Spring 2011 Journal of Dermatology for Physician Assistants by Angela Simiele

Volume 5 number 2 SPRING 2011

SDPA News and Current Affairs

dermatology pa news and notes

clinical dermatology

surgical dermatology

cosmetic dermatology

Professional development

Official Journal of the Society of Dermatology Physician Assistants

Vol. 5, No. 2 SPRING 2011

EDITORIAL BOARD

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

DEPARTMENT EDITORS

Clinical Department Editors Susan E. King-Barry, MPAS, PA-C Karen Graham, MPAS, PA-C Drugs in Dermatology Editor Stephen Wolverton, MD Surgical Department Editor Christy Kerr, MPAS, PA-C Cosmetic Department Editor Nancy Primo, MPAS, PA-C Prof Dev Department Editor Abby Jacobson, MS, PA-C

SDPA Board of Directors

PrESiDEnT Abby Jacobson, MS, PA-C PrESiDEnT-ElECT Keri Holyoak, MPH, PA-C iMMEDiATE PAST PrESiDEnT Kristine Kucera, DHS, MPAS, PA-C ViCE PrESiDEnT CaSondra Soto, MPAS, PA-C SECrETAry / TrEASurEr Casey Croes, MPAS, PA-C DirECTors AT lArGE Mark Hyde, MMS, PA-C John Notabartolo, MPAS, PA-C Jennifer Winter, PA-C Jason Roddick, MS, MSPAS, PA-C Society of Dermatology Physician Assistants, Inc P.O. Box 701461 San Antonio, Texas 78270 1-800-380-3992 SDPA@dermpa.org www.dermpa.org

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 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: of 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. 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.

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 5, Number 2, Spring 2011. 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). TM Periodicals postage rate paid at New York, NY 10001 and additional mailing offices. ÂŠ 2011 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. P.O. Box 701461, San Antonio, Texas 78270; 1-800-380-3992. THIS ISSUE IS SPONSORED BY

Journal of Dermatology for Physician Assistants

Editor’s Message

A Welcoming Tone Journal of Dermatology for Physician Assistants

The Official Journal of the SDPA

s my wife and I entered the labor and delivery unit for our third time in the past eight years, we were greeted at the door by a warm and welcoming smile. This friendly greeting helped to set the tone for an experience that would be as special as our other two. Throughout the duration of the day we were taken care of by caring and friendly healthcare staff who took the time to get to know us personally. Two nurses even remembered us from our two previous deliveries. Rather than being indifferent to this fact, they maintained a level of excitement and interest that was equal to our first visit. Their attention and enthusiasm helped to create a very comfortable and welcoming tone. After experiencing healthcare from the patient’s perspective, I returned to work finding myself reflecting on whether my staff and I pay as much attention to creating a friendly follow-up visit for our patients as we do creating a welcoming first visit. Oftentimes established patients might be rushed through on the assumption that they want a quick follow-up and that they don’t want or need to hear the same information that they received during their previous visits. While they may not need another detailed explanation of their diagnosis, what they do need is our time and attention. In addition to gathering any new pertinent medical information, we should make an effort to simply focus on them. How have they been doing? Do they have any new interests or hobbies? How are their families, children, or grandchildren? We can and should take time to nourish our established relationships with our follow-up patients. Setting the right tone at each and every visit can change an ordinary experience into a warm and lasting memory. Our most recent experience during labor and delivery is just as memorable and special as the first two times both because of our beautiful new baby girl and because of the friendly staff who helped to set the warm and welcoming tone. J

Dermatology PA Brochure SDPA members can personalize this FREE brochure with their practice demographics and/or photos of the practice’s providers.

Travis Hayden, MPAS, PA-C Editor in chief

Download and have printed for your office today! Available in the new SDPA Member Document Library

Vol. 5, No. 2 SPRING 2011

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.

The Clues to Chronic Kidney Disease Just May Be Skin Deep By Michelle DiBaise, DFAAPA, MPAS, PA-C

CME

10 Derm PA News & Notes – part one

• See Spot • Check Spot – May is Melanoma/Skin Cancer Detection and Prevention Month® • Certification Review – All Those Things Inside the Skin You Might Have Forgotten • Camp Discovery 2011 • Student Scoop – The Importance of Being a Preceptor

19 Clinical Dermatology

• CME Article – The Clues to Chronic Kidney Disease Just May Be Skin Deep • Drugs in Dermatology – Ivermectin in the Treatment of Scabies

Departments

04 Editorial Board 05 Editor’s Message 09 SDPA News & Current Affairs 10 Dermatology Market Watch 25 From The Patient’s Perspective 29 Dermoscopy 30 Clinical Snapshots 42 Surgical Wisdom 47 Cosmetic Pearls 56 Notes from your Office Manager 59 Outside & Inside the 9 to 5... 62 The Difference We Make 66 Professional Opportunities and Development

38 Surgical Dermatology

• Mohs Surgery - An Interview with Keith Duffy, MD

43 Cosmetic Dermatology

• Going to Great Lengths for Beautiful Hair – Hair Care Tips for Healthy and Damaged Hair

48 Professional Development

• Dermatology Billing & Coding – Destruction Services vs. Shave Removals • Judicial and Ethical Affairs - Autonomy and Informed Consent

60 Derm PA News & Notes – part two • From the Desk of… • Supervising Physician Corner

Go Green - Read Online

Journal of Dermatology for Physician Assistants

dermPA.org

Vol. 5, No. 2 SPRING 2011

Journal of Dermatology for Physician Assistants

Calendar

FROM THE SPDA News & Current Affairs

of events

2011

june SDPA Annual Summer Dermatology Conference June 2 - 5, 2011 JW Marriott Hotel Washington, DC August AAD Summer Academy Meeting August 3 - 7, 2011 JW Marriott Hotel New York, NY NOVEMBER SDPA 9th Annual Fall Conference November 9 - 12, 2011 Loews Portofino Bay Hotel Orlando, FL

2012

FEBRUARY 70th AAD Annual Academy Meeting March 16 - 20, 2012 San Diego, CA

Calendar of Events Submissions

A Year: Sixteen Years in the Making

s my term as SPDA President comes to an end this July, I wanted to take a moment and recognize the SDPA’s past Presidents. Over the past sixteen years many volunteers have come together to grow the SDPA and PA dermatology profession. Each of them deserves our appreciation, praise, and gratitude. However, these eleven individuals who took on the role of ‘captain of the ship’ (those who served as President more than once are identified with an asterisk) deserve additional kudos. • Joe Monroe * • Kurtis Opp * • Jim Page • Jim Sotack * • Kristine Kucera * • Greg Buttolph • Michele DiBaise • Gordon Day • Daniel Hickey • Robert Higham • Bethany Grubb Whether we agreed with every decision that was made or word that was printed by these past SDPA Presidents, we should recognize the contributions and dedication of these individuals. I encourage SDPA members to take the moment to thank these former leaders of the SDPA and ask yourselves, ‘When is it time for us to take the lead?’ J

Send information to: Editor@jdpa.org

Abby Jacobson, MS, PA-C President Society of Dermatology Physician Assistants

Vol. 5, No. 2 SPRING 2011

Dermatology PA news & notes

Dermatology Market Watch Canfield Reinvents the Dermatoscope The DermScope™ from Canfield Imaging Systems (Fairfield, NJ) introduces a new generation of intelligent dermatoscope for today’s skin care professional. Combining Canfield’s clinically proven skin imaging technology with the mobile image capture and communication capabilities of an iPhone®, DermScope delivers unprecedented quality and convenience in a hand held system. DermScope couples directly to an iPhone 4 and displays a highly magnified live preview over a large, 15mm viewing field. Intuitive on-screen controls allow easy image capture, storage and location tagging. Additionally, a selectable millimeter scale, one-touch zoom to 30X magnification and image enhancement facilitate rapid clinical evaluation of suspicious lesions. Selectable cross polarized or standard lighting, contact or non-contact viewing and precision Schneider optics assure the highest possible image quality in any examination mode.

Important DLI Updates DLI/Diplomate Deadlines and Ongoing Diplomate Requirements All SDPA Fellow members who have ENROLLED in the DLI prior to June 2011 are considered SDPA Diplomates. The entire DLI course must be COMPLETED by June 2012 in order for these members to continue to be recognized as SDPA Diplomates. If enrolling for the first time after June 30, 2011, a member will need to complete all 10 modules before becoming a SDPA Diplomate. There is no deadline for this completion. In order to maintain Diplomate status once the entire DLI has been completed, a SDPA Diplomate must complete any additional DLI modules within one year of the release of the new module. In addition to completing any additional modules, SDPA Diplomates need to either attend ONE SDPA conference every 2 years or complete ALL JDPA CME activities in a 2-year period. These ongoing requirements will be verified by random audit. 10 Journal of Dermatology for Physician Assistants

Ergonomic arm’s length imaging provides a more comfortable experience for both clinician and patient while allowing the physician to view lesions more accurately from the high resolution display. The result is an accelerated skin examination with increased confidence in the results. As an added benefit, the communications power of an iPhone offers instant integration capabilities with the patient chart along with unlimited tele-consultation possibilities. DermScope’s innovative design draws upon Canfield’s extensive experience in skin imaging technology. Over the past 25 years Canfield has developed a wide range of medical imaging systems for dermatological practice and research, while supporting over 2,000 clinical studies worldwide. DermScope combines this unique expertise with modern mobile technology to produce a powerful new solution for today’s dermatology practice.

Foundation for Ichthyosis & Related Skin Types, Inc.™ (FIRST) 2011 Regional Meetings The Foundation for Ichthyosis & Related Skin Types, Inc.™ (FIRST) is the only national non-profit organization dedicated to helping families with the genetic skin disorders collectively called ichthyosis. Our mission is to educate, inspire, and connect those touched by ichthyosis and related disorders through emotional support, information, advocacy, and research funding for better treatments and eventual cures. FIRST provides support, information, education, and advocacy for individuals and families affected by ichthyosis. The Foundation features a Regional Support Network for individuals to come together and support each other through the sharing of knowledge, experience, and advice. In 2011, 4 Regional Meetings are planned to provide medical information, and networking for affected individuals and their families. The meeting dates are: Region 2 April 30, 2011 Richmond, Virginia Region 7 June 11, 2011 Seattle, Washington Region 3 July 16, 2011 Atlanta, Georgia Region 4 September 10, 2011 Chicago, Illinois To obtain any additional information about these upcoming Regional Meetings or any other FIRST related projects, please visit their website at www.firstskinfoundation.org or contact them at 1-800-545-3286. ...continued on page 13

FOR THE TREATMENT OF ACNE VULGARIS

Dive in

with Atralin

Optimized for efficacy with minimal irritation

mean reduction in inflammatory • 36% lesions at 12 weeks* mean reduction in noninflammatory • 41% lesions at 12 weeks* • Low irritation profile • Moisturizing and hydrating agents 1

† 2-4

*Combined results of two 12-week, prospective, multicenter, randomized, vehicle-controlled studies of patients with mild to moderate acne vulgaris of the face.1 †The contribution of individual components to efficacy has not been evaluated.

Indication and Important Safety Information: Atralin Gel is indicated for the treatment of acne vulgaris. The most common adverse reaction was mild to moderate irritation of the skin (ie, dry skin, skin burning, erythema, and exfoliative dermatitis), which occurred during the ﬁrst few weeks of treatment with Atralin Gel. To prevent aggravating the skin, protect it from sun, tanning lights, extreme wind or cold, and harsh skincare products. Use of sunscreen products of at least SPF 15 and protective clothing over treated areas are recommended when exposure cannot be avoided. Atralin Gel should not be used on eczematous or sunburned skin due to potential for severe irritation. References: 1. Data on ﬁle, CORIA Laboratories. 2. Weindl G, Schaller M, Schäfer-Korting M, Korting HC. Hyaluronic acid in the treatment and prevention of skin diseases: molecular, biological, pharmaceutical and clinical aspects. Skin Pharmacol Physiol. 2004;17(5):207-213. 3. Morganti P. Skin hydration. In: Magdassi S, Touitou E, eds. Novel Cosmetic Delivery Systems. New York, NY. Marcel Dekker, Inc; 1999:71-98. 4. Kraft JN, Lynde CW. Moisturizers: what they are and a practical approach to product selection. Skin Therapy Lett. 2005;10(5):1-8.

AtralinGel.com

Please see brief summary of prescribing information on next page.

Vol. 5, No. 2 SPRING 2011 11

Vehicle Gel (n = 487)

109 (16%) 78 (12%) 53 (8%) 47 (7%) 11 (2%) 7 (1%) 7 (1%)

8 (2%) 7 (1%) 8 (2%) 1 (<1%) 3 (1%) 0 (0%) 3 (1%)

Marketed by:

263100gi301PI_JDPA

Atralin Gel (n = 674)

Event Dry Skin Peeling/Scaling/Flaking Skin Skin Burning Sensation Erythema Pruritus Pain of Skin Sunburn

Output @ 100% Giant Creative Strategy

Table 1. Number of Subjects with Selected Adverse Reactions (Occurring in At Least 1% of Subjects)

DRUG INTERACTIONS When treating with Atralin Gel, caution should be exercised with the use of concomitant topical medication, medicated or abrasive soaps and cleansers, products that have a strong drying effect, and products with high concentrations of alcohol, astringents, spices, or lime. Particular caution should be exercised with the concomitant use of topical over-the-counter acne preparations containing benzoyl peroxide, sulfur, resorcinol, or salicylic acid. Allow the effects of such preparations to subside before use of Atralin Gel is begun. USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C. There are no well-controlled trials in pregnant women treated with Atralin Gel. Atralin Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Atralin Gel at doses of 0.1, 0.3 and 1 g/kg/day was tested for maternal and developmental toxicity in pregnant Sprague-Dawley rats by dermal application. The dose of 1 g/kg/day was approximately 4 times the clinical dose assuming 100% absorption and based on body surface area comparison. Possible tretinoin-associated teratogenic effects (craniofacial abnormalities [hydrocephaly], asymmetrical thyroids, variations in ossification, and increased supernumerary ribs) were noted in the fetuses of Atralin Gel treated animals. These findings were not observed in control animals. Other maternal and reproductive parameters in the Atralin Gel treated animals were not different from control. For purposes of comparison of the animal exposure to human exposure, the clinical dose is defined as 2 g of Atralin Gel applied daily to a 50-kg person. Oral tretinoin has been shown to be teratogenic in rats, mice, rabbits, hamsters and nonhuman primates. Tretinoin was teratogenic in Wistar rats when given orally in doses greater than 1 mg/kg/day (approximately 8 times the clinical dose based on body surface area comparison). In the cynomolgus monkey, fetal malformations were reported for doses of 10 mg/kg/day, but none were observed at 5 mg/kg/day (approximately 80 times the clinical dose based on body surface area comparison), although increased skeletal variations were observed at all doses. Dose-related increases in embryolethality and abortion also were reported. Similar results have also been reported in pigtail macaques. Topical tretinoin in a different formulation has generated equivocal results in animal teratogenicity tests. There is evidence for teratogenicity (shortened or kinked tail) of topical tretinoin in Wistar rats at doses greater than 1 mg/kg/day (approximately 8 times the clinical dose assuming 100% absorption and based on body surface area comparison). Anomalies (humerus: short 13%, bent 6%, os parietal incompletely ossified 14%) have also been reported when 10 mg/kg/day (approximately 160 times the clinical dose assuming 100% absorption and based on body surface area comparison) was topically applied. Supernumerary ribs have been a consistent finding in rats when dams were treated topically or orally with retinoids. With widespread use of any drug, a small number of birth defect reports associated temporally with the administration of the drug would be expected by chance alone. Cases of temporally associated congenital malformations have been reported with use of other topical tretinoin products. The significance of these spontaneous reports in terms of risk to the fetus is not known. Nonteratogenic effects on fetuses: Oral tretinoin has been shown to be fetotoxic in rats when administered in doses 20 times the clinical dose based on a body surface area comparison. Topical tretinoin has been shown to be fetotoxic in rabbits when administered in doses 8 times the clinical dose based on a body surface area comparison. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Atralin Gel is administered to a nursing woman. Pediatric Use Safety and effectiveness in children below the age of 10 have not been established. A total of 381 pediatric subjects (aged 10 to 16 years), treated with Atralin Gel were enrolled into the two clinical studies. Across these two studies, comparable safety and efficacy were observed between pediatric and adult subjects. Geriatric Use Safety and effectiveness in a geriatric population have not been established. Clinical studies of Atralin Gel did not include any subjects over age 65 to determine whether they respond differently than younger subjects.

100%

BRIEF SUMMARY (see package insert for full prescribing information) For topical use only INDICATIONS AND USAGE Atralin Gel is a retinoid indicated for topical treatment of acne vulgaris. Important Limitations of Use The safety and efficacy of the use of this product in the treatment of any other disorders have not been evaluated. CONTRAINDICATIONS None WARNINGS AND PRECAUTIONS Skin Irritation The skin of certain individuals may become dry, red, or exfoliated while using Atralin Gel. If the degree of irritation warrants, patients should be directed to temporarily reduce the amount or frequency of application of the medication, discontinue use temporarily, or discontinue use altogether. Efficacy at reduced frequencies of application has not been established. If a reaction suggesting sensitivity occurs, use of the medication should be discontinued. Mild to moderate skin dryness may also be experienced; if so, use of an appropriate moisturizer during the day may be helpful. Tretinoin has been reported to cause severe irritation on eczematous or sunburned skin and should be used with caution in patients with these conditions. Topical over-the-counter acne preparations, concomitant topical medication, medicated cleansers, topical products with alcohol or astringents, when used with Atralin Gel, should be used with caution [see Drug Interactions (7)]. Ultraviolet Light and Environmental Exposure Unprotected exposure to sunlight, including sunlamps, should be minimized during the use of Atralin Gel. Patients who normally experience high levels of sun exposure, and those with inherent sensitivity to sun, should be warned to exercise caution. Use of sunscreen products of at least SPF 15 and protective clothing over treated areas is recommended when exposure cannot be avoided. Weather extremes, such as wind or cold, also may be irritating to patients under treatment with tretinoin. Fish Allergies Atralin Gel contains soluble fish proteins and should be used with caution in patients with known sensitivity or allergy to fish. Patients who develop pruritus or urticaria should contact their health care provider. ADVERSE REACTIONS Clinical Studies Experience Because clinical trials are conducted under prescribed conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. In two randomized, controlled trials, 674 subjects received treatment for up to 12 weeks with Atralin Gel [see Clinical Studies (14)]. In these studies, 50% of the subjects who were treated with Atralin Gel reported one or more adverse reactions; 30% of the subjects reported treatment-related adverse reactions. In the vehicle group, 29% of the 487 randomized subjects reported at least one adverse reaction; 5% of the subjects reported events that were treatment-related. There were no serious, treatment-related adverse reactions reported by subjects in any of the treatment groups. Selected adverse reactions that occurred in at least 1% of subjects in the two studies combined, are shown in Table 1 (below). Most skin-related adverse reactions first appear during the first two weeks of treatment with Atralin Gel, and the incidence rate for skin-related reactions peaks around the second and third week of treatment. In some subjects the skin-related adverse reactions persist throughout the treatment period.

Manufactured by: DPT LABORATORIES, LTD. San Antonio, Texas 78215

12 Journal of Dermatology for Physician Assistants PACIFIC DIGITAL IMAGE • 333 Broadway, San Francisco CA 94133 • 415.274.7234 • www.pacdigital.com

CORIA Laboratories, a division of Valeant Pharmaceuticals North America, Aliso Viejo, CA 92656

Patent No.: 5,670,547 Revised: 11/2009 137623-1109

Dermatology Market Watch First new lupus drug approved in 56 years

The U.S. Food and Drug Administration has approved Benlysta (belimumab) to treat patients with active, autoantibodypositive lupus (systemic lupus erythematosus) who are receiving standard therapy, including corticosteroids, antimalarials, immunosuppressives, and nonsteroidal anti-inflammatory drugs. Benlysta is delivered directly into a vein (intravenous infusion) and is the first inhibitor designed to target Blymphocyte stimulator (BLyS) protein, which may reduce the number of abnormal B cells thought to be a problem in lupus. Two clinical studies involving 1,684 patients with lupus demonstrated the safety and effectiveness of Benlysta. The studies diagnosed patients with active lupus and randomized them to receive Benlysta plus standard therapy, or an inactive infused solution (placebo) plus standard therapy. The studies excluded patients who had received prior B-cell targeted therapy or intravenous cyclophosphamide, and those who had active lupus involving the kidneys or central nervous system. Patients treated with Benlysta and standard therapies experienced less disease activity than those who received a placebo and standard of care medicines. Results suggested, but did not definitively establish, that some patients had a reduced likelihood of severe flares, and some reduced their steroid doses. Prior to Benlysta, FDA last approved drugs to treat lupus, Plaquenil (hydroxychloroquine) and corticosteroids, in 1955. Aspirin was approved to treat lupus in 1948.

AIM at Melanoma

Advocating for our Patients and Profession Spring is around the corner and as the weather warms up so do the state legislatures. Many proposed bills will involve tanning legislation, reimbursement, and practice governance. Dermatology PAs have the opportunity to get involved in these processes and proactively shape the future of our profession and advocate for our patients. Here are a couple of ways to get involved: Join the AAPA’s grass roots advocacy and information network at http://capwiz.com/aapa/ issues/alert/?alertid=13475126 This group will keep you up to date on legislative issues in your area that pertain to the profession. Work with individual patient advocacy groups. One example is Aim at Melanoma: http://www.aimatmelanoma.org/aim-for-acure/legislative-accomplishments-in-melanoma/ tanning-restrictions-for-minors.html For additional information, please contact Samantha Guild at sguild@AIMatMelanoma.org or call 916-706-0599.

Advocacy Boot Camp & SDPA Capitol Hill Day

Enhance Your Advocacy Skills and Make a Difference on Capitol Hill New this year, the SDPA Annual Summer Dermatology Conference in Washington, D.C. will feature a Virtual Advocacy Boot Camp and SDPA Capitol Hill Day. Take advantage of this amazing opportunity to deliver a powerful unified message about PAs in dermatology and the patients we serve to the members of the US Congress. AAPA will provide comprehensive web-based advocacy training, logistical support, briefing materials, and transportation to and from Capitol Hill. Then, on Thursday afternoon, June 2, 2011, you’ll join forces with your fellow PAs from across the country in conducting face-to-face meetings with members of Congress and staff on the key legislative issues that directly affect you, your patients, and the future of our profession. Don’t miss this exciting new addition to the SDPA in 2011. Novice and seasoned advocates alike will benefit from SDPA Capitol Hill Day. Make an impact - speak for the profession. Sign up today when registering for the SDPA Annual Summer Dermatology Conference! Vol. 5, No. 2 SPRING 2011 13

DERmatology pa news & notes

FDA Approves Benlysta to Treat Lupus

...continued from page 10

The first Monday of May (this year May 2nd) is Melanoma Monday® and the official launch of Melanoma/ Skin Cancer Detection and Prevention Month®. Through the AAD’s National Melanoma/ Skin Cancer Screening Program, dermatology providers volunteer to provide free skin cancer screenings in their communities. Since 1985, this public service program has screened more than 2.1 million people and detected more than 206,800 suspicious lesions, including more than 23,500 suspected melanomas. By conducting free skin cancer screenings, dermatology providers are bringing attention to the profession of dermatology, helping to educate millions of people about the importance of sun protection and early skin cancer detection, and most important, helping to directly save lives by finding melanomas in their earliest, most treatable stage.

While May is designated as Melanoma/Skin Cancer Detection and Prevention Month, skin cancer screenings can be performed at any time throughout the year. As this is an AAD-sponsored program and a member benefit, Academy member dermatologists must order all materials, serve as the Program Director and be present at the screening. Physician assistants can conduct skin cancer screenings under the supervision of a dermatologist. If you are interested in volunteering, visit the AAD’s website at www.aad.org/screenings to find a free skin cancer screening location and to learn more about the guidelines for screening coordinators. J Reprinted with permission from the American Academy of Dermatology

Certification Review

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

Are you recertifying soon? Each issue of the JDPA features one board question accompanied by a brief explanation of the answer along with any pertinent test taking tips. Don’t forget – past issues of the JDPA are always available in the SDPA members-only section at www.dermpa.org. This is a great way to start off your board review preparation. Best of luck! Question: A 35 year-old female with a history of infertility presents with a history of mild vaginal bleeding and right-sided abdominal pain. She states her last menses was 6 weeks ago. On physical examination, she is afebrile and right-sided abdominal tenderness is noted with mild guarding. Pelvic exam is normal. Laboratory testing reveals a positive pregnancy test and normal CBC. Which of the following is the next best step in the evaluation of this patient? A. Laparoscopic procedure B. Serum FSH/LH levels C. Pelvic ultrasound D. GC culture Explanation: Ectopic pregnancy presents with amenorrhea for 4-8 weeks, unilateral abdominal pain, and possible mild vaginal bleeding. Risk factors for ectopic pregnancy include a history of infertility, prior 14 Journal of Dermatology for Physician Assistants

ectopic pregnancy, tubal ligation, pelvic inflammatory disease, IUD use, and endometriosis. Diagnosis is made by noting a low β-HCG for gestational age with failure of the β-HCG to double every 24-48 hours and a lack of an intrauterine pregnancy on ultrasound. Treatment consists of methotrexate to clear trophoblastic tissue or laparoscopic repair and removal. FSH/LH levels are used in the evaluation of amenorrhea to determine if etiology is due to hypothalamic-pituitary dysfunction or ovarian failure. GC cultures, while they may be obtained in this patient, are utilized in the diagnosis of PID. PID would present with fever and cervical motion tenderness. J The correct answer is C.

Dermatology PA news & notes

May is Melanoma/Skin Cancer Detection and Prevention Month®

James A. Van Rhee, MS, PA-C, is the Program Director for the Northwestern University Feinberg School of Medicine Department of Family Medicine Physician Assistant Program. Mr. Van Rhee has been involved in physician assistant education for over 14 years. He has served as project director and test item writer for the Physician Assistant Education Association’s (PAEA) Physician Assistant Clinical Knowledge Rating Assessment Tool (PACKRAT) and is the author of the Physician Assistant: Certification and Re-certification Review Book, published by Elsevier. For the last ten years, he has been course director and presenter of the Physician Assistant Board Review, which is now being produced live online by Kaplan Medical.

Proven effective in moderate to severe acne1,2

Power Trade places with Acanya position

To treat

To please

In studies with more than 2800 patients with moderate to severe acne, Acanya®Gel demonstrated:

●

64% median reduction in inflammatory lesion counts at 12 weeks (34% for vehicle)1,2 49% median reduction in noninflammatory lesion counts at 12 weeks (26% for vehicle)1,2

●

With ease!

No patient treated with Acanya Gel discontinued treatment due to erythema, scaling, burning, stinging, or itching in pivotal trials1

●

Neat and simple: No jar, no mess

●

No pharmacy admixing: Pump now replaces the Acanya Gel jar

●

Measured dose: Consistent delivery

Low potential for cutaneous irritation may lead to increased adherence to treatment

Indication and Important Safety Information Acanya Gel is indicated for the topical treatment of acne vulgaris in patients 12 years of age or older. Acanya Gel is contraindicated in patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis. Discontinuation is recommended if significant diarrhea develops. In controlled clinical trials, the following application-site adverse reactions occurred in less than 0.2% of patients treated with Acanya Gel: applicationsite pain (0.1%), application-site exfoliation (0.1%), and application-site irritation (0.1%). Of the patients who experienced cutaneous symptoms of erythema, scaling, itching, burning, and/or stinging, regardless of the relationship to therapy, the majority of cases were mild to moderate in severity, occurred early in treatment, and decreased thereafter.

To learn more, please visit www.AcanyaGel.com Please see the following page for references and brief summary of full prescribing information.

Now

in a ready-to-use 50g pump for your patients’ convenience

Acanya Gel Disp: 50g Sig: Apply to aﬀected area once daily ®

refills ACAN-1010-0002

Vol. 5, No. 2 SPRING 2011 15

USE IN SPECIFIC POPULATIONS Pregnancy Category C There are no well-controlled trials in pregnant women treated with ACANYA Gel. It also is not known whether ACANYA Gel can cause fetal harm when administered to a pregnant woman. ACANYA Gel should be used during pregnancy only if the potential benefi t justifies the potential risk to the fetus. ACANYA® (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/2.5% Brief summary. Please see full prescribing information for complete product information. INDICATIONS AND USAGE ACANYA Gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older. The safety and efficacy of this product in the treatment of any other disorders have not been evaluated. DOSAGE AND ADMINISTRATION Apply a pea-sized amount of ACANYA Gel to the face once daily. Use of ACANYA Gel beyond 12 weeks has not been evaluated. ACANYA Gel is not for oral, ophthalmic, or intravaginal use. CONTRAINDICATIONS ACANYA Gel is contraindicated in patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.

Animal reproductive/developmental toxicity studies have not been conducted with ACANYA Gel or benzoyl peroxide. Developmental toxicity studies of clindamycin performed in rats and mice using oral doses of up to 600 mg/kg/day (240 and 120 times amount of clindamycin in the highest recommended adult human dose based on mg/m2, respectively) or subcutaneous doses of up to 200 mg/kg/day (80 and 40 times the amount of clindamycin in the highest recommended adult human dose based on mg/m2, respectively) revealed no evidence of teratogenicity. Nursing Mothers: It is not known whether clindamycin is excreted in human milk after topical application of ACANYA Gel. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to use ACANYA Gel while nursing, taking into account the importance of the drug to the mother. Pediatric Use: Safety and effectiveness of ACANYA Gel in pediatric patients under the age of 12 have not been evaluated. Clinical trials of ACANYA Gel included patients 12-17 years of age. Geriatric Use Clinical studies of ACANYA Gel did not include sufficient numbers of patients aged 65 and older to determine whether they respond differently from younger patients.

Trade places with Acanya position

WARNINGS AND PRECAUTIONS Colitis Systemic absorption of clindamycin has been demonstrated following topical use of clindamycin. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin. When significant diarrhea occurs, ACANYA Gel should be discontinued.

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

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.

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.

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.

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 3.6, 10.8, and 60 times amount of benzoyl peroxide in the highest recommended adult human dose of 2.5 g ACANYA Gel based on mg/m2, respectively) did not cause any increase in tumors. However, topical treatment with a different gel formulation containing 1% clindamycin and 5% benzoyl peroxide at doses of 100, 500, and 2000 mg/kg/ day caused a 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 2.4, 7.2, and 24 times amount of benzoyl peroxide in the highest recommended adult human dose of 2.5 g ACANYA Gel based on mg/m2, respectively) for up to 97 weeks did not cause any increase in tumors. In a 52-week dermal photocarcinogenicity study in hairless mice, (40 weeks of treatment followed by 12 weeks of observation), the median time to onset of skin tumor formation decreased and the number of tumors per mouse increased relative to controls following chronic concurrent topical administration of the higher concentration benzoyl peroxide formulation (5000 and 10000 mg/kg/day, 5 days/week) and exposure to ultraviolet radiation.

Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug clinically effective against C. difﬁcile colitis. Ultraviolet Light and Environmental Exposure Minimize sun exposure following drug application. (See NONCLINICAL TOXICOLOGY.) ADVERSE REACTIONS Clinical Studies Experience Because clinical trials are conducted under prescribed conditions, adverse reaction rates observed in the clinical trial may not reflect the rates observed in practice. Because clinical trials are also conducted under widely varying conditions, adverse reactions observed in the clinical trials of a drug cannot always be directly compared to rates in the clinical trials of another drug. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse reactions that appear to be related to drug use and for approximating rates. The following selected adverse reactions occurred in less than 0.2% of patients treated with ACANYA Gel: application site pain (0.1%); application site exfoliation (0.1%); and application site irritation (0.1%). During clinical trials, patients were assessed for local cutaneous signs and symptoms of erythema, scaling, itching, burning and stinging. Most local skin reactions increased and peaked around week 4 and continually decreased over time reaching near baseline levels by week 12. The percentage of patients that had symptoms present before treatment, the maximum value recorded during treatment, and the percent with symptoms present at week 12 are shown below. Local Skin Reactions—Percent Patients with Symptoms Present. Combined Results from the Two Phase 3 Trials (N = 773) Before Treatment (Baseline)

Maximum During Treatment

Clindamycin phosphate was not genotoxic in the human lymphocyte chromosome aberration assay. Benzoyl peroxide has been found to cause DNA strand breaks in a variety of mammalian cell types, to be mutagenic in S. typhimurium tests by some but not all investigators, and to cause sister chromatid exchanges in Chinese hamster ovary cells. Fertility studies have not been performed with ACANYA Gel or benzoyl peroxide, but fertility and mating ability have been studied with clindamycin. Fertility studies in rats treated orally with up to 300 mg/kg/day of clindamycin (approximately 120 times the amount of clindamycin in the highest recommended adult human dose of 2.5 g ACANYA Gel, based on mg/m2) revealed no effects on fertility or mating. HOW SUPPLIED ACANYA Gel is supplied as a 50 g pump (NDC 13548-132-50). Dispensing instructions for the pharmacist Dispense ACANYA Gel with a 10 week expiration date. Specify “Store at room temperature up to 25°C (77°F). Do not freeze.”

End of Treatment (Week 12)

Storage and Handling PHARMACIST: Prior to dispensing, store in a refrigerator, 2°C to 8°C (36°F to 46°F).

Mild

Mod*

Severe

Mild

Mod*

Severe

Mild

Mod*

Severe

Erythema

Scaling

Keep out of the reach of children.

Itching

Keep container tightly closed.

Burning

RX Only

Stinging

Distributed by CORIA Laboratories, a division of Valeant Pharmaceuticals North America, Fort Worth, TX 76107

*Mod=Moderate

DRUG INTERACTIONS Erythromycin ACANYA Gel should not be used in combination with topical or oral erythromycin-containing 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.

PATIENT: Store at room temperature at or below 25°C (77°F). Protect from freezing.

Concomitant Topical Medications Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents. Neuromuscular Blocking Agents Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, ACANYA Gel should be used with caution in patients receiving such agents.

16 Journal of Dermatology for Physician Assistants

References: 1. Pivotal studies, data on file, CORIA Laboratories. 2. Gold M. A new, once daily, optimized, fi xed combination of clindamycin phosphate 1.2% and low-concentration benzoyl peroxide 2.5% gel for the treatment of moderate-to-severe acne. J Clin Aesthet Derm. 2009;5:44-48.

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In 1993, during his presidency, Dr. Mark Dahl founded Camp Discovery along with the American Academy of Dermatology (Academy), offering a single camp for about 50 kids at Camp Knutson in Crosslake, Minnesota. Little did we know how much Camp would grow over the next 18 years. Camp Horizon began in 1995; Teen Camp followed in 1998 and in 2006 Camp Dermadillo began. 2010 was a huge year for the program as we opened Camp Liberty in Hebron, Connecticut and also have changed the names of our two camps in Minnesota. These two camps have always been known as Camp Discovery or Jr. Camp Discovery and Teen Camp Discovery. However, because this does get somewhat confusing, we decided to change their names to Camp Little Pine and Camp Big Trout. Both of these names are also that of lakes on the Whitefish Chain of lakes in Crosslake, Minnesota where Camp Knutson, the site of these two camps is located. We are proud to say that more than 3,000 kids have benefited from attending one of these camps over the past 18 years. This year the Academy is proud to offer six camping sessions, including our newest camp, Camp Reflection, in Carnation, Washington. The Camp Discovery family of camps is for young people with chronic skin conditions who are between the ages of 8 and 16. Under the expert care of dermatologists and nurses, Camp Discovery gives campers the opportunity to spend a week with other young people with skin conditions, while participating in everything from swimming, fishing, horseback riding, to lots of camp games and just plain fun! There is no fee to attend this very special camp. Full scholarships, including transportation, are provided by the Academy through generous donations from its members, outside organizations and individuals. All campers must be referred by their dermatology provider. For more information about attending or volunteering please visit the website at campdiscovery. org or contact Janine Mueller at (847) 240-1737 or jmueller@aad.org. J

Dermatology PA news & notes

CORAC6957–JAAD, PEDIATRIC DERMATOLOGY, CUTIS DERMATOLOGY DEMO, DERMATOLOGY WORLD, ARCHIVES OF DERMATOLOGY Colors: BW + live/trim_DO NOT PRINT Bleed: 8.5"w x 11.125"h Trim: 7.75"w x 10.75"h Live: 6.75"w x 9.75"h B O R O LL Output @ 100% HE CR CA CR MI 262676gi302_Jrnl_PI Giant Creative Strategy VI

Camp Discovery 2011

Camp Discovery 2011 Dates: • June 26 – July 1, Camp Little Pine in Crosslake, Minnesota (ages 10 – 14) • June 26 – July 1, Camp Reflection in Carnation, Washington (ages 8 – 16) • July 10 – 15, Camp Big Trout in Crosslake, Minnesota (ages 14 – 16) • August 14 – 19, Camp Liberty in Hebron, Connecticut (ages 10-16) • August 6 – 12, Camp Dermadillo in Burton, Texas (ages 9 – 15) • August 13 – 19, Camp Horizon in Millville, Pennsylvania (ages 8 – 13)

Vol. 5, No. 2 SPRING 2011 17

Student Scoop - The Importance of Being a Preceptor

Dermatology PA news & notes

By Catrina Shubert, PA-S SDPA Student Affairs Coordinator

The first year of PA school provides students with a basic foundation of medical knowledge through numerous hours of sitting in lectures followed by long nights of caffeine and studying. However, it is the second year when this basic foundation is expanded upon to develop necessary critical thinking and the ability to manage multiple patients and their various diseases. What is taught in the classroom versus what is seen and done in practice can vary tremendously, and the best way for a student to bridge the gap between the two is with diligent guidance and positive critique. Far too often, PA students are placed in rotations where they are never asked to make decisions or form opinions and are not required to deal with or resolve conflicts when they arise. On the opposite spectrum, there are rotations where students are thrown into situations with no direction or instruction at all and they have very limited supervision. Of course those are examples of two extremes, and there are definitely many wonderful preceptors in between. As the field continues to grow and the number of PA programs amplifies, there is an increasing demand for providers who are dedicated to the advancement of excellence within the PA profession and who are willing to teach future PAs. Obviously PA students need to interact with and learn from all types of health care providers, but who better to teach a PA student than a working

PA? Who better than someone who has experienced the actual roles and responsibilities of a practicing PA? Who better than someone with knowledge of what is typically covered in class lectures as well as what is typically left out, with past experience of the personal struggles of a new graduate, and with the opportunity to help a future colleague avoid pitfalls and prepare for their first job? If you are a practicing PA, I want to encourage you to consider enriching the educational experience of students near you by either contacting the SDPA to serve as a preceptor or by contacting your local PA school(s). I want to say a special thank you to all of you who have given up your time, energy, and resources to serve as preceptors in the past, and I hope that everyone will find a way to become involved in being a preceptor in the future. As Henry Brooks Adams was quoted saying, “A teacher affects eternity; he can never tell, where his influence stops.” J Catrina Shubert, PA-S, is currently enrolled at the Salus University Physician Assistant Program in Elkins Park, PA. She currently holds the position of Student Affairs Coordinator for the SDPA. She will be graduating in September 2011 and plans to practice in dermatology.

JDPA...Your Journal, Your Life. The Journal of Dermatology for Physician Assistants (JDPA) is the first PA specialty publication dedicated specifically to serving the needs of the dermatology PA community. The journal is a peer-reviewed publication that delivers innovative clinical, surgical, cosmetic and professional content exclusively for dermatology PAs. Write

for the

JDPA

The JDPA serves as a printed forum in which dermatology PAs can share clinical information, practice tips and other relevant professional insights with an already established network of their colleagues.

WRITE FOR THE JDPA

We are looking for dermatology PAs who are interested in contributing to our profession by writing for the JDPA. There are a variety of subjects to write about in the JDPA. To the right is a list of the sections and their respective topics that are featured in each issue. You can find more detailed information regarding these topics online at: wwwjdpa.org.

18 Journal of Dermatology for Physician Assistants

News and Notes • From the Desk of... • The Difference We Make Clinical Dermatology • CME Articles • Derm Case Reports • From the Patient’s Perspective (Have your patient’s story published, in their own words)

• Clinical Snapshots • Journal Club (Review an article)

• Drugs in Dermatology Surgical Dermatology • Feature Articles • Journal Club (Review an article)

• Surgical Wisdom Cosmetic Dermatology • Feature Articles

• Journal Club (Review an article)

• Cosmetic Pearls Professional Development • Feature Articles • Outside & Inside the 9 to 5

(Share the story of the work you do outside of your daily dermatology profession)

• Notes from your Office Manager • Judicial & Ethical Affairs

Clinical Dermatology

The Clues to Chronic Kidney Disease Just May Be Skin Deep By Michelle DiBaise, DFAAPA, MPAS, PA-C

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

CME

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

Approval is valid for 1 year from the issue date of APRIL 2011. Participants may submit the self-assessment exam at any time during that period. This program was planned in accordance with AAPAâ&#x20AC;&#x2122;s CME Standards for Enduring Material Programs and for Commercial Support of Enduring Material Programs.

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

Learning Objectives: 1. Identify the skin color and nail changes that occur in the presence of chronic kidney disease. 2. Differentiate the etiology and presentation of uremic pruritis from other causes of pruritis and list the commonly used treatment options. 3. Differentiate porphyria cutanea tarda from pseudoporphyria and identify the effective treatment options. 4. Recognize the presentation for severe skin diseases such as calciphylaxis and nephrogenic systemic fibrosis and identify when to refer or hospitalize these patients. . Vol. 5, No. 2 SPRING 2011 19

The Clues to Chronic Kidney Disease Just May Be Skin Deep SDPA Members Only Content

CLINICAL Dermatology

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

20 Journal of Dermatology for Physician Assistants

The Clues to Chronic Kidney Disease Just May Be Skin Deep SDPA Members Only Content

CLINICAL 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.

Vol. 5, No. 2 SPRING 2011 21

The Clues to Chronic Kidney Disease Just May Be Skin Deep SDPA Members Only Content

CLINICAL 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

The Clues to Chronic Kidney Disease Just May Be Skin Deep SDPA Members Only Content

CLINICAL 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.

Vol. 5, No. 2 SPRING 2011 23

The Clues to Chronic Kidney Disease Just May Be Skin Deep SDPA Members Only Content

CLINICAL 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.

Michelle DiBaise, DFAAPA, MPAS, PA-C is a graduate of the Physician Assistant Program at the University of Nebraska Medical Center in Omaha, Nebraska. She is a member of the Society of Dermatology Physician Assistants. She presently resides in Scottsdale, Arizona where she is an Adjunct Associate Professor at A. T. Still University in Mesa, Arizona. This paper was developed for a course in the Doctor of Health Science Program at A. T. Still University. She would like to thank the course director, Randy Danielsen, the online writing center at ATSU, and the students enrolled in the course for their input and guidance. She has indicated no relationships to disclose relating to the content of this article. 24 Journal of Dermatology for Physician Assistants

From The Patient’s Perspective

A “PA”tient with Basal Cell Carcinoma Nevus Syndrome Back when I was in 8th grade, after having three when my large skull size led to an air ventriculogram. large keratocystic odontogenic tumors removed from Diagnosed with mild hydrocephalus, careful monitoring my mandible and maxilla, was all that was required. As I was diagnosed with Basal a child (growing up in the “Those of us with rare syndromes Cell Carcinoma Nevus country), I had numerous pits Syndrome (BCCNS), aka on my palms and soles, which need all the information we can Gorlin Syndrome, BCNS, were always dirty and hard and Nevoid Basal Cell to get clean. My pediatrician get. I am grateful and relieved Carcinoma Syndrome (NBCS). had no idea why the pits were to have the BCCNS Life Support Subsequently, at the age of 18, present or what they were. I had huge, calcified, ovarian Network to go to for information.” After my diagnosis in fibromas removed just prior to 1970, my mother volunteered starting college. At the time, me to participate in many neither my parents nor I had Grand Rounds at Massachusetts General Hospital. been informed that ovarian cysts are a manifestation Physicians would examine my pitted palms, which I was of this syndrome. Feeling something hard in my lower required to stick through the cubicle curtain. The vast abdomen and menstruating every two weeks for months majority of practitioners had no clue about the diagnosis prior to this surgery, I was too naive and scared to say or despite these clear, pronounced clinical signs. do anything. The good, the bad, and the ugly of BCCNS Multiple hospital experiences and the opportunity have shown their faces regularly since then. to shadow a young pediatrician during my senior year BCCNS is an autosomal dominant genetic in high school, led me to believe that I wanted to do syndrome that affects all body systems. Most something in medicine, yet without the hours and prominently, these can include the heart, nervous system, responsibility of being a physician. After applying to skeletal/orthopedic, gynecologic, and dermatologic both the Nurse Practitioner Program at Yale University problems. There are other manifestations that can and the PA Program at Emory University, I decided to develop as well. attend Emory and the rest is history. What a great choice In retrospect, signs of BCCNS were present at birth this has been.

...continued on next page

Dermoscopy Q A By John Burns, PA-C

Figure 1 - Pigmented lesion of the left nasal ala with polarized immersion dermoscopy complement.

A 44 year-old white male presented with an asymptomatic, pigmented lesion on his nose. He reported it had appeared approximately nine months ago and was slowly increasing in size. He denied any prior treatment of the area and denied similar lesions elsewhere. He had no personal or family history of skin cancer. 1. What is the correct diagnosis? 2. What are the significant clinical findings for this lesion? 2. What are the clinical differential diagnoses for this lesion? 3. What are the dermoscopic differential diagnoses for this lesion? 4. If you decided it was necessary to biopsy this lesion, how would you do this? Answer on page 29 Vol. 5, No. 2 SPRING 2011 25

CLINICAL Dermatology

By Julie Ammen Breneiser, PA-C (Retired)

CLINICAL Dermatology

While practicing as a PA, I underwent a number of surgical procedures including frequent and extensive MOHS procedures, followed immediately by plastic surgery reconstruction and repair. These procedures were particularly difficult, since I would see patients or scrub in the OR a day or two after being treated myself. Having this disease while being a PA increased my ability to empathize with patients as they did with me. This ability was further enhanced after my two children were born, each inheriting BCCNS. My friends called me the “Energizer Bunny” because I kept on going. What choice was there? Last year I joined an 18-month clinical trial of the Genentech drug Vismodegib, an oral inhibitor of the hedgehog pathway. For me, the results have been positively incredible. In the twelve months that I have been on the drug, 60% of the basal cell carcinomas present at the study’s initial exam have disappeared. The hundreds of pits on my palms and soles have vanished. The side effects including loss of taste of food, hair loss, and muscle cramps are significant. When I get frustrated with these, I think back to 2009 when I required minor or major skin cancer surgery (biopsies, MOHS, plastic surgery reconstruction and repair) every month for the first six months of that year. There is NO comparison. For decades prior to 2009, these surgeries had occurred every three months. Years ago, I realized that I would probably never be cancer free. Now, thanks to Vismodegib, that potential exists! This is amazing. Even though I retired from the world of medicine about ten years ago, I am still learning about the many manifestations of BCCNS. I do not know everything about the syndrome, but I do know that it is best to ask, inform, listen, and communicate. In addition, the websites noted below are excellent information sources. One of, if not the most valuable statements I was taught at Emory was, “to listen is to communicate.” Julie Ammen Breneiser was a practicing PA from 1981 to 2000. The specialties in which she worked included orthopedics, neurosurgery, cardiac surgery, and otolaryngology. After retiring for a few years, Julie now works as an assistant teacher of children with multiple disabilities. Over the past few years, she has become actively involved in the Basal Cell Carcinoma Nevus Syndrome Life Support Network, and was elected to their Board of Trustees in 2010. Julie is a strong advocate of this organization, participating in fundraising and recruitment of clinical trial participants. She feels strongly that active involvement in clinical trials will lead to improvement in the quality and quantity of life of those with BCCNS. After all, simply put, life comes down to quality and quantity. Julie lives in Pennsylvania with her husband of 22 years and two teenage children. She enjoys traveling, exercising, reading, and spending time with her family and friends. Community Service is important to Julie. Along with her volunteer work for the Network, she is an active volunteer at her local community library.

26 Journal of Dermatology for Physician Assistants

From my perspective as a “PA”tient, I would like to add that “knowledge is power” in caring for oneself. Those of us with rare syndromes need all the information we can get. I am grateful and relieved to have the BCCNS Life Support Network to go to for information; this is a patient oriented, advocacy, non-profit organization. Even though I was a PA for almost twenty years, I still think this is a wonderful source. Given that it is impossible to go to one medical provider for comprehensive care, patients with BCCNS need an “orchestra conductor.” Since regular dermatology visits are essential, it makes sense that these providers take up the baton. As PAs in dermatology, it is critical to provide all the information needed to help your patients and their families get the care they need from all the appropriate physicians. J

Helpful Websites for Patients: www.bccns.org www.gorlinsyndrome.org

Take Home points for derm pas: By Steven K. Shama, MD, MPH 1. “To listen is to communicate.” As health care practitioners we were taught in school that in order to make the right diagnosis and provide the best treatment, we need to truly listen to the patient... simply listen. We must allow the space when with a patient for him/her to feel that the environment is a trusted and confidential one. It is in that sacred space that patients tell us what is truly going on and how we can help. 2. “Knowledge is power.” Patients should be given as much information as possible so that they feel in as much control of their disease as possible. Refer patients to websites with good up-to-date scientific knowledge, and also include addresses of local support groups. In situations with complex syndromes, you often can’t do it alone. 3. “Be the orchestra conductor.” When treating patients with complicated syndromes like BCCNS, you may involve many specialists from totally different disciplines. Patients deeply appreciate the fact that you are still the “clearing house” for referrals and general advice, and that you are still there to simply listen. After all, you still are their caregiver. Never forget that.

For the treatment of actinic keratosisâ&#x20AC;&#x201D;

Zyclara

Significant lesion reduction with long-term benefits Once-daily dosing in a simple course s WEEKS ON WEEKS OFF WEEKS ON s COMPLIANCE RATE WITH THE DOSING SCHEDULE IN CLINICAL TRIALS1 n #OMPLIANCE DEl NED AS PATIENTS WHO RECEIVED OR MORE OF PRESCRIBED MEDICATION

Many patients who cleared with Zyclara remained clear s OF PATIENTS HAD COMPLETE CLEARANCE1 s HAD PARTIAL CLEARANCE1 n 0ARTIAL CLEARANCE DEl NED AS REDUCTION IN THE NUMBER OF LESIONS AT BASELINE s REDUCTION IN OVERALL LESION COUNT1 s OF PATIENTS WITH COMPLETE CLEARANCE REMAINED LESION FREE AT MONTHS POSTTREATMENT

Treats the lesions you can seeâ&#x20AC;&#x201D;and the ones you canâ&#x20AC;&#x2122;t1 s OF PATIENTS HAD PREVIOUSLY UNDETECTED LESIONS REVEALED AND TREATED

Weeks On

Weeks Off

Weeks On

Sustained clearance...simple course

Zyclara Cream is indicated for the topical treatment of clinically typical visible or palpable actinic keratoses (AK) of the full face or balding scalp in immunocompetent adults. In clinical studies, the most common side effects involved skin reactions in the application area. These reactions included erythema, scabbing or crusting, flaking, scaling or dryness, edema, erosion or ulceration, and weeping or exudate. Most skin reactions were rated as mild to moderate. Intense local inflammatory reactions and/or flu-like systemic signs and symptoms can occur. Dosing interruptions may be required. Exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) should be avoided or minimized during use of Zyclara Cream. Please see Brief Summary of Full Prescribing Information on adjacent page. Visit us at www.ZyclaraCream.com References: 1. Swanson N, Abramovits W, Berman B, et al. Imiquimod 2.5% and 3.75% for the treatment of actinic keratoses: results of 2 placebo-controlled studies of daily application to the face and balding scalp for two 2-week cycles. J Am Acad Dermatol. 2010;62(4):582-590. 2. Swanson N, Hanke CW, Berman B, et al. Twelve month sustained clearance of actinic keratosis of the full face or balding scalp after imiquimod 2.5% and 3.75% applied daily for two 2-week or 3-week cycles. Poster presented at: 68th American Academy of Dermatology Annual Meeting; March 2010; Miami, FL.

ÂŠ2010 Graceway Pharmaceuticals, LLC, Bristol, TN

www.gracewaypharma.com

www.ZyclaraCream.com

ZYC0310102

Vol. 5, No. 2 SPRING 2011 27

28 Journal of Dermatology for Physician Assistants

Dermoscopy Q A SDPA Members Only Content

Figure 2 - Dermoscopy criteria for the melanoma in situ of the face shown in Figure 1.

CLINICAL 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.

Table - Dermoscopy criteria for the melanoma in situ of the face denoted in Figure 2. John Burns, PA-C is a graduate of the Physician Assistant Program at Louisiana State University Health Science Center Shreveport, Louisiana, and completed a fellowship in dermatology at the University of Texas Southwestern Medical Center. He is a Diplomate of the Society of Dermatology Physician Assistants. He presently resides in Frisco, Texas where he works in dermatology with Dr. Eric Weisberg. He has indicated no relationships to disclose relating to the content of this article.

Vol. 5, No. 2 SPRING 2011 29

Clinical snapshots Erythema Dyschromicum Perstans By Erik Sorenson, MPAS, PA-C

SDPA Members Only Content

CLINICAL 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.

Erik P. Sorenson, MPAS, PA-C has practiced dermatology for ten years and works with Frederic Rosenberg, MD at Advanced Dermatology in Lakewood, California. He has indicated no relationships to disclose relating to the content of this article.

30 Journal of Dermatology for Physician Assistants

For moderate to severe plaque psoriasis

Take scalp psoriasis head on

Important Safety Information CLOBEX® (clobetasol propionate) Spray, 0.05%, is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older. Clobetasol propionate has been shown to suppress the HPA axis at the lowest doses tested. Clobetasol propionate spray should not be used in the treatment of rosacea or perioral dermatitis and should not be used on the face, groin or axillae. In controlled clinical trials, the following adverse reactions have been reported: burning, pruritus, hyperpigmentation, infections and infestations, nasopharyngitis, upper respiratory tract infection, and skin and subcutaneous tissue disorders. Treatment should be limited to 4 weeks. Treatment beyond 2 weeks should be limited to localized lesions of moderate to severe plaque psoriasis that have not sufﬁciently improved after the initial 2 weeks of treatment with CLOBEX® Spray, 0.05%. CLOBEX® Spray, 0.05%, should not exceed 50 g (59 mL or 2 ﬂ oz) per week. CLOBEX® Spray, 0.05%, is not recommended for use on anyone younger than 18 years of age. Pregnancy Category C. Please see adjacent page for brief summary of Prescribing Information.

Vol. 5, No. 2 SPRING 2011 31

CLOBEX

(clobetasol propionate) Spray, 0.05% Rx Only BRIEF SUMMARY

INDICATIONS AND USAGE: CLOBEX® (clobetasol propionate) Spray, 0.05% is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older (see PRECAUTIONS). Treatment should be limited to 4 consecutive weeks. The total dosage should not exceed 50 g (59 mL or 2 fl. oz.) per week. Before prescribing for more than 2 weeks, any additional benefits of extending treatment to 4 weeks should be weighed against the risk of HPA axis suppression. Patients should be instructed to use CLOBEX® (clobetasol propionate) Spray, 0.05% for the minimum amount of time necessary to achieve the desired results (see PRECAUTIONS). Use in patients under 18 years of age is not recommended because safety has not been established and because numerically high rates of HPA axis suppression were seen with other clobetasol propionate topical formulations (see PRECAUTIONS: Pediatric Use). CONTRAINDICATIONS: CLOBEX® (clobetasol propionate) Spray, 0.05% is contraindicated in patients who are hypersensitive to clobetasol propionate, to other corticosteroids, or to any ingredient in this preparation. PRECAUTIONS: General: Clobetasol propionate is a highly potent topical corticosteroid that has been shown to suppress the HPA axis at the lowest doses tested. In studies evaluating the potential for hypothalamic-pituitary-adrenal (HPA) axis suppression, using the Cosyntropin Stimulation Test, CLOBEX® (clobetasol propionate) Spray, 0.05% demonstrated rates of suppression that were comparable after 2 and 4 weeks of twice-daily use (19% and 15-20%, respectively), in adult patients with moderate to severe plaque psoriasis (≥ 20%BSA). In these studies, HPA axis suppression was defined as serum cortisol level ≤18 �g/dL 30-min post cosyntropin stimulation. (See CLINICAL PHARMACOLOGY). Patients with acute illness or injury may have increased morbidity and mortality with intermittent HPA axis suppression. Patients should be instructed to use CLOBEX® (clobetasol propionate) Spray, 0.05% for the minimum amount of time necessary to achieve the desired results (see INDICATIONS AND USAGE). Systemic absorption of topical corticosteroids has caused reversible adrenal suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment. HPA axis suppression has not been evaluated in psoriasis patients treated with CLOBEX® (clobetasol propionate) Spray, 0.05% who are less than 18 years old. Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios (see PRECAUTIONS: Pediatric Use). The potential increase in systemic exposure does not correlate with any proven benefit, but may lead to an increased potential for hypothalamic-pituitary-adrenal (HPA) axis suppression. Conditions which increase systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Therefore, patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of adrenal suppression (see laboratory tests below). If adrenal suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products. If irritation develops, CLOBEX® (clobetasol propionate) Spray, 0.05% should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noting a clinical exacerbation, as with most topical products not containing corticosteroids. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, use of CLOBEX® (clobetasol propionate) Spray, 0.05% should be discontinued until the infection has been adequately controlled. CLOBEX® (clobetasol propionate) Spray, 0.05% should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae. Information for Patients: Patients using topical corticosteroids should receive the following information and instructions: • This medication is to be used as directed by the physician and should not be used longer than the prescribed time period. • This medication should not be used for any disorder other than that for which it was prescribed. • The treated skin area should not be bandaged, otherwise covered, or wrapped so as to be occlusive unless directed by the physician. • Patients should wash their hands after applying the medication. • Patients should report any signs of local or systemic adverse reactions to the physician. • Patients should inform their physicians that they are using CLOBEX® (clobetasol propionate) Spray, 0.05% if surgery is contemplated. • This medication is for external use only. It should not be used on the face, underarms, or groin area. Also avoid contact with the eyes and lips. • As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician. • Patients should not use more than 50 g (59 mL or 2 fl. oz.) per week of CLOBEX® (clobetasol propionate) Spray, 0.05%. Instructions to the Pharmacist: 1. Remove the spray pump from the wrapper 2. Remove and discard the cap from the bottle 3. Keeping the bottle vertical, insert the spray pump into the bottle and turn clockwise until well-fastened 4. Dispense the bottle with the spray pump inserted Laboratory Tests: The cosyntropin stimulation test may be helpful in evaluating patients for HPA axis suppression. Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term animal studies have not been performed to evaluate the carcinogenic potential of clobetasol propionate. Clobetasol propionate was negative in the in vitro mammalian chromosomal aberration test and in the in vivo mammalian erythrocyte micronucleus test. The effect of subcutaneously administered clobetasol propionate on fertility and general reproductive toxicity was studied in rats at doses of 0, 12.5, 25, and 50 �g/kg/day. Males were treated beginning 70 days before mating and females beginning 15 days before mating through day 7 of gestation. A dosage level of less than 12.5 �g/kg/day clobetasol propionate was considered to be the no-observed-effect-level (NOEL) for paternal and maternal general toxicity based on decreased weight gain and for male reproductive toxicity based on increased weights of the seminal vesicles with fluid. The female reproductive NOEL was 12.5 �g/kg/day (ratio of animal dose to proposed human dose of 0.03 on a mg/m2/day basis) based on reduction in the numbers of estrous cycles during the pre-cohabitation period and an increase in the number of nonviable embryos at higher doses. Pregnancy: Teratogenic effects: Pregnancy Category C. 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 to laboratory animals. Clobetasol propionate is absorbed percutaneously, and when administered subcutaneously it was a significant teratogen in both the rabbit and the mouse. Clobetasol propionate has greater teratogenic potential than steroids that are less potent. The effect of clobetasol propionate on pregnancy outcome and development of offspring was studied in the rat. Clobetasol propionate was administered subcutaneously to female rats twice daily (0, 12.5, 25, and 50 �g/kg/day) from day 7 of presumed gestation through day 25 of lactation or day 24 presumed gestation for those rats that did not deliver a litter. The maternal NOEL for clobetasol propionate was less than 12.5 �g/kg/day due to reduced body weight gain and feed consumption during the gestation period. The reproductive NOEL in the dams was 25 �g/kg/day (ratio of animal dose to proposed human dose of 0.07 on a mg/m2/day basis) based on prolonged delivery at a higher dose level. The no-observed-adverse-effect-level (NOAEL) for viability and growth in the offspring was 12.5 �g/kg/day (ratio of animal dose to proposed human dose of 0.03 on a mg/m2/day basis) based on incidence of stillbirths, reductions in pup body weights on days 1 and 7 of lactation, increased pup mortality, increases in the incidence of umbilical hernia, and increases in

32 Journal of Dermatology for Physician Assistants

the incidence of pups with cysts on the kidney at higher dose levels during the preweaning period. The weights of the epididymides and testes were significantly reduced at higher dosages. Despite these changes, there were no effects on the mating and fertility of the offspring. There are no adequate and well-controlled studies of the teratogenic potential of clobetasol propionate in pregnant women. CLOBEX® (clobetasol propionate) Spray, 0.05% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 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 breast milk. Because many drugs are excreted in human milk, caution should be exercised when CLOBEX® (clobetasol propionate) Spray, 0.05% is administered to a nursing woman. Pediatric Use: Use in patients under 18 years of age is not recommended, because safety has not been established and because numerically high rates of HPA axis suppression were seen with other clobetasol propionate topical formulations. Safety and effectiveness in pediatric patients treated with CLOBEX® (clobetasol propionate) Spray, 0.05% have not been established (see PRECAUTIONS: General). 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 and Cushing’s syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of glucocortisteroid insufficiency during and/or after withdrawal of 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. Geriatric Use: Clinical studies of CLOBEX® (clobetasol propionate) Spray, 0.05% did not include sufficient numbers of patients aged 65 and over to adequately determine whether they respond differently than younger patients. In the two Phase 3 studies, 21 of the 240 patients (9%) were over the age of 65. In general, dose selection for an elderly patient should be made with caution, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. ADVERSE REACTIONS: In controlled, clinical trials with CLOBEX® (clobetasol propionate) Spray, 0.05%, the most common adverse reaction was burning at the site of application [40% of subjects treated with CLOBEX® (clobetasol propionate) Spray, 0.05% and 47% of subjects treated with Spray Vehicle]. Other commonly reported adverse reactions for CLOBEX® (clobetasol propionate) Spray, 0.05% and Spray Vehicle, respectively, are noted in Table 2. Table 2 - Commonly Occurring Adverse Events Adverse Reaction

Clobetasol Propionate 0.05% Spray (N=120)

Vehicle Spray (N=120)

50 (42%)

56 (47%)

System Organ Class General disorders and administration site conditions Application site atrophy

0 (0%)

1 (1%)

Application site burning

48 (40%)

56 (47%)

Application site dryness

2 (2%)

0 (0%)

Application site irritation

1 (1%)

0 (0%)

Application site pain

1 (1%)

2 (2%)

Application site pigmentation changes

1 (1%)

0 (0%)

Application site pruritus

4 (3%)

3 (3%)

17 (14%)

12 (10%)

Infections and infestations Influenza

0 (0%)

2 (2%)

Nasopharyngitis

6 (5%)

3 (3%)

Pharyngitis streptococcal

1 (1%)

0 (0%)

10 (8%)

2 (2%)

4 (3%)

2 (2%)

0 (0%)

Upper respiratory tract infection Skin and subcutaneous tissue disorders Eczema asteatotic

Other adverse events occurred at rates less than 1.0%. Most local adverse events were rated as mild to moderate and they are not affected by age, race or gender. The following additional local adverse reactions have been reported with topical corticosteroids. They may occur more frequently with the use of occlusive dressings and higher potency corticosteroids, including clobetasol propionate. These reactions are listed in an approximate decreasing order of occurrence: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae and miliaria. Systemic absorption topical corticosteroids has produced hypothalamic-pituitary-adrenal (HPA) axis suppression manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients. OVERDOSAGE: Topically applied CLOBEX® (clobetasol propionate) Spray, 0.05% can be absorbed in sufficient amount to produce systemic effects. (See PRECAUTIONS). DOSAGE AND ADMINISTRATION: CLOBEX® (clobetasol propionate) Spray, 0.05% should be sprayed directly onto the affected skin areas twice daily and rubbed in gently and completely. (See INDICATIONS AND USAGE). CLOBEX® (clobetasol propionate) Spray, 0.05% contains a super-high potent topical corticosteroid; therefore treatment should be limited to 4 weeks. Treatment beyond 2 weeks should be limited to localized lesions of moderate to severe plaque psoriasis that have not sufficiently improved after the initial 2 weeks of treatment with CLOBEX® (clobetasol propionate) Spray, 0.05%. The total dosage should not exceed 50 g (59 mL or 2 fluid ounces) per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Use in pediatric patients younger than 18 years is not recommended because of the potential for HPA axis suppression (see PRECAUTIONS: Pediatric Use). Unless directed by physician, CLOBEX® (clobetasol propionate) Spray, 0.05% should not be used with occlusive dressings. HOW SUPPLIED: CLOBEX® (clobetasol propionate) Spray, 0.05% is supplied in a white HDPE bottle with a white polypropylene cap and white LDPE liner in the following sizes: 2 fl oz/59 mL NDC 0299-3849-02 4.25 fl oz/125 mL NDC 0299-3849-04 Store under controlled room temperature conditions of 20˚C - 25˚C (68˚F - 77˚F) with excursions permitted between 15˚C and 30˚C (59˚F and 86˚F). Do not freeze, refrigerate or store above 30˚C. Spray is flammable; keep away from heat or flame. US Patent Nos: 5,972,920; 5,990,100 and foreign patents pending. Marketed by: GALDERMA LABORATORIES, L.P., Fort Worth, Texas 76177 USA Manufactured by: CPL, Mississauga, Ontario, Canada L5N 6L6, Made in Canada. GALDERMA is a registered trademark. www.psoriasispro.com 2003739-0906 Revised: September 2006

Drugs in Dermatology

Ivermectin in the Treatment of Scabies By Sarah McBane, PharmD, CDE, BCPS

SDPA Members Only Content

CLINICAL 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.

Sarah McBane, PharmD, CDE, BCPS is an assistant professor at University of California, San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences. She currently manages hypertension, diabetes, asthma, and hyperlipidemia under a collaborative practice agreement at UCSD Family Medicine. She received her PharmD from the University of North Carolina, Chapel Hill in 2003 and completed a Pharmacotherapy Specialty Residency in Family Medicine in 2004 at East Carolina University/Pitt County Memorial Hospital in Greenville, NC. Dr. She served on faculty at the School of Pharmacy at Campbell University from 2004 to 2009, and was also an Assistant Professor with Duke University School of Medicine in the Department of Community and Family Medicine during that time. She maintained an ambulatory care clinical pharmacy practice at Duke Family Medicine in Durham, NC. As part of a collaborative practice agreement, she managed patients with various chronic diseases, including diabetes, tobacco abuse, polypharmacy, and thromboembolic disorders. She is board certified as a Diabetes Educator through the National Certification Board for Diabetes Educators. In addition, she is Board Certified in Pharmacotherapy through the Board of Pharmaceutical Specialties. Her expertise includes numerous topics within family medicine, including diabetes, womenâ&#x20AC;&#x2122;s health, tobacco abuse, and mental health.

Vol. 5, No. 2 SPRING 2011 33

The SDPA congratulates all Diplomate Physician Assistants! AlABAmA Miranda P Frith MPAS PA-C / Christopher Harmon MD ARiZonA Kenan Arkawi PA-C / Kristine Romine MD Michelle A Campbell MPAS, PA-C / Samantha Carter MD Rebecca L Caudle PA-C / Keith Haar MD Lisa Greenan PA-C / Mary Fredenberg MD Melinia J Honjo MPAS, PA-C / Gary A. McCraken MD Kathlynn H Hurt PA-C / Keith Haar MD Elizabeth J Jacobsen PA-C / William Ko MD Beth B Lopez MPAS, PA-C / Bogna Nowak MD Anngela Park MPAS, PA-C / Glenn Brown MD John C Rimer PA-C / Keith Haar MD Yuliya S Schoenling MPAS, PA-C / Kristine Romine MD Annie Sullivan MPAS, PA-C / Burrell Wolk MD Wendy A Thompson MPAS, PA-C / Catherine P. Chen-Tsai MD Francisco J Trejo MPAS, PA-C / Katherine Orlick MD Devon N Updegraff-Day PA-C / Bryan Updegraff MD CAliFoRniA Irene G Bayer PA-C / Bente Berman MD Roger T Bellamy PA-C / Timothy Richardson MD Raylene M Blandino PA-C / Peter Webb MD Rae Calamia MPAS, PA-C / John Maddox MD Carolyn S Calma PA-C / Vince Afsahi MD Judy W Cheng MPAS, PA-C / Lawrence Rivkin MD Renee Christenson PA-C / Donald Richey MD Yvonne Clark PA-C / Lawrence F. Eichenfield MD Annie W Coots PA-C / Bruce Maltz MD Kasey Drapeau DAmato MPAS, PA-C / Lauren Reager MD Tiara Esani MPAS, PA-C / Larry Eichenfield MD April S Ethridge PA-C / Pamela Broska MD Sarah E Frazier MPAS, PA-C / Jonathan Baron MD Aaron A Furey PA-C / Valantina Sosa MD Christina Hampton PA-C / Ronald Chappler MD Robert C Higham MPAS, PA-C / Allan Wirtzer MD Mark J Hollis PA-C / R. Jeffrey Herten MD

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34 Journal of Dermatology for Physician Assistants

Jeffrey M Soares PA-C / Kenneth Reed MD Christine M David PA-C / Nina Blumenthal MD mARylAnD Beverly D Connolly PA-C / Michael Del Torto MD Christina L Dolinar PA-C / Risa Jampel MD Lauren M Fisher PA-C / Ronald Prussick MD Lauren M Fisher PA-C / Ronald Prussick MD Amy Gawler PA-C / Roberta Palestine MD Mary M Hoke PA-C / Robert Berger MD Edgar F Peithman PA-C / Kenneth Judd MD Brenda Schneider PA-C / Diane Orlinsky MD Kristina R Trunnell PA-C / Elizabeth Liotta MD Melissa A Veneracion PA-C / Allan Hartley MD mAine Alison J Ravis MPAS, PA-C / Peter Bouman MD miCHiGAn Matthew Adler MPAS, PA-C / Howard Lipkin MD Jennifer Anderson PA-C / David Spurlin MD Lisa K Bowersox PA-C / Murray Cotter MD PhD Terenia A Custer PA-C / Brian Sandler MD Molly R Duiven MPAS, PA-C / Jack Dekkinga MD Jeffry S Freeman PA-C / David Semler MD Laura K Ginoza PA-C / Stephen Guthrie MD Jason C Hui PA-C / Kimball Silverton MD Amber E Kintigh MPAS, PA-C / Jack Dekkinga MD Nicole Luszczyk PA-C / Wendy McFalda MD Jessica M MacDougall MPAS, PA-C / Ann Hern MD Leah M MacMartin MPAS, PA-C / Brian Sandler MD Mary R Proctor PA-C / Mark Saunders MD Ronald W Reusch PA-C / Jack Dekkinga MD Emily Roberts PA-C / Stephanie Neider MD Thomas D Till PA-C / Donn LaTour MD Kurt J Vander Veen PA-C / Jack Dekkinga MD Jared P Wilson PA-C / Donn LaTour MD minneSotA Jacalyn J Beiler MPAS, PA-C / Patrick Carney MD Heather R Haberman MPAS, PA-C / Cynthia Vehe MD Katherine R Larson PA-C / Patrick Carney MD Nicole T Manecke PA-C / Paul Lundstrom MD Deborah A Steinbar PA-C Natalie Roholt MD Larry D Weidell PA-C Patrick Carney MD

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neBRASkA Saundra D Brennan MPAS, PA-C / Jill Nelson MD Laura A Fox MPAS, PA-C / Jennifer Alberts MD Jacklynn A Kment MPAS, PA-C / Margaret Sutton MD Kerri S Otto PA-C / Rodney Basler MD Rebecca A Reinke PA-C / Margaret Sutton MD Michelle R Sitzman MPAS, PA-C / Margaret Sutton MD new HAmPSHiRe Stacy L Filion MPAS, PA-C / Robert Posnick MD Jacqueline A Fournier PA-C / Stephen Del Giudice MD Jennifer L Krasovic PA-C / Christine Kannler MD George H Lewis PA-C / Robert Posnick MD new JeRSey Shari B Ashton PA-C / Patricia McCormack MD Janet Clarkson PA-C / Daniel Groisser MD Casey R Croes MPAS, PA-C / Daniel Groisser MD Allison R Ginsberg PA-C / Cheryl Fialkoff MD Savy Guthrie MPAS, PA-C / Daniel Kessel MD Beth A Hellstern PA-C / Roderick Kaufmann MD Patricia A McTaggart PA-C / Patricia McCormack MD Kimberly A Newhook PA-C / Warren Kurnick MD Lauralee M Pakozdi PA-C / Lisa Coppa Breslauer MD Jenna N Rogers MPAS, PA-C / Christine Papa DO Gerard W Stroup PA-C / Coyle Connolly DO Antonella F Viterbo PA-C / Coyle Connolly DO Sarah Wasser PA-C / Mathias Zemel MD Jennifer Zimbalist MPAS, PA-C / David Wrone MD Genet M DeFazio PA-C / Dmitry Khasak MD nevADA Isaac Gier MPAS, PA-C / Elizabeth Langford MD Daniel B Hickey PA-C / Martin J. Safko MD John V Notabartolo MPAS, PA-C / Jonathan Woodson MD new yoRk Dawn M Barilli PA-C / Joseph Tuchman MD

Nicole J Cassara MPAS, PA-C / Joseph Onorato MD Elizabeth Choe PA-C / John F. Romano MD Kelly A Christman PA-C / Steven Simon MD Tania D Cohen MPAS, PA-C / Hendrik I. Uyttendaele MD Maria A DeRosa MPAS, PA-C / Joseph Wojciechowski MD Elizabeth M Femenia PA-C / david Cooper MD Ari J Fisher PA-C / Robert Shoss MD Ari J Fisher PA-C / Robert Shoss MD Patrick A Franck PA-C / Steven Resnick MD Travis M Hayden MPAS, PA-C / John Tu MD Susan B Hirsch PA-C / Mary Ruth Buchness MD Kelly T Joyce PA-C / Nathalie Zeitouni MD Patricia Kennedy PA-C / Daniel Cuozzo MD Karl Kruszynski PA-C / Marie-Louise Johnson MD Gary A Levine PA-C / Patricia McCormack MD Sandra S Mamis PA-C / Henry A. Greenblatt MD Mary Ann Pelzer PA-C / Jordan Zuckerman MD Matthew F Rossano PA-C / Richard Urbanek MD Allison C Santhouse PA-C / Debra Jaliman MD Timothy P Smith PA-C / Stephen Presser MD Avraham Sokoloff PA-C / Joseph Tuchman MD Melissa A Spencer-Winker MPAS, PA-C / Michelle L. Bennett MD Anna Stassiy PA-C / Josiane Lederman MD Jamie Sturm PA-C / Stephen Presser MD oHio Michelle E Bodie PA-C / Thomas Fleming MD John A France MPAS, PA-C / David Knox MD Shannon K Hammond PA-C / Christy Lorton MD Sarah J Kudelko PA-C / Patrick Shannon MD Amy M Lauer MPAS, PA-C / Brian Adams MD Nina N Rettig PA-C / Mounir Boutros MD Sherri L Whitcomb PA-C / Christy Lorton MD oklAHomA Randy R Bluethman PA-C / Craig Abbott MD Tara D Linville PA-C / John Ashley MD Kelly J Walworth PA-C / Mark A. Dawkins MD

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SoutH DAkotA S. Darlene Shafer PA-C / Marc Boddicker MD Karen K Zepp PA-C / Roger Knutsen MD tenneSSee Amy Bonner PA-C / Mark Fairhurst MD Tammie M Campanali PA-C / Chris Robb MD Jennifer H Hall PA-C / Michael Bell MD Angela M Heikes PA-C / Ronald Nelson MD Andrew W Hull PA-C / Robert Clemons MD Daniel L Kachelmyer PA-C / Julie Pena MD Waynette M Kingman PA-C / Robert Paul Unkefer MD Darrell R Millsap PA-C / James Patrick Rash MD Kathrin K Nunes PA-C / Samuel Banks MD Melissa K Taylor PA-C / Paul Benson MD texAS Piipar S Allen PA-C / Christopher Jones MD Karla J Blixt PA-C / Martha McCollough MD Cathleen Y Chidester PA-C / Ronald Grimwood MD Jennifer M Conner MPAS, PA-C / Paula Vogel MD Heidi B Cook MPAS, PA-C / Forrest Brown MD Carol Fields PA-C / Larry Becker MD Kirk F Gautier PA-C / William Grabski MD Bethany L Grubb MPAS, PA-C / Kent Aftergut MD Sheryl L Gyr MPAS, PA-C / Mark Ray MD April L Harrison MPAS, PA-C / Suzanne Bruce MD Lindsay A Hayler PA-C / Dr. Shelley Sekula-Gibbs MD Jennifer J Jordan PA-C / Michael Coverman MD Kristine Kucera DHS, MPAS, PA-C / Kelly Warren MD Denise Marquez PA-C / Paul Friedman MD Allison L Martin PA-C / Vincent Quintero MD Lisa Moody PA-C / Jeannine Hoang MD Gabriel R Nanagas PA-C / Matthew Barrows MD Erin M Nulf MPAS, PA-C / Forrest C Brown MD Kristie Obranovich PA-C / Lisa Rhodes MD Lisa M Ostrowski PA-C / M.G. Mullanax MD Michelle B Purtle PA-C / Steven Smith MD Jill H Hude-Ray MPAS, PA-C / Dana Jeng MD Diana Reyes MPAS, PA-C / Bryan Selkin MD Katie C Rose PA-C / Forrest C. Brown MD Jennifer K Scheiderich MPAS, PA-C / Lori Stetler MD Toni L Smith PA-C / Kelly Herne MD Cynthia J Trickett PA-C / Dan McCoy MD Ray C Vaughn MPAS, PA-C / Isaac Perez MD Joleen M Volz MPAS, PA-C / Alan Menter MD Teresa M Willis PA-C / D. Scott Miller MD

utAH Stephen T Anderson PA-C / Cheryl Lee Eberting MD Lynn A Birrell MPAS, PA-C / C David Hansen MD Keri L Holyoak PA-C / Joseph D. Jensen MD Mark A Hyde MPAS, PA-C / Glen Bowen MD Kent B Whitaker PA-C / Bradley Summers MD viRGiniA Kelly G Barriault MPAS, PA-C / Michael Gross MD Jennifer D Bauer MPAS, PA-C / Georgia Seely MD Kevin K Charles MPAS, PA-C / Steve Cronquist MD Lauran R Glover PA-C / Leslie Coker MD Kevin S Koch Sr PA-C / Calvin McCall MD Cecilia D Ross PA-C / Frances Slade Rotter MD Amanda M Waggoner MPAS, PA-C / David Pariser MD veRmont Phoebe E Pelkey MPAS PA-C / MitchellSchwartz MD wASHinGton Scott B Ahrndt MPAS, PA-C / Joel Sears MD William R Bies PA-C / Eric Rasmussen MD Stacey L Bryant MPAS, PA-C / Walter Williams MD Christine V Carpenter PA-C / Robert Hopp MD Gina M Fragione MPAS, PA-C / Nicole Kageyama MD Matt Furber PA-C / Amber Fowler MD James L Garcia PA-C / William, Philip Werschler MD Megan E Landis Ferestien PA-C / John Headley MD Corey R Richardson MPAS, PA-C / Theresa Mah Zhen Qian MD Kurt Schlecht PA-C / Zheng Qian MD David Sprouse PA-C / Maureen Mooney MD Heidi A Tate PA-C / Dr. Russell Johnson MD Dan W Walkowski PA-C / Claire Haycox MD Jennifer E Winter PA-C / Mark Bauer MD wiSConSin Gregory D Buttolph MPAS, PA-C / Karl Noll MD Kurt S Holst PA-C / Vernon Casterline MD Courtney A Papp PA-C / Kathleen Stokes MD weSt viRGiniA Johnathan M Pierson MPAS, PA-C / Thomas Karrs MD

Vol. 5, No. 2 SPRING 2011 35

VECTICAL® (calcitriol) OINTMENT, 3 mcg/g

For topical use only. Not for oral, ophthalmic, or intravaginal use. Not to be applied to the eyes, lips, or facial skin. BRIEF SUMMARY INDICATIONS AND USAGE: VECTICAL Ointment is a vitamin D analog indicated for the topical treatment of mild to moderate plaque psoriasis in adults 18 years and older. CONTRAINDICATIONS None WARNINGS AND PRECAUTIONS Effects on Calcium Metabolism In controlled clinical trials with VECTICAL Ointment, among subjects having laboratory monitoring, hypercalcemia was observed in 24% (18/74) of subjects exposed to active drug and in 16% (13/79) of subjects exposed to vehicle. However, the increases in calcium and albumin-adjusted calcium levels were less than 10% above the upper limit of normal. If aberrations in parameters of calcium metabolism occur, treatment should be discontinued until these parameters have normalized. The effects of VECTICAL Ointment on calcium metabolism following treatment durations greater than 52 weeks have not been evaluated. Increased absorption may occur with occlusive use. Ultraviolet Light Exposure Animal data suggest that the vehicle of VECTICAL Ointment may enhance the ability of ultraviolet radiation (UVR) to induce skin tumors. Subjects who apply VECTICAL Ointment to exposed skin should avoid excessive exposure of the treated areas to either natural or artificial sunlight, including tanning booths and sun lamps. Physicians may wish to limit or avoid use of phototherapy in patients who use VECTICAL Ointment. Unevaluated Uses The safety and effectiveness of VECTICAL Ointment in patients with known or suspected disorders of calcium metabolism have not been evaluated. The safety and effectiveness of VECTICAL Ointment in patients with erythrodermic, exfoliative, or pustular psoriasis have not been evaluated. ADVERSE REACTIONS Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Clinical Studies Experience VECTICAL Ointment was studied in two vehicle-controlled studies (419 subjects), and in one open label study (324 subjects). The table below describes exposure to VECTICAL Ointment in 743 subjects, including 239 exposed for 6 months and 116 exposed for one year. Four hundred and nineteen subjects were treated with VECTICAL Ointment twice daily for 8 weeks. The population included subjects ages 13 to 87, males (284) and females (135), Caucasians (372) and non-Caucasians (47); with mild (105) to moderate (313) chronic plaque psoriasis. Selected Adverse Events Occurring in at least 1% of Subjects in the Two Pooled Vehicle-Controlled Studies VECTICAL Ointment Vehicle Ointment (n=419) (n=420) 3% 2% Discomfort skin Pruritus 1% 1% Among subjects having laboratory monitoring, hypercalcemia was observed in 24% (18/74) of subjects exposed to active drug and in 16% (13/79) of subjects exposed to vehicle, however the elevations were less than 10% above the upper limit of normal. The open label study enrolled 324 subjects with psoriasis who were then treated for up to 52 weeks. Adverse events reported at a rate of greater than or equal to 3% of subjects treated with VECTICAL Ointment were lab test abnormality (8%), urine abnormality (4%), psoriasis (4%), hypercalciuria (3%), and pruritus (3%). Kidney stones were reported in 3 subjects and confirmed in two. Postmarketing Experience The following adverse reactions have been identified during worldwide postapproval use of VECTICAL Ointment: acute blistering dermatitis, erythema, pruritus, skin burning sensation, and skin discomfort. 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 VECTICAL Ointment should be used with caution in patients receiving medications known to increase the serum calcium level, such as thiazide diuretics. Caution should also be exercised in patients receiving calcium supplements or high doses of vitamin D.

USE IN SPECIFIC POPULATIONS Pregnancy Teratogenic Effects: Pregnancy Category C. VECTICAL Ointment contains calcitriol which has been shown to be fetotoxic. There are no adequate and well-controlled studies for VECTICAL Ointment in pregnant women. VECTICAL Ointment should be used during pregnancy only if the potential benefit to the patient justifies the potential risk to the fetus. Teratogenicity studies with calcitriol were performed in which rats were treated orally at dosages up to 0.9 mcg/kg/day (5.4 mcg/m2/day) and in which rabbits received topical application of calcitriol ointment (3 ppm) to 6.4% of the body surface area. No effects on reproductive or fetal parameters were observed in rats. In rabbits, topically applied calcitriol induced a significantly elevated mean post-implantation loss and an increased incidence of minor skeletal abnormalities due to retarded ossification of the pubic bones. A slightly increased incidence of skeletal variation (extra 13th rib, reduced ossification of epiphyses) was also observed. These effects may have been secondary to maternal toxicity. Based on the recommended human dose and instructions for use, it is not possible to calculate human dose equivalents for animal exposures in these studies. Nursing Mothers It is not known whether calcitriol is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when VECTICAL Ointment is administered to a nursing woman. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric Use Clinical studies of VECTICAL Ointment did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported experience has not identified differences in responses between the elderly and younger patients. OVERDOSAGE Topically applied calcitriol can be absorbed in sufficient amounts to produce systemic effects. NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility When calcitriol was applied topically to mice for up to 24 months, no significant changes in tumor incidence were observed. Concentrations of calcitriol in ointment base of 0 (vehicle control), 0.3, 0.6 and 1.0 ppm were evaluated. A two-year carcinogenicity study was conducted in which calcitriol was orally administered to rats at dosages of approximately 0.005, 0.03, and 0.1 mcg/kg/day (0.03, 0.18, and 0.6 mcg/m2/day, respectively). The incidence of benign pheochromocytomas was significantly increased in female rats. No other significant differences in tumor incidence data were observed. In a study in which albino hairless mice were exposed to both ultra-violet radiation (UVR) and topically applied calcitriol ointment, a reduction in the time required for UVR to induce the formation of skin tumors was observed in all groups that received the ointment base, including the vehicle-treated control group, relative to animals that received no ointment but which were exposed to UVR. The time required for UVR to induce the formation of skin tumors did not differ between animals that received plain vehicle and those that received vehicle that contained calcitriol. Concentrations of calcitriol in ointment base of 0 (vehicle control), 0.3, 0.6 and 1.0 ppm were evaluated. These data suggest that the vehicle of VECTICAL Ointment may enhance the ability of UVR to induce skin tumors. Calcitriol did not elicit genotoxic effects in the mouse lymphoma TK locus assay. Studies in which male and female rats received oral doses of calcitriol of up to 0.6 mcg/kg/day (3.6 mcg/m2/day) indicated no impairment of fertility or general reproductive performance. Based upon the recommended human dose and instructions for use, it is not possible to calculate human dose equivalents for animal exposure in these studies. PATIENT COUNSELING INFORMATION This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects. Patients using VECTICAL Ointment should receive the following information: Instructions for Use This medication is to be used as directed by the physician. It is for external use only. This medication is to be applied only to areas of the skin affected by psoriasis, as directed. It should be gently rubbed into the skin so that no medication remains visible. Adverse Reactions Patients should report any signs of adverse reactions to their physician. Marketed by: GALDERMA LABORATORIES, L.P. Fort Worth, Texas 76177 USA Manufactured by: Galderma Production Canada Inc. Baie d’Urfé, QC, H9X 3S4 Canada Made in Canada.

References: 1. Gerritsen MJP, Rulo HFC, Van Vlijmen-Willems I, Van Erp PEJ, Van De Kerkhof PCM. Topical treatment of psoriatic plaques with 1,25-dihydroxyvitamin D3: a cell biological study. Br J Dermatol. 1993;128:666673. 2. Krueger JG, Bowcock A. Psoriasis pathophysiology: current concepts of pathogenesis. Ann Rheum Dis. 2005;64(suppl 2):ii30-ii36. 3. Data on file. Galderma Laboratories. 4. Lebwohl M, Menter A, Weiss J, et al. Calcitriol 3 μg/g ointment in the management of mild to moderate plaque type psoriasis: results from 2 placebo-controlled, multicenter, randomized double-blind, clinical studies. J Drugs Dermatol. 2007;6:428-435. 5. Vectical® Prescribing Information. Fort Worth, TX: Galderma Laboratories, L.P.; 2009.

GALDERMA and Vectical are registered trademarks. P51460-0 Revised: December 2009 © 2011 Galderma Laboratories, L.P. GALDERMA and Vectical are registered trademarks. Galderma Laboratories, L.P. 14501 N. Freeway, Fort Worth, TX 76177 VEC-608 Printed in USA 01/11

36 Journal of Dermatology for Physician Assistants

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PSORIASIS IS A COMPLEX CHRONIC CONDITION

Vitamin D3 helps regulate differentiation

B:12.25 in

Largest T:12 in

Smallest T:10.75 in

S:9.5 in

Abnormal keratinocyte differentiation leads to recurring plaque formation2 • In a multicenter, open-label, regimen study of patients given a high-potency corticosteroid for 4 weeks, followed by Vectical® Ointment for 8 weeks: —Affected body surface area remained stable or improved in 98.8% of patients using Vectical® (calcitriol) Ointment 3 mcg/g for mild to moderate plaque psoriasis (n=170)3 • In a pivotal trial, 34% of patients with mild to moderate plaque psoriasis treated with Vectical® Ointment achieved treatment success (Global Severity Score clear or minimal) at 8 weeks vs 22% with vehicle (P=.005) (n=418)4

Available in 100-g tubes5

Important Safety Information for Vectical® Ointment Vectical® (calcitriol) Ointment 3 mcg/g is a topical treatment for mild to moderate plaque psoriasis in adults 18 years and older. The most frequent adverse events (≥3%) reported in clinical trials were lab test abnormality, urine abnormality, psoriasis, hypercalciuria, pruritus and skin discomfort. Vectical® should be used with caution in patients with known or suspected disturbances in calcium

homeostasis, who are taking calcium or Vitamin D supplements or who are on diuretics. If aberrations in parameters of calcium metabolism occur, discontinue use until these normalize. Caution patients to avoid excessive exposure to natural or artificial sunlight after applying the ointment. Avoid contact with eyes, lips and face. Limit use to 200 grams per week. Please see adjacent page for brief summary of Prescribing Information. Vol. 5, No. 2 SPRING 2011 37

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SURGICAL Dermatology

Mohs Surgery

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

Dr. Keith Duffy is an assistant professor at the University of Utah School of Medicine. He received his undergraduate degree from Boston College in Boston, MA and his M.D. degree from SUNY Syracuse Health Sciences Center in Syracuse, NY where he also performed a pathology fellowship. He completed a medical internship in Boston at Tufts University-St. Elizabethâ&#x20AC;&#x2122;s Medical Center and completed his Dermatology residency at the University of Utah. He has received subsequent fellowship training in dermatopathology at the University of Chicago as well as fellowship training in Mohs micrographic surgery and cutaneous oncology at the University of British Columbia in Vancouver, Canada. Dr. Duffy is board certified in both dermatology and dermatopathology. He is a fellow of the American Academy of Dermatology and the American College of Mohs Surgery and is a member of the American Society of Dermatopathology and the American Society of Dermatologic Surgery. He has been elected to the American Board of Pathology honor society as well as the Alpha Omega Alpha medical honor society. His clinical interests include Mohs micrographic surgery and reconstruction as well as diagnostic dermatopathology. His research interests include melanoma and non-melanoma skin cancers. He has published peer-reviewed articles in the dermatologic, dermatologic surgical, and dermatopathology literature.

38 Journal of Dermatology for Physician Assistants

...continued on page 41

When it comes to fine facial wrinkles and hyperpigmentation,

Refissa meets her needs ®

The only tretinoin that is: • 0.05% concentration for effective strength • Emollient base for gentle hydration • Fragrance-free formulation to reduce the potential for allergic reactions

Important Safety Information: Refissa 0.05% is indicated as an adjunctive agent for mitigation (palliation) of fine facial wrinkles, mottled hyperpigmentation, and tactile roughness in patients who use a comprehensive skin care and sunlight-avoidance program (including sunscreen). Refissa does not eliminate wrinkles, repair sun-damaged skin, reverse photoaging, or restore more youthful or younger skin. Do not use if the patient is taking drugs known to be photosensitizers, pregnant, attempting pregnancy, or nursing. Refissa, early in treatment, may cause redness, itching, burning, stinging, and peeling. If the degree of irritation warrants, patients should be advised to use less medication and decrease the frequency of application. If still significant, patient should be advised to discontinue use. Please see reverse for brief summary of full prescribing information.

Reﬁ 40g / ssa 0.05 % Use a s dire cted 2 reﬁ lls

Contact a CORIA® representative for samples, or call customer service at 1-800-556-1937 Vol. 5, No. 2 SPRING 2011 39

Output @ 100% Giant Creative Strategy 260665gi301DPA_PI

Fine facial wrinkles and hyperpigmentation were scored at baseline and at Week 24 by the investigator using a 10-point scale on which 0 represents no damage, 2-3=mild, 4-5=moderate, 6-7=moderate/ severe and 8-9=severe. The change was calculated as baseline minus the Week 24 evaluations.* ++ Please note: The clinical data in the package insert are from Ortho Dermatologics original clinical trials for Renova® 0.05% as required for FDA approval. *Data on File, CORIA Pharmaceuticals. CONTRAINDICATIONS This drug is contraindicated in individuals with a history of sensitivity reactions to any of its components. It should be discontinued if hypersensitivity to any of its ingredients is noted. WARNINGS TRETINOIN CREAM, USP (EMOLLIENT) is a dermal irritant, and the results of continued irritation of the skin for greater than 48 weeks in chronic, long term use are not known. Safety and effectiveness of TRETINOIN CREAM, USP (EMOLLIENT) in individuals with moderately or heavily pigmented skin have not been established. Refissa® [TRETINOIN CREAM, USP (EMOLLIENT)] should not be administered if the patient is also taking drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of augmented phototoxicity. Because of heightened burning susceptibility, exposure to sunlight (including sunlamps) should be avoided or minimized during use of Refissa®. Patients must be warned to use sunscreens (minimum of SPF of 15) and protective clothing when using Refissa®. Patients

ADVERSE REACTIONS (See WARNINGS and PRECAUTIONS sections.) Local reactions such as peeling, dry skin, burning, stinging, erythema, and pruritus were reported by almost all subjects during therapy. These signs and symptoms were usually of mild to moderate severity and generally occurred early in therapy. OVERDOSAGE Application of larger amounts of medication than recommended has not been shown to lead to more rapid or better results, and marked redness, peeling, or discomfort may occur. Oral ingestion of the drug may lead to the same side effects as those associated with excessive oral intake of Vitamin A. DOSAGE AND ADMINISTRATION Refissa® [TRETINOIN CREAM, USP (EMOLLIENT)] should be applied to the face once a day before retiring using only enough to cover the entire affected area lightly. Patients should gently wash their face with a mild soap, pat the skin dry, and wait 20 to 30 minutes before applying. The patient should apply a pea-sized amount of cream to cover the entire face lightly. Special caution should be taken when applying the cream to avoid the eyes, ears, nostrils, and mouth. With discontinuation of therapy, a majority of patients will lose most mitigating effects on fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin; however, the safety and effectiveness of using TRETINOIN CREAM, USP (EMOLLIENT) daily for greater than 48 weeks have not been established. Manufactured by DPT Laboratories, San Antonio, TX 78215 Distributed by CORIA Laboratories, a division of Valeant Pharmaceuticals North America, Fort Worth, TX 76107 (800-321-4576) Refissa is a registered trademark of Spear Pharmaceuticals, Inc. Renova® is a registered trademark of Ortho Dermatologics, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.

100%

Reﬁssa ® [Tretinoin Cream, USP (Emollient) 0.05%] Brief Summary of Full Prescribing Information DESCRIPTION Tretinoin is available as Refissa® [Tretinoin Cream, USP (Emollient)] at a concentration of 0.05% w/w in a water-in-oil emulsion formulation consisting of light mineral oil, sorbitol solution, hydroxyoctacosanyl hydroxystearate; methoxy PEG-22/dodecyl glycol copolymer, PEG45/dodecyl glycol copolymer, stearoxytrimethylsilane and stearyl alcohol, dimethicone 50 cs, methylparaben, edetate disodium, propylparaben, butylated hydroxytoluene, citric acid monohydrate, and purified water. INDICATIONS AND USAGE Refissa® is indicated as an adjunctive agent for use in the mitigation (palliation) of fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin in patients who do not achieve such palliation using comprehensive skin care and sun avoidance programs alone. Neither the safety nor the effectiveness of Tretinoin Cream, USP (Emollient) for the prevention or treatment of actinic keratoses or skin neoplasms has been established. (Please see third bullet point in this section of the full prescribing information for additional populations in which effectiveness has not been established.) Refissa® DOES NOT ELIMINATE WRINKLES, REPAIR SUN DAMAGED SKIN, REVERSE PHOTO-AGING, or RESTORE A MORE YOUTHFUL or YOUNGER DERMAL HISTOLOGIC PATTERN. Refissa® should only be used under medical supervision as an adjunct to a comprehensive skin care and sun avoidance program that includes the use of effective sunscreens (minimum SPF of 15) and protective clothing when desired results on fi ne wrinkles, mottled hyperpigmentation, and roughness of facial skin have not been achieved with a comprehensive skin care and sun avoidance program alone. Neither the safety nor the efficacy of using TRETINOIN CREAM, USP (EMOLLIENT) daily for greater than 48 weeks has been established, and daily use beyond 48 weeks has not been systematically and histologically investigated in adequate and well-controlled trials. CLINICAL TRIALS DATA The Spear Refissa® bioequivalence 6-month study of 382 patients revealed Refissa® and Renova® 0.05% products are bioequivalent.++ In effect, Refissa® and Renova® 0.05% demonstrated no statistical difference from one another, neither product being superior to the other, but both proved superior to placebo. Refissa® Results: Improvement No Improvement Fine Facial Wrinkles 71% 29% Mottled Hyperpigmentation 83% 17%

with sunburn should be advised not to use until fully recovered. Patients who may have considerable sun exposure due to their occupation and those patients with inherent sensitivity to sunlight should exercise particular caution when using and assure that the precautions outlined in the Patient Package Insert are observed. Refissa® should be kept out of the eyes, mouth, angles of the nose, and mucous membranes. Topical use may cause severe local erythema, pruritus, burning, stinging, and peeling at the site of application. If the degree of local irritation warrants, patients should be directed to use less medication, decrease the frequency of application, discontinue use temporarily or discontinue use altogether. Tretinoin has been reported to cause severe irritation on eczematous skin and should be used only with utmost caution in patients with this condition. PRECAUTIONS General: If a drug sensitivity, chemical irritation, or a systemic adverse reaction develops, use should be discontinued. Drug Interactions: Concomitant topical medication, medicated or abrasive soaps, shampoos, cleansers, cosmetics with a strong drying effect, products with high concentration of alcohol, astringents, spices or lime, permanent wave solutions, electrolysis, hair depilatories or waxes, and products that may irritate the skin should be used with caution in patients being treated because they may increase irritation with use. Refissa® should not be administered if the patient is also taking drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of augmented phototoxicity. Carcinogenesis, Mutagenesis, Impairment of Fertility There was no evidence of carcinogenic potential when tretinoin was administered topically at a dose 5 times the average recommended human topical clinical dose. The mutagenic potential of tretinoin was valuated in the Ames assay and in the in vivo mouse micronucleus assay, both of which were negative. Pregnancy: Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. Refissa® should not be used during pregnancy. Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when administered to nursing women. Pediatric Use: Safety and effectiveness in patients less than 18 years of age have not been established. Geriatric Use: Safety and effectiveness in individuals older than 50 years of age have not been established.

40 Journal of Dermatology for Physician Assistants

...continued from page 38

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SURGICAL 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.

Vol. 5, No. 2 SPRING 2011 41

SDPA Members Only Content

SURGICAL 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.

SURGICAL wisdom General Anesthesia Risks for Pediatric Patients 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.

42 Journal of Dermatology for Physician Assistants

cosmetic Dermatology

Going to Great Lengths for Beautiful Hair Hair Care Tips for Healthy and Damaged Hair 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.

Vol. 5, No. 2 SPRING 2011 43

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COSMETIC Dermatology

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

44 Journal of Dermatology for Physician Assistants

Vol. 5, No. 2 SPRING 2011 45

ACZONE® (dapsone) Gel 5% INDICATIONS AND USAGE ACZONE® Gel, 5%, is indicated for the topical treatment of acne vulgaris.

CONTRAINDICATIONS None.

WARNINGS AND PRECAUTIONS Hematological Effects Oral dapsone treatment has produced dose-related hemolysis and hemolytic anemia. Individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency are more prone to hemolysis with the use of certain drugs. G6PD deficiency is most prevalent in populations of African, South Asian, Middle Eastern and Mediterranean ancestry. There was no evidence of clinically relevant hemolysis or anemia in patients treated with ACZONE® Gel, 5%, including patients who were G6PD deficient. Some subjects with G6PD deficiency using ACZONE® Gel developed laboratory changes suggestive of mild hemolysis. If signs and symptoms suggestive of hemolytic anemia occur, ACZONE® Gel, 5% should be discontinued. ACZONE® Gel, 5% should not be used in patients who are taking oral dapsone or antimalarial medications because of the potential for hemolytic reactions. Combination of ACZONE® Gel, 5%, with trimethoprim/sulfamethoxazole (TMP/SMX) may increase the likelihood of hemolysis in patients with G6PD deficiency. Peripheral Neuropathy Peripheral neuropathy (motor loss and muscle weakness) has been reported with oral dapsone treatment. No events of peripheral neuropathy were observed in clinical trials with topical ACZONE® Gel, 5% treatment. Skin Skin reactions (toxic epidermal necrolysis, erythema multiforme, morbilliform and scarlatiniform reactions, bullous and exfoliative dermatitis, erythema nodosum, and urticaria) have been reported with oral dapsone treatment. These types of skin reactions were not observed in clinical trials with topical ACZONE® Gel, 5% treatment.

Pediatric Use Safety and efficacy was evaluated in 1169 children aged 12-17 years old treated with ACZONE® Gel, 5%, in the clinical studies. The adverse event rate for ACZONE® Gel, 5%, was similar to the vehicle control group. Safety and efficacy was not studied in pediatric patients less than 12 years of age, therefore ACZONE® Gel, 5%, is not recommended for use in this age group. Geriatric Use Clinical studies of ACZONE® Gel, 5%, did not include sufficient number of patients aged 65 and over to determine whether they respond differently from younger patients. G6PD Deficiency ACZONE® Gel, 5% and vehicle were evaluated in a randomized, double-blind, cross-over design clinical study of 64 patients with G6PD deficiency and acne vulgaris. Subjects were Black (88%), Asian (6%), Hispanic (2%) or of other racial origin (5%). Blood samples were taken at Baseline, Week 2, and Week 12 during both vehicle and ACZONE® Gel, 5% treatment periods. There were 56 out of 64 subjects who had a Week 2 blood draw and applied at least 50% of treatment applications. ACZONE® Gel was associated with a 0.32 g/dL drop in hemoglobin after two weeks of treatment, but hemoglobin levels generally returned to baseline levels at Week 12. There were no changes from baseline in haptoglobin or lactate dehydrogenase during ACZONE® or vehicle treatment at either the 2-week or 12-week time point. The proportion of subjects who experienced decreases in hemoglobin ≥1 g/dL was similar between ACZONE® Gel, 5% and vehicle treatment (8 of 58 subjects had such decreases during ACZONE® treatment compared to 7 of 56 subjects during vehicle treatment among subjects with at least one on-treatment hemoglobin assessment). Subgroups based on gender, race, or G6PD enzyme activity did not display any differences in laboratory results from the overall study group. There was no evidence of clinically significant hemolytic anemia in this study. Some of these subjects developed laboratory changes suggestive of mild hemolysis.

OVERDOSAGE ACZONE® Gel, 5%, is not for oral use. If oral ingestion occurs, medical advice should be sought.

ADVERSE REACTIONS Clinical Studies Experience Because clinical trials are conducted under prescribed 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. Serious adverse reactions reported in patients treated with ACZONE® Gel, 5%, during clinical trials included but were not limited to the following: • Nervous system/Psychiatric – Suicide attempt, tonic clonic movements. • Gastrointestinal – Abdominal pain, severe vomiting, pancreatitis. • Other – Severe pharyngitis In the clinical trials, a total of 12 out of 4032 patients were reported to have depression (3 of 1660 treated with vehicle and 9 of 2372 treated with ACZONE® Gel, 5%). Psychosis was reported in 2 of 2372 patients treated with ACZONE® Gel, 5%, and in 0 of 1660 patients treated with vehicle. Combined contact sensitization/irritation studies with ACZONE® Gel, 5%, in 253 healthy subjects resulted in at least 3 subjects with moderate erythema. ACZONE® Gel, 5%, did not induce phototoxicity or photoallergy in human dermal safety studies. ACZONE® Gel, 5%, was evaluated for 12 weeks in four controlled studies for local cutaneous events in 1819 patients. The most common events reported from these studies include oiliness/peeling, dryness, and erythema. One patient treated with ACZONE® Gel in the clinical trials had facial swelling which led to discontinuation of medication. In addition, 486 patients were evaluated in a 12 month safety study. The adverse event profile in this study was consistent with that observed in the vehicle-controlled studies. Experience with Oral Use of Dapsone Although not observed in the clinical trials with ACZONE® Gel (topical dapsone) serious adverse reactions have been reported with oral use of dapsone, including agranulocytosis, hemolytic anemia, peripheral neuropathy (motor loss and muscle weakness), and skin reactions (toxic epidermal necrolysis, erythema multiforme, morbilliform and scarlatiniform reactions, bullous and exfoliative dermatitis, erythema nodosum, and urticaria).

DRUG INTERACTIONS Trimethoprim-Sulfomethoxazole A drug-drug interaction study evaluated the effect of the use of ACZONE® Gel, 5%, in combination with double strength (160 mg/800 mg) trimethoprim-sulfamethoxazole (TMP/SMX). During co-administration, systemic levels of TMP and SMX were essentially unchanged. However, levels of dapsone and its metabolites increased in the presence of TMP/SMX. Systemic exposure (AUC0-12) of dapsone and N-acetyl-dapsone (NAD) were increased by about 40% and 20% respectively in presence of TMP/SMX. Notably, systemic exposure (AUC0-12) of dapsone hydroxylamine (DHA) was more than doubled in the presence of TMP/SMX. Exposure from the proposed topical dose is about 1% of that from the 100 mg oral dose, even when co-administered with TMP/SMX. Topical Benzoyl Peroxide Topical application of ACZONE® Gel followed by benzoyl peroxide in subjects with acne vulgaris resulted in a temporary local yellow or orange discoloration of the skin and facial hair (reported by 7 out of 95 subjects in a clinical study) with resolution in 4 to 57 days. Drug Interactions with Oral Dapsone Certain concomitant medications (such as rifampin, anticonvulsants, St. John’s wort) may increase the formation of dapsone hydroxylamine, a metabolite of dapsone associated with hemolysis. With oral dapsone treatment, folic acid antagonists such as pyrimethamine have been noted to possibly increase the likelihood of hematologic reactions.

USE IN SPECIFIC POPULATIONS Pregnancy Teratogenic Effects: Pregnancy Category C There are no adequate and well controlled studies in pregnant women. Dapsone has been shown to have an embryocidal effect in rats and rabbits when administered orally in doses of 75 mg/kg/day and 150 mg/kg/day (approximately 800 and 500 times the systemic exposure observed in human females as a result of use of the maximum recommended topical dose, based on AUC comparisons), respectively. These effects were probably secondary to maternal toxicity. ACZONE® Gel, 5%, should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers Although systemic absorption of dapsone following topical application of ACZONE® Gel, 5%, is minimal relative to oral dapsone administration, it is known that dapsone is excreted in human milk. Because of the potential for oral dapsone to cause adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue ACZONE® Gel, 5%, taking into account the importance of the drug to the mother.

46 Journal of Dermatology for Physician Assistants

Cosmetic pearls Tips for Incorporating Cosmeceuticals into Our Patientsâ&#x20AC;&#x2122; Regimen By Nancy Primo, MPAS, PA-C Cosmetic Department Editor

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Nancy Primo, MPAS, PA-C has practiced dermatology for 27 years and works with Martin H. Kay, MD at Kay Aesthetic Dermatology, in Burbank, California.Â She has indicated no relationships to disclose relating to the content of this article.

Vol. 5, No. 2 SPRING 2011 47

Professional development

Dermatology Billing & Coding Destruction Services vs. Shave Removals By Inga Ellzey, MPA, RHIA, CDC

...continued on page 51 Ms. Ellzey, President/CEO of the Inga Ellzey Practice Group, Inc., in Casselberry, FL, is an expert on dermatology coding, documentation and reimbursement. She has more than 35 years of experience in the field of dermatology and is the CEO and founder of two nationwide dermatology billing services. You can reach her at the following number: (800) 318-3271, or email her at: inga@iepg.com.

48 Journal of Dermatology for Physician Assistants

The cycle of inﬂammatory rosacea warrants

the only FDA-approved oral treatment...

Formulated for an Effective Anti-inflammatory Response • Signiﬁcant reduction in inﬂammatory lesion count seen as early as week 3 (vs placebo [P=.005]; 61% mean reduction at week 16 [N=251; P<.001])1,2 • In a large community-based trial, 75% of patients were clear or near clear at week 12 (change in IGA* score; n=826)3 • Favorable tolerability vs doxycycline 100 mg with 5x less gastrointestinal upset4 • No evidence of bacterial resistance in a long-term safety study 5 *Investigator’s Global Assessment.

Important Safety Information

Oracea® (doxycycline, USP) is indicated for the treatment of only inﬂammatory lesions (papules and pustules) of rosacea in adult patients. In clinical trials, the most common adverse events reported were gastrointestinal upsets, nasopharyngitis/pain, and nasal congestion/sinusitis. Oracea® should not be used to treat microbial infections, and should be used only as indicated. This drug is contraindicated in people who have shown hypersensitivity to any of the tetracyclines, and, like other tetracycline drugs, may cause fetal harm when administered to a pregnant woman. Oracea® should not be used during pregnancy, by nursing mothers, or during tooth development (up to the age of 8 years). Although photosensitivity was not observed in clinical trials, Oracea® patients should minimize or avoid exposure to natural or artiﬁcial sunlight. All contraindications, warnings, and precautions associated with tetracyclines must be considered before prescribing Oracea®. The safety of Oracea® treatment beyond 9 months has not been established. Please see brief summary of Prescribing Information on next page.

References: 1. Del Rosso JQ, Webster GF, Jackson M, et al. Two randomized phase III clinical trials evaluating anti-inflammatory dose doxycycline (40-mg doxycycline, USP capsules) administered once daily for treatment of rosacea. J Am Acad Dermatol. 2007;56(5):791-802. 2. Data on file. Galderma Laboratories, L.P. 3. Webster GF. An open label, community-based, 12-week assessment of the effectiveness and safety of monotherapy with doxycycline 40-mg (30-mg immediate-release and 10-mg delayed-release beads). Cutis. 2010;86(suppl 5[i]):7-15. 4. Del Rosso JQ, Schlessinger J, Werschler P. Comparison of anti-inflammatory dose doxycycline versus doxycycline 100 mg in the treatment of rosacea. J Drugs Dermatol. 2008;7(6):573-576. 5. Preshaw PM, Novak MJ, Mellonig J, et al. Modified-release subantimicrobial dose doxycycline enhances scaling and root planing in subjects with periodontal disease. J Periodontol. 2008;79(3):440-452. Oracea and Galderma are registered trademarks of Galderma Laboratories, L.P. ©2011 Galderma Laboratories, L.P. Galderma Laboratories, L.P. 14501 N. Freeway Fort Worth, TX 76177 ORA-525 Printed in USA 01/11

hcp.oracea.com

Vol. 5, No. 2 SPRING 2011 49

Rx Only

Keep out of reach of children.

Brief Summary of Full Prescribing Information INDICATIONS AND USAGE ORACEA is indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. The dosage of ORACEA differs from that of doxycycline used to treat infections. To reduce the development of resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, ORACEA should be used only as indicated. CLINICAL PHARMACOLOGY Pharmacokinetics ORACEA capsules are not bioequivalent to other doxycycline products. CONTRAINDICATIONS This drug is contraindicated in persons who have shown hypersensitivity to doxycycline or any of the other tetracyclines. WARNINGS Teratogenic effects: 1) Doxycycline, like other tetracycline-class antibiotics, can cause fetal harm when administered to a pregnant woman. If any tetracycline is used during pregnancy or if the patient becomes pregnant while taking these drugs, the patient should be informed of the potential hazard to the fetus and treatment stopped immediately. ORACEA should not be used during pregnancy (see PRECAUTIONS: Pregnancy). 2) The use of drugs of the tetracycline class during tooth development (last half of pregnancy, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). This adverse reaction is more common during long-term use of the drug but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. Tetracycline drugs, therefore, should not be used during tooth development unless other drugs are not likely to be effective or are contraindicated. 3) All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in fibula growth rate has been observed in premature human infants given oral tetracycline in doses of 25 mg/kg every 6 hours. This reaction was shown to be reversible when the drug was discontinued. Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can cause retardation of skeletal development on the developing fetus. Evidence of embryotoxicity has been noted in animals treated early in pregnancy (see PRECAUTIONS: Pregnancy section). Gastrointestinal effects: Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of “antibiotic-associated colitis”. If a diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to discontinuation of the drug alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against Clostridium difficile colitis. Metabolic effects: The anti-anabolic action of the tetracyclines may cause an increase in BUN. While this is not a problem in those with normal renal function, in patients with significantly impaired function, higher serum levels of tetracycline-class antibiotics may lead to azotemia, hyperphosphatemia, and acidosis. If renal impairment exists, even usual oral or parenteral doses may lead to excessive systemic accumulations of the drug and possible liver toxicity. Under such conditions, lower than usual total doses are indicated, and if therapy is prolonged, serum level determinations of the drug may be advisable. Photosensitivity: Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Although this was not observed during the duration of the clinical studies with ORACEA, patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using ORACEA. If patients need to be outdoors while using ORACEA, they should wear loose-fitting clothes that protect skin from sun exposure and discuss other sun protection measures with their physician. PRECAUTIONS General: Safety of ORACEA beyond 9 months has not been established. As with other antibiotic preparations, use of ORACEA may result in overgrowth of non-susceptible microorganisms, including fungi. If superinfection occurs, ORACEA should be discontinued and appropriate therapy instituted. Although not observed in clinical trials with ORACEA, the use of tetracyclines may increase the incidence of vaginal candidiasis. ORACEA should be used with caution in patients with a history of or predisposition to candidiasis overgrowth. Bacterial resistance to tetracyclines may develop in patients using ORACEA. Because of the potential for drugresistant bacteria to develop during the use of ORACEA, it should be used only as indicated. Autoimmune Syndromes: Tetracyclines have been associated with the development of autoimmune syndromes. Symptoms may be manifested by fever, rash, arthralgia, and malaise. In symptomatic patients, liver function tests, ANA, CBC, and other appropriate tests should be performed to evaluate the patients. Use of all tetracycline-class drugs should be discontinued immediately. Tissue Hyperpigmentation: Tetracycline class antibiotics are known to cause hyperpigmentation. Tetracycline therapy may induce hyperpigmentation in many organs, including nails, bone, skin, eyes, thyroid, visceral tissue, oral cavity (teeth, mucosa, alveolar bone), sclerae and heart valves. Skin and oral pigmentation has been reported to occur independently of time or amount of drug administration, whereas other pigmentation has been reported to occur upon prolonged administration. Skin pigmentation includes diffuse pigmentation as well as over sites of scars or injury. Pseudotumor cerebri: Bulging fontanels in infants and benign intracranial hypertension in adults have been reported in individuals receiving tetracyclines. These conditions disappeared when the drug was discontinued. Laboratory Tests: Periodic laboratory evaluations of organ systems, including hematopoietic, renal and hepatic studies should be performed. Appropriate tests for autoimmune syndromes should be performed as indicated. Drug Interactions: 1. Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. 2. Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin. 3. The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity. 4. Absorption of tetracyclines is impaired by bismuth subsalicylate, proton pump inhibitors, antacids containing aluminum, calcium or magnesium and ironcontaining preparations. 5. Doxycycline may interfere with the effectiveness of low dose oral contraceptives. To avoid contraceptive failure, females are advised to use a second form of contraceptive during treatment with doxycycline. 6. There have been reports of pseudotumor cerebri (benign intracranial hypertension) associated with the concomitant use of isotretinoin and tetracyclines. Since both oral retinoids, including isotretinoin and acitretin, and the tetracyclines, primarily minocycline, can cause increased intracranial pressure, the concurrent use of an oral retinoid and a tetracycline should be avoided.

50 Journal of Dermatology for Physician Assistants

MICROBIOLOGY The plasma concentrations of doxycycline achieved with ORACEA during administration (see DOSAGE AND ADMINISTRATION) are less than the concentration required to treat bacterial diseases. In vivo microbiological studies utilizing a similar drug exposure for up to 18 months demonstrated no detectable long-term effects on bacterial flora of the oral cavity, skin, intestinal tract, and vagina. Carcinogenesis, Mutagenesis, Impairment of Fertility: Doxycycline was assessed for potential to induce carcinogenesis in a study in which the compound was administered to Sprague-Dawley rats by gavage at dosages of 20, 75, and 200 mg/kg/day for two years. An increased incidence of uterine polyps was observed in female rats that received 200 mg/kg/day, a dosage that resulted in a systemic exposure to doxycycline approximately 12.2 times that observed in female humans who use ORACEA (exposure comparison based upon area under the curve (AUC) values). No impact upon tumor incidence was observed in male rats at 200 mg/kg/ day, or in either gender at the other dosages studied. Evidence of oncogenic activity was obtained in studies with related compounds, i.e., oxytetracycline (adrenal and pituitary tumors) and minocycline (thyroid tumors). Doxycycline demonstrated no potential to cause genetic toxicity in an in vitro point mutation study with mammalian cells (CHO/HGPRT forward mutation assay) or in an in vivo micronucleus assay conducted in CD-1 mice. However, data from an in vitro assay with CHO cells for potential to cause chromosomal aberrations suggest that doxycycline is a weak clastogen. Oral administration of doxycycline to male and female Sprague-Dawley rats adversely affected fertility and reproductive performance, as evidenced by increased time for mating to occur, reduced sperm motility, velocity, and concentration, abnormal sperm morphology, and increased pre-and post-implantation losses. Doxycycline induced reproductive toxicity at all dosages that were examined in this study, as even the lowest dosage tested (50 mg/kg/day) induced a statistically significant reduction in sperm velocity. Note that 50 mg/kg/day is approximately 3.6 times the amount of doxycycline contained in the recommended daily dose of ORACEA for a 60-kg human when compared on the basis of AUC estimates. Although doxycycline impairs the fertility of rats when administered at sufficient dosage, the effect of ORACEA on human fertility is unknown. Pregnancy: Teratogenic Effects: Pregnancy Category D. (see WARNINGS section). Results from animal studies indicate that doxycycline crosses the placenta and is found in fetal tissues. Nonteratogenic effects: (see WARNINGS section). Labor and Delivery: The effect of tetracyclines on labor and delivery is unknown. Nursing Mothers: Tetracyclines are excreted in human milk. Because of the potential for serious adverse reactions in infants from doxycycline, ORACEA should not be used in mothers who breastfeed. (see WARNINGS section). Pediatric Use: ORACEA should not be used in infants and children less than 8 years of age (see WARNINGS section). ORACEA has not been studied in children of any age with regard to safety or efficacy, therefore use in children is not recommended. ADVERSE REACTIONS Adverse Reactions in Clinical Trials of ORACEA: In controlled clinical trials of adult patients with mild to moderate rosacea, 537 patients received ORACEA or placebo over a 16-week period. The most frequent adverse reactions occurring in these studies are listed in the table below. Incidence (%) of Selected Adverse Reactions in Clinical Trials of ORACEA (n=269) vs. Placebo (n=268)

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

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

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

Note: Percentages based on total number of study participants in each treatment group. Adverse Reactions for Tetracyclines: The following adverse reactions have been observed in patients receiving tetracyclines at higher, antimicrobial doses: Gastrointestinal: anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, and inflammatory lesions (with vaginal candidiasis) in the anogenital region. Hepatotoxicity has been reported rarely. Rare instances of esophagitis and esophageal ulcerations have been reported in patients receiving the capsule forms of the drugs in the tetracycline class. Most of the patients experiencing esophagitis and/or esophageal ulceration took their medication immediately before lying down. (see DOSAGE AND ADMINISTRATION section). Skin: maculopapular and erythematous rashes. Exfoliative dermatitis has been reported but is uncommon. Photosensitivity is discussed above. (see WARNINGS section). Renal toxicity: Rise in BUN has been reported and is apparently dose-related.(see WARNINGS section). Hypersensitivity reactions: urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, serum sickness, pericarditis, and exacerbation of systemic lupus erythematosus. Blood: Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia have been reported. OVERDOSAGE In case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures. Dialysis does not alter serum half-life and thus would not be of benefit in treating cases of overdose. DOSAGE AND ADMINISTRATION THE DOSAGE OF ORACEA DIFFERS FROM THAT OF DOXYCYCLINE USED TO TREAT INFECTIONS. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS INCLUDING THE DEVELOPMENT OF RESISTANT MICROORGANISMS. One ORACEA Capsule (40 mg) should be taken once daily in the morning on an empty stomach, preferably at least one hour prior to or two hours after meals. Efficacy beyond 16 weeks and safety beyond 9 months have not been established. Administration of adequate amounts of fluid along with the capsules is recommended to wash down the capsule to reduce the risk of esophageal irritation and ulceration. (see ADVERSE REACTIONS section). HOW SUPPLIED ORACEA (beige opaque capsule printed with CGPI 40) containing doxycycline, USP in an amount equivalent to 40 mg of anhydrous doxycycline. Bottle of 30 (NDC 64682-009-01). Storage: All products are to be stored at controlled room temperatures of 15°C-30°C (59°F-86°F) and dispensed in tight, light-resistant containers (USP). Keep out of reach of children. Patent Information: U.S. Patents 5,789,395; 5,919,775; 7,232,572; 7,211,267 and patents pending. ORACEA is a registered trademark of CollaGenex Pharmaceuticals, Inc. Manufactured by: Marketed by: CardinalHealth Galderma Laboratories, L.P. Winchester, KY 40391 Fort Worth, TX 76177 7961-01 BPI 06/08

...continued from page 48

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52 Journal of Dermatology for Physician Assistants

SDPA Members Only Content

Pr Of Es

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sician olog y Phy of Dermat ks twenty years from the Society as it mar from less history of organization ession has grown By bers and les on the Patricia prof series of artic mark year for our 1,800 mem Ferr atology PA four-part a land The derm A currently has over high-qualityer, MPAS, PA-C third in a sand ten is al union. This is the SDP Two thou two refined, form . chairs; The has its PA) y. A (SD Thiee committ years from e than 2200 toda The SDP s is s, we Assistants second nizations. (BOD) and and fifteen tantthe mor n to orga ctors assis Assista A 0s eptio in a fou Dire 199 ician nt AAP its conc nts rd of phys in the early all constitue hard working Boa s. As dermatology its concep (SDPA). Two r-part series of than 25 PAs most organized of tion and tion d cate and fift thousand ten articles on the organiza ty. than 25 is one of the E meetings and a dedi other constituent idable socie PA be een years from is a landmark history of the for is one of mittseeintothe lish this form ear its form Society year for annual CM considered a model the mo irs Com helped estab ation ly 1990s to is cal Affaann st org our oper more tha al union. The our organizat of Dermatolog those who Ethi ual to ing and the SDPA CM tion keep cial s anized of all dermatolo ion as it y Physici n 2200 E ncie and apprecia etin con and the Judi for interpreting the SDPA tod ma an discrepame gs and owe much any ble a dedicat stituent AAPA ay. The SDPA gy PA profession rks twenty yea owge mu is considered “responsi current and resolvin org ed and rs ch appreci a ts hard wo anizations. currently has has grown from from g n model for oth documen e atio The SD over rking now bein less er to those them.” 2004-2006 21st century with mor who hel constituent org Board of Dir PA has two 1800 members between erences were son, and Part iii: nded ped esta refined ani ectors (BO red the and CME conf John A expa ia Pa ente zat A SDP ees, ions. , hig blish this , Glor The ii: 1999 olphrt The SDP ting sed committ le relations with formida As dermatolo D) and commit h-quality -20 t coordina by Greg Butt(an even and focu 04 Fro ptab d ned ker). ble gy tee m acce nize plan , phy Haw the soci 199 e chairs; orga of sician assi ety. 0 to e Simple formaleorg t the and Ros 199expa gy education ion and support 8 thendSD stants, anizati Events Mad aged by to improvemen t dermatolo d SDMik gnit ers we on PA PA reco inue offic man ting wit hisssed cont , full creacers evolved to h offi in grea andasse company ia by suppor the AAD cal industry, and medcoll h com become aland and ed Mr. Day atology were nues, t from whic ationthe ecte y,fees euti allow derm a educ in olog d mac mit This info gy reve mat PAs phar pharma rmally es in Der , received tees. The contrib dermatolo services. to increase ceuticars of uting new financi presen iewce.Notreco society’s l of member use of our ability care, and easing the zededby40 hou became offer al sgni ensive Rev sletter Anote the mik.industry, SDPA beca and 6. Compreh in 200 the work incThe to patient new demand d by DerAAD for our and was the form the official SD articles. Jud ludedspon sed ments, icians. All der sore sletter was, Joe y Reese accessibility org PA new at and was relea improve our supervising phys dividends in the dermatolomatoloMr. form aesthet E and were Day sent to dthe anization’s gy CM I CMinfo ics of oursletter editor and ally Un gy ted invi rmation category and conJoneEs con to atten memb ld pay big burden for official booth at der the leadersh the AAD related Eug The ene tract pea ference announership -2004 wou 2005new publica improved to PAs rls, In Aprilopp from 1999 tion. s. Galder the AAD An ip of Jim Sot ter, and ham 2004-2005 Higslet also pub in dermatolo and any cema pro g five year nua ack the Robertortu ident from niti lish Pres roe, ary gy vid es and upcomin A ed the SDPA list. Mon and ed fun l Meeting a booth was SDP Day’s prim hig In 1999 yhly covetedthe SDPA. Mr. Sot was star ding for the continued to log Gordon Day President-elect. Mr. son position to ted ato Jim SD Ma ack job rm at Sot PA new thrive. mis bec of Deack roe the A Liai he on derma encourage -2006 tyam reta becam20 inc d derma AAPA Annua sletter 04side and Joe Mon to initiate an AAP by the AAPA and Day tology e Pre ludcie so ed Jim e Sectan volu ts: tolo l sub ry/T ed was Me nte Mr. nt gy ject fund etin reas Pag er and and Joe n as sis son. and objective Sotack and participat s at PA CME PAs to lecture g. Monro e, Sue Rancis, urer. The SD Sandra supported ham as the first Liai nal and ysis cia ’s tenure e. Derma meetin Phthu PA BO e at all Ku the the AAD essio help Hig as rits the Prof gs the ert r D SDPA tolo SDPA and also ees: Rob AA pape appo m gistintedAAD. Opp, Lora and inv ing to incrtreas appointed three new committ develop a position Discov to volunteer D Allied He venues. Duringto Gu olvemeRobe Higha e then to thes wer e hiring ation ery. The alth Joe Mo nt. at AAPA liaiso SDPA 2005 more PAsrule, firstNo resoluti n-PAs nroe) and established irs Committee to stituent Organiz AAD Boa the Special Committee Mr. the AAPAmembersh ed Ma on Randy Con s, d asked ip num , ry Mo Mareceiv rd of Adv Olympics Awar SDPA at the resi for PAs to rti Ullation Ull Clinical Affaon, Member and t members’ need and c Educ endorf nroe (forme bers isor reg informa endorfPubli ) help (wi r for derma dent rate. Mr ister at the AA s began dra Camp on supervisi to evaluate and assis fting a Kalin, tion via the SD ed in collecti fe of decease wife of uated from ee there was tology PAs . Sotack arra D Annual Thoma ng and d PA-C grad ch in Committ Meetin at the nged a s Fenger, PA newslet dissem PA init r, MPAS, Bran

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matolo Patricia others The 5 gy PAs ing a certific g where aska 200 started 1998 and ber of Ferr er, . in the 199SDPA success the ation rsity of Nebr Associate mem . versity MPAS, PA- C an the Unive full 0s. Ou 2004 1998Uni of grad PA-C, ip). She is member of the AAPA nine r web y embraced and scholarsh w bec ts obtainedTexas Medical Branuatedrehen gy for fromsive thestan and Fello Assi Uni and tho ame a hub site, maintaine the evolving Comp her Mas in dermatolol. She has no ch w the SDPA in Notes in of Physician scholarsversity of Neb working ters Deg By raskricia atica Revie was se. olog y to be invse new to derma resources for d by Steve Pricinternet ree from hip). She Pat She has beencurrently on sabb try of atology a in Ferr Derm itsthe SDPGreg Dermat to disclo is s from and indusety in is an Asso 2003er,(SDP MPA on Day and withSoci A AAD leted behind olved with the tology. Mary dermatology e, S, PA-C years and onsh and Fello ips the A S, e and than comp d the PAciate mem twenty year Gord She has articlks joine -the-sce PAs Ferrer, MPA lph less history of ibuted as Monro website FDA in w mem d to allCSDPA Ou to this de relati from it mar the bee e the outsi who grownButto ber of offere on nes n ber By Patricia . e befor les wor SDPA tion yea one con contr r con con is is tinoin king ying and list rs and bers. Thi is of the AAP ten of the ession has tinued testifbers all who organizalopmentPA series of artic prof Patricia 0 mem of oral isotre currentl insderm A. the ogyt mem Derma of free journa tributions to t along with for kour like to than woulddefenseoutsideann y on sab atolfirs four-part Patricia woul the gy al in the deve tolo atology relaual ls her in (SD for a fou mardk year over tion thos1,40 lity like bati Dermatolo final of a has2004 instrument ships withPA e who high to than -qua a land ). Tw cal. She nine r-partNews, and gy (no longer grew to includ SDPA newslet 2004 July n. The .derm A currsently completedite. who wereal unio k all who o thohas This is the Study may eThe sand ten is thoseits mentioned SDP e Cro ter. a publica instrum letter from Kucetwo refined,wer concepindu Cosme the force form es of art usano rs;enta contribu SDPA webs nd ten anseri have been today.de: Two thou years from ne has ra, andnot hav chai tionstry to lose SDPA news SDP tic Derma tion), Ski ss Section in eeWork e bee cle for icle may not posted onl inowe 0 e inclu The is a arti with Kristi A Arnold,Ran the dev 25 ted to thisanddisc n men dycom (SDPA). on the 220 Ullemitt and Skins & fifteen. articl tha n dencs.esThe tionwe and elopPA article t lan e thanthis spontion D) imp and fifteen 0s to mor histtolo “PAdm en, Terry menst in o,orta ndorfassis niza arktheyea are tants, ed. Sad Allergy Dr. Jay & Allergy l corre (BO orygy. and years from s are Sources for s Haydctors of the ear ; emai A orga conception Nancy Prim building now decease ly, Jim r for ise, TraviDire 2006 Herbst Ne AAP of Sota physntician bes wsofinthewhSociety itsnform the ck, st the SDP gyrces our Alywho 1990s to Ninetee elle Diba t kep the early 199 all cons d – Octo titueberntGrub blocks wrote atoloSou Board ofersationsAswith Michking orgetani ninetyt secr al uni their conmoBruc for this of De ich he clai e ani for the but CM org Cla 25 PAs in morkregat ny hardb,wor s. derm 1999 – Oct phone convtion ninon. n,zed article inzat SDPA. Betha andof tributionKali nized of e endThe thaher derion E rt Higham. merm orga niza and email and as incl t ma me n d ed d atolog y Phy Robe roe; it ing obe orga der s 220 all mos ude tolo etin cate ty. bec for wit ma nt Day, Mon Micshele r 2003; sur constit : SDPA con 0 tod gy.” rks twe hma a pos g andame of the titue a dedi Joe r cons veyay. Joetolo Gordon email corr new side idable socie Assistant uentert AA gynro Mo datThe nty yea sician Assista presen othe PAe and a from Buttolph, tings and Buttolph DiBaise, and red a mo a dedicatDe Greg ed with this form profess esponde sletters from SDSD rma PA tati for Physician rs nts lish Mar work ed gy PA CME mee idered a model for tolo on and org bb Ade ion PA key Jan and app estab del y nce atolo cur Mon on Gru ter Gor uar y for oth fell sreci hargy” ren has le has grown from its withatio roe. Pho helpednal of Derm for the anizatthe d wo ion“Th Kristnine Day. ical Cen er constit ct Bethany donMed s. The e Utiliza owtlyme ne toKuc SDPA is cons tion to those who Byuen from ersr thoera, 34 Jour rch the tyea rkingMa SD tion of mbove se who con President-ele s Southwestern director of the PAconversations with ecia orgr 2000 theBoard200 has PAs 1600 members less than of 0 AAD AnPA helpedtinued ), Tom much appr Greg italo (now ersit y of Texa esta gro anizat ionSD Directo nua a refiinned and Australia

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rs and l Meetin , hig Mul Univ helm as blish wth PAder is one was Jim Sot s. As ensland, this. form h-quality THrammer), nts Karen macru g. isin aloncommit tolo tee participa Universit y of Queme the main prog E Ea Preside President and idaack ent annual ble was Robert once agagyg phy at nt-elect g anh chairs; the society. ctor), asrlY YEars beca p Summit, 2007-Pres Program SD . ImportaKristine Kucera in siciwit assistan 1990 -19 ir eventually PA Program Direee The Chaide Part iV: SDPA 2007 Leadershidential message outlined ts, we ow PA is nt happen , PA- at the aies 98 of the conceiv rator Knight (whoJones (UTSW tions Committ e much ded goals: ings wer C, became At the ming presi Laboed in 199 SDPA as and Eugene A Industrial Rela orters Cor e taking praiactic and his inten to an org initial inco I). inThe 0 becaus ing place: (DL Higham’s A accomplishments AAD, allow PAs ng Vol. 4, well as SDP and financial supp dermatolo e of a des anization was congre the Initiative The rvisi No. firs uming with ning supe Day 2 ire gat cons ions SPR recent SDP Lear their t 8, don gy to e step ING in other PA Gor have PA for good relat without experie it offtotheshare 201for mer of 200 the Distance 0 33 s maintain AAD conferences bership category ding to get nces, com g to develop ched in the Sum energy accompliss practicing min kno laun in der the PA D was n of the mon attend the create an AAD mem ban on PAs atten He hed by ptio dge incewle DLI was us amount of BOD Thecam , red to s, the placing matology. Thi to identify build ible. referand aralyder physician atology, and lift at AAD conferences. of ads in a tremendosmoothly as poss was prev ie.year Joes to hadious severa s was PAs in derm cosmetic courses ent of the Journal SDPA’s nroe ng four ide to of Mo ground as in 2004 (when it ion),gro takithe cem seeking l PA journals n gatthe surgical and d the commen tants (JDPA), the ons and up ofexamaple her to find DLI bega ance Learning Opt 8; a good unce dermatolo madtolo focus this oth and hele-mder also anno gy for Physician Assiscreated by Publicati and gy PA s as the Dist e to fruition in 200and sing gy PA s. er andinde den to was step atolo his A Hay , is wif ssary com ped Derm tion Six e, Mary nece now forme LLC. finally al. The JDP Chair Trav , organiza that was Sartori, for ward: Ric Monro r official journ ons Committee Communications,A was rmination with the projectcol lab k e, dete ora icati tant ted in ma aged lved Watts, Jim Page, He the JDP Commun by Physician Assis project. this though l issue of of all invo idi Ojay On the SDPA ir, manking this huge ee Cha Ho t , Tom a developed of 2007, the inauguramembers, making own peer mitt plete In kan rea s 199 com Com lity. son e year A thre ld, CME con ces2,forthe Opp. In , and Kurtis In the Fall and sent to all SDP nizations with its d of the Momitt ee nroes sideredE Com Terr y ArnoCME Conferen De cem var published few specialty PA orgading Editorial Boar tor in the ber 199 Fall to the CM ious nam first itment, (Edi foun the SDPA duties of call thi lty recru es s new one of the the PA newsletter for 4 The first ent, facu 08). The ication. The den, MPAS, PA-CFerrer, MPAS, of gro 5-20 der lopm publ D up ma (200 deve cia reviewed ded: Travis Hay Orleans SDPA member this tim went out and program settled tology PA s and PA-C, Patri Primo, MPAS, included on Phy Rosema , February 6, s meeting at JDPA inclu Monroe, MPAS, PA s had e 23 dermatolo by , Nancy era, sician Assista 199 Opp. Bacrie Palting, Nan 5. From left the AAD Con nts Chief), Joe on Day, R.Ph, PA-CPA-C, Kristine Kuc foundi responded. Thegy fere with the in Dermato ., ng Jerry Dav k: Pat Zanolli, cy Heller, Mar to right – Fron nce in New PA-C, Gord ne Jones, Ph.D Menter, MD. log acrony y Mon t: Terr Lind what we members of idson (dec Euge m of PA y eased), a Findley, Jim roe, Sue Rancis,i Beck, PA-C, P. S, PA-C, and Alan D. Society now call the Leka and Joe uated from Monroe. s, Richard SartKurtis DHS, MPA S, PA-C grad in Physici of Dermatolog Patricia ori, Ferrer, MPA Medical Branch from an Ferrer, Patricia ee the Texas during MPAS, face-to Assistants mey Univers rsity of ers Degr -fac the her Mast the Unive t 1998 and ity of Texa PA- C graduate New Or February first tim e for the obtained aska in 2003 (SDPA of s Medical d obta from ber 1998 and 199 the Uni ined her e in leans. Branch 5 AA D rsity of Nebr Associate mem working vers an the Unive annual one room scholars ity of Neb Masters Deg in been ip). She is In the rask ree meetin . She has ntly scholarsh the SDP hip). She is an a in 2003 (SDP from g in disallowed 1990s throug and the AAPA years and is currefor A Asso the SDPA dent, Fello She has and Presi h to the gy for nine e mem A the “PA atology PA w mem ciat attende t Row: bee ber of n working ediat in dermatolo time as a derm locally and in bere early -C” yeators Fron Imm e Row partand in derme of the AAPA. rt isHigham; identif badges, thus designation 2000s the AA working VA and volunteers try to disclose. right, Back outsRobe Patrto atology entlCom ide rela currions icia wou dent-elect, n ying fell on y on mitte red D con 2007 - Left for uci sab Relat tion the Tucso onships with indus article and Presi ld like to Industry nine ference ng the batical. attend thos shipon Swartz; Hickeey; s with who wer roe; thank allsurer, Shar de relati She has chance the con ow PA s. The d to this Danielwho Mon who indu Nan e insttary/Trea no strycy AA s contribute who con President has no outsi physici fere dent, Joe the SDPA entab; not hav Secrerum Vice tributedatology to disclose. Past Presi may ans and nce only wit D allowed of Mexico. She like to thank all who development of l inand on Day; e beeGrub the earl Derm the d to PA s to session PA s cou r Gord h their n men al rces for e, Bethany ChaiSou mental in CMEy develop this article and Patricia woul s. tioned. July 2006 at Largthis articleA 6th Annu were instru ioned. ment of ctorespo the Mo At the 1995 ld only attend supervising ny Direcorr ment include letters from those who the SDP 2007 Ne ncesSDP nro Kurt thende : phone have been A SDPA newsKristine Kucera, Betha with n, D.C. o isatOpp displayin es sat outside w Orleans the plenar y Prim may not intervie FAll 2010 35 e include: , PA-C e WashingtoLind correspo AA this articl 4ws and dences with and phon osium in , Jim Pag a Findley,. PA-C 4, No. Symp email introdu g a sign asking the AA D exh D conference Sources for ; email correspon Arnold; email Gordon Day, and , Sue and Mar ndences with e, PA-CVol ce thems ibit hal Tom Hok , and Rick Sato Rancis, PA-C dermatolo y Monroe. – June 2010 s Hayden, and Terryo, Greg Buttolph, tha elve , l ans t ri, severa PA-C on, PA-C s. gy Grubb, Travi with Nancy Prim , Joe Mon . Email were offe l dermatolo Both of them PA s to stop ions roe, PA-C conversat am. and , practic ring their servgists stopped were surprised Robert High es, to them tha to find out ices to help findask if they t they had more abo PA PA s wo ut PA s, and s for their rking in to their pra inform ctices. Vol.4,

No. 1 WIN

Know Your SDPA History… Visit the JDPA Past Issues located in the members only section of the SDPA website at www.dermpa.org A sincere thank you to Patricia Ferrer, MPAS, PA-C for all of her hard work and dedication in researching and writing the four History of the SDPA articles that were published in 2010, JDPA Volume 4, Numbers 1, 2, 3, 4. We greatly appreciate her contribution to the SDPA in providing this thorough and detailed historical record.

TER 201 0 35

Vol. 5, No. 2 SPRING 2011 53

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Judicial and Ethical Affairs

Autonomy and Informed Consent By Karen Scully, MD, FRCPC, MA Ethics

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54 Journal of Dermatology for Physician Assistants

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

If you have an ethical dilemma that you have encountered or a topic that you would like discussed, please pass it along to: Editor@jdpa.org

What Do You Want To Read About In The JDPA? Weâ&#x20AC;&#x2122;re interested in knowing what kind of articles SDPA members would be interested in reading more about in order to help improve their practice of dermatology. Share your content ideas today. Email them to editor@jdpa.org Vol. 5, No. 2 SPRING 2011 55

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Notes from your Office Manager CMS Electronic Prescribing Program SDPA Members Only Content

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Reprinted with permission from the American Academy of Dermatology.

56 Journal of Dermatology for Physician Assistants

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OUT OF POCKET* Introducing the No-Pay copay* for Taclonex® Ointment and Taclonex Scalp® *Up to $200 off per prescription fill. Restrictions apply. Please see reverse for eligibility, terms, and conditions.

Vol. 5, No. 2 SPRING 2011 57

Terms and Conditions 1. This card is not valid for prescriptions reimbursed in whole or in part by Medicaid, Medicare, or other federal or state programs (including any state prescription drug programs), or by private indemnity or HMO insurance plans that reimburse you for the entire cost of your prescription drugs. Not valid for patients who are Medicare eligible and enrolled in an employer-sponsored health plan or prescription drug benefit program for retirees (i.e. you are eligible for Medicare Part D but receive a prescription drug benefit through a former employer). 2. This card is not insurance. 3. This card is good for use only with a valid Taclonex® Ointment or Taclonex Scalp® Topical Suspension prescription. Original card must be presented to the pharmacist at the time the prescription is filled. Not valid if reproduced. 4. You must be 18 years of age or older to be eligible. Only one card per patient, not transferable. 5. Claims submitted to private insurers must fully reflect all discounts, rebates, or other reductions in price. 6. This card is good for 6 prescription fills. Program expires on 12/31/12. 7. Offer good only in the USA at participating retail pharmacies. 8. LEO Pharma Inc. redeems this card and reserves the right to rescind, revoke, or amend this offer without notice. 9. Offer void in Massachusetts. Void if prohibited by law, taxed, or restricted. 10. The selling, purchasing, trading, or counterfeiting of this card is prohibited by law. 11. Not valid with any other offers, discounts, or programs. Card has no cash value. 12. You understand and agree to the terms and conditions as set forth above. Patients may save up to $200 off per prescription fill, which may make copays as low as $0.

Please see Taclonex.com for Important Safety Information and full Prescribing Information. The LEO and Lion Design trademarks and all other marks included herein are owned by LEO Pharma A/S. ©2011 LEO Pharma Inc. 3428-TAC-0211-054 February 2011 Printed in USA

58 Journal of Dermatology for Physician Assistants

Outside & Inside the 9 to 5... We recently had the pleasure of interviewing Joleen Volz, MPAS, PA-C. Upon graduating PA school seven years ago, Joleen began working in dermatology at Lower Cape Fear Dermatology in Wilmington, NC. She currently practices in Dallas, TX at Texas Dermatology Associates with Dr. Alan Menter. Joleen is currently serving as the SDPA Constituent Relations Committee Chairperson, and one of her responsibilities is helping facilitate new state chapters to become affiliated with the SDPA.

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T:10.75 in

S:10.75 in

is over 1,800 members strong, we are able to reach many members to obtain support for specific legislation. There are networking opportunities available through the SDPA via the I had wanted to become more website forum, newsletter, JDPA, and involved in the organization that I at conferences. State Affiliates also feel has helped my profession as receive support from the SDPA Board a dermatology physician assistant of Directors. As a benefit of becoming grow to its current capacity. I am affiliated, State Affiliates of the SDPA proud not only to be a physician are provided with a basic Internet assistant, but I am especially proud web page paid for by the SDPA. This of the growth within the profession website is then linked to the SDPA of dermatology physician assistants. website for easy accessibility and The SDPA has been a leader amongst Joleen Volz, MPAS, PA-C outreach to each of our members. specialty societies. The SDPA has much information on our website about how to become affiliated. When working with the State Affiliates, what does your typical week/month look like? What are your greatest sources of inspiration? I answer multiple questions from people who My greatest source of inspiration has been from are trying to have their state chapters become other leaders in the SDPA. Those who have affiliated with the SDPA. I help the state chapters taken time out, above and beyond their 9 to 5 throughout the entire process beginning with commitments, to contribute to the development questions about starting the affiliate process all the and growth of all dermatology physician assistants. way through assisting in approving applications The SDPA offers programs such as the Distance for affiliation. Learning Initiative that help to put our profession on a higher level and are an additional source of What are the greatest challenges of working in inspiration. your SDPA position and with State Affiliates? Being new to my position with the SDPA, I sometimes have to learn while working with members. They may come to me with questions that are new, and I have to research or ask the appropriate leaders for guidance. I would like to stress to any potential State Affiliates that even if I do not know an answer to a question immediately, I am here for them and will obtain the correct answer and information they need. My favorite bit of advice for SDPA members isâ&#x20AC;Ś The SDPA offers many advantages and resources available to state affiliates. Given that the SDPA

Looking into the future, describe your ideal vision for dermatology physician assistants. In the short time that I have been a dermatology physician assistant, I would never have envisioned that we would be in the position we are today. Dermatology PAs have grown in number in the short seven years I have been in practice. Dermatology PAs are faced with increased criticism and scrutiny within the field of dermatology. Thanks to the SDPA and other leaders within our profession, I look forward to continued growth and acceptance within our dermatology community.

Vol. 5, No. 2 SPRING 2011 59

professional development

What interested you about the SDPA and about becoming more involved with the Constituent Relations Committee position?

Dermatology PA news & notes

From the Desk of... Ann Davis, PA-C

AAPA Senior Director for State Advocacy and Outreach

Ideal State Laws for PA Practice - Getting There from Here States license and regulate health professionals to protect those within their borders from unqualified or unscrupulous practitioners. During the relatively brief tenure of the PA profession we have seen rapid evolution in the state laws that govern PAs. When the first state laws regulating PA practice were enacted 40 years ago, they were often passed as brief amendments to the medical practice acts that allowed PAs to provide care without being guilty of the “unlicensed practice of medicine.” As the profession grew, states realized that PAs needed to be addressed in the law as a separate profession. This led to a second wave of PA laws that attempted to specify the tasks and medical services that PAs could provide. But these types of laws proved impractical for two significant reasons. First, since physician-PA teams practice in every clinical specialty and every practice setting, a list in the PA practice acts could not possibly include every service that PAs can provide. Second, the process for revising state laws cannot keep pace with the rapidly evolving field of medicine. Today, the majority of state PA practice acts are written in a way that allows supervising physicians, as leaders of the medical team, to determine how best to utilize PAs in a practice. In order to help PAs, physicians, and policymakers grasp the concepts that are integral to modern laws for PAs, the AAPA has identified Six Key Elements of a Modern PA Practice Act. These will be readily identifiable to PAs in clinical practice as the basic requirements for efficient and effective practice. Ann Davis, PA-C iis the senior director for state advocacy and outreach for the American Academy of Physician Assistants, a position she has held since 1994. In this role Ann researches and summarizes state laws for PAs, drafts legislation to improve state laws, and educates state and national groups on utilization and regulation of physician assistants. Ann is a graduate of the University of Colorado physician assistant program. Prior to joining the Academy staff she practiced as a PA in pediatrics and taught at the University of Colorado PA program.

60 Journal of Dermatology for Physician Assistants

Here is a quick rundown of the Six Key Elements: 1. “Licensure” as the Regulatory Term Forty-six states already use the term “licensure” to describe the process by which the state authorizes PAs to practice, but four (Massachusetts, New York, Ohio, and Vermont) still use the terms “certification” or “registration.” If a PA practice act uses a term other than “licensure,” then PAs can be excluded from state laws that use broad terms such as “licensed health professionals.” 2. Scope of Practice Determined at Practice Site Ideal laws allow physicians to determine what responsibilities to delegate to the PAs they supervise and work with these PAs to customize the flow of clinical work in a way that best fits the practice. State laws that include a specific list of services that PAs can provide or that require the scope of practice of each individual PA to be approved by the state medical board restrict the ability of supervising physicians and physician assistants to provide care most effectively. 3. Adaptable Supervision Requirements Some state laws specify that a physician must either be on site for a specific amount of time or within a specific physical proximity to the PA. Different methods of supervision are appropriate in different clinical settings. Imposing supervision requirements through state laws rather than allowing them to be determined at the practice level imposes unnecessary limitations. 4. Full Prescriptive Authority Laws that restrict the ability of supervising physicians to delegate prescriptive authority to PAs have the potential to cause interruptions in the delivery of care. Currently all states authorize PAs to prescribe, but Florida and Kentucky do not yet include controlled medications in PA prescriptive authority. Thirty-six states authorize PAs to prescribe Schedules II-V medications.

The Six Key Elements of a Modern PA Practice Act are reflected in the AAPA Model State Legislation and the AAPAâ&#x20AC;&#x2122;s Guidelines for State Regulation of Physician Assistants. In addition, many of the Six Key Elements are supported by policies of national physician organizations, including

the American Medical Association, the American Academy of Family Physicians, and the American College of Physicians, as well as by the Federation of State Medical Boards. To date, only two states (North Dakota and Rhode Island) have PA laws that include all six of the key elements. Seven states have five and many have four. The great news is that PA advocates across the country are working to make laws better. At present, PA leaders in eighteen states are advocating for improvements in at least one of the Six Key Elements. For PAs who practice in dermatology, laws outside the PA practice acts also impact practice. Among these are laws governing lasers, injectable fillers, outpatient surgery, and off-label use of drugs. Across the country, twenty-six states in total are supporting improvements to state laws and many of these will specifically impact PAs in dermatology. The AAPAâ&#x20AC;&#x2122;s State Advocacy department works closely with the SDPA, state chapters, and other PA specialty societies to improve state laws for PA practice. Working together, we can get there from here! J

Vol. 5, No. 2 SPRING 2011 61

DERmatology pa news & notes

5. Chart Co-Signature Requirements Determined at Practice Site When state laws contain rigid chart cosignature requirements, supervising physicians are forced to spend an inordinate amount of time signing off on routine episodes of care. Ideally, physician co-signature requirements should be determined at the practice level, when the supervising physician, the PA, or the facility determines that it is necessary. 6. Number of PAs a Physician May Supervise Determined at Practice Level In many settings, a supervising physician can adequately supervise multiple PAs. In a complex surgical setting, a physician might appropriately choose to supervise only one PA. State laws should not impose a limit that applies to all clinical settings.

The Difference We Make Minimal Medicine

DERmatology pa news & notes

By Brian T. Maurer, PA-C

Sometimes I wonder whether we as a society Here’s Bittman musing again: “Usually, I was either have not over-medicalized life. We spend so much of taught to make something or I modeled it myself, as our time browsing health columns, monitoring vital best I could. I refused to buy into the notion that there signs, ruminating on our symptoms, and consulting was a ‘correct’ way to prepare a given dish; rather, I our doctors. Many of us have become so health tried to understand its spirit and duplicate that, no matter where I was cooking.” Osler advocated that conscious that we balk at deviating from the straight and narrow path. When it comes to our health, we “the practical shall take the place of didactic teaching.” have become risk averse. Even those of us who spend To acquire the skills necessary to perform medical their days in clinical practice recognize that medicine procedures, students are encouraged to “see one, do does not encompass all of life. Perhaps we all need one, teach one.” In 1867 the physician Oliver Wendell to learn to practice minimal Holmes argued that the “most medicine. essential part of a student’s “As it turns out, These thoughts ran through instruction is obtained … not my head as I read Mark Bittman’s the lecture-room, but at the the culinary arts share inbedside.” final New York Times (NYT) Bittman maintains that, Minimalist culinary column. Over “as Jacques Pépin once said to a good deal with a span of thirteen years Bittman me, you never cook a recipe authored nearly 700 weekly the same way twice, even if you medical practice.” columns for the NYT Dining try.” How true. And you never section. As it turns out, the perform a physical examination culinary arts share a good deal with medical practice. or surgical procedure in exactly the same way. There “I discovered that you never cook with someone else are always confounding factors which necessitate without learning something,” Bittman writes. “In every workarounds and thinking outside the box. case, there’s a two-way transfer of knowledge. If they Medical practice, like cooking, is always a know less than you do, you grow from teaching. If compromise. Like their culinary counterparts, clinicians more, of course, you grow from learning.” “almost never have the time, the ideal ingredients or equipment, or all of the skills we’d like.” “Shop avidly, Bittman’s words bring to mind Sir William Osler’s description of a medical teacher and a student, “the keep a full refrigerator and pantry,” Bittman advises; pupil and the teacher working together on the same “pull things out and get to work.” Where would the lines, only one a little ahead of the other. This is the good clinician be without a well-stocked surgery? ideal toward which we should move.” After 25 years “My growing conviction that the meat-heavy of practice, Osler observed, “I have learned … to be American diet and our increasing dependence on a better student, and to be ready to say to my fellow prepared and processed foods is detrimental not only students, ‘I do not know’.” Osler reckoned that “no to our personal health but to that of the planet has man can teach successfully who is not at the same had an impact on my life.” A nutshell of sound dietary time a student.” advice, one every practicing clinician should take to heart. Brian T. Maurer has practiced pediatric medicine as a physician assistant for thirty years. Over the past two decades Mr. Maurer has Bittman concludes: “What I see as the continuing explored the illness narrative as a tool to cultivate an appreciation for attack on good, sound eating and traditional farming the delivery of humane medical care. He has published numerous in the United States is a political issue.” What I see vignettes, editorials, and essays in both national and international as the continuing attack on good sound traditional journals. Mr. Maurer has been a contributing author to the online open-access journal Dermanities (www.dermanities.com) since medical practice has lately become a political issue its inception. Readers can visit the author on the web at http:// as well. J briantmaurer.wordpress.com.

62 Journal of Dermatology for Physician Assistants

When comedonal acne is your primary concern…

PRESCRIBE DIFFERIN® GEL, 0.3%

Primarily comedonal acne: EXAMPLE A

EXAMPLE B

POWERFUL EFFICACY

HIGH PATIENT SATISFACTION

From baseline to week 12, lesion reduction (total, noninﬂammatory, and inﬂammatory) was similar to tazarotene gel, 0.1%1*

86% of patients on adapalene gel, 0.3% were satisﬁed or very satisﬁed vs 69% on tazarotene gel, 0.1%1* Local tolerability scores comparable to tretinoin gel microsphere, 0.04%2†

*A phase 3b, 12-week, noninferiority, multicenter, investigator-blinded, controlled clinical study of patients 12 to 35 years of age with acne vulgaris (N=172). At the end of 12 weeks, neither product was found to be inferior. 160 patients participated in the satisfaction survey. A single-center, randomized, investigator/evaluator-blinded, bilateral (split-face) comparison of healthy subjects ≥18 years of age (N=30). Subjects received Differin® Gel, 0.3% on one half of the face and tretinoin gel microsphere, 0.04% on the other half for 22 days.

†

Important Safety Information Of the patients who experienced cutaneous irritation (erythema, scaling, dryness, and/or stinging/burning) during the clinical trial, the majority of cases were mild to moderate in severity, occurred early in treatment, and decreased thereafter. Adverse events that occurred in greater than 1% of the subjects included dry skin (14.0%), skin discomfort (5.8%), pruritus (1.9%), desquamation (1.6%), and sunburn (1.2%). Pregnancy Category C. Concomitant use of potentially irritating products or overexposure to sunlight or sunlamps, extreme wind or cold, may increase the potential for irritation. Use of sunscreen and protective clothing over treated areas are recommended when exposure cannot be avoided.

Please see brief summary of Prescribing Information on adjacent page.

www.differin.com

Vol. 5, No. 2 SPRING 2011 63

DIFFERIN® (adapalene) Gel, 0.3% BRIEF SUMMARY

Rx only

For topical use only. Not for ophthalmic, oral or intravaginal use. INDICATIONS AND USAGE: DIFFERIN® Gel, 0.3% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. CONTRAINDICATIONS: DIFFERIN® Gel, 0.3% should not be administered to individuals who are hypersensitive to adapalene or any of the components in the gel vehicle. PRECAUTIONS: General: Certain cutaneous signs and symptoms of treatment such as erythema, scaling, dryness, and stinging/burning may be experienced with use of DIFFERIN® Gel, 0.3%. These are most likely to occur during the first four weeks of treatment, are mostly mild to moderate in intensity, and usually lessen with continued use of the medication. Depending upon the severity of these side effects, patients should be instructed to either use a moisturizer, reduce the frequency of application of DIFFERIN® Gel, 0.3% or discontinue use. If a reaction suggesting sensitivity or chemical irritation occurs, use of the medication should be discontinued. Exposure to sunlight, including sunlamps, should be minimized during use of adapalene. Patients who normally experience high levels of sun exposure, and those with inherent sensitivity to sun, should be warned to exercise caution. Use of sunscreen products and protective clothing over treated areas is recommended when exposure cannot be avoided. Weather extremes, such as wind or cold, also may be irritating to patients under treatment with adapalene. Avoid contact with the eyes, lips, angles of the nose, and mucous membranes. The product should not be applied to cuts, abrasions, eczematous or sunburned skin. As with other retinoids, use of “waxing” as a depilatory method should be avoided on skin treated with adapalene. Information for Patients: Patients using DIFFERIN® Gel, 0.3%, should receive the following information and instructions: 1. This medication is to be used only as directed by the physician. 2. It is for external use only. 3. Avoid contact with the eyes, lips, angles of the nose, and mucous membranes. 4. Cleanse affected area with a mild or soapless cleanser before applying this medication. 5. Moisturizers may be used if necessary; however, products containing alpha hydroxy or glycolic acids should be avoided. 6. Exposure of the eye to this medication may result in reactions such as swelling, conjunctivitis, and eye irritation. 7. This medication should not be applied to cuts, abrasions, eczematous, or sunburned skin. 8. Wax epilation should not be performed on treated skin due to the potential for skin erosions. 9. During the early weeks of therapy, an apparent exacerbation of acne may occur. This may be due to the action of the medication on previously unseen lesions and should not be considered a reason to discontinue therapy. Drug Interactions: As DIFFERIN® Gel, 0.3% has the potential to induce local irritation in some patients, concomitant use of other potentially irritating topical products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect, and products with high concentrations of alcohol, astringents, spices, or lime) should be approached with caution. Particular caution should be exercised in using preparations containing sulfur, resorcinol, or salicylic acid in combination with DIFFERIN® Gel, 0.3%. If these preparations have been used, it is advisable not to start therapy with DIFFERIN® Gel, 0.3%, until the effects of such preparations have subsided. Carcinogenesis, Mutagenesis, Impairment of Fertility: Carcinogenicity studies with adapalene have been conducted in mice at topical doses of 0.4, 1.3, and 4.0 mg/kg/day, and in rats at oral doses of 0.15, 0.5, and 1.5 mg/kg/day. These doses are up to 3 times (mice) and 2 times (rats) in terms of mg/m²/day the potential exposure at the maximum recommended human dose (MRHD), assumed to be 2.5 grams DIFFERIN® Gel, 0.3%. In the oral study, increased incidence of benign and malignant pheochromocytomas in the adrenal medullas of male rats was observed. No photocarcinogenicity studies were conducted. Animal studies have shown an increased risk of skin neoplasms with the use of pharmacologically similar drugs (e.g., retinoids) when exposed to UV irradiation in the laboratory or to sunlight. Although the significance of these studies to human use is not clear, patients should be advised to avoid or minimize exposure to either sunlight or artificial UV irradiation sources. Adapalene did not exhibit mutagenic or genotoxic effects in vitro (Ames test, Chinese hamster ovary cell assay, mouse lymphoma TK assay) and in vivo (mouse micronucleus test). Reproductive function and fertility studies were conducted in rats administered oral doses of adapalene in amounts up to 20 mg/kg/day (up to 26 times the MRHD based on mg/m² comparisons). No effects of adapalene were found on the reproductive performance or fertility of the F0 males or females. There were also no detectable effects on the growth, development and subsequent reproductive function of the F1 offspring. Pregnancy: Teratogenic effects. Pregnancy Category C. Retinoids may cause fetal harm, when administered to pregnant women. Adapalene has been shown to be teratogenic in rats and rabbits when administered orally (see Animal Data below). There are no adequate and well-controlled studies in pregnant women. DIFFERIN® Gel, 0.3% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The safety and efficacy of DIFFERIN® Gel, 0.3% in pregnancy has not been established. 1. Human Data In clinical trials involving DIFFERIN® Gel, 0.3% in the treatment of acne vulgaris, women of child-bearing potential initiated treatment only after having had a negative pregnancy test and used effective birth control measures during therapy. However, 6 women treated with DIFFERIN® Gel, 0.3% became pregnant. One patient elected to terminate the pregnancy, two patients delivered healthy babies by normal delivery, two patients delivered prematurely and the babies remained in intensive care until reaching a healthy state and one patient was lost to follow-up. 2. Animal Data • No teratogenic effects were seen in rats at oral doses of 0.15 to 5.0 mg/kg/day adapalene representing up to 6 times the maximum recommended human dose (MRHD) based on mg/m² comparisons. Adapalene has been shown to be teratogenic in rats and rabbits when administered orally at doses 25 mg/kg representing 32 and 65 times, respectively, the MRHD based on mg/m² comparisons. Findings included cleft palate, microphthalmia, encephalocele and skeletal abnormalities in the rat and umbilical hernia, exophthalmos and kidney and skeletal abnormalities in the rabbit. • Cutaneous teratology studies in rats and rabbits at doses of 0.6, 2.0, and 6.0 mg/kg/day exhibited no fetotoxicity and only minimal increases in supernumerary ribs in both species and delayed ossification in rabbits. Systemic exposure (AUC0-24h) to adapalene 0.3% gel at topical doses of 6.0 mg/kg/day in rats and rabbits represented 5.7 and 28.7 times, respectively, the exposure in acne patients treated with adapalene 0.3% gel applied to the face, chest and back (2 grams applied to 1000 cm2 of acne involved skin). Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when DIFFERIN® Gel, 0.3% is administered to a nursing woman. Pediatric Use: Safety and effectiveness in pediatric patients below the age of 12 have not been established. Geriatric Use: Clinical studies of DIFFERIN® Gel, 0.3% did not include subjects 65 years of age and older to determine whether they respond differently than younger subjects. Safety and effectiveness in geriatric patients age 65 and above have not been established.

64 Journal of Dermatology for Physician Assistants

ADVERSE REACTIONS: In the multi-center, controlled clinical trial, signs and symptoms of local cutaneous irritation were monitored in 258 acne patients who used DIFFERIN® Gel, 0.3% once daily for 12 weeks. Of the patients who experienced cutaneous irritation (erythema, scaling, dryness, and/or burning/stinging), the majority of cases were mild to moderate in severity, occurred early in treatment and decreased thereafter. The incidence of local cutaneous irritation with DIFFERIN® Gel, 0.3% from the controlled clinical study is provided in the following table: Table 2: Physician assessed local cutaneous irritation with DIFFERIN® Gel Incidence of Local Cutaneous Irritation with DIFFERIN® Gel, 0.3% from Controlled Clinical Study (N=253*) Maximum Severity Scores Higher Than Baseline Erythema Scaling Dryness Burning/Stinging

Mild 66 (26.1%) 110 (43.5%) 113 (44.7%) 72 (28.5%)

Moderate 33 (13.0%) 47 (18.6%) 43 (17.0%) 36 (14.2%)

Severe 1 (0.4%) 3 (1.2%) 2 (0.8%) 9 (3.6%)

* Total number of subjects with local cutaneous data for at least one post-Baseline evaluation. Table 3: Patient reported local cutaneous adverse events with DIFFERIN® Gel DIFFERIN® (adapalene) Gel, 0.3% Related* Adverse Events Dry Skin Skin Discomfort Desquamation

Vehicle Gel

N=258

N=134

57 (22.1%) 36 (14%) 15 (5.8%) 4 (1.6%)

6 (4.5%) 2 (1.5%) 0 (0.0%) 0 (0.0%)

* Selected adverse events defined by investigator as Possibly, Probably or Definitely Related Related adverse events from the controlled clinical trial that occurred in greater than 1% of patients who used DIFFERIN® Gel, 0.3% once daily included: dry skin (14.0%), skin discomfort (5.8%), pruritus (1.9%), desquamation (1.6%), and sunburn (1.2%). The following selected adverse events occurred in less than 1% of patients: acne flare, contact dermatitis, eyelid edema, conjunctivitis, erythema, pruritus, skin discoloration, rash, and eczema. In a one-year, open-label safety study of 551 patients with acne who received DIFFERIN® Gel, 0.3%, the pattern of adverse events was similar to the 12-week controlled study. OVERDOSAGE: DIFFERIN® Gel, 0.3% is intended for topical use only. If the medication is applied excessively, no more rapid or better results will be obtained and marked redness, scaling, or skin discomfort may occur. Chronic ingestion of the drug may lead to the same side effects as those associated with excessive oral intake of vitamin A. Marketed by: GALDERMA LABORATORIES, L.P. Fort Worth, Texas 76177 USA Manufactured by: DPT Laboratories, Ltd. San Antonio, Texas 78215 USA GALDERMA is a registered trademark. Revised: June 2007 325089-0607

Reference: 1. Thiboutot D, Pariser DM, Egan N, et al; Adapalene Study Group. Adapalene gel 0.3% for the treatment of acne vulgaris: a multicenter, randomized, double-blind, controlled, phase III trial. J Am Acad Dermatol. 2006;54:242-250. Marketed by: GALDERMA LABORATORIES, L.P. References: 1. Thiboutot D, Arsonnaud S, Soto P. Efﬁcacy and tolerability of adapalene 0.3% gel Fort Worth, Texas 76177 USA compared to tazarotene 0.1% gel in the treatment of acne vulgaris. J Drugs Dermatol. 2008;7 Manufactured by: (6)(suppl):S3-S10. 2. Data on ﬁle. Galderma Laboratories, L.P. A 3-week, single-center, randomized, DPT Laboratories, Ltd. investigator/evaluator-blinded, San Antonio, Texas 78215 USA bilateral (split-face) comparison, clinical study of adults 18 years of age GALDERMA is ahealthy registered and older with skintrademark. (N=30). Revised: June 2007 325089-0607 Differin andisGalderma aretrademark. registered trademarks. Galderma a registered ©2007 Galderma Laboratories, L.P. ©2010 Galderma Laboratories, L.P. Galderma Laboratories, L.P. Galderma Laboratories, L.P. 14501 N. Freeway 14501 N. Freeway Fort Worth, TX 76177 Fort Worth, TX 76177 DIFF-088 Printed03/10 www.differin.com DIF-888 in USA 11/07

Supervising Physician CORNER Prayer of the Orphan Patient to the Doctor By Walter B. Shelley & E. Dorinda Shelley Introduction By Benjamin Barankin, MD

T:11”

B:12.25”

S:9.5”

Benjamin Barankin, MD grew up in Toronto, Canada, received a BA in psychology from Queen’s University, and then graduated from The University of Western Ontario medical school. He completed his dermatology residency at the University of Alberta in Edmonton, Alberta, Canada. He is the Founder & Medical Director of the Toronto Dermatology Centre (www. torontodermatologycentre.com) in Toronto, Ontario, Canada and loving every minute of it. The online journal Dermanities was launched in December of 2002 by Dr. Barankin and Dr. David J. Elpern, based on the lack of coverage of the humanities and patient care in the dermatology literature. This article was reprinted with permission from Dermanities. To read more please visit the Dermanities website at www.dermanities.com com .

Listen to me Don’t be cynical, indifferent, or in a hurry. Ask me what makes my problem better or worse. Ask me what I think the cause is. Ask me to look for clues and teach me what they are.

Think about me Think of my problem when you read those books, journals, and atlases. Think of my problem when you attend meetings. Think of asking your colleagues about me.

Test me Order specific tests to help you decide on my diagnosis and treatment. Could I have AIDS, cancer, or lupus? Do I need a biopsy? A challenge with a medication? Do I need hospital help? Do I need to see a consultant?

Don’t give up on me There is always one more treatment you can try. Just imagine I have a different disease and treat me for that. See me during an attack to get new ideas and new tests. Ask me lots of questions during every visit. I won’t give up on you, for I am an orphan.

Vol. 5, No. 2 SPRING 2011 65

DERmatology pa news & notes

alter B. Shelley, M.D., Ph.D. (who passed away January 30, 2009) is one of the great figures of American dermatology. His research on the secretion of the armpit glands led to antiperspirants; he devised a test to detect penicillin sensitivity; and he found the cell causing allergic reaction to poison ivy. Dr. Shelley wrote the textbook Dermatology (1956), and an autobiography, The Skin Around Me: Adventures in Dermatology (2007). His prolific writing career included numerous textbooks and more than 400 peer-reviewed papers. Dr. Walter B. Shelley was married to E. Dorinda Shelley, M.D., another great icon of American dermatology. The legendary dermatology team of Walter and Dorinda Shelley were known to have been a little different: thinking more, publishing more, and discovering more. While both are regarded as great scientists and physicians, the Shelleys have always been great humanitarians and creative spirits. Here is one or the Shelley’s poems to inspire and enlighten us.

Professional Opportunities and Development

CME

Advertiser INDE X OrthoDermatologics – Retin-A Micro......Pages 2, 3 Ranbaxy – Kenalog Spray.......................... Pages 7, 8 Coria – Atralin......................................Pages 11, 12 Coria – Acanya...................................... Pages 15, 16 Graceway – Zyclara...............................Pages 27, 28 Galderma – Clobex Spray......................Pages 31, 32 Galderma – Vectical...............................Pages 36, 37 Coria – Refissa.......................................Pages 39, 40 Allergan – Aczone..................................Pages 45, 46 Galderma – Oracea...............................Pages 49, 50 Leo – Taclonex....................................... Pages 57, 58 Galderma – Differin 0.3.......................Pages 63, 64 PharmaDerm – Veregen........................ Pages 67, 68 For more information on advertising opportunities in the JDPA, please log on to www.jdpa.org

6.5 AMA PRA Category 1 CreditsTM

Denver, CO. Sat. April 30 | St. Louis, MO. Sat. Sept. 24

The International Hyperhidrosis Society

in partnership with Eastern Virginia Medical School, is offering two outstanding opportunities for all healthcare providers to get their hyperhidrosis diagnosis, treatment, and practice management skills into top form.

Hyperhidrosis: Best Practices and Emerging Technologies in Contemporary Care offers attendees

dynamic, live-patient training from world leaders in hyperhidrosis management. This educational activity has been approved for 6.5 AMA PRA Category 1 CreditsTM. The itinerary is a morning lecture and discussion that is focused on hyperhidrosis basics, including topical therapies, iontophoresis, injection treatments of axillary and non axillary hyperhidrosis, and incorporating office staff into patient treatment and management. The afternoon session is devoted to live-patient instruction. Local physicians, alongside members of the expert panel, will provide hyperhidrosis treatment with Botox or iontophoresis, as necessary, to their patient volunteers. The demonstrations will be done in small group settings so all participants will experience optimal learning. Join Us!

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14TH ANNUAL PEMHIGUS & PEMPHIGOID PATIENT/DOCTOR MEETING MAY 20-22, 2011 JOIN US IN DETROIT FOR OUR ANNUAL PATIENT/DOCTOR MEETING! 66 Journal of Dermatology for Physician Assistants

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

Veregen

USE IN SPECIFIC POPULATIONS

Pregnancy

(sinecatechins)

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

Ointment, 15%

Nursing Mothers

Rx Only

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

Pediatric Use

For Topical Dermatologic Use Only

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use INDICATIONS AND USAGE Veregen® is indicated for the topical treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older. The safety and effectiveness of Veregen® have not been established for treatment beyond 16-weeks or for multiple treatment courses. The safety and effectiveness of Veregen® in immunosuppressed patients have not been established.

CONTRAINDICATIONS None

CLINICAL STUDIES Two randomized, double-blind, vehicle-controlled studies were performed to investigate the safety and efficacy of Veregen® in the treatment of immunocompetent patients 18 years of age and older with external genital and perianal warts. The subjects applied the ointment 3 times daily for up to 16 weeks or until complete clearance of all warts (baseline and new warts occurring during treatment). Over both studies the median baseline wart area was 51 mm2 (range 12 to 585 mm2), and the median baseline number of warts was 6 (range 2 to 30). The primary efficacy outcome measure was the response rate defined as the proportion of patients with complete clinical (visual) clearance of all external genital and perianal warts (baseline and new) by week 16, presented in Tables 1 and 2 for all randomized subjects dispensed medication.

Table 1: Efficacy by Region Complete Clearance All Countries (includes the United States) Veregen® 15% (N = 397)

213 (53.6%)

Vehicle (N = 207)

73 (35.3%)

United States Veregen® 15% (N = 21)

5 (23.8%)

Vehicle (N = 9)

0 (0.0%)

Table 2: Efficacy by Gender Complete Clearance Males Veregen® 15% (N = 205)

97 (47.3%)

Vehicle (N = 118)

34 (28.8%)

Females Veregen® 15% (N = 192)

116 (60.4%)

Vehicle (N = 89)

39 (43.8%)

Median time to complete wart clearance was 16 weeks and 10 weeks, respectively, in the two phase 3 clinical trials. The rate of recurrence of external genital and perianal warts 12 weeks after completion of treatment in subjects with complete clearance is 6.8% (14/206) for those treated with Veregen® and 5.8% (4/69) for those treated with vehicle.

WARNINGS AND PRECAUTIONS Veregen® has not been evaluated for the treatment of urethral, intra-vaginal, cervical, rectal, or intra-anal human papilloma viral disease and should not be used for the treatment of these conditions. Use of Veregen® on open wounds should be avoided. Patients should be advised to avoid exposure of the genital and perianal area to sun/ UV-light as Veregen® has not been tested under these circumstances.

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

ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In Phase 3 clinical trials, a total of 397 subjects received Veregen® three times per day topical application for the treatment of external genital and perianal warts for up to 16 weeks. Serious local adverse events of pain and inflammation were reported in two subjects (0.5%), both women. In clinical trials, the incidence of patients with local adverse events leading to discontinuation or dose interruption (reduction) was 5% (19/397). These included the following events: application site reactions (local pain, erythema, vesicles, skin erosion/ulceration), phimosis, inguinal lymphadenitis, urethral meatal stenosis, dysuria, genital herpes simplex, vulvitis, hypersensitivity, pruritus, pyodermitis, skin ulcer, erosions in the urethral meatus, and superinfection of warts and ulcers. Local and regional reactions (including adenopathy) occurring at >1% in the groups treated with Veregen® (N=397) or vehicle (N=207), respectively, were: erythema (70%, 32%), pruritus (69%, 45%), burning (67%, 31%), pain/discomfort (56%, 14%), erosion/ulceration (49%, 10%), edema (45%, 11%), induration (35%, 11%), rash vesicular (20%, 6%), regional lymphadenitis (3%, 1%), desquamation (5%, <1%), discharge (3%, <1%), bleeding (2%, <1%), reaction (2%, 0%), scar (1%, 0%), irritation (1%, 0%), and rash (1%, 0%). A total of 266/397 (67%) of subjects in the Veregen® group had either a moderate or a severe reaction that was considered probably related to the drug, of which 120 (30%) subjects had a severe reaction. Severe reactions occurred in 37% (71/192) of women and in 24% (49/205) of men. The percentage of subjects with at least one severe, related adverse event was 26% (86/328) for subjects with genital warts only, 42% (19/45) in subjects with both genital and perianal warts and 48% (11/23) of subjects with perianal warts only. Phimosis occurred in 3% of uncircumcised male subjects (5/174) treated with Veregen® and in 1% (1/99) in vehicle. The maximum mean severity of erythema, erosion, edema, and induration was observed by week 2 of treatment. Less common local adverse events included urethritis, perianal infection, pigmentation changes, dryness, eczema, hyperesthesia, necrosis, papules, and discoloration. Other less common adverse events included cervical dysplasia, pelvic pain, cutaneous facial rash, and staphylococcemia. In a dermal sensitization study of Veregen® in healthy volunteers, hypersensitivity (type IV) was observed in 5 out of 209 subjects (2.4%) under occlusive conditions.

DOSAGE AND ADMINISTRATION Veregen® is to be applied three times per day to all external genital and perianal warts. Treatment with Veregen® should be continued until complete clearance of all warts, however no longer than 16 weeks.

HOW SUPPLIED/STORAGE AND HANDLING Veregen® is a brown ointment and is supplied in an aluminum tube containing 15 grams (NDC # 10337-450-15) of ointment per tube. Prior to dispensing to the patient, store refrigerated 2°C to 8°C (36°F to 46°F). After dispensing, store refrigerated or up to 25°C (77°F). Do not freeze.

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

Manufactured for:

www.pharmaderm.com

Melville, NY 11747 USA

98NVE390210

Vol. 5, No. 2 SPRING 2011 67

A clear message for external genital and perianal warts (EGW)...

“I don’t want to see you again.” VEREGEN® Delivers Complete Clearance With Low Recurrence • Demonstrated complete clearance in 53.6% of all patients studied1

• Only 6.8% rate of recurrence among patients with complete clearance 12 weeks posttreatment1

• Proven effective in clearing both baseline and newly emerging EGW in male and female patients1

The FIRST

BOTANICAL DRUG approved for prescription use in the United States2

VEREGEN

(sinecatechins) Ointment,15%

Get out and stay out. VEREGEN® is indicated for the topical treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older. Important Selected Safety Information

VEREGEN® has not been evaluated to treat urethral, intra-vaginal, cervical, rectal, or intra-anal human papilloma viral disease and should not be used to treat these conditions. Avoid use of VEREGEN® on open wounds. Avoid exposure of VEREGEN®-treated areas to sun/UV-light because VEREGEN® has not been tested under these circumstances. Safety and efficacy of VEREGEN® have not been established in immunosuppressed or pediatric patients, or pregnant women, or for the treatment of external genital and perianal warts beyond 16 weeks or for multiple treatment courses. The most common adverse reactions are local skin and application site reactions including (incidence ≥ 20%) erythema, pruritus, burning, pain/discomfort, erosion/ulceration, edema, induration, and rash vesicular. References: 1. VEREGEN® Ointment, 15% [Prescribing Information, 2008]. Melville, NY: PharmaDerm, a division of Nycomed US Inc. 2. Data on file, PharmaDerm. Please see adjacent page for Brief Summary of full Prescribing Information.

68 Journal of Dermatology for Physician Assistants