JDPA Winter 2015

DPA J

V o l u m e 9 • n u m b e r 1 • W I N T ER 2 0 1 5 • www.jdpa.org

Journal of Dermatology for Physician Assistants

dermatology Pa news & notes

Student Corner 17 __________________________________

clinical dermatology Dermatology Case Report 26 __________________________________

Surgical dermatology Journal Club

34

_________________________________

Cosmetic dermatology Cosmetic Pearls

40

_____________________________ professional development

›› Earn CME credit with this issue CME A Review of Herpes Zoster

18

Physician Assistants in Specialty Practice: A Valued Role in the Healthcare Team 44

Official Journal of the Society of Dermatology Physician Assistants

Volume 9 • number 1 • winter 2015

1

Is this YOUR year to become a Diplomate?

Join your peers as an elite Derm PA! The SDPA wishes to congratulate all of our Physician Assistant members who have completed the rigorous Distance Learning Initiative.

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

070714

We are pleased to announce that as of January 1, 2014 all DLI modules are now AAPA approved to be used for the new “self assessment” category I CME requirement.

Visit the AAPA or NCCPA websites for complete details on the new CME requirements being implemented in 2014.

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

Volume 9 • number 1 • winter 2015

3

Journal of Dermatology for Physician Assistants

EDITORIAL BOARD

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

DEPARTMENT EDITORS

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

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

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

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

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

This Issue: The JDPA includes articles that have been reviewed and approved for Category I (Preapproved) CME credit by the American Academy of Physician Assistants. Approval is valid for 1 year from the issue date, and participants may submit the self-assessment at any time during that period. Category I CME articles included in JDPA are planned and developed in accordance with 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 with the SDPA:

JDPA/Journal of Dermatology for Physician Assistants (ISSN 1938-9574) is published quarterly (4 issues per volume, one volume per year) by Physician Assistant Communications, LLC, P.O. Box 416, Manlius NY 13104-0416. Volume 9, Number 1, Winter 2015. One year subscription rates: $40 in the United States and Possessions. Single copies (prepaid only): $10 in the United States (Include $6.50 per order plus $2 per additional copy for US postage and handling). Periodicals postage rate paid at New York, NY 10001 and additional mailing offices. Š 2015 Physician Assistant Communications, LLC. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including by photocopy, recording, or information storage and retrieval system, without permission in writing from the publisher.

Postmaster: Send address changes to Society of Dermatology Physician Assistants, Inc., 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

A

s 2015 begins, many people look to make changes for the New Year. While it is great to have goals and resolutions to make positive changes in our lives, how many people are still going strong with their intended changes now that we are a few months into the New Year? Regardless of whether you are still following your other resolutions, I believe that there is still time to resolve to volunteer and make a difference within the SDPA and the field of dermatology.

The SDPA recently celebrated 20 years as an organization. This is a feat that could not have been possible without the dedication of so many volunteers through out the years. It is possible that some of the original SDPA leaders had resolutions or goals to become more involved within the field of dermatology and look where that has lead us all. While volunteering for the SDPA will benefit the organization, its members, and the PA profession, it can also be of great benefit to those actually volunteering.

Prioritizing your health, wellness, and mental well-being is very important to an individual’s overall functioning, and volunteering can be a key component in this prioritization.

Volunteering helps you connect with other dermatology PAs, network within the field, increase your social and relationship skills, build your sense of self-confidence, learn valuable job skills, make a difference and create an impact, and advance your career. As you begin to volunteer within the SDPA, you will discover that our members are from a variety of geographic locations and practice in many different areas within the field of dermatology. The opportunities that exist for you to volunteer with the SDPA are as varied as our membership, and it would be surprising if you had any trouble finding a niche within the organization to share your interests and talents.

Now that the New Year is in full swing, please consider adding volunteering with the SDPA to your list of goals for this year; you will be glad you did. Volunteering with the SDPA will prove to be one of the resolutions that you find yourself staying committed to throughout the entire year and beyond. J

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

Volume 9 • number 1 • winter 2015

5

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 A Review of Herpes Zoster

By Samantha Erie, MSPAS, PA-C and Karen Graham, PhD, MPAS, PA-C

›› CME 10 Derm PA News & Notes – part one

• Certification Review & Maintenance • SDPA State Affiliates: Volunteers Needed for SDPA State Liaison Positions • Student Corner: SDPA Student Members Help to Celebrate “20 Years of Excellence”

18 Clinical Dermatology

• CME Article – A Review of Herpes Zoster • Dermatology Case Report: Lymphangioma Circumscriptum

Departments

04 Editorial Board 05 Editor’s Message 09 SDPA News & Current Affairs 10 Dermatology Market Watch 24 From The Patient’s Perspective 28 Clinical Snapshots 35 Surgical Wisdom 40 Cosmetic Pearls 46 Notes from your Office Manager 47 Outside & Inside the 9 to 5…

51 The Difference We Make 57 JDPA Information for Authors 58 Professional Opportunities and Development

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

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

44 Professional Development

• Physician Assistants in Specialty Practice: A Valued Role in the Healthcare Team

51 Derm PA News & Notes – part two

Go Green & Read On the Go 6

Journal of Dermatology for Physician Assistants

• Workplace Excellence • From the Desk of…

• Supervising Physician Corner: An Interview with Christopher Crotty, MD

dermpa.org

HALOG Cream and Ointment are designed for a difference your patients can truly feel.

BIPHASIC CREAM for sustained relief.1,2 PLASTIBASE® OINTMENT for enhanced spreadability and appeal.3

INDICATIONS AND USAGE: HALOG (Halcinonide, USP) 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

For topical use only.

For Important Safety Information, please see Brief Summary on reverse. For full Prescribing Information see Product Package Insert at HalogRx.com REFERENCES: 1. Blecker, J. Double-blind comparison between two new topical steroids, halcinonide 0.1% and clobetasol propionate cream 0.05%. Curr Med Res Opin. 1975;3:225-228. 2. Bagatell FK. Halcinonide: a new potent anti-inflammatory drug. Cutis. 1974:14:459-462.

3. Thau P, Fox C. A new procedure for the preparation of polyethylenemineral oil gels. J Soc Cosmet Chem. 1965;16:359-363.

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

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Volume 9 • number 1 • winter 2015

7

8

Journal of Dermatology for Physician Assistants

FROM THE SDPA

News & Current Affairs

CALENDAR OF EVENTS 2015

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

JUNE SDPA Summer Dermatology Conference June 4 – 7, 2015 Caesars Palace Las Vegas, NV AUGUST AAD Summer Academy Meeting August 19 - 23, 2015 New York, NY NOVEMBER SDPA 13th Annual Fall Dermatology Conference November 12 - 15, 2015 Loews Portofino Bay Hotel Orlando, FL

T

he SDPA just finished celebrating 20 years as an organization.

As we embark on the next 20 years, we envision an even stronger, more well rounded Society.

As always, our Board of Directors and committee volunteers strive to meet the needs of our members. We understand the importance of CME and will continue to provide the highest quality CME through our conferences and journal. We are aware of the new NCCPA guidelines, and we are developing the required self-assessment (SA) and performance improvement (PI) CME. In addition, we are working on the replacement for the current Diplomate program, which will be expiring at the end of 2016.

As with the CME Committee, other SDPA committees are working hard to improve our organization. The Membership Committee continues to work on maintaining and adding benefits to increase the value of your membership. The Legislative Committee works almost daily with states and the AAPA on important legislation to help our patients and our profession. We have revamped the Public Relations Committee to foster innovative ways to promote our dermatology PA brand to the public and to our dermatologist colleagues. We have created a new Media Relations Committee to help manage our social media accounts, and to provide you with up-to-date information in the format you choose.

Possibly one of our biggest endeavors this year will be to create an SDPA Philanthropic Foundation. This foundation is only in the beginning stages, but we envision it funding research, awarding scholarships, and performing many other philanthropic services.

As you can see, we are busy working on many projects this year.

What we are lacking are additional volunteers. Please consider volunteering some of your time to help with the various projects we are working on. Some of our Committee Chairs are working alone without any members on their committees and they would appreciate any help you can give. Our leaders are a close knit, fun, family-like group.

Once you get involved, you will not regret it. Our passion to help our Society and the dermatology PA profession is contagious. Let’s start a volunteer epidemic. J

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

Volume 9 • number 1 • winter 2015

9

Dermatology PA news & notes

Dermatology Market Watch New App for Isotretinoin Patients Promius Pharma, LLC expands the reach of the Promius Promise According to an FDA review of Year 5 of the iPLEDGE™ program (3/1/10 – 2/28/11), over 400,000 attempts to fill isotretinoin prescriptions were denied due to failures to meet iPLEDGE™ requirements.1 To help support patients, Promius Pharma, marketers of ZenataneTM (Isotretinoin Capsules USP), a generic form of isotretinoin, has created the Promius Promise App designed to help educate and guide patients through the various treatment requirements.

The Promius Promise App can be downloaded free of charge by anyone who has received a prescription for ZenataneTM through the Promius Promise program. It provides answers to frequently asked questions and makes it easy for the patient to find important information, which may make sticking with treatment requirements easier. The App, which acknowledges that there are many steps involved in the treatment process, and outlines them with an easy-to-follow roadmap. The idea for the App came from market research that suggested it may be especially beneficial for young adults and teenagers. It can serve as a tool for parents as well, who may want easy access to Promius Promise information and phone numbers in the event a question arises, so they can support the isotretinoin patient in their life. Providers can also use the App to access the new secure web portal if they desire current information on prescriptions of ZenataneTM for their patients.

Features of the App include sections such as “At My First Visit,” “Before My Next Visit,” “At My Next Office Visit,”

and “Between All Office Visits,” which continue to move the patient through the isotretinoin treatment protocols to help ensure successful continuation of treatment. Especially useful features of the new App are the sections that come at the end of the treatment period; “At My Last Visit,” and “30 Days After My Last Dose,” which effectively continue to “hold the patient’s hand.”

“We wanted to include all the features that would help to support a successful outcome,” said Victor Caliman, Associate Director of Marketing for Promius Pharma. “Adhering to a strict set of guidelines, as required with the use of isotretinoin, may be challenging for some patients, so we included an easy access path to the Promius Promise call center and pharmacy staff. We also added a feature to set up notifications, reminding the patient to take their required dose at a certain time, and not to miss follow up visits with their doctor. Through the App we facilitate easy linking to iPLEDGE.com, myrxcoupons. com, so patients can obtain rebates for other medications, and Zenatane.com for further information on the medication. The App is designed so that on almost every screen the user is just a touch away from reaching the call center staff by phone. It’s like having a builtin coach to help get you to the finish line.” J Reference: 1. 2010 FDA review of iPLEDGE™ program: Drug Safety and Risk Management Advisory Committee, Dermatologic and Ophthalmic Drugs Advisory Committee Briefing Document for iPLEDGE™.

AIM's 1st International Melanoma Tissue Bank Site to Open AIM at Melanoma is proud to be building an openly collaborative International Melanoma Tissue Bank Consortium (IMTBC). The first bank will open at the University of Pittsburgh Medical Center during the first half of 2015.

The goal is to acquire fresh-frozen primary tissue samples from melanoma patients so DNA and RNA can be preserved for more intensive study. This is a fundamental research tool that does not currently exist on the international level.

The oncology community believes it will change 10 Journal of Dermatology for Physician Assistants

the melanoma landscape in terms of predicting who is susceptible and identifying diagnostic and prognostic biomarkers. The outcome will be a more strategic approach to personalized medicine through improved diagnostics, preemptive treatments, and targeted therapies.

Along with their International Brain Metastases Bank and Clinical Trial, AIM is working to change the landscape of melanoma and improve the outcome for families and the hundreds of thousands of others who develop melanoma.

For more information about the IMTBC and to learn how you can help, please visit www.aimatmelanoma.org/ en/aim-for-a-cure/developing-research.html. Together, we can help AIM provide researchers with the tools they need most to find the CURE. J

TM

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• Free overnight shipping to home or work • Help for patients in navigating the treatment process • Application of rebates for eligible patients* - $0 co-pay for commercially insured patients - Savings of up to $100 for cash-paying patients *Call 1.888.959.7600 for eligibility requirements

You can count on us to continuously explore new ways to help patients stay on track with treatment.

We’re a pharmacy and support service that: • Provides an extensive patient toolkit • Reminds patients to schedule their next appointment if they wish us to do so We are available weekdays 8 AM – 11 PM EST and even on Saturdays 9 AM – 3 PM EST.

GIVE YOUR PATIENTS ALL THE BENEFITS OF THE PROMIUS PROMISE™. FIND OUT MORE TODAY. Call 1.888.959.7600 or fax prescriptions to: 1.855.345.6789.

For e-prescriptions, select Direct Success Pharmacy at zip code 07727.

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For information about the iPLEDGE program call 1.866.495.0654 or visit www.ipledgeprogram.com

Volume iPLEDGE TM is a trademark owned by McKesson Specialty Arizona Inc. ©2014 Promius Pharma, LLC. All rights reserved. ZNT-0514-101

9 • number 1 • winter 2015 11

Certification Review

All Those Things Inside the Skin You Might Have Forgotten

By James A. Van Rhee, MS, PA-C

QUESTION: A 25-year-old female presents to the office with amenorrhea. Pregnancy test is positive.

Which of the following tests should be completed in the second trimester to screen for possible neural tube defects?

A. Pregnancy-associated plasma protein A B. Free human chorionic gonadotropin C. Maternal serum alpha-fetoprotein D. Chorionic villus sampling E. Unconjugated estriol EXPLANATION: Neural tube defects occur in 1.5 - 2 per 1,000 births and are the second most common major congenital abnormality worldwide.

Screening for possible neural tube defects is completed in the second trimester via the maternal serum alphafetoprotein. The pregnancy-associated plasma protein A and free human chorionic gonadotropin (hCG)

are used in the first trimester to screen for Down syndrome. The triple screen, which includes alphafetoprotein, unconjugated estriol, and hCG, is used to screen for Down syndrome and trisomy 18. Chorionic villus sampling is used during the first trimester when prenatal analysis of DNA is required for the diagnosis of genetic disorders. J The correct answer is C.

DERmatology pa news & notes

Are you recertifying soon? Start your board review early. Each issue of the JDPA features one board question accompanied by a brief explanation of the answer along with any pertinent test taking tips. Best of luck!

James A. Van Rhee, MS, PA-C, is the Program Director for the Yale University School of Medicine Physician Associate Program. Mr. Van Rhee has been involved in physician assistant education for almost 20 years. He has served as project director and test item writer for the Physician Assistant Education Association’s (PAEA) Physician Assistant Clinical Knowledge Rating Assessment Tool (PACKRAT) and is the author of the Physician Assistant: Certification and Re-certification Review Book, published

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

Dermatology Market Watch

...continued from pg. 10

New Oil-Free Gel Cleanser from Avène Striking the right balance for normal-to-combination sensitive skin For perfectly balanced cleansing, Avène has the ultimate solution: New OilFree Gel Cleanser for normalto-combination sensitive skin.

Soap-based cleansers can disrupt the moisture barrier by removing essential lipids, leading to excessive evaporation of water. The result: dehydration (leaving skin feeling tight, taut and rough to the touch, and can become easily irritated).

Even oil-prone areas such as the T-zone can become dehydrated.

On the other hand, you don’t want an oil-rich cleanser that can leave skin looking dull, feeling greasy and can also result in clogged pores. Avène’s new oil-free gel cleanser is a crystalclear formula that offers powerful cleansing that is also exceptionally gentle.

12 Journal of Dermatology for Physician Assistants

Exclusive to healthcare providers, the new oil-free gel cleanser is a lightweight, refreshing gel formula that provides clinically-proven cleansing benefits without irritation. Key to the cleanser’s effectiveness is a very high concentration (60%) of Avène Thermal Spring Water (ATSW) for optimal hydration and skin-softening benefits combined with a unique sebo-regulating complex for balanced oil control. Not only is the innovative formula oil-free, it is also soap-free, which helps to maintain skin’s pH balance.

What helps to make quick work of washing away dirt, excess oil and make-up without stripping protective lipids is the infusion of non-aggressive surfactants in a gentle cleansing base. Keeping skin’s protective moisture barrier intact not only helps to seal in water for a soft, smooth, supple complexion, it also minimizes the risk for irritation.

The high percentage of ATSW soothes and softens skin while Avène’s sebo-regulating complex keeps oil flow in check, helping to mattify the skin. For the utmost in purity, safety and tolerance, the hypoallergenic and noncomedogenic formula is also fragrance-, paraben- and colorant free. J

NEW FOR THE TREATMENT OF COMEDONAL AND INFLAMMATORY ACNE

For more information, please visit www.OnextonGel.com INDICATION ONEXTON (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/3.75% is indicated for the topical treatment of acne vulgaris in patients 12 years of age or older.

IMPORTANT SAFETY INFORMATION • ONEXTON Gel is contraindicated in patients with a known hypersensitivity to clindamycin, benzoyl peroxide, any component of the formulation or lincomycin.

• ONEXTON Gel is contraindicated in patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.

• Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical or systemic clindamycin. ONEXTON Gel should be discontinued if significant diarrhea occurs.

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

• Anaphylaxis, as well as other allergic

•

•

• •

reactions leading to hospitalizations, has been reported in postmarketing use of products containing clindamycin/benzoyl peroxide.

If a patient develops symptoms of an allergic reaction such as swelling and shortness of breath, they should be instructed to discontinue use and contact a physician immediately.

The most common local adverse reactions experienced by patients in clinical trials were burning sensation, contact dermatitis, pruritus and rash. All occurred in <0.5% of patients.

ONEXTON Gel should not be used in combination with erythromycin-containing products because of its clindamycin component.

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

Patients should avoid exposure to natural sunlight and avoid artificial sunlight (tanning beds or UVA/B treatment) while using ONEXTON Gel.

Please see Brief Summary of Prescribing Information on the following page.

Except as otherwise indicated, all product names, slogans, and other marks are trademarks of the Valeant family of companies. © 2014 Valeant Pharmaceuticals North America LLC. DM/ONX/14/0026

Volume 9 • number 1 • winter 2015 13

BRIEF SUMMARY OF FULL PRESCRIBING INFORMATION

Neuromuscular Blocking Agents

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

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

ONEXTONâ&#x201E;˘ (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/3.75%, for topical use Initial U.S. Approval: 2000 CONTRAINDICATIONS Hypersensitivity ONEXTON Gel is contraindicated in those individuals who have shown hypersensitivity to clindamycin, benzoyl peroxide, any components of the formulation, or lincomycin.

Anaphylaxis, as well as allergic reactions leading to hospitalization, has been reported in postmarketing use with ONEXTON Gel [see Adverse Reactions] WARNINGS AND PRECAUTIONS Colitis/Enteritis Systemic absorption of clindamycin has been demonstrated following topical use of clindamycin. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin. If significant diarrhea occurs, ONEXTON Gel should be discontinued.

Severe colitis has occurred following oral and parenteral administration of clindamycin with an onset of up to several weeks following cessation of therapy.

Antiperistaltic agents such as opiates and diphenoxylate with atropine may prolong and/or worsen severe colitis. Severe colitis may result in death.

Studies indicate toxin(s) produced by Clostridia is one primary cause of antibiotic-associated colitis. The colitis is usually characterized by severe persistent diarrhea and severe abdominal cramps and may be associated with the passage of blood and mucus. Stool cultures for Clostridium difficile and stool assay for C. difficile toxin may be helpful diagnostically.

Ultraviolet Light and Environmental Exposure Minimize sun exposure (including use of tanning beds or sun lamps) following drug application [see Nonclinical Toxicology].

ADVERSE REACTIONS The following adverse reaction is described in more detail in the Warnings and Precautions section of the label: Colitis [see Warnings and Precautions].

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

These adverse reactions occurred in less than 0.5% of subjects treated with ONEXTON Gel: burning sensation (0.4%); contact dermatitis (0.4%); pruritus (0.4%); and rash (0.4%).

During the clinical trial, subjects were assessed for local cutaneous signs and symptoms of erythema, scaling, itching, burning and stinging. Most local skin reactions either were the same as baseline or increased and peaked around week 4 and were near or improved from baseline levels by week 12. The percentage of subjects that had symptoms present before treatment (at baseline), during treatment, and the percent with symptoms present at week 12 are shown in Table 1.

Table 1: Local Skin Reactions - Percent of Subjects with Symptoms Present.

Results from the Phase 3 Trial of ONEXTON Gel 1.2%/3.75% (N = 243) Before Treatment (Baseline)

Maximum During Treatment

End of Treatment (Week 12)

Mild Mod.* Severe

Mild Mod.* Severe

Mild Mod.* Severe

Erythema

20

6

0

28

5

<1

15

2

0

Scaling

10

1

0

19

3

0

10

<1

0

Itching

14

3

<1

15

3

0

7

2

0

Burning

5

<1

<1

7

1

<1

3

<1

0

Stinging

5

<1

0

7

0

<1

3

0

<1

*Mod. = Moderate

Postmarketing Experience Because postmarketing adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Anaphylaxis, as well as allergic reactions leading to hospitalizations, has been reported in postmarketing use of products containing clindamycin phosphate/benzoyl peroxide.

DRUG INTERACTIONS Erythromycin Avoid using ONEXTON Gel in combination with topical or oral erythromycincontaining products due to its clindamycin component. In vitro studies have shown antagonism between erythromycin and clindamycin. The clinical significance of this in vitro antagonism is not known.

Concomitant Topical Medications Concomitant topical acne therapy should be used with caution since a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents. If irritancy or dermatitis occurs, reduce frequency of application or temporarily interrupt treatment and resume once the irritation subsides. Treatment should be discontinued if the irritation persists.

14 Journal of Dermatology for Physician Assistants

USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women treated with ONEXTON Gel. ONEXTON Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Animal reproductive/developmental toxicity studies have not been conducted with ONEXTON Gel or benzoyl peroxide. Developmental toxicity studies of clindamycin performed in rats and mice using oral doses of up to 600 mg/kg/day (240 and 120 times amount of clindamycin in the highest recommended adult human dose based on mg/m2, respectively) or subcutaneous doses of up to 200 mg/kg/day (80 and 40 times the amount of clindamycin in the highest recommended adult human dose based on mg/m2, respectively) revealed no evidence of teratogenicity.

Nursing Mothers It is not known whether clindamycin is excreted in human milk after topical application of ONEXTON Gel. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to use ONEXTON Gel while nursing, taking into account the importance of the drug to the mother.

Pediatric Use Safety and effectiveness of ONEXTON Gel in pediatric patients under the age of 12 have not been evaluated.

Geriatric Use Clinical trials of ONEXTON Gel did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects.

NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity, mutagenicity and impairment of fertility testing of ONEXTON Gel have not been performed.

Benzoyl peroxide has been shown to be a tumor promoter and progression agent in a number of animal studies. Benzoyl peroxide in acetone at doses of 5 and 10 mg administered topically twice per week for 20 weeks induced skin tumors in transgenic Tg.AC mice. The clinical significance of this is unknown.

Carcinogenicity studies have been conducted with a gel formulation containing 1% clindamycin and 5% benzoyl peroxide. In a 2-year dermal carcinogenicity study in mice, treatment with the gel formulation at doses of 900, 2700, and 15000 mg/kg/day (1.8, 5.4, and 30 times amount of clindamycin and 2.4, 7.2, and 40 times amount of benzoyl peroxide in the highest recommended adult human dose of 2.5 g ONEXTON Gel based on mg/m2, respectively) did not cause any increase in tumors. However, topical treatment with a different gel formulation containing 1% clindamycin and 5% benzoyl peroxide at doses of 100, 500, and 2000 mg/kg/day caused a dose-dependent increase in the incidence of keratoacanthoma at the treated skin site of male rats in a 2-year dermal carcinogenicity study in rats. In an oral (gavage) carcinogenicity study in rats, treatment with the gel formulation at doses of 300, 900 and 3000 mg/kg/day (1.2, 3.6, and 12 times amount of clindamycin and 1.6, 4.8, and 16 times amount of benzoyl peroxide in the highest recommended adult human dose of 2.5 g ONEXTON Gel based on mg/ m2, respectively) for up to 97 weeks did not cause any increase in tumors. In a 52-week dermal photocarcinogenicity study in hairless mice, (40 weeks of treatment followed by 12 weeks of observation), the median time to onset of skin tumor formation decreased and the number of tumors per mouse increased relative to controls following chronic concurrent topical administration of the higher concentration benzoyl peroxide formulation (5000 and 10000 mg/kg/day, 5 days/week) and exposure to ultraviolet radiation.

Clindamycin phosphate was not genotoxic in the human lymphocyte chromosome aberration assay. Benzoyl peroxide has been found to cause DNA strand breaks in a variety of mammalian cell types, to be mutagenic in S. typhimurium tests by some but not all investigators, and to cause sister chromatid exchanges in Chinese hamster ovary cells.

Fertility studies have not been performed with ONEXTON Gel or benzoyl peroxide, but fertility and mating ability have been studied with clindamycin. Fertility studies in rats treated orally with up to 300 mg/kg/day of clindamycin (approximately 120 times the amount of clindamycin in the highest recommended adult human dose of 2.5 g ONEXTON Gel, based on mg/m2) revealed no effects on fertility or mating ability.

PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information).

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

Certification Maintenance - Frequently Asked Questions

This new process requires new types of CME activities; self-assessment (SA) and performance improvement (PI) CME. To learn more about the new requirements, SDPA members are encouraged to visit www.nccpa.net/CertMain. Below are some of the most frequently asked questions by SDPA members pertaining to these new changes in certification maintenance.

Q: Where can SDPA members find SA-CME and/or PI-CME opportunities?

A: The AAPA expects the number of SA-CME and PI-CME programs to grow quickly as the first PAs transitioned into the new requirements in 2014. Also, many PA specialists still deal with issues related to overall health and wellness for which there are already numerous SA and PI-CME opportunities available.

That said, in the cases in which PAs are involved so deeply within a specialty that there are no SA or PI-CME opportunities relevant to that practice, the AAPA anticipates defining alternative approaches to satisfying these requirements in a way that ensures their relevance to PA practice and patient care. If you need assistance finding an activity that is relevant to your practice, contact AAPA at 703-836-2272, option 2 for recommendations.

For SDPA members, the following SA-CME and PI-CME opportunities in the field of dermatology are currently available:

SA-CME: • Starting last year in San Diego at the SDPA’s 12th Annual Fall Dermatology Conference, SDPA members could claim SA-CME for lectures they attended that were labeled as “selfassessment.” Moving forward, every SDPA conference will have SA-CME available to attendees.

• The SDPA’s Distance Learning Initiative (DLI) program is also approved for AAPA Category 1 Self-Assessment CME credit.

PI-CME: • AAD PI-CME for Dermatology – Melanoma • AAD PI-CME for Dermatology – Skin Biopsy Tracking and Follow-up • AAD PI-CME for Dermatology - Translating Psoriasis Guidelines into Practice • AAD PI-CME for Dermatology - Chronic Urticaria • AAD PI-CME for Dermatology - Venous Insufficiency • AAD PI-CME for Dermatology - Laser and Light-Based Therapies for Skin Rejuvenation To view these as well as additional self-assessment and PI-CME opportunities outside of dermatology, please visit www.aapa.org/picme. AAPA will add more self-assessment and PI-CME activities to these lists as they are identified and approved. If you have questions or would like to recommend a selfassessment or PI-CME activity for inclusion, please email cme@aapa.org. J

What Do You Want To Read About In The JDPA? We’re interested in knowing what kind of articles SDPA members would be interested in reading more about in order to help improve their practice of dermatology.

Share your content ideas today.

Email them to editor@jdpa.org

JDPA Journal of Dermatology for Physician Assistants

Volume 9 • number 1 • winter 2015 15

DERmatology pa news & notes

Last year, 2014 marked the beginning of the PA profession's transition to a 10-year certification maintenance process.

PAs who passed PANCE, regained certification, or wrapped up a sixyear certification maintenance cycle in 2014 were the first to begin the new 10-year process. SDPA members can log into their NCCPA accounts and review their dashboards to confirm when they will move into this new 10-year cycle.

SDPA State Affiliates

Volunteers Needed for SDPA State Liaison Positions

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

DERmatology pa news & notes

SDPA State Liaison for a Non-Affiliated State: Duties & Expectations

Would you like to represent your state for the SDPA but feel overwhelmed by the process of becoming an SDPA State Affiliate? Here is your chance! If you reside in a state that currently does not have an SDPA State Affiliate chapter, consider volunteering to be an SDPA State Liaison. The SDPA Constituent Relations Committee is seeking volunteers to become an SDPA State Liaison and work with the SDPA to eventually organize your state into an official SDPA State Affiliate chapter.

The SDPA currently has 17 State Affiliate chapters. We continue to grow and would love to have all 50 states participating! By volunteering to become an SDPA State Liaison, you can assist the SDPA in reaching this goal. It takes teamwork and a strong commitment. Included here is a list of the SDPA State Liaison duties and expectations. If you have any further questions or are interested in volunteering, please contact me at rblock@dermpa. org. I am here to help you!

16 Journal of Dermatology for Physician Assistants

An SDPA State Liaison’s purpose is to represent the state in which the Liaison resides in. The State Liaison will be responsible for facilitating the communication and coordination of his/her state’s activities between the two organizations (state and SDPA). The goal of an SDPA State Liaison is to achieve the best utilization of resources and services from one organization to another.

The following are the duties and expectations for an SDPA State Liaison: 1) Represent his/her state for a period of two years starting with the July 1st term.* 2) Responsible for sharing vital information within the state he/she resides in with the SDPA. 3) Request to send information and/or post to the SDPA website (with SDPA Board approval), in regards to his/her state’s legislative issues, local events, and/or important information that dermatology PAs need to know within the state.

4) Maintain active membership within his/her AAPA State Chapter and be in communication with the AAPA State Chapter to inform the SDPA of any information that is deemed necessary.

5) Communicate with the dermatologists in his/her state through the dermatologists’ state organization.

6) Have fun with his/her mission!

The SDPA State Liaison’s name and email address will be listed on the SDPA Map via the SDPA website and he/she will be a member of the SDPA Constituent Relations Committee. *The first SDPA State Liaison may have a term that is longer than two years due to recruitment of Liaisons, which began in Fall 2014. J

Student Corner

SDPA Student Members Help to Celebrate “20 Years of Excellence” at the Annual Fall Dermatology Conference

This past November the Society of Dermatology On Saturday, students participated in the 1st annual Miles Physician Assistants (SDPA) continued to celebrate its “20 for Melanoma San Diego 5k Run/ 1mile Walk presented Years of Excellence” at the 12th Annual Fall Dermatology by the SDPA and the Melanoma Research Foundation.

Conference in San Diego, California. A record 537 SDPA This event was a huge success and raised over $30,000 for members were in attendance and enjoyed a variety of speakers melanoma education, prevention, treatments, and research. on dermatological topics, product theaters hosted by our The SDPA’s Student Affairs Committee is comprised sponsors, supplemental of three student workshops, and several leaders, each serving a receptions honoring 3-year term with Marc the SDPA’s 20 years of Kawohl, PA-C serving empowering, educating, as the Recent Graduate and advancing the future Advisor, Stephanie of dermatology.

Palazzolo, PA-S2 serving In continued as the Senior Student support of its student Coordinator, and Maria members, the SDPA Kelly, PA-S1 serving as recently began offering the newly elected Junior free conference Student Coordinator. registration to the first On behalf of the ten SDPA student SDPA and its Student From left to right: SDPA Student Affairs Committee Recent Graduate members to register Affairs Committee, we Advisor Marc Kawohl, PA-C; SDPA Student Affairs Committee Junior for each biannual would like to thank Student Coordinator Maria Kelly, PA-S1; Ana Goldberg, PA-S2; SowFong conference. The SDPA our students for their Ng, PA-S1; AAPA President John McGinnity, MS, PA-C; SDPA President was proud to welcome involvement with our Vicki Roberts, MPAS, PA-C; SDPA Student Affairs Committee Senior six students who were organization. Further, Student Coordinator Stephanie Palazzolo, PA-S2; Angela Sheffield, PA-S2; and SDPA Director at Large and Student Affairs Committee Board Liaison in attendance at this we thank these students’ Jang Mi Johnson, PA-C. fall’s conference in San program directors for Diego. These students, allowing their students who represented both Nova Southeastern University to attend the SDPA conferences. We believe the opportunity Jacksonville’s Physician Assistant Program and Emory to attend such conferences serves as an important adjunct to University’s Physician Assistant Program, had the chance the education of physician assistant students. to become involved with the SDPA’s Student Affairs If you would like more information or to get involved Committee and get a sneak peek at what goes on behind the with the SDPA Student Affairs Committee, please contact scenes at these large conferences. us at studentaffairs@dermpa.org, visit our website (www.

The San Diego conference afforded these students dermpa.org/students), or ‘like’ us on Facebook! We encourage not only the opportunity to enjoy various educational you or anyone you know to become a member or student dermatological lectures but also to network with a variety member of the SDPA. Some of the benefits of becoming a of other SDPA members. Students excitedly joined in on student member of the SDPA include access to conferences the SDPA Board of Directors’ meeting, which was also at no charge or at a discounted student rate, an interactive attended by AAPA President John McGinnity, where they Derm PA Resume, dermatology job listings, networking on were able to learn more about the SDPA leadership and the discussion forums, Dermcast TV, dermatology preceptors happenings that drive a successful, professional organization. list, and complimentary subscriptions to both the Journal Students participated in introducing our distinguished of Dermatology for Physician Assistants (JDPA) and the guests and speakers and in the Student Affairs Committee quarterly/monthly SDPA e-newsletters. The SDPA has meeting, where the group brainstormed ideas for expanding membership available for any physician assistant, supervising student involvement with the SDPA. In addition, students physician, healthcare provider, or student who is interested volunteered their time at the Intermediate Skin Surgery in learning more about dermatology. J Workshop that was offered to members at the conference.

Volume 9 • number 1 • winter 2015 17

DERmatology pa news & notes

By Maria Kelly, PA-S1, Stephanie Palazzolo, PA-S2, and Marc Kawohl, PA-C SDPA Student Affairs Committee

Clinic al Dermatology

A Review of Herpes Zoster

By Samantha Erie, MSPAS, PA-C and Karen Graham, PhD, 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.

›› 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 January 2015. 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. Identify the risk factors and typical disease presentation for immunocompetent patients with herpes zoster.

2. Describe the diagnostic and treatment options available for the management of herpes zoster.

3. Recognize the complications of herpes zoster 4. Consider important patient selection factors and screening parameters for the Zostavax® vaccination.

18 Journal of Dermatology for Physician Assistants

A Review of Herpes Zoster SDPA Members Only Content

CLINIC AL Dermatology

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

Volume 9 • number 1 • winter 2015 19

A Review of Herpes Zoster 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

A Review of Herpes Zoster SDPA Members Only Content

CLINIC AL Dermatology

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

Volume 9 • number 1 • winter 2015 21

A Review of Herpes Zoster SDPA Members Only Content

CLINIC AL Dermatology

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

22 Journal of Dermatology for Physician Assistants

A Review of Herpes Zoster SDPA Members Only Content

Samantha Erie, MSPAS, PA-C completed her undergraduate degree in Community Health Education at the University of Wisconsin-La Crosse. She then completed her Master of Science in Physician Assistant Studies at the University of Wisconsin-La Crosse-Gundersen-Mayo Physician Assistant Program. She is now practicing family medicine. She has indicated no relationships to disclose relating to the content of this article.

Karen Graham, PhD, MPAS, PA-C is a clinical associate professor in the University of Wisconsin-La Crosse Gundersen Mayo PA Program, as well as an adjunct lecturer for the Carroll University PA Program and the Shenandoah University PA Program. She is currently practicing in a primary care setting.

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

Volume 9 â&#x20AC;˘ number 1 â&#x20AC;˘ winter 2015 23

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

Clinic al Dermatology

From The Patient’s Perspective Lupus Can Be Life Changing

By Jordyn Broas

M

y name is Jordyn; I’m on the right pictured here with my cousin Natalie. I am often told that I don’t look sick and that makes it hard for people to understand what I’m dealing with. I may look like your typical college student, but I have been affected by an ‘invisible disease.’

CLINIC AL Dermatology

One week before I started my freshman semester at Daemen College in Amherst, New York, I was diagnosed with lupus and fibromyalgia. At first I had no idea what my doctor was talking about. But soon

The Lupus Alliance of Upstate New York is committed to serving lupus patients and their loved ones. We understand the isolation and fear patients often feel when they are first diagnosed with lupus. We also recognize the impact the disease can have on family members and friends. The Lupus Alliance of Upstate New York is dedicated to improving the quality of life for patients with lupus and their loved ones. We accomplish this by: ● Educating and informing patients with lupus, their families, the medical community, and the general public by promoting awareness and understanding of lupus. ● Supporting patients with lupus and their families by providing moral support, encouragement, and service to those whose lives have been affected by lupus. ● Promoting and supporting research for better treatment and an eventual cure for this disabling disease.

Contact Information: www.lupusupstateny.org 3871 Harlem Rd, Cheektowaga, NY 14215 Email: info@lupusupstateny.org Phone: (800) 300-4198 Facebook: Lupus Alliance of Upstate 24 Journal of Dermatology for Physician Assistants

enough, I knew everything about lupus. All that I cared about was playing basketball for such a great college.

I thought I could be a normal college student and athlete - enjoying myself, staying up late, and doing everything that my friends were doing. I managed to finish my freshman year and made the all-freshman team for the American Mideast Conference. This accomplishment allowed me to feel as though I didn’t have lupus, which was a great feeling. But practices and games were becoming harder as I continued to suffer from joint pain and fatigue. It was difficult watching my ability to perform at a high level diminish. Due to the frustration from the slip in my ability, I started working out and pushing myself but ignored my body telling me when I needed to take a break.

On Thanksgiving day, my second year of college, I was hospitalized with a blood clot. It was discovered that I was prone to blood clots and I would need to take a blood thinner for the rest of my life. My basketball career was over and I was devastated. I then spent Christmas night in the emergency room and soon after I was diagnosed with pericarditis, inflammation of the lining of the heart. Throughout all of this I was

Lupus also affected my overall physical appearance.

I lost a lot of my hair, I had the infamous butterfly rash on my face, and my weight fluctuated. Internally I faced nausea, inflammation, fatigue, fogginess, headaches, a change in appetite, mood swings, and other wonderful symptoms.

“I also needed support from people who I could relate to - people who have gone through the same things or even worse.”

I was forced to tell my coach that I could no longer play basketball. It was one of the hardest things I have ever had to do, and I will never forget that day for the rest of my life. My teammates were great, and all of them showed up in support of the Annual Lupus Walk this September.

Soon after the Lupus Walk I had to have a kidney biopsy and was diagnosed with lupus nephritis. I am now on high dosages of medication and doctor visits are a weekly event. Despite having gone through a biopsy, dozens of doctor visits, countless tests, surprises, and disappointments, I always try to have a smile on my face.

Honestly I don’t think I would be at this point in my life without my biggest support team: my loving mother, father, and sister. However, I also needed support from people who I could relate to - people who have gone through the same things or even worse.

I have been going to the Lupus Alliance of Upstate New York for talks and volunteering and have been blessed to meet so many caring people who can guide me to a happier and healthier life. The Lupus Alliance of Upstate New York has gotten me and others through tough times, and I am grateful for such a wonderful organization so close to home. I’m determined not to let lupus destroy my future hopes and dreams. J

Take Home Points for Derm PAs:

By Steven K. Shama, MD, MPH, FAAD 1. This was a beautifully written, concise, and powerful perspective about a young woman, in the prime of her life, who needed to come to the realization that the hopes and dreams of the typical teenager would not be her reality. Jordyn’s story resonated so deeply with me and I believe her story is one to which all of us can connect. Each of us has a dream, no mater how young or old, that we hope will be realized.

How do we come to the harsh conclusion that we need to dramatically modify that dream? Jordyn had the answer. We need to look to our patients for their answer. They are our teachers as well as we are theirs.

2. While I’m sure Jordyn’s clinicians were helpful to her for psychological support, she credits her family for being there for her and also mentions that she needed to connect with people with whom she could relate…people who had gone through the “same thing or even worse.” She credits the Lupus Alliance of Upstate New York for getting her through rough times and for connecting her with people who have guided her to a happier and healthier life.

I have written this thought in my other reflections in the Patient’s Perspective section, and I write it again…we as clinicians must recognize the tremendous value support groups add to the wellbeing of our patients. We must form support groups when none exist, and refer our patients to them when we sense that our patients are in need of the experiences of other seasoned, caring patients.

Volume 9 • number 1 • winter 2015 25

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trying to manage my academics, basketball, family, friends, significant other, and most importantly my health. My grades suffered, basketball was gone, I became depressed, and although I wasn’t, I felt alone.

Dermatology Case Report Lymphangioma Circumscriptum

By Gina Mangin, MPAS, PA-C and Nicole Hill, MPAS, PA-C

SDPA Members Only Content

Figure 1

CLINIC AL Dermatology

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

Figure 2

26 Journal of Dermatology for Physician Assistants

SDPA Members Only Content

Gina Mangin, MPAS, PA-C has been a practicing physician assistant for 15 years. She completed her undergraduate degree at the University of North Carolina at Wilmington and then her PA studies at East Carolina University. She then went on to complete her Masters degree in PA studies at the University of Nebraska. She has been practicing dermatology for 7 years and currently works at Sand Lake Dermatology Center in Orlando, FL. Gina has been active in the SDPA, holding a committee member position in the Distance Learning Committee and is a Diplomate of the SDPA. She is a past President of the Florida Society of Dermatology Physician Assistants (FSDPA) and has held previous positions of Secretary and Director at Large. She has indicated no relationships to disclose relating to the content of this article.

Nicole Hill, PA-C is a dermatology physician assistant currently practicing at Sand Lake Dermatology Center in Orlando, FL. Nicole received her bachelor’s degree in food science and human nutrition from the University of Florida and her master’s degree in physician assistant studies from South College in Knoxville, TN. Nicole is an active member of the SDPA and FSDPA. She has indicated no relationships to disclose relating to the content of this article.

Prepare for Grand Rounds!

We’re looking forward to Grand Rounds at the SDPA Annual Summer Dermatology Conference on June 4-7, 2015 at Caesars Palace, Las Vegas, NV! Please submit your interesting cases and photographs in advance of the conference. They will then be presented during the Grand Rounds lecture that will be facilitated by our Summer Medical Director, Dr. Whitney High.

Download the Grand Rounds Submission Guidelines from the Member Document Library at Dermpa.org Submit your cases and photographs to Grandrounds@dermpa.org Volume 9 • number 1 • winter 2015 27

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 Cutaneous Umbilical Endometriosis

By Samantha Wennerberg, PA-C and Suguru Imaeda, MD

SDPA Members Only Content

CLINIC AL Dermatology

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

Figure

Samantha Wennerberg, PA-C has been a physician assistant since 2008 and has been employed at Yale Health in dermatology since 2011. Ms. Wennerberg has indicated no conflicts of interest to disclose relating to the content of this article.

Suguru Imaeda, MD is an Assistant Professor of Dermatology within the Department of Dermatology at Yale University and the Director of Dermatology at the Veterans Hospital in West Haven, CT, and at Yale University Health Services. Dr. Imaeda has indicated no conflicts of interest to disclose relating to the content of this article.

28 Journal of Dermatology for Physician Assistants

Journal Club: Practice Changing Articles for Dermatology PAs Timing of Subsequent New Tumors in Patients Who Present With Basal Cell Carcinoma or Cutaneous Squamous Cell Carcinoma

JAMA Dermatol. Published online January 14, 2015. doi:10.1001/jamadermatol.2014.3307 Wehner MR1, Linos E2, Parvataneni R 2, Stuart SE2, Boscardin WJ3, Chren MM2,4 1 Medical student at Stanford University School of Medicine, Stanford, California, now with Department of Dermatology, University of California, San Francisco 2 Department of Dermatology, University of California, San Francisco 3 Department of Epidemiology and Biostatistics, University of California, San Francisco 4 Dermatology Service, San Francisco Veterans Affairs Medical Center, San Francisco, California

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.

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

Volume 9 â&#x20AC;˘ number 1 â&#x20AC;˘ winter 2015 29

When choosing a biologic for adult chronic moderate to severe plaque psoriasis

ENBREL is a Biological Place to Start

In moderate to severe plaque psoriasis (PsO): 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

Established safety profile • Safety data from 7 PsO trials that included 4,410 patients3-10 • Consistent adverse event rates through 3 years of treatment in over 1,100 patients in clinical trials11-15

Experience • Evaluated in clinical studies over the past 20 years in rheumatoid arthritis (RA)16* - Over 15 years of postmarketing experience since approval for moderate to severe RA in 199817 - 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 10 years of postmarketing experience since approval for adult moderate to severe plaque PsO in 200418

www.enbrel.com

30 Journal of Dermatology for Physician Assistants

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.

Please see additional Important Safety Information on the following page and Brief Summary of the Prescribing Information at the end of this advertisement. *Initial clinical research in RA patients began in 1993.

IMPORTANT SAFETY INFORMATION SERIOUS INFECTIONS Patients treated with ENBREL 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.

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.

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.

Pediatric Patients 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.

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.

HEMATOLOGIC EVENTS 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.

HEPATITIS B REACTIVATION Reactivation of hepatitis B has been reported in patients who were previously infected with hepatitis B virus (HBV) and received concomitant TNF-blocking agents, including ENBREL. Most reports occurred in patients also taking immunosuppressive agents, which may contribute to hepatitis B reactivation.

Exercise caution when considering ENBREL in these patients.

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 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.

DRUG INTERACTIONS 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.

References: 1. Data on file, Amgen; 1642 Subanalysis: May 31, 2007. 2. Enbrel® (etanercept) Prescribing Information, Immunex Corporation, Thousand Oaks, Calif. November 2013. 3. Data on file, Amgen; CSR1632: April 7, 2003. 4. Data on file, Amgen; CSR1642: October 8, 2003. 5. Data on file, Amgen; CSR1639: October 8, 2003. 6. Data on file, Amgen; CSR117: February 24, 2006. 7. Data on file, Amgen; CSR20030190: November 18, 2005. 8. Data on file, Amgen; CSR115: November 28, 2005.

9. Data on file, Amgen; CSR20040216: March 6, 2008. 10. 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. 11. Data on file, Amgen; Exposure-adjusted Rate of OI: October 5, 2010. 12. Data on file, Amgen; IPoD Safety Analysis of Malignancy: October 23, 2009. 13. Data on file, Amgen; Year 1 Summary of Adverse Events: October 14, 2010. 14. Data on file, Amgen; Year 2 Summary of Adverse Events: October 14, 2010. 15. Data on file, Amgen; Year 3 Summary of Adverse Events: October 14, 2010. 16. Data on file, Amgen; Enbrel RA Clinical Trials Experience: December 13, 2012.

17. Data on file, Amgen; RA Approval Letter: November 2, 1998. 18. Data on file, Amgen; PsO Approval Letter: April 30, 2004.

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.

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

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

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

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

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

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

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

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

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

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

Psoriatic Arthritis Enbrel is indicated for reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with psoriatic arthritis (PsA). Enbrel can be used 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

32 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 1140 pediatric patients representing 1927.2 patient-years of therapy, no malignancies, including lymphoma or NMSC, have been reported.

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

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

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

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

Hepatitis B Reactivation Reactivation of hepatitis B in patients who were previously infected with the hepatitis B virus (HBV) and had received concomitant TNF-blocking agents, including very rare cases (< 0.01%) with Enbrel, has been reported. In some instances, hepatitis B reactivation occurring in conjunction with TNF-blocker therapy has been fatal. The majority of these reports have occurred in patients concomitantly receiving other medications that suppress the immune system, which may also contribute to hepatitis B reactivation. Patients at risk for HBV infection should be evaluated for prior evidence of HBV infection before initiating TNF-blocker therapy. Prescribers should exercise caution in prescribing TNF blockers in patients previously infected with HBV. Adequate data are not available on the safety or efficacy of treating patients who are carriers of HBV with anti-viral therapy in conjunction with TNF-blocker therapy to prevent HBV reactivation. Patients previously infected with HBV and require treatment with Enbrel should be closely monitored for clinical and laboratory signs of active HBV infection throughout therapy and for several months following termination of therapy. In patients who develop HBV reactivation, consideration should be given to stopping Enbrel and initiating anti-viral therapy with appropriate supportive treatment. The safety of resuming Enbrel therapy after HBV reactivation is controlled is not known.

Therefore, prescribers should weigh the risks and benefits when considering resumption of therapy in this situation.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Enbrelc (N = 349)

Percent of Patients

Enbrelc (N = 415)

Percent of Patients 81 65

39 30

50 38

86 70

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

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

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

Enbrela (N = 876)

Reaction

Percent of Patients

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

28 14

27 12

17

17

6

15

2 1 2 – – 1

3 1 1 1 1 –

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

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

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

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

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

Skin and subcutaneous tissue disorders:

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

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

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: Blood and lymphatic pancytopenia, anemia, leukopenia, neutropenia, system disorders: thrombocytopenia, lymphadenopathy, aplastic anemia [see Warnings and Precautions] Cardiac disorders: congestive heart failure [see Warnings and Precautions] Gastrointestinal disorders: inflammatory bowel disease (IBD) General disorders: angioedema, chest pain Hepatobiliary disorders: autoimmune hepatitis, elevated transaminases, hepatitis B reactivation Immune disorders: macrophage activation syndrome, systemic vasculitis Musculoskeletal and lupus-like syndrome connective tissue disorders: Neoplasms benign, melanoma and non-melanoma skin cancers, malignant, and unspecified: merkel cell carcinoma [see Warnings and Precautions] Nervous system disorders: convulsions, multiple sclerosis, demyelination, optic neuritis, transverse myelitis, paresthesias [see Warnings and Precautions] Ocular disorders: uveitis, scleritis Respiratory, thoracic interstitial lung disease and mediastinal disorders:

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

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

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

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

USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category B Pregnancy Surveillance Program There is a Pregnancy Surveillance Program that monitors outcomes in women exposed to Enbrel during pregnancy. Women who become pregnant during Enbrel treatment are encouraged to enroll. Patients or their physicians should call 1-800-77-AMGEN (1-800-772-6436) to enroll.

Risk Summary There are no adequate and well controlled studies in pregnant women.

Based on limited data, etanercept concentration in cord blood at the time of delivery showed that etanercept crossed the placenta in small amounts.

Developmental toxicity studies have been performed in rats and rabbits at doses ranging from 60- to 100-fold higher than the human dose and have revealed no evidence of harm to the fetus due to Enbrel. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Human Data Three case reports showed that cord blood levels of etanercept at delivery in infants, born to mothers administered etanercept during pregnancy, were between 3 and 32% of the maternal serum level.

Nursing Mothers Limited data from published literature show that etanercept is present in low levels in human milk and minimally absorbed by a breastfed infant. Caution should be exercised when Enbrel is administered to a nursing woman. The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for Enbrel and any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition.

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

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

Rare (< 0.1%) cases of IBD have been reported in JIA patients receiving Enbrel, which is not effective for the treatment of IBD [see Adverse Reactions (6.2)].

The clinical significance of infant exposure to Enbrel in utero is unknown. The safety of administering live or live-attenuated vaccines in exposed infants is unknown. Risks and benefits should be considered prior to administering live or live-attenuated vaccines to exposed infants.

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

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

Rx Only.

This brief summary is based on ENBREL prescribing information v.53: 11/2013 US License Number 1132 © 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 All rights reserved.

60077-R5-V1

PMV53

Volume 9 • number 1 • winter 2015 33

SURGIC AL Dermatology Journal Club: Practice Changing Articles for Dermatology PAs Purse-String Suture vs. Second Intention Healing Results of a Randomized, Blind Clinical Trial JAMA Dermatol. Published online November 05, 2014. doi:10.1001/jamadermatol.2014.2313 Joo J1, Custis T1, Armstrong AW2, King TH1, Omlin K1,3, Kappel ST4, Eisen DB1 1 Department of Dermatology, University of California Davis Medical Center, Sacramento 2 Department of Dermatology, University of Colorado Denver School of Medicine, Aurora 3 Department of Dermatology, The Permanente Medical Group, Vacaville, California 4 Laser & Skin Surgery Center of Northern California, Sacramento

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.

34 Journal of Dermatology for Physician Assistants

SURGICAL wisdom Reducing Surgical Site Infections

An Opportunity for Performance Improvement SDPA Members Only Content

BERS M E M S D PA

HIP

SURGIC AL Dermatology

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

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 9 • number 1 • winter 2015 35 RAMC_3.25x4.75.indd 1

1/31/13 12:49 PM

FAQs (frequently asked questions)

“Surgical Site Infections”

SURGIC AL Dermatology

What is a Surgical Site Infection (SSI)?

A surgical site infection is an infection that occurs after surgery in the SDPA Members part of the body where the surgery took place. Most patients who have surgery do not develop an infection. However, infections develop in Only about 1Content to 3 out of every 100 patients who have surgery.

Some of the common symptoms of a surgical site infection are: A complimentary subscription • Redness and pain around the area where you had surgery to the•JDPA is provided to the Drainage of cloudy fluid from your surgical wound members of the SDPA. • Fever

Please visit www.dermpa.org today the SDPA and Can SSIstobejoin treated? gain full access to the valuable Yes. Most surgical site infections can be treated with antibiotics. The content of to theyouJDPA. antibiotic given depends on the bacteria (germs) causing the

infection. Sometimes patients with SSIs also need another surgery to treat the infection.

What are some of the things that hospitals are doing to prevent SSIs? To prevent SSIs, doctors, nurses, and other healthcare providers: • Clean their hands and arms up to their elbows with an antiseptic agent just before the surgery.

• Clean their hands with soap and water or an alcohol-based hand rub before and after caring for each patient.

• May remove some of your hair immediately before your surgery using electric clippers if the hair is in the same area where the procedure will occur. They should not shave you with a razor.

• Wear special hair covers, masks, gowns, and gloves during surgery to keep the surgery area clean.

• Give you antibiotics before your surgery starts. In most cases, you should get antibiotics within 60 minutes before the surgery starts and the antibiotics should be stopped within 24 hours after surgery.

• Clean the skin at the site of your surgery with a special soap that kills germs.

What can I do to help prevent SSIs? Before your surgery: • Tell your doctor about other medical problems you may have.

Health problems such as allergies, diabetes, and obesity could affect your surgery and your treatment.

Co-sponsored by:

36 Journal of Dermatology for Physician Assistants

about

• Quit smoking. Patients who smoke get more infections. Talk to your doctor about how you can quit before your surgery.

• Do not shave near where you will have surgery. Shaving with a razor can irritate your skin and make it easier to develop an infection.

At the time of your surgery: • Speak up if someone tries to shave you with a razor before surgery.

Ask why you need to be shaved and talk with your surgeon if you have any concerns.

• Ask if you will get antibiotics before surgery.

After your surgery: • Make sure that your healthcare providers clean their hands before examining you, either with soap and water or an alcohol-based hand rub.

If you do not see your providers clean their hands, please ask them to do so.

• Family and friends who visit you should not touch the surgical wound or dressings.

• Family and friends should clean their hands with soap and water or an alcohol-based hand rub before and after visiting you. If you do not see them clean their hands, ask them to clean their hands.

What do I need to do when I go home from the hospital?

• Before you go home, your doctor or nurse should explain everything you need to know about taking care of your wound. Make sure you understand how to care for your wound before you leave the hospital.

• Always clean your hands before and after caring for your wound.

• Before you go home, make sure you know who to contact if you have questions or problems after you get home.

• If you have any symptoms of an infection, such as redness and pain at the surgery site, drainage, or fever, call your doctor immediately.

If you have additional questions, please ask your doctor or nurse.

Volume 9 • number 1 • winter 2015 37

COSMETIC deRMATOLOGY Journal Club: Practice Changing Articles for Dermatology PAs Laser Hair Removal Brings â&#x20AC;&#x2DC;Significant Improvementâ&#x20AC;&#x2122; to Military Amputees Laser hair removal significantly improves the quality of life for military personnel who have suffered combatassociated amputations, according to a study recently released at the 2014 ASDS Annual Meeting.

ASDS Press Release. Published online November 2014. https://www.asds.net/_Media.aspx?id=8488 Miletta N1, Kim S, Marquart J 1 Walter Reed National Military Medical Center, Bethesda, 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.

38 Journal of Dermatology for Physician Assistants

SDPA Members Only Content

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.

SDPA ANNUAL SUMMER DERMATOLOGY CONFERENCE 2015

LAS VEGAS, NV - CAESARS PALACE

FEATURED COURSES: 1. Pediatric Nails: Diagnoses and Treatments by Jane Bellet MD 2. Aging Gracefully: Cosmetic Concerns by Kasey D’Amato PA-C 3. Tough Itchy Cases: Dermatitis, Urticaria and Neurodermatitis by Matthew Zirwas MD, Ted Rosen MD, and Whitney High, MD, JD, MEng 4. Differential Diagnoses of Red Extremities by Colby Evans MD 5. Red All Over & Emergency Conditions in Dermatology by Whitney High MD, JD, MEng VISIT WWW.DERMPA.ORG FOR MORE DETAILS

Volume 9 • number 1 • winter 2015 39

COSMETIC Dermatology

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

Cosmetic pearls Tips to Treat and Control Dandruff

COSMETIC Dermatology

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.

Adam Friedman, MD, FAAD is is an assistant professor of medicine (dermatology) and physiology and biophysics and serves as Director of Dermatologic Research at the Unified Division of Dermatology of Montefiore Medical Center - Albert Einstein College of Medicine.

Reprinted with permission from the American Academy of Dermatology

40 Journal of Dermatology for Physician Assistants

PROVEN

EFFICACY

CUSTOMIZED, WITH WEIGHT-BASED1,2

DOSING

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

Indication and Usage SOLODYN is indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older.

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

References: 1. SOLODYN Tablets Package Insert. Scottsdale, AZ: Valeant Dermatology; February 2012.

2. Data on file, Valeant Pharmaceuticals.

Except as otherwise indicated, all product names, slogans and other marks are trademarks of the Valeant family of companies. ©2014 Valeant Pharmaceuticals North America LLC. DM/SDN/14/0005

Volume 9 • number 1 • winter 2015 41

BRIEF SUMMARY (see package insert for full prescribing information) SOLODYN® (minocycline HCl, USP) Extended Release Tablets Rx Only KEEP OUT OF REACH OF CHILDREN INDICATIONS AND USAGE Indication SOLODYN is indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older.

Limitations of Use SOLODYN did not demonstrate any effect on non-inflammatory acne lesions. Safety of SOLODYN has not been established beyond 12 weeks of use. This formulation of minocycline has not been evaluated in the treatment of infections.

animals treated early in pregnancy (see Use in Specific Populations).

Pseudomembranous Colitis Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.

Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia.

Studies indicate that a toxin produced by Clostridium difficile is a primary cause of “antibiotic-associated colitis”.

After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to discontinuation of To reduce the development of drugthe drug alone. In moderate to severe resistant bacteria as well as to maintain the cases, consideration should be given to effectiveness of other antibacterial drugs, management with fluids and electrolytes, SOLODYN should be used only as indicated protein supplementation, and treatment (see Warnings and Precautions). with an antibacterial drug clinically effective against Clostridium difficile colitis.

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

WARNINGS AND PRECAUTIONS Teratogenic Effects A. MINOCYCLINE, LIKE OTHER TETRACYCLINE-CLASS DRUGS, CAN CAUSE FETAL HARM WHEN ADMINISTERED TO A PREGNANT WOMAN. IF ANY TETRACYCLINE IS USED DURING PREGNANCY OR IF THE PATIENT BECOMES PREGNANT WHILE TAKING THESE DRUGS, THE PATIENT SHOULD BE APPRISED OF THE POTENTIAL HAZARD TO THE FETUS. SOLODYN should not be used during pregnancy or by individuals of either gender who are attempting to conceive a child (see Nonclinical Toxicology & Use in Specific Populations).

B. THE USE OF DRUGS OF THE TETRACYCLINE CLASS DURING TOOTH DEVELOPMENT (LAST HALF OF PREGNANCY, INFANCY, AND CHILDHOOD UP TO THE AGE OF 8 YEARS) MAY CAUSE PERMANENT DISCOLORATION OF THE TEETH (YELLOW-GRAY-BROWN).

This adverse reaction is more common during long-term use of the drug but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. TETRACYCLINE DRUGS, THEREFORE, SHOULD NOT BE USED DURING TOOTH DEVELOPMENT. C. All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in fibula growth rate has been observed in premature human infants given oral tetracycline in doses of 25 mg/kg every 6 hours. This reaction was shown to be reversible when the drug was discontinued.

Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can cause retardation of skeletal development on the developing fetus. Evidence of embryotoxicity has been noted in

Hepatotoxicity Post-marketing cases of serious liver injury, including irreversible drug-induced hepatitis and fulminant hepatic failure (sometimes fatal) have been reported with minocycline use in the treatment of acne.

Metabolic Effects The anti-anabolic action of the tetracyclines may cause an increase in BUN. While this is not a problem in those with normal renal function, in patients with significantly impaired function, higher serum levels of tetracycline-class drugs may lead to azotemia, hyperphosphatemia, and acidosis.

If renal impairment exists, even usual oral or parenteral doses may lead to excessive systemic accumulations of the drug and possible liver toxicity. Under such conditions, lower than usual total doses are indicated, and if therapy is prolonged, serum level determinations of the drug may be advisable.

Central Nervous System Effects Central nervous system side effects including light-headedness, dizziness or vertigo have been reported with minocycline therapy. Patients who experience these symptoms should be cautioned about driving vehicles or using hazardous machinery while on minocycline therapy.

These symptoms may disappear during therapy and usually rapidly disappear when the drug is discontinued.

Benign Intracranial Hypertension Pseudotumor cerebri (benign intracranial hypertension) in adults and adolescents has been associated with the use of tetracyclines. Minocycline has been reported to cause or precipitate pseudotumor cerebri, the hallmark of which is papilledema. Clinical manifestations include headache and blurred vision. Bulging fontanels have been associated with the use of tetracyclines in infants. Although signs and symptoms of pseudotumor cerebri resolve after discontinuation of treatment, the possibility for permanent sequelae such as visual loss that may be permanent or severe exists.

Patients should be questioned for visual

42 Journal of Dermatology for Physician Assistants

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

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

Superinfection As with other antibiotic preparations, use of SOLODYN may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, SOLODYN Autoimmune Syndromes should be discontinued and appropriate Tetracyclines have been associated with the therapy instituted. development of autoimmune syndromes.

Laboratory Monitoring The long-term use of minocycline in the Periodic laboratory evaluations of organ treatment of acne has been associated systems, including hematopoietic, renal with drug-induced lupus-like syndrome, and hepatic studies should be performed. autoimmune hepatitis and vasculitis.

Appropriate tests for autoimmune syndromes Sporadic cases of serum sickness have should be performed as indicated. presented shortly after minocycline ADVERSE REACTIONS use. Symptoms may be manifested by fever, rash, arthralgia, and malaise. In Clinical Trial Experience symptomatic patients, liver function tests, Because clinical trials are conducted under ANA, CBC, and other appropriate tests prescribed conditions, adverse reaction should be performed to evaluate the rates observed in the clinical trial may not patients. Use of all tetracycline-class drugs reflect the rates observed in practice. should be discontinued immediately.

The following table summarizes selected Photosensitivity adverse reactions reported in clinical trials Photosensitivity manifested by an at a rate of ≥1% for SOLODYN. exaggerated sunburn reaction has been Selected Treatment-Emergent Adverse observed in some individuals taking Reactions in at least 1% of Clinical tetracyclines. This has been reported Trial Subjects rarely with minocycline. Patients should Adverse Reactions SOLODYN PLACEBO minimize or avoid exposure to natural or (1 mg/kg) N=364 artificial sunlight (tanning beds or UVA/B N=674 (%) (%) treatment) while using minocycline. If At least one treatment- 379 (56) 197 (54) patients need to be outdoors while using minocycline, they should wear loose-fitting emergent event 152 (23) 83 (23) clothes that protect skin from sun exposure Headache 62 (9) 24 (7) and discuss other sun protection measures Fatigue Dizziness 59 (9) 17 (5) with their physician.

Pruritus 31 (5) 16 (4) Serious Skin/Hypersensitivity Malaise 26 (4) 9 (3) Reaction Mood alteration 17 (3) 9 (3) Cases of anaphylaxis, serious skin reactions 13 (2) 3 (1) (e.g. Stevens Johnson syndrome), erythema Somnolence 10 (2) 1 (0) multiforme, and drug rash with eosinophilia Urticaria 10 (2) 5 (1) and systemic symptoms (DRESS) syndrome Tinnitus Arthralgia 9 (1) 2 (0) have been reported postmarketing with Vertigo 8 (1) 3 (1) minocycline use in patients with acne.

Dry mouth 7 (1) 5 (1) DRESS syndrome consists of cutaneous Myalgia 7 (1) 4 (1) reaction (such as rash or exfoliative dermatitis), eosinophilia, and one or more Postmarketing Experience of the following visceral complications Adverse reactions that have been reported such as: hepatitis, pneumonitis, nephritis, with minocycline hydrochloride use in a myocarditis, and pericarditis. Fever and variety of indications include: lymphadenopathy may be present. In some Skin and hypersensitivity reactions: cases, death has been reported. If this fixed drug eruptions, balanitis, erythema syndrome is recognized, the drug should be multiforme, Stevens-Johnson syndrome, discontinued immediately. anaphylactoid purpura, photosensitivity, Tissue Hyperpigmentation pigmentation of skin and mucous Tetracycline-class antibiotics are known membranes, hypersensitivity reactions, to cause hyperpigmentation. Tetracycline angioneurotic edema, anaphylaxis, DRESS therapy may induce hyperpigmentation in syndrome (see Warnings and Precautions). many organs, including nails, bone, skin, Autoimmune conditions: polyarthralgia, eyes, thyroid, visceral tissue, oral cavity pericarditis, exacerbation of systemic lupus, (teeth, mucosa, alveolar bone), sclerae and pulmonary infiltrates with eosinophilia, heart valves. Skin and oral pigmentation transient lupus-like syndrome. has been reported to occur independently Central nervous system: pseudotumor of time or amount of drug administration, cerebri, bulging fontanels in infants, whereas other tissue pigmentation has decreased hearing. been reported to occur upon prolonged administration. Skin pigmentation includes Endocrine: brown-black microscopic thyroid diffuse pigmentation as well as over sites discoloration, abnormal thyroid function. of scars or injury.

Oncology: thyroid cancer.

Development of Drug Resistant Oral: glossitis, dysphagia, tooth Bacteria discoloration.

Bacterial resistance to the tetracyclines may develop in patients using SOLODYN, Gastrointestinal: enterocolitis, pancreatitis, therefore, the susceptibility of bacteria hepatitis, liver failure. associated with infection should be Renal: reversible acute renal failure. considered in selecting antimicrobial Hematology: hemolytic anemia, therapy. Because of the potential for thrombocytopenia, eosinophilia.

Preliminary studies suggest that use of minocycline may have deleterious effects on human spermatogenesis (see Nonclinical Toxicology).

DRUG INTERACTIONS Anticoagulants Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.

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

Minocycline was assessed for effects on peri- and post-natal development of rats in a study that involved oral administration to Penicillin pregnant rats from day 6 of gestation Since bacteriostatic drugs may interfere through the period of lactation (postpartum with the bactericidal action of penicillin, it is day 20), at dosages of 5, 10, or 50 advisable to avoid giving tetracycline-class mg/kg/day. In this study, body weight gain drugs in conjunction with penicillin. was significantly reduced in pregnant females that received 50 mg/kg/day Methoxyflurane (resulting in approximately 2.5 times the The concurrent use of tetracycline and methoxyflurane has been reported to result systemic exposure to minocycline observed in patients as a result of use of SOLODYN). in fatal renal toxicity.

No effects of treatment on the duration of Antacids and Iron Preparations the gestation period or the number of live Absorption of tetracyclines is impaired by pups born per litter were observed. Gross antacids containing aluminum, calcium external anomalies observed in F1 pups or magnesium and iron-containing (offspring of animals that received preparations. minocycline) included reduced body size, improperly rotated forelimbs, and reduced Low Dose Oral Contraceptives size of extremities. No effects were In a multi-center study to evaluate the observed on the physical development, effect of SOLODYN on low dose oral behavior, learning ability, or reproduction contraceptives, hormone levels over one of F1 pups, and there was no effect on menstrual cycle with and without gross appearance of F2 pups (offspring SOLODYN 1 mg/kg once-daily were of F1 animals). measured. Based on the results of this trial, minocycline-related changes in Nursing Mothers estradiol, progestinic hormone, FSH and Tetracycline-class antibiotics are excreted LH plasma levels, of breakthrough in human milk. Because of the potential for bleeding, or of contraceptive failure, serious adverse effects on bone and tooth cannot be ruled out. To avoid contraceptive development in nursing infants from the failure, female patients are advised to use tetracycline-class antibiotics, a decision a second form of contraceptive during should be made whether to discontinue treatment with minocycline. nursing or discontinue the drug, taking into account the importance of the drug to the Drug/Laboratory Test Interactions mother (see Warnings and Precautions).

False elevations of urinary catecholamine levels may occur due to interference with Pediatric Use the fluorescence test.

SOLODYN is indicated to treat only inflammatory lesions of non-nodular USE IN SPECIFIC POPULATIONS moderate to severe acne vulgaris Pregnancy in patients 12 years and older.

Teratogenic Effects: Pregnancy category D Safety and effectiveness in pediatric (see Warnings and Precautions) patients below the age of 12 has not been established.

SOLODYN should not be used during pregnancy. If the patient becomes pregnant Use of tetracycline-class antibiotics below while taking this drug, the patient should be the age of 8 is not recommended due to apprised of the potential hazard to the fetus the potential for tooth discoloration (see and stop treatment immediately.

Warnings and Precautions).

There are no adequate and well-controlled Geriatric Use studies on the use of minocycline in Clinical studies of SOLODYN did not pregnant women. Minocycline, like other include sufficient numbers of subjects aged tetracycline-class drugs, crosses the 65 and over to determine whether they placenta and may cause fetal harm when respond differently from younger subjects. administered to a pregnant woman.

Other reported clinical experience has not

NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility

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

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

NDC 99207-466-30

Mutagenesis—Minocycline was not mutagenic in vitro in a bacterial reverse mutation assay (Ames test) or CHO/HGPRT mammalian cell assay in the presence or absence of metabolic activation.

Minocycline was not clastogenic in vitro using human peripheral blood lymphocytes or in vivo in a mouse micronucleus test.

Impairment of Fertility—Male and female reproductive performance in rats was unaffected by oral doses of minocycline of up to 300 mg/kg/day (which resulted in up to approximately 40 times the level of systemic exposure to minocycline observed in patients as a result of use of SOLODYN). However, oral administration of 100 or 300 mg/kg/day of minocycline to male rats (resulting in approximately 15 to 40 times the level of systemic exposure to minocycline observed in patients as a result of use of SOLODYN) adversely affected spermatogenesis. Effects observed at 300 mg/kg/day included a reduced number of sperm cells per gram of epididymis, an apparent reduction in the percentage of sperm that were motile, and (at 100 and 300 mg/kg/day) increased numbers of morphologically abnormal sperm cells.

Morphological abnormalities observed in sperm samples included absent heads, misshapen heads, and abnormal flagella.

Limited human studies suggest that minocycline may have a deleterious effect on spermatogenesis.

Bottle of 30

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

Bottle of 30

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

Bottle of 30

Storage Store at 25ºC (77ºF); excursions are permitted to 15º-30ºC (59º-86ºF) [See USP Controlled Room Temperature].

Handling Keep out of reach of children Protect from light, moisture, and excessive heat.

Dispense in tight, light-resistant container with child-resistant closure.

U.S. Patents 5,908,838; 7,790,705; 7,919,483; and Patents Pending* *90 mg is also covered by U.S. Patents 7,541,347 and 7,544,373 Manufactured for: Medicis, The Dermatology Company Scottsdale, AZ 85256 02/2012 17110264

SOLODYN should not be used by individuals of either gender who are attempting to conceive a child.

HOW SUPPLIED/STORAGE AND HANDLING How Supplied SOLODYN (minocycline HCl, USP) Extended Release Tablets are supplied as aqueous film coated tablets containing minocycline hydrochloride equivalent to 55 mg, 65 mg, 80 mg, 105 mg or 115 mg minocycline, are supplied as follows.

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

Volume 9 • number 1 • winter 2015 43

PROFESSIONAL de VELOPMENT

Physician Assistants in Specialty Practice A Valued Role in the Healthcare Team

By Jane Mast, PA-C and Ann Davis, MS, PA-C

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

44 Journal of Dermatology for Physician Assistants

SDPA Members Only Content

Jane Mast, PA-C is a current SDPA Director at Large. Prior to this role she served as the SDPA Legislative Affairs Committee Chair for three years. She has been a practicing dermatology PA for 13 years in Merritt Island, FL. Jane graduated with honors from the University of Florida College of Medicine PA Program. A native of Cincinnati, Ohio she received her bachelors degree from Miami University in Oxford, Ohio.

Ann Davis, MS, PA-C, is Vice President of Constituent Organization Outreach and Advocacy for the American Academy of Physician Assistants (AAPA). Supervising a staff of seven, Ann oversees and coordinates legislative and regulatory advocacy initiatives supporting the PA profession in all 50 states, the District of Columbia and the U.S. territories. She is also responsible for assuring and managing AAPA’s affiliations with its state and federal service chapters, specialty organizations, caucuses and special interest groups.

As AAPA’s lead state government staff resource, Ann monitors trends in health law and policy development at health professional and health-related organizations. She drafts legislation to improve state laws, educates state and national groups on utilization and regulation of physician-PA teams and provides guidance on regulation and best practice models for the physician assistant profession.

In working with AAPA’s constituent organizations, Ann coordinates and implements services, affiliation, capacity building and alignment for the organizations, helping to assure that PAs can find organizational homes with AAPA and the constituent organizations most relevant to their professional development and career path.

Ann is a graduate of the University of Colorado Physician Assistant Program. Prior to joining the Academy staff in 1994 she practiced as a PA in pediatrics in Flagstaff, Ariz., and in Grass Valley and Sacramento, Calif. Ann served as the well child coordinator for Coconino County, Ariz., and as the pediatric care coordinator for the Flagstaff Bureau of Indian Affairs Student Dormitory. From 19851987, she served on the pediatric faculty at the University of Colorado Health Sciences Center and taught at the University of Colorado PA Program.

In 1991, Ann was a member of the inaugural class of the Public Health Service Primary Care Policy Fellowship and from 1999-2008 served as a member of the board of directors for the National Fund for Medical Education. She is the author of many journal articles and several chapters of texts, primarily relating to advocacy, PA practice and the regulation of physician assistants.

This article was first published in The Dermatologist, December 2014 issue. Reprinted with permission from The Dermatologist.

Volume 9 • number 1 • winter 2015 45

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.

Notes from your Office Manager Prescription Medications and Patient Safety The Risk:

Patient injuries and malpractice claims can result from known risks and side effects, allergic reactions, drug interactions, or errors in prescribing.

Recommendations:

professional development

➊ Since there are significant risks and

side effects associated with prescribed drugs, healthcare providers must discuss this information with their patients and document these discussions in the medical record. ➋ The patient's allergic history must be reviewed before a new drug is prescribed.

Known allergies must be documented and flagged in a prominent, easily viewable place in the medical record. ➌ Medication updates, including dosage changes and refills, and the use of any over-the-counter drugs, must be clearly documented in the medical record.

A medication flow sheet can be used

to monitor and track current and past medication usage, as well as allergies. ➍ Any specific instructions provided to patients regarding the medications must also be written in the record. ➎ There must be written confirmation that the laboratory and/or diagnostic tests necessary to monitor certain drugs for their effectiveness or side effects are ordered, as recommended by professional guidelines, and the test results viewed and necessary adjustments made. ➏ The rationale for the discontinuing of a medication must be documented in the medical record. J

These Risk Management Tips have been reprinted with permission from: MLMIC Dateline, published by Medical Liability Mutual Insurance Company, 2 Park Avenue, Room 2500, New York, NY 10016. Copyright ©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.

Visit the Patient’s Perspective library of articles at www.jdpa.org/advocacy.html If you know a patient who would like to share his/her story, please contact us at editor@jdpa.org 46 Journal of Dermatology for Physician Assistants

Outside & Inside the 9 to 5...

On November 8th, the country, resulting in 2014 over 250 participants millions of dollars of donations competed in the 2nd Annual to the Melanoma Research Miles for Melanoma Atlanta 5K Foundation, which supports run/1 mile walk to raise money research and education. Farrell for the Melanoma Research lost his battle with melanoma Foundation and to increase in 2010, but his legacy of awareness concerning a goodwill continues to help cancer that kills over 9,000 others. people a year.

Matthew Brunner, of the Georgia Dermatology Physician “We decided as a group that Participants Executive Director of the GDPA Assistants (GDPA) team (including members, family, it was important to do a service and friends) at the 2nd Annual Miles for Melanoma and President-Elect of the project and felt like Miles For Atlanta 5K run/1 mile walk.

SDPA, considers it an honor to Melanoma was a cause close to have run in all three SDPA Miles our hearts,” said GDPA president for Melanoma races in Seattle, Norma Gordon. Sporting royal Atlanta, and San Diego. Like blue GDPA hats, and bundled many participants, Brunner has against the chilly morning, the a personal connection with GDPA team participated in the disease. According to Mr. the run/walk. The GDPA team Brunner, “It was important to raised $2,115 for the cause, me to demonstrate that PAs second only to Team Momma in dermatology are passionate, Bear, which collected $5,000. not just about their profession, The 24 participants on the but also about the lives of those GDPA team included members, we care for each day. Having family, and friends. had friends and patients succumb to melanoma as well From left to right: Matthew Brunner, MHS, PA-C, Amanda Sanders, co-captain GDPA Executive Director and SDPA President-Elect, as family members diagnosed of the GDPA team and co-chair Monica Sohani, PA-C, and 2014 GDPA Supervising with it, has further helped of the GDPA membership Physician of the Year Maria Pico, MD. me realize the importance of committee, emphasized the acting now to advance melanoma research.” importance of community activism and shared why this event was important to the GDPA, “Our goal was As a group, dermatology PAs demonstrate a to be a visible presence at the event and I believe we commitment to using their knowledge and skills to were very successful. We plan on making Miles for make a difference in others’ lives. Dermatology PAs Melanoma Atlanta our annual volunteer community are active in a variety of volunteer programs including service project. Having an annual service event will let free skin cancer screenings, medical mission trips, people know that the GDPA is serious about making camps for children with chronic skin diseases, a difference and being an active participant in the and mentoring PA students. This record of service community.” by dermatology PAs demonstrates a philosophy perhaps best summed up by a quote from Winston The Miles for Melanoma program was launched in Churchill, “We make a living by what we get, but we 2002 by Steve Farrell of New Jersey after his second make a life by what we give.” J bout of melanoma. Races are now organized across Volume 9 • number 1 • winter 2015 47

professional development

Founded in 2002, the Georgia Dermatology Physician Assistants (GDPA) is a State Affiliate chapter of the SDPA with 108 members. The organization is active in providing continuing education programs for its members. After taking part in the Inaugural Miles for Melanoma Atlanta event held in conjunction with the 2013 SDPA Annual Fall Dermatology Conference, the GDPA decided to make the event an annual tradition to heighten awareness of melanoma among the PA profession and support the community. The JDPA is pleased to share with our readers what motivated this SDPA State Affiliate to participate in this event as well as insights into the experience from some of the participating members of the GDPA.

IMPORTANT SAFETY INFORMATION (cont’d) Warnings and Precautions (cont’d) for patients with a history of depression and/or suicidal thoughts/behavior, or in patients who develop such symptoms while on Otezla. Patients, caregivers, and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes, and they should contact their healthcare provider if such changes occur ◆ Weight Decrease: Body weight loss

of 5-10% occurred in 12% (96/784) of patients treated with Otezla and in 5% (19/382) of patients treated with placebo. Body weight loss of ≥10% occurred in 2% (16/784) of patients treated with Otezla compared to 1% (3/382) of patients treated with

placebo. Monitor body weight regularly; evaluate unexplained or clinically significant weight loss, and consider discontinuation of Otezla ◆ Drug Interactions: Apremilast

exposure was decreased when Otezla was co-administered with rifampin, a strong CYP450 enzyme inducer; loss of Otezla efficacy may occur. Concomitant use of Otezla with CYP450 enzyme inducers (eg, rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended

Adverse Reactions ◆ Adverse reactions reported in ≥5%

of patients were (Otezla%, placebo%): diarrhea (17, 6), nausea (17, 7), upper respiratory tract infection (9, 6), tension headache (8, 4), and headache (6, 4).

Use in Specific Populations ◆ Pregnancy and Nursing Mothers: Otezla is Pregnancy Category C; it has not been studied in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether apremilast or its metabolites are present in human milk. Caution should be exercised when Otezla is administered to a nursing woman ◆ Renal

Impairment: Otezla dosage should be reduced in patients with severe renal impairment (creatinine clearance less than 30 mL/min); for details, see Dosage and Administration, Section 2, in the Full Prescribing Information

Please turn the next page for Brief Summary of Full Prescribing Information.

References: 1. Schafer PH, Parton A, Capone L, et al.

Cell Signal. 2014;26:2016-2029. 2. Otezla [package insert].

Summit, NJ: Celgene Corporation; 2014. 3. Data on file, Celgene Corporation.

Otezla® is a registered trademark of Celgene Corporation. © 2014 Celgene Corporation 09/14 USII-APR130019e

48 Journal of Dermatology for Physician Assistants

◆

◆

Otezla® (apremilast) was evaluated in 2 multicenter, double-blind, placebo-controlled trials of similar design. Patients with moderate to severe plaque psoriasis (N = 1257) were randomized 2:1 to Otezla 30 mg or placebo twice daily for 16 weeks, after a 5-day titration2,3

◆

PASI-75 response at week 16 (primary endpoint)2,3 – Study 1: Otezla 33% vs placebo 5% (P < 0.0001) – Similar PASI-75 response was achieved in Study 2

Inclusion criteria: Age ≥18 years, BSA involvement ≥10%, sPGA ≥3, PASI score ≥12, candidates for phototherapy or systemic therapy2

BSA, body surface area; PASI, Psoriasis Area and Severity Index; sPGA, static Physician Global Assessment.

IMPORTANT SAFETY INFORMATION Contraindications ◆ Otezla® is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation Warnings and Precautions ◆ Depression: Treatment with Otezla

is associated with an increase in adverse reactions of depression

During clinical trials, 1.3% (12/920) of patients treated with Otezla reported depression compared to 0.4% (2/506) on placebo; 0.1% (1/1308) of Otezla patients discontinued treatment due to depression compared with none on placebo (0/506). Depression was reported as serious in 0.1% (1/1308) of patients exposed to Otezla, compared to none in placebo-treated patients

(0/506). Suicidal behavior was observed in 0.1% (1/1308) of patients on Otezla, compared to 0.2% (1/506) on placebo. One patient treated with Otezla attempted suicide; one patient on placebo committed suicide Carefully weigh the risks and benefits of treatment with Otezla Continued to the left

Get the latest news at otezlapro.com Volume 9 • number 1 • winter 2015 49

Rx Only OTEZLA® (apremilast) tablets, for oral use The following is a Brief Summary; refer to Full Prescribing Information for complete product information.

INDICATIONS AND USAGE OTEZLA® (apremilast) is indicated for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

CONTRAINDICATIONS OTEZLA is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation [see Adverse Reactions (6.1)].

WARNINGS AND PRECAUTIONS Depression: Treatment with OTEZLA is associated with an increase in adverse reactions of depression. Before using OTEZLA in patients with a history of depression and/or suicidal thoughts or behavior prescribers should carefully weigh the risks and benefits of treatment with OTEZLA in such patients.

Patients, their caregivers, and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes, and if such changes occur to contact their healthcare provider.

Prescribers should carefully evaluate the risks and benefits of continuing treatment with OTEZLA if such events occur. During the 0 to 16 week placebocontrolled period of the 3 controlled clinical trials, 1.3% (12/920) of patients treated with OTEZLA reported depression compared to 0.4% (2/506) treated with placebo. During the clinical trials, 0.1% (1/1308) of patients treated with OTEZLA discontinued treatment due to depression compared with none in placebo-treated patients (0/506). Depression was reported as serious in 0.1% (1/1308) of patients exposed to OTEZLA, compared to none in placebo-treated patients (0/506). Instances of suicidal behavior have been observed in 0.1% (1/1308) of patients while receiving OTEZLA, compared to 0.2% (1/506) in placebo-treated patients. In the clinical trials, one patient treated with OTEZLA attempted suicide while one who received placebo committed suicide.

Weight Decrease: During the controlled period of the trials in psoriasis, weight decrease between 5%-10% of body weight occurred in 12% (96/784) of patients treated with OTEZLA compared to 5% (19/382) treated with placebo. Weight decrease of ≥10% of body weight occurred in 2% (16/784) of patients treated with OTEZLA 30 mg twice daily compared to 1% (3/382) patients treated with placebo. Patients treated with OTEZLA should have their weight monitored regularly. If unexplained or clinically significant weight loss occurs, weight loss should be evaluated, and discontinuation of OTEZLA should be considered.

Drug Interactions: Co-administration of strong cytochrome P450 enzyme inducer, rifampin, resulted in a reduction of systemic exposure of apremilast, which may result in a loss of efficacy of OTEZLA. Therefore, the use of cytochrome P450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) with OTEZLA is not recommended [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

ADVERSE REACTIONS Clinical Trials Experience in Psoriasis: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trial 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. Diarrhea, nausea, and upper respiratory tract infection were the most commonly reported adverse reactions. The most common adverse reactions leading to discontinuation for patients taking OTEZLA were nausea (1.6%), diarrhea (1.0%), and headache (0.8%). The proportion of patients with psoriasis who discontinued treatment due to any adverse reaction was 6.1% for patients treated with OTEZLA 30 mg twice daily and 4.1% for placebo-treated patients.

Table 3: Adverse Reactions Reported in ≥1% of Patients on OTEZLA and With Greater Frequency Than in Patients on Placebo; up to Day 112 (Week 16) Placebo (N=506) n (%)

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

Diarrhea

32 (6)

160 (17)

Nausea

35 (7)

155 (17)

Upper respiratory tract infection

31 (6)

84 (9)

Tension headache

21 (4)

75 (8)

Headache

19 (4)

55 (6)

Abdominal pain*

11 (2)

39 (4)

Vomiting

8 (2)

35 (4)

Fatigue

9 (2)

29 (3)

Preferred Term

(continued)

50 Journal of Dermatology for Physician Assistants

Table 3: Adverse Reactions Reported in ≥1% of Patients on OTEZLA and With Greater Frequency Than in Patients on Placebo; up to Day 112 (Week 16) Placebo (N=506) n (%)

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

Dyspepsia

6 (1)

29 (3)

Decrease appetite

5 (1)

26 (3)

Insomnia

4 (1)

21 (2)

Back pain

4 (1)

20 (2)

Migraine

5 (1)

19 (2)

Frequent bowel movements

1 (0)

17 (2)

Depression

2 (0)

12 (1)

Bronchitis

2 (0)

12 (1)

Tooth abscess

0 (0)

10 (1)

Folliculitis

0 (0)

9 (1)

Sinus headache

0 (0)

9 (1)

Preferred Term

*Two subjects treated with OTEZLA experienced serious adverse reaction of abdominal pain.

Severe worsening of psoriasis (rebound) occurred in 0.3% (4/1184) patients following discontinuation of treatment with OTEZLA (apremilast).

DRUG INTERACTIONS Strong CYP 450 Inducers: Apremilast exposure is decreased when OTEZLA is co-administered with strong CYP450 inducers (such as rifampin) and may result in loss of efficacy [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.3)].

USE IN SPECIFIC POPULATIONS Pregnancy: Pregnancy Category C : OTEZLA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Pregnancy Exposure Registry: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to OTEZLA during pregnancy.

Information about the registry can be obtained by calling 1-877-311-8972.

Nursing Mothers: It is not known whether OTEZLA or its metabolites are present in human milk. Because many drugs are present in human milk, caution should be exercised when OTEZLA is administered to a nursing woman. Pediatric use: The safety and effectiveness of OTEZLA in pediatric patients less than 18 years of age have not been established. Geriatric use: Of the 1257 patients who enrolled in two placebo-controlled psoriasis trials (PSOR 1 and PSOR 2), a total of 108 psoriasis patients were 65 years of age and older, including 9 patients who were 75 years of age and older. No overall differences were observed in the efficacy and safety in elderly patients ≥65 years of age and younger adult patients <65 years of age in the clinical trials. Renal Impairment: OTEZLA pharmacokinetics were not characterized in patients with mild (creatinine clearance of 60-89 mL per minute estimated by the Cockcroft–Gault equation) or moderate (creatinine clearance of 30-59 mL per minute estimated by the Cockroft–Gault equation) renal impairment. The dose of OTEZLA should be reduced to 30 mg once daily in patients with severe renal impairment (creatinine clearance of less than 30 mL per minute estimated by the Cockroft–Gault equation) [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3)]. Hepatic Impairment: Apremilast pharmacokinetics were characterized in patients with moderate (Child Pugh B) and severe (Child Pugh C) hepatic impairment. No dose adjustment is necessary in these patients.

OVERDOSAGE In case of overdose, patients should seek immediate medical help. Patients should be managed by symptomatic and supportive care should there be an overdose.

Manufactured for: Celgene Corporation, Summit, NJ 07901 OTEZLA® is a registered trademark of Celgene Corporation.

Pat. http://www.celgene.com/therapies ©2014 Celgene Corporation, All Rights Reserved.

Based on APRPI.003

OTZ_PsO_HCP_BSv.003 09_2014

Dermatology PA news & notes

The Difference We Make A Pain in the Bottom

By Brian T. Maurer, PA-C Bottom: “Ready. Name what part I am for, and proceed.”

A Mid-Summer Night’s Dream, I, ii.

Next month this boy will celebrate his 18th birthday and segue into young adulthood. Despite that fact, he’s here with his father today, mostly for moral support, I suspect.

Even though I’ve known him since he was a newborn infant, at his age he’s a bit uncomfortable discussing his medical problem: a pain in the bottom.

“It just came up last night,” the boy tells me. “It hurt so bad, almost like I was being cut with knife blades.”

“He was banging his head against the wall, it hurt so much,” his father adds. “We had a few Percocet tabs left over from the emergency room visit, so he took one of those. It took the edge off, but he was still uncomfortable throughout the night.”

“Have you been constipated recently?” I ask. “Passed any blood in your stool?”

“Yeah, I’ve always had a tough time going to the bathroom. Sometimes I don’t go for a few days. Then it’s really hard to go.”

“We used to have to give him laxatives when he was a baby,” his father says. “You probably remember.”

I nod my head. “So what brought you to the emergency room?”

“Same problem—pain,” the boy says. “They said I had a fissure that got infected. The doctor put me on an antibiotic, gave me pain medicine, and said I should follow up with you.”

“When was this?” I ask.

“Two weeks ago,” the boy says.

“We didn’t come in right away because he seemed to get better after taking the medicine for a couple of days,” the father says.

I notice the boy’s face is flushed. The skin is very dry; even his lips are parched. Traces of cystic acne dot his cheeks. I flip through the chart to review my notes. Three months ago, thinking he would benefit from a course of oral isotretinoin, I referred him to a dermatologist.

“I suppose we should have a look at your bottom,” I say, reaching for a pair of exam gloves.

“Whoa!” he pipes up. “I’m allergic to latex, remember?”

Indeed, this fact is borne out by the red sticker on his chart. “Ah, yes. I’m glad you said something. Let’s have you drop your drawers and spread your cheeks.”

The father turns his head and studies the bulletin board on the wall while I inspect the boy’s bottom.

“You are quite red. I can see a fissure. There’s no hemorrhoid,” I report.

The boy pulls up his briefs and buttons his trousers. “So

what do you think?” he asks. “Why is this happening?”

“Did you end up going to see the dermatologist for your acne?” I ask him. “Did they start you on medication for your skin?”

“Yeah, that stuff you said: Accutane. I’ve been taking it for the last three months. It’s been working wonders on my skin.”

“Unfortunately, I think the same medicine is also affecting your bottom,” I explain. “You see how dry and cracked your lips are? Well, the same thing is happening to the mucous membrane in your rectum.”

“Oh, boy; what do we do about that?”

“We’ll put you on another course of antibiotics. If it worked last time, it will probably do the trick this time too.

I’ll give you some special ointment to soothe your bottom, as well as a stool softener to keep your bowels open. You’ll probably feel much better in a day or two like last time. The problem is the Accutane. You might have to stop taking it for a while.”

The boy drops his head. “It’s working so well,” he whispers.

“I know—your skin looks so much better. We’ll see if we can get you through the next couple of weeks. By then your therapy should be coming to an end.”

“No matter how you look at it, it’s still a pain in the butt,” he says. J

REFERENCES: 1. Erpolat S, Gorpelioglu C, Sarifakioglu E. Isotretinoin associated anal fissure and rectal bleeding: a rare complication. Int J Dermatol. 2012 Mar;51(3):358-9.

2. Radmanesh M. Anal fissure, rectal bleeding and proctitis as complications of systemic isotretinoin therapy: report of two cases. J Eur Acad Dermatol Venereol. 2006 Nov;20(10):1394.

3. Martin P, Manley PN, Depew WT, Blakeman JM. Isotretinoin-associated proctosigmoiditis. Gastroenterology. 1987 Sep;93(3):606-9.

4. Spada C, Riccioni ME, Marchese M, Familiari P, Costamagna G. Isotretinoinassociated pan-enteritis. J Clin Gastroenterol. 2008 Sep;42(8):923-5.

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 openaccess journal Dermanities (www.dermanities.com) since its inception.

Readers can visit the author on the web at http://briantmaurer. wordpress.com. This article was reprinted with permission from the author and the Online Journal of Community and Person-Centered Dermatology (OJCPCD). The OJCPCD is a free, full text, open-access, online publication that addresses all aspects of skin disease that concern patients, their families, and practitioners. All posts can be viewed at www.ojcpcd.com.

Volume 9 • number 1 • winter 2015 51

Workplace Excellence

Developing the Will Power and Way Power Needed to Make Change

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

round the start of a new year, many turn their attention to their resolutions for change, which are often a blend of both personal and professional goals for improvement. In the book Switch: How to Change Things When Change is Hard, authors Chip and Dan Heath assert that most individuals and organizations are trying to change something. It’s an obvious insight, but somehow I find that comforting. We’re all trying to make change of some kind. We all have habits we’d like to stop, habits we’d like to start, and habits we’re trying to continue. Trying to change is actually what is most common to human beings and organizations.

So why do we often feel so isolated and frustrated by our attempts to make change? Unfortunately, I think too often we’re trying to make change with little, no, or wrong information.

If you’re working on making a change in your personal life or workplace culture, or if you’re trying to help patients to stop a bad habit or begin a healthy habit, here are three important insights from Switch that I encourage you to consider: 1. When you set out to change your behavior, don’t forget to make changes in your situation.

Too often we focus all our efforts on trying to change our personal defects of character and personality: “If only I had more self-discipline I could change my behavior. What is wrong with me?” We can always find ways to strengthen our character. But what the research shows is that we also need to make changes in the context of our situation. This is what’s often described as the difference between will power and way power: Will power is my hope and desire for change; way power is the ability to find an effective way to reach 52 Journal of Dermatology for Physician Assistants

our goal. We must know ourselves (our strengths and our weaknesses) and then do everything in our control to structure situations that favor the likelihood of our success – will power and way power. For example, want to lose some weight?

Begin by removing all the junk food out of the house; cut up fresh vegetables to eat instead. Have gum at the ready to chew when you’d normally eat out of habit or boredom. Move the treadmill from the basement next to the TV, since you like TV and you hate going to the basement to walk.

Take any diet and lifestyle change you might want to make and do a Situation Self-Study to identify things you could change or replace that would remove the opportunity to engage in the bad habit, and enhance the likelihood of the good habit. Changes in our situations will remove obvious temptations that attack us at our weakest points and increase our little victories, which builds self-confidence. Bottom line: when we focus on changing ourselves, we forget that changes in situation often support changes in self!

2. Remember that self-control is a muscle - one that also gets tired. How many times have I been so good all day by adhering to my good habits and by being focused, on-task, watching my diet, drinking my water, and being disciplined? Then all of a sudden the voice of craving inside me rises up, and the muscles of restraint give way. Bam! The floodgates of restraint give way, and I overindulge, undoing all the good I have worked so hard to achieve. And to make it worse, I beat myself up for my weakness with negative selftalk and self-rejection. I’m not a bad person, I’m a

An old adage says, “Except for babies, nobody likes to be changed.” And yet, change often brings about feelings of great relief, joy, and empowerment.

Perhaps the resistance to change is because too often we frame the need to change as something terribly wrong with me or us, instead of a common need in all of us.

Remember: change isn’t easy, but almost everybody is trying to change something. Embracing this reality and building a community of support around it will give us the support and challenge we need to make change. Don’t forget to combine will power and way power by doing the following: 1) Make changes to your situation (throw out the junk food, paint your workout room, or get a new treadmill); 2) Work on changing one thing at a time and build in some opportunities for rest and reward to keep you fresh and motivated; and 3) Melt your resistance to change by focusing on specific strategies and insights for doing things differently. J REFERENCE: 1. Heath C and Heath D. Switch: How to change things when change is hard.

New York, Broadway Books. 2010.

Matthew L. Davidson, Ph.D. is the Founder, President, and Director of Education for the Institute for Excellence & Ethics (IEE), a 501(c)3 nonprofit corporation dedicated to helping individuals and organizations achieve excellence. He is a National Spokesperson for the Business Bureau National Center for Character Ethics. The IEE specializes in the development and dissemination of research-based tools for developing the culture and competencies of excellence and ethics in schools, athletics, the workplace, and the home; this is done through professional development workshops & academies, teaching & learning resources, assessment, and consulting services.

He is a frequent national presenter and is available for keynote lectures, professional development, retreats, and organizational consulting. He has indicated no relationships to disclose relating to the content of this article. For additional information or to contact the IEE, please visit www.excellenceandethics.org.

Volume 9 • number 1 • winter 2015 53

DERmatology pa news & notes

tired person. I was actually strong for 23.5 hours!

When we are trying to make our muscles strong, we must strive for a good blend of stress (to build the muscles) and rest (to allow for recovery).

However, we forget that self-control is also a muscle that can get very weak if we never exercise it, and very tired if we never give it rest.

When starting a new habit that requires selfcontrol and discipline, we are going from no stress (I’ve been eating what I want for as long as I can remember) to total stress (I’m going to eat only carrots and water all day). We have to find ways to create an optimal plan. For example, build in some small indulgences across the day or some special things to look forward to that also provide a little rest for tired self-control muscles (maybe a little chocolate at 4:30 or a little nap after dinner).

Remember that self-control is required for lots of things, so giving yourself a chance to watch a favorite movie, read for pleasure, or engage in other healthy, enjoyable hobbies helps to rest your self-control muscle, which is really being taxed by your new diet. Work on one new habit at a time, and when you get tired and weak, don’t worry; you’re not a bad person, you’re a tired person.

Rest and get back at it again. Expect to get tired, and plan what you’ll do to limit big slides.

3. What looks like resistance is often a lack of clarity about what to do. Funny how we’re often pretty protective of our bad habits, isn’t it?

I hate this about myself; it’s bringing me lots of unhappiness and negative consequences, but I don’t want others touching it! And if they try, I get defensive and put up resistance. True enough - unfortunately! But the opposite is also true: I’m resistant because I’m really not sure what I should do (or how to stop what I’m currently doing).

General, obvious suggestions are easy to agree with but often hard to get started implementing, (e.g., eat healthy; exercise more; reduce stress). If you’re struggling to make change, it’s important to recognize that you may actually be missing some important knowledge regarding what to do and how to do it. So ask good questions that verify and clarify the specifics: Are you saying no meat, or no red meat? Can you layout a week’s worth of meals? Could you help me to create an effective exercise plan that will take into consideration my bad back? Knowledge is power and resistance is often a lack of clarity about what to do or how to do it. We’re looking for the, “Eat this, not that; do this, not that; follow this plan” insights that can get us on the path to change.

From the Desk of...

DERmatology pa news & notes

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

As discussed in the SDPA President’s Message this issue, the SDPA Board and committee members dedicate a great deal of time to not only bettering our Society, but to improving the dermatology PA profession as well. One of the ways we can work towards this goal is providing education about what a dermatology PA is and the role of our profession within the field of dermatology. Sometimes opportunities for educating others present themselves in forms other than teaching in a classroom, educating the public at heath fairs, or educating patients within our practice settings. One way we can provide education outside of what might be deemed as the traditional scope is writing articles for publication as well as writing letters in response to articles that we feel do not portray our profession accurately. As dermatology PAs we can use our voices in the written form to share accurate information and educate several audiences. There was an article printed in JAMA recently that caught the attention of the SDPA. Vicki Roberts, SDPA President shares the unpublished letter she wrote to the Editor of JAMA in response to the article.

Even if you don't take the time to write a letter in response to articles, you can still help by sharing these types of articles with your supervising physicians. It is very important that we keep our supervising physicians aware and up-todate on the latest articles and information that is being published about our profession, whether it is accurate or not.

This is how we will be successful in helping our Society and in turn bettering the quality of information our patients receive and ultimately the care they receive.

To the Editor: I am writing in response to the article Scope of Physician Procedures Independently Billed by Mid-Level Providers in the Office Setting (JAMA Dermatology article published online August 11, 2014 at http://archderm.jamanetwork.com/article. aspx?articleid=1895673).

In their article, the authors provide some impressive sounding figures for the number of things that PAs are billing independently, such as “2.6 million dermatologic

procedures were destruction of premalignant lesions.”

But this number is meaningless since the authors omit the total dermatologic procedures that are performed every year in the billing categories analyzed. If PAs bill independently for 10 percent of all procedures performed, for example, this large number might not seem so earth shattering. In fact, it is surprising that some of these procedures are not billed independently more often. Removal of skin tags, for example, only occurred approximately 10,000 times, and PAs are clearly adequately trained for such tasks. Given the relatively low volume of 10,000 procedures, one could argue that physicians are underutilizing their PAs. Unfortunately, the authors are incorrect about many details of how PAs bill for the services they provide, and indeed how PAs and physicians practice medicine as a team. The authors suggest that if a PA bills under their own National Provider Identifier (NPI) number, it means they are practicing independently without a physician onsite. They justify this suggestion by providing this caveat: “It is also possible that these mid-level providers were billing independently with a physician on the premises, although this seems unlikely because they will be paid at only 85% of the fee schedule instead of reporting incident to and the physician receiving 100% of the fee schedule.” In other words, if PAs are following Medicare regulations and billing independently with a physician on premise then the entire rationale for their conclusion falls apart. The authors argue this type of billing can’t be happening because why would offices bill at the 85% PA rate when they could bill at the 100% physician rate? The obvious answer, of course, is because it is how practices are supposed to bill. PAs regularly see new patients or established patients with new conditions with their collaborating physician on site. Asserting that PAs and their physicians must be ignoring Medicare rules for increased monetary gain is to assert that they are routinely committing Medicare fraud and until the authors can provide some data to support this speculation it seems that this article does not bear much merit. J

The American Academy of Dermatology (AAD) issued a press release in response to the original article. “The American Academy of Dermatology supports a dermatologist-led care team. We know that many dermatologists employ and appropriately supervise nurse practitioners and physician assistants as part of their integrated team to help provide care for an expanding number of patients, and we support this practice,” said Mark Lebwohl, MD, FAAD, President-Elect of the AAD. “However, the billing patterns reported in this article bring provocative and concerning questions to the table regarding the supervision of procedures performed by some nonphysician clinicians in the office setting.” The press release also stated, “JAMA Dermatology article, “Scope of Practice Procedures Independently Billed by Mid-Level Providers in the Office Setting” was authored by Brett Coldiron, MD, FAAD, in a private capacity and does not represent an official Academy-sanctioned article.” The press release in its entirety can be viewed at www.aad. org/stories-and-news/news-releases/american-academy-of-dermatology-responds-to-scope-of-practice-questions.

54 Journal of Dermatology for Physician Assistants

Supervising Physician CORNER An Interview with Christopher Crotty, MD

By J. Margaret Casey

JDPA: What motivated you to pursue a career in the field of dermatology?

Dr. Crotty: My father was a dermatologist and the most content physician I knew, so he was a big influence on my entering the field. I initially pursued an internal medicine residency but didn’t find many satisfied internists.

Dermatology was a broad field with interesting medical dermatological problems and a whole host of exotic diseases with a myriad of presentations. There was also the opportunity to do surgery and see all ages. In addition, it allowed me to use an intuitive approach to medicine and take advantage of a broad cook- book of medications and approaches. My boards in dermatopathology and the clinical-pathologic approach to diagnosis added still other elements of interest. Maybe it was a genetic thing, but I love the practice of dermatology as much as my father and never regretted my decision.

JDPA: Please share with the readers your experience in leading medical mission trips to Jamaica.

Dr. Crotty: I’ve always wanted to be a complete doctor so volunteering in Jamaica for the last ten years allowed me to practice general medicine as well as dermatology. I grew personally and developed insight into the frustrations of poverty and the limitations of resources and time constraints of the poor. I also have spent time volunteering in Americana Samoa, India, and the Dominican Republic.

JDPA: What would you say has been the greatest reward from conducting these trips? Any challenges?

Dr. Crotty: I will admit that part of my interest has to do with a love of adventure and having different experiences. I am especially proud of Americans who have a heart for missions and volunteering, which I believe is a terrific character trait of Americans. I work with Shepherds Hope, Ryan White Foundation, and Orange County.

My mantra has always been, “How can I expect others to

step up if I can’t or won’t do it myself?” Much has been given to us, so much is expected. The biggest challenges of volunteering abroad are the local government bureaucracy and the difficulty establishing a true partnership over time.

JDPA: What are your goals for future medical mission trips and/or volunteering?

Dr. Crotty: After ten years of staffing the Jamaican medical clinic, we are at a transitional point where we are reexamining our vision. Our goal is to recruit more local Jamaican physicians and dentists to pick up the responsibility of treating their people. My greatest reward was seeing a year-round clinic established in Jamaica with the help of local Jamaicans.

The other reward was deepening my understanding of the Jamaican culture and its people and learning to diminish negative stereotypes. I am at a crossroads and may look to volunteer in another country with another project. I also volunteer at UCF medical center interviewing prospective medical students.

JDPA: Any advice or insight you would like to share with PAs who are considering participating in a medical mission or volunteering their services?

Dr. Crotty: For PAs one opportunity to raise the visibility of their profession is to volunteer locally at places like Shepherds Hope. Not everyone has the heart for missions or sense of adventure for overseas volunteering.

However PAs have the skills to give back and I encourage all of my PAs to do something like this above and beyond themselves.

JDPA: When did you start utilizing PAs in your practice?

Dr. Crotty: I hired my first PA around nine years ago. I think PAs are a valuable adjunct to the practice of dermatology. I am lucky to have three excellent PAs working with me currently.

My mantra has always been, “How can I expect others to step up if I can’t or won’t do it myself?”

Volume 9 • number 1 • winter 2015 55

DERmatology pa news & notes

Christopher Crotty, MD has been named one of Orlando’s “Top Doctors” by Orlando magazine on several occasions. For the past ten years, Dr. Crotty has led a team of volunteer healthcare providers on medical mission trips to Jamaica. In 2006, Dr. Crotty was selected as Primary Care Access Network (PCAN) Volunteer Physician of the Year and was recognized by his peers in the AAD’s Dermatology World “Members Making a Difference” column for his extensive volunteer experience. Dr. Crotty feels it is important for PAs to volunteer in order to raise visibility of the PA profession. He believes that PAs have the skills to give back and encourages all of his PAs to do something above and beyond themselves. The JDPA had the opportunity to interview Dr. Crotty and learn more about his role as a supportive supervising physician of PAs and his experience volunteering on medical missions.

DERmatology pa news & notes

JDPA: What role do you see PAs playing within the field of dermatology?

Dr. Crotty: I strongly believe that PAs function best working right alongside the dermatologist as we do in our office. Practicing independently in a satellite office is not in the best interest of the patient particularly when seeking specialty care.

JDPA: What makes for a successful supervising physician/PA relationship?

Dr. Crotty: Professional interaction between a PA and his/her supervising physician can be a very satisfying relationship when the PA does not feel over his/her head. Besides, patients know that PAs can talk to their dermatologists in the next room and can be confident that optimum care is being rendered. In the words of William Mayo, “The best interest of the patient is the only interest to be considered.”

We encourage all of our PAs to read daily, learn constantly, and maintain an active intellectual curiosity.

It is easy to think you know a field, but the danger is one doesn’t know what one doesn’t know. We really emphasize collegiality in our practice and believe that being a team player is critical. We encourage our PAs to talk to their supervising physician about any patient at any time and to never be afraid to say that they don’t know what is going on. We have a textbook discussion weekly, and our PAs are

frequently given articles from journals to review. The more our PAs talks to me and have questions about patients, the more confident I feel that they are growing and learning. J Christopher P. Crotty, MD is a Mayo Clinictrained dermatologist and dermopathologist with extensive training and practice in internal medicine, dermatology, pathology and surgery. Dr. Crotty attended the University of Nebraska School of Medicine after completing his undergraduate degree at Notre Dame University. He completed a residency in internal medicine at Denver's Presbyterian Medical Center followed by a residency in dermatology at the Mayo Graduate School of Medicine in Rochester, Minnesota. While at the Mayo clinic, Dr. Crotty studied under Dr. Fred Mohs where he learned the Mohs micrographic surgical technique. Awarded the prestigious Osborne Fellowship, Dr. Crotty continued his studies in dermatopathology under the tutelage of Dr. A. Bernard Ackerman at New York University.

After six years of practicing dermatology and dermatopathology in Omaha, Nebraska, Dr. Crotty moved to Orlando and established Sand Lake Dermatology Center in 1988. A former president of the Central Florida Society of Dermatology, Dr. Crotty has served as an active participant since 1991. He is a member of the Leader's Society of the American Academy of Dermatology, the Sorin Society at the University of Notre Dame, and the Doctor's Mayo Society. Dr. Crotty is very active throughout the Central Florida community. He is an assistant professor of dermatology at the UCF School of Medicine and also serves on the school's admission committee.

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

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

www.dermcast.tv 56 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 9 • number 1 • winter 2015 57

Professional Opportunities and Development

A dver t iser INDE X • Ranbaxy – Halog..................................Pages 7, 8 • Promius Pharma – Promius Promise........Page 11 • Valeant – Onexton............................Pages 13, 14 • Amgen – Enbrel............................ Pages 30 - 33 • Valeant – Solodyn........................... Pages 41 - 43

Yosemite National Park August 13-15, 2015

• Celgene – Otezla.......................... Pages 48 - 50 • Valeant – Jublia...............................Pages 59, 60 For more information on advertising opportunities in the JDPA, please log on to www.jdpa.org

To register, visit americandermoscopy.com

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58 Journal of Dermatology for Physician Assistants

BRIEF SUMMARY OF PRESCRIBING INFORMATION This Brief Summary does not include all the information needed to use JUBLIA safely and effectively. See full prescribing information for JUBLIA.

JUBLIA® (efinaconazole) topical solution, 10% For topical use Initial U.S. Approval: 2014 INDICATIONS AND USAGE JUBLIA (efinaconazole) topical solution, 10% is an azole antifungal indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.

DOSAGE AND ADMINISTRATION Apply JUBLIA to affected toenails once daily for 48 weeks, using the integrated flow-through brush applicator. When applying JUBLIA, ensure the toenail, the toenail folds, toenail bed, hyponychium, and the undersurface of the toenail plate, are completely covered.

JUBLIA is for topical use only and not for oral, ophthalmic, or intravaginal use.

CONTRAINDICATIONS None.

ADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In two clinical trials, 1227 subjects were treated with JUBLIA, 1161 for at least 24 weeks and 780 for 48 weeks. Adverse reactions reported within 48 weeks of treatment and in at least 1% of subjects treated with JUBLIA and those reported in subjects treated with the vehicle are presented in Table 1.

Table 1: Adverse Reactions Reported by at Least 1% of Subjects Treated for up to 48 Weeks Adverse Event, n (%)

JUBLIA N = 1227

Vehicle N = 413

Ingrown toenail

28 (2.3%)

3 (0.7%)

Application site dermatitis

27 (2.2%)

1 (0.2%)

Application site vesicles

20 (1.6%)

0 (0.%)

Application site pain

13 (1.1%)

1 (0.2%)

DRUG INTERACTIONS In vitro studies have shown that JUBLIA, at therapeutic concentrations, neither inhibits nor induces cytochrome P450 (CYP450) enzymes.

Subcutaneous doses of 1, 5, and 10 mg/kg/day efinaconazole were administered during the period of organogenesis (gestational days 6-19) to pregnant female rabbits. In the presence of maternal toxicity, there was no embryofetal toxicity or malformations at 10 mg/kg/day (154 times the MRHD based on AUC comparisons).

In a pre- and post-natal development study in rats, subcutaneous doses of 1, 5 and 25 mg/kg/day efinaconazole were administered from the beginning of organogenesis (gestation day 6) through the end of lactation (lactation day 20). In the presence of maternal toxicity, embryofetal toxicity (increased prenatal pup mortality, reduced live litter sizes and increased postnatal pup mortality) was noted at 25 mg/kg/day. No embryofetal toxicity was noted at 5 mg/kg/day (17 times the MRHD based on AUC comparisons). No effects on postnatal development were noted at 25 mg/kg/day (89 times the MRHD based on AUC comparisons).

Nursing Mothers It is not known whether efinaconazole is excreted in human milk. After repeated subcutaneous administration, efinaconazole was detected in milk of nursing rats.

Because many drugs are excreted in human milk, caution should be exercised when JUBLIA is administered to nursing women.

Pediatric Use Safety and effectiveness of JUBLIA in pediatric subjects have not been established.

Geriatric Use Of the total number of subjects in clinical trials of JUBLIA, 11.3% were 65 and over, while none were 75 and over. No overall differences in safety and effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and the younger subjects, but greater sensitivity of some older individuals cannot be ruled out.

NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility A 2-year dermal carcinogenicity study in mice was conducted with daily topical administration of 3%, 10% and 30% efinaconazole solution. Severe irritation was noted at the treatment site in all dose groups, which was attributed to the vehicle and confounded the interpretation of skin effects by efinaconazole. The high dose group was terminated at week 34 due to severe skin reactions. No drug-related neoplasms were noted at doses up to 10% efinaconazole solution (248 times the MRHD based on AUC comparisons).

Efinaconazole revealed no evidence of mutagenic or clastogenic potential based on the results of two in vitro genotoxicity tests (Ames assay and Chinese hamster lung cell chromosome aberration assay) and one in vivo genotoxicity test (mouse peripheral reticulocyte micronucleus assay).

No effects on fertility were observed in male and female rats that were administered subcutaneous doses up to 25 mg/kg/day efinaconazole (279 times the MRHD based on AUC comparisons) prior to and during early pregnancy.

Efinaconazole delayed the estrous cycle in females at 25 mg/kg/day but not at 5 mg/kg/day (56 times MRHD based on AUC comparisons).

PATIENT COUNSELING INFORMATION See FDA-Approved Patient Labeling (Patient Information).

USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C There are no adequate and well-controlled studies with JUBLIA in pregnant women. JUBLIA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Systemic embryofetal development studies were conducted in rats and rabbits. Subcutaneous doses of 2, 10 and 50 mg/kg/day efinaconazole were administered during the period of organogenesis (gestational days 6-16) to pregnant female rats. In the presence of maternal toxicity, embryofetal toxicity (increased embryofetal deaths, decreased number of live fetuses, and placental effects) was noted at 50 mg/kg/day [559 times the Maximum Recommended Human Dose (MRHD) based on Area Under the Curve (AUC) comparisons]. No embryofetal toxicity was noted at 10 mg/kg/day (112 times the MRHD based on AUC comparisons). No malformations were observed at 50 mg/kg/day (559 times the MRHD based on AUC comparisons).

Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA Manufactured by: Kaken Pharmaceutical Co. Ltd, Shizuoka, Japan Product of Japan U.S. Patents 8,039,494; 7,214,506 Based on 9391901 DM/JUB/14/0030(1)b Issued: 06/2014

Volume 9 • number 1 • winter 2015 59

TACKLE

*

AT THE SITE OF INFECTION1 *For the treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.

INDICATION JUBLIA (efinaconazole) topical solution, 10% is indicated for the topical treatment of onychomycosis (tinea unguium) of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.

IMPORTANT SAFETY INFORMATION • JUBLIA is for topical use only and is not for oral, ophthalmic, or intravaginal use.

• Patients should be instructed to contact their health care professional if a reaction suggesting sensitivity or severe irritation occurs.

Rx Only

• The most common adverse reactions (incidence >1%) were (vs vehicle): ingrown toenail (2.3% vs 0.7%), application-site dermatitis (2.2% vs 0.2%), application-site vesicles (1.6% vs 0%), and application-site pain (1.1% vs 0.2%).

• JUBLIA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, and should be used with caution in nursing women. The safety and effectiveness in pediatric patients have not been established.

Please see Brief Summary of full Prescribing Information on the adjacent page.

Reference: 1. JUBLIA [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC; 2014.

Find out more by visiting www.JubliaRx.com.

Except as otherwise indicated, all product names, slogans, and other marks are trademarks of the Valeant family of companies. © 2014 Valeant Pharmaceuticals North America LLC DM/JUB/14/0016a(1)b

60 Journal of Dermatology for Physician Assistants