: Service Animals, p. 2. (2011). Accessed on August 18, 2015 at http://www.oysterpoint.com/Forms/ADA/ADA%20Revised%20 ADA%20Requirements_%20Service%20 Animals-8.16.2013.pdf.

Medical Liability Mutual Insurance Company, 2 Park Avenue, Room 2500, New York, NY 10016. Copyright © 2015 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. This article originally appeared in Dateline Volume 14, Number 3, Fall 2015.

4. The facility must determine whether the presence of the horse will compromise legitimate safety requirements of the facility. In some situations, a service horse may be excluded. If a patient who uses a service horse to pull his wheelchair enters the waiting room of a provider and the horse then breaks loose from its harness and runs around, frightening other patients and staff, or leaves excrement on the floor, the service horse may be determined to be a direct threat to the health and safety of other patients and excluded from the facility, since the horse is not under the control of the patient or is not housebroken. Alternative reasonable accommodations must then be offered to the patient so he/she can continue treatment with the provider without facing discrimination.

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

JDPA Journal of Dermatology for Physician Assistants

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3. The facility must be able to accommodate the horse’s type, size, and weight.

Outside & Inside the 9 to 5... In Memory of Nancy Primo, MPAS, PA-C By Abby A. Jacobson, MS, PA-C and Travis Hayden, MPAS, PA-C

professional development

Nancy Primo worked as a PA in dermatology for thirty-six years in Michigan and California. She passed away on December 24, 2015 after a long battle from complications of breast cancer. She loved her family deeply and passed away peacefully in her home surrounded by her family. Nancy had a lasting impact on our profession through her various leadership roles that she had held through the years. The following personal reflections from fellow SDPA members are shared with our JDPA audience to honor Nancy and her many contributions to the SDPA, as well as her time spent serving our profession. It is with a heavy heart that I remember the significant contribution that Nancy Primo made to the dermatology PA profession. Nancy was my first board advisor in 2001 when I first became involved with SDPA leadership. She was the SDPA Vice President for many years. During this time the SDPA was very small. The budget was very little and so many leaders, like Nancy, often reached into their own pockets to fund various SDPA projects. Nancy was passionate about her leadership positions and cared deeply for the SDPA. In addition to her service to our profession, Nancy was able to balance being a mother and wife. She married a fellow PA, Dana Primo, and always had wonderful things to say about him. She adored her kids and was always very proud to share with us stories about them. Nancy left a life long mark on the SDPA and PA profession. She will be missed by many. J Abby A. Jacobson, MS, PA-C Past President of the SDPA Nancy and I first met in 2005 in San Antonio, TX at the 3rd Annual SDPA Fall CME Conference. From our very first meeting, Nancy was instrumental in encouraging my involvement with the SDPA when she kindly â&#x20AC;&#x153;volunteeredâ&#x20AC;? me to serve as the SDPA Publications/ Communications Committee Chair, a position I still enjoy holding to this day. I think of Nancy often in gratitude for encouraging me to become involved with the SDPA. In addition, Nancy was supportive and helpful with the inception of the JDPA. As busy as she was with her own work and family, she always took the time to volunteer and lend her support to the publication. I always looked forward to collaborating with her and greatly valued her input and advice. Her passion for our profession led her to volunteer with the JDPA. Nancy not only wrote for the publication, she also gave of her time and held the positions of JDPA Editorial Board Member and JDPA Cosmetic Department Editor.

48 Journal of Dermatology for Physician Assistants

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

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

www.dermcast.tv Volume 10 • number 1 • WINTER 2016 49

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Working with Nancy through the years I have always considered her a great friend and a valued and respected colleague. I enjoyed getting together with her at our annual SDPA conferences and was amazed at her capacity to find a real and deep enjoyment in whatever project she was engaged in at the time. Whether it was working as the SDPA Director at Large (2003-2005), her time serving as the SDPA Vice President (2005-2007), or her work with the California Dermatology PA Society (which she was a co-founder of), her passion to be involved in bettering the PA profession was evident to anyone who had the privilege of meeting her. She always had a smile and an air of excitement about what she was involved with at the time, and never missed an opportunity to want to know what it was you were up to as well. She was truly a remarkable women, an amazing PA, and a greatly respected mentor. She will be missed by many and her contributions to our profession will be felt for years to come. J Travis Hayden, MPAS, PA-C JDPA Editor in Chief SDPA Publications/Communications Committee Chair

Dermatology PA news & notes

The Difference We Make

Listeners and Healers By Brian T. Maurer, PA-C

At the end of a recent afternoon session at the office an informal discussion on the relative merits of the physical examination arose among the members of the clinical staff. The junior PA, an astute practitioner with three years of experience in the field, argued that quality medical care centers on careful physical examination of the patient. “It’s so important to develop your observational skills,” she said. “If you want to clinch the diagnosis, you’ve got to know what you’re looking for, regardless of whether it’s a heart murmur, a deviated eye, an enlarged spleen, or a skin lesion.” “That’s what they tell us in PA school,” the student piped up. “It’s all about learning clinical signs and symptoms.” One of the older pediatricians had a different take. “So much of what we diagnose is actually brought to our attention by the patients themselves,” he said. “And with our modern technological advances, we can readily detect physical maladies. For instance, much of what we used to refer to as congenital heart disease is now diagnosed by ultrasound in utero. As clinicians, we would do much better to ask a few open-ended questions in the patient interview, and then sit back and listen to what the patient has to say.” This impromptu discussion got me thinking: What does it mean to care for the patient in our age of accelerated technological practice, where computer driven devices allow us to glean volumes of lab values from minute specimens of bodily fluids; where sophisticated scans enable us to peer inside the living body and tag its idiosyncratic pathologies, and where our modern pharmacological armamentarium allows us to treat previously universally fatal diseases with effective drugs and transplanted tissues and organs? Surely, there has never been a time in the history of medicine where the benefits of diagnosis and 50 Journal of Dermatology for Physician Assistants

treatment have shown greater promise than now. And yet, as we surge ahead toward greater technological expertise, might we be in danger of losing something in the process? Are we in fact overlooking the whole point of the practice of medicine - to cure sometimes, to relieve often, to comfort always? Have we in fact forgotten that first and foremost the art of medicine rests upon our ability to listen to the patient, and thus impart some degree of healing in the process? A hospitalist colleague e-mailed me his observations on this topic: “Soon computer capability may exist to diagnose and recommend treatment to a degree unimaginable right now. Such advances may ease the burden on the clinician and improve the quality of care. But without a human connection, such a medical encounter falls short of providing a healing environment.” Doctors are now debating the relative merits of continuing to teach students the art of cardiac auscultation. In 2012, New York’s Mt. Sinai Hospital provided medical students with hand-held ultrasound devices capable of generating realtime images of the heart at the bedside. Such devices have proven to be superior to the physical examination, nearly doubling the likelihood of accurate cardiac diagnoses. There are those who would have us discard the archaic, inaccurate stethoscope for such sophisticated technological tools. In a recent New England Journal of Medicine essay, Dr. Elazer Edelman writes “auscultation is a fading art.” Yet he makes a case for continuing to teach clinical medicine at the bedside, albeit by the use of an electronic stethoscope linked to a speaker. The projected sounds allow “everyone in the room to hear and understand what the patient is experiencing.”

to become true healers in our chosen vocation, we must take the time to train ourselves to listen, not only with our ears, but with our hearts as well. For it is only when we listen with the heart that we can truly hope to provide a measure of healing to the patient. J REFERENCE: Edelman, ER, Weber, BN. Tenuous Tether. NEJM 2015;373:2199–2201 (December 3, 2015). Brian T. Maurer has practiced pediatric medicine as a PA for thirtysix years. Over the past two decades Mr. Maurer has explored the illness narrative as a tool to cultivate an appreciation for the delivery of humane medical care. He has published numerous vignettes, editorials, and essays in both national and international journals. Mr. Maurer has been a contributing author to the online open-access journal Dermanities (www.dermanities.com) since its inception. Readers can visit the author on the web at http:// briantmaurer.wordpress.com.

Important Notice A NEW Diplomate Program is Currently Being Developed. Stay tuned for details! Great News! All current Diplomates will be grandfathered in as long as maintenance requirements are met. See more details at: bit.ly/DLI_changes

www.dermpa.org Volume 10 • number 1 • WINTER 2016 51

DERmatology pa news & notes

“In teaching at the bedside,” Dr. Edelman writes, “explanations of the finer elements of auscultation are less important than what the sounds tell us.” “Projected sounds … engage our patients, for they hear what we hear (often for the first time), and appreciate what we are doing (also often for the first time), which binds them to us and us to them.” In the practice of clinical medicine Dr. Edelman opines: “We must in a sense become part of our patients -physically engaging them so that we can feel what they feel, sense how they suffer, and fully comprehend what they are trying to tell us. It is not only the teaching of auscultation that is improved when physician and patient are tethered to one another, but also the teaching of patient care and the practice of clinical medicine.” Dr. Edelman concludes: “The stethoscope can help us diagnose and teach, but above all it ties us to our patients.” I agree with much of what Dr. Edelman has to say. When we as clinicians distance ourselves from the patient - either physically or empathetically something of the caring aspect of the art of medicine is lost. But I would take it one step further. If we wish

Workplace Excellence

Intentional Culture: The Key to Improving Efficiency & Effectiveness By Matthew Davidson, PhD

DERmatology pa news & notes

In my work as President of the Institute for Excellence & Ethics (IEE) I have had the opportunity to work with diverse individuals and organizations in their quest to achieve excellence. This column dedicated to workplace excellence explores the organizational, interpersonal, and ethical issues that contribute to (or detract from) individual or organizational excellence within the physician assistant profession. If you have any workplace topics you would like to see covered in the JDPA please feel free to share them with us. Email editor@ jdpa.org with any topic ideas or questions concerning the workplace.

September and January are two months in

the year when I feel called to pause and reflect on my efficiency and effectiveness, both personally and professionally. These are times for me when I find myself performing an audit of what I do and how I do it, asking myself the familiar Dr. Phil question, “How’s that working for you?” In this audit-mode I am looking at inputs and outputs; I am trying to look across my life portfolio and seek out what’s working well and what are the areas where I am losing time and energy. I’m trying to get back in control of things, to be proactive in my behaviors and rituals, not reactive, so that I don’t run around like a fire fighter trying to stamp out little fires that threaten to engulf my productivity and peace of mind. I am convinced that individuals and organizations are maxed out, stressed out, pressed for time, short on resources, and challenged to achieve greater results with less. I’m not sure if it is worse now than at previous historical times; I’m not sure if technology is to blame for the problem or what we should look to for the solution. This stressful reality often means that our first instinct is to think that there isn’t time to reflect on what we do and how we do it. We have to go hard, go fast, and go now. I get it, I really do. As a father of four, the head of an organization, as a person involved in church, community, and my kids’ school, I get it. We don’t have the time or resources we need to do what we want to do, the way we ought to do it. But, this is in fact the very reason why we have to continuously establish and recover intentionality in our lives. INTENTIONALITY: there’s no more important concept for achieving your goals with efficiency and effectiveness. Why do we do what we do, when we do 52 Journal of Dermatology for Physician Assistants

it, in the way we do it? If you’re not sure of the answers, slow down for a minute to recover some intentionality and watch your efficiency and effectiveness improve. This is at the center of work at the Institute for Excellence & Ethics, shaping intentional culture. Culture is generally defined as the shared values, beliefs, and operational norms of a group or organization. It’s a shared way. Leaders shape culture by establishing and reinforcing the shared norms and organizational habits. It is in and through your shared organizational habits that individual habits are shaped. As Aristotle put it, “Excellence then, is not an act, but a habit. It is what we are repeatedly led to do.” Whether you hold the title “leader” or not, you are a leader. In some part of your life, in some portion of your day, you are a leader, whether you’re a PA, a physician, a nurse, a parent, a spouse, an employer, or an employee. As the head of your group you have the opportunity (and responsibility) to repeatedly lead those in your group to do things your way; if you lead them to repeatedly and consistently do things your way they will in turn develop habits as a result. It takes time and energy, but you can either spend time intentionally shaping the culture to develop the positive habits needed for the realization of your core mission, or spend time reactively responding to the negative behaviors shaped by the unintentional de facto culture - what John Dewey called “mis-education” or “collateral learning.” (It sounds like: “No, not like that, like this.” Or “Not that way, this way.”) Pick a medical practice, hospital, family, team, or organization that stands out to you for its exceptionality, and you will invariably find great intentionality regarding their organizational habits; they do things a very specific way, for a very specific reason. There

Intense and intentional cultures leave a mark on the individual; as the sociologist Gerald Grant described it, these are cultures that “imprint.” It’s not just that they technically or functionally fulfill their core mission; in addition, the organizational habits (how they fulfill their core mission) are done with such intensity and intentionality that a distinctive organization mark is transferred onto the individual, which is evident in their personal habits (i.e., character). For example, a healthcare culture that imprints certainly fulfills its core mission to transfer knowledge from healthcare providers to patients; but in an intentional culture of excellence and ethics there is significant attention paid to developing the character and culture needed for the general philosophy and specific pedagogy by paying as much attention to how we do things as to what we do. The key to shaping intentional culture is developing and regularly renewing your foundational rituals and routines. Thoughtful rituals and routines are so important because they operationalize our espoused values and ensure that they are in fact lived reality, and they do so in an efficient and consistent way. So, if you espouse a commitment to trust, respect, teamwork, and collaboration and see these as essential to accomplishing your core mission, then you can’t leave it to chance that your group will figure out how to incorporate these into the context of your shared work together. Therefore, you need to define HOW you do things so that those animating values are experienced. The espoused values must be linked to clearly defined operative verbs. For example, the espoused value is trust. The defined operative verbs could be communicate like this, negotiate like this, work in groups like this, or solve problems like this. What we believe must be linked to intentional norms for HOW we will live. Defining what we do and how we do it will contribute to overall efficiency and effectiveness. In an effort to be more intentional, consider the following: Can you identify and describe the “signature practices” (strategies, norms, or organizational habits) that instill in your group members the “distinguishing marks” (i.e., character) of your healthcare practice, hospital, family, school, team, or organization? Not a list of things you do (we eat together, we have staff meetings, we have an awards ceremony or we go away together), but a description of HOW what you do is done with

intensity and consistency so that they result in a set of shared ideas, beliefs, and habits that uniquely impact and define their group. Ask yourself this concerning any ritual or habit of your group: “How does doing this way help us to more fully realize our mission and goals?” List the practices of your group and ask yourself, “Why do we do it this way?” and “Is there anything we could change or improve to that would add intentionality so that we better reach our goals?” Look across your organization or group and ask yourself, “What are the areas where we are routinely expending resources to reactively respond to problems, inefficiencies, and inconsistencies?” and “What habits have begun to detract from their intended purpose and the core organizational philosophy and goals?” and “What lived habits and behaviors conflict with or are in tension with their espoused values” For example, we are doing this to build trust, but it’s being done in a way that actually undermines trust. If indeed, “We are what we are repeatedly led to do,” then we must examine our rituals and routines to ensure that they contribute to (and do not detract from) our core mission, shared values, and stated goals. As Tom Lickona put it, “You must practice what you preach, but you must also preach what you practice.” What do we do? Why do we do it this way? Why is doing it this way better than the other ways? If you don’t know the answers to these questions or the answers aren’t convincing to you or those you lead, it’s not the end of the world. Intentional culture is not a destination; it’s an ideal to strive for. However, reconsidering and reformulating the what, why, and how of your rituals and routines can pay huge dividends towards becoming more efficient and effective in achieving your goals. 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.

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DERmatology pa news & notes

is also intensity (deliberate guided education and practice promotes fidelity); commitment of resources (especially time); and strong accountability which leads to widespread buy in ensuring that the shared norms are pervasive throughout the organization - not relegated to “pockets of excellence.”

Tetrix Protects the Skin Like a Glove

Specially Formulated for Treating Hand Eczema with Powerful Barrier Protection Tetrix® Cream is contraindicated in persons with a known hypersensitivity to any of the components of the formulation. Proven skin barrier protection against the sensitization caused by Nickel Sulfate, Neomycin, and Fragrance Antigen.1

Rx Only Topical Use Only Do Not Use in Eyes For Topical Dermatologic Use Only Product Description Tetrix® Cream is a non-sterile cream formulation intended for prescription use only. Indications and Usage Tetrix® Cream is indicated to manage and relieve the burning and itching experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and irritant contact dermatitis. Tetrix® Cream helps to relieve dry, waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process. Directions for Use Apply a thin layer to affected areas 2-3 times per day or as directed by a physician.

Ingredients Tetrix® is a nonsteroidal cream comprised of aluminum magnesium hydroxide stearate, cetyl dimethicone copolyol, cyclomethicone, dimethicone, hexyl laurate, polyglyceryl-4-isostearate, purified water, and sodium chloride. Contains phenoxyethanol and propylparaben as preservatives. Contraindications Tetrix® Cream is contraindicated in persons with a known hypersensitivity to any of the components of the formulation. Precautions For external use only. Avoid contact with eyes and other mucous membranes. Do not use the product if the packaging is damaged or after the expiration date. If your condition does not improve within 10-14 days, consult your physician. The safety and efficacy of Tetrix® Cream has not been determined in pediatric patients.

1. Data on file.

54 Journal of Dermatology for Physician Assistants

Keep out of the reach of children. Tetrix® Cream contains no dyes or fragrances and is well tolerated and safe. How Supplied Tetrix® Cream is available in a 2-oz. tube. Store at controlled room temperature: 15°C to 30°C (59°F to 86°F). Do not freeze. Distributed by: Encore Dermatology, Inc. 5 Great Valley Parkway Malvern, PA 19355 Manufactured by: DPT Laboratories, Ltd. San Antonio, TX 78215

www.encorederm.com

1-844-848-6543

Patent No. 5,482,714 HRI 8569-000002 TX1049 12/15

Dermatology PA news & notes

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June 19 – 24, Camp Little Pine in Crosslake, Minnesota (ages 10 – 14) ● June 19 – 24, Camp Reflection in Carnation, Washington (ages 7 – 16) ● July 3 – 8, Camp Big Trout in Crosslake, Minnesota (ages 14 – 16) ● August 7 – 12, Camp Dermadillo in Burton, Texas (ages 9 – 15) ● August 13 – 19, Camp Horizon in Millville, Pennsylvania (ages 8 – 13) ● Dates TBD, Camp Liberty in Andover, Connecticut (ages 8 – 16)

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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. J

For more information about attending or volunteering please visit the Camp Discovery website at www.campdiscovery.org or contact Janine Mueller at (847) 240-1737 or jmueller@aad.org.

Volume 10 • number 1 • WINTER 2016 55

DERmatology pa news & notes

Camp Discovery 2016

From the Desk of... Jennifer L. Dorn Chief Executive Officer, AAPA

PA Communications Guide

DERmatology pa news & notes

A Guide for Writing and Talking About PAs One way we can provide education about our profession is through writing letters if we feel our profession could be portrayed more accurately through making a profession wide change or adjustment. As dermatology PAs we can use our voices in the written form to share accurate information and educate several audiences. Jennifer Dorn, CEO of AAPA shares with us a letter she has written addressing the importance of using the term PAs verses physician assistants when writing or speaking about our profession. You can help contribute to improving our profession by sharing these types of articles with your supervising physicians. It is very important that we keep our supervising physicians aware and up-todate on the latest articles and information that is being published about our profession. This is how we will be successful in helping our Society and in turn bettering the quality of information our patients receive and ultimately the care they receive. We have also included a copy of the AAPA Guide for Writing and Talking about PAs. November 24, 2015 Dear Society of Dermatology PAs members, Language is the means with which we express ideas, compel understanding and propel others to action. As the PA profession takes on healthcare needs today and in the future, it is vital that the language we employ to discuss the profession does the same. The continued growth of the profession, coupled with the ongoing modernization of PA laws and regulations, is rapidly shifting the way PAs practice and the language we use to describe what you do. To that end, AAPA created a communications guide (see page 59) to help transform the way we talk about PAs and to reflect the realities of modern PA practice. We use the abbreviated PA to refer to the profession, no longer using the title “physician assistant” unless clarification is needed for certain audiences. It is important to drive universal adoption of the widely recognized PA title and ensure that we use it to create appreciation of the important patient care PAs deliver. We use direct and meaningful language to accurately underscore what PAs do – PAs practice medicine – and how PAs work in collaboration with the healthcare team. SDPA has embraced this new lexicon and we deeply appreciate your leadership in putting the language and the AAPA communications guide into action through your materials and discussions. SDPA’s continued stewardship in PA specialty practice and in delivering PA messages is invaluable. J Our deepest appreciation,

Jennifer L. Dorn Chief Executive Officer, AAPA J

...continued on page 59 56 Journal of Dermatology for Physician Assistants

Finacea® (azelaic acid) Foam, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea.

The first and only prescription foam approved by the FDA for the treatment of rosacea In the art of rosacea therapy...

Proven efficacy has another profile with Finacea Foam ®

IMPORTANT SAFETY INFORMATION Warnings and Precautions Skin Reactions: There have been isolated reports of hypopigmentation after use of azelaic acid. Because azelaic acid has not been well studied in patients with dark complexion, monitor these patients for early signs of hypopigmentation. Eye and Mucous Membranes Irritation: Azelaic acid has been reported to cause irritation of the eyes. Avoid contact with the eyes, mouth and other mucous membranes. If Finacea® Foam does come in contact with the eyes, wash the eyes with large amounts of water and consult a healthcare professional if eye irritation persists. Flammability: The propellant in Finacea® Foam is flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application. Do not puncture and/or incinerate the containers. Do not expose containers to heat and/or store at temperatures above 120°F (49°C). Most Common Adverse Reactions In clinical studies, the most frequently observed adverse reactions in ≥ 0.5% of subjects treated with Finacea® Foam included local site pain (6.2%), pruritus (2.5%), dryness (0.7%), and erythema (0.7%). For Topical Use Only Finacea® Foam is not for oral, ophthalmic or intravaginal use. Avoid the use of occlusive dressings or wrappings at the application site. Avoid use of alcoholic cleansers, tinctures and astringents, abrasives and peeling agents. Patients should be reassessed if no improvement is observed upon completing 12 weeks of therapy. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. For important risk and use information, see the full Prescribing Information. For important risk and use information, see the Brief Summary on the following page.

Discover The Foamulation www.finaceafoam.com

Volume 10 • number 1 • WINTER 2016 57

FINACEAÂŽ

(azelaic acid) Foam, 15% for topical use

For Topical Use Onlyâ&#x20AC;&#x201C;Not for Oral, Ophthalmic or Intravaginal Use Rx only BRIEF SUMMARY CONSULT PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE Finacea (azelaic acid) Foam, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. 5 WARNINGS AND PRECAUTIONS 5.1 Skin Reactions There have been isolated reports of hypopigmentation after use of azelaic acid. Because azelaic acid has not been well studied in patients with dark complexion, monitor these patients for early signs of hypopigmentation. 5.2 Eye and Mucous Membranes Irritation Azelaic acid has been reported to cause irritation of the eyes. Avoid contact with the eyes, mouth and other mucous membranes. If Finacea Foam does come in contact with the eyes, wash the eyes with large amounts of water and consult a physician if eye irritation persists. 5.3 Flammability The propellant in Finacea Foam is flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application. Do not puncture and/or incinerate the containers. Do not expose containers to heat and/or store at temperatures above 120Â°F (49Â°C). 6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in the prescribing information: t )ZQPQJHNFOUBUJPO [see Warnings and Precautions (5.1)]. t Eye and Mucous Membranes Irritation [see Warnings and Precautions (5.2)]. 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. Finacea Foam was evaluated for the treatment of papulopustular rosacea in two multicenter, randomized, double-blind, vehicle-controlled, 12-week clinical trials involving a total of 1362 (Finacea Foam, 15%: 681; vehicle: 681) subjects. Overall, 95.7% of subjects were White, 73.4% were female, and the mean age was 50.6 years. Table 1: Adverse Reactions Occurring in â&#x2030;Ľ 0.5% of Subjects Treated with Finacea Foam Compared with Subjects Treated with Vehicle System/Organ Class Preferred

Finacea Foam, 15% (N=681) n (%)

Vehicle (N=681) n (%)

General disorders and application site conditions Application site pain* Application site pruritus Application site dryness Application site erythema

42 (6.2%) 17 (2.5%) 5 (0.7%) 5 (0.7%)

10 (1.5%) 2 (0.3%) 5 (0.7%) 6 (0.9%)

* â&#x20AC;&#x153;Application site painâ&#x20AC;? is a term used to describe disagreeable skin sensations, including burning, stinging, paraesthesia and tenderness. 6.2 Post-Marketing Experience )ZQFSTFOTJUJWJUZ SBTI BOE XPSTFOJOH PG BTUINB IBWF CFFO SFQPSUFE GSPN the postmarketing experience of azelaic acid-containing formulations. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Local Tolerability Studies In a 21-day cumulative irritation study under occlusive conditions, mildto-moderate irritation was observed for azelaic acid pre-foam emulsion. In B IVNBO SFQFBU JOTVMU QBUDI UFTU )3*15 TUVEZ OP TFOTJUJ[BUJPO QPUFOUJBM was observed for azelaic acid pre-foam emulsion. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Teratogenic Effects: Pregnancy Category B There are no adequate and well-controlled studies in pregnant women. Therefore, Finacea Foam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

58 Journal of Dermatology for Physician Assistants

Dermal embryofetal developmental toxicology studies have not been performed with azelaic acid, 15% foam. Oral embryofetal developmental studies were conducted with azelaic acid in rats, rabbits, and cynomolgus monkeys. Azelaic acid was administered during the period of organogenesis in all three animal species. Embryotoxicity was observed in rats, rabbits, and monkeys at oral doses of azelaic acid that generated some maternal toxicity. Embryotoxicity was observed in rats given 2500 mg/kg/day [162 UJNFT UIF NBYJNVN SFDPNNFOEFE IVNBO EPTF .3)% CBTFE PO CPEZ surface area (BSA)], rabbits given 150 or 500 mg/kg/day (19 or 65 times UIF .3)% CBTFE PO #4" BOE DZOPNPMHVT NPOLFZT HJWFO NH LH EBZ UJNFT UIF .3)% CBTFE PO #4" B[FMBJD BDJE /P UFSBUPHFOJD FGGFDUT were observed in the oral embryofetal developmental studies conducted in rats, rabbits and cynomolgus monkeys. An oral peri- and post-natal developmental study was conducted in rats. Azelaic acid was administered from gestational day 15 through day 21 postpartum up to a dose level of 2500 mg/kg/day. Embryotoxicity was PCTFSWFE JO SBUT BU BO PSBM EPTF PG NH LH EBZ UJNFT UIF .3)% based on BSA) that generated some maternal toxicity. In addition, slight disturbances in the post-natal development of fetuses was noted in rats at oral doses that generated some maternal toxicity (500 and 2500 mg/ LH EBZ BOE UJNFT UIF .3)% CBTFE PO #4" /P FGGFDUT PO TFYVBM maturation of the fetuses were noted in this study. 8.3 Nursing Mothers It is not known if azelaic acid is secreted into human milk in vivo /P XFMM controlled studies of topically administered azelaic acid in nursing women BSF BWBJMBCMF /FWFSUIFMFTT UIF EFDJTJPO UP EJTDPOUJOVF OVSTJOH PS UP discontinue the drug should take into account the importance of the drug to the mother. 8.4 Pediatric Use The safety and efficacy of Finacea Foam in children below the age of 18 years have not been established. 8.5 Geriatric Use Of the total number of subjects in clinical studies of Finacea Foam, 18.8 QFSDFOU XFSF BOE PWFS XIJMF QFSDFOU XFSF BOE PWFS /P PWFSBMM differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. 17 PATIENT COUNSELING INFORMATION Inform patients using Finacea Foam of the following information and instructions: t 'PS FYUFSOBM VTF POMZ t $MFBOTF BGGFDUFE BSFB T XJUI B WFSZ NJME TPBQ PS B TPBQMFTT DMFBOTJOH lotion and pat dry with a soft towel. t 4IBLF XFMM CFGPSF VTF t "WPJE VTF PG BMDPIPMJD DMFBOTFST UJODUVSFT BOE BTUSJOHFOUT BCSBTJWFT BOE peeling agents. t "WPJE DPOUBDU XJUI UIF FZFT NPVUI BOE PUIFS NVDPVT NFNCSBOFT *G Finacea Foam does come in contact with the eyes, wash the eyes with large amounts of water and consult your physician if eye irritation persists. t *G BMMFSHJD SFBDUJPOT PDDVS EJTDPOUJOVF VTF BOE DPOTVMU ZPVS QIZTJDJBO t 8BTI IBOET JNNFEJBUFMZ GPMMPXJOH BQQMJDBUJPO PG 'JOBDFB 'PBN t $PTNFUJDT NBZ CF BQQMJFE BGUFS UIF BQQMJDBUJPO PG 'JOBDFB 'PBN IBT ESJFE t "WPJE UIF VTF PG PDDMVTJWF ESFTTJOHT BOE XSBQQJOHT t 5P IFMQ NBOBHF SPTBDFB BWPJE BOZ USJHHFST UIBU NBZ QSPWPLF FSZUIFNB flushing, and blushing. These triggers can include spicy and thermally hot food and drinks such as hot coffee, tea, or alcoholic beverages. t 5IF QSPQFMMBOU JO 'JOBDFB 'PBN JT nBNNBCMF "WPJE mSF nBNF PS smoking during and immediately following application. t %JTDBSE QSPEVDU XFFLT BGUFS PQFOJOH ÂŠ #BZFS )FBMUI$BSF 1IBSNBDFVUJDBMT *OD "MM SJHIUT SFTFSWFE Manufactured for:

#BZFS )FBMUI$BSF 1IBSNBDFVUJDBMT *OD 8IJQQBOZ /+ Manufactured in Switzerland

6798100BS

PA Communications Guide

...continued from page 56

A Guide for Writing and Talking About PAs

THE PA ABBREVIATION Use “PA” as the title of the profession, not “physician assistant,” in all copy. We do not use “physician assistant” any longer to refer to the profession as the name does not adequately depict the medical services PAs provide to patients every day. If you must spell it out to aid in external audience awareness, only use “physician assistant” once in parentheses after the first PA reference (i.e., PA (physician assistant)); for all subsequent references, use the title PA.

WHO ARE PAs? PAs are nationally certified and state licensed to practice medicine and prescribe medication in every medical and surgical specialty and setting and in all 50 states, the District of Columbia and all U.S. territories, with the exception of Puerto Rico. PAs are educated at the graduate level, with most PAs receiving a Master’s degree or higher. In order to maintain national certification, PAs are required to complete 100 hours of continuing medical education every two years and to recertify as medical generalists every 10 years.

WHAT DO PAs DO? ● ● ● ●

PAs practice medicine. PAs practice in every medical and surgical specialty and setting. PAs manage the full scope of patient care, often handling patients with multiple morbidities. PAs conduct physical exams, diagnose and treat illnesses, order and interpret tests, assist in surgery, coordinate care, counsel on preventive healthcare, prescribe medications and more.

HOW DO PAs WORK? PAs’ scope of practice is determined by their education and experience. Scope of practice is also subject to state laws and facility policy. In optimal settings, PAs practice at the top of their education, training and experience, and the

scope is determined at the practice level. ● PAs practice medicine in teams with physicians and other healthcare professionals.

WHY ARE PAs UNIQUE? PAs increase access to healthcare. PAs provide quality care and have been shown to positively impact patient outcomes. ● PAs are educated, to seamlessly work in a team-based model of care. ● PAs are educated as medical generalists and recertify as medical generalists. ● PAs are one of the most versatile healthcare providers; during the course of their career, most PAs will have worked in two to three specialties. ● PAs manage patient care coordination and provide clinical preventive services. ● Four out of five PAs report high job satisfaction. ● ●

OUTDATED LEXICON/MYTHS/ MISPERCEPTIONS Inaccurate Terminology: “PAs are mid-level providers, physician extenders, non-physician providers, advanced practice providers or advanced practice clinicians.” These terms are often misunderstood by consumers and do not accurately portray or describe how PAs practice medicine to other providers or patients. Nor do they reflect their license or legal title. If PAs need to be referenced as part of a larger group, use “healthcare provider,” “healthcare practitioner,” or “clinician” but the preferred reference would include simply the title name of each profession (e.g., “PAs and NPs”). Inaccurate Terminology: “PAs work on physician-led teams.” or “PAs are supervised by a physician.” It is no longer the case that physicians have to be at the helm of the patient care team. Today’s PAs collaborate with physicians. In 2014, the AAPA House of Delegates adopted a policy that describes PAs as practicing medicine “in collaboration” with physicians. Supervision should only be referenced when required by legal and regulatory documentation. For example, patient-centered medical homes allow for various health professionals to function as leaders of teams, including PAs. In practice, a PA’s scope typically grows over time with clinical experience. It is common for a PA to serve as the lead on care coordination teams and see patients in all settings without a physician present. In fact, in many rural and underserved areas, a PA may be the only provider, with PA-physician collaboration occurring via telecommunication. J Volume 10 • number 1 • WINTER 2016 59

DERmatology pa news & notes

As the PA profession evolves, so does the language used to talk about it. The explosive growth of the profession, coupled with the continued modernization of PA laws, is rapidly changing the way PAs practice and the language we use to describe what they do. This is a reference guide for how to communicate about the profession in a way that reflects the realities of modern PA practice. If you have any questions, please contact Deirdre Middleton, Vice President Communications and Media Relations (phone 571-319-4482 or email dmiddleton@aapa.org).

Supervising Physician CORNER An Interview with the New SDPA Summer Conference Educational Planning Committee’s CME Medical Director – Ted Rosen, MD By J. Margaret Casey

DERmatology pa news & notes

The SDPA’s Summer Conference Educational Planning Committee would like to welcome the new SDPA CME Medical Director. The creation of this position was a result of the Committee thoughtfully listening to feedback from our members and using their recommendations to help continually improve our conference and the SDPA overall. Dr. Ted Rosen will be serving as the SDPA CME Medical Director for the 2016 SDPA Summer Dermatology Conference. As the CME Medical Director, Dr. Rosen will be providing the Committee with guidance and direction to help improve the quality of the conferences. We had an opportunity to interview Dr. Rosen and learn more about his experience volunteering with the SDPA in his new role as Medical Director and what he foresees for future conferences.

JDPA: What special skills and/or experiences do you have that you think help in your new role? Dr. Rosen: I have been an academic dermatologist for my entire 37 year career. As such, teaching others is second nature to me. I have developed what I believe to be an informative and yet entertaining and engaging lecture style by routinely presenting to both small and large dermatology audiences in the United States and around the world. I hope that the SDPA membership will not only learn from but also enjoy the lectures and workshops, which I will give. Planning a meeting of this size requires a different skill set. I have honed my organizational skills by being responsible for all aspects of one of the busiest Veterans Affairs dermatology clinics in the entire country. JDPA: What has been your experience thus far in working with and/or educating dermatology PAs? Dr. Rosen: I currently practice alongside two dermatology PAs. How did I ever survive without them, I wonder? I have spoken at a number of past SDPA meetings, at various state dermatology PA societies, at the annual DNA meeting, and at many additional national conferences directed solely to dermatologyoriented PAs and NPs. I have uniformly found these audiences to be refreshingly eager to learn, to be ready to improve their skills, and to be able to adopt new and emerging therapeutic interventions. Nothing makes for a more enthusiastic educator than a receptive set of pupils. 60 Journal of Dermatology for Physician Assistants

JDPA: What do you hope to gain from this experience with the SDPA? Dr. Rosen: The dermatology experience of PAs is quite varied and may be substantially different from that of a supervisory physician. My interactions with dermatology PAs at SDPA conferences provide me with insights into patient care, which can be useful in my own professional activities. Fundamentally, however, I ENJOY teaching colleagues at all levels of seniority. I hope and expect to be happy knowing that I have, in some small way, made a good provider even better. Ultimately, that will benefit the patients we all strive to serve. JDPA: How do you see the role of dermatology PAs changing in the future? Dr. Rosen: I see ever-expanding use of PAs and NPs in the dermatological realm. From a purely pragmatic standpoint, there is simply too much demand for dermatological care for the latter to be delivered solely by physicians. The role of the non-physician provider should be a collaborative one. Together, we can insure that patients receive timely and cost-efficient care. JDPA: What advice would you share with fellow dermatologists who are considering volunteering their time to helping educate dermatology PAs? Dr. Rosen: Without sounding too flippant and not trying to steal Nike’s thunder: Just do it! It feels good, and frankly it’s the right thing to do. By educating PAs, NPs, and our dermatological colleagues, you can inspire as well as enlighten. Where would I be without the efforts

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Some people really believe that I am a vampire. Maybe so, in any event, if you have comments or suggestions, I would love to hear from you: vampireted@aol.com. J Ted Rosen, MD attended Michigan State University as a National Merit Scholar. Dr. Rosen graduated from the University of Michigan Medical School cum laude. He trained in internal medicine at the University of Alabama and in dermatology at Baylor College of Medicine where he currently serves as Professor of Dermatology and Chief of Dermatology at the Houston Veterans Affairs Medical Center. Dr. Rosen recently served a term on the Board of Directors of the American Academy of Dermatology. He is a past Vice-President of Texas Dermatological Society, a pastPresident and Secretary-Treasurer of the Houston Dermatological Society, and prior Chairman and Secretary-Treasurer of the Dermatology Section, Southern Medical Association. Dr. Rosen has written over three hundred peer-reviewed journal articles, twenty-four textbook chapters, and three textbooks. He has been a plenary speaker for various city, state, regional, national, and international dermatology organizations including the national dermatology societies of Hong Kong, Mexico, Chile, Argentina, Korea, Australia, New Zealand, and Canada.

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DERmatology pa news & notes

of my own teachers, from high school through college, medical school, and my post-graduate training years? To quote the Dalai Lama XIV: “Share your knowledge. It is a sure way to achieve immortality.” JDPA: Any additional information that you would like to share with the SDPA readers? Dr. Rosen: As an outside observer, I have always seen the SDPA as a flagship organization; you should be proud to be a member. SDPA meetings are an opportunity to reinforce, sharpen, or enhance your clinical acumen. Take advantage of that opportunity. I am humbled and honored to have been asked to provide some modicum of guidance and input. I promise to do my very best to make the SDPA Summer Conference a beacon of educational excellence. But let’s not lose sight of this: we should all feel very privileged and sublimely happy to be in the field of dermatology! Therefore, let’s also try to have some fun at these meetings! John Cheese, who is a columnist for the magazine and website “Cracked” said, “He who laughs most, learns best.” JDPA: Any personal facts you would like to share? Dr. Rosen: I am a cat person. It’s not that I hate dogs. Rather, I admire the independent spirit inherent to cats. I am a numismatist; that means I collect coins. I am a lifelong Chicago Cubs fan. Please take pity on me.

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© 2012 American Academy of Dermatology. Use of this poster does not imply product or service endorsement by the American Academy of Dermatology. © 2012 American Academy of Dermatology. Use of this poster does not imply product or service endorsement by the American Academy of Dermatology.

62 Journal of Dermatology for Physician Assistants

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] 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 DM/ONX/14/0031(1)

Volume 10 • number 1 • WINTER 2016 63

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Acne

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

INDICATION

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

IMPORTANT SAFETY INFORMATION

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

•

• •

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

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

64 Journal of Dermatology for Physician Assistants