JDPA Fall 2015 by Angela Simiele

DPA J

V o l u m e 9 • n u m b e r 4 • F A LL 2 0 1 5 • www.jdpa.org

Journal of Dermatology for Physician Assistants

Dermatology PA News & Notes Student Corner 15 __________________________________

CLINIcal dermatology Clinical Snapshots

__________________________________

surgical dermatology Dermatology Case Report 33 _________________________________

cosmetic dermatology Journal Club 36 __________________________________

professional development Dermatology Billing & Coding – Welcome to ICD-10

›› Earn CME credit with this issue CME A Guide to More Effective Pregnancy Prevention Counseling When 17 Prescribing Isotretinoin

Official Journal of the Society of Dermatology Physician Assistants

Volume 9 • number 4 • FALL 2015

Dedicated to discovery. Centered on care.

Impact of Clearer Skin on Quality of Life Psoriasis patients who achieved PASI ≥90 had a significantly higher quality of life than those with PASI scores 75 to < 90 (P =.007).1

Patients achieving a DLQI of 0 or 1 (%)

Association between PASI scores and DLQI

Improvement in PASI scores PASI=Psoriasis Area and Severity Index; DLQI (0,1)=Dermatology Life Quality Index 0,1=No Impact on Quality of Life.

To learn more about Lilly’s commitment to improving the lives of psoriasis patients, call 1-800-LillyRx (1-800-545-5979).

Reference: 1. Torii H, Sato N, Yoshinari T, Nakagawa H, on behalf of the Japanese Infliximab Study Investigators. Dramatic impact of a Psoriasis Area and Severity Index 90 response on the quality of life in patients with psoriasis: An analysis of Japanese clinical trials of infliximab. J Dermatol . 2012;39:253-259. PP-LI-US-0118 09/2015 PRINTED IN USA ©2015, LILLY USA, LLC. ALL RIGHTS RESERVED.

Volume 9 • number 4 • FALL 2015

Journal of Dermatology for Physician Assistants

EDITORIAL BOARD

Travis Hayden, MPAS, PA-C, Editor in Chief Joe R. Monroe, MPAS, PA Patricia Ferrer, MPAS, PA-C Gordon Day, R.Ph, PA-C Nancy Primo, MPAS, PA-C Lauren Zajac, MHS, PA-C Michelle DiBaise, MPAS, PA-C P. Eugene Jones, PhD, PA-C Mark Archambault, DHSc, PA-C Kristine Kucera, DHS, MPAS, PA-C Jennifer Winter, PA-C Mark Hyde, MMS, PA-C Jennifer Conner, MPAS, PA-C Jeffrey LaDuca, PhD, MD Alan Menter, MD

DEPARTMENT EDITORS

Clinical Department Editors Susan E. King-Barry, MPAS, PA-C Karen Graham, PhD, MPAS, PA-C Dermatology Grand Rounds Editor Cynthia F. Griffith, MPAS, PA-C Dermoscopy Editor John Burns, MSPA, PA-C Drugs in Dermatology Editor Stephen Wolverton, MD Surgical Department Editor Christy Kerr, MPAS, PA-C Cosmetic Department Editor Nancy Primo, MPAS, PA-C Prof Dev Department Editor Abby Jacobson, MS, PA-C

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

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

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

JDPA/Journal of Dermatology for Physician Assistants (ISSN 1938-9574) is published quarterly (4 issues per volume, one volume per year) by Physician Assistant Communications, LLC, P.O. Box 416, Manlius NY 13104-0416. Volume 9, Number 4, Fall 2015. One year subscription rates: $40 in the United States and Possessions. Single copies (prepaid only): $10 in the United States (Include $6.50 per order plus $2 per additional copy for US postage and handling). Periodicals postage rate paid at New York, NY 10001 and additional mailing offices. © 2015 Physician Assistant Communications, LLC. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including by photocopy, recording, or information storage and retrieval system, without permission in writing from the publisher. Postmaster: Send address changes to Society of Dermatology Physician Assistants, Inc., 8400 Westpark Drive, 2nd Floor, McLean, VA 22102 1-800-380-3992., email SDPA@dermpa.org, www.dermpa.org. THIS ISSUE IS SPONSORED BY

Journal of Dermatology for Physician Assistants

Editor’s Message

uring the past ten years that I have been involved with the SDPA I have seen many significant projects, initiatives, and legislative changes within our profession that the SDPA has made lasting contributions to. The various SDPA committees continue to commit to improve and grow our profession, which ultimately impacts our daily work and the quality of care that our dermatology patients receive. A recent and exciting development that will continue in this same positive contributing tradition for our Society is the establishment of the Dermatology PA Foundation (DPAF). This wonderful foundation was just established by the SDPA at our 13th Annual Fall Dermatology Conference that was held in Orlando, Florida this past November 12-15, 2015. The DPAF was created in order to help dermatology PAs expand their leadership and contributions to the field of dermatology. The DPAF is led by a Board of Trustees, who have been appointed by the SDPA Board of Directors. This Foundation, which has applied with the IRS for 501c3 status, was established exclusively for charitable and educational purposes. The DPAF will engage in research, scholarship, and philanthropy designed to improve the practice of dermatologic patient care by PAs and other medical professionals. As time unfolds it will become more clear exactly how our membership can assist the DPAF in achieving its goals and mission. This is an exciting time for the SDPA and this opportunity is yet another way that we as dermatology PAs can blaze a new trail and leave yet another lasting contribution to our profession, the field of dermatology, and our patients. J

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

The SDPA has a long history of philanthropic and educational activities. In 2012, the SDPA established a philanthropic task force, which was transformed in 2013 into the Philanthropic Committee in order to promote the desire of its members to engage in fund raising and increasing awareness of dermatologic disease treatments and cures. The initial projects of the task force and Philanthropic Committee included Miles for Melanoma 5K walk/run races in Seattle, Atlanta, and San Diego. The SDPA Philanthropic Committee was replaced by the Dermatology PA Foundation (DPAF) on November 14, 2015 when the DPAF Board of Trustees met for the first time at the SDPA’s 13th Annual Fall Dermatology Conference at the Loews Portofino Bay Hotel in Orlando, Florida. The first official joint project of the DPAF and SDPA also took place in Orlando at the 4th Annual SDPA Miles for Melanoma 5K walk/run. The DPAF would like to thank all who participated, volunteered, and/or donated to this event. At the event this year the DPAF was able to raise nearly $5,000 for the Melanoma Research Foundation! The DPAF extends its most sincere appreciation for all who joined in to help make this year’s SDPA Miles for Melanoma event another huge success. As always, the Foundation is eternally grateful for every ones efforts and dedication to this charitable endeavor. Together we are making a difference!

Volume 9 • number 4 • FALL 2015

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

A Guide to More Effective Pregnancy Prevention Counseling When Prescribing Isotretinoin By Sara Wilchowski, MS, PA-C and Steven Leon, MS, PA-C

›› CME 10 Derm PA News & Notes – part one • Certification Review • Student Corner – Introducing the Newly Appointed SDPA Student Affairs Committee Junior Student Coordinator • SDPA State Affiliates – The Florida Society of Dermatology Physician Assistants

17 Clinical Dermatology • CME Article – A Guide to More Effective Pregnancy Prevention Counseling When Prescribing Isotretinoin • Dermatology Case Report – Pili Annulati

Departments 04 Editorial Board 05 Editor’s Message 09 SDPA News & Current Affairs 10 Dermatology Market Watch 21 From The Patient’s Perspective 26 Clinical Snapshots 35 Surgical Wisdom 37 Cosmetic Pearls 43 Notes from your Office Manager 46 The Difference We Make 56 Now Showing on Dermcast.tv 57 JDPA Information for Authors 58 Professional Opportunities and Development

33 Surgical Dermatology • Dermatology Case Report – How Should You Manage This Patient With Facial Melanoma?

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

41 Professional Development • Dermatology Billing & Coding – Welcome to ICD-10 • Outside & Inside the 9 to 5… The Power of Jambo

46 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 Anita Singh, MD, FACOG

dermpa.org

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

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

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

Volume 9 • number 4 • FALL 2015

Journal of Dermatology for Physician Assistants

FROM THE SDPA

News & Current Affairs Greetings Colleagues,

CALENDAR OF EVENTS 2015

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

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

This has been one of those weeks when I am simply amazed at the great honor we have as PAs to provide care for our patients. I had so many incredible patient encounters where patients expressed how much they appreciated what I had done for them. Then there were the patients who just needed that little bit of extra attention, the reassurance we could cure their skin cancer, or a few minutes to listen to the story about their family member. There was also the patient whose second melanoma resulted in a digit amputation by an oncology surgeon and on whom I found yet a third melanoma. Each of these encounters was meaningful to the patient who needed care but also because the interactions had meaning for me as well. I was productive and contributed to the well being of my patients’ lives. This was a good week. At times likes this, I reflect that I can’t imagine finding a more meaningful career to pursue. It is really a great honor and privilege to be a medical care provider. I’ll be the first to admit that I don’t always feel this way, especially when a day has been tough or a patient has been really challenging. I often find this feeling is most acute when I return from vacation, and my batteries are fully recharged. I fully ascribe to the theory that we need to plan time off once a quarter. If you are feeling burned out or resentful of the demands placed upon you, let me encourage you to take a break and get out of town. I guarantee you will feel less discouraged after a break from the daily demands of patient care. As professionals, we should celebrate that we have the privilege to be healers. While we may not always be able to cure every dermatologic condition, we are often able to provide treatment options and some form of relief from the things that afflict our patients’ skins and sometimes their emotions. While we don’t practice psychiatry, we do have a role to play in listening to our patients and letting them know we care. I think about the patient who comes in for a skin cancer check and then candidly admits towards the end of the visit that they have lost their spouse since I last saw them. Yes, sometimes this takes an extra five minutes I don’t have to let them talk, give them a tissue, or even give a hug, but I know this is a meaningful exchange that makes every other difficult part of my day worth it. I can go to bed that night knowing I made a difference in the life of a patient and so can you. J Best Wishes,

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

Volume 9 • number 4 • FALL 2015

Dermatology PA news & notes

Dermatology Market Watch Galderma Announces Epiduo Forte Gel The US Food and Drug Administration (FDA) has approved a topical gel combination of adapalene 0.3% and benzoyl peroxide 2.5% (Epiduo Forte, Galderma) for the treatment of acne vulgaris. Epiduo Forte gel combines two, antibiotic-free medicines in one gel and is proven to control moderate to severe inflammatory acne. With the highest concentration of the retinoid adapalene combined with benzoyl peroxide, Epiduo Forte gel was well tolerated in the clinical trial, and works to treat current breakouts by reducing the inflammation and redness associated with acne, and helps prevent future pimples from forming by unclogging pores and killing bacteria under the skin. The approval was based on a phase 3 randomized double-blind study involving 217 patients, all aged 12 years

and older, with an average patient age of 20 years. In the study, Epiduo Forte gel was superior to vehicle control gel in the overall study population of patients with moderate to severe acne at week 12 for the Investigator's Global Assessment Success Rate and for changes in inflammatory and noninflammatory lesion count. In addition, half of the patients had severe acne at baseline, and more than half of this group (50.5%) saw marked improvement during the study, with results seen as early as 1 week, with continued improvement through week 12. Epiduo Forte gel, Galderma’s fourth available antibiotic-free acne treatment, contributes to the company’s commitment to antibiotic stewardship by arming patients and providers with another safe and effective tool to help fight acne. For more information, please visit: GaldermaUSA.com or www.epiduoforte.com. J

AbbVie's Humira® (Adalimumab) Receives First and Only U.S. FDA Approval for Moderate to Severe Hidradenitis Suppurativa AbbVie, a global biopharmaceutical company, announced in September that the U.S. Food and Drug Administration (FDA) approved Humira® (adalimumab) for the treatment of moderate to severe hidradenitis suppurativa (HS). Humira is now the first and only FDA-approved therapy for adults with HS. Earlier this year, the FDA granted Humira orphan drug designation for the treatment of moderate to severe HS (Hurley Stage II and Hurley Stage III disease), a population of fewer than 200,000 patients. The orphan drug designation provides Humira the potential to be granted seven years of market exclusivity for the treatment of moderate to severe HS. In July, the European Commission approved Humira for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic HS treatment in the European Union. Other treatment options for people with HS include surgery to remove skin affected by the disease and antibiotics to treat infections that may occur. HS can be progressive in some people, and diagnosing and managing the disease early 10 Journal of Dermatology for Physician Assistants

is important. This can be difficult, and many people with HS experience a lengthy delay in diagnosis and treatment. It's important for HS patients and people who think they may have HS to see a dermatology provider who is trained to recognize and manage the disease. The FDA approval for HS adds to the comprehensive record of clinical studies that Humira has established over its 17 years of use in immunology. This FDA approval is based on the results of two pivotal Phase 3 studies, PIONEER I and PIONEER II, and represents the ninth approved indication for HUMIRA in the U.S. PIONEER I and PIONEER II included 633 people with moderate to severe HS. Patients in these studies were randomly assigned to receive either Humira or placebo in addition to daily use of topical antiseptic. Both studies showed that more patients given Humira had reductions in the total number of abscesses and inflammatory nodules than patients given placebo. No new safety risks were identified in these trials. More information on PIONEER I and PIONEER II is available at www. clinicaltrials.gov (NCT01468207 and NCT01468233, respectively). J ...continued on page 13

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

FOR YOUR PATIENTS WITH ACUTE, LOCALIZED DERMATOSES

CLODERM® (clocortolone pivalate) CREAM, 0.1%, AND ITS AUTHORIZED GENERIC MAY EXPAND PATIENT ACCESS WITH: Enhanced formulary access

Fewer insurance challenges

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Now available through The Promius Promise

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

Volume 9 • number 4 • FALL 2015 11

RxOnly

5. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings. Laboratory Tests: The following tests may be helpful in evaluating the HPA axis suppression: Urinary free cortisol test ACTH stimulation test

FOR TOPICAL DERMATOLOGIC USE ONLY– NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE. WARNING: KEEP OUT OF REACH OF CHILDREN

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

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

Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results. Pregnancy Category C: Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time. Nursing Mothers: It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman. Pediatric Use: Pediatric patients may demonstrate greater susceptibility to topical corticosteroidinduced HPA axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface area body weight ratio. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children. ADVERSE REACTIONS: The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: Burning, Itching, Irritation, Dryness, Folliculitis, Hypertrichosis, Acneiform eruptions, Hypopigmentation, Perioral dermatitis, Allergic contact dermatitis, Maceration of the skin, Secondary infection, Skin atrophy, Striae, Miliaria. OVERDOSAGE: Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS). DOSAGE AND ADMINISTRATION: Apply Cloderm (clocortolone pivalate) Cream 0.1% sparingly to the affected areas three times a day and rub in gently. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings.

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

Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.

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

Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity. (See PRECAUTIONS-Pediatric Use).

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

NDC-67857-804-30 NDC-67857-804-51 NDC-67857-804-45 NDC-67857-804-90

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

If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled. Information for the Patient: Patients using topical corticosteroids should receive the following information and instructions: 1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.

www.promiuspharma.com Promius Pharma, LLC

200 Somerset Corporate Blvd., Floor 7, Bridgewater, NJ 08807 Cloderm® is a trademark of Coria Laboratories, Ltd. Manufactured by: DPT LABORATORIES, LTD. San Antonio, Texas 78215

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

12 Journal of Dermatology for Physician Assistants

Issued 0711

004158

Certification Review

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

EXPLANATION: This patient presents with the classic pain presentation noted in acute appendicitis. Pain starts in the periumbilical or central abdominal region and then migrates to the right lower quadrant. Nausea with or without vomiting typically develops after the abdominal pain. Laboratory testing reveals an elevated white blood cell count. On physical examination a positive Rovsing’s sign, palpation of the left lower

quadrant worsens right lower quadrant pain, would be noted. Other positive exam findings can include a positive psoas and obturator sign. Homans’ sign is noted in patients with a deep venous thrombosis and elicited when pain is noted in the calf on dorsiflexion of the foot at the ankle. Grey-Turner’s sign is ecchymosis noted in the flanks with hemorrhagic pancreatitis. Chadwick’s sign is a cyanosis of the cervix noted in pregnancy. Murphy’s sign is an increase in tenderness with a sudden stop inspiration when palpating the right upper quadrant; it is noted in cholecystitis. J The correct answer is B.

QUESTION: A 16-year-old female presents to the emergency room with abdominal pain. The patient states the pain started in the periumbilical region and has now migrated to the right lower quadrant. She has also developed nausea and vomiting since the pain started. Laboratory testing reveals an elevated white blood cell count, negative urinalysis, and a negative pregnancy test. Which one of the following physical examination findings would most likely be noted in this patient? A. Homans’ sign B. Rovsing’s sign C. Grey-Turner’s sign D. Chadwick’s sign E. Murphy’s sign

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 Now Available! – The Mole Mapper App AIM at Melanoma is excited to announce that they have collaborated on the Mole Mapper iPhone app – a project that will help AIM in their fight against melanoma. This free app was released in October and is designed to give users the ability to label and track their moles, and to more confidently monitor their own health. Mole Mapper

users can contribute photos of their moles to the database. By providing this invaluable visual data, users can help researchers figure out how to recognize melanoma earlier when a cure is most likely. AIM envisions a future app that will allow you to analyze your own moles and use screening software to get a quick and easy diagnosis. To learn more about Mole Mapper, please visit www.ohsu.edu/xd/health/services/dermatology/war-onmelanoma. To download this free app, visit Apple’s App Store (the Mole Mapper app is not currently available on Androidbased phones). Happy Mapping! J Volume 9 • number 4 • FALL 2015 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!

Finacea Foam has entered the picture ÂŽ

(azelaic acid) Foam,15%

www.finaceafoam.com ÂŠ 2015 Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ 07981. Bayer, the Bayer Cross, and Finacea are registered trademarks of Bayer. All rights reserved. PP-825-US-0349 September 2015

14 Journal of Dermatology for Physician Assistants

Student Corner

The SDPA Student Affairs Committee has been busy the past few months screening several applicants for the Junior Student Coordinator position. Thank you to all individuals who applied, and while it was a difficult decision, the committee chose the applicant who Brittney Franley, we felt was the strongest candidate PA-S2 for the position. We would like to welcome the newly appointed SDPA Junior Student Coordinator, Brittney Franley, PA-S2. Brittney is a second year physician assistant student at Tri-C/Cleveland State University’s PA program in Cleveland, Ohio and will graduate in December 2016. She earned her Bachelor of Science degree in Business Administration in Marketing from John Carroll University in 2009, where she played on the women’s golf team for four years. Upon graduation Brittney worked for a cardiac medical device company for four years as a field clinical specialist. When she is not in PA school, Brittney enjoys “spending time and traveling with my husband and our dog, Wrigley. I enjoy playing and watching sports, reading, and cooking. In the summer I spend a good amount of time kayaking and hiking, and in the winter I try to ski

a few weekends without significantly harming myself.” Brittney is excited for this opportunity with the SDPA and looks forward to advancing her dermatology knowledge as well as being an advocate for students. The SDPA currently has two Student Coordinators and one Recent Graduate Advisor in order to allow for more continuity and ease of transition from year to year within the Student Affairs Committee. Those eligible for the Junior Student Coordinator position are first year PA students who are enrolled in a two year PA program. The Junior Student Coordinator position is now a three year position, similar to that of SDPA President-Elect, President, and Immediate Past President. We are confident that Brittney is going to be an integral part of the Student Affairs Committee team. Please join us in welcoming her as a new student leader for the SDPA. J Sincerely, Maria Kelly, PA-S2 SDPA Student Affairs Committee Senior Student Coordinator Stephanie Palazzolo, PA SDPA Student Affairs Committee Recent Graduate Advisor

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

JDPA Journal of Dermatology for Physician Assistants

Volume 9 • number 4 • FALL 2015 15

DERmatology pa news & notes

Introducing the Newly Appointed SDPA Student Affairs Committee Junior Student Coordinator

SDPA State Affiliates

The Florida Society of Dermatology Physician Assistants By Renata M. Block, MMS, PA-C SDPA Constituent Relations Committee Chair

DERmatology pa news & notes

The Constituent Relations Committee was proud to have the SDPA’s 13th Annual Fall Dermatology Conference hosted in Orlando, Florida. The SDPA’s Florida State Affiliate was the very first recipient of the SDPA Constituent Affiliate Award in 2014. The SDPA Constituent Relations Chair, Renata M. Block, MMS, PA-C had the opportunity to sit down with Florida Society of Dermatology Physician Assistants (FSDPA) Immediate Past President, Gina Mangin, PA-C to share her insights regarding the continued success of the FSDPA.

Renata: When did your state chapter become established and for what reason? Gina: The FSDPA was established in 2007. The organization was developed to create a society for Florida dermatology PAs to network and to provide educational opportunities locally. Renata: How many members do you have, and how often do you meet? Gina: The FSDPA has 595 members and continues to grow yearly. The society meets annually at the New Wave Educational Symposium, which is hosted by the FSDPA. Renata: What type of topics do you discuss at this annual symposium? Gina: The topics that are discussed are new and upcoming educational opportunities and regional journal club events. Renata: Does the FSDPA have a tax ID and is it registered as a not-for-profit organization (e.g., 501(c)(3) or 501 (c)(6))? Gina: The FSDPA does have a federal tax ID number, and it is also registered as a 501 (C)(3) organization. Renata: Are you in contact with your state’s AAPA State Chapter? Gina: Yes, we are in contact with the Florida chapter of the AAPA. Many of the FSDPA Board of Directors and current members attend local regional AAPA dinners. Jeff Johnson, PA-C, our current FSDPA President, receives emails from the AAPA in regards to current events and is also in touch with the lobbyists representing the Florida Association of Physician Assistants (FAPA) at the state capital. This is to ensure that we are kept abreast of any legislative activities that may affect our profession. 16 Journal of Dermatology for Physician Assistants

Renata: When did the FSDPA become an SDPA State Affiliate and for what reason? Gina: The FSDPA became a constituent of the SDPA in 2007 in order to continue to work together to support Florida dermatology PAs. Most importantly, being a state constituent of the SDPA allows the FSDPA to obtain CME hours from the AAPA for our educational symposiums and workshops. Being an SDPA state constituent also allows PAs to volunteer their time on a local level with the potential to work with SDPA leadership in the future. Renata: How can Florida PAs contact you if they are interested in joining your State Affiliate? Do you have yearly dues? Gina: To become an FSDPA member an individual can visit our website at www.fsdpa.org. As of August 2015, all FSDPA memberships are free! Renata: What makes your State Affiliate so successful? Gina: Our chapter is a success because of the volunteers who commit their time to the organization. In addition, our members are loyal and continue to support the events sponsored by the FSDPA. Renata: What future plans do you have for the FSDPA? Gina: The FSDPA will continue to sponsor our yearly educational symposium and would like to begin offering educational opportunities online. J The SDPA Constituent Relations Committee is actively seeking PAs in other states to start an SDPA State Affiliate or become an SDPA State Liaison. Please do not hesitate to contact me at rblock@dermpa.org with any questions on how to get started.

Clinic al Dermatology

A Guide to More Effective Pregnancy Prevention Counseling When Prescribing Isotretinoin By Sara Wilchowski, MS, PA-C and Steven Leon, MS, PA-C

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

›› CME

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

Approval is valid for 1 year from the issue date of October 2015. Participants may submit the selfassessment exam at any time during that period. This program was planned in accordance with AAPA’s CME Standards for Enduring Material Programs and for Commercial Support of Enduring Material Programs.

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

Learning Objectives:

1. Explore the various contraceptive options available for female patients who are taking isotretinoin. 2. Address the failure rates of the most common types of oral contraceptives. 3. Understand the common embryopathies associated with fetal exposure to isotretinoin. 4. Know when to refer a female patient to OB/ GYN for additional contraceptive counseling. Volume 9 • number 4 • FALL 2015 17

A Guide to More Effective Pregnancy Prevention Counseling When Prescribing Isotretinoin

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.

18 Journal of Dermatology for Physician Assistants

A Guide to More Effective Pregnancy Prevention Counseling When Prescribing Isotretinoin

SDPA Members Only Content

CLINIC AL Dermatology

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

Volume 9 • number 4 • FALL 2015 19

A Guide to More Effective Pregnancy Prevention Counseling When Prescribing Isotretinoin

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.

Sara M. Wilchowski, MS, PA-C is a graduate of Wayne State University in Detroit, Michigan and has been practicing in dermatology since graduation. She completed her undergraduate degree while a Division 1 athlete at Eastern Michigan University. Sara currently is an SDPA Diplomate and a Melanoma Research Foundation Certified Melanoma Educator. She is currently serving as the SDPAâ&#x20AC;&#x2122;s Membership Committee Co-Chair and is an active member of the Michigan Dermatology Physician Assistants. She has indicated no relationships to disclose relating to the content of this article. Steven Leon, MS, PA-C has been practicing for nine years and is currently working at Dermatology and Skin Cancer of Bakersfield. He has a special interest in acne management and this is his fourth publication on the subject. He has indicated no relationships to disclose relating to the content of this article.

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Empower. Educate. Advance.

From The Patient’s Perspective Psoriasis Clearance and Regaining Confidence

don’t know what it’s like to live without affliction. Shortly before my fifth birthday I developed psoriasis, a disease which ultimately helped form me into the person I am today. When faced with any sort of challenge, I always try to find a way to learn from it. Growing up with psoriasis also meant growing up with a lack of self-confidence, the pointing and staring of the uneducated, the hurtful words of bullies, and the neverending efforts to find a treatment that actually worked. Unfortunately, psoriasis entered my life at a time when it was still a mystery to even the world of medical professionals. In fact, it wasn’t until my late teens that I learned of the link between psoriasis, arthritis, and other comorbidities. By that time I had seen at least six dermatologists, all of whom had left me feeling hopeless. My psoriasis was clear for a few months while I was on steroids, but they were not something I felt

The National Psoriasis Foundation (NPF) is a nonprofit organization with a mission to drive efforts to cure psoriatic disease and improve the lives of those affected. Founded in 1966 from a tiny classified ad in a Portland, OR newspaper, the Psoriasis Foundation has evolved to become the leading patient advocacy group for the 7.5 million Americans living with psoriasis and psoriatic arthritis. As emerging research continues to demonstrate the serious, systemic effects of these chronic autoimmune diseases, our highest priority is to find a cure.

National Psoriasis Foundation Contact Information: www.psoriasis.org 6600 SW 92nd Ave., Suite 300, Portland, OR 97223 NPF Blog: www.psoriasis.org/blog Phone: (800) 723-9166 Email: getinfo@psoriasis.org

comfortable taking regularly. I had tried more topical ointments than I could count; I also tried light therapy, coal tar shampoos and ointments, other shampoos for psoriasis, and even ones just for dandruff. Not one made a noticeable impact. I reached a point where turning to doctors for answers felt like a waste of time. I felt defeated and hopeless after every failed effort. Thankfully there have been people in my life who have maintained hope when I couldn’t. Growing up, my dad saw me trying one thing after another without relief, and he too began searching for answers. He once ordered salts from the Dead Sea for me to soak in that literally ended up being money sent straight down the drain. He suggested new doctors for me to see a couple of times, which I did. In college I was prescribed a biologic, a TNF antagonist, for the first time. It was frightening to first read all of the possible side effects and warnings. For a while I was convinced it was going to give me cancer. I was on this medication that provided no relief for over a year before my doctor decided I should try something else. In early 2010, I was switched to another biologic that caused an allergic reaction. The injection site on my leg swelled to the size of a tennis ball. I decided I was officially giving up on treating my psoriasis. In the spring of 2012 I was working as a waitress when I was diagnosed with plantar fasciitis. It was incredibly painful and resulted in me having to find another job. However, I always try to look for the good in the seemingly bad. I had been without a primary care provider; so when the pain in my feet appeared, I made an appointment with a new doctor who went above and beyond my expectations. Dr. Rachel Gruner diagnosed the pain I was experiencing, but also suggested I start seeing a dermatologist again. She insisted that the research on psoriasis had advanced considerably and referred me to Dr. Stephanie Frederic. As I sat in the waiting room before my first appointment with Dr. Frederic, my thoughts were anything but optimistic. I questioned why I was there at all, but my pessimism immediately faded once she began speaking with me. For the first time, the history of trying to treat my psoriasis felt like it had value. Dr. Frederic wanted to hear it all and suggested a treatment to try, one that I had never heard of. On July 6, 2012, I had my first infusion of another TNF antagonist biologic agent and, Volume 9 • number 4 • FALL 2015 21

CLINIC AL Dermatology

By Alison Burbank

CLINIC AL Dermatology

doesn’t hurt, but also because it doesn’t leave behind an not even a week later, my arms were almost completely embarrassing trail of white flakes. It means making it clear. On July 20, 2012, I shaved my legs without my through an entire day without scratching my skin raw psoriasis plaques bleeding for the first time in my life. because of the itch. It means not having to even think I was ecstatic. I also learned that I had freckles on my about my skin. My skin used to be a part of me that knees and found myself ridiculously happy about this I absolutely detested. People discovery. In just a month I who lacked compassion went from having zero faith “To those who have never made it easy for me to look in dermatology to declaring at my own skin as something my love for this medication experienced it, psoriasis is just a unacceptable. I thought of and an appreciation of my rash, but to those living with it, my skin as gross and would newest doctor. Sometimes it find myself apologizing just takes twenty years! psoriasis is a never-ending battle.” often to people because I was so For a little over a year use to the negative remarks. I had great results with my Being clear of psoriasis has third biologic, but eventually its effectiveness decreased, meant that it doesn’t even cross my mind to apologize for and my doctor added an antimetabolite to my treatment my skin. In fact, it sometimes means bragging about my regimen. This particular drug and biologics are more skin, my successful treatment, and my doctors. Because powerful together than on their own. However, of my triumph, I am able to look back on all the negativity antimetabolites can affect liver function. After a little as an obstacle I was able to overcome and not just on over six months, my blood work results suggested that the the outside. My on-again, off-again efforts to treat my medication was doing more harm than good, and I had to psoriasis have evolved into a persistence that I have been stop taking it. My doctor and I discussed increasing the able to duplicate in other areas of my life. Ultimately, dose of my biologic, but we were reluctant because of the my treatment success means feeling confident in my skin associated risks. I was already having vasovagal responses and in my ability to persevere through any challenge that with my infusion requiring me to start each infusion I may face whether medical, professional, or personal. slowly with a precautionary antihistamine beforehand. It means feeling hopeful for every kid out there who will The first time this happened I was terrified because also have to grow up and learn to thrive with psoriasis. I couldn’t yell out to get the nurse’s attention. I could To those who have never experienced it, psoriasis is just barely raise my arm to signal that I needed help. It may a rash, but to those living with it, psoriasis is a neverhave only been ninety seconds, but it was a long ninety ending battle. Right now victory feels pretty great, but seconds. A few months later, in the evening after what I know another time will come when I will have to would be my last infusion, I broke out in hives. That’s wave a white flag and surrender to my immune system when we decided that this medication was no longer a again. However, unlike in the past, I know that it will be safe choice for me, and I was switched to a different selftemporary. I know that there will always be something injected biologic, an IL-12 and IL-23 antagonist. else to try and that my amazing doctors will always be I started the new biologic in October of last year, and right there with me. so far it has been the best treatment experience I’ve had. Its effectiveness has been even better than the previous Acknowledgments: Technical assistance with editing and styling of the manuscript for submission was provided biologic; it has mostly cleared up my scalp psoriasis, an by Complete Healthcare Communications, LLC and was area where I’ve never had success. I’m approaching the funded by Novartis Pharmaceuticals Corporation. The one-year anniversary with this drug, which makes me a author is fully responsible for all content and editorial little anxious because I fear it will also lose its effectiveness; decisions and received no financial support or other however, until that day comes, I will remain grateful. I form of compensation related to the development of this am lucky to have found such amazing doctors, not only manuscript. The opinions expressed in the manuscript are for giving me a successful psoriasis treatment, but also those of the author and Novartis Pharmaceuticals had no for giving me a reason to be thankful and optimistic for influence on the contents. the advances in medicine. Finally, being mostly clear means more than just not having visible skin plaques and flakes in my hair or on my clothes. It means not having to endure pain from just bending my arm because my skin was so tight from the thick, dry plaques. It means being able to set my arm on an armrest without a thought, not only because it ...continued on page 25 22 Journal of Dermatology for Physician Assistants

TINEA

Due to Trichophyton rubrum and Epidermophyton floccosum in adults

STRIKE NOW. TREAT FAST.

2 weeks, 14 doses for tinea pedis; efﬁcacy seen at 4 weeks post-treatment 1 week, 7 doses for tinea cruris and tinea corporis; efficacy seen at 3 weeks post-treatment LUZU may help some patients with interdigital tinea pedis become fungus free. Individual results may vary. Indications and Usage LUZU (luliconazole) Cream, 1% is indicated for the topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum and Epidermophyton floccosum in patients 18 years of age and older. Important Safety Information LUZU is indicated for topical use only and is not indicated for ophthalmic, oral or intravaginal use. LUZU should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when LUZU is prescribed for nursing mothers. The most common adverse reactions in clinical trials were application site reactions, which occurred in less than 1% of subjects in both LUZU and vehicle arms. Most adverse reactions were mild in severity. Please see Brief Summary of full Prescribing Information for LUZU on adjacent 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/LUZ/15/0131a

Volume 9 • number 4 • FALL 2015 23

BRIEF SUMMARY OF FULL PRESCRIBING INFORMATION FOR LUZU (luliconazole) This Brief Summary does not include all the information needed to use LUZU safely and effectively. See full Prescribing Information for LUZU.

noted at 25 mg/kg/day (3 times the MRHD based on BSA comparisons). Increased incidences of skeletal variation (14th rib) were noted at 25 mg/kg/day. No treatment related effects on skeletal variation were noted at 5 mg/kg/day (0.6 times the MRHD based on BSA comparisons).

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

Subcutaneous doses of 4, 20 and 100 mg/kg/day luliconazole were administered during the period of organogenesis (gestational days 6-18) to pregnant female rabbits. No treatment related effects on maternal toxicity, embryofetal toxicity or malformations were noted at 100 mg/kg/day (24 times the MRHD based on BSA comparisons).

Rx Only INDICATIONS LUZU (luliconazole) Cream, 1% is an azole antifungal indicated for the topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum and Epidermophyton floccosum, in patients 18 years of age and older. DOSAGE AND ADMINISTRATION For topical use only. LUZU Cream, 1% is not for ophthalmic, oral, or intravaginal use. When treating interdigital tinea pedis, a thin layer of LUZU Cream, 1% should be applied to the affected area and approximately 1 inch of the immediate surrounding area(s) once daily for two (2) weeks. When treating tinea cruris or tinea corporis, LUZU Cream, 1% should be applied to the affected area and approximately 1 inch of the immediate surrounding area(s) once daily for one (1) week. ADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug, and may not reflect the rates observed in practice. In three Phase 3 clinical trials, 616 subjects were exposed to LUZU Cream, 1%: 305 with interdigital tinea pedis and 311 subjects with tinea cruris. Subjects with interdigital tinea pedis or tinea cruris applied LUZU Cream, 1% or vehicle cream once daily for 14 days or 7 days, respectively, to affected and adjacent areas. During clinical trials with LUZU Cream, 1% the most common adverse reactions were application site reactions which occurred in less than 1% of subjects in both the LUZU and vehicle arms. Most adverse reactions were mild in severity. Post-Marketing Experience The following adverse reactions have been identified during postmarketing use of luliconazole cream, 1%: contact dermatitis and cellulitis. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. DRUG INTERACTIONS The potential of luliconazole to inhibit cytochrome P-450 (CYP) enzymes 1A2, 2C9, 2C19, 2D6, and 3A4 was evaluated in vitro. Based on in vitro assessment, luliconazole at therapeutic doses, particularly when applied to patients with moderate to severe tinea cruris, may inhibit the activity of CYP2C19 and CYP3A4. However, no in vivo drug interaction trials have been conducted to evaluate the effect of luliconazole on other drugs that are substrates of CYP2C19 and CYP3A4. Luliconazole is not expected to inhibit CYPs 1A2, 2C9 and 2D6 based on in vitro assessment. The induction potential of luliconazole on CYP enzymes has not been evaluated. USE IN SPECIFIC POPULATIONS Pregnancy: Pregnancy Category C. There are no adequate and well-controlled studies of LUZU Cream, 1% in pregnant women. LUZU Cream, 1% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The animal multiples of human exposure calculations were based on daily dose body surface area (BSA) comparisons (mg/m2) for the reproductive toxicology studies described in this section and in Section 13.1 of the prescribing information. The Maximum Recommended Human Dose (MRHD) was set at 8 g 1% cream per day (1.33 mg/kg/day for a 60 kg individual which is equivalent to 49.2 mg/m2/day). Systemic embryofetal development studies were conducted in rats and rabbits. Subcutaneous doses of 1, 5 and 25 mg/kg/day luliconazole were administered during the period of organogenesis (gestational days 7-17) to pregnant female rats. No treatment related effects on maternal toxicity or malformations were

24 Journal of Dermatology for Physician Assistants

In a pre- and post-natal development study in rats, subcutaneous doses of 1, 5 and 25 mg/kg/day luliconazole were administered from the beginning of organogenesis (gestation day 7) through the end of lactation (lactation day 20). In the presence of maternal toxicity, embryofetal toxicity (increased prenatal pup mortality, reduced live litter sizes and increased postnatal pup mortality) was noted at 25 mg/kg/day. No embryofetal toxicity was noted at 5 mg/kg/day (0.6 times the MRHD based on BSA comparisons). No treatment effects on postnatal development were noted at 25 mg/kg/day (3 times the MRHD based on BSA comparisons). Nursing Mothers It is not known whether luliconazole is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when LUZU Cream, 1% is administered to women who are breastfeeding. Pediatric Use The safety and effectiveness of LUZU Cream, 1% in pediatric patients have not been established. The number of pediatric patients â&#x2030;Ľ12 years of age were too small to adequately assess safety and efficacy. Geriatric Use Of the total number of subjects in clinical studies of LUZU Cream, 1%, 8 percent were 65 and over, while 1.4 percent were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies to evaluate the carcinogenic potential of LUZU Cream, 1% have not been conducted. Luliconazole revealed no evidence of mutagenic or clastogenic potential based on the results of two in vitro genotoxicity tests (Ames assay and Chinese hamster lung cell chromosomal aberration assay) and one in vivo genotoxicity test (mouse bone marrow micronucleus test). In a fertility study in rats, subcutaneous doses of 1, 5 and 25 mg/kg/day luliconazole were administered prior to and during mating and through early pregnancy. Treatment related effects on reproductive function were noted in females (decreased live embryos and decreased corpus luteum) at 5 and 25 mg/kg/day and males (decreased sperm counts) at 25 mg/kg/day. No treatment related effects on fertility or reproductive function were noted at 1 mg/kg/day (0.1X MRHD based on BSA comparisons). PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information) Inform patients that LUZU Cream, 1% is for topical use only. LUZU Cream, 1% is not intended for intravaginal or ophthalmic use. Manufactured for: Medicis, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807

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

...continued from page 22

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

I truly believe that when a patient is suffering, as Alison writes about herself, and when the treatments have given minimal relief or have had significant side effects and had to be stopped, it may be time to have an honest conversation with the patient about your

own personal frustrations and to show deep empathy. We can see this suffering going on, this hurt, and this feeling of hopelessness… it may be that time to voice it. 2. While I’ve never asked a patient this question, there comes a time in every clinician’s care of the chronically ill patient that he or she must sit with the patient and ask a few questions, “What have you learned from your skin disease that you taught yourself? What can you teach others?” and finally, “What can you teach me?” Once we’ve asked these questions we really need to listen to the answers. There is so much to learn from our patients. Let us not miss these opportunities to learn why we have chosen dermatology as our live’s work. J

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 member’s name on the application. Referral of supervising physicians and student members will NOT qualify for this campaign, but are certainly encouraged.

Volume 9 • number 4 • FALL 2015 25

CLINIC AL Dermatology

1. There are times in our careers when we see a patient with an intractable chronic skin disorder. We know that while we are trying hard, nothing seems to be working and the patient feels hopeless and is in pain. Wouldn’t it be a gift to both the patient and the clinician if we were to ask the patient questions such as, “How are you feeling?” or “I hope you know that I’m trying my best, but is there anything you’d like to tell me about whether you believe we’ll ever find some relief for you or even a cure?”

Clinical snapshots

Macular Amyloidosis By Gina Mangin, MPAS, PA-C and Christopher P. Crotty, MD

SDPA Members Only Content

CLINIC AL Dermatology

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

Figure

Christopher P. Crotty, MD is a Mayo Clinic-trained dermatologist and dermopathologist with extensive training and practice in internal medicine, dermatology, pathology and surgery. Dr. Crotty attended

26 Journal of Dermatology for Physician Assistants

Gina Mangin, MPAS, PA-C has been a physician assistant for fifteen years. She has been practicing dermatology for seven years and is currently working at Sand Lake Dermatology Center in Orlando, FL. She has been active in the Society of Dermatology Physician Assistants (SDPA) as a Distance CME Committee member and currently sits on the Board of Directors as a Director at Large. In the past, Mrs. Mangin has also been involved with the Florida Society of Dermatology Physician Assistants (FSDPA) and has served numerous roles, including President, Vice President, and CME Chair. Her passion for volunteering and educating PAs in dermatology is evident throughout her work with these great organizations, committees, and time spent precepting PA students in her office.

CLINIC AL Dermatology

the University of Nebraska School of Medicine after completing his undergraduate degree at Notre Dame University. He completed a residency in internal medicine at Denver's Presbyterian Medical Center followed by a residency in dermatology at the Mayo Graduate School of Medicine in Rochester, Minnesota. While at the Mayo clinic, Dr. Crotty studied under Dr. Fred Mohs where he learned the Mohs micrographic surgical technique. Awarded the prestigious Osborne Fellowship, Dr. Crotty continued his studies in dermatopathology under the tutelage of Dr. A. Bernard Ackerman at New York University. After six years of practicing dermatology and dermatopathology in Omaha, Nebraska, Dr. Crotty moved to Orlando and established Sand Lake Dermatology Center in 1988. A former president of the Central Florida Society of Dermatology, Dr. Crotty has served as an active participant since 1991. He is a member of the Leader's Society of the American Academy of Dermatology, the Sorin Society at the University of Notre Dame, and the Doctor's Mayo Society. Dr. Crotty is very active throughout the Central Florida community and serves on the admission committee of the UCF School of Medicine.

Let them know they’re not alone... Share a story with your patients.

Visit the Patient’s Perspective library of articles at www.jdpa.org/advocacy.html If you know a patient who would like to share his/her story, please contact us at editor@jdpa.org

Volume 9 • number 4 • FALL 2015 27

Dermatology Case Report Pili Annulati By Marissa Rosgaard, MPAS, PA-C, Douglas DiRuggiero, MHS, PA-C, and Kavita Mariwalla, MD, FAAD

SDPA Members Only Content

CLINIC AL Dermatology

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

Figure 1

Photo of patient’s hair.

Figure 2

A sample of the patient’s hair using an Olympus BX-40 microscope under 4x magnification.

Marissa Rosgaard, MPAS, PA-C completed her undergraduate degree at Stony Brook University and has recently graduated from Touro College with her Masters degree in Physician Assistant Studies. Marissa is a member of the SDPA and Golden Key International Honour Society. She has indicated no relationships to disclose relating to the content of this article. Douglas DiRuggiero, MHS, PA-C completed his Master's degree in Health Science and graduated from Duke University’s Physician Assistant Program in 1997. Douglas has practiced dermatology for the past 16 years. He started the Georgia Dermatology PA Society, the first state dermatology group in the country, and is currently the President of the New York Society of Dermatology PAs. He currently works for a Mohs surgeon, Kavita Mariwalla, MD in Long Island, NY. He has indicated no relationships to disclose relating to the content of this article. Kavita Mariwalla, MD, FAAD is a nationally recognized leader in dermatology and dermatologic surgery. As a boardcertified dermatologist and fellowship-trained Mohs surgeon, she has served on the faculty of Yale School of Medicine and Columbia University; and currently maintains academic ties in the Department of Dermatology at SUNY, Stony Brook. She has indicated no relationships to disclose relating to the content of this article. 28 Journal of Dermatology for Physician Assistants

Volume 9 • number 4 • FALL 2015 29

30 Journal of Dermatology for Physician Assistants

Enbrel® (etanercept) Brief Summary SEE PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION

WARNINGS SERIOUS INFECTIONS AND MALIGNANCIES Patients treated with Enbrel are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions and Adverse Reactions]. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Enbrel should be discontinued if a patient develops a serious infection or sepsis. Reported infections include: • Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before Enbrel use and during therapy. Treatment for latent infection should be initiated prior to Enbrel use. • Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness. • Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria. The risks and benefits of treatment with Enbrel should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with Enbrel, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy. MALIGNANCIES Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including Enbrel.

INDICATIONS AND USAGE Rheumatoid Arthritis Enbrel is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis (RA). Enbrel can be initiated in combination with methotrexate (MTX) or used alone. Polyarticular Juvenile Idiopathic Arthritis Enbrel is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients ages 2 and older. Psoriatic Arthritis Enbrel is indicated for reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with psoriatic arthritis (PsA). Enbrel can be used with or without MTX. Ankylosing Spondylitis Enbrel is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis (AS). Plaque Psoriasis Enbrel is indicated for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy. CONTRAINDICATIONS Enbrel should not be administered to patients with sepsis. WARNINGS AND PRECAUTIONS Serious Infections Patients treated with Enbrel are at increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death. Opportunistic infections due to bacterial, mycobacterial, invasive fungal, viral, parasitic, or other opportunistic pathogens including aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, histoplasmosis, legionellosis, listeriosis, pneumocystosis, and tuberculosis have been reported with TNF blockers. Patients have frequently presented with disseminated rather than localized disease. Treatment with Enbrel should not be initiated in patients with an active infection, including clinically important localized infections. Patients greater than 65 years of age, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants (such as corticosteroids or methotrexate), may be at greater risk of infection. The risks and benefits of treatment should be considered prior to initiating therapy in patients: with chronic or recurrent infection; who have been exposed to tuberculosis; with a history of an opportunistic infection; who have resided or traveled in areas of endemic tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis; or with underlying conditions that may predispose them to infection, such as advanced or poorly controlled diabetes [see Adverse Reactions]. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with Enbrel. Enbrel should be discontinued if a patient develops a serious infection or sepsis. A patient who develops a new infection during treatment with Enbrel should be closely monitored, undergo a prompt and complete diagnostic workup appropriate for an immunocompromised patient, and appropriate antimicrobial therapy should be initiated. Tuberculosis Cases of reactivation of tuberculosis or new tuberculosis infections have been observed in patients receiving Enbrel, including patients who have previously received treatment for latent or active tuberculosis. Data from clinical trials and preclinical studies suggest that the risk of reactivation of latent tuberculosis infection is lower with Enbrel than with TNF-blocking monoclonal antibodies. Nonetheless, postmarketing cases of tuberculosis reactivation have been reported for TNF blockers, including Enbrel. Tuberculosis has developed in patients who tested negative for latent tuberculosis prior to

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

patient-years of therapy, the observed rate of NMSC was 3.54 cases per 100 patient-years vs 1.28 cases per 100 patient-years among 720 control-treated patients representing 156 patient-years. Postmarketing cases of Merkel cell carcinoma have been reported very infrequently in patients treated with Enbrel. Periodic skin examinations should be considered for all patients at increased risk for skin cancer. Pediatric Patients Malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with TNF-blocking agents (initiation of therapy at ≤ 18 years of age), including Enbrel. Approximately half the cases were lymphomas, including Hodgkin’s and non-Hodgkin’s lymphoma. The other cases represented a variety of different malignancies and included rare malignancies usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. The malignancies occurred after a median of 30 months of therapy (range 1 to 84 months). Most of the patients were receiving concomitant immunosuppressants. These cases were reported postmarketing and are derived from a variety of sources, including registries and spontaneous postmarketing reports. In clinical trials of 1140 pediatric patients representing 1927.2 patient-years of therapy, no malignancies, including lymphoma or NMSC, have been reported. Postmarketing Use In global postmarketing adult and pediatric use, lymphoma and other malignancies have been reported. Patients With Heart Failure Two clinical trials evaluating the use of Enbrel in the treatment of heart failure were terminated early due to lack of efficacy. One of these studies suggested higher mortality in Enbrel-treated patients compared to placebo [see Adverse Reactions]. There have been postmarketing reports of worsening of congestive heart failure (CHF), with and without identifiable precipitating factors, in patients taking Enbrel. There have also been rare (< 0.1%) reports of new onset CHF, including CHF in patients without known preexisting cardiovascular disease. Some of these patients have been under 50 years of age. Physicians should exercise caution when using Enbrel in patients who also have heart failure, and monitor patients carefully. Hematologic Events Rare (< 0.1%) reports of pancytopenia, including very rare (< 0.01%) reports of aplastic anemia, some with a fatal outcome, have been reported in patients treated with Enbrel. The causal relationship to Enbrel therapy remains unclear. Although no high-risk group has been identified, caution should be exercised in patients being treated with Enbrel who have a previous history of significant hematologic abnormalities. All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (eg, persistent fever, bruising, bleeding, pallor) while on Enbrel. Discontinuation of Enbrel therapy should be considered in patients with confirmed significant hematologic abnormalities. Two percent of patients treated concurrently with Enbrel and anakinra developed neutropenia (ANC < 1 x 10 9/L). While neutropenic, one patient developed cellulitis that resolved with antibiotic therapy. Hepatitis B Reactivation Reactivation of hepatitis B in patients who were previously infected with the hepatitis B virus (HBV) and had received concomitant TNF-blocking agents, including very rare cases (< 0.01%) with Enbrel, has been reported. In some instances, hepatitis B reactivation occurring in conjunction with TNF-blocker therapy has been fatal. The majority of these reports have occurred in patients concomitantly receiving other medications that suppress the immune system, which may also contribute to hepatitis B reactivation. Patients at risk for HBV infection should be evaluated for prior evidence of HBV infection before initiating TNF-blocker therapy. Prescribers should exercise caution in prescribing TNF blockers in patients previously infected with HBV. Adequate data are not available on the safety or efficacy of treating patients who are carriers of HBV with anti-viral therapy in conjunction with TNF-blocker therapy to prevent HBV reactivation. Patients previously infected with HBV and require treatment with Enbrel should be closely monitored for clinical and laboratory signs of active HBV infection throughout therapy and for several months following termination of therapy. In patients who develop HBV reactivation, consideration should be given to stopping Enbrel and initiating anti-viral therapy with appropriate supportive treatment. The safety of resuming Enbrel therapy after HBV reactivation is controlled is not known. Therefore, prescribers should weigh the risks and benefits when considering resumption of therapy in this situation. Allergic Reactions Allergic reactions associated with administration of Enbrel during clinical trials have been reported in < 2% of patients. If an anaphylactic reaction or other serious allergic reaction occurs, administration of Enbrel should be discontinued immediately and appropriate therapy initiated. Caution: The following components contain dry natural rubber (a derivative of latex), which may cause allergic reactions in individuals sensitive to latex: the needle cover of the prefilled syringe and the needle cover within the needle cap of the SureClick® autoinjector. Immunizations Live vaccines should not be given concurrently with Enbrel. It is recommended that pediatric patients, if possible, be brought up-to-date with all immunizations in agreement with current immunization guidelines prior to initiating Enbrel therapy [see Drug Interactions]. Autoimmunity Treatment with Enbrel may result in the formation of autoantibodies [see Adverse Reactions] and, rarely (< 0.1%), in the development of a lupus-like syndrome or autoimmune hepatitis [see Adverse Reactions], which may resolve following withdrawal of Enbrel. If a patient develops symptoms and findings suggestive of a lupus-like syndrome or autoimmune hepatitis following treatment with Enbrel, treatment should be discontinued and the patient should be carefully evaluated. Immunosuppression TNF mediates inflammation and modulates cellular immune responses. TNFblocking agents, including Enbrel, affect host defenses against infections. The effect of TNF inhibition on the development and course of malignancies is not fully understood. In a study of 49 patients with RA treated with Enbrel, there was no evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector cell populations [see Adverse Reactions]. Use in Wegener’s Granulomatosis Patients

The use of Enbrel in patients with Wegener’s granulomatosis receiving Volume 9 • number 4 • FALL 2015 31

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

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

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

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

Enbrelc (N = 349)

Percent of Patients

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

Enbrelc (N = 415)

Percent of Patients 81 65

39 30

50 38

86 70

9 2 1 – 1 –

8 3 2 3 – –

16 19 5 4 4 1

16 13 5 2 2 1

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

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

Enbrela (N = 876)

Reaction

Percent of Patients

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

28 14

27 12

2 1 2 – – 1

3 1 1 1 1 –

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

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

32 Journal of Dermatology for Physician Assistants

Skin and subcutaneous tissue disorders:

cutaneous lupus erythematous, cutaneous vasculitis (including leukocytoclastic vasculitis), erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, subcutaneous nodule, new or worsening psoriasis (all sub-types including pustular and palmoplantar) Opportunistic infections, including atypical mycobacterial infection, herpes zoster, aspergillosis and Pneumocystis jiroveci pneumonia, and protozoal infections have also been reported in postmarketing use. DRUG INTERACTIONS Specific drug interaction studies have not been conducted with Enbrel. Vaccines Most PsA patients receiving Enbrel were able to mount effective B-cell immune responses to pneumococcal polysaccharide vaccine, but titers in aggregate were moderately lower and fewer patients had 2-fold rises in titers compared to patients not receiving Enbrel. The clinical significance of this is unknown. Patients receiving Enbrel may receive concurrent vaccinations, except for live vaccines. No data are available on the secondary transmission of infection by live vaccines in patients receiving Enbrel. Patients with a significant exposure to varicella virus should temporarily discontinue Enbrel therapy and be considered for prophylactic treatment with varicella zoster immune globulin [see Warnings and Precautions]. Immune-Modulating Biologic Products In a study in which patients with active RA were treated for up to 24 weeks with concurrent Enbrel and anakinra therapy, a 7% rate of serious infections was observed, which was higher than that observed with Enbrel alone (0%) [see Warnings and Precautions] and did not result in higher ACR response rates compared to Enbrel alone. The most common infections consisted of bacterial pneumonia (4 cases) and cellulitis (4 cases). One patient with pulmonary fibrosis and pneumonia died due to respiratory failure. Two percent of patients treated concurrently with Enbrel and anakinra developed neutropenia (ANC < 1 x 10 9/L). In clinical studies, concurrent administration of abatacept and Enbrel resulted in increased incidences of serious adverse events, including infections, and did not demonstrate increased clinical benefit [see Warnings and Precautions]. Cyclophosphamide The use of Enbrel in patients receiving concurrent cyclophosphamide therapy is not recommended [see Warnings and Precautions]. Sulfasalazine Patients in a clinical study who were on established therapy with sulfasalazine, to which Enbrel was added, were noted to develop a mild decrease in mean neutrophil counts in comparison to groups treated with either Enbrel or sulfasalazine alone. The clinical significance of this observation is unknown. USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category B Pregnancy Surveillance Program There is a Pregnancy Surveillance Program that monitors outcomes in women exposed to Enbrel during pregnancy. Women who become pregnant during Enbrel treatment are encouraged to enroll. Patients or their physicians should call 1-800-77-AMGEN (1-800-772-6436) to enroll. Risk Summary There are no adequate and well controlled studies in pregnant women. Based on limited data, etanercept concentration in cord blood at the time of delivery showed that etanercept crossed the placenta in small amounts. Developmental toxicity studies have been performed in rats and rabbits at doses ranging from 60- to 100-fold higher than the human dose and have revealed no evidence of harm to the fetus due to Enbrel. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Human Data Three case reports showed that cord blood levels of etanercept at delivery in infants, born to mothers administered etanercept during pregnancy, were between 3 and 32% of the maternal serum level. Nursing Mothers Limited data from published literature show that etanercept is present in low levels in human milk and minimally absorbed by a breastfed infant. Caution should be exercised when Enbrel is administered to a nursing woman. The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for Enbrel and any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition. Women who choose to continue Enbrel treatment while nursing are encouraged to enroll in Amgen’s Lactation Surveillance Program. Patients or their physicians should call 1-800-77-AMGEN (1-800-772-6436) to enroll. Pediatric Use Enbrel has not been studied in children < 2 years of age with JIA. The safety and efficacy of Enbrel in pediatric patients with PsO have not been studied. Rare (< 0.1%) cases of IBD have been reported in JIA patients receiving Enbrel, which is not effective for the treatment of IBD [see Adverse Reactions (6.2)]. The clinical significance of infant exposure to Enbrel in utero is unknown. The safety of administering live or live-attenuated vaccines in exposed infants is unknown. Risks and benefits should be considered prior to administering live or live-attenuated vaccines to exposed infants. Geriatric Use A total of 480 RA patients ages 65 years or older have been studied in clinical trials. In PsO randomized clinical trials, a total of 138 out of 1965 subjects treated with Enbrel or placebo were age 65 or older. No overall differences in safety or effectiveness were observed between these patients and younger patients, but the number of geriatric PsO subjects is too small to determine whether they respond differently from younger subjects. Because there is a higher incidence of infections in the elderly population in general, caution should be used in treating the elderly. Use in Diabetics There have been reports of hypoglycemia following initiation of Enbrel therapy in patients receiving medication for diabetes, necessitating a reduction in anti-diabetic medication in some of these patients. Rx Only. This brief summary is based on ENBREL prescribing information v. 55 3/2015 US License Number 1132 © 1998 – 2015 Immunex Corporation. All rights reserved. US Patent Nos. 7,915,225; 5,605,690; Re. 36,755. For more information please call 1-888-436-2735 or visit www.enbrel.com © 2015 Amgen Inc., Thousand Oaks, CA 91320 All rights reserved.

USA-EDRM-105992 USA-916-104255

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SURGIC AL Dermatology

Dermatology Case Report How Should You Manage This Patient With Facial Melanoma? By Ian C. Hoppe, MD, Craig J. Pastor, MD, and Mark S. Granick, MD

Figure 1 Preoperative appearance of the lesion

Figure 2 Defect following excision

Volume 9 â&#x20AC;˘ number 4 â&#x20AC;˘ FALL 2015 33

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Figure 6 Result 1 week after excision

SURGIC AL Dermatology

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

Figure 3 Cervicofacial flap incised

Figure 4 Cervicofacial flap elevated

Figure 5 Cervicofacial flap advanced into position with drain in place

Ian C. Hoppe, MD - Plastic Surgery Resident, New Jersey Medical School - University of Medicine and Dentistry of New Jersey (UMDNJ), Newark, New Jersey. He has indicated no relationships to disclose relating to the content of this article. Craig J. Pastor, MD - Plastic Surgery Resident, New Jersey Medical School - University of Medicine and Dentistry of New Jersey (UMDNJ), Newark, New Jersey. He has indicated no relationships to disclose relating to the content of this article. Mark S. Granick, MD - Professor, Surgery; Chief, Plastic Surgery, Department of Surgery, New Jersey Medical School - University of Medicine and Dentistry of New Jersey (UMDNJ); Chief, Plastic Surgery, University Hospital, Newark, New Jersey. He has indicated no relationships to disclose relating to the content of this article.

Reprinted with permission from Medscape 2013, available at: http://www. medscape.com/viewarticle/806652. All images were courtesy of the authors. 34 Journal of Dermatology for Physician Assistants

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

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

SURGIC AL Dermatology

SDPA Members Only Content

Image by Tudor

This Dermcast.tv live blog was recorded at the 2013 SDPA Annual Summer Dermatology Conference in St. Louis, Missouri and was posted online July 2015. It is available at www.dermcast.tv/live-blog-skin-cancer-and-surgicaltreatment-pearls. Dermcast.tv is the official online media resource of the SDPA. We are very proud that Dermcast is the #1 iTunes Podcast in dermatology. Dermcast.tv is your source for audio podcasts, the most current dermatology news and research, procedural videos, conference highlights, and much, much more. As members of the SDPA, everything on Dermcast.tv is not only tailored precisely for you and your needs, it is available to you FREE! To read more SDPA live blogs and/or to follow the next live blog from the SDPA Annual Summer Dermatology Conference in Austin, Texas please visit the Dermcast.tv website at www.dermcast.tv.

Volume 9 â&#x20AC;˘ number 4 â&#x20AC;˘ FALL 2015 35

COSMETIC deRMATOLOGY Journal Club: Practice Changing Articles for Dermatology PAs

Intralesional Cryotherapy for the Treatment of Keloid Scars. Plast Reconstr Surg. 2015 Feb;135(2):580-9. van Leeuwen MC1, van der Wal MB, Bulstra AE, Galindo-Garre F, Molier J, van Zuijlen PP, van Leeuwen PA, Niessen FB. 1

Amsterdam and Beverwijk, The Netherlands From the Departments of Plastic and Reconstructive Surgery, Biostatistics, and Surgery, and the MOVE Institute, VU University Medical Center; and the Department of Plastic and Reconstructive Surgery and the Burn Center, Red Cross Hospital.

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

36 Journal of Dermatology for Physician Assistants

Cosmetic pearls Tips to Treat Common Warts SDPA Members Only Content

COSMETIC Dermatology

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

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

Volume 9 • number 4 • FALL 2015 37

Cosmetic pearls 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.

Adam Friedman, MD, FAAD is an associate professor of dermatology, residency program director and director of translational research in the department of dermatology at The George Washington University School of Medicine & Health Sciences. His clinical interests in medical and pediatric dermatology include acne, eczema, psoriasis, skin infections, hair loss, wound healing, urticaria, blistering diseases, lupus, sarcoidosis, and skin cancer. Dr. Friedman completed his undergraduate training at the University of Pennsylvania and graduated with distinction in dermatologic research at the Albert Einstein College of Medicine in New York. He completed his internship at New York Hospital Queens, returned to Einstein for his dermatology residency and was appointed chief resident during his final year.

P R E V E N T. D E T E C T. L I V E . PPRREEVVEENNTT. . DDEETTEECCTT. . LLI IVVEE. . No matter what sport you play, the type of gear you wear is important. Next you head to play, don’t thewear most important piece of gear — sunscreen. No time matter what sport you play, the type offorget gear is important. No matter what sport youout play, the type of gear you you wear is important. Next time you head to play, don’t forget most important piece of gear — sunscreen. Next time youat head out out to play, don’t forget the the most important piece of gear — sunscreen. Learn more www.SpotSkinCancer.org Learn at www.SpotSkinCancer.org Learn moremore at www.SpotSkinCancer.org © 2012 American Academy of Dermatology. Use of this poster does not imply product or service endorsement by the American Academy of Dermatology. 2012 American Academy of Dermatology. Use poster of this does poster does notproduct imply product or service endorsement by the American Academy of Dermatology. © 2012©American Academy of Dermatology. Use of this not imply or service endorsement by the American Academy of Dermatology.

38 Journal of Dermatology for Physician Assistants

HELP YOUR PATIENTS

FIGHT

Acne

– with –

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

INDICATION

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

IMPORTANT SAFETY INFORMATION

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

•

• •

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

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

Volume 9 • number 4 • FALL 2015 39

BRIEF SUMMARY OF FULL PRESCRIBING INFORMATION

Neuromuscular Blocking Agents

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

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

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

Maximum During Treatment

End of Treatment (Week 12)

Mild Mod.* Severe

Erythema

Scaling

Itching

Burning

Stinging

*Mod. = Moderate

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

40 Journal of Dermatology for Physician Assistants

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

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

Professional development

Dermatology Billing & Coding Welcome to ICD-10 By Sean Cavanaugh Deputy Administrator and Director of the Center for Medicare

Volume 9 â&#x20AC;˘ number 4 â&#x20AC;˘ FALL 2015 41

Welcome to ICD-10 SDPA Members Only Content

professional development

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

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 42 Journal of Dermatology for Physician Assistants

Notes from your Office Manager

The Risks of Physician Shadowing

Therefore, when responding to a request to allow a high school or college student to shadow you at an office or facility, consider the following: • High school and college students may not understand state and federal patient privacy laws, and there is an increased risk that they will share their experiences with friends and family, as well as in college and on job applications. You must ensure HIPAA compliance for any person who is permitted to access patient health information. • You must be fully aware of the student’s medical history/status, including his/her vaccination record.

• Patients must understand and agree to have an unlicensed individual in the room during their encounter with you, and their consent should be clearly documented in the patient’s medical record. • There are liability risks associated with allowing untrained, unlicensed persons to assist in patient care. The “shadowed” physician would likely be held responsible for any injury caused by a student. Likewise, you cannot allow an unlicensed, untrained person to perform tasks that require a license. Improper delegation of tasks may subject the supervising physician to action by the Office of Professional Medical Conduct (OPMC). • In addition to the potential harm to patients, students and other unlicensed persons are also at risk for personal injury when using equipment that is unfamiliar to them. Considering the above risks, it is recommended that healthcare providers should only permit individuals such as medical, physician assistant, or nursing students in an established training program to “shadow” them. These programs should provide documentation of adequate liability insurance for their students. The programs must also delineate in writing those specific tasks, which the students have been credentialed to perform. They may perform those credentialed tasks only if the patient’s consent has previously been obtained. J

This Risk Management article has been reprinted with permission from: MLMIC Dateline, published by 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 the MLMIC.com blog on July 8, 2015.

Volume 9 • number 4 • FALL 2015 43

professional development

A recent news report indicated that a physician at a New York hospital allowed a college student to insert a tube down an anesthetized patient’s throat to help the patient breathe, even though the student had no training to perform the procedure. The student, who was considering going to medical school, was “shadowing” the physician. An operating room employee reported the incident to management, but the hospital did nothing about it until state inspectors showed up to investigate a complaint about the event on behalf of the federal Centers for Medicare and Medicaid Services. Inspectors categorized the incident as “immediate jeopardy,” the most serious type of deficiency that can cause serious injury or death to patients.

Outside & Inside the 9 to 5...

The Power of Jambo By Keri Holyoak, MPH, PA-C

professional development

Through Passion to Heal SM, an initiative of Valeant Pharmaceuticals NA LLC (VPNA), Free The Children has developed a comprehensive program for advanced diagnosis and treatment of skin conditions in rural Kenya and India through medical volunteer trips. In collaboration with Free The Children’s implementation partner, Me to We Trips, the Passion to Heal SM initiative funds the cost of the medical volunteer trips. This provides American dermatology health care providers the opportunity to travel free of charge to help treat and educate community members, and train local clinicians to create sustainable solutions. Former SDPA President and current SDPA Conference Educational Planning Committee Fall Chair, Keri Holyoak, MPH, PA-C shares with our readers her reflections about her recent medical volunteer trip to Southwest Kenya with Passion to Heal SM.

“Jambo” in Swahili means “hello” and is the most common greeting you’ll hear when traveling on the rolling savannahs of Southwest Kenya. “Jambo!” yelled the children as they enthusiastically chased after us on the dusty roads. “Jambo!” waved the natives in their brightly colored shukas walking home with a herd of cows or goats. I smiled and responded “Jambo!” not yet realizing that just one word had the power to change me as a person and a physician assistant. The Baraka Health Clinic serves this part of Kenya. Baraka, another Swahili word that means “blessing,” provides healthcare to the most vulnerable segments of the Kenyan population. Through the Passion to HealSM initiative, I was privileged to have the opportunity to travel to Baraka. Here I experienced life-changing events that were incredibly rewarding. I learned that no matter where you are in your career as a PA, you can make a difference in the lives of people around the world. One of my most unforgettable patients was a young girl 44 Journal of Dermatology for Physician Assistants

who walked five hours by foot to the clinic. She had delivered a baby girl that morning and was seeking postpartum care and immunizations for her newborn. As a mother myself, I was overwhelmed to see the sacrifice she had made and the determination she had to receive medical attention. It was difficult to imagine that she had walked that far after giving birth. I felt such a great sense of empathy and an immediate bond with this girl and her situation. Her situation made me better appreciate my own. I shared with her some of my mothering experiences that had both of us laughing. Through my experiences on this trip, I learned to appreciate the simple pleasures in life. One afternoon our group screened school children for disease. Since many were quite young and small in stature, I knelt down so I could be at their level. I saw up close their threadbare clothes, bare feet covered with dirt, and rotting teeth; however, their smiles were beautiful, and they melted my heart. I felt great compassion and honor to have the

The medical volunteer trips are free of charge for trip participants; costs are covered by the generous support of VPNA. Change others’ lives and your own by traveling to Kenya or India to volunteer. If you have any questions about the program or are interested in learning more about a potential volunteer opportunity, please email passiontoheal@freethechildren.com. For more information please visit www. passiontoheal.com. J

Volume 9 • number 4 • FALL 2015 45

professional development

privilege to serve humble and beautiful children. I learned to love and better understand a culture I had never experienced. I was inspired by the native physicians and by the pride and enthusiasm they expressed for their mission. They loved the people they served, and they loved their work. I would encourage you to consider traveling to Baraka to experience firsthand the power of “Jambo.”

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

Dermatology PA news & notes

The Difference We Make Being Kind…Pays (Literally) By Steven K. Shama, MD, MPH, FAAD

Kindness has always been a wonderful quality to have, a natural attraction for people. Because of a new government questionnaire which rates the care patients get in medical institutions and ranks these institutions as well, kindness is now an even more valuable attribute amongst medical personnel. Over the years I've interviewed many people for positions in my office, and I have found that there is no greater quality to look for in a person than kindness… the quality of being friendly, generous, and considerate. I would also add empathetic as a quality within the definition of kindness. I recall the Dalai Lama’s words, “My religion is kindness.” To live one’s life with kindness, in kindness, and expressing kindness. Hospitals in the last few years have received (or failed to receive) hundreds of thousands to millions of dollars in increased Medicare reimbursements by being rated by patients as being kinder (or not so kind) than other medical institutions in their area. Not only that, but hospitals are awarded a star rating from 1 to 5, with this rating being easily available via the Internet to patients nationwide. This same rating system is coming to medical practices around the country in the next year or two. So now kindness actually pays. How can we increase the kindness in the people who work in our offices? Is there a way to teach this quality to those who are not so kind? I believe I can teach anyone any skill that will help him or her to work better in a dermatology practice, except perhaps kindness. Kindness is instilled at an early age, somehow homegrown, and not something easily taught. It's my impression that some people have it, and it shows easily during an interview; other people simply don't have it and are unlikely to acquire it. Our offices need staff who are kind, compassionate, and emphathetic. This is especially true with patients who visit our offices and who have to put themselves in vulnerable situations, such as getting totally undressed for full body skin exams, being asked very intimate questions about their life, or being told that they might have a cancer which could conceivably threaten their appearance or their life. It is the kind front office person who greets a new patient with a genuine smile, and the 46 Journal of Dermatology for Physician Assistants

clinical staff or clinician who compassionately and with great empathy, discusses with the patient the disease they may have which could change their life in the negative forever. While interviewing potential staff, we often focus on a person's prior experience in a dermatology practice and on skills such as doing biopsies and making medical diagnoses. Yet when I choose between two candidates with equally good educational backgrounds, I choose the person I like the best based on kindness. So how do you find kind people? One secret I've found is to look for people who have worked with children (e.g., in child day care centers). I look for words in references describing an applicant as kind, understanding, caring, compassionate, and/or empathetic. Hiring such individuals will add a special spirit to your office, change patient attitudes and expectations, and even improve the overall culture of your office. Hospitals, emergency departments, surgical care units, and nursing homes are now being evaluated by a questionnaire given to patients who have recently visited these institutions. These surveys that measure patient experiences with healthcare institutions and provider practice settings are called CG CAHPS, the Clinician and Group Consumer Assessment of Healthcare Providers and Systems and have been developed by the Centers for Medicare and Medicaid Services (CMS). On the basis of the scoring on these questionnaires, the federal government and many insurance companies are reimbursing providers at a greater or lesser rate. In the next year or two, these questionnaires will be used to evaluate private practices. Not only will the results of the questionnaires affect reimbursement, but these same results will be available on the Internet and may be used by patients or staff members who are looking for a practice to join. Reimbursement for services rendered is now changing to a value-based purchasing system rather than a fee for individual services. It has been shown scientifically that the patient experience, as reflected in the questionnaire, is correlated with quality outcomes. For example, the more positive the patient experience the more likely a patient with a chronic disorder such as

always been important in medicine to be friendly, generous, considerate, and kind. And now, even though it has always been the right thing to do, now… being kind…pays. J P.S. An excellent reference which explains the ins and outs of the CG CAHPS is the book: “The CG CAHPS Handbook: A Guide to Improve Patient Experience and Clinical Outcomes” published by Fire Starter Publishing, Pensacola Florida 2015. Authors: Jeff Morris, Barbara Hotko and Matthew Bates. Dr. Steve Shama was practicing general dermatology for 30 years in Boston, Massachusetts until last year. He retired at that time but continues in a 20 year career as a professional speaker and enjoys speaking on topics such as, “Dealing With Difficult People and Looking Forward To It!” and “Rediscovering The Joys of Medicine and of Life.” He gives these talks at medical meetings, in private practices, and to general audiences and youth throughout the country. You can reach Dr. Shama at www.steveshama.com.

SAVE OVER 20% ON AAD’s ANNUAL MEETING REGISTRATION

Registration

begins WEDNESDA Y,

DECEMBER 2 at 12 p.m. noon

(CT)

74th Annual Meeting Washington, D.C. March 4-8, 2016 WALTER E. WASHINGTON CONVENTION CENTER

Enroll in the AAD DermCare Team and save up to $210 on Annual Meeting Registration. Don’t miss the largest, dermatology meeting in the world! • Full access to over 325 educational sessions • MOC sessions approved for AAPA Category 1 self-assessment CME credit • A variety of complimentary networking opportunities VISIT US IN DC FOR A MONUMENTAL EXPERIENCE!

Don’t forget, Physician attendance is not required for PAs to attend. For information regarding registration requirements for PAs, visit aad.org/AM16/nonmembers.

Learn more about enrolling in the DermCare Team at aad.org/DermCareTeam.

15-891-MKT

Volume 9 • number 4 • FALL 2015 47

DERmatology pa news & notes

diabetes is likely to improve, the less likely the patient is to be readmitted to a hospital, the happier the clinicians tend to be, and the lower their malpractice claims tend to be. All good news. The questionnaire evaluates clinicians including physicians, physician assistants, and nurse practitioners. Among the 34 total questions, there are 15 questions that are normally reported as measures of the patient experience. The questions represent five overall categories including access to care/information, provider communications, office staff courtesy/helpfulness, lab results follow-up, and the overall rating of the provider. Some questions related to provider communication include the following. How often did this provider explain things in a way that was easy to understand? How often did this provider listen carefully to you? How often did this provider give you easy to understand information about your health questions or concerns? How often did this provider spend enough time with you? How often did this provider show respect for what you had to say? As you can see, all of the patient responses are eliciting patient perceptions, and they are critical in the scoring of the test. I believe the questions elicit whether the patient was treated with compassion, caring, empathy, and kindness. Showing kindness to patients is going to be key to a successful practice. It has

Workplace Excellence Attitude + Effort = Improvement

Make the Choice - Form the Habit - Reach Your Potential 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.

Technological

advances have transformed almost every aspect of human performance; in art, in music, in athletics, in entertainment, in medicine, and in manufacturing - in every walk of life. What we can achieve compared to even fifty short years ago has been completely transformed. There are, however, some essential aspects of human performance that remain unchanged. Chief among them is that there is still no substitute for hard work in the pursuit of greatness. For example, computers have made how we write and edit significantly easier than it was once with a pencil or typewriter; nonetheless, becoming a great writer is still hard work. As the writer Cheever famously said, “There are no great writers, only great rewriters.” This was true then and is still true today. Writing is still hard work, and achieving greatness still involves the combination of talent and hard work. J.K. Rowling, one of the most popular and successful writers today, was rejected by 12 editors prior to being accepted by the 13th and embarking upon her billion dollar series, Harry Potter. Were it not for her perseverance, positive attitude, and unwavering effort we might never have known of her abilities. Within the factors that contribute to excellence, none are more powerful than attitude and effort. Attitude and effort are the Achilles heel of human performance. These two character qualities are essential catalysts for human performance that no combination of technology and talent can supersede. No matter how sophisticated our medical techniques and teaching, no matter how advanced our tools and technology, no matter how much natural talent and ability a person might possess, without a lot of hard work there is little hope of achieving greatness. Success requires working hard, working smart, and working consistently. Many times we work hard but 48 Journal of Dermatology for Physician Assistants

not smart, which often means working in isolation and trying in vain to improve without proper focus on the deliberate practice required to improve our areas of weakness. Consistently working hard in a targeted way is essential. Working hard means getting outside your comfort zone. Working smart and working hard consistently require targeted, intentional work on things you’re not good at when you don’t want to, when it isn’t easy or fun. Getting comfortable and “being uncomfortable” is essential for growth. Working hard and not working hard are choices; we choose our attitude and effort. That’s a simple but powerful truth. We choose if we want to put in the effort and whether we have a good attitude or a bad attitude; we choose. As the holocaust survivor Viktor Frankl powerfully stated, “Everything can be taken from a man or a woman but one thing, the last of the human freedoms: to choose one’s attitude in any given set of circumstances.” Working hard is a habit and so is not working hard. As Aristotle famously said, “We are what we repeatedly do. Excellence then is not an act, but a habit.” We take the building blocks of hard work (attitude and effort) and we put them into a simple but powerful formula: attitude + effort = improvement. This is a simple notion, but not necessarily easy. How much improvement can I expect? How long will it take before I see results? It depends. We are not arguing that if you simply give great effort and attitude that you will always succeed or reach your goals. Talent matters, good fortune matters, and timing matters. However, we do know that there are very few examples of successful people who do not demonstrate great attitude and effort. It can be challenging to put the attitude + effort = improvement formula into practice in our own lives, especially when we apply it to things

don’t have to work hard (So if I’m working hard and success isn’t coming fast enough or easy enough, then I must not be talented). Or, we give it our all and fail, and it robs us of all the excuses we use to protect our fragile egos. Not succeeding doesn’t always mean you didn’t work hard enough, but it’s exceedingly rare to see somebody who is successful who hasn’t worked very hard, who hasn’t had a very strong attitude and effort over time. One additional thought about effort is that attitude and hard work relate to gratitude. In my estimation gratitude and attitude are the chicken and egg. When you’re grateful, you are most likely to have a positive attitude and to work hard. When you take things for granted or feel entitled, it is usually accompanied by negative attitude and unwillingness to work hard. You work hard on things you love and on things you believe are valuable. We are often not aware of how precious our gifts and abilities are, and so we often don’t fight hard to protect and develop them. Gratitude researcher Robert Emmons defines gratitude as “the recognition that life owes me nothing and all the good that I have is gift.” When we see the world as a gift we are grateful for everything and we will work hard and choose the path of positive attitude and persistent effort no matter the circumstance. Unfortunately, too often we have to have our “gifts” taken away from us to appreciate them and to work hard on them. Instead, we must find those “secret ingredients”: positive attitude, effort, and a willingness to give everything you have to the people and pursuits you love most. As the great runner Steve Prefontaine said, “To give anything less than your best is to sacrifice the gift.” When we see everything as a gift we choose to give our best; we develop the habit of working hard, and in so doing, we maximize our potential for excellence and find the peace that comes from doing the best that our capabilities allow. J Matthew L. Davidson, Ph.D. is the Founder, President, and Director of Education for the Institute for Excellence & Ethics (IEE), a 501(c)3 nonprofit corporation dedicated to helping individuals and organizations achieve excellence. He is a National Spokesperson for the Business Bureau National Center for Character Ethics. The IEE specializes in the development and dissemination of research-based tools for developing the culture and competencies of excellence and ethics in schools, athletics, the workplace, and the home; this is done through professional development workshops & academies, teaching & learning resources, assessment, and consulting services. He is a frequent national presenter and is available for keynote lectures, professional development, retreats, and organizational consulting. He has indicated no relationships to disclose relating to the content of this article. For additional information or to contact the IEE, please visit www.excellenceandethics.org.

Volume 9 • number 4 • FALL 2015 49

DERmatology pa news & notes

we don’t particularly like or aren’t particularly good at. Therefore, it’s helpful to think about factors that drive or encourage positive attitude and effort, as well as factors that prevent positive attitude and effort. For example, factors that encourage or contribute to a positive attitude about something are liking it, being naturally good at it, understanding the purpose and importance of it, and seeing the short and long-term benefit of it. By comparison, some factors that prevent or get in the way of positive attitude and effort are not liking it, not being naturally good at it, not seeing the purpose of it, lacking confidence, being hungry, tired, sad, or mad, and not seeing the short or long-term benefit of it. One of the key pieces for attitude and effort is to take these vague, relative concepts and define them. In the attitude + effort = improvement formula we insert some more definitive anchors. For example, someone with a bad attitude is resistant, defensive, defeated. We know what that looks like and sounds like: “That will never work”; “I already tried that”; or “Why do I have to do that?”. When we begin to have a shared understanding of a standard, it becomes easier to practice and teach that standard. For healthcare providers, teachers, parents, and mentors in any walk of life, the attitude + effort = improvement formula is essential for maximizing human potential. We encourage folks to take the formula and use it as is or to adapt the anchors with your own indicators; to engage in continuous self-study monitoring by examining when and how you met the standards or fell short; to look for other examples of what it looks like in action (or what it looks like when it’s missing); and finally, to seek support and challenge through accountability partners who can help you as you attempt to put the standard into action. Positive attitude and effort are mindsets, ways of approaching life. One of the most powerful ways to change your mindset is to proactively shape the stories you tell yourself. Positive self-talk is not simply a gimmick; research shows that self-talk is a powerful shaper of attitude, effort, and overall performance. Developing your own self-talk phrases literally tells your mind and body a different, positive story. Positive self-talk prevents empty space where negative thoughts and attitudes get formed. All day long, no matter what the situation, just keep thinking and saying positive thoughts such as, “Keep moving forward. You can do it. Next patient. Next phone call. Focus on improvement. Mind over matter. I choose how I feel.” Focus on whatever works for you; find those phrases; replace the negative with the positive. Focus on what’s within your control. We often choose to give up or give in because we falsely believe that talented people

From the Desk of... Jennifer Conner, MPAS, PA-C SDPA President-Elect, Diplomate

DERmatology pa news & notes

SDPA Receives the AAPA Constituent Organization Award for Growing the PA Profession The SDPA was our work with the MRF, the proud recipient of the SDPA Legislative the AAPA Constituent Affairs Committee has Organization Award made great strides in for Growing the PA enacting laws regulating Profession at the annual and banning tanning bed AAPA conference in San use by minors in a majority Francisco, CA on May of states. These actions 24, 2015. I was able to resulted in the banning accept the award on behalf of tanning bed use by of our organization and minors in 10 states and participated in a leadership restriction of tanning bed From left to right: Erin Cramer, PA-C, Oregon Society forum with other use by minors in another of PAs, Kim Zuber, PA-C, American Academy of constituent organization 31 states. The SDPA Nephrology PAs, and Jennifer Conner, MPAS, PA-C, award winners. The forum provided support for the SDPA President-Elect. allowed leaders from each FDA risk reclassification organization to present their organization’s winning of UV lamps in May 2014, leading to a required blackproject and answer questions from the audience box warning on the devices informing users of the regarding the project’s success and importance. The increased risk of skin cancer. Growing the PA Profession Award was bestowed upon The SDPA is dedicated to continuing to take a the SDPA for our dedication to melanoma advocacy stand in the fight against melanoma through advocacy and legislation. programs to support advancements in treatment

SDPA leaders and options, better screening to members have played an save lives, and legislation active role in advocating for to reduce tanning bed prevention and research for accessibility. Dermatology PAs melanoma treatment options play an increasingly important over the past few years. Our role in reducing the impact Philanthropy Committee’s of melanoma on the patients partnership with the Melanoma we serve, and the SDPA will Research Foundation (MRF) continue to actively engage has allowed for expansion of and support our members their Miles for Melanoma in this effort. Greater PA program into new cities around involvement will inevitably From left to right: John McGinnity, MS, PA-C, the United States and has lead to better patient outcomes AAPA Immediate Past President and Jennifer helped raise nearly $100,000 Conner, MPAS, PA-C, SDPA President-Elect. and continued recognition for the MRF over the past three of our commitment to the years. The SDPA has helped establish annual races in advancement of dermatology. We would like to extend Seattle, Atlanta, and San Diego. We will continue our a big ‘thank you’ to all SDPA members who have contribution with the upcoming Miles for Melanoma been involved in these endeavors and encourage all to race at our fall conference in Orlando. In addition to participate in the future! J

50 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 ANTIBIOTIC-FREE 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 9 • number 4 • FALL 2015 51

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.

52 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 10/15

www.epiduoforte.com/hcp

Supervising Physician CORNER An Interview with Anita Singh, MD, FACOG

Isotretinoin Pregnancy Prevention Counseling - An OB/GYN Perspective By Sara Wilchowski, MS, PA-C

What advice do you have for dermatology providers who want to start patients on birth control pills and manage them themselves? Dr. Singh: This depends on the interest and knowledge level of the dermatology provider on contraceptive management. Contraceptive management is often more complex than just prescribing a birth control pill. In choosing a contraceptive for an individual there are many factors to consider. The factors include the patient’s medical history, personal preferences, and the large variety of new options. Contraception has gone beyond just the basic oral contraceptive pill. Other forms of contraceptives include contraceptive rings, subdermal implants, injectables, and intrauterine devices (IUDs). Surgical options also exist such as tubal ligation. If dermatology providers are interested in prescribing contraception, they should have a basic understanding of all the contraceptive options and have a few options that they feel comfortable prescribing. If the patient has more in depth questions or complex needs, a referral to an OB/GYN for more comprehensive counseling can help. A first time contraceptive user would most likely be in higher need of referral to an OB/GYN. What are the basic facts concerning oral contraceptive pills (OCPs) that patients should be told during their initial counseling? Dr. Singh: There are many different birth control pills currently available. The pills are either monophasic or multiphasic. Monophasic pills have the same amount of estrogen and progesterone in all the pills. Multiphasic having varying amounts. The same estrogen (ethinyl estradiol) is in almost all the currently available OCPs. The amount of estrogen varies from 10ug to 50ug. There are mainly eight different progestins available in OCPs, and some progestins are more androgenic than others. The least androgenic are progestins from the estrane family such as norethindrone acetate along with third and fourth generation progestins desogestrel, norgestimate, and drospirenone. Birth control pills are best started on the first day of a patient’s period. The benefits of a day

one start are that the speed of contraceptive efficacy is faster and it is easier to remember to start on day one. Another option is a Sunday start. If a patient does the first Sunday after her period starts, a backup form of contraception should be used for the entire first month. If she does a day one start, the patient should use backup contraception for just the first week as there is enhanced ovulation suppression effect with an earlier start. Due to the potential complications from isotretinoin, I’m sure every dermatology provider would ideally like their patients on the most effective birth control. Can you summarize the pros and cons of under the skin implants and IUDs to help us better explain these relatively effective options to patients? Dr. Singh: There are many excellent contraceptive options that are not user dependent and have a less than 1% failure rate. The implantable rods in the arms, which were first introduced in the early 2000’s, have some limitations and side effects. The implantable rods require a skilled clinician for insertion and removal. Patients can experience irregular bleeding, and incision site scarring and weight gain are potential side effects. I find that the IUDs are a better option. There are four IUDs currently available in the United States. One manufacturer has two models that contain a small amount of progesterone hormone. One model is smaller with less progesterone and lasts for three years; the other one lasts five years. The copper IUD is a non-hormonal option and lasts ten years. The fourth is a generic IUD similar to the branded Mirena IUD, but it is only approved for three years versus five years with Mirena. There are very few contraindications to the IUDs. This is especially true of the copper IUD. The branded Mirena IUD is hormonal and provides some non-contraceptive benefits similar to OCPs such as lighter or no periods and fewer menstrual cramps. The hormones are small amounts and have primarily a local uterine effect. What is the difference between a blood pregnancy test and a urine pregnancy test? Dr. Singh: All urine pregnancy tests should be Volume 9 • number 4 • FALL 2015 53

DERmatology pa news & notes

Anita Singh, MD, FACOG is board certified in Obstetrics and Gynecology and Reproductive Endocrinology and Infertility. The JDPA recently had the opportunity to interview Dr. Singh and learn more about the role of pregnancy prevention counseling within dermatology, prescribing contraception medications to patients taking isotretinoin, and other OB/GYN issues concerning dermatology providers.

DERmatology pa news & notes

able to detect pregnancy two weeks after conception. A serum pregnancy test can detect a pregnancy as early as seven days post conception as it can detect very low levels of human chorionic gonadotropin (hCG) in the serum. The hCG hormone isn’t secreted into the maternal blood until seven days after conception. Urine pregnancy tests vary in both sensitivity and specificity; you can get a high degree of false positive or negatives from cross reactants. If you do a urine pregnancy test, check the package insert to see what the hCG detection level is. A test kit that detects levels of 25 mIU/ml or less is optimal. How do you get an accurate sexual history from an adolescent female who often will have a parent present? Dr. Singh: You do need to separate the patient from the parent. This is standard practice in OB/ GYN practices. The information provided by minors is protected health information. You can prescribe birth control and provide contraceptive counseling without a parent’s permission. It is important for the adolescent to know that the information she provides to you will be kept confidential. You can explain to the parents that a private discussion with their child is necessary due to the serious birth defects that can occur with isotretinoin. It is important to inform abstinent adolescents that if they do become sexually active and have unprotected

intercourse, they should seek additional counseling from their healthcare provider or parents about how to handle the potential medical complications relating to such a situation. The iPLEDGE book is very comprehensive, however it is also over 70 pages and many patients may not read through it all. One of the reasons it is so large is that it provides information for all patients, whatever their pregnancy prevention plan is. Do you think there is a need for a short handout covering just what an abstinent patient would need to know? Dr. Singh: Yes I think a handout of that type would be useful. In my experience, most schools provide general contraceptive education for adolescents. However, the depth of this education is highly variable so providing adolescents with additional handouts is a good secondary resource. The National Institute of Health and American College of Obstetrics and Gynecology have many good handouts available on their websites. J Anita Singh, MD, FACOG is board certified in Obstetrics and Gynecology and Reproductive Endocrinology and Infertility. She is in private practice in Agoura Hills, CA. She has indicated no conflicts of interest to disclose relating to the content of this article.

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bit.ly/SA_NCCPA Did you know that the upcoming Orlando conference offers the opportunity to earn 6 SA credit hours towards maintaining your NCCPA certification?

TO LEARN MORE VISIT SDPACONFERENCES.ORG 54 Journal of Dermatology for Physician Assistants

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Volume 9 â&#x20AC;˘ number 4 â&#x20AC;˘ FALL 2015 55

Now Showing on Dermcast.tv The Official Online Media Resource of the SDPA

Dermcast.tv is the official online media resource of the SDPA. We are very proud that Dermcast is the #1 iTunes Podcast in dermatology. Dermcast.tv is your source for audio podcasts, the most current dermatology news and research, procedural videos, conference highlights, and much, much more. As members of the SDPA, everything on Dermcast.tv is not only tailored precisely for you and your needs, it is available to you FREE!

DERmatology pa news & notes

The First and Only Therapy for Hidradenitis Suppurativa Approved