Spring 2013 Journal of Dermatology for Physician Assistants

DPA J

V o l u m e 7 • n u m b e r 2 • S P R I N G 2 0 1 3 • www.jdpa.org

Journal of Dermatology for Physician Assistants

dermatology Pa news & notes

SDPA State Affiliates 13 __________________________________

clinical dermatology JDPA Grand Rounds 36 __________________________________

Surgical dermatology Surgical Wisdom

39

_________________________________

Cosmetic dermatology Journal Club

40

_____________________________ professional development Judicial and Ethical Affairs

›› Earn CME credit with this issue CME Stress Induced Psychocutaneous Manifestations 18

47

Official Journal of the Society of Dermatology Physician Assistants

Volume 7 • number 2 • SPRING 2013

1

#1 PRESCRIBED,

BRANDED TOPICAL ACNE AGENT IN THE WORLD IS...1

NOW THE ONLY TOPICAL ACNE AGENT APPROVED FOR PATIENTS AS YOUNG AS 9 YEARS OF AGE! Important Safety Information Indication: EPIDUO® Gel is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.

Adverse Events: In controlled clinical studies, the most commonly reported adverse events (≥1%) in patients treated with EPIDUO® Gel were dry skin, contact dermatitis, application site burning, application site irritation and skin irritation.

Warnings/Precautions: Patients taking EPIDUO® Gel should avoid exposure to sunlight and sunlamps and wear sunscreen when sun exposure cannot be avoided. Erythema, scaling, dryness, stinging/burning, irritant and allergic contact dermatitis may occur with use of EPIDUO® Gel and may necessitate discontinuation.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see brief summary of full Prescribing Information on next page.

www.epiduo.com/hcp

IMPORTANT INFORMATION ABOUT ®

EPIDUO GEL

(adapalene and benzoyl peroxide) Gel, 0.1% / 2.5% WHAT ARE THE MOST COMMON SIDE EFFECTS OF EPIDUO GEL?

BRIEF SUMMARY This summary contains important information about EPIDUO (EP-E-Do-Oh) gel. It is not meant to take the place of your doctor’s instructions. Read this information carefully before you start using EPIDUO gel. Ask your doctor or pharmacist if you do not understand any of this information or if you want to know more about EPIDUO gel. For full Prescribing Information and Patient Information please see the package insert.

WHAT IS EPIDUO GEL? EPIDUO gel is a prescription medicine for skin use only (topical) used to treat acne vulgaris in people 9 years of age or older. Acne vulgaris is a condition in which the skin has blackheads, whiteheads, and pimples.

The most commonly reported side effects when using EPIDUO gel include erythema, scaling, dryness, application site irritation, stinging and burning.

Depending upon the severity of these side effects, patients should be instructed to use a moisturizer, reduce the frequency of the application of EPIDUO gel, or discontinue use.

Tell your doctor right away if these side effects continue for longer than 4 weeks or get worse, you may have to stop using EPIDUO gel. Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of EPIDUO gel. For more information, ask your doctor or pharmacist.

WHO IS EPIDUO GEL FOR? EPIDUO gel is for use in people 9 years of age and older. It is not known if EPIDUO gel is safe and effective for children younger than 9 years old.

You are encouraged to report negative side effects of prescription drugs to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088. You may also contact GALDERMA LABORATORIES, L.P. at 1-866-735-4137.

Do not use EPIDUO gel for a condition for which it was not prescribed. Do not give EPIDUO gel to other people, even if they have the same symptoms you have. It may harm them.

HOW SHOULD I USE EPIDUO GEL? • Use EPIDUO gel exactly as your doctor tells you to use it. EPIDUO gel is for skin use only. Do not use EPIDUO gel in or on your mouth, eyes, or vagina.

• Apply EPIDUO gel 1 time a day.

• Do not use more EPIDUO gel than you need to cover the treatment area.

Using too much EPIDUO gel or using it more than 1 time a day may increase your chance of skin irritation.

B:12.25”

S:9.5”

T:10.5”

WHAT SHOULD I TELL MY DOCTOR BEFORE USING EPIDUO GEL? Before you use EPIDUO gel, tell your doctor if you: • have other skin problems, including cuts or sunburn.

• have any other medical conditions.

• are pregnant or planning to become pregnant. It is not known if EPIDUO gel can harm your unborn baby.

• are breastfeeding or plan to breastfeed. It is not known if EPIDUO gel passes into your breast milk and if it can harm your baby. Talk to your doctor about the best way to feed your baby if you use EPIDUO gel.

Tell your doctor about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

• Especially tell your doctor if you use any other medicine for acne. Using EPIDUO gel with topical medicines that contain sulfur, resorcinol or salicylic acid may cause skin irritation.

• Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

WHAT SHOULD I AVOID WHILE USING EPIDUO GEL? • You should avoid spending time in sunlight or artificial sunlight, such as tanning beds or sunlamps. EPIDUO gel can make your skin sensitive to sun and the light from tanning beds and sunlamps. You should wear sunscreen and wear a hat and clothes that cover the areas treated with EPIDUO gel if you have to be in the sunlight.

• You should avoid weather extremes such as wind and cold as this may cause irritation to your skin.

• You should avoid applying EPIDUO gel to cuts, abrasions and sunburned skin.

• You should avoid skin products that may dry or irritate your skin such as harsh soaps, astringents, cosmetics that have strong skin drying effects and products containing high levels of alcohol.

• You should avoid the use of “waxing” as a hair removal method on skin treated with EPIDUO gel.

• EPIDUO gel may bleach your clothes or hair. Allow EPIDUO gel to dry completely before dressing to prevent bleaching of your clothes.

APPLYING EPIDUO GEL: • Wash the area where the gel will be applied with a mild cleanser and pat dry.

• EPIDUO gel comes in a tube and a pump. If you have been prescribed the: ο Tube: Squeeze a small amount (about the size of a pea) of EPIDUO gel onto your fingertips and spread a thin layer over the affected area. ο Pump: Depress the pump to dispense a small amount (about the size of a pea) of EPIDUO gel and spread a thin layer over the affected area.

WHERE SHOULD I GO FOR MORE INFORMATION ABOUT EPIDUO GEL? • Talk to your doctor or pharmacist • Go to www.epiduo.com or call 1-866-735-4137

GALDERMA LABORATORIES, L.P., Fort Worth, Texas 76177 USA Revised: February 2013

Reference: 1. IMS Health - Monthly Midas Database, all countries selected - Topical Anti Acne Market - November 2012 MAT, retail RX market - at sales manufacturer local currency dollar value - Copyright IMS Health or its affiliates. All rights reserved.

Galderma and Epiduo are registered trademarks. ©2013 Galderma Laboratories, L.P. Galderma Laboratories, L.P. 14501 N. Freeway Fort Worth, TX 76177 EPI-984R Printed in USA 02/13

www.epiduo.com/hcp

Journal of Dermatology for Physician Assistants

EDITORIAL BOARD

Travis Hayden, MPAS, PA-C, Editor in Chief Joe R. Monroe, MPAS, PA-C 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 Dermoscopy Editor John Burns, 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

SDPA Board of Directors PrESiDEnT John Notabartolo, MPAS, PA-C PrESiDEnT-ElECT Jennifer Winter, PA-C iMMEDiATE PAST PrESiDEnT Keri Holyoak, MPH, PA-C ViCE PrESiDEnT Jacki Kment, MPAS, PA-C SECrETAry / TrEASurEr Joleen Volz, MPAS, PA-C DirECTors AT lArGE Matthew Brunner, MHS, PA-C Greg Buttolph, MPAS, PA-C Jennifer Conner, MPAS, PA-C Vicki Roberts, MPAS, PA-C

editorial missioN: The JDPA is the official clinical journal of the Society of Dermatology Physician Assistants. The mission of the JDPA is to improve dermatological patient care by publishing the most innovative, timely, practiceproven educational information available for the physician assistant profession.

PUBLISHED CONTENT IN THE JDPA: Statements and opinions expressed in the articles and communications herein are those of the authors and not necessarily those of the Publisher or the Society of Dermatology Physician Assistants (SDPA).

The Publisher and the SDPA disclaim any responsibility or liability for such material, including but not limited to any losses or other damage incurred by readers in reliance on such content. Neither Publisher nor SDPA verify any claims or other information appearing in any of the advertisements contained in the publication and cannot take responsibility for any losses or other damage incurred by readers in reliance on thereon. Neither Publisher nor SDPA guarantees, warrants, or endorses any product or service advertised in this publication, nor do they guaranty any claim made by the manufacturer of such product or service.

This Issue: The JDPA includes articles that have been reviewed and approved for Category I (Preapproved) CME credit by the American Academy of Physician Assistants. Approval is valid for 1 year from the issue date, and participants may submit the self-assessment at any time during that period. Category I CME articles included in JDPA are planned and developed in accordance with AAPA’s CME Standards for Journal Articles and for Commercial Support of Journal Articles. going green: Since its inception, the JDPA has utilized eco-friendly printing practices. The JDPA is printed on paper obtained from sustainable forests that meet strict environmental standards. Soy-based inks that have a low environmental impact are used during printing of the journal and the journal is printed using 100% renewable energy. SDPA members may join us in our efforts and opt to receive the JDPA in digital format.

Publishing Staff 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:

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 7, Number 2, Spring 2013. 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. Š 2013 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

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Journal of Dermatology for Physician Assistants

Editor’s Message

I

think it is a fair thing to say that in today’s day and age many of us are able to stay virtually well connected to our friends and family. With the advent of mobile devices and online social networks, we are able to keep in touch with our social support groups regardless of geographic locations. These connections can prove to be beneficial in keeping us up-to-date with our loved ones. Given all of this connectedness, we can easily lose sight of the reality that there are still individuals who may not be connected to their social support networks, including some of our own patients.

Take for example an elderly, widowed patient who lives alone, has outlived all of her close friends, and whose family is living out-of-state. What will she do when you recommend a care plan that she is unable to comply with? Oftentimes our instincts (or even our staff’s) may pick up on situations like this and allow us to assist such patients in managing their overall care by connecting them with available community support resources. On the other hand, how many patients who have no social support systems are we missing? The American Medical Association and the American Psychiatric Association are encouraging healthcare educators to reference in their lectures to students the importance of community auxiliary and ancillary healthcare services. The goal is to educate healthcare students so that they understand that today’s clinical medicine is a shared responsibility among providers representing different areas of expertise, who are all working together for the greater good of patients.

Utilizing a short social inventory checklist in our offices can be a useful tool in identifying this at risk but not always obvious population. If we utilize such a checklist prior to providing care instructions to patients, we can preemptively address issues relating to the dermatological treatments and procedures that are performed in our offices. Patients can answer the short list of questions while they are waiting to be seen for their appointments.

The following are some questions you might want to include: Do you have someone who can help you at home? Do you have access to transportation? Do you have any stress in your life? Do you have any physical limitations? Are you in an abusive relationship (mentally and/or physically), and if so, do you need help? Be sure to include a space at the end of the checklist for patients to jot down any additional questions/concerns they may have.

Reviewing this checklist with our patients before finalizing our treatment plans can often lead to a dialogue where the need for supportive services can be discussed, and we can then make appropriate referrals and encourage utilization of community support resources.

Being familiar with the state of our patients’ social support networks can help us formulate a better care plan for them. Careful use of appropriate support resources (e.g., home care, physical and occupational therapies, infusion therapy, and social services) can optimize our patients’ health outcomes. If we take the time to address our patients’ needs prior to performing a procedure or developing a care plan, we can use these insights to help create a care plan that will make the treatment and recovery process as smooth as possible for our patients. J

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

Volume 7 • number 2 • SPRING 2013

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

18 Stress Induced Psychocutaneous Manifestations

By Melanie S. Nevid, PA-S, Karen Graham, PhD, MPAS, PA-C, Mary Showstark, MPAS, PA-C, and Jeffrey M. Weinberg, MD

›› CME 10 Derm PA News & Notes – part one • SDPA State Affiliates • Certification Review

18 Clinical Dermatology

Departments

04 Editorial Board 05 Editor’s Message 09 SDPA News & Current Affairs 10 Dermatology Market Watch 17 Now Showing on Dermcast.tv 23 From The Patient’s Perspective 26 Dermatopathology Q&A 30 Clinical Snapshots 39 Surgical Wisdom 42 Cosmetic Pearls 46 Notes from your Office Manager 49 Outside & Inside the 9 to 5...

55 The Difference We Make 60 Dermatology in Art 61 JDPA Information for Authors 62 Professional Opportunities and Development

• CME Article – Stress Induced Psychocutaneous Manifestations • Dermoscopy • JDPA Grand Rounds

38 Surgical Dermatology • Journal Club: Practice Changing Articles for Dermatology PAs

40 Cosmetic Dermatology • Journal Club: Practice Changing Articles for Dermatology PAs

45 Professional Development • Dermatology Billing & Coding • Judicial and Ethical Affairs

51 Derm PA News & Notes – part two

Go Green - Read Online 6

Journal of Dermatology for Physician Assistants

• From the Desk of…

• Workplace Excellence • Supervising Physician Corner

dermpa.org

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Indication: Kenalog® Spray (triamcinolone acetonide topical aerosol, USP) is indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Important Safety Information: Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.

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

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see PRECAUTIONS, Pediatric Use).

You are encouraged to report negative side effects of prescription drugs to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch For topical use only. Please see adjacent page for full prescribing information.

For more information, visit www.kenalogspray.com Reference: 1. Data on file. Ranbaxy Laboratories, Inc. Princeton, NJ. * After spraying, the nonvolatile vehicle remaining on the skin contains approximately 0.2% triamcinolone acetonide. Each gram of spray provides 0.147 mg triamcinolone acetonide in a vehicle of isopropyl palmitate, dehydrated alcohol (10.3%), and isobutane propellant.

KENALOG® is a licensed trademark of Bristol-Myers Squibb Company.

KS 1212

Volume 7 • number 2 • SPRING 2013

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Journal of Dermatology for Physician Assistants

FROM THE SDPA

News & Current Affairs

CALENDAR OF EVENTS 2013 JUNE SDPA Summer Dermatology Conference June 27 - 30, 2013 Hyatt Regency at the Arch St. Louis, MO JULY/AUGUST AAD Summer Academy Meeting July 31 – August 4, 2013 Hilton New York New York, NY NOVEMBER SDPA 11th Annual Fall Conference November 13 - 16, 2013 InterContinental Buckhead Atlanta, GA

2014

march 72nd AAD Annual Academy Meeting March 21 - 25, 2014 Denver, CO

Ethics and Integrity: What’s Your Name Worth?

W

e all know them. The speakers who are recognized “experts” on every disease. They are at conferences and dinner programs in every state, speaking on numerous topics, sometimes even presenting on competing products. Do you feel that overexposure dilutes their message?

Most of us do not face such a dilemma. Well, at least not on the same scale.

However, don’t we sometimes get inundated by contradictory information about the medications we write? So how do you decide what is the perfect product for your patient? This is not only a medical question but an ethical one as well.

Having recently had such a conundrum arise in my own life, it set me to thinking, “Would I sell out and, if so, for how much?” There are those who believe that money is the answer, and every person has a price. I’m not one of those people. When I precept students, one of the first lessons I teach is on integrity. My working definition of integrity is, “Doing the right thing, even when no one is watching.” Every prescription you write and chart you complete has your name on it. Sometimes charts are reviewed and prescriptions are audited, but not that often. So what do you do when you know no one is watching?

The SDPA has been focusing some space in the JDPA and at our annual conferences regarding the role of ethics in our profession, workplace, and the field of medicine. My state of Nevada even requires two hours of Ethics CME every two years for state licensing. With the changes to the PhRMA code and the new Sunshine Act policy, all meant to shed light on some potentially unethical practices, I challenge you all to examine your motivation. Who do you represent? Is it your practice, your patients, or yourself? And what is your name worth to you? J

John Notabartolo, MPAS, PA-C SDPA President, Diplomate

Volume 7 • number 2 • SPRING 2013

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Dermatology PA news & notes

Dermatology Market Watch SPOT Orange on Melanoma Monday® Please join the SDPA and the American Academy of Dermatology in painting the nation orange for skin cancer awareness on Monday, May 6th – Melanoma Monday®.

It is currently estimated that one in five Americans will develop skin cancer in their lifetime. Numbers like that make a world without skin cancer seem to be an impossible goal. But it is in our reach. Skin cancer is highly treatable when caught early. The five-year survival rate for people whose melanoma is detected and treated before it spreads to the lymph nodes is 98 percent. Yet, sadly, one American dies from melanoma, the deadliest form of skin cancer, almost every hour.

Help spread the word and encourage others to prevent and detect skin cancer. If you’d like to promote SPOT Orange on Melanoma Monday® to your family, friends and coworkers, visit www.SpotSkinCancer.org/ SPOTOrange for resources. The site also offers a downloadable body mole map for tracking changes in your skin, a search tool to find free skin cancer screenings in your area, and SPOT products.

Camp Discovery Celebrates its 20th Anniversary This year the American Academy of Dermatology (AAD) is celebrating the 20th Anniversary of Camp Discovery with six weeks of Camp in five states; providing an amazing camp experience to approximately 380 children.

Under the expert care of dermatologists, dermatology PAs and nurses, Camp Discovery offers young people the opportunity to spend a week with other children who have similar skin conditions.

Activities include fishing and swimming, ropes courses, horseback riding, arts and craft and hanging out with friends, just to name a few. Many of the counselors also have skin conditions and can provide support and advice.

There is no fee to attend, full scholarships, including transportation, are provided by the AAD through generous donations from its members, outside organizations and individuals. All campers must be referred by their dermatology provider.

For more information about attending or volunteering please visit campdiscovery.org or contact Janine Mueller at (847) 240-1737 or jmueller@aad.org. J 10 Journal of Dermatology for Physician Assistants

Camp Discovery 2013 Dates: Little Pine, Crosslake, Minnesota – ages 10-14 – June 23-28 Camp Reflection, Carnation, Washington – ages 8-16 – June 24-28 Big Trout, Crosslake, Minnesota – ages 14-16 – July 7-12 Camp Horizon, Millville, Pennsylvania – ages 8-13 – August 10-17 Camp Dermadillo, Burton, Texas – ages 9-15, August 11-16 Camp Liberty, Hebron, Connecticut – ages 8-16, August 11-17

CLODERM CREAM The difference is baked right in. ®

Cloderm Cream’s unique molecule, clocortolone pivalate, has no generic alternative • Provides Class IV efficacy with an excellent safety profile1-3 • The pivalate group enhances lipid solubility1 – Clocortolone pivalate is more lipophilic than other commonly used branded midpotent steroids4 • Statistically significant improvement of symptoms at day 43

Not a cookie-cutter corticosteroid

Make Cloderm Cream your 1st choice topical steroid • No age restriction • Available in 90 g tube and 75 g pump • To request samples or for further information, contact Promius Pharma at 888.384.6929 or visit www.Cloderm.com Indication and Important Safety Information Cloderm Cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. The most common adverse events with Cloderm Cream include burning, itching, irritation, dryness, and folliculitis. Cloderm Cream is contraindicated in patients who are hypersensitive to any of the ingredients of this product. As with all topical corticosteroids, systemic absorption can produce reversible HPA-axis suppression. See full prescribing information on reverse side. For more information see www.Cloderm.com.

References: 1. Bikowski J, Pillai R, Shroot B. The position not the presence of the halogen in corticosteroids influences potency and side effects. J Drugs Dermatol. 2006;5(2):125-130. 2. Del Rosso J, Friedlander SF. Corticosteroids: options in the era of steroid-sparing therapy. J Am Acad Dermatol. 2005; 53(1 Suppl 1):S50-58. 3. Data on file. Promius Pharma LLC. Bridgewater, NJ. 4. Royal Society of Chemistry Website. Chem Spider, the free chemical database. Available at http://www.chemspider.com. Accessed June 1, 2011.

Cloderm® is a trademark of Coria Laboratories, Ltd.

Volume 7 • number 2 • SPRING 2013 11

RxOnly

Laboratory Tests: The following tests may be helpful in evaluating the HPA axis suppression: Urinary free cortisol test ACTH stimulation test Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.

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

DESCRIPTION: Cloderm Cream 0.1% contains the medium potency topical corticosteroid, clocortolone pivalate, in a specially formulated water-washable emollient cream base consisting of purified water, white petrolatum, mineral oil, stearyl alcohol, polyoxyl 40 stearate, carbomer 934P, edetate disodium, sodium hydroxide, with methylparaben and propylparaben as preservatives.

Chemically, clocortolone pivalate is 9-chloro-6α-fluoro-11β, 21-dihydroxy-16α methylpregna-1, 4-diene-3, 20-dione 21-pivalate.

Its structure is as follows:

CLINICAL PHARMACOLOGY: Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions.

The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

Pharmacokinetics: The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.

Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses.

(See DOSAGE AND ADMINISTRATION).

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees.

Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

INDICATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.

Pregnancy Category C: Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

Nursing Mothers: It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

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

Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.

ADVERSE REACTIONS: The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: Burning, Itching, Irritation, Dryness, Folliculitis, Hypertrichosis, Acneiform eruptions, Hypopigmentation, Perioral dermatitis, Allergic contact dermatitis, Maceration of the skin, Secondary infection, Skin atrophy, Striae, Miliaria.

OVERDOSAGE: Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

DOSAGE AND ADMINISTRATION: Apply Cloderm (clocortolone pivalate) Cream 0.1% sparingly to the affected areas three times a day and rub in gently.

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

CONTRAINDICATIONS: Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

PRECAUTIONS: General: Systemic absorption of topical corticosteroids has produced reversible hypothalamicpituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.

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

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

Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

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

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

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

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

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

Avoid freezing.

Distributed by:

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity.

(See PRECAUTIONS-Pediatric Use).

If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.

In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

Information for the Patient: Patients using topical corticosteroids should receive the following information and instructions: 1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.

2. Patients should be advised not to use this medication for any disorder other than for which it was prescribed.

3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.

4. Patients should report any signs of local adverse reactions especially under occlusive dressing.

5. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.

12 Journal of Dermatology for Physician Assistants

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

Issued 0711

004158

SDPA State Affiliates

The Missouri Society of Dermatology Physician Assistants

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

RENATA - When did your State Affiliate become established and for what reason?

MOSDPA - We started the St. Louis/Missouri chapter in 2005 as a way to get to know fellow dermatology PA's/ NP's in the area and discuss current issues.

RENATA - How many members do you currently have and how often do you meet?

MOSDPA - There are roughly fifteen PAs in dermatology in the greater St. Louis area with several others in Kansas City, rural Missouri, and southern Illinois. There are several NPs working in dermatology as well. Everyone is invited to join us for our meetings including our supervising physicians (the current dermatology PA/physician relationship is very friendly).

Most meetings consist of a fairly stable group of eight to ten members.

The atmosphere is that of collaboration; we love to get together to learn from one another.

RENATA - What types of topics do you discuss at your meetings?

MOSDPA - We maintain the integrity of our original vision, which was to discuss current dermatology issues, diseases, therapies, and journals. We trade stories and discuss contract negotiations and other professional topics. We have had PAs from out of state, physicians from the area, and a dermatopathologist (once a year) come to speak to our group.

RENATA - Do you have a Tax ID and are you registered as a not-for-profit organization?

MOSDPA - We have our Tax ID number but we are not a 501(c)(3) or 501(c)(6). We organized mainly to

help facilitate and legitimize our sponsorships for monthly meetings. As a group we voted not to pursue a not-forprofit status.

RENATA - Are you in contact with your AAPA State Chapter?

MOSDPA - Several of us are members of the Missouri Academy of Physician Assistants (MOAPA), but we have no official affiliation and are not active in volunteering or lobbying of any kind.

RENATA - You have been an SDPA State Affiliate chapter since 2009. Who should people contact if they are interested in joining your state chapter?

MOSDPA - You can contact anyone of us: Erin Yoffie at erinyoffie@ hotmail.com, Scott Maury at skmdermpa25@att.net, or the current MOSDPA President, Amee Minton at minton33@hotmail.com.

RENATA – What future plans do you have for MOSDPA? MOSDPA - For the most part, this is a very laid back collection of members. We enjoy meeting monthly to discuss local issues affecting dermatology PAs, interesting cases, and new developments within dermatology. We have been doing the same thing for years, and this is what works for us. We are happy maintaining the status quo.

The SDPA currently has 16 State Affiliate chapters.

We continue to grow and would love to have all 50 states participating! It takes teamwork and a strong commitment. For anyone who is interested in starting a SDPA State Affiliate chapter or if you have a state chapter and need some advice about becoming affiliated with the SDPA, please contact me at rblock@dermpa. org. I am here to help all of you! J Volume 7 • number 2 • SPRING 2013 13

DERmatology pa news & notes

The SDPA is excited to be holding its Summer 2013 Dermatology Conference in St. Louis, Missouri this June 27th to the 30th. As Missouri will be the host state for the event, I thought it would be a perfect opportunity to interview the Missouri Society of Dermatology Physician Assistants (MOSDPA) Board of Directors, an SDPA State Affiliate, to find out how they work. The following responses were collaborated among Erin Yoffie, PA-C, Scott Maury, PA-C, and Amee Minton, PA-C. We look forward to seeing everyone in the “Show Me State” this June!

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!

DERmatology pa news & notes

EXPLANATION: The triptans, such as rizatriptan, are effective, acute anti-migraine agents. The mechanism of action is a 5-HT1B/1D agonist leading to constriction of intracranial blood vessels. Significant elevation of blood pressure and cardiac events have been noted with triptan use; therefore, triptans should not be administered to patients with risk factors for coronary artery disease without a cardiac evaluation prior to administration. Drugs used in the prophylactic treatment of migraine headaches include

droperidol (Inapsine), which works as an anti-dopaminergic agent; amitriptyline (Elavil), which works as a serotoninnorepinephrine reuptake inhibitor; and topiramate (Topamax), which works by blocking voltage-dependent sodium channels. J The correct answer is A.

QUESTION: Which of the following is the mechanism of action of rizatriptan (Maxalt)?Which of the following is the most likely diagnosis?

A. 5-HT1 agonist B. Anti-dopaminergic C. Serotonin-norepinephrine reuptake inhibitor D. Blockage of voltage-dependent sodium channels

James A. Van Rhee, MS, PA-C, is the Program Director for the Northwestern University Feinberg School of Medicine Department of Family Medicine Physician Assistant Program. Mr. Van Rhee has been involved in physician assistant education for over 16 years. He has served as project director and test item writer for the Physician Assistant Education Association’s (PAEA) Physician Assistant Clinical Knowledge Rating Assessment Tool (PACKRAT) and is the author of the Physician Assistant: Certification and Re-certification Review Book, published

by Elsevier. For the last ten years he has been course director and presenter of the Physician Assistant Board Review, which is now being produced live online and on-demand by Kaplan Medical.

Being a SDPA Diplomate has great benefits: 1. Earn 70* hours Category 1 CME 2. Online support available 3. $50 Discount on SDPA conferences 4. Private invite-only receptions 5. Personal recognition in medical journals such as the AAD’s Dermatology World, Skin & Aging, and Practical Dermatology 6. Receive a SDPA Diplomate Certificate after completion of the DLI

*CME hours are approximate Benefits_sign_JDPA_HalfPage.indd 1

14 Journal of Dermatology for Physician Assistants

10/12/12 9:46 AM

In the first-line treatment of external genital and perianal warts (EGW)…

Put patients in the clear.

VEREGEN® Delivers Complete Clearance With Low Recurrence*1 • 53.6% of patients demonstrated complete clearance1 —Only 6.8% of patients with complete clearance experienced recurrence at 12 weeks posttreatment1 • Sinecatechins Ointment, 15% is now included in the Centers for Disease Control and Prevention (CDC) Sexually Transmitted Diseases Treatment Guidelines2 —Listed as a patient-applied treatment option for EGW

• The most common adverse reactions were local skin and application site reactions1 *At 12 weeks posttreatment in the two phase 3 studies.

VEREGEN® is indicated for the topical treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older.

Important Selected Safety Information VEREGEN® has not been evaluated to treat urethral, intra-vaginal, cervical, rectal, or intra-anal human papilloma viral disease and should not be used to treat these conditions. Avoid use of VEREGEN® on open wounds.

Avoid exposure of VEREGEN®-treated areas to sun/UV-light because VEREGEN® has not been tested under these circumstances. Safety and efficacy of VEREGEN® have not been established in immunosuppressed patients or patients under 18 years of age, or The FIRST pregnant women, or for the treatment BOTANICAL DRUG of external genital and perianal warts approved for prescription use in the United States beyond 16 weeks or for multiple treatment courses.

The most common adverse reactions are local skin and application site reactions including (incidence ≥ 20%) erythema, pruritus, burning, pain/ discomfort, erosion/ulceration, edema, induration, and rash vesicular.

3

References: 1. VEREGEN® Ointment, 15% [Prescribing Information, 2011]. Melville, NY: PharmaDerm, a division of Fougera Pharmaceuticals Inc. 2. Workowski KA, Berman S; Centers for Disease Control and Prevention.

Sexually transmitted diseases treatment guidelines, 2010. MMWR Recomm Rep. 2010;59(RR-12):1-110. 3. Data on file, PharmaDerm.

Please see adjacent page for Brief Summary of full Prescribing Information.

VEREGEN is a registered trademark of MediGene AG, D-82152 Planegg/Martinsried, Germany. ©2012 PharmaDerm, a division of Fougera Pharmaceuticals Inc. Melville, NY 11747. All rights reserved. 98NVE030212

Volume 7 • number 2 • SPRING 2013 15

Brief Summary of Prescribing Information–See Package Insert for Full Prescribing Information at www.pharmaderm.com

Veregen

®

(sinecatechins)

Ointment, 15% Rx Only

For Topical Dermatologic Use Only

Nursing Mothers It is not known whether topically applied Veregen® is excreted in breast milk.

Pediatric Use Safety and effectiveness in pediatric patients have not been established.

Geriatric Use Seven patients (1.4%), older than 65 years of age were treated with Veregen® in clinical studies. This, however, is an insufficient number of subjects to determine whether they respond differently from younger subjects.

ADVERSE REACTIONS

INDICATIONS AND USAGE

Veregen® is a topical ointment indicated for the treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older.

Limitations of Use: Safety and effectiveness of Veregen® have not been established in immunosuppressed patients, in treatment of external genital and perianal warts beyond 16-weeks, or for multiple treatment courses.

CONTRAINDICATIONS None

CLINICAL STUDIES

Two randomized, double-blind, vehicle-controlled studies were performed to investigate the safety and efficacy of Veregen® in the treatment of immunocompetent patients 18 years of age and older with external genital and perianal warts. The subjects applied the ointment 3 times daily for up to 16 weeks or until complete clearance of all warts (baseline and new warts occurring during treatment).

Over both studies the median baseline wart area was 51 mm2 (range 12 to 585 mm2), and the median baseline number of warts was 6 (range 2 to 30).

The primary efficacy outcome measure was the response rate defined as the proportion of patients with complete clinical (visual) clearance of all external genital and perianal warts (baseline and new) by week 16, presented in Tables 1 and 2 for all randomized subjects dispensed medication.

Table 1: Efficacy by Region Complete Clearance All Countries (includes the United States) Veregen® 15% (N = 397) 213 (53.6%) Vehicle (N = 207) 73 (35.3%) United States Veregen® 15% (N = 21) 5 (23.8%) Vehicle (N = 9) 0 (0.0%) Table 2: Efficacy by Gender Complete Clearance Males Veregen® 15% (N = 205) 97 (47.3%) Vehicle (N = 118) 34 (28.8%) Females Veregen® 15% (N = 192) 116 (60.4%) Vehicle (N = 89) 39 (43.8%) Median time to complete wart clearance was 16 weeks and 10 weeks, respectively, in the two phase 3 clinical trials.

The rate of recurrence of external genital and perianal warts 12 weeks after completion of treatment in subjects with complete clearance is 6.8% (14/206) for those treated with Veregen® and 5.8% (4/69) for those treated with vehicle.

WARNINGS AND PRECAUTIONS

Veregen® should not be used to treat urethral, intra-vaginal, cervical, rectal, or intra-anal human papilloma viral disease.

Use of Veregen® on open wounds should be avoided.

Avoid exposure of Veregen® treated areas to sun/UV-light as Veregen® has not been tested under these circumstances.

USE IN SPECIFIC POPULATIONS

Pregnancy Pregnancy Category C: There are no adequate and well controlled studies in pregnant women. Veregen® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

16 Journal of Dermatology for Physician Assistants

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 Phase 3 clinical trials, a total of 397 subjects received Veregen® three times per day topical application for the treatment of external genital and perianal warts for up to 16 weeks.

Serious local adverse events of pain and inflammation were reported in two subjects (0.5%), both women.

In clinical trials, the incidence of patients with local adverse events leading to discontinuation or dose interruption (reduction) was 5% (19/397). These included the following events: application site reactions (local pain, erythema, vesicles, skin erosion/ulceration), phimosis, inguinal lymphadenitis, urethral meatal stenosis, dysuria, genital herpes simplex, vulvitis, hypersensitivity, pruritus, pyodermitis, skin ulcer, erosions in the urethral meatus, and superinfection of warts and ulcers.

Local and regional reactions (including adenopathy) occurring at >1% in the groups treated with Veregen® (N=397) or vehicle (N=207), respectively, were: erythema (70%, 32%), pruritus (69%, 45%), burning (67%, 31%), pain/discomfort (56%, 14%), erosion/ulceration (49%, 10%), edema (45%, 11%), induration (35%, 11%), rash vesicular (20%, 6%), regional lymphadenitis (3%, 1%), desquamation (5%, <1%), discharge (3%, <1%), bleeding (2%, <1%), reaction (2%, 0%), scar (1%, 0%), irritation (1%, 0%), and rash (1%, 0%).

A total of 266/397 (67%) of subjects in the Veregen® group had either a moderate or a severe reaction that was considered probably related to the drug, of which 120 (30%) subjects had a severe reaction. Severe reactions occurred in 37% (71/192) of women and in 24% (49/205) of men. The percentage of subjects with at least one severe, related adverse event was 26% (86/328) for subjects with genital warts only, 42% (19/45) in subjects with both genital and perianal warts and 48% (11/23) of subjects with perianal warts only.

Phimosis occurred in 3% of uncircumcised male subjects (5/174) treated with Veregen® and in 1% (1/99) in vehicle.

The maximum mean severity of erythema, erosion, edema, and induration was observed by week 2 of treatment.

Less common local adverse events included urethritis, perianal infection, pigmentation changes, dryness, eczema, hyperesthesia, necrosis, papules, and discoloration. Other less common adverse events included cervical dysplasia, pelvic pain, cutaneous facial rash, and staphylococcemia.

In a dermal sensitization study of Veregen® in healthy volunteers, hypersensitivity (type IV) was observed in 5 out of 209 subjects (2.4%) under occlusive conditions.

DOSAGE AND ADMINISTRATION

Veregen® is to be applied three times per day to all external genital and perianal warts.

Apply about an 0.5 cm strand of ointment to each wart using the finger(s), dabbing it on to ensure complete coverage and leaving a thin layer of the ointment on the warts.

Veregen® is not for ophthalmic, oral, intra-vaginal, or intra-anal use.

HOW SUPPLIED/STORAGE AND HANDLING

Veregen® is a brown ointment and is supplied in an aluminum tube containing 15 grams (NDC # 10337-450-15) of ointment per tube.

Prior to dispensing to the patient, store refrigerated 2°C to 8°C (36°F to 46°F).

After dispensing, store refrigerated or up to 25°C (77°F). Do not freeze.

Manufactured for:

Manufactured by: C.P.M. Contract Pharma GmbH & Co. KG Frühlingstrasse 7 D-83620 Feldkirchen-Westerham Germany U.S. Patent Nos. 5795911 and 5968973

98NVE060312

Now Showing on Dermcast.tv

The Official Online Media Resource of the SDPA Updated weekly, Dermcast.tv is your source for audio podcasts, the most current dermatology news and research, procedural videos, conference highlights, and much, much more. Best of all, as members of the SDPA, everything on Dermcast.tv is not only tailored precisely for you and your needs, it is available to you FREE!

SPECIFIC URL: http://dermcast. http://bit.ly/XinRgf Image by Valerie Yermal

SPECIFIC URL: http://bit. ly/11Y7Ptp Image by Tom Lohdan

SPECIFIC URL: http://bit.ly/XNMKuY Image by Glen Harper

Vermont: Supervising Physicians Ruled Not Responsible for PAs Actions The Vermont Supreme Court recently ruled that supervising physicians are not legally liable for the actions of their PAs, in an interesting-but-bizarre case that could have had negative consequences for PAs around the USA.

Relax, Don’t Do it: German Study Shows Main Motivation for Tanning Beds is Relaxation While it is true that every third cancer case diagnosed in developed countries is skin related, researchers in a new study found that information is still quite limited regarding the prevalence of tanning beds and the characteristics of users.

For instance, what is the true motivation of those using tanning beds; could it be that motivating factors go beyond just simply "getting tan"?

Obamacare and the Ever-Growing Need for PAs

What does the Affordable Care Act, also known as Obamacare, mean for PAs as well as those treated by PAs? The Affordable Care Act is extending healthcare to more American citizens and therefore increasing the need for more healthcare providers. This demand is not quickly met with the rigorous and time intensive requirements of obtaining an MD/DO.

SDPA Rebuffs Inaccurate Article in Practical Dermatology

The November 2012 edition of Practical Dermatology contained an article entitled, “We Have an Identity Crisis,” which attempted to lay out the crucial need for standardized terminology within the medical community, particularly when it comes to non-physician medical providers.

Unfortunately, the article, written by three nurse practitioners (NP) and two physicians, contained numerous errors about physician assistants. In response, SDPA Director-at-Large Vicki Roberts, PA-C has written an official rebuttal, which has recently been published in Practical Dermatology. J

Volume 7 • number 2 • SPRING 2013 17

DERmatology pa news & notes

SPECIFIC URL: http://bit.ly/16nyUFk Image by Norman B. Leventhal Map Center at the BPL

Clinic al Dermatology

Stress Induced Psychocutaneous Manifestations

By Melanie S. Nevid, MPAS, PA-S, Karen Graham, PhD, MPAS, PA-C, Mary Showstark, MPAS, PA-C and Jeffrey M. Weinberg, MD

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

›› CME

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

Approval is valid for 1 year from the issue date of April 2013.

Participants may submit the self-assessment exam at any time during that period.

This program was planned in accordance with AAPA’s CME Standards for Enduring Material Programs and for Commercial Support of Enduring Material Programs.

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

Learning Objectives: 1. Understand the role of stress in psychocutaneous disease.

2. Recognize the classification of psychodermatologic disorders.

3.

Recognize the following psychodermatologic disorders: acne excoriée, neurodermatitis, dermatitis artefacta, trichotillomania, neurotic excoriations, and psychogenic pruritus.

4. Describe treatment options for psychodermatologic disorders.

18 Journal of Dermatology for Physician Assistants

Stress Induced Psychocutaneous Manifestations 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 7 • number 2 • SPRING 2013 19

Stress Induced Psychocutaneous Manifestations SDPA Members Only Content

CLINIC AL Dermatology

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

20 Journal of Dermatology for Physician Assistants

Stress Induced Psychocutaneous Manifestations 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 7 • number 2 • SPRING 2013 21

Stress Induced Psychocutaneous Manifestations Melanie S. Nevid, MPAS, PA-S is currently enrolled at Touro College, School of Health Sciences, Physician Assistant Program in New York, NY. She will be graduating in April 2013 and plans to practice in dermatology. She has indicated no relationships to disclose relating to the content of this article.

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.

Karen Graham, PhD, MPAS, PA-C is an associate clinical professor at the University of Wisconsin-La Crosse-GundersenMayo Physician Assistant Program, where she teaches courses in evidence-based medicine and clinical practice skills. She received her Master’s degree from the University of Iowa in Physician Assistant Studies and her PhD in Higher Education Administration from the University of Toledo. She has indicated no relationships to disclose relating to the content of this article.

Mary Showstark, MPAS, PA-C is a physician assistant who graduated with a Master’s Degree, in 2004 from the University of Florida. She has worked in trauma surgery, emergency medicine, urgent care, and for the federal government: DMAT. She currently works as an instructor and clinical coordinator for the Touro College, School of Health Sciences, Physician Assistant Program.

She has indicated no relationships to disclose relating to the content of this article.

CLINIC AL Dermatology

Jeffrey M. Weinberg, MD, is an associate clinical professor of dermatology at Columbia University College of Physicians and Surgeons in New York City. In addition, he is director of the Clinical Research Center at St. Luke’s-Roosevelt Hospital Center and acting director of the Division of Dermatology at Jamaica Hospital Medical Center, both in New York City. Dr. Weinberg graduated from the University of Pennsylvania School of Medicine in Philadelphia and completed an internship in medicine at Columbia-Presbyterian Medical Center in New York City. He then completed a residency in dermatology at the University of Pennsylvania School of Medicine.

Dr. Weinberg is a Fellow of the American Academy of Dermatology, where he has served on several committees, and a member of the Dermatology Foundation. He is a diplomate of the American Board of Dermatology.

&

Dermatopathology Q A

By Dipti Anand, MD

Question: A 62 year old female presents with an intensely pruritic papular eruption involving the dorsal aspect of her hands and ankles and the flexor aspect of her forearms. The clinical impression is lichen planus.

A punch biopsy from her forearm will show which one of the two histologic findings?

Under the microscope [H&E stain (400x)] Answer on page 26

22 Journal of Dermatology for Physician Assistants

From The Patient’s Perspective If Only I Had Listened

Forty years ago (I'm 59 now) having a tan was an absolute Next stop was to meet with my melanoma oncologist, Dr. necessary "fashion accessory." Unfortunately, I have blonde Drabich, who was back from vacation. The first time I met hair, light green eyes, and very fair skin. I simply didn't tan. with him I forbade him to give me a prognosis (I knew it was I burned. My mother was always lecturing me that spending grim from all that I had read). I told him that all I needed to too much time in the sun was bad for me. So, much to my know was what we were going to do next to move forward. My mother's dismay, from the time I was fifteen years old my daughter was a senior in high school and my son a junior in mission every summer was to get as tan as possible. Sunblock college. Nope. Don't have time for this. Let's get moving and wasn't a concept back then, so I used suntan lotion or at times, I want the most "kick-ass" treatment you have. He smiled and even worse, baby oil with iodine. I found the most effective said he had one for me called Interleukin 2 (IL-2), a biotherapy time to lay out was between 10:00AM - 2:00PM. Of course, I that is very effective on a small number of patients (less than had to get an even tan, so I would set a timer and "flip" every 6%), but works well on those patients who respond favorably hour on the hour. I did this every single day in the summer to it. He explained that I would have to have both heart and that I could when I wasn't working. lung screenings before attempting the treatment because it is "pretty Fast forward to the fall of rough." (That was the biggest “I forbade him to give me a 2002. I had a suspicious mole understatement I think I've ever removed from the back of my prognosis… I told him that all I heard). I "passed" both tests and left shoulder. Thankfully, the approved for treatment. dermatologist was "certain" needed to know was what we were was However, before I started, I that he got it all. I was fine, go for a second opinion at the "horse hadn't left the barn," going to do next to move forward.” did Johns Hopkins Hospital. I met and I was told it was a very good with Dr. Scharfman, who is a prognosis. All remained well until recognized expert in the treatment July of 2008. I began to develop a dry, of metastatic melanoma.

He examined me, looked at all of unproductive cough that I just couldn't seem to get rid of. my scans and test results, and agreed with the treatment plan Then on July 30th, 2008 (funny how there are some dates you that had been laid out by Dr. Drabich at the Hershey Medical just never forget), I ended up in the emergency room because I Center. Since I lived so close to the hospital in Hershey, I couldn't stop coughing, and my chest had become very tight. elected to get the treatment done there.

I thought I might be having a heart attack and didn't want to take any chances. After about five hours in the ER and a IL-2 is such a toxic treatment that it is administered multitude of scans and tests, the ER doctor on duty told me inpatient. At the time (and now I'm finding that they are that I had cancer - tumors in my brain, lungs, uterus, and an "tweaking" the protocol in some clinical trials, so the treatment especially large one that was growing and pressing against my delivery varies, to some degree these days), the plan was for windpipe, which was causing the cough. me to be admitted to the hospital and “offered” fourteen treatments (one every eight hours) each hospitalization. The I was admitted immediately into the Milton S. Hershey Medical Center (about 5 minutes from my house). Based on my past history of the melanoma that had been removed, they were guessing that the spots they were now seeing were metastatic melanoma. It turned out they were right, and my world began to come crashing down on me. Gratefully, the doctors at the hospital acted very quickly. Within a day of my discharge, the brain oncologist called me personally and asked me if I could come in the next day; he wanted to meet with me. The oncologist specializing in melanoma was on vacation, The mission of AIM at Melanoma is to increase support for and the brain oncologist wanted to address the brain "mets" melanoma research; to promote prevention and education ASAP so that my treatments with the melanoma oncologist among the general public and medical professionals; and could start as quickly as possible upon his return. I met with to provide comprehensive and easily accessible melanoma resources for patients, survivors, and caregivers.

Dr. Wagner who discussed my options and suggested that they perform Gamma Knife surgery to "knock out" the spot on Contact information: www.AIMatMelanoma.org my brain. I agreed, and within just a few days I found myself 3217 Bob O Link Court, Plano, TX 75093 having a metal "halo" screwed into my skull (a device used to Patient support: nurseoncall@aimatmelanoma.org 877-AIM-2ME calibrate the radiation rays and make sure that as little brain Patients and caregivers can call or e-mail for answers about early tissue as possible is damaged, focusing the treatment on the detection, diagnosis, treatment, and follow-up. cancer metastasis).

Volume 7 • number 2 • SPRING 2013 23

CLINIC AL Dermatology

By Sharon Swanger

CLINIC AL Dermatology

From The Patient’s Perspective times they “offered” the treatments were 7:00AM, 3:00PM, and 11:00PM. I was monitored around the clock for blood pressure, heart rate, and blood oxygen levels. Assuming everything looked ok, I would be “offered” another treatment.

I knew that my best chance was to get as much of this stuff in my system as possible, so I never refused a treatment. The ones I missed were because my vital signs were questionable, and the physician monitoring this process would pass until the next treatment time. The nurses told me they considered seven treatments out of fourteen a success. As I recall, the first week I was able to tolerate twelve of fourteen sessions. IL-2 is not chemotherapy or radiation but a biotherapy which is designed to "ramp up" the patient's immune system to attack the cancer cells. Unfortunately, the patient feels as though it's the worse flu they've ever had. Your body is wracked with tremors (for me, lasting about a half an hour after treatment, with unbelievable chills and sweats). About the only thing that gave me relief was a shot of Demerol administered at exactly the right time.

So, the plan was to have one week in the hospital, one week off, and then back in to do it all again. I would wait two weeks and then have scans to determine if I was responding.

Side effects after being discharged from the hospital (for me) were a water weight gain of about thirty pounds, bloating, itchy skin, and very sore joints. After I completed the first successful round of IL-2, I started my second. During the second round, I was only able to tolerate eight treatments the first week.

After seven treatments during the second week, I developed a very serious infection in my port. That was it. I was done with IL-2. They removed the port, and I was sent home - sick, stiff, sore, and feeling that I had failed. Scans showed that the tumors were still shrinking, and I was definitely moving in the right direction. My melanoma oncologist then put me on an oral chemotherapy drug called Temodar. I had regular threemonth checkups and scans that showed both no new evidence of disease and the tumors continuing to shrink.

One bump in the road was that the spot on my brain had reappeared. In retrospect, knowing that IL-2 causes swelling, doctors believed that the effects of the IL-2 caused the "dead tissue” left by the Gamma Knife surgery to swell and grow. The spot began to cause problems with my judgment, memory, and depth perception. I had to stop driving. They tried a second Gamma Knife surgery to address this issue, but it didn't help. The spot continued to increase in size and cause problems. The good news was that there wasn't anything new showing up, just the same stubborn area. It was decided that I would have brain surgery to remove the spot. Around July of 2009, I had the brain surgery to remove what turned out to be “dead tissue” with no signs of cancer at all.

Recovery from the brain surgery took me about three months, but brain scans (I have them every two years) look good with no evidence of disease or further problems. Since that time, the only treatments I have had are regular six month scans and appointments with my melanoma oncologist, and two year follow-ups with the brain oncologist. July of this year will mark five years since my diagnosis! After my next scan, my oncologist has stated that he will most likely put me on a one year schedule. He even hinted at the using the word cure. I've 24 Journal of Dermatology for Physician Assistants

since read that patients with my diagnosis generally have a less than 10% chance of living five years. I've learned not to focus on these numbers.

Now, about the tanning bed issue. When I was diagnosed, I retired so that I could battle my disease. As a result, I had a lot of free time on my hands and began reading quite a bit.

I soon learned that young people (especially young women) were being diagnosed with advanced stage melanoma in "epidemic proportions." Why? From what I've learned, one reason is because of the increased use of tanning beds by our teens. I will admit that I have never set foot in a tanning bed.

I abused my skin the free and old-fashioned way - laying out unprotected in the sun. However, my point is MELANOMA IS MELANOMA. The consequences are the same, no matter how you get the disease. This prompted a discussion with my sister-in-law, Pennsylvania House Representative RoseMarie Swanger. We talked about the status of tanning bed regulations (or lack thereof) in the state of PA. RoseMarie witnessed firsthand the horrors of the treatment associated with this disease and, as she learned more about the dangers that tanning beds pose especially to young people, she became determined to do something about it. She considers herself a public servant, sworn to protect the health and safety of the citizens of PA. In proposing her legislation, she has endured criticism from those factions who consider this type of legislation "inconsequential," infringing on the rights of parents to make their own decisions for their children, and of course, doing harm to small business owners (many of them women) in the state of PA. It hasn't been easy. I'm proud to tell you that on Monday, April 8th, 2013 she held a press conference to announce the introduction of HB 977 that will protect our teens in the state of PA from using tanning beds.

She could cave to the criticism and walk away. However, now that she knows what she knows, she simply can't walk away.

Sadly, in researching and learning about this issue, we've "met" too many parents who simply didn't know and/or understand the dangers posed by tanning beds. In fact, one of the voices that was heard on Monday at the press conference was that of Doreen Nortum-Buckel who lost her beautiful daughter Jen to tanning bed use. It was a needless death.

Doreen promised Jen before she passed away that she would do everything possible to get the word out about the dangers of tanning bed use and better yet, support efforts to keep kids from using indoor tanning in the same manner that we don't allow them to make the decision to smoke before they're eighteen. There simply is no difference. The results of teen tanning and teen smoking are the same - illness, suffering, unnecessary medical expenses, and worst of all, in many instances, death.

And, I haven't even mentioned the cost. I checked with my insurance company a couple of years ago to find out how much they had paid out in treatment costs for me. About three years ago my treatment cost was up to $860,000. I'm guessing that by now I am a million dollar woman. Why? Because I didn't listen to my mother who knew better. More than likely, this could have been avoided; it didn't have to be. If only I had listened. J

Take Home Points for Derm PAs:

By Steven K. Shama, MD, MPH

2. It is difficult to know how a patient’s positive attitude helps in terms of long-term survival but it would appear that Sharon certainly had a very positive one from the very beginning of being diagnosed with melanoma. She lets us know that she is the captain of her team by sharing that she is meeting with “my” oncologist. She forbid her oncologist to “give me a prognosis… all I needed to know was what we were going to do next to move forward… Let’s get moving and I want the most ‘kick-ass’ treatment you have.” Can we help shape the energy a patient brings to the first meeting and direct it in a way that supports realistic hope?

3. I have written about this before in a previous piece about hope in the JDPA. Sharon states that she has learned not to focus on the numbers, given patients with her diagnosis generally have a less than 10% chance of surviving five years. May I suggest that you leave it up to your patients to decide whether they will focus on the 10% chance of surviving, or the 90% likelihood of dying in five years. While you can suggest the 10% survival numbers may be a positive way of looking at the future, our patients are the only ones who can define hope for themselves and can work with you on treatment options. It is only fair.

a r e f Re

!

R E B P I M H S E R M EMBE S D PA M

d our n e t x e to excited e r a e W paign! m a C r Membe Refer a

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.

Volume 7 • number 2 • SPRING 2013 25

CLINIC AL Dermatology

Sharon Swanger is retired after twenty-eight years of working with the Social Security Administration. She lives in Hershey, PA with her best friend, husband, and caregiver, Michael, with whom she will celebrate their 30th wedding anniversary this year.

She and Michael have two children, Philip age 25 and Sara age 21. Since her retirement, she has been working to help her sister-in-law RoseMarie Swanger push to get legislation passed in PA that would protect teens under the age of 18 from using tanning beds.

She also serves as a “Voices of Hope” speaker for the American Cancer Society. In her spare time, she enjoys traveling and walking dogs for the Harrisburg Area Humane Society.

1. When you are dealing with a teenager, be aware of how you word your message.

Sharon lets us know that her mother told her, “spending too much time in the sun was bad for me” so her “mission every summer was to get as tan as possible.” While it is difficult to know exactly how to express your message about the dangers of tanning, let your young patients know that you understand why they may want to look more tan, that there is much information to suggest that the sun is not necessarily their friend, and that there are ways of tanning (e.g., using skin cream applied dihydroxyacetone products) that are not known to be harmful to the skin.

Look for a buy-in, by asking, ”Would you try this approach for me and let me know how it is working?”

&

Dermatopathology Q A

By Dipti Anand, MD

SDPA Members Only Content

CLINIC AL Dermatology

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

Dipti Anand, MD is a board-certified dermatopathologist specializing in the diagnosis of various inflammatory and neoplastic diseases of the skin. She is an associate dermatopathologist at SkinPath Solutions in Atlanta, Georgia. Dr. Anand received her medical degree at M.S. Ramaiah Medical College in India. She then successfully completed internships at Dr. Ram Manohar Lohia Hospital and Handa Medical Center and Diagnostic Laboratory in New Delhi. She then moved to Philadelphia, Pennsylvania in 2004 and completed an internship in Internal Medicine at Albert Einstein Medical Center and a Pathology Residency at the Hospital of University of Pennsylvania. She attended a fellowship in dermatopathology at the University of Texas Southwestern under the training of Dr. Cockerell.

Dr. Anand is board certified in pathology as well as dermatopathology. She enjoys teaching dermatopathology to dermatologists, residents, and physician assistants. She is active in the education of residents at the Medical College of Georgia and Emory University Medical School. Dr. Anand is an active member of the Atlanta Dermatology and Dermatologic Surgery Society, the Georgia Society of Dermatology and Dermatologic Surgery, the American Academy of Dermatology, and the American Society of Dermatopathology. She has indicated no relationships to disclose relating to the content of this article.

26 Journal of Dermatology for Physician Assistants

For the treatment of moderate to severe plaque psoriasis for up to 4 weeks in adults

THINK FAST Early results with Clobex® (clobetasol propionate) Spray, 0.05% • An average of 80% of patients were clear or almost clear at week 4 in 2 pivotal phase III trials with CLOBEX® Spray (n=120)1* • At week 1, 74% of patients showed improvement in Overall Disease Severity (ODS) by at least one grade2 • The most common adverse reactions (>2%) were burning, pruritus, nasopharyngitis and upper respiratory tract infection1*

*From 2 randomized, vehicle-controlled clinical trials that were identically designed to assess the efficacy and safety of CLOBEX® Spray (n=120) or vehicle spray (n=120) in patients with moderate to severe plaque psoriasis for up to 4 weeks. Patients were evaluated on their ODS.1 Important Safety Information for Clobex® Spray Indication: CLOBEX® Spray, 0.05% is indicated for the topical treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in adults 18 years of age or older. Adverse Events: In controlled clinical studies, the most common adverse reactions (> 2%) were burning, pruritus, nasopharyngitis and upper respiratory tract infection. Local adverse reactions may occur more frequently with the use of occlusive dressings. Warnings/Precautions: Clobetasol propionate has been shown to suppress the HPA axis at the lowest doses tested. Treatment should be limited to 4 weeks. The total dosage should not exceed 50 g (59 mL or 2 fl oz) per week. Do not use more than 26 sprays for each application or more than 52 sprays in 1 day.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see adjacent page for brief summary of Prescribing Information.

Volume 7 • number 2 • SPRING 2013 27

IMPORTANT INFORMATION ABOUT ®

CLOBEX SPRAY, 0.05% (clobetasol propionate)

BRIEF SUMMARY This summary contains important information about CLOBEX [KLO-bex] Spray, 0.05%. It is not meant to take the place of your doctor’s instructions.

Read this information carefully before you start using CLOBEX Spray.

Ask your doctor or pharmacist if you do not understand any of this information or if you want to know more about CLOBEX Spray. For full Prescribing Information and Patient Information please see the package insert.

WHAT IS CLOBEX SPRAY? CLOBEX Spray is a prescription corticosteroid medicine used to treat adults with moderate to severe plaque psoriasis that affects up to 20% of the body’s skin surface. CLOBEX Spray is for use on the skin only (topical).

• CLOBEX Spray should only be used for the shortest amount of time needed to treat your plaque psoriasis.

• Do not use more than 26 sprays for each application or more than 52 sprays in 1 day.

• You should not apply more than 59 mL (2 fluid ounces) of CLOBEX Spray to your skin in 1 week.

You should not use CLOBEX SPRAY: • on your face, under arms (armpits), or groin area • if you have thinning of the skin (atrophy) at the treatment site • to treat rosacea or perioral dermatitis (a rash around the mouth) WHO IS CLOBEX SPRAY FOR? CLOBEX Spray is for use in adults 18 years of age or older.

Use in people under 18 years of age is not recommended because safety has not been established and because numerically high rates of HPA axis suppression were seen with other clobetasol propionate topical formulations.

Do not use CLOBEX Spray for a condition for which it was not prescribed. Do not give CLOBEX Spray to other people, even if they have the same symptoms you have. It may harm them.

WHAT SHOULD I TELL MY DOCTOR BEFORE USING CLOBEX SPRAY? Before you use CLOBEX SPRAY, tell your doctor if you: • have a skin infection. You may need medicine to treat the skin infection before you use CLOBEX Spray.

• plan to have surgery.

• have any other medical conditions.

• are pregnant or plan to become pregnant. It is not known if CLOBEX Spray will harm your unborn baby.

• are breast-feeding or plan to breast-feed. It is not known if CLOBEX Spray passes into your breast milk. Talk to your doctor about the best way to feed your baby if you use CLOBEX Spray.

Tell your doctor about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Especially tell your doctor if you take other corticosteroid medicines by mouth or use other products on your skin that contain corticosteroids.

Ask your doctor or pharmacists if you are not sure.

WHAT ARE THE MOST COMMON SIDE EFFECTS OF CLOBEX SPRAY? CLOBEX SPRAY can pass through your skin. Too much CLOBEX Spray passing through your skin can shut down your adrenal glands. Your doctor may need to do blood tests to check for adrenal gland function while you are on CLOBEX Spray.

The most common side effects with CLOBEX Spray include: • burning at treated site • upper respiratory tract infection • runny nose • sore throat • dry, itchy, and reddened skin If you go to another doctor for illness, injury or surgery, tell that doctor you are using CLOBEX Spray. Tell your doctor if you have any side effect that bothers you or doesn’t go away. These are not all of the possible side effects of CLOBEX Spray. For more information, ask your doctor or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088. You may also contact GALDERMA LABORATORIES, L.P. AT 1-866-735-4137.

HOW SHOULD I USE CLOBEX SPRAY? • Use CLOBEX Spray exactly as your doctor tells you to use it.

• Your doctor should tell you how much CLOBEX Spray to use and when to apply it.

• CLOBEX Spray is for use on skin only. Do not get CLOBEX Spray near or in your eyes, mouth, or vagina.

• You should not use CLOBEX Spray on your face, under arms (armpits), or groin area.

• Apply CLOBEX Spray 2 times each day.

• Apply only enough CLOBEX Spray to cover the affected skin area.

Rub in gently.

• Wash your hands after using CLOBEX Spray.

• Throw away any unused CLOBEX Spray.

• Do not bandage or cover your treated areas unless your doctor tells you to.

• Tell your doctor if your skin condition is not getting better after 2 weeks of using CLOBEX Spray.Your doctor may tell you to apply CLOBEX Spray to certain areas of your skin for up to 2 more weeks if needed. You should not use CLOBEX Spray for more than 4 weeks unless your doctor tells you to. This can increase your risk of serious side effects.

WHERE SHOULD I GO FOR MORE INFORMATION ABOUT CLOBEX SPRAY? • Talk to your doctor or pharmacist • Go to www.clobex.com or call 1-866-735-4137 GALDERMA LABORATORIES, L.P., Fort Worth, Texas 76177 USA Revised: March 2012 2004953-0111-BS

WHAT SHOULD I AVOID WHILE USING CLOBEX SPRAY? • CLOBEX Spray is flammable. Avoid heat, flames or smoking while applying CLOBEX Spray to your skin.

References: 1. Clobex® Spray Prescribing Information. September 2012. Galderma Laboratories, L.P. 2. Data on file. Galderma Laboratories, L.P. © 2013 Galderma Laboratories, L.P. GALDERMA and CLOBEX are registered trademarks.

Galderma Laboratories, L.P., 14501 N. Freeway, Fort Worth, TX 76177 CLO-887 Printed in USA 03/13

28 Journal of Dermatology for Physician Assistants

Dermoscopy Dermoscopic Features of Skin Tumors and Their Clinical and Histologic Counterparts

By John Burns, MSPA, PA-C

SDPA Members Only Content

Hyperpigmentation (clinical view)

Stratum corneum

Melanin

Bleed: 12.25” Largest Trim: 12” Smallest A- Size Trim: 10.75” Live: 9.5”

Black dots (under dermoscopy)

Melanin

John Burns, MSPA, PA-C is a graduate of the Physician Assistant Program at Louisiana State University Health Science Center Shreveport, Louisiana. He completed his fellowship training in dermatology at University of Texas Southwestern Medical Center, Dallas, Texas from 2007 to 2008 and is a Diplomate of the Society of Dermatology Physician Assistants. He presently resides in Frisco, Texas where he works in dermatology with Dr. Eric Weisberg.

Volume 7 • number 2 • SPRING 2013 29

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 â&#x20AC;&#x153;Limes Diseaseâ&#x20AC;?

By Larry Bishop, MD

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

CLINIC AL Dermatology

Figure: Clinical view of phytophotodermatitis

Larry Bishop, MD completed his residency in dermatology at Wilford Hall Medical Center in San Antonio, TX. While at Wilford Hall, Dr. Bishop served as an exchange resident at the world's oldest hospital dedicated to dermatology, Hospital Saint-Louis in Paris, France. Dr. Bishop currently practices at MIMA Dermatology in Melbourne, FL. His areas of special interest are cosmetic and surgical dermatology including Mohs Micrographic Surgery and nonsurgical rejuvenation of the face. Dr. Bishop has indicated no conflicts of interest to disclose relating to the content of this article.

30 Journal of Dermatology for Physician Assistants

IMPORTANT SAFETY INFORMATION SERIOUS INFECTIONS

HEMATOLOGIC EVENTS

Patients treated with Enbrel® (etanercept) are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids or were predisposed to infection because of their underlying disease. ENBREL should not be initiated in the presence of sepsis, active infections, or allergy to ENBREL or its components. ENBREL should be discontinued if a patient develops a serious infection or sepsis. Reported infections include: 1) Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent TB before ENBREL use and periodically during therapy. Treatment for latent infection should be initiated prior to ENBREL use, 2) Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease.

Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric antifungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness, and 3) Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

Rare cases of pancytopenia, including aplastic anemia, some fatal, have been reported.

The causal relationship to ENBREL therapy remains unclear. Exercise caution when considering ENBREL in patients who have a previous history of significant hematologic abnormalities. Advise patients to seek immediate medical attention if they develop signs or symptoms of blood dyscrasias or infection. Consider discontinuing ENBREL if significant hematologic abnormalities are confirmed.

The risks and benefits of treatment with ENBREL should be carefully considered prior to initiating therapy in patients 1) with chronic or recurrent infection, 2) who have been exposed to TB, 3) who have resided or traveled in areas of endemic TB or endemic mycoses, or 4) with underlying conditions that may predispose them to infections such as advanced or poorly controlled diabetes. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with ENBREL, including the possible development of TB in patients who tested negative for latent TB prior to initiating therapy.

MALIGNANCIES Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including ENBREL. In adult clinical trials of all TNF blockers, more cases of lymphoma were seen compared to control patients. The risk of lymphoma may be up to several-fold higher in RA and psoriasis patients. The role of TNF blocker therapy in the development of malignancies is unknown.

Cases of acute and chronic leukemia have been reported in association with postmarketing TNF blocker use in RA and other indications. The risk of leukemia may be higher in patients with RA (approximately 2-fold) than the general population.

HEPATITIS B VIRUS REACTIVATION Use of TNF blockers, including ENBREL, has been associated with reactivation of hepatitis B virus (HBV) in chronic carriers of this virus. The majority of these reports occurred in patients on concomitant immunosuppressive agents, which may also contribute to HBV reactivation. Exercise caution when considering ENBREL in patients identified as carriers of HBV. ALLERGIC REACTIONS Allergic reactions associated with administration of ENBREL during clinical trials have been reported in < 2% of patients. If an anaphylactic reaction or other serious allergic reaction occurs, administration of ENBREL should be discontinued immediately and appropriate therapy initiated.

IMMUNIZATIONS Live vaccines should not be administered to patients on ENBREL. JIA patients, if possible, should be brought up to date with all immunizations prior to initiating ENBREL. In patients with exposure to varicella virus, consider temporary discontinuation of ENBREL and prophylactic treatment with Varicella Zoster Immune Globulin.

AUTOIMMUNITY Autoantibodies may develop with ENBREL, and rarely lupus-like syndrome or autoimmune hepatitis may occur. These may resolve upon withdrawal of ENBREL. Stop ENBREL if lupus-like syndrome or autoimmune hepatitis develops.

WEGENER’S GRANULOMATOSIS PATIENTS The use of ENBREL in patients with Wegener’s granulomatosis receiving immunosuppressive agents (eg, cyclophosphamide) is not recommended.

MODERATE TO SEVERE ALCOHOLIC HEPATITIS Based on a study of patients treated for alcoholic hepatitis, exercise caution when using ENBREL in patients with moderate to severe alcoholic hepatitis.

ADVERSE EVENTS

Melanoma and non-melanoma skin cancer (NMSC) have been reported in patients treated with TNF blockers, including ENBREL. Periodic skin examinations should be considered for all patients at increased risk for skin cancer.

The most commonly reported adverse events in RA clinical trials were injection site reaction, infection, and headache. In clinical trials of all other adult indications, adverse events were similar to those reported in RA clinical trials.

Pediatric Patients

DRUG INTERACTIONS

In patients who initiated therapy at ≤ 18 years of age, approximately half of the reported malignancies were lymphomas (Hodgkin’s and non-Hodgkin’s lymphoma). Other cases included rare malignancies usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. Most of the patients were receiving concomitant immunosuppressants.

The use of ENBREL in patients receiving concurrent cyclophosphamide therapy is not recommended. The risk of serious infection may increase with concomitant use of abatacept therapy. Concurrent therapy with ENBREL and anakinra is not recommended.

Hypoglycemia has been reported following initiation of ENBREL therapy in patients receiving medication for diabetes, necessitating a reduction in anti-diabetic medication in some of these patients.

NEUROLOGIC EVENTS Treatment with TNF-blocking agents, including ENBREL, has been associated with rare (< 0.1%) cases of new onset or exacerbation of central nervous system demyelinating disorders, some presenting with mental status changes and some associated with permanent disability, and with peripheral nervous system demyelinating disorders.

Cases of transverse myelitis, optic neuritis, multiple sclerosis, Guillain-Barré syndromes, other peripheral demyelinating neuropathies, and new onset or exacerbation of seizure disorders have been reported in postmarketing experience with ENBREL therapy.

Prescribers should exercise caution in considering the use of ENBREL in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders.

References: 1. Data on file, Amgen. 2. Enbrel® (etanercept) Prescribing Information, Immunex Corporation, Thousand Oaks, Calif. December 2012. 3. Pariser DM, Leonardi CL, Gordon K, et al. Integrated safety analysis: short- and long-term safety profiles of etanercept in patients with psoriasis. J Am Acad Dermatol. 2012;67:245-256.

Please see Brief Summary of Prescribing Information on following pages.

CONGESTIVE HEART FAILURE Cases of worsening congestive heart failure (CHF) and, rarely, new-onset cases have been reported in patients taking ENBREL. Caution should be used when using ENBREL in patients with CHF. These patients should be carefully monitored.

Volume 7 • number 2 • SPRING 2013 31

When choosing a biologic for adult chronic

ENBREL IS A BIOLOGI

ENBREL is indicated for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Efficacy Efficacy established through 24 weeks in a worldwide pivotal trial1 • In medical studies, nearly half of patients saw 75% skin clearance in their moderate to severe plaque psoriasis in 3 months with ENBREL. Overall, 3 out of 4 patients saw 50% skin clearance in 3 months1,2

Safety profile Safety data from 7 PsO trials that included 4,410 patients1,3 Consistent adverse event rates through 3 years of treatment in over 1,100 patients in clinical trials1 32 Journal of Dermatology for Physician Assistants

Experience Evaluated in clinical studies over the past 19 years in rheumatoid arthritis (RA)1* • > 14 years of postmarketing experience since approval for moderate to severe RA in 19981 • ENBREL is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis. ENBREL can be initiated in combination with methotrexate (MTX) or used alone > 8 years of postmarketing experience since approval for moderate to severe PsO in 20041

c moderate to severe plaque psoriasis (PsO)

ICA PLACE TO START ICAL

Important Safety Considerations: ENBREL has been associated with serious and sometimes fatal infections, including opportunistic infections and TB. Malignancies, neurologic events, hematologic events, hepatitis B reactivation, and serious allergic reactions have also been reported. Common adverse reactions: headache, infection, and injection site reaction. ENBREL is contraindicated in patients with sepsis.

Prescription ENBREL is administered by injection. *Initial clinical research in RA patients began in 1993.

www.enbrel.com Please see Important Safety Information on previous page.

Please see Brief Summary of Prescribing Information on following pages.

72675-R1-V1

Volume 7 â&#x20AC;˘ number 2 â&#x20AC;˘ SPRING 2013 33

Enbrel® (etanercept) Brief Summary SEE PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION WARNINGS SERIOUS INFECTIONS AND MALIGNANCIES Patients treated with Enbrel are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions and Adverse Reactions]. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Enbrel should be discontinued if a patient develops a serious infection or sepsis.

Reported infections include: • A ctive tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before Enbrel use and during therapy. Treatment for latent infection should be initiated prior to Enbrel use.

• Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.

• B acterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

The risks and benefits of treatment with Enbrel should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.

Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with Enbrel, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.

MALIGNANCIES Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including Enbrel.

INDICATIONS AND USAGE Rheumatoid Arthritis Enbrel is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis (RA). Enbrel can be initiated in combination with methotrexate (MTX) or used alone.

Polyarticular Juvenile Idiopathic Arthritis Enbrel is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients ages 2 and older.

Psoriatic Arthritis Enbrel is indicated for reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with psoriatic arthritis (PsA). Enbrel can be used in combination with methotrexate (MTX) in patients who do not respond adequately to MTX alone.

Ankylosing Spondylitis Enbrel is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis (AS).

Plaque Psoriasis Enbrel is indicated for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.

CONTRAINDICATIONS Enbrel should not be administered to patients with sepsis.

WARNINGS AND PRECAUTIONS Serious Infections Patients treated with Enbrel are at increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death.

Opportunistic infections due to bacterial, mycobacterial, invasive fungal, viral, parasitic, or other opportunistic pathogens including aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, histoplasmosis, legionellosis, listeriosis, pneumocystosis, and tuberculosis have been reported with TNF blockers. Patients have frequently presented with disseminated rather than localized disease.

Treatment with Enbrel should not be initiated in patients with an active infection, including clinically important localized infections. Patients greater than 65 years of age, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants (such as corticosteroids or methotrexate), may be at greater risk of infection. The risks and benefits of treatment should be considered prior to initiating therapy in patients: with chronic or recurrent infection; who have been exposed to tuberculosis; with a history of an opportunistic infection; who have resided or traveled in areas of endemic tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis; or with underlying conditions that may predispose them to infection, such as advanced or poorly controlled diabetes [see Adverse Reactions].

Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with Enbrel.

Enbrel should be discontinued if a patient develops a serious infection or sepsis. A patient who develops a new infection during treatment with Enbrel should be closely monitored, undergo a prompt and complete diagnostic workup appropriate for an immunocompromised patient, and appropriate antimicrobial therapy should be initiated.

Tuberculosis Cases of reactivation of tuberculosis or new tuberculosis infections have been observed in patients receiving Enbrel, including patients who have previously received treatment for latent or active tuberculosis. Data from clinical trials and preclinical studies suggest that the risk of reactivation of latent tuberculosis infection is lower with Enbrel than with TNF-blocking monoclonal antibodies. Nonetheless, postmarketing cases of tuberculosis reactivation have been reported for TNF blockers, including Enbrel. Tuberculosis has developed in patients who tested negative for latent tuberculosis prior to

initiation of therapy. Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating Enbrel and periodically during therapy. Tests for latent tuberculosis infection may be falsely negative while on therapy with Enbrel.

Treatment of latent tuberculosis infection prior to therapy with TNF-blocking agents has been shown to reduce the risk of tuberculosis reactivation during therapy. Induration of 5 mm or greater with tuberculin skin testing should be considered a positive test result when assessing if treatment for latent tuberculosis is needed prior to initiating Enbrel, even for patients previously vaccinated with Bacille Calmette-Guerin (BCG).

Anti-tuberculosis therapy should also be considered prior to initiation of Enbrel in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent tuberculosis but having risk factors for tuberculosis infection. Consultation with a physician with expertise in the treatment of tuberculosis is recommended to aid in the decision whether initiating antituberculosis therapy is appropriate for an individual patient.

Tuberculosis should be strongly considered in patients who develop a new infection during Enbrel treatment, especially in patients who have previously or recently traveled to countries with a high prevalence of tuberculosis, or who have had close contact with a person with active tuberculosis.

Invasive Fungal Infections Cases of serious and sometimes fatal fungal infections, including histoplasmosis, have been reported with TNF blockers, including Enbrel. For patients who reside or travel in regions where mycoses are endemic, invasive fungal infection should be suspected if they develop a serious systemic illness. Appropriate empiric antifungal therapy should be considered while a diagnostic workup is being performed. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. When feasible, the decision to administer empiric antifungal therapy in these patients should be made in consultation with a physician with expertise in the diagnosis and treatment of invasive fungal infections and should take into account both the risk for severe fungal infection and the risks of antifungal therapy. In 38 Enbrel clinical trials and 4 cohort studies in all approved indications representing 27,169 patient-years of exposure (17,696 patients) from the United States and Canada, no histoplasmosis infections were reported among patients treated with Enbrel.

Neurologic Events Treatment with TNF-blocking agents, including Enbrel, has been associated with rare (< 0.1%) cases of new onset or exacerbation of central nervous system demyelinating disorders, some presenting with mental status changes and some associated with permanent disability. Cases of transverse myelitis, optic neuritis, multiple sclerosis, Guillain-Barré syndromes, other peripheral demyelinating neuropathies, and new onset or exacerbation of seizure disorders have been reported in postmarketing experience with Enbrel therapy. Prescribers should exercise caution in considering the use of Enbrel in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders [see Adverse Reactions].

Malignancies Lymphomas In the controlled portions of clinical trials of TNF-blocking agents, more cases of lymphoma have been observed among patients receiving a TNF blocker compared to control patients. During the controlled portions of Enbrel trials in adult patients with RA, AS, and PsA, 2 lymphomas were observed among 3306 Enbrel-treated patients versus 0 among 1521 control patients (duration of controlled treatment ranged from 3 to 36 months).

Among 6543 adult rheumatology (RA, PsA, AS) patients treated with Enbrel in controlled and uncontrolled portions of clinical trials, representing approximately 12,845 patient-years of therapy, the observed rate of lymphoma was 0.10 cases per 100 patient-years. This was 3-fold higher than the rate of lymphoma expected in the general US population based on the Surveillance, Epidemiology, and End Results (SEER) Database. An increased rate of lymphoma up to several-fold has been reported in the RA patient population, and may be further increased in patients with more severe disease activity.

Among 4410 adult PsO patients treated with Enbrel in clinical trials up to 36 months, representing approximately 4278 patient-years of therapy, the observed rate of lymphoma was 0.05 cases per 100 patient-years, which is comparable to the rate in the general population. No cases were observed in Enbrel- or placebo-treated patients during the controlled portions of these trials.

Leukemia Cases of acute and chronic leukemia have been reported in association with postmarketing TNF-blocker use in rheumatoid arthritis and other indications.

Even in the absence of TNF-blocker therapy, patients with rheumatoid arthritis may be at higher risk (approximately 2-fold) than the general population for the development of leukemia.

During the controlled portions of Enbrel trials, 2 cases of leukemia were observed among 5445 (0.06 cases per 100 patient-years) Enbrel-treated patients versus 0 among 2890 (0%) control patients (duration of controlled treatment ranged from 3 to 48 months).

Among 15,401 patients treated with Enbrel in controlled and open portions of clinical trials representing approximately 23,325 patient-years of therapy, the observed rate of leukemia was 0.03 cases per 100 patient-years.

Other Malignancies Information is available from 10,953 adult patients with 17,123 patient-years and 696 pediatric patients with 1282 patient-years of experience across 45 Enbrel clinical studies.

For malignancies other than lymphoma and non-melanoma skin cancer, there was no difference in exposure-adjusted rates between the Enbrel and control arms in the controlled portions of clinical studies for all indications. Analysis of the malignancy rate in combined controlled and uncontrolled portions of studies has demonstrated that types and rates are similar to what is expected in the general US population based on the SEER database and suggests no increase in rates over time. Whether treatment with Enbrel might influence the development and course of malignancies in adults is unknown.

Melanoma and Non-melanoma skin cancer (NMSC) Melanoma and non-melanoma skin cancer has been reported in patients treated with TNF antagonists including etanercept.

Among 15,401 patients treated with Enbrel in controlled and open portions of clinical trials representing approximately 23,325 patient-years of therapy, the observed rate of melanoma was 0.043 cases per 100 patient-years.

Among 3306 adult rheumatology (RA, PsA, AS) patients treated with Enbrel in controlled clinical trials representing approximately 2669 patient-years of therapy, the observed rate of NMSC was 0.41 cases per 100 patient-years vs 0.37 cases per 100 patient-years among 1521 control-treated patients representing 1077 patient-years. Among 1245 adult psoriasis patients treated with Enbrel in controlled clinical trials, representing approximately 283

34 Journal of Dermatology for Physician Assistants

patient-years of therapy, the observed rate of NMSC was 3.54 cases per 100 patient-years vs 1.28 cases per 100 patient-years among 720 control-treated patients representing 156 patient-years.

Postmarketing cases of Merkel cell carcinoma have been reported very infrequently in patients treated with Enbrel.

Periodic skin examinations should be considered for all patients at increased risk for skin cancer.

Pediatric Patients Malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with TNF-blocking agents (initiation of therapy at ≤ 18 years of age), including Enbrel. Approximately half the cases were lymphomas, including Hodgkin’s and non-Hodgkin’s lymphoma. The other cases represented a variety of different malignancies and included rare malignancies usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. The malignancies occurred after a median of 30 months of therapy (range 1 to 84 months). Most of the patients were receiving concomitant immunosuppressants. These cases were reported postmarketing and are derived from a variety of sources, including registries and spontaneous postmarketing reports.

In clinical trials of 696 patients representing 1282 patient-years of therapy, no malignancies, including lymphoma or NMSC, have been reported.

Postmarketing Use In global postmarketing adult and pediatric use, lymphoma and other malignancies have been reported.

Patients With Heart Failure Two clinical trials evaluating the use of Enbrel in the treatment of heart failure were terminated early due to lack of efficacy. One of these studies suggested higher mortality in Enbrel-treated patients compared to placebo [see Adverse Reactions]. There have been postmarketing reports of worsening of congestive heart failure (CHF), with and without identifiable precipitating factors, in patients taking Enbrel. There have also been rare (< 0.1%) reports of new onset CHF, including CHF in patients without known preexisting cardiovascular disease. Some of these patients have been under 50 years of age. Physicians should exercise caution when using Enbrel in patients who also have heart failure, and monitor patients carefully.

Hematologic Events Rare (< 0.1%) reports of pancytopenia, including very rare (< 0.01%) reports of aplastic anemia, some with a fatal outcome, have been reported in patients treated with Enbrel. The causal relationship to Enbrel therapy remains unclear. Although no high-risk group has been identified, caution should be exercised in patients being treated with Enbrel who have a previous history of significant hematologic abnormalities. All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (eg, persistent fever, bruising, bleeding, pallor) while on Enbrel. Discontinuation of Enbrel therapy should be considered in patients with confirmed significant hematologic abnormalities.

Two percent of patients treated concurrently with Enbrel and anakinra developed neutropenia (ANC < 1 x 10 9/L). While neutropenic, one patient developed cellulitis that resolved with antibiotic therapy.

Hepatitis B Virus Reactivation Use of TNF-blocking agents has been associated with reactivation of hepatitis B virus (HBV), including very rare cases (< 0.01%) with Enbrel, in patients who are chronic carriers of this virus. In some instances, HBV reactivation occurring in conjunction with TNF-blocker therapy has been fatal. The majority of these reports have occurred in patients concomitantly receiving other medications that suppress the immune system, which may also contribute to HBV reactivation. Patients at risk for HBV infection should be evaluated for prior evidence of HBV infection before initiating TNF-blocker therapy. Prescribers should exercise caution in prescribing TNF blockers for patients identified as carriers of HBV. Adequate data are not available on the safety or efficacy of treating patients who are carriers of HBV with anti viral therapy in conjunction with TNF-blocker therapy to prevent HBV reactivation.

Patients who are carriers of HBV and require treatment with Enbrel should be closely monitored for clinical and laboratory signs of active HBV infection throughout therapy and for several months following termination of therapy. In patients who develop HBV reactivation, consideration should be given to stopping Enbrel and initiating anti viral therapy with appropriate supportive treatment. The safety of resuming Enbrel therapy after HBV reactivation is controlled is not known. Therefore, prescribers should weigh the risks and benefits when considering resumption of therapy in this situation.

Allergic Reactions Allergic reactions associated with administration of Enbrel during clinical trials have been reported in < 2% of patients. If an anaphylactic reaction or other serious allergic reaction occurs, administration of Enbrel should be discontinued immediately and appropriate therapy initiated.

Caution: The following components contain dry natural rubber (a derivative of latex), which may cause allergic reactions in individuals sensitive to latex: the needle cover of the prefilled syringe and the needle cover within the needle cap of the SureClick® autoinjector.

Immunizations Live vaccines should not be given concurrently with Enbrel. It is recommended that pediatric patients, if possible, be brought up-to-date with all immunizations in agreement with current immunization guidelines prior to initiating Enbrel therapy [see Drug Interactions].

Autoimmunity Treatment with Enbrel may result in the formation of autoantibodies [see Adverse Reactions] and, rarely (< 0.1%), in the development of a lupus-like syndrome or autoimmune hepatitis [see Adverse Reactions], which may resolve following withdrawal of Enbrel. If a patient develops symptoms and findings suggestive of a lupus-like syndrome or autoimmune hepatitis following treatment with Enbrel, treatment should be discontinued and the patient should be carefully evaluated.

Immunosuppression TNF mediates inflammation and modulates cellular immune responses. TNFblocking agents, including Enbrel, affect host defenses against infections. The effect of TNF inhibition on the development and course of malignancies is not fully understood. In a study of 49 patients with RA treated with Enbrel, there was no evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector cell populations [see Adverse Reactions].

Use in Wegener’s Granulomatosis Patients The use of Enbrel in patients with Wegener’s granulomatosis receiving

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

Use with Anakinra or Abatacept Use of Enbrel with anakinra or abatacept is not recommended [see Drug Interactions].

compared to placebo-treated patients. In RA Study III, no pattern of increased autoantibody development was seen in Enbrel patients compared to MTX patients [see Warnings and Precautions].

Other Adverse Reactions Table 3 summarizes adverse reactions reported in adult RA patients. The types of adverse reactions seen in patients with PsA or AS were similar to the types of adverse reactions seen in patients with RA. Table 3. Percent of Adult RA Patients Experiencing Adverse Reactions in Controlled Clinical Trials

Use in Patients with Moderate to Severe Alcoholic Hepatitis In a study of 48 hospitalized patients treated with Enbrel or placebo for moderate to severe alcoholic hepatitis, the mortality rate in patients treated with Enbrel was similar to patients treated with placebo at 1 month but significantly higher after 6 months. Physicians should use caution when using Enbrel in patients with moderate to severe alcoholic hepatitis.

ADVERSE REACTIONS Across clinical studies and postmarketing experience, the most serious adverse reactions with Enbrel were infections, neurologic events, CHF, and hematologic events [see Warnings and Precautions]. The most common adverse reactions with Enbrel were infections and injection site reactions.

Clinical Studies Experience Adverse Reactions in Adult Patients With Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, or Plaque Psoriasis The data described below reflect exposure to Enbrel in 2219 adult patients with RA followed for up to 80 months, in 182 patients with PsA for up to 24 months, in 138 patients with AS for up to 6 months, and in 1204 adult patients with PsO for up to 18 months.

In controlled trials, the proportion of Enbrel-treated patients who discontinued treatment due to adverse events was approximately 4% in the indications studied.

Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not predict the rates observed in clinical practice.

Infections Infections, including viral, bacterial, and fungal infections, have been observed in adult and pediatric patients. Infections have been noted in all body systems and have been reported in patients receiving Enbrel alone or in combination with other immunosuppressive agents.

In controlled portions of trials, the types and severity of infection were similar between Enbrel and the respective control group (placebo or MTX for RA and PsA patients) in RA, PsA, AS and PsO patients. Rates of infections in RA and PsO patients are provided in Table 3 and Table 4, respectively.

Infections consisted primarily of upper respiratory tract infection, sinusitis and influenza.

In controlled portions of trials in RA, PsA, AS and PsO, the rates of serious infection were similar (0.8% in placebo, 3.6% in MTX, and 1.4% in Enbrel/ Enbrel + MTX-treated groups). In clinical trials in rheumatologic indications, serious infections experienced by patients have included, but are not limited to, pneumonia, cellulitis, septic arthritis, bronchitis, gastroenteritis, pyelonephritis, sepsis, abscess and osteomyelitis. In clinical trials in PsO, serious infections experienced by patients have included, but are not limited to, pneumonia, cellulitis, gastroenteritis, abscess and osteomyelitis. The rate of serious infections was not increased in open-label extension trials and was similar to that observed in Enbrel- and placebo-treated patients from controlled trials.

In 66 global clinical trials of 17,505 patients (21,015 patient-years of therapy), tuberculosis was observed in approximately 0.02% of patients. In 17,696 patients (27,169 patient-years of therapy) from 38 clinical trials and 4 cohort studies in the US and Canada, tuberculosis was observed in approximately 0.006% of patients. These studies include reports of pulmonary and extrapulmonary tuberculosis [see Warnings and Precautions].

Injection Site Reactions In placebo-controlled trials in rheumatologic indications, approximately 37% of patients treated with Enbrel developed injection site reactions. In controlled trials in patients with PsO, 15% of patients treated with Enbrel developed injection site reactions during the first 3 months of treatment. All injection site reactions were described as mild to moderate (erythema, itching, pain, swelling, bleeding, bruising) and generally did not necessitate drug discontinuation. Injection site reactions generally occurred in the first month and subsequently decreased in frequency. The mean duration of injection site reactions was 3 to 5 days. Seven percent of patients experienced redness at a previous injection site when subsequent injections were given.

Immunogenicity Patients with RA, PsA, AS or PsO were tested at multiple time points for antibodies to etanercept. Antibodies to the TNF receptor portion or other protein components of the Enbrel drug product were detected at least once in sera of approximately 6% of adult patients with RA, PsA, AS or PsO. These antibodies were all non-neutralizing. Results from JIA patients were similar to those seen in adult RA patients treated with Enbrel.

In PsO studies that evaluated the exposure of etanercept for up to 120 weeks, the percentage of patients testing positive at the assessed time points of 24, 48, 72 and 96 weeks ranged from 3.6%–8.7% and were all non-neutralizing.

The percentage of patients testing positive increased with an increase in the duration of study; however, the clinical significance of this finding is unknown.

No apparent correlation of antibody development to clinical response or adverse events was observed. The immunogenicity data of Enbrel beyond 120 weeks of exposure are unknown.

The data reflect the percentage of patients whose test results were considered positive for antibodies to etanercept in an ELISA assay, and are highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of any antibody positivity in an assay is highly dependent on several factors, including assay sensitivity and specificity, assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to etanercept with the incidence of antibodies to other products may be misleading.

Autoantibodies Patients with RA had serum samples tested for autoantibodies at multiple time points. In RA Studies I and II, the percentage of patients evaluated for antinuclear antibodies (ANA) who developed new positive ANA (titer ≥ 1:40) was higher in patients treated with Enbrel (11%) than in placebo-treated patients (5%). The percentage of patients who developed new positive antidouble-stranded DNA antibodies was also higher by radioimmunoassay (15% of patients treated with Enbrel compared to 4% of placebo-treated patients) and by Crithidia luciliae assay (3% of patients treated with Enbrel compared to none of placebo-treated patients). The proportion of patients treated with Enbrel who developed anticardiolipin antibodies was similarly increased

Placebo Controlleda (Studies I, II, and a Phase 2 Study) Placebo (N = 152) Reaction

Enbrelc (N = 349)

Percent of Patients

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

Vaccines Most PsA patients receiving Enbrel were able to mount effective B-cell immune responses to pneumococcal polysaccharide vaccine, but titers in aggregate were moderately lower and fewer patients had 2-fold rises in titers compared to patients not receiving Enbrel. The clinical significance of this is unknown. Patients receiving Enbrel may receive concurrent vaccinations, except for live vaccines. No data are available on the secondary transmission of infection by live vaccines in patients receiving Enbrel.

Enbrelc (N = 415)

Percent of Patients

39 30

50 38

86 70

81 65

15

21

59

54

11

37

18

43

9 2 1 – 1 –

8 3 2 3 – –

16 19 5 4 4 1

16 13 5 2 2 1

Patients with a significant exposure to varicella virus should temporarily discontinue Enbrel therapy and be considered for prophylactic treatment with varicella zoster immune globulin [see Warnings and Precautions].

Immune-Modulating Biologic Products In a study in which patients with active RA were treated for up to 24 weeks with concurrent Enbrel and anakinra therapy, a 7% rate of serious infections was observed, which was higher than that observed with Enbrel alone (0%) [see Warnings and Precautions] and did not result in higher ACR response rates compared to Enbrel alone. The most common infections consisted of bacterial pneumonia (4 cases) and cellulitis (4 cases). One patient with pulmonary fibrosis and pneumonia died due to respiratory failure. Two percent of patients treated concurrently with Enbrel and anakinra developed neutropenia (ANC < 1 x 10 9/L).

Includes data from the 6-month study in which patients received concurrent MTX therapy in both arms.

Study duration of 2 years. c Any dose. d Includes bacterial, viral, and fungal infections. e Most frequent Upper Respiratory Infections were upper respiratory tract infection, sinusitis, and influenza. a

b

In clinical studies, concurrent administration of abatacept and Enbrel resulted in increased incidences of serious adverse events, including infections, and did not demonstrate increased clinical benefit [see Warnings and Precautions].

In placebo-controlled PsO trials, the percentages of patients reporting adverse reactions in the 50 mg twice a week dose group were similar to those observed in the 25 mg twice a week dose group or placebo group.

Table 4 summarizes adverse reactions reported in adult PsO patients from Studies I and II. Table 4. Percent of Adult PsO Patients Experiencing Adverse Reactions in Placebo-Controlled Portions of Clinical Trials (Studies I & II) Placebo (N = 359)

Percent of Patients

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

28 14

27 12

17

17

6

15

2 1 2 – – 1

3 1 1 1 1 –

Nursing Mothers It is not known whether Enbrel is excreted in human milk or absorbed systemically after ingestion. Because many drugs and immunoglobulins are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from Enbrel, a decision should be made whether to discontinue nursing or to discontinue the drug.

Women who choose to continue Enbrel treatment while nursing are encouraged to enroll in Amgen’s Lactation Surveillance Program. Patients or their physicians should call 1-800-77-AMGEN (1-800-772-6436) to enroll.

Includes 25 mg SC QW, 25 mg SC BIW, 50 mg SC QW, and 50 mg SC BIW doses.

Includes bacterial, viral and fungal infections. c Most frequent Upper Respiratory Infections were upper respiratory tract infection, nasopharyngitis and sinusitis.

Pediatric Use Enbrel is indicated for treatment of polyarticular JIA in patients ages 2 years and older [see Indications and Usage, Warnings and Precautions, Adverse Reactions].

b

Adverse Reactions in Pediatric Patients In general, the adverse reactions in pediatric patients were similar in frequency and type as those seen in adult patients [see Warnings and Precautions]. The types of infections reported in pediatric patients were generally mild and consistent with those commonly seen in the general pediatric population. Two JIA patients developed varicella infection and signs and symptoms of aseptic meningitis, which resolved without sequelae.

In open-label clinical studies of children with JIA, adverse reactions reported in those ages 2 to 4 years were similar to adverse reactions reported in older children.

Postmarketing Experience Adverse reactions have been reported during post approval use of Enbrel in adults and pediatric patients. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to Enbrel exposure.

Adverse reactions are listed by body system below:

Cardiac disorders: Gastrointestinal disorders: General disorders: Hepatobiliary disorders: Immune disorders: Musculoskeletal and connective tissue disorders: Neoplasms benign, malignant, and unspecified: Nervous system disorders:

Ocular disorders: Respiratory, thoracic and mediastinal disorders:

Sulfasalazine Patients in a clinical study who were on established therapy with sulfasalazine, to which Enbrel was added, were noted to develop a mild decrease in mean neutrophil counts in comparison to groups treated with either Enbrel or sulfasalazine alone. The clinical significance of this observation is unknown.

Women who become pregnant during Enbrel treatment are encouraged to enroll in Amgen’s Pregnancy Surveillance Program. Patients or their physicians should call 1-800-77-AMGEN (1-800-772-6436) to enroll.

a

Blood and lymphatic system disorders:

Cyclophosphamide The use of Enbrel in patients receiving concurrent cyclophosphamide therapy is not recommended [see Warnings and Precautions].

USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category B. Developmental toxicity studies have been performed in rats and rabbits at doses ranging from 60- to 100-fold higher than the human dose and have revealed no evidence of harm to the fetus due to Enbrel.

There are, however, no studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Enbrela (N = 876)

Reaction

cutaneous lupus erythematous, cutaneous vasculitis (including leukocytoclastic vasculitis), erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, subcutaneous nodule, new or worsening psoriasis (all sub-types including pustular and palmoplantar) Opportunistic infections, including atypical mycobacterial infection, herpes zoster, aspergillosis and Pneumocystis jiroveci pneumonia, and protozoal infections have also been reported in postmarketing use.

DRUG INTERACTIONS Specific drug interaction studies have not been conducted with Enbrel.

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

Skin and subcutaneous tissue disorders:

p ancytopenia, anemia, leukopenia, neutropenia, thrombocytopenia, lymphadenopathy, aplastic anemia [see Warnings and Precautions] congestive heart failure [see Warnings and Precautions] inflammatory bowel disease (IBD) angioedema, chest pain autoimmune hepatitis, elevated transaminases macrophage activation syndrome, systemic vasculitis lupus-like syndrome melanoma and non-melanoma skin cancers, merkel cell carcinoma [see Warnings and Precautions] convulsions, multiple sclerosis, demyelination, optic neuritis, transverse myelitis, paresthesias [see Warnings and Precautions] uveitis, scleritis interstitial lung disease

Enbrel has not been studied in children < 2 years of age with JIA. The safety and efficacy of Enbrel in pediatric patients with PsO have not been studied.

Rare (<0.1%) cases of IBD have been reported in JIA patients receiving Enbrel, which is not effective for the treatment of IBD [see Adverse Reactions].

Geriatric Use A total of 480 RA patients ages 65 years or older have been studied in clinical trials. In PsO randomized clinical trials, a total of 138 out of 1965 subjects treated with Enbrel or placebo were age 65 or older. No overall differences in safety or effectiveness were observed between these patients and younger patients, but the number of geriatric PsO subjects is too small to determine whether they respond differently from younger subjects. Because there is a higher incidence of infections in the elderly population in general, caution should be used in treating the elderly.

Use in Diabetics There have been reports of hypoglycemia following initiation of Enbrel therapy in patients receiving medication for diabetes, necessitating a reduction in anti-diabetic medication in some of these patients.

Rx Only.

This brief summary is based on ENBREL prescribing information v. 50: 12/2012 Manufactured by: Immunex Corporation Thousand Oaks, CA 91320-1799 US License Number 1132 Marketed by Amgen Inc. and Pfizer Inc. © 1998 – 2013 Immunex Corporation. All rights reserved.

US Patent Nos. 7,915,225; 5,605,690; Re. 36,755.

For more information please call 1-888-436-2735 or visit www.enbrel.com

© 2013 Amgen Inc., Thousand Oaks, CA 91320 and Pfizer Inc. All rights reserved. ©2010 Amgen Inc., Thousand Oaks, CA 9132060077-R3-V1 and Pfizer Inc. All rights re

Volume 7 • number 2 • SPRING 2013 35

JDPA Grand Rounds

Hair Loss and An Itchy Rash

By Cynthia Faires Griffith, MPAS, PA-C

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

CLINIC AL Dermatology

Figure 1

Figure 2

36 Journal of Dermatology for Physician Assistants

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.

Cynthia Faires Griffith, MPAS, PA-C, is a 2011 graduate of UT Southwestern Medical Center Physician Assistant program. She received her Bachelor’s of Science degree in psychology from John Brown University. She practices in the dermatology department at the University of Texas Southwestern Medical Center with two other great physician assistants and eighteen wonderful physicians in Dallas, Texas. She has indicated no relationships to disclose relating to the content of this article.

Volume 7 • number 2 • SPRING 2013 37

SURGIC AL Dermatology Journal Club: Practice Changing Articles for Dermatology PAs Melanoma in situ in a private practice setting 2005 through 2009: Location, lesion size, lack of concern.

J Am Acad Dermatol. 2012; 67(3):e105-9.

Stricklin SM, Stoecker WV, Malters JM, Drugge R, Oliviero M, Rabinovitz HS, Perry LA University of Missouri-School of Medicine, Columbia, Missouri, USA.

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.

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.

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SURGICAL wisdom Advice for PAs Interested in Mohs Surgery SDPA Members Only Content

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Dermcast.tv is the official online media resource of the SDPA. Updated weekly, it is your source for audio podcasts, the most current dermatology news and research, procedural videos, conference highlights, and much, much more.

Best of all, as members of the SDPA everything on Dermcast.tv is not only tailored precisely for you and your needs, it is available to you free!

Volume 7 â&#x20AC;˘ number 2 â&#x20AC;˘ SPRING 2013 39

COSMETIC deRMATOLOGY Journal Club: Practice Changing Articles for Dermatology PAs Superficial Hemangioma: pulsed dye laser versus wait-and-see.

Dermatol Surg. 2013; 39(3 Pt 1):414-21.

Kessels JP, Hamers ET, Ostertag JU Department of Dermatology, Catharina Hospital Eindhoven, Eindhoven, The Netherlands.

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40 Journal of Dermatology for Physician Assistants

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.

Announcing the next phase of high quality category 1 CME! Visit Dermpa.org/Diplomate to experience this innovative educational program developed by the SDPA. These new Distance Learning Initiative modules are available to ALL Society of Dermatology Physician Assistants members, including students and NPs. Volume 7 â&#x20AC;˘ number 2 â&#x20AC;˘ SPRING 2013 41

Cosmetic pearls Utilizing Outbound Marketing to Capture Potential Cosmetic Patients

By Risha Bellomo, MPAS, PA-C

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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.

Risha Bellomo, MPAS, PA-C has practiced dermatology for 12 years and currently works at Advanced Dermatology & Cosmetic Surgery in Orlando, Florida. She has been their Director of PA/NP Cosmetic Training for the last 6 years and is also the founder and CEO of Bellomo Consulting, Inc. and Practical Medical Solutions, LLC. Risha's passion is educating and creating awareness to healthcare providers and the community She has indicated no relationships to disclose relating to the content of this article.

42 Journal of Dermatology for Physician Assistants

Break the Cycle of Inflammatory Rosacea With Or acea ®

The only FDA-approved oral treatment—

Formulated for an effective anti-inflammatory response

*

*

• Results from a clinical study showed: —Almost a 50% reduction in total inflammatory lesion count by week 41 — 5x less gastrointestinal upset vs doxycycline 100 mg1

Oracea® is the

#1

ROSACEA BRAND among dermatologists2

Important Safety Information Oracea is indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients.

In clinical trials, the most common adverse events reported were nasopharyngitis/pain, gastrointestinal upsets, hypertension, and nasal congestion/sinusitis. Oracea® should not be used to treat microbial infections, and should be used only as indicated. This drug is contraindicated in people who have shown hypersensitivity to any of the tetracyclines, and, like other tetracycline drugs, may cause fetal harm when administered to a pregnant woman.

Oracea® should not be used during pregnancy, by nursing mothers, or during tooth development (up to the age of 8 years). Although photosensitivity was not observed in clinical trials, Oracea® patients should minimize or avoid exposure to natural or artificial sunlight.

All contraindications, warnings, and precautions associated with tetracyclines must be considered before prescribing Oracea®. The efficacy of Oracea® beyond 16 weeks and safety beyond 9 months have not been established. ®

• Anti-inflammatory dose remains below the antimicrobial threshold 2 — No evidence of bacterial resistance in a long-term (9-month) safety study3

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.

References: 1. Del Rosso JQ, Schlessinger J, Werschler P. Comparison of anti-inflammatory dose doxycycline versus doxycycline 100 mg in the treatment of rosacea. J Drugs Dermatol. 2008;7(6):573-576. 2. Data on file. Galderma Laboratories, L.P. 3. Preshaw PM, Novak MJ, Mellonig J, et al. Modifiedrelease subantimicrobial dose doxycycline enhances scaling and root planing in subjects with periodontal disease. J Periodontol. 2008;79(3):440-452.

Please see brief summary of Prescribing Information on next page.

Oracea and Galderma are registered trademarks. ©2011 Galderma Laboratories, L.P. Galderma Laboratories, L.P. 14501 N. Freeway Fort Worth, TX 76177 ORA-668 Printed in USA 11/11

hcp.oracea.com

Volume 7 • number 2 • SPRING 2013 43

T:6.75”

Rx Only

Keep out of reach of children.

Brief Summary of Full Prescribing Information INDICATIONS AND USAGE ORACEA is indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients.

The dosage of ORACEA differs from that of doxycycline used to treat infections. To reduce the development of resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, ORACEA should be used only as indicated.

CLINICAL PHARMACOLOGY Pharmacokinetics ORACEA capsules are not bioequivalent to other doxycycline products.

CONTRAINDICATIONS This drug is contraindicated in persons who have shown hypersensitivity to doxycycline or any of the other tetracyclines.

PRECAUTIONS General: Safety of ORACEA beyond 9 months has not been established.

As with other antibiotic preparations, use of ORACEA may result in overgrowth of non-susceptible microorganisms, including fungi. If superinfection occurs, ORACEA should be discontinued and appropriate therapy instituted. Although not observed in clinical trials with ORACEA, the use of tetracyclines may increase the incidence of vaginal candidiasis.

ORACEA should be used with caution in patients with a history of or predisposition to candidiasis overgrowth.

Bacterial resistance to tetracyclines may develop in patients using ORACEA. Because of the potential for drugresistant bacteria to develop during the use of ORACEA, it should be used only as indicated.

Autoimmune Syndromes: Tetracyclines have been associated with the development of autoimmune syndromes. Symptoms may be manifested by fever, rash, arthralgia, and malaise. In symptomatic patients, liver function tests, ANA, CBC, and other appropriate tests should be performed to evaluate the patients. Use of all tetracycline-class drugs should be discontinued immediately.

Tissue Hyperpigmentation: Tetracycline class antibiotics are known to cause hyperpigmentation. Tetracycline therapy may induce hyperpigmentation in many organs, including nails, bone, skin, eyes, thyroid, visceral tissue, oral cavity (teeth, mucosa, alveolar bone), sclerae and heart valves. Skin and oral pigmentation has been reported to occur independently of time or amount of drug administration, whereas other pigmentation has been reported to occur upon prolonged administration. Skin pigmentation includes diffuse pigmentation as well as over sites of scars or injury.

Pseudotumor cerebri: Bulging fontanels in infants and benign intracranial hypertension in adults have been reported in individuals receiving tetracyclines. These conditions disappeared when the drug was discontinued.

Laboratory Tests: Periodic laboratory evaluations of organ systems, including hematopoietic, renal and hepatic studies should be performed. Appropriate tests for autoimmune syndromes should be performed as indicated.

Drug Interactions: 1. Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.

2. Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin. 3. The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity. 4. Absorption of tetracyclines is impaired by bismuth subsalicylate, proton pump inhibitors, antacids containing aluminum, calcium or magnesium and ironcontaining preparations. 5. Doxycycline may interfere with the effectiveness of low dose oral contraceptives. To avoid contraceptive failure, females are advised to use a second form of contraceptive during treatment with doxycycline. 6. There have been reports of pseudotumor cerebri (benign intracranial hypertension) associated with the concomitant use of isotretinoin and tetracyclines. Since both oral retinoids, including isotretinoin and acitretin, and the tetracyclines, primarily minocycline, can cause increased intracranial pressure, the concurrent use of an oral retinoid and a tetracycline should be avoided.

44 Journal of Dermatology for Physician Assistants

ADVERSE REACTIONS Adverse Reactions in Clinical Trials of ORACEA: In controlled clinical trials of adult patients with mild to moderate rosacea, 537 patients received ORACEA or placebo over a 16-week period. The most frequent adverse reactions occurring in these studies are listed in the table below.

Incidence (%) of Selected Adverse Reactions in Clinical Trials of ORACEA (n=269) vs. Placebo (n=268)

Nasopharyngitis Pharyngolaryngeal Pain Sinusitis Nasal Congestion Fungal Infection Influenza Diarrhea Abdominal Pain Upper Abdominal Distention Abdominal Pain Stomach Discomfort

ORACEA 13 (4.8) 3 (1.1) 7 (2.6) 4 (1.5) 5 (1.9) 5 (1.9) 12 (4.5) 5 (1.9) 3 (1.1) 3 (1.1) 3 (1.1)

Placebo 9 (3.4) 2 (0.7) 2 (0.7) 2 (0.7) 1 (0.4) 3 (1.1) 7 (2.6) 1 (0.4) 1 (0.4) 1 (0.4) 2 (0.7)

Note: Percentages based on total number of study participants in each treatment group.

Adverse Reactions for Tetracyclines: The following adverse reactions have been observed in patients receiving tetracyclines at higher, antimicrobial doses: Gastrointestinal: anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, and inflammatory lesions (with vaginal candidiasis) in the anogenital region. Hepatotoxicity has been reported rarely. Rare instances of esophagitis and esophageal ulcerations have been reported in patients receiving the capsule forms of the drugs in the tetracycline class. Most of the patients experiencing esophagitis and/or esophageal ulceration took their medication immediately before lying down. (see DOSAGE AND ADMINISTRATION section).

Skin: maculopapular and erythematous rashes. Exfoliative dermatitis has been reported but is uncommon.

Photosensitivity is discussed above. (see WARNINGS section).

Renal toxicity: Rise in BUN has been reported and is apparently dose-related.(see WARNINGS section).

Hypersensitivity reactions: urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, serum sickness, pericarditis, and exacerbation of systemic lupus erythematosus.

Blood: Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia have been reported.

OVERDOSAGE In case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures.

Dialysis does not alter serum half-life and thus would not be of benefit in treating cases of overdose.

DOSAGE AND ADMINISTRATION THE DOSAGE OF ORACEA DIFFERS FROM THAT OF DOXYCYCLINE USED TO TREAT INFECTIONS. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS INCLUDING THE DEVELOPMENT OF RESISTANT MICROORGANISMS. One ORACEA Capsule (40 mg) should be taken once daily in the morning on an empty stomach, preferably at least one hour prior to or two hours after meals.

Efficacy beyond 16 weeks and safety beyond 9 months have not been established.

Administration of adequate amounts of fluid along with the capsules is recommended to wash down the capsule to reduce the risk of esophageal irritation and ulceration. (see ADVERSE REACTIONS section).

HOW SUPPLIED ORACEA (beige opaque capsule printed with CGPI 40) containing doxycycline, USP in an amount equivalent to 40 mg of anhydrous doxycycline. Bottle of 30 (NDC 64682-009-01).

Storage: All products are to be stored at controlled room temperatures of 15°C-30°C (59°F-86°F) and dispensed in tight, light-resistant containers (USP). Keep out of reach of children.

Patent Information: U.S. Patents 5,789,395; 5,919,775; 7,232,572; 7,211,267 and patents pending.

ORACEA is a registered trademark of CollaGenex Pharmaceuticals, Inc. Manufactured by: Marketed by: CardinalHealth Galderma Laboratories, L.P. Winchester, KY 40391 Fort Worth, TX 76177 7961-01 BPI 06/08

T:9.5”

WARNINGS Teratogenic effects: 1) Doxycycline, like other tetracycline-class antibiotics, 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 informed of the potential hazard to the fetus and treatment stopped immediately.

ORACEA should not be used during pregnancy (see PRECAUTIONS: Pregnancy).

2) 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 unless other drugs are not likely to be effective or are contraindicated.

3) 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 animals treated early in pregnancy (see PRECAUTIONS: Pregnancy section).

Gastrointestinal effects: 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”.

If a diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to discontinuation of the drug 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 Clostridium difficile colitis.

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 antibiotics 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.

Photosensitivity: Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Although this was not observed during the duration of the clinical studies with ORACEA, patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using ORACEA. If patients need to be outdoors while using ORACEA, they should wear loose-fitting clothes that protect skin from sun exposure and discuss other sun protection measures with their physician.

MICROBIOLOGY The plasma concentrations of doxycycline achieved with ORACEA during administration (see DOSAGE AND ADMINISTRATION) are less than the concentration required to treat bacterial diseases. In vivo microbiological studies utilizing a similar drug exposure for up to 18 months demonstrated no detectable long-term effects on bacterial flora of the oral cavity, skin, intestinal tract, and vagina.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Doxycycline was assessed for potential to induce carcinogenesis in a study in which the compound was administered to Sprague-Dawley rats by gavage at dosages of 20, 75, and 200 mg/kg/day for two years. An increased incidence of uterine polyps was observed in female rats that received 200 mg/kg/day, a dosage that resulted in a systemic exposure to doxycycline approximately 12.2 times that observed in female humans who use ORACEA (exposure comparison based upon area under the curve (AUC) values). No impact upon tumor incidence was observed in male rats at 200 mg/kg/ day, or in either gender at the other dosages studied. Evidence of oncogenic activity was obtained in studies with related compounds, i.e., oxytetracycline (adrenal and pituitary tumors) and minocycline (thyroid tumors).

Doxycycline demonstrated no potential to cause genetic toxicity in an in vitro point mutation study with mammalian cells (CHO/HGPRT forward mutation assay) or in an in vivo micronucleus assay conducted in CD-1 mice. However, data from an in vitro assay with CHO cells for potential to cause chromosomal aberrations suggest that doxycycline is a weak clastogen.

Oral administration of doxycycline to male and female Sprague-Dawley rats adversely affected fertility and reproductive performance, as evidenced by increased time for mating to occur, reduced sperm motility, velocity, and concentration, abnormal sperm morphology, and increased pre-and post-implantation losses. Doxycycline induced reproductive toxicity at all dosages that were examined in this study, as even the lowest dosage tested (50 mg/kg/day) induced a statistically significant reduction in sperm velocity. Note that 50 mg/kg/day is approximately 3.6 times the amount of doxycycline contained in the recommended daily dose of ORACEA for a 60-kg human when compared on the basis of AUC estimates. Although doxycycline impairs the fertility of rats when administered at sufficient dosage, the effect of ORACEA on human fertility is unknown.

Pregnancy: Teratogenic Effects: Pregnancy Category D. (see WARNINGS section). Results from animal studies indicate that doxycycline crosses the placenta and is found in fetal tissues.

Nonteratogenic effects: (see WARNINGS section).

Labor and Delivery: The effect of tetracyclines on labor and delivery is unknown.

Nursing Mothers: Tetracyclines are excreted in human milk. Because of the potential for serious adverse reactions in infants from doxycycline, ORACEA should not be used in mothers who breastfeed. (see WARNINGS section).

Pediatric Use: ORACEA should not be used in infants and children less than 8 years of age (see WARNINGS section). ORACEA has not been studied in children of any age with regard to safety or efficacy, therefore use in children is not recommended.

Professional development

Dermatology Billing & Coding Auditing Electronic Chart Notes

By Inga Ellzey, MPA, RHIA, CDC

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.

B:12.25”

S:9.5”

T:10.5”

Ms. Ellzey, President/CEO of the Inga Ellzey Practice Group, Inc., in Casselberry, FL, is an expert on dermatology coding, documentation and reimbursement. She has more than 35 years of experience in the field of dermatology and is the CEO and founder of two nationwide dermatology billing services. You can reach her at the following number: (800) 318-3271, or email her at: inga@iepg.com.

Volume 7 • number 2 • SPRING 2013 45

Notes from your Office Manager Managing Medication Samples 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.

These Risk Management Tips have been reprinted with permission from: MLMIC Dateline, published by Medical Liability Mutual Insurance Company, 2 Park Avenue, Room 2500, New York, NY 10016. Copyright ©2010 by Medical Liability Mutual Insurance Company. All Rights Reserved. No part of this article may be reproduced or transmitted in any form or by any means, electronic, photocopying, or otherwise, without the written permission of MLMIC.

Let them know they’re not alone...

Share a story with your patients

JDPA

Visit the Patient’s Perspective library of articles at www.jdpa.org/advocacy.html

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

46 Journal of Dermatology for Physician Assistants

Judicial and Ethical Affairs

Genetic Testing to Predict Disease: Some Ethical Issues

By Karen Scully, MD, FRCPC, MA Ethics

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 7 • number 2 • SPRING 2013 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.

Karen Scully is a board-certified dermatologist in the United States and Canada. She had a private practice in the Toronto area for many years and then accepted a teaching position at the Johns Hopkins Medical Institutions where she practiced and taught dermatology residents and medical students. More recently she moved to Charlotte, North Carolina and completed a Masterâ&#x20AC;&#x2122;s Degree in Ethics and Applied Philosophy at the University North Carolina at Charlotte.

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

JDPA Journal of Dermatology for Physician Assistants

48 Journal of Dermatology for Physician Assistants

Outside & Inside the 9 to 5...

JDPA: What interested you in the field staged, we look for a treatment plan of dermatology? that will treat their cancer with as few side effects as possible.

Mrs. Douglas: While in college, we were presented with only the basics of JDPA: What are the challenges dermatology. Since dermatology has and rewards to working with always intrigued me, I read further comprehensive patch testing? on my own to get beyond the basics.

Mrs. Douglas: We keep hundreds Then during a relocation process, of allergens in stock. Most are housed I transitioned from emergency in a syringe that has to be refrigerated. medicine to dermatology. I looked These allergens must be meticulously forward to the challenge of learning numbered and sorted, and the this specialty in more depth. supplies must be kept well-organized JDPA: What influenced your decision at all times. In this subspecialty, it pays to subspecialize within the field of to have a type A personality. dermatology?

Another challenge is the amount J. Desiree Douglas, MPA, PA-C of time needed to make the allergen Mrs. Douglas: One word – trays. After interviewing a patient, I then decide what opportunity. When I was hired, I had the choice to work in general dermatology or subspecialize in the contact trays will be needed. Approximately 99% of patients dermatitis clinic and/or the cutaneous oncology clinic. I get the standard tray, which can be made the day before their appointments. However, we have specialty chose to seize this unique opportunity and learn both of trays available to further investigate certain cases of these subspecialties. dermatitis. For instance, a beautician specialty tray can Working in the Occupational and Contact Dermatitis be helpful for a patient with hand dermatitis who works Center has offered me the chance to help patients as a hair stylist. These specialty trays are often made eliminate their dermatitis by identifying the specific while patients are waiting and source. Each initial interview can prolong their appointment involves investigative work to times up to an additional thirty identify any possible contact minutes. sources. Appropriate allergen trays are then chosen, and After the interview process patch testing ensues. When an and patch testing is completed, it is gratifying to find allergic allergic response is found, the reactions that are relevant. This specific allergen is identified, means finding allergens that and allergen avoidance is taught. the patients are being currently After patients eliminate their exposure to specific allergens, exposed to and teaching them the dermatitis can resolve and Making a patch test tray allergen avoidance. Again, when the exposure to the specific patients are much happier. allergen is eliminated, the dermatitis resolves, and the Cutaneous oncology was an entirely new field for patients are very grateful. me. Prior to working in dermatology, I had very limited JDPA: What are the challenges and rewards of working experience with oncology, let alone dermatology itself. within cutaneous oncology?

We see a large amount of cutaneous T-cell lymphoma patients, B-cell lymphomas, and graft-vs-host disease.

Mrs. Douglas: The biggest challenge has been the Patients present with either a suspicious rash or an change from quick patient interactions in the emergency already diagnosed cutaneous lymphoma from a room to developing long-term relationships with our previous biopsy. We then help them through the workpatients. Thankfully most of our patients present in up and staging process. After they are diagnosed and the early stages of cutaneous T-cell lymphoma and are Volume 7 • number 2 • SPRING 2013 49

professional development

J. Desiree Douglas, MPA, PA-C graduated from Duquesne University in 2000.

She started her career in emergency medicine, and in 2007 she transitioned into dermatology. She is currently working at the University of Pittsburgh Medical Center’s (UPMC) Cutaneous Oncology Clinic as well as the Occupational and Contact Dermatitis Center. In 2009 she was promoted to Co-Director of the Occupational and Contact Dermatitis Center. The JDPA had an opportunity to interview Mrs. Douglas about her work within these two subspecialty fields of dermatology.

professional development

under our care for many years. I even see some patients JDPA: What advice or insight would you provide to monthly. Because of this frequency, I have developed dermatology PAs who are considering pursuing a similar close relationships with some of my patients. They tell path? me stories about their families and a few patients even Mrs. Douglas: Comprehensive patch testing is ask how my children enjoyed the usually offered in a university setting. weekend. Long-term follow up care First, be prepared to invest a large was at first a challenging concept, amount of time studying. Patch but I now see it as a reward. testing is not an easy field to jump We all want to see our patients live into. There are hundreds of allergens long and happy lives. When patients that patients can be tested against. It are in remission or are doing so well takes time and dedication to become that we can decrease their treatment, familiar with each of these allergens. they are so joyful that they often hug Second, if it’s possible, shadow a us when we deliver the good news.

PA or physician who has experience Seeing their happiness is the greatest in patch testing. It is very helpful to reward. watch a provider go through the JDPA: Describe your typical workday. patient interview process, review the How do you manage working in both decision making in regards to what comprehensive patch testing and trays to test against, prepare the Patch testing with standard and specialized trays being utilized cutaneous oncology? allergen trays, and apply the patches.

The final reading appointment is Mrs. Douglas: I keep my also very beneficial to observe because this is when schedule and patient lists with me at all times! My time the interpretation of patch testing is done, along with is divided to accommodate these two subspecialties. education on allergen avoidance.

Every day I am in the hospital with our oncology patients performing history and University of Pittsburgh Medical physical exams for extracorporeal Center’s (UPMC) Cutaneous Oncology photopheresis and various infusions, Clinic is one of thirteen CTCL reviewing their labs, and completing treatment centers in the northeastern their discharge summaries. I have US. If you are interested in locating a one day each week that I spend treatment center near you, please go in our cutaneous oncology clinic. to www.clfoundation.org/treatment/ In addition, I work in the contact treatment-centers/usa/northeast. dermatitis clinic with patch testing JDPA: If I knew then what I know several days a week. This involves now… spending time in two separate Mrs. Douglas: I would know that clinics, one for outside referrals and changing specialties from emergency the other for in-house referrals. I also medicine to dermatology would be have academic time that involves challenging yet rewarding. It was monitoring patients’ biopsy results Extracorporeal photopheresis unit a lot of hard work, but it paid off. I and monthly labs, ordering patch would have loved to have known that test supplies, creating patient handouts for allergen I would go on to publish over ten articles on contact avoidance education, and even authoring articles about dermatitis subjects and complete resident lectures. If contact dermatitis.

I had not studied these subspecialties, I would never JDPA: What is the most rewarding aspect of your work? have had these opportunities. All of my fears about Mrs. Douglas: In high school I decided to look subspecializing within dermatology would have faded towards a career in medicine. Once I found my calling, away, and I could have enjoyed the journey a bit more. it was a great feeling. I decided to attend Duquesne JDPA: Any additional information or fun facts you University to earn my Master’s of Physician Assistant would like to share with our readers? and have never regretted this decision. Those years Mrs. Douglas: My favorite thing is getting hello hugs have prepared me for my career, and I am so thankful. from my four kids when I get home from work. Even A physician assistant is the best career in my opinion. though I work full time, I enjoy doing math homework It has allowed me over the years to have multiple job with my fourth grader, reading with my first grader, offers in several states. As a physician assistant, I am playing cars with my three year old, and cuddling with able to work in multiple specialties and have a flexible my eight month old. It’s a busy life, but a happy life. schedule. I can help others who need medical attention When life slows down, my husband and I love takingJ the and I can support my family. I could not be happier. kids on vacations to the beach! J 50 Journal of Dermatology for Physician Assistants

Dermatology PA news & notes

From the Desk of...

By Michelle DiBaise, DFAAPA, MPAS, PA-C

How New Certification Requirements Will Impact Dermatology PAs Beginning in 2014, the National Commission for the Certification of Physician Assistants (NCCPA) will implement the new maintenance of certification (MOC) requirements. There are two major changes: 1) a move to a ten-year recertification cycle and 2) directed CME every two-year cycle incorporating 20 Category I credits in self-assessment CME and/or professional improvement CME (PI-CME). So what does that mean to individual PAs? What are the implications for CME sponsored by constituent organizations?

If a PA is due to recertify in 2013, the PA will stay in the old MOC process for the next cycle. In other words, if a PA takes the recertification exam in 2013, that PA will collect 100 hours as he/she always has every two years, and then in 2019, the PA will transition into the new MOC process. If a PA is due to recertify in 2014 or later, he/she will switch to the new process. PI- CME and self-assessment CME do not need to be collected until the transition into the new MOC process is complete.

The two-year cycle and the required 100 hours of CME for each cycle will stay the same. As in the past, at least 50 of the 100 credit hours must be Category I CME. The new process requires that 20 of the 50 Category I credits must be earned through PI-CME and/or selfassessment CME. By the end of the new ten-year cycle, a PA will have earned 40 credit hours of PI-CME and 40 hours of self-assessment CME. PI-CME incorporates evidence-based medicine and quality improvement concepts to improve patient safety and health outcomes. There are three stages for PI-CME: 1) identify evidence-based measure(s) and assess practice(s); 2) apply an intervention(s); and 3) remeasure and document if there is improvement. Each completed stage will earn 5 Category I credits and once all three stages are completed an additional 5 credits will be awarded (total of 20 credits). For example in Stage 1 pull twenty-five medical charts of teenage or young adult acne patients and determine how many were questioned on tanning behavior and counseled about decreasing UV exposure. In Stage 2 conduct an in-service with the office staff, medical assistants, and providers on the risks of UV exposure and how to educate patients about adequate sun/UV precautions.

As an alternative, develop a mechanism to incorporate

questions about tanning behavior into interviews with patients who come to the practice for skin care. In Stage 3 pull twenty-five new charts and re-measure how often the new intervention occurs. There does not need to be improvement to receive credit for the PI-CME. Multiple PAs in the practice can work on the same PI-CME project as long as they are all actively participating.

Self-assessment CME involves a systematic review of the PA’s performance, knowledge base, or skill set using self-directed modules. An example of this type of CME is the SDPA’s Distance Learning Initiative. The AAPA has been working with the NCCPA to develop learning modules for both PI-CME and self-assessment CME that will be available to members when the new MOC is implemented. There is ample opportunity for specialty organizations and state chapters to develop new CME options. Constituent organizations (CO) can partner with the AAPA to develop learning modules.

Alternatively, COs can incorporate PI-CME workshops into the regularly scheduled CME events, print or online articles, or asynchronous online modules.

Additional self-assessment modules can be developed, marketed, and serve as a potential benefit to increase member enrollment. The SDPA is well poised to help integrate the new MOC process elements in order to provide members with high quality CME options. J Michelle DiBaise, DFAAPA, MPAS, PA-C is a graduate of the Physician Assistant Program at the University of Nebraska Medical Center in Omaha, Nebraska. She is a current member and past President (2003-2004) of the SDPA. She has had the opportunity of serving in various leadership positions, including: AAPA committees (Chapter Relations, Public Education, and Awards); Student Academy (Vice President, Chief Delegate, and Graduate Advisor); AAPA House of Delegates with nearly twenty-two years of experience; and AAPA Board of Directors for three years. She has served as a President of four constituent organizations including: Nebraska Academy of PAs, Iowa PA Society, Arizona State Association of PAs, and the SDPA. During this time she has spent over ten years in the field of education in Nebraska and Arizona, and is currently an Associate Professor at the newly developed Northern Arizona University PA Program. Michelle is currently running for President-elect of the AAPA Board of Directors.

Articles written by candidates are provided as information for our readers. The publishing of articles about candidates neither implies nor infers a specific endorsement of any candidate by any individual on the SDPA Board of Directors (BOD) or by the SDPA BOD collectively as an organization.

Volume 7 • number 2 • SPRING 2013 51

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

Indication

Erivedge® (vismodegib) 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.

Boxed Warning and Additional Important Safety Information • 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

52 Journal of Dermatology for Physician Assistants

• Advise patients to contact their healthcare provider immediately if they suspect they (or, for males, their female partner) may be pregnant • 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

ORAL, ONCE-DAILY THERAPY1

TRANSFORM THE TREATMENT OF ADVANCED BCC Erivedge— a unique treatment option • Systemic therapy that targets dysregulated Hedgehog pathway signaling, a known driver of BCC1,2 • One 150-mg capsule a day until disease progression or unacceptable toxicity1 • Erivedge reduced lesions in patients with advanced BCC1,3 Objective response rates (ORR) by IRF from ERIVANCE1,3* laBCC (n=63) ORR (95% CI) Complete response

43% (n=27) (30.5-56.0) 21% (n=13)

mBCC (n=33) 30% (n=10) (15.6-48.2) 0%

Partial response

22% (n=14)

30% (n=10)

7.6 (5.7-9.7)

7.6 (5.6-NE)

Median response duration (months) (95% CI)

*Patients received at least 1 dose of Erivedge with independent pathologist-confirmed diagnosis of BCC. Response in laBCC: absence of disease progression and either ≥30% reduction in lesion size (sum of the longest diameter) from baseline in target lesions by radiography or in externally visible dimension (including scar tissue); or complete resolution of ulceration in all target lesions. Complete responders also had no residual BCC on sampling biopsy and partial responders had residual BCC on sampling biopsy. Response in mBCC: assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0.

IRF=Independent Review Facility. laBCC=locally advanced BCC. mBCC=metastatic BCC. CI=confidence interval. NE=not estimable.

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%) Please see Brief Summary of Prescribing Information on following page.

© 2012 Genentech USA, Inc. All rights reserved. HED0001473000 Printed in USA.

See what you can offer your patients with advanced BCC at www.Erivedge.com References: 1. Erivedge® (vismodegib) capsule Prescribing Information.

Genentech, Inc. January 2012. 2. Epstein EH. Nat Rev Cancer. 2008; 8:743-754. 3. Sekulic A, Migden MR, Oro AE, et al. N Engl J Med. 2012;366:2171-2179.

Volume 7 • number 2 • SPRING 2013 53

S: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)].

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) 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%)

-

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

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.

2 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

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

54 Journal of Dermatology for Physician Assistants

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)] 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). t "EWJTF QBUJFOUT UIBU &3*7&%(& FYQPTVSF EVSJOH QSFHOBODZ DBO cause embryo-fetal death or severe birth defects. t *OTUSVDU GFNBMF QBUJFOUT PG SFQSPEVDUJWF QPUFOUJBM UP VTF B IJHIMZ 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. t *OTUSVDU BMM NBMF QBUJFOUT FWFO UIPTF XJUI QSJPS WBTFDUPNZ UP VTF condoms with spermicide, during sexual intercourse with female partners while taking ERIVEDGE and for at least 2 months after the last dose of ERIVEDGE. t *OTUSVDU QBUJFOUT UP JNNFEJBUFMZ DPOUBDU UIFJS IFBMUIDBSF QSPWJEFS if they (or, for males, their female partner) become pregnant or if pregnancy is suspected following exposure to ERIVEDGE. t *OTUSVDU QBUJFOUT UP JNNFEJBUFMZ SFQPSU BOZ QSFHOBODZ FYQPTVSF UP ERIVEDGE and encourage participation in the ERIVEDGE pregnancy pharmacovigilance program by calling the Genentech Adverse Event Line at 1-888-835-2555. t *OGPSN GFNBMF QBUJFOUT PG UIF QPUFOUJBM GPS TFSJPVT BEWFSTF reactions in nursing infants from ERIVEDGE, taking into account the importance of the drug to the mother. t "EWJTF QBUJFOUT OPU UP EPOBUF CMPPE PS CMPPE QSPEVDUT XIJMF UBLJOH ERIVEDGE and for at least 7 months after the last dose of ERIVEDGE. t "EWJTF QBUJFOUT UP TXBMMPX &3*7&%(& DBQTVMFT XIPMF BOE OPU UP 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. © 2012 Genentech, Inc. 1 DNA Way South San Francisco, CA 94080-4990 1013 5 4 9 3 HED0000832301

The Difference We Make

Personality is Destiny: Self-selections in Medical Careers According to Ramachandran, "Mont SainteVictoire" is pleasurable precisely because it is so spare.

Cézanne's blank spots force the brain to engage in perceptual problem solving, as it struggles to find meaning in the brushstrokes.

I once knew an individual who excelled at predicting the specialty that any given medical student was likely to pursue. Quiet, cerebral students might be earmarked for psychiatry, while dashing, determined, physical types might be drawn to surgery. Shy introverts could make comfortable careers as pathologists. Once at a morning grand rounds presentation, a fellow sitting next to me gestured toward the white-coated marfanesque pathologist who stood by the blackboard in the amphitheatre, chalk in hand. “Even his writing is dull and thin,” he remarked. In medical practice, perhaps personality is destiny.

I rap on the door and step into the exam room to find my patient - a 17-year-old boy here for his annual physical exam - neatly folding his T-shirt and laying it on top of his equally neatly folded trousers in the chair. His shoes rest side by side, centered directly below his clothing. All of this is a far cry from the usual piles of clothing cast haphazardly in the middle of the room by nearly all of my adolescent patients.

“How are you doing?” I greet him, extending my hand.

“Very well, thank you,” he replies. “How are you?”

“Me? Oh, I’m fine,” I stammer, unaccustomed to such a query from an adolescent patient.

“You’re here for a physical exam. A junior this year - how’s school going?

“Very well. So far I’ve managed to maintain a straight ‘A’ average in all of my classes.”

“Well, that’s impressive. Good for you.

What do you do for fun when you’re not in school?”

“I like to dabble in art - writing, drawing, painting, sculpting; although sculpting is my favorite.”

A bit intrigued, I ask him what medium he works in.

“Clay mostly,” he says. “I take a weekly class with a resident sculptor here in town.”

“And what do you make, abstract pieces?”

He laughs. “No, I’m afraid that’s not me. I prefer to produce realistic renditions. Lately, I’ve been doing busts of human heads and faces.”

“I see. I imagine you’re college bound after graduation. Have you looked at any schools yet?”

“Yes, I’ve visited a couple.” He lists two or three prestigious colleges in the northeast.

“My parents have hired a career counselor who’s been meeting with me to discuss where I might go.”

“I suppose you’d like to pursue a career in some facet of art, given your interest in sculpture.”

He shakes his head. “No, not really. Sculpting is just a hobby, really.”

“So what would you like to study?”

Without hesitation he says, “I want to become a plastic surgeon.”

Given the cut of his hair, the flawless dentition, the folded clothing, and his outside interests, suddenly it all fits together nicely. Even his boxer shorts have been ironed. J Brian T. Maurer 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.

Volume 7 • number 2 • SPRING 2013 55

DERmatology pa news & notes

By Brian T. Maurer, PA-C

Workplace Excellence

Putting Integrity in Action– Everywhere, All the Time

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.

A

famous character adage argues that “character is who you are when nobody is looking.” True enough.

But character is also who you are when everybody is looking! Consider, for example, the 1982 Johnson & Johnson (J&J) Tylenol recall; in 1982 seven people died after taking Tylenol capsules laced with cyanide, which were sold in five stores in the Chicago area.

James Burke, then CEO of J&J, led a $100 million effort to recall 31 million bottles of Tylenol and to re-launch the product two months later in a tamperproof package. In the book, Lasting Leadership, Burke argued that his actions were guided by J&J’s credo, a seminal document articulating the company’s guiding beliefs since its founding in 1887. The J&J Credo states that the company is responsible first to its customers, then to its employees, the community, and the stockholders, in that order. According to Burke, “The credo made it very clear at that point exactly what we were all about.”

At the time many believed that the recall would most definitely result in the total annihilation of J&J’s reputation and likely lead to demise of the organization itself. Guided by the credo, Burke aligned the espoused values of the company with actions J&J would use to respond to the crisis. As a result J&J not only recovered economically to reach its pre-recall market share, but trust in the J&J brand was actually enhanced by its ethical navigation of this potentially catastrophic event.

In his book, Living a Life That Matters, Harold Kushner states: “Too often we compromise our integrity. We do something that we don’t really believe in doing to reach some important goal, only to find out one of two frustrating things happening: Either we gain the prize and realize it wasn’t worth gaining, 56 Journal of Dermatology for Physician Assistants

or we end up with neither the prize nor our integrity.”

Integrity means acting according to a consistent ethic or standard. Integrity means consistency between my espoused values and my methods and behaviors.

The J&J Tylenol recall is a story of not compromising integrity, a story of consistency between the espoused values and lived behaviors. There are countless historical and contemporary examples of individuals and organizations that have compromised their integrity; the cost is real and substantial; the damage is often irreversible.

C.S. Lewis said, “Courage is not simply one of the virtues but the form of every virtue at the testing point.” The J&J recall shows the virtue of integrity at the testing point. One can only imagine the courage required at that time. It’s not always easy to do the right thing. It is precisely when your values are put to the test that we must demonstrate the courage of our convictions. At times it appears that those without integrity seem to profit, and there seems to be little incentive to do the right thing. However, the rewards of integrity are real; for starters there are the peace of mind, enduring relationships, and development of trust, and then there is the economic rewards. In The Economics of Integrity economist Anna Bernasek states: “When you have a relationship of trust and integrity, that relationship - that integrity - is an asset that produces economic value…Brands are a means of encapsulating a promise that consumers can trust. One survey of top global brands in 2008 put their combined values at $1.2 trillion.” Is your organizational brand “a promise that consumers can trust?” How about your personal brand? When you are known by and for integrity, it is an asset of inestimable value.

as a practical guide for decision-making and behavior.

It’s almost never easy to act with integrity because there is often not one right choice. We make hundreds of decisions every day. Each and every decision potentially builds up or tears down our individual and organizational integrity. The Integrity-In-Action Checklist outlines the following nine tests to use as a guide for putting integrity into action.

Integrity-In-Action Checklist Golden Rule Test: If this situation were reversed, is this how I would want to be treated?

Fairness Test: Is it fair to everyone involved in and affected by my actions?

Truth Test: Does this represent the whole truth no distortions, omissions, or spin?

Conscience Test: Will I feel good about this afterwards, no regrets, no guilt?

Friends & Family Test: Would my closest friends and family be proud of this?

Front Page Test: Would I want this reported on the front-page of the newspaper?

Consequences Test: Will this lead to positive consequences and avoid negative consequences now and in the future?

What-if-everybody-did-this Test: Would I want to live in a world where everybody did this?

Guiding Beliefs Test: Would this be supported by the philosophical, religious, political, and/or ideological world-views guiding my life?

If all of your answers are the same, it’s pretty clear what to do. If it’s evenly split, it’s probably a sign to stop, think it over, and seek additional counsel from individuals whose integrity you respect. The Integrityin-Action Checklist isn’t simply a guide for the obvious integrity challenges: Should I lie? Should I cheat?

Should I steal? It’s as important for the less obvious and often more difficult challenges we face every day: Do your best or just the minimum? Tell the whole truth or leave out important details? Admit a mistake or try to cover it up? Pass along a rumor or keep it to yourself? We recommend that you brainstorm the most common integrity challenges you are most likely to face (such as patient confidentiality, staff interactions, or billing and coding issues) and run those challenges through the checklist together.

Why a checklist? We often use checklists when we want to ensure consistent results, when performance challenges and pressures are high, and when we need Volume 7 • number 2 • SPRING 2013 57

DERmatology pa news & notes

What strategies might you use to help prepare for putting integrity into action? At the organizational level the first recommendation is an obvious, but often overlooked step: identify if you have an organizational mission, vision, or values statement? Having a guiding document is the first step; using it is the next step. Consider engaging in an audit where you seek input concerning the degree and the ways the lived experience matches the espoused values amongst your colleagues and for those you serve.

If you don’t have a vision or values statement, or if you do have one but would like to refresh it, you might consider developing a touchstone. IEE’s Excellence & Ethics Organizational Touchstone is a process that helps refine and express an organization’s collective commitment to live according to its espoused values.

It provides a map and compass on the organization’s journey toward becoming an intentional culture of excellence and ethics. There are three simple steps: 1.

Identify the essential moral character values (such as integrity, respect, honesty, and responsibility) and performance character values (such as attitude, effort, passion, and craftsmanship) needed to reach your organizational goals according to your specific, particular, and unique organizational mission and vision.

2. For each value, create “we” statements describing what this value looks, sounds, and feels like in action (what do we do or NOT do). Use strong action verbs and memorable phrasing to express how you will put that value into action (e.g., “We learn from our mistakes;” “We show pride in everything we do;” “We give our best and expect the best from each other”).

3. Craft one summary sentence that provides a concise and memorable motto expressing an underlying belief in your shared way (e.g., “Wherever we go, whatever we do”).

We have created touchstones with many organizations. The process is pretty simple, and yet the actual experience and time required varies with every organization with which we work. Some organizations craft theirs in a single day retreat. Others have taken more than a year of discussions and of gathering input from stakeholders. We have also helped individuals to craft their own personal touchstones (as well as creating them for families and in school, classroom, and team settings).

Our Excellence & Ethics Integrity-In-Action Checklist is another tool that we recommend for use

DERmatology pa news & notes

to ensure clear thinking and effective execution. For example, checklists are used in many aspects of the medical field to ensure proper protocols are followed.

Putting integrity into action in the real world is a full speed, full contact sport, and developing confidence in your abilities requires practice and simulation before you’re under the pressures of a live event. A familiar checklist can be a valuable guide when the pressure is high and you want to get it right!

What if this particular checklist doesn’t work for you? No problem; we recommend that you create your own checklist that does ensure efficient, effective, and consistent thinking and action that ensures you put your deepest individual and organizational values into action.

A common recommendation for individuals wanting to live a life of integrity is to think about what you would want people to say about you at your funeral and then to live consistent with those values for which you would like to be remembered. James Burke, former CEO at J&J, died recently at the age of 87. Fittingly he will forever be remembered for putting integrity into action. Hopefully his example inspires us to put integrity into action in our own lives - everywhere, all the time. J

REFERENCES: • Bernasek A. The economics of integrity: From dairy farmers to Toyota, how wealth is built on trust & what that means for our future. New York: Harper Collins; 2010.

• Kushner HS. Living a life that matters. New York: Anchor Books; 2001:33,87.

• Wharton School Publishing. Lasting leadership: What you can learn from the top 25 business people of our times. New Jersey: Pearson Education; 2005.

Matthew L. Davidson, PhD is the Founder, President, and Director of Education for the Institute for Excellence & Ethics (IEE), a 501(c)3 nonprofit corporation dedicated to helping individuals and organizations achieve excellence. He is a National Spokesperson for the Business Bureau National Center for Character Ethics. The IEE specializes in the development and dissemination of research-based tools for developing the culture and competencies of excellence and ethics in schools, athletics, the workplace, and the home; this is done through professional development workshops & academies, teaching & learning resources, assessment, and consulting services. He is a frequent national presenter and is available for keynote lectures, professional development, retreats, and organizational consulting. He has indicated no relationships to disclose relating to the content of this article. For additional information or to contact the IEE, please visit www. excellenceandethics.org.

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1 58STD_StLouis_02.indd Journal of Dermatology for Physician Assistants

1/10/13 2:30 PM

Supervising Physician CORNER My Physician Mentor An Interview with Robert Greenberg, MD What do you think makes a good physician/PA relationship?

Dr. Greenberg: I think mutual trust and respect forms the foundation for a good physician/PA relationship. If the physician respects the PA as a colleague and valued member of the health care team, he or she can then trust the PA to provide quality professional care in a manner that the physician would personally provide. For the PA, respect for the physician as a mentor, teacher, and colleague fosters the necessary trust in the physician that the PA could rely on to provide the best possible care for the patient.

What led you to hire your first PA? Dr. Greenberg: I recognized a need in our busy practice for another provider who could provide care to our patients in a personal, attentive manner while helping to alleviate our appointment backlog.

What qualities do you think PAs should have that benefit patients?

Dr. Greenberg: The qualities that PAs should possess include a warm and caring heart, a desire to help people in distress, a willingness to work hard, a focus to act as the patient’s advocate, and a realistic confidence in his or her medical knowledge and professional skills.

How do you see the role of dermatology PAs evolving?

Dr. Greenberg: I see the role of dermatology PAs expanding given a future where shortages in dermatologists become more widespread. Some health care economists predict that PAs will become the professional ‘first-provider’ for patients in a structured system of accountable care organizations and large health care institutions.

What qualities do you think a supervising physician should possess?

Dr. Greenberg: A supervising physician should be an educator, mentor, and colleague to the PA whom he or she supervises. Important attributes would include a willingness to invest the time to mentor the PA, patience, and the confidence to delegate to the PA important responsibilities and then to recognize the PA for his/her accomplishments.

What did you enjoy most about being a supervising physician?

Dr. Greenberg: I enjoyed the personal and professional relationships I developed with my PAs whom I supervised the most. Nothing was more satisfying to me than when a PA recognized something that we had seen or talked about and then felt confident in being able to handle it alone.

What led you to practice dermatology?

Dr. Greenberg: While in medical school, I recognized that dermatology was a specialty wherein I could actually help people by providing effective medical and surgical treatment and care for all types of patients, from infants to the elderly. I found the ailments and dermatologic

conditions fascinating and that, as a visual learner, I could fit into dermatology more easily than other fields.

Please discuss your leadership roles in the AAD and why you chose to get involved.

Dr. Greenberg: I have served in a number of capacities within the Academy including Advisory Board Chair; Ethics Committee Chair; Secretary-Treasurer; and member of the Board of Directors to name a few of the positions I have held over the forty-one years I have been an AAD member. I chose to become involved in the Academy because I felt I could make a contribution to benefit the specialty and my fellow dermatologists.

How do you feel your interest in photography helped you in dermatology?

Dr. Greenberg: Dermatology is a visual specialty and the ability to recognize a ‘picture’ of the patient’s rash or skin lesion is akin to composing a scene and taking a photograph of it. I find dermatology and photography are both very intellectual and artistic endeavors.

Looking back on your career, what would you say were some of the most rewarding moments/events?

Dr. Greenberg: For me, the most rewarding times were when patients expressed gratitude that I was able to help them with their dermatologic problem. I also found it quite satisfying when my non-dermatologic colleagues chose to come to me for their own personal or family dermatologic issues. Finally, I found it very enjoyable to work with my office staff, many of whom I had worked with for many, many years.

How do you plan to spend your retirement?

Dr. Greenberg: My wife and I have just acquired an RV and plan later this year to take a several month trip across the country. We have no itinerary or schedule, but plan to visit family and friends along the way with many stops at national and state parks. We look forward to traveling on back roads, visiting quaint towns and villages, interesting museums, as well as areas of wilderness. Of course, I will be taking many photographs during our sojourn and will be adding them to my photography website at www. bobgreenbergphotography.com. J Dr. Robert Greenberg recently retired after fortyone years of practicing dermatology in Vernon, CT. He has been an active member of the American Academy of Dermatology holding many leadership positions, including Secretary-Treasurer and Ethics Committee Chairman. For six years I had the good fortune of working as a physician assistant with Dr. Greenberg. He was an incredible mentor to me. He provided constant support, while always looking for teaching moments. He graciously allowed me to interview him for the JDPA.

Volume 7 • number 2 • SPRING 2013 59

DERmatology pa news & notes

By Debra Vinick, PA-C

Dermatology in Art

By W. Stephen Steiner, PA-C

DERmatology pa news & notes

Dr. Bernard Ackerman likened the study of dermatology to art history. The parallels between appreciation of art and the evaluation of skin are many. A neophyte describes a painting in regards to color, brushstroke, content, and structure.

A skilled art historian assimilates these details unconsciously and may declare, “It looks like a Monet.” Each description is equally valid, and each serves a unique purpose. Similarly, one may describe the violaceous polygonal papules arising on the volar wrist; another may describe it simply as lichen planus. While blood work and biopsies are critical to our specialty, it is what we appreciate on the surface of the skin that largely influences decisions in clinical practice.

This series explores the depictions of dermatologic conditions in classic artwork. The condition may be the focus of the painting, but often it is a quiet detail, only for the discerning and trained eye. If you know of a piece of art that you would like to share with the JDPA readers, please contact us at editor@jdpa.org.

A mask in African culture has a variety of significance. In its most obvious form, a mask hides the face of the wearer, allowing the wearer anonymity, not only of his identity, but also of his human form. In certain religious ceremonies, the wearer takes on the characteristics of an animal or person the mask portrays. A mask may have occupational or societal significance and may be worn by a societal leader, a warrior, or a healer. One may appreciate a mask just for its artistic beauty.

Here we see a mask from Nigeria showing stigmata of advanced leprosy. The nasal bridge is cleft; the lips appear eroded. Interestingly the ears, an area commonly affected by leprosy, show no evidence of involvement. The significance of the mask is debatable. The artist may simply be recording a face of a fellow tribesman. Perhaps the wearer of the mask feels protection, immunity to the maladies caused by leprosy. Maybe the mask represents an evil force of ill health and was worn as a part of a ceremony demonstrating the healing powers of a particular shaman. Perhaps the mask represents the ability to inflict an illness on an enemy? J

Nigerian Mask: A representation of leprosy disfigurement

W. Stephen Steiner, PA-C is employed by Marietta Dermatology Associates. He has worked in dermatology for the past twelve years. Outside of work, he enjoys woodworking and spending time with his wife and boys (Photo credit: Charles Davis. Photo courtesy of the National Museum of Health and Medicine).

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 60 Journal of Dermatology for Physician Assistants

JDPA Journal of Dermatology for Physician Assistants

Journal of Dermatology for Physician Assistants Information for Authors – The JDPA is a peer-reviewed publication that delivers innovative clinical, surgical, cosmetic, and professional content exclusively for dermatology PAs. Submissions to the JDPA are peer-reviewed by a panel of experienced dermatology PAs, educational PAs, and dermatologists before articles are accepted for publication.

Manuscripts submitted for publication will be reviewed with the understanding that they are original and have not been submitted elsewhere nor are being considered by other journals. Electronic submissions are accepted and should be sent to editor@ jdpa.org.

The five main sections featured in each issue of the JDPA are listed below along with a brief description of the various topics that authors can contribute to. Regardless of the section, all articles must follow the following criteria: • Formatting - Times New Roman font, 12 point, double-spaced, left aligned.

• Article Order - Title, Author(s), Author bios (including disclosures), Text of Article, References, Tables, and Figures • Reference Citations - Utilize the AMA Manual of Style, 10th Edition.

Dermatology PA News and Notes Feature Articles

Write a review about a new or innovative dermatological procedure, device, and/or approach to patient care (500-1000 words).

From The Desk Of…

Write an opinion essay sharing your insight regarding a current “hot item” issue (e.g., specialty PA credentialing, dermatology access to care, supervising physician relationships, etc.) or any other topic regarding the field of dermatology (250-1000 words).

Clinical Dermatology CME articles

Content should be specific to the field of dermatology following any of the following formats: Study – Original research (clinical or basic science).

Professional issues or health policy papers.

Review – Scholarly review of a topic.

Content length: 6 pages (requires 4 self-assessment Q&A) = .5hr of Cat. I CME. 12 pages (requires 8 self-assessment Q&A) = 1hr of Cat. I CME. Article should include written learning objectives (3-4 required).

Dermatology Case Report

Write a report and discuss a case(s) that illustrate an important or interesting observation (500-1500 words).

Journal Club: Dermatology PA Perspectives

Write a review of an already published article from an established dermatology journal (e.g., JAAD, Cos Dermatol, Dermatol Surg, etc.), summarizing the practical thoughts and clinical issues (250-1000 words).

From the Patient’s Perspective

Patients’ stories published in their own words. JDPA staff can even assist patients with writing their stories (250-1000 words).

Clinical Snapshots

Write a brief written description and clinical facts about an interesting cutaneous anomaly (250-500 words).

Drugs in Dermatology

Write about the current information regarding a particular dermatological medication, drug interaction, or medication side effect/adverse reaction (250-1000 words).

Dermatology Evidence-Based Medicine (derm EBM)

Write a brief, evidence-based assessment of the one or two most relevant studies retrieved to answer a focused clinical question that may have arisen from a real-life situation. A derm EBM is not a comprehensive review of a subject or a synthesis of all the available knowledge (500–1500 words).

Surgical Dermatology Feature Articles

Write a review about a new or innovative surgical procedure, device, and/or approach to patient care (500-1000 words).

Surgical Wisdom

Write a brief article on a fact or pearl for the surgical setting (250-500 words).

Surgical Dermatology Case Report

Write a report and discuss a case(s) that illustrate an important or interesting observation (500-1500 words).

Journal Club: Dermatology PA Perspectives

Write a review of an already published article from an established dermatology journal (e.g., JAAD, Cos Dermatol, Dermatol Surg, etc.), summarizing the practical thoughts and clinical issues (250-1000 words).

Cosmetic Dermatology Feature Articles

Write a review about a new or innovative cosmetic procedure, device, and/or approach to patient care (500-1000 words).

Cosmetic Pearls

Write a brief article on a fact or pearl for the cosmetic setting (250500 words).

Cosmetic Dermatology Case Report Write a report and discuss a case(s) that illustrate an important or interesting observation (500-1500 words).

Journal Club: Dermatology PA Perspectives

Write a review of an already published article from an established dermatology journal (e.g., JAAD, Cos Dermatol, Dermatol Surg, etc.), summarizing the practical thoughts and clinical issues (250-1000 words).

Professional Development Feature Articles

Write an article that explores the professional issues dermatology PAs face such as reimbursement, education, medical trends, contracts, office management, etc. (500-1500 words).

Outside & Inside the 9 to 5

Allow us to share your story of the good work that you do either outside or inside your practice of dermatology. You can write this article yourself or the JDPA staff can interview you to write the article (250-1000 words). Notes From Your Office Manager Write a brief article on a fact or pearl for the office setting (250-500 words).

Judicial and Ethical Affairs

Write an article that explores the complex or multifaceted ethical or judicial professional issues that affect the practice of dermatology for PAs (250-1000 words).

Volume 7 • number 2 • SPRING 2013 61

Professional Opportunities and Development

A dver t iser INDE X Galderma – Epiduo Gel......................... Pages 2, 3 Ranbaxy – Kenalog Spray.......................Pages 7, 8 Promius – Cloderm............................Pages 11, 12 PharmaDerm – Veregen..................... Pages 15, 16 Galderma – Clobex Spray...................Pages 27, 28 Amgen – Enbrel............................... Pages 31 - 35 Galderma – Oracea........................... Pages 43, 44 Genentech – Erivedge....................... Pages 52 - 54 Bayer HealthCare – Finacea.............. Pages 63, 64 For more information on advertising opportunities in the JDPA, please log on to www.jdpa.org

HHS Secretary Kathleen Sebelius at IMPACT 2013 The AAPA is excited to announce that U.S. Department of Health and Human Services Secretary Kathleen Sebelius is a confirmed speaker at the Daily Kick Start General Session on Tuesday, May 28th, 2013.

Join us at 8 a.m. in the Walter E. Washington Convention Center for an informative presentation by this healthcare industry leader.

To register to attend this year’s conference, please visit www.pastakewashington.org.

.C. WASHINGTON, D

MAY 25-29, 2013

TIONS A L U T A R G N CO bers! m e M t n e d Stu If you are graduating within your paid student membership year, the SDPA would like to offer you a gift by upgrading you to a full membership for the remainder of the year.* *category of membership will be dependent on employment.

To apply, please send proof of graduation to sdpa@dermpa.org.

62 Journal of Dermatology for Physician Assistants Grad_Promo.indd 1

1/24/13 1:56 PM

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 INDICATIONS AND USAGE FINACEA 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. Patients should be instructed to avoid spicy foods, thermally hot foods and drinks, alcoholic beverages and to use only very mild soaps or soapless cleansing lotion for facial cleansing.

CONTRAINDICATIONS FINACEA Gel, 15%, is contraindicated in individuals with a history of hypersensitivity to propylene glycol or any other component of the formulation.

WARNINGS FINACEA Gel, 15%, is for dermatologic use only, and not for ophthalmic, oral or intravaginal use.

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, these patients should be monitored for early signs of hypopigmentation.

PRECAUTIONS General: Contact with the eyes should be avoided. If sensitivity or severe irritation develops with the use of FINACEA Gel, 15%, treatment should be discontinued and appropriate therapy instituted.

In a transgenic mouse study, chronic use of FINACEA Gel led to an increased number of animals with papillomas at the treatment site [see PRECAUTIONS: Carcinogenesis, Mutagenesis, and Impairment of Fertility]. The clinical relevance of the findings in animal studies to humans is not clear.

Information for Patients: Patients using FINACEA Gel, 15%, should receive the following information and instructions: • FINACEA Gel, 15%, is to be used only as directed by the physician.

• FINACEA Gel, 15%, is for external use only. It is not to be used orally, intravaginally, or for the eyes.

• Cleanse affected area(s) with a very mild soap or a soapless cleansing lotion and pat dry with a soft towel before applying FINACEA Gel, 15%. Avoid alcoholic cleansers, tinctures and astringents, abrasives and peeling agents.

• Avoid contact of FINACEA Gel, 15%, with the mouth, eyes and other mucous membranes. If it does come in contact with the eyes, wash the eyes with large amounts of water and consult a physician if eye irritation persists.

• The hands should be washed following application of FINACEA Gel, 15%.

• Cosmetics may be applied after FINACEA Gel, 15%, has dried.

• Skin irritation (e.g., pruritus, burning, or stinging) may occur during use of FINACEA Gel, 15%, usually during the first few weeks of treatment. If irritation is excessive or persists, use of FINACEA Gel, 15%, should be discontinued, and patients should consult their physician [See ADVERSE REACTIONS].

• Avoid any foods and beverages that might provoke erythema, flushing, and blushing (including spicy food, alcoholic beverages, and thermally hot drinks, including hot coffee and tea).

• Patients should report abnormal changes in skin color to their physician.

• Avoid the use of occlusive dressings or wrappings.

Drug Interactions: There have been no formal studies of the interaction of FINACEA Gel, 15%, with other drugs.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Systemic long-term animal studies have not been performed to evaluate the carcinogenic potential of azelaic acid. In a 26-week dermal carcinogenicity study using transgenic (Tg.AC) mice, FINACEA Gel, 15%, and the gel vehicle, when applied once or twice daily, did not increase the number of female Tg.AC animals with papillomas at the treatment site. No statistically significant increase in the number of animals with papillomas at the treatment site was observed in male Tg.AC animals after once daily application. After twice daily application, FINACEA Gel, 15%, and the gel vehicle induced a statistically significant increase in the number of male animals with papillomas at the treatment site when compared to untreated males. This suggests that the positive effect may be associated with the vehicle application.

The clinical relevance of the findings in animals to humans is not clear.

Azelaic acid was not mutagenic or clastogenic in a battery of in vitro (Ames assay, HGPRT in V79 cells {Chinese hamster lung cells}, and chromosomal aberration assay in human lymphocytes) and in vivo (dominant lethal assay in mice and mouse micronucleus assay) genotoxicity tests.

Oral administration of azelaic acid at dose levels up to 2500 mg/kg/day (162 times the maximum recommended human dose based on body surface area) did not affect fertility or reproductive performance in male or female rats.

Pregnancy: Teratogenic Effects: Pregnancy Category B There are no adequate and well-controlled studies of topically administered azelaic acid in pregnant women. The experience with FINACEA Gel, 15%, when used by pregnant women is too limited to permit assessment of the safety of its use during pregnancy.

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 based on body surface area), rabbits given 150 or 500 mg/kg/day (19 or 65 times the maximum recommended human dose based on body surface area) and cynomolgus monkeys given 500 mg/kg/day (65 times the maximum recommended human dose based on body surface area) 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 that generated some maternal toxicity (2500 mg/kg/day; 162 times the maximum recommended human dose based on body surface area). 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 maximum recommended human dose based on body surface area). No effects on sexual maturation of the fetuses were noted in this study.

Because animal reproduction studies are not always predictive of human response, this drug should be used only if clearly needed during pregnancy.

Nursing Mothers: Equilibrium dialysis was used to assess human milk partitioning in vitro. 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, indicating that passage of drug into maternal milk may occur. Since less than 4% of a topically applied dose of azelaic acid cream, 20%, 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.

However, caution should be exercised when FINACEA Gel, 15%, is administered to a nursing mother.

Pediatric Use: Safety and effectiveness of FINACEA Gel, 15%, in pediatric patients have not been established.

Geriatric: Clinical studies of FINACEA Gel, 15%, did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

ADVERSE REACTIONS Overall, treatment related adverse events, including burning, stinging/tingling, dryness/ tightness/scaling, itching, and erythema/irritation/redness, were 19.4% (24/124) for FINACEA Gel, 15%, and 7.1% (9/127) for the active comparator gel at 15 weeks.

In two vehicle controlled, and one active controlled U.S. clinical studies, treatment safety was monitored in 788 patients who used twice daily FINACEA Gel, 15%, for 12 weeks (N=333) or for 15 weeks (N=124), or the gel vehicle (N=331) for 12 weeks.

Table 3. Cutaneous Adverse Events Occurring in ≥1% of Subjects in the Rosacea Trials

by Treatment Group and Maximum Intensity* FINACEA Gel, 15% N=457 (100%) Mild Moderate Severe n=99 n=61 n=27 (22%) (13%) (6%) Burning/ stinging/ tingling Pruritus Scaling/dry skin/xerosis Erythema/ irritation Contact dermatitis Edema Acne

Vehicle N=331 (100%) Mild Moderate Severe n=46 n=30 n=5 (14%) (9%) (2%)

71 (16%) 29 (6%)

42 (9%) 18 (4%)

17 (4%) 5 (1%)

8 (2%) 9 (3%)

6 (2%) 6 (2%)

2 (1%) 0 (0%)

21 (5%)

10 (2%)

5 (1%)

31 (9%)

14 (4%)

1 (<1%)

6 (1%)

7 (2%)

2 (<1%)

8 (2%)

4 (1%)

2 (1%)

2 (<1%) 3 (1%) 3 (1%)

3 (1%) 2 (<1%) 1 (<1%)

0 (0%) 0 (0%) 0 (0%)

1 (<1%) 3 (1%) 1 (<1%)

0 (0%) 0 (0%) 0 (0%)

0 (0%) 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.

FINACEA Gel, 15%, and its vehicle caused irritant reactions at the application site in human dermal safety studies. FINACEA Gel, 15%, caused significantly more irritation than its vehicle in a cumulative irritation study. Some improvement in irritation was demonstrated over the course of the clinical studies, but this improvement might be attributed to subject dropouts.

No phototoxicity or photoallergenicity were reported in human dermal safety studies.

In patients using azelaic acid formulations, the following additional adverse experiences have been reported rarely: worsening of asthma, vitiligo depigmentation, small depigmented spots, hypertrichosis, reddening (signs of keratosis pilaris), and exacerbation of recurrent herpes labialis.

Post-marketing safety-Skin: facial burning and irritation; Eyes: iridocyclitis on accidental exposure with FINACEA Gel, 15%, to the eye [see PRECAUTIONS]. ©2012, Bayer HealthCare Pharmaceuticals Inc. All rights reserved.

Manufactured for:

Bayer HealthCare Pharmaceuticals Inc. Wayne, NJ 07470

Manufactured in Italy M 6706804BS Rev. May 2012

Volume 7 • number 2 • SPRING 2013 63

CONTINUING TO SUPPORT YOUR PATIENTS WITH COPAY SAVINGS

For mild to moderate rosacea

The first and only gel approved to treat all 3 symptoms INFLAMMAT

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ORY PA PULES

THE

MA

INFLAM

MAT

ORY

T PUS in the p

UL

ES

resence o

f papules and pustules

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.

3 Symptoms, 1 Medicine

for clearer-looking skin • 61% of patients achieved treatment success in 12-week clinical studies1

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

FINACEA Gel, 15% is contraindicated in individuals with a history of hypersensitivity to propylene glycol or any other components of the formulation. 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, these patients should be monitored for early signs of hypopigmentation. FINACEA and its vehicle caused irritant reactions at the application site in human dermal safety studies. 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/or persists during use with FINACEA, discontinue use and institute appropriate therapy.

In clinical trials with FINACEA, the most common local adverse events (AE’s) (inclusive of mild, moderate and severe categories) 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.

Rarely reported AE’s included: worsening of asthma, vitiligo depigmentation, small depigmented spots, hypertrichosis, reddening (signs of keratosis pilaris) and exacerbation of recurrent herpes labialis.

Post-marketing safety information: Skin (facial burning and irritation); Eyes (iridocyclitis on accidental exposure with FINACEA to the eyes). To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare at 1-866-463-3634 or FDA at 1-800-FDA-1088 or www.fda.gov/ medwatch.

FINACEA is for topical use only. It is not for ophthalmic, oral or intravaginal use. In case of accidental eye exposure, wash eyes with large amounts of water and consult a physician if eye irritation persists. Wash hands following application of FINACEA. See adjacent page for Brief Summary of full Prescribing Information.

Model used for illustrative purposes only.

Reference: 1. FINACEA [package insert]. Morristown, NJ: Intendis, Inc; 2010.

© 2012 Bayer HealthCare Inc. Bayer and the Bayer Cross are registered trademarks of Bayer. FINACEA is a registered trademark of Intendis GmbH. All rights reserved. FIN-10-0003-12 November 2012 Printed in USA.

64 Journal of Dermatology for Physician Assistants