Fall 2009 Journal of Dermatology for Physician Assistants

Page 1

Volume 3 number 4 FALL 2009

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. 3, No. 4 FALL 2009


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RETIN-A MICRO (tretinoin gel) microsphere, 0.04% and 0.1% are indicated for topical application in the treatment of acne vulgaris. RETIN-A MICRO 0.04% and 0.1% showed a visible reduction in total mean lesion count in as little as 2 weeks with full benefit of therapy seen after 7 weeks. The most common adverse reactions to RETIN-A MICRO 0.04% and 0.1% were limited to mild or moderate irritation of the skin. 1.3% of patients using RETIN-A MICRO 0.04% and 6% of patients using RETIN-A MICRO 0.1% discontinued due to irritation. Please see brief summary of prescribing information on the next page. *Reported at the end of the 12-week P.U.M.P. Study. † Data based on a consumer preference study designed to evaluate preference of Pump versus tube delivery. 104 male and female acne sufferers between the ages of 13 and 36 completed the study.3 References: 1. RETIN-A MICRO 0.04%/0.1% [prescribing information]. Los Angeles, Calif: OrthoNeutrogena; May 2006. 2. Eichenfield LF, Nighland M, Rossi AB, et al; PUMP Study Group. Phase 4 study to assess tretinoin pump for the treatment of facial acne. J Drugs Dermatol. 2008;7(12):1129-1136. 3. Data on file, Ortho Dermatologics. 4. Embil K, Nacht S. The Microsponge ® Delivery System (MDS): a topical delivery system with reduced irritancy incorporating multiple triggering mechanisms for the release of actives. J Microencapsul. 1996;13(5):575-588. RETIN-A MICRO is a trademark of Ortho Dermatologics. © 2009 Ortho Dermatologics 09DD0052 Printed in USA


FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE. Brief Summary Retin-A Micro® (tretinoin gel) microsphere, 0.1% and 0.04% is a formulation containing 0.1% or 0.04%, by weight, tretinoin for topical treatment of acne vulgaris. This formulation uses patented methyl methacrylate/glycol dimethacrylate crosspolymer porous microspheres (MICROSPONGE® System) to enable inclusion of the active ingredient, tretinoin, in an aqueous gel. IMPORTANT NOTE: This information is a BRIEF SUMMARY of the complete prescribing information provided with the product and therefore should not be used as the basis for prescribing the product. This summary has been prepared by deleting information from the complete prescribing information such as certain text, tables, and references. The physician should be thoroughly familiar with the complete prescribing information before prescribing the product. INDICATIONS AND USAGE: Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%, is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the use of this product in the treatment of other disorders have not been established. 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. PRECAUTIONS: General: • The skin of certain individuals may become excessively dry, red, swollen, or blistered. 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 all together. Efficacy at reduced frequencies of application has not been established. If a reaction suggesting sensitivity occurs, use of the medication should be discontinued. Excessive skin dryness may also be experienced; if so, use of an appropriate emollient during the day may be helpful. • Unprotected exposure to sunlight, including sunlamps, should be minimized during the use of Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%, and patients with sunburn should be advised not to use the product until fully recovered because of heightened susceptibility to sunlight as a result of the use of tretinoin. Patients who may be required to have considerable sun exposure due to occupation and those with inherent sensitivity to the sun should exercise particular caution. Use of sunscreen products (SPF 15) and protective clothing over treated areas are recommended when exposure cannot be avoided. • Weather extremes, such as wind or cold, also may be irritating to patients under treatment with tretinoin. • Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%, should be kept away from the eyes, the mouth, paranasal creases of the nose, and mucous membranes. • Tretinoin has been reported to cause severe irritation on eczematous skin and should be used with utmost caution in patients with this condition. Information for Patients: A Patient Information Leaflet has been prepared and is included with each package of Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%. Drug Interactions: Concomitant topical medication, medicated or abrasive soaps and cleansers, products that have a strong drying effect, products with high concentrations of alcohol, astringents, or spices should be used with caution because of possible interaction with tretinoin. Avoid contact with the peel of limes. Particular caution should be exercised with the concomitant use of topical over-the-counter acne preparations containing benzoyl peroxide, sulfur, resorcinol, or salicylic acid with Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%. It also is advisable to allow the effects of such preparations to subside before use of Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%, is begun. Carcinogenesis, Mutagenesis, Impairment of Fertility: In a 91-week dermal study in which CD-1 mice were administered 0.017% and 0.035% formulations of tretinoin, cutaneous squamous cell carcinomas and papillomas in the treatment area were observed in some female mice. These concentrations are near the tretinoin concentration of these clinical formulations (0.04% and 0.1%). A dose-related incidence of liver tumors in male mice was observed at those same doses. The maximum systemic doses associated with the administered 0.017% and 0.035% formulations are 0.5 and 1.0 mg/kg/day, respectively. These doses are two and four times the maximum human systemic dose applied topically, when normalized for total body surface area. The biological significance of these findings is not clear because they occurred at doses that exceeded the dermal maximally tolerated dose (MTD) of tretinoin and because they were within the background natural occurrence rate for these tumors in this strain of mice. There was no evidence of carcinogenic potential when 0.025 mg/kg/day of tretinoin was administered topically to mice (0.1 times the maximum human systemic dose, normalized for total body surface area). For purposes of comparisons of the animal exposure to systemic human exposure, the maximum human systemic dose applied topically is defined as 1 gram of Retin-A Micro (tretinoin gel) microsphere, 0.1% applied daily to a 50 kg person (0.02 mg tretinoin/kg body weight). Dermal carcinogenicity testing has not been performed with Retin-A Micro (tretinoin gel) microsphere, 0.04% or 0.1%. Studies in hairless albino mice suggest that concurrent exposure to tretinoin may enhance the tumorigenic potential of carcinogenic doses of UVB and UVA light from a solar simulator. This effect has been confirmed in a later study in pigmented mice, and dark pigmentation did not overcome the enhancement of photocarcinogenesis by 0.05% tretinoin. Although the significance of these studies to humans is not clear, patients should minimize exposure to sunlight or artificial ultraviolet irradiation sources. The mutagenic potential of tretinoin was evaluated in the Ames assay and in the in vivo mouse micronucleus assay, both of which were negative. The components of the microspheres have shown potential for genetic toxicity and teratogenesis. EGDMA, a component of the excipient acrylates copolymer, was positive for induction of structural chromosomal aberrations in the in vitro chromosomal aberration assay in mammalian cells in the absence of metabolic activation, and negative for genetic toxicity in the Ames assay, the HGPRT forward mutation assay, and the mouse micronucleus assay. In dermal Segment I fertility studies of another tretinoin formulation in rats, slight (not statistically significant) decreases in sperm count and motility were seen at 0.5 mg/kg/day (4 times the maximum human systemic dose applied topically, and normalized for total body surface area), and slight (not statistically significant) increases in the number and percent of nonviable embryos in females treated with 0.25 mg/kg/day (2 times the maximum human systemic dose applied topically and normalized for total body surface area) and above were observed. In oral Segment I and Segment III studies in rats with tretinoin, decreased survival of neonates and growth retardation were observed at doses in excess of 2 mg/kg/day (17 times the human topical dose normalized for total body surface area). Dermal fertility and perinatal development studies with Retin-A Micro (tretinoin gel) microsphere, 0.1% or 0.04%, have not been performed in any species. Pregnancy: Teratogenic Effects: Pregnancy Category C. In a study of pregnant rats treated with topical application of Retin-A Micro (tretinoin gel) microsphere, 0.1%, at doses of 0.5 to 1 mg/kg/day on gestation days 6-15 (4 to 8 times the maximum human systemic dose of tretinoin normalized for total body surface area after topical administration of Retin-A Micro (tretinoin gel) microsphere, 0.1%) some alterations were seen in vertebrae and ribs of offspring. In another study, pregnant

New Zealand white rabbits were treated with Retin-A Micro (tretinoin gel) microsphere, 0.1%, at doses of 0.2, 0.5, and 1.0 mg/kg/day, administered topically for 24 hours a day while wearing Elizabethan collars to prevent ingestion of the drug. There appeared to be increased incidences of certain alterations, including domed head and hydrocephaly, typical of retinoidinduced fetal malformations in this species, at 0.5 and 1.0 mg/kg/day. Similar malformations were not observed at 0.2 mg/kg/day, 3 times the maximum human systemic dose of tretinoin after topical administration of Retin-A Micro (tretinoin gel) microsphere, 0.1%, normalized for total body surface area. In a repeat study of the highest topical dose (1.0 mg/kg/day) in pregnant rabbits, these effects were not seen, but a few alterations that may be associated with tretinoin exposure were seen. Other pregnant rabbits exposed topically for six hours to 0.5 or 0.1 mg/kg/day tretinoin while restrained in stocks to prevent ingestion, did not show any teratogenic effects at doses up to 17 times (1.0 mg/kg/day) the maximum human systemic dose after topical administration of Retin-A Micro (tretinoin gel) microsphere, 0.1%, adjusted for total body surface area, but fetal resorptions were increased at 0.5 mg/kg. In addition, topical tretinoin in non Retin-A Micro (tretinoin gel) microsphere formulations was not teratogenic in rats and rabbits when given in doses of 42 and 27 times the maximum human systemic dose after topical administration of Retin-A Micro (tretinoin gel) microsphere, 0.1%, normalized for total body surface area, respectively, (assuming a 50 kg adult applied a daily dose of 1.0 g of 0.1% gel topically). At these topical doses, however, delayed ossification of several bones occurred in rabbits. In rats, a dose-dependent increase of supernumerary ribs was observed. Oral tretinoin has been shown to be teratogenic in rats, mice, rabbits, hamsters, and subhuman primates. Tretinoin was teratogenic in Wistar rats when given orally or topically in doses greater than 1 mg/kg/day (8 times the maximum human systemic dose normalized for total body surface area). However, variations in teratogenic doses among various strains of rats have been reported. In the cynomolgus monkey, which metabolically is more similar to humans than other species in its handling of tretinoin, fetal malformations were reported for doses of 10 mg/kg/day or greater, but none were observed at 5 mg/kg/day (83 times the maximum human systemic dose normalized for total body surface area), 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 animal teratogenicity tests has generated equivocal results. There is evidence for teratogenicity (shortened or kinked tail) of topical tretinoin in Wistar rats at doses greater than 1 mg/kg/day (8 times the maximum human systemic dose normalized for total body surface area). Anomalies (humerus: short 13%, bent 6%, os parietal incompletely ossified 14%) have also been reported when 10 mg/kg/day was topically applied. Supernumerary ribs have been a consistent finding in rats when dams were treated topically or orally with retinoids. There are no adequate and well-controlled studies in pregnant women. Retin-A Micro should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 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. Thirty human cases of temporally associated congenital malformations have been reported during two decades of clinical use of Retin-A. Although no definite pattern of teratogenicity and no causal association has been established from these cases, five of the reports describe the rare birth defect category holoprosencephaly (defects associated with incomplete midline development of the forebrain). The significance of these spontaneous reports in terms of risk to the fetus is not known. Non-Teratogenic Effects: Topical tretinoin has been shown to be fetotoxic in rabbits when administered 0.5 mg/kg/day (8 times the maximum human systemic dose applied topically and normalized for total body surface area), resulting in fetal resorptions and variations in ossification. Oral tretinoin has been shown to be fetotoxic, resulting in skeletal variations and increased intrauterine death in rats when administered 2.5 mg/kg/day (21 times the maximum human systemic dose applied topically and normalized for total body surface area). There are, however no adequate and well-controlled studies in pregnant women. Animal Toxicity Studies: In male mice treated topically with Retin-A Micro (tretinoin gel) microsphere 0.1%, at 0.5, 2.0, or 5.0 mg/kg/day tretinoin (2, 8, or 21 times the maximum human systemic dose after topical administration of Retin-A Micro (tretinoin gel) microsphere, 0.1%, normalized for total body surface area) for 90 days, a reduction in testicular weight, but with no pathological changes were observed at the two highest doses. Similarly, in female mice there was a reduction in ovarian weights, but without any underlying pathological changes, at 5.0 mg/kg/day (21 times the maximum human dose). In this study there was a dose-related increase in the plasma concentration of tretinoin 4 hours after the first dose. A separate toxicokinetic study in mice indicates that systemic exposure is greater after topical application to unrestrained animals than to restrained animals, suggesting that the systemic toxicity observed is probably related to ingestion. Male and female dogs treated with Retin-A Micro (tretinoin gel) microsphere, 0.1%, at 0.2, 0.5, or 1.0 mg/kg/day tretinoin (5, 12, or 25 times the maximum human systemic dose after topical administration of Retin-A Micro (tretinoin gel) microsphere, 0.1%, normalized for total body surface area, respectively) for 90 days showed no evidence of reduced testicular or ovarian weights or pathological changes. 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 Retin-A Micro (tretinoin gel) microsphere, 0.1% or 0.04%, is administered to a nursing woman. Pediatric Use: Safety and effectiveness in children below the age of 12 have not been established. Geriatric Use: Safety and effectiveness in a geriatric population have not been established. Clinical studies of Retin-A Micro did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. ADVERSE REACTIONS: The skin of certain sensitive individuals may become excessively red, edematous, blistered, or crusted. If these effects occur, the medication should either be discontinued until the integrity of the skin is restored, or the medication should be adjusted to a level the patient can tolerate. However, efficacy has not been established for lower dosing frequencies. True contact allergy to topical tretinoin is rarely encountered. Temporary hyper- or hypopigmentation has been reported with repeated application of tretinoin. Some individuals have been reported to have heightened susceptibility to sunlight while under treatment with tretinoin. OVERDOSAGE: Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%, is intended for topical use only. If medication is applied excessively, no more rapid or better results will be obtained and marked redness, peeling, or discomfort may occur. Oral ingestion of large amounts of the drug may lead to the same side effects as those associated with excessive oral intake of Vitamin A. Rx only. Patent Nos.: 4,690,825; 5,145,675 & 5,955,109

Distributed by: OrthoNeutrogena DIVISION OF ORTHO-MCNEIL PHARMACEUTICAL, INC. Los Angeles, CA 90045 © OMP 2006 06DD0123 7/06 RETIN-A MICRO® is a registered trademark of Ortho-McNeil Pharmaceutical, Inc. MICROSPONGE® is a registered trademark of Cardinal Health, Inc., Dublin, OH.


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 Alan Menter, MD

DEPARTMENT EDITORS

Clinical Department Editor Susan E. King-Barry, 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 Kristine Kucera, DHS, MPAS, PA-C PrESiDEnT-ElECT Abby Jacobson, MS, PA-C iMMEDiATE PAST PrESiDEnT Bethany Grubb, MPAS, PA-C ViCE PrESiDEnT CaSondra Soto, PA-C SECrETAry / TrEASurEr Sharon Swartz, PA-C DirECTors AT lArGE Mark Hyde, MMS, PA-C Lauren R. Zajac, MHS, PA-C John Notabartolo, PA-C Casey Croes, 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 Website Editor Amy Archambault 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, practice-proven 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 AAPA’s CME Standards for Journal Articles and for Commercial Support of Journal Articles.

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 3, Number 4, Fall 2009. 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. Š 2009 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

Journal of Dermatology for Physician Assistants

The Official Journal of the SDPA

Respecting the Environment… In an effort to support environmentally friendly practices, the SDPA is Going Green! If you have any eco-friendly suggestions for our organization please e-mail sdpa@dermpa.org.

Finding Our Way This fall I watched my oldest child step onto the school bus for the

first time and head off to kindergarten. As my daughter lovingly waved her ‘kissing hand’ from the window of the departing school bus, my feelings were a mixture of excitement, pride, and nervousness. I stood in shock, waving back and thinking, “What did I just do?” Our family had been reading, “The Kissing Hand” by Audrey Penn, to prepare for this big day, but the book did not explain to us how our daughter would find her way in the big world outside of our home. My wife and I tried our best to reassure our daughter that she would make new friends, learn new things, have fun, and be just fine. Yet, I could not shake the uneasy feeling that she might not be “just fine.” Had I done enough as a parent to prepare her for this big step? It was hard to let go for the first time. Prior to leaving for work, mentally and emotionally exhausted, my wife and I were able to reflect on the events of the morning. As difficult as it was, we knew that we had to let go and have confidence that we had done enough and are continually giving our daughter the support and tools that she needs to find her way. With quiet understanding we listened and reassured one another that although we may feel uneasy during these milestones, our daughter will be able to find her own way through the first day of school and eventually through life. This experience caused me to reflect on a similar work related situation that some of us have encountered while precepting PA students. We spend time training our PA students only to turn around and send them off to their next rotation, leaving us to wonder if we have given them enough education, information, and tools to succeed. I believe our apprehension is not due to a lack of confidence in their abilities, but rather due to our lack of assurance that we have done everything possible to prepare them. It is an awesome responsibility to be the one to take off the proverbial training wheels and let the students ride off on their own. Just like parents, we need to have confidence that we have helped them develop the skills, tools, and self-assurance that they will need to find their own way as they move on with their training and eventually become practicing PAs. As our family sat around the dinner table that night, we listened as our daughter excitedly shared with us every detail of that wonderful first day of kindergarten. Her only concern was that she wondered whether mom and dad were going to follow the bus to school everyday to give her one last hug and kiss. Letting go is hard, but it helps if you do so slowly. In the end, our daughter found her own way just fine and so did we as parents. J

Travis Hayden Editor in chief

Vol. 3, No. 4 FALL 2009


table of contents

ONLY on the WEB at dermpa.org Clinical Dermatology, Surgical Dermatology and Cosmetic Dermatology are web exclusive content. Visit dermpa.org to access this information.

10 Derm PA News & Notes – part one

• Dermatology Market Watch • Progress Made This Summer in the Fight Against Indoor Tanning

16 Clinical Dermatology WEB ONLY

Departments

04 Editorial Board 05 Editor’s Message 09 SDPA News & Current Affairs 13 SDPA Student Scoop 13 Dermatology Humor 22 From The Patient’s Perspective 26 Dermoscopy 27 Clinical Snapshots WEB ONLY 29 Surgical Wisdom 33 Cosmetic Pearls 40 Notes from your Office Manager 41 Outside the 9 to 5 44 The Difference We Make 46 Professional Opportunities and Development

• CME Article – Dermoscopy and the Evaluation of a Skin Tumor’s Vascular Pattern • Drugs in Dermatology – Biotin

28 Surgical Dermatology WEB ONLY

• Beyond the Ellipse – Rhomboid Transposition Flaps

32 Cosmetic Dermatology WEB ONLY

• Management of Hypotrichosis Using Bimatoprost Ophthalmic Solution 0.03%

34 Professional Development WEB ONLY

• Dermatology Billing & Coding – PAs and Consultations • Judicial and Ethical Affairs – Dealing With Substance Abuse

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

Since its inception, the JDPA has utilized eco-friendly printing practices: -The journal is printed on paper obtained from sustainable forests that meet strict environmental standards. -Soy-based inks that carry a low environmental impact are used during printing of the journal. -The journal is printed using 100% renewable energy. Starting in 2010 the JDPA will offer an electronic only option to interested SDPA members. If you wish to only receive this digital format of the JDPA please contact us at editor@jdpa.org.

Journal of Dermatology for Physician Assistants


Vol. 3, No. 4 FALL 2009


Journal of Dermatology for Physician Assistants


Calendar

FROM THE SPDA News & Current Affairs

of events

2009 NOVEMBER SDPA 7th Annual Fall Conference November 11-14, 2009 Fairmont Scottsdale Princess Scottsdale, AZ

2010

MARCH 68th AAD Annual Academy Meeting March 5-9, 2010 Miami, FL june SDPA 1st Summer Dermatology Conference June 10-13, 2010 Chicago, IL NOVEMBER SDPA 8th Annual Fall Conference November 10-13, 2010 Gaylord Texan Resort Grapevine, TX Calendar of Events Submissions Send information to: Editor@jdpa.org

My Favorite Time of the Year

W

arm days and cool nights tell me that my favorite time of the year is here. I catch myself counting the days all summer long to finally hear the words that the first cold front of the season is approaching. Fall brings us a welcome relief from the summer heat, blows a whole new feel into the air and kicks off the best time of the year to watch sporting events. My Texas Longhorns and Dallas Cowboys football T-shirts and sweatshirts all come out of storage as I prepare for the perfect game day look each weekend. My Dallas Stars sweatshirts and blankets also come out to keep me warm as my husband and I attend a few games of our favorite ice hockey team. Yes, we are quite the sports fans but what I love the most is having something in common that we can share and enjoy together. This reminds me of my favorite thing about fall: spending time with loved ones. This time of the year brings with it many opportunities and holidays for bonding with family and friends. It seems that too often we get caught up in our daily routines, focus too much on work, spend too much time on extracurricular activities, or just get too tired and stressed to remember what is most important in our lives. My motto has always been to work hard and play hard but make time for those who hold a special place in my heart. I may be biased but I feel that as dermatology physician assistants we hold ourselves to a higher standard. To achieve this we are constantly reading, educating ourselves, attending meetings, teaching others, serving on committees, and writing for books and journals. I am proud to be one of the leaders of a society whose members are so dedicated to their profession. I believe it is because of this dedication that the SDPA has grown to be such a well respected organization. To all who have given their time and energy and to those who continue to play an important role in this organization – I must say thanks. Just please don’t forget to stop and smell the roses, tell the ones close to you thanks for being a part of your life, and kiss the ones you love. This is the perfect time of the year for all of those things. J

Kristine Kucera, DHS, MPAS, PA-C President Society of Dermatology Physician Assistants

Vol. 3, No. 4 FALL 2009

9


Dermatology PA news & notes

Dermatology Market Watch Aim at Melanoma Launches New Website Aim at Melanoma has developed the most comprehensive, state of the art website available for the melanoma community and the public at large – AimAtMelanoma.org. The website is the first one-stop one-shop melanoma resource center offering: • Breaking News in the changing world of melanoma • Prevention and Early Detection Guides • On-call Oncology Nurse free of charge 1-877-AIM-2MEL • Virtual Support Network for melanoma patients, survivors, and caregivers • Resource Links for patient and caregiver support • Clinical Trial Matching & Referral Service Aim at Melanoma is the largest international melanoma non-profit organization focused on melanoma research, education, awareness, and legislation. The Foundation continues to bring together on a biannual basis international melanoma experts, from both academia and industry, leveraging their knowledge and working collaboratively to fight the disease on all fronts. To further support this effort, Aim at Melanoma is moving forward in creating the first international melanoma tissue bank.

Addressing Compliance in the Management of Acne Vulgaris Promius Pharma Launches Promiseb™ Cream Promius Pharma, LLC has announced the launch of Promiseb Cream, a topical nonsteroidal cream for the treatment of seborrheic dermatitis, that has demonstrated both anti-inflammatory and antifungal properties. Promiseb Cream has been clinically shown to treat seborrheic dermatitis with comparable efficacy and fewer relapses than a low-potency topical corticosteroid in a randomized clinical study. The study concluded that Promiseb Cream offers an efficacious treatment with anti-inflammatory properties that can be used first line for mild to moderate seborrheic dermatitis flares and for maintenance without any safety or usage limitations. Promiseb Cream can be used daily for ongoing use. 10 Journal of Dermatology for Physician Assistants

Jocelyn Confino, MPAS, PA-C • Rochelle Weiss, MD • Otto H. Mills, Jr, PhD

The literature has a number of references pointing to the lack of patient compliance in acne populations. Additional papers detail how one may monitor compliance or the lack thereof. Understanding product characteristics which appear to encourage compliance may be of help in the management of acne. In order to evaluate patient and physician observations about products, we focused on successful formulations: topically applied salicylic acid and benzoyl peroxide available together in a kit. Evaluations, questionnaires and interviews were completed in a private practice office. Nine patients (5 males, 4 females) signed informed consent and used the products for four weeks. Findings of the private practice evaluation noted the products color coding appeared to encourage compliance and the pad size was comfortable for face, chest and back application providing medication in hard to reach places. There was no visible residue and was compatible with makeup among the female patients. These products had characteristics which appeared to encourage compliance in the management of acne. www.jsjpharm.com/inova.htm


&ORôTHEôMULTI FACETEDôCHALLENGESô OFôMILDôTOôMODERATEôROSACEA

offering more in one convenient package )NTRODUCING

MYFINACEA COMôj>ñTB?PFQBñCLOñM>QFBKQñPRMMLOQñ>KAñBAR@>QFLK #FK>@B>ñFPñFKAF@>QBAñCLOñQLMF@>IñQOB>QJBKQñLCñFKCI>JJ>QLOVñM>MRIBPñ>KAñMRPQRIBPñLCñJFIAñQLñJLABO>QBñOLP>@B> ñ IQELRDEñPLJBñOBAR@QFLKñLCñ BOVQEBJ>ñTEF@EñT>PñMOBPBKQñFKñM>QFBKQPñTFQEñM>MRIBPñ>KAñMRPQRIBPñLCñOLP>@B>ñL@@ROOBAñFKñ@IFKF@>IñPQRAFBP ñBCCF@>@VñCLOñQOB>QJBKQñLCñ BOVQEBJ>ñFKñOLP>@B>ñFKñQEBñ>?PBK@BñLCñM>MRIBPñ>KAñMRPQRIBPñE>PñKLQñ?BBKñBS>IR>QBA #FK>@B>ñFPñCLOñABOJ>QLILDF@ñRPBñLKIV ñ>KAñKLQñCLOñLMEQE>IJF@ ñLO>I ñLOñFKQO>S>DFK>IñRPB ñ#FK>@B>ñFPñ@LKQO>FKAF@>QBAñFKñFKAFSFAR>IPñTFQEñ>ñEFPQLOVñLCñ EVMBOPBKPFQFSFQVñQLñMOLMVIBKBñDIV@LIñLOñ>KVñLQEBOñ@LJMLKBKQñLCñQEBñCLOJRI>QFLK ñ&Kñ@IFKF@>IñQOF>IP ñPBKP>QFLKPñLCñ?ROKFKD PQFKDFKD QFKDIFKDñL@@ROOBAñ FKñ ñLCñM>QFBKQP ñ>KAñFQ@EFKDñFKñ ñOBD>OAIBPPñLCñQEBñOBI>QFLKPEFMñQLñQEBO>MV ñ-LPQ J>OHBQFKDñP>CBQVjñ0HFK ñC>@F>Iñ?ROKFKDñ>KAñFOOFQ>QFLK ñ"VBP ñ FOFAL@V@IFQFPñLKñ>@@FABKQ>IñBUMLPROBñQLñQEBñBVB ñ1EBOBñE>SBñ?BBKñFPLI>QBAñOBMLOQPñLCñEVMLMFDJBKQ>QFLKñ>CQBOñRPBñLCñ>WBI>F@ñ>@FA ñ0FK@Bñ>WBI>F@ñ>@FAñ E>PñKLQñ?BBKñTBIIñPQRAFBAñFKñM>QFBKQPñTFQEñA>OHñ@LJMIBUFLK ñQEBPBñM>QFBKQPñPELRIAñ?BñJLKFQLOBAñCLOñB>OIVñPFDKPñLCñEVMLMFDJBKQ>QFLK 0LEASEôSEEôBRIEFôSUMMARYôOFô0RESCRIBINGô)NFORMATIONôONôFOLLOWINGôPAGE

Vol. 3, No. 4 FALL 2009 11


BRIEF SUMMARY

Nursing Mothers:

For Dermatologic Use Only – Not for Ophthalmic, Oral, or Intravaginal Use Rx only CONTRAINDICATIONS FINACEAŽ Gel, 15%, is contraindicated in individuals with a history of hypersensitivity to propylene glycol or any other component of the formulation.

Equilibrium dialysis was used to assess human milk partitioning in vitro. At an azelaic acid CONCENTRATION OF ÂŤG M, THE MILK PLASMA DISTRIBUTION COEFFICIENT WAS AND THE MILK BUFFER DISTRIBUTION WAS INDICATING THAT PASSAGE OF DRUG INTO MATERNAL MILK MAY OCCUR 3INCE LESS THAN OF A TOPICALLY APPLIED DOSE OF AZELAIC ACID CREAM IS SYSTEMICALLY ABSORBED the uptake of azelaic acid into maternal milk is not expected to cause a significant change FROM BASELINE AZELAIC ACID LEVELS IN THE MILK (OWEVER CAUTION SHOULD BE EXERCISED WHEN FINACEAÂŽ Gel, 15%, is administered to a nursing mother.

WARNINGS FINACEAÂŽ Gel, 15%, is for dermatologic use only, and not for ophthalmic, oral, or intravaginal use. There have been isolated reports of hypopigmentation after use of azelaic acid. Since azelaic acid has not been well studied in patients with dark complexion, these patients should be monitored for early signs of hypopigmentation. PRECAUTIONS General: Contact with the eyes should be avoided. If sensitivity or severe irritation develops with the use ÂŽ of FINACEA Gel, 15%, treatment should be discontinued and appropriate therapy instituted. The safety and efficacy of FINACEAÂŽ Gel, 15%, has not been studied beyond 12 weeks. Information for Patients: Patients using FINACEAÂŽ Gel, 15%, should receive the following information and instructions: s &).!#%!ÂŽ Gel, 15%, is to be used only as directed by the physician. s &).!#%!ÂŽ Gel, 15%, is for external use only. It is not to be used orally, intravaginally, or for the eyes. s #LEANSE AFFECTED AREA S WITH A VERY MILD SOAP OR A SOAPLESS CLEANSING LOTION AND PAT DRY WITH a soft towel before applying FINACEAÂŽ Gel, 15%. Avoid alcoholic cleansers, tinctures, and astringents, abrasives, and peeling agents. s !VOID CONTACT OF &).!#%!ÂŽ Gel, 15%, with the mouth, eyes and other mucous membranes. If it does come in contact with the eyes, wash the eyes with large amounts of water and consult a physician if eye irritation persists. s 4HE HANDS SHOULD BE WASHED FOLLOWING APPLICATION OF &).!#%!ÂŽ Gel, 15%. s #OSMETICS MAY BE APPLIED AFTER &).!#%!ÂŽ Gel, 15%, has dried. s 3KIN IRRITATION E G PRURITUS BURNING OR STINGING MAY OCCUR DURING USE OF &).!#%!ÂŽ Gel, 15%, usually during the first few weeks of treatment. If irritation is excessive or persists, use of FINACEAÂŽ Gel, 15%, should be discontinued, and patients should consult their physician 3EE !$6%23% 2%!#4)/.3 s !VOID ANY FOODS AND BEVERAGES THAT MIGHT PROVOKE ERYTHEMA FLUSHING AND BLUSHING INCLUDING SPICY FOOD ALCOHOLIC BEVERAGES AND THERMALLY HOT DRINKS INCLUDING HOT COFFEE AND TEA s 0ATIENTS SHOULD REPORT ABNORMAL CHANGES IN SKIN COLOR TO THEIR PHYSICIAN s !VOID THE USE OF OCCLUSIVE DRESSINGS OR WRAPPINGS Drug Interactions: There have been no formal studies of the interaction of FINACEAÂŽ Gel, 15%, with other drugs. Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term animal studies have not been performed to evaluate the carcinogenic potential of FINACEAÂŽ Gel, 15%. Azelaic acid was not mutagenic or clastogenic in a battery of in vitro !MES ASSAY ('024 IN 6 CELLS [#HINESE HAMSTER LUNG CELLS] AND CHROMOSOMAL ABERRATION ASSAY IN HUMAN LYMPHOCYTES AND in vivo DOMINANT LETHAL ASSAY IN MICE AND MOUSE MICRONUCLEUS ASSAY GENOTOXICITY TESTS

Pediatric Use: Safety and effectiveness of FINACEAÂŽ Gel, 15%, in pediatric patients have not been established. Geriatric: Clinical studies of FINACEAÂŽ 'EL DID NOT INCLUDE SUFFICIENT NUMBERS OF SUBJECTS AGED and over to determine whether they respond differently from younger subjects. ADVERSE REACTIONS /VERALL TREATMENT RELATED ADVERSE EVENTS INCLUDING BURNING STINGING TINGLING DRYNESS TIGHTNESS SCALING ITCHING AND ERYTHEMA IRRITATION REDNESS WERE FOR FINACEAÂŽ 'EL AND FOR THE ACTIVE COMPARATOR GEL AT WEEKS In two vehicle controlled, and one active controlled U.S. clinical studies, treatment safety was monitored IN PATIENTS WHO USED TWICE DAILY &).!#%!ÂŽ 'EL FOR WEEKS . OR FOR WEEKS . OR THE GEL VEHICLE . FOR WEEKS Table 3. Cutaneous Adverse Events Occurring in ĂŚ1% of Subjects in the Rosacea Trials by Treatment Group and Maximum Intensity* FINACEA ÂŽ 'EL .

6EHICLE .

Mild N

Moderate N

Severe N

Mild N

Moderate N

Severe N

"URNING STINGING TINGLING

0RURITUS

3CALING DRY SKIN XEROSIS

%RYTHEMA IRRITATION

Contact DERMATITIS

%DEMA

!CNE

*3UBJECTS MAY HAVE CUTANEOUS ADVERSE EVENT THUS THE SUM OF THE FREQUENCIES OF PREFERRED TERMS MAY exceed the number of subjects with at least 1 cutaneous adverse event.

Pregnancy: Teratogenic Effects: Pregnancy Category B

FINACEAÂŽ Gel, 15%, and its vehicle caused irritant reactions at the application site in human dermal safety studies. FINACEAÂŽ Gel, 15%, caused significantly more irritation than its vehicle in a cumulative irritation study. Some improvement in irritation was demonstrated over the course of the clinical studies, but this improvement might be attributed to subject dropouts. No phototoxicity or photoallergenicity were reported in human dermal safety studies.

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

In patients using azelaic acid formulations, the following additional adverse experiences have been reported rarely: worsening of asthma, vitiligo depigmentation, small depigmented spots, hypertrichosis, REDDENING SIGNS OF KERATOSIS PILARIS AND EXACERBATION OF RECURRENT HERPES LABIALIS

/RAL ADMINISTRATION OF AZELAIC ACID AT DOSE LEVELS UP TO MG KG DAY TIMES THE MAXIMUM RECOMMENDED HUMAN DOSE BASED ON BODY SURFACE AREA DID NOT AFFECT FERTILITY OR REPRODUCTIVE performance in male or female rats.

$ERMAL EMBRYOFETAL DEVELOPMENTAL TOXICOLOGY STUDIES HAVE NOT BEEN PERFORMED WITH AZELAIC ACID GEL /RAL EMBRYOFETAL DEVELOPMENTAL STUDIES WERE CONDUCTED WITH AZELAIC ACID IN RATS rabbits, and cynomolgus monkeys. Azelaic acid was administered during the period of organogeneisis in all three animal species. Embryotoxicity was observed in rats, rabbits, and monkeys at oral doses of azelaic acid that generated some maternal toxicity. Embryotoxicity was observed in rats given MG KG DAY TIMES THE MAXIMUM RECOMMENDED HUMAN DOSE BASED ON BODY SURFACE AREA RABBITS GIVEN OR MG KG DAY OR TIMES THE MAXIMUM RECOMMENDED HUMAN DOSE BASED ON BODY SURFACE AREA AND CYNOMOLGUS MONKEYS GIVEN MG KG DAY TIMES THE MAXIMUM RECOMMENDED HUMAN DOSE BASED ON BODY SURFACE AREA AZELAIC ACID .O TERATOGENIC effects were observed in the oral embryofetal developmental studies conducted in rats, rabbits, and cynomolgus monkeys. An oral peri- and postnatal developmental study was conducted in rats. Azelaic acid was administered from gestational day 15 through day 21 postpartum up to a dose level of MG KG DAY %MBRYOTOXICITY WAS OBSERVED IN RATS AT AN ORAL DOSE THAT GENERATED SOME MATERNAL TOXICITY MG KG DAY TIMES THE MAXIMUM RECOMMENDED HUMAN DOSE BASED ON BODY SURFACE AREA )N ADDITION SLIGHT DISTURBANCES IN THE POSTNATAL DEVELOPMENT OF FETUSES WAS NOTED IN RATS AT ORAL DOSES THAT GENERATED SOME MATERNAL TOXICITY AND MG KG DAY AND TIMES THE MAXIMUM RECOMMENDED HUMAN DOSE BASED ON BODY SURFACE AREA .O EFFECTS ON SEXUAL maturation of the fetuses were noted in this study. Because animal reproduction studies are not always predictive of human response, this drug should be used only if clearly needed during pregnancy.

12 Journal of Dermatology for Physician Assistants

0OST MARKETING SAFETYn3KIN FACIAL BURNING AND IRRITATION %YES IRIDOCYCLITIS ON ACCIDENTAL EXPOSURE WITH FINACEAÂŽ 'EL TO THE EYE SEE PRECAUTIONS OVERDOSAGE FINACEAÂŽ Gel, 15%, is intended for cutaneous use only. If pronounced local irritation occurs, patients should be directed to discontinue use and appropriate therapy should be instituted 3EE PRECAUTIONS $ECEMBER $ISTRIBUTED UNDER LICENSE U.S. Patent No 4,713,394 Manufactured by Intendis Manufacturing S.p.A., Segrate, Milan, Italy $ISTRIBUTED BY 0INE "ROOK .* FINACEA is a registered trademark of Intendis, Inc. #ERA6E IS A REGISTERED TRADEMARK OF #/2)! ,ABORATORIES ,TD ÂĽ )NTENDIS )NC !LL RIGHTS RESERVED *! &EBRUARY


Dermatology Market Watch

Results from a Phase III program evaluating shortcourse regimens of two concentrations of imiquimod cream (3.75% and 2.5%) demonstrated imiquimod 3.75%, administered daily on two two-week treatment cycles, separated by a two week nontreatment period, produced clearance rates superior to placebo for actinic keratosis (AK). Imiquimod 3.75% was also more effective than 2.5% with comparable safety. The new data, presented at the American Academy of Dermatology Summer Academy Meeting, are in a new drug application (NDA) accepted for review by the U.S. Food and Drug Administration for imiquimod 3.75% utilizing a two-week cycle regimen in the treatment of AK.

With respect to the treatment of AK, the existing approved 5% imiquimod formulation is indicated only for the treatment of nonhyperkeratotic, nonhypertrophic AK on a very limited area of the skin (i.e., less than 25 cm2) for a full 16 weeks of treatment. The intent of the clinical studies conducted with the new 3.75% imiquimod formulation was to evaluate a new treatment paradigm for clinically typical AK lesions on patients with extensive disease (i.e., patients with 5 to 20 AK lesions over the full face or balding scalp).

Dermatology HUMOR

© Tim August 2001

Jennifer was shocked when the doctor confirmed her worst suspicion – She had caught something from sitting on a dirty toilet seat.

Student Scoop Practice to Profession By Kristi Cox, PA-S SDPA Student Coordinator

As many dermatology physician assistants already know, working in dermatology is a rewarding experience and positions as a dermatology PA are highly sought after. The job search for a PA student who is interested in this particular specialty needs to start before graduation. There is so much to do as a PA student that just keeping on top of your scholastic work can be overwhelming. However, taking the extra initiative early will pay off in the future. According to Stephen Covey, the well-known motivational speaker and author, we should “Begin with the end in mind.” Keep the end goal of working as a dermatology PA in the forefront of your mind at all times. Here are some helpful tips for students so you can land your dream job in dermatology: l Join the SDPA and your local SDPA state constituent chapter to begin networking (online and at conferences/meetings). l Look on the SDPA website for current job postings. l Expand your dermatology knowledge: attend SDPA conferences, read dermatology journals (JDPA and the JAAD), and volunteer to shadow willing dermatology PAs. l Make sure the faculty at your school knows of your interest in the field of dermatology. They are invaluable resources with many connections and may be able to inform you of any job openings before they are posted to the general public. l Schedule your dermatology rotation towards the end of your clinical year. Look for clinics with the potential of permanence and use your rotation time both as a trial period and for training. l Recognize what you can add to a practice and be able to prove your value at any moment. Your dermatology rotation might not yet know that they are looking for a PA! l If you know of a dermatologist who is looking for a physician assistant, try to do a rotation at his/her office. While there, be eager to help and learn. Demonstrate that you would be a good addition to the office. Focus on making yourself stand out now while you are a student so that later you are not just one of many in the applicant pool. Taking a few extra steps as a student will make your transition to a new physician assistant in the field of dermatology much smoother. Good luck! J The SDPA is excited about student involvement and is looking for students who have a passion for dermatology and a desire to get involved. If you are interested in becoming a student leader within the SDPA please contact Kristi Cox, PA-S at kcox@dermpa.org.

Vol. 3, No. 4 FALL 2009 13

Dermatology PA news & notes

Data Demonstrate New Imiquimod Formulation as Short Course Treatment for Actinic Keratosis


Progress Made This Summer in the Fight Against Indoor Tanning Texas enacts the most restrictive indoor tanning law in the country and the World Health Organization recategorizes tanning bed UV radiation to its highest cancer risk category.

O Dermatology PA news & notes

n June 22, 2009 Texas Governor Rick Perry signed a bill into law that will prohibit the use of indoor tanning devices for all Texans under the age of 16.5 and will require in-person parental consent for those between the ages of 16.5 and 18. “We thank the state of Texas for taking the initiative to be the first in the nation to pass the most restrictive law in the country banning the use of indoor tanning devices for all children under the age of 16.5,” said Susan Hammerling, PA-C, Legislative Affairs Committee Chair of the SDPA. “The SDPA supports similar efforts in other states and will continue to work on protecting children from the dangers of indoor tanning.” In July, the International Agency for Research on Cancer (IARC), a division of the World Health Organization (WHO), recategorized tanning bed UV radiation to its highest cancer risk category and labeled them as “carcinogenic to humans.” By placing UV radiation into its highest category, Group 1, tanning beds are now in the same category as asbestos, tobacco products, and arsenic. These results did not come as a surprise to Aim at Melanoma, an international, nonprofit melanoma organization that has been directly involved in tanning bed legislation over the last several years. “UV is the largest single avoidable cause of melanoma, and is implicated in 90% of melanomas. It is not over exposure but any recreational exposure to UV that is the culprit. More than 1.2 million new cases of skin cancer will be diagnosed in the United States this year. 14 Journal of Dermatology for Physician Assistants

68,000 cases of invasive melanoma, 60,000 additional cases of melanoma in situ, and 8,600 deaths a year in the U.S. alone are no ‘scare’ but a real epidemic. It is for this reason we strongly advocate that minors under the age of 18 be banned from using tanning facilities.” says Valerie Guild, President of Aim at Melanoma. According to the U.S. Department of Health and Human Services the ultraviolet (UV) radiation from the sun and artificial sources (such as tanning beds and sun lamps) is a known carcinogen. Despite the risk, nearly 30 million people (of these, 2.3 million are teens) tan indoors in the United States annually. The WHO report, published in The Lancet Oncology medical journal, found that indoor tanning before the age of 35 has been associated with a significant increase in the risk of melanoma, the deadliest form of skin cancer. It also stated that “the risk of cutaneous melanoma is increased by 75% when use of tanning devices starts before 30 years of age.” Limiting exposure to UV radiation from the sun and artificial sources such as tanning beds and sun lamps is the best way to reduce the risk of skin cancer. The WHO, the AMA, the AAD, and the SDPA all recommend that minors under the age of 18 be banned from using a tanning facility. To learn more about what is happening in your state and how you can get involved, visit AimAtMelanoma.org or e-mail Susan Hammerling, PA-C, Legislative Affairs Committee Chair of the SDPA at shammerling@dermpa.org. J


SDPA

th Annual Fall Dermatology Conference 2009 The Fairmont Princess Hotel - Scottsdale, Arizona November 11–14, 2009 Register Now at www.dermpa.org!

PLANNED WORKSHOPS: (May change without prior notice) 1. Surgery Workshops: A. Basic B. Intermediate C. Advanced 2. Facial Rejuvenation 3. Dermatology Update Lecture Series

E IS C A P S ED! LIMIT

PLANNED TOPICS TO INCLUDE: (May change without prior notice) 1. Burden of Disease (Psoriasis to CAD) 2. Contracts: Compensation and Negotiation 3. Ethics in Daily Dermatology 4. Acne: The Antibiotic Dilemma 5. Pigmented Lesions of the Vulva 6. Adult Atopic Dermatitis 7. Dermoscopy 8. Inflammatory Dermatoses 9. Lasers in the Cosmetic Patient 10.Differential Diagnosis and Treatment Options for the Inflammatory Scalp

FACULTY TO INCLUDE: Keynote Speaker: Vivan Bucay, MD Mark Blair, MD Joseph Bikowski, MD Kristina Callis-Duffin, MD James Del Rosso, DO Zoe Draelos, MD Libby Edwards, MD Lester Fahrner, MD Leon Kircik, MD Darrell Rigel, MD Roy (Nick) Rogers, MD Edward (Vic) Ross, MD Jeffrey Sugarman, MD David Swanson, MD Allan Wirtzer, MD Matthew Zirwas, MD

This program has been reviewed and is approved for AAPA Category 1 CME Credit. Physician Assistants should claim only those hours actually spent participating in the CME activity.

Main Conference (Thurs-Sat): 19 hours - Optional Pre-Conference (Wed): 16 hours For Questions: Call SDPA at 800-380-3992.

Vol. 3, No. 4 FALL 2009 15


Clinical Dermatology

Dermoscopy and the Evaluation of a Skin Tumor’s Vascular Pattern By John Burns, PA-C

ONLY on the WEB at dermpa.org

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 OCTOBER 2009. Participants may submit the self-assessment exam at any time during that period. This program was planned in accordance with AAPA’s CME Standards for Enduring Material Programs and for Commercial Support of Enduring Material Programs.

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

Learning Objectives: 1) Review the principles of dermoscopy 2) Discuss a practical algorithm for the identification of various vascular patterns commonly seen in a general dermatology practice 3) Review clear examples of commonly observed vascular patterns. 4) Expound on the clinical significance of commonly observed vascular patterns 16 Journal of Dermatology for Physician Assistants


CLINICAL Dermatology

Dermoscopy and the Evaluation of a Skin Tumor’s Vascular Pattern

Vol. 3, No. 4 FALL 2009 17


CLINICAL Dermatology

Dermoscopy and the Evaluation of a Skin Tumor’s Vascular Pattern

18 Journal of Dermatology for Physician Assistants


CLINICAL Dermatology

Dermoscopy and the Evaluation of a Skin Tumor’s Vascular Pattern

Vol. 3, No. 4 FALL 2009 19


CLINICAL Dermatology

Dermoscopy and the Evaluation of a Skin Tumor’s Vascular Pattern

20 Journal of Dermatology for Physician Assistants


Drugs in Dermatology - Biotin ONLY on the WEB at dermpa.org

Vol. 3, No. 4 FALL 2009 21

CLINICAL Dermatology

Dermoscopy and the Evaluation of a Skin Tumor’s Vascular Pattern


From The Patient’s Perspective Our Mission to Save Our Daughter’s Life By Lori Sames

CLINICAL Dermatology

ONLY on the WEB at dermpa.org

...continued on page 25 22 Journal of Dermatology for Physician Assistants


SOLODYN INNOVATION Introducing 2 New Dosing Options

SOLODYN is indicated to treat only inammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. SOLODYN did not demonstrate any effect on non-inammatory lesions. Safety of SOLODYN has not been established beyond 12 weeks of use. This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, SOLODYN should be used only as indicated. SOLODYN Tablets Important Safety Information t 5IF NPTU DPNNPOMZ SFQPSUFE TJEF FGGFDUT XFSF headache, fatigue, dizziness, and pruritus. t .JOPDZDMJOF MJLF PUIFS UFUSBDZDMJOFT DBO DBVTF GFUBM harm when administered to a pregnant woman. t 5FUSBDZDMJOF ESVHT TIPVME OPU CF VTFE EVSJOH UPPUI development (last half of pregnancy and up to 8 years of age) as they may cause permanent discoloration of teeth. t 1TFVEPNFNCSBOPVT DPMJUJT IBT CFFO SFQPSUFE XJUI 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. t $FOUSBM OFSWPVT TZTUFN TJEF FGGFDUT JODMVEJOH light-headedness, dizziness, or vertigo, have been reported with minocycline therapy. t *O SBSF DBTFT QIPUPTFOTJUJWJUZ IBT CFFO SFQPSUFE t 4IPVME OPU CF VTFE EVSJOH QSFHOBODZ OPS CZ individuals of either gender who are attempting to conceive a child; concurrent use of tetracyclines with oral contraceptives may render oral contraceptives less effective. t 5IJT ESVH JT DPOUSBJOEJDBUFE JO QFSTPOT XIP IBWF shown hypersensitivity to any of the tetracyclines.

See reverse side for brief summary of Full Prescribing Information. SOLODYN and Benefits built in are trademarks of Medicis Pharmaceutical Corporation. Š 2009 Medicis, The Dermatology Company SOL 08-045 01/30/10

Vol. 3, No. 4 FALL 2009 23


BRIEF SUMMARY (see package insert for Full Prescribing Information) SOLODYN® (MINOCYCLINE HCl, USP) EXTENDED RELEASE TABLETS Rx Only KEEP OUT OF REACH OF CHILDREN INDICATIONS AND USAGE SOLODYN® is indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older.SOLODYN® did not demonstrate any effect on non-inflammatory lesions.Safety of SOLODYN® has not been established beyond 12 weeks of use. This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, SOLODYN® should be used only as indicated. CONTRAINDICATIONS This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines. WARNINGS Teratogenic effects 1) MINOCYCLINE, LIKE OTHER TETRACYCLINECLASS 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 APPRISED OF THE POTENTIAL HAZARD TO THE FETUS. SOLODYN® should not be used during pregnancy nor by individuals of either gender who are attempting to conceive a child (see PRECAUTIONS: Impairment of Fertility & 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. 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).

usual total doses are indicated, and if therapy is prolonged, serum level determinations of the drug may be advisable.

measures with their physician.Treatment should be discontinued at the first evidence of skin erythema. 2. Patients who experience central nervous Central nervous system effects system symptoms (see WARNINGS) should 1. Central nervous system side effects including be cautioned about driving vehicles or using light-headedness, dizziness or vertigo have been hazardous machinery while on minocycline reported with minocycline therapy.Patients who should also be cautioned therapy.Patients experience these symptoms should be cautioned about seeking medical help for headaches or about driving vehicles or using hazardous blurred vision. machinery while on minocycline therapy.These symptoms may disappear during therapy and 3. Concurrent use of tetracycline may render usually rapidly disappear when the drug is oral contraceptives less effective (See Drug discontinued. Interactions). 2. Pseudotumor cerebri (benign intracranial 4. Autoimmune syndromes, including drughypertension) in adults and adolescents has induced lupus-like syndrome, autoimmune been associated with the use of tetracyclines. hepatitis, vasculitis and serum sickness Minocycline has been reported to cause or have been observed with tetracycline-class precipitate pseudotumor cerebri, the hallmark antibiotics, including minocycline.Symptoms of which is papilledema.Clinical manifestations may be manifested by arthralgia, fever, rash include headache and blurred vision.Bulging and malaise.Patients who experience such fontanels have been associated with the use symptoms should be cautioned to stop the of tetracyclines in infants.Although signs and drug immediately and seek medical help. symptoms of pseudotumor cerebri resolve after 5. Patients should be counseled about discontinuation of treatment, the possibility for discoloration of skin, scars, teeth or gums that permanent sequelae such as visual loss that can arise from minocycline therapy. may be permanent or severe exists.Patients 6. Take SOLODYN® exactly as directed.Skipping should be questioned for visual disturbances doses or not completing the full course of prior to initiation of treatment with tetracyclines therapy may decrease the effectiveness of and should be routinely checked for papilledema the current treatment course and increase the while on treatment. likelihood that bacteria will develop resistance Concomitant use of isotretinoin and minocycline and will not be treatable by other antibacterial should be avoided because isotretinoin, a drugs in the future. systemic retinoid, is also known to cause 7. SOLODYN® should not be used by pregnant pseudotumor cerebri. women or women attempting to conceive a Photosensitivity child (See Pregnancy, Carcinogenesis and Photosensitivity manifested by an exaggerated Mutagenesis sections). sunburn reaction has been observed in some 8. It is recommended that SOLODYN® not be individuals taking tetracyclines.This has been used by men who are attempting to father a reported rarely with minocycline. Patients should child (See Impairment of Fertility section). minimize or avoid exposure to natural or artificial Laboratory Tests sunlight (tanning beds or UVA/B treatment) Periodic laboratory evaluations of organ systems, while using minocycline.If patients need to be including hematopoietic, renal and hepatic outdoors while using minocycline, they should wear loose-fitting clothes that protect skin from studies should be performed.Appropriate tests for autoimmune syndromes should be performed sun exposure and discuss other sun protection as indicated. measures with their physician.

100 and 300 mg/kg/day) increased numbers of morphologically abnormal sperm cells. Morphological abnormalities observed in sperm samples included absent heads, misshapen heads, and abnormal flagella. Limited human studies suggest that minocycline may have a deleterious effect on spermatogenesis. SOLODYN® should not be used by individuals of either gender who are attempting to conceive a child. Pregnancy—Teratogenic Effects: Pregnancy category D (See WARNINGS) All pregnancies have a background risk of birth defects, loss, or other adverse outcome regardless of drug exposure.There are no adequate and well-controlled studies on the use of minocycline in pregnant women.Minocycline, like other tetracycline-class antibiotics, crosses the placenta and may cause fetal harm when administered to a pregnant woman.Rare spontaneous reports of congenital anomalies including limb reduction have been reported with minocycline use in pregnancy in post-marketing experience. Only limited information is available regarding these reports; therefore, no conclusion on causal association can be established. Minocycline induced skeletal malformations (bent limb bones) in fetuses when administered to pregnant rats and rabbits in doses of 30 mg/kg/day and 100 mg/kg/day, respectively, (resulting in approximately 3 times and 2 times, respectively, the systemic exposure to minocycline observed in patients as a result of use of SOLODYN®).Reduced mean fetal body weight was observed in studies in which minocycline was administered to pregnant rats at a dose of 10 mg/kg/day (which resulted in approximately the same level of systemic exposure to minocycline as that observed in patients who use SOLODYN®). SOLODYN® should not be used during pregnancy.If the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus and stop treatment immediately.

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 antacids containing aluminum, calcium or magnesium and iron-containing preparations. 5. In a multi-center study to evaluate the effect of SOLODYN® on low dose oral contraceptives, hormone levels over one menstrual cycle with and without SOLODYN® 1 mg/kg once-daily were measured. Based on the results of this trial, minocyclinerelated changes in estradiol, progestinic hormone, FSH and LH plasma levels, of breakthrough bleeding, or of contraceptive failure, can not be ruled out.To avoid contraceptive failure, female patients are advised to use a second form of contraceptive during treatment with minocycline.

Nursing Mothers Tetracycline-class antibiotics are excreted in human milk.Because of the potential for serious adverse effects on bone and tooth development in nursing infants from the tetracycline-class antibiotics, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother (see WARNINGS).

PRECAUTIONS General Safety of SOLODYN® beyond 12 weeks of use has not been established. As with other antibiotic preparations, use of SOLODYN® may result in overgrowth of nonsusceptible organisms, including fungi.If superinfection occurs, the antibiotic should be discontinued and appropriate therapy instituted. Bacterial resistance to the tetracyclines may develop in patients using SOLODYN,® therefore the susceptibility of bacteria associated with infection should be considered in selecting antimicrobial therapy.Because of the potential for drug-resistant bacteria to develop during the use of SOLODYN,® it should be used only as indicated.

Autoimmune Syndromes Tetracyclines have been associated with the development of autoimmune syndromes.The long-term use of minocycline in the treatment of acne has been associated with drug-induced lupus-like syndrome, autoimmune hepatitis and vasculitis.Sporadic cases of serum sickness Gastro-intestinal effects have presented shortly after minocycline 1. Pseudomembranous colitis has been use.Symptoms may be manifested by fever, reported with nearly all antibacterial rash, arthralgia, and malaise.In symptomatic agents and may range from mild to lifepatients, liver function tests, ANA, CBC, and threatening. Therefore, it is important to other appropriate tests should be performed to consider this diagnosis in patients who evaluate the patients.Use of all tetracycline-class Drug/Laboratory Test Interactions present with diarrhea subsequent to the drugs should be discontinued immediately. False elevations of urinary catecholamine administration of antibacterial agents. levels may occur due to interference with the Serious Skin/Hypersensitivity Reaction Treatment with antibacterial agents alters fluorescence test. Post-marketing cases of anaphylaxis and the normal flora of the colon and may permit serious skin reactions such as Stevens Johnson Carcinogenesis, Mutagenesis & overgrowth of clostridia.Studies indicate that syndrome and erythema multiforme have been Impairment of Fertility a toxin produced by Clostridium difficile is a reported with minocycline use in treatment Carcinogenesis—Long-term animal studies primary cause of “antibiotic-associated colitis”. of acne. have not been performed to evaluate the After the diagnosis of pseudomembranous carcinogenic potential of minocycline.A Tissue Hyperpigmentation colitis has been established, therapeutic structurally related compound, oxytetracycline, Tetracycline class antibiotics are known to measures should be initiated.Mild cases of was found to produce adrenal and pituitary cause hyperpigmentation.Tetracycline therapy pseudomembranous colitis usually respond to tumors in rats. may induce hyperpigmentation in many organs, discontinuation of the drug alone.In moderate Mutagenesis—Minocycline was not mutagenic including nails, bone, skin, eyes, thyroid, to severe cases, consideration should be given in vitro in a bacterial reverse mutation assay visceral tissue, oral cavity (teeth, mucosa, to management with fluids and electrolytes, (Ames test) or CHO/HGPRT mammalian cell alveolar bone), sclerae and heart valves.Skin protein supplementation, and treatment with assay in the presence or absence of metabolic and oral pigmentation has been reported to an antibacterial drug clinically effective against activation.Minocycline was not clastogenic in occur independently of time or amount of Clostridium difficile colitis. vitro using human peripheral blood lymphocytes drug administration, whereas other tissue 2. Hepatotoxicity – Post-marketing cases or in vivo in a mouse micronucleus test. pigmentation has been reported to occur upon of serious liver injury, including irreversible prolonged administration.Skin pigmentation Impairment of Fertility—Male and female drug-induced hepatitis and fulminant hepatic includes diffuse pigmentation as well as over reproductive performance in rats was unaffected failure (sometimes fatal) have been reported with sites of scars or injury. by oral doses of minocycline of up to 300 mg/ minocycline use in the treatment of acne. kg/day (which resulted in up to approximately Information for Patients Metabolic effects 40 times the level of systemic exposure to (See Patient Package Insert for additional The anti-anabolic action of the tetracyclines minocycline observed in patients as a result of information to give patients) ® may cause an increase in BUN.While this 1. Photosensitivity manifested by an exaggerated use of SOLODYN ).However, oral administration is not a problem in those with normal of 100 or 300 mg/kg/day of minocycline to male sunburn reaction has been observed in some renal function, in patients with significantly rats (resulting in approximately 15 to 40 times individuals taking tetracyclines, including impaired function, higher serum levels of the level of systemic exposure to minocycline minocycline.Patients should minimize or tetracycline-class antibiotics may lead to patients as a result of use of avoid exposure to natural or artificial sunlight observed in ® azotemia, hyperphosphatemia, and acidosis. (tanning beds or UVA/B treatment) while using SOLODYN ) adversely affected spermatogenesis. If renal impairment exists, even usual oral or Effects observed at 300 mg/kg/day included minocycline.If patients need to be outdoors parenteral doses may lead to excessive systemic a reduced number of sperm cells per gram while using minocycline, they should wear accumulations of the drug and possible liver loose-fitting clothes that protect skin from sun of epididymis, an apparent reduction in the toxicity.Under such conditions, lower than percentage of sperm that were motile, and (at exposure and discuss other sun protection

24 Journal of Dermatology for Physician Assistants

Pediatric Use SOLODYN® is indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years and older. Safety and effectiveness in pediatric patients below the age of 12 has not been established. Use of tetracycline-class antibiotics below the age of 8 is not recommended due to the potential for tooth discoloration (see WARNINGS). Geriatric Use Clinical studies of SOLODYN® did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.Other reported clinical experience has not identified differences in responses between the elderly and younger patients.In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy. ADVERSE REACTIONS Because clinical trials are conducted under prescribed conditions, adverse reaction rates observed in the clinical trial may not reflect the rates observed in practice.However, adverse reaction information from clinical trials provides a basis for identifying the adverse events that appear to be related to drug use. Adverse events reported in clinical trials for SOLODYN® are described below in Table 2. Table 2 – Selected Treatment-Emergent Adverse Events in at least 1% of Clinical Trial Subjects Adverse Event At least one treatmentemergent event Headache Fatigue Dizziness Pruritus Malaise Mood alteration Somnolence Urticaria Tinnitus Arthralgia Vertigo Dry mouth Myalgia

SOLODYN® PLACEBO N=364 (1 mg/kg) (%) N=674 (%) 379 (56)

197 (54)

152 (23) 62 (9) 59 (9) 31 (5) 26 (4) 17 (3) 13 (2) 10 (2) 10 (2) 9 (1) 8 (1) 7 (1) 7 (1)

83 (23) 24 (7) 17 (5) 16 (4) 9 (3) 9 (3) 3 (1) 1 (0) 5 (1) 2 (0) 3 (1) 5 (1) 4 (1)

Adverse reactions not observed in the clinical trials, but that have been reported with minocycline hydrochloride use in a variety of indications include: Skin and hypersensitivity reactions: fixed drug eruptions, balanitis, erythema multiforme, Stevens-Johnson syndrome, anaphylactoid purpura, photosensitivity, pigmentation of skin and mucous membranes, hypersensitivity reactions, angioneurotic edema, anaphylaxis. Autoimmune conditions: polyarthralgia, pericarditis, exacerbation of systemic lupus, pulmonary infiltrates with eosinophilia, transient lupus-like syndrome. Central nervous system: pseudotumor cerebri, bulging fontanels in infants, decreased hearing. Endocrine: thyroid discoloration, abnormal thyroid function. Oncology: papillary thyroid cancer. Oral: glossitis, dysphagia, tooth discoloration. Gastrointestinal: enterocolitis, pancreatitis, hepatitis, liver failure. Renal: reversible acute renal failure. Hematology: hemolytic anemia, thrombocytopenia, eosinophilia. Preliminary studies suggest that use of minocycline may have deleterious effects on human spermatogenesis (see Carcinogenesis, Mutagenesis, Impairment of Fertility section). OVERDOSAGE In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures.Minocycline is not removed in significant quantities by hemodialysis or peritoneal dialysis. HOW SUPPLIED SOLODYN® (MINOCYCLINE HCl, USP) Extended Release Tablets are supplied as aqueous film coated tablets containing minocycline hydrochloride equivalent to 45 mg, 65 mg, 90 mg, 115 mg or 135 mg minocycline. The 45 mg extended release tablets are gray, unscored, coated, and debossed with “DYN-045” on one side.Each tablet contains minocycline hydrochloride equivalent to 45 mg minocycline, supplied as follows: NDC 99207-460-30 Bottle of 30 NDC 99207-460-10 Bottle of 100 The 65 mg extended release tablets are blue, unscored, coated, and debossed with “DYN-065” on one side.Each tablet contains minocycline hydrochloride equivalent to 65 mg minocycline, supplied as follows: NDC 99207-463-30 Bottle of 30 The 90 mg extended release tablets are yellow, unscored, coated, and debossed with “DYN-090” on one side.Each tablet contains minocycline hydrochloride equivalent to 90 mg minocycline, supplied as follows: NDC 99207-461-30 Bottle of 30 NDC 99207-461-10 Bottle of 100 The 115 mg extended release tablets are green, unscored, coated, and debossed with “DYN-115” on one side.Each tablet contains minocycline hydrochloride equivalent to 115 mg minocycline, supplied as follows: NDC 99207-464-30 Bottle of 30 The 135 mg extended release tablets are pink (orange-brown), unscored, coated, and debossed with “DYN-135” on one side.Each tablet contains minocycline hydrochloride equivalent to 135 mg minocycline, supplied as follows: NDC 99207-462-30 Bottle of 30 NDC 99207-462-10 Bottle of 100 Store at 25ºC (77ºF); excursions are permitted to 15º-30ºC (59º-86ºF) [See USP Controlled Room Temperature]. Protect from light, moisture, and excessive heat. Dispense in tight, light-resistant container with child-resistant closure. U.S. Patent 5,908,838* and Patents Pending *90 mg is also covered by U.S. Patents 7,541,347 and 7,544,373 Manufactured for: Medicis, The Dermatology Company Scottsdale, AZ 85256 July 2009 17110103


From The Patient’s Perspective ONLY on the WEB at dermpa.org

...continued from page 22

Take Home points for derm pas: By Steven K. Shama, MD, MPH

CLINICAL Dermatology

ONLY on the WEB at dermpa.org

&

Dermoscopy Q A Journal of Dermatology for Physician Assistants

The Official Journal of the SDPA Are you a PA who may be... • Interested in writing? • Have a paper you wish to get published? Contact Editor@jdpa.org

Q: What is it?

ONLY on the WEB at dermpa.org

Answer on page 26 Vol. 3, No. 4 FALL 2009 25


&

Dermoscopy Q A

CLINICAL Dermatology

ONLY on the WEB at dermpa.org

SDPA 1st SUMMER DERMATOLOGY CONFERENCE Chicago Marriott Downtown Magnificent Mile Chicago, IL June 10 - June 13, 2010 chicagoFlyer_B.indd 1

26 Journal of Dermatology for Physician Assistants

Mark Your Calendars Now! 3/19/09 12:54 PM


Clinical snapshots Fordyce’s Spots By Travis Hayden, MPAS, PA-C JDPA Editor in Chief

CLINICAL Dermatology

ONLY on the WEB at dermpa.org

Vol. 3, No. 4 FALL 2009 27


SURGICAL Dermatology

Beyond the Ellipse‌

Rhomboid Transposition Flaps By Douglas DiRuggiero, PA-C and John Chung, MD

ONLY on the WEB at dermpa.org

Douglas DiRuggiero, PA-C has practiced dermatology for 9 years and works with John Chung, MD who is a board certified dermatologist and fellowshiptrained Mohs surgeon. 28 Journal of Dermatology for Physician Assistants


SURGICAL wisdom

surgical Dermatology

Ten Steps to a Seamless Excision Step 6 Deep Suture Placement Step 7 Eversion

By Michael Fraykor, PA-C

ONLY on the WEB at dermpa.org

Vol. 3, No. 4 FALL 2009 29


SURGICAL wisdom

surgical Dermatology

ONLY on the WEB at dermpa.org

For most physician assistants working in the field of dermatology, excisions are an everyday occurrence. Excisions can occasionally be challenging and intimidating due to size, location, and a patient’s expectations. Since I work strictly for a Mohs surgeon, performing excisions and suturing have become second nature to me. I have put together the 10 key points that I have learned that help ensure good excisions as well as good cosmetic results. Hopefully, this 10 part series will provide you with the tools needed for a seamless excision.

30 Journal of Dermatology for Physician Assistants


Transforming healTh care is a big job. We should know. We’re doing it every day.

Physician assistants are a vital part of America’s health care team. Every day, more than 75,000 physician assistants (PAs) extend the promise of better health care to more Americans, especially those most in need. As the population grows and ages and the health care system changes, well-trained, highly skilled PAs will be even more essential to providing high-quality health care that’s also cost effective. It’s a big job, but one we’re ready for. In fact, we’re already doing it.

Visit www.aapa.org to learn more.

Vol. 3, No. 4 FALL 2009 31


COSMETIC deRMATOLOGY

Management of Hypotrichosis Using Bimatoprost Ophthalmic Solution 0.03%

What you should know before patients ask you about their eyelashes By Risha Bellomo, MPAS, PA-C and Travis Hayden, MPAS, PA-C

ONLY on the WEB at dermpa.org

Risha Bellomo, MPAS, PA-C has practiced dermatology for over 8 years. She currently works at Advanced Dermatology & Cosmetic Surgery in Orlando, Florida and has been their Director of PA/NP Cosmetic Training for the last 3 years. She has indicated no relationships to disclose relating to the content of this article. Travis Hayden, MPAS, PA-C practices dermatology with John Tu, MD at Dermatology Associates of Rochester, New York. He has indicated no relationships to disclose relating to the content of this article. 32 Journal of Dermatology for Physician Assistants


cosmetic Dermatology

Cosmetic pearls ONLY on the WEB at dermpa.org

Vol. 3, No. 4 FALL 2009 33


Professional development

PAs and Consultations By Inga Ellzey, MPA, RHIA, CDC

ONLY on the WEB at dermpa.org

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.

34 Journal of Dermatology for Physician Assistants


professional development Vol. 3, No. 4 FALL 2009 35


professional development

1

pa_prof_sdpa_D_print.indd 1

2

36 Journal of Dermatology for Physician Assistants

3

4/19/09 5:05 PM


Differin® Gel, 0.3% at work:

POWERFUL EFFICACY FOR YOUR MORE CHALLENGING COMEDONAL ACNE PATIENTS1

Effective for noninflammatory, inflammatory, and total lesions1, 2

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%), and desquamation (1.6%). Please see brief summary of Prescribing Information on adjacent page.

www.differin.com

Vol. 3, No. 4 FALL 2009 37


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.

38 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: 1. Data on file. Galderma Laboratories, L.P. 2. Thiboutot D, Arsonnaud S, Soto P. Efficacy and References: GALDERMA L.P.gel compared to tazarotene 0.1% gel in the treatment of acne vulgaris. tolerability ofLABORATORIES, adapalene 0.3% Fort Worth, Texas 76177 USA 6):S3-S10. J Drugs Dermatol . 2008;7(suppl Manufactured by: DPT Laboratories, Ltd. San Antonio, Texas 78215 USA GALDERMA is a registered trademark. Revised: June 2007 325089-0607 “Experience the Power” and Differin andare Galderma aretrademarks. registered trademarks. www.differin.com Galderma registered ©2007 Galderma Laboratories, L.P. ©2009 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-041 Printed07/09 DIF-888 in USA 11/07


Judicial and Ethical Affairs Ethical Dilemmas in Dermatology: Dealing with Substance Abuse By Diane C. Williams, MPAS, PA-C

professional development

ONLY on the WEB at dermpa.org

Diane C. Williams, MPAS, PA-C is a graduate of the Essex Community College Physician Assistant Program and received her Master’s degree from the University of Nebraska Medical Center. Prior to becoming a PA, Diane earned a Master of Divinity degree and worked as an adult religious educator. Diane practices medical dermatology in Havre de Grace, Maryland.

Vol. 3, No. 4 FALL 2009 39


professional development

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

Notes from your Office Manager Going Green In keeping with the SDPA initiative towards “Going Green,” here are some environmentally friendly tips for use in your office. By implementing simple changes, we can have a great impact on the overall carbon footprint we leave in the workplace. TEMPERATURE CONTROL - Keep the office temperatures at a comfortable setting. Take advantage of programmable thermostats and don’t cool/heat office space during nonworking hours. Keep doors and windows closed so as to not cool/heat outside spaces. Utilize window blinds/shades to help with heating/ cooling of rooms. COMPUTER MONITORS - Remind employees to turn off monitors and set computers to go into sleep mode when not in use. LIGHTING - Turn off lights when a room is not in use. Better yet, consider investing in motion detectors so lights shut off automatically when a room is vacant. When a room is in steady use during working hours, open window blinds/shades to provide a source of natural lighting. Consider installing energy efficient light bulbs (if the expense seems overwhelming, start by replacing a few lights per month).

40 Journal of Dermatology for Physician Assistants

OFFICE EQUIPMENT - Evaluate office needs and consider purchasing all-in-one equipment that serves as a printer, fax, and copy machine. Keeping multiple separate machines typically wastes energy; turn off nonessential machines at night. REDUCE PAPER WASTE - Encourage employees to cut back on making unnecessary copies (if copies are necessary make them double-sided). Read emails instead of printing them and receive incoming faxes as electronic documents instead of printed copies. These steps will not only save on paper and ink but will also conserve electricity. RECYCLE - Encourage employees to cut back on making unnecessary copies (if copies are necessary make them double-sided). Read emails instead of printing them and receive incoming faxes as electronic documents instead of printed copies. In addition, use recycled paper where possible. These steps will not only save on paper and ink but will also conserve electricity. If we all commit to making small changes in our offices, these little steps can amount to great savings in both energy and resources. Good luck going green - you will be glad you did! J


Outside the 9 to 5...

Volunteering with the National Psoriasis Foundation By Sarah Kurts, PA-C A year ago at the NPF National Conference, I recommended Denver to be one of the fifteen cities nationwide to host a NPF Walk to Cure Psoriasis. These walks have been extremely successful fundraisers, raising over $1.5 million in two years for the foundation. Working with my committee of eleven members we have secured multiple in-kind donations, an Emmy-award winning news anchor as emcee, and an eight piece At some point, I jazz band for the event realized there were no scheduled at the time this psoriasis support groups article is being written to in my home state of take place September 13th, Colorado. I understood 2009. Our ambitious goal that the time investment this inaugural year is to in starting a support raise $30,000. With a weak group in the Denver area From left to right: Sarah Kurts (co-leader, Mile High economy, local corporate Psoriasis Network), CariDee English (spokesperson for could be considerable sponsors have been few the National Psoriasis Foundation and America’s Next so I pondered the idea and far between. We are Top Model winner 2006), and Robert Winters for a while before finally counting on our families (co-leader, Mile High Psoriasis Network). contacting the National as well as corporate and Psoriasis Foundation (NPF). At the 2008 Annual AAD medical walk teams to bring in these funds. Our Winter Meeting, I stopped by the NPF booth and teenage ambassador, Kelly Runyan, (another patient of learned that the organization was open to starting mine) recently found her way to me through the Mile new support groups. Once I was back in Denver, High Psoriasis Network. She had severe and extensive I started the wheels rolling. The NPF encourages psoriasis that had previously been misdiagnosed and support groups to have two co-leaders so I recruited under treated. Currently Kelly is on biologic therapy one of my psoriasis patients, Robert Winters, to join and, while her psoriasis is not cured, her symptoms me in my efforts (Robert has recently been promoted are well controlled. Kelly is once again living the life of to one of three regional support group leader a normal teenager. positions). The two of us went through leadership This is why I do what I do, in the hope that more training via both teleconference sessions and the NPF psoriasis sufferers can live more normally. There is National Conference. The Denver psoriasis support still a long way to go in terms of a cure, but there are group we helped to create, the Mile High Psoriasis Network, launched with its first meeting in November forty drugs in the 2009 pipeline! Financial resources 2008. At our inaugural meeting we had six attendees are needed to fund necessary research and the walks (including Robert and myself). Our monthly meetings help provide these resources. In the meantime, local support groups help our patients cope with their have now grown to an average of twenty attendees. psoriasis until a cure is found. J Speakers have included a dermatologist, a PhD, a life coach, and a nurse practitioner. Sometimes there is no speaker at all and we just talk amongst ourselves. The Do you know a dermatolog y PA we could highlight for a meetings provide information, emotional support, future “Outside the 9 to 5...� article? Please contact us at: and comradery, letting psoriasis sufferers in Denver Editor@jdpa.com know they are not alone.

Vol. 3, No. 4 FALL 2009 41

professional development

When I started as a dermatology physician assistant nearly eight years ago, I was involved in a number of psoriasis clinical trials. Biologic therapies were brand new to the market and neither patients nor providers had seen anything like them. Witnessing the change in these patients as their psoriasis significantly improved was incredibly rewarding, and I rapidly developed a passion for treating psoriasis.


Dermatology PA news & notes

From the Desk of... Donna M. Kilkelly, PA-C

As Veterans Day, 2009 approaches, we as physician assistants may want to take some time to recognize the many veterans who are our patients. While I have been fortunate to work with these very special patients for just over eight years, it was not until recently that I explored the history of my employer, the Veterans Affairs (VA) system. I would like to share a glimpse into the VA system and its history as well as how this patient population is deserving of our regard, care, and above all, compassion. Abraham Lincoln once said “…to care for him who shall have borne the battle, and his widow and his orphan…” This statement, spoken by President Lincoln during his second inaugural address, is the motto of the VA health care system. Those same words decorate the entrance into the VA Medical Center in Nashville, Tennessee where I have been given the opportunity to serve for eight years, of which four have been in dermatology. Each morning as I enter the facility, I am reminded of this promise made to care for those veterans. Every day, I have the opportunity to provide health care to those who have served our country and in turn have served me. While everyone deserves good health care, I believe that this population is especially deserving of the best care available. The United States has the most comprehensive system of assistance for veterans of any nation. Benefits for veterans in the US can be traced back to 1636, when the Pilgrims of Plymouth Colony were Donna M. Kilkelly, PA-C completed her PA studies at Midwestern University-Glendale, AZ campus in 2001. She is employed at the VA Medical Center in Nashville, TN where she has enjoyed working in the dermatology outpatient clinic for the last five years.

42 Journal of Dermatology for Physician Assistants

at war with the Pequot Indians. At that time, the Pilgrims passed a law that stated that all disabled soldiers were to be supported by the colony. Over the centuries, the VA system has gone through several developmental stages and tremendous change, but the formal establishment of the VA came in 1930 when President Herbert Hoover was authorized to coordinate government activities affecting veterans of war. Since that time in 1930, the VA health care system has grown from 54 hospitals to 171 medical centers, over 350 outpatient clinics (including community and outreach facilities), 126 nursing home units, and 35 domiciliaries. As of January 31, 2009, there were 1842 physician assistants in the VA system. Not only does the system provide employment for many physician assistants, it also has afforded many PA students the opportunity to train within a VA facility. What many people may not know is that veterans must go through an approval process to acquire care in the VA system. Either they must have a service-connected illness (meaning a condition diagnosed while on active duty) or have approval based on a Means Test (which determines eligibility based on financial assets). Once approved and in the system, the medication formulary from which their medications are prescribed may not allow as many first line choices as they would have in the private sector and if the prescription is available, it may need to be approved by pharmacy. Some veterans are required to pay co-payments for treatment as well as medications. Other limitations are found within each VA hospital department as far as the types of treatments that are available. Most veterans who I encounter have skin that was ravaged by the sun during their time in service. There is the full gamut of skin disease, mostly primary, but also those secondary to internal disease.


While listening to these men and women it is apparent that many suffer from symptoms of Posttraumatic Stress Disorder (PTSD) and experience psychocutaneous symptoms. Nightmares are also a frequent complaint and I have witnessed many in actual distress because they are still mourning the loss of their compatriots. Sometimes they ask: “Can I just talk to you?” I have heard countless heroic tales and have met a survivor of the USS Indianapolis, numerous POWs, a soldier with whom Ernie Pyle (journalist and military correspondent during WWII) had his final lunch, and hundreds of faithful human beings many of whom risked their lives for our country. I am in awe of what many of them

have endured, so it never ceases to amaze me that a number of them would willingly “go back and do it all again.” Despite their past experiences and the limitations on the care they receive within the VA, the amount of gratitude these veterans display astonishes me. After many visits, I have had challenge coins placed in my hand and have received cards, letters, photos, produce from their gardens, and special pieces crafted in their personal workshops. Everyone says “thank you” in his or her own way and each time I honestly feel a bit guilty because I am just doing the work that I am paid to do. After receiving a token of appreciation or the voiced “thank you,” I always reply, “No, thank you for what you have done.” They always look surprised and one or two have even stated, “that’s never happened.” Most have never been shown appreciation, and some have even been ridiculed for serving our country. These fine men and women have given a lot of themselves. They are national treasures. Even if they were not on the battlefield, they all did their part in defending our country and deserve our best. As this Veterans Day approaches, if you get an opportunity, see what you can do for a veteran. Perhaps the next time you meet a veteran or an active duty service member, you too can say, “thank you.” I know they will appreciate the gesture. J

SDPA Fall Conference is Going GREEN We are very excited about our new “Going Green” initiative. Here are some of the changes that you will see at the upcoming SDPA Fall Conference in Scottsdale, AZ: 1. WATER STATIONS Bottled water is expensive and wasteful. We will stop offering bottled water and instead have water stations throughout the conference hall and on tables during lectures. 2. THUMB DRIVES In place of the traditional paper syllabus/lectures, conference attendees will receive a thumb

drive with the syllabus/lectures that they can take home. The syllabus/lectures will also be available on the SDPA website two weeks before and after the conference. At the conference, notebooks will be given to attendees to take notes during lectures. 3. LOG CME CREDITS ONLINE AT THE CONFERENCE Attendees will be able to log CME credits directly into NCCPA accounts at the conference. CME hours logged using this method will be exempt from audit. J Vol. 3, No. 4 FALL 2009 43

DERmatology pa news & notes

These veterans not only have service-connected illnesses but many are now homeless because of disabilities. With the homeless population, there needs to be a completely different approach to care. While they may have a horrible skin infection (usually secondary to their living conditions), they are in survival mode; therefore we as providers need to make sure their basic needs of food, shelter, and safety are being met. Without these needs being met, compliance will be low, if not nonexistent. Empathy, persistence, compassion, and patience are all key in caring for the homeless. Sometimes what concerns veterans more than their skin complaints or their living situations are the emotional issues stemming from painful haunting memories. Frequently these patients just need to talk, share their stories, and have someone listen.


The Difference We Make: The Julie Principle

DERmatology pa news & notes

By Steven K. Shama, MD, MPH Each time I have a conversation with my twentyeight year old daughter Julie I learn something new about myself as a person and also as a father. Recently Julie called me from her new home in Los Angeles and during that conversation she unknowingly taught me about myself as a dermatologist and how I practice dermatology. I will never forget that conversation. Julie had just moved to Los Angeles about one year ago and found a nice solid job with a large music management company. She earns $25,000 a year, enough to survive but not enough to save, and she works a full forty-hour week. Health insurance was included but for the first two years of her new job she was given only one week of time off, which included vacation and sick days. As a young person she thought this was perhaps enough time but as it worked out it was not. When Julie called me she told me that she hadn’t been feeling well a few weeks before and had gone to see her doctor. She said he called the day before and wanted to see her again for a follow-up. While she was feeling better she wasn’t totally recovered and realized that she needed to keep that follow-up appointment. I wondered why she was calling me about this. She said that she had used up all of her five days of time off and she had no more time left for her doctor’s appointment. “They look down upon people who take more than the time allowed and I’m afraid of losing my job if I ask them for more time off. I need half a day to drive to his office, wait to see him and then to drive back. Sometimes he is late and so an appointment can take as much as two hours.” I told her that she simply had to go back to the doctor if that is what he wanted and she understood. “Just explain to your boss that it is important to go to the doctor and I am sure he will let you go.” Julie kept the appointment and also kept her job. However, she was fearful of taking time off again no matter how poorly she was feeling. Soon after that I started to think about my conversation with Julie. I wondered how many “Julies” there were in my practice and how many patients went the extra mile to see me. How many twenty-eight year-old young women (and men) who were starting a new job had I asked to take time off for a follow-up? How critical to me was that follow-up Dr. Steve Shama has been practicing general dermatology for 30 years in Boston, Massachusetts. Dr. Shama has been a professional speaker for 20 of those years and enjoys speaking on many topics, some of which include: “Dealing With Difficult People and Looking Forward To It!” and “Rediscovering The Joys of Medicine and of Life.” He gives these talks at medical meetings and for the general public throughout the country. He also travels to private offices to present his workshops and talks. You can reach Dr. Shama at www.steveshama.com.

44 Journal of Dermatology for Physician Assistants

visit? What would they have to do to come to see me? Was it simply time off or lost pay? Could the day off possibly jeopardize their job? Was the appointment really, really, really necessary? I realized that I should apply the Julie Principle to as many situations with patients as I could. I then generalized this principle to all patients. When I arrange for a follow-up visit I must consider what effort is involved for patients to come to see me and whether the visit is truly necessary. Is there another way of getting the information I need? What effort does it take patients to see me for a follow-up? What does parking and gas cost and is it perhaps necessary for them to hire an assistant if they are elderly? Do they have to ask a family member to come with them who would normally go to work? Can I have extended office hours earlier in the day or later to help patients avoid having to take time off from work? Most patients respect us so much as clinicians that they believe that a follow-up visit is truly important. How often do we simply expect a follow-up visit without considering what effort it takes? Can a phone call be just as efficient in telling you that a child’s acne is clearing? Perhaps the parents have a good camera and they can send you an e-mail showing the child’s face. I now realize that I should at least consider the Julie Principle when planning any follow-up visit. I also apply the Julie Principle when I get a phone call about a new problem from an established patient. Can phone call advice be sufficient or do they truly need to be seen? It is not clear to me that I have ever considered what a follow-up visit costs in time and effort for patients. I am sure that if I did some office visits could be avoided, and as an added benefit I would have more time for urgent visits. May I suggest that in the next week or so that you consider how many times you have patients come back for a follow-up visit. Then apply the Julie Principle. What effort does it take for patients to come and see you and is it really necessary for you to see them face-to-face? Can you do that follow-up in some other way? I believe there are many “Julies” out there, hard working and conscientious patients who respect you as a clinician and will do what you would like them to do. Perhaps all of us could think even more about what it takes for them to come to a visit and then exercise the Julie Principle. I thank my sweet daughter Julie for teaching me this very important lesson. J

Steven K. Shama, MD, MPH


Supervising Physician CORNER A Team Built on Trust By Mary Kate Monsour, PA-C

My responsibilities as a physician assistant in our practice go beyond patient care and include implementing new technologies and office services. In order to perform this valuable function we must Through product research and working with sales work well with our supervising physician. I believe representatives I have been able to incorporate our the most important component to making this new VISIA complexion analysis system. Currently relationship work well is trust. Physician assistants we are in the process need to have trust of transitioning to in the physician’s When your supervising physician has electronic medical decisions and records and I protocols, and the confidence in your work, this reflects have assumed the physician needs to positively to the staff and to the patients. responsibilities of have trust in the researching and physician assistant’s organizing in order to capabilities and make our paperless transition as seamless as possible. training. I am very fortunate to have such a relationship with my supervising physician, Janine When your supervising physician has O. Hopkins, MD. By working side by side, Dr. confidence in your work, this reflects positively Hopkins and I have been able to build a strong to the staff and to the patients. Our practice uses relationship based on mutual respect in each other’s promotions to support me, allowing my position knowledge and skills. She is always available for and name to be associated with the practice and me to consult with regarding any questions or my physician’s reputation. We use local advertising, concerns, especially with difficult cases. I often periodic announcements through mail and email, use photographs to document findings to aid us our web site, and a quarterly newsletter featuring in making diagnoses and for continuity of our a topic by myself and by Dr. Hopkins. This has patients’ care. Frequently we review charts and helped the patients to be more receptive to seeing pathology reports together at the end of the day. me and has helped my part of the practice grow. We definitely have open lines of communication There are many ways for a physician assistant to be that help us to more easily address any patient, utilized. Having a positive physician-PA relationship office, and staff issues. built on trust is the foundation for having a successful team practice. J Mutual trust opens up more possibilities for the practice. To help me further specialize in dermatology, Dr. Hopkins is very supportive of my participation in advanced educational opportunities such as annual SDPA conferences. The lectures and workshops are very educational and the interaction with other dermatology physician assistants is extremely informative and beneficial. After the conferences, Dr. Hopkins and I have a meeting to discuss a prepared summary on the topics covered. This contributes to the practice by helping us stay up-to-date on treatment modalities. I fortunately entered into a very progressive and established practice. Janine O. Hopkins, MD and Mary Kate Monsour, PA-C

Vol. 3, No. 4 FALL 2009 45

DERmatology pa news & notes

Our physician assistant profession was established to help expand medical care to patients.


Professional Opportunities and Development

Advertiser INDE X OrthoDermatologics – Retin-A Micro... Pages 2, 3 Ranbaxy – Kenalog Spray...................Pages 7, 8 Intendis – Finacea.......................... Pages 11, 12 Medicis – Solodyn...........................Pages 23, 24 Galderma – Differin 0.3.................Pages 37, 38 Graceway – Aldara.........................Pages 47, 48 For more information on advertising opportunities in the JDPA, please log on to www.jdpa.org

Got Compassion? www.pasforglobalhealth.org

Our mission is to raise funds for a treatment and cure of Giant Axonal Neuropathy (GAN). Life-saving research is underway with the goal of a clinical trial in Fall of 2011. “Give all you can to cure GAN” www.hannahshopefund.org

THE NEW 2009 EDITION Comprehensive Review Notes in Dermatology for the Physician Assistant Educational Competency Review and Self Assessment Examination The 2009 Edition covers vital dermatology concepts in a user-friendly format NEW Highlights Include: • PA take-away points: summaries at the end of each chapter, written by physician assistants for physician assistants • PA-authored online questions: for the most relevant review • Companion online exams: redeemable for up to 40 category 1 CME credits Complimentary to all 2009 SDPA members Request your FREE copy today: visit www.dermpa.org Provided through an educational grant from

46 Journal of Dermatology for Physician Assistants

The 2008 election of a new Administration and Congress offers physician assistants the opportunity to work for changes to our country’s health care system. It will be difficult to resolve our economic troubles without also addressing the huge expenditures for health care and the lack of coverage for 46 million Americans. AAPA has contacted President Obama and promised to work on health care reform. PAs for a Healthy America is the advocacy initiative for AAPA members. To learn more, please visit www.aapa.org/ advocacy-and-practice-resources/federaladvocacy/pas-for-a-healthy-america.


ALDARA® (imiquimod) Cream, 5% Brief Summary of Actinic Keratosis Prescribing Information See Package Insert for Full Prescribing Information INDICATIONS AND USAGE: Actinic Keratosis: Aldara Cream is indicated for the topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp in immunocompetent adults. Unevaluated Populations: Safety and efficacy of Aldara Cream in immunosuppressed patients have not been established. Aldara Cream should be used with caution in patients with pre-existing autoimmune conditions. The efficacy and safety of Aldara Cream have not been established for patients with Basal Cell Nevus Syndrome or Xeroderma Pigmentosum. CONTRAINDICATIONS: None. WARNINGS AND PRECAUTIONS: Local Inflammatory Reactions: Intense local inflammatory reactions including skin weeping or erosion can occur after few applications of Aldara Cream and may require an interruption of dosing. Aldara Cream has the potential to exacerbate inflammatory conditions of the skin, including chronic graft versus host disease. Administration of Aldara Cream is not recommended until the skin is completely healed from any previous drug or surgical treatment. Systemic Reactions: Flu-like signs and symptoms may accompany, or even precede, local inflammatory reactions and may include malaise, fever, nausea, myalgias and rigors. An interruption of dosing should be considered. Ultraviolet Light Exposure: Exposure to sunlight (including sunlamps) should be avoided or minimized during use of Aldara Cream because of concern for heightened sunburn susceptibility. Patients should be warned to use protective clothing (e.g., a hat) when using Aldara Cream. Patients with sunburn should be advised not to use Aldara Cream until fully recovered. Patients who may have considerable sun exposure, e.g., due to their occupation, and those patients with inherent sensitivity to sunlight should exercise caution when using Aldara Cream. Aldara Cream shortened the time to skin tumor formation in an animal photococarcinogenicity study. The enhancement of ultraviolet carcinogenicity is not necessarily dependent on phototoxic mechanisms. Therefore, patients should minimize or avoid natural or artificial sunlight exposure. Unevaluated Uses: Safety and efficacy have not been established for Aldara Cream in the treatment of actinic keratosis with repeated use, i.e., more than one treatment course in the same area. The safety of Aldara Cream applied to areas of skin greater than 25 cm2 for the treatment of actinic keratosis has not been established. ADVERSE REACTIONS: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical Trials Experience: Actinic Keratosis The data described below reflect exposure to Aldara Cream or vehicle in 436 subjects enrolled in two double-blind, vehicle-controlled studies. Subjects applied Aldara Cream or vehicle to a 25 cm2 contiguous treatment area on the face or scalp 2 times per week for 16 weeks. Table 1: Selected Adverse Reactions Occurring in >1% of Aldara-Treated Subjects and at a Greater Frequency than with Vehicle in the Combined Studies (Actinic Keratosis) Preferred Term Application Site Reaction Upper Resp Tract Infection Sinusitis Headache Carcinoma Squamous Diarrhea Eczema Back Pain Fatigue Fibrillation Atrial Infection Viral Dizziness Vomiting Urinary Tract Infection Fever Rigors Alopecia

Aldara Cream (n=215)

Vehicle (n=221)

71 (33%) 33 (15%) 16 (7%) 11 (5%) 8 (4%) 6 (3%) 4 (2%) 3 (1%) 3 (1%) 3 (1%) 3 (1%) 3 (1%) 3 (1%) 3 (1%) 3 (1%) 3 (1%) 3 (1%)

32 (14%) 27 (12%) 14 (6%) 7 (3%) 5 (2%) 2 (1%) 3 (1%) 2 (1%) 2 (1%) 2 (1%) 2 (1%) 1 (<1%) 1 (<1%) 1 (<1%) 0 (0%) 0 (0%) 0 (0%)

Table 2: Application Site Reactions Reported by >1% of Aldara-Treated Subjects and at a Greater Frequency than with Vehicle in the Combined Studies (Actinic Keratosis) Included Term Itching Burning Bleeding Stinging Pain Induration Tenderness Irritation

Aldara Cream n=215

Vehicle n=221

44 (20%) 13 (6%) 7 (3%) 6 (3%) 6 (3%) 5 (2%) 4 (2%) 4 (2%)

17 (8%) 4 (2%) 1 (<1%) 2 (1%) 2 (1%) 3 (1%) 3 (1%) 0 (0%)

The adverse reactions that most frequently resulted in clinical intervention (e.g., rest periods, withdrawal from study) were local skin and application site reactions. Overall, in the clinical studies, 2% (5/215) of subjects discontinued for local skin/application site reactions. Of the 215 subjects treated, 35 subjects (16%) on Aldara Cream and 3 of 220 subjects (1%) on vehicle cream had at least one rest period. Of these Aldara Cream subjects, 32 (91%) resumed therapy after a rest period. In the actinic keratosis studies, 22 of 678 (3.2%) of Aldara-treated subjects developed treatment site infections that required a rest period off Aldara Cream and were treated with antibiotics (19 with oral and 3 with topical). Of the 206 Aldara subjects with both baseline and 8-week post-treatment scarring assessments, 6 (2.9%) had a greater degree of scarring scores at 8-weeks post-treatment than at baseline. Clinical Trials Experience: Dermal Safety Studies Provocative repeat insult patch test studies involving induction and challenge phases produced no evidence that Aldara Cream causes photoallergenicity or contact sensitization in healthy skin; however, cumulative irritancy testing revealed the potential for Aldara Cream to cause irritation, and application site reactions were reported in the clinical studies. Postmarketing Experience: The following adverse reactions have been identified during post-approval use of Aldara Cream. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Body as a Whole: angioedema. Cardiovascular: capillary leak syndrome, cardiac failure, cardiomyopathy, pulmonary edema, arrhythmias (tachycardia, atrial fibrillation, palpitations), chest pain, ischemia, myocardial infarction, syncope. Endocrine: thyroiditis. Hematological: decreases in red cell, white cell and platelet counts (including idiopathic thrombocytopenic purpura), lymphoma. Hepatic: abnormal liver function. Neuropsychiatric: agitation, cerebrovascular accident, convulsions (including febrile convulsions), depression, insomnia, multiple sclerosis aggravation, paresis, suicide. Respiratory: dyspnea. Urinary System Disorders: proteinuria. Skin and Appendages: exfoliative dermatitis, erythema multiforme, hyperpigmentation. Vascular: Henoch-Schonlein purpura syndrome. USE IN SPECIFIC POPULATIONS: Pregnancy: Pregnancy Category C: Systemic embryofetal development studies were conducted in rats and rabbits. Oral doses of 1, 5 and 20 mg/kg/day imiquimod were administered during the period of organogenesis (gestational days 6 – 15) to pregnant female rats. In the presence of maternal toxicity, fetal effects noted at 20 mg/kg/day (577X MRHD based on AUC comparisons) included increased resorptions, decreased fetal body weights, delays in skeletal ossification, bent limb bones, and two fetuses in one litter (2 of 1567 fetuses) demonstrated exencephaly, protruding tongues and low-set ears. No treatment related effects on embryofetal toxicity or teratogenicity were noted at 5 mg/kg/day (98X MRHD based on AUC comparisons). Intravenous doses of 0.5, 1 and 2 mg/kg/day imiquimod were administered during the period of organogenesis (gestational days 6 – 18) to pregnant female rabbits. No treatment related effects on embryofetal toxicity or teratogenicity were noted at 2 mg/kg/day (1.5X MRHD based on BSA comparisons), the highest dose evaluated in this study, or 1 mg/kg/day (407X MRHD based on AUC comparisons). A combined fertility and peri- and post-natal development study was conducted in rats. Oral doses of 1, 1.5, 3 and 6 mg/kg/day imiquimod were administered to male rats from 70 days prior to mating through the mating period and to female rats from 14 days prior to mating through parturition and lactation. No effects on growth, fertility, reproduction or post-natal development were noted at doses up to 6 mg/kg/day (87X MRHD based on AUC comparisons), the highest dose evaluated in this study. In the absence of maternal toxicity, bent limb bones were noted in the F1 fetuses at a dose of 6 mg/kg/day (87X MRHD based on AUC comparisons). This fetal effect was also noted in the oral rat embryofetal development study conducted with imiquimod. No treatment related effects on teratogenicity were noted at 3 mg/kg/day (41X MRHD based on AUC comparisons). There are no adequate and wellcontrolled studies in pregnant women. Aldara Cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers: It is not known whether imiquimod is excreted in human milk following use of Aldara Cream. Because many drugs are excreted in human milk, caution should be exercised when Aldara Cream is administered to nursing women. Pediatric Use: AK is not a condition generally seen within the pediatric population. The safety and efficacy of Aldara Cream for AK in patients less than 18 years of age have not been established. Aldara Cream was evaluated in two randomized, vehicle-controlled, double-blind trials involving 702 pediatric subjects with molluscum contagiosum (MC) (470 exposed to Aldara; median age 5 years, range 2-12 years). Subjects applied Aldara Cream or vehicle 3 times weekly for up to 16 weeks. These studies failed to demonstrate efficacy. Similar to the studies conducted in adults, the most frequently reported adverse reaction from 2 studies in children with MC was application site reaction. Adverse events which occurred more frequently in Aldara-treated subjects compared with vehicle-treated subjects generally resembled those seen in studies in indications approved for adults and also included otitis media (5% Aldara vs. 3% vehicle) and conjunctivitis (3% Aldara vs. 2% vehicle). Erythema was the most frequently reported local skin reaction. Severe local skin reactions reported by Aldara-treated subjects in the pediatric studies included erythema (28%), edema (8%), scabbing/crusting (5%), flaking/scaling (5%), erosion (2%) and weeping/exudate (2%). Systemic absorption of imiquimod across the affected skin of 22 subjects aged 2 to 12 years with extensive MC involving at least 10% of the total body surface area was observed after single and multiple doses at a dosing frequency of 3 applications per week for 4 weeks. Among the 20 subjects with evaluable laboratory assessments, the median WBC count decreased by 1.4*109/L and the median absolute neutrophil count decreased by 1.42*109/L. Geriatric Use: Of the 215 subjects treated with Aldara Cream in the AK clinical studies, 127 subjects (59%) were 65 years and older, while 60 subjects (28%) were 75 years and older. Of the 185 subjects treated with Aldara Cream in the superficial basal cell carcinoma clinical studies, 65 subjects (35%) were 65 years and older, while 25 subjects (14%) were 75 years and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. No other clinical experience has identified differences in responses between the elderly and younger subjects, but greater sensitivity of some older individuals cannot be ruled out. OVERDOSAGE: Topical overdosing of Aldara Cream could result in an increased incidence of severe local skin reactions and may increase the risk for systemic reactions. The most clinically serious adverse event reported following multiple oral imiquimod doses of >200 mg (equivalent to imiquimod content of >16 packets) was hypotension, which resolved following oral or intravenous fluid administration.

Local skin reactions were collected independently of the adverse reaction “application site reaction” in an effort to provide a better picture of the specific types of local reactions that might be seen. The most frequently reported local skin reactions were erythema, flaking/scaling/dryness, and scabbing/crusting. The prevalence and severity of local skin reactions that occurred during controlled studies are shown in the following table. Table 3: Local Skin Reactions in the Treatment Area as Assessed by the Investigator (Actinic Keratosis) Aldara Cream (n=215) Erythema Flaking/Scaling/Dryness Scabbing/Crusting Edema Erosion/Ulceration Weeping/Exudate Vesicles *Mild, Moderate, or Severe

All Grades* 209 (97%) 199 (93%) 169 (79%) 106 (49%) 103 (48%) 45 (22%) 19 (9%)

Severe 38 (18%) 16 (7%) 18 (8%) 0 (0%) 5 (2%) 0 (0%) 0 (0%)

Vehicle (n=220) All Grades* 206 (93%) 199 (91%) 92 (42%) 22 (10%) 20 (9%) 3 (1%) 2 (1%)

Severe 5 (2%) 7 (3%) 4 (2%) 0 (0%) 0 (0%) 0 (0%) 0 (0%)

Rx Only

Manufactured by 3M Health Care Limited Loughborough LE11 1EP England Distributed by Graceway Pharmaceuticals, LLC Bristol, TN 37620

ALD100807 US52 Rev1107-2 6204 0913 2 Revised: November 2007 Aldara is a registered trademark of Graceway Pharmaceuticals, LLC

Vol. 3, No. 4 FALL 2009 47


In the treatment of Actinic Keratosis (AK)

Aldara clears both visible and subclinical lesions

1,2

CLEARANCE FROM WITHIN Aldara is not chemodestructive or cytotoxic. The mechanism of action of Aldara Cream in treating AK and sBCC lesions is unknown. Aldara Cream is indicated for the topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp in immunocompetent adults. Exposure to sunlight (including sunlamps) should be avoided or minimized during use of Aldara Cream because of concern for heightened sunburn susceptibility. Patients should be warned to use protective clothing (hat) when using Aldara Cream. In AK clinical studies, the most common side effects involved skin reactions in the application area. These included redness, swelling, erosions, weeping, scabbing, itching, and burning. Most skin reactions were rated mild to moderate. Please see brief summary of Prescribing Information on adjacent pages. References: 1. Lebwohl M, Dinehart S, Whiting D, et al. Imiquimod 5% cream for the treatment of actinic keratosis: Results from two phase III, randomized, double-blind, parallel group, vehicle-controlled trials. J Am Acad Dermatol. 2004;50(5):714-721. 2. Lee PK, Harwell WB, Loven KH, et al. Long-term clinical outcomes following treatment of actinic keratosis with imiquimod 5% cream. Dermatol Surg. 2005;31(6):659-663.

Š2009 Graceway Pharmaceuticals, LLC, Bristol, TN

www.gracewaypharma.com

48 Journal of Dermatology for Physician Assistants

www.aldara.com

ALD030921


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