Summer 2010 Journal of Dermatology for Physician Assistants

Page 1

Volume 4 number 3 SUMMER 2010

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. 4, No. 3 SUMMER 2010


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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. Important Safety Information: RETIN-A MICRO (tretinoin gel) microsphere, 0.04% and 0.1% is contraindicated in individuals with a history of sensitivity reactions to any of its components. The skin of certain individuals may become excessively dry, red, swollen or blistered. If warranted, these individuals should temporarily reduce the amount or frequency of application, or discontinue use temporarily or altogether. Patients should be encouraged to minimize exposure to sunlight, including sunlamps, and to use a sunscreen with a SPF of 15 or higher and protective clothing. 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. 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 benefits seen after 7 weeks. 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: Ortho Dermatologics; 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 brand of Ortho Dermatologics division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. © Ortho Dermatologics division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. 2009 09DD0217 10/09 Printed in the 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 retinoid-induced 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 Mark Hyde, MMS, PA-C Jeffrey LaDuca, Ph.D., MD 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 Abby Jacobson, MS, PA-C PrESiDEnT-ElECT Keri Holyoak, MPH, PA-C iMMEDiATE PAST PrESiDEnT Kristine Kucera, DHS, MPAS, PA-C ViCE PrESiDEnT CaSondra Soto, MPAS, PA-C SECrETAry / TrEASurEr Casey Croes, MPAS, PA-C DirECTors AT lArGE Mark Hyde, MMS, PA-C John Notabartolo, MPAS, PA-C Jennifer Winter, PA-C Jason Roddick, MS, MSPAS, PA-C

Society of Dermatology Physician Assistants, Inc P.O. Box 701461 San Antonio, Texas 78270 1-800-380-3992 SDPA@dermpa.org www.dermpa.org

Publishing Staff

Publisher Travis Hayden, MPAS, PA-C Managing Editor Jennifer M. Hayden, M.Ed Copy Editor Douglas Morris Art Director Angela Simiele Website Design Terry Scanlon

SALES Office

Physician Assistant Communications, LLC P.O. Box 416, Manlius NY 13104-0416 Phone (315) 663-4147 PAC@pacommunications.org www.pacommunications.org editorial missioN: The JDPA is the official clinical journal of the Society of Dermatology Physician Assistants. The mission of the JDPA is to improve dermatological patient care by publishing the most innovative, timely, practiceproven educational information available for the physician assistant profession. PUBLISHED CONTENT IN THE JDPA: Statements and opinions expressed in the articles and communications herein are those of the authors and not necessarily those of the Publisher or the Society of Dermatology Physician Assistants (SDPA). The Publisher and the SDPA disclaim any responsibility or liability for such material, including but not limited to any losses or other damage incurred by readers in reliance on such content. Neither Publisher nor SDPA verify any claims or other information appearing in any of the advertisements contained in the publication and cannot take responsibility for any losses or other damage incurred by readers in reliance on thereon. Neither Publisher nor SDPA guarantees, warrants, or endorses any product or service advertised in this publication, nor do they guaranty any claim made by the manufacturer of such product or service. This Issue: of JDPA includes articles that have been reviewed and approved for Category I (Preapproved) CME credit by the American Academy of Physician Assistants. Approval is valid for 1 year from the issue date, and participants may submit the self-assessment at any time during that period. Category I CME articles included in JDPA are planned and developed in accordance with AAPA’s CME Standards for Journal Articles and for Commercial Support of Journal Articles. Since its inception, the JDPA has utilized eco-friendly printing practices. The JDPA is printed on paper obtained from sustainable forests that meet strict environmental standards. Soy-based inks that have a low environmental impact are used during printing of the journal and the journal is printed using 100% renewable energy. SDPA members, please join us in our efforts and opt to receive the JDPA in digital format.

JDPA/Journal of Dermatology for Physician Assistants (ISSN 1938-9574) is published quarterly (4 issues per volume, one volume per year) by Physician Assistant Communications, LLC, P.O. Box 416, Manlius NY 13104-0416. Volume 4, Number 3, Summer 2010. 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 2010 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

Safeguarding the Boys of Summer Journal of Dermatology for Physician Assistants

The Official Journal of the SDPA

Are You a SDPA Diplomate? Achieve the highest honor available as a dermatology PA...

T

he boys of summer are back. And I don’t mean the actual baseball players themselves. I am referring to the energetic, fun loving, eight year-old boys who are fresh out of school and full of bumps, bruises, bug bites, and skinned knees. One such little boy recently came into the office with his mother for her annual skin exam. In order to keep him occupied he came in carrying a handful of baseball cards that were rubber banded together. When I asked him what he had there, he proceeded to proudly show me his favorite cards, teams, and players. These cards were well handled, quite worn, and rough around the edges with frayed corners and sticky popsicle stains. Kids will be kids. The encounter reminded me of my youth and the baseball cards I had once carried around with the same sticky handed pride. Having a son of my own now, I thought it would be neat to take out the shoeboxes of baseball cards I had once collected and start to hand them over to my son. Unlike my father’s baseball cards that did not survive my grandmother’s annual springcleaning, my mother thankfully offered my collection to me before pitching them into the trash. As I sat down and began thumbing through my baseball card collection with my son, I noticed an interesting pattern. The cards from my early youth, around the same age as the sticky handed little boy who came into the office, had been well played with and were in pretty rough shape. However, the cards’ conditions seemed to improve the older I got. By my early teens the cards were in near mint condition with some even encased in hard plastic covers, hardly handled at all. Of course, these were the ones my son wanted to pry open to get his sticky little hands on right away. I know this may be coming out of left field (pun intended) but I found this pattern to be very interesting. Much like our patients’ skin, and our own skin for that matter, in our youth we unknowingly (or knowingly) may handle it quite roughly by forgetting sunscreen and getting sunburned. As we mature though, we begin to realize the value of things and our attitudes and actions change in order to protect our assets. Thankfully we have our parents around to safeguard us until we reach this point. Yes, kids will be kids but parents will also be parents and for that we are all very fortunate. J

Travis Hayden Editor in chief

Become a SDPA Diplomate today!

Vol. 4, No. 3 SUMMER 2010


table of contents

15

SDPA Members Only Content

Case Study of Cutaneous T-cell Lymphoma (CTCL) Staging

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

By Mark Hyde, MMS, PA-C and Allison S. Felshaw PA-S

CT CL

CME

10 Derm PA News & Notes – part one

• Certification Review - All Those Things Inside the Skin You Might Have Forgotten

15 Clinical Dermatology

• CME Article – Case Study of Cutaneous T-cell Lymphoma (CTCL) Staging • Drugs in Dermatology – Ipilimumab Update

Departments

29 Surgical Dermatology

04 Editorial Board 05 Editor’s Message 09 SDPA News & Current Affairs 10 Dermatology Market Watch 21 From The Patient’s Perspective 22 Dermatoscopy 26 Clinical Snapshots 31 Surgical Wisdom 33 Cosmetic Pearls 40 Notes from your Office Manager 43 Outside & Inside the 9 to 5... 47 The Difference We Make 48 “Derm Quotes” 50 Professional Opportunities and Development

• Dermatology Case Report – Decubitus Ulcers in a Patient with Diabetes and Psychosis

32 Cosmetic Dermatology

• How To Integrate an Aesthetician into Your Dermatology Practice

34 Professional Development

• The History of the SDPA • Dermatology Billing & Coding – What You Should Know By Now

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

Go Green – Read Online As part of the “Going Green” initiative, the JDPA is now available as an electronic only option to interested SDPA members. To start receiving your copy of the JDPA in digital format please visit the SDPA website and update your membership profile.

Journal of Dermatology for Physician Assistants


Vol. 4, No. 3 SUMMER 2010


Journal of Dermatology for Physician Assistants


Calendar

FROM THE SPDA News & Current Affairs

of events

2010 AUGUST AAD Summer Academy Meeting August 4 - 8, 2010 Chicago, IL NOVEMBER SDPA 8th Annual Fall Conference November 10-13, 2010 Gaylord Texan Resort Grapevine, TX

2011

FEBRUARY 69th AAD Annual Academy Meeting February 4 - 8, 2011 New Orleans, LA june SDPA 2nd Annual Summer Dermatology Conference June 2 - 5, 2011 JW Marriott Hotel Washington, DC

Pride, Anxiousness, and Excitement All Wrapped Up Into One!

T

hose are the three words that come to mind as I assume the role of SDPA President. I feel great pride about being a dermatology PA and the high quality dermatologic care that my PA colleagues provide. I am proud of how the SDPA has developed into a mature, highly functioning, volunteer run organization. I am also proud of the other SDPA leaders whom I have the priviledge to work with. In addition, I am also feeling anxious. I am anxious to “do the right thing” in leading our group in the right direction and anxious about my ability to learn how to balance being a PA, mom, wife, businesswoman, and SDPA President. I am excited about the possibilities that this year can bring. We are poised to make real inroads with the AAD that will result in tangible benefits to our members. I feel our conferences are far and away the best dermatology education out there. The potential projects that the SDPA can accomplish are only limited by one factor - volunteers. We need more hands and heads in the game to make the SDPA the best possible society. Volunteer today. Even if you can only give two hours a year, we have a job for you. Committee descriptions and committee chair contacts are listed on the SDPA website at www.dermpa.org under the “contact us” section. If you are interested in volunteering or have any questions, please e-mail me directly at ajacobson@dermpa.org. J

Calendar of Events Submissions Send information to: Editor@jdpa.org

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

Vol. 4, No. 3 SUMMER 2010

9


Dermatology PA news & notes

Dermatology Market Watch Galderma Announces Availability of New Nozzle for Clobex® Spray for Moderate to Severe Plaque Psoriasis Galderma Laboratories, L.P announced the availability of a new nozzle for Clobex® (clobetasol propionate 0.05%) Spray, a superpotent topical steroid indicated to treat moderate to severe plaque psoriasis in patients 18 years and older. The new packaging for Clobex® Spray, features a more targeted nozzle delivery system to help psoriasis patients apply the product more easily and precisely to affected areas of the body and scalp. Clobex® Spray is a powerful topical steroid that comes in easy-to-use 2 oz. and 4.25 oz. bottles with a non-aerosol, measured-dose spray, and provides clinically proven relief of common symptoms associated with psoriasis. The updated nozzle delivery system allows patients to target the application of Clobex® Spray to the affected areas of their body and scalp.

Glytone Body Lotion SPF 15 Shea butter and Glycolic Acid work together to gently exfoliate and hydrate skin while offering UV protection. The Novasome® Microvesicle delivery system provides a continued release of skin-rejuvenating Glycolic Acid and moisturizing agents to the skin. It enables active ingredients to be protected, enhancing an ingredients’ stability, while providing a high performance delivery with less irritation. Benefits: Effectively hydrates and moisturizes dry skin and improves tone and texture for renewed smoothness with time released Glycolic Acid Complex. Provides UV protection while offering skin retexturization. Contains: 12% Glycolic Acid Complex 7.5% Octinoxate 5% Octisalate 3% Oxybenzone Direction for use: Apply daily to cleansed body skin or as directed; avoid face. Apply generously before sun exposure and as needed.

Graceway® Pharmaceuticals announces FDA Approval of Zyclara™ (imiquimod) Cream, 3.75% for the Treatment of Actinic Keratoses Graceway® Pharmaceuticals announced that the Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Zyclara™, determining it to be safe and effective for the treatment of clinically typical, visible or palpable actinic keratoses (AK). The new treatment can be used on large areas of skin, including the full face or balding scalp on a convenient, 6-week dosing cycle. Zyclara™ (imiquimod) Cream, 3.75% is a prescription topical medication that is applied topically to the skin daily on two 2-week treatment cycles, separated by a 2-week non-treatment period, for a total of six weeks; working by activating the skin’s immune system to fight AK, including those lesions that may appear during treatment. Zyclara shares the same active ingredient as Aldara® (imiquimod) Cream, 5% and while both topicals are FDAapproved for the treatment of AK, there are notable differences between the two. Zyclara is indicated for daily use on an accelerated 6-week dosing cycle comprised of two weeks of daily treatment with Zyclara, two weeks of non-treatment, followed by two weeks of daily treatment with Zyclara. Aldara is not approved for daily use and its approved dosing regimen is for a full 16 weeks. Additionally, Zyclara is indicated for use on larger areas of skin, the full face or balding scalp, while Aldara is restricted to a 25 cm2 area of skin. For more information on Zyclara, please visit www.ZyclaraCream.com. 10 Journal of Dermatology for Physician Assistants


Vol. 4, No. 3 SUMMER 2010 11


12 Journal of Dermatology for Physician Assistants


Certification Review

All Those Things Inside the Skin You Might Have Forgotten A re you recertifying soon? Don’t worry - the JDPA is committed to helping you pass your boards. Future issues of the JDPA will feature a board question accompanied by a brief explanation of the answer. We hope this helps you in your preparation for the boards. Best of luck!

Question: A 24 year-old female presents to the office with menorrhagia. The physical exam is normal. Laboratory testing reveals a normal complete blood count, prolonged bleeding time, and elevated PTT. Which of the following is the most likely diagnosis? a. Hemophilia A b. Factor XI deficiency c. Von Willebrand’s disease d. Immune thrombocytopenic purpura Explanation: The correct answer is C. Generally, bleeding disorders secondary to platelet abnormalities present with bleeding from the mucus membranes, ecchymoses, and petechia. Clotting factor deficiencies present with bleeding into deep tissues and joints; mucus membrane bleeding is rare. Von Willebrand’s disease is due to a platelet function abnormality. Total numbers of platelets are normal but they fail to aggregate normally. Von Willebrand’s factor (vWF) also serves to protect factor VIII from degradation; lack of vWF leads to a decrease in

factor VIII levels. Factor VIII activity is measured by the PTT; therefore, in von Willebrand’s disease the PTT will be prolonged. Hemophilia A, a sex-linked disorder, is most commonly seen in males and is due to a factor VIII deficiency. Hemophilia A presents with bleeding into the soft tissue and hemiarthrosis. Factor XI deficiency (Hemophilia C) is a rare factor deficiency most commonly seen in Ashkenazi Jews. Menorrhagia may be present but typically bleeding into the soft tissues and joints is present. Immune thrombocytopenic purpura (ITP) is a platelet consumption disorder. Laboratory testing reveals a thrombocytopenia and normal PT and PTT test results. J James A. Van Rhee, MS, PA-C, is the Program Director for the Northwestern University Feinberg School of Medicine Department of Family Medicine Physician Assistant Program. Mr. Van Rhee has been involved in physician assistant education for over 13 years. He has served as project director and test item writer for the Physician Assistant Education Association’s (PAEA) Physician Assistant Clinical Knowledge Rating Assessment Tool (PACKRAT) and is the author of the Physician Assistant: Certification and Re-certification Review Book, published by Elsevier. For the last ten years, he has been course director and presenter of the Physician Assistant Board Review, which is now being produced Live Online by Kaplan Medical. More information is available at www.kaptest.com/ PAliveonline.

JDPA...Your Journal, Your Life.

Write

for the

JDPA

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

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

WRITE FOR THE JDPA

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

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

• Clinical Snapshots • Journal Club (Review an article)

• Drugs in Dermatology Surgical Dermatology • Feature Articles • Journal Club

Cosmetic Dermatology • Feature Articles • Journal Club (Review an article)

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

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

• Notes from your Office Manager • Judicial & Ethical Affairs

(Review an article)

• Surgical Wisdom

Vol. 4, No. 3 SUMMER 2010 13

Dermatology PA news & notes

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


The society of dermatology physician assistants

SDPA 8th Annual Fall Dermatology ConFerenCe Gaylord Texan resorT, Grapevine, Texas

November 10-13, 2010

Register Now at www.dermpa.org WORKSHOPS TO INCLUDE: (at an additional cost)

s )NTRODUCTORY 3KIN 3URGERY AND "IOPSY 4ECHNIQUES s )NTERMEDIATE 3KIN 3URGERY s !DVANCED 3KIN 3URGERY s &ACIAL 2EJUVENATION PLANNED TOPICS TO INCLUDE: 4OPICS MAY CHANGE WITHOUT PRIOR NOTICE

s !TOPIC $ERMATITIS s 0REGNANCY #OUNSELING AND $ERMATOLOGIC $RUGS IN 0REGNANCY s 5SING &ACIAL &ILLERS TO #ONSTRUCT &ACIAL #ONTURING s %THICS IN $ERMATOLOGY s $IFFERENTIAL $IAGNOSIS AND 4REATMENT /PTIONS FOR 3CARRING AND .ON 3CARRING !LOPECIA s 3AFE /PTIONS !LTERNATIVES FOR $AILY ,IVING WITH 0ATIENTS WITH #ONTACT $ERMATITIS 14 Journal of Dermatology for Physician Assistants

s )NFESTATIONS s 5PDATE OF 2EIMBURSEMENT #HALLENGES s 3PECTRUM OF /RAL 4REATMENT !LTERNATIVES FOR 6ESICULOBULLOUS $ISEASES s 0ROGNOSIS 3TAGING AND 4REATMENT OF #4#, s $ERMATOPATHOLOGY FOR #OMMON 3CARRING $ISORDERS s #OSMETIC -ANAGEMENT OF !CNE AND 2OSACEA xxAND MUCH MORE educational session will be conducted by an outstanding faculty of dermatology thought leaders.

TEXAS

This program is not yet approved for CMe credit. Conference organizers plan for 32 hours of Category i CMe Credit to be available. Questions: Call 800-380-3992.


Clinical Dermatology

Case Study of Cutaneous T-cell Lymphoma (CTCL) Staging By Mark Hyde, MMS, PA-C and Allison S. Felshaw PA-S

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

CME

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

Approval is valid for 1 year from the issue date of JULY 2010. 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) Discuss the staging criteria of cutaneous T-cell lymphoma. 2) Review the diagnostic principles of cutaneous T-cell lymphoma as they pertain to staging. 3) Overview of cutaneous T-cell lymphoma management/therapy. Vol. 4, No. 3 SUMMER 2010 15


Case Study of Cutaneous T-cell Lymphoma (CTCL) Staging SDPA Members Only Content

CLINICAL Dermatology

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

16 Journal of Dermatology for Physician Assistants


Case Study of Cutaneous T-cell Lymphoma (CTCL) Staging SDPA Members Only Content

CLINICAL Dermatology

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

Vol. 4, No. 3 SUMMER 2010 17


Case Study of Cutaneous T-cell Lymphoma (CTCL) Staging SDPA Members Only Content

CLINICAL Dermatology

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

18 Journal of Dermatology for Physician Assistants


Case Study of Cutaneous T-cell Lymphoma (CTCL) Staging SDPA Members Only Content

Mark Hyde, MMS, PA-C is a graduate of the Physician Assistant Program at Midwestern University in Glendale, Arizona. He is a Diplomate of the Society of Dermatology Physician Assistants. He presently resides in Salt Lake City, Utah where he works with the Melanoma and Cutaneous Oncology Program for the Huntsman Cancer Institute at the University of Utah. He has indicated no relationships to disclose relating to the content of this article. Allison S. Felshaw PA-S is currently attending the Utah Physician Assistant Program in Salt Lake City, UT and will be graduating in August 2010. She has indicated no relationships to disclose relating to the content of this article.

&

Dermatoscopy Q A Q: What is it?

Under Dermatoscopy

Answer on page 22 Vol. 4, No. 3 SUMMER 2010 19

CLINICAL Dermatology

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


Congratulations to all of our SDPA Diplomates!

After June 2011

All 10 modules need to be completed for Diplomate Status

Enroll today! Become a SDPA Diplomate! www.dermPA.org/diplomate 1 20diplomate_001a.indd Journal of Dermatology for Physician Assistants

6/30/10 2:34 PM


From The Patient’s Perspective Defining Beauty From The Inside Out Hair is one of the most defining features of an individual. The color, texture, and length all distinguish one person from another. Women spend more time on their hair than on any other feature of their body. Millions of dollars a year are spent on hair products, haircuts, and hair colors. Men may be a bit different, but they too have very definite opinions about hair styles for their spouses….long, short, blond, brunette, etc. My daughter, Moriah, has had to define her identity through means other than those relating to her hair. She has a disease called alopecia universalis. When she was three years old, I recall brushing out her hair one day and seeing a small, perfectly round bald spot on the back of her head. My first thought was that her big brother had taken a pair of scissors and experimented being a barber on his little sister. She was very adamant that he had not cut her hair, nor had she. I paid little attention to it until a few days later when I found another small, perfectly round bald spot on the front part of her head. I took her to the pediatrician. I assumed these two spots had something to do with her type 1 diabetes. Her doctor said, “She probably just pulled her hair out. Don’t worry, it will grow back.” A month later, more hair was falling out so I took her to another doctor who said, “She has allergies. Let’s put her on some steroids and she will be fine in just a few days.” This little bit of advice landed us in the ER with uncontrollable blood sugar levels. We did not go back to that doctor. Tina Hill resides in Lindale, Texas. She is married and has 4 beautiful children, 2 son-in-loves, 1 chosen son and 2 grandchildren. She is a pastoral counselor and director of a women’s home. Moriah is her youngest child and has just celebrated her 16th birthday. When Moriah was first diagnosed with alopecia universalis, the teenage years were the ones that Tina most dreaded. After raising 2 other girls, she knew how important Moriah’s appearance would be for her. Now, after 13 years, Tina can confidently say, “Moriah’s identity goes much deeper then her external beauty. She is stunning from the inside out.”

We still had gotten no answers, until one day I went to a little country practice and saw a doctor there for a common cold. I had my daughter with me. During my exam, I asked him if he had any thoughts about these strange little bald spots. He looked closely at them and with a sense of sadness said, “I am sorry to tell you, but it would appear to me that she has alopecia areata. I want to send you to a dermatologist for an accurate diagnosis, but I am pretty sure that is what it is.” This was thirteen years ago. Today, she still is under the care of a dermatologist for alopecia universalis. She has no hair on her head, arms, or legs, and has no eyebrows or eye lashes. Occasionally she will see some growth, but shortly thereafter it will fall out again. It is still amazing to me that after all these years I have never found one strand of hair that has fallen out. She is a beautiful young lady. She has had to find her identity as a woman through other channels. We have never allowed her to base her identity on her illness. Rather we have taught her that she is defined by her faith in the One who created her. She is very intelligent, musically gifted, loves life, and loves to love others. She finds joy in every circumstance, good or bad. The most difficult times for her have been when people assume that she has cancer. She gets comments like, “It’s okay honey, it will grow back. Mine did after my treatments.” or, “I am so sorry you have cancer, are you going to be okay?” These types of misunderstandings of alopecia have been the most difficult part. The Locks of Love Foundation has been extremely helpful in giving beauty and dignity back to the children afflicted by alopecia. They provide beautiful natural hair prostheses for children with this disease. I am very grateful for their sensitivity to our daughter and other children dealing with alopecia and similar diseases. They understand that hair does have an intrinsic value in defining one’s beauty. Moriah’s life has been greatly impacted by their generosity and compassion. Our pursuit is now focused on finding the missing link to Moriah’s healing. Her medical issues center around her autoimmune system and we are passionate to get to the root of the problem. Until then, we will continue to face the challenges head on, believing that it is simply a matter of time before a cure is found. Moriah has always been a source of faith and perseverance; it is for her and other children like her that we must find an answer. Vol. 4, No. 3 SUMMER 2010 21

CLINICAL Dermatology

By Tina Hill


From The Patient’s Perspective Take Home points for derm pas: By Steven K. Shama, MD, MPH l I am touched by this mother’s love for her

child. When caring for patients, we should strongly consider working with a close relative to help patients not only treat their skin conditions but to understand them.

l When others misunderstand Moriah’s skin

condition by assuming it is secondary to a cancer treatment, I only wish we could do more public education, not only to recognize

&

Dermatoscopy Q A CLINICAL Dermatology

A: Melanoma in situ

Under Dermatoscopy

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

22 Journal of Dermatology for Physician Assistants

certain skin changes, but to be sensitive to the emotional needs of patients. l How wonderful it is that this mother is

left with hope that one day there will be a cure for alopecia areata. As health care practitioners, we should always have hope and leave patients with hope that one day a cure will be found for whatever is affecting them. J


Expectations

Reformulated

A tretinoin re-invented for success • Delivered within a unique aqueous gel with a smart combination of ingredients that are known to moisturize and hydrate skin* • Efficacy you can expect only from a tretinoin1 • Low irritation profile1

Important Safety Information: • The most common adverse reactions were mild to moderate irritation of the skin and occurred during the first few weeks of treatment with ATRALIN® Gel. • To prevent aggravating the skin, protect it from sun, tanning lights, extreme wind or cold, and harsh skincare products. • Use of sunscreen products of at least SPF 15 and protective clothing over treated areas is recommended when exposure cannot be avoided. • Please see next page for Brief Summary of Prescribing Information. *The contribution to efficacy of individual components has not been evaluated.

www.atralingel.com Reference: 1. Data on file. CORIA Laboratories. ATRALIN and CORIA are registered trademarks of CORIA Laboratories. ©2008 CORIA Laboratories ATR–10011–0908

Vol. 4, No. 3 SUMMER 2010 23


BRIEF SUMMARY

(see package insert for full prescribing information)

For topical use only INDICATIONS AND USAGE Atralin Gel is a retinoid indicated for topical treatment of acne vulgaris. Important Limitations of Use The safety and efficacy of the use of this product in the treatment of any other disorders have not been evaluated. CONTRAINDICATIONS None WARNINGS AND PRECAUTIONS Skin Irritation The skin of certain individuals may become dry, red, or exfoliated while using Atralin Gel. If the degree of irritation warrants, patients should be directed to temporarily reduce the amount or frequency of application of the medication, discontinue use temporarily, or discontinue use altogether. Efficacy at reduced frequencies of application has not been established. If a reaction suggesting sensitivity occurs, use of the medication should be discontinued. Mild to moderate skin dryness may also be experienced; if so, use of an appropriate moisturizer during the day may be helpful. Tretinoin has been reported to cause severe irritation on eczematous or sunburned skin and should be used with caution in patients with these conditions. Topical over-the-counter acne preparations, concomitant topical medication, medicated cleansers, topical products with alcohol or astringents, when used with Atralin Gel, should be used with caution [see Drug Interactions (7)]. Ultraviolet Light and Environmental Exposure Unprotected exposure to sunlight, including sunlamps, should be minimized during the use of Atralin Gel. Patients who normally experience high levels of sun exposure, and those with inherent sensitivity to sun, should be warned to exercise caution. Use of sunscreen products of at least SPF 15 and protective clothing over treated areas is recommended when exposure cannot be avoided. Weather extremes, such as wind or cold, also may be irritating to patients under treatment with tretinoin. Fish Allergies Atralin Gel contains soluble fish proteins and should be used with caution in patients with known sensitivity or allergy to fish. Patients who develop pruritus or urticaria should contact their health care provider. ADVERSE REACTIONS Clinical Studies Experience Because clinical trials are conducted under prescribed conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. In two randomized, controlled trials, 674 subjects received treatment for up to 12 weeks with Atralin Gel [see Clinical Studies (14)]. In these studies, 50% of the subjects who were treated with Atralin Gel reported one or more adverse reactions; 30% of the subjects reported treatment-related adverse reactions. In the vehicle group, 29% of the 487 randomized subjects reported at least one adverse reaction;

5% of the subjects reported events that were treatment-related. There were no serious, treatment-related adverse reactions reported by subjects in any of the treatment groups. Selected adverse reactions that occurred in at least 1% of subjects in the two studies combined, are shown in Table 1 (below). Most skin-related adverse reactions first appear during the first two weeks of treatment with Atralin Gel, and the incidence rate for skin-related reactions peaks around the second and third week of treatment. In some subjects the skin-related adverse reactions persist throughout the treatment period. Table 1. Number of Subjects with Selected Adverse Reactions (Occurring in At Least 1% of Subjects) Event

Atralin Gel (n = 674)

Vehicle Gel (n = 487)

Dry Skin

109 (16%)

8 (2%)

78 (12%)

7 (1%)

53 (8%)

8 (2%)

Erythema

47 (7%)

1 (<1%)

Pruritus

11 (2%)

3 (1%)

Pain of Skin

7 (1%)

0 (0%)

Sunburn

7 (1%)

3 (1%)

Peeling/Scaling/ Flaking Skin Skin Burning Sensation

DRUG INTERACTIONS When treating with Atralin Gel, caution should be exercised with the use of concomitant topical medication, medicated or abrasive soaps and cleansers, products that have a strong drying effect, and products with high concentrations of alcohol, astringents, spices, or lime. Particular caution should be exercised with the concomitant use of topical over-the-counter acne preparations containing benzoyl peroxide, sulfur, resorcinol, or salicylic acid. Allow the effects of such preparations to subside before use of Atralin Gel is begun. USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C. There are no wellcontrolled trials in pregnant women treated with Atralin Gel. Atralin Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Atralin Gel at doses of 0.1, 0.3 and 1 g/kg/day was tested for maternal and developmental toxicity in pregnant Sprague-Dawley rats by dermal application. The dose of 1 g/kg/day was approximately 4 times the clinical dose assuming 100% absorption and based on body surface area comparison. Possible tretinoin-associated teratogenic effects (craniofacial abnormalities [hydrocephaly], asymmetrical thyroids, variations in ossification, and increased supernumerary ribs) were noted in the fetuses of Atralin Gel treated animals. These findings were not observed in control animals. Other maternal and reproductive parameters in the Atralin Gel treated animals were not different from control. For purposes of comparison of the animal exposure to human exposure, the clinical dose is defined as 2 g of Atralin Gel applied daily to a 50-kg person. Oral tretinoin has been shown to be teratogenic in rats, mice, rabbits, hamsters and nonhuman primates. Tretinoin was teratogenic in Wistar rats when given orally in doses greater than 1 mg/kg/day (approximately 8 times the clinical dose based on body surface area comparison). In the cynomolgus monkey, fetal malformations were reported for doses of 10 mg/kg/day, but none were observed at 5 mg/kg/day (approximately 80 times the clinical dose

24 Journal of Dermatology for Physician Assistants

based on body surface area comparison), although increased skeletal variations were observed at all doses. Dose-related increases in embryolethality and abortion also were reported. Similar results have also been reported in pigtail macaques. Topical tretinoin in a different formulation has generated equivocal results in animal teratogenicity tests. There is evidence for teratogenicity (shortened or kinked tail) of topical tretinoin in Wistar rats at doses greater than 1 mg/kg/day (approximately 8 times the clinical dose assuming 100% absorption and based on body surface area comparison). Anomalies (humerus: short 13%, bent 6%, os parietal incompletely ossified 14%) have also been reported when 10 mg/kg/day (approximately 160 times the clinical dose assuming 100% absorption and based on body surface area comparison) was topically applied. Supernumerary ribs have been a consistent finding in rats when dams were treated topically or orally with retinoids. With widespread use of any drug, a small number of birth defect reports associated temporally with the administration of the drug would be expected by chance alone. Cases of temporally associated congenital malformations have been reported with use of other topical tretinoin products. The significance of these spontaneous reports in terms of risk to the fetus is not known. Nonteratogenic effects on fetuses: Oral tretinoin has been shown to be fetotoxic in rats when administered in doses 20 times the clinical dose based on a body surface area comparison. Topical tretinoin has been shown to be fetotoxic in rabbits when administered in doses 8 times the clinical dose based on a body surface area comparison. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Atralin Gel is administered to a nursing woman. Pediatric Use Safety and effectiveness in children below the age of 10 have not been established. A total of 381 pediatric subjects (aged 10 to 16 years), treated with Atralin Gel were enrolled into the two clinical studies. Across these two studies, comparable safety and efficacy were observed between pediatric and adult subjects. Geriatric Use Safety and effectiveness in a geriatric population have not been established. Clinical studies of Atralin Gel did not include any subjects over age 65 to determine whether they respond differently than younger subjects. Marketed by:

CORIA Laboratories, a division of Valeant Pharmaceuticals North America, Aliso Viejo, CA 92656 Manufactured by: DPT LABORATORIES, LTD. San Antonio, Texas 78215 Patent No.: 5,670,547 Revised: 11/2009 137623-1109


Drugs in Dermatology Ipilimumab Update An interview with Svetomir Markovic, MD, Ph.D.

SDPA Members Only Content

CLINICAL Dermatology

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

Svetomir Markovic, MD, Ph.D - is a Professor of Medicine, Oncology and Associate Professor of Immunology at the Mayo Medical School and has the distinction of being the Charles F. Mathy Professor of Melanoma Research at the Mayo Clinic. Dr. Markovic serves as the Chair of the Melanoma Study Group of the Mayo Clinic as well as the Chair of the Melanoma Working Group of the North Central Cancer Treatment Group. Dr. Markovic’s primary academic interest focuses on developmental therapeutics for advanced melanoma with a special emphasis on innovative treatment combinations incorporating conventional cytotoxic agents, immune modulators, inhibitors of angiogenesis and small molecules. Some of Dr. Markovic’s work is already accepted as “standard practice” in the management of advanced melanoma.

Vol. 4, No. 3 SUMMER 2010 25


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

Clinical snapshots CLINICAL Dermatology

Nevus Sebaceous By Travis Hayden, MPAS, RPA-C

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

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.

26 Journal of Dermatology for Physician Assistants


SOLODYN INNOVATION

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.

SOLODYN Tablets Important Safety Information • The most commonly reported side effects were headache, fatigue, dizziness, and pruritus. • Minocycline, like other tetracyclines, can cause fetal harm when administered to a pregnant woman. • Tetracycline drugs should not be used during tooth development (last half of pregnancy and up to 8 years of age) as they may cause permanent discoloration of teeth. • Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range from mild to life-threatening; therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the

administration of antibacterial agents. • Central nervous system side effects, including light-headedness, dizziness, or vertigo, have been reported with minocycline therapy. • In rare cases, photosensitivity has been reported. • Should not be used during pregnancy nor by individuals of either gender who are attempting to conceive a child; concurrent use of tetracyclines with oral contraceptives may render oral contraceptives less effective. • This drug is contraindicated in persons who have 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. © 2009 Medicis, The Dermatology Company SOL 09-028 10/30/10

Vol. 4, No. 3 SUMMER 2010 27


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).

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 therapy. Patients should also be cautioned 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).

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

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 Tetracycline therapy cause hyperpigmentation. pseudomembranous colitis usually respond to may induce hyperpigmentation in many organs, tumors in rats. 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 Skin alveolar bone), sclerae and heart valves. 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 sunburn reaction has been observed in some of 100 or 300 mg/kg/day of minocycline to male 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

28 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


SURGICAL Dermatology

Dermatology Case Report

Decubitus Ulcers in a Patient with Diabetes and Psychosis By Erin Cunningham, PA-C and Alison C. Essary, MHPE, PA-C

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

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SDPA Members Only Content

SURGICAL Dermatology

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

Erin Cunningham, PA-C is a graduate of Midwestern University, Glendale, AZ. She works in dermatology with John Kazmierowski, MD at Allergy, Asthma and Dermatology Associates in Portland, OR. She has no relationships to disclose relating to the content of this article. Alison C. Essary, MHPE, PA-C is Associate Professor / Associate Program Director at Midwestern University Physician Assistant Program in Glendale, AZ. She has no relationships to disclose relating to the content of this article.

30 Journal of Dermatology for Physician Assistants


SURGICAL wisdom

Dermatologic Electrosurgery

Interference with Pacemakers and Defibrillators SDPA Members Only Content

1

ds-01c_horizontal.indd 1

2

SURGICAL Dermatology

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3

5/28/10 3:32 PM

Vol. 4, No. 3 SUMMER 2010 31


COSMETIC deRMATOLOGY

How To Integrate an Aesthetician into Your Dermatology Practice By Risha Bellomo, MPAS, PA-C

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Risha Bellomo, MPAS, PA-C has practiced dermatology for 10 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 4 years. She has indicated no relationships to disclose relating to the content of this article. 32 Journal of Dermatology for Physician Assistants


SDPA Members Only Content

Cosmetic pearls On the Horizon - Anticipated FDA Sunscreen Label Revisions SDPA Members Only Content A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

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COSMETIC dERMATOLOGY

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Professional development

The History of the SDPA By Patricia Ferrer, MPAS, PA-C

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

Patricia Ferrer, MPAS, PA-C graduated from the University of Texas Medical Branch in 1998 and obtained her Masters Degree from the University of Nebraska in 2003 (SDPA scholarship). She is an Associate member of the SDPA and Fellow member of the AAPA. She has been working in dermatology for nine years and is currently on sabbatical. She has no outside relationships with industry to disclose. Patricia would like to thank all who contributed to this article and those who were instrumental in the development of the SDPA who may not have been mentioned. Sources for this article include: SDPA newsletters from July 2004 – October 2006; email correspondences with Kristine Kucera, Bethany Grubb, Michelle Dibaise, Travis Hayden, Terry Arnold, and Joe Monroe; email and phone conversations with Nancy Primo, Greg Buttolph, Gordon Day, Robert Higham.

34 Journal of Dermatology for Physician Assistants


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professional development

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professional development

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36 Journal of Dermatology for Physician Assistants


ACNE REGIMEN

REDEFINED

EPIDUO GEL: A VISIBLE DIFFERENCE* ®

1

Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5%—A unique fixed-dose combination developed for the first-line treatment of inflammatory and comedonal lesions

www.epiduo.com/hcp *In a phase 3 clinical trial of 1670 patients, median reduction in inflammatory lesions was 70% and median reduction in comedonal lesions was 62% at week 12.

Important Safety Information Epiduo® Gel is a retinoid and antimicrobial combination product indicated for the topical treatment of acne vulgaris in patients 12 years and older. The most common adverse events associated with use of Epiduo® Gel are erythema, scaling, dryness, stinging and burning. In addition, in clinical trials, adverse events reported in greater than 1% of patients treated with the Gel included contact dermatitis and skin irritation. Excessive exposure to sunlight and sunlamps should be avoided during treatment, and use of sunscreen products and protective clothing is recommended. Concomitant use of irritating topical products (like products containing resorcinol, salicylic acid or sulfur) should be avoided. Epiduo® Gel has not been tested in pregnant or nursing women, or with the elderly. Pregnancy Category C.

Please see brief summary of Prescribing Information on next page.

Vol. 4, No. 3 SUMMER 2010 37


EPIDUO™

Rx only

(adapalene and benzoyl peroxide) Gel 0.1% / 2.5% For Topical Use Only Not For Ophthalmic, Oral, or Intravaginal Use. BRIEF SUMMARY INDICATIONS AND USAGE EPIDUO Gel is a combination of adapalene, a retinoid, and benzoyl peroxide, and is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. CONTRAINDICATIONS None. WARNINGS AND PRECAUTIONS Ultraviolet Light and Environmental Exposure: Avoid exposure to sunlight and sunlamps. Wear sunscreen when sun exposure cannot be avoided. Erythema, scaling, dryness, and stinging/burning may occur with use of EPIDUO Gel. ADVERSE REACTIONS Observed local adverse reactions in patients treated with EPIDUO Gel were erythema, scaling, dryness, stinging, and burning. Other most commonly reported adverse events (≥1%) in patients treated with EPIDUO Gel were dry skin, contact dermatitis, application site burning, application site irritation, skin irritation. DRUG INTERACTIONS Exercise caution in using preparations containing sulfur, resorcinol, or salicylic acid, medicated or abrasive soaps and cleansers and products with high concentrations of alcohol or astringents in combination with EPIDUO Gel. Concomitant use of topical products with a strong drying effect can increase irritation. Use with caution. Pregnancy Pregnancy Category C. There are no well-controlled trials in pregnant women treated with EPIDUO Gel. Animal reproduction studies have not been conducted with the combination gel or benzoyl peroxide. Furthermore, such studies are not always predictive of human response; therefore, EPIDUO Gel should be used during pregnancy only if the potential benefit justifies the risk to the fetus. No teratogenic effects were observed in rats treated with oral doses of 0.15 to 5.0 mg adapalene/kg/day, up to 25 times (mg/m2/day) the maximum recommended human dose (MRHD) of 2 grams of EPIDUO Gel. However, teratogenic changes were observed in rats and rabbits when treated with oral doses of ≥ 25 mg adapalene/kg/day representing 123 and 246 times MRHD, respectively. Findings included cleft palate, microphthalmia, encephalocele and skeletal abnormalities in rats; and umbilical hernia, exophthalmos and kidney and skeletal abnormalities in rabbits. Dermal teratology studies conducted in rats and rabbits at doses of 0.6-6.0 mg adapalene/kg/day [25-59 times (mg/m2) the MRHD] exhibited no fetotoxicity and only minimal increases in supernumerary ribs in both species and delayed ossification in rabbits. Nursing Mothers It is not known whether adapalene or benzoyl peroxide is excreted in human milk following use of EPIDUO Gel. Because many drugs are excreted in human milk, caution should be exercised when EPIDUO Gel is administered to a nursing woman. Pediatric Use Safety and effectiveness of EPIDUO Gel in pediatric patients under the age of 12 have not been established. Geriatric Use Clinical studies of EPIDUO Gel did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Carcinogenesis, Mutagenesis, Impairment of Fertility No carcinogenicity, photocarcinogenicity, genotoxicity, or fertility studies were conducted with EPIDUO Gel. Carcinogenicity studies with adapalene have been conducted in mice at topical doses of 0.4, 1.3, and 4.0 mg/kg/day (1.2, 3.9, and 12 mg/m2/day), and in rats

at oral doses of 0.15, 0.5, and 1.5 mg/kg/day (0.9, 3.0, and 9.0 mg/m2/day). In terms of body surface area, the highest dose levels are 9.8 (mice) and 7.4 times (rats) the MRHD of 2 grams of EPIDUO Gel. In the rat study, an increased incidence of benign and malignant pheochromcytomas in the adrenal medulla of male rats was observed. No significant increase in tumor formation was observed in rodents topically treated with 15-25% benzoyl peroxide carbopol gel (6-10 times the concentration of benzoyl peroxide in EPIDUO Gel) for two years. Rats received maximum daily applications of 138 (males) and 205 (females) mg benzoyl peroxide/kg. In terms of body surface area, these levels are 27-40 times the MRHD. Similar results were obtained in mice topically treated with 25% benzoyl peroxide carbopol gel for 56 weeks followed by intermittent treatment with 15% benzoyl peroxide carbopol gel for rest of the 2 years study period, and in mice topically treated with 5% benzoyl peroxide carbopol gel for two years. The role of benzoyl peroxide as a tumor promoter has been well established in several animal species. However, the significance of this finding in humans is unknown. In a photocarcinogenicity study conducted with 5% benzoyl peroxide carbopol gel, no increase in UV-induced tumor formation was observed in hairless mice topically treated for 40 weeks. No photocarcinogenicity studies were conducted with adapalene. However, animal studies have shown an increased tumorigenic risk with the use of pharmacologically similar drugs (e.g., retinoids) when exposed to UV irradiation in the laboratory or sunlight. Although the significance of these findings to humans is not clear, patients should be advised to avoid or minimize exposure to either sunlight or artificial irradiation sources. Adapalene did not exhibit mutagenic or genotoxic effects in vitro (Ames test, Chinese hamster ovary cell assay, mouse lymphoma TK assay) or in vivo (mouse micronucleus test). Bacterial mutagenicity assays (Ames test) with benzoyl peroxide has provided mixed results, mutagenic potential was observed in a few but not in a majority of investigations. Benzoyl peroxide has been shown to produce single-strand DNA breaks in human bronchial epithelial and mouse epidermal cells, it has caused DNA-protein cross-links in the human cells, and has also induced a dose-dependent increase in sister chromatid exchanges in Chinese hamster ovary cells. In rat oral studies, 20 mg adapalene/kg/day (120 mg/m2/day; 98 times the MRHD based on mg/m2/day comparison) did not affect the reproductive performance and fertility of F0 males and females, or growth, development and reproductive function of F1 offspring. No fertility studies were conducted with benzoyl peroxide. PATIENT COUNSELING INFORMATION – Advise patients to cleanse the area to be treated with a mild or soapless cleanser; pat dry. Apply EPIDUO Gel as a thin layer, avoiding the eyes, lips and mucous membranes. – Advise patients not to use more than the recommended amount and not to apply more than once daily as this will not produce faster results, but may increase irritation. – EPIDUO Gel may cause irritation such as erythema, scaling, dryness, stinging or burning. – Advise patients to minimize exposure to sunlight, including sunlamps. Recommend the use of sunscreen products and protective apparel, (e.g., hat) when exposure cannot be avoided. – EPIDUO Gel may bleach hair and colored fabric.

Marketed by: GALDERMA LABORATORIES, L.P. Fort Worth, Texas 76177 USA Manufactured by: Galderma Production Canada Inc. Baie d’Urfé, QC, H9X 3S4 Canada Made in Canada. GALDERMA is a registered trademark. Revised: December 2008 P51356-0

Reference: 1. Gollnick HPM, Draelos Z, Glenn MJ, et al; Adapalene–BPO Study Group. Adapalene–benzoyl peroxide, a unique fixed-dose combination topical gel for the treatment of acne vulgaris: a transatlantic, randomized, double-blind, controlled study in 1670 patients. Br J Dermatol. 2009;161(5):1180-1189.

Galderma is a registered trademark. ©2010 Galderma Laboratories, L.P. Galderma Laboratories, L.P. 14501 N. Freeway Fort Worth, TX 76177 EPI-317 Printed in USA 01/10

www.epiduo.com/hcp

38 Journal of Dermatology for Physician Assistants


Dermatology Billing & Coding What You Should Know By Now By Inga Ellzey, MPA, RHIA, CDC

SDPA Members Only Content

B:12.25”

T:11”

S:9.5”

professional development

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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.

Vol. 4, No. 3 SUMMER 2010 39


SDPA Members Only Content

professional development

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

Notes from your Office Manager Phone Fixes Helpful Tips to Successfully Manage Phone Calls SDPA Members Only Content A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

J

Rosemarie Nelson, MS - Practice Management Consultant, MGMA Health Care Consulting Group 114 Janet Drive, Syracuse, N.Y., 13224; (315) 391-2695; RosemarieNelson@alum.syracuse.edu 40 Journal of Dermatology for Physician Assistants


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A 12-week, multicenter, randomized, double-blind, parallel-group study of patients 12 to 18 years of age with acne vulgaris (N=1075). The most frequent adverse event reported was dryness. Erythema, stinging/burning, and scaling may also occur.1

* †

Important Safety Information Differin® Lotion, 0.1% is indicated for the topical treatment of acne vulgaris in patients 12 years and older. A thin film of Differin® Lotion, 0.1% should be applied once per day to the face and other areas of the skin affected by acne. In clinical trials, the most common adverse event (>1%) reported with use of Differin® Lotion, 0.1% was mild to moderate skin dryness. Erythema, scaling, stinging and burning may also occur. Excessive exposure to sunlight and sunlamps should be avoided during treatment, and use of sunscreen products and protective clothing is recommended. Concomitant use of drying or irritating topical products (like products containing resorcinol, salicylic acid or sulfur) should be used with caution. Instruct patients to avoid the eyes, lips and mucous membranes when applying Differin® Lotion, 0.1%, and not to apply to areas that have been depilated with wax products. Differin® Lotion, 0.1% has not been tested in pregnant or nursing women, or with the elderly. Pregnancy Category C. www.differin.com/HCP Please see Brief Summary of Prescribing Information on adjacent page.

Vol. 4, No. 3 SUMMER 2010 41


DIFFERIN®

Rx only

(adapalene) Lotion 0.1% For Topical Use Only Not For Oral, Ophthalmic, or Intravaginal Use. BRIEF SUMMARY INDICATIONS AND USAGE DIFFERIN Lotion is a retinoid product indicated for the topical treatment of acne vulgaris in patients 12 years and older. CONTRAINDICATIONS None. WARNINGS AND PRECAUTIONS Ultraviolet Light and Environmental Exposure: Avoid exposure to sunlight and sunlamps. Wear sunscreen when sun exposure cannot be avoided. Erythema, scaling, dryness, and stinging/burning may occur with use of DIFFERIN Lotion. ADVERSE REACTIONS Dry skin of mild to moderate severity was the most frequently reported (≥ 1%) treatment related adverse event. Erythema, scaling, dryness, burning/stinging were also seen during treatment. DRUG INTERACTIONS Concomitant use of topical products with a strong drying effect can increase skin irritation. Use with caution, especially in using preparations containing sulfur, resorcinol, or salicylic acid in combination with DIFFERIN Lotion. Wax depilation should not be performed on treated skin. Pregnancy Pregnancy Category C. There are no well-controlled trials in pregnant women treated with DIFFERIN Lotion. Therefore, DIFFERIN Lotion should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal reproduction studies have not been conducted with DIFFERIN Lotion. Furthermore, such studies are not always predictive of human response. Human Data In clinical trials involving DIFFERIN Lotion, 0.1% in the treatment of acne vulgaris, women of childbearing potential initiated treatment only after a negative pregnancy test. Two women became pregnant while using DIFFERIN Lotion, 0.1%. One patient delivered a healthy full term baby and the other patient electively terminated her pregnancy. Animal Data No teratogenic effects were observed in rats treated with oral doses of 0.15 to 5.0 mg adapalene/kg/day, up to 25 times (mg/m2/day) the maximum recommended human dose (MRHD) of 2 grams of DIFFERIN Lotion. However, teratogenic changes were observed in rats and rabbits when treated with oral doses of ≥ 25 mg adapalene/kg/day representing 123 and 246 times MRHD, respectively. Findings included cleft palate, microphthalmia, encephalocele and skeletal abnormalities in rats; and umbilical hernia, exophthalmos and kidney and skeletal abnormalities in rabbits. Dermal teratology studies conducted in rats and rabbits at doses of 0.66.0 mg adapalene/kg/day [25-59 times (mg/m2) the MRHD] exhibited no fetotoxicity and only minimal increases in supernumerary ribs in both species and delayed ossification in rabbits. Systemic exposure (AUC 0-24h) to adapalene at topical doses (6.0 mg/kg/day) in rats represented 101 times the exposure to adapalene in patients with acne treated with DIFFERIN Lotion applied to the face, chest and back (2 grams applied to 1000 cm² of acne-involved skin). Nursing Mothers It is not known whether adapalene is excreted in human milk following use of DIFFERIN Lotion. Because many drugs are excreted in human milk, caution should be exercised when DIFFERIN Lotion is administered to a nursing woman. Pediatric Use Safety and effectiveness of DIFFERIN Lotion in pediatric patients under the age of 12 have not been established. Geriatric Use Clinical studies of DIFFERIN Lotion did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Carcinogenesis, Mutagenesis, Impairment of Fertility No carcinogenicity, mutagenicity and impairment of fertility studies were conducted with DIFFERIN Lotion. Carcinogenicity studies with adapalene have been conducted in mice at topical doses of 0.4, 1.3, and 4.0 mg/kg/day (1.2, 3.9, and 12 mg/m²/day),

42 Journal of Dermatology for Physician Assistants

and in rats at oral doses of 0.15, 0.5, and 1.5 mg/kg/day (0.9, 3.0, and 9.0 mg/m2/day). In terms of body surface area, the highest dose levels are 9.8 (mice) and 7.4 times (rats) the MRHD of 2 grams of DIFFERIN Lotion. In the rat study, an increased incidence of benign and malignant pheochromocytomas in the adrenal medulla of male rats was observed. No photocarcinogenicity studies were conducted with adapalene. However, animal studies have shown an increased tumorigenic risk with the use of pharmacologically similar drugs (e.g. retinoids) when exposed to UV irradiation in the laboratory or sunlight. Although the significance of these findings to humans is not clear, patients should be advised to avoid or minimize exposure to either sunlight or artificial irradiation sources. Adapalene did not exhibit mutagenic or genotoxic effects in vitro (Ames test, Chinese hamster ovary cell assay, mouse lymphoma TK assay) or in vivo (mouse micronucleus test). In rat oral studies, 20 mg adapalene/kg/day (120 mg/m2/day; 98 times the MRHD based on mg/m2/day comparison) did not affect the reproductive performance and fertility of F0 males and females, or growth, development and reproductive function of F1 offspring. PATIENT COUNSELING INFORMATION • Apply a thin film of DIFFERIN Lotion to the affected areas of the skin once daily, after washing gently with a mild soapless cleanser. Dispense a nickel size amount of DIFFERIN Lotion (3-4 actuations of the pump) to cover the entire face. Avoid application to the areas of skin around eyes, lips and mucous membranes. DIFFERIN Lotion may cause irritation such as erythema, scaling, dryness, stinging or burning. • Advise patients to cleanse the area to be treated with a mild or soapless cleanser; pat dry. Apply DIFFERIN Lotion to the entire face or other acne affected areas as a thin layer, avoiding the eyes, lips and mucous membranes. • Exposure of the eye to this medication may result in reactions such as swelling, conjunctivitis and eye irritation. • Patients should be advised not to use more than the recommended amount and not to apply more than once daily as this will not produce faster results, but may increase irritation. • Advise patients to minimize exposure to sunlight including sunlamps. Recommend the use of sunscreen products and protective apparel (e.g., hat) when exposure cannot be avoided. • Moisturizers may be used if necessary; however, products containing alpha hydroxy or glycolic acids should be avoided. • This medication should not be applied to cuts, abrasions, eczematous, or sunburned skin. • Wax depilation should not be performed on treated skin due to the potential for skin erosions. • This product is for external use only. Marketed by: GALDERMA LABORATORIES, L.P., Fort Worth, Texas 76177 USA Manufactured by: Galderma Production Canada Inc., Baie d’Urfé, QC, H9X 3S4 Canada Made in Canada. GALDERMA is a registered trademark. P51503-0 Revised: March 2010

Reference: 1. Data on file. Galderma Laboratories, L.P. Galderma is a registered trademark. ©2010 Galderma Laboratories, L.P. Galderma Laboratories, L.P. 14501 N. Freeway Fort Worth, TX 76177 DIFF-053    Printed in USA    04/10

www.differin.com/HCP


Outside & Inside the 9 to 5...

We recently had the pleasure of interviewing Kurtis Opp, PA-C, a founding member and former President of the SDPA (1996-1998). Kurtis has been a PA for nineteen years, seventeen of which have been in dermatology. He has had the good fortune of working his entire career in dermatology alongside Marcus Conant, MD. Dr. Conant is a well-respected dermatologist in the field of HIV dermatology and in 1981 helped to identify the first cases of Kaposi’s sarcoma, lending to the eventual diagnosis of HIV/AIDS. Kurtis was the first PA to work with Dr. Conant and the first dermatology PA in San Francisco. For this installment of the Outside & Inside the 9 to 5, Kurtis shares with us his experience of working with Dr. Conant caring for patients in the largest HIV/AIDS clinic on the west coast.

What do you find most rewarding about working in dermatology? The most rewarding aspect is diagnosing melanoma. I am also very pleased when Accutane or facial fillers work well for my patients. When my care can help patients to look totally different, it affects their life in such a positive way.

What is the greatest challenge of working in your current position? Not working too much and striving to live more of a balanced life. The position I work in needs more… Help and medical assistance. Providers in this position who have an internal medicine background are extremely helpful to the HIV/AIDS community. My favorite bit of advice for patients is… Always have hope! Always wear sunscreen. What my patients (or staff) may tell you about me… I am a good listener and knowledgeable.

What is your typical schedule like? In my current position, I work in a People may be surprised to know… large dermatology clinic that sees 60% That I have three children who are in general dermatology and 40% HIV their twenties. related dermatoses (e.g., treatment of facial wasting, Kaposi’s sarcoma, viral Who is your greatest source of Kurtis Opp, PA-C infections such as molluscum and inspiration? Dr. Conant. He is my mentor HPV, squamous cell carcinoma of the and I credit him with establishing for the genitalia, psoriasis, hepatitis C related cutaneous SDPA the model of what a dermatology supervising maladies, and managing contraindications for physician should be. patients on protease inhibitors). In addition, I work What is your greatest accomplishment to date? at two nonprofit clinics a half day each per week Being involved in founding the SDPA and watching it that only see patients with HIV related dermatoses. grow has been a very rewarding experience. I was in I am also fortunate to be able to continue to work the right place at the right time and had Dr. Conant part time with Dr. Conant in his clinic assisting him there to help lend advice. He had extensive experience with his research and serving as a sub-investigator for in creating bylaws for organizations similar to the SDPA clinical trials. and encouraged us (the SDPA founding members) to How is your current position unique compared move forward by electing officers amongst ourselves to working in general dermatology? Working with and going from there. During my SDPA presidency, patients who are HIV positive is unique compared my priority was that the SDPA develop into a formal to working in general dermatology because some organization in order to be recognized by the AAD. disease processes are more recalcitrant. Because My favorite bit of advice for my fellow dermatology of that, we receive more referrals from primary PAs is… Camaraderie. PAs should establish care providers concerning stubborn dermatology camaraderie and continue that with colleagues. conditions that require me to continuously expand I have found that establishing a dermatology PA my knowledge (e.g., plantar warts that require more journal club in my hometown of San Francisco has aggressive therapy utilizing a regional nerve block in helped to do just that. J order to administer bleomycin injections). Vol. 4, No. 3 SUMMER 2010 43

professional development

What inspired you to become a PA? I began my career in medicine working as a respiratory therapist for ten years. During this time I worked alongside some amazing PAs and became inspired to pursue a career as a PA.


Dermatology PA news & notes

From the Desk of...

By Annie Sullivan, MMS, PA-C

Getting Into Dermatology How did I have the good fortune of landing a job in dermatology? I am often asked to share this experience with coworkers, but only recently did I entertain sharing it with a larger audience. I have been a PA for seven years: six in family practice and one in dermatology. Both my family practice and dermatology jobs were secured through the same job search techniques, with slight variations due to the different specialties. I am fascinated by dermatology and finding a career specialty that was enjoyable was critical to me because of the need for job and life satisfaction. George Bernard Shaw once said, “The people who get on in this world are the people who get up and look for the circumstances they want, and, if they can’t find them, make them.” My current dermatology job was not an advertised position. Nonetheless, I utilized classified ads, networking, job search websites, and dermatology society websites as tools in my job hunt. Unfortunately, they did not land me any job offers. I then decided to create my own position. I obtained a list of every dermatologist in my geographic area regardless of whether Annie Sullivan MMS, PA-C practices dermatology at the Skin and Cancer Center of Arizona and is adjunct faculty at Midwestern University, Glendale, Arizona. The author has indicated no relationships to disclose relating to the content of this article.

44 Journal of Dermatology for Physician Assistants

they already had a PA or not and sent a cover letter and resume to all of them. The cover letter explained my interest in dermatology, noted my previous dermatology experience (in family practice), listed the dermatology societies I was involved with, and noted the dermatology rotation I completed in PA school. Most of these cover letters and resumes were sent by fax, providing an economical way to reach a wide audience of potential employers. One month after distributing these letters, I received a call from my current office manager asking, “How did you know we were thinking about hiring a PA?” She was pleasantly surprised by the letter because she typically had to pay a headhunter to find interested PAs. Personally, I have found the aforementioned method the most successful way to find a job. However, I would like to acknowledge that I have found the Society of Dermatology Physician Assistants (SDPA) website to be especially helpful. The SDPA website provides educational materials that are indispensible to dermatology PAs and their supervising physicians. The SDPA is an organization that aspiring dermatology PAs will definitely want to become involved with. For anyone searching for a physician assistant position in dermatology or another specialty, I recommend trying these selfpromoting techniques. I hope this article will help my colleagues find a satisfying new career. J


For moderate to severe plaque psoriasis

Introducing a real sharpshooter NEW

spray nozzle more precisely hits a range of plaques on the body and scalp • Efficacy of Clobex® Spray confirmed in multiple clinical trials totaling more than 2000 patients1-3 —An average of 80% of patients clear or almost clear at 4 weeks1,2

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

Log on to www.psoriasispro.com Vol. 4, No. 3 SUMMER 2010 45


CLOBEX

®

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

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

the incidence of pups with cysts on the kidney at higher dose levels during the preweaning period. The weights of the epididymides and testes were significantly reduced at higher dosages. Despite these changes, there were no effects on the mating and fertility of the offspring. There are no adequate and well-controlled studies of the teratogenic potential of clobetasol propionate in pregnant women. CLOBEX® (clobetasol propionate) Spray, 0.05% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers: Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Because many drugs are excreted in human milk, caution should be exercised when CLOBEX® (clobetasol propionate) Spray, 0.05% is administered to a nursing woman. Pediatric Use: Use in patients under 18 years of age is not recommended, because safety has not been established and because numerically high rates of HPA axis suppression were seen with other clobetasol propionate topical formulations. Safety and effectiveness in pediatric patients treated with CLOBEX® (clobetasol propionate) Spray, 0.05% have not been established (see PRECAUTIONS: General). Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing’s syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of glucocortisteroid insufficiency during and/or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children. HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Geriatric Use: Clinical studies of CLOBEX® (clobetasol propionate) Spray, 0.05% did not include sufficient numbers of patients aged 65 and over to adequately determine whether they respond differently than younger patients. In the two Phase 3 studies, 21 of the 240 patients (9%) were over the age of 65. In general, dose selection for an elderly patient should be made with caution, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. ADVERSE REACTIONS: In controlled, clinical trials with CLOBEX® (clobetasol propionate) Spray, 0.05%, the most common adverse reaction was burning at the site of application [40% of subjects treated with CLOBEX® (clobetasol propionate) Spray, 0.05% and 47% of subjects treated with Spray Vehicle]. Other commonly reported adverse reactions for CLOBEX® (clobetasol propionate) Spray, 0.05% and Spray Vehicle, respectively, are noted in Table 2. Table 2 - Commonly Occurring Adverse Events Adverse Reaction

Clobetasol Propionate 0.05% Spray (N=120)

Vehicle Spray (N=120)

50 (42%)

56 (47%)

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

0 (0%)

1 (1%)

Application site burning

48 (40%)

56 (47%)

Application site dryness

2 (2%)

0 (0%)

Application site irritation

1 (1%)

0 (0%)

Application site pain

1 (1%)

2 (2%)

Application site pigmentation changes

1 (1%)

0 (0%)

Application site pruritus

4 (3%)

3 (3%)

17 (14%)

12 (10%)

Infections and infestations Influenza

0 (0%)

2 (2%)

Nasopharyngitis

6 (5%)

3 (3%)

Pharyngitis streptococcal

1 (1%)

0 (0%)

10 (8%)

2 (2%)

4 (3%)

2 (2%)

2 (2%)

0 (0%)

Upper respiratory tract infection Skin and subcutaneous tissue disorders Eczema asteatotic

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

References: 1. Clobex® Spray Prescribing Information. September 2006. Galderma Laboratories, L.P. 2. Koo JYM. Relevance of the COBRA Trial in current psoriasis practice. Cutis. 2007;80(suppl 5):4-11. 3. Menter A, Abramovits W, Colón LE, Johnson LA, Gottschalk RW. Comparing clobetasol propionate 0.05% spray to calcipotriene 0.005% betamethasone dipropionate 0.064% ointment for the treatment of moderate to severe plaque psoriasis. J Drugs Dermatol. 2009;8:52-57. © 2010 Galderma Laboratories, L.P. GALDERMA and CLOBEX are registered trademarks. Galderma Laboratories, L.P., 14501 N. Freeway, Fort Worth, TX 76177 CLO-604 Printed in USA 04/10

46 Journal of Dermatology for Physician Assistants


The Difference We Make

If It Weren’t For the Need To Stay On Time…

Bleed:12.5 in

Largest Trim:12.25 in

Live Area:10 in

Smallest Trim:10.75 in

If it weren’t for the need to stay on time, I’d really enjoy seeing patients. If I could only see patients, listen to their stories, their concerns, examine their skin, make a diagnosis, give treatment, and then… see the next patient, no matter how far behind in the schedule I am, I think my life and my practice would be just wonderful. Somehow I would see some reasonable number of patients in a session and, even if one were complicated or if a few had lots of questions or needed a number of biopsies, somehow I would be able to go from one patient to another. Patients wouldn’t mind waiting because they would know that during their visit I would be thorough and take care of all their needs. Rescheduling another visit for additional thoughts or procedures would not be needed. Wouldn’t that be wonderful? But, that is not what typically happens, is it? In fact, it probably rarely happens in most practices. What probably happens is that you do your best to respond to patient requests, needs, and sometimes demands and then you go on to the next patient. Eventually, you start running behind in the schedule, because not all patients come in for a spot, not all diagnoses are straight forward, and not all patients have only one question. Patients may feel that it is their time to unload their many questions such as: why do I have these hives, why is my hair falling out, and why does my backside itch? All of these concerns take time, a lot of time, time you didn’t plan for. So you do your best, but eventually you run behind; sometimes hopelessly and miserably behind and there is no way you can make up this time. You have passed the point of no return. You will drift into your lunch hour and leave yourself little time for lunch before your afternoon session begins. The afternoon offers little hope of being better. You repeat this kind of day for weeks, months, and sometime years. Finally one day out of desperation you wonder, isn’t there another way? You then look at the realities of your practice. If you only didn’t need to 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.

worry about paying rent, your employees, or yourself or worry about insurance companies paying you less, you could see fewer patients and have more time to deal with all of the seemingly unforeseen challenges of everyday practice. So how can you solve the problem? Is there a solution? I believe the primary reason why we run behind schedule is that both our patients and we have unrealistic expectations. Somehow we assume (I believe it is really we hope) that on average throughout a full session some patients will be easier to sort out while some will be more challenging. Unfortunately, sometimes and perhaps most of the time the average doesn’t fit into the time frame of a session and we run over or stress to keep on time. We let our office schedule patients according to their chief concern; assuming that on average we will keep up. But what about the patient who has unrealistic expectations of what we can evaluate during an office visit? What about the patient who comes for a full skin exam and has a list of ten unanticipated questions including hair loss, hives, pruritus ani, and mal odors? Are they simply unreasonable to expect you to cover all of this in a regular office visit? While most of us don’t have the ability to efficiently field that many questions during one visit, these situations suggest that patients don’t know how long a visit should take or what is involved in answering their questions. Have we ever told them? How can they ever learn what we need and expect from them if we have never told them in verbal or written form? Here are my suggestions: 1. Tell the AMA and the AAD not to advertise patients to bring a list of questions when they visit their providers. Patients are only doing what our national organizations are suggesting! 2. Have a sign in your waiting / reception area warning that you are running behind. Indicate that as of this hour only one difficult skin issue can be discussed per patient. Other questions will have to be saved for another visit . 3. Patients should be aware that generally you will only deal with their chief concern, the one that they scheduled their appointment for. Other issues will require additional appointments.

Vol. 4, No. 3 SUMMER 2010 47

DERmatology pa news & notes

By Steven K. Shama, MD, MPH


4. Patients should know that there is no adding on a spouse or a child to their vist even if they have something on their skin that will “just take a moment to diagnose.” 5. With regard to the patient lists, providers reserve the right to put in order the most significant concerns that exist and to address only those that our schedule permits.

DERmatology pa news & notes

Have a front desk sign that can be displayed saying,“Our office may overbook appointments. This is one of those days that we are really far and hopelessly behind schedule. We would like a few of you to reschedule. As compensations we offer you a free

parking voucher and no copays for your next 3 visits.” Somewhere in between having all the time and money in the world to see fewer patients and catering to every question they have and having signs and attitudes we have discussed above, is a place we need to be. I invite the readers to ponder what has been written above and to let me know your approach to these common problems. Please know I don’t have the answer. I’m still working on mine. J

Steven K. Shama, MD, MPH

Derm Quotes

In a year, as of June 2011, [SDPA fellow members] will have to start and complete all 10 [DLI] modules before they will be awarded the title of ‘Diplomate’ of the SDPA. Bethany Grubb, MPAS, PA-C, SDPA Distance CME Committee Member and Former President of the SDPA Speaking about the important deadline coming up for the Distance Learning Initiative (DLI). Dermcast.tv – June 21st, 2010

DLI scoring has been modified to allow for more treatment options, which will [make for a] much smoother process for everyone registered. [The scoring modifications] are going to eliminate a lot of the early frustrations. The whole program is [now] very user friendly and is a great educational tool! Kasey Drapeau-D’Amato, MPAS, PA-C, SDPA Distance CME Committee Chairperson Speaking about the recent improvements made to the SDPA Distance Learning Initiative (DLI). Dermcast.tv – June 21st, 2010

?

48 Journal of Dermatology for Physician Assistants

MYSTERY QUOTE REVEALED It’s a matter of educating the physicians about who we are and what we do. Kurtis Opp, PA-C, Former SDPA President Speaking about the growth of the SDPA and the improved relationship between the SDPA and AAD. Dermcast.tv – April 6th, 2009


Supervising Physician CORNER Michael Fisher, Ph.D., MD Georgia’s Supervising Physician of the Year The Georgia Dermatology Physician Assistants JDPA: What part of being a SP to PAs is the most (GDPA) Supervising Physician of the Year award is given rewarding? each spring to a physician who goes above and beyond Dr. Fisher: Being able to help train my PAs is the most the call of duty. The recipient provides more than just rewarding. When I have a difficult patient with a unique the required supervision and mentorship of dermatology skin disease, I ask the PAs to make a diagnosis. When I see PAs. Some of the past recipients have been recognized for them making those difficult diagnoses, it is very rewarding. their philanthropic work, while others have stood out by JDPA: How have you seen the role of PAs in dermatology providing exceptional compassion evolve? to their staff and patients. There are Dr. Fisher: With the changes in no set criteria for the Supervising medicine, it is more important than Physician of the Year award and ever to have PAs in a dermatology each recipient is nominated for his practice. or her own uniqueness. This award JDPA: Who is your greatest source of is one way that the GDPA shows its inspiration? gratitude to the physicians who take time to educate dermatology PAs, thus Dr. Fisher: My greatest source of enabling them to provide better care inspiration while in school was the for their patients. department chairperson. He was not only a great doctor but also a great Michael Fisher, Ph.D., MD was From left to right: Barbara Rosing, PA-C, person. He treated all of the residents awarded the 2010 GDPA Supervising Michael Fisher, Ph.D., MD, Alexandra Palgon, with respect. Physician of the Year award. PA-C, Felicia Dennis, PA-C, Norma Gordon, According to Felicia Dennis, PA-C, PA-C, Mary Loggins, PA-C. JDPA: People may be surprised to who works with Dr. Fisher, “He was know… nominated due to his generosity to patients who have been Dr. Fisher: I used to skydive. affected by the economic crisis as well as his never-ending JDPA: What would your staff tell us about you? devotion to teaching his six PAs. He seems to attract both the rare and difficult to treat patients, and he makes an effort Dr. Fisher: Doctor Fisher is fun to work with! to involve at least one of his PAs in the process of diagnosing JDPA: What are your favorite bits of advice for PAs working and treating them.” Ms. Dennis also states, “His generosity in dermatology? is further exemplified by providing patients assistance with Dr. Fisher: “Knowing is not enough; we must apply. obtaining therapy that insurance companies initially deny. Willing is not enough; we must do.” “A noble person He will stay after work writing letters to insurance providers attracts noble people, and knows how to hold on to them.” and fighting for patients’ rights to receive treatment. Dr. JDPA: What advice do you have for PAs regarding Michael Fisher epitomizes what the GDPA organization becoming involved in their communities outside of recognizes as an outstanding supervising physician and is work (e.g. volunteering, Camp Discovery, Dermatology extremely deserving of this award.” Foundation, etc.)? We had the pleasure of interviewing Dr. Michael Dr. Fisher: “Not the maker of plans and promises, but Fisher. We thank him for taking the time to share with us rather the one who offers faithful service in small matters. his insights and congratulate him on receiving this year’s This is the person who is most likely to achieve what is good GDPA Supervising Physician of the Year award. and lasting” It is important that we use our skills to reach JDPA: Describe what qualities a supervising physician out to others. should posses. JDPA: What is your favorite Derm Textbook to reference? Dr. Fisher: A statement from a German philosopher Dr. Fisher: Jean L. Bolognia Second Edition Dermatology describes the important qualities: “Treat people as if they JDPA: What is your greatest accomplishment to date? were what they ought to be, and you help them to become what they are capable of being.” Dr. Fisher: I received my Ph.D. and was doing skin cancer research with mice. I became allergic to the mice and could JDPA: How do you utilize PAs in your practice? not breathe. Therefore, I had to leave the research field. At Dr. Fisher: The PAs in our practice are treated like the age of forty-one, I went back to medical school and professionals. They do not have selected patients to see as eventually became a dermatologist. J in acne and warts but they are allowed to see anyone that comes into the clinic. Vol. 4, No. 3 SUMMER 2010 49

DERmatology pa news & notes

By J. Margaret Casey, staff writer


Professional Opportunities and Development

Advertiser INDE X OrthoDermatologics – Retin-A Micro... Pages 2, 3 Ranbaxy – Kenalog Spray...................Pages 7, 8 Allergan – Tazorac......................... Pages 11, 12 Coria – Atralin................................Pages 23, 24 Medicis – Solodyn..........................Pages 27, 28 Galderma – Epiduo........................Pages 37, 38 Galderma – Differin Lotion............Pages 41, 42 Galderma –Clobex Spray................Pages 45, 46 Graceway – Zyclara........................ Pages 51, 52

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Introducing .org— a website from the National Psoriasis Foundation just for kids with psoriasis! Through the fun and informative pages of www.PsoMe.org, your pediatric patients can: ä learn about their disease ä help find a cure ä educate others ä connect to kids across the country living with psoriasis Special pages for parents help the whole family get involved in helping find a cure.

50 Journal of Dermatology for Physician Assistants


Vol. 4, No. 3 SUMMER 2010 51


For the treatment of actinic keratosis—

Zyclara

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

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

Treats the lesions you can see—and the ones you can’t1 s OF PATIENTS HAD PREVIOUSLY UNDETECTED LESIONS REVEALED AND TREATED

Weeks On

Weeks Off

Weeks On

Sustained clearance...simple course

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

Š2010 Graceway Pharmaceuticals, LLC, Bristol, TN

www.gracewaypharma.com

www.ZyclaraCream.com

52 Journal of Dermatology for Physician Assistants

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