Volume 5 number 4 FALL 2011
SDPA News and Current Affairs
dermatology pa news and notes
Official Journal of the Society of Dermatology Physician Assistants
Vol. 5, No. 4 FALL 2011
FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE. Brief Summary Retin-A MicroÂŽ (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 (MICROSPONGEÂŽ 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: t5IFTLJOPGDFSUBJOJOEJWJEVBMTNBZCFDPNFFYDFTTJWFMZESZ SFE TXPMMFO PSCMJTUFSFE*GUIF 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. &YDFTTJWF TLJO ESZOFTT NBZ BMTP CF FYQFSJFODFE JG TP VTF PG BO BQQSPQSJBUF FNPMMJFOU during the day may be helpful. t6OQSPUFDUFEFYQPTVSFUPTVOMJHIU JODMVEJOHTVOMBNQT TIPVMECFNJOJNJ[FEEVSJOHUIFVTFPG 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 TVOFYQPTVSFEVFUPPDDVQBUJPOBOEUIPTFXJUIJOIFSFOUTFOTJUJWJUZUPUIFTVOTIPVMEFYFSDJTF QBSUJDVMBSDBVUJPO6TFPGTVOTDSFFOQSPEVDUT 41' BOEQSPUFDUJWFDMPUIJOHPWFSUSFBUFE BSFBTBSFSFDPNNFOEFEXIFOFYQPTVSFDBOOPUCFBWPJEFE t8FBUIFSFYUSFNFT TVDIBTXJOEPSDPME BMTPNBZCFJSSJUBUJOHUPQBUJFOUTVOEFSUSFBUNFOU with tretinoin. t3FUJO".JDSP USFUJOPJOHFM NJDSPTQIFSF BOE TIPVMECFLFQUBXBZGSPNUIF eyes, the mouth, paranasal creases of the nose, and mucous membranes. t5SFUJOPJOIBTCFFOSFQPSUFEUPDBVTFTFWFSFJSSJUBUJPOPOFD[FNBUPVTTLJOBOETIPVMECFVTFE with utmost caution in patients with this condition. Information for Patients: A Patient Information Leaflet has been prepared and is included with FBDIQBDLBHFPG3FUJO".JDSP USFUJOPJOHFM NJDSPTQIFSF BOE 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 XJUIUIFQFFMPGMJNFT1BSUJDVMBSDBVUJPOTIPVMECFFYFSDJTFEXJUIUIFDPODPNJUBOUVTFPGUPQJDBM PWFSUIFDPVOUFSBDOFQSFQBSBUJPOTDPOUBJOJOHCFO[PZMQFSPYJEF TVMGVS SFTPSDJOPM PSTBMJDZMJDBDJE 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: *O B XFFL EFSNBM TUVEZ JO XIJDI $% NJDF XFSF BENJOJTUFSFE BOE GPSNVMBUJPOT PG USFUJOPJO DVUBneous 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 PCTFSWFEBUUIPTFTBNFEPTFT5IFNBYJNVNTZTUFNJDEPTFTBTTPDJBUFEXJUIUIFBENJOJTUFSFE BOEGPSNVMBUJPOTBSFBOENHLHEBZ SFTQFDUJWFMZ5IFTFEPTFTBSF UXPBOEGPVSUJNFTUIFNBYJNVNIVNBOTZTUFNJDEPTFBQQMJFEUPQJDBMMZ XIFOOPSNBMJ[FE for total body surface area. The biological significance of these findings is not clear because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ermal carcinogenicity testing has not been performed with Retin-A Micro (tretinoin gel) microsphere, 0.04% or 0.1%. 4UVEJFTJOIBJSMFTTBMCJOPNJDFTVHHFTUUIBUDPODVSSFOUFYQPTVSFUPUSFUJOPJONBZFOIBODFUIF UVNPSJHFOJDQPUFOUJBMPGDBSDJOPHFOJDEPTFTPG67#BOE67"MJHIUGSPNBTPMBSTJNVMBUPS5IJT FGGFDUIBTCFFODPOGJSNFEJOBMBUFSTUVEZJOQJHNFOUFENJDF BOEEBSLQJHNFOUBUJPOEJEOPU PWFSDPNFUIFFOIBODFNFOUPGQIPUPDBSDJOPHFOFTJTCZUSFUJOPJO"MUIPVHIUIFTJHOJGJDBODF PGUIFTFTUVEJFTUPIVNBOTJTOPUDMFBS QBUJFOUTTIPVMENJOJNJ[FFYQPTVSFUPTVOMJHIUPSBSUJGJDJBM 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. 5IFDPNQPOFOUTPGUIFNJDSPTQIFSFTIBWFTIPXOQPUFOUJBMGPSHFOFUJDUPYJDJUZBOEUFSBUPHFOFTJT &(%." BDPNQPOFOUPGUIFFYDJQJFOUBDSZMBUFTDPQPMZNFS XBTQPTJUJWFGPSJOEVDUJPOPGTUSVDUVSBM chromosomal aberrations in the in vitro chromosomal aberration assay in mammalian cells in UIFBCTFODFPGNFUBCPMJDBDUJWBUJPO BOEOFHBUJWFGPSHFOFUJDUPYJDJUZJOUIF"NFTBTTBZ UIF HGPRT forward mutation assay, and the mouse micronucleus assay. In dermal Segment I fertility studies of another tretinoin formulation in rats, slight (not statistiDBMMZTJHOJGJDBOU EFDSFBTFTJOTQFSNDPVOUBOENPUJMJUZXFSFTFFOBUNHLHEBZ UJNFT UIFNBYJNVNIVNBOTZTUFNJDEPTFBQQMJFEUPQJDBMMZ BOEOPSNBMJ[FEGPSUPUBMCPEZTVSGBDF area), and slight (not statistically significant) increases in the number and percent of nonviable FNCSZPTJOGFNBMFTUSFBUFEXJUINHLHEBZ UJNFTUIFNBYJNVNIVNBOTZTUFNJDEPTF BQQMJFEUPQJDBMMZBOEOPSNBMJ[FEGPSUPUBMCPEZTVSGBDFBSFB BOEBCPWFXFSFPCTFSWFE*OPSBM Segment I and Segment III studies in rats with tretinoin, decreased survival of neonates and HSPXUISFUBSEBUJPOXFSFPCTFSWFEBUEPTFTJOFYDFTTPGNHLHEBZ UJNFTUIFIVNBO UPQJDBMEPTFOPSNBMJ[FEGPSUPUBMCPEZTVSGBDFBSFB 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) NJDSPTQIFSF BU EPTFT PG UP NHLHEBZ PO HFTUBUJPO EBZT UP UJNFT UIF NBYJNVN IVNBO TZTUFNJD EPTF PG USFUJOPJO OPSNBMJ[FE GPS UPUBM CPEZ TVSface 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 EPTFTPG BOENHLHEBZ BENJOJTUFSFEUPQJDBMMZGPSIPVSTBEBZXIJMFXFBSJOH &MJ[BCFUIBODPMMBSTUPQSFWFOUJOHFTUJPOPGUIFESVH5IFSFBQQFBSFEUPCFJODSFBTFEJODJEFODFT of certain alterations, including domed head and hydrocephaly, typical of retinoid-induced GFUBM NBMGPSNBUJPOT JO UIJT TQFDJFT BU BOE NHLHEBZ 4JNJMBS NBMGPSNBUJPOT XFSF OPUPCTFSWFEBUNHLHEBZ UJNFTUIFNBYJNVNIVNBOTZTUFNJDEPTFPGUSFUJOPJOBGUFS UPQJDBMBENJOJTUSBUJPOPG3FUJO".JDSP USFUJOPJOHFM NJDSPTQIFSF OPSNBMJ[FEGPSUPUBM CPEZTVSGBDFBSFB*OBSFQFBUTUVEZPGUIFIJHIFTUUPQJDBMEPTF NHLHEBZ JOQSFHOBOU rabbits, these effects were not seen, but a few alterations that may be associated with tretinoin FYQPTVSFXFSFTFFO0UIFSQSFHOBOUSBCCJUTFYQPTFEUPQJDBMMZGPSTJYIPVSTUPPSNH LHEBZUSFUJOPJOXIJMFSFTUSBJOFEJOTUPDLTUPQSFWFOUJOHFTUJPO EJEOPUTIPXBOZUFSBUPHFOJD FGGFDUTBUEPTFTVQUPUJNFT NHLHEBZ UIFNBYJNVNIVNBOTZTUFNJDEPTFBGUFSUPQJDBM administration of Retin-A Micro (tretinoin gel) microsphere, 0.1%, adjusted for total body surface BSFB CVUGFUBMSFTPSQUJPOTXFSFJODSFBTFEBUNHLH*OBEEJUJPO UPQJDBMUSFUJOPJOJOOPO Retin-A Micro (tretinoin gel) microsphere formulations was not teratogenic in rats and rabbits XIFOHJWFOJOEPTFTPGBOEUJNFTUIFNBYJNVNIVNBOTZTUFNJDEPTFBGUFSUPQJDBMBENJOJTUSBUJPOPG3FUJO".JDSP USFUJOPJOHFM NJDSPTQIFSF OPSNBMJ[FEGPSUPUBMCPEZTVSGBDF BSFB SFTQFDUJWFMZ BTTVNJOHBLHBEVMUBQQMJFEBEBJMZEPTFPGHPGHFMUPQJDBMMZ 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 subhuNBOQSJNBUFT5SFUJOPJOXBTUFSBUPHFOJDJO8JTUBSSBUTXIFOHJWFOPSBMMZPSUPQJDBMMZJOEPTFT HSFBUFSUIBONHLHEBZ UJNFTUIFNBYJNVNIVNBOTZTUFNJDEPTFOPSNBMJ[FEGPSUPUBM body surface area). However, variations in teratogenic doses among various strains of rats have CFFOSFQPSUFE*OUIFDZOPNPMHVTNPOLFZ XIJDINFUBCPMJDBMMZJTNPSFTJNJMBSUPIVNBOTUIBO other species in its handling of tretinoin, fetal malformations were reported for doses of 10 NHLHEBZPSHSFBUFS CVUOPOFXFSFPCTFSWFEBUNHLHEBZ UJNFTUIFNBYJNVNIVNBO TZTUFNJDEPTFOPSNBMJ[FEGPSUPUBMCPEZTVSGBDFBSFB BMUIPVHIJODSFBTFETLFMFUBMWBSJBUJPOT 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 GPSUFSBUPHFOJDJUZ TIPSUFOFEPSLJOLFEUBJM PGUPQJDBMUSFUJOPJOJO8JTUBSSBUTBUEPTFTHSFBUFS UIBONHLHEBZ UJNFTUIFNBYJNVNIVNBOTZTUFNJDEPTFOPSNBMJ[FEGPSUPUBMCPEZTVSGBDF BSFB "OPNBMJFT IVNFSVTTIPSU CFOU PTQBSJFUBMJODPNQMFUFMZPTTJGJFE IBWF BMTPCFFOSFQPSUFEXIFONHLHEBZXBTUPQJDBMMZBQQMJFE4VQFSOVNFSBSZSJCTIBWFCFFOB 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 VTFEEVSJOHQSFHOBODZPOMZJGUIFQPUFOUJBMCFOFGJUKVTUJGJFTUIFQPUFOUJBMSJTLUPUIFGFUVT 8JUIXJEFTQSFBEVTFPGBOZESVH BTNBMMOVNCFSPGCJSUIEFGFDUSFQPSUTBTTPDJBUFEUFNQPSBMMZ XJUI UIF BENJOJTUSBUJPO PG UIF ESVH XPVME CF FYQFDUFE CZ DIBODF BMPOF5IJSUZ IVNBO DBTFT 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 TJHOJGJDBODFPGUIFTFTQPOUBOFPVTSFQPSUTJOUFSNTPGSJTLUPUIFGFUVTJTOPULOPXO Non-Teratogenic Effects: 5PQJDBM USFUJOPJO IBT CFFO TIPXO UP CF GFUPUPYJD JO SBCCJUT XIFO BENJOJTUFSFENHLHEBZ UJNFTUIFNBYJNVNIVNBOTZTUFNJDEPTFBQQMJFEUPQJDBMMZBOE OPSNBMJ[FEGPSUPUBMCPEZTVSGBDFBSFB SFTVMUJOHJOGFUBMSFTPSQUJPOTBOEWBSJBUJPOTJOPTTJGJDBUJPO0SBMUSFUJOPJOIBTCFFOTIPXOUPCFGFUPUPYJD SFTVMUJOHJOTLFMFUBMWBSJBUJPOTBOEJODSFBTFE JOUSBVUFSJOFEFBUIJOSBUTXIFOBENJOJTUFSFENHLHEBZ UJNFTUIFNBYJNVNIVNBO TZTUFNJDEPTFBQQMJFEUPQJDBMMZBOEOPSNBMJ[FEGPSUPUBMCPEZTVSGBDFBSFB 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) miDSPTQIFSF BU PSNHLHEBZUSFUJOPJO PSUJNFTUIFNBYJNVNIVNBO systemic dose after topical administration of Retin-A Micro (tretinoin gel) microsphere, 0.1%, OPSNBMJ[FEGPSUPUBMCPEZTVSGBDFBSFB GPSEBZT BSFEVDUJPOJOUFTUJDVMBSXFJHIU CVUXJUI 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 NHLHEBZ UJNFTUIFNBYJNVNIVNBOEPTF *OUIJTTUVEZUIFSFXBTBEPTFSFMBUFE JODSFBTFJOUIFQMBTNBDPODFOUSBUJPOPGUSFUJOPJOIPVSTBGUFSUIFGJSTUEPTF"TFQBSBUFUPYJDPLJOFUJDTUVEZJONJDFJOEJDBUFTUIBUTZTUFNJDFYQPTVSFJTHSFBUFSBGUFSUPQJDBMBQQMJDBUJPOUP VOSFTUSBJOFEBOJNBMTUIBOUPSFTUSBJOFEBOJNBMT TVHHFTUJOHUIBUUIFTZTUFNJDUPYJDJUZPCTFSWFE is probably related to ingestion. Male and female dogs treated with Retin-A Micro (tretinoin gel) NJDSPTQIFSF BU PSNHLHEBZUSFUJOPJO PSUJNFTUIFNBYJNVN human systemic dose after topical administration of Retin-A Micro (tretinoin gel) microsphere, OPSNBMJ[FEGPSUPUBMCPEZTVSGBDFBSFB SFTQFDUJWFMZ GPSEBZTTIPXFEOPFWJEFODFPG reduced testicular or ovarian weights or pathological changes. Nursing Mothers:*UJTOPULOPXOXIFUIFSUIJTESVHJTFYDSFUFEJOIVNBONJML#FDBVTFNBOZ ESVHTBSFFYDSFUFEJOIVNBONJML DBVUJPOTIPVMECFFYFSDJTFEXIFO3FUJO".JDSP USFUJOPJO 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. $MJOJDBMTUVEJFTPG3FUJO".JDSPEJEOPUJODMVEFTVGGJDJFOUOVNCFSTPGTVCKFDUTBHFEBOE over to determine whether they respond differently from younger subjects. ADVERSE REACTIONS: 5IFTLJOPGDFSUBJOTFOTJUJWFJOEJWJEVBMTNBZCFDPNFFYDFTTJWFMZSFE FEFNBUPVT CMJTUFSFE PS crusted. If these effects occur, the medication should either be discontinued until the integrity PGUIFTLJOJTSFTUPSFE PSUIFNFEJDBUJPOTIPVMECFBEKVTUFEUPBMFWFMUIFQBUJFOUDBOUPMFSBUF 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 VTFPOMZ*GNFEJDBUJPOJTBQQMJFEFYDFTTJWFMZ OPNPSFSBQJEPSCFUUFSSFTVMUTXJMMCFPCUBJOFEBOE NBSLFESFEOFTT QFFMJOH PSEJTDPNGPSUNBZPDDVS0SBMJOHFTUJPOPGMBSHFBNPVOUTPGUIFESVH NBZMFBEUPUIFTBNFTJEFFGGFDUTBTUIPTFBTTPDJBUFEXJUIFYDFTTJWFPSBMJOUBLFPG7JUBNJO" Rx only.
Distributed by: Ortho Dermatologics Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., -PT"OHFMFT $" ÂŞ0.1 %% RETIN-A MICRO ÂŽ JT B SFHJTUFSFE USBEFNBSL PG 0SUIP.D/FJM 1IBSNBDFVUJDBM *OD ÂŽ MICROSPONGE JTBSFHJTUFSFEUSBEFNBSLPG".$0-*OUFSOBUJPOBM$PSQPSBUJPO
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 Mark Archambault, DHSc, PA-C Kristine Kucera, DHS, MPAS, PA-C Jennifer Winter, PA-C Mark Hyde, MMS, PA-C Jeffrey LaDuca, Ph.D., MD Alan Menter, MD
Clinical Department Editors Susan E. King-Barry, MPAS, PA-C Karen Graham, MPAS, PA-C Drugs in Dermatology Editor Stephen Wolverton, MD Surgical Department Editor Christy Kerr, MPAS, PA-C Cosmetic Department Editor Nancy Primo, MPAS, PA-C Prof Dev Department Editor Abby Jacobson, MS, PA-C
SDPA Board of Directors
PrESiDEnT Keri Holyoak, MPH, PA-C PrESiDEnT-ElECT John Notabartolo, MPAS, PA-C iMMEDiATE PAST PrESiDEnT Abby Jacobson, MS, PA-C ViCE PrESiDEnT Jacki Kment, MPAS, PA-C SECrETAry / TrEASurEr Casey Croes, MPAS, PA-C DirECTors AT lArGE Susan Hammerling, MPAS, PA-C Kristine Kucera, DHS, MPAS, PA-C Vicki Roberts, MPAS, PA-C Jennifer Winter, PA-C
Society of Dermatology Physician Assistants, Inc.
4111 W. Alameda Ave. Suite 412 Burbank, CA 91505 1-800-380-3992 SDPA@dermpa.org www.dermpa.org
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Physician Assistant Communications, LLC P.O. Box 416, Manlius NY 13104-0416 Phone (315) 663-4147 PAC@pacommunications.org www.pacommunications.org editorial missioN: The JDPA is the official clinical journal of the Society of Dermatology Physician Assistants. The mission of the JDPA is to improve dermatological patient care by publishing the most innovative, timely, practiceproven educational information available for the physician assistant profession. PUBLISHED CONTENT IN THE JDPA: Statements and opinions expressed in the articles and communications herein are those of the authors and not necessarily those of the Publisher or the Society of Dermatology Physician Assistants (SDPA). The Publisher and the SDPA disclaim any responsibility or liability for such material, including but not limited to any losses or other damage incurred by readers in reliance on such content. Neither Publisher nor SDPA verify any claims or other information appearing in any of the advertisements contained in the publication and cannot take responsibility for any losses or other damage incurred by readers in reliance on thereon. Neither Publisher nor SDPA guarantees, warrants, or endorses any product or service advertised in this publication, nor do they guaranty any claim made by the manufacturer of such product or service. This Issue: of JDPA includes articles that have been reviewed and approved for Category I (Preapproved) CME credit by the American Academy of Physician Assistants. Approval is valid for 1 year from the issue date, and participants may submit the self-assessment at any time during that period. Category I CME articles included in JDPA are planned and developed in accordance with AAPAâ€™s CME Standards for Journal Articles and for Commercial Support of Journal Articles. Since its inception, the JDPA has utilized eco-friendly printing practices. The JDPA is printed on paper obtained from sustainable forests that meet strict environmental standards. Soy-based inks that have a low environmental impact are used during printing of the journal and the journal is printed using 100% renewable energy. SDPA members may join us in our efforts and opt to receive the JDPA in digital format.
JDPA/Journal of Dermatology for Physician Assistants (ISSN 1938-9574) is published quarterly (4 issues per volume, one volume per year) by Physician Assistant Communications, LLC, P.O. Box 416, Manlius NY 13104-0416. Volume 5, Number 4, Fall 2011. One year subscription rates: $40 in the United States and Possessions. Single copies (prepaid only): $10 in the United States (Include $6.50 per order plus $2 per additional copy for US postage and handling). TM Periodicals postage rate paid at New York, NY 10001 and additional mailing offices. ÂŠ 2011 Physician Assistant Communications, LLC. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including by photocopy, recording, or information storage and retrieval system, without permission in writing from the publisher. Postmaster: Send address changes to Society of Dermatology Physician Assistants, Inc., 4111 W. Alameda Ave. Suite 412, Burbank, CA 91505, 1-800-380-3992. THIS ISSUE IS SPONSORED BY
Journal of Dermatology for Physician Assistants
Editor’s Message “Education is not the filling of a pail but the lighting of a fire.” Journal of Dermatology for Physician Assistants
The Official Journal of the SDPA
Dermcast.tv Blog Visit dermcast.tv today to keep up with the latest news and information affecting dermatology PAs.
– William Butler Yeats
n 1965, with a shortage of primary care physicians looming, Dr. Eugene Stead of the Duke University Medical Center put together the first class of physician assistants. Two years later on October 6, 1967, the Duke University PA Program graduated its inaugural class who proudly became our country’s first three practicing PAs. When I give thought to this milestone, I am impressed with the amount of intense medical training that was provided to these pioneers of the PA profession by Dr. Stead and his fellow physician educators. With the constant help of educators like these, what started out as three dedicated PA students has steadily grown into more than 81,000 practicing PAs. Today educators in the PA profession continue to give generously of themselves to help PAs light their personal fires of growth and learning. Thinking about the amount of energy that goes into teaching has inspired my own appreciation for dermatology PAs who help provide our fellow SDPA members with high quality dermatological education. Dermatology PA educators have contributed to our continuing education through a multitude of SDPA venues such as the DLI, the online forum, annual conferences, and this very publication including its contributing authors and our dedicated editorial board. As many of us may know, writing high quality, well-researched medical articles is no easy task. An author can spend numerous hours writing and rewriting an article, while editors spend additional time molding it into its final form for publication. I would like to express my gratitude to all past, present, and future dermatology PA writers and editors who have shared and will share their time and talents with our profession. What started out as a few PAs interested in furthering our dermatological profession through the written word has inspired many more to volunteer to help ignite the passion for learning within our dermatology PA profession. J
Travis Hayden, MPAS, PA-C Editor in chief
Vol. 5, No. 4 FALL 2011
table of contents SDPA Members Only Content A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.
A Review Article on Commonly Seen Vesiculobullous Disorders By Susan E. King-Barry, MPAS, PA-C
10 Derm PA News & Notes – part one • Certification Review – All Those Things Inside the Skin You Might Have Forgotten
14 Clinical Dermatology
04 Editorial Board 05 Editor’s Message 09 SDPA News & Current Affairs 10 Dermatology Market Watch 18 From The Patient’s Perspective 20 Dermoscopy Q&A 29 Clinical Snapshots 36 Surgical Wisdom 41 Cosmetic Pearls 48 Notes from your Office Manager 49 Outside & Inside the 9 to 5... 54 The Difference We Make 59 Professional Opportunities and Development
• CME Article – A Review Article on Commonly Seen Vesiculobullous Disorders • Dermatology Case Report - Bullous Pemphigoid • Drugs in Dermatology - An Update on the Management of Cicatricial Alopecia with a Focus on PPARγ Agonists
34 Surgical Dermatology
• Beyond the Ellipse - What do I do now?
39 Cosmetic Dermatology • Understanding Self-Tanning Preparations
42 Professional Development
53 Derm PA News & Notes – part two
Go Green - Read Online
• Dermatology Billing & Coding – New ICD-9 Code Changes in Effect as of October 1, 2011 • Judicial and Ethical Affairs - Research Ethics: Ghostwriting
Journal of Dermatology for Physician Assistants
• From the Desk of… • Student Scoop - Tips for Students on How to Find a Preceptor • Supervising Physician Corner
Vol. 5, No. 4 FALL 2011
Journal of Dermatology for Physician Assistants
FROM THE SPDA News & Current Affairs
2011 NOVEMBER SDPA 9th Annual Fall Conference November 9 - 12, 2011 Loews Portofino Bay Hotel Orlando, FL
2012 MARCH 70th AAD Annual Academy Meeting March 16 - 20, 2012 San Diego, CA JULY SDPA Summer Dermatology Conference July 11 - 15, 2012 The Westin Hotel Seattle, WA October/nOVEMBER SDPA 10th Annual Fall Conference October 31 - November 3, 2012 Caesars Palace Hotel Las Vegas, NV
Calendar of Events Submissions Send information to: Editor@jdpa.org
ot long ago, a shy young woman came to my office with severe acne. Her lack of eye contact was an inner reflection of her outer complexion. I prescribed a medication that cleared up her skin and watched her confidence grow. Years have passed. She has since married, had children, and now enjoys a very successful career. She came by the office last week to tell us how she had spoken highly of us throughout the years and how thankful she was to have received our care. There is no way to describe the feeling when someone says â€œthank youâ€? and lets you know that you are valued. Being appreciated by our patients is one thing. However, being appreciated by our peers, those whom we respect the most, is another. Having just celebrated National Physician Assistant Week (October 6 -12th), let us continue to support and increase public awareness of physician assistants. So many of our colleagues operate quietly behind the scenes to help their patients, and this month we have the opportunity to publically celebrate and appreciate them. J
Keri Holyoak, MPH, PA-C President Society of Dermatology Physician Assistants
Vol. 5, No. 4 FALL 2011
Dermatology PA news & notes
Dermatology Market Watch Foundation for Ichthyosis & Related Skin Types (FIRST) Tele-Ichthyosis
The Foundation for Ichthyosis & Related Skin Types, Inc.™ (FIRST) is proud to announce that a teledermatology website has been created to assist local dermatology providers with the diagnosis and treatment of patients with ichthyosis and related skin types. The diagnosis of many types of ichthyosis can be made largely on the basis of visual findings. Therefore, telemedicine can be a useful tool in providing care to patients and connecting local dermatology providers with ichthyosis experts across the country. The Tele-Ichthyosis site provides a framework to upload questions, documents, and images for input from ichthyosis and related skin type experts. It uses a store-and-forward teledermatology approach in a secure, HIPAA-compliant environment to facilitate communication between dermatology providers dealing with this rare set of diseases.
To access Tele-Ichthyosis, go to the FIRST website (www.firstskinfoundation.org) to register and upload your case information, questions, and photos. The expert panel will review the case and recommendations will be provided in a timely manner. In many cases, it will be possible to have ongoing diagnostic and treatment support as needed over the course of care for an individual patient. Tele-Ichthyosis has been funded through a grant from the Lennox Foundation in memory of Dane Christian Phelps. To obtain additional information about TeleIchthyosis or other FIRST related projects, please visit their website at www.firstskinfoundation.org or contact them at 1-800-545-3286.
First-In-Nation Bill Banning Minors From Tanning Beds Awaits Passage California would be the first state to enact tanning bed ban AIM at Melanoma, the largest international foundation dedicated to melanoma research and patient advocacy, announced recently that the California Senate approved and sent to Governor Jerry Brown, Senate Bill (SB) 746, which would ban children under 18 from using indoor tanning beds. Co-sponsored by AIM at Melanoma and the California Society of Dermatology & Dermatological Surgery, SB 746 would replace the current law, which requires 14-17 year olds to obtain parental permission to use a tanning bed. Currently, children under 14 are prohibited from using tanning beds. Nearly 28 million individuals use tanning beds in the U.S. annually, of which 2.3 million are teens. Those who use tanning beds before the age of 20 double their risk of developing melanoma. Melanoma is the number one cancer killer of young women between the ages of 25-30, and second only to breast cancer in women 30-34. Over 8,000 new cases of melanoma were diagnosed in California in 2011. 10 Journal of Dermatology for Physician Assistants
Valerie Guild, president of AIM at Melanoma, urged Governor Brown to break new ground by signing SB 746 into law. “It is highly disturbing that so many young women are being affected unnecessarily by this horrific disease,” said Guild. “Governor Brown has a unique opportunity to blaze a trail by banning minors from using tanning beds. We want him to join us in the fight against this preventable killer.” “Scientific research has shown conclusively that tanning beds cause skin cancer,” said Senator Ted Lieu, who backed the bill in the Senate. “The younger kids are when they start using tanning beds, the greater the cumulative damage to their skin and the more likely they are to die of skin cancer.” If SB 746 is signed into law, it would take effect January 1, 2012 and make the Golden State the first in the nation with such a ban. For more information, visit www.AIMatMelanoma.org, a comprehensive website available to the melanoma community and public at large. ...continued on page 13
CLODERM CREAM Not a cookie-cutter topical steroid ®
Different by Design • Unique molecular structure provides midstrength efficacy with an excellent safety profile1-3 • Only Cloderm Cream offers the versatility of both a tube and pump To request samples or for further information, contact Promius Pharma at 888.384.6929 Indication and Important Safety Information Cloderm Cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. The most common adverse events with Cloderm Cream include burning, itching, irritation, dryness, and folliculitis. Cloderm Cream is contraindicated in patients who are hypersensitive to any of the ingredients of this product. As with all topical corticosteroids, systemic absorption can produce reversible HPA-axis suppression. See full prescribing information on reverse side. For more information see www.Cloderm.com. References: 1. Bikowski J, Pillai R, Shroot B. The position not the presence of halogen in corticosteroids influences potency and side effects. J Drug Dermatol. 2006;5(2):125-130. 2. Del Rosso J, Friedlander S. Corticosteroids: options in the era of steroid-sparing therapy. J Am Acad Dermatol. 2005;53(1 Suppl 1):S50-58. 3. Data on file. Promius Pharma, LLC: Bridgewater, NJ. Cloderm® is a trademark of Coria Laboratories, Ltd.
Vol. 5, No. 4 FALL 2011 11
RxOnly Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results. FOR TOPICAL DERMATOLOGIC USE ONLYâ€“ NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE. WARNING: KEEP OUT OF REACH OF CHILDREN DESCRIPTION: Cloderm Cream 0.1% contains the medium potency topical corticosteroid, clocortolone pivalate, in a specially formulated water-washable emollient cream base consisting of purified water, white petrolatum, mineral oil, stearyl alcohol, polyoxyl 40 stearate, carbomer 934P, edetate disodium, sodium hydroxide, with methylparaben and propylparaben as preservatives. Chemically, clocortolone pivalate is 9-chloro-6_-fluoro-11`, 21-dihydroxy-16_ methylpregna-1, 4-diene-3, 20-dione 21-pivalate. Its structure is as follows: CLINICAL PHARMACOLOGY: Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man. Pharmacokinetics: The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses. (See DOSAGE AND ADMINISTRATION). Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile. INDICATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. CONTRAINDICATIONS: Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. PRECAUTIONS: General: Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushingâ€™s syndrome, hyperglycemia, and glucosuria in some patients. Conditions which augment 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 receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis 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 and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.
Pregnancy Category C: Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time. Nursing Mothers: It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman. Pediatric Use: Pediatric patients may demonstrate greater susceptibility to topical corticosteroidinduced HPA axis suppression and Cushingâ€™s syndrome than mature patients because of a larger skin surface area body weight ratio. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushingâ€™s syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children. ADVERSE REACTIONS: The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: Burning, Itching, Irritation, Dryness, Folliculitis, Hypertrichosis, Acneiform eruptions, Hypopigmentation, Perioral dermatitis, Allergic contact dermatitis, Maceration of the skin, Secondary infection, Skin atrophy, Striae, Miliaria OVERDOSAGE: Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS). DOSAGE AND ADMINISTRATION: Apply Cloderm (clocortolone pivalate) Cream 0.1% sparingly to the affected areas three times a day and rub in gently. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted. HOW SUPPLIED: Cloderm (clocortolone pivalate) Cream 0.1% is supplied in 30 gram and 75 gram pump bottles, 45 gram and 90 gram tubes. Store Cloderm Cream between 15Â° and 30Â° C (59Â° and 86Â° F). Avoid freezing. Distributed by:
Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity. (See PRECAUTIONS-Pediatric Use). If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. 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, the corticosteroid should be discontinued until the infection has been adequately controlled. Information for the Patient: Patients using topical corticosteroids should receive the following information and instructions: 1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes. 2. Patients should be advised not to use this medication for any disorder other than for which it was prescribed. 3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician. 4. Patients should report any signs of local adverse reactions especially under occlusive dressing. 5. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings. Laboratory Tests: The following tests may be helpful in evaluating the HPA axis suppression: Urinary free cortisol test ACTH stimulation test
12 Journal of Dermatology for Physician Assistants
XXXQSPNJVTQIBSNBDPN Promius Pharma, LLC 200 Somerset Corporate Blvd., Bridgewater, NJ 08807 Manufactured by: DPT LABORATORIES, LTD. San Antonio, Texas 78215 ClodermÂŽ is a trademark of Coria Laboratories, Ltd. Reorder No.13548-031-30 (30g) pump bottle Reorder No.13548-031-45 (45g) tube Reorder No.13548-031-75 (75g) pump bottle Reorder No.13548-031-90 (90g) tube Rev.Date June 2011
All Those Things Inside the Skin You Might Have Forgotten By James A. Van Rhee, MS, PA-C
EXPLANATION: Meningitis, infection of the pia mater and cerebrospinal fluid (CSF), is typically due to viral or bacterial etiologies. Presenting symptoms for both include headache, neck stiffness, change in mental status, and fever. The very young and very old may present without fever and minimal signs of inflammation. On physical examination a positive Kernig’s and Brudzinski’s sign may be noted. A petechial rash if noted may indicate infection secondary to Neisseria meningitidis. Typical CSF laboratory studies results are noted in Table 1. In the elderly, the most likely bacterial etiologies include Streptococcus pneumoniae, Neisseria meningitidis, gram-negative bacilli, and Listeria monocytogenes. A third generation cephalosporin, such as ceftriaxone, is the treatment of choice
Table 1- Meningitis CSF Laboratory Results Agent Normal Bacterial Viral Fungal
Opening Pressure High High High
WBC (/cm3) <5 >100 >50 >50
PMN (%) 0 >80 <50 <50
Lymph (%) 100 >20 >50 >50
Protein (g/dl) <50 >100 >50 >50
Glucose (g/dl) >50 <30 >59 <30
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.
Dermatology Market Watch
...continued from page 10
Passion To Heal - Helping those in need
Many healthcare professionals feel a passion to give back. Here, abroad, or anywhere communities are underserved. These medical efforts can be personally gratifying and help to change the outcomes of patients’ lives. Unfortunately, bureaucratic and logistical obstacles often get in the way, lessening the profound impact healthcare professionals can have on the lives of those in need. Medicis has quietly supported many worthy causes in the past. Moving forward they have decided to play a more substantial role. Medicis will be making charitable contributions to fund non-profit organizations that connect talented dermatologists, plastic surgeons, residents, and healthcare professionals in these specialties with
communities in need. This Medicis initiative seeks to increase availability of specialized healthcare to such communities both in the United States and around the world. The program Passion to Heal will help charitable organizations that enable healthcare professionals to volunteer their skills to change the lives of patients. Providers will be able to choose the timing and duration of their volunteer activities and decide whether they want to volunteer domestically or internationally. To learn more about Passion to Heal, select a charitable organization, and begin helping patients in need please visit the website www. PassiontoHeal.com. Vol. 5, No. 4 FALL 2011 13
DERmatology pa news & notes
QUESTION: A 70 year-old male presents with headache and neck stiffness. On physical examination, the patient is afebrile and a positive Kernig’s sign is noted. Cerebrospinal fluid studies reveal a white blood cell count of 550/cm3 with 100% segmented neutrophils, total protein 200mg/dl, and glucose 30mg/dl. Which of the following is the treatment of choice for this patient? A. Acyclovir (Zovirax) B. Fluconazole (Diflucan) C. Ampicillin and ceftriaxone (Rocephin) D. Penicillin and chloramphenicol (Chloromycetin)
for possible Streptococcus, Neisseria, and gram negative bacilli. Ampicillin must be added because of the risk of possible Listeria infection in this elderly patient. Acyclovir is indicated in herpes meningitis and fluconazole is indicated in fungal meningitis. Chloramphenicol is not indicated as first line therapy secondary to severe side effects, such as aplastic anemia. J
The correct answer is C.
Are you recertifying soon? Start your board review early. Each issue of the JDPA features one board question accompanied by a brief explanation of the answer along with any pertinent test taking tips. Best of luck!
A Review Article on Commonly Seen Vesiculobullous Disorders By Susan E. King-Barry, MPAS, PA-C JDPA Clinical Department Editor
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.
This program has been reviewed and is approved for a maximum of .5 hours of AAPA Category I CME credit by the Physician Assistant Review Panel.
Approval is valid for 1 year from the issue date of OCTOBER 2011. Participants may submit the self-assessment exam at any time during that period. This program was planned in accordance with AAPAâ€™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. Recognize the various clinical presentations of the most commonly seen vesiculobullous disorders: pemphigus, bullous pemphigoid, and epidermolysis bullosa. 2. Describe the pathophysiology of these vesiculobullous disorders. 3. State the diagnostic tests used to classify the vesiculobullous disorders. 14 Journal of Dermatology for Physician Assistants
A Review Article on Commonly Seen Vesiculobullous Disorders SDPA Members Only Content
A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.
Vol. 5, No. 4 FALL 2011 15
A Review Article on Commonly Seen Vesiculobullous Disorders 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.
16 Journal of Dermatology for Physician Assistants
A Review Article on Commonly Seen Vesiculobullous Disorders 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.
Susan E. King-Barry, RN, MPAS, PA-C is a 1989 graduate of the Western Michigan University Physician Assistant Program with a bachelorâ€™s degree in medicine and received her MPAS from the University of Nebraska Medical Center, with an emphasis in dermatology. She practiced hospital-based internal medicine for eight years followed by thirteen years practicing dermatology. She presently resides in Grand Rapids, Michigan and is an Assistant Professor at Western Michigan University Physician Assistant Program, College of Health and Human Services. She has indicated no relationships to disclose relating to the content of this article. Vol. 5, No. 4 FALL 2011 17
From The Patient’s Perspective How Eczema Has Defined My Life
By Angeline Fowler Whether I want to admit it or not, eczema has on the playground. I was the last one picked for teams. defined my life and who I am. If I stop to think of who I was referred to not by my birth name but my general I would be if I had been born without eczema, I know nickname of “Spot.” I would hide in the toilets during I would be a totally different person. Even if a cure is lunchtime and recess and scratch. I would try with all my discovered tomorrow, eczema has might not to scratch, not to flake already defined me and shaped skin over my desk, not to crack, my path, whether I like I or not. and not to bleed. Today I’m a respected My mum and dad working professional with experimented with everything an advanced degree, a happy they could think of. They marriage, and a young daughter. bandaged my hands, put boxing But as I write this on my lunch gloves on me, lathered me with hour at work, I desperately want cream, filled me full of vitamins, to rip off my jeans and scratch the and took me to doctor after backs of my knees; today my scalp doctor. I was at the doctor’s office “A photo of me as a young girl with my siblings (I am on the right).” is flaking and it hurts to smile so often that I only attended because the cracks on the side of school two days a week for the my mouth are healing shut. first two years. You would think this would mean I fell behind, I was born in a small town but school was my way to prove in rural England in the 1970s myself. I studied, I learned, I at a time when eczema was excelled. My skin couldn’t be not recognized by the British perfect but my brain could. medical profession. In the United Kingdom’s National Morbidity When I was eight, my surveys, the rate of children under mum and dad found a specialist “My husband, five consulting professionals for running a clinical trial for eczema. Christian, and I. eczema was 90 in 1,000 in 1971, He put me on a food exclusion Don’t believe your and the rate was 28 in 1,000 diet where I could only eat turkey, eyes. I have makeup among children 5 to14 year rice, and pineapple. I had to on and paid for it the next day.” olds. This was in a time before drink a liquid medicine before the Internet, a time when to get eating any meal, and then I could information you had to go to introduce one new food every the library or write away for it. month (but never bread, milk, or My parents had a healthy child eggs). I was on that diet for five for two months and then it all years. Throughout junior high, went downhill. A small rash on I lived on an Atkins-like diet of my cheeks turned into cracked sausages for lunch. So now I was lips, bleeding joints, incessant the spotty, scaling kid who ate scratching, and crying. My crazy food. doctors saw eczema as a rash that While elementary school was unfortunate, but not much was hard, junior high was even more. more traumatic. For a start, I was My first conscious memory of still going to school with people my eczema was in preschool. It is sad for a child as young I had been with since I was five years old, and you never as three to know that they are different, to have other grow out of people’s perceptions of you. I wanted to start parents pull their kids away from you and tell them not wearing different clothes, and I wanted to wear more to touch you because they are scared, to have kids look at than just colors that I could bleed on without people you with disgust, and to have no one ever hold your hand noticing. I wanted to dye my hair. I wanted to wear 18 Journal of Dermatology for Physician Assistants
my hair, and I stopped forcing myself into nylon, drycleaned shirts that aggravated my skin. People stared, and coworkers made comments. Even today, when I meet new moms at my daughter’s school, they struggle to make eye contact at first. I’m pretty sure I’ve lost promotions because of my skin and my less-than-perfect hair, but this makes me try and work harder. With age and motherhood comes the ability to ignore people’s hesitation when they first meet me. I smile politely and introduce myself while saying to myself, “I’m talented, I’m bright, I’m a good mother, I have a good job and a good family, and I’m funny as hell. And if you don’t want to see that, too bad for you.” Some days this is easy, and some days I want to curl up into a ball and not get out of bed. But then my daughter walks over and says, “Are you sick today, mommy? Can I help take care of you?” And I realize that it’s time to get up, push through the pain, and try to get through another day. J Angeline Fowler lives in the Pacific Northwest and is a working professional with an advanced degree, a happy marriage, a young daughter, and newborn son. Angeline is also a volunteer Telephone Support Contact for the National Eczema Association, www.nationaleczema.org.
Take Home points for derm pas: By Steven K. Shama, MD, MPH 1. “All I wanted was to be normal and to be happy.” Who doesn’t want that for themselves? And yet, Angeline’s eczema has never allowed her to fully accept herself as whole. To a great extent it is her child’s unconditional love that gives her the power to overcome and to forget her negative feelings. We, as heathcare practitioners, must also accept our patient’s perceived deficiencies with the same innocent love of a child for his/her mother. We need to embrace with words, with touch, and especially with our spirit. These are all healing intentions. 2. Eczema can hurt both psychologically as well as physically. When we literally face a patient, we should introduce to them those possible feelings. Do it with a smile and an open heart. When we can’t cure someone, we should all consider prescribing a “potion,” wrapped in a caring word for greater absorption. Vol. 5, No. 4 FALL 2011 19
makeup and I wanted to stop using the coal-tar shampoo and soap so I could stop smelling like tar. I didn’t care if it made me worse. I wanted to be normal. My parents were very strict about my skin and routines. Now I understand that they had invested an enormous part of their lives trying to help me get better. How could they sit by and watch me flare up because I wanted to wear neon pink eyeliner? How could they risk me getting my ears pierced and reacting to the metal? How could they trust that I wouldn’t flare on a school trip? My skin started to improve in high school, but I was still socially awkward. In comfortable settings at home or with small groups of close friends, I was able to be myself. Whether I was or wasn’t, I thought I was the ugly girl and had no idea why anybody would want to talk or be friends with me. Unfortunately, such thinking becomes a self-fulfilling prophecy because if you lack confidence and self worth, those are not attractive qualities. All I wanted was to be normal and to be happy. I wanted to be asked to the school dance. I wanted a boyfriend. Looking back, I’m not sure how much I sabotaged myself. I’m not sure how much my anger, my pain, and my general low esteem got in the way. When I look back at photos of me as a child, I realize I was not unattractive. When I was sixteen years old, my eczema went through a shift, moving off my face and remaining solely on my body. I figured out a way to cover it with tights and polo necks (luckily it was the height of the grunge movement and layers were my friend). Inside though, I hadn’t changed. I got my first boyfriend and dated through the next two years. I sabotaged my relationships because I was miserable and truly didn’t understand why anyone would want to date me. I was desperate to be accepted, loved, and was far too needy. My life changed when I graduated. I signed up to be an exchange student and spent a year in the United States, specifically Alaska. It was a huge change and move, but it allowed me to start afresh and figure out who I was independent of eczema. By this point, my eczema was on my joints and back only, so to the average eye I was normal. The new people I met had never met “Spot” and never would. It was during this time that I met my friend and future husband. He was my friend first, and he looked after me. He saw the bloodied clothes and didn’t think less of me. He saw both sides of me and accepted both. This acceptance slowly taught me selfacceptance. For ten years, only two or three people had ever met or seen the real me. It wasn’t until I was pregnant with my daughter that everything changed. My eczema flared severely the second I got pregnant and returned to my face. But covering it up and making excuses wasn’t a priority anymore, my daughter was. I stopped wearing makeup to work, I stopped putting products in
Dermoscopy Q A By John Burns, PA-C
A 45 year-old male presented with the irregularly pigmented macule on his lower leg (see Figures 1A & 1B). He denied knowledge of the area and suffered no personal or family history of skin cancer. Please answer the following questions regarding this lesion.
Questions: 1. Should one expect a 45 year-old individual to develop a nevus? 2. What is the diagnosis for this lesion? 3. Which of the following is the appropriate treatment option for this lesion? a. Complete surgical removal of the lesion. b. Three month observation of the lesion. c. No treatment is required for the lesion. 4. What are the potential dermoscopic presentations of this type of lesion? Answer on page 26
A Figure 1 - Clinical presentation of an irregularly pigmented macule on patientâ€™s lower leg viewed with the naked-eye (A) and polarized-immersion, contact, dermoscopic presentation of the same lesion (B).
The clock is ticking...
Answers on page 30
www.dermpa.org/diplomate 1. Must be enrolled by June 30, 2011 to be Diplomate 2. After June 30, 2011 if Fellow members are not currently enrolled they will not be considered Diplomates until all 10 modules are completed. 3. June 2012: all members who complete 10 modules will hold Diplomate status, those who have not completed all 10 modules will lose Diplomate status until they have completed all 10 modules - (No Grace Periods will be allowed)* *The DLI modules will continue to be available for education and CME even after the 2012 deadlines. Diplomate status will be awarded upon the completion of all 10 modules and maintaining all of the SDPA Diplomate requirements.
20 Journal of Dermatology for Physician Assistants
For moderate to severe plaque psoriasis up to 4 weeks in adults
A TOP DOG
to clear plaques CLOBEX® (clobetasol propionate) Spray, 0.05%: powerful efficacy for body and scalp psoriasis1-4
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. Important Safety Information Clobetasol propionate has been shown to suppress the HPA axis at the lowest doses tested. Clobetasol propionate spray should not be used in the treatment of rosacea or perioral dermatitis and should not be used on the face, groin or axillae. In controlled clinical trials, the following adverse reactions have been reported: burning, pruritus, hyperpigmentation, infections and infestations, nasopharyngitis, upper respiratory tract infection, and skin and subcutaneous tissue disorders. Treatment should be limited to 4 weeks. Treatment beyond 2 weeks should be limited to localized lesions of moderate to severe plaque psoriasis that have not sufficiently improved after the initial 2 weeks of treatment with CLOBEX® Spray, 0.05%. CLOBEX® Spray, 0.05%, should not exceed 50 g (59 mL or 2 ﬂ oz) per week. CLOBEX® Spray, 0.05%, is not recommended for use on anyone younger than 18 years of age. Pregnancy Category C. Please see adjacent page for brief summary of Prescribing Information.
Vol. 5, No. 4 FALL 2011 21
(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)
System Organ Class General disorders and administration site conditions Application site atrophy
Application site burning
Application site dryness
Application site irritation
Application site pain
Application site pigmentation changes
Application site pruritus
Infections and infestations Influenza
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. Data on file. Galderma Laboratories. 2. Clobex® Spray Prescribing Information. September 2006. Galderma Laboratories, L.P. 3. Koo JYM. Relevance of the COBRA Trial in current psoriasis practice. Cutis. 2007;80(suppl 5):4-11. 4. 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. © 2011 Galderma Laboratories, L.P. GALDERMA and CLOBEX are registered trademarks. Galderma Laboratories, L.P., 14501 N. Freeway, Fort Worth, TX 76177 CLO-738 Printed in USA 08/11
22 Journal of Dermatology for Physician Assistants
Dermatology Case Report Bullous Pemphigoid By Jennifer R. McCarren, MPA, PA-C and Syed O. Ali, MD
SDPA Members Only Content
Figure 3 Vol. 5, No. 4 FALL 2011 23
SDPA Members Only Content
100 x lgG Bullous Pemphigoid
100 x C3 Bullous Pemphigoid
24 Journal of Dermatology for Physician Assistants
SDPA Members Only Content
Jennifer R. McCarren, MPA, PA-C has practiced dermatology for 10 years and works with Syed O. Ali, MD and Sarah Taylor, MD at D.D. Eisenhower Army Medical Center, Fort Gordon, GA. Syed O. Ali, MD is Chief of Dermatology at D.D. Eisenhower Army Medical Center, Fort Gordon, GA. Dr. Ali is Board Certified by the American Board of Dermatology and is a Diplomate of the American Academy of Dermatology. Vol. 5, No. 4 FALL 2011 25
Dermoscopy Q A
Figure 2 - Image of Figure 1(B) with arrows indicating globules and dashed lines denoting a â€œtieredâ€? arrangement.
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.
John Burns, PA-C is a graduate of the Physician Assistant Program at Louisiana State University Health Science Center Shreveport, Louisiana and completed a fellowship in dermatology at the University of Texas Southwestern Medical Center. He is a Diplomate of the Society of Dermatology Physician Assistants. He presently resides in Frisco, Texas where he works in dermatology with Dr. Eric Weisberg. He has indicated no relationships to disclose relating to the content of this article.
26 Journal of Dermatology for Physician Assistants
PSORIASIS IS A COMPLEX CHRONIC CONDITION
Help manage the flow of recurring plaque psoriasis
Enhance your current regimen with Vitamin D3—a topical treatment that normalizes keratinocyte function to help prevent recurring plaques in mild to moderate plaque psoriasis1-3
Important Safety Information for Vectical® Ointment Vectical® (calcitriol) Ointment 3 mcg/g is a topical treatment for mild to moderate plaque psoriasis in adults 18 years and older. The most frequent adverse events (≥3%) reported in clinical trials were lab test abnormality, urine abnormality, psoriasis, hypercalciuria, pruritus and skin discomfort. Vectical® should be used with caution in patients with known or suspected disturbances in calcium
homeostasis, who are taking calcium or Vitamin D supplements or who are on diuretics. If aberrations in parameters of calcium metabolism occur, discontinue use until these normalize. Caution patients to avoid excessive exposure to natural or artificial sunlight after applying the ointment. Avoid contact with eyes, lips and face. Limit use to 200 grams per week. Please see adjacent page for brief summary of Prescribing Information.
Vol. 5, No. 4 FALL 2011 27
VECTICAL® (calcitriol) OINTMENT, 3 mcg/g
For topical use only. Not for oral, ophthalmic, or intravaginal use. Not to be applied to the eyes, lips, or facial skin. BRIEF SUMMARY INDICATIONS AND USAGE: VECTICAL Ointment is a vitamin D analog indicated for the topical treatment of mild to moderate plaque psoriasis in adults 18 years and older. CONTRAINDICATIONS None WARNINGS AND PRECAUTIONS Effects on Calcium Metabolism In controlled clinical trials with VECTICAL Ointment, among subjects having laboratory monitoring, hypercalcemia was observed in 24% (18/74) of subjects exposed to active drug and in 16% (13/79) of subjects exposed to vehicle. However, the increases in calcium and albumin-adjusted calcium levels were less than 10% above the upper limit of normal. If aberrations in parameters of calcium metabolism occur, treatment should be discontinued until these parameters have normalized. The effects of VECTICAL Ointment on calcium metabolism following treatment durations greater than 52 weeks have not been evaluated. Increased absorption may occur with occlusive use. Ultraviolet Light Exposure Animal data suggest that the vehicle of VECTICAL Ointment may enhance the ability of ultraviolet radiation (UVR) to induce skin tumors. Subjects who apply VECTICAL Ointment to exposed skin should avoid excessive exposure of the treated areas to either natural or artificial sunlight, including tanning booths and sun lamps. Physicians may wish to limit or avoid use of phototherapy in patients who use VECTICAL Ointment. Unevaluated Uses The safety and effectiveness of VECTICAL Ointment in patients with known or suspected disorders of calcium metabolism have not been evaluated. The safety and effectiveness of VECTICAL Ointment in patients with erythrodermic, exfoliative, or pustular psoriasis have not been evaluated. ADVERSE REACTIONS Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Clinical Studies Experience VECTICAL Ointment was studied in two vehicle-controlled studies (419 subjects), and in one open label study (324 subjects). The table below describes exposure to VECTICAL Ointment in 743 subjects, including 239 exposed for 6 months and 116 exposed for one year. Four hundred and nineteen subjects were treated with VECTICAL Ointment twice daily for 8 weeks. The population included subjects ages 13 to 87, males (284) and females (135), Caucasians (372) and non-Caucasians (47); with mild (105) to moderate (313) chronic plaque psoriasis. Selected Adverse Events Occurring in at least 1% of Subjects in the Two Pooled Vehicle-Controlled Studies VECTICAL Ointment Vehicle Ointment (n=419) (n=420) 3% 2% Discomfort skin Pruritus 1% 1% Among subjects having laboratory monitoring, hypercalcemia was observed in 24% (18/74) of subjects exposed to active drug and in 16% (13/79) of subjects exposed to vehicle, however the elevations were less than 10% above the upper limit of normal. The open label study enrolled 324 subjects with psoriasis who were then treated for up to 52 weeks. Adverse events reported at a rate of greater than or equal to 3% of subjects treated with VECTICAL Ointment were lab test abnormality (8%), urine abnormality (4%), psoriasis (4%), hypercalciuria (3%), and pruritus (3%). Kidney stones were reported in 3 subjects and confirmed in two. Postmarketing Experience The following adverse reactions have been identified during worldwide postapproval use of VECTICAL Ointment: acute blistering dermatitis, erythema, pruritus, skin burning sensation, and skin discomfort. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. DRUG INTERACTIONS VECTICAL Ointment should be used with caution in patients receiving medications known to increase the serum calcium level, such as thiazide diuretics. Caution should also be exercised in patients receiving calcium supplements or high doses of vitamin D.
USE IN SPECIFIC POPULATIONS Pregnancy Teratogenic Effects: Pregnancy Category C. VECTICAL Ointment contains calcitriol which has been shown to be fetotoxic. There are no adequate and well-controlled studies for VECTICAL Ointment in pregnant women. VECTICAL Ointment should be used during pregnancy only if the potential benefit to the patient justifies the potential risk to the fetus. Teratogenicity studies with calcitriol were performed in which rats were treated orally at dosages up to 0.9 mcg/kg/day (5.4 mcg/m2/day) and in which rabbits received topical application of calcitriol ointment (3 ppm) to 6.4% of the body surface area. No effects on reproductive or fetal parameters were observed in rats. In rabbits, topically applied calcitriol induced a significantly elevated mean post-implantation loss and an increased incidence of minor skeletal abnormalities due to retarded ossification of the pubic bones. A slightly increased incidence of skeletal variation (extra 13th rib, reduced ossification of epiphyses) was also observed. These effects may have been secondary to maternal toxicity. Based on the recommended human dose and instructions for use, it is not possible to calculate human dose equivalents for animal exposures in these studies. Nursing Mothers It is not known whether calcitriol is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when VECTICAL Ointment is administered to a nursing woman. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric Use Clinical studies of VECTICAL Ointment did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported experience has not identified differences in responses between the elderly and younger patients. OVERDOSAGE Topically applied calcitriol can be absorbed in sufficient amounts to produce systemic effects. NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility When calcitriol was applied topically to mice for up to 24 months, no significant changes in tumor incidence were observed. Concentrations of calcitriol in ointment base of 0 (vehicle control), 0.3, 0.6 and 1.0 ppm were evaluated. A two-year carcinogenicity study was conducted in which calcitriol was orally administered to rats at dosages of approximately 0.005, 0.03, and 0.1 mcg/kg/day (0.03, 0.18, and 0.6 mcg/m2/day, respectively). The incidence of benign pheochromocytomas was significantly increased in female rats. No other significant differences in tumor incidence data were observed. In a study in which albino hairless mice were exposed to both ultra-violet radiation (UVR) and topically applied calcitriol ointment, a reduction in the time required for UVR to induce the formation of skin tumors was observed in all groups that received the ointment base, including the vehicle-treated control group, relative to animals that received no ointment but which were exposed to UVR. The time required for UVR to induce the formation of skin tumors did not differ between animals that received plain vehicle and those that received vehicle that contained calcitriol. Concentrations of calcitriol in ointment base of 0 (vehicle control), 0.3, 0.6 and 1.0 ppm were evaluated. These data suggest that the vehicle of VECTICAL Ointment may enhance the ability of UVR to induce skin tumors. Calcitriol did not elicit genotoxic effects in the mouse lymphoma TK locus assay. Studies in which male and female rats received oral doses of calcitriol of up to 0.6 mcg/kg/day (3.6 mcg/m2/day) indicated no impairment of fertility or general reproductive performance. Based upon the recommended human dose and instructions for use, it is not possible to calculate human dose equivalents for animal exposure in these studies. PATIENT COUNSELING INFORMATION This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects. Patients using VECTICAL Ointment should receive the following information: Instructions for Use This medication is to be used as directed by the physician. It is for external use only. This medication is to be applied only to areas of the skin affected by psoriasis, as directed. It should be gently rubbed into the skin so that no medication remains visible. Adverse Reactions Patients should report any signs of adverse reactions to their physician. Marketed by: GALDERMA LABORATORIES, L.P. Fort Worth, Texas 76177 USA Manufactured by: Galderma Production Canada Inc. Baie d’Urfé, QC, H9X 3S4 Canada Made in Canada.
References: 1. Langner A, Verjans H, Stapór V, Mol M, Fraczykowska M. 1α,25-dihydroxyvitamin D3 (calcitriol) ointment in psoriasis. J Dermatol Treat. 1992;3:177-180. 2. Tanghetti EA. The role of topical vitamin D modulators in psoriasis therapy. J Drugs Dermatol. 2009;8(suppl 8):s4-s8. 3. Data on file. Galderma Laboratories.
28 Journal of Dermatology for Physician Assistants
GALDERMA and Vectical are registered trademarks. P51460-0 Revised: December 2009 © 2011 Galderma Laboratories, L.P. GALDERMA and Vectical are registered trademarks. Galderma Laboratories, L.P. 14501 N. Freeway, Fort Worth, TX 76177 VEC-653 Printed in USA 05/11
Clinical snapshots Erythema Toxicum Neonatorum By Travis Hayden, MPAS, RPA-C
SDPA Members Only Content
A 4 day-old male newborn with white papules surrounded by blotchy, erythematous halos visible on the trunk.
Travis Hayden, MPAS, PA-C practices dermatology with Lesley Loss, MD and John Tu, MD at Dermatology Associates of Rochester, New York. He has indicated no relationships to disclose relating to the content of this article.
Vol. 5, No. 4 FALL 2011 29
The SDPA congratulates all Diplomate Physician Assistants! Alabama Ellen S Burkhalter PA-C / John L Anthony MD Miranda P Frith PA-C / Christopher Harmon MD Alaska Kim Kinnebrew PA-C / Peter G Ehrnstrom MD Carmen TJoens PA-C / Peter G Ehrnstrom MD Arizona Kenan Arkawi PA-C / Helen R Ross MD Jason W Arnett PA-C / Mark Rosenberg MD Michelle A Campbell PA-C / Joseph P Janik MD Rebecca L Caudle PA-C / Keith J Haar MD Lisa Greenan PA-C / Mary Fredenberg MD Melinia J Honjo MPAS, PA-C / Gary A McCraken MD Beth B Lopez MPAS, PA-C / Bogna Nowak MD Katrina R Lynch MPAS, PA-C / Neil Superfon DO John C Rimer PA-C / Keith J Haar MD Yuliya S Schoenling MPAS, PA-C / Catherine P Chen-Tsai MD Annie Sullivan PA-C / Burrell H Wolk MD Francisco J Trejo PA-C / Katherine A Orlick MD Devon N Updegraff-Day PA-C / Bryan Updegraff MD Arkansas Douglas A Clark MPAS, PA-C / Scott M Dinehart MD Joshua F Matthews PA-C / Christopher Schach MD Robert E Stevens PA-C / Eric J Stewart MD California Roger T Bellamy PA-C / Jesse D Mitchell MD Raylene Blandino PA-C / Peter K Webb MD Renee Christenson MPAS, PA-C / Doanld F Richey MD :WPOOF-$MBSL.1"4 1"$-BXSFODF'&JDIFOmFME.% Sandra Diaz PA-C / Philip Lee MD Kasey Drapeau Dâ€™Amato PA-C / Lauren L Reager MD April S Ethridge PA-C / Pamela Broska MD Miriam Gulkar PA-C / Aleksandr Itkin MD (SFH4)BEmFME1"$+BNFT3,BIO.% Christina Hampton PA-C / Ronald R Chappler MD Donna M Hastert PA-C / Randolph Jacobs MD Robert C Higham MPAS, PA-C / Allan Wirtzer MD Mark J Hollis PA-C / Robert J Herten MD Erin M Jensen PA-C / Jeffrey Rebish MD Helene S Jolly MPAS, PA-C / Paul Dean MD Christy L Kerr MPAS, PA-C / Hubert Greenway MD
Jennifer Konior PA-C / Steven E Hodgkin MD Anette J Lecair PA-C / Elissa Gropen MD Steven D Leon PA-C / Jasbir Sandhu MD Melissa S Montes PA-C / Michael Lin MD Brett Moore PA-C / Hubert Greenway MD Michael J Nelms PA-C / Eric Gerstenfeld MD Edward H Parker PA-C / Quan Nguyen MD Heather L Pastor PA-C / Amelia Kaymen MD Robert E Phillips PA-C / Randolph Jacobs MD Daniell B Pollack PA-C / Michelle T Pelle MD Nancy Primo PA-C / Marin H Kay MD Alison L Randall PA-C / Abdallah Khourdaji MD Brian A Reber PA-C / Craig A Kraffert MD James L Reith MPAS, PA-C / David M Lipman MD Jason L Roddick MPAS, PA-C / Robert M Peppercorn MD Mary C Rozelle PA-C / Hayes B Gladstone MD Laura A Rummel PA-C / Michael W Moats MD Pauline Saedler PA-C / Jonathon Baron MD Kerry A Schlosser MPAS, PA-C / Debra B Luftman MD Fariba Seraj PA-C / William J Wickwire MD Nicole R Smith PA-C / Ezra Kest MD Brooke M Stidham PA-C / Edward G Rohaly MD Debra M Stock PA-C / John K Geisse MD Brian C Sutton PA-C / Nahm K Walter MD Gary M Westbrock PA-C / Charles B Fishman MD Doug M Williams PA-C / Bradley Kurgis DO Colorado Joanna Baskett PA-C / John Steinbaugh MD %POOB4#FEEJOHmFME1"$"OUIPOZ5JNLP.% Patrick J Galaska MPAS, PA-C / Larry Cole MD Kim Guthke PA-C / Steven Hong MD John M Hoffstetter PA-C / James V Twede MD Amy J Huber PA-C / Kimberly Stone MD Daniel C King PA-C / Sandra Zila-Eivins MD Brooke W Lewis PA-C / John Steinbaugh MD Catherine W Pacocha PA-C / Diane L Kallgren MD Kristin E Pogue MPAS, PA-C / Mark Gaughan MD Susan L Rancis PA-C / Diane Kallgren MD Angie J Riddleberger PA-C / Steven R Hong MD David J Seitz PA-C / Patrick J Lillis MD Robin Sproule PA-C / Robert C Wright MD ConnecticutĂ¸ Kelly A Christman PA-C / Stuart M Zweibel MD Gail M Fowler PA-C / Andrew V Atton MD Melissa Lemiech PA-C / Rachel A Ivker MD Christopher S Thompson PA-C / Kristen Stewart MD Florida Randy G Banks PA-C / Kevin J Poitras MD Terri A Beck PA-C / David Dorton DO Paula M Brezavscek PA-C / Judith E Crowell MD Elisa D Endicott PA-C / Matthew J Knight MD Terrie Felpeto MPAS, PA-C / Debra Price MD Audrey F Ford PA-C / Amy S Ross MD Richard S Gagnon PA-C / Theodore A Schiff MD Noreen M Godfrey PA-C / Melvin Lu MD
Michelle L Goff PA-C / Steven Proper MD Susan Hammerling PA-C / Ruben Moreno MD Anna Iskandar PA-C / Theodore A Schiff MD Jeffrey N Johnson PA-C / Theodore Schiff MD Christine Kahlbaum PA-C / Daniel Rivlin MD Amanda Kowalski PA-C / Joseph Yohn MD Whitney L Krohn PA-C / Stephen Horwitz MD Mark J Leach MPAS, PA-C / Dwayne Montie DO Gina D Mangin PA-C / Michael Bond MD Lianne R Martin PA-C / Rebecca W Lambert MD Emily B Massey PA-C / Sandra N Hannegan MD Jane C Mast PA-C / James Earhart MD Jane P McKinney PA-C / Robert Skidmore MD Kenneth J Meehan PA-C / E Victor Ross MD Laura Millns PA-C / John Millns MD Beth P Mitchell PA-C / Theodore A Schiff MD Sandra E Montie PA-C / Dwayne Montie MD Eunice Mowery PA-C / Anita Saluja MD Brenda L Oâ€™Hair MPAS, PA-C / William Roth MD Amanda R Parrish PA-C / Robert A Skidmore MD Lindsay A Pelchen PA-C / Jere Mammino DO Miladys S Perez PA-C / Flor Mayoral MD Cynthia Price PA-C / Emily F Arsenault MD Reeli Reinu PA-C / Kevin Spohr DO Tina S Roberts-Smith PA-C / James Taylor MD Megan E Rog PA-C / Jerry L Hedrick MD Karen E Rosochowicz PA-C / Ricahrd Miller MD Rosa M Singleton MPAS, PA-C / Farooq M Lateef MD Allan J Snyder MPAS, PA-C / Bradley Glick DO Elleanor S Swartz PA-C / Christopher Snyder MD Nathaniel A Swartz MPAS, PA-C / J Morgan ODonoghue MD Denise M West MPAS, PA-C / Monica K Bedi MD Thomas Wildes PA-C / Catherine Clayton MD Jennifer K Winkleman PA-C / Russell D Metz MD Rosemary Woolfe PA-C / Adam S Plotkin MD Georgia Jim Adkins PA-C / Yvette A Georhe MD Laura P Bush PA-C / James T Sandwich MD Tomas J Chao MPAS, PA-C / Ji Hyun Ellen Koo MD Jason M Cheyney PA-C / David J Cohen MD Cynthia A Doallas PA-C / Sidney Smith MD Lauren M Fisher PA-C / Ronald Prussick MD Chasity D Geiger PA-C / Edward A DiPreta MD Christi G Gibson PA-C / Michael Sharkey MD
Gloria J Thielking MPAS, PA-C / Vincent Angeloni MD Julie Truman PA-C / Kathi C Madison MD Indiana Andrew Burns PA-C / Lori Swan MD A. Michelle Ferguson PA-C / Jeffrey Sassmannshausen MD Bradley C Hurliman MPAS, PA-C / John Randall MD Christina L Race PA-C / Kenneth W Dawes MD Meredith L Woodard PA-C / C William Hanke MD Kansas Kristin K Bowen PA-C / Frank C Koranda MD Judy Ky PA-C / Christopher Moeller MD Erin E Thornton PA-C / David W Harden MD Kentucky Mitzi L Carter MPAS, PA-C / Sarah M Howell MD Melinda Garrett PA-C / Halden Ford MD Dana N Jennings PA-C / Michael J Crowe MD Louisiana Piper Estep MPAS, PA-C / Chad L Prather MD Amy T Smith MPAS, PA-C / Donna Nunnally MD Amy M Suter PA-C / Elizabeth Long MD Maine Alison J Ravis MPAS, PA-C / Peter H Bouman MD Maryland Jenifer W Abbott PA-C / Howard N Robinson MD Justin G Adrien PA-C / Allan C Harrington MD Rebecca W Bower PA-C / Teri A Kahn MD Beverly D Connolly PA-C / Alan M Gardner MD Christina L Dolinar PA-C / Risa M Jampel MD Benjamin M Farkas PA-C / Howard Robinson MD Monica B Francis PA-C / Debra Coats-Walton MD Amy A Hoffman PA-C / Angela Peterman MD Mary M Hoke PA-C / Robert Berger MD Jayme Kleiner PA-C / David Strobel MD Nicoleta Negoita PA-C / Mark Lowitt MD Tamara B Patterson PA-C / Debra Coats-Walton MD Ed F Peithman PA-C / Kenneth Judd MD Mariella B Purvis PA-C / Maral Skelsey MD Brenda Schneider PA-C / Diane J Orlinsky MD Kristina R Trunnell PA-C / Elizabeth A Liotta MD
Peter B Gray MPAS, PA-C / Ricahrd DeAngelis MD Michael S Kelleher PA-C / Michelle Futral MD Heather Kitchens PA-C / Avis Yount MD Dawn Paletta PA-C / G A Slagel MD Delano Parker PA-C / Michael Sharkey MD Michelle L Reeves PA-C / Lewis R Collins MD Beverly Ringuette PA-C / Jonathan Weiss MD Myrtle H Sanders PA-C / Mark Bonner MD Horace A Saunders MPAS, PA-C / Alexander S Gross MD Christin T Smith MPAS, PA-C / Jason L Smith MD Justin R Smith PA-C / Margaret Kopchick MD Mark M Spatz PA-C / Joshua E Lane MD Wm. Stephen Steiner PA-C / Jonathan S Weiss MD Laurel M Whitmer PA-C / Sylvia W Wright MD
Diane C Williams MPAS, PA-C / Davd F Jaffe MD
Hawaii Dawn K Duff PA-C / Christina J Lyons MD Clifford M Syner PA-C / Bernard Cohen MD
Michigan Matthew Adler PA-C / Howard Lipkin DO Lisa K Bowersox PA-C / Murray A Cotter MD Terenia A Custer PA-C / Brian G Sandler MD Molly R Duiven PA-C / Jack A Dekkinga MD Jason C Evans PA-C / Michael T Siegel MD Jeffry S Freeman PA-C / David Semler MD Adam T Gomoll MPAS, PA-C / Eric Seiger DO Jason C Hui PA-C / Kimball Silverton DO Amber E Kintigh MPAS, PA-C / Jack Dekkinga MD Jessica M MacDougall PA-C / Ann Hern MD Leah M MacMartin MPAS, PA-C / Brian Sandler MD Lisa M Pilley PA-C / Robert Singer MD Mary R Proctor PA-C / Mark Saunders MD Ronald W Reusch PA-C / Jack Dekkinga MD Emily Roberts PA-C / Stephanie Neider MD Thomas D Till PA-C / Donn A LaTour MD/PHD Sheli L Tinkelman PA-C / Barry I Auster MD Kurt J Vander Veen PA-C / Jack A Dekkinga MD Jared P Wilson PA-C / Donn LaTour MD/PHD
Idaho Lura A Brown MPAS, PA-C / Stephen Craig MD Richard A Flygare PA-C / Stephen D Craig MD Brian D Friedt PA-C / Randall Burr MD Ryan McCulloch PA-C / Earl Stoddard MD Kent B Whitaker PA-C / Bradely K Summers MD Illinois Jennifer L Adams MPAS, PA-C / Sheldon S Shore MD Christopher R Arico PA-C / Te-Shao Hsu MD Kristine Bennett PA-C / Fred V Kemp MD Gina C Bird MPAS, PA-C / Lester Fahrner MD Renata Block PA-C / Kevin Pinski MD Karie Hall PA-C / Kenneth B Bielinski MD Bernice Ik-Jang Mi Johnson PA-C / Steven Mandrea MD Amber Kelley PA-C / Debra Babich MD Eric D King PA-C / Jeffrey S Altman MD Jacob A Klaustermeier MPAS, PA-C / Suleman Bangash DO Nicole Luszczyk PA-C / Wendy McFalda DO Jeremy L Medler PA-C / Craig Neitzel MD Erin K Melley PA-C / David A Lorber MD Alison C Monagan MPAS, PA-C / James Herrmann MD Mark E Moran PA-C / John H Exner MD Stephanie L Natyshok PA-C / Ted Van Acker DO Emily A Oehler PA-C / Amy Taub MD Steven M Prus PA-C / Amy Taub MD Dawn C Roman PA-C / Paula K Lapinski MD Leigh A Ruelo MPAS, PA-C / Jeffrey Bakal MD Marilyn J Stombaugh PA-C / George Nahass MD Rex E Stombaugh PA-C / George Nahass MD Judy Valkenburg PA-C / Cheuk W Yung MD Jessica M Weniger PA-C / Donna L Stockton MD Iowa Saundra D Brennan PA-C / Christopher Huerter MD Angela M Buttjer PA-C / Bryan Sands DO Mary Heatley MPAS, PA-C / Bryan D Sands DO Jody K McKee PA-C / Kristi J Robson MD Susan L Rhyan PA-C / Vincent L Angeloni MD
30 Journal of Dermatology for Physician Assistants
Massachusetts Jessica L Bahros PA-C / Ramzi Saad MD Dawn M Baird PA-C / Ronald Nadel MD Stefanie L Delaney PA-C / Robert J Oâ€™Brien MD Bethany Foster PA-C / Glenn Genest MD Darlene M Haviland PA-C / Steven A Franks MD Jennifer L Krasovic PA-C / Christine Kannler MD Blair Maerowitz PA-C / Seth Kates MD Elizabeth J McLeish PA-C / Ramzi Saad MD Heather A Olivieri PA-C / Andrew D Simkin MD Sneha R Patel Campanella MPAS, PA-C / M L Goldaber MD Susan J Salander PA-C / Thomas H Cahn MD
Minnesota Jacalyn J Beiler PA-C / Patrick Carney MD Sheila M Cavallaro MPAS, PA-C / Heidi H Cole Md Heather R Haberman MPAS, PA-C / Cynthia Vehe MD Katherine R Larson PA-C / Patrick S Carney MD Nicole T Manecke PA-C / Paul Lundstrom MD Nadine Miller PA-C / Jaime Davis MD Deborah A Steinbar PA-C / Natalie S Roholt MD/MS Larry D Weidell PA-C / Patrick Carney MD Mississippi Ron F Marascalco MPAS, PA-C / John Marascalco MD Missouri Lindsay Delmont PA-C / Melody L Stone MD Christine B Edwards PA-C / Jeffrey T Reed MD Scott K Maury PA-C / Jacquelyn Garrett MD Montana Peter Bulley PA-C / Philip G Tallman MD
www.dermpa.org/diplomate Nebraska Laura A Fox PA-C / Jennifer H Alberts MD Jacklynn A Kment MPAS, PA-C / Margaret Sutton MD Rebecca A Reinke PA-C / Margaret Sutton MD Michelle R Sitzman MPAS, PA-C / Margaret Sutton MD Nevada Bert E Bonner PA-C / Steven D Peine MD Lisa T Durden PA-C / Dan E Rowe MD Isaac Gier PA-C / Elizabeth Langford DO Daniel B Hickey PA-C / Martin Safko MD John V Notabartolo MPAS, PA-C / Linda Woodson MD Amy R Schoening PA-C / Dan Rowe MD New Hampshire Shari Ashton PA-C / Peter Sands MD John F Chambliss PA-C / Samuel D Goos MD Stacy L Filion PA-C / Robert B Posnick MD Jacqueline A Fournier PA-C / Stephen Del Giudice MD Gale J Furey MPAS, PA-C / David Abels MD Nathan K Hand PA-C / Rafael Pupo MD George H Lewis PA-C / Robert Posnick MD New Jersey Megan Boose PA-C / Daniel S Groisser MD Janet Clarkson PA-C / Frederic R Rothman MD Casey R Croes PA-C / Daniel S Groisser MD Allison R Ginsberg PA-C / Cheryl Fialkoff MD Beth A Hellstern PA-C / Rachel Grossman MD Rachel L LiVecchi PA-C / Steven Kazenoff MD Patricia A McTaggart PA-C / Patricia C McCormack MD Donna Naranjo PA-C / Amy S Pappert MD Kimberly A Newhook PA-C / Warren Kurnick MD Lauralee M Pakozdi PA-C / Lisa M Coppa Breslauer MD Terri Raymond PA-C / Hirshel Kahn MD Jenna Rogers MPAS, PA-C / Christine A Papa DO Matthew F Rossano PA-C / Ricahrd Urbanek MD Avraham Sokoloff PA-C / Joseph G Tuchman MD Gerard W Stroup PA-C / Thomas Burke DO "OUPOFMMB'7JUFSCP1"$+VMJBOOF),VnJL.% Lauren A Vitolo PA-C / Brian C Machler MD Sarah Wasser PA-C / Mathias Zemel MD Jennifer Zimbalist MPAS, PA-C / David A Wrone MD
New York Dawn M Barilli PA-C / Joseph Tuchman MD Nicole J Cassara PA-C / Joseph Onorato MD Tania D Cohen MPAS, PA-C / Cindy Hoffman DO Maria A DeRosa PA-C / Joseph M Wojciechowski MD Magda A DeSimone PA-C / Dennis Gross MD Elizabeth M Femenia PA-C / Jeffrey A Sklar MD Ari J Fisher PA-C / Robert G Shoss MD Patrick A Franck PA-C / Steven Resnick MD Travis M Hayden MPAS, PA-C / John Tu MD Susan B Hirsch PA-C / Mary R Buchness MD Kelly T Joyce PA-C / Nathalie C Zeitouni MD Karl Kruszynski PA-C / Marie-Louise Johnson MD/PHD Gary A Levine PA-C / Patricia McCormack MD Sandra S Mamis PA-C / Henry Greenblatt MD Mary Ann Pelzer PA-C / Jordan S Zuckerman MD Marianne Pistilli PA-C / Bruce E Katz MD Kathy Ray PA-C / Jerome C Hill MD Michele Rodriguez PA-C / Pamela J Basuk MD Allison C Santhouse PA-C / H Debra Jaliman MD Erica Scarrone PA-C / Sourab Choudhury DO Kurt H Schroeder PA-C / Kenneth Kircher DO Timothy P Smith PA-C / Stephen E Presser MD Melissa A Spencer-Winker PA-C / David J Altman MD/PHD Anna Stassiy PA-C / Josiane S Lederman MD Jamie Sturm PA-C / Stephen Presser MD Fiona Sukhnandan PA-C / Eric J Fryer MD Michelle Tagliaferri PA-C / Vincent Vaccaro MD Nicole Tardio MPAS, PA-C / Theodore J Daly MD Gretchen E Thorner PA-C / Michael E Eidelman MD Amanda Tirado PA-C / Alexander Doctoroff DO North Carolina Clifford Amos PA-C / Dennis C Polley DO Melinda R Asfaw PA-C / Jean Kois MD Timothy August PA-C / Curren Custer MD English B Black PA-C / Beth Goldstein MD Katherine C Caggiano MPAS, PA-C / David S Whittaker MD Anne T Casperson PA-C / David T DeVries MD Adele Clark PA-C / Alan B Fleischer MD Samantha B Conner PA-C / Amy E Devore MD David J Dorenfeld PA-C / John H Reid MD Joanne Erickson PA-C / Christopher A Snyder MD Allen J Gifford PA-C / Russell P Hall MD Debbie A Hauser PA-C / Christine Yuengel-Bienenfeld MD Adina Kulcsar PA-C / Stephen Scheibner MD Catherine A Pollard MPAS, PA-C / Sean J Murphy DO Della Sue Reynolds MPAS, PA-C / Daniel Zivony MD Victoria F Rhodes PA-C / Dan M Henshaw MD Angela F Richardson PA-C / Navjeet Sidhu-Malik MD Kimberly H Rikard PA-C / James Polo MD Michael E Sabol PA-C / Dennis C Polley DO Charlene M Snyder PA-C / Jonathan Crane DO Sharon M Swartz PA-C / Jennifer L Vesper MD .JDIBFM%8BMLFS1"$8FTMFZ3)BXmFME.% Elyshia M Warden MPAS, PA-C / Stuart O Tafeen MD Sallie S White PA-C / Paul J Kostuchenko MD
North Dakota Erin C Hegge PA-C / David Flach MD Judy L Reese PA-C / David Flach MD Brooke K Schmidt MPAS, PA-C / Thomas J Matzke MD Ohio Debra L Babcock PA-C / Cynthia Halcin MD Michelle E Bodie PA-C / Thomas E Fleming MD Meghan Haley PA-C / Hope Mitchell MD Shannon K Hammond PA-C / Christy Lorton MD Amy M Lauer MPAS, PA-C / Brian B Adams MD April M Lopez PA-C / Eugene Conte DO Nina N Rettig PA-C / Mounir Boutros MD Sherri L Whitcomb PA-C / Christy Lorton MD Randy R Bluethman PA-C / Craig L Abbott MD Tara D Linville PA-C / John Ashley MD Oregon Holly B Chandler PA-C / Beata L Rydzik MD Teresa L George PA-C / Michael Goodenberger MD Laurie A Leece PA-C / Todd Knapp MD Jason C Ling PA-C / William Lear MD Kris J Miller MPAS, PA-C / Gregory C Richterich MD Lucy M Nusrala PA-C / Cynthia A Dreyer MD Amy J Simpson PA-C / Phoebe Rich MD Nathan B Smith PA-C / Cynthia A Dreyer MD Mark D Williams PA-C / John Young MD Pennsylvania Desiree A Antonacci PA-C / Bruce A Brod MD +PDFMZO.$POmOP1"$3PDIFMMF8FJTT.% Erin M Doherty PA-C / Lisa W Hostetler MD Greg S Forsyth MPAS, PA-C / Ira J Berman MD Chantelle Gastinger PA-C / Scott Gottlieb MD Richard D Graper PA-C / Jeffrey Weaver DO Kristen M Grippe PA-C / David Benjamin MD Savy Guthrie PA-C / Daniel Kessel MD Dayna L Hrovath PA-C / Amy Norton MD Abby A Jacobson PA-C / Bruce Brod MD Amy L Jones PA-C / Jonathan T Wolfe MD Katie B Joshi PA-C / Grace Lee MD Nicole A Koci MPAS, PA-C / Jean Braun MD Sarah J Kudelko PA-C / Patrick Shannon MD Gina B Kuloszewski PA-C / Joanne S Zenker MD Barbara A Lozada PA-C / Joanne S Zenker MD
Lucia Y Martin MPAS, PA-C / Christine S Stanko MD Jason D Oberdick PA-C / George J Francis MD Laurie A Powell-Isenberg PA-C / Jane E Rowe DO Noel M Prevost PA-C / Joseph English MD Michelle D Ramsberger PA-C / David Vasily MD Maria H Ressler PA-C / Rebecca Caserio MD Ashley R Serena PA-C / Robin B Scheiner MD Caitlyn W Smith PA-C / Kimberly A Rau MD Carly R Soda PA-C / Daniel I Shrager MD Barbara S Stein PA-C / Mark A Marsili MD/PHD Jil K Swanson PA-C / Justin J Vujevich MD Debora M Szafran PA-C / Jonathan Wolfe MD Kimberly A Tacconi PA-C / Susan J Kucirka MD Jessica Wackowski PA-C / Laura Ferris MD Lauren R Zajac MPAS, PA-C / David A Amato DO Rhode Island Graciette DaSilva PA-C / Gwenn M Vittimberga MD Stefanie A Goodrich MPAS, PA-C / Seth Kates MD Mark A Trott PA-C / Raymond H Welch MD South Carolina Allyson N Cook PA-C / Peter J Neidenbach MD Michelle L Evans PA-C / Jeffrey Smith MD April M McNeill PA-C / Jim Chow MD Michael D Overcash PA-C / Hudson Rogers MD Rebecca K Repaire PA-C / Todd E Schlesinger MD Edward R Reynolds PA-C / Phillip L Latham MD Vicki S Roberts PA-C / Jeffrey K Smith MD Thy Tran PA-C / Donald L Baxter MD South Dakota Sylvia D Shafer PA-C / Marc E Boddicker MD Tennessee Laura S Bauer PA-C / Julie Pena MD Tammie M Campanali PA-C / Christopher W Robb MD Deedra Garrison PA-C / Robert P Unkefer MD Jennifer H Hall PA-C / Michael W Bell MD Angela M Heikes PA-C / Ronald Nelson MD Andrew W Hull PA-C / Robert Clemons MD Daniel L Kachelmyer PA-C / Julie M Pena MD Waynette M Kingman PA-C / Robert P Unkefer MD Ashley C Messick PA-C / Ken Takegami MD Darrell R Millsap PA-C / James P Rash MD Kathrin K Nunes PA-C / Samuel L Banks MD Marcia M Starns MPAS, PA-C / James E Turner MD/PHD Melissa K Taylor PA-C / Paul M Benson MD Amanda C Wilks PA-C / Edward J Primka III MD Matthew Wilks PA-C / Edward J Primka III MD Texas Piipar S Allen PA-C / Christopher R Jones MD Christina L Bailey MPAS, PA-C / Kent Aftergut MD Ami P Bhattacharya MPAS, PA-C / Bryan Selkin MD Michael E Booth MPAS, PA-C / Vicente Quintero MD Joseph L Capasso PA-C / Dina V Grice MD Cathleen Y Chidester PA-C / Ronald E Grimwood MD
Jennifer M Conner MPAS, PA-C / Paula S Vogel MD Heidi B Cook PA-C / Forrest C Brown MD Jennifer M Felan PA-C / Robert L Chappel MD Carol Fields PA-C / Richard A Keller MD Bethany L Grubb MPAS, PA-C / Kent Aftergut MD Sheryl L Gyr MPAS, PA-C / Mark Ray MD April L Harrison PA-C / Suzanne Bruce MD Lindsay A Hayler PA-C / Shelley Sekula-Gibbs MD Jill H Hude Ray PA-C / Dana Jeng MD Alana L Isaacks PA-C / Anh Nguyen MD Jennifer J Jordan PA-C / Eric Weisberg MD Beth B Jouett PA-C / Angela Bowers-Plott MD Kristine Kucera MPAS, PA-C / Kelly Warren MD Mui Lee PA-C / Don King MD Denise Marquez PA-C / Lucile E White MD Allison L Martin PA-C / Vincent Quintero MD Eryn M McIntyre PA-C / Colby Evans MD Rachel L Miller PA-C / R JR J Fox MD Lisa Moody PA-C / Jeannine K Hoang MD Robert Morron PA-C / Michael Simpson MD Gabriel R Nanagas PA-C / Micahel McGuiness MD Erin M Nulf PA-C / Forrest C Brown MD Kristie Obranovich PA-C / Lisa Rhodes MD Lisa M Ostrowski PA-C / Milton G Mullanax MD Robin M Person PA-C / Ronald Smits MD Michelle B Purtle PA-C / Steven Smith MD Diana Reyes PA-C / Michael McGuiness MD Katie C Rose PA-C / Forrest Brown MD Amy Rossiter PA-C / Marie F Mack MD Gilbert Saenz III PA-C / Matthew Smetanick DO Jennifer K Scheiderich PA-C / Lori D Stetler MD Toni Smith PA-C / Sherry N Ingraham MD Wendy A Thompson MPAS, PA-C / Michael L Sonabend MD Cynthia J Trickett PA-C / Danny K McCoy MD Ray C Vaughn MPAS, PA-C / Isaac Perez MD Joleen M Volz MPAS, PA-C / Alan Menter MD Laura Watson PA-C / Ponciano Cruz MD Teresa M Willis PA-C / Scott D Miller MD Amanda C Ziegeweid PA-C / Ponciano Cruz MD Utah Stephen T Anderson PA-C / Cheryl Lee Eberting MD Lynn A Birrell MPAS, PA-C / C D Hansen MD Keri L Holyoak PA-C MPH / Joseph Jensen MD
Mark A Hyde PA-C / Glen Bowen MD Erik S Zenger MPAS, PA-C / Ricahrd A Stone MD Vermont Phoebe E Pelkey MPAS, PA-C / Mitchell Schwartz MD Virginia Rathi Blankenship PA-C / Donna M Corvette MD Aileen P Cassidy PA-C / John F Oâ€™Neill MD Kevin K Charles PA-C / Steven D Cronquist MD Sarah J Donovan PA-C / Theodore S Sebastien MD Cynthia Ferguson PA-C / Antoinette F Hood MD Lauran R Glover PA-C / Leslie R Coker MD Rana M Hassan PA-C / Sherry Maragh MD Nicole Keeter PA-C / Martin Braun MD Katherine L Riley MPAS, PA-C / Theodore Sebastien MD Cecilia D Ross PA-C / Frances Rotter MD Melissa A Veneracion PA-C / A Howland Hartley MD Amanda M Waggoner MPAS, PA-C / David M Pariser MD Stacy J Williams PA-C / An Yen MD Lori L Wood PA-C / Donna Corvette MD Washington Scott B Ahrndt PA-C / Joel K Sears MD William R Bies PA-C / Eric O Rasmussen MD Stacey L Bryant PA-C / Walter L Williams MD Christine V Carpenter PA-C / Robert B Hopp MD Jennifer Cozart PA-C / James L Brazil MD Jonathan D Cyphers PA-C / Elie Levy MD Susan C Duffy PA-C / Jessica H Kim MD Jeanne M Ellern PA-C / Curtis D Henderson MD Gina M Fragione PA-C / Nicole Kageyama MD James L Garcia PA-C / WM P Werschler MD Shane A Keck PA-C / Julie E Voss MD Megan E Landis Ferestien PA-C / John L Headley MD Lisa V Miner PA-C / Julie E Voss MD Carolyn L Oâ€™Brien PA-C / Jessica H Kim MD Corey R Richardson MPAS, PA-C / Zhen Qian MD Kurt Schlecht PA-C / Elizabeth V Seiverling MD David Sprouse PA-C / Maureen A Mooney MD Heidi A Tate PA-C / Robert B Hopp MD Jennifer E Winter PA-C / John M Bauer MD West Virginia Johnathan M Pierson MPAS, PA-C / Thomas M Karrs MD Wisconsin Gregory D Buttolph MPAS, PA-C / Karl R Noll MD Nicholas P Grimm PA-C / Katz Kenneth MD Kurt S Holst PA-C / Paul M Stover MD Mary E Peeters PA-C / Michael J White MD Michelle L Thomas PA-C / Theresa Behrs MD Brittany Zimmerman PA-C / Marguerite R Compton MD
Vol. 5, No. 4 FALL 2011 31
Drugs in Dermatology An Update on the Management of Cicatricial Alopecia with a Focus on PPARÎł Agonists By Adriana N. Schmidt, MD and Vera H. Price, MD
SDPA Members Only Content
Table Lymphocyte-predominant Disorders Figure 1
Lichen planopilaris Frontal fibrosing alopecia Central centrifugal alopecia Pseudopelade (Brocq) Neutrophil-predominant Disorders Folliculitis decalvans Tufted folliculitis
32 Journal of Dermatology for Physician Assistants
SDPA Members Only Content
Adriana N. Schmidt, MD is a board-certified dermatologist working in private practice in Santa Monica, California. She completed her medical doctorate and advanced dermatology residency training at Vanderbilt University after receiving her Bachelors of Arts degree at Brown University, where she graduated magna cum laude. Dr. Schmidt is a member of the American Academy of Dermatology, the Womens Dermatologic Society, and the North American Hair Research Society. Vera H. Price, MD has served as a Director of the American Academy of Dermatology (AAD) and is a consultant to the Academy. She is the co-founder of the National Alopecia Areata Foundation and the Cicatricial Alopecia Research Foundation. She is also founding member and past President of the North American Hair Research Society. The years she spent at the Western Regional Research Laboratory studying human hair with the wool chemists led her to her expertise and subspecialty in hair. She has described several new hair disorders.
Journal of Dermatology for Physician Assistants
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Contact us at: Editor@jdpa.org Vol. 5, No. 4 FALL 2011 33
Beyond the Ellipse... What do I do now? By Duke Ballard, PA
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.
34 Journal of Dermatology for Physician Assistants
SDPA Members Only Content
Duke Ballard, PA has practiced dermatology for 11 years and works with John Chung, MD who is a board certified dermatologist and fellowship-trained Mohs surgeon.
Vol. 5, No. 4 FALL 2011 35
A New Implement in the Tool Belt Modified Vertical Mattress Suture By Mark Hyde, MMS, PA-C
To learn more about the modified vertical mattress suture and to see how it is performed, please visit dermcast.tv. (www.dermcast.tv/surgical-procedures-coe-mcgrath)
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.
36 Journal of Dermatology for Physician Assistants
Vol. 5, No. 4 FALL 2011 37
38 Journal of Dermatology for Physician Assistants
Understanding Self-Tanning Preparations By Zoe Diana Draelos, MD
Vol. 5, No. 4 FALL 2011 39
SDPA Members Only Content
Zoe Diana Draelos, MD, is a practicing board-certified dermatologist and a Fellow of the American Academy of Dermatology with a research interest in cosmetics, toiletries, and biologically active skin medications. She is in solo private practice in High Point, North Carolina, and a Consulting Professor of Dermatology at Duke University. In 1988, she founded Dermatology Consulting Services to provide education, develop formulations, and conduct clinical studies in association with industry. Prior to pursuing a medical career, Dr. Draelos completed an undergraduate degree in Mechanical Engineering and was elected a Rhodes Scholar. A member of Sigma Xi research honorary and Alpha Omega Alpha medical honorary, she is author of the textbooks Cosmetics in Dermatology and Hair Cosmetics, as well as the editor of Cosmeceuticals, now in its second edition and translated into 5 languages. She has contributed chapters to 32 textbooks, served as the principle investigator on 274 studies, and written 270 published papers and she currently serves on 8 journal editorial boards, functions as the editor-in-chief of the Journal of Cosmetic Dermatology, and is a past member of the Board of Directors of the American Academy of Dermatology and the American Society for Dermatologic Surgery. She is Vice-President Elect of the American Academy of Dermatology. She received a lifetime achievement award from Health Beauty America for her research and the 2008 DermArts award for her contributions to dermatology. In 2010, she received the Albert Kligman Innovation Award.
40 Journal of Dermatology for Physician Assistants
Cosmetic pearls The Role of Cosmetic Interventions in Helping to Improve Patientsâ€™ Self-Images SDPA Members Only Content
Vol. 5, No. 4 FALL 2011 41
Dermatology Billing & Coding
New ICD-9 Code Changes in Effect as of October 1, 2011 By Inga Ellzey, MPA, RHIA, CDC
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: firstname.lastname@example.org.
42 Journal of Dermatology for Physician Assistants
When it comes to fine facial wrinkles and hyperpigmentation,
Refissa meets her needs ®
The only tretinoin that is: • 0.05% concentration for effective strength • Emollient base for gentle hydration • Fragrance-free formulation to reduce the potential for allergic reactions
Important Safety Information: Refissa 0.05% is indicated as an adjunctive agent for mitigation (palliation) of fine facial wrinkles, mottled hyperpigmentation, and tactile roughness in patients who use a comprehensive skin care and sunlight-avoidance program (including sunscreen). Refissa does not eliminate wrinkles, repair sun-damaged skin, reverse photoaging, or restore more youthful or younger skin. Do not use if the patient is taking drugs known to be photosensitizers, pregnant, attempting pregnancy, or nursing. Refissa, early in treatment, may cause redness, itching, burning, stinging, and peeling. If the degree of irritation warrants, patients should be advised to use less medication and decrease the frequency of application. If still significant, patient should be advised to discontinue use. Please see reverse for brief summary of full prescribing information.
Reﬁ 40g / ssa 0.05 % Use a s dire cted 2 reﬁ lls
Contact a CORIA® representative for samples, or call customer service at 1-800-556-1937 Vol. 5, No. 4 FALL 2011 43
Output @ 100% Giant Creative Strategy 260665gi301DPA_PI
Fine facial wrinkles and hyperpigmentation were scored at baseline and at Week 24 by the investigator using a 10-point scale on which 0 represents no damage, 2-3=mild, 4-5=moderate, 6-7=moderate/ severe and 8-9=severe. The change was calculated as baseline minus the Week 24 evaluations.* ++ Please note: The clinical data in the package insert are from Ortho Dermatologics original clinical trials for Renova® 0.05% as required for FDA approval. *Data on File, CORIA Pharmaceuticals. CONTRAINDICATIONS This drug is contraindicated in individuals with a history of sensitivity reactions to any of its components. It should be discontinued if hypersensitivity to any of its ingredients is noted. WARNINGS TRETINOIN CREAM, USP (EMOLLIENT) is a dermal irritant, and the results of continued irritation of the skin for greater than 48 weeks in chronic, long term use are not known. Safety and effectiveness of TRETINOIN CREAM, USP (EMOLLIENT) in individuals with moderately or heavily pigmented skin have not been established. Refissa® [TRETINOIN CREAM, USP (EMOLLIENT)] should not be administered if the patient is also taking drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of augmented phototoxicity. Because of heightened burning susceptibility, exposure to sunlight (including sunlamps) should be avoided or minimized during use of Refissa®. Patients must be warned to use sunscreens (minimum of SPF of 15) and protective clothing when using Refissa®. Patients
ADVERSE REACTIONS (See WARNINGS and PRECAUTIONS sections.) Local reactions such as peeling, dry skin, burning, stinging, erythema, and pruritus were reported by almost all subjects during therapy. These signs and symptoms were usually of mild to moderate severity and generally occurred early in therapy. OVERDOSAGE Application of larger amounts of medication than recommended has not been shown to lead to more rapid or better results, and marked redness, peeling, or discomfort may occur. Oral ingestion of the drug may lead to the same side effects as those associated with excessive oral intake of Vitamin A. DOSAGE AND ADMINISTRATION Refissa® [TRETINOIN CREAM, USP (EMOLLIENT)] should be applied to the face once a day before retiring using only enough to cover the entire affected area lightly. Patients should gently wash their face with a mild soap, pat the skin dry, and wait 20 to 30 minutes before applying. The patient should apply a pea-sized amount of cream to cover the entire face lightly. Special caution should be taken when applying the cream to avoid the eyes, ears, nostrils, and mouth. With discontinuation of therapy, a majority of patients will lose most mitigating effects on fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin; however, the safety and effectiveness of using TRETINOIN CREAM, USP (EMOLLIENT) daily for greater than 48 weeks have not been established. Manufactured by DPT Laboratories, San Antonio, TX 78215 Distributed by CORIA Laboratories, a division of Valeant Pharmaceuticals North America, Fort Worth, TX 76107 (800-321-4576) Refissa is a registered trademark of Spear Pharmaceuticals, Inc. Renova® is a registered trademark of Ortho Dermatologics, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Reﬁssa ® [Tretinoin Cream, USP (Emollient) 0.05%] Brief Summary of Full Prescribing Information DESCRIPTION Tretinoin is available as Refissa® [Tretinoin Cream, USP (Emollient)] at a concentration of 0.05% w/w in a water-in-oil emulsion formulation consisting of light mineral oil, sorbitol solution, hydroxyoctacosanyl hydroxystearate; methoxy PEG-22/dodecyl glycol copolymer, PEG45/dodecyl glycol copolymer, stearoxytrimethylsilane and stearyl alcohol, dimethicone 50 cs, methylparaben, edetate disodium, propylparaben, butylated hydroxytoluene, citric acid monohydrate, and purified water. INDICATIONS AND USAGE Refissa® is indicated as an adjunctive agent for use in the mitigation (palliation) of fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin in patients who do not achieve such palliation using comprehensive skin care and sun avoidance programs alone. Neither the safety nor the effectiveness of Tretinoin Cream, USP (Emollient) for the prevention or treatment of actinic keratoses or skin neoplasms has been established. (Please see third bullet point in this section of the full prescribing information for additional populations in which effectiveness has not been established.) Refissa® DOES NOT ELIMINATE WRINKLES, REPAIR SUN DAMAGED SKIN, REVERSE PHOTO-AGING, or RESTORE A MORE YOUTHFUL or YOUNGER DERMAL HISTOLOGIC PATTERN. Refissa® should only be used under medical supervision as an adjunct to a comprehensive skin care and sun avoidance program that includes the use of effective sunscreens (minimum SPF of 15) and protective clothing when desired results on fi ne wrinkles, mottled hyperpigmentation, and roughness of facial skin have not been achieved with a comprehensive skin care and sun avoidance program alone. Neither the safety nor the efficacy of using TRETINOIN CREAM, USP (EMOLLIENT) daily for greater than 48 weeks has been established, and daily use beyond 48 weeks has not been systematically and histologically investigated in adequate and well-controlled trials. CLINICAL TRIALS DATA The Spear Refissa® bioequivalence 6-month study of 382 patients revealed Refissa® and Renova® 0.05% products are bioequivalent.++ In effect, Refissa® and Renova® 0.05% demonstrated no statistical difference from one another, neither product being superior to the other, but both proved superior to placebo. Refissa® Results: Improvement No Improvement Fine Facial Wrinkles 71% 29% Mottled Hyperpigmentation 83% 17%
with sunburn should be advised not to use until fully recovered. Patients who may have considerable sun exposure due to their occupation and those patients with inherent sensitivity to sunlight should exercise particular caution when using and assure that the precautions outlined in the Patient Package Insert are observed. Refissa® should be kept out of the eyes, mouth, angles of the nose, and mucous membranes. Topical use may cause severe local erythema, pruritus, burning, stinging, and peeling at the site of application. If the degree of local irritation warrants, patients should be directed to use less medication, decrease the frequency of application, discontinue use temporarily or discontinue use altogether. Tretinoin has been reported to cause severe irritation on eczematous skin and should be used only with utmost caution in patients with this condition. PRECAUTIONS General: If a drug sensitivity, chemical irritation, or a systemic adverse reaction develops, use should be discontinued. Drug Interactions: Concomitant topical medication, medicated or abrasive soaps, shampoos, cleansers, cosmetics with a strong drying effect, products with high concentration of alcohol, astringents, spices or lime, permanent wave solutions, electrolysis, hair depilatories or waxes, and products that may irritate the skin should be used with caution in patients being treated because they may increase irritation with use. Refissa® should not be administered if the patient is also taking drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of augmented phototoxicity. Carcinogenesis, Mutagenesis, Impairment of Fertility There was no evidence of carcinogenic potential when tretinoin was administered topically at a dose 5 times the average recommended human topical clinical dose. The mutagenic potential of tretinoin was valuated in the Ames assay and in the in vivo mouse micronucleus assay, both of which were negative. Pregnancy: Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. Refissa® should not be used during pregnancy. Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when administered to nursing women. Pediatric Use: Safety and effectiveness in patients less than 18 years of age have not been established. Geriatric Use: Safety and effectiveness in individuals older than 50 years of age have not been established.
© 2010 CORIA Laboratories REF-0610-0004
44 Journal of Dermatology for Physician Assistants
SDPA Members Only Content
Vol. 5, No. 4 FALL 2011 45
SDPA Members Only Content
46 Journal of Dermatology for Physician Assistants
Judicial and Ethical Affairs Research Ethics: Ghostwriting By Karen Scully, MD, FRCPC, MA Ethics
SDPA Members Only Content
Karen Scully is a board-certified dermatologist in the United States and Canada. She had a private practice in the Toronto area for many years and then accepted a teaching position at the Johns Hopkins Medical Institutions where she practiced and taught dermatology residents and medical students. More recently she moved to Charlotte, North Carolina and completed a Masterâ€™s Degree in Ethics and Applied Philosophy at the University North Carolina at Charlotte.
Vol. 5, No. 4 FALL 2011 47
To commemorate the 30th anniversary of the original publication of “Bad Blood: The Tuskegee Syphilis Experiment,” the Wake Forest University Center for Bioethics, Health, & Society presents a conference, Research Ethics: Re-examining Key Concerns, to promote reflection and discussion of critical issues in research ethics. The conference will be held November 10 & 11, 2011. To learn more about the conference or to register, please visit: http://bioethics.wfu.edu/ and click on “Research Ethics Conference.”
If you have an ethical dilemma that you have encountered or a topic that you would like discussed, please pass it along to: Editor@jdpa.org
Notes from your Office Manager Promoting Communication Between Referring and Consulting Providers 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.
48 Journal of Dermatology for Physician Assistants
Outside & Inside the 9 to 5...
How did you become involved with the SDPA? In my other position, as the SDPA’s Industry Relations Shortly after PA school, having been involved as a student Committee Chair, it has been rewarding working with leader with the PA student society from 1997 to 1999, I the pharmaceutical industry and cultivating longfelt it was important to give back to the profession I was term relationships with these industry partners. This about to enter. Since I was heading into dermatology, relationship has also changed over the years. The it only made sense that I join the SDPA. pharmaceutical industry has recently taken Shortly after becoming a member in 1999 on many restrictions. What used to be a (there were only a few hundred members fairly streamlined process has become at that time), I started working on the SDPA’s more cumbersome to obtain support for database, provided clerical assistance for the Society and our projects. However, the Society, and was involved in the early having built long-term relationships with development of our SDPA web page. In individuals within the industry has benefited 2004 I was elected to the Board of Directors the Society tremendously. As a result of these key industry relations, we have been (BOD) as a Director at Large and in January 2005 became the liaison to the AAD for the able to find funding for our projects and AAPA (a position I still enjoy holding today). meetings. This has really helped the SDPA I then had the honor of serving as SDPA Robert Higham, MPAS, PA-C stay on a strong financial footing. President-Elect, President, and Immediate Past President, July 2006 through July 2009. After serving What is your favorite SDPA position to date? the SDPA as President, in 2009 I was appointed Chair of As I had mentioned earlier, I really enjoy being liaison the Industry Relations Committee. to the AAD, but I also enjoyed my time as President of the Society because I was able to leave the organization What about your current positions are the most better than when I started. I was able to assist with the rewarding? upgrade of our corporate identity and branding and In regards to the position I currently hold for the AAPA, launch some exciting projects, including Dermcast.tv. It serving as liaison to the AAD, the relationships and the has been fun to watch that project continue to grow. continued interactions with the AAD have been both the most challenging and the most rewarding. The What part of working with Dermcast.tv is the most SDPA’s relationship with the AAD has been a decade plus rewarding? courtship. What started as an adversarial, “we don’t want Dermcast.tv really has been a labor of love. It is a project to talk with you,” type of relationship has blossomed into we developed internally and were really ahead of our a relationship in which we now enjoy an open dialogue time. I always felt strongly that new media including the and communication with the elected leaders and staff web, video, and podcasts were going to be a big part of the AAD. I think this will be the kind of thing that I look of our Society. In the beginning, some thought that the back on my career and think, “Wow, that was a real help.” idea was crazy. But looking back now I can’t imagine Being able to be in this position for so long and build key our Society without it. The amount of information and relationships has helped our Society move a long way education that is free to our members, or anyone who forward. It has been neat to see where we started with wants to subscribe to the Dermcast.tv podcasts, is the AAD in 1999 and where our relationship is now; the remarkable. This is something very unique that is not difference is really night and day. I am looking forward being done in any other PA specialty to the degree that to seeing what is ahead for both organizations, because Dermcast.tv is doing it. we are going to do great work together. Vol. 5, No. 4 FALL 2011 49
We recently had the pleasure of interviewing Robert Higham, MPAS, PA-C, a former SDPA President and current SDPA Industry Relations Committee Chair and AAPA liaison to the AAD. Robert has been a dermatology PA for thirteen years and currently practices at Mid Valley Dermatology and Cosmetic Surgery Center in Sherman Oaks, CA . In 2008, serving as SDPA Immediate Past President, Robert formally presented the Dermcast.tv project to the SDPA Board of Directors. Since the inception of Dermcast.tv, Robert has enjoyed serving as the primary host and interviewer for the programming as well as helping to develop content and topics. Robert shares with us now his thoughts regarding his work with the SDPA, what he sees for the future of Dermcast.tv, and how SDPA members can take advantage of this wonderful educational program.
What do you hear most from SDPA members relating to Dermcast.tv? I hear quite often how people cannot believe they haven’t been plugged into the podcasts sooner and what a great way it is to learn. People frequently comment that the video and audio podcasts are very beneficial to their practice of dermatology, to their practice as PAs, and even to things unrelated to medicine that they may be involved in (such as lobbying or advocacy issues). What I hear most from people is, “I don’t understand why it has taken me so long to get on board with Dermcast.tv and the podcasts.” My favorite bit of advice for dermatology PAs using Dermcast.tv is… I would advise spending some time listening to old podcasts, especially some of the historical ones about the Society. Learn about our Society. Go back to some of the early podcasts and early videos from our SDPA conferences starting in 2008. Everything since then is still available online. See where we were then compared to where we are now. I think some people will be amazed to see the growth of the SDPA in just the past three years. What is the greatest challenge of working with Dermcast.tv? Coming up with new ideas is challenging and we are trying to work on different angles, subjects to interview, scenarios, situations, and articles and videos of interest. The exciting thing is that there is always something new. We enjoy working with different organizations on joint video and audio podcasts to bring issues to PAs across the nation, even those outside of our Society. If I only knew then what I know now… The difficulty of recruiting additional volunteers to serve as hosts for Dermcast.tv is one thing I never anticipated. I started as the primary host and interviewer, and we have had some great people along the way come onboard to help out, but it has taken a bit longer to get people comfortable and familiar with the process. There have been some great members who have stepped up along the way to be a host, interviewer, or the voice for Dermcast.tv. This has been fun to see. People may be surprised to know… I have no formal training in interviewing, videography, producing podcasts, or any of the technical aspects relating to Dermcast.tv. This is something I have learned along the way. The SDPA has a great communications team that supports the project and has coached me in terms of conducting interviews, but this is not my full time job. It is something I enjoy doing as a volunteer for the SDPA that is completely part-time. 50 Journal of Dermatology for Physician Assistants
What is your greatest source of inspiration? In terms of Dermcast.tv. - Charlie Rose (ha ha). Dermcast.tv needs more… We need more ideas for content. I chuckle when I see Mike Rowe, host of the Discovery channel’s show Dirty Jobs, asking for ideas; we need ideas too. We are happy to explore topics and see if it is something we can put together. Topics could relate to something members want to know about the SDPA, about being a dermatology PA, or about the larger PA community as a whole. Let us know your ideas and we will see if we can make it happen (email content ideas to sdpa@dermpa. org). What are some of your favorite Dermcast.tv podcasts or interviews? Some of my favorite audio podcasts are those from our most recent meetings. I live in Los Angeles and as you can imagine, have a fair amount of traffic to contest with - it is a good forty-five minute commute to and from my office. What is amazing is that is the average length of time for most Dermcast.tv audio podcasts. Before I leave for work in the morning, I just pick a few of the latest podcasts I haven’t listened to yet and enjoy them during my daily commute. In terms of my favorite Dermcast.tv interviews, those would have to be the historical ones where we interviewed important past SDPA members who helped shape the future of our Society and our profession. My favorite interviews include: Joe Monroe discussing the founding of the SDPA; Travis Hayden talking about the evolution of the JDPA; MOHs surgery PAs detailing what they are doing; and the early UTSW post-graduate dermatology PAs discussing their residencies. Describe your ideal Dermcast.tv interview. Talking with SDPA members who are passionate about a particular subject that not only touches dermatology PAs, but the larger PA and/or patient communities as a whole. Being able to bring a unique twist or point of view on an issue is a thing I enjoy the most in doing interviews for Dermcast.tv. What is your greatest accomplishment to date? I am proud as an SDPA leader to have helped move our Society to the next level. Increasing our brand awareness, adopting corporate processes, expanding fiduciary responsibilities, and helping to turn a small non-profit organization into a high level PA specialty organization are what I have enjoyed being part of. Bringing Dermcast. tv to fruition and off the ground is another thing I am proud of - it has been a truly rewarding experience. J
The cycle of inﬂammatory rosacea warrants
the only FDA-approved oral treatment...
Formulated for an Effective Anti-inflammatory Response • Signiﬁcant reduction in inﬂammatory lesion count seen as early as week 3 (vs placebo [P=.005]; 61% mean reduction at week 16 [N=251; P<.001])1,2 • In a large community-based trial, 75% of patients were clear or near clear at week 12 (change in IGA* score; n=826)3 • Favorable tolerability vs doxycycline 100 mg with 5x less gastrointestinal upset4 • No evidence of bacterial resistance in a long-term safety study 5 *Investigator’s Global Assessment.
Important Safety Information
Oracea® (doxycycline, USP) is indicated for the treatment of only inﬂammatory lesions (papules and pustules) of rosacea in adult patients. In clinical trials, the most common adverse events reported were gastrointestinal upsets, nasopharyngitis/pain, and nasal congestion/sinusitis. Oracea® should not be used to treat microbial infections, and should be used only as indicated. This drug is contraindicated in people who have shown hypersensitivity to any of the tetracyclines, and, like other tetracycline drugs, may cause fetal harm when administered to a pregnant woman. Oracea® should not be used during pregnancy, by nursing mothers, or during tooth development (up to the age of 8 years). Although photosensitivity was not observed in clinical trials, Oracea® patients should minimize or avoid exposure to natural or artiﬁcial sunlight. All contraindications, warnings, and precautions associated with tetracyclines must be considered before prescribing Oracea®. The safety of Oracea® treatment beyond 9 months has not been established. Please see brief summary of Prescribing Information on next page.
References: 1. Del Rosso JQ, Webster GF, Jackson M, et al. Two randomized phase III clinical trials evaluating anti-inﬂammatory dose doxycycline (40-mg doxycycline, USP capsules) administered once daily for treatment of rosacea. J Am Acad Dermatol. 2007;56(5):791-802. 2. Data on ﬁle. Galderma Laboratories, L.P. 3. Webster GF. An open label, community-based, 12-week assessment of the effectiveness and safety of monotherapy with doxycycline 40-mg (30-mg immediate-release and 10-mg delayed-release beads). Cutis. 2010;86(suppl 5[i]):7-15. 4. Del Rosso JQ, Schlessinger J, Werschler P. Comparison of anti-inﬂammatory dose doxycycline versus doxycycline 100 mg in the treatment of rosacea. J Drugs Dermatol. 2008;7(6):573-576. 5. Preshaw PM, Novak MJ, Mellonig J, et al. Modiﬁed-release subantimicrobial dose doxycycline enhances scaling and root planing in subjects with periodontal disease. J Periodontol. 2008;79(3):440-452. Oracea and Galderma are registered trademarks of Galderma Laboratories, L.P. ©2011 Galderma Laboratories, L.P. Galderma Laboratories, L.P. 14501 N. Freeway Fort Worth, TX 76177 ORA-525 Printed in USA 01/11
Vol. 5, No. 4 FALL 2011 51
Keep out of reach of children.
Brief Summary of Full Prescribing Information INDICATIONS AND USAGE ORACEA is indicated for the treatment of only inﬂammatory lesions (papules and pustules) of rosacea in adult patients. The dosage of ORACEA differs from that of doxycycline used to treat infections. To reduce the development of resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, ORACEA should be used only as indicated. CLINICAL PHARMACOLOGY Pharmacokinetics ORACEA capsules are not bioequivalent to other doxycycline products. CONTRAINDICATIONS This drug is contraindicated in persons who have shown hypersensitivity to doxycycline or any of the other tetracyclines. WARNINGS Teratogenic effects: 1) Doxycycline, like other tetracycline-class antibiotics, can cause fetal harm when administered to a pregnant woman. If any tetracycline is used during pregnancy or if the patient becomes pregnant while taking these drugs, the patient should be informed of the potential hazard to the fetus and treatment stopped immediately. ORACEA should not be used during pregnancy (see PRECAUTIONS: Pregnancy). 2) The use of drugs of the tetracycline class during tooth development (last half of pregnancy, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). This adverse reaction is more common during long-term use of the drug but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. Tetracycline drugs, therefore, should not be used during tooth development unless other drugs are not likely to be effective or are contraindicated. 3) All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in ﬁbula growth rate has been observed in premature human infants given oral tetracycline in doses of 25 mg/kg every 6 hours. This reaction was shown to be reversible when the drug was discontinued. Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can cause retardation of skeletal development on the developing fetus. Evidence of embryotoxicity has been noted in animals treated early in pregnancy (see PRECAUTIONS: Pregnancy section). Gastrointestinal effects: Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. Treatment with antibacterial agents alters the normal ﬂora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difﬁcile is a primary cause of “antibiotic-associated colitis”. If a diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to discontinuation of the drug alone. In moderate to severe cases, consideration should be given to management with ﬂuids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against Clostridium difﬁcile colitis. Metabolic effects: The anti-anabolic action of the tetracyclines may cause an increase in BUN. While this is not a problem in those with normal renal function, in patients with signiﬁcantly impaired function, higher serum levels of tetracycline-class antibiotics may lead to azotemia, hyperphosphatemia, and acidosis. If renal impairment exists, even usual oral or parenteral doses may lead to excessive systemic accumulations of the drug and possible liver toxicity. Under such conditions, lower than usual total doses are indicated, and if therapy is prolonged, serum level determinations of the drug may be advisable. Photosensitivity: Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Although this was not observed during the duration of the clinical studies with ORACEA, patients should minimize or avoid exposure to natural or artiﬁcial sunlight (tanning beds or UVA/B treatment) while using ORACEA. If patients need to be outdoors while using ORACEA, they should wear loose-ﬁtting clothes that protect skin from sun exposure and discuss other sun protection measures with their physician. PRECAUTIONS General: Safety of ORACEA beyond 9 months has not been established. As with other antibiotic preparations, use of ORACEA may result in overgrowth of non-susceptible microorganisms, including fungi. If superinfection occurs, ORACEA should be discontinued and appropriate therapy instituted. Although not observed in clinical trials with ORACEA, the use of tetracyclines may increase the incidence of vaginal candidiasis. ORACEA should be used with caution in patients with a history of or predisposition to candidiasis overgrowth. Bacterial resistance to tetracyclines may develop in patients using ORACEA. Because of the potential for drugresistant bacteria to develop during the use of ORACEA, it should be used only as indicated. Autoimmune Syndromes: Tetracyclines have been associated with the development of autoimmune syndromes. Symptoms may be manifested by fever, rash, arthralgia, and malaise. In symptomatic patients, liver function tests, ANA, CBC, and other appropriate tests should be performed to evaluate the patients. Use of all tetracycline-class drugs should be discontinued immediately. Tissue Hyperpigmentation: Tetracycline class antibiotics are known to cause hyperpigmentation. Tetracycline therapy may induce hyperpigmentation in many organs, including nails, bone, skin, eyes, thyroid, visceral tissue, oral cavity (teeth, mucosa, alveolar bone), sclerae and heart valves. Skin and oral pigmentation has been reported to occur independently of time or amount of drug administration, whereas other pigmentation has been reported to occur upon prolonged administration. Skin pigmentation includes diffuse pigmentation as well as over sites of scars or injury. Pseudotumor cerebri: Bulging fontanels in infants and benign intracranial hypertension in adults have been reported in individuals receiving tetracyclines. These conditions disappeared when the drug was discontinued. Laboratory Tests: Periodic laboratory evaluations of organ systems, including hematopoietic, renal and hepatic studies should be performed. Appropriate tests for autoimmune syndromes should be performed as indicated. Drug Interactions: 1. Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. 2. Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin. 3. The concurrent use of tetracycline and methoxyﬂurane has been reported to result in fatal renal toxicity. 4. Absorption of tetracyclines is impaired by bismuth subsalicylate, proton pump inhibitors, antacids containing aluminum, calcium or magnesium and ironcontaining preparations. 5. Doxycycline may interfere with the effectiveness of low dose oral contraceptives. To avoid contraceptive failure, females are advised to use a second form of contraceptive during treatment with doxycycline. 6. There have been reports of pseudotumor cerebri (benign intracranial hypertension) associated with the concomitant use of isotretinoin and tetracyclines. Since both oral retinoids, including isotretinoin and acitretin, and the tetracyclines, primarily minocycline, can cause increased intracranial pressure, the concurrent use of an oral retinoid and a tetracycline should be avoided.
52 Journal of Dermatology for Physician Assistants
MICROBIOLOGY The plasma concentrations of doxycycline achieved with ORACEA during administration (see DOSAGE AND ADMINISTRATION) are less than the concentration required to treat bacterial diseases. In vivo microbiological studies utilizing a similar drug exposure for up to 18 months demonstrated no detectable long-term effects on bacterial ﬂora of the oral cavity, skin, intestinal tract, and vagina. Carcinogenesis, Mutagenesis, Impairment of Fertility: Doxycycline was assessed for potential to induce carcinogenesis in a study in which the compound was administered to Sprague-Dawley rats by gavage at dosages of 20, 75, and 200 mg/kg/day for two years. An increased incidence of uterine polyps was observed in female rats that received 200 mg/kg/day, a dosage that resulted in a systemic exposure to doxycycline approximately 12.2 times that observed in female humans who use ORACEA (exposure comparison based upon area under the curve (AUC) values). No impact upon tumor incidence was observed in male rats at 200 mg/kg/ day, or in either gender at the other dosages studied. Evidence of oncogenic activity was obtained in studies with related compounds, i.e., oxytetracycline (adrenal and pituitary tumors) and minocycline (thyroid tumors). Doxycycline demonstrated no potential to cause genetic toxicity in an in vitro point mutation study with mammalian cells (CHO/HGPRT forward mutation assay) or in an in vivo micronucleus assay conducted in CD-1 mice. However, data from an in vitro assay with CHO cells for potential to cause chromosomal aberrations suggest that doxycycline is a weak clastogen. Oral administration of doxycycline to male and female Sprague-Dawley rats adversely affected fertility and reproductive performance, as evidenced by increased time for mating to occur, reduced sperm motility, velocity, and concentration, abnormal sperm morphology, and increased pre-and post-implantation losses. Doxycycline induced reproductive toxicity at all dosages that were examined in this study, as even the lowest dosage tested (50 mg/kg/day) induced a statistically signiﬁcant reduction in sperm velocity. Note that 50 mg/kg/day is approximately 3.6 times the amount of doxycycline contained in the recommended daily dose of ORACEA for a 60-kg human when compared on the basis of AUC estimates. Although doxycycline impairs the fertility of rats when administered at sufﬁcient dosage, the effect of ORACEA on human fertility is unknown. Pregnancy: Teratogenic Effects: Pregnancy Category D. (see WARNINGS section). Results from animal studies indicate that doxycycline crosses the placenta and is found in fetal tissues. Nonteratogenic effects: (see WARNINGS section). Labor and Delivery: The effect of tetracyclines on labor and delivery is unknown. Nursing Mothers: Tetracyclines are excreted in human milk. Because of the potential for serious adverse reactions in infants from doxycycline, ORACEA should not be used in mothers who breastfeed. (see WARNINGS section). Pediatric Use: ORACEA should not be used in infants and children less than 8 years of age (see WARNINGS section). ORACEA has not been studied in children of any age with regard to safety or efﬁcacy, therefore use in children is not recommended. ADVERSE REACTIONS Adverse Reactions in Clinical Trials of ORACEA: In controlled clinical trials of adult patients with mild to moderate rosacea, 537 patients received ORACEA or placebo over a 16-week period. The most frequent adverse reactions occurring in these studies are listed in the table below. Incidence (%) of Selected Adverse Reactions in Clinical Trials of ORACEA (n=269) vs. Placebo (n=268)
Nasopharyngitis Pharyngolaryngeal Pain Sinusitis Nasal Congestion Fungal Infection Inﬂuenza Diarrhea Abdominal Pain Upper Abdominal Distention Abdominal Pain Stomach Discomfort
ORACEA 13 (4.8) 3 (1.1) 7 (2.6) 4 (1.5) 5 (1.9) 5 (1.9) 12 (4.5) 5 (1.9) 3 (1.1) 3 (1.1) 3 (1.1)
Placebo 9 (3.4) 2 (0.7) 2 (0.7) 2 (0.7) 1 (0.4) 3 (1.1) 7 (2.6) 1 (0.4) 1 (0.4) 1 (0.4) 2 (0.7)
Note: Percentages based on total number of study participants in each treatment group. Adverse Reactions for Tetracyclines: The following adverse reactions have been observed in patients receiving tetracyclines at higher, antimicrobial doses: Gastrointestinal: anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, and inﬂammatory lesions (with vaginal candidiasis) in the anogenital region. Hepatotoxicity has been reported rarely. Rare instances of esophagitis and esophageal ulcerations have been reported in patients receiving the capsule forms of the drugs in the tetracycline class. Most of the patients experiencing esophagitis and/or esophageal ulceration took their medication immediately before lying down. (see DOSAGE AND ADMINISTRATION section). Skin: maculopapular and erythematous rashes. Exfoliative dermatitis has been reported but is uncommon. Photosensitivity is discussed above. (see WARNINGS section). Renal toxicity: Rise in BUN has been reported and is apparently dose-related.(see WARNINGS section). Hypersensitivity reactions: urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, serum sickness, pericarditis, and exacerbation of systemic lupus erythematosus. Blood: Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia have been reported. OVERDOSAGE In case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures. Dialysis does not alter serum half-life and thus would not be of beneﬁt in treating cases of overdose. DOSAGE AND ADMINISTRATION THE DOSAGE OF ORACEA DIFFERS FROM THAT OF DOXYCYCLINE USED TO TREAT INFECTIONS. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS INCLUDING THE DEVELOPMENT OF RESISTANT MICROORGANISMS. One ORACEA Capsule (40 mg) should be taken once daily in the morning on an empty stomach, preferably at least one hour prior to or two hours after meals. Efﬁcacy beyond 16 weeks and safety beyond 9 months have not been established. Administration of adequate amounts of ﬂuid along with the capsules is recommended to wash down the capsule to reduce the risk of esophageal irritation and ulceration. (see ADVERSE REACTIONS section). HOW SUPPLIED ORACEA (beige opaque capsule printed with CGPI 40) containing doxycycline, USP in an amount equivalent to 40 mg of anhydrous doxycycline. Bottle of 30 (NDC 64682-009-01). Storage: All products are to be stored at controlled room temperatures of 15°C-30°C (59°F-86°F) and dispensed in tight, light-resistant containers (USP). Keep out of reach of children. Patent Information: U.S. Patents 5,789,395; 5,919,775; 7,232,572; 7,211,267 and patents pending. ORACEA is a registered trademark of CollaGenex Pharmaceuticals, Inc. Manufactured by: Marketed by: CardinalHealth Galderma Laboratories, L.P. Winchester, KY 40391 Fort Worth, TX 76177 7961-01 BPI 06/08
Dermatology PA news & notes
From the Desk of... John Notabartolo, MPAS, PA-C SDPA President-Elect
Just The First Step
When I hear people who have been around the SDPA for a while speak about our organization, the metaphor I hear used most often is that of a caterpillar transforming into a butterfly. This is an apt comparison, although incomplete (I’ll get to that later). We went from being a small, struggling group to the second largest and most well run of any PA specialty. So how did we do it? No small amount of help came from our partners in the pharmaceutical industry, but even money only goes so far. Financial support may be how we became successful, but it isn’t how we’ve remained successful. That is through the work and dedication of our member volunteers. Yeah, I mean you guys. Our member volunteers help run our CME meetings, update the Distance Learning Initiative and answer your questions, help the state dermatology PA organizations get off the ground, and work together to make the decisions that keep us growing and getting better. We keep growing and getting better… maybe the butterfly metaphor isn’t so good after all. See, a caterpillar cocoons and emerges as a beautiful butterfly, but that’s it. It reaches its John Notabartolo, MPAS, PA-C graduated in 1998 from the University of Nebraska through the Interservice Physician Assistant Program in San Antonio, TX. He works with Johnnie Woodson, MD and Linda Woodson, MD at Woodson Dermatology in Las Vegas, NV and is currently serving as the President-Elect for the SDPA.
peak and never becomes anything better. We haven’t reached our peak yet. Every year our meetings get better, our volunteer leaders become more engaged, our relations with other professional organizations like the AAPA and AAD become stronger, and we are able to offer more benefits to our members. It is through the interest and activity of your fellow members that we are gaining strength and momentum. Although we try to do things better than we did last year, last month, or last week, we don’t always get it quite right. It’s during those times that we call on you to help. Perhaps you have an idea about a better way to do something, a proposal for a new project, or simply want to put your shoulder to the wheel and help propel us further forward? Contact one of our Board of Directors members or a committee chair, and they will happily ensure that you are engaged at whatever level you feel comfortable. We are evolving and improving every year. How long can we keep this progress up? As long as we have members who are willing to give of themselves. It could be an hour a month, an hour a week, or a few days in November to help at the annual meeting. Whatever your abilities or comfort level, we can help you find an outlet. It’s through the direction determined by you, our members, that we all strive to become better clinicians, better volunteers, and better leaders. It’s through you that we will continue to be reborn as something greater. J
Vol. 5, No. 4 FALL 2011 53
The Difference We Make A Rash Reaction
Dermatology PA news & notes
By Brian T. Maurer, PA-C
“His cough got worse and he vomited last night. I’m would ricochet inside his head: “Rockets over Da Nang! not sure that medicine you prescribed is helping him,” this Rockets over Da Nang!” The gut reaction was something he couldn’t control. father bellows, as though he were a commercial TV news commentator. Back in the early 1980s when I was plugging my way The boy sits on the exam table next to his mother. In through a postgraduate residency program in pediatrics, preparation for today’s exam she has removed his shirt a colleague working in the ED sent an admission up to so I can have a good listen to his chest. “And just now I’m where I stood watch as house officer on the seventhnoting this rash,” the mother says, floor ward - a three year-old girl gently running the backs of her with a two day history of URI “The moment I visualize the symptoms and new onset fever fingers over her son’s cheek. with a body rash. My colleague eruption on his face, I become Two days ago these parents described the rash to me over the had brought their son to see more concerned about the rash telephone: a petechial eruption me for a chesty cough. In the on the face, upper chest, and than the persisting cough.” office he sounded croupy. The abdomen. Preliminary blood work mother has bad asthma and was pending. The child was in she was concerned that her son radiology waiting for a chest x-ray en route to my ward. might have developed something similar. But on that By the time the little girl arrived on my floor, the exam his lungs were clear - normal breath sounds over all petechiae had spread to her arms and legs. I secured lobes. I prescribed a short course of oral prednisolone to intravenous access and started an infusion of antibiotics dampen down the inflammation that had settled into his immediately. Despite aggressive therapy, over the ensuing subglottic airway. four hours those petechiae grew in number and size Despite this treatment the cough persisted, so until they became frank ecchymoses. Slowly the child the parents brought the boy back to the office for slipped into septic shock. The final diagnosis, Waterhousereevaluation. The moment I visualize the eruption on Friderichsen syndrome, was made postmortem. his face, I become more concerned about the rash than the persisting cough. A close examination reveals tiny A vivid image of that little girl (something akin to pinpoints of bleeding just below the surface of the skin. “Rockets over Da Nang!”) flashes through my mind as I study the eruption on the face of the boy seated on the The rash does not blanch with gentle pressure - the telltale sign of a petechial eruption. exam table before me. Through further questioning I ascertain that the boy had vomited forcibly immediately Shortly before my high school graduation, an older after the prior evening’s dose of prednisolone syrup, a buddy of mine enlisted in the army and served a tour bitter medicine to swallow. of duty in Vietnam. Eighteen months later he returned Over the past fourteen hours the petechiae have stateside diagnosed with shellshock, that psychiatric not progressed below the jawline. This boy has no fever. malady we now recognize as post-traumatic stress disorder. Whenever local fire sirens suddenly sounded, Apart from the rash and intermittent cough, he does not he would involuntarily cringe like a gun-shy retriever at even appear ill. I listen to the boy’s chest, finish with the a duck hunt. He told me that on these occasions words remainder of my exam, and make my pronouncement. “His lungs are crystal clear,” I tell the parents. “The rash on Brian T. Maurer has practiced pediatric medicine as a physician his face is secondary to the vomiting episode. He threw assistant for thirty years. Over the past two decades Mr. Maurer has up with enough force to pop some of the tiny blood explored the illness narrative as a tool to cultivate an appreciation for vessels in the skin of his face. The rash hasn’t progressed, the delivery of humane medical care. He has published numerous so there’s no need to worry.” vignettes, editorials, and essays in both national and international journals. Mr. Maurer has been a contributing author to the online The words that I speak seem to reassure me as much open-access journal Dermanities (www.dermanities.com) since as the parents. At this juncture “Rockets over Da Nang!” is its inception. Readers can visit the author on the web at http:// merely an echo from the distant past. J briantmaurer.wordpress.com. 54 Journal of Dermatology for Physician Assistants
FOR THE TREATMENT OF ACNE VULGARIS
Optimized for efficacy with minimal irritation
mean reduction in inﬂammatory • 36% lesions at 12 weeks* mean reduction in noninﬂammatory • 41% lesions at 12 weeks* • Low irritation proﬁle • Moisturizing and hydrating agents 1
*Combined results of two 12-week, prospective, multicenter, randomized, vehicle-controlled studies of patients with mild to moderate acne vulgaris of the face.1 †The contribution of individual components to efficacy has not been evaluated.
Indication and Important Safety Information: Atralin Gel is indicated for the treatment of acne vulgaris. The most common adverse reaction was mild to moderate irritation of the skin (ie, dry skin, skin burning, erythema, and exfoliative dermatitis), which occurred during the ﬁrst few weeks of treatment with Atralin Gel. To prevent aggravating the skin, protect it from sun, tanning lights, extreme wind or cold, and harsh skincare products. Use of sunscreen products of at least SPF 15 and protective clothing over treated areas are recommended when exposure cannot be avoided. Atralin Gel should not be used on eczematous or sunburned skin due to potential for severe irritation. References: 1. Data on ﬁle, CORIA Laboratories. 2. Weindl G, Schaller M, Schäfer-Korting M, Korting HC. Hyaluronic acid in the treatment and prevention of skin diseases: molecular, biological, pharmaceutical and clinical aspects. Skin Pharmacol Physiol. 2004;17(5):207-213. 3. Morganti P. Skin hydration. In: Magdassi S, Touitou E, eds. Novel Cosmetic Delivery Systems. New York, NY. Marcel Dekker, Inc; 1999:71-98. 4. Kraft JN, Lynde CW. Moisturizers: what they are and a practical approach to product selection. Skin Therapy Lett. 2005;10(5):1-8.
Please see brief summary of prescribing information on next page.
© 2010 CORIA Laboratories, a division of Valeant Pharmaceuticals North America COR-137791-1210
Vol. 5, No. 4 FALL 2011 55
Vehicle Gel (n = 487)
Dry Skin Peeling/Scaling/Flaking Skin Skin Burning Sensation Erythema Pruritus Pain of Skin Sunburn
109 (16%) 78 (12%) 53 (8%) 47 (7%) 11 (2%) 7 (1%) 7 (1%)
8 (2%) 7 (1%) 8 (2%) 1 (<1%) 3 (1%) 0 (0%) 3 (1%)
Atralin Gel (n = 674)
Output @ 100% Giant Creative Strategy
Table 1. Number of Subjects with Selected Adverse Reactions (Occurring in At Least 1% of Subjects)
DRUG INTERACTIONS When treating with Atralin Gel, caution should be exercised with the use of concomitant topical medication, medicated or abrasive soaps and cleansers, products that have a strong drying effect, and products with high concentrations of alcohol, astringents, spices, or lime. Particular caution should be exercised with the concomitant use of topical over-the-counter acne preparations containing benzoyl peroxide, sulfur, resorcinol, or salicylic acid. Allow the effects of such preparations to subside before use of Atralin Gel is begun. USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C. There are no well-controlled trials in pregnant women treated with Atralin Gel. Atralin Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Atralin Gel at doses of 0.1, 0.3 and 1 g/kg/day was tested for maternal and developmental toxicity in pregnant Sprague-Dawley rats by dermal application. The dose of 1 g/kg/day was approximately 4 times the clinical dose assuming 100% absorption and based on body surface area comparison. Possible tretinoin-associated teratogenic effects (craniofacial abnormalities [hydrocephaly], asymmetrical thyroids, variations in ossification, and increased supernumerary ribs) were noted in the fetuses of Atralin Gel treated animals. These findings were not observed in control animals. Other maternal and reproductive parameters in the Atralin Gel treated animals were not different from control. For purposes of comparison of the animal exposure to human exposure, the clinical dose is defined as 2 g of Atralin Gel applied daily to a 50-kg person. Oral tretinoin has been shown to be teratogenic in rats, mice, rabbits, hamsters and nonhuman primates. Tretinoin was teratogenic in Wistar rats when given orally in doses greater than 1 mg/kg/day (approximately 8 times the clinical dose based on body surface area comparison). In the cynomolgus monkey, fetal malformations were reported for doses of 10 mg/kg/day, but none were observed at 5 mg/kg/day (approximately 80 times the clinical dose based on body surface area comparison), although increased skeletal variations were observed at all doses. Dose-related increases in embryolethality and abortion also were reported. Similar results have also been reported in pigtail macaques. Topical tretinoin in a different formulation has generated equivocal results in animal teratogenicity tests. There is evidence for teratogenicity (shortened or kinked tail) of topical tretinoin in Wistar rats at doses greater than 1 mg/kg/day (approximately 8 times the clinical dose assuming 100% absorption and based on body surface area comparison). Anomalies (humerus: short 13%, bent 6%, os parietal incompletely ossified 14%) have also been reported when 10 mg/kg/day (approximately 160 times the clinical dose assuming 100% absorption and based on body surface area comparison) was topically applied. Supernumerary ribs have been a consistent finding in rats when dams were treated topically or orally with retinoids. With widespread use of any drug, a small number of birth defect reports associated temporally with the administration of the drug would be expected by chance alone. Cases of temporally associated congenital malformations have been reported with use of other topical tretinoin products. The significance of these spontaneous reports in terms of risk to the fetus is not known. Nonteratogenic effects on fetuses: Oral tretinoin has been shown to be fetotoxic in rats when administered in doses 20 times the clinical dose based on a body surface area comparison. Topical tretinoin has been shown to be fetotoxic in rabbits when administered in doses 8 times the clinical dose based on a body surface area comparison. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Atralin Gel is administered to a nursing woman. Pediatric Use Safety and effectiveness in children below the age of 10 have not been established. A total of 381 pediatric subjects (aged 10 to 16 years), treated with Atralin Gel were enrolled into the two clinical studies. Across these two studies, comparable safety and efficacy were observed between pediatric and adult subjects. Geriatric Use Safety and effectiveness in a geriatric population have not been established. Clinical studies of Atralin Gel did not include any subjects over age 65 to determine whether they respond differently than younger subjects.
BRIEF SUMMARY (see package insert for full prescribing information) For topical use only INDICATIONS AND USAGE Atralin Gel is a retinoid indicated for topical treatment of acne vulgaris. Important Limitations of Use The safety and efficacy of the use of this product in the treatment of any other disorders have not been evaluated. CONTRAINDICATIONS None WARNINGS AND PRECAUTIONS Skin Irritation The skin of certain individuals may become dry, red, or exfoliated while using Atralin Gel. If the degree of irritation warrants, patients should be directed to temporarily reduce the amount or frequency of application of the medication, discontinue use temporarily, or discontinue use altogether. Efficacy at reduced frequencies of application has not been established. If a reaction suggesting sensitivity occurs, use of the medication should be discontinued. Mild to moderate skin dryness may also be experienced; if so, use of an appropriate moisturizer during the day may be helpful. Tretinoin has been reported to cause severe irritation on eczematous or sunburned skin and should be used with caution in patients with these conditions. Topical over-the-counter acne preparations, concomitant topical medication, medicated cleansers, topical products with alcohol or astringents, when used with Atralin Gel, should be used with caution [see Drug Interactions (7)]. Ultraviolet Light and Environmental Exposure Unprotected exposure to sunlight, including sunlamps, should be minimized during the use of Atralin Gel. Patients who normally experience high levels of sun exposure, and those with inherent sensitivity to sun, should be warned to exercise caution. Use of sunscreen products of at least SPF 15 and protective clothing over treated areas is recommended when exposure cannot be avoided. Weather extremes, such as wind or cold, also may be irritating to patients under treatment with tretinoin. Fish Allergies Atralin Gel contains soluble fish proteins and should be used with caution in patients with known sensitivity or allergy to fish. Patients who develop pruritus or urticaria should contact their health care provider. ADVERSE REACTIONS Clinical Studies Experience Because clinical trials are conducted under prescribed conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. In two randomized, controlled trials, 674 subjects received treatment for up to 12 weeks with Atralin Gel [see Clinical Studies (14)]. In these studies, 50% of the subjects who were treated with Atralin Gel reported one or more adverse reactions; 30% of the subjects reported treatment-related adverse reactions. In the vehicle group, 29% of the 487 randomized subjects reported at least one adverse reaction; 5% of the subjects reported events that were treatment-related. There were no serious, treatment-related adverse reactions reported by subjects in any of the treatment groups. Selected adverse reactions that occurred in at least 1% of subjects in the two studies combined, are shown in Table 1 (below). Most skin-related adverse reactions first appear during the first two weeks of treatment with Atralin Gel, and the incidence rate for skin-related reactions peaks around the second and third week of treatment. In some subjects the skin-related adverse reactions persist throughout the treatment period.
Manufactured by: DPT LABORATORIES, LTD. San Antonio, Texas 78215
56 Journal of Dermatology for Physician Assistants PACIFIC DIGITAL IMAGE • 333 Broadway, San Francisco CA 94133 • 415.274.7234 • www.pacdigital.com
CORIA Laboratories, a division of Valeant Pharmaceuticals North America, Aliso Viejo, CA 92656
Patent No.: 5,670,547 Revised: 11/2009 137623-1109
Tips for Students on How to Find a Preceptor
For me, one of the hardest parts of the second year of PA school is the first week of each new rotation. It
can be very stressful walking into an office with a staff you have never met, no knowledge of what is expected of you, and fear of being either constantly in the way or relentlessly sized up. Wouldn’t it be nice if you knew ahead of time that you were going to have a good experience and that the preceptor was genuinely interested in helping you develop as a practitioner? This is obviously not possible for the majority of your rotations since the school usually sets up the locations for core requirements. However, for those rotations which are either elective or that you are allowed to organize yourself, I want to offer fellow PA students a few tips for helping to secure the best outcomes. First, you want to find a practice that interests you. You can use the Internet, phone book, or references from faculty, friends, and family. For dermatology specific rotations, I would recommend joining the SDPA as a student member and using the SDPA student website at www.dermpa.org/students. Once you are logged in, you can use the “Derm Rotations” link. Here the SDPA provides student members with a list of practicing dermatology PAs who have volunteered their time and resources for the benefit of students like you. Whether you are contacting one of the PAs on the SDPA website or simply searching the Internet, you need to be aware that practitioners are very busy, and most do not have time to spend sifting through emails or returning phone calls from students. If you do not have a personal connection with the office you want to contact, I suggest going in person. When you initially call, the office manager will be able to tell you the best times to stop by the office or can help you set up an actual meeting. Going in person will not only show that you are very interested, but will also help you get a feel for the area, the office environment, and the personalities and interactions within the staff. And of course, if meeting in person, always dress professionally and show up on time. If you are trying to Catrina Shubert, PA-C, graduated from Salus University Physician Assisgraduated from Salus University Physician Assistant Program in Elkins Park, PA in September 2011. Catrina held the position of Student Affairs Coordinator for the SDPA from 2010-2011 and plans to practice in dermatology.
set something up out of state, and it is not possible for you to visit the office, then I advise calling and asking the office manager how the practitioner would prefer to be contacted. Once you have set up an office appointment, scheduled a telephone conversation, or are composing an email, you must be prepared to provide all of the information that a preceptor may want to know. Here are some examples of pertinent questions that you may be asked. How long is the rotation? Is there paperwork that needs to be completed up front or along the way? Does the school have liability insurance for their students? What do you expect to get out of the rotation? What does the school expect you to get out of the rotation? By taking one student, does this mean that I will have to take more students or can I decide when and how many students I want? What is the deadline for making a final decision? How many hours are you required to work per week? Why are you interested in this practice or this specialty? What previous experiences do you have? By providing the practitioner with all of the information about the rotation up front, he or she will be better able to decide if this is something feasible for the practice. Through this process you will hopefully eliminate the possibility of any hidden surprises that could compromise the practice’s willingness to proceed with the rotation. This initial meeting also gives you the opportunity to decide if the practice is somewhere you would want to spend your time, and if your personality and goals fit with those of the prospective preceptor. Finally, I recommend having a back-up plan. Even if there is one site that you are really interested in and everything seems to be working out perfectly, remember that life is unpredictable and cancellations can and do happen at the last minute. It is a good idea to have a couple of preceptors who you have met with and are comfortable working with in case things do not go according to plan. You obviously do not want to tell a practice that you will be coming and then cancel on them, but it is acceptable to tell them that you are looking at multiple options, have many interests, and would like to know if they are willing to have a student if that is what you decide. Hopefully you now feel ready to start your search, and I wish you the best of luck with all of your future rotations! J Vol. 5, No. 4 FALL 2011 57
DERmatology pa news & notes
By Catrina Shubert, PA-S SDPA Student Affairs Coordinator 2010-2011
Supervising Physician CORNER Communication is Key By Justin Love, PA-C
Dermatology PA news & notes
bel Torres, MD, JD has been practicing dermatology for twenty-five years. Early in his career Dr. Torres co-started a residency training program in dermatology, established a fellowship training program in Mohs/ Dermatologic Surgery, and became a Professor and head of the Dermatology Division at Loma Linda University School of Medicine. He has served on the ACGME Residency Review Committee in Dermatology and was elected to the Board of Directors of the American College for Mohs Micrographic Surgery and Cutaneous Oncology. In 1991 Dr. Torres graduated from the Loyola of Los Angeles Law School and passed the bar exam. In 1998, Dr Torres was recruited to start a Center for Mohs/Skin Cancer Surgery at the Dana Farber Cancer Institute and Brigham and Woman’s Hospital at the Harvard Medical School Department of Dermatology and was later asked to become the residency training program director for the Harvard Department of Dermatology. While at Harvard, he also served as Associate Chief of Dermatology for the Brigham and Woman’s Hospital and as a member of the executive committee for the Harvard Department of Dermatology. In 2001 Dr. Torres and his family decided to return to California and bring his funded research on noninvasive immunomodulatory skin cancer therapy and invivo confocal microscopy imaging to Loma Linda. Since returning to Loma Linda, he has become Chairman of the new Department of Dermatology at Loma Linda University and was recently elected to serve on the Board of Directors for the American Society for Dermatologic Surgery (ASDS). This past year he was elected to the Board of Directors of the American Academy of Dermatology (AAD). Dr. Torres has been working with physician assistants since 2004. Justin Love, PA-C has worked in dermatology for four years with Dr. Torres as his primary supervising physician and shares with us now his thoughts regarding his supervising physician and what he thinks makes his physician/PA team work so well together.
What do you think is your supervising physician’s greatest strength in working with PAs? My supervising physician’s greatest strength in working with a PA is his ability to teach in a constructive manner and act as a mentor. Dr. Torres has also always encouraged me to grow professionally within appropriate guidelines. What is your supervising physician’s philosophy on PAs working in dermatology? Dr. Torres’ view of PAs in dermatology is that it provides increasing accessibility for dermatology patients and that PAs act as an extension of their supervising physician(s). What makes your physician/PA team work well? Our physician/PA team works well because we exercise regular and open communication regarding patient care and other professional issues. The PAs in our practice always 58 Journal of Dermatology for Physician Assistants
have direct access to our supervising physician(s) and regular meetings through out the week are encouraged. In addition it has been arranged so that I would have direct access to others physicians when needed.
When did you know that you had a great supervising physician? I knew I had a great supervising physician when Dr. Torres started giving me more responsibility that fit into the dermatology PA scope of practice. What is the secret to a great physician/PA team? The secret to a great physician/PA team is having the supervising physician set the guidelines for the PA from the beginning and having open communication regarding those guidelines or any modifications on a regular basis. What is the greatest challenge of your workday and how does your supervising physician help you with these challenges? The greatest challenge in my workday is managing difficult cases. Given that I work within an academic setting we tend to see some more rare and difficult cases/diagnoses. Dr. Torres helps me with these challenges by discussing the differential diagnoses and using those cases as a means for educating. How does your supervising physician encourage you? Dr. Torres encourages me by promoting educational growth on a regular basis through meetings and lectures. What is your advice to new PAs trying to decide what type of supervising physician they will work best with? My advice to new PAs trying to decide what type of supervising physician to work with would be to look to work with someone who values the PA education and training and look for a supervising physician who wants to help you grow professionally. It is also important to make sure that the supervising physician has worked with a PA before; if not, it may be helpful for the supervising physician to spend time where they are using PAs appropriately. J Justin Love, PA-C is a graduate of Loma Linda University Physician Assistant Program located in Loma Linda, California. He has been practicing dermatology for four years and currently serves as the lead physician assistant on the faculty of physician and surgeons at Loma Linda University School of Medicine-Department of Dermatology. Abel Torres, MD, JD completed his medical education at The Mount Sinai School of Medicine graduating from a six year BS-MD program. Upon graduation he headed west to California to Loma Linda University and after finishing his residency in internal medicine, he completed a residency training program in dermatology at New York University. He was the first recipient of a surgical dermatology scholarship sponsored by the International Society for Dermatologic Surgery (ISDS), and after finishing the scholarship at the University of Seville, Spain, he then completed a fellowship in Dermatologic Surgery/Mohs at the University of California, San Francisco.
Professional Opportunities and Development
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Information you can trust.
Â’Patient education materials Â’Electronic newsletter and quarterly newsletter Â’Tips from leading eczema experts Â’The latest eczema research and treatment news Â’ National Eczema Association Seal of Acceptance products Support for your patients.
Â’Support Groups nationwide Â’Facebook fan page for connection and information Â’Online Support Community: private and conďŹ dential Â’National Patient Conference & Kids Camp, June 2012 You can count on us.
Â’Info & online support community: nationaleczema.org Â’Phone: 415-499-3474 or 800-818-7546 Â’ Email: email@example.com Â’ Facebook: facebook.nationaleczema.org Â’ Physician Referral Directory: contact us to be included
Vol. 5, No. 4 FALL 2011 59
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60 Journal of Dermatology for Physician Assistants
Published on Oct 5, 2011
Published on Oct 5, 2011
Volume 5, Number 4, Fall 2011. The JDPA is the official clinical journal of the Society of Dermatology Physician Assistants. The mission of...