JDPA Spring 2015

DPA J

V o l u m e 9 • n u m b e r 2 • S P R I N G 2 0 1 5 • www.jdpa.org

Journal of Dermatology for Physician Assistants

clinical dermatology

Dermoscopy 28 __________________________________

Surgical dermatology Surgical Wisdom

40

_________________________________

Cosmetic dermatology Popular Anti-aging Treatment Emerges as Effective Treatment for Difficult Scars 44

_____________________________ professional development Judicial and Ethical Affairs 51 __________________________________

dermatology Pa news & notes Workplace Excellence

63

›› Earn CME credit with this issue CME Melanoma: A Brief Overview Including Established Immunotherapy 20 Treatment Options

Official Journal of the Society of Dermatology Physician Assistants

Volume 9 • number 2 • SPRING 2015

1

IMPORTANT SAFETY INFORMATION (cont’d) Warnings and Precautions Depression (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 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)

◆ Adverse

Otezla® is a registered trademark of Celgene Corporation. © 2015 Celgene Corporation 02/15 USII-APR150022a

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. Otezla [package insert]. Summit, NJ: Celgene Corporation; 2014. 2. Data on file, Celgene Corporation.

◆

◆

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 titration1,2

◆

PASI-75 response at week 16 (primary endpoint)1,2 – 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 therapy1

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 on the left page

Get the latest news at otezlapro.com Volume 9 • number 2 • SPRING 2015

3

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)

4

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

We invite you to attend

7th Annual Dermatology PEARLS CME Conference

Oct 1-3, 2015

Cobb Galleria Centre, Atlanta, GA

Featured Lectures Include:

Scarring Alopecias and Non-Scarring Alopecias by Jerry Shapiro MD Sunscreen Science and Controversies by Douglas DiRuggiero PA-C Dermatologic Infectious Disease Update by Ted Rosen MD PA and NP Economics and Negotiation Skills by Abby Jacobson PA-C Other Featured Faculty Include:

Hilary Baldwin MD Linda Stein Gold MD Julie Harper MD Pearl Kwong MD Workshops Include:

Intermediate Surgery Skills Neurotoxins & Fillers Hyperhidrosis

Lodging available at:

Renaissance Waverly Hotel from $185 To register visit:

www.GaDermPA.org Provided by:

Georgia Dermatology Physician Assistants

This program is not yet approved for CME Credit. Conference organizers plan to request maximum of 26.5 hours (22 maximum earnable by any attendee) of Category I and Self-Assessment CME Credit from AAPA. PAs should only claim credit for Category I CME or Self-Assessment Volume 9 â&#x20AC;˘ number 2 â&#x20AC;˘ SPRING 2015CME5if they participate in an activity that is dual accredited. PAs cannot claim both types of credit for the same activity.

Journal of Dermatology for Physician Assistants

EDITORIAL BOARD

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

DEPARTMENT EDITORS

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

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

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

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

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

This Issue: The JDPA includes articles that have been reviewed and approved for Category I (Preapproved) CME credit by the American Academy of Physician Assistants. Approval is valid for 1 year from the issue date, and participants may submit the self-assessment at any time during that period. Category I CME articles included in JDPA are planned and developed in accordance with AAPAâ&#x20AC;&#x2122;s CME Standards for Journal Articles and for Commercial Support of Journal Articles. going green: Since its inception, the JDPA has utilized eco-friendly printing practices. The JDPA is printed on paper obtained from sustainable forests that meet strict environmental standards. Soy-based inks that have a low environmental impact are used during printing of the journal and the journal is printed using 100% renewable energy. SDPA members may join us in our efforts and opt to receive the JDPA in digital format.

Publishing Staff Publisher Travis Hayden, MPAS, PA-C Managing Editor Jennifer M. Hayden, M.Ed Copy Editor Douglas Morris Art Director Angela Simiele Website Design Terry Scanlon SALES Office Physician Assistant Communications, LLC P.O. Box 416, Manlius NY 13104-0416 Phone (315) 663-4147 PAC@pacommunications.org www.pacommunications.org keep current with the SDPA:

JDPA/Journal of Dermatology for Physician Assistants (ISSN 1938-9574) is published quarterly (4 issues per volume, one volume per year) by Physician Assistant Communications, LLC, P.O. Box 416, Manlius NY 13104-0416. Volume 9, Number 2, Spring 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

6

Journal of Dermatology for Physician Assistants

Editor’s Message

PA - Progress in Action PAs are making huge strides in shaping the landscape of today’s health care system. Across all specialties, we are pulling together and making our numbers work towards improving patient care in every area of medicine. No doubt, definite progress in action.

On the national level, great progress is being made to incorporate more PA-friendly provisions in proposed legislative bills. This spring the US Senate overwhelmingly passed the bill (HR 2) to repeal Medicare's SGR formula. Recognizing the role PAs play in providing complex chronic care to patients, the bill proposes treating PAs in the same fashion as physicians and nurse practitioners in the value-based performance payment program, and allowing PAs to perform the face-to-face encounters in documenting the need for durable medical equipment (DME) for Medicare beneficiaries. This huge accomplishment was made possible because of the hard work of the AAPA as well as that of its members who took the time to reach out to their representatives voiced their concerns.

Within our field of dermatology, steady progress is being made as well. The SDPA is continuing to work closely with the AAD on the DermCare Team initiative.

This new initiative is designed to make specific AAD products and educational activities available to our SDPA members who practice with members of the AAD. Unfortunately, as it stands now, participation in the initiative requires teams to sign an attestation that states that the AAD member will be onsite whenever the PA practices (unless there are “extenuating circumstances”). Both the SDPA and the AAPA prefer to not have such a restriction placed on the DermCare Team model and have sent a letter requesting that the AAD either remove the mandatory attestation or update its current position statement requiring the onsite presence of a dermatologist at all times. Ultimately, the SDPA believes that the goal is to incorporate language that will support the AAD DermCare Team initiative while not imposing new restrictions on dermatologists and PAs. This is a work in progress but with constant attention to it there is hope for a better future. J

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

Volume 9 • number 2 • SPRING 2015

7

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.

20

Melanoma: A Brief Overview Including Established Immunotherapy Treatment Options

By Melissa Porter, MPA, PA-C and Judith Stallings, Ed.D., PA-C

›› CME 12 Derm PA News & Notes – part one

• Certification Review & Maintenance • SDPA State Affiliates: The SDPA Annual Summer Dermatology Conference • Student Corner: Call for SDPA Junior Student Coordinator Applicants

20 Clinical Dermatology

• CME Article – Melanoma: A Brief Overview Including Established Immunotherapy Treatment Options • Dermoscopy: Dermoscopic Notes from the 2014 American Dermoscopy Meeting • Dermatology Evidence Based Medicine: Dermoscopy Significantly Improves the Accuracy of Diagnosing Malignant Melanoma

Departments

06 Editorial Board 07 Editor’s Message 11 SDPA News & Current Affairs 12 Dermatology Market Watch 24 From The Patient’s Perspective 30 Clinical Snapshots 40 Surgical Wisdom 46 Cosmetic Pearls 52 Notes from your Office Manager 56 Outside & Inside the 9 to 5…

58 Camp Discovery 2015 61 The Difference We Make 66 Now Showing on Dermcast.tv 69 JDPA Information for Authors 70 Professional Opportunities and Development

39 Surgical Dermatology

• Journal Club: Practice Changing Articles for Dermatology

44 Cosmetic Dermatology

• Popular Anti-aging Treatment Emerges as Effective Treatment for Difficult Scars

50 Professional Development

• SDPA Legislative Update • Judicial and Ethical Affairs: Rethinking Medical Codes of Ethics What Patients Teach Us

58 Derm PA News & Notes – part two

Go Green & Read On the Go 8

Journal of Dermatology for Physician Assistants

• Workplace Excellence • From the Desk of…

• Supervising Physician Corner: An Interview with the First Medical Director of the SDPA, Marcus Conant, MD • Success on SGR “Fix” PA Advocacy Still Needed on Hospice Bill

dermpa.org

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

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

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

For topical use only.

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

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

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

HLGJI1Ba 01/14

Volume 9 • number 2 • SPRING 2015

9

10 Journal of Dermatology for Physician Assistants

FROM THE SDPA

News & Current Affairs

CALENDAR OF EVENTS 2015 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

2016 March 74th AAD Annual Academy Meeting March 4 – 8, 2016 Washington, DC

I

joined the AAPA as a student in 1997 and have paid my dues diligently each and every year since. I have been in dermatology my entire career as a PA, and the SDPA seemed to provide me with everything I needed.

At times I wondered if I needed to continue my AAPA membership.

PAs are lifelong learners. Five years ago when I decided to volunteer for the SDPA I began to understand how much behind the scenes work is involved in keeping an organization like this running. I also realized that my membership dues meant more than a discount to a conference. As a volunteer leader, I learned that the SDPA helps its members with their clinical practices, networking, education, legislative issues, philanthropic endeavors, and business discounts to name a few. With the SDPA doing so much great stuff, what did the AAPA have to offer?

Then I became President-Elect of the SDPA and was suddenly overseeing everything that went on in the organization. I began to realize what a critical role the AAPA plays in helping us. As an official constituent organization to the AAPA, all the resources and experience of a large national organization are at the SDPA’s disposal. When legislative issues have come up in various states, we have teamed with the AAPA’s talented writers and expert lawyers to help thwart legislation that could have negatively impacted PAs. Recently when the DermCare Team was launched by the AAD, the AAPA joined with us to both praise the efforts of the AAD to promote the team approach to dermatology practice and to quickly and vehemently object to the restrictive details of the agreement. Ann Davis of the AAPA staff helped us state our case to the AAD at their Annual Meeting in San Francisco this year; we continue to work on this together.

These are just a few examples of how the AAPA is there to help us succeed. Working with the AAPA makes sense. Their resources, experts, and sheer number of their members provides the SDPA with support and the comfort of knowing that ‘they have our back.’ Dermatology PAs are a small percentage of PAs overall, and we benefit from the larger voice the AAPA provides.

As you debate each year whether or not to renew your membership with the AAPA, please know that I will be renewing mine. They are working tirelessly behind the scenes to make sure that PAs remain a viable and relevant profession in the field of medicine. Together we are stronger. J

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

Volume 9 • number 2 • SPRING 2015 11

Dermatology PA news & notes

Dermatology Market Watch AIM Launches European Outreach According to the World Health Organization, 132,000 cases of melanoma occur globally each year and the global incidence of melanoma continues to increase. However, there are few patient advocacy groups outside of the U.S. that have the knowledge and tools available to help melanoma patients and their caregivers, and families navigate their melanoma journey.

To meet this need, AIM at Melanoma (AIM) has launched country specific websites in five European countries as well as created a program to mentor patient advocacy groups that could provide assistance in each of their respective countries. AIM is assisting these patient advocacy groups in providing the melanoma community with, among other things, information on the standard of care in that country, finding a melanoma specialist, and

locating clinical trials. AIM is working with each patient advocacy group to file necessary legal documents, create a Facebook community, develop a melanoma specific website, as well as responding to the specific needs of individual melanoma patients. The end result is to have country specific patient advocacy groups that are sustainable in the long run.

To learn more about each of these county specific melanoma patient advocacy groups, please visit: • France: https://www.facebook.com/groups/ melanomamatesfr/ • Germany: https://www.facebook.com/pages/MelanomDeutschland/1564792970462522?fref=ts • Spain: https://www.facebook.com/pages/Melanoma-Espa %C3%B1a/343588885796401?fref=ts • Italy: https://www.facebook.com/pages/MelanomaItalia/1496434247273783?fref=ts • United Kingdom: http://www.melanomauk.org.uk/ J

Trianex® 0.05%(Triamcinolone Acetonide Ointment) Now Available From Promius Pharma

Promius Pharma Annonces Zenatane™ (Isotretinoin Capsules) 30mg

Promius Pharma, LLC has acquired the rights to market and distribute Trianex® 0.05% (Triamcinolone Acetonide Ointment, USP) in the United States from CMP Pharma, Inc. Trianex Ointment, a midpotency corticosteroid, is notable for its white formulation that has the look and feel of a cream.

Trianex Ointment will be available in a 430 gram jar and features a proprietary cream-like formulation. It will be the only ointment to offer this combination, making it an appealing option for those patients with inflammatory skin conditions that cover large areas and who don’t like the typical greasy feel of ointments. Also, to make it more affordable, Trianex Ointment offers a significant savings program to all eligible insured patients who receive a prescription for the 430 gram jar. J 12 Journal of Dermatology for Physician Assistants

Promius Pharma, LLC has announced that Zenatane™ (Isotretinoin Capsules, USP) is now available in a 30mg dose. Zenatane, AB rated equivalent to Accutane 30mg, has been introduced in response to dermatology providers who have continued to request this strength of the drug.

Zenatane 30mg will also be supported by The Promius Promise, a pharmacy service designed specifically to support Zenatane prescribers and patients. The Promius Promise program is designed to assist with patient education about treatment requirements and deliver Zenatane within 24 hours to US locations, at a reduced, if not zero, out of pocket expense, for eligible patients. J

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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.

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

iPLEDGE® is a trademark owned by McKesson Specialty Arizona Inc. ©2015 Promius Pharma, LLC. All rights reserved. ZNT-0115-121

Volume 9 • number 2 • SPRING 2015 13

Certification Review

All Those Things Inside the Skin You Might Have Forgotten

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

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

DERmatology pa news & notes

A. Acromioclavicular dislocation B. Anterior shoulder dislocation C. Rotator cuff impingement D. Serratus anterior paralysis E. Adhesive capsulitis EXPLANATION: Anterior shoulder dislocations occur with falls on an externally rotated, abducted arm.

After the injury, the patient will hold the arm in abduction and with a slight external rotation with the shoulder having a “squared off” appearance on clinical exam. An x-ray (as seen above) will reveal that the humeral head is no longer located in its correct anatomical position of the glenoid fossa. Serratus anterior paralysis would lead to winging of the scapula. Acromioclavicular dislocation presents with tenderness and swelling of the AC joint, and an x-ray would show separation of the AC joint.

Adhesive capsulitis (frozen shoulder), presents with insidious onset of pain and restriction in motion; an x-ray would be normal. Adhesive capsulitis can be confused with a posterior shoulder dislocation. Rotator cuff impingement presents with pain and inability to abduct and flex the shoulder. A drop test may be positive, and x-rays are normal or may reveal calcium deposits.

14 Journal of Dermatology for Physician Assistants

TEST TAKING TIP: Remember to work x-ray questions backwards. Don’t spend time reviewing the x-ray in detail; look at the answer choices, identify the pertinent x-ray findings for that given choice and then go look for those findings in the x-ray. J The correct answer is B.

QUESTION: A 30-year-old male presents to the emergency room after a fall. He states his left shoulder is painful, and any movement of the shoulder greatly increases the pain. On physical examination the patient’s arm is held in abduction with slight external rotation. The patient’s x-ray is noted below. Which of the following is the most likely diagnosis?

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.

CONGRATULATIONS STUDENT MEMBERS! IF YOU ARE GRADUATING WITHIN YOUR PAID STUDENT MEMBERSHIP YEAR, THE SDPA WOULD LIKE TO OFFER YOU A GIFT BY UPGRADING YOU TO A FULL MEMBERSHIP FOR THE REMAINDER OF THE YEAR.* *category of membership will be de pendent on employment.

TO APPLY, PLEASE SEND PROOF OF GRADUATION TO SDPA@DERMPA.ORG.

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

Volume 9 • number 2 • SPRING 2015 15

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速 (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).

16 Journal of Dermatology for Physician Assistants

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

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: I'm already involved in quality improvement where I practice. Will that count towards the new PICME requirement?

A: As you know, all PI-CME activities must be approved for AAPA Category 1 PI-CME credit in order to satisfy the new requirements. Due to this fact, AAPA created a new Hospital and Health System Quality Improvement (QI) application, which will enable PAs to receive AAPA Category 1 PI-CME credit for QI activities in which they already participate. In order for a QI project to be approved through the Hospital and Health System QI application, the PA employer must apply and act as the provider of the activity. You can learn more at aapa.org/cmeproviders.

AAPA Category 1 PI-CME credit by completing AAPA’s Personalized PI-CME module. This module is an online system that will allow PAs to design their own personal project or to enter data from a QI project that they complete at their institution. AAPA is building this module now, with a plan to launch the module in late 2015.

Q. How will I do PI-CME if I'm not in clinical practice?

A. There are currently two PI-CME options available for PAs who are not clinically practicing. The first option is an Interprofessional Education PI-CME module provided by PAEA. In order to successfully complete this program, participants must be a PA educator or in a supervisory or administrative role in a clinical environment. The second option for nonclinically practicing PAs is the Patient Safety Certificate Program provided by Johns Hopkins University School of Medicine. This course is an acceptable substitution for PI-CME for PAs who are not in clinical practice or who are unable to find an AAPA accredited PI-CME activity that is relevant to their practice. To obtain AAPA Category 1 PI-CME credit, PAs must access this activity through AAPA's Learning Central; there is also special pricing on this activity for PAs through AAPA. Additional choices for non-clinically practicing PAs will be added in 2015. J

A second option for PAs who are already participating in QI projects is for the PAs to receive

To view additional SA and PI-CME opportunities inside and outside of dermatology, please visit www.aapa.org/picme. AAPA will add more SA and PI-CME activities to these lists as they are identified and approved. If you have questions or would like to recommend a SA or PI-CME activity for inclusion, please email cme@aapa.org.

Write for the JDPA! Are you a PA who...

• Is interested in writing?

• Has a paper you want to get published?

Share your knowledge today.

Contact editor@jdpa.org

JDPA Journal of Dermatology for Physician Assistants

Volume 9 • number 2 • SPRING 2015 17

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

The SDPA Annual Summer Dermatology Conference

DERmatology pa news & notes

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

It was time for the SDPA to visit Las Vegas, Nevada this year where, "What happens in Vegas, stays in Vegas" was put to rest June 4th - 7th. I thought I could share some insights with you in regards to the dermatology PAs who practice in Nevada and encourage more participation in this SDPA State Affiliate.

Nevada does have an SDPA State Affiliate.

There are currently twenty dermatology PAs practicing within the state of Nevada who are SDPA members, and the number continues to grow. The SDPA encourages PAs in all states to establish an SDPA State Affiliate chapter or to become an SDPA State Liaison. For the dermatology PAs working in Nevada, the benefits of participating in the Nevada SDPA State Affiliate include influencing the passage of appropriate state laws concerning PA practice, the chance to be members of a strong networking body, and the opportunity to have a strong voice for their profession within their state.

The AAPA does have a Nevada State Affiliate and encourages Nevada dermatology PAs to be active in and network with the Nevada Academy of Physician Assistants (NAPA). The NAPA is aggressively lobbying to protect the PA profession in Carson City and needs your help to fight against a recently proposed BDR 260 (Bill Draft Request) submitted in this city to restrict PA practice. It is important that dermatology PAs play an integral part in these significant legislative decisions.

18 Journal of Dermatology for Physician Assistants

The SDPA Constituent Relations Committee is encouraging PAs in Nevada and other states to keep your SDPA State Affiliate active, start an SDPA State Affiliate, or become an SDPA State Liaison.

I held a meeting at the SDPA Annul Summer Dermatology Conference for those interested in reactivating or forming an SDPA State Affiliate or becoming an SDPA State Liaison. If you werenâ&#x20AC;&#x2122;t able to make the meeting please contact me at rblock@dermpa.org with any questions. For PAs in Nevada, please visit the NAPA website at www. nevadapa.com to show your support and learn more about the BDR 260 legislative issue and how you can help. J The SDPA currently has 17 State Affiliate chapters. We continue to grow and would love to have all 50 states participating! It takes teamwork and a strong commitment.

For anyone who is interested in starting an SDPA State Affiliate chapter or if you have a state chapter and need some advice about becoming affiliated with the SDPA, please contact me at rblock@dermpa.org. I am here to help you!

Student Corner

Here is your chance to become involved in the PA professional community. The SDPA is currently accepting applications for the Junior Student Coordinator position.

The deadline is September 1st, 2015.

This position is a 3-year commitment.

The selected applicant will spend his/her first year as Junior Student Coordinator (first year PA-S), then advance to Senior Student Coordinator (second year PA-S), and finish the commitment with a year serving as Recent Graduate Advisor.

Some of the responsibilities of the position include participation in monthly conference calls with the SDPA Board of Directors and other Committee Chairs, attendance at yearly SDPA conferences, and facilitate student involvement in the SDPA. Considering how busy PA school can be, the Junior Student Coordinator, Senior Student Coordinator, and Recent Graduate Advisor all work together to ensure the proper balance of responsibilities.

The SDPA is currently accepting applications for the Junior Student Coordinator position the deadline is September 1st, 2015.

posting services, as well as opportunities to become more involved in the leadership and direction of your chosen profession as PAs. The SDPA encourages everyone who is interested in dermatology to join as a student member for just $25, to receive all of the wonderful opportunities (join now at www. dermpa.org/signup).

If you are interested in becoming involved in the SDPA as a Junior Student Coordinator please go to www.dermpa.org. From the homepage, click on the Student tab, complete the application, and submit it by September 1st. If you have any questions, please contact Maria Kelly, PA-S1, SDPA Student Affairs Committee Junior Student Coordinator at mkelly@dermpa.org. J Thank you, Maria Kelly, PA-S1 SDPA Student Affairs Committee Junior Student Coordinator Stephanie Palazzolo, PA-S2 SDPA Student Affairs Committee Senior Student Coordinator Marc Kawohl, MMS, PA-C SDPA Student Affairs Committee Recent Graduate Advisor Jang Mi Johnson, PA-C SDPA Director at Large, Diplomate

Applicants interested in the Junior Student Coordinator position must be a SDPA student member. Some of the benefits of becoming a SDPA student member include having access to the Journal of Dermatology for Physician Assistants (the official and peer reviewed journal of the SDPA), access to the interactive online content through the Distance Learning Initiative, the job listings and resume Volume 9 â&#x20AC;˘ number 2 â&#x20AC;˘ SPRING 2015 19

DERmatology pa news & notes

Call for SDPA Junior Student Coordinator Applicants

Clinic al Dermatology

Melanoma: A Brief Overview Including Established Immunotherapy Treatment Options

By Melissa Porter, MPA, PA-C and Judith Stallings, Ed.D., 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 April 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) Provide a basic understanding of melanoma including the risk factors, diagnostic testing, and staging.

2) Clearly explain the differences between the various types of the first established immunotherapies.

3) Familiarize providers with three well-established and approved immunotherapeutic treatment options for late stage melanoma.

4) Educate providers so they can, in turn, educate their patients regarding additional options of adjuvant therapy for the treatment of their melanoma.

20 Journal of Dermatology for Physician Assistants

Melanoma: A Brief Overview 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 2 • SPRING 2015 21

Melanoma: A Brief Overview 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

Melanoma: A Brief Overview 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.

Melissa Porter, MPA, PA-C graduated from Georgia Reagents University’s Physician Assistant Program. She currently works at Southcentral Foundation in Anchorage, Alaska. She has indicated no relationships to disclose relating to the content of this article.

Judith B. Stallings, Ed.D., PA-C graduated from Georgia Regents University’s Physician Assistant Program. She currently is on faculty as an Associate Professor. She has indicated no relationships to disclose relating to the content of this article.

Volume 9 • number 2 • SPRING 2015 23

From The Patient’s Perspective Hair Dyes, Cosmetic Cream Preservatives, and Hip Replacements

By Mrs. Helen

CLINIC AL Dermatology

I The Society for Pediatric Dermatology’s (SPD) objective is to promote, develop, and advance education, research, and care of skin disease in all pediatric age groups. The organization holds meetings twice a year to educate physicians about advances in pediatric dermatology, help them support children with dermatological diseases, and improve the care of these children.

Society for Pediatric Dermatology Contact Information: www.pedsderm.net 8365 Keystone Crossing, Suite 107, Indianapolis, IN 46240 Email: info@pedsderm.net Phone: (317) 202-0224 Allergens causing clinically relevant allergic contact dermatitis in adults in the US are important in children as well. Notably, there is a significant lack of published studies performed on US children. That is why the Society for Pediatric Dermatology is supporting the Loma Linda University launch of its "Pediatric Contact Dermatitis Registry" initiative, which has two specific components: 1) A brief 'click through' provider registry/survey, which records the demographics of the clinical provider offering patch test services to children, available at: http://lomalindahealth.org/medical-center/ourservices/dermatology/for-health-care-professionals/ practitioner-database-registration-form.page 2) An entirely optional case log component, which any registered provider can voluntarily record his/ her cases on a provided short reporting form into the database.

The purpose of collecting this data is to: • Increase the number of verified cases of contact dermatitis in children ages 0-18 years in the US. • Promote awareness of contact dermatitis in pediatric populations.

• Shed light on the demographics of providers offering pediatric patch test services.

• Help to highlight regional disparities in access to patch test care and evaluation for children.

Accurately representing the key role of PAs involved with providing patch testing services is paramount. Please help and take the brief survey today. Thank you.

24 Journal of Dermatology for Physician Assistants

have had sensitive skin and allergies all my life and have taken allergy medication and shots. I experienced eczema and even had numerous skin cancers removed.

To top it off, I am a breast cancer survivor of thirteen years, so I have had my share of medical issues to deal with in my fifty-seven years. Nothing, however, prepared me for the experience I would be thrust into in February 2003. I was prescribed a well-known statin drug, and after a few days of taking it my face began to itch and rash. On the fifth day I woke up looking like a monster with a bright red, swollen, and indescribably itchy face. I called the office where I had been prescribed the medication and was informed they could not fit me in. I informed them that I was indeed “coming in,” and when they saw my face I was sure that they would see me right away. When the medical assistant slid open the glass door into the patient waiting room, his eyes widened in disbelief with a hint of horror; a look I was to see many times over in the next few years from those who witnessed me during a major flare-up or saw my “show and tell” photos that I took to all of my appointments for the next two years. The doctor gave me a shot of cortisone and a prescription for a prednisone dosepack. Over the next few days, thanks to steroids, the red, swollen, and itchy skin was replaced by parched skin that had the consistency of sandpaper and then miraculously turned into clear, fresh dewy looking smooth skin.

Thus began a two-year sentence of tortuous skin eruptions and an emotional roller coaster ride. I experienced severe flare-ups, often several times a week.

The flare-ups would begin with an itchy face and very rough skin. Then the skin would begin to feel raw and burned, and most ointments or creams felt like pouring alcohol on an open wound. The next phase that followed was peeling, parchment-dry, sandpaper like skin that no cream, moisturizer, or diaper ointment alleviated. One dermatologist prescribed a soothing mask of fresh cold yogurt followed by Crisco, which provided short-term relief. Several times I was given antibiotics when the inflamed skin became secondarily infected. Despite vast quantities of Benadryl, prescription antihistamines, and creams, nothing helped except the systemic steroids.

I began my long journey seeking help within the medical community, first seeing my allergist. After seeing my inflamed face, sometimes with bright red circles around my eyes several times, the doctor diagnosed “allergic contact dermatitis” or ACD, not hives as I had assumed. This was my first introduction to the name of this hideous disease.

Volume 9 • number 2 • SPRING 2015 25

CLINIC AL Dermatology

occurring. Then in August of 2003, we bought a vacation

By March, I had seen my dermatologist and allergist several condo. The realtor left a big basket of cleaning products, times and found an endocrinologist, who after many tests, which included liquid fabric softener, something I do not told me I had a compromised immune system, a sluggish use at home. Lo and behold, after two nights sleeping on adrenal system, and was possibly pre-auto-immune though the sheets and pillowcases, I did not test positive for it.

I began a flare-up. This was He put me on a daily regimen one of the countless times I of 10mg of prednisone for the “People like me with chemical racked my brain to figure out next three months and told what I was using that was allergies have sometimes been me it was dangerous to be on or “new” and the it any longer than that and referred to as this century’s canaries… “different” liquid fabric softener light that the prednisone would bulb lit up! I discovered by make me gain weight (how Perhaps it is time to heed the trial and error and my own true!). warnings of the canaries!” amateur investigative work After I was off the that MCI/MI is in most prednisone for the appropriate liquid fabric softeners and time, my allergist ordered some liquid soaps.

The ingredients are not listed on these a T.R.U.E. Test® (allergen patch test) to be performed, products for competitive purposes. which yielded no results! Perhaps this was because a It was then I discovered that finding product medical assistant, uneducated in proper patch test reading ingredients when they are not listed on the product is not a techniques and protocol, had administered the test. I was simple task. The ingredients are not on company web sites never told to come back for a final reading on Friday, after and you must put in a request, either in writing or by email the assistant removed the patches on Wednesday and saw and eventually be contacted. You will not be provided with no reactions. I was still in the dark about what was causing a list of ingredients, but will be told if indeed the substance my flare-ups, which continued week after week. you ask about is in the product. MCI/MI is in liquid fabric I never knew when I accepted a social invitation, if I softeners (not sheets) from the three major manufacturers would really be able to attend. I missed numerous days at that I checked with. This is typical of the sleuth work work, hiding my face at home during a flare-up or going that the patient must go through to eliminate any known to doctors’ appointments. After many months, I let more allergen! and more friends and colleagues see me during a flare-up.

Over eighteen agonizing months, I saw six Often I would burst into tears upon waking up in a full dermatologists, three allergists and continued to see my fledged flare-up, knowing the impending cycle to come endocrinologist searching for answers. I spent thousands over the next four or five days. of dollars on my portion of numerous medical tests, untold My second allergist also administered a T.R.U.E. amounts of creams, OTC medications or supplements, Test® in August 2003 and discovered I was very reactive acupuncture, products and devices, including an electric to a common preservative, methylchloroisothiazolinone/ hand-held anti-itch device ordered from the Internet. methylisothiazolinone (MCI/MI). Knowing I was highly Amazingly, the anti-itch device for $49.99 actually did allergic to MCI/MI was a big help, as I could begin to provide some temporary relief! I switched to organic examine everything in my medicine cabinet and extensive pest control in my house in an attempt to rid my life of arsenal of makeup, hair, and skin products. I eliminated unnecessary chemicals, and began eating organic food products and carefully scrutinized all product labels before whenever possible. I went to a medical intuitive who told buying. I read the long list of ingredients on products me my adrenal system was not working well but gave no looking for MCI/MI or synonyms for it. good path to recovery. I even tried drinking fresh aloe Sounds fairly simple, but not so fast! I had begun to to cleanse my immune system. At this point, if someone notice that every time I went on a business trip and stayed in told me rubbing monkey dung on my face would solve the a hotel, I started to flare up by the second or third day. The problem, I would have tried this too! dreaded itchy rash returned on my face often accompanied I was on systemic corticosteroids for a three-month by swollen eyes, a portent of a full flare-up to come. I period in 2003, a one-month period in 2004, and had at carried “melt in your mouth” children’s Benadryl and least three cortisone shots and many dose packs along the would copiously pop them in my mouth at the first sign of way. I vaguely knew they had a potential to be dangerous, trouble, to no avail. I carried tinted glasses, so when my eyes but desperation and agony usually preceded my requests for began to swell I could cover them up and still help work the this relief. I also knew people with asthma took prednisone vendor booth for the company I partially own. When the for years. flare-up was really bad, I would often call a doctor to get a At some point during my odyssey, I realized via my prescription for a steroid dose pack to alleviate the problem internet research that I needed extended patch testing. First and allow me to finish the trip without a major flare-up

CLINIC AL Dermatology

I started asking the allergists and the six dermatologists, including one at the Cleveland Clinic, hoping they could either administer the extended patch test, or would know someone (anywhere!) who did. Nada! One allergist had provided the name of a doctor in New York City, whom I was unable to contact. After several months, I printed out a long list of local Miami dermatologists from my insurance company web site and began phoning to ask if they performed extended patch testing. Most of the appointment schedulers did not have a clue as to what I was talking about, and I usually had to hold for a nurse, or be called back. Many phone calls later; I eventually hit pay dirt when I called the University of Miami Dermatology Group. The scheduler happened to ask a nurse in the presence of a resident. I was given the name of Bruce Brod, MD, at the University of Pennsylvania. This contact became vital to my eventual diagnosis.

Coincidentally, or by the grace of God, I had a vendor show coming up in Philadelphia three weeks after getting Dr. Brod’s name. It is amazing what begging can do. The scheduler actually took pity on me when I told her my situation and fit me in to see Dr. Brod in May 2004, a full fifteen months after my first severe flare up.

In Philadelphia, Dr. Brod was very compassionate, saying I must get help as my quality of life was suffering.

What an understatement, but at last I had found someone who truly related to my plight! Dr. Brod said he could perform tests in Philadelphia, but I might be more interested in a physician on the west coast of Florida, Anthony Fransway, MD. Fransway was not taking new patients, so the necessary referral paperwork was administered and I eventually got a blessed appointment for August 4th, 2004 in Ft. Myers, Florida.

On a Monday eighteen months after my first severe flare-up, Dr. Fransway administered an extended patch test and 206 ingredients were positioned on my back next to identifying numbers and covered with tape. I could not get my back wet for the five-day test duration. On Wednesday, the patches were removed for the first reading and I returned Friday for the second reading. Finally! I was given an extensive list of allergens and directions for following an “avoidance” regimen. My allergens included bacitracin, gold-sodium-thiosulfate (gold), nickel, fragrance mixture, methylchloroisothiazolinone/ methylisothiazolinone (MCI/ MI), bromo-nitropropane diol, paraphenylenediamine mix (PPD), and dermatophagoides (dust mites). Later, tetracaine, 2,5-diaminotoluene sulfate, and ammonium persulfate would be added to this list. Gone was my gold jewelry (replaced by platinum, silver, or stainless steel tested for nickel content). No more hair color, as hair dye contains PPD, one of my major allergens. I changed many personal products including my laundry detergent, my toothpaste, and looked for “fragrance free” products that did not contain my allergens. The flare-ups did not entirely 26 Journal of Dermatology for Physician Assistants

go away, but subsided immensely! On a follow up visit to Dr. Fransway, several months later, I gave Fransway a big hug, telling him he had given me my life back!

My sixth dermatologist informed me in December 2004 that thankfully, Miami now had a dermatologist specializing in allergic contact dermatitis! This was my introduction to Sharon Jacob, MD, Assistant Professor of Clinical Dermatology at the University of Miami, who has been so important in my diagnosis, education, and understanding of allergic contact dermatitis. Ironically, that resident in clinic who directed me to Dr. Brod in the first place had been Dr. Jacob. A marvelous touch of fate provided the help I so desperately needed. Through Dr. Jacob, I am still learning new ways to avoid allergens each and every day. I learned additional products to avoid. I learned I needed to purge all products from my life that were not “fragrance free.” I had not been strict about “fragrance free,” and consequently when I got serious, I eliminated a large shopping bag full of products from my home. I learned the term “unscented” means yet another chemical has been added to the product to mask the scent.

Read product labels and you will see chemicals upon chemicals upon chemicals.

Dr. Jacob also sternly warned me about the dangers of over-use of steroids, as I still had big flare ups when I stayed in hotels and had a prescription for a few more dose packs that I would use in desperation. Sadly Dr. Jocob’s warning came too late! I started having right leg pain around the middle of January 2005. I had just taken a yoga class, so I attributed the pain to a pulled muscle or tendon. The pain worsened, causing me to limp part of the time and to have pain every morning. I saw two orthopedics in the beginning of February and one began the process of x-rays, bone scans, and MRI’s. By the beginning of March, I was also having pain on my left side, walking with a cane, in lots of pain at night and severe pain in the morning. I still attributed this to a soft tissue injury, and went into major shock when I was given my diagnosis in mid March 2005.

My diagnosis - bilateral osteonecrosis or avascular necrosis. Loss of blood supply to the bone or increased pressure within the bone causes the blood vessels to narrow; making it hard for the vessels to deliver enough blood to the bone cells and the bone literally necroses or dies. The probable cause - off and on systemic corticosteroid use for a two-year period. My treatment - complete hip replacement or hip decompression surgery for both hips!

I am now using crutches or painfully lurching around on a walker and seeking the best orthopedic surgeon to perform my needed surgery and treatment. When the pain is not too bad, I work on the computer from my house, as going into the office is difficult. Friends take me grocery shopping and my over-stressed husband is trying to run a business and take care of chores he never even dreamed of in the past. In the 19th century, miners carried canaries

My current orthopedic condition was avoidable and is a human medical tragedy I will have to make the best of. I am telling my story to prevent someone else from going through what I have, and what I face in the next year. There is a serious lack of education regarding allergic contact dermatitis by lay people, doctors, and medical personnel. There is a serious lack of knowledge of the side effects of systemic corticosteroids too. And finally, there is a major lack of access to the patch testing modality. Had the majority of my allergens been diagnosed within the first six months, I would not have taken steroids for two years and would not be facing extensive surgery and orthopedic treatment. This did not need to happen to me and should not happen to anyone else. J

BERS M E M S D PA

HIP

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

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

RAMC_3.25x4.75.indd 1

Take Home Points for Derm PAs:

1/31/13 12:49 PM

By Steven K. Shama, MD, MPH, FAAD Helen has made two points: better education about contact dermatitis and the skills involved in patch testing.

1. The author clearly suffered from what many of us in the contact dermatitis field see as avoidable.

There is no doubt that not enough of us in the field of contact dermatitis are educating clinicians in specialties other than dermatology about what a contact dermatitis looks like and what can be done to sort out the specific causes.

Even with our own dermatologic colleagues, it is truly unfortunate how many are limited in experience, specific knowledge, and interest. We as clinicians in dermatology must lay claim to this subspecialty and either do it “the right way" or refer to an experienced colleague. Those of us who perform patch tests on a regular basis must make ourselves more available.

CLINIC AL Dermatology

in small wooden cages down into the mines. The little garden-variety songbirds served as sentinels for miners, warning them by dying or falling off their perch when toxic fumes were in the mineshaft. The cheerful birds were extra sensitive to poisonous gases, so they'd react to them well before the miners, who would then quickly evacuate.

People like me with chemical allergies have sometimes been referred to as this century’s canaries. What is the proliferation of chemical additives in foods and products doing to our children, our environment, and ourselves?

Perhaps it is time to heed the warnings of the canaries!

2. The side effects of systemic corticosteroids are often silent until… We have in this patient’s story an ending that might have been different had a patch test specialist been involved soon after the first course of prednisone was administered. It is this writer’s humble opinion that in some instances of chronic itchy eruptions, multiple courses of prednisone are given “innocently,” without true appreciation of the harm that it might be doing.

It is “easy” to administer a short course of prednisone and then repeat it in a month or two and then bimonthly, without realizing that multiple short courses of high dose prednisone may have similar side effects (at least in regard to joint concerns) to a one long course of low dose.

Beware of prescribing prednisone anytime, but especially whenever the diagnosis is in doubt and especially when you prescribe that second course for the same diagnosis. J Volume 9 • number 2 • SPRING 2015 27

Dermoscopy Dermoscopic Notes from the 2014 American Dermoscopy Meeting

By John Burns, MSPA, PA-C

SDPA Members Only Content

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Fig. A

Fig. B

Figure 1: Dermoscopic photograph figure A represents a melanoma with blue globules denoted by red arrows and a pigmented network denoted by a star. Dermoscopic photograph figure B is of a pigmented basal cell carcinoma with blue globules that are also marked by red arrows and is lacking a pigmented network.

Figure 2: Melanoma demonstrating peripheral streaks.

28 Journal of Dermatology for Physician Assistants

SDPA Members Only Content

Figure 3: Nodular melanoma of the leg

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

Volume 9 â&#x20AC;˘ number 2 â&#x20AC;˘ SPRING 2015 29

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Clinical snapshots Folliculitis Decalvans

By Kruti Gandhi, MPH, PA-C and David Casper, MD

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CLINIC AL Dermatology

Figure B - After Treatment

Figure A - Before Treatment Kruti Gandhi, MPH, PA-C completed her undergraduate degree at BirminghamSouthern College and then her Masters in Public Health at University of Alabama in Birmingham. She then went on to complete her Masters degree in Physician Assistant studies at Barry University. She works at Alliant Dermatology in The Villages, FL. Kruti is a member of the SDPA, Florida Society of Dermatology Physician Assistants (FSDPA), and Florida Society of Physician Assistants (FAPA). She has indicated no relationships to disclose relating to the content of this article.

David Casper, MD is Board Certified by the American Board of Dermatology and is a Fellow of the American Academy of Dermatology, Fellow of the American Society for Mohs Surgery, Fellow of the American Society for Dermatologic Surgery, and Fellow of the Florida Society for Dermatologic Surgery. He completed his undergraduate degree at the University of Iowa and went on to complete medical school at Temple University. He did his dermatology residency and Mohs fellowship at University of South Florida. He works at Alliant Dermatology in The Villages, FL. He has indicated no relationships to disclose relating to the content of this article.

30 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 2 • SPRING 2015 31

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

32 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 2 • SPRING 2015 33

Dermatology Evidence Based Medicine Dermoscopy Significantly Improves the Accuracy of Diagnosing Malignant Melanoma

By Nicole Harvey, PA-C and Karen Graham, PhD, MPAS, PA-C

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. Image by Cardiff University

34 Journal of Dermatology for Physician Assistants

SDPA Members Only Content

Nicole Harvey, PA-C is a graduate of the Physician Assistant Program at the University of Wisconsin - La Crosse. She currently resides in Bloomington, MN and is working as a family practice PA at Entira Family Clinics in White Bear Lake, MN. 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.

Understanding Evidence Based Medicine Sensitivity, Specificity, and Confidence Intervals

By Karen Graham, PhD, MPAS, PA-C

Volume 9 â&#x20AC;˘ number 2 â&#x20AC;˘ SPRING 2015 35

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.

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

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

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

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

• Due to the nature of aBCC and its clinical factors (ie, lesion recurrence, location/size, and invasiveness) some patients may not be candidates for surgery or radiation1,2 • Erivedge is an oral treatment option dosed as a 150-mg capsule once daily until disease progression or unacceptable toxicity3 • Erivedge reduced lesions in patients with aBCC1,3 Objective response rates (ORR) by IR from ERIVANCE1,3* laBCC (n=63)

mBCC (n=33)

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

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

Complete response

21% (n=13)

0%

Partial response

22% (n=14)

30% (n=10)

7.6 (5.7-9.7)

7.6 (5.6-NE)

ORR (95% CI)

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

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

IR=Independent Review; laBCC=locally advanced BCC; ORR=objective response rate; CI=confidence interval; NE=not estimable; mBCC=metastatic BCC; RECIST=Response Evaluation Criteria in Solid Tumors; SLD=sum of the longest diameter.

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

Please see Brief Summary of Prescribing Information on following page.

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

05/14 HED0001655401 Printed in USA.

Volume 9 • number 2 • SPRING 2015 37

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

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

ERIVEDGE (vismodegib) capsule Initial U.S. Approval: 2012 This is a brief summary of information about ERIVEDGE. Before prescribing, please see full prescribing information.

WARNING: EMBRYO-FETAL DEATH AND SEVERE BIRTH DEFECTS ERIVEDGE (vismodegib) capsule can result in embryo-fetal death or severe birth defects. ERIVEDGE is embryotoxic and teratogenic in animals. Teratogenic effects included severe midline defects, missing digits, and other irreversible malformations.

Verify pregnancy status prior to the initiation of ERIVEDGE. Advise male and female patients of these risks. Advise female patients of the need for contraception and advise male patients of the potential risk of ERIVEDGE exposure through semen [see Warnings and Precautions (5.1), Use in Specific Populations (8.1, 8.6)].

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

All Grades 3 (%)

Grade 3 (%)

Grade 4 (%)

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

1 (0.7%) 1 (0.7%) -

-

55 (39.9%)

7 (5.1%)

1 (0.7%)

62 (44.9%)

10 (7.2%)

-

35 (25.4%)

3 (2.2%)

-

99 (71.7%) 22 (15.9%)

5 (3.6%) 1 (0.7%)

-

76 (55.1%) 15 (10.9%)

-

-

88 (63.8%)

-

-

aBCC = Advanced Basal Cell Carcinoma.

MedDRA = Medical Dictionary for Regulatory Activities.

3 Grading according to NCI-CTCAE v3.0.

Amenorrhea: In clinical trials, a total of 3 of 10 pre-menopausal women developed amenorrhea while receiving ERIVEDGE [see Non-Clinical Toxicology (13.1)].

Laboratory Abnormalities: Treatment-emergent Grade 3 laboratory abnormalities observed in clinical trials were hyponatremia in 6 patients (4%), hypokalemia in 2 patients (1%), and azotemia in 3 patients (2%).

1 2

7 DRUG INTERACTIONS 7.1 Effects of Other Drugs on Vismodegib Drugs that Inhibit or Induce Drug Metabolizing Enzymes Vismodegib elimination involves multiple pathways. Vismodegib is predominantly excreted as an unchanged drug. Several minor metabolites are produced by multiple CYP enzymes. Although vismodegib is a substrate of CYP2C9 and CYP3A4 in vitro, CYP inhibition is not predicted to alter vismodegib systemic exposure since similar steady-state plasma vismodegib concentrations were observed in patients in clinical trials concomitantly treated with CYP3A4 inducers (i.e., carbamazepine, modafinil, phenobarbital) and those concomitantly treated with CYP3A4 inhibitors (i.e., erythromycin, fluconazole).

Drugs that Inhibit Drug Transport Systems In vitro studies indicate that vismodegib is a substrate of the efflux transporter P-glycoprotein (P-gp). When ERIVEDGE is coadministered with drugs that inhibit P-gp (e.g. clarithromycin, erythromycin, azithromycin), systemic exposure of vismodegib and incidence of adverse events of ERIVEDGE may be increased.

Drugs that Affect Gastric pH Drugs that alter the pH of the upper GI tract (e.g. proton pump inhibitors, H2-receptor antagonists, and antacids) may alter the solubility of vismodegib and reduce its bioavailability. However, no formal clinical study has been conducted to evaluate the effect of gastric pH altering agents on the systemic exposure of vismodegib. Increasing the dose of ERIVEDGE when coadministered with such agents is not likely to compensate for the loss of exposure. When ERIVEDGE is coadministered with a proton pump inhibitor, H2-receptor antagonist or antacid, systemic exposure of vismodegib may be decreased and the effect on efficacy of ERIVEDGE is unknown.

7.2 Effects of Vismodegib on Other Drugs Results of a drug-drug interaction study conducted in cancer patients demonstrated that the systemic exposure of rosiglitazone (a CYP2C8 substrate) or oral contraceptives (ethinyl estradiol and norethindrone) is not altered when either drug is co-administered with vismodegib.

In vitro studies indicate that vismodegib is an inhibitor of CYP2C8, CYP2C9, CYP2C19 and the transporter BCRP. Vismodegib does not induce CYP1A2, CYP2B6, or CYP3A4/5 in human hepatocytes.

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category D ERIVEDGE capsule can cause fetal harm when administered to a pregnant female based on its mechanism of action. Vismodegib is teratogenic in rats at doses corresponding to an exposure of 20% of the exposure at the recommended human dose (estimated AUC 0-24hr steady-state exposure). In rats, malformations included craniofacial anomalies, open perineum, and absent or fused digits.

Fetal retardations and variations were also observed. Vismodegib is embryolethal in rats at exposures within the range achieved at the recommended human dose. If ERIVEDGE is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the embryo or fetus.

Report immediately exposure to ERIVEDGE during pregnancy to the Genentech Adverse Event Line at 1-888-835-2555. Encourage women who may have been exposed to ERIVEDGE during pregnancy, either directly or through seminal fluid, to participate in the ERIVEDGE pregnancy pharmacovigilance program by contacting the Genentech Adverse Event Line at 1-888-835-2555 [see Boxed Warning, Warnings and Precautions (5.1)].

In an embryo-fetal developmental toxicity study, pregnant rats were administered oral vismodegib at doses of 10, 60, or 300 mg/kg/day during the period of organogenesis. Pre- and post-implantation loss were increased at doses of ≥ 60 mg/kg/day (approximately ≥ 2 times the systemic exposure (AUC) in patients at the recommended human dose), which included early resorption of 100% of the fetuses. A dose of 10 mg/kg/day (approximately 0.2 times the AUC in patients at the recommended dose) resulted in malformations (including missing and/or fused digits, open perineum and craniofacial anomalies) and retardations or variations (including dilated renal pelvis, dilated ureter, and incompletely or unossified sternal elements, centra of vertebrae, or proximal phalanges and claws).

8.3 Nursing Mothers It is not known whether vismodegib is excreted in human breast milk. Because many drugs are excreted in human milk and because

38 Journal of Dermatology for Physician Assistants

Female patients Determine pregnancy status within 7 days prior to initiation of treatment in females of reproductive potential. For females with a negative pregnancy test, initiate a highly effective form of contraception (failure rate of less than 1%) prior to the first dose. Continue highly effective contraception during therapy and for 7 months after the last dose of ERIVEDGE. If a patient becomes pregnant while taking ERIVEDGE, or during the 7 months after the last dose of treatment, report the pregnancy to the Genentech Adverse Event Line at 1-888-835-2555.

Encourage pregnant females to participate in the ERIVEDGE pregnancy pharmacovigilance program by calling the Genentech Adverse Event Line at 1-888-835-2555. Counsel pregnant females about the teratogenic risk to the fetus.

Amenorrhea has been observed in clinical trials in females of reproductive potential. Reversibility of amenorrhea is unknown [see Adverse Reactions (6), Nonclinical Toxicology (13.1)].

Male patients Male patients should use condoms with spermicide, even after a vasectomy, during sexual intercourse with female partners while being treated with ERIVEDGE capsule and for 2 months after the last dose to avoid exposing an embryo or fetus to vismodegib.

8.7 Hepatic Impairment The safety and effectiveness of ERIVEDGE capsule have not been established in patients with hepatic impairment [see Clinical Pharmacology (12.3)].

8.8 Renal Impairment The safety and effectiveness of ERIVEDGE capsule have not been established in patients with renal impairment [see Clinical Pharmacology (12.3)].

10 OVERDOSAGE There is no information on overdosage in humans. In clinical trials, ERIVEDGE capsule was administered at 540 mg orally once daily; exposure did not increase between 150 mg and 540 mg daily.

17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Medication Guide).

• Advise patients that ERIVEDGE exposure during pregnancy can cause embryo-fetal death or severe birth defects.

• Instruct female patients of reproductive potential to use a highly effective form of contraception (failure rate of less than 1%) while taking ERIVEDGE and for at least 7 months after the last dose of ERIVEDGE. • Instruct all male patients, even those with prior vasectomy, to use condoms with spermicide, during sexual intercourse with female partners while taking ERIVEDGE and for at least 2 months after the last dose of ERIVEDGE. • Instruct patients to immediately contact their healthcare provider if they (or, for males, their female partner) become pregnant or if pregnancy is suspected following exposure to ERIVEDGE. • Instruct patients to immediately report any pregnancy exposure to ERIVEDGE and encourage participation in the ERIVEDGE pregnancy pharmacovigilance program by calling the Genentech Adverse Event Line at 1-888-835-2555.

• Inform female patients of the potential for serious adverse reactions in nursing infants from ERIVEDGE, taking into account the importance of the drug to the mother.

• Advise patients not to donate blood or blood products while taking ERIVEDGE and for at least 7 months after the last dose of ERIVEDGE. • Advise patients to swallow ERIVEDGE capsules whole and not to crush or open the capsules.

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

Safety:10"

1 INDICATIONS AND USAGE ERIVEDGE capsule is indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation.

2 DOSAGE AND ADMINISTRATION The recommended dose of ERIVEDGE is 150 mg taken orally once daily until disease progression or until unacceptable toxicity [see Clinical Studies (14)].

ERIVEDGE may be taken with or without food. Swallow capsules whole. Do not open or crush capsules.

If a dose of ERIVEDGE is missed, do not make up that dose; resume dosing with the next scheduled dose.

4 CONTRAINDICATIONS None.

5 WARNINGS AND PRECAUTIONS 5.1 Embryo-Fetal Death and Severe Birth Defects ERIVEDGE capsules can cause fetal harm when administered to a pregnant woman based on its mechanism of action. Vismodegib is teratogenic, embryotoxic, and fetotoxic in rats at maternal exposures lower than the human exposures at the recommended dose of 150 mg/day. In rats, malformations included craniofacial anomalies, open perineum, and absent or fused digits. Fetal retardations and variations were also observed.

Verify pregnancy status prior to the initiation of ERIVEDGE. Advise male and female patients of the risks of embryo-fetal death and severe birth defects and the need for contraception during and after treatment. Advise patients to contact their healthcare provider immediately if they suspect they (or, for males, their female partner) may be pregnant. Female and male patients of reproductive potential should be counseled regarding pregnancy prevention and planning. If ERIVEDGE is used during pregnancy or if a patient becomes pregnant while taking (or for a male patient, if his female partner is exposed to) ERIVEDGE, the patient should be apprised of the potential hazard to the fetus. Report immediately exposure to ERIVEDGE during pregnancy to the Genentech Adverse Event Line at 1-888-835-2555. Encourage women who may have been exposed to ERIVEDGE during pregnancy, either directly or through seminal fluid, to participate in the ERIVEDGE pregnancy pharmacovigilance program by contacting the Genentech Adverse Event Line at 1-888-835-2555 [see Boxed Warning, Use in Specific Populations (8.1, 8.6)].

5.2 Blood Donation Advise patients not to donate blood or blood products while receiving ERIVEDGE and for at least 7 months after the last dose of ERIVEDGE. 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

ERIVEDGE capsule was administered as monotherapy at doses ≥ 150 mg orally daily in four open-label, uncontrolled, dose-ranging or fixed single dose clinical trials enrolling a total of 138 patients with advanced basal cell carcinoma (BCC). The median age of these patients was 61 years (range 21 to 101), 100% were White (including Hispanics), and 64% were male. The median duration of treatment was approximately 10 months (305 days; range 0.7 to 36 months); 111 patients received ERIVEDGE for 6 months or longer.

The most common adverse reactions (≥ 10%) were muscle spasms, alopecia, dysgeusia, weight loss, fatigue, nausea, diarrhea, decreased appetite, constipation, arthralgias, vomiting, and ageusia (Table 1).

Table 1: Adverse Reactions Occurring in ≥ 10% of Advanced BCC Patients

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

of the potential for serious adverse reactions in nursing infants from ERIVEDGE, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

8.4 Pediatric Use The safety and effectiveness of ERIVEDGE capsule have not been established in pediatric patients.

In repeat-dose toxicology studies in rats, administration of oral vismodegib resulted in toxicities in bone and teeth. Effects on bone consisted of closure of the epiphyseal growth plate when oral vismodegib was administered for 26 weeks at ≥ 50 mg/kg/day (approximately ≥ 0.4 times the systemic exposure (AUC) in patients at the recommended human dose). Abnormalities in growing incisor teeth (including degeneration/ necrosis of odontoblasts, formation of fluid-filled cysts in the dental pulp, ossification of the root canal, and hemorrhage resulting in breakage or loss of teeth) were observed after administration of oral vismodegib at ≥ 15 mg/kg/day (approximately ≥ 0.2 times the AUC in patients at the recommended human dose).

8.5 Geriatric Use Clinical studies of ERIVEDGE capsule did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.

8.6 Females of Reproductive Potential and Males ERIVEDGE capsule can cause harm to the embryo or fetus when administered during pregnancy. Counsel female and male patients regarding pregnancy prevention and planning. Advise patients to contact their healthcare provider immediately if they suspect they (or, for males, their female partner) may be pregnant [see Boxed Warning, Warnings and Precautions (5.1), Use in Specific Populations (8.1)]

SURGIC AL Dermatology Journal Club: Practice Changing Articles for Dermatology PAs Surgical Excision versus Mohs Micrographic Surgery for Basal Cell Carcinoma of the Face: A Randomised Clinical Trial with 10-year Follow-up Eur J Cancer. 2014;50(17):3011-20. Published online November 2014. doi: 10.1016/j.ejca.2014.08.018. Epub 2014 Sep 25. van Loo E1, Mosterd K 2, Krekels GA 3, Roozeboom MH2, Ostertag JU4, Dirksen CD5, Steijlen PM6, Neumann HA7, Nelemans PJ8, Kelleners-Smeets NW6.

1 Maastricht University, Netherlands 2 Department of Dermatology, Maastricht University Medical Centre, Netherlands; GROW Research Institute for Oncology and Developmental Biology, Maastricht University, Netherlands 3 Department of Dermatology, Maastricht University Medical Centre, Netherlands; Expertise Centre for Mohs Micrographic Surgery, Netherlands 4 Department of Dermatology, Maastricht University Medical Centre, Netherlands 5 Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Centre, Netherlands 1

Department of Dermatology, Maastricht University Medical Centre, Netherlands; GROW Research Institute for Oncology and Developmental Biology, Maastricht University, Netherlands; Department of Dermatology, Catharina Hospital, Netherlands 7 Department of Dermatology, Maastricht University Medical Centre, Netherlands; Erasmus Medical Centre, Netherlands 8 Department of Epidemiology, Maastricht University Medical Centre, Netherlands 6

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.

Volume 9 â&#x20AC;˘ number 2 â&#x20AC;˘ SPRING 2015 39

SURGICAL wisdom Nanoparticles Can Promote Wound Healing

By Joleen M. Volz, MPAS, PA-C SDPA Secretary/Treasurer, Diplomate

SDPA Members Only Content

SURGIC AL Dermatology

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

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40 Journal of Dermatology for Physician Assistants

HELP THEM LOOK FORWARD TO CLEARER SKIN WITH EPIDUO GEL— • Early results and the power to help prevent future breakouts1-4 • The ONLY antibiotic-free fixed-dose combination

Prescribe

1

# THE BRANDED TOPICAL ACNE PRODUCT AMONG DERMATOLOGISTS AND PEDIATRICIANS5

Important Safety Information Indication: EPIDUO® (adapalene and benzoyl peroxide) Gel, 0.1%/2.5% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. Adverse Events: In controlled clinical studies, the most commonly reported adverse events (≥1%) in patients treated with EPIDUO® Gel were dry skin, contact dermatitis, application site burning, application site irritation and skin irritation. Warnings/Precautions: Patients taking EPIDUO® Gel should avoid exposure to sunlight and sunlamps and wear sunscreen when sun exposure cannot be avoided. Erythema, scaling, dryness, stinging/burning, irritant and allergic contact dermatitis may occur with use of EPIDUO® Gel and may necessitate discontinuation.

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

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

Volume 9 • number 2 • SPRING 2015 41

IMPORTANT INFORMATION ABOUT ®

EPIDUO GEL

(adapalene and benzoyl peroxide) Gel, 0.1% / 2.5% BRIEF SUMMARY

WHAT ARE THE MOST COMMON SIDE EFFECTS OF EPIDUO GEL?

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

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

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

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

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

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

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

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

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

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

• Apply EPIDUO gel 1 time a day.

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

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

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

• have any other medical conditions.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

References: 1. Gollnick HPM, Draelos Z, Glenn MJ, et al; Adapalene–BPO Study Group. Adapalene–benzoyl peroxide, a unique fixed-dose combination topical gel for the treatment of acne vulgaris: a transatlantic, randomized, double-blind, controlled study in 1670 patients. Br J Dermatol. 2009;161(5):1180-1189. 2. Czernielewski J, Michel S, Bouclier M, Baker M, Hensby C. Adapalene biochemistry and the evolution of a new topical retinoid for treatment of acne. J Eur Acad Dermatol Venereol. 2001;15(suppl 3):5-12. 3. Phase 3 (CSR 18088). Data on file. Galderma Laboratories, L.P. 4. Pariser DM, Westmoreland P, Morris A, Gold MH, Liu Y, Graeber M. Long-term safety and efficacy of a unique fixed-dose combination gel of adapalene 0.1% and benzoyl peroxide 2.5% for the treatment of acne vulgaris. J Drugs Dermatol. 2007;6(9):899-905. 5. According to data from Symphony Health Solutions, Pharmaceutical Audit Suite, Retail Audit, December 2013-November 2014.

All trademarks are the property of their respective owners. ©2015 Galderma Laboratories, L.P. Galderma Laboratories, L.P. 14501 N. Freeway Fort Worth, TX 76177 EPID-304A Printed in USA 01/15

www.epiduo.com/hcp

42 Journal of Dermatology for Physician Assistants

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 state yourvisit state, dermpa.org/diplomate visit dermpa.org/diplomate Current list of diplomates effective as of Dec 2013

070714

Volume 9 â&#x20AC;˘ number 2 â&#x20AC;˘ SPRING 2015 43

COSMETIC deRMATOLOGY

Popular Anti-aging Treatment Emerges as Effective Treatment for Difficult Scars 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 A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

COSMETIC Dermatology

Jill S. Waibel, MD, FAAD is a clinical voluntary professor at University of Miami and subsection chief of dermatology at Baptist Hospital of Miami. She is a recognized expert in the use of cutaneous laser technologies for the treatment of scars, especially burn scars. Dr. Waibel completed her medical degree and her dermatology residency at Wright State School of Medicine in Dayton, Ohio.

EXPAND YOUR EXPERTISE… at the premier dermatology event of the summer!

20 August 19-23, 2015 New York, N.Y. NEW YORK HILTON MIDTOWN

REGISTRATION BEGINS WEDNESDAY,

MAY 27 AT 12 p.m. noon (CT)

The AAD’s 2015 Summer Meeting offers Physician Assistants: • • • •

Four days of information-packed educational sessions Two days of exhibits featuring the latest products and services MOC sessions approved for AAPA Category 1 self-assessment CME credit A variety of networking opportunities to help build professional relationships

DON’T MISS YOUR CHANCE TO ATTEND! For information regarding registration requirements for Physician Assistants, please visit www.aad.org/SAM15/nonmembers. Physician attendance is not required for PA’s to attend.

Visit www.aad.org/SAM15 for more information 15-529-MKT

Volume 9 • number 2 • SPRING 2015 45

Cosmetic pearls SDPA Members Only Content

COSMETIC Dermatology

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

Authentic Vial

Counterfeit Vial

46 Journal of Dermatology for Physician Assistants

Counterfeit Package

INDICATION & USAGE Desonate® (desonide) Gel 0.05% is indicated for the treatment of mild to moderate atopic dermatitis in patients 3 months of age and older.

Patients should be instructed to use Desonate® for the minimum amount of time as necessary to achieve the desired results because of the potential for Desonate® to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Treatment should not exceed 4 consecutive weeks.

Put the

squeeze

on atopic dermatitis.

4

Approved for use in patients with mild to moderate atopic dermatitis 3 months of age and older

4

$0 COPAY with unlimited fills*

4

No AB rated generic equivalent1

*Up to a maximum benefit of $200 per fill. Eligibility rules apply.

Actual product and sample tube shown. According to the Prescribing Information the Desonate® formulation ranges from translucent to opaque. Available by prescription only.

IMPORTANT SAFETY INFORMATION Desonate® is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Topical corticosteroids can produce reversible hypothalamic pituitary adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency, Cushing’s syndrome, hyperglycemia and unmasking of latent diabetes.

Systemic absorption may require periodic evaluation for HPA axis suppression. If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Use of more than one corticosteroid-containing product at the same time may increase the total systemic corticosteroid exposure.

Pediatric patients may be more susceptible to systemic toxicity due to their larger skin surface-to-body mass ratios.

Unless directed by a physician, do not use on the underarm or groin area of children. Do not use to treat diaper dermatitis.

Use in children less than 3 months of age is not recommended.

Local adverse reactions may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Reactions may include skin atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria.

Some local adverse reactions may be irreversible.

If concomitant skin infections are present or develop during treatment, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of Desonate® should be discontinued until the infection is adequately controlled.

If irritation develops, Desonate® should be discontinued and appropriate therapy instituted.

The most common adverse reactions (incidence ≥ 1%) are headache, application site burning and rash.

Desonate® is for topical use only. Not for ophthalmic, oral or intravaginal use. As with other corticosteroids, therapy should be discontinued when control is achieved.

See Brief Summary of full Prescribing Information for Desonate® on next page.

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

References: 1. US Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Active ingredient search results from “OB_Rx” table for query on “desonide.” http://www.accessdata.fda.gov/scripts/cder/ob/docs/ tempai.cfm. Accessed March 2015.

© 2015 Bayer HealthCare Pharmaceuticals Inc. Bayer, the Bayer Cross, Desonate and the Desonate logo are registered trademarks of Bayer. All rights reserved. PP-850-US-0166 | April 2015

Volume 9 • number 2 • SPRING 2015 47

DESONATE® (desonide) Gel 0.05% For Topical Use Only Rx Only BRIEF SUMMARY CONSULT PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE Desonate is indicated for the treatment of mild to moderate atopic dermatitis in patients 3 months of age and older.

Patients should be instructed to use Desonate for the minimum amount of time as necessary to achieve the desired results because of the potential for Desonate to suppress the hypothalamic-pituitary-adrenal (HPA) axis [see Warnings and Precautions (5.1)].

Treatment should not exceed 4 consecutive weeks [see Dosage and Administration (2)].

4 CONTRAINDICATIONS Desonate is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

5 WARNINGS AND PRECAUTIONS 5.1 Effects on Endocrine System Systemic absorption of topical corticosteroids can produce reversible hypothalamicpituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid.

The effect of Desonate on HPA axis function was investigated in pediatric subjects, 6 months to 6 years old, with atopic dermatitis covering at least 35% of their body, who were treated with Desonate twice daily for 4 weeks. One of 37 subjects (3%) displayed adrenal suppression after 4 weeks of use, based on the cosyntropin stimulation test.

As follow-up evaluation of the subject’s adrenal axis was not performed, it is unknown whether the suppression was reversible [see Use In Specific Populations (8.4) and Clinical Pharmacology (12.2)].

Pediatric patients may be more susceptible than adults to systemic toxicity from equivalent doses of Desonate due to their larger skin surface-to-body mass ratios [see Use In Specific Populations (8.4)].

Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of more potent steroids, use over large surface areas, use over prolonged periods, use under occlusion, use on an altered skin barrier, and use in patients with liver failure.

An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression.

If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids.

Cushing’s syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids.

Use of more than one corticosteroid-containing product at the same time may increase the total systemic corticosteroid exposure.

5.2 Local Adverse Reactions with Topical Corticosteroids Local adverse reactions may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Reactions may include skin atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. Some local adverse reactions may be irreversible.

5.3 Concomitant Skin Infections If concomitant skin infections are present or develop during treatment, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of Desonate should be discontinued until the infection is adequately controlled.

5.4 Skin Irritation If irritation develops, Desonate should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.

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

In controlled clinical studies of 425 Desonate-treated subjects and 157 Vehicle-treated subjects, adverse events occurred at the application site in 3% of subjects treated with Desonate and the incidence rate was not higher compared with vehicle-treated subjects.

The most common local adverse events in Desonate treated subjects were application site burning in 1% (4/425) and rash in 1% (3/425) followed by application site pruritus in <1% (2/425).

Adverse events that resulted in premature discontinuation of study drug in Desonate treated subjects were telangiectasia and worsening of atopic dermatitis in one subject each. Additional adverse events observed during clinical trials for patients treated with Desonate included headache in 2% (8/425) compared with 1% (2/157) in those treated with vehicle.

The following additional local adverse reactions have been reported infrequently with topical corticosteroids. They may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, secondary infection, skin atrophy, striae, and miliaria.

48 Journal of Dermatology for Physician Assistants

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Teratogenic effects: Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Therefore, Desonate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.

No reproductive studies in animals have been performed with Desonate. Dermal embryofetal development studies were conducted in rats and rabbits with a desonide cream, 0.05% formulation. Topical doses of 0.2, 0.6, and 2.0 g cream/kg/day of a desonide cream, 0.05% formulation or 2.0 g/kg of the cream base were administered topically to pregnant rats (gestational days 6-15) and pregnant rabbits (gestational days 6-18). Maternal body weight loss was noted at all dose levels of the desonide cream, 0.05% formulation in rats and rabbits. Teratogenic effects characteristic of corticosteroids were noted in both species. The desonide cream, 0.05% formulation was teratogenic in rats at topical doses of 0.6 and 2.0 g cream/kg/day and in rabbits at a topical dose of 2.0 g cream/kg/day. No teratogenic effects were noted for the desonide cream, 0.05% formulation at a topical dose of 0.2 g cream/kg/day in rats and 0.6 g cream/kg/day in rabbits. These doses (0.2 g cream/kg/day and 0.6 g cream/kg/day) are similar to the maximum recommended human dose based on body surface area comparisons.

8.3 Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Desonate is administered to a nursing woman.

8.4 Pediatric Use Safety and effectiveness of Desonate in pediatric patients less than 3 months of age have not been evaluated, and therefore its use in this age group is not recommended.

The effect of Desonate on HPA axis function was investigated in pediatric subjects, with atopic dermatitis covering at least 35% of their body, who were treated with Desonate twice daily for 4 weeks. One of 37 subjects (3%) displayed adrenal suppression after 4 weeks of use, based on the cosyntropin stimulation test [see Warnings and Precautions (5.1)].

In controlled clinical studies in subjects 3 months to 18 years of age, 425 subjects were treated with Desonate and 157 subjects were treated with vehicle [see Adverse Reactions (6) and Clinical Studies (14)].

Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression when they are treated with topical corticosteroids. They are therefore also at greater risk of glucocorticosteroid insufficiency after withdrawal of treatment and of Cushing’s syndrome while on treatment.

Adverse effects, including striae, have been reported with inappropriate use of topical corticosteroids in infants and children. HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

8.5 Geriatric Use Clinical studies of Desonate did not include patients aged 65 and older to determine if they respond differently than younger patients. Treatment of this patient population should reflect the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

17 PATIENT COUNSELING INFORMATION Patients using topical corticosteroids should receive the following information and instructions: • This medication is to be used as directed by the physician. It is for external use only.

Avoid contact with the eyes.

• This medication should not be used for any disorder other than that for which it was prescribed.

• Unless directed by the physician, the treated skin area should not be bandaged or otherwise covered or wrapped so as to be occlusive.

• Unless directed by a physician, this medication should not be used on the underarm or groin areas of pediatric patients.

• Parents of pediatric patients should be advised not to use Desonate in the treatment of diaper dermatitis. Desonate should not be applied in the diaper area, as diapers or plastic pants may constitute occlusive dressing [see Dosage and Administration (2)].

• Patients should report to their physician any signs of local adverse reactions.

• Other corticosteroid-containing products should not be used with Desonate without first consulting with the physician.

• As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 4 weeks, contact the physician. © 2014, Bayer HealthCare Pharmaceuticals Inc. All rights reserved.

Manufactured for:

Bayer HealthCare Pharmaceuticals Inc. Whippany, NJ 07981 Manufactured in Canada

6706906BS3 Rev. July 2014

A BASE TAN

IS NOT

A SAFE TAN DON’T GET BURNED BY TANNING MYTHS #TanMy th There is a common misconception that a tan acts as the body’s natural protection against sunburn.

#BurningTruth A tan is the body’s response to injury from UV rays, showing that damage has been done. A “base tan” only provides a sun protection factor (SPF) of about 3 or less, which does little to protect you from future UV exposure.

@cdc_cancer * www.cdc.gov/cancer/skin/burningtruth/ * #burningtruth

National Center for Chronic Disease Prevention and Health Promotion Volume 9 • number 2 • SPRING 2015 49 Division of Cancer Prevention and Control

PROFESSIONAL de VELOPMENT

SDPA Legislative Update

By Wendy Thompson Ridenour, MSPAS, MPH, PA-C and Jane Mast, 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.

Wendy Ridenour, MPAS, PA-C is currently the Chair of the SDPA Legislative Affairs Committee.

She has been a practicing dermatology PA for seven years. Wendy graduated from the PA Program at Touro University in Vallejo, California.

A native of Ohio she received her bachelors degree from Miami University in Oxford, Ohio.

Jane Mast, PA-C is currently an 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 thirteen 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.

How to Receive Up-to-date Information Regarding the ACA

50 Journal of Dermatology for Physician Assistants

Judicial and Ethical Affairs Rethinking Medical Codes of Ethics What Patients Teach Us

By Karen Scully, MD, FRCPC, MA Ethics

SDPA Members Only Content

professional development

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

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

Volume 9 • number 2 • SPRING 2015 51

Notes from your Office Manager

The Universal Patient Compact

professional development

Patient Safety Awareness Week was observed March 18th -14th and is an annual education and awareness campaign for health care safety led by the National Patient Safety Foundation (NPSF). Each year, health care organizations around the globe take part in the event by prominently displaying the NPSF campaign logo and promotional materials within their organizations, creating awareness in the community, and utilizing NPSF educational resources among hospital staff and patients.

The theme for 2015 is “United in Safety.” Everyone in the health care process plays a role in delivering safe care and by uniting together and sharing that common goal; together we can make a difference in patient safety. From patients to care providers, from the front lines to the executive suite, from the patient and family advocate to the corporate solutions provider - we are all united in the goal of keeping patients and those who care for them free from harm. The focus of this campaign is patient engagement and emphasizes the importance of the relationship between health care providers and patients and their families. Enhanced communication begins with an informed and engaged patient and helps to lead to safer care.

For Patient Safety Awareness Week 2015, NPSF has teamed up with expert organizations in the field to develop and disseminate educational materials for clinicians, health systems, and patients and consumers specifically related to better understanding how patients and providers can enhance communication, which can increase engagement.

The office setting is the most common setting for health care provider-patient contact. These interactions present an opportunity for health care providers and their staff to foster a positive experience for patients. The Universal Patient Compact™ is a statement of principles established

by NPSF to help create and maintain strong partnerships between patients and providers.

NPSF believes that this partnership is critical to

52 Journal of Dermatology for Physician Assistants

the delivery of safe and high quality care. The Compact’s principles are important to forming a patient-and-family-centered care process that respects the rights of patients and providers.

What are the principles of the Compact?

The Compact includes principles that: • Define elements of patient-and-familycentered care.

• Respect the rights of patients and health care providers.

• Focus on relationship between the patients and health care providers rather than just one side.

• Include the patient and the family on the team rather than working with the team • Help to build open and clear communication between health care providers and patients and families.

How were these principles developed?

The Universal Patient Compact™ is the outcome of a discussion during the 2007 McKesson Nursing Leadership Congress. It was introduced as part of the 2009 Patient Safety Awareness Week celebrations. The document was created with input from the Patient and Family Committee at NPSF, patient advocacy groups, NPSF Board members, Stand Up for Patient Safety member organizations, and a variety of other patient and provider representatives.

How can health care providers and patients use the Compact?

Here are some suggestions for using the Compact: • Health care providers and patients can print the Compact and bring it with them to their next appointment to help remember what they can do as an important member of the health care team.

As your health care partner we pledge to: • Include you as a member of the team.

• Treat you with respect, honesty, and compassion.

• Always tell you the truth.

• Include your family or advocate when you would like us to.

• Hold ourselves to the highest quality and safety standards.

• Be responsive and timely with our care and information to you.

• Help you to set goals for your health care and treatment plans.

• Listen to you and answer your questions.

• Provide information to you in a way you can understand.

• Respect your right to your own medical information.

• Respect your privacy and the privacy of your medical information.

• Communicate openly about benefits and risks associated with any treatments.

• Provide you with information to help you make informed decisions about your care and treatment options.

• Work with you, and other partners who treat you, in the coordination of your care.

As a patient I pledge to: • Be a responsible and active member of my health care team.

• Treat you with respect, honesty, and consideration.

• Always tell you the truth.

• Respect the commitment you have made to health care and healing.

• Give you the information that you need to treat me.

• Learn all that I can about my condition.

• Participate in decisions about my care.

• Understand my care plan to the best of my ability.

• Tell you what medications I am taking.

• Ask questions when I do not understand and until I do understand.

• Communicate any problems I have with the plan for my care.

• Tell you if something about my health changes.

• Tell you if I have trouble reading.

• Let you know if I have family, friends, or an advocate to help me with my health care.

For more information on the Universal Patient Compact™ please visit the National Patient Safety Foundation (NPSF) website at www.npsf.org. J

Let them know they’re not alone...

Share a story with your patients.

Visit the Patient’s Perspective library of articles at www.jdpa.org/advocacy.html If you know a patient who would like to share his/her story, please contact us at editor@jdpa.org Volume 9 • number 2 • SPRING 2015 53

professional development

• Patients can share the Compact with their health care providers and talk openly about what the principles mean.

• Health care providers can find out if their local hospital has a Patient and Family Advisory Council and discuss whether they may want to build a program around the Compact’s principles.

• Health care providers and patients can share the Compact with their friends and family to help spread the word about this document and the importance of patient-and-familycentered care.

The vision to look ahead,

Š 2015 Amgen Inc. All rights reserved. 83231-R1-V1

54 Journal of Dermatology for Physician Assistants

the knowledge to know the way

Volume 9 • number 2 • SPRING 2015 55

Outside & Inside the 9 to 5...

professional development

Shirisha Vallarapu, PA-C, a Diplomate of the SDPA, has over ten years of health care experience. Currently, Mrs. Vallarapu works at the Florida Skin Center where she sees patients for routine skin examinations and problem visits. She also enjoys performing surgical procedures at the office including routine biopsies and excisions. In addition, she preforms specialized procedures such as sclerotherapy, dermal fillers, neurotoxin injections, and laser treatments for vascular, hair removal, and tattoo removal.

Mrs. Vallarapu frequently gives lectures locally to fellow colleagues as well as lectures on the importance of skin health throughout her community. She enjoys spending time with patients and is always trying to further her dermatologic knowledge by attending conferences and workshops. The JDPA had the opportunity to interview Mrs. Vallarapu and learn more about her experience working within the field of dermatology, the role of community involvement at her practice, and the Dermatology From the Heart Program that she helped start seven years ago to provide dermatological care for underserved children. your children suffering from a disease and JDPA: How long have you been a feeling like there is no hope for them. Our dermatology PA? skin is something we can’t hide from. I have Mrs. Vallarapu: I have been a treated many patients in my ten years as a PA for over ten years and have been dermatology PA; however, there are always with the same dermatology practice a few patients who stand out or really since graduation. During PA school, make an impact. Some of the highlights my friends all found a specialty include being able to clear up the skin of that they immediately fell in love a teenager with severe acne who is too with. It wasn’t until my elective in embarrassed to even sit in the waiting dermatology that I realized this was room; using a laser to treat a hemangioma the field for me. I knew right away on the face of a young girl so she won’t during rotations that I wanted to have to hide it with her hair or fear leaving work in dermatology. I loved the the house without makeup; and having a balance of being able to practice twenty-year old patient come back to the medicine with procedures and office and tell you she was finally able to Shirisha Vallarapu, PA-C cosmetics. go to the beach in a skirt because we were JDPA: What are some of the challenges/rewards you able to clear up her psoriasis. Seeing what a difference have found from working in dermatology? you can make in a young person’s life is the best reward.

Mrs. Vallarapu: The biggest challenge during my JDPA: Any goals you hope to achieve as a member of career in dermatology has been educating patients the SDPA and/or within the field of dermatology? on what PAs do - our education, background, and Mrs. Vallarapu: I love working with patients and expertise. When I started with the practice I was the having the face-to-face interactions. However, with first PA who was hired. I encountered patients who the way the world is so technology driven, I feel that had never heard of a PA before or who had a negative telemedicine is the wave of the future and dermatology experience with a mid level provider in the past. It could be a leader for this type of practice of medicine. took time, and I had to build trust with our patients I would love to work within this realm. I think it would to prove that I was a capable provider. It also helped be great if the SPDA and the AAD could work together that my supervising physician, Dr. Aurora Badia, has to be involved with local government agencies in always been very supportive of the PA profession, obtaining insurance coverages for these services. and together we have worked hand in hand treating JDPA: What are some positive aspects of working and educating our patients. She has valued my input within the field of dermatology? and knowledge in helping to develop Florida Skin Center into the practice it is today. The PA profession Mrs. Vallarapu: Working within the field of has grown so much in the last ten years since I started dermatology provides a great opportunity to have practicing. It is so important to continue to educate the balance in my life and work. I have two small children, public about our profession. and I think dermatology is a great field in which you can have a balance of procedures, aesthetics, and general The rewards have been endless. My passion dermatology while still balancing a family. I love the is working with children. As a mother of two, I mix of seeing patients of all ages. Being in practice for understand how heartbreaking it can be to have 56 Journal of Dermatology for Physician Assistants

March of Dimes Walk and just recently this year became involved in the Juvenile Diabetes Research Foundation. For the past three years we have given away over one hundred turkeys around the holiday season to families in need. We call this event Grab a Gobbler.

We have a volunteer committee as part of our staff that dedicates time to collecting monthly donations and researching different volunteer opportunities within the community for our practice to participate in. We are very excited because this year we will be working with the Melanoma Research Foundation to hold the First Annual Melanoma Walk in Southwest Florida.

JDPA: As an SDPA Diplomate, what are your thoughts on the SDPA’s DLI program?

Mrs. Vallarapu: I think the cases were challenging, and it is a great accomplishment to all PAs who have completed the course. I think that completing the DLI and becoming an SDPA Diplomate is a true testament of a PA’s hard work and dedication to the field of dermatology. My supervising physician now requires all of her PAs to complete the program within their second year of joining the practice.

JDPA: What do you see in the future for the dermatology PA profession?

Mrs. Vallarapu: I see the dermatology PA profession growing. With more people having access to health care and baby boomers getting older, there will be a need for PAs in the field of dermatology. I think we have a great support structure for our specialty with the SDPA, and the Diplomate program is a way to distinguish our credentials and set us apart from other health care providers.

JDPA: Any advice or insights you would like to share with PA students or PAs who are new to the field of dermatology?

Mrs. Vallarapu: It’s a great field of medicine. I think there are lots of opportunities to grow within the field.

Don’t get comfortable; push yourself to see and do more whether it be procedures, cosmetics, or surgery.

Be sure to become active within the community and give back. It is the best way for people to recognize how beneficial the PA profession is to medicine. J

Volume 9 • number 2 • SPRING 2015 57

professional development

over a decade, I see patients who were once coming to me for eczema as babies and now are dealing with acne issues as young adolescents.

JDPA: What types of dermatology cases do you treat?

Mrs. Vallarapu: Being in practice in Southwest Florida, we see patients for many different issues. I see patients for anything from eczema and warts to annual skin checks. I do excisions and biospies as well as vascular laser treatments, laser hair removal, and tattoo removal. I do cosmetic treatments for patients using dermal fillers and neurotoxins and I see pediatric patients. I pride myself on always keeping upto-date on new techniques and treatment modalities.

The last thing you want is to feel too comfortable. In our office, we do an interesting case of the month, and you can find those write-ups on our website, www. floridaskincenter.com.

I have a specific interest in pediatric dermatology.

At our practice, we treat everything including hemangiomas, eczema, acne, verucca/molluscum contagiosum, and psoriasis. I enjoy being able to educate parents and helping children with conditions that can be embarrassing and frustrating for both the parents and children. By the time they get to us, oftentimes patients and parents are frustrated because they have tried so many things with no success.

Knowing that we can make a difference in a child’s life is a great feeling.

JDPA: How is your practice involved within your community?

Mrs. Vallarapu: We try to get involved in the community as much as possible because we believe in giving back to the community we serve. We volunteer to speak at local events and schools about the importance of sun safety and the ABCDEs of moles.

An event that we started about seven years ago is Dermatology from the Heart.

At our annual Dermatology from the Heart Program we see children ages eighteen and under free of charge. During this event, we see on average close to 100 to 120 children every year. Because of economic distress for many families and changes in health care, it is a good feeling to know that we can reach and treat underserved children. We volunteer every year at the

Dermatology PA news & notes

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June 21 – 26, Camp Little Pine in Crosslake, Minnesota (ages 10 – 14) ● June 22 – 26, Camp Reflection in Carnation, Washington (ages 9 – 16) ● July 5 – 10, Camp Big Trout in Crosslake, Minnesota (ages 14 – 16) ● August 9 – 15, Camp Liberty in Andover, Connecticut (ages 8-16) ● August 9 – 14, Camp Dermadillo in Burton, Texas (ages 9 – 15) ● August 15 – 22, Camp Horizon in Millville, Pennsylvania (ages 8 – 13)

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CAMP DISCOVERY 2015 Dates: ●

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Camp Discovery was founded in 1993 and offers a summer camp experience like no other. Every summer, the American Academy of Dermatology sponsors six weeks of camp in five locations where everyone can experience activities such as fishing, swimming, archery, horseback riding, nature trails, and just plain fun!

Under the expert care of dermatologists and dermatology healthcare professionals, Camp Discovery offers campers the opportunity to spend a week among other young people who have similar skin conditions. Many of the counselors have chronic skin conditions as well, and can provide support and advice to campers.

There is no fee for camp. All costs, including transportation, are provided by the American Academy of Dermatology through generous donations from its members, other organizations, and individuals. The American Academy of Dermatology is proud to offer this experience to about 380 children each year.

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

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58 Journal of Dermatology for Physician Assistants

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 2 • SPRING 2015 59

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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

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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.

60 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)

Dermatology PA news & notes

The Difference We Make

Empathy - How Much Should We Feel For Our Patients and How Much Is Just Right?

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A phrase from my medical school years that I have never forgotten still has significance in the way I practice medicine, “Patients don't care how much you know until they know how much you care.” One could interpret the word “care” to mean how empathetic the clinician is.

Empathy is a way of connecting and appreciating another human being. Brené Brown, an American scholar, author, public speaker, and someone who has gotten over 20 million views of her TED talks, speaks of one of the greatest human needs: the need to connect with another and truly with life. The famous philosopher and novelist William James suggests that perhaps the greatest human need is the need to be appreciated. Empathy, the ability to see the world from another person's point of view, is a powerful way of connecting to and appreciating others.

I would suggest that empathy needs to be expressed every day of our lives and especially in our medical practices where people need us the most.

Expressing empathy makes us real, makes us human.

Empathy can refresh our soul, refresh us physically, give us value as a person, give meaning to our lives, and make us more effective clinicians. Studies have shown that clinicians who have been rated by their patients as having high empathic scores have themselves a greater sense of well-being. They are more successful clinicians in the care of their patients. With specific references to diabetes, patients who are cared for by clinicians with high empathic ratings have less complications and better glucose controls. These patients are known to be more compliant and tend to sue their caregivers less often.

I have no doubt that these positive outcomes between patients with diabetes and empathetic clinicians can be generalized to clinicians and patients in all specialties, including dermatology.

Yet how often do we remember this when in a clinical situation? A striking statistic reveals that physicians overlook 75 to 90% of opportunities to be empathic with their patients. Where does this insensitivity to empathic moments begin? Studies that track empathy in physicians have shown that medical students enter medical school with a high degree of empathy; for some reason they have a significant drop-off during their third and fourth years of medical school and in their subsequent training. When physicians are polled about their views on empathy, many believe that being empathetic will increase their clinical

office visit time and may lead to a loss of objectivity.

Fortunately, in recent years, medical students have been taught how to be more empathic with their patients, and yes, it appears that empathy can be taught.

I refer the reader to articles published by the Studer Group (www.studergroup.com) on empathy and also to the website www.empathetics.com (developed by Harvard Medical School scholars), both of which have programs which can be used to teach empathy. With all due respect to the phrase, “Fake it till you make it,” there are several effective ways of teaching empathy. One technique is to truly listen to others and repeat back to them the essence of what they said. Another approach includes words that you may use such as, “I can understand how difficult this must be.” Of course, it is not so much the words you use but where they are coming from, meaning that words without a caring emotional source are much less powerful than an empathetic statement. Body language can also suggest to the patient that the clinician is empathic. For example, the clinician’s hands and legs should be uncrossed and he/she should lean in towards the patient.

The hope is that once you recognize the effectiveness of empathy and know how to look like you are empathic, your brain will be imprinted with true feelings of empathy.

Incentives to at least give patients the impression that the clinician is empathetic have their rewards. Third-party payers, especially Medicare, are increasingly looking for providers who are more empathetic (as determined by a questionnaire given to patients ) and are actually paying them at a higher rate. The phrase, “It pays to be nice,” may have a literal meaning.

All expressions of empathy are not the same. There seem to be three forms of empathy according to a 2008 interview on the Greater Good website with the American psychologist Paul Ekman, who is a pioneer in the study of emotions and their relation to facial expressions. The first, cognitive empathy, is simply knowing how the other person feels and what they may be thinking. It does not involve internalizing that feeling. One is simply labeling what he or she believes the other person is feeling. “You seem upset” might be a verbal response. The empathizer does not internalize this feeling and feels nothing physically or emotionally, nor are they moved to action.

Volume 9 • number 2 • SPRING 2015 61

DERmatology pa news & notes

By Steven K. Shama, MD, MPH, FAAD

DERmatology pa news & notes

The second form is called emotional empathy when you physically feel what another person feels. This form of empathy depends in large part on cells in our brain called mirror neurons, which fire when we sense another's emotional state, thus creating the state of feeling in our own minds. In this state you may actually get upset yourself and feel jittery. When emotional empathy is too strong, it can lead to psychological exhaustion on our part and burnout. Our own defense mechanism may create a sense of detachment from the person and give the impression that we simply don't care.

The third form of empathy is called compassionate empathy, which gives us the feeling that we are all connected, all one as the Buddhists believe. This form of empathy causes us to react and take some action.

Compassionate empathy might very well be expressed when we see the tragic results of a natural disaster on helpless people. We not only feel with emotional empathy what these people are going through, but we want to take action, go to where they live, and offer our personal assistance.

All forms of empathy may be of value depending on the situation. When you need to cause someone discomfort or actual pain for his/her own good (for example, numbing an area of skin with a needle before a biopsy), cognitive empathy may be your choice. You may choose not to totally feel what the person is feeling

Hire a DermPA

in order to perform your procedure. Emotional empathy is closer to the kind of empathy that all of us should have throughout our day. It is the empathy that most of us think about when we think about empathy (i.e. are we attuned to another person's emotional state? Do we feel what they are feeling? Do we say things in a kind and compassionate way?). Perhaps the most useful form of empathy, compassionate empathy, not only involves emotional empathy but causes us to act to make things better.

Throughout our day, we transition from one from of empathy to another. This transition allows us to be one who performs procedures (cognitive empathy), be the humanist (emotional empathy) who comforts his/her patient, and the reformer (compassionate empathy) who makes the world a better place by taking action against the suffering. I suggest we embrace all forms of empathy in every aspect of our lives because it makes us real, allows us to heal others more effectively, and keeps us in touch with our humanity. J Dr. Steve Shama was practicing general dermatology for 30 years in Boston, Massachusetts until last year. He retired at that time but continues in a 20 year career as a professional speaker and enjoys speaking on topics such as, “Dealing With Difficult People and Looking Forward To It!” and “Rediscovering The Joys of Medicine and of Life.” He gives these talks at medical meetings, in private practices, and to general audiences and youth throughout the country. You can reach Dr. Shama at www.steveshama.com.

The Perfect Complement to the Modern Dermatologist

Announcing the All New: HireADermPA.com

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Contact Us: 844-DERMPAS 62 Journal of Dermatology for Physician Assistants

Workplace Excellence Remember, Everything Is A Gift

By Matthew Davidson, PhD

Over the course of this year in my work

says, “Gratitude is the recognition that life owes me nothing and all the good I have is a gift.”

When we forget this we slip into an entitlement mindset, which essentially says, “I deserve this,” or “I’m owed this.” Life doesn’t owe you good health, a good job, vacation time, a light work schedule, food to eat, warm clothes, or anything else. It’s all a gift; and when we remember this we’re grateful for everything.

with several different organizations around the country, we have been working on the topic of gratitude. When it was first introduced to me by a collegiate athletic director, I thought, “Wow, interesting topic to focus on for high performing student-athletes who are strong, healthy, smart, and blessed in so many ways with gifts “Gratitude is the recognition that and abilities.” And yet, the more I explored But here’s life owes me nothing and the topic with and for the thing that is all the good I have is a gift.” coaches and studentso difficult about athletes the more I gratitude, we often ~ Robert Emmons realized the relevance only remember and of this topic and how give thanks for what it is applicable to so many groups of individuals. we have when it is taken away and given back The same concepts could easily be applied to or simply taken away. You take food for granted, those working in healthcare and their quest for until you’re hungry; you take your health for optimal performance – as medical providers granted until you’re injured or sick; you take your and human beings. Equally as important, I’ve time as a PA student or healthcare provider for realized the central importance of this in my granted until it’s over. I am reminded of a story own life.

I read about Dean Smith, the great University of North Carolina Basketball coach that hit me I’ve come to the conclusion that it’s not easy hard on so many different levels. As he suffered for any of us to be grateful – especially those from dementia, so many of his wonderful gifts most blessed with gifts, talents, abilities, and were being taken away. Would I, or did others good fortune. For most, it’s not a natural instinct appreciate his gifts when they were there? Hard or habit. In fact, we often have to remember to be to say if we ever fully appreciate anything or grateful. Robert Emmons, whose work focuses anyone. But it’s clear we appreciated Coach on gratitude, has a quote that for me captures Smith’s gifts more as they were taken away from the essence of what we need to remember; he him - and us.

Volume 9 • number 2 • SPRING 2015 63

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.

DERmatology pa news & notes

The word “compassion” means “to suffer with.” I don’t need to be Dean Smith, his family, or one of his former players in order to suffer with him as many of his amazing gifts were taken away. When and if we can suffer with others, I believe we also develop a gratitude mindset. If you’re healthy, go sit with a patient in an exam room whose diagnosis is greatly impacting his/ her daily routine (and maybe even life) as he/she is waiting for treatment. I bet you’ll feel grateful for you own health. I bet you won’t think you “have to go to work to help more patients,” I bet you will begin to think you “get to go to work to help more patients.” Lose your job and see how grateful you are to get to go to work at your next job. Volunteer on a medical mission trip in a developing country and see how grateful you begin to feel for the country you are able to live in and utilize its healthcare system (flaws and all). It’s almost as if compassion and gratitude are interconnected; the more you suffer with others in their pain, the more grateful you are for what you have - especially if they’re suffering with something that you treasure very much (imagine

parents suffering with a fellow parent who has lost a child).

Abraham Lincoln said, “Most people are about as happy as they make up their minds to be.” Gratitude is a mindset, a way of framing and re-framing constantly so that we remember that everything we have is a gift. J Matthew L. Davidson, Ph.D. is the Founder, President, and Director of Education for the Institute for Excellence & Ethics (IEE), a 501(c)3 nonprofit corporation dedicated to helping individuals and organizations achieve excellence. He is a National Spokesperson for the Business Bureau National Center for Character Ethics. The IEE specializes in the development and dissemination of research-based tools for developing the culture and competencies of excellence and ethics in schools, athletics, the workplace, and the home; this is done through professional development workshops & academies, teaching & learning resources, assessment, and consulting services. He is a frequent national presenter and is available for keynote lectures, professional development, retreats, and organizational consulting. He has indicated no relationships to disclose relating to the content of this article. For additional information or to contact the IEE, please visit www.excellenceandethics.org.

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 64 Journal of Dermatology for Physician Assistants

From the Desk of...

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

The American Academy of Dermatology (AAD) recently announced the DermCare Team, a new initiative designed to make specific AAD products and educational activities available to those who practice with AAD members. Unfortunately, participation in the initiative requires teams to sign an attestation that the AAD member is onsite when the PA practices unless there are “extenuating circumstances.”

The American Academy of Physician Assistants (AAPA) and the Society of Dermatology Physician Assistants (SDPA) sent a letter requesting that the AAD either remove the mandatory attestation or update its current position statement requiring the

onsite presence of a dermatologist at all times.

SDPA leaders, Robert Higham, MPAS, PA-C (the AAPA’s Liaison to the AAD), and AAPA staff met with AAD leaders on March 22nd at the AAD’s 73rd Annual Meeting in San Francisco to discuss the issue. Ideally, language will be developed that will support the AAD DermCare Team initiative while not imposing new restrictions on dermatologists and PAs. The AAPA, SDPA, and AAD will continue to work on a resolution and will possibly meet again to continue to discuss this issue. Look for updates regarding this issue in future SDPA and AAPA communications. J

SDPA and AAPA Leaders at the AAD’s 73rd Annual Meeting From left to right: Matthew Brunner, MHS, PA-C, SDPA President-Elect, Vicki Roberts, MPAS-PA-C, SDPA President, Ann Davis, MS, PA-C, AAPA VP Constituent Organization Outreach and Advocacy, Jennifer Winter, MSPAS, PA-C, SDPA Immediate Past President, and Robert Higham, MPAS, PA-C, AAPA Liaison to AAD.

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 2 • SPRING 2015 65

DERmatology pa news & notes

SDPA and AAPA Meet with AAD Regarding the DermCare Team

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

Dermcast.tv is the official online media resource of the SDPA. We are very proud that Dermcast is the #1 iTunes Podcast in dermatology. Dermcast.tv is your source for audio podcasts, the most current dermatology news and research, procedural videos, conference highlights, and much, much more.

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

DERmatology pa news & notes

The Year of the Biosimilar Has Arrived Now How Do We Name Them?

Read More: http://bit.ly/dermcast1

The Food and Drug Administration (FDA) recently approved the first biosimilar in the US – Sandoz’s Zarxio, a biosimilar version of Amgen’s Neupogen (filgrastim). This approval launched a new industry where lower-cost biosimilars will create a competitive market potentially saving billions per year in drug spending in the US. However, important safety issues remain, including how to name these products.

Since biosimilar medicines are made from living cells, they cannot be exact copies of the “brand” product. So, how do we name these?

The FDA continues to struggle with developing a comprehensive naming policy for these biosimilars.

Link Between the Inflammation Response Post Injury and In Regeneration

Read More: http://bit.ly/inflamresp

Recent studies have found new links between the inflammatory response seen after tissue injury and regeneration. This inflammatory response leads to signal pathways that are activated by the receptor protein gp130, which then turns on several transcription factors. The transcription factors involved are responsible for healing and repair of tissue by stimulating regrowth of normal tissue stem cells. These findings may prove to be pivotal in ongoing research of plaque psoriasis and atopic dermatitis.

Are We Sanitizing Our Children To The Point Of Allergy?

A recent study has shown that washing dishes by hand, not machine, can reduce the rising risk of childhood allergies.

Read More: http://bit.ly/1iffQjU

66 Journal of Dermatology for Physician Assistants

Lead study researcher Dr. Bill Hesselmar, an allergist at the University Of Gothenburg Department of Pediatrics in Sweden, found that children living with families that used a dishwasher were 40% more likely to have allergies. J

Supervising Physician CORNER An Interview with the First Medical Director of the SDPA Marcus Conant, MD

By J. Margaret Casey

JDPA: Dr. Conant, you were recently JDPA: Is there anything happening now awarded the 2014 SDPA Lifetime in medicine that you see akin to the AIDS Achievement Award. What does this epidemic? award mean to you?

Dr. Conant: It is as though we have Dr. Conant: Receiving the award was learned nothing from the AIDS epidemic, a very nice honor. One of the individuals we have made the same mistakes with the who helped to start the SDPA back in the recent Ebola epidemic. When an epidemic early 1980s was Kurtis Opp, who just so begins we do the same thing again and happened to be working with me at the again. History speaks to this - from the Black time. I took Kurtis with me to an AAD Death to now, we go through this over and Annual Meeting back then and told him over again. Denial (this isn't Ebola) blaming he should start a similar organization others (health care workers), and putting up tailored specifically for dermatology PAs. emotional barriers; these are a few of the same It is nice to see that the vision translated mistakes we repeat time and time again. The into the Society it is today; with a clear only thing we really learn is that those who concentration on education, as evident do not read history are doomed to repeat it. at the SDPA conferences and in both I have found that it is important that you do Marcus Conant, MD the SDPA newsletters and journal. It not define yourself by being a ‘dermatologist’ is wonderful to see what the SDPA has or a ‘dermatology PA.’ You should move on accomplished. from a specialty in order to empower yourself and best help society. Do not define yourself by your degree - move on! In JDPA: What gave you the confidence that the SDPA the five year time period that I was met with the Kaposi’s organization would succeed? sarcoma outbreak, I was working outside of my comfort Dr. Conant: I was practicing at the University of zone of dermatology and helping to run the largest AIDS California when the AIDS epidemic began. In 1982 clinic in San Francisco at the time and serving as a US Kaposi’s sarcoma made up 80% of the patients I was Senate advisor for the AIDS epidemic. treating in our dermatology office. We started seeing a JDPA: What are the very large number of patients biggest challenges ahead with AIDS and witnessed that you see for the SDPA? as Pneumocystic carinii “You should move on from a specialty pneomonia took many of Dr. Conant: I think in order to empower yourself and best our patients’ lives. This was the biggest challenge for when I began to help to the SDPA will be the help society. Do not define yourself by start the Kaposi’s Sarcoma impact that technology will your degree - move on!”

Foundation and the San have on patient care and Francisco AIDS Foundation. education. I would suggest These experiences gave me the opportunity to learn some that the SDPA bring in a committee of expert advisors who things about starting an organization. This is why I was can help keep them on the cutting edge of this wave in confident when Kurtis Opp was helping to start the SDPA, regards to how technology impacts the delivery of medical I had the first hand experience to tell him, “The SDPA can services. None of us are moving in the way we need to (e.g., have a chance to succeed too.”

EMR systems had to be forced upon our profession vs. us selecting to utilize it ten years earlier).

Volume 9 • number 2 • SPRING 2015 67

DERmatology pa news & notes

Marcus Conant, MD was the first medical director of the SDPA and helped to develop the SDPA Bylaws and other important documents that were essential to the establishment of the SDPA. Dr. Conant received the 2014 SDPA Lifetime Achievement Award at the SDPA Annual Fall Dermatology Conference in San Diego, CA in recognition and appreciation for his dedication, guidance, and support in developing the building blocks on which our organization now so firmly stands. The JDPA recently had the opportunity to interview Dr. Conant and learn more about his contributions to medicine, his passion for the field of dermatology, and his thoughts on the role of PAs in dermatology

DERmatology pa news & notes

JDPA: Do you have any advice for dermatologists who are not currently utilizing PAs in their practice of dermatology?

Dr. Conant: Back in the 1980’s when we were so overwhelmed with the AIDS epidemic, we couldn’t get enough physicians to help us treat the volume of patients coming in, and this was a life threatening disease! We were loosing lives because insurance companies were demanding that we see four patients per hour. For such complicated cases, this was and still is impossible. Patients were coming in with extremely complicated cases and families needed to be educated and comforted. We needed many more hands to provide time, evaluation, education, emotional support, and treatment. With the Affordable Care Act, physicians are being asked to see even more complicated patients per hour. I believe we are only going to continue to see more patients dissatisfied with their health care. Physicians will be hearing, “Why are you writing my prescriptions before I have even told you what is wrong with me?” The heath care profession needs PAs to help improve this situation.

JDPA: What is the most important aspect of the dermatology PA/supervising physician relationship?

Dr. Conant: I think the most important aspect is for a supervising physician to treat his/her PA as an equal, not as a subordinate. Having an open door policy so a PA knows he/she can come to you with any questions is key;

you want your PA to be confident in asking questions. This atmosphere will promote continued learning. Supervising physicians should consider themselves constant teachers.

JDPA: What are you currently working on?

Dr. Conant: I am devoting much of my time right now into research that will hopefully one day find a cure for AIDS. The recent discovery of a treatment and cure for the Hepatitis C infection was made possible because of what we have accomplished thus far in AIDS research/ clinical trials and advancements in understanding of the HIV infection.

JDPA: Any additional insights or interesting information that you would like to share with our readers?

Dr. Conant: I am currently involved in a legal case in California dealing with the topic of terminal illnesses and allowing physicians to provide enough medications to make their patients remaining days as comfortable as possible. I feel we are not letting our patients die comfortably, or with dignity for that matter. PAs really should consider what their clinical role is in this practice (depending on their current state laws), and look into how they can research the topic further in order to learn more about it and possibly help to influence legislation on the subject. J

Success on SGR “Fix”

PA Advocacy Still Needed on Hospice Bill PA Advocates - you did it!! Last month the U.S. Senate overwhelmingly passed (92-8) HR 2, the bill to repeal Medicare's SGR formula, hours before a 21 percent cut in payments to providers took place. HR 2 will also extend the Children's Health Insurance Program (CHIP) and finding for National Health Service Corps and Community Health Centers programs.

Thanks to YOUR advocacy, the bill, which President Obama signed into law on April 16th, 2015 contains the following PA-friendly provisions: • Treats PAs in the same fashion as physicians and nurse practitioners in the value-based performance payment program.

• Recognizes the role of PAs in providing complex chronic care to patients.

• Allows PAs to perform the face-to-face encounters in documenting the need for durable medical equipment (DME) for Medicare beneficiaries.

Now that SGR is behind us, we're making a full-court press on the hospice issue. The AAPA is asking all PAs to PLEASE reach out to their legislators and urge them to support HR 1202, the Medicare Patient Access to Hospice 68 Journal of Dermatology for Physician Assistants

Act of 2015, which would authorize PAs to provide hospice care.

The AAPA has been hard at work in the halls on Capitol Hill, and have found that there is a lot of support for this bill. However, offices are also telling us that they are not hearing from constituents back home, and, as you know, they look to constituents to make issues personal, relevant, and local.

You are the ones who ultimately have a big say in whether a legislator supports a bill or not.

Please contact your House members today and urge them to support authorizing PAs to provide hospice care by cosponsoring HR 1202. The more cosponsors we get, the more likely (and the sooner) the bill could be considered for a vote. Take action online here - http://www.capwiz. com/aapa/issues/alert/?alertid=64205611. Please be sure to personalize the suggested text with your name, facility, and a personal example or story.

Thank you for your advocacy! J

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 2 • SPRING 2015 69

Professional Opportunities and Development

A dver tiser INDE X • Celgene – Otezla............................Pages 2 - 4 • GDPA.....................................................Page 5 • Ranbaxy – Halog............................Pages 9, 10 • Promius Pharma – Promius Promise.......Page 13 • Valeant – Jublia.............................Pages 15, 16 • Valeant – Solodyn........................ Pages 31 - 33 • Genentech – Erivedge.................Pages 36 - 38 • Galderma – Epiduo.......................Pages 41, 42 • AAD Summer Academy Meeting .......Pages 45 • Bayer HealthCare – Desonate........Pages 47, 48 • Amgen Dermatology .................... Pages 54, 55 • Valeant – Onexton.........................Pages 59, 60 • Valeant – Luzu...............................Pages 71, 72 For more information on advertising opportunities in the JDPA, please log on to www.jdpa.org

Prepare for Grand Rounds!

Submit Your Interesting Cases...

Best Case Submission Wins an iPad Mini!* *$399 Value

Submit your cases and photographs to Grandrounds@dermpa.org

DID YOU KNOW - MEMBERSHIP DUES HAVE NOT CHANGED IN 11 YEARS

MEMBERSHIP PRICES INCREASE MAY 20TH Yosemite National Park August 13-15, 2015

NEW PRICING Fellows $110/Year Associates $115/Year Affiliates $120/Year NO INCREASE TO CATEGORIES BELOW: Diplomates $100/Year Students $25/Year Physicians $0/Year WHEN SUPERVISING A CURRENT FELLOW MEMBER

In addition - the 2 year membership option will be discontinued.

To register, visit americandermoscopy.com

70 Journal of Dermatology for Physician Assistants

We support rolling-membership and automatic renewal!

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

noted at 25 mg/kg/day (3 times the MRHD based on BSA comparisons).

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

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

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

Rx Only INDICATIONS LUZU (luliconazole) Cream, 1% is an azole antifungal indicated for the topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum and Epidermophyton floccosum, in patients 18 years of age and older.

DOSAGE AND ADMINISTRATION For topical use only. LUZU Cream, 1% is not for ophthalmic, oral, or intravaginal use.

When treating interdigital tinea pedis, a thin layer of LUZU Cream, 1% should be applied to the affected area and approximately 1 inch of the immediate surrounding area(s) once daily for two (2) weeks.

When treating tinea cruris or tinea corporis, LUZU Cream, 1% should be applied to the affected area and approximately 1 inch of the immediate surrounding area(s) once daily for one (1) week.

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

In three Phase 3 clinical trials, 616 subjects were exposed to LUZU Cream, 1%: 305 with interdigital tinea pedis and 311 subjects with tinea cruris.

Subjects with interdigital tinea pedis or tinea cruris applied LUZU Cream, 1% or vehicle cream once daily for 14 days or 7 days, respectively, to affected and adjacent areas. During clinical trials with LUZU Cream, 1% the most common adverse reactions were application site reactions which occurred in less than 1% of subjects in both the LUZU and vehicle arms. Most adverse reactions were mild in severity.

Post-Marketing Experience The following adverse reactions have been identified during postmarketing use of luliconazole cream, 1%: contact dermatitis and cellulitis. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

DRUG INTERACTIONS The potential of luliconazole to inhibit cytochrome P-450 (CYP) enzymes 1A2, 2C9, 2C19, 2D6, and 3A4 was evaluated in vitro. Based on in vitro assessment, luliconazole at therapeutic doses, particularly when applied to patients with moderate to severe tinea cruris, may inhibit the activity of CYP2C19 and CYP3A4. However, no in vivo drug interaction trials have been conducted to evaluate the effect of luliconazole on other drugs that are substrates of CYP2C19 and CYP3A4.

Luliconazole is not expected to inhibit CYPs 1A2, 2C9 and 2D6 based on in vitro assessment. The induction potential of luliconazole on CYP enzymes has not been evaluated.

USE IN SPECIFIC POPULATIONS Pregnancy: Pregnancy Category C. There are no adequate and well-controlled studies of LUZU Cream, 1% in pregnant women. LUZU Cream, 1% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

The animal multiples of human exposure calculations were based on daily dose body surface area (BSA) comparisons (mg/m2) for the reproductive toxicology studies described in this section and in Section 13.1 of the prescribing information. The Maximum Recommended Human Dose (MRHD) was set at 8 g 1% cream per day (1.33 mg/kg/day for a 60 kg individual which is equivalent to 49.2 mg/m2/day).

Systemic embryofetal development studies were conducted in rats and rabbits.

Subcutaneous doses of 1, 5 and 25 mg/kg/day luliconazole were administered during the period of organogenesis (gestational days 7-17) to pregnant female rats. No treatment related effects on maternal toxicity or malformations were

In a pre- and post-natal development study in rats, subcutaneous doses of 1, 5 and 25 mg/kg/day luliconazole were administered from the beginning of organogenesis (gestation day 7) through the end of lactation (lactation day 20). In the presence of maternal toxicity, embryofetal toxicity (increased prenatal pup mortality, reduced live litter sizes and increased postnatal pup mortality) was noted at 25 mg/kg/day. No embryofetal toxicity was noted at 5 mg/kg/day (0.6 times the MRHD based on BSA comparisons). No treatment effects on postnatal development were noted at 25 mg/kg/day (3 times the MRHD based on BSA comparisons).

Nursing Mothers It is not known whether luliconazole is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when LUZU Cream, 1% is administered to women who are breastfeeding.

Pediatric Use The safety and effectiveness of LUZU Cream, 1% in pediatric patients have not been established. The number of pediatric patients ≥12 years of age were too small to adequately assess safety and efficacy.

Geriatric Use Of the total number of subjects in clinical studies of LUZU Cream, 1%, 8 percent were 65 and over, while 1.4 percent were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies to evaluate the carcinogenic potential of LUZU Cream, 1% have not been conducted.

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

In a fertility study in rats, subcutaneous doses of 1, 5 and 25 mg/kg/day luliconazole were administered prior to and during mating and through early pregnancy. Treatment related effects on reproductive function were noted in females (decreased live embryos and decreased corpus luteum) at 5 and 25 mg/kg/day and males (decreased sperm counts) at 25 mg/kg/day. No treatment related effects on fertility or reproductive function were noted at 1 mg/kg/day (0.1X MRHD based on BSA comparisons).

PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information) Inform patients that LUZU Cream, 1% is for topical use only. LUZU Cream, 1% is not intended for intravaginal or ophthalmic use.

Manufactured for: Medicis, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807

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

Volume 9 • number 2 • SPRING 2015 71

DO YOUR PATIENTS HAVE ATHLETE’S FOOT BETWEEN THE TOES?

WTF What the Foot?

For tinea pedis due to Trichophyton rubrum and Epidermophyton floccosum in adult patients

for more information, go to LuzuRx.com.

LUZU has the strength to clear fungus and relieve signs and symptoms of interdigital tinea pedis.* LUZU is the only topical azole antifungal approved to treat interdigital tinea pedis with once-daily, 2-week dosing. Efficacy demonstrated at 4 weeks post-treatment. Treat it fast with LUZU. The complete clearance rates (primary efficacy outcome) in the two trials, assessed at 4 weeks post-treatment following two weeks of double-blind once-daily treatment, were 26% vs 2% (N=209) and 14% vs 3% (N=214) for LUZU vs vehicle, respectively. Complete clearance was defined as achieving both clinical cure (absence of erythema, scaling, and pruritis) and mycological cure (negative KOH and negative fungal culture).

*

If your patients are asking WTF? What the Foot? Tell them about LUZU. Visit LuzuRx.com for more information.

Indication LUZU (luliconazole) Cream, 1% is indicated for the topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the or ganisms Trichophy ton rubrum and Epidermophyton floccosum in patients 18 years of age and older.

Important Safety Information LUZU is indicated for topical use only and is not indicated for ophthalmic, oral or intravaginal use.

LUZU should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when LUZU is prescribed for nursing mothers.

The most common adverse reactions in clinical trials were application site reactions, which occurred in less than 1% of subjects in both LUZU and vehicle arms. Most adverse reactions were mild in severity.

Please see Brief Summary of Prescribing Information for LUZU on next page.

Reference: 1. LUZU [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals; 2014. ®/TMs are trademarks of Valeant Pharmaceuticals International, Inc. or its affiliates.

Any other product or brand names and logos are the property of their respective owners. ©2015 Valeant Pharmaceuticals North America LLC DM/LUZ/14/0116c

72 Journal of Dermatology for Physician Assistants