JDPA Summer 2014 by Angela Simiele

DPA J

V o l u m e 8 • n u m b e r 3 • S UMMER 2 0 1 4 • www.jdpa.org

Journal of Dermatology for Physician Assistants

dermatology Pa news & notes

Certification Maintenance 15 __________________________________

clinical dermatology Dermoscopy 28 __________________________________

Surgical dermatology Surgical Wisdom

_________________________________

Cosmetic dermatology Cosmetic Pearls

_____________________________ professional development Physician Assistants in Dermatology A Survey of Fellows of the SDPA

›› Earn CME credit with this issue CME Hyperhidrosis: A Review of the Impact of Primary Hyperhidrosis on Quality of Life

Official Journal of the Society of Dermatology Physician Assistants

Volume 8 • number 3 • SUMMER 2014

Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936-1080

ÂŠ2014 Novartis

4/14

XDP-1301721

I’M TIRED OF BEING STARED AT. BUT WORSE, I DON’T EVEN WANT TO SEE MYSELF. Many patients with moderate to severe psoriasis (PsO) have trouble expressing how they’re doing. You probably have patients in your practice who still suffer from embarrassment, poor self-image, and social isolation but aren’t talking to you about it.1-4 But with just 1 revealing question, you can uncover the dissatisfaction your patients may have trouble expressing, and help make a real difference in managing their PsO.

MAKE A CONNECTION. MAKE A DIFFERENCE. Find out how you can help at PSOMUCHMORE.COM References: 1. Data on file. Kantar Health 2013. Novartis Pharmaceuticals Corp; 2014. 2. Gupta MA, Gupta AK, Watteel GN. Perceived deprivation of social touch in psoriasis is associated with greater psychologic morbidity: an index of the stigma experience in dermatologic disorders. Cutis. 1998;61(6):339-342. 3. Schmid-Ott G, Jaeger B, Kuensebeck HW, Ott R, Lamprecht F. Dimensions of stigmatization in patients with psoriasis in a ‘‘Questionnaire on Experience with Skin Complaints.’’ Dermatology. 1996;193(4):304-310. 4. Armstrong AW, Schupp C, Wu J, Bebo B. Quality of life and work productivity impairment among psoriasis patients: findings from the National Psoriasis Foundation survey data 2003-2011. PLoS One. 2012;7(12):e52935.

Volume 8 • number 3 • SUMMER 2014

Journal of Dermatology for Physician Assistants

EDITORIAL BOARD

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

DEPARTMENT EDITORS

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

2014-15 SDPA Board of Directors PRESIDENT Vicki Roberts, MPAS, PA-C PRESIDENT-ELECT Matthew Brunner, MHS, PA-C IMMEDIATE PAST PRESIDENT Jennifer Winter, MSPAS, PA-C VICE PRESIDENT Jacki Kment, MPAS, PA-C SECRETARY / TREASURER Joleen Volz, MPAS, PA-C DIRECTORS AT LARGE Scott B. Ahrndt, MPAS, PA-C Jennifer Conner, MPAS, PA-C Jang Mi Johnson, PA-C Jane Mast, PA-C

editorial missioN: The JDPA is the official clinical journal of the Society of Dermatology Physician Assistants. The mission of the JDPA is to improve dermatological patient care by publishing the most innovative, timely, practiceproven educational information available for the physician assistant profession. PUBLISHED CONTENT IN THE JDPA: Statements and opinions expressed in the articles and communications herein are those of the authors and not necessarily those of the Publisher or the Society of Dermatology Physician Assistants (SDPA). The Publisher and the SDPA disclaim any responsibility or liability for such material, including but not limited to any losses or other damage incurred by readers in reliance on such content. Neither Publisher nor SDPA verify any claims or other information appearing in any of the advertisements contained in the publication and cannot take responsibility for any losses or other damage incurred by readers in reliance on thereon. Neither Publisher nor SDPA guarantees, warrants, or endorses any product or service advertised in this publication, nor do they guaranty any claim made by the manufacturer of such product or service. This Issue: The JDPA includes articles that have been reviewed and approved for Category I (Preapproved) CME credit by the American Academy of Physician Assistants. Approval is valid for 1 year from the issue date, and participants may submit the self-assessment at any time during that period. Category I CME articles included in JDPA are planned and developed in accordance with AAPAâ&#x20AC;&#x2122;s CME Standards for Journal Articles and for Commercial Support of Journal Articles. going green: Since its inception, the JDPA has utilized eco-friendly printing practices. The JDPA is printed on paper obtained from sustainable forests that meet strict environmental standards. Soy-based inks that have a low environmental impact are used during printing of the journal and the journal is printed using 100% renewable energy. SDPA members may join us in our efforts and opt to receive the JDPA in digital format. Publishing Staff Publisher Travis Hayden, MPAS, PA-C Managing Editor Jennifer M. Hayden, M.Ed Copy Editor Douglas Morris Art Director Angela Simiele Website Design Terry Scanlon SALES Office Physician Assistant Communications, LLC P.O. Box 416, Manlius NY 13104-0416 Phone (315) 663-4147 PAC@pacommunications.org www.pacommunications.org keep current with the SDPA:

JDPA/Journal of Dermatology for Physician Assistants (ISSN 1938-9574) is published quarterly (4 issues per volume, one volume per year) by Physician Assistant Communications, LLC, P.O. Box 416, Manlius NY 13104-0416. Volume 8, Number 3, Summer 2014. One year subscription rates: $40 in the United States and Possessions. Single copies (prepaid only): $10 in the United States (Include $6.50 per order plus $2 per additional copy for US postage and handling). Periodicals postage rate paid at New York, NY 10001 and additional mailing offices. ÂŠ 2014 Physician Assistant Communications, LLC. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including by photocopy, recording, or information storage and retrieval system, without permission in writing from the publisher. Postmaster: Send address changes to Society of Dermatology Physician Assistants, Inc., 4111 W. Alameda Ave. Suite 412, Burbank, CA 91505, 1-800-380-3992., email SDPA@dermpa.org, www.dermpa.org. THIS ISSUE IS SPONSORED BY

Journal of Dermatology for Physician Assistants

Editor’s Message

ecently, I was reminded of our cultural misnomer that having a tan is often associated with being healthy, especially in the minds of young people. As I was boarding a plane to attend the recent SDPA Summer Dermatology Conference in Indianapolis, I saw a teenager and her mother taking some “selfies” together as they prepared to board. They appeared to be excited about their upcoming trip and were enjoying their time together. After boarding, they were seated just behind me and could be overheard looking through their photos, commenting on what they liked about each one. I heard the daughter say, “Well that one is great. Look how tan I look!” Having the opportunity to observe this exchange brought to mind the continued importance of educating the public, in particular our youth, about the dangers of indoor tanning. According to the AAD, it is currently estimated that 2.3 million U.S. teenagers tan indoors each year. This staggering amount begs the question, “How many of these 2.3 million adolescent tanners are we actually seeing in our offices and are able to warn of the risks of indoor tanning?” While we may not be able to reach each and every one of these teenagers personally, the U.S. Food and Drug Administration (FDA) has recently stepped in to help protect these youth. This past May, the FDA announced it is reclassifying all tanning beds and sun lamps to now be considered as high-risk, class II devices. Previously, tanning machines were classified as low-risk devices, considered to be as safe as bandages and tongue depressors. With this reclassification, the FDA now requires sunlamps used in tanning salons to carry a prominent black-box warning about the cancer risks associated with indoor tanning, stating that children under the age of eighteen should not use these products. Materials used to market the UV lamps and tanning beds such as websites, brochures, or user instructions must now include information on cancer risks including a recommendation that regular tanning bed users “should be regularly evaluated for skin cancer” due to repeated exposure to the lamps’ UV radiation; users must also be warned that UV lamps can be particularly dangerous for those with a family history of skin cancer. The FDA now requires manufacturers to meet certain safety and design requirements including timers and limits on the radiation levels that the products produce. This reclassification allows the FDA to review the safety and design of tanning devices before manufacturers begin selling them. There is hope that the FDA’s reclassification of tanning beds will now encourage even more states to take action and pursue laws that ban minors from using indoor tanning equipment. The most recent state to join this movement was Hawaii, which in July became the tenth state to ban indoor tanning for minors under the age of eighteen. Hawaii joins Vermont, California, Illinois, Louisiana, Minnesota, Oregon, Nevada, Texas, and Washington by passing this legislation. The science is clear. According to the AAD, the risk for developing melanoma increases by 59 percent in individuals who have been exposed to UV radiation from indoor tanning devices, and the risks increase with each subsequent use. Since 2.3 million teens tan indoors in the U.S. annually, restricting teens’ access to indoor tanning is critical to preventing skin cancer. It is my hope that we can continue to work together as a society to encourage even more states to join the ban on indoor tanning use by minors. Let’s make a commitment today to replace the misinformed cultural belief that having a tan is healthy with the positive message that exercising good sun protection and avoidance habits are truly what is healthy. J

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

Volume 8 • number 3 • SUMMER 2014

table of contents 16 Hyperhidrosis: A Review of the Impact of Primary Hyperhidrosis on Quality of Life By Eleni Moraites, MD, Shola Akinshemoyin Vaughn, BS and Samantha Hill, MD, FAAD © Photo courtesy of Adelaide Hebert, MD Univ of Texas c/o International Hyperhidrosis Society. All rights reserved

›› CME

10 Derm PA News & Notes – part one • Certification Review & Maintenance

16 Clinical Dermatology • CME Article – Hyperhidrosis: A Review of the Impact of Primary Hyperhidrosis on Quality of Life • Dermatology Case Report: Adult-Onset Still’s Disease

39 Surgical Dermatology • Journal Club: Practice Changing Articles for

Departments

04 Editorial Board 05 Editor’s Message 09 SDPA News & Current Affairs 10 Dermatology Market Watch 22 From The Patient’s Perspective 28 Dermoscopy 32 Clinical Snapshots 40 Surgical Wisdom 45 Cosmetic Pearls 51 Outside & Inside the 9 to 5… 53 Notes from your Office Manager 58 The Difference We Make 67 Now Showing on Dermcast.tv 68 Dermatology in Art 69 JDPA Information for Authors 70 Professional Opportunities and Development

Dermatology

43 Cosmetic Dermatology • Natural Ingredients Used in New Topical Treatments

for Hyperpigmentation

47 Professional Development • Physician Assistants in Dermatology: A Survey of Fellows of the SDPA

58 Derm PA News & Notes – part two

Go Green & Read On the Go 6

Journal of Dermatology for Physician Assistants

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

dermpa.org

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

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

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

Volume 8 • number 3 • SUMMER 2014

Journal of Dermatology for Physician Assistants

FROM THE SDPA

News & Current Affairs

CALENDAR OF EVENTS AUGUST AAD Summer Academy Meeting August 6 - 10, 2014 Chicago, IL

2014

NOVEMBER SDPA 12th Annual Fall Dermatology Conference November 12 - 15, 2014 Manchester Grand Hyatt San Diego, CA

2015

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

JUNE SDPA Summer Dermatology Conference June 4 – 7, 2015 Caesars Palace Las Vegas, NV

hen we see the red background and distinct white lettering for Coca Cola or the golden arches of McDonalds, it creates an immediate understanding of what is being offered. Our brains are remarkably efficient at recognizing abstract symbols and associating them with a much more complicated set of ideas. Having an easily recognized symbol that people associate with your product is a classic example of “branding” – using a symbol, phrase, or color scheme to identify and differentiate your product from others. At the last annual meeting in Boston, the AAPA’s House of Delegates (HOD) voted to emphasize the use of “PA’”instead of “physician assistant” whenever possible. The name physician assistant has caused a great deal of controversy because those two words sometimes can be interpreted in ways that do not accurately represent the collaborative nature of our profession. For over forty years, we have been introducing and explaining our profession over and over again. Unfortunately, for many, the term physician assistant does not immediately invoke images of a medical practitioner who sees patients and writes prescriptions; some people still envision a physician assistant standing at the ready next to a physician to get him/her the things he/she needs. It is important to create a brand for the profession. By emphasizing our education, training, and collaborative work ethic, we can create a brand with a positive association of competent medical practitioners in the minds of the public and the medical community. The AAPA HOD has initiated the creation of this brand by emphasizing the use of PA rather than physician assistant; hopefully this will help minimize the confusion that the term “assistant” sometimes creates. In addition, the SDPA has been working on the national level by meeting with the AAD and reiterating our long-term goals of collaborating with them, writing as much as we can in journals emphasizing these goals, and attempting to counter any articles with inaccuracies about PAs, especially when we are lumped incorrectly with other medical professionals with different goals and regulations. While we are working diligently at the national level to create a positive brand around the PA profession, particularly as it pertains to clarifying the roles that PAs play in a medical team, we won’t be successful without efforts at the local level as well. We need each and every one of you to work in your states and in your practices to help create the PA brand. One way to participate locally is to join and participate in your state PA societies to help them work on these important issues. Just as importantly, when a patient asks how you are trained or how you are different from other medical professionals, seize the opportunity to positively highlight and differentiate PAs from other medical professionals. Download, print, and share the SDPA’s “What is a dermatology PA?” brochure or video from our website. Together we can brand the PA name to be synonymous with high quality, compassionate, team based care. J

Vicki Roberts, MPAS, PA-C SDPA President, Diplomate

Volume 8 • number 3 • SUMMER 2014

Dermatology PA news & notes

Dermatology Market Watch First Topical Triazole Antifungal for Onychomycosis Approved by FDA - Jublia The US Food and Drug Administration (FDA) has recently approved efinaconazole 10% topical solution (Jublia, Valeant Pharmaceuticals) for the treatment of onychomycosis of the toenail. Efinaconazole is a topical antifungal that is the first in the triazole class of agents to be developed for the treatment of distal lateral subungual onychomycosis. The FDA declined to approve efinaconazole for onychomycosis in May 2013, as reported by Medscape Medical News, citing questions related to chemistry, manufacturing, and controls related to areas of the container closure apparatus. The agency had no efficacy or safety concerns at that time. Efinaconazole is applied daily to the nail with a novel bottle that has a built in flow through the brush applicator. It dries quickly, and there is no need to remove excess product, the company says. Efinaconazole was studied in 2 identical randomized, doubled-blind phase 3 clinical trials involving 1655 patients

with onychomycosis. Complete cure rates with efinaconazole were 17.8% in study 1 and 15.2% in study 2 compared with 3.3% and 5.5%, respectively, for vehicle controls (P < .001). Complete cure was defined as 0% clinical involvement of the target toenail, as well as negative potassium hydroxide examination and fungal culture at week 52. Mycologic cure rates (negative nail culture and microscopy results) were also significantly better with efinaconazole, at 55.2% and 53.4%, compared with controls (P <. 001). Adverse events that were reported were generally mild and transient and were similar between patients treated with efinaconazole and those treated with vehicle controls. The most commonly reported adverse events in patients treated with efinaconazole were application site dermatitis and application site vesicles. There are no concerns for systemic adverse effects such as drug–drug interactions or acute liver injury, according to the company. J

AAD Statement on Sunscreen in Schools and Summer Camps Recent stories in the media are showcasing the fact that schools and summer camps in certain regions are not allowing OTC drugs such as sunscreen in schools and summer camps without a medical providers note because of safety concerns and state regulations. The American Academy of Dermatology (AAD) encourages all schools and summer camp programs to allow students to bring and possess sunscreen without restriction and without requiring medical authorization. The American Medical Association recently adopted a resolution to exempt sunscreen from OTC medication possession bans in schools. The AAD supports this resolution. Sunscreens are a safe and effective way to protect against the damaging effects from exposure to ultraviolet 10 Journal of Dermatology for Physician Assistants

(UV) radiation. Scientific evidence supports the benefits of sunscreen to minimize short- and long-term damage to the skin from UV radiation. In fact, research has found that daily sunscreen use can cut the incidence of melanoma, the deadliest form of skin cancer, in half. Current estimates are that one in five Americans will develop skin cancer in their lifetime. Melanoma, the deadliest form of skin cancer, is now the most common form of cancer for young adults 25-29 years old, and the second most common form of cancer for adolescents and young adults 15-29 years old. Everyone, regardless of age, can develop skin cancer and unprotected sun exposure is the most preventable risk factor for skin cancer. To reduce your risk of skin cancer, the AAD recommends that everyone protect themselves from the sun by seeking shade, wearing protective clothing and generously applying a water-resistant, broad-spectrum sunscreen – that protects against both types of ultraviolet radiation (UVA and UVB) – with an SPF 30 or higher on exposed skin. J

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8 • number 3 • SUMMER 2014 11

Dermatology Market Watch

...continued from pg. 10

DERmatology pa news & notes

FDA Approves Ragwitek for Short Ragweed Pollen Allergies The U.S. Food and Drug Administration (FDA) has approved Ragwitek (Merck and Co., Inc.), the first allergen extract administered under the tongue (sublingually) to treat short ragweed pollen induced allergic rhinitis (hay fever), with or without conjunctivitis (eye inflammation), in adults 18 years through 65 years of age. Ragwitek contains an extract from short ragweed (Ambrosia artemisiifolia) pollen. It is a tablet that is taken once daily by placing it sublingually, where it rapidly dissolves. Treatment with Ragwitek is started 12 weeks before the start of ragweed pollen season and continued throughout the season. The first dose is taken in a health care professional’s office where the patient is to be observed for at least 30 minutes for potential adverse reactions. After the first dose, patients can take Ragwitek at home. “The approval of Ragwitek offers millions of adults living with ragweed pollen allergies in the United States an alternative to allergy shots to help manage their disease,” said Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research.

Short ragweed pollen is one of the most common seasonal allergens and is prevalent during the late summer and early fall months in most of the United States. Short ragweed pollen induced allergies are generally managed by avoiding the allergen, medications to relieve symptoms, or with allergy shots. The safety and effectiveness of Ragwitek was evaluated in studies conducted in the United States and internationally. Safety was assessed in approximately 1,700 adults. The most commonly reported adverse reactions by patients treated with Ragwitek were itching in the mouth and ears and throat irritation. Of the 1,700 adults, about 760 were evaluated to determine effectiveness. Some patients received Ragwitek; others received an inactive substitute (placebo). The patients reported their symptoms and additional medications needed to get through the allergy season. During treatment for one ragweed pollen season, patients who received Ragwitek experienced approximately a 26 percent reduction in symptoms and the need for medications compared to those who received a placebo. The Prescribing Information includes a boxed warning to inform that severe allergic reactions, some of which can be life-threatening, can occur. J

OTC Topical Acne Products Rare But Serious Hypersensitivity Reactions Possible Reported in Recent FDA Drug Safety Communication On June 25th, 2014 the US Food and Drug Administration (FDA) warned that certain over-the-counter (OTC) topical acne products can cause "rare but serious and potentially life-threatening" allergic reactions or severe irritation. The statement can be found here on the FDA website: http:// w w w.fd a .gov/Sa fet y/MedWatc h /Sa fet yIn format ion / SafetyAlertsforHumanMedicalProducts/ucm402722.htm. The products of concern are marketed under various brand names such as Proactiv (Guthy-Renker), Neutrogena (Neutrogena), MaxClarity (Stiefel Laboratories, Inc.), Oxy (The Mentholatum Company), Ambi (Valeant Pharmaceuticals), Aveeno (Johnson & Johnson Consumer Companies, Inc), and Clean & Clear (Johnson & Johnson Consumer Companies, Inc.) and as store brands. These products are available as gels, lotions, face washes, solutions, cleansing pads, toners, face scrubs, and other products. The FDA stated that consumers should stop using their topical acne product and seek emergency medical attention immediately if they experience hypersensitivity reactions such as throat tightness; difficulty breathing; feeling faint; or swelling of the eyes, face, lips, or tongue. Consumers should also stop using the product if they develop hives or itching. The hypersensitivity reactions may occur within minutes to a day or longer after product use. The FDA notes that these serious hypersensitivity reactions differ from the local skin irritation that may occur at the product application site, such as redness, burning, dryness, itching, peeling, or slight swelling, that are already included in the Drug Facts labels. The FDA has stated that for now it is unclear whether 12 Journal of Dermatology for Physician Assistants

the serious hypersensitivity reactions that have been reported were triggered by the acne products' active ingredients (benzoyl peroxide or salicylic acid), the inactive ingredients, or a combination of both. The FDA is continuing to monitor and evaluate this safety issue and will work with manufacturers regarding any future label changes that would address the risk for severe hypersensitivity reactions. The FDA recommended that clinicians should advise their patients who are using an OTC topical acne product for the first time to apply a small amount to one or two small affected areas for 3 days to make sure they don't develop any hypersensitivity symptoms. If no discomfort occurs, they can follow the directions on the Drug Facts label. Healthcare professionals are encouraged to report adverse events or side effects related to the use of these products to the MedWatch, the FDA’s Safety Information and Adverse Event Reporting Program by: • Completing and submitting the report Online: www.fda. gov/MedWatch/report.htm. • Download the form (http://www.fda.gov/Safety/ MedWatch/HowToReport/DownloadForms/default.htm) or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178. J

Skin is as important to us as it is to you. So at Celgene, we’re bringing our scientific expertise and innovative thinking to dermatology. It’s our commitment to help you help your patients.

Certification Review

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

Are you recertifying soon? Start your board review early. Each issue of the JDPA features one board question accompanied by a brief explanation of the answer along with any pertinent test taking tips. Best of luck! diaphoresis and heavy or crushing pain that is intense and lasts greater than thirty minutes. The pain is substernal and may radiate to the arm or jaw. Vitals and physical exam may be normal. Cardiac markers (troponin and CPK) may be elevated. In the initial stages of an acute MI the EKG reveals ST-segment elevation. In an anterior wall MI, ST-segment elevation will be noted in the anterior leads V3 and V4. Reciprocal ST-segment depression may be noted in the inferior leads II, III, and aVF. Congestive heart failure would present with shortness of breath and edema. Physical examination would reveal crackles on lung examination and peripheral edema. Cardiac tamponade presents with hypotension, soft or absent heart sounds, and jugular venous distention (JVD). EKG would reveal low amplitude QRS complexes and electrical alternans (alteration in QRS amplitude or axis between beats). Acute pericarditis presents with chest pain that improves with leaning forward, pericardial friction rub, and EKG reveals diffuse ST-segment elevation in two or three standard leads (V2 to V6). Aortic dissection presents with chest pain that is describes as severe and tearing; the EKG would be unremarkable. J The correct answer is A

DERmatology pa news & notes

QUESTION: A 50-year-old male presents with a one-hour history of chest pain. He states the pain is an 8 out of 10 and is located substernal with radiation to the neck. He denies shortness of breath or edema. On physical examination, patient is afebrile, blood pressure 145/88 mmHg, pulse 84/minute, and respiratory rate 20/minute. Heart examination reveals a regular rhythm without murmur, lungs clear to auscultation, and remainder of exam is normal. EKG is noted below. Which of the following is the most likely diagnosis for this patient?

A. Acute anterior wall myocardial infarct B. Congestive heart failure C. Cardiac tamponade D. Acute pericarditis E. Aortic dissection EXPLANATION: Patients with acute myocardial infarction (MI) typically present with a precipitating event such as exercise or stress. Presenting symptoms include

James A. Van Rhee, MS, PA-C, is the Program Director for the Yale University School of Medicine Physician Associate Program. Mr. Van Rhee has been involved in physician assistant education for over 17 years. He has served as project director and test item writer for the Physician Assistant Education Associationâ&#x20AC;&#x2122;s (PAEA) Physician Assistant Clinical Knowledge Rating Assessment Tool (PACKRAT) and is the author of the Physician Assistant: Certification and Re-certification Review Book, published by Elsevier. For the last ten years he has been course director and presenter of the Physician Assistant Board Review, which is now being produced live online by Kaplan Medical.

What Do You Want To Read About In The JDPA? Weâ&#x20AC;&#x2122;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 14 Journal of Dermatology for Physician Assistants

JDPA Journal of Dermatology for Physician Assistants

The year 2014 marks the beginning of the physician assistant profession's transition to a 10-year certification maintenance process. Physician assistants who pass PANCE, regain certification, or wrap up a six-year certification maintenance cycle in 2014 will be the first to begin the new 10year process. SDPA members can log into their NCCPA accounts and review their dashboards to confirm when they will move into this new 10-year cycle. This new process requires new types of CME activities; self-assessment (SA) and performance improvement (PI) CME. To learn more about the new requirements, SDPA members are encouraged to visit www.nccpa.net/ CertMain. Below are some of the most frequently asked questions by SDPA members pertaining to these new changes in certification maintenance. Q: What is “self-assessment CME,” and where will I find it? Does the SDPA’s DLI program count as selfassessment? A: Unlike traditional lecture-learner CME sessions in which the PA is a passive participant, self-assessment CME activities involve a more active process of conducting a systematic review of one's performance, knowledge base, or skill set. Only programs approved for AAPA Category 1 self-assessment CME credit qualify. Examples include

the American College of Physicians Medical Knowledge Self-Assessment Program (MKSAP) 16 Digital and the Society of Dermatology Physician Assistants Distance Learning Initiative. The AAPA also keeps an updated list of activities that are currently certified for AAPA Category 1 self-assessment CME credit at www.aapa.org/ threeColumnLanding.aspx?id=744. Q: How do the new changes affect the cost of certification maintenance? A: NCCPA's Board just reviewed fees and costs with this new process in mind. The only change NCCPA is making is the elimination of the discount for early CME logging. Certification maintenance fees will remain $130 per two-year CME cycle, and PANRE fees are holding steady at $350. As far as the cost of the CME itself, PAs who have been meeting all their CME requirements through free CME opportunities will likely have to begin spending some money. However, it may not be much. Many of the self-assessment and PI-CME opportunities out there today are very low cost. For example, 20 PI-CME credits can be earned at a variety of price points, including some free options. Keep in mind, that these types of CME activities generally don't require travel; they are programs you complete in your practice and online. Many PAs may actually find that their CME expenses come down under this new process. J

S D PA M

I H S R E EMB

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

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

RAMC_6.75x4.75.indd 1

1/31/13 12:49 PM Volume 8 • number 3 • SUMMER 2014 15

DERmatology pa news & notes

Certification Maintenance - Frequently Asked Questions

Clinic al Dermatology

Hyperhidrosis: A Review of the Impact of Primary Hyperhidrosis on Quality of Life By Eleni Moraites, MD, Shola Akinshemoyin Vaughn, BS and Samantha Hill, MD, FAAD

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

›› CME

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

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

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

Learning Objectives: 1. Describe the impact of primary hyperhidrosis on quality of life. 2. Identify methods to screen patients for primary hyperhidrosis. 3. Review the role of current therapeutic options in improving the quality of life in patients with primary hyperhidrosis. 16 Journal of Dermatology for Physician Assistants

Hyperhidrosis SDPA Members Only Content

CLINIC AL Dermatology

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

Volume 8 • number 3 • SUMMER 2014 17

Hyperhidrosis 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

Hyperhidrosis SDPA Members Only Content

CLINIC AL Dermatology

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

Volume 8 • number 3 • SUMMER 2014 19

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

CLINIC AL Dermatology

Eleni Moraites, MD earned her medical degree at the University of Wisconsin School of Medicine and Public Health in Madison, Wisconsin. She is thrilled to begin her internship this year at the Hennepin County Medical Center in Minneapolis, which will be followed by her residency in dermatology at the University of Minnesota. She is a selected member of the Gold Humanism Honor Society. Her interests include medical dermatology and quality of life outcomes in dermatology. She has indicated no relationships to disclose relating to the content of this article. Olushola Akinshemoyin Vaughn, BA is a fourth year medical student at the University of Wisconsin School of Medicine and Public Health in Madison, Wisconsin. She attended Harvard University, followed by several years of playing in rock bands in Los Angeles, California, before returning to her home state of Wisconsin for medical school. She is a selected member of the Gold Humanism Honor Society. Her interests include pediatric dermatology and pigmented skin lesions. She has indicated no relationships to disclose relating to the content of this article. Samantha Hill, MD, FAAD earned her medical degree from the Medical College of Wisconsin in 2003, completed a pediatric residency and internship at Nationwide Children’s Hospital in Columbus, Ohio in 2006, and completed a dermatology residency at Saint Louis University Hospital in 2009. She then completed a fellowship in pediatric dermatology at Children’s Hospital of Wisconsin in 2010. After training, she practiced on the faculty at the Medical College of Wisconsin, followed by a position at ’Specially for Children at Dell Children’s Medical Center in Austin, Texas. Currently, she is in private practice with RidgeView Dermatology in Lynchburg, Virginia. Dr. Hill treats a variety of skin diseases in children and adolescents and specializes in the treatment of hyperhidrosis. Dr. Hill initiated Pediatric Hyperhidrosis Clinics at both the Children’s Hospital of Wisconsin and at 'Specially for Children in Austin. Dr. Hill also lectures at regional and national meetings. She has indicated no relationships to disclose relating to the content of this article.

20 Journal of Dermatology for Physician Assistants

SDPA 12TH ANNUAL FALL DERMATOLOGY CONFERENCE 2014

Nov 12th - Nov 15th, 2014 Manchester Grand Hyatt San Diego, CA This high energy Conference will include:

Medical Director: Dr. Matthew Zirwas

• Leading Faculty and Dynamic Topics • Interactive Panel Discussions • Workshops to include Patch Testing, Dermoscopy, Basic to Advanced Skin Surgery, and Cosmetics • Keynote speaker - Professor and Researcher, Sonja Lyubomirsky, PhD, Author of “The How of Happiness”

Register Now: www.dermpa.org Maximum of 39.5 hours (27.5 maximum earnable by any attendee) of Category I CME Credit from AAPA will be requested. This program is not yet approved for CME Credit. Volume 8 • number 3 • SUMMER 2014 21

From The Patient’s Perspective It’s Not Just a Pink Rash By Kevin Allen

CLINIC AL Dermatology

f it had not been for a local pediatrician who was notorious for throwing outright fits in defense of his patients, I would not have received the attention needed as a child. Inability to pay, lack of insurance, and society’s reluctance to assist adults in obtaining a difficult diagnosis probably would have prevented me from being diagnosed as an adult. However, my local pediatrician insisted I go to Texas Children’s Hospital in Houston. As a result, I was seen by Dr. Earl Brewer Jr (a pediatric rheumatologist and founder of the American College of Rheumatology). In June 1976, Dr. Brewer diagnosed me with idiopathic juvenile rheumatoid arthritis (a.k.a., Still’s disease). Since this article is supposed to be about adult-onset Still’s disease (AOSD), I should explain that children with Still’s become adults with Still’s. There is no cure and, although controversial, one school of thought suggests that AOSD and juvenile onset are one in the same. My experience suggests this is possible. Some of my earliest memories are of complaining to my parents about a recurrent rash. The faint pink rash was quickly dismissed as a “heat rash.” The benign nature of a heat rash meant there was no need to seek medical attention. In fact, it usually did not rate high enough to get out the calamine lotion. Little did anyone know at the time, the innocent looking rash was an ominous warning. At the same time, severe joint pain in my knees and hips at night was dismissed as “growing pains.” At times, relatives even insisted the pain had to be muscle cramps. When I suggested arthritis, I was told that I was too young to have arthritis. Nighttime fever spikes were thought of as something that “just happens with children.” Symptoms were repeatedly dismissed until a blood count alerted my pediatrician to a bigger problem. My blood count came back with numbers that indicated leukemia, and x-rays of my hips showed severe deformities. The results caused my local pediatrician to insist upon admission to Texas Children’s Hospital; he even arranged for the Shriners organization to cover the medical expenses. Texas Children’s Hospital followed up with an endless battery of tests. I clearly remember many of them as being very painful. However, within weeks Dr. Brewer had made a diagnosis of idiopathic juvenile rheumatoid arthritis. Although the symptoms leading to my diagnosis included elevated white counts high enough to make a pediatrician concerned about leukemia and x-rays of 22 Journal of Dermatology for Physician Assistants

my hips that caused concern for possible bone cancer, “arthritis” was the word my family and many medical professionals related to. Not even our family physician was educated about Still’s disease. Within two years, my parents discontinued medical treatment. Since I was so young, I did not understand what Dr. Brewer had said. Adult family members assumed warnings from Dr. Brewer about potential problems with my heart, eyes, ears, and other organs were simply an attempt to squeeze more money out of the diagnosis. “After all,” they would say, “arthritis does not cause those problems.” I was told, “Don’t run or your legs will hurt,” and “Don’t play; it will make your legs hurt.” My parents did not believe that the annual testing recommended by Dr. Brewer and continued medical treatments were real concerns. Pitting edema and swollen fingers were readily dismissed, even more than ten years after diagnosis. Complaints of chest pain and fatigue were dismissed as excuses and laziness. Falling asleep immediately upon my return from school was considered cute. Feeling bad after a night of spiking fever and joint pain was looked upon as

It is the mission of the International Still’s Disease Foundation, Inc. to: provide support to those who live with Still’s disease; encourage and facilitate communication between people living with, and those impacted by, Still’s disease; provide up-to-date information on Still’s disease research, treatments and related studies to those with the disease, their families, and health care professionals; and increase general awareness of Still’s disease. Contact Information: www.stillsdisease.org 1123 S. Kimbrel Ave., Panama City, FL 32404 Phone: (850) 871-6656 Fax: (850) 871-6656 Twitter: Still's Disease Fnd @StillsAndNews ISDF Blog: www.stillsdisease.org/index.php/blog/

a child being difficult. GI problems associated with Still’s were thought to be “learning difficulties.” At ten years old, to teach me responsibility and a trade, I was expected to work construction. If I tried to quit, my only recreational opportunities, fishing and camping, were not allowed. Of course, as I grew older I did learn to be a better worker. In time, when I was in remission, I could out produce the collective efforts of any three carpenters. However, every few years a flare-up would strike. During flare-ups, I could barely keep up with one carpenter, if I could keep up at all. When flare-ups hit, work productivity, relationships, and social obligations all suffered. By this time, I began blaming myself for not trying hard enough. I would push even harder. Pushing harder caused my flare-ups to escalate. As flare-ups escalated, everything suffered even more. It was no use. I could not figure it out.

lower extremities (if associated with Felty’s syndrome). Even after becoming educated about Still’s, proper testing and treatment for flare-ups is difficult. My own parents still do not understand that Still’s disease and JRA are the same. I have had licensed physicians ask, “What is Still’s disease?” On one occasion while working out of town, I began to not feel well and was unable to see my regular physician. Even with me explaining Still’s and suggesting that the new doctor look it up on the Internet, the doctor would not listen. He denied the possibility of an early stage pleural effusion and suggested that I had asthma. Within days, the flare-up was full blown. My temperature spiked to 105.8 F and breathing was nearly impossible. I could not get transportation to a medical facility for three days. When I did, the same doctor again denied the possibility of a pleural effusion due to a Still’s flare-up. Because standing chest x-rays only show pleural effusions of 300ml or greater, I asked him to repeat a chest x-ray. He refused. He insisted I was having an asthma attack. This is something I have experienced many times before I understood Still’s disease well enough to advocate for myself. I was shocked it was happening again, especially with me telling a trained physician what I was dealing with. In the following weeks, my blood pressure dropped to 60/30, pitting edema and breathing problems remained, fevers continued to spike, and acid reflux became unmanageable. I became so pale that a neighbor would frequently ask if I needed a ride to the doctor. However, my insurance (after initialization of the Affordable Care Act) would not cover a pre-existing diagnosis of Still’s. I could not afford tests that would not lead to treatment. I decided to wait until I got home to my own physician.

Nearly thirty years after my diagnosis, while attending graduate school, I had another flare-up. This time, the doctor kept uncovering autoimmune issues. I vaguely remembered that the juvenile rheumatoid arthritis diagnosis was considered to be an autoimmune disease. So, finally armed with an education and the Internet, I began researching idiopathic juvenile rheumatoid arthritis (idiopathic JRA). I discovered that idiopathic JRA is also known by several other names and is divided into two classes (juvenile onset and adult onset), all of which adds to the difficulty in locating information. Even JRA is differentiated into pauciarticular JRA, polyarticular JRA, and idiopathic (a.k.a. systemic) JRA. Idiopathic JRA is the specific subset of JRA known as Still’s. Eventually, the pieces fell into place. Still’s disease, as I learned it was called, explained every symptom of mine to the minute detail. In time, I found the International Still’s Disease Foundation (ISDF) support group. There I met others with similar stories. For example, Jamie, was not diagnosed until she was a teen, and she suffers from severe joint damage. Others were not diagnosed until they became adults. By the time I became educated about Still’s, I had gone untreated for nearly three decades. Typical symptoms of Still’s disease (e.g., pain, swelling, pitting edema, rash, fevers, etc.) were trivialized, or dismissed altogether, and were the same that I had experienced with pulmonary emboli, pleural effusions, splenomegaly, liver problems, vision problems, and critically low blood pressure. There are also Still’s related dermatological issues such as photosensitivity and possibly discoloration of the

When I arrived in my hometown, eight months later, I was recovering some. I worked construction two more months before I could save enough money to see my physician. The PA who had been involved in treating me in the past listened to my lungs and conducted a physical exam that revealed itching, bronzing and inflammation of the skin over my knees, and an enlarged liver and spleen. She immediately ordered a chest x-ray and blood chemistries. I explained I had done some web research and suspected Felty’s syndrome. I asked that she add a CBC to the blood tests, which she did. The chest x-ray indicated an enlarged heart and pulmonary infiltrates. The liver profile came back with bilirubin levels so high that the physician called me at home that evening to ask Volume 8 • number 3 • SUMMER 2014 23

CLINIC AL Dermatology

“Little did anyone know at the time, the innocent looking rash was an ominous warning.”

CLINIC AL Dermatology

me to come in the next day. The CBC came back showing neutropenia and anemia. Treatment with steroids, antiinflammatories, hydrocodone, and a newly released acid blocker helped with the symptoms, but it was months before they subsided. Treatment with methotrexate was not performed, because my physician was uncomfortable prescribing the medication. However, he did offer to refer me to a rheumatologist for treatment, but it was not something I could afford at the time. What you should learn from my story is not how Still’s disease can negatively affect one’s life, but rather remember that identifying early symptoms, making an early diagnosis, and patient/family education are critical in the management of Still’s disease. I know this is a professional audience, but my experience demands that I be blunt. That pink rash one might see on the next patient could be a sign of something devastating – even life threatening. However, the rash alone does not make a diagnosis. All factors, even those considered insignificant by patients and/or family members, need to be identified. It is up to the medical professional to ask the questions that will identify the symptoms. If a patient knows of an existing diagnosis, please listen. Once a diagnosis is made, appropriate action is imperative. J Kevin Allen holds a BA in Public Relations Journalism and a MS in Resource Interpretation. His experience with Still’s disease has led him to become an advocate for other patients with Still’s disease. He serves as the Systemic Onset Juvenile Idiopathic Arthritis (SOJIA) Representative for the International Still’s Disease Foundation (ISDF) Board of Directors. He still works construction and enjoys writing peace stories and other literary works, including a variety of Christian resources. His most successful written work was dramatized at the 2009 International Forum for Literature and Culture of Peace’s, International Peace Stories Festival in Haifa, Israel. A few of his literary works are geared toward provoking awareness and appreciation of Still’s disease.

The International Still’s Disease Foundation, Inc. (ISDF) is participating in a patient centered study led by the International Foundation for Autoimmune Arthritis. The study, funded by Janssen Global, Inc., involves a patient survey to identify early onset symptoms of five autoimmune diseases, including adultonset Still’s disease (AOSD). To participate in this study AOSD patients may go to: http://fluidsurveys.com/s/early-symptomsautoimmune-arthritis-study/. The deadline to participate in this study is August 30th, 2014.

24 Journal of Dermatology for Physician Assistants

Take Home Points for Derm PAs: By Steven K. Shama, MD, MPH, FAAD 1. When an author writes well, writes about himself and his disorder, and is a passionate advocate to educate the public on a particular disease, we should all listen. But in another sense, it really doesn't matter who is writing about his or her disorder and how eloquent he or she writes. As clinicians we should listen to all our patients when they say something doesn't make sense, something is wrong, and I'm still hurting. It took nearly one third of Kevin Allen's life for someone to make a proper diagnosis and in the mean time many other clinicians simply dismissed his symptoms as “heat rash,” “growing pains,” and the like. We must follow our patients, sometimes for years and sometimes for a lifetime, and never give up looking for that specific diagnosis amidst the seemingly nonspecific symptoms. One day it may all make sense. Never give up on your patients. Perhaps one day you'll discover a new disorder amidst a lifetime of nonspecific symptoms and signs and make that patient whole again. 2. Kevin Allen makes another excellent point. Sometimes family members can sway the clinician’s thoughts regarding a proper diagnosis. My own feeling is that the patient, no matter how young or old he/she may be, somehow knows that all is not well. Once you have found the exact diagnosis and hopefully the best treatment, there will be relief in the patient's demeanor. Until then you, as the clinician in charge, should sense that something is not complete. Keep all your senses open for what a disease, through the patient, is telling you. Only as a seasoned clinician will you know when it's time to write that proper, final prescription or when you must continue to wonder about something else you are missing.

When first-line therapy is either inappropriate or ineffective in managing mild-to-moderate eczema,

HELP BREAK THE ECZEMA CYCLE itc

• Helps manage the progression of mild-to-moderate flares1

• Significantly reduces pruritus and clears the visible signs and symptoms of eczema2* • ELIDEL is available in 30g, 60g, and 100g tubes2 • ELIDEL is not indicated for use in children less than 2 years of age or for long-term use (see Boxed Warning below)

Not an actual patient. Image for representation only.

ELIDEL (pimecrolimus) Cream 1% is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments or when those treatments are not advisable. ELIDEL Cream is not indicated for use in children less than 2 years of age.

WARNING:

Long-term Safety of Topical Calcineurin Inhibitors Has Not Been Established. Although a causal relationship has not been established, rare cases of malignancy (e.g., skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including ELIDEL Cream.

Therefore: • Continuous long-term use of topical calcineurin inhibitors, including ELIDEL Cream, in any age group should be avoided, and application limited to areas of involvement with atopic dermatitis. • ELIDEL Cream is not indicated for use in children less than 2 years of age.

IMPORTANT SAFETY INFORMATION ELIDEL Cream is contraindicated in individuals with a history of hypersensitivity to pimecrolimus or any of the components of the cream. Patients should be reevaluated by their healthcare provider if signs and symptoms of atopic dermatitis do not improve within 6 weeks. Treatment should be discontinued upon resolution of signs and symptoms (e.g., itch, rash and redness) for atopic dermatitis. Before commencing treatment with ELIDEL Cream, bacterial or viral infections at treatment sites should be resolved. The most common adverse events seen in clinical studies included application-site burning, headache, pharyngitis, nasopharyngitis, cough, influenza, pyrexia, and viral infection.

The most common local adverse event seen in clinical studies was application-site burning, which occurred in 8% to 26% of patients treated with ELIDEL Cream. In clinical studies, skin papillomas or warts were observed in 1% of ELIDEL patients. If patients have lymphadenopathy that is unresolved or of unclear etiology, discontinuation should be considered. ELIDEL Cream should not be used with occlusive dressings. ELIDEL Cream should not be applied to areas of active cutaneous infections. During the course of treatment, patients should minimize or avoid natural or artificial sunlight exposure, even while ELIDEL Cream is not on the skin. The potential effects of ELIDEL on skin response to ultraviolet damage are unknown.

*In an investigator’s global assessment, 57% of Elidel-treated patients had mild-to-no pruritus vs 34% with vehicle; 35% of ELIDEL-treated patients were rated clear or almost clear at Day 43 vs 18% with vehicle. Pooled results from two 6-week, randomized, double-blind, multicenter studies investigating the efficacy and safety of ELIDEL in pediatric patients with predominantly moderate atopic dermatitis (n=403). References: 1. Data on file, Valeant Pharmaceuticals North America LLC. 2. Elidel Cream Package Insert. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC; 2010.

Please see Brief Summary of full Prescribing Information on following pages. ELIDEL is a registered trademark of Meda Pharma S.A.R.L. and is used under license by Valeant. Except as otherwise indicated, all product names, slogans and other marks are trademarks of the Valeant family of companies. © 2014 Valeant Pharmaceuticals North America LLC DM/ELD/14/0015

Volume 8 • number 3 • SUMMER 2014 25

BRIEF SUMMARY (see package insert for Full Prescribing Information) ® (pimecrolimus) Cream 1%

Elidel

FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE. Rx Only. See WARNINGS and boxed WARNING concerning long-term safety of topical calcineurin inhibitors. CONTRAINDICATIONS ELIDEL (pimecrolimus) Cream 1% is contraindicated in individuals with a history of hypersensitivity to pimecrolimus or any of the components of the cream. WARNINGS WARNING Long-term Safety of Topical Calcineurin Inhibitors Has Not Been Established Although a causal relationship has not been established, rare cases of malignancy (e.g., skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including ELIDEL Cream. Therefore: • Continuous long-term use of topical calcineurin inhibitors, including ELIDEL Cream, in any age group should be avoided, and application limited to areas of involvement with atopic dermatitis. • ELIDEL Cream is not indicated for use in children less than 2 years of age. Prolonged systemic use of calcineurin inhibitors for sustained immunosuppression in animal studies and transplant patients following systemic administration has been associated with an increased risk of infections, lymphomas, and skin malignancies. These risks are associated with the intensity and duration of immunosuppression. Based on this information and the mechanism of action, there is a concern about a potential risk with the use of topical calcineurin inhibitors, including ELIDEL Cream. While a causal relationship has not been established, rare cases of skin malignancy and lymphoma have been reported in patients treated with topical calcineurin inhibitors, including ELIDEL Cream. Therefore: • ELIDEL Cream should not be used in immunocompromised adults and children. • If signs and symptoms of atopic dermatitis do not improve within 6 weeks, patients should be re-examined by their healthcare provider and their diagnosis be confirmed (see PRECAUTIONS). • The safety of ELIDEL Cream has not been established beyond one year of non-continuous use. (See CLINICAL PHARMACOLOGY, WARNINGS, boxed WARNING, PRECAUTIONS, INDICATIONS AND USAGE, and DOSAGE AND ADMINISTRATION.) PRECAUTIONS General: The use of ELIDEL Cream should be avoided on malignant or pre-malignant skin conditions. Malignant or pre-malignant skin conditions, such as cutaneous T-cell lymphoma (CTCL), can present as dermatitis. ELIDEL Cream should not be used in patients with Netherton’s Syndrome or other skin diseases where there is the potential for increased systemic absorption of pimecrolimus. The safety of ELIDEL Cream has not been established in patients with generalized erythroderma. The use of ELIDEL Cream may cause local symptoms such as skin burning (burning sensation, stinging, soreness) or pruritus. Localized symptoms are most common during the first few days of ELIDEL Cream application and typically improve as the lesions of atopic dermatitis resolve (see ADVERSE REACTIONS). Bacterial and Viral Skin Infections: Before commencing treatment with ELIDEL Cream, bacterial or viral infections at treatment sites should be resolved. Studies have not evaluated the safety and efficacy of ELIDEL Cream in the treatment of clinically infected atopic dermatitis. While patients with atopic dermatitis are predisposed to superficial skin infections including eczema herpeticum (Kaposi’s varicelliform eruption), treatment with ELIDEL Cream may be independently associated with an increased risk of varicella zoster virus infection (chicken pox or shingles), herpes simplex virus infection, or eczema herpeticum. In clinical studies, 15/1,544 (1%) cases of skin papilloma (warts) were observed in patients using ELIDEL Cream. The youngest patient was age 2 and the oldest was age 12. In cases where there is worsening of skin papillomas or they do not respond to conventional therapy, discontinuation of ELIDEL Cream should be considered until complete resolution of the warts is achieved. Patients with Lymphadenopathy: In clinical studies, 14/1,544 (0.9%) cases of lymphadenopathy were reported while using ELIDEL Cream. These cases of lymphadenopathy were usually related to infections and noted to resolve upon appropriate antibiotic therapy. Of these 14 cases, the majority had either a clear etiology or were known to resolve. Patients who receive ELIDEL Cream and who develop lymphadenopathy should have the etiology of their lymphadenopathy investigated. In the absence of a clear etiology for the lymphadenopathy, or in the presence of acute infectious mononucleosis, ELIDEL Cream should be discontinued. Patients who develop lymphadenopathy should be monitored to ensure that the lymphadenopathy resolves. Sun Exposure: During the course of treatment, it is prudent for patients to minimize or avoid natural or artificial sunlight exposure, even while ELIDEL is not on the skin. The potential effects of ELIDEL Cream on skin response to ultraviolet damage are not known. Immunocompromised Patients: The safety and efficacy of ELIDEL Cream in immunocompromised patients have not been studied. Information for Patients (See Medication Guide.) Drug Interactions: Potential interactions between ELIDEL and other drugs, including immunizations, have not been systematically evaluated. Due to low blood levels of pimecrolimus detected in some patients after topical application, systemic drug interactions are not expected, but cannot be ruled out. The concomitant administration of known CYP3A family of inhibitors in patients with widespread and/or erythrodermic disease should be done with caution. Some examples of such drugs are erythromycin, itraconazole, ketoconazole, fluconazole, calcium channel blockers and cimetidine. Carcinogenesis, Mutagenesis, Impairment of Fertility: In a 2-year rat dermal carcinogenicity study using ELIDEL Cream, a statistically significant increase in the incidence of follicular cell adenoma of the thyroid was noted in low, mid and high dose male

26 Journal of Dermatology for Physician Assistants

animals compared to vehicle and saline control male animals. Follicular cell adenoma of the thyroid was noted in the dermal rat carcinogenicity study at the lowest dose of 2 mg/kg/day [0.2% pimecrolimus cream; 1.5× the Maximum Recommended Human Dose (MRHD) based on AUC comparisons]. No increase in the incidence of follicular cell adenoma of the thyroid was noted in the oral carcinogenicity study in male rats up to 10 mg/kg/day (66× MRHD based on AUC comparisons). However, oral studies may not reflect continuous exposure or the same metabolic profile as by the dermal route. In a mouse dermal carcinogenicity study using pimecrolimus in an ethanolic solution, no increase in incidence of neoplasms was observed in the skin or other organs up to the highest dose of 4 mg/kg/day (0.32% pimecrolimus in ethanol) 27x MRHD based on AUC comparisons. However, lymphoproliferative changes (including lymphoma) were noted in a 13 week repeat dose dermal toxicity study conducted in mice using pimecrolimus in an ethanolic solution at a dose of 25 mg/kg/day (47x MRHD based on AUC comparisons). No lymphoproliferative changes were noted in this study at a dose of 10 mg/kg/day (17x MRHD based on AUC comparison). However, the latency time to lymphoma formation was shortened to 8 weeks after dermal administration of pimecrolimus dissolved in ethanol at a dose of 100 mg/kg/day (179-217x MRHD based on AUC comparisons). In a mouse oral (gavage) carcinogenicity study, a statistically significant increase in the incidence of lymphoma was noted in high dose male and female animals compared to vehicle control male and female animals. Lymphomas were noted in the oral mouse carcinogenicity study at a dose of 45 mg/kg/day (258-340x MRHD based on AUC comparisons). No drugrelated tumors were noted in the mouse oral carcinogenicity study at a dose of 15 mg/kg/day (60-133x MRHD based on AUC comparisons). In an oral (gavage) rat carcinogenicity study, a statistically significant increase in the incidence of benign thymoma was noted in 10 mg/kg/day pimecrolimus treated male and female animals compared to vehicle control treated male and female animals. In addition, a significant increase in the incidence of benign thymoma was noted in another oral (gavage) rat carcinogenicity study in 5 mg/kg/day pimecrolimus treated male animals compared to vehicle control treated male animals. No drug-related tumors were noted in the rat based on AUC comparisons) and at a dose of 5 mg/kg/day for female animals (21x MRHD based on AUC comparisons). In a 52-week dermal photo-carcinogenicity study, the median time to onset of skin tumor formation was decreased in hairless mice following chronic topical dosing with concurrent exposure to UV radiation (40 weeks of treatment followed by 12 weeks of observation) with the ELIDEL Cream vehicle alone. No additional effect on tumor development beyond the vehicle effect was noted with the addition of the active ingredient, pimecrolimus, to the vehicle cream. A 39-week oral monkey toxicology study was conducted with pimecrolimus doses of 15, 45 and 120 mg/kg/day. A dose dependent increase in expression of immunosuppressive-related lymphoproliferative disorder (IRLD) associated with lymphocryptovirus (a monkey strain of virus related to human Epstein Barr virus) was observed. IRLD in monkeys mirrors what has been noted in human transplant patients after chronic systemic immunosuppressive therapy, post transplantation lymphoproliferative disease (PTLD), after treatment with chronic systemic immunosuppressive therapy. Both IRLD and PTLD can progress to lymphoma, which is dependent on the dose and duration of systemic immunosuppressive therapy. A dose dependent increase in opportunistic infections (a signal of systemic immunosuppression) was also noted in this monkey study. An oral fertility and embryofetal developmental study in rats revealed estrus cycle disturbances, post-implantation loss and reduction in litter size at the 45 mg/kg/day dose (38× MRHD based on AUC comparisons). No effect on fertility in female rats was noted at 10 mg/kg/day (12× MRHD based on AUC comparisons). No effect on fertility in male rats was noted at 45 mg/kg/day (23× MRHD based on AUC comparisons), which was the highest dose tested in this study (see full Prescribing Information for additional Carcinogenesis, Mutagenesis and Impairment of Fertility data). Pregnancy Teratogenic Effects Pregnancy Category C: There are no adequate and well-controlled studies of topically administered pimecrolimus in pregnant women. The experience with ELIDEL Cream when used by pregnant women is too limited to permit assessment of the safety of its use during pregnancy. Pimecrolimus was transferred across the placenta in oral rat and rabbit embryofetal developmental studies. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used only if clearly needed during pregnancy. Nursing Mothers: It is not known whether this drug is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from pimecrolimus, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use: ELIDEL Cream is not indicated for use in children less than 2 years of age. The long-term safety and effects of ELIDEL Cream on the developing immune system are unknown (see WARNINGS, boxed WARNING, and INDICATIONS AND USAGE). Three Phase 3 pediatric studies were conducted involving 1,114 patients 2-17 years of age. Two studies were 6-week randomized vehicle-controlled studies with a 20-week openlabel phase and one was a vehicle-controlled (up to 1 year) safety study with the option for sequential topical corticosteroid use. Of these patients 542 (49%) were 2-6 years of age. In the short-term studies, 11% of ELIDEL patients did not complete these studies and 1.5% of ELIDEL patients discontinued due to adverse events. In the one-year study, 32% of ELIDEL patients did not complete this study and 3% of ELIDEL patients discontinued due to adverse events. Most discontinuations were due to unsatisfactory therapeutic effect. The most common local adverse event in the short-term studies of ELIDEL Cream in pediatric patients ages 2-17 was application site burning (10% vs. 13% vehicle); the incidence in the long-term study was 9% ELIDEL vs. 7% vehicle (see ADVERSE REACTIONS). Adverse events that were more frequent (>5%) in patients treated with ELIDEL Cream compared to vehicle were headache (14% vs. 9%) in the short-term trial. Nasopharyngitis (26% vs. 21%), influenza (13% vs. 4%), pharyngitis (8% vs. 3%), viral infection (7% vs. 1%), pyrexia (13% vs. 5%), cough (16% vs. 11%), and headache (25% vs. 16%) were increased over vehicle in the 1-year safety study (see ADVERSE REACTIONS). In 843 patients ages 2-17 years treated with ELIDEL Cream, 9 (0.8%) developed eczema herpeticum (5 on ELIDEL Cream alone and 4 on ELIDEL Cream used in sequence with corticosteroids). In 211 patients on vehicle alone, there were no cases of eczema herpeticum. The majority of adverse events were mild to moderate in severity.

Two Phase 3 studies were conducted involving 436 infants age 3 months-23 months. One 6-week randomized vehicle-controlled study with a 20-week open-label phase and one safety study, up to one year, were conducted. In the 6-week study, 11% of ELIDEL and 48% of vehicle patients did not complete this study; no patient in either group discontinued due to adverse events. Infants on ELIDEL Cream had an increased incidence of some adverse events compared to vehicle. In the 6-week vehicle-controlled study these adverse events included pyrexia (32% vs. 13% vehicle), URI (24% vs. 14%), nasopharyngitis (15% vs. 8%), gastroenteritis (7% vs. 3%), otitis media (4% vs. 0%), and diarrhea (8% vs. 0%). In the open-label phase of the study, for infants who switched to ELIDEL Cream from vehicle, the incidence of the above-cited adverse events approached or equaled the incidence of those patients who remained on ELIDEL Cream. In the 6 month safety data, 16% of ELIDEL and 35% of vehicle patients discontinued early and 1.5% of ELIDEL and 0% of vehicle patients discontinued due to adverse events. Infants on ELIDEL Cream had a greater incidence of some adverse events as compared to vehicle. These included pyrexia (30% vs. 20%), URI (21% vs. 17%), cough (15% vs. 9%), hypersensitivity (8% vs. 2%), teething (27% vs. 22%), vomiting (9% vs. 4%), rhinitis (13% vs. 9%), viral rash (4% vs. 0%), rhinorrhea (4% vs. 0%), and wheezing (4% vs. 0%). Geriatric Use: Nine (9) patients ≥65 years old received ELIDEL Cream in Phase 3 studies. Clinical studies of ELIDEL did not include sufficient numbers of patients aged 65 and over to assess efficacy and safety. ADVERSE REACTIONS No phototoxicity and no photoallergenicity were detected in clinical studies with 24 and 33 normal volunteers, respectively. In human dermal safety studies, ELIDEL (pimecrolimus) Cream 1% did not induce contact sensitization or cumulative irritation. In a one-year safety study in pediatric patients age 2-17 years old involving sequential use of ELIDEL Cream and a topical corticosteroid, 43% of ELIDEL patients and 68% of vehicle patients used corticosteroids during the study. Corticosteroids were used for more than 7 days by 34% of ELIDEL patients and 54% of vehicle patients. An increased incidence of impetigo, skin infection, superinfection (infected atopic dermatitis), rhinitis, and urticaria were found in the patients that had used ELIDEL Cream and topical corticosteroid sequentially as compared to ELIDEL Cream alone. In 3 randomized, double-blind vehicle-controlled pediatric studies and one active-controlled adult study, 843 and 328 patients respectively, were treated with ELIDEL Cream. In these clinical trials, 48 (4%) of the 1,171 ELIDEL patients and 13 (3%) of 408 vehicle-treated patients discontinued therapy due to adverse events. Discontinuations for AEs were primarily due to application site reactions, and cutaneous infections. The most common application site reaction was application site burning, which occurred in 8%-26% of patients treated with ELIDEL Cream. The following table depicts the incidence of adverse events pooled across the 2 identically designed 6-week studies with their open label extensions and the 1-year safety study for pediatric patients ages 2-17. Data from the adult active-controlled study is also included in this table. Adverse events are listed regardless of relationship to study drug. Two cases of septic arthritis have been reported in infants less than one year of age in clinical trials conducted with ELIDEL Cream (n = 2,443). Causality has not been established. Treatment Emergent Adverse Events ( ≥1%) Pediatric Pediatric Patients* Patients* Vehicle-Controlled Open-Label (20 (6 Weeks) (1 Year) Weeks) Elidel Elidel Elidel Elidel Elidel Cream Cream Cream Cream Cream (N=267) (N=136) (N=335) (N=272) (N=75) % % % % % At Least 1 AE 68 71 72 85 75 Infections and Infestations Upper Respiratory 14 13 19 5 8 Tract Infection NOS Nasopharyngitis 10 7 20 27 21 Skin Infection NOS 3 5 5 2 4 Influenza 3 1 7 13 4 Ear Infection NOS 3 5 5 2 4 Otitis Media 2 1 3 3 5 Impetigo 2 2 4 4 5 Bacterial Infection 2 2 1 1 0 Folliculitis 1 1 1 2 4 Sinusitis 1 1 3 2 1 Pneumonia NOS 1 1 2 0 1 Pharyngitis NOS 1 2 1 8 3 Pharyngitis 1 2 3 0 <1 Streptococcal Molluscum 1 0 1 2 0 Contagiosum Staphylococcal <1 4 2 0 <1 Infection Bronchitis NOS <1 2 1 11 8 Herpes Simplex <1 0 1 3 3 Tonsillitis NOS <1 0 1 6 0 Viral Infection NOS 1 1 <1 7 1 Gastroenteritis NOS 0 2 1 7 3 Chickenpox 1 0 1 3 4 Skin Papilloma <1 0 1 3 <1 Tonsillitis Acute NOS 0 0 0 3 0 Pediatric Patients* Vehicle-Controlled

*Ages 2-17 years

Adult Active Comparator (1 Year) Elidel Cream (N=328) % 78 4 8 6 10 6 1 2 2 6 1 <1 1 0 0 1 2 4 1 0 2 <1 0 0

Upper Respiratory Tract <1 0 1 Infection Viral NOS Herpes Simplex 0 0 <1 Dermatitis Bronchitis Acute NOS 0 0 0 Eye Infection NOS 0 0 0 General Disorders and Administration Site Conditions Application Site 10 13 2 Burning Pyrexia 8 9 12 Application Site 3 5 2 Reaction NOS Application Site 3 6 1 Irritation Influenza Like Illness <1 0 1 Application Site <1 0 0 Erythema Application Site 1 2 1 Pruritus Respiratory, Thoracic and Mediastinal Disorders Cough 12 8 9 Nasal Congestion 3 2 2 Rhinorrhea 2 1 1 Asthma Aggravated 2 2 4 Sinus Congestion 1 1 1 Rhinitis <1 0 2 Wheezing <1 1 1 Asthma NOS 1 1 3 Epistaxis 0 1 0 Dyspnea NOS 0 0 0 Gastrointestinal Disorders Abdominal Pain Upper 4 4 3 Sore Throat 3 4 5 Vomiting NOS 3 4 4 Diarrhea NOS 1 1 1 Nausea <1 2 1 Abdominal Pain NOS <1 1 2 Toothache <1 1 1 Constipation <1 0 1 Loose Stools 0 1 1 Reproductive System and Breast Disorders Dysmenorrhea 1 0 2 Eye Disorders Conjunctivitis NEC 1 1 2 Skin and Subcutaneous Tissue Disorders Urticaria 1 0 <1 Acne NOS 0 1 <1 Immune System Disorders Hypersensitivity NOS 4 4 5 Injury and Poisoning Accident NOS 1 1 <1 Laceration 1 1 2 Musculoskeletal, Connective Tissue and Bone Disorders Back Pain <1 2 <1 Arthralgias 0 0 <1 Ear and Labyrinth Disorders Earache 1 1 0 Nervous System Disorders Headache 14 9 11

2 1

0 <1

16 2 <1 1 <1 4 1 4 3 2

11 1 1 1 <1 7 <1 3 1 1

2 1 0 0 1 2 0 2 <1 1

6 8 7 8 4 4 3 4 <1

7 5 8 5 7 4 1 <1 <1

<1 4 1 2 2 <1 1 0 0

<1 2

<1 <1

1 2

<1 <1

1 <1

0 0

<1 1

0 1

2 2

*Ages 2-17 years

POST-MARKETING EVENTS The following adverse reactions have been reported in patients using ELIDEL Cream. 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. General: Anaphylactic reactions, ocular irritation after application of the cream to the eye lids or near the eyes, angioneurotic edema, facial edema, skin flushing associated with alcohol use, skin discoloration Hematology/Oncology: Lymphomas, basal cell carcinoma, malignant melanoma, squamous cell carcinoma OVERDOSAGE There has been no experience of overdose with ELIDEL (pimecrolimus) Cream 1%. If oral ingestion occurs, medical advice should be sought. Manufactured by: Novartis Pharma Produktions GmbH Wehr, Germany Distributed by: Valeant Pharmaceuticals North America, LLC. Bridgewater, NJ 08807 REV. 02/2014 (based on #2079799 06/11) DM/ELD/14/0010(1)

Volume 8 • number 3 • SUMMER 2014 27

Dermoscopy Dermoscopic Notes from the 2013 American Dermoscopy Meeting By John Burns, MSPA, PA-C

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CLINIC AL Dermatology

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Figure A

Figure B

28 Journal of Dermatology for Physician Assistants

John Burns, MSPA, PA-C is a graduate of the Physician Assistant Program at Louisiana State University Health Science Center Shreveport, LA. He completed his fellowship training in dermatology at University of Texas Southwestern Medical Center, Dallas, TX from 2007 to 2008 and is a Diplomate of the SDPA. He presently resides in Vancouver, Washington where he works in dermatology at the Vancouver Clinic with Dr. Benjamin Vazquez. He has indicated no relationships to disclose relating to the content of this article.

Author of the best-seller, The How of Happiness and the more recent, The Myths of Happiness In her keynote, Dr. Lyubomirsky will share some of her research - on the possibility of permanently increasing happiness. Her research has been honored with numerous grants, including a million dollar grant from NIMH. Register Today at www.dermpa.org Volume 8 â&#x20AC;˘ number 3 â&#x20AC;˘ SUMMER 2014 29

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Dermatology Case Report

Adult-Onset Stillâ&#x20AC;&#x2122;s Disease By Sara M. Wilchowski, MS, PA-C and David Altman, MD

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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

Figure 2

30 Journal of Dermatology for Physician Assistants

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Sara M. Wilchowski, MS, PA-C completed her undergraduate studies at Eastern Michigan University. She went on to complete her physician assistant studies and master's degree at Wayne State University in 2012 and has been practicing in dermatology ever since. She has indicated no relationships to disclose relating to the content of this article. David Altman, MD graduated from the University of Michigan Medical School and completed his residency at Henry Ford Hospital in Detroit, Michigan. He has been practicing dermatology for over 20 years and is a clinical professor at Michigan State University and the St. Joseph Residency program. He has indicated no relationships to disclose relating to the content of this article.

Volume 8 • number 3 • SUMMER 2014 31

CLINIC AL Dermatology

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

Clinical snapshots Lichen Sclerosus et Atrophicus

Classic Genital Presentation In Adult Females By Jennifer McCarren, MPA, PA-C and Travis Hayden, MPAS, PA-C

Figure A - Lichen sclerosus demonstrating white, hypopigmented plaques with atrophic skin involving the vulva.

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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.

This image is the property of the ASCCP & ISSVD Image Data Bank and is reprinted with their permission. ÂŠAmerican Society for Colposcopy and Cervical Pathology 2012. No copies of the image shall be made without the prior written consent of ASCCP.

Figure B - Lichen sclerosus demonstrating a characteristic figure-8, hourglass, or butterfly pattern involving the vulvar and perianal areas.

...continued on page 35 32 Journal of Dermatology for Physician Assistants

Image used courtesy of Jeffrey Meffert, MD, University of Texas School of Medicine at San Antonio, published by Medscape Reference (http://emedicine.medscape.com/), 2013, and available at: http://emedicine.medscape.com/ article/1123316-overview.

Once-a-day

Efficacy Tough on acne • Proven effective in the treatment of both inflammatory and noninflammatory lesions1 • 2.5% benzoyl peroxide (BPO) concentration exceeds the activity needed to inhibit P acnes growth2

With tolerance and convenience in mind Acanya (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/2.5%, is indicated for the topical treatment of acne vulgaris in patients 12 years or older.

• Contains no preservatives, parabens, or surfactants1 • Less than 0.2% of patients experienced cutaneous irritation1 • Use concomitant topical acne medications with caution due to the risk of cumulative irritancy • Available in a ready-to-use, premixed, 50g pump1

Important Safety Information • Acanya 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. Acanya Gel should be discontinued if significant diarrhea occurs.

• The most common local adverse reactions experienced by patients in clinical trials were mild and moderate erythema, scaling, itching, burning, and stinging. • Acanya Gel should not be used in combination with erythromycincontaining products because of its clindamycin component. • Use of Acanya Gel beyond 12 weeks has not been evaluated.

• Orally and parenterally administered clindamycin has been associated with severe colitis, which may result in death.

• Patients should be advised to avoid contact with the eyes or mucous membranes.

• 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, he or she should be instructed to discontinue use and contact a physician immediately.

• Patients should minimize exposure to natural and avoid artificial sunlight (tanning beds or UVA/UVB treatment) while using Acanya Gel. To minimize exposure to sunlight, protective clothing should be worn and a sunscreen with SPF 15 rating or higher should be used.

References: 1. Acanya Gel Package Insert. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC; 2013. 2. Data on file, Dow Pharmaceutical Sciences, Inc.

Please see Brief Summary of full Prescribing Information on following page. Except as otherwise indicated, all product names, slogans and other marks are trademarks of the Valeant family of companies. © 2014 Valeant Pharmaceuticals North America LLC DM/ACY/14/0012

Volume 8 • number 3 • SUMMER 2014 33

BRIEF SUMMARY OF FULL PRESCRIBING INFORMATION This Brief Summary does not include all the information needed to use ACANYA Gel safely and effectively. See full prescribing information for ACANYA Gel. ACANYA速 (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/2.5%, for topical use Initial U.S. Approval: 2000

Revised: 02/2014 CONTRAINDICATIONS ACANYA Gel is contraindicated in patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis. WARNINGS AND PRECAUTIONS Colitis 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. When significant diarrhea occurs, ACANYA 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 antibioticassociated 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. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against C. difficile colitis. Ultraviolet Light and Environmental Exposure Minimize sun exposure including use of tanning beds or sun lamps following drug application [see Nonclinical Toxicology]. ADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under prescribed conditions, adverse reaction rates observed in the clinical trial may not reflect the rates observed in practice. Because clinical trials are also conducted under widely varying conditions, adverse reactions observed in the clinical trials of a drug cannot always be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following selected adverse reactions occurred in less than 0.2% of patients treated with ACANYA Gel: application site pain (0.1%); application site exfoliation (0.1%); and application site irritation (0.1%). During clinical trials, subjects were assessed for local cutaneous signs and symptoms of erythema, scaling, itching, burning and stinging. Most local skin reactions increased and peaked around week 4 and continually decreased over time, reaching near baseline levels by week 12. The percentage of subjects that had symptoms present before treatment, the maximum value recorded 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. Combined Results from the Two Phase 3 Trials (N = 773) Before Treatment (Baseline) Mild

Mod.* Severe

Maximum During Treatment Mild

Mod.* Severe

End of Treatment (Week 12) Mild

Mod.* Severe

Erythema

Scaling

Itching

Burning

Stinging

*Mod. = Moderate

Postmarketing Experience Anaphylaxis, as well as allergic reactions leading to hospitalizations, has been reported in postmarketing use of products containing clindamycin/benzoyl peroxide. 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 Erythromycin ACANYA Gel should not be used 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. Neuromuscular Blocking Agents Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, ACANYA Gel should be used with caution in patients receiving such agents.

34 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 ACANYA Gel. ACANYA 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 ACANYA 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 ACANYA 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 ACANYA Gel while nursing, taking into account the importance of the drug to the mother. Pediatric Use Safety and effectiveness of ACANYA Gel in pediatric patients under the age of 12 have not been evaluated. Geriatric Use Clinical trials of ACANYA 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 ACANYA 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 15,000 mg/kg/day (1.8, 5.4, and 30 times amount of clindamycin and 3.6, 10.8, and 60 times amount of benzoyl peroxide in the highest recommended adult human dose of 2.5 g ACANYA 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 dosedependent 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 2.4, 7.2, and 24 times amount of benzoyl peroxide in the highest recommended adult human dose of 2.5 g ACANYA 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 10,000 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 ACANYA 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 ACANYA 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 Rev. 02/2014 DM/ACY/14/0016(1)

2006787 9379500

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Jennifer McCarren, MPA, PA-C has been practicing dermatology since receiving her Master’s degree from Duquesne University in 2001. She presently resides in Georgia where she works with Dr. Frances T. Florentino at Evans Dermatology. She has indicated no relationships to disclose relating to the content of this article. Travis Hayden, MPAS, PA-C graduated from the Sisters of Charity Medical Center Physician Assistant Program in 1998. He then proudly served in the U.S. Navy, working in military and family medicine and completed his Masters Degree in Physician Assistant Studies from the University of Nebraska. He presently resides in upstate New York where he has enjoyed practicing dermatology since 2003 at Dermatology Associates of Rochester. He is an adjunct instructor and preceptor for both Le Moyne College Physician Assistant Program and SUNY Upstate Medical University Department of Physician Assistant Studies. He has indicated no relationships to disclose relating to the content of this article.

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

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

Volume 8 • number 3 • SUMMER 2014 35

CLINIC AL Dermatology

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Simulated image based on locally advanced BCC patient at Week 24.

BOXED WARNING AND ADDITIONAL IMPORTANT SAFETY INFORMATION Embryo-Fetal Death and Severe Birth Defects • Erivedge capsule can cause fetal harm when administered to a pregnant woman based on its mechanism of action • Verify pregnancy status prior to the initiation of Erivedge. Advise male and female patients of these risks. Advise female patients of the need for contraception during and after treatment and advise male patients of the potential risk of Erivedge exposure through semen • Advise patients to contact their healthcare provider immediately if they suspect they (or, for males, their female partner) may be pregnant 36 Journal of Dermatology for Physician Assistants

• Immediately report exposure to Erivedge during pregnancy and encourage women who may have been exposed to Erivedge during pregnancy, either directly or through seminal fluid, to participate in the Erivedge pregnancy pharmacovigilance program by contacting the Genentech Adverse Event Line at (888) 835-2555 Blood Donation • Advise patients not to donate blood or blood products while receiving Erivedge and for at least 7 months after the last dose of Erivedge Nursing Mothers • Inform female patients of the potential for serious adverse reactions in nursing infants from Erivedge, taking into account the importance of the drug to the mother

TRANSFORM THE TREATMENT OF ADVANCED BASAL CELL CARCINOMA ((aBCC) ERIVEDGE IS A UNIQUE ORAL THERAPY (Not actual size)

• Due to the nature of aBCC and its clinical factors (ie, lesion recurrence, location/size, and invasiveness) some patients may not be candidates for surgery or radiation1,2 • Erivedge is an oral treatment option dosed as a 150-mg capsule once daily until disease progression or unacceptable toxicity3 • Erivedge reduced lesions in patients with aBCC1,3 Objective response rates (ORR) by IR from ERIVANCE1,3* ORR (95% CI)

laBCC (n=63)

mBCC (n=33)

43% (n=27) (30.5-56.0)

30% (n=10) (15.6-48.2)

Complete response

21% (n=13)

Partial response

22% (n=14)

30% (n=10)

7.6 (5.7-9.7)

7.6 (5.6-NE)

Median duration of response (months) (95% CI)

Indication Erivedge® (vismodegib) capsule is a hedgehog pathway inhibitor indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation. *Patients received at least 1 dose of Erivedge with independent pathologist-confirmed diagnosis of BCC. Locally advanced BCC patients were considered responders if they did not experience progression and had ≥30% reduction in lesion size (sum of the longest diameter) from baseline in target lesions by radiography or in externally visible dimension of target lesions (scar tissue was measured); or had complete resolution of ulceration in all target lesions. Complete response was objective response with no residual BCC on sampling biopsy. Partial response was objective response with presence of residual BCC on sampling biopsy. In the metastatic BCC cohort, response was assessed according to RECIST version 1.0. Complete response was disappearance of all target and nontarget lesions. Partial response was ≥30% decrease in SLD of target lesions from baseline. IR=Independent Review; laBCC=locally advanced BCC; ORR=objective response rate; CI=confidence interval; NE=not estimable; mBCC=metastatic BCC; RECIST=Response Evaluation Criteria in Solid Tumors; SLD=sum of the longest diameter.

Adverse Reactions • The most common adverse reactions (≥10%) were muscle spasms, alopecia, dysgeusia, weight loss, fatigue, nausea, diarrhea, decreased appetite, constipation, arthralgias, vomiting, and ageusia • In clinical trials, a total of 3 of 10 premenopausal women developed amenorrhea while receiving Erivedge • Treatment-emergent grade 3 laboratory abnormalities observed in clinical trials were hyponatremia in 6 patients (4%), hypokalemia in 2 patients (1%), and azotemia in 3 patients (2%) You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555. Please see Brief Summary of Prescribing Information on following page.

See what you can offer your patients with aBCC at www.Erivedge.com References: 1. Sekulic A, Migden MR, Oro AE, et al. N Engl J Med. 2012;366:2171-2179. 2. Walling HW, et al. Cancer Metastasis Rev. 2004;23:389-402. 3. Erivedge® (vismodegib) capsule Prescribing Information. Genentech, Inc. January 2012. © 2014 Genentech USA, Inc. All rights reserved. 05/14 HED0001655401 Printed in USA.

Volume 8 • number 3 • SUMMER 2014 37

Safety:7" Table 1: Adverse Reactions Occurring in ≥ 10% of Advanced BCC Patients (cont)

MedDRA Preferred Term2 Metabolism and nutrition disorders Decreased appetite Musculoskeletal and connective tissue disorders Muscle spasms Arthralgias Nervous system disorders Dysgeusia Ageusia Skin and subcutaneous tissue disorders Alopecia

ERIVEDGE (vismodegib) capsule Initial U.S. Approval: 2012 This is a brief summary of information about ERIVEDGE. Before prescribing, please see full prescribing information. WARNING: EMBRYO-FETAL DEATH AND SEVERE BIRTH DEFECTS ERIVEDGE (vismodegib) capsule can result in embryo-fetal death or severe birth defects. ERIVEDGE is embryotoxic and teratogenic in animals. Teratogenic effects included severe midline defects, missing digits, and other irreversible malformations. Verify pregnancy status prior to the initiation of ERIVEDGE. Advise male and female patients of these risks. Advise female patients of the need for contraception and advise male patients of the potential risk of ERIVEDGE exposure through semen [see Warnings and Precautions (5.1), Use in Specific Populations (8.1, 8.6)].

All aBCC1 Patients (N = 138) MedDRA Preferred Term2 Gastrointestinal disorders Nausea Diarrhea Constipation Vomiting General disorders and administration site conditions Fatigue Investigations Weight loss

All Grades 3 (%)

Grade 3 (%)

Grade 4 (%)

42 (30.4%) 40 (29.0%) 29 (21.0%) 19 (13.8%)

1 (0.7%) 1 (0.7%) -

55 (39.9%)

7 (5.1%)

1 (0.7%)

62 (44.9%)

10 (7.2%)

35 (25.4%)

3 (2.2%)

99 (71.7%) 22 (15.9%)

5 (3.6%) 1 (0.7%)

76 (55.1%) 15 (10.9%)

88 (63.8%)

aBCC = Advanced Basal Cell Carcinoma. MedDRA = Medical Dictionary for Regulatory Activities. 3 Grading according to NCI-CTCAE v3.0. Amenorrhea: In clinical trials, a total of 3 of 10 pre-menopausal women developed amenorrhea while receiving ERIVEDGE [see Non-Clinical Toxicology (13.1)]. Laboratory Abnormalities: Treatment-emergent Grade 3 laboratory abnormalities observed in clinical trials were hyponatremia in 6 patients (4%), hypokalemia in 2 patients (1%), and azotemia in 3 patients (2%). 1 2

7 DRUG INTERACTIONS 7.1 Effects of Other Drugs on Vismodegib Drugs that Inhibit or Induce Drug Metabolizing Enzymes Vismodegib elimination involves multiple pathways. Vismodegib is predominantly excreted as an unchanged drug. Several minor metabolites are produced by multiple CYP enzymes. Although vismodegib is a substrate of CYP2C9 and CYP3A4 in vitro, CYP inhibition is not predicted to alter vismodegib systemic exposure since similar steady-state plasma vismodegib concentrations were observed in patients in clinical trials concomitantly treated with CYP3A4 inducers (i.e., carbamazepine, modafinil, phenobarbital) and those concomitantly treated with CYP3A4 inhibitors (i.e., erythromycin, fluconazole). Drugs that Inhibit Drug Transport Systems In vitro studies indicate that vismodegib is a substrate of the efflux transporter P-glycoprotein (P-gp). When ERIVEDGE is coadministered with drugs that inhibit P-gp (e.g. clarithromycin, erythromycin, azithromycin), systemic exposure of vismodegib and incidence of adverse events of ERIVEDGE may be increased. Drugs that Affect Gastric pH Drugs that alter the pH of the upper GI tract (e.g. proton pump inhibitors, H2-receptor antagonists, and antacids) may alter the solubility of vismodegib and reduce its bioavailability. However, no formal clinical study has been conducted to evaluate the effect of gastric pH altering agents on the systemic exposure of vismodegib. Increasing the dose of ERIVEDGE when coadministered with such agents is not likely to compensate for the loss of exposure. When ERIVEDGE is coadministered with a proton pump inhibitor, H2-receptor antagonist or antacid, systemic exposure of vismodegib may be decreased and the effect on efficacy of ERIVEDGE is unknown. 7.2 Effects of Vismodegib on Other Drugs Results of a drug-drug interaction study conducted in cancer patients demonstrated that the systemic exposure of rosiglitazone (a CYP2C8 substrate) or oral contraceptives (ethinyl estradiol and norethindrone) is not altered when either drug is co-administered with vismodegib. In vitro studies indicate that vismodegib is an inhibitor of CYP2C8, CYP2C9, CYP2C19 and the transporter BCRP. Vismodegib does not induce CYP1A2, CYP2B6, or CYP3A4/5 in human hepatocytes. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category D ERIVEDGE capsule can cause fetal harm when administered to a pregnant female based on its mechanism of action. Vismodegib is teratogenic in rats at doses corresponding to an exposure of 20% of the exposure at the recommended human dose (estimated AUC 0-24hr steady-state exposure). In rats, malformations included craniofacial anomalies, open perineum, and absent or fused digits. Fetal retardations and variations were also observed. Vismodegib is embryolethal in rats at exposures within the range achieved at the recommended human dose. If ERIVEDGE is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the embryo or fetus. Report immediately exposure to ERIVEDGE during pregnancy to the Genentech Adverse Event Line at 1-888-835-2555. Encourage women who may have been exposed to ERIVEDGE during pregnancy, either directly or through seminal fluid, to participate in the ERIVEDGE pregnancy pharmacovigilance program by contacting the Genentech Adverse Event Line at 1-888-835-2555 [see Boxed Warning, Warnings and Precautions (5.1)]. In an embryo-fetal developmental toxicity study, pregnant rats were administered oral vismodegib at doses of 10, 60, or 300 mg/kg/day during the period of organogenesis. Pre- and post-implantation loss were increased at doses of ≥ 60 mg/kg/day (approximately ≥ 2 times the systemic exposure (AUC) in patients at the recommended human dose), which included early resorption of 100% of the fetuses. A dose of 10 mg/kg/day (approximately 0.2 times the AUC in patients at the recommended dose) resulted in malformations (including missing and/or fused digits, open perineum and craniofacial anomalies) and retardations or variations (including dilated renal pelvis, dilated ureter, and incompletely or unossified sternal elements, centra of vertebrae, or proximal phalanges and claws). 8.3 Nursing Mothers It is not known whether vismodegib is excreted in human breast milk. Because many drugs are excreted in human milk and because

38 Journal of Dermatology for Physician Assistants

Female patients Determine pregnancy status within 7 days prior to initiation of treatment in females of reproductive potential. For females with a negative pregnancy test, initiate a highly effective form of contraception (failure rate of less than 1%) prior to the first dose. Continue highly effective contraception during therapy and for 7 months after the last dose of ERIVEDGE. If a patient becomes pregnant while taking ERIVEDGE, or during the 7 months after the last dose of treatment, report the pregnancy to the Genentech Adverse Event Line at 1-888-835-2555. Encourage pregnant females to participate in the ERIVEDGE pregnancy pharmacovigilance program by calling the Genentech Adverse Event Line at 1-888-835-2555. Counsel pregnant females about the teratogenic risk to the fetus. Amenorrhea has been observed in clinical trials in females of reproductive potential. Reversibility of amenorrhea is unknown [see Adverse Reactions (6), Nonclinical Toxicology (13.1)]. Male patients Male patients should use condoms with spermicide, even after a vasectomy, during sexual intercourse with female partners while being treated with ERIVEDGE capsule and for 2 months after the last dose to avoid exposing an embryo or fetus to vismodegib. 8.7 Hepatic Impairment The safety and effectiveness of ERIVEDGE capsule have not been established in patients with hepatic impairment [see Clinical Pharmacology (12.3)]. 8.8 Renal Impairment The safety and effectiveness of ERIVEDGE capsule have not been established in patients with renal impairment [see Clinical Pharmacology (12.3)]. 10 OVERDOSAGE There is no information on overdosage in humans. In clinical trials, ERIVEDGE capsule was administered at 540 mg orally once daily; exposure did not increase between 150 mg and 540 mg daily. 17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Medication Guide). • Advise patients that ERIVEDGE exposure during pregnancy can cause embryo-fetal death or severe birth defects. • Instruct female patients of reproductive potential to use a highly effective form of contraception (failure rate of less than 1%) while taking ERIVEDGE and for at least 7 months after the last dose of ERIVEDGE. • Instruct all male patients, even those with prior vasectomy, to use condoms with spermicide, during sexual intercourse with female partners while taking ERIVEDGE and for at least 2 months after the last dose of ERIVEDGE. • Instruct patients to immediately contact their healthcare provider if they (or, for males, their female partner) become pregnant or if pregnancy is suspected following exposure to ERIVEDGE. • Instruct patients to immediately report any pregnancy exposure to ERIVEDGE and encourage participation in the ERIVEDGE pregnancy pharmacovigilance program by calling the Genentech Adverse Event Line at 1-888-835-2555. • Inform female patients of the potential for serious adverse reactions in nursing infants from ERIVEDGE, taking into account the importance of the drug to the mother. • Advise patients not to donate blood or blood products while taking ERIVEDGE and for at least 7 months after the last dose of ERIVEDGE. • Advise patients to swallow ERIVEDGE capsules whole and not to crush or open the capsules.

ERIVEDGE ® [vismodegib] capsule Manufactured by: Patheon, Inc. Mississauga, Canada Distributed by: Genentech USA, Inc. ERIVEDGE is a registered trademark A Member of the Roche Group of Genentech, Inc. © 2013 2012 Genentech, Inc. 1 DNA Way South San Francisco, CA 94080-4990 1013 5 4 9 3 HED0000832301

Safety:10"

1 INDICATIONS AND USAGE ERIVEDGE capsule is indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation. 2 DOSAGE AND ADMINISTRATION The recommended dose of ERIVEDGE is 150 mg taken orally once daily until disease progression or until unacceptable toxicity [see Clinical Studies (14)]. ERIVEDGE may be taken with or without food. Swallow capsules whole. Do not open or crush capsules. If a dose of ERIVEDGE is missed, do not make up that dose; resume dosing with the next scheduled dose. 4 CONTRAINDICATIONS None. 5 WARNINGS AND PRECAUTIONS 5.1 Embryo-Fetal Death and Severe Birth Defects ERIVEDGE capsules can cause fetal harm when administered to a pregnant woman based on its mechanism of action. Vismodegib is teratogenic, embryotoxic, and fetotoxic in rats at maternal exposures lower than the human exposures at the recommended dose of 150 mg/day. In rats, malformations included craniofacial anomalies, open perineum, and absent or fused digits. Fetal retardations and variations were also observed. Verify pregnancy status prior to the initiation of ERIVEDGE. Advise male and female patients of the risks of embryo-fetal death and severe birth defects and the need for contraception during and after treatment. Advise patients to contact their healthcare provider immediately if they suspect they (or, for males, their female partner) may be pregnant. Female and male patients of reproductive potential should be counseled regarding pregnancy prevention and planning. If ERIVEDGE is used during pregnancy or if a patient becomes pregnant while taking (or for a male patient, if his female partner is exposed to) ERIVEDGE, the patient should be apprised of the potential hazard to the fetus. Report immediately exposure to ERIVEDGE during pregnancy to the Genentech Adverse Event Line at 1-888-835-2555. Encourage women who may have been exposed to ERIVEDGE during pregnancy, either directly or through seminal fluid, to participate in the ERIVEDGE pregnancy pharmacovigilance program by contacting the Genentech Adverse Event Line at 1-888-835-2555 [see Boxed Warning, Use in Specific Populations (8.1, 8.6)]. 5.2 Blood Donation Advise patients not to donate blood or blood products while receiving ERIVEDGE and for at least 7 months after the last dose of ERIVEDGE. 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. ERIVEDGE capsule was administered as monotherapy at doses ≥ 150 mg orally daily in four open-label, uncontrolled, dose-ranging or fixed single dose clinical trials enrolling a total of 138 patients with advanced basal cell carcinoma (BCC). The median age of these patients was 61 years (range 21 to 101), 100% were White (including Hispanics), and 64% were male. The median duration of treatment was approximately 10 months (305 days; range 0.7 to 36 months); 111 patients received ERIVEDGE for 6 months or longer. The most common adverse reactions (≥ 10%) were muscle spasms, alopecia, dysgeusia, weight loss, fatigue, nausea, diarrhea, decreased appetite, constipation, arthralgias, vomiting, and ageusia (Table 1). Table 1: Adverse Reactions Occurring in ≥ 10% of Advanced BCC Patients

All aBCC1 Patients (N = 138) Grade 3 Grade 4 All Grades 3 (%) (%) (%)

of the potential for serious adverse reactions in nursing infants from ERIVEDGE, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. 8.4 Pediatric Use The safety and effectiveness of ERIVEDGE capsule have not been established in pediatric patients. In repeat-dose toxicology studies in rats, administration of oral vismodegib resulted in toxicities in bone and teeth. Effects on bone consisted of closure of the epiphyseal growth plate when oral vismodegib was administered for 26 weeks at ≥ 50 mg/kg/day (approximately ≥ 0.4 times the systemic exposure (AUC) in patients at the recommended human dose). Abnormalities in growing incisor teeth (including degeneration/ necrosis of odontoblasts, formation of fluid-filled cysts in the dental pulp, ossification of the root canal, and hemorrhage resulting in breakage or loss of teeth) were observed after administration of oral vismodegib at ≥ 15 mg/kg/day (approximately ≥ 0.2 times the AUC in patients at the recommended human dose). 8.5 Geriatric Use Clinical studies of ERIVEDGE capsule did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. 8.6 Females of Reproductive Potential and Males ERIVEDGE capsule can cause harm to the embryo or fetus when administered during pregnancy. Counsel female and male patients regarding pregnancy prevention and planning. Advise patients to contact their healthcare provider immediately if they suspect they (or, for males, their female partner) may be pregnant [see Boxed Warning, Warnings and Precautions (5.1), Use in Specific Populations (8.1)]

SURGIC AL Dermatology Journal Club: Practice Changing Articles for Dermatology PAs Final trial report of sentinel-node biopsy versus nodal observation in melanoma N Engl J Med. 2014 Feb 13;370(7):599-609. doi: 10.1056/NEJMoa1310460. Morton DL, Thompson JF, Cochran AJ, Mozzillo N, Nieweg OE, Roses DF, Hoekstra HJ, Karakousis CP, Puleo CA, Coventry BJ, Kashani-Sabet M, Smithers BM, Paul E, Kraybill WG, McKinnon JG, Wang HJ, Elashoff R, Faries MB; MSLT Group. Funded by the National Cancer Institute, National Institutes of Health, and the Australia and New Zealand Melanoma Trials Group; ClinicalTrials.gov number, NCT00275496.

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

Volume 8 â&#x20AC;˘ number 3 â&#x20AC;˘ SUMMER 2014 39

SURGICAL wisdom Safe Injection Practices Are Essential SDPA Members Only Content

SURGIC AL Dermatology

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

40 Journal of Dermatology for Physician Assistants

Finacea® (azelaic acid) Gel, 15% is indicated for topical treatment of inflammatory papules and pustules of mild to moderate rosacea. Although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated.

Rosacea is with her wherever she goes . So is Finacea . It’s true. Rosacea is complex and it’s with her for life. Pivotal clinical studies showed reduction of inflammatory papules and pustules of mild to moderate rosacea and some reduction of associated erythema. Efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated. You have made Finacea® the #1 Dermatologist-prescribed topical rosacea brand.1

INDICATION & USAGE Finacea® (azelaic acid) Gel, 15% is indicated for topical treatment of inflammatory papules and pustules of mild to moderate rosacea. Although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated. IMPORTANT SAFETY INFORMATION Skin irritation (e.g. pruritus, burning or stinging) may occur during use with Finacea®, usually during the first few weeks of treatment. If sensitivity or severe irritation develops and persists during use with Finacea®, discontinue use and institute appropriate therapy. There have been isolated reports of hypopigmentation after use of azelaic acid. Since azelaic acid has not been well studied in patients with dark complexion, monitor these patients for early signs of hypopigmentation. Avoid contact with the eyes, mouth, and other mucous membranes. In case of eye exposure, wash eyes with large amounts of water. Wash hands immediately following application of Finacea®. Avoid use of alcoholic cleansers, tinctures and astringents, abrasives and peeling agents. Avoid the use of occlusive dressings or wrappings. In clinical trials with Finacea®, the most common treatment-related adverse events (AE’s) were: burning/stinging/ tingling (29%), pruritus (11%), scaling/dry skin/xerosis (8%) and erythema/irritation (4%). Contact dermatitis, edema and acne were observed at frequencies of 1% or less. Finacea® is for topical use only. It is not for ophthalmic, oral or intravaginal use. Patients should be reassessed if no improvement is observed upon completing 12 weeks of therapy. Please see Brief Summary of full Prescribing Information on adjacent page. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. 1. According to IMS NPATM (National Prescription Audit) July 2010-June 2014 © 2014 Bayer HealthCare Pharmaceuticals Inc. Bayer, the Bayer Cross, Finacea and the Finacea logo are registered trademarks of Bayer. All rights reserved. FIN-10-0001-14f | July 2014

Volume 8 • number 3 • SUMMER 2014 41

SURGIC AL Dermatology

FINACEA®

(azelaic acid) Gel, 15% For Dermatologic Use Only–Not for Ophthalmic, Oral, or Intravaginal Use Rx only BRIEF SUMMARY CONSULT PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE FINACEA® Gel is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. Although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated. 5 WARNINGS AND PRECAUTIONS 5.1 Skin Reactions Skin irritation (i.e. pruritus, burning or stinging) may occur during use of FINACEA Gel, usually during the first few weeks of treatment. If sensitivity or severe irritation develops and persists, discontinue treatment and institute appropriate therapy. There have been isolated reports of hypopigmentation after use of azelaic acid. Since azelaic acid has not been well studied in patients with dark complexion, monitor these patients for early signs of hypopigmentation. 5.2 Eye and Mucous Membranes Irritation Avoid contact with the eyes, mouth and other mucous membranes. If FINACEA Gel does come in contact with the eyes, wash the eyes with large amounts of water and consult a physician if eye irritation persists [see Adverse Reactions (6.2)].

7 DRUG INTERACTIONS There have been no formal studies of the interaction of FINACEA Gel with other drugs. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Teratogenic Effects: Pregnancy Category B There are no adequate and well-controlled studies in pregnant women. Therefore, FINACEA Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Dermal embryofetal developmental toxicology studies have not been performed with azelaic acid, 15% gel. Oral embryofetal developmental studies were conducted with azelaic acid in rats, rabbits, and cynomolgus monkeys. Azelaic acid was administered during the period of organogenesis in all three animal species. Embryotoxicity was observed in rats, rabbits, and monkeys at oral doses of azelaic acid that generated some maternal toxicity. Embryotoxicity was observed in rats given 2500 mg/kg/day [162 times the maximum recommended human dose (MRHD) based on body surface area (BSA)], rabbits given 150 or 500 mg/kg/day (19 or 65 times the MRHD based on BSA) and cynomolgus monkeys given 500 mg/kg/day (65 times the MRHD based on BSA) azelaic acid. No teratogenic effects were observed in the oral embryofetal developmental studies conducted in rats, rabbits and cynomolgus monkeys. An oral peri- and post-natal developmental study was conducted in rats. Azelaic acid was administered from gestational day 15 through day 21 postpartum up to a dose level of 2500 mg/kg/day. Embryotoxicity was observed in rats at an oral dose of 2500 mg/kg/day (162 times the MRHD based on BSA) that generated some maternal toxicity. In addition, slight disturbances in the post-natal development of fetuses was noted in rats at oral doses that generated some maternal toxicity (500 and 2500 mg/kg/day; 32 and 162 times the MRHD based on BSA). No effects on sexual maturation of the fetuses were noted in this study. 8.3 Nursing Mothers It is not known whether azelaic acid is excreted in human milk; however, in vitro studies using equilibrium dialysis were conducted to assess the potential for human milk partitioning. The studies demonstrated that, at an azelaic acid concentration of 25 µg/mL, the milk/plasma distribution coefficient was 0.7 and the milk/buffer distribution was 1.0. These data indicate that passage of drug into maternal milk may occur. Since less than 4% of a topically applied dose of 20% azelaic acid cream is systemically absorbed, the uptake of azelaic acid into maternal milk is not expected to cause a significant change from baseline azelaic acid levels in the milk. Nevertheless, a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. 8.4 Pediatric Use Safety and effectiveness of FINACEAGelin pediatric patients have not been established. 8.5 Geriatric Use Clinical studies of FINACEA Gel did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. 17 PATIENT COUNSELING INFORMATION Inform patients using FINACEA Gel of the following information and instructions: Use only as directed by your physician. • For external use only. • Before applying FINACEA Gel, cleanse affected area(s) with a very mild soap or a soapless cleansing lotion and pat dry with a soft towel. • Avoid use of alcoholic cleansers, tinctures and astringents, abrasives and peeling agents. • Avoid contact with the eyes, mouth and other mucous membranes. If FINACEA Gel does come in contact with the eyes, wash the eyes with large amounts of water and consult your physician if eye irritation persists. • Wash hands immediately following application of FINACEA Gel. • Cosmetics may be applied after the application of FINACEA Gel has dried. • Avoid the use of occlusive dressings or wrappings. • Skin irritation (e.g., pruritus, burning, or stinging) may occur during use of FINACEA Gel, usually during the first few weeks of treatment. If irritation is excessive or persists, discontinue use and consult your physician. • Report abnormal changes in skin color to your physician. • To help manage rosacea, avoid any triggers that may provoke erythema, flushing, and blushing. These triggers can include spicy and thermally hot food and drinks such as hot coffee, tea, or alcoholic beverages.

6 ADVERSE REACTIONS 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In two vehicle-controlled and one active-controlled U.S. clinical trials, treatment safety was monitored in 788 subjects who used twice-daily FINACEA Gel for 12 weeks (N=333) or 15 weeks (N=124), or the gel vehicle (N=331) for 12 weeks. In all three trials, the most common treatment-related adverse events were: burning/stinging/tingling (29%), pruritus (11%), scaling/dry skin/xerosis (8%) and erythema/irritation (4%). In the active-controlled trial, overall adverse reactions (including burning, stinging/tingling, dryness/tightness/scaling, itching, and erythema/irritation/redness) were 19.4% (24/124) for FINACEA Gel compared to 7.1% (9/127) for the active comparator gel at 15 weeks. Table 1: Adverse Events Occurring in ≥1% of Subjects in the Rosacea Trials by Treatment Group and Maximum Intensity* FINACEA Gel, 15% Vehicle N=457 (100%) N=331 (100%) Mild Moderate Severe Mild Moderate Severe n=99 n=61 n=27 n=46 n=30 n=5 (22%) (13%) (6%) (14%) (9%) (2%) Burning/ 71 (16%) 42 (9%) 17 (4%) 8 (2%) 6 (2%) 2 (1%) stinging/ tingling Pruritus 29 (6%) 18 (4%) 5 (1%) 9 (3%) 6 (2%) 0 (0%) Scaling/ 21 (5%) 10 (2%) 5 (1%) 31 (9%) 14 (4%) 1 (<1%) dry skin/ xerosis Erythema/ 6 (1%) 7 (2%) 2 (<1%) 8 (2%) 4 (1%) 2 (1%) irritation Contact 2 (<1%) 3 (1%) 0 (0%) 1 (<1%) 0 (0%) 0 (0%) dermatitis Edema 3 (1%) 2 (<1%) 0 (0%) 3 (1%) 0 (0%) 0 (0%) Acne 3 (1%) 1 (<1%) 0 (0%) 1 (<1%) 0 (0%) 0 (0%) * Subjects may have >1 cutaneous adverse event; thus, the sum of the frequencies of preferred terms may exceed the number of subjects with at least 1 cutaneous adverse event. In patients using azelaic acid formulations, the following adverse events have been reported: worsening of asthma, vitiligo, depigmentation, small depigmented spots, hypertrichosis, reddening (signs of keratosis pilaris) and exacerbation of recurrent herpes labialis. © 2014, Bayer HealthCare Pharmaceuticals Inc. All rights reserved. Local Tolerability Studies FINACEA Gel and its vehicle caused irritant reactions at the application site in human dermal safety studies. FINACEA Gel caused significantly more irritation than its Manufactured for: vehicle in a cumulative irritation study. Some improvement in irritation was demonstrated over the course of the clinical trials, but this improvement might be attributed to subject dropouts. No phototoxicity or photoallergenicity were reported in human dermal safety studies. Bayer Healthcare Pharmaceuticals Inc. 6.2 Post-Marketing Experience Whippany, NJ 07981 The following adverse reactions have been identified post approval of FINACEA Gel. Because these reactions are reported voluntarily from a population of uncertain Manufactured in Italy size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure: Eyes: iridocyclitis upon accidental exposure of the eyes to FINACEA Gel 6706806BS

42 Journal of Dermatology for Physician Assistants

COSMETIC deRMATOLOGY

Natural Ingredients Used in New Topical Treatments for Hyperpigmentation SDPA Members Only Content A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

Volume 8 • number 3 • SUMMER 2014 43

COSMETIC Dermatology

Rebat M. Halder, MD, FAAD, is a professor and chair in the department of dermatology at Howard University College of Medicine in Washington, D.C. Dr. Halder is an internationally recognized expert in the areas of ethnic skin disease and pigmentary skin disorders. He has been active in both laboratory and clinical research studies in these areas. Dr. Halder received his medical education at Howard University and completed his residency in dermatology at Howard University Hospital. Dr. Halder is member of many professional organizations including the American Academy of Dermatology, the Society for Investigative Dermatology, and the American Dermatological Association. Reprinted with permission from the American Academy of Dermatology

ATTENDING THE SDPA 12TH ANNUAL FALL DERMATOLOGY CONFERENCE? RSVP TODAY! SPACE IS LIMITED!

WHAT Legislative Update - Appetizers & Drinks WHEN Thursday, November 13, 2014, 7:15pm WHERE Stone Brewing Company Tap Room 795 J Street San Diego, CA 92101

RSVP TO: CONFERENCES@DERMPA.ORGÂ OR CALL ROSE: (830) 980-8489 SPONSORED BY JANSSEN

44 Journal of Dermatology for Physician Assistants

Cosmetic pearls Don’t Get Burned

Tips for Patients on Preventing and Treating Sunburns SDPA Members Only Content

The “Sunburn: How to Treat” video is posted to the American Academy of Dermatology’s website (http://www.aad.org/spotskin-cancer/understanding-skin-cancer/how-do-i-prevent-skincancer/how-to-treat-sunburn) and the Academy’s YouTube channel (https://www.youtube.com/user/AcademyofDermatology). This video is part of the Dermatology A to Z: Video Series, which offers relatable videos that demonstrate tips people can use to properly care for their skin, hair and nails. A new video in the series posts to the Academy’s website and YouTube channel each month.

Volume 8 • number 3 • SUMMER 2014 45

COSMETIC Dermatology

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

COSMETIC Dermatology

Elizabeth S. Martin, MD, FAAD maintains a private practice in Hoover, Alabama.

Reprinted with permission from the American Academy of Dermatology

SDPA Student Affairs

Prepare for Grand Rounds! Weâ&#x20AC;&#x2122;re looking forward to Grand Rounds at the SDPA 12th Annual Fall Dermatology Conference on November 12-15th! Please submit your interesting cases and photographs in advance of the conference. They will then be presented during the Grand Rounds lecture that will be facilitated by our Fall Medical Director, Dr. Matthew Zirwas. Download the Grand Rounds Submission Guidelines from the Member Document Library at Dermpa.org Submit your cases and photographs to Grandrounds@dermpa.org 46 Journal of Dermatology for Physician Assistants

PROFESSIONAL de VELOPMENT

Physician Assistants in Dermatology: A Survey of Fellows of the SDPA

By Evan Thomas, Jennifer Coombs, PA-C, PhD, Jaewan Kim, PhD, Mark Hyde, MMS, PA-C

Volume 8 • number 3 • SUMMER 2014 47

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.

Evan Thomas received his BA in Communications from Weber State University. Evan is a prospective PA student and lives in Bountiful, Utah with his wife and seven children. He has indicated no relationships to disclose relating to the content of this article. Jennifer Coombs, PA-C, PhD is a physician assistant educator. She is an Assistant Professor for the Division of Physician Assistant Studies at the University of Utah. Her PhD is in public health from the University of Utah. She has indicated no relationships to disclose relating to the content of this article. Jaewhan Kim, PhD is a health economist and statistician. He is an Assistant Professor for the Division of Public Health at the University of Utah. He has indicated no relationships to disclose relating to the content of this article. Mark Hyde, MMS, PA-C is a graduate of the Physician Assistant Program at Midwestern University in Glendale, Arizona. He is a Fellow of the SDPA and presently resides in Salt Lake City, Utah where he works with the Melanoma and Cutaneous Oncology Program for the Huntsman Cancer Institute at the University of Utah. He has indicated no relationships to disclose relating to the content of this article.

48 Journal of Dermatology for Physician Assistants

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.

Volume 8 • number 3 • SUMMER 2014 49

SDPA Members Only Content

professional development

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

The SDPA is proud to announce

5 NEW DLI Modules! 1. Acneiform Eruptions 2. Papulosquamous Disorders 3. Fungal Infections 4. Viral Infections 5. Skin Cancer

These new Distance Learning Initiative modules are available to ALL SDPA members, including students and NPs. These modules provide high quality interactive Category 1 CME accessible 24 hours a day!

www.dermpa.org/diplomate 50 Journal of Dermatology for Physician Assistants

Outside & Inside the 9 to 5...

Luke Walters, PA-C, graduated from South College Physician Assistant Program in 2011. Mr. Walters has been a practicing physician assistant in dermatology for two and a half years at Dermatology and MOHs Surgery Institute in Bloomington, IL. He has recently joined the SDPA Philanthropic Committee as a Chair. The mission of this committee is to serve to research and create charitable opportunities for our organization and its members in order to further expand our service to the dermatology community. The JDPA had an opportunity to interview Mr. Walters and learn about his vision regarding his new role with the SDPA as well as his experiences with other volunteer endeavors that he has had the pleasure to participate in.

their school system, and their closeknit community that is self-sustaining for agriculture, water sources, and Mr. Walters: The SDPA is becoming medical care. This pillar system is an incredible force in the world of necessary to ensure the survival of dermatology and the quintessential the people of the Maasai Mara region. society for other PA specialties to I believe that my experience with model after. This organization is filled this mission provided me with some with inspiring people. At a recent incredible insight as to how these trips conference John Notabartolo, an SDPA are organized and efficiently run. I was past President, convinced me that now privy to the level of structure needed Luke Walters, PA-C is the time to “ride the wave.” for our safety that made this trip such JDPA: Can you please explain your new role as the a success. My exposure to the crucial teamwork SDPA Philanthropic Committee Chair. and communication needed to manage this clinic Mr. Walters: Jennifer Conner, SDPA Director at will definitely carry over to my new role with the Large, is steering the ship on this new committee, Philanthropic Committee. and I’m rowing it in whatever JDPA: What has been your direction is necessary; doing most memorable moment assignments such as the annual being involved in these types of Miles for Melanoma Walk/Run endeavors? for the SDPA conferences. Mr. Walters: Going into I am also writing an article a trip like this, you have all of detailing the medical mission these preconceived notions trip I recently embarked on about what will ensue on the to Kenya. Our hope is that voyage. It is a challenge to step sharing articles such as this will outside of your comfort zone help to inspire SDPA members and plunge into a project like to become more involved this. However, once you do, with philanthropic endeavors. then you lose yourself in the JDPA: Can you tell us more experience, and the bonding about the medical mission with local residents and fellow trip to Kenya and how you participants that comes next feel your experience there will is a feeling of euphoria that is lend to your role with the SDPA unparalleled. Philanthropic Committee? JDPA: What do you see as the biggest challenge or Mr. Walters: In September 2013, I participated obstacle to volunteering for philanthropic activities? in a “Free the Children” medical mission trip, Mr. Walters: Escaping the daily clinic routine and sponsored by Medicis, to the Maasai Mara region of dedicating time to volunteering can be a difficult rural Kenya. During the mission, we were exposed to dermatologic conditions endemic to East Africa, task. Sometimes days, weeks, and months may pass Volume 8 • number 3 • SUMMER 2014 51

professional development

JDPA: What inspired you to become involved and volunteer with the SDPA?

before we realize a new year has already begun. Every year I make a list of goals for my personal and professional life including activities that I would like to do. Without it, I would be entering 2020 and still be saying “I should volunteer somewhere.”

professional development

JDPA: What advice do you have for a PA who is interested in becoming more involved with these types of experiences? Mr. Walters: I have always had a vision of volunteering abroad to both learn a new culture and immerse myself in a project I believed in. A speaker at a recent SDPA conference encouraged me to absolutely take a chance and get five friends together and head to Africa. I would encourage those considering volunteering to direct their thoughts towards something they are passionate about and discover what is available. I spoke with several people who volunteered abroad before finally deciding to pursue my own project. The best advice I received was to volunteer for an organization that is highly structured and has experienced members. JDPA: Do you have any goals that you would like to achieve while working with the SDPA Philanthropic Committee? Mr. Walters: Participating in the National Alopecia Areata Foundation’s fundraiser walk in St. Louis last year was special to me because I witnessed a glimpse of what life was like for both the parents and kids who were struggling with such a potentially socially challenging disease. Since I am partial to the pediatric patient population, I would love to assemble a fundraiser or similar event for an

organization that directly benefits and works with children with dermatological conditions. JDPA: Any final thoughts or insights that you would like to share with our readers? Mr. Walters: Life is a long lesson in humility. There is no clearer way to exhibit this than to volunteer your efforts to others. J

Let them know they’re not alone... Share a story with your patients. Visit the Patient’s Perspective library of articles at www.jdpa.org/advocacy.html

JDPA Journal of Dermatology for Physician Assistants

If you know a patient who would like to share his/her story, please contact us at editor@jdpa.org

52 Journal of Dermatology for Physician Assistants

Notes from your Office Manager The “Credentialed” Medical Assistant Important New Meaningful Use Rule As some of you may know, there is a new rule that practices must adhere to in order to remain in compliance with the “meaningful use” criteria of the Electronic Health Record (EHR) incentive program. The Center for Medicare and Medicaid Services (CMS) has established that use of the Computerized Physician Order Entry (CPOE) within the electronic health record should be limited to eligible professionals and “credentialed” medical assistants. What does this mean? If you are 1) participating in the Medicare/Medicaid EHR incentive program and 2) your medical assistants actively participate in the entry of lab orders or prescriptions into the EHR, then they must be “credentialed” or their activity will count against core measures! So, how does CMS define “credentialed”? Rather than specifying exactly which credentials medical assistants must have in order to fulfill this requirement, CMS instead only mandates that “the credentialing would have to be obtained from an organization other than the employing organization.” Certainly those medical assistants who have tested and currently hold the credential title of Registered Medical Assistant (RMA) through the American Medical Technologists (AMT) or Certified Medical Assistant (CMA) through the American Association of Medical Assistants (AAMA) fulfill this requirement. The problem arises when offices employ informally trained medical assistants who have never earned a credential or medical assistants whose AAMA/AMT certification has expired. In the end, it is clear that this rule affects a large number of staff working in dermatology practices throughout the country! How can you satisfy this rule for those staff members who do not currently hold CMA or RMA certification? One option is the successful

completion of the Association of Certified Dermatology Techs (ACDT) course. Upon completion of the online 15.5 hour ACDT course, medical assistants who have at least 6 months of dermatology experience earn the credential of Certified Dermatology Tech® (CDT). Alternatively, the AAMA provides another option in their Assessment-Based Recognition in Order Entry (ABR-OE) program (www.aama-ntl.org/ continuing-education/abr). The ABR-OE is a 5-hour online program, but interestingly graduates from either a Commission on Accreditation of Allied Health Education Programs (CAAHEP) or an Accrediting Bureau of Health Education Schools (ABHES) accredited medical assisting program are not eligible to take the ABR-OE course. It is worth noting that CMS does not limit the “medical assistant” job description to only those who have received formal training in an accredited trade school or college program. Consider the following response from the CMS Frequently Asked Questions page: “If a staff member of the eligible provider is appropriately credentialed and performs similar assistive services as a medical assistant but carries a more specific title due to either specialization of their duties or to the specialty of the medical professional they assist, he or she can use the CPOE function of CEHRT and have it count towards the measure. This determination must be made by the eligible provider based on individual workflow and the duties performed by the staff member in question. Whether a staff member carries the title of medical assistant or another job title, he or she must be credentialed to perform the medical assistant services by an organization other than the employing organization. Also, each provider must evaluate his or her own ordering workflow, including

Volume 8 • number 3 • SUMMER 2014 53

professional development

By Timothy August, MPAS, PA-C

professional development

Notes from your Office Manager the use of CPOE, to ensure compliance with all applicable federal, state, and local law and professional guidelines.” CMS recognizes that many medical assistants are trained on the job and it is not interfering with the right of physicians to designate who fills that role within each practice. Again, CMS only requires that your medical assistant staff are “credentialed.” Presumably for safety reasons, they are trying to avoid having those with absolutely no medical knowledge (i.e., “scribes”) from playing an active role in the charting, lab order, and prescribing process. Additional resources regarding this requirement can be found in the Federal Register (http://www. gpo.gov/fdsys/pkg/FR-2012-09-04/pdf/201221050.pdf) where it is most specifically addressed in the middle column on page 53986. J

Timothy August, MPAS, PA-C has been a practicing physician assistant since 1998. He completed his Physician Assistant studies at UTMB – Galveston. He then went on to complete his Masters degree in physician assistant studies through the University of Nebraska. Mr. August has been practicing dermatology for 15 years and currently works at Current Dermatology in Sylva, NC. He is the founder and lead author of The Association of Certified Dermatology Techs (ACDT). The ACDT was established in 2012 to provide education and certification to those working in the supportive roles of clinical dermatology. The mission of the ACDT is to provide training through its Certified Dermatology Tech® training course. The ACDT online training modules are authored by Timothy August, MPAS, PA-C with Russell Metz, MD serving as senior editor. Together they bring over thirty years of combined clinical dermatology experience to the program. If you have any additional questions, comments, or suggestions, please e-mail the ACDT directly at info@ dermatologytech.org or visit www.dermatologytech.org.

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54 Journal of Dermatology for Physician Assistants

| 1-800-380-3922

PROVEN

EFFICACY

CUSTOMIZED, WITH WEIGHT-BASED1,2

DOSING

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

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

Volume 8 • number 3 • SUMMER 2014 55

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

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

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

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

56 Journal of Dermatology for Physician Assistants

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

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

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

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

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

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

NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility

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

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

NDC 99207-466-30

Mutagenesis—Minocycline was not mutagenic in vitro in a bacterial reverse mutation assay (Ames test) or CHO/HGPRT mammalian cell assay in the presence or absence of metabolic activation. Minocycline was not clastogenic in vitro using human peripheral blood lymphocytes or in vivo in a mouse micronucleus test. Impairment of Fertility—Male and female reproductive performance in rats was unaffected by oral doses of minocycline of up to 300 mg/kg/day (which resulted in up to approximately 40 times the level of systemic exposure to minocycline observed in patients as a result of use of SOLODYN). However, oral administration of 100 or 300 mg/kg/day of minocycline to male rats (resulting in approximately 15 to 40 times the level of systemic exposure to minocycline observed in patients as a result of use of SOLODYN) adversely affected spermatogenesis. Effects observed at 300 mg/kg/day included a reduced number of sperm cells per gram of epididymis, an apparent reduction in the percentage of sperm that were motile, and (at 100 and 300 mg/kg/day) increased numbers of morphologically abnormal sperm cells. Morphological abnormalities observed in sperm samples included absent heads, misshapen heads, and abnormal flagella. Limited human studies suggest that minocycline may have a deleterious effect on spermatogenesis.

Bottle of 30

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

Bottle of 30

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

Bottle of 30

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

SOLODYN should not be used by individuals of either gender who are attempting to conceive a child. HOW SUPPLIED/STORAGE AND HANDLING How Supplied SOLODYN (minocycline HCl, USP) Extended Release Tablets are supplied as aqueous film coated tablets containing minocycline hydrochloride equivalent to 55 mg, 65 mg, 80 mg, 105 mg or 115 mg minocycline, are supplied as follows.

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

Volume 8 • number 3 • SUMMER 2014 57

Dermatology PA news & notes

The Difference We Make When We Know By Brian T. Maurer, PA-C

Nothing jolts the mind more deeply than glimpsing the subject line of an unexpected e-mail as you simultaneously come to the sudden realization that someone you had at one time known and respected is now no longer counted among the living. There are those who mentored us in our youth, perhaps a handful of special individuals - special for their presence, their wit, their innate intelligence, and their caring. We envision visiting again to let them know how appreciative we are of the interest they took in us as students; reminiscing about former times, and discussing the current state of the world. We jot their names on a mental list and tell ourselves that one day, one day soon, when we can tear ourselves away for a couple of days from the rat race that has become our life, we will look them up and pay our respects. And then the obituary notice arrives and suddenly we realize that the opportunity has passed and will not rap on our door again. In addition to providing me with a solid grounding in chemistry, this particular mentor taught me a way of looking at the world. In numerous discussions after school he gave me informal lessons on various ways through which we come to understand things in life in short, how we know what we know. The technical term is epistemology. I recall being so taken with this concept that as editor of our high school newspaper I devoted a large part of an interview with this teacher to that very subject. Much later in life those same seeds appeared in an essay I authored to launch an open

access online journal for humane medicine and the medical humanities, Cell2Soul. In addition to his scientific and philosophical bent, this teacher also shared a secret desire: he wanted to become a writer of stories, in particular science fiction. He outlined his idea for a novel during one of our chats, a novel he was in the midst of writing at the time. Whether it was ever published or subsequently abandoned, I don’t know. Ironically, although I posted a piece about him on this blog sometime ago, I doubt that he ever saw it. The best I can offer is an observation that the knowledge, which is imparted to us by our mentors provides a way for us to carry them forward after they are gone. If we are diligent mentors ourselves, perhaps one day our torches of knowledge will be carried and in time passed along by those we have taken the time to instruct. J Brian T. Maurer, PA-C, has practiced pediatric medicine as a physician assistant for thirty years. Over the past two decades Mr. Maurer has explored the illness narrative as a tool to cultivate an appreciation for the delivery of humane medical care. He has published numerous vignettes, editorials, and essays in both national and international journals. Mr. Maurer has been a contributing author to the online open-access journal Dermanities (www.dermanities.com) since its inception. Readers can visit the author on the web at http://briantmaurer.wordpress.com. This article was reprinted with permission from the author. Originally published on Brian T Mauer’s Weblog- Marginal Musings form a New England Author, May 11th 2014.

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

58 Journal of Dermatology for Physician Assistants

JDPA Journal of Dermatology for Physician Assistants

From the Desk of... John V. Notabartolo, MPAS, PA-C

SDPA Media Relations Committee Chair SDPA Diplomate, Past President

Boston was the scene of this year’s AAPA House of Delegates (HoD) meeting. The HoD is the body that considers policy and recommends changes that impact PAs practicing everywhere in the US and in every specialty. Representatives from every state, specialty, and interest group come together to shape the future of our profession. The AAPA also represents PAs in a political sense. They are our united voice to legislators on Capitol Hill and set priorities when lobbying to best affect our future. They are the “keepers of the keys” and maintain policy statements that are used to influence PA legislation across the country. For as long as I’ve been a PA, nearly 20 years now, this has been the published AAPA definition of “What Is A Physician Assistant?” Physician assistants are health professionals licensed, or in the case of those employed by the federal government, credentialed to practice medicine with supervision. Physician assistants are qualified by graduation from an accredited physician assistant educational program and/or certification by the National Commission on Certification of Physician Assistants. Within the physician-PA relationship, physician assistants exercise autonomy in medical decisionmaking and provide a broad range of diagnostic and therapeutic services. The 2014 HoD took on the task of updating this definition, and here’s the result (changes are Underlined and in Bold): PAs are health professionals licensed, or in the case of those employed by the federal government, credentialed to practice medicine in association with designated collaborating physicians. PAs are qualified by graduation from an accredited PA educational program and/or certification

by the National Commission on Certification of Physician Assistants. Within the physician-PA relationship, PAs provide patient-centered medical care services as a member of a health care team. PAs practice with defined levels of autonomy and exercise independent medical decision making within their scope of practice. In an overwhelming vote the HoD changed the words that define who we are. Notice that the word “supervision” is no longer included and has been replaced by “collaboration.” This word better conveys to both physicians and the public what we really do every day. This is pretty exciting but dig a little deeper; you’ll notice the phrase “physician assistant” is only used when spelling out the name of the NCCPA. The AAPA decided to limit the use of the word “assistant” to avoid the need to explain the complexity of our professional relationships and the inadequacies of our name. What does this mean for us in clinical practice? It means better branding of the term PA, the opportunity to revise legislation within our states to reflect collaboration rather than supervision, and a clear pathway to a future that includes the physicianPA team model of practice for many years to come. J John V. Notabartolo, MPAS, PA-C is a recognized leader in his field with more than 14 years of dermatology experience. Specializing in Psoriasis, skin cancer, acne and eczema he has done clinical and laboratory research, written for several journals and lectured on numerous topics. Active in the PA profession as Past President and Committee Chair of the Society of Dermatology PAs, committee chair and member of the House of Delegates of the American Academy of PAs and past President and Treasurer of the Society of Air Force PAs. He is veteran with 21 years of active duty service, part-time actor and musician, and has a difficult time sitting still.

Volume 8 • number 3 • SUMMER 2014 59

DERmatology pa news & notes

AAPA Vote Changes Official Definition of “What is a Physician Assistant?”

Workplace Excellence

Is Your Office a Great Place to Work? 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.

n today’s workplace, across all sectors, organizations are trying to create a positive and productive environment, one where stakeholders feel a deep sense of commitment to the mission and to one another, as well as a deep sense of engagement. In even the biggest and most prominent companies, there is still a realization that resources are limited - most especially human resources. Every organization aspires to goals beyond their resources (e.g., Amazon is huge and successful, but trying to get bigger and better). Thus, creating a culture of excellence where the members of the organization “row as one” is essential. Creating a culture infused with quality of life - at work and away from work - where people feel engaged, supported, and cared for is an essential organizational asset. I recently conducted a workplace excellence retreat where we utilized data gathered using the IEE’s Culture of Excellence & Ethics Assessment for the Workplace. We gathered data in the spring and then planned the retreat using a “praise and polish” approach. There were some very important things worthy of praise including clear evidence of a culture of integrity, respect, and kindness. There were also some clear areas worthy of polish and continued improvement including the need for improved communication, accountability, time-priority-stress management, and better overall life balance - themes for improvement that we see very frequently in our work. We focused our time together trying to audit the things we should START, STOP, CONTINUE, or IMPROVE to enhance communication, community, and overall commitment to their shared performance goals and their desire to create the best work environment in their industry. Ironically, a day before the retreat the New York Times featured a most compelling opinion piece by Tony

60 Journal of Dermatology for Physician Assistants

Schwartz and Christine Porath under the captivating title, “Why You Hate Work.” (http://www.nytimes. com/2014/06/01/opinion/sunday/why-you-hate-work. html?hp&rref=opinion&_r=3) The article shared significant data showing the connection between how people feel about their workplace and how they perform. In the workplace today, the bottom line is being impacted because too many work environments leave their workers missing purpose and focus, feeling undervalued, and burnt out. The article’s conclusion is that far too many people hate where they work and how they work, which impacts how well they work. Not surprisingly, the research indicates that the climate of your workplace is an important factor in how well you perform your work. Think about it this way: you have to do some lawn work at your house. You wake up, and it’s cold and rainy with dark skies. How do you feel about doing that work? Or, you wake up, it’s warm and sunny, and you’ve got bright blue skies. Same work to do, but how you feel about doing it is very different. The climate of our workplace is important. Here’s the challenge: changing how people feel about work isn’t always easy. Putting a box of doughnuts in the kitchen is nice, but really won’t make people feel better about the workplace if our norms and habits don’t change too. It can actually make people feel worse if it seems like a cheap gesture that fails to address root issues. Here’s a breakdown of the relationship between climate and culture: workplace climate (the way we feel about our workplace) is shaped by culture and character (our habits and routines). We shape and define our culture, and it in turn impacts how people feel, which in turn impacts how well we do our work. So there’s an important culture-climateexcellence relationship in the workplace.

communication (amongst our staff as well as with our customers), for giving and receiving constructive criticism, for any of the other interpersonal and ethical situations we frequently encounter? 2. What looks like laziness is often exhaustion. What changes can your organization make to engage stakeholders’ emotional and motivational sides so they can more optimally manage their energy and avoid stress and burnout? Do we have “mandatory fun” built in, flexible schedules, responsive home/ family policies, and exercise and nutrition support? 3. What looks like a people problem is often a situation problem. What can your organization change in its situation or environment to better help each stakeholder group overcome its challenges and more optimally contribute to its shared goals? Would better policies for technology help us, how about improving new employee formation practices, or even simply new routines for lunchtime, end of day, or beginning meetings? The culture and climate of your organization is having an influence on the quality of your customer’s experience and on your overall workplace team. The question is whether it’s having the influence you desire. The authors of Switch argue that successful change requires three things to happen at once: 1) Changes in the situation, 2) Changes in heart (motivation), 3) Changes in mind (clarity of what is expected). These are some important steps in creating a great place to work for those you work with and those you work for. J REFERENCE: 1. http://www.nytimes.com/2014/06/01/opinion/sunday/why-you-hate-work. html?hp&rref=opinion&_r=1 2. Switch: How to make change when change is hard. 2010. Chip and Dan Heath. New York: Broadway Books. Matthew L. Davidson, Ph.D. is the Founder, President, and Director of Education for the Institute for Excellence & Ethics (IEE), a 501(c)3 nonprofit corporation dedicated to helping individuals and organizations achieve excellence. He is a National Spokesperson for the Business Bureau National Center for Character Ethics. The IEE specializes in the development and dissemination of research-based tools for developing the culture and competencies of excellence and ethics in schools, athletics, the workplace, and the home; this is done through professional development workshops & academies, teaching & learning resources, assessment, and consulting services. He is a frequent national presenter and is available for keynote lectures, professional development, retreats, and organizational consulting. He has indicated no relationships to disclose relating to the content of this article. For additional information or to contact the IEE, please visit www.excellenceandethics.org

Volume 8 • number 3 • SUMMER 2014 61

DERmatology pa news & notes

Here are four qualities of a great work environment and why it matters to mission and margin: 1. A great work environment is an engaged work environment. We’re not burned out, stressed out, resentful, or demoralized. We are motivated to go the extra yard, to give the extra effort. 2. A great work environment is a kind, helpful, and collegial environment. We like each other. We wish each other well and do anything and everything in our power to help one another achieve our shared goals. We have congeniality; we’re nice to each other. We also have collegiality; we’re willing to give and receive constructive criticism and to use critical and creative thinking and problem solving to get the most from our available resources. 3. A great work environment benefits its customers. When we create an engaged, kind, and collegial environment, the customers we serve are the direct beneficiaries. We exist for our customers - whether they are students, patients, or any other type of client who uses our products and services. As they say in school settings, “Feed the teachers so they don’t eat the students.” Similarly, we could assert “Feed the healthcare providers so they don’t eat the patients” or “Feed your administrative assistants so they don’t eat the providers.” We all serve our customers better in a great work environment. 4. A great work environment attracts great people. Salaries and benefits matter and state of the art facilities are important for pride and productivity, but there is no substitute for great people. Total care for each employee means that others will want to work with us. The single best indicator of a great work environment is whether there would be a line of people signing up for any position in which we have a vacancy. Whether you’re going from bad to good or good to great, continuous improvement requires a commitment to continuous change and adaptation. In the book Switch: How to Make Change When Change is Hard, the authors argue, “For anything to change, someone has to start acting differently.” This is simple, but not easy. There must be clarity about what we want to START, STOP, CONTINUE, or IMPROVE. The book Switch presents three important reminders to consider about making change: 1. What looks like resistance is often a lack of clarity about what to do better or differently. What changes can your organization make to more optimally provide clear direction for one another about what they want to do better or differently (and/or avoid doing)? Have we defined our norms for effective

Is this YOUR year to become a Diplomate? Join your peers as an elite Derm PA! The SDPA wishes to congratulate all of our Physician Assistant members who have completed the rigorous Distance Learning Initiative.

For For more more information information on achieving on achieving DIPLOMATE DIPLOMATE status status in in your s yourvisit state, dermpa.org/diplomate visit dermpa.org/diplomate Current list of diplomates effective as of Dec 2013 62 Journal of Dermatology for Physician Assistants

070714

Supervising Physician CORNER An Interview with the New SDPA Fall Conference Educational Planning Committee’s CME Medical Director - Matthew Zirwas, MD By J. Margaret Casey

JDPA: How do you view your new role with the SDPA? What do you see as your mission in this role? Dr. Zirwas: I believe that PAs are the most important part of the future of medical dermatology. As more and more dermatologists are focusing on cosmetics, skin cancer, and surgery, patients with the fundamental diseases of dermatology (acne, atopic dermatitis, contact dermatitis, psoriasis, alopecia, etc.) are having trouble getting access to quality dermatologic care. PAs have already been one of the main solutions to this problem and will only continue to grow in importance. I see my role as being to help optimize the already exceptional educational experiences provided by the SDPA and to work with the SDPA to continue building the already very high acceptance of and respect for PAs by all dermatologists. JDPA: What role do PAs play in your practice? Any insights into what dermatology PAs should focus on if they are interested in learning more about contact dermatitis/patch testing? Dr. Zirwas: We currently have a PA as part of our practice at Ohio State; she sees many of my patients with contact dermatitis during follow-up appointments. We also have a PA at the VA facility where I work. She and I work very closely since most of the patients I see there are via telederm, and those whom I think need to be seen in person come to see her. PAs who want to get more involved in contact dermatitis/patch testing should really consider coming to the Annual Hands-on Patch Test Training Workshop put on by Smartpractice. This two-day patch testing workshop provides attendees with the latest updates in patch testing for the diagnosis and management of allergic contact dermatitis. I have enjoyed teaching at this course and have the pleasure of

serving as one of the main faculty. We have been holding it annually for several years but are about to offer it biannually, once in Phoenix and once in Louisville. I know several PAs who have attended it and then started incorporating comprehensive patch testing into their practices, even becoming referral centers for their cities. I love getting e-mails from them in the ensuing years telling me what a difference it has made for the patients, how much they are enjoying it, and asking me questions about tough cases. JDPA: What special skills and/or experiences do you have that you think will lend to your new role? Dr. Zirwas: While I am passionate about contact dermatitis, my biggest passion is for teaching dermatology. As a residency director in dermatology, I can’t tell you the number of hours I’ve spent over the last decade thinking about and working on ways to help people think about dermatology with a rational, thoughtful approach. Part of the beauty of being a residency director has been getting to try out different approaches and see how they work. What really makes somebody turn into the kind of thoughtful provider whom I would want taking care of my family or myself rather than a “cookbook” provider who does not understand why they are making the diagnoses they are making or using the treatments they are implementing? JDPA: What characteristics/qualities make a CME conference high quality? Dr. Zirwas: Several things are important for the best conferences. First and most importantly is that the people attending the conference are excited to be there and to learn. Second is that presenters are thinking in a practical way and teaching about real problems that Volume 8 • number 3 • SUMMER 2014 63

DERmatology pa news & notes

The SDPA’s Fall Conference Educational Planning Committee has recently established the first ever SDPA CME Medical Director position. The addition of this position is a result of the Committee thoughtfully listening to feedback from our members and using their recommendations to help continually improve our conference and the SDPA overall. Dr. Matthew Zirwas will be serving as the Medical Director for the 2014 SDPA Fall Dermatology Conference. As the CME Medical Director, Dr. Zirwas will be providing the Committee with guidance and direction to help improve the quality of the conferences. We had an opportunity to interview Dr. Zirwas and learn more about his experience volunteering with the SDPA in his new role as Medical Director and what he foresees for future conferences.

DERmatology pa news & notes

providers see in their practices and real approaches to those problems. Third is that the topics are selected because they are relevant to everyday practice, not because there is a new drug or device out there that a company wants to promote. JDPA: What has been your experience thus far in working with or educating dermatology PAs? Dr. Zirwas: I LOVE working with PAs and teaching PAs. The fundamental thing that makes working with and teaching someone worthwhile is real desire and enthusiasm to get better and to learn as much as possible. As a group, I see this type of enthusiastic attitude more in PAs than I see in any other group I have been associated with in medicine. JDPA: What do you hope to gain from this experience with the SDPA? Dr. Zirwas: The same things that I hope to gain from everything I do, a feeling that I did something that was important and made a difference in the world. In this case, I hope that there are PAs out there that are doing a better job of taking care of patients because of what they learned at a conference that I helped plan. JDPA: Do you have any specific goals in mind that you would like to achieve while in this position? Dr. Zirwas: It may sound strange, but I am not a goal oriented person, with one exception – my goal is to spend as much time doing things that I consider worthwhile (and doing them well) and as little time as possible doing things that I do not consider worthwhile. I already know that this position is as worthwhile as it gets, so that means the goal is to feel like I am doing an awesome job. JDPA: What insights or advice would you share with fellow dermatologists who are considering volunteering their time to helping educate dermatology PAs (nationally with the SDPA and/or locally in their own communities)? Dr. Zirwas: First, I would tell them to do it. They are not going to find a better way to contribute to the future of dermatology nor will they find a group that will be more appreciative of the effort. Second, I would remind them to keep in mind is whom their audience is, the biggest challenge in teaching dermatology PAs is the huge variation in how much experience and knowledge different individuals have. For example, giving a talk about psoriasis directed at SDPA Diplomates who have been practicing for five years is completely different from giving a talk about psoriasis to PAs who just started working in dermatology six months ago. The challenge, (which is unique to teaching dermatology PAs) is trying 64 Journal of Dermatology for Physician Assistants

to figure out how to teach so that the experienced people aren’t bored and the newbies aren’t lost; this is what makes it so much fun. JDPA: Any thoughts on the changing landscape of healthcare or specifically the field of dermatology? How do you see the role of PAs in dermatology changing in the future? Dr. Zirwas: I think I jumped the gun on this one a little bit in one of my earlier answers. However, I see two big challenges: finding a way to lower the barriers for PAs to enter into dermatology (i.e., getting their initial training) and doing a better job of standardizing that initial training. One suggestion would be to establish PA dermatology fellowships, which in my ideal vision of the world would have experienced PAs as the teaching faculty. JDPA: Any additional facts or information that you would like to share with the SDPA readers? Dr. Zirwas: I want people to know that being asked to be the Medical Director for the SDPA Fall Dermatology Conference is probably what I consider to be the greatest honor of my career. It means that a lot of smart people whom I respect have thought highly enough of my approach to teaching dermatology that, out of all the dermatologists out there, they thought I would do the best job. In addition, I have said many times that I think the SDPA conferences are probably the best educational events in dermatology, bar none, so being part of the leadership of them is really cool. J Dr. Zirwas originally hails from Pittsburgh, Pennsylvania. He completed his undergraduate degree, medical school, and dermatology residency all at the University of Pittsburgh, where he also took his first faculty job. He moved to Ohio State University in 2006 and has been the residency director and has run the contact dermatitis clinic ever since. His practice is dedicated exclusively to seeing patients with difficult to figure out or difficult to control pruritic dermatoses. He is a member of the North American Contact Dermatitis Group and on the Board of Directors of the Association of Professors of Dermatology. He is the world’s leading expert on hot tub allergy. Dr. Zirwas has two wonderful daughters, two wonderful step-children, a beautiful wife, and absolutely no free time.

ZYCLARA : ®

Efficacy for the Full Field Treatment of Actinic Keratosis FROM HERE

TO HERE

TREATS THE FULL FACE OR BALDING SCALP WITH A METERED DOSE PUMP. Indication ZYCLARA (imiquimod) Cream 3.75% is indicated for the topical treatment of clinically typical, visible or palpable actinic keratoses (AK) of the full face or balding scalp in immunocompetent adults.1 Important Safety Information for ZYCLARA Cream · Intense local skin reactions including skin weeping or erosion can occur after a few applications of ZYCLARA Cream and may require an interruption of dosing. ZYCLARA Cream has the potential to exacerbate inflammatory conditions of the skin, including chronic graft versus host disease.1 · Administration of ZYCLARA Cream is not recommended until the skin is healed from any previous drug or surgical treatment.1 · ZYCLARA Cream should be used with caution in patients with pre-existing autoimmune conditions because imiquimod activates immune cells.1 · Exposure to sunlight (including sunlamps) should be avoided or minimized during use of ZYCLARA Cream. Patients should be warned to use protective clothing (e.g., hat) when using ZYCLARA Cream. Patients with sunburn should be advised not to use ZYCLARA Cream until fully recovered. Patients who may have considerable sun exposure, e.g. due to their occupation, and those patients with inherent sensitivity to sunlight should exercise caution when using ZYCLARA Cream.1 · Avoid concomitant use of ZYCLARA Cream and any other imiquimod cream because of increased risk for adverse reactions.1 · In clinical studies for actinic keratosis, the most common adverse events involved skin reactions in the application area including erythema, scabbing/crusting, flaking/scaling/dryness, edema, erosion/ ulceration, and exudate. Most local skin reactions were rated as mild to moderate.1

Please see Brief Summary of Full Prescribing Information on adjacent page. References: 1. ZYCLARA Cream Package Insert. Scottsdale, AZ: Medicis, the Dermatology Company; February 2012. Except as where otherwise indicated, all product names, slogans, and other marks are trademarks of the Valeant family of companies. ©2013 Valeant Pharmaceuticals North America LLC. DM/ZCL/13/0004

Volume 8 • number 3 • SUMMER 2014 65

Zyclara Brief Summary CONTRAINDICATIONS None WARNINGS AND PRECAUTIONS Local Skin Reactions Intense local skin reactions including skin weeping or erosion can occur after a few applications of ZYCLARA Cream and may require an interruption of dosing [see Dosage and Administration (2) and Adverse Reactions (6)]. Z YCL AR A Cream has the potential to exacerbate inflammatory conditions of the skin, including chronic graft versus host disease. Severe local inflammatory reactions of the female external genitalia can lead to severe vulvar swelling. Severe vulvar swelling can lead to urinary retention. Dosing should be interrupted or discontinued for severe vulvar swelling. Administration of ZYCLARA Cream is not recommended until the skin is healed from any previous drug or surgical treatment. Systemic Reactions Flu-like signs and symptoms may accompany, or even precede, local skin reactions and may include fatigue, nausea, fever, myalgias, arthralgias, malaise and chills. An interruption of dosing and an assessment of the patient should be considered [see Adverse Reactions (6)] Lymphadenopathy occurred in 2% of subjects with actinic keratosis treated with ZYCLARA Cream, 3.75% and in 3% of subjects treated with ZYCLARA Cream, 2.5% [see Adverse Reactions (6)]. This reaction resolved in all subjects by 4 weeks after completion of treatment. Ultraviolet Light Exposure Risks Exposure to sunlight (including sunlamps) should be avoided or minimized during use of ZYCL AR A Cream. Patients should be warned to use protective clothing (e.g., a hat) when using ZYCLARA Cream. Patients with sunburn should be advised not to use ZYCLARA Cream until fully recovered. Patients who may have considerable sun exposure, e.g. due to their occupation, and those patients with inherent sensitivity to sunlight should exercise caution when using ZYCLARA Cream. In an animal photo-carcinogenicity study, imiquimod cream shortened the time to skin tumor formation [see Nonclinical Toxicology (13.1)]. The enhancement of ultraviolet carcinogenicity is not necessarily dependent on phototoxic mechanisms. Therefore, patients should minimize or avoid natural or artificial sunlight exposure. Increased Risk of Adverse Reactions with Concomitant Imiquimod Use Concomitant use of ZYCLARA Cream and any other imiquimod products, in the same treatment area, should be avoided since they contain the same active ingredient (imiquimod) and may increase the risk for and severity of local skin reactions. The safety of concomitant use of ZYCL AR A Cream and any other imiquimod products has not been established and should be avoided since they contain the same active ingredient (imiquimod) and may increase the risk for and severity of systemic reactions. Immune Cell Activation in Autoimmune Disease ZYCLARA Cream should be used with caution in patients with pre-existing autoimmune conditions because imiquimod activates immune cells [see Clinical Pharmacology (12.2)]. ADVERSE REACTIONS 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. Clinical Trials Experience: Actinic Keratosis The data described below reflect exposure to ZYCLARA Cream or vehicle in 479 subjects enrolled in two double-blind, vehicle-controlled trials. Subjects applied up to two packets of ZYCLARA Cream or vehicle daily to the skin of the affected area (either entire face or balding scalp) for two 2-week treatment cycles separated by a 2-week no treatment period. Table 1: Selected Adverse Reactions Occurring in ≥ 2% of ZYCLARATreated Subjects and at a Greater Frequency than with Vehicle in the Combined Studies (AK) ZYCLARA Cream, 3.75% (N=160)

ZYCLARA Cream, 2.5% (N=160)

Headache

10 (6%)

3 (2%)

5 (3%)

Application site pruritus

7 (4%)

6 (4%)

1 (<1%)

Adverse Reactions

Vehicle (N=159)

Fatigue

7 (4%)

2 (1%)

Nausea

6 (4%)

1 (1%)

2 (1%) 0

Influenza like illness

1 (<1%)

6 (4%)

Application site irritation

5 (3%)

4 (3%)

Pyrexia

5 (3%)

Anorexia

4 (3%)

Dizziness

4 (3%)

1 (<1%)

Herpes simplex

4 (3%)

1 (<1%)

Application site pain

5 (3%)

2 (1%)

Lymphadenothapy

3 (2%)

4 (3%)

Oral herpes Arthralgia

2 (1%)

4 (3%)

Cheilitis

3 (2%)

Diarrhea

3 (2%)

2 (1%)

Local skin reactions were recorded as adverse reactions only if they extended beyond the treatment area, if they required any medical intervention, or they resulted in patient discontinuation from the study. The incidence and severity of selected local skin reactions are shown in Table 2.

female rabbits. No treatment related effects on embryofetal toxicity or teratogenicity were noted at 2 mg/kg/day (2.1X MRHD based on BSA comparisons), the highest dose evaluated in this study, or 1 mg/kg/day (115X MRHD based on AUC comparisons). A combined fertility and peri- and post-natal development study was Table 2: Local Skin Reactions in the Treatment Area in ZYCLARA- conducted in rats. Oral doses of 1, 1.5, 3 and 6 mg/kg/day imiquimod were administered to male rats from 70 days prior to mating through the Treated Subjects as Assessed by the Investigator (AK) mating period and to female rats from 14 days prior to mating through parturition and lactation. No effects on growth, fertility, reproduction or All Grades* (%) ZYCLARA ZYCLARA post-natal development were noted at doses up to 6 mg/kg/day (25X Cream, Cream, Vehicle Severe MRHD based on AUC comparisons), the highest dose evaluated in this 3.75% 2.5% (N=159) study. In the absence of maternal toxicity, bent limb bones were noted (N=160) (N=160) in the F1 fetuses at a dose of 6 mg/kg/day (25X MRHD based on AUC Erythema 96% 96% 78% comparisons). This fetal effect was also noted in the oral rat embryofetal development study conducted with imiquimod. No treatment related Severe Erythema 25% 14% 0% effects on teratogenicity were noted at 3 mg/kg/day (12X MRHD based Scabbing/Crusting on AUC comparisons). 93% 84% 45% Severe Scabbing/ Nursing Mothers 14% 9% 0% Crusting It is not known whether imiquimod is excreted in human milk following use of ZYCLARA Cream. Because many drugs are excreted in human Edema 75% 63% 19% milk, caution should be exercised when ZYCLARA Cream is administered Severe Edema 6% 4% 0% to nursing women. Erosion/Ulceration Severe Erosion/ Ulceration

62% 11%

52% 9%

9% 0%

Exudate Severe Exudate

51% 6%

39% 1%

4% 0%

Flaking/Scaling/ Dryness Severe Flaking/ Scaling/Dryness

91% 8%

88% 4%

77% 1%

* All Grades: mild, moderate or severe Overall, in the clinical trials, 11% (17/160) of subjects in the ZYCLARA Cream, 3.75% arm, 7% (11/160) of subjects in the ZYCLARA Cream, 2.5% arm, and 0% in the vehicle cream arm required rest periods due to adverse local skin reactions. Other adverse reactions observed in subjects treated with ZYCLARA Cream include: application site bleeding, application site swelling, chills, dermatitis, herpes zoster, insomnia, lethargy, myalgia, pancytopenia, pruritus, squamous cell carcinoma, and vomiting. Postmarketing Experience The following adverse reactions have been identified during post-approval use of imiquimod. 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.

Pediatric Use AK is a condition not generally seen within the pediatric population. The safety and effectiveness of ZYCLARA Cream for AK in patients less than 18 years of age have not been established. Safety and effectiveness in patients with external genital/perianal warts below the age of 12 years have not been established. Imiquimod 5% cream was evaluated in two randomized, vehiclecontrolled,double-blind trials involving 702 pediatric subjects with molluscum contagiosum (MC) (470 exposed to imiquimod; median age 5 years, range 2–12 years). Subjects applied imiquimod cream or vehicle 3 times weekly for up to 16 weeks. Complete clearance (no MC lesions) was assessed at Week 18. In Study 1, the complete clearance rate was 24% (52/217) in theimiquimod cream group compared with 26% (28/106) in the vehicle group. In Study 2, the clearance rates were 24% (60/253) in the imiquimod cream group compared with 28% (35/126) in the vehicle group. These studies failed to demonstrate efficacy. Similar to the studies conducted in adults, the most frequently reported adverse reaction from 2 studies in children with molluscum contagiosum was application site reaction. Adverse events which occurred more frequently in imiquimod-treated subjects compared with vehicle-treated subjects generally resembled those seen in studies in indications approved for adults and also included otitis media (5% imiquimod vs. 3% vehicle) and conjunctivitis (3% imiquimod vs. 2% vehicle). Erythema was the most frequently reported local skin reaction. Severe local skin reactions reported by imiquimod-treated subjects in the pediatric studies included erythema (28%), edema (8%), scabbing/ crusting (5%), flaking/scaling (5%), erosion (2%) and weeping/ exudate (2%). Systemic absorption of imiquimod across the affected skin of 22 subjects aged 2 to 12 years with extensive MC involving at least 10% of the total body surface area was observed after single and multiple doses at a dosing frequency of 3 applications per week for 4 weeks. The investigator determined the dose applied, either 1, 2 or 3 packets per dose, based on the size of the treatment area and the subject’s weight. The overall median peak serum drug concentrations at the end of week 4 was between 0.26 and 1.06 ng/mL except in a 2-year old female who was administered 2 packets of study drug per dose, had a Cmax of 9.66 ng/ mL after multiple dosing. Children aged 2–5 years received doses of 12.5 mg (one packet) or 25 mg (two packets) of imiquimod and had median multiple-dose peak serum drug levels of approximately 0.2 or 0.5 ng/ mL, respectively. Children aged 6–12 years received doses of 12.5 mg, 25 mg, or 37.5 mg (three packets) and had median multiple dose serum drug levels of approximately 0.1, 0.15, or 0.3 ng/mL, respectively. Among the 20 subjects with evaluable laboratory assessments, the median WBC count decreased by 1.4*10 9/L and the median absolute neutrophil count decreased by 1.42*10 9/L.

Application Site Disorders: tingling at the application site Body as a Whole: angioedema Cardiovascular: capillary leak syndrome, cardiac failure, cardiomyopathy, pulmonary edema, arrhythmias (tachycardia, supraventricular tachycardia, atrial fibrillation, palpitations), chest pain, ischemia, myocardial infarction, syncope Endocrine: thyroiditis Gastro-Intestinal System Disorders: abdominal pain Hematological: decreases in red cell, white cell and platelet counts (including idiopathic thrombocytopenic purpura), lymphoma Hepatic: abnormal liver function Infections and Infestations: herpes simplex Musculo-Skeletal System Disorders: arthralgia Neuropsychiatric: agitation, cerebrovascular accident, convulsions (including febrile convulsions), depression, insomnia, multiple sclerosis aggravation, paresis, suicide Respiratory: dyspnea Urinary System Disorders: proteinuria, urinary retention, dysuria Skin and Appendages: exfoliative dermatitis, erythema multiforme, hyperpigmentation, hypertrophic scar, hypopigmentation Vascular: Henoch-Schonlein purpura syndrome Geriatric Use Of the 320 subjects treated with ZYCLARA Cream in the AK clinical USE IN SPECIFIC POPULATIONS studies, 150 subjects (47%) were 65 years or older. No overall differences Pregnancy in safety or effectiveness were observed between these subjects and Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. younger subjects. ZYCLARA Cream should be used during pregnancy only if the potential Clinical studies of ZYCLARA Cream for EGW did not include sufficient numbers of subjects aged 65 and over to determine whether they benefit justifies the potential risk to the fetus. The animal multiples of human exposure calculations were based on daily respond differently from younger subjects. Of the 400 subjects treated dose comparisons for the reproductive toxicology studies described in with ZYCLARA Cream, 3.75% in the EGW clinical studies, 5 subjects (1%) this section and in Section 13.1. The animal multiples of human exposure were 65 years or older. were based on weekly dose comparisons for the carcinogenicity studies OVERDOSAGE described in Section 13.1. For the animal multiple of human exposure Topical overdosing of ZYCLARA Cream could result in an increased ratios presented in this section and Section 13.1, the Maximum incidence of severe local skin reactions and may increase the risk for Recommended Human Dose (MRHD) was set at 2 packets (500 mg systemic reactions. cream) per treatment of actinic keratosis with ZYCLARA Cream (imiquimod Hypotension was reported in a clinical trial following multiple oral 3.75%, 18.75 mg imiquimod) for BSA comparison. The maximum human imiquimod doses of >200 mg (equivalent to ingestion of the imiquimod AUC value obtained in the treatment of external genital and perianal warts content of more than 21 packets or pump actuations of ZYCLARA Cream, was higher than that obtained in the treatment of actinic keratosis and 3.75% or more than 32 packets or pump actuations of ZYCLARA Cream, was used in the calculation of animal multiples of MRHD that were based 2.5%). The hypotension resolved following oral or intravenous fluid on AUC comparison. administration. Systemic embryofetal development studies were conducted in rats and PATIENT COUNSELING INFORMATION rabbits. Oral doses of 1, 5 and 20 mg/kg/day imiquimod were administered “See FDA-approved patient labeling (Patient Information)” during the period of organogenesis (gestational days 6–15) to pregnant female rats. In the presence of maternal toxicity, fetal effects noted at 20 mg/kg/day (163X MRHD based on AUC comparisons) included increased resorptions, decreased fetal body weights, delays in skeletal ossification, bent limb bones, and two fetuses in one litter (2 of 1567 fetuses) demonstrated exencephaly, protruding tongues and low-set ears. No treatment related effects on embryofetal toxicity or teratogenicity were noted at 5 mg/kg/day (28X MRHD based on AUC comparisons). Intravenous doses of 0.5, 1 and 2 mg/kg/day imiquimod were administered during the period of organogenesis (gestational days 6–18) to pregnant

66 Journal of Dermatology for Physician Assistants

Manufactured for Medicis, The Dermatology Company Scottsdale, AZ 85256 Manufactured by 3M Health Care Limited Loughborough LE11 1EP England Revised: 02/2012 DM/ZCL/13/0011

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