Volume 6 number 2 SPRING 2012
SDPA News and Current Affairs
dermatology pa news and notes
clinical dermatology
surgical dermatology
cosmetic dermatology
Professional development
Official Journal of the Society of Dermatology Physician Assistants
Vol. 6, No. 2 SPRING 2012
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: t 5IF TLJO PG DFSUBJO JOEJWJEVBMT NBZ CFDPNF FYDFTTJWFMZ ESZ SFE TXPMMFO PS CMJTUFSFE *G UIF 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. t 6OQSPUFDUFE FYQPTVSF UP TVOMJHIU JODMVEJOH TVOMBNQT TIPVME CF NJOJNJ[FE EVSJOH UIF VTF PG 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 TVO FYQPTVSF EVF UP PDDVQBUJPO BOE UIPTF XJUI JOIFSFOU TFOTJUJWJUZ UP UIF TVO TIPVME FYFSDJTF QBSUJDVMBS DBVUJPO 6TF PG TVOTDSFFO QSPEVDUT 41' BOE QSPUFDUJWF DMPUIJOH PWFS USFBUFE BSFBT BSF SFDPNNFOEFE XIFO FYQPTVSF DBOOPU CF BWPJEFE t 8FBUIFS FYUSFNFT TVDI BT XJOE PS DPME BMTP NBZ CF JSSJUBUJOH UP QBUJFOUT VOEFS USFBUNFOU with tretinoin. t 3FUJO " .JDSP USFUJOPJO HFM NJDSPTQIFSF BOE TIPVME CF LFQU BXBZ GSPN UIF eyes, the mouth, paranasal creases of the nose, and mucous membranes. t 5SFUJOPJO IBT CFFO SFQPSUFE UP DBVTF TFWFSF JSSJUBUJPO PO FD[FNBUPVT TLJO BOE TIPVME CF VTFE with utmost caution in patients with this condition. Information for Patients: A Patient Information Leaflet has been prepared and is included with FBDI QBDLBHF PG 3FUJO " .JDSP USFUJOPJO HFM 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 XJUI UIF QFFM PG MJNFT 1BSUJDVMBS DBVUJPO TIPVME CF FYFSDJTFE XJUI UIF DPODPNJUBOU VTF PG UPQJDBM PWFS UIF DPVOUFS BDOF QSFQBSBUJPOT DPOUBJOJOH CFO[PZM QFSPYJEF TVMGVS SFTPSDJOPM PS TBMJDZMJD BDJE 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 PCTFSWFE BU UIPTF TBNF EPTFT 5IF NBYJNVN TZTUFNJD EPTFT BTTPDJBUFE XJUI UIF BENJOJTUFSFE BOE GPSNVMBUJPOT BSF BOE NH LH EBZ SFTQFDUJWFMZ 5IFTF EPTFT BSF UXP BOE GPVS UJNFT UIF NBYJNVN IVNBO TZTUFNJD EPTF BQQMJFE UPQJDBMMZ XIFO OPSNBMJ[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%. 4UVEJFT JO IBJSMFTT BMCJOP NJDF TVHHFTU UIBU DPODVSSFOU FYQPTVSF UP USFUJOPJO NBZ FOIBODF UIF UVNPSJHFOJD QPUFOUJBM PG DBSDJOPHFOJD EPTFT PG 67# BOE 67" MJHIU GSPN B TPMBS TJNVMBUPS 5IJT FGGFDU IBT CFFO DPOGJSNFE JO B MBUFS TUVEZ JO QJHNFOUFE NJDF BOE EBSL QJHNFOUBUJPO EJE OPU PWFSDPNF UIF FOIBODFNFOU PG QIPUP DBSDJOPHFOFTJT CZ USFUJOPJO "MUIPVHI UIF TJHOJGJDBODF PG UIFTF TUVEJFT UP IVNBOT JT OPU DMFBS QBUJFOUT TIPVME NJOJNJ[F FYQPTVSF UP TVOMJHIU PS BSUJGJDJBM 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. 5IF DPNQPOFOUT PG UIF NJDSPTQIFSFT IBWF TIPXO QPUFOUJBM GPS HFOFUJD UPYJDJUZ BOE UFSBUPHFOFTJT &(%." B DPNQPOFOU PG UIF FYDJQJFOU BDSZMBUFT DPQPMZNFS XBT QPTJUJWF GPS JOEVDUJPO PG TUSVDUVSBM chromosomal aberrations in the in vitro chromosomal aberration assay in mammalian cells in UIF BCTFODF PG NFUBCPMJD BDUJWBUJPO BOE OFHBUJWF GPS HFOFUJD UPYJDJUZ JO UIF "NFT BTTBZ UIF HGPRT forward mutation assay, and the mouse micronucleus assay. In dermal Segment I fertility studies of another tretinoin formulation in rats, slight (not statistiDBMMZ TJHOJGJDBOU EFDSFBTFT JO TQFSN DPVOU BOE NPUJMJUZ XFSF TFFO BU NH LH EBZ UJNFT UIF NBYJNVN IVNBO TZTUFNJD EPTF BQQMJFE UPQJDBMMZ BOE OPSNBMJ[FE GPS UPUBM CPEZ TVSGBDF area), and slight (not statistically significant) increases in the number and percent of nonviable FNCSZPT JO GFNBMFT USFBUFE XJUI NH LH EBZ UJNFT UIF NBYJNVN IVNBO TZTUFNJD EPTF BQQMJFE UPQJDBMMZ BOE OPSNBMJ[FE GPS UPUBM CPEZ TVSGBDF BSFB BOE BCPWF XFSF PCTFSWFE *O PSBM Segment I and Segment III studies in rats with tretinoin, decreased survival of neonates and HSPXUI SFUBSEBUJPO XFSF PCTFSWFE BU EPTFT JO FYDFTT PG NH LH EBZ UJNFT UIF IVNBO UPQJDBM EPTF OPSNBMJ[FE GPS UPUBM CPEZ TVSGBDF BSFB 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 NH LH EBZ 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 EPTFT PG BOE NH LH EBZ BENJOJTUFSFE UPQJDBMMZ GPS IPVST B EBZ XIJMF XFBSJOH &MJ[BCFUIBO DPMMBST UP QSFWFOU JOHFTUJPO PG UIF ESVH 5IFSF BQQFBSFE UP CF JODSFBTFE JODJEFODFT of certain alterations, including domed head and hydrocephaly, typical of retinoid-induced GFUBM NBMGPSNBUJPOT JO UIJT TQFDJFT BU BOE NH LH EBZ 4JNJMBS NBMGPSNBUJPOT XFSF OPU PCTFSWFE BU NH LH EBZ UJNFT UIF NBYJNVN IVNBO TZTUFNJD EPTF PG USFUJOPJO BGUFS UPQJDBM BENJOJTUSBUJPO PG 3FUJO " .JDSP USFUJOPJO HFM NJDSPTQIFSF OPSNBMJ[FE GPS UPUBM CPEZ TVSGBDF BSFB *O B SFQFBU TUVEZ PG UIF IJHIFTU UPQJDBM EPTF NH LH EBZ JO QSFHOBOU rabbits, these effects were not seen, but a few alterations that may be associated with tretinoin FYQPTVSF XFSF TFFO 0UIFS QSFHOBOU SBCCJUT FYQPTFE UPQJDBMMZ GPS TJY IPVST UP PS NH LH EBZ USFUJOPJO XIJMF SFTUSBJOFE JO TUPDLT UP QSFWFOU JOHFTUJPO EJE OPU TIPX BOZ UFSBUPHFOJD FGGFDUT BU EPTFT VQ UP UJNFT NH LH EBZ UIF NBYJNVN IVNBO TZTUFNJD EPTF BGUFS UPQJDBM administration of Retin-A Micro (tretinoin gel) microsphere, 0.1%, adjusted for total body surface BSFB CVU GFUBM SFTPSQUJPOT XFSF JODSFBTFE BU NH LH *O BEEJUJPO UPQJDBM USFUJOPJO JO OPO Retin-A Micro (tretinoin gel) microsphere formulations was not teratogenic in rats and rabbits XIFO HJWFO JO EPTFT PG BOE UJNFT UIF NBYJNVN IVNBO TZTUFNJD EPTF BGUFS UPQJDBM BENJOJTUSBUJPO PG 3FUJO " .JDSP USFUJOPJO HFM NJDSPTQIFSF OPSNBMJ[FE GPS UPUBM CPEZ TVSGBDF BSFB SFTQFDUJWFMZ BTTVNJOH B LH BEVMU BQQMJFE B EBJMZ EPTF PG H PG HFM UPQJDBMMZ 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 subhuNBO QSJNBUFT 5SFUJOPJO XBT UFSBUPHFOJD JO 8JTUBS SBUT XIFO HJWFO PSBMMZ PS UPQJDBMMZ JO EPTFT HSFBUFS UIBO NH LH EBZ UJNFT UIF NBYJNVN IVNBO TZTUFNJD EPTF OPSNBMJ[FE GPS UPUBM body surface area). However, variations in teratogenic doses among various strains of rats have CFFO SFQPSUFE *O UIF DZOPNPMHVT NPOLFZ XIJDI NFUBCPMJDBMMZ JT NPSF TJNJMBS UP IVNBOT UIBO other species in its handling of tretinoin, fetal malformations were reported for doses of 10 NH LH EBZ PS HSFBUFS CVU OPOF XFSF PCTFSWFE BU NH LH EBZ UJNFT UIF NBYJNVN IVNBO TZTUFNJD EPTF OPSNBMJ[FE GPS UPUBM CPEZ TVSGBDF BSFB BMUIPVHI JODSFBTFE TLFMFUBM WBSJBUJPOT 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 GPS UFSBUPHFOJDJUZ TIPSUFOFE PS LJOLFE UBJM PG UPQJDBM USFUJOPJO JO 8JTUBS SBUT BU EPTFT HSFBUFS UIBO NH LH EBZ UJNFT UIF NBYJNVN IVNBO TZTUFNJD EPTF OPSNBMJ[FE GPS UPUBM CPEZ TVSGBDF BSFB "OPNBMJFT IVNFSVT TIPSU CFOU PT QBSJFUBM JODPNQMFUFMZ PTTJGJFE IBWF BMTP CFFO SFQPSUFE XIFO NH LH EBZ XBT UPQJDBMMZ BQQMJFE 4VQFSOVNFSBSZ SJCT IBWF CFFO B 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 VTFE EVSJOH QSFHOBODZ POMZ JG UIF QPUFOUJBM CFOFGJU KVTUJGJFT UIF QPUFOUJBM SJTL UP UIF GFUVT 8JUI XJEFTQSFBE VTF PG BOZ ESVH B TNBMM OVNCFS PG CJSUI EFGFDU SFQPSUT BTTPDJBUFE UFNQPSBMMZ XJUI UIF BENJOJTUSBUJPO PG UIF ESVH XPVME CF FYQFDUFE CZ DIBODF BMPOF 5IJSUZ 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 TJHOJGJDBODF PG UIFTF TQPOUBOFPVT SFQPSUT JO UFSNT PG SJTL UP UIF GFUVT JT OPU LOPXO Non-Teratogenic Effects: 5PQJDBM USFUJOPJO IBT CFFO TIPXO UP CF GFUPUPYJD JO SBCCJUT XIFO BENJOJTUFSFE NH LH EBZ UJNFT UIF NBYJNVN IVNBO TZTUFNJD EPTF BQQMJFE UPQJDBMMZ BOE OPSNBMJ[FE GPS UPUBM CPEZ TVSGBDF BSFB SFTVMUJOH JO GFUBM SFTPSQUJPOT BOE WBSJBUJPOT JO PTTJGJDBUJPO 0SBM USFUJOPJO IBT CFFO TIPXO UP CF GFUPUPYJD SFTVMUJOH JO TLFMFUBM WBSJBUJPOT BOE JODSFBTFE JOUSBVUFSJOF EFBUI JO SBUT XIFO BENJOJTUFSFE NH LH EBZ UJNFT UIF NBYJNVN IVNBO TZTUFNJD EPTF BQQMJFE UPQJDBMMZ BOE OPSNBMJ[FE GPS UPUBM CPEZ TVSGBDF BSFB 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 PS NH LH EBZ USFUJOPJO PS UJNFT UIF NBYJNVN IVNBO systemic dose after topical administration of Retin-A Micro (tretinoin gel) microsphere, 0.1%, OPSNBMJ[FE GPS UPUBM CPEZ TVSGBDF BSFB GPS EBZT B SFEVDUJPO JO UFTUJDVMBS XFJHIU CVU XJUI 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 NH LH EBZ UJNFT UIF NBYJNVN IVNBO EPTF *O UIJT TUVEZ UIFSF XBT B EPTF SFMBUFE JODSFBTF JO UIF QMBTNB DPODFOUSBUJPO PG USFUJOPJO IPVST BGUFS UIF GJSTU EPTF " TFQBSBUF UPYJDPLJOFUJD TUVEZ JO NJDF JOEJDBUFT UIBU TZTUFNJD FYQPTVSF JT HSFBUFS BGUFS UPQJDBM BQQMJDBUJPO UP VOSFTUSBJOFE BOJNBMT UIBO UP SFTUSBJOFE BOJNBMT TVHHFTUJOH UIBU UIF TZTUFNJD UPYJDJUZ PCTFSWFE is probably related to ingestion. Male and female dogs treated with Retin-A Micro (tretinoin gel) NJDSPTQIFSF BU PS NH LH EBZ USFUJOPJO PS UJNFT UIF NBYJNVN human systemic dose after topical administration of Retin-A Micro (tretinoin gel) microsphere, OPSNBMJ[FE GPS UPUBM CPEZ TVSGBDF BSFB SFTQFDUJWFMZ GPS EBZT TIPXFE OP FWJEFODF PG reduced testicular or ovarian weights or pathological changes. Nursing Mothers: *U JT OPU LOPXO XIFUIFS UIJT ESVH JT FYDSFUFE JO IVNBO NJML #FDBVTF NBOZ ESVHT BSF FYDSFUFE JO IVNBO NJML DBVUJPO TIPVME CF FYFSDJTFE XIFO 3FUJO " .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. $MJOJDBM TUVEJFT PG 3FUJO " .JDSP EJE OPU JODMVEF TVGGJDJFOU OVNCFST PG TVCKFDUT BHFE BOE over to determine whether they respond differently from younger subjects. ADVERSE REACTIONS: 5IF TLJO PG DFSUBJO TFOTJUJWF JOEJWJEVBMT NBZ CFDPNF FYDFTTJWFMZ SFE FEFNBUPVT CMJTUFSFE PS crusted. If these effects occur, the medication should either be discontinued until the integrity PG UIF TLJO JT SFTUPSFE PS UIF NFEJDBUJPO TIPVME CF BEKVTUFE UP B MFWFM UIF QBUJFOU DBO UPMFSBUF 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 VTF POMZ *G NFEJDBUJPO JT BQQMJFE FYDFTTJWFMZ OP NPSF SBQJE PS CFUUFS SFTVMUT XJMM CF PCUBJOFE BOE NBSLFE SFEOFTT QFFMJOH PS EJTDPNGPSU NBZ PDDVS 0SBM JOHFTUJPO PG MBSHF BNPVOUT PG UIF ESVH NBZ MFBE UP UIF TBNF TJEF FGGFDUT BT UIPTF BTTPDJBUFE XJUI FYDFTTJWF PSBM JOUBLF PG 7JUBNJO " Rx only.
Distributed by: Ortho Dermatologics Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., -PT "OHFMFT $" ÂŞ 0.1 %% RETIN-A MICRO ÂŽ JT B SFHJTUFSFE USBEFNBSL PG 0SUIP .D/FJM 1IBSNBDFVUJDBM *OD MICROSPONGE ÂŽ JT B SFHJTUFSFE USBEFNBSL PG ".$0- *OUFSOBUJPOBM $PSQPSBUJPO
Publishing Staff
EDITORIAL BOARD
Travis Hayden, MPAS, PA-C, Editor in chief Joe R. Monroe, MPAS, PA-C Patricia Ferrer, MPAS, PA-C Gordon Day, R.Ph., PA-C Nancy Primo, MPAS, PA-C Lauren Zajac, MHS, PA-C Michelle DiBaise, MPAS, PA-C P. Eugene Jones, Ph.D., PA-C Mark Archambault, DHSc, PA-C Kristine Kucera, DHS, MPAS, PA-C Jennifer Winter, PA-C Mark Hyde, MMS, PA-C Jennifer Connor, MPAS, PA-C Jeffrey LaDuca, Ph.D., MD Alan Menter, MD
DEPARTMENT EDITORS
Clinical Department Editors Susan E. King-Barry, MPAS, PA-C Karen Graham, MPAS, PA-C Drugs in Dermatology Editor Stephen Wolverton, MD Surgical Department Editor Christy Kerr, MPAS, PA-C Cosmetic Department Editor Nancy Primo, MPAS, PA-C Prof Dev Department Editor Abby Jacobson, MS, PA-C
SDPA Board of Directors
PrESiDEnT 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
Publisher Travis Hayden, MPAS, PA-C Managing Editor Jennifer M. Hayden, M.Ed Copy Editor Douglas Morris Art Director Angela Simiele Website Design Terry Scanlon
SALES Office
Physician Assistant Communications, LLC P.O. Box 416, Manlius NY 13104-0416 Phone (315) 663-4147 PAC@pacommunications.org www.pacommunications.org editorial missioN: The JDPA is the official clinical journal of the Society of Dermatology Physician Assistants. The mission of the JDPA is to improve dermatological patient care by publishing the most innovative, timely, practiceproven educational information available for the physician assistant profession. PUBLISHED CONTENT IN THE JDPA: Statements and opinions expressed in the articles and communications herein are those of the authors and not necessarily those of the Publisher or the Society of Dermatology Physician Assistants (SDPA). The Publisher and the SDPA disclaim any responsibility or liability for such material, including but not limited to any losses or other damage incurred by readers in reliance on such content. Neither Publisher nor SDPA verify any claims or other information appearing in any of the advertisements contained in the publication and cannot take responsibility for any losses or other damage incurred by readers in reliance on thereon. Neither Publisher nor SDPA guarantees, warrants, or endorses any product or service advertised in this publication, nor do they guaranty any claim made by the manufacturer of such product or service. This Issue: of JDPA includes articles that have been reviewed and approved for Category I (Preapproved) CME credit by the American Academy of Physician Assistants. Approval is valid for 1 year from the issue date, and participants may submit the self-assessment at any time during that period. Category I CME articles included in JDPA are planned and developed in accordance with AAPA’s CME Standards for Journal Articles and for Commercial Support of Journal Articles. Since its inception, the JDPA has utilized eco-friendly printing practices. The JDPA is printed on paper obtained from sustainable forests that meet strict environmental standards. Soy-based inks that have a low environmental impact are used during printing of the journal and the journal is printed using 100% renewable energy. SDPA members 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 6, Number 2, Spring 2012. One year subscription rates: $40 in the United States and Possessions. Single copies (prepaid only): $10 in the United States (Include $6.50 per order plus $2 per additional copy for US postage and handling). TM Periodicals postage rate paid at New York, NY 10001 and additional mailing offices. Š 2012 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
Journal of Dermatology for Physician Assistants
The Official Journal of the SDPA
Calling All Running & Walking Enthusiasts! On Saturday, July 14th plan to participate in the SDPA’s inaugural Miles for Melanoma 5K Run/1 Mile Walk.
P
rofessional Writing is vital to the health and growth of the PA profession. Articles, books, and other professional documents written by PAs not only educate those who read this literature, but also help to promote the awareness of our profession. Jim Cawley, a PA educator, author, and current Director of the George Washington University PA Program has said, “…our profession is judged in part by the quality and content of the PA literature.” Dermatology PAs who contribute to this body of literature are creating a lasting positive impression on all of our supervising physicians about the vital role that PAs play in dermatology. I recently came across two PA authored articles that are excellent examples of this sort of quality literature. The first article was written by Mark Hyde, MMS, PA-C, et al. and was published in Archives of Dermatology, March, 2012, titled: A Randomized Trial of the Off-label Use of Imiquimod, 5%, Cream With vs. Without Tazarotene, 0.1%, Gel for the Treatment of Lentigo Maligna, Followed by Conservative Staged Excisions. The second article was written by Bethany Grubb, MPAS, PA-C, et al. and was published in JAAD, November, 2011, titled: Adult T-cell lymphoma/leukemia presenting as pagetoid reticulosis of the palms and soles. These two SDPA Fellow members illustrate that publishing quality, well written articles by dermatology PAs within the pages of respected physician journals is not only achievable, but enhances our standing as a PA specialty community. Publishing PA authored literature promotes the awareness of our profession, is imperative to our professional development, and creates an opportunity outside of our clinical setting to demonstrate to our supervising physicians our depth of dermatological knowledge. I encourage all dermatology PAs to pick up your pens, fire up your keyboards, and start contributing to this body of written knowledge. Your contributions, whether a brief summary of the recent FDA sunscreen label changes or a thoroughly conducted clinical research project, are essential for the continued health and growth of our PA profession. J
Travis Hayden, MPAS, PA-C Editor in chief
Sign-up today when you register for the 2012 SDPA Summer Dermatology Conference in Seattle, WA. All proceeds will benefit the Melanoma Research Foundation. Vol. 6, No. 2 SPRING 2012
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.
19
Hyperhidrosis
- A Review of Primary Hyperhidrosis and its Current Management By Samantha Hill, MD, and Danielle Glade, MS
CME
10 Derm PA News & Notes – part one
• Certification Review - All Those Things Inside the Skin You Might Have Forgotten • A New Prescription for the Healthcare Industry: Sunshine • SDPA State Affiliates Round Table Discussion - Does My State Need a Chapter?
19 Clinical Dermatology
• CME Article – Hyperhidrosis - A Review of Primary Hyperhidrosis and its Current Management • Drugs in Dermatology – Vemurafenib & Ipilimumab – New Targeted Therapies Help Patients with Advanced Melanoma
Departments
04 Editorial Board 05 Editor’s Message 09 SDPA News & Current Affairs 10 Dermatology Market Watch 14 Now Showing on Dermcast.tv 25 From The Patient’s Perspective 29 Dermoscopy Q&A 30 Clinical Snapshots 34 Surgical Wisdom 38 Cosmetic Pearls 47 Outside & Inside the 9 to 5... 49 Notes from your Office Manager 54 The Difference We Make 59 Dermatology in Art 61 JDPA Information for Authors 62 Professional Opportunities and Development
34 Surgical Dermatology
• Surgical Wisdom - Needle Stick Prevention
37 Cosmetic Dermatology • Journal Club: Dermatology PA Perspectives
41 Professional Development
51 Derm PA News & Notes – part two
Go Green - Read Online
• Dermatology Billing & Coding – Be In Charge of Your Own Destiny • Judicial and Ethical Affairs – The Ethics of Enhancement “Is Better Always Good?”
Journal of Dermatology for Physician Assistants
• From the Desk of… • Student Scoop - Pay it Forward • Workplace Excellence - Creating an Intentional Culture of Excellence in the Workplace • Supervising Physician Corner • Camp Discovery 2012
dermPA.org
Vol. 6, No. 2 SPRING 2012
Journal of Dermatology for Physician Assistants
Calendar
FROM THE SPDA News & Current Affairs
of events
2012
R
JULY SDPA Summer Dermatology Conference July 11 - 15, 2012 The Westin Hotel Seattle, WA
ecently, $5,700 in cash and coins fell out of an unsecured door of an armored truck on a Maryland freeway. Thirty motorists stopped to frantically grab fistfuls of money, risking their lives in what one motorist called a “snow globe of cash.” Police urged the motorists to return the money with no questions asked and no charges filed. However, by that evening no one had returned any of the money.
AUGUST AAD Summer Academy Meeting August 15 - 19, 2012 Boston, MA
Would you return it? Or would you feel justified keeping it, convincing yourself that the money was insured, and it was their loss and your gain?
OCTOBER/NOVEMBER SDPA 10th Annual Fall Conference October 31 - November 3, 2012 Caesars Palace Hotel Las Vegas, NV
2013 MARCH 71st AAD Annual Academy Meeting March 1 - 5, 2013 Miami, FL
Whether encountering loose money on a freeway or practicing dermatology, ethical questions challenge us daily. Are we practicing medicine outside of the scope of our supervising physician; performing unnecessary biopsies, using upcoding and discount billing, receiving inappropriate pharmaceutical industry funding, or breaking patient confidentiality? Depending on how we chose to respond may potentially raise ethical red flags. In today’s busy world of medicine, it is valuable to pause for a moment and consider the importance of having ethics in our daily lives and day-to-day practices. May integrity guide our every action. J
Keri Holyoak, MPH, PA-C SDPA President, Diplomate
Vol. 6, No. 2 SPRING 2012
9
Dermatology PA news & notes
Dermatology Market Watch Ellzey Coding Solutions Announces DermCoder Online Ellzey Coding Solutions (ECS), a company specializing in dermatology-specific coding and billing tools, unveiled their new internetbased version of its popular DermCoder software. The new application will run on any web-enabled device including PCs, Macs, iPhones, iPads, and Android devices. The new application eliminates the need for installing and downloading updates or unlocking the software for access. Customers that update their computers or hardware, or change locations will no longer have to reinstall DermCoder or contact support to get DermCoder running again. Just log into the website and DermCoder is available 24 hours a day. DermCoder Online will be available at no charge for customers with a current subscription. The older CD-based versions of DermCoder will be phased out over the next few months. For more information on DermCoder, visit www.dermcoder. com. Free training videos are also available for viewing at www.youtube.com/ellzeycoding.
FDA Approves New T.R.U.E. TEST® Patch Test Allergens SmartPractice®, manufacturer and distributor of T.R.U.E. TEST, announced that the FDA has approved seven new allergens: • Gold sodium thiosulfate (Metal) • Hydrocortisone-17- butyrate (Steroid) • Methyldibromo glutaronitrile (Preservative) • Bacitracin (Antibiotic) • Parthenolide (Plant allergen) • Disperse blue 106 (Azo dye) • Bronopol (Antimicrobial agentpreservative) The addition of the seven new allergens completes the T.R.U.E. TEST three-panel system (36 allergen/ allergen mixes/control), and now provides a tool to diagnose 90% of the most common contact allergies. The complete 3-Panel T.R.U.E. TEST allergen patch test system will be available in May 2012 through SmartPractice. For more information on T.R.U.E. TEST, visit www.truetest.com. ...continued on page 13 10 Journal of Dermatology for Physician Assistants
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. 6, No. 2 SPRING 2012 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 ONLY– 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 Cushing’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 Cushing’s syndrome than mature patients because of a larger skin surface area body weight ratio. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’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 15° and 30° C (59° and 86° 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
XXX QSPNJVTQIBSNB DPN 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
Dermatology Market Watch
...continued from page 10
Utah Signs SB 41 Into Law
This new law is a step in the right direction in addressing the growing incidence of melanoma in Utah, as it will significantly decrease indoor tanning bed use among teenagers. During 2007-2008, Utah had the highest rate of new melanoma cases per capita in the U.S.
(most up-to-date statistics from the National Cancer Registry). The bill’s chief sponsor was Senator Patricia Jones. The House sponsor was Representative Brad Wilson. The effort was led by a number of organizations and individuals including Dr. Sancy Leachman, MD, PhD, Director of the Melanoma and Cutaneous Oncology Program at the University of Utah School of Medicine, AIM at Melanoma, Huntsman Cancer Institute, University of Utah Health Care, Sol Survivors, and others. AIM greatly appreciates everyone who supported this bill, which included the SDPA and its members. For more information on the bill see: http://le.utah. gov/~2012/htmdoc/sbillhtm/SB0041S05.htm or visit www.AIMatMelanoma.org, a comprehensive website available to the melanoma community and public at large.
May is Melanoma/Skin Cancer Detection and Prevention Month® The first Monday of May (this year May 7th) is Melanoma Monday® and the official launch of Melanoma/ Skin Cancer Detection and Prevention Month®. Through the AAD’s National Melanoma/ Skin Cancer Screening Program, dermatology providers volunteer to provide free skin cancer screenings in their communities. Since 1985, this public service program has screened more than 2.1 million people and detected more than 206,500 suspicious lesions, including more than 23,500 suspected melanomas. By conducting free skin cancer screenings, dermatology providers are bringing attention to the profession of dermatology, helping to educate millions of people about the importance of sun protection and early skin cancer detection, and most important, helping to directly save lives by finding melanomas in their earliest, most treatable stage.
While May is designated as Melanoma/Skin Cancer Detection and Prevention Month, skin cancer screenings can be performed at any time throughout the year. As this is an AADsponsored program and a member benefit, Academy member dermatologists must order all materials, serve as the Program Director and be present at the screening. Physician assistants can conduct skin cancer screenings under the supervision of a dermatologist. If you are interested in volunteering, visit the AAD’s website at www.aad.org/screenings to find a free skin cancer screening location and to learn more about the guidelines for screening coordinators. J
Vol. 6, No. 2 SPRING 2012 13
DERmatology pa news & notes
Utah’s Senate Bill (SB) 41 was signed into law by Governor Gary Herbert on March 26th, 2012. The law will require that a tanning facility may not allow anyone under the age of 18 from using a tanning device unless the minor (i) has a written order from a physician or (ii) at each time of use the minor is accompanied at the tanning facility by a parent or legal guardian who provides written consent authorizing the minor to use the tanning device. The law strengthens the existing law, which required a parent or legal guardian to provide a written consent at least once each twelve month period thereafter in which the minor uses the tanning device.
Now Showing on Dermcast.tv The official online media resource of the SDPA
DERmatology pa news & notes
Your source for audio podcasts, the most current dermatology news and research, procedural videos, conference highlights, and much, much more.
SPECIFIC URL: http://dermcast. tv/utah-teentanning-billpasses-bothhouse-and-senate image by Brian Turner
Utah Teen Tanning Bill Makes Waves
SPECIFIC URL: http://dermcast. tv/fda-approvesvismodegiberivedge-basal-cellcarcinoma-treatment image by Tony the Misfit
FDA Approves Vismodegib for Basal Cell Carcinoma Treatment
SPECIFIC URL: http://dermcast. tv/audio-podcastwomen-andpsoriasis-abbyvan-voorhees-md
Audio Podcast: Women and Psoriasis with Abby Van Voorhees, MD
SPECIFIC URL: http://dermcast. tv/surgicalprocedures-coemcgrath
Surgical Procedures with Coe McGrath
14 Journal of Dermatology for Physician Assistants
In March, after much debate, the Utah House and Senate passed SB 41, a breakthrough teen tanning legislation in the fight against melanoma. This bill prohibits the use of tanning salons by anyone under the age of 13, and requires minors aged 14-18 to be accompanied by a parent, unless the minor has a written order from a physician.
In February, the US Food and Drug Administration (FDA) approved the oral capsule vismodegib (ERIVEDGE) to treat adults in advanced stages of BCC, the first drug of its kind to be given approval for basal cell carcinoma.
In this podcast, Dr. Van Voorhees covers issues particularly related to women with psoriasis. She journeys through a variety of scenarios including treatment issues unique to young women, mothers, and women in the menopausal period.
In this video, Coe McGrath reviews a quick surgical technique particularly useful with the elderly, as learned at the 8th annual Fall SDPA conference.
A New Prescription for the Healthcare Industry: Sunshine By Sarah Richardson, Chief Compliance Officer, Medicis Pharmaceutical Corporation
Ethical Issues The rising costs of healthcare have subjected interactions between the pharmaceutical industry and HCPs to increased scrutiny. In this context, industryprovider interactions have been blamed for the rising cost of drug reimbursements to state and federal healthcare programs and have been criticized for threatening the integrity of therapeutic decision-making. Investigations and prosecutions of drug companies and HCPs (including PAs) have occurred based on inappropriate industryprovider relationships.
Codes of Conduct There are, of course, numerous interactions between drug companies and HCPs that benefit patients and enhance the practice of medicine. Relationships that provide real value to patients include, for example, clinical research and consulting arrangements. To reinforce the appropriate nature of such interactions (and respond to Sarah Richardson is the Chief Compliance Officer for Medicis Pharmaceutical Corporation and is responsible for overseeing the company’s corporate compliance program. Prior to joining Medicis, Mrs. Richardson was in private practice at Hunton & Williams, LLP and specialized in FDA regulatory law, healthcare fraud and abuse laws, and development of pharmaceutical/medical device company compliance programs. Mrs. Richardson is a graduate of Furman University, St. Andrews University, and Northwestern University School of Law.
what had been viewed as egregious sales and marketing excesses), the Pharmaceutical Research and Manufacturers of America (PhRMA) created the PhRMA Code on Interactions with Healthcare Professionals in 2002 that was designed to reflect “best practices” for industry and establish a minimum standard of conduct for company representatives to follow. The introduction of the PhRMA Code marked a significant shift in drug industry marketing practices. Among other things, the code provided guidance on the provision of meals to HCPs, the entertainment of HCPs, and the giving of practice-related items to HCPs. Several years later, PhRMA issued a revised PhRMA Code that took effect in January 2009 and was intended to respond to specific criticisms of industry practices. Of note, the revised code: 1. Allows field-based sales representatives and their immediate managers to provide an occasional modest meal to HCPs and their staff in connection with a scientific or clinical presentation or discussion, but only in the HCP’s office or a hospital setting (the 2002 PhRMA Code required only that the venue of the meal be conducive to informational communication). Field-based sales representatives thus are prohibited from providing out-of-office meals to HCPs. 2. Prohibits companies from providing entertainment or recreation in any interactions with HCPs (the 2002 PhRMA Code permitted entertainment in certain contexts). 3. Prohibits company representatives from giving to HCPs any “practice-related gifts” of nominal value imprinted with the company’s name or logo (e.g., pens, mugs, or notepads), but permits the giving of “educational items” designed to educate patients or HCPs so long as they are valued at $100 or less and do not have value outside of the HCP’s medical practice.
Transparency Requirements The federal government declared that compliance with the PhRMA Code, while not insulating a firm from liability as a matter of law, would “substantially reduce the risk of fraud and abuse” and “demonstrate a good faith effort to comply with applicable federal health care program requirements.” Many states have considered industry codes to be the basis for determining appropriate Vol. 6, No. 2 SPRING 2012 15
DERmatology pa news & notes
The U.S. government recently proposed a regulation that is intended to enhance public trust and restore confidence in the healthcare industry by increasing awareness of financial relationships between pharmaceutical companies and healthcare professionals (HCPs). Under the proposed regulation, which was issued by the Centers for Medicare and Medicaid Services (CMS) pursuant to the Physician Payments Sunshine Act, pharmaceutical companies will be required to report annually, payments and other transfers of value to HCPs, and the government will post the payment information on a public website. This move to bring such payments into the “sunshine” is the latest effort to regulate industry interactions with HCPs and increase the transparency of such relationships. These efforts have accelerated over the last decade or so and have addressed many of the ethical issues associated with industry-provider interactions. In so doing, these actions have affected the practice of dermatology, including among physician assistants (PAs).
Certification Review
All Those Things Inside the Skin You Might Have Forgotten By James A. Van Rhee, MS, PA-C
QUESTION: A 21-year-old male presents with acute onset of right knee pain, inflamed conjunctiva, and mucocutaneous lesions. Patient states that ten days ago he had intermittent fevers and diarrhea for three days. Which of the following is the most likely diagnosis? A. Systemic lupus erythematous B. Ankylosing spondylitis C. Polyarteritis nodosa D. Reiter syndrome
fever, malaise, and weight loss. On physical examination, palpable purpura and a non-deforming arthritis are noted. Reiter syndrome, or reactive arthritis, is a seronegative spondyloarthropathy. It is common in young adults and is secondary to chlamydial urethritis or gastrointestinal infection, most commonly Campylobacter. The patient presents with low back pain, asymmetric arthritis of the knees or ankles, conjunctivitis, mucocutaneous lesions, and swelling of the fingers or toes (sausage digits). J
EXPLANATION: Systemic lupus erythematous is a multiple system disease that is most commonly noted in females of reproductive age. It presents with fever, weight loss, malaise, and symmetrical peripheral arthralgias. On physical examination, a facial butterfly rash is noted. The anti-nuclear antibody (ANA) test is positive. Ankylosing spondylitis is a seronegative spondyloarthropathy. It is most common in males ages 30 to 50. It involves the sacroiliac joint, spine, and hips. The patient presents with morning stiffness and low back pain. Spinal x-ray reveals sacroiliitis and a bamboo spine. Polyarteritis nodosa is a vasculitic disease of the medium-sized arteries. Most common in middle-aged men, the patient presents with
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 15 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.
A New Prescription
The correct answer is D.
DERmatology pa news & notes
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!
...continued from page 15
industry conduct, but others have set more stringent standards. In recent years, four states (Massachusetts, Minnesota, Vermont, and West Virginia) and D.C. have required companies to undertake specific compliance activities and publicly disclose all payments made by the company to a HCP. Some of these states have totally banned certain marketing activities such as occasional meals. In 2010, Congress enacted a federal statute entitled the Physician Payments Sunshine Act that requires drug companies to report annually the payments and other transfers of value they make to physicians and teaching hospitals. The federal regulation that was recently proposed would implement this statute. Under federal sunshine requirements, every “transfer of anything of 16 Journal of Dermatology for Physician Assistants
value” to a physician, from research grants to in-office meals, will be posted on a public website beginning in 2013 (and every year thereafter). While the regulation and the timing of its implementation is not yet final, certain transfers of value to PAs, such as in-office meals, likely will be disclosed in the name of the supervising physician. Some commentators fear that public disclosure of industry payments to HCPs will have a chilling effect on legitimate company-provider interactions. Others fear that disclosure will discourage beneficial research relationships. Hopefully this will not be the case, and instead the sunshine measures will be the prescription for ensuring ethical interactions between company representatives and HCPs that benefit patients and enhance the practice of medicine. J
SDPA State Affiliates Round Table Discussion Does My State Need a Chapter?
Joleen M Volz, MPAS, PA-C
Matthew Brunner, MHS, PA-C
Jacki Kment, MPAS, PA-C
SDPA Constituent Relations Committee Chair
SDPA Constituent Relations Committee Member President of Georgia Dermatology Physician Assistants
SDPA Vice President Founder and President of Nebraska Dermatology Physician Assistants
Joleen - How does one know if there is a need to have a state chapter? Matthew - That’s a great question and one that I think a lot of individuals may be wondering. I can’t speak for every situation, but in Georgia we had a larger number of dermatology PAs who were practicing in the geographic area of metropolitan Atlanta. Several of the PAs who came before me had gotten to know one another through different dinner programs and felt that it would be ideal to have a group of dermatology PAs who could get together for both dinner programs and to discuss legislative matters as they might affect those of us who practiced dermatology in Georgia. So I think the answer to your question would be that at any point that a group feels they have a common interest in promoting PAs in the field of dermatology, it makes sense to have a state group. Jacki - In the state of Nebraska we have seen an exponential increase in dermatology PAs in the past ten years and foresee this increase continuing into the future. We started to organize years ago by having a journal club, and as the number of dermatology PAs increased, it became apparent that a more official structured organization needed to be formed. The need to form a state chapter arises as the interest among dermatology PAs to gather together for growth increases.
think another way to organize would be through formation of a group on Facebook or another social network. One limitation to the social network model is that not all of the interested PAs may be using these tools. Jacki - For us it started with two PA colleagues discussing the needs of dermatology PAs within our state and the hope to begin our own state chapter. Then we developed a database of potential members. This can be accomplished by making contacts with other area dermatology PAs, contacting your state PA society, medical board, area PA programs, and even utilizing pharmaceutical representatives for contact information to obtain a list of dermatology PAs within your state. An email was sent out to all the dermatology PAs within our state to determine if a true need to organize was apparent. Once the need was evident, we set a meeting date, place, and time, and the rest became history. Joleen - What are the first steps to organizing as a state chapter?
Joleen - How did you get the people together to form a state chapter?
Matthew – Well, to begin with, I would think you would need to be sure there are no competing groups within your same state. So I’d first set out to find if there are any other leaders or groups that already meet or have some organization. You don’t want to duplicate the efforts of others, as that will waste time and energy. The second step is to find other volunteers to help start the process of creating a name and deciding what the purpose and goals will be of the organization.
Matthew - In our case, we all networked through pharmaceutical representatives by asking them to invite the dermatology PAs they called on to attend our first meeting. This was before social networking became big. I
Jacki - First and foremost bring potential members together. Then establish a board of directors and set your bylaws. Begin designated quarterly (or monthly) meetings. Next, incorporate your organization to become officially Vol. 6, No. 2 SPRING 2012 17
DERmatology pa news & notes
The purpose of this first installment of the SDPA state affiliates round table discussion is to provide dermatology PAs guidance in determining if there is a need for a state chapter in their state and advice on how to organize their state’s dermatology PAs to form a state affiliate chapter of the SDPA. Leading the discussion panel will be Joleen M Volz, MPAS, PA-C, SDPA Constituent Relations Committee Chair. She is joined at this round table by Matthew Brunner, MHS, PA-C, President of Georgia Dermatology Physician Assistants, and Jacki Kment, MPAS, PA-C, Founder and President of Nebraska Dermatology Physician Assistants.
recognized. Finally, consider becoming an affiliate chapter of the SDPA. You may also wish to investigate the need for becoming a tax-exempt organization. Joleen - How did you get PAs interested in forming a chapter?
DERmatology pa news & notes
Matthew - I think like most movements it starts with your friends, and then it begins to spread through extended relationships. Don’t forget to utilize the pharmaceutical representatives to help you as they probably know far more dermatology PAs than you know. We initially had a pharmaceutical company help sponsor our first meeting. You can also contact your state PA society to see if they keep a database of PAs by specialty. Jacki – For our state it started with just two dermatology PAs sitting down and discussing the possibility of forming a state chapter. From there we discussed the idea with other colleagues who showed interest. This discussion extended to include other dermatology PAs and the interest grew. It may simply take one or two people to ‘light the fire’ and if interest is shown then an initial meeting of potential members can ensue. Joleen - How would you recommend communicating with the interested dermatology PAs?
Matthew - I think this ultimately depends on the number of members your organization has. Initially, I highly recommend all groups use email. We graduated from email to having our own website to communicate with members and also using Evite to electronically invite members to events. The latter was very helpful in disseminating invitations for our dinner programs as it helped us keep up with RSVPs and was free to use. We have worked some with Facebook, and I think this is certainly another option to consider as long as you understand its limitations. Jacki - I would recommend communicating by ‘word of mouth’ initially to gain a few interested individuals to help with the initial stages of forming a state chapter. Email has been the best form of communication for our state chapter. A direct mailer would also be a possibility, but due to the expense it may not be desirable other than for those potential members without email accessibility. This may not be feasible in the beginning stages of forming a state chapter when funding is not readily available. However, I would encourage contacting your state PA society and/or the SDPA to see if an article or advertisement about your group could be placed in a newsletter or other media source to try and reach a larger audience. J
Future topics that may be discussed at the round table include: steps to becoming affiliated with the SDPA, how to incorporate your state affiliate, keeping your state affiliate active, and how to interact with your local state medical board. If you have any other topics that you would like to see covered, please feel free to share them with us. Email editor@jdpa.org with any topic ideas or state affiliate questions.
Are you a SDPA Diplomate? Currently 30% of SDPA membership has earned the prestigious SDPA Diplomate designation! These highly trained Dermatology Physician Assistants are working towards completion of the 70 hour Dermatology Distance Learning Initiative developed by the SDPA and UT Southwestern! Annual verifications confirm that 100% of Diplomates work along side a Board Certified Dermatologist! The SDPA is committed to providing advanced continuing education to its members, and promoting a team approach to medical care! Sign up to become a SDPA Diplomate today at www.dermpa.org/diplomate
18 Journal of Dermatology for Physician Assistants
Clinical Dermatology
Hyperhidrosis - A Review of Primary Hyperhidrosis and its Current Management By Samantha Hill, MD, and Danielle Glade, MS
SDPA Members Only Content A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.
CME
This program has been reviewed and is approved for a maximum of .5 hours of AAPA Category I CME credit by the Physician Assistant Review Panel.
Approval is valid for 1 year from the issue date of APRIL 2012. Participants may submit the self-assessment exam at any time during that period. This program was planned in accordance with AAPA’s CME Standards for Enduring Material Programs and for Commercial Support of Enduring Material Programs.
SDPA members may access the posttest at www.jdpa.org
Learning Objectives: 1. Describe the pathophysiology of primary hyperhidrosis and its impact on patients. 2. Identify the differential diagnoses and recognize the clinical presentations of primary hyperhidrosis. 3. Review the current therapeutic options used in the management of primary hyperhidrosis. Vol. 6, No. 2 SPRING 2012 19
Hyperhidrosis SDPA Members Only Content
CLINICAL Dermatology
A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.
20 Journal of Dermatology for Physician Assistants
Hyperhidrosis SDPA Members Only Content
CLINICAL Dermatology
A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.
Vol. 6, No. 2 SPRING 2012 21
Hyperhidrosis SDPA Members Only Content
CLINICAL Dermatology
A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.
22 Journal of Dermatology for Physician Assistants
Hyperhidrosis SDPA Members Only Content
CLINICAL Dermatology
A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.
Vol. 6, No. 2 SPRING 2012 23
Hyperhidrosis SDPA Members Only Content
CLINICAL Dermatology
A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.
Samantha Hill, MD earned her medical degree from The Medical College of Wisconsin in 2003, completed a pediatric residency and internship at Nationwide Children’s Hospital in Columbus, Ohio in 2006, and completed a dermatology residency at Saint Louis University Hospital in 2009. She then completed a fellowship in pediatric dermatology at Children’s Hospital of Wisconsin in 2010. Following her training, she joined the faculty of the Medical College of Wisconsin where she practiced at Children’s Hospital of Wisconsin. Currently, Dr. Hill is on faculty as a pediatric and adolescent dermatologist with ’Specially for Children and Dell Children’s Medical Center in Austin, Texas. She has also been appointed as Clinical Assistant Professor of Dermatology in the UT-Southwestern Medical School Department of Dermatology. Dr. Hill treats a variety of skin diseases in children and adolescents and specializes in the treatment of hyperhidrosis. In 2010, Dr. Hill initiated the Pediatric Hyperhidrosis Clinic at The Children’s Hospital of Wisconsin. More than 100 patients were treated in the first year and the clinic continues to help children with hyperhidrosis. With the start of 2012, a new hyperhidrosis clinic for children and adults has been launched at ’Specially for Children in Austin, Texas. Dr. Hill also regularly lectures at regional and national meetings. She has indicated no relationships to disclose relating to the content of this article. Danielle Glade is a fourth year medical student at Texas A&M Health Science Center, College of Medicine in Round Rock, Texas, pursuing a residency in Pediatrics. She is a selected member of the Arnold P. Gold Humanism Honor Society. Her interests include medical student well being and patient advocacy. She has indicated no relationships to disclose relating to the content of this article. 24 Journal of Dermatology for Physician Assistants
From The Patient’s Perspective Sol Survivor
I have always had a lot of moles growing up, and I didn’t like to talk about what had happened to me. because of this fact, I was told to make sure I took good I was horrified by what I looked like. It took about a year care of my skin. I was well aware of the ABCD’s of of intensive laser treatments for scar revision before I was abnormal moles and what to look for. I thought I was comfortable enough to come out and share my story. After being safe and very careful with my skin. the laser treatments I felt like I could go out and possibly make a difference. I wanted During my teenage years and early to tell people, especially the kids, my story twenties I was very vain about the way I so they didn’t have to go through the same looked, as I think most of us are at those thing I did. I thought about all of the ages. I had started indoor tanning because times I had heard the tanning industry say, I really liked the way I looked with a tan. “Just follow the guidelines in our tanning I thought I looked healthier, and it made beds and you will be safe.” I started doing me feel better about myself. When I went interviews on TV and on the radio, sharing tanning I was very careful and never burned my story. The interest in my story started to in a tanning bed. Half way through a pick up, and teachers began asking me to session I would cover my face with a towel come and speak to their classrooms. I would because I didn’t like the freckles that would spend all day at a school, talking to each appear afterwards. of their health classes. Some kids would At the age of twenty-three, I noticed a Before being diagnosed literally faint during my speech. It was the very pink mole forming on my left cheek. the melanoma is visible on first time that I felt like a survivor and not a my left cheek. It didn’t bother me so much, and I wasn’t victim of melanoma. worried because it looked nothing It was around this time that like an abnormal mole; there I realized that my home state of were no signs of the ABCD’s I Utah didn’t have an organization had been taught to look out for. that primarily focused on It wasn’t until I was twenty-four melanoma. While there are many that the mole started to bother great organizations out there me. It was more noticeable now, for cancer, I felt that melanoma a lot more pink, and people really needed something more. would make comments about it. It is such a confusing and It was then that I decided, for pure disfiguring cancer that I believed that vanity reasons alone, that I needed we could somehow do better. This is to have the mole removed. I made an when our patient advocacy group for appointment with a plastic surgeon people with melanoma was started. and had the mole removed on a My husband came up with the name, Friday. By Monday I had received the “Sol Survivors.” call that it was melanoma. Our group is just starting Two surgeries later I was home out and we have looked to other with a six-inch scar down my cheek established advocacy groups, such as and several more scars across my AIM at Melanoma, for guidance in neck wondering, what had I done our efforts. It has been an incredible to myself? At that point in my life I Recovering after surgery – the melanoma and experience thus far. I have met so twenty-six lymph nodes on the left side of my had no other family members who many amazing people. When I would had been diagnosed with skin cancer. neck were removed. speak at schools, many kids shared Being diagnosed at such a young age with me how they were able to get around the current was an extreme shock! I would cry at night thinking about indoor tanning law and tan at their leisure without their the damage I had done to my skin while not even knowing parents’ knowledge. Our group recently had a chance I was doing it. I thought a sunburn was the only bad thing to help this year with legislation in Utah to try and ban that could cause skin cancer. I didn’t realize that a tan was anyone under the age of eighteen from using a tanning just as dangerous. I believe that the melanoma was caused device. At each legislative hearing we would fill the room by the tanning beds I had been using.
It was the first time that I felt like a survivor and not a victim of melanoma.
Vol. 6, No. 2 SPRING 2012 25
CLINICAL Dermatology
By MaryAnn Gerber
CLINICAL Dermatology
full of young women and their families who had been tanning and were diagnosed with melanoma. We posted comments on Facebook and AIM at Melanoma was right there in our corner. It was a long and drawn out battle but in the end we did it! On March 26th, 2012 our governor signed into law Utah’s Senate Bill (SB) 41: A tanning facility may not allow anyone under the age of 18 from using a tanning device unless the minor (i) has a written order from a physician or (ii) at each time of use the minor is accompanied at the tanning facility by a parent or legal guardian who provides written consent authorizing the minor to use the tanning device. This bill strengthens the existing law, which required a parent or legal guardian to provide a written consent at least once each twelve-month period thereafter in which the minor uses the tanning device. While SB 41 is a big step in the right direction, our group will continue our efforts to achieve a complete ban on indoor tanning for those under the age of eighteen. I am looking forward to seeing what we can accomplish in the future! J MaryAnn Gerber is thirty years old and lives in Syracuse, Utah. She has been married for ten years to a wonderful man named Rick Gerber. MaryAnn has a bachelor’s degree from Weber State University in Business Administrative with an emphasis in Marketing. She has been working for Mountain West Small Business Finance in Salt Lake City, Utah for twelve years and is currently the Staff Accountant. She is the founder of a grassroots patient advocacy group for melanoma patients and their families called Sol Survivors. MaryAnn has been volunteering her time for nearly five years in Utah educating teens and their families about skin cancer and the dangers of tanning beds. To learn more about Sol Survivors please visit www.wix.com/solsurvivors/mgerber.
&
Dermoscopy Q A
Question: Which pigmented lesion is considered to be “asymmetric” under dermoscopy?
A
B Answer on page 29
26 Journal of Dermatology for Physician Assistants
Take Home points for derm pas: By Steven K. Shama, MD, MPH 1. It seems to me that we, as dermatology health care providers, need to start including this question when asking our patients if any moles have changed, “Are there any spots on your skin that are different/changing or that you don’t like for perhaps cosmetic reasons?” It was primarily because of MaryAnn’s self-professed vanity that she went to the plastic surgeon to have the spot removed from her left cheek. Clearly, teaching only the ABCD’s and E’s (evolution/changing) of moles may not be sufficient. We may need to include a cosmetic “angle” to our interview questions. In doing so, we may just save a life. 2. When I reread MayAnn’s story I realized something was missing. There was no mention of a dermatology health care provider involved in her care, despite the fact that she was aware of having many moles and also of the ABCD’s of melanoma. In fact, her first reaction when she was getting comments from friends about the changing spot on her left cheek was to see a plastic surgeon. Fortunately this surgeon didn’t discourage her from having the spot removed because of the possibility of scarring, especially since her lesion didn’t have the classic changes of melanoma. We need to continually educate our medical colleagues, especially plastic surgeons, about the variations in expressions of melanoma and to encourage them to involve dermatology if there is suspicion about whether a lesion warrants a biopsy or excision in a cosmetically sensitive area. We also need to educate the general public to see a dermatology health care provider for regular skin exams. 3. I realize how successful patients like MaryAnn can be in educating others, especially when such patients are committed to making a difference. They can be perhaps as good as or even better advocates for seeing a dermatology health care provider than we can. We should encourage such motivated teenagers to bring their message about skin care to their peers. By soliciting their help, we might be even more successful in educating teenagers about the dangers of melanoma.
Indications and Usage Picato® gel is indicated for the topical treatment of actinic keratosis. Important Safety Information For topical use only; not for oral, ophthalmic, or intravaginal use. Eye disorders, including severe eye pain, eyelid edema, eyelid ptosis, periorbital edema can occur after exposure. Patients should wash hands well after applying Picato® gel, and avoid transfer of the drug to the periocular area during and after application. Severe skin reactions in the treated area, including erythema, crusting, swelling, vesiculation/pustulation, and erosion/ ulceration, can occur after application. Administration of Picato® gel is not recommended until the skin is healed from any previous drug or surgical treatment. The most common adverse reactions (≥2%) observed in clinical trials are local skin reactions, application site pain, application site pruritus, application site irritation, application site infection, periorbital edema, nasopharyngitis and headache. There are no adequate and well-controlled studies of Picato® gel in pregnant women. Picato® gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The safety and effectiveness of Picato® gel for actinic keratosis in patients less than 18 years of age have not been established. Please see reverse for brief summary of full Prescribing Information for Picato®.
Picato is a registered trademark of LEO Laboratories Limited. LEO and the LEO Lion Design are registered trademarks of LEO Pharma A/S. ©2012 LEO Pharma Inc. 3428-PI-11-149 All rights reserved. January 2012 Printed in USA.
Vol. 6, No. 2 SPRING 2012 27
Table 4: Adverse reactions occurring in ≥2% of subjects treated with Picato® gel and at higher frequency than vehicle (trunk/extremities trials)
Picato® (ingenol mebutate) gel, 0.015%, 0.05% For topical use only. Not for oral, ophthalmic, or intravaginal use. BRIEF SUMMARY INDICATIONS AND USAGE: Picato gel is indicated for the topical treatment of actinic keratosis. ®
WARNINGS AND PRECAUTIONS: Eye disorders, including severe eye pain, eyelid edema, eyelid ptosis, periorbital edema can occur after exposure. Patients should wash hands well after applying Picato® gel, and avoid transfer of the drug to the periocular area during and after application. If accidental exposure occurs, the area should be flushed with water and the patient should seek medical care as soon as possible. Severe skin reactions in the treated area, including erythema, crusting, swelling, vesiculation/pustulation, and erosion/ulceration, can occur after topical application of Picato® gel. Administration of Picato® gel is not recommended until the skin is healed from any previous drug or surgical treatment. ADVERSE REACTIONS: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The data described below reflect exposure to Picato® gel in 499 subjects with actinic keratosis, including 274 subjects exposed to Picato® gel field treatment (skin area of 25 cm2 in the face or scalp regions) at a concentration of 0.015% once daily for 3 consecutive days, and 225 subjects exposed to Picato® gel field treatment (skin area of 25 cm2 in the trunk or extremities regions) at a concentration of 0.05% once daily for 2 consecutive days. Table 1: Investigator Assessment of Maximal Local Skin Reactions in the Treatment Area during the 57 Days Post Treatment Period (face/scalp trials) Picato® gel, 0.015% once daily for 3 days
Face and Scalp (n=545)
Any Gradea > Baseline
Grade 4
Picato® gel (n=274)
Vehicle (n=271)
Picato® gel (n=274)
Vehicle (n=271)
Erythema
258 (94%)
69 (25%)
66 (24%)
0 (0%)
Flaking/Scaling
233 (85%)
67 (25%)
25 (9%)
0 (0%)
Crusting
220 (80%)
46 (17%)
16 (6%)
0 (0%)
Swelling
217 (79%)
11 (4%)
14 (5%)
0 (0%)
Vesiculation/Pustulation
154 (56%)
1 (0%)
15 (5%)
0 (0%)
Erosion/Ulceration
87 (32%)
3 (1%)
1 (0%)
0 (0%)
Skin reactions
a
Mild (grade 1), Moderate (grade 2-3) or Severe (grade 4).
Table 2: Investigator Assessment of Maximal Local Skin Reactions in the Treatment Area during the 57 Days Post Treatment Period (trunk/extremities trials) Picato® gel, 0.05% once daily for 2 days
Trunk and Extremities (n=457)
Adverse Reactions
Picato® gel, 0.05% (N=225)
Application Site Pruritus
18 (8%)
Vehicle (N=232) 0 (0%)
Application Site Irritation
8 (4%)
1 (0%)
Nasopharyngitis
4 (2%)
2 (1%)
Application Site Pain
5 (2%)
0 (0%)
Less common adverse reactions in subjects treated with Picato included: eyelid edema, eye pain, conjunctivitis. A total of 108 subjects treated with Picato® gel on the face/scalp and 38 subjects treated on the trunk/extremities were followed for 12 months. Results from these studies did not change the safety profile of Picato® gel. ®
USE IN SPECIFIC POPULATIONS: Pregnancy: Pregnancy Category C There are no adequate and well-controlled studies of Picato® gel in pregnant women. Picato® gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Systemic embryofetal development studies were conducted with ingenol mebutate in rats and rabbits. Intravenous doses of 1.5, 3, and 5 μg/kg/day (9, 18, and 30 μg/m2/day) ingenol mebutate were administered during the period of organogenesis (gestational days 6 –16) to pregnant female rats. No treatment related effects on embryofetal toxicity or teratogenicity were noted at doses up to 5 μg/kg/day (30 μg/m2/day). Intravenous doses of 1, 2, and 4 μg/kg/day (12, 24, and 48 μg/m2/day) ingenol mebutate were administered during the period of organogenesis (gestational days 6 –18) to pregnant female rabbits. An increase in embryo-fetal mortality was noted at 4 μg/kg/day (48 μg/m2/day). An increased incidence of fetal visceral and skeletal variations was noted in all three ingenol mebutate dose groups. The clinical relevance of these findings is unclear since systemic exposure of ingenol mebutate was not detected in subjects with actinic keratosis treated with Picato® gel, 0.05% applied to a 100 cm2 treatment area. Pediatric Use: Actinic keratosis is not a condition generally seen within the pediatric population. The safety and effectiveness of Picato® gel for actinic keratosis in patients less than 18 years of age have not been established. OVERDOSAGE: Topical overdosing of Picato® gel could result in an increased incidence of local skin reactions. DOSAGE AND ADMINISTRATION: Picato® gel is for external use only. Advise patients to avoid contact with the eyes. For the treatment of actinic keratosis on the face and scalp, Picato® gel, 0.015% should be applied to the affected area once daily for 3 consecutive days. For the treatment of actinic keratosis on the trunk and extremities, Picato® gel, 0.05% should be applied to the affected area once daily for 2 consecutive days. Picato® gel may be applied to the affected area, up to one contiguous skin area of approximately 25 cm2 (e.g., 5 cm × 5 cm) using one unit dose tube.
Any Gradea > Baseline
Grade 4
Picato® gel (n=225)
Vehicle (n=232)
Picato® gel (n=225)
Vehicle (n=232)
Erythema
207 (92%)
43 (19%)
34 (15%)
0 (0%)
DISTRIBUTED BY: LEO Pharma Inc., Parsippany, NJ 07054, USA
Flaking/Scaling
203 (90%)
44 (19%)
18 (8%)
0 (0%)
Crusting
167 (74%)
23 (10%)
8 (4%)
0 (0%)
Picato is a registered trademark of LEO Laboratories Limited. LEO and the LEO Lion Design are registered trademarks of LEO Pharma A/S.
Swelling
143 (64%)
13 (6%)
7 (3%)
0 (0%)
BRFS-PI-0112
Vesiculation/Pustulation
98 (44%)
2 (1%)
3 (1%)
0 (0%)
Erosion/Ulceration
58 (26%)
6 (3%)
2 (1%)
0 (0%)
Skin reactions
a
MANUFACTURED BY:
Mild (grade 1), Moderate (grade 2-3) or Severe (grade 4).
Local skin reactions typically occurred within 1 day of treatment initiation, peaked in intensity up to 1 week following completion of treatment, and resolved within 2 weeks for areas treated on the face and scalp, and within 4 weeks for areas treated on the trunk and extremities. Adverse reactions that occurred in ≥2% of subjects treated with Picato® gel and at a higher frequency than the vehicle are presented in Table 3 and Table 4. Table 3: Adverse reactions occurring in ≥2% of subjects treated with Picato® gel and at higher frequency than vehicle (face/scalp trials) Adverse Reactions
Picato® gel, 0.015% (N=274)
Vehicle (N=271)
Application Site Pain
42 (15%)
1 (0%)
Application Site Pruritus
22 (8%)
3 (1%)
Application Site Infection
7 (3%)
0 (0%)
Periorbital Edema
7 (3%)
0 (0%)
Headache
6 (2%)
3 (1%)
28 Journal of Dermatology for Physician Assistants
LEO Laboratories Ltd., Dublin 12, Ireland or DPT Laboratories, Ltd., San Antonio, TX 78215, USA
&
Dermoscopy Q A By Ashfaq A. Marghoob, MD
SDPA Members Only Content A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA. Under Dermoscopy
B CLINICAL Dermatology
A
Ashfaq A. Marghoob, MD is a board-certified dermatologist specializing in the diagnosis and treatment of cancers of the skin. He is the director of Memorial SloanKettering’s regional skin cancer clinic in Hauppauge, Long Island. “Although providing the best care possible for my patients remains my primary goal, I also remain committed to education and clinical research. My hope is that educating healthcare providers and the public about the importance of early skin cancer detection will help save lives.” Dr. Marghoob is very active in clinical research and has published numerous papers on topics related to skin cancer with an emphasis on melanoma, atypical/dysplastic nevi, and congenital melanocytic nevi. His research interests are focused on the use of imaging instruments such as photography, dermoscopy, and confocal laser microscopy to recognize skin cancer early in its development. He frequently lectures on these topics both nationally and internationally and will be on faculty at the inaugural American Dermoscopy Meeting (ADM) to be held this summer, June 22-23, 2012 in Jackson Hole, Wyoming. He has indicated no relationships to disclose relating to the content of this article.
Vol. 6, No. 2 SPRING 2012 29
Clinical snapshots Human Papillomavirus-induced Periungual Pigmented Bowen’s Disease By Marigdalia K. Ramirez-Fort, MD Figure 1: Clinical view
SDPA Members Only Content
CLINICAL Dermatology
A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.
Figure 2: Dermatoscopic view
Figure 3: Dermatopathologic view
Marigdalia K. Ramirez-Fort, MD works at the Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA. She has indicated no conflicts of interest to disclose relating to the content of this article. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author (©2012 Ramirez-Fort) and source (Case report: human papillomavirus induced periungual pigmented Bowen’s disease. Dermatol Pract Conc. 2012;2(1):11) are credited.
30 Journal of Dermatology for Physician Assistants
Drugs in Dermatology Vemurafenib & Ipilimumab New Targeted Therapies Help Patients with Advanced Melanoma SDPA Members Only Content
Melanoma Statistics1 It is estimated that 9,180 Americans will die from melanoma in 2012. In 2012, it is estimated that the number of Americans diagnosed with melanoma will be 7 percent greater than in 2011. While the five-year survival rate for localized melanoma is 98 percent, the survival rate of distant, or advanced stage, melanoma is 15 percent.
Darrell S. Rigel, MD, FAAD is a graduate of MIT with a BS in Computer Sciences, an MS (MBA) from the Sloan School of Management at MIT and received his MD from George Washington University in 1978. He attended Cornell University Medical Center for Internship in Internal Medicine in 1979 and completed his training at NYU where he was Resident, Chief Resident and Dermatology Surgery Fellow from 1979-1982. He is a clinical professor in the department of dermatology, NYU Langone Medical Center, New York, NY. Dr. Rigel has received numerous awards and honors including American Cancer Society’s National Honor Citation for Skin Cancer Programs and a Presidential Citation from the American Academy of Dermatology for public education programs. In addition, Dr. Rigel maintains a private dermatology practice in Manhattan where he specializes in skin cancer, sun damage, and aging problems of the skin.
Vol. 6, No. 2 SPRING 2012 31
CLINICAL Dermatology
A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.
THE PATIENT I S WA I T I NG 32 Journal of Dermatology for Physician Assistants
The Passion to HealSM initiative increases the availability of specialized healthcare providers to communities in need. Through this initiative, Medicis provides financial support to highly respected non-profit organizations. These organizations will in turn underwrite the costs associated with the volunteer activities of dermatologists, plastic surgeons, residents, and healthcare professionals in these specialties. Medicis contributes funding, products and services with a value of up to $2 from the sale of each prescription, vial, and syringe of our key U.S. dermatology and aesthetics products in support of Passion to Heal and our other charitable initiatives. We are hopeful that the service needs of these organizations and the volunteer spirit of specialists like you will allow Medicis to contribute millions of dollars each year. There are many ways your skills can contribute to this exciting initiative. You will be able to volunteer at the times that accommodate your busy schedule for a few hours or a few weeks. We hope that you’ll be inspired to get involved. www.PassionToHeal.com
Passion to Heal is a service mark of Medicis Pharmaceutical Corporation. SER 12-033B 04/30/13
Vol. 6, No. 2 SPRING 2012 33
SURGICAL Dermatology
SURGICAL wisdom Needle Stick Prevention – Step 2: Message Development 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.
Figure: Campaign Process
In the next issue, the JDPA will highlight Step 3: Message Delivery of the CDC’s STOP STICKS campaign. For additional information on the campaign please visit the CDC website at www.cdc.gov/niosh/stopstick.
34 Journal of Dermatology for Physician Assistants
THE SKIN BARRIER OF ROSACEA PATIENTS IS COMPROMISED
CHOOSE THE ONE VEHICLE THAT PROTECTS WHILE IT PERFORMS1,2*
METROGEL® (metronidazole) Gel, 1% FEATURES A SOPHISTICATED FORMULATION FOR POWERFUL EFFICACY AND TOLERABILITY
t The only ONE with niacinamide that helps protect the skin barrier and facilitate drug delivery1,3
t ONE with powerful QD efficacy: 71% median reduction in inflammatory lesion count at week 10 (P=.0005 vs vehicle)2
t ONE with a tolerable formulation: mild-tomoderate local skin irritation (ie, dryness and scaling) reported in clinical trials2
t Now the only ONE in a pump t Rosacea sufferers surveyed prefer the2 pump over the tube (69% vs 31%; N=207) †
MetroGel® (metronidazole) Gel, 1% is indicated for the topical treatment of inflammatory lesions of rosacea. Important Safety Information The following adverse experiences have been reported with the topical use of metronidazole: nasopharyngitis, upper respiratory tract infections and headache. Patients may also experience local burning, skin irritation, dryness and transient redness. Although rare, patients may also experience metallic taste, numbness or paresthesia of the extremities and nausea with use of MetroGel® 1%, and peripheral neuropathy has been reported with use of metronidazole. MetroGel® 1% therapy should be reevaluated if these symptoms occur. Caution should be used when prescribing metronidazole products for patients with blood dyscrasia, and patients using blood thinning agents such as coumarin or warfarin may experience prolonged prothrombin times. MetroGel® 1% is contraindicated in patients with a history of hypersensitivity to metronidazole or any other ingredient in the formulation. Please see next page for brief summary of full Prescribing Information. *MetroGel® 1% does not further damage the already compromised skin barrier of rosacea patients. † Claims are based on a Consumer Packaging Preference Study of 207 physician-diagnosed, male and female rosacea patients aged 25 to 65 years. Patients were asked to complete a self-administered Internet survey following video presentations highlighting the steps involved when applying medication from a pump and a tube. References: 1. Bissett D. Topical niacinamide and barrier enhancement. Cutis. 2002;70(suppl 6):8-12. 2. Data on file. Galderma Laboratories, L.P. 3. Dow G, Basu S. A novel aqueous metronidazole 1% gel with hydrosolubilizing agents (HSA-3). Cutis. 2006;77(suppl 4):18-26.
NOW AVAILABLE
IN A PUMP Distinguished delivery.
Powerful results. MetroGel and Galderma are registered trademarks. ©2011 Galderma Laboratories, L.P. Galderma Laboratories, L.P. 14501 N. Freeway Fort Worth, TX 76177 MET-949 Printed in USA 11/11
www.metrogel.com
Vol. 6, No. 2 SPRING 2012 35
METROGEL® (metronidazole) Gel, 1% Rx Only For topical use only. Not for oral, ophthalmic or intravaginal use. Talk to your doctor or pharmacist to learn more about METROGEL. You can also learn more at www.metrogel.com. BRIEF SUMMARY INDICATIONS AND USAGE METROGEL® (metronidazole) Gel, 1% is a nitroimidazole indicated for the topical treatment of inflammatory lesions of rosacea. CONTRAINDICATIONS METROGEL is contraindicated in those patients with a history of hypersensitivity to metronidazole or to any other ingredient in this formulation. WARNINGS AND PRECAUTIONS • Peripheral neuropathy, characterized by numbness or paresthesia of an extremity has been reported in patients treated with systemic metronidazole. Although not evident in clinical trials for topical metronidazole, peripheral neuropathy has been reported with the post approval use. The appearance of abnormal neurologic signs should prompt immediate reevaluation of METROGEL therapy. • Metronidazole is a nitroimidazole and should be used with care in patients with evidence of, or history of, blood dyscrasia. • If dermatitis occurs, patients may need to discontinue use. • Topical metronidazole has been reported to cause tearing of the eyes. Therefore, contact with the eyes should be avoided. ADVERSE REACTIONS Most common adverse reactions (incidence >2%) are nasopharyngitis, upper respiratory tract infection, and headache. In a controlled clinical trial, 557 patients used metronidazole gel, 1% and 189 patients used the gel vehicle once daily for up to 10 weeks. The following table summarizes selected adverse reactions that occurred at a rate of ≥1%: Table 1: Adverse Reactions That Occurred at a Rate of ≥1% System Organ Class/Preferred Term Metronidazole Gel Gel, 1% Vehicle N=557 N=189 Patients with at least one AE Number (%) of Patients 186 (33.4) 51 (27.0) Infections and infestations 76 (13.6) 28 (14.8) Bronchitis 6 (1.1) 3 (1.6) Influenza 8 (1.4) 1 (0.5) Nasopharyngitis 17 (3.1) 8 (4.2) Sinusitis 8 (1.4) 3 (1.6) Upper respiratory tract infection 14 (2.5) 4 (2.1) Urinary tract infection 6 (1.1) 1 (0.5) Vaginal mycosis 1 (0.2) 2 (1.1) Musculoskeletal and connective tissue disorders 19 (3.4) 5 (2.6) Back pain 3 (0.5) 2 (1.1) Neoplasms 4 (0.7) 2 (1.1) Basal cell carcinoma 1 (0.2) 2 (1.1) Nervous system disorders 18 (3.2) 3 (1.6) Headache 12 (2.2) 1 (0.5) Respiratory, thoracic and mediastinal disorders 22 (3.9) 5 (2.6) Nasal congestion 6 (1.1) 3 (1.6) Skin and subcutaneous tissue disorders 36 (6.5) 12 (6.3) Contact dermatitis 7 (1.3) 1 (0.5) Dry Skin 6 (1.1) 3 (1.6) Vascular disorders 8 (1.4) 1 (0.5) Hypertension 6 (1.1) 1 (0.5) Table 2: Local Cutaneous Signs and Symptoms of Irritation That Were Worse Than Baseline Metronidazole Gel, 1% Gel Vehicle Sign/Symptom N=544 N=184 Dryness 138 (25.4) 63 (34.2) Mild 93 (17.1) 41 (22.3) Moderate 42 (7.7) 20 (10.9) Severe 3 (0.6) 2 (1.1) Scaling 134 (24.6) 60 (32.6) Mild 88 (16.2) 32 (17.4) Moderate 43 (7.9) 27 (14.7) Severe 3 (0.6) 1 (0.5) Pruritus 86 (15.8) 35 (19.0) Mild 53 (9.7) 21 (11.4) Moderate 27 (5.0) 13 (7.1) Severe 6 (1.1) 1 (0.5) Stinging/burning 56 (10.3) 28 (15.2) Mild 39 (7.2) 18 (9.8) Moderate 7 (1.3) 9 (4.9) Severe 10 (1.8) 1 (0.5)
36 Journal of Dermatology for Physician Assistants
The following additional adverse experiences have been reported with the topical use of metronidazole: skin irritation, transient redness, metallic taste, tingling or numbness of extremities, and nausea. Post Marketing Experience The following adverse reaction has been identified during post approval use of topical metronidazole: peripheral neuropathy. Because this reaction is reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure. DRUG INTERACTIONS Oral metronidazole has been reported to potentiate the anticoagulant effect of coumarin and warfarin, resulting in a prolongation of prothrombin time. Drug interactions should be kept in mind when METROGEL is prescribed for patients who are receiving anticoagulant treatment, although they are less likely to occur with topical metronidazole administration because of low absorption. USE IN SPECIFIC POPULATIONS Pregnancy: Teratogenic Effects: Pregnancy Category B. There are no adequate and well-controlled studies with the use of METROGEL in pregnant women. Metronidazole crosses the placental barrier and enters the fetal circulation rapidly. No fetotoxicity was observed after oral administration of metronidazole in rats or mice at 200 and 20 times, respectively, the expected clinical dose. However, oral metronidazole has shown carcinogenic activity in rodents. Because animal reproduction studies are not always predictive of human response, METROGEL should be used during pregnancy only if clearly needed. Nursing Mothers After oral administration, metronidazole is secreted in breast milk in concentrations similar to those found in the plasma. Even though blood levels taken after topical metronidazole application are significantly lower than those achieved after oral metronidazole a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother and the risk to the infant. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric Use Sixty-six subjects aged 65 years and older were treated with metronidazole gel, 1% in the clinical study. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Carcinogenesis, Mutagenesis, Impairment of Fertility Metronidazole has shown evidence of carcinogenic activity in a number of studies involving chronic, oral administration in mice and rats, but not in studies involving hamsters. In several long-term studies in mice, oral doses of approximately 225 mg/m2/day or greater (approximately 37 times the human topical dose on a mg/m2 basis) were associated with an increase in pulmonary tumors and lymphomas. Several long-term oral studies in the rat have shown statistically significant increases in mammary and hepatic tumors at doses >885 mg/m2/day (144 times the human dose). Metronidazole has shown evidence of mutagenic activity in several in vitro bacterial assay systems. In addition, a dose-related increase in the frequency of micronuclei was observed in mice after intraperitoneal injections. An increase in chromosomal aberrations in peripheral blood lymphocytes was reported in patients with Crohn’s disease who were treated with 200 to 1200 mg/day of metronidazole for 1 to 24 months. However, in another study, no increase in chromosomal aberrations in circulating lymphocytes was observed in patients with Crohn’s disease treated with the drug for 8 months. In one published study, using albino hairless mice, intraperitoneal administration of metronidazole at a dose of 45 mg/m2/day (approximately 7 times the human topical dose on a mg/m2 basis) was associated with an increase in ultraviolet radiationinduced skin carcinogenesis. Neither dermal carcinogenicity nor photocarcinogenicity studies have been performed with METROGEL or any marketed metronidazole formulations. PATIENT COUNSELING INFORMATION Patients using METROGEL should receive the following information and instructions: 1. This medication is to be used as directed. 2. It is for external use only. 3. Avoid contact with the eyes. 4. Cleanse affected area(s) before applying METROGEL. 5. This medication should not be used for any condition other than that for which it is prescribed. 6. Keep out of reach of children. 7. Patients should report any adverse reaction to their physicians. US Patent No. 6,881,726 and 7,348,317
Marketed by: Galderma Laboratories, L.P. Fort Worth, Texas 76177 USA P50742-3-BS Revised: November 2011
Manufactured by: G Production Inc. Baie d’Urfé, QC, H9X 3S4 Canada Made in Canada.
COSMETIC deRMATOLOGY
Journal Club: Dermatology PA Perspectives Alternative Hair Dye Products for Persons Allergic to para-Phenylenediamine Dermatitis 2011; Volume 22(4):189-192 Andrew Scheman, Christina Cha, and Manpreet Bhinder Reviewed By J. Desiree Douglas, MPA, PA-C
SDPA Members Only Content A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.
J. Desiree Douglas, MPA, PA-C has been a physician assistant for twelve years and has worked in dermatology for five years. She is Co-Director of the Occupational and Allergic Contact Dermatitis Clinic at the University of Pittsburgh Medical Center. She has indicated no relationships to disclose relating to the content of this article.
Vol. 6, No. 2 SPRING 2012 37
Cosmetic pearls Understanding the Different Types of Hair Dyes SDPA Members Only Content
COSMETIC Dermatology
A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.
38 Journal of Dermatology for Physician Assistants
Vol. 6, No. 2 SPRING 2012 39
40 Journal of Dermatology for Physician Assistants
Professional development
Dermatology Billing & Coding Be In Charge of Your Own Destiny By Inga Ellzey, MPA, RHIA, CDC
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.
We understand that physician assistants (PAs) cannot practice without the supervision of a physician. While there are some PAs who are given the opportunity to buy into their practices; the majority of PAs are not free agents. They are at the mercy of the practices they join, the efficiency of their practice’s billing staff, the quality of their management with respect to credentialing, and the ethical and legal compliance of the owner(s) of the practice. The Office of the Inspector General (OIG) is now more aggressive than ever and is starting to indict everyone in a practice that engages in false claims submission from the billing manager all the way up to the Board of Directors. So get your head out of the proverbial sand and take charge of your charges, make sure that the name the bill is sent out under is correct, be sure you comply with the incident to criteria, and verify your credentialing status with the carriers that your practice contracts with.
Credentialing
Problem number one is credentialing. At an absolute minimum, you must do the following: 1. Obtain a Medicare NPI number. 2. Make sure you are added to the group with Medicare. a. If you are added to a practice with only one provider, your practice owner must set up a group with Medicare and get a group NPI number. b. You must be added to that group number. c. This requires two separate forms. 3. Complete these steps for commercial carriers: a. You must get credentialed. b. You must get yourself added to the group.
Vol. 6, No. 2 SPRING 2012 41
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.
professional development
Ms. Ellzey, President/CEO of the Inga Ellzey Practice Group, Inc., in Casselberry, FL, is an expert on dermatology coding, documentation and reimbursement. She has more than 35 years of experience in the field of dermatology and is the CEO and founder of two nationwide dermatology billing services. You can reach her at the following number: (800) 318-3271, or email her at: inga@iepg.com.
Editor’s Note
Write for the JDPA! Are you a PA who... • Is interested in writing? • Has a paper you want published? Share your knowledge today. Contact editor@jdpa.org
42 Journal of Dermatology for Physician Assistants
For the first-line treatment of inflammatory and comedonal acne
BRANDED TOPICAL ACNE PRODUCT BRANDED TOPICAL ACNE
PRODUCT AMONG DERMATOLOGISTS1
NOW AVAILABLE IN A PUMP! The only, once-daily adapalene/benzoyl peroxide combination—in a patient-preferred PUMP. t t
of acne patients preferred the PUMP over the tube2* of acne patients reported satisfaction with the PUMP2*
Measured dose for consistent delivery.
*Survey of 291 patients 12 to 35 years of age who completed a randomized study of Epiduo® Gel tube vs pump after 1 week of treatment with each dispenser. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Please see brief summary of Prescribing Information on next page.
Vol. 6, No. 2 SPRING 2012 43
EPIDUO®
(adapalene and benzoyl peroxide) Gel 0.1% / 2.5%
Rx only
For Topical Use Only Not For Ophthalmic, Oral, or Intravaginal Use. BRIEF SUMMARY INDICATIONS AND USAGE EPIDUO Gel is a combination of adapalene, a retinoid, and benzoyl peroxide, and is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. CONTRAINDICATIONS None. WARNINGS AND PRECAUTIONS Ultraviolet Light and Environmental Exposure: Avoid exposure to sunlight and sunlamps. Wear sunscreen when sun exposure cannot be avoided. Erythema, scaling, dryness, and stinging/burning may occur with use of EPIDUO Gel. ADVERSE REACTIONS Observed local adverse reactions in patients treated with EPIDUO Gel were erythema, scaling, dryness, stinging, and burning. Other most commonly reported adverse events (*1%) in patients treated with EPIDUO Gel were dry skin, contact dermatitis, application site burning, application site irritation, skin irritation. DRUG INTERACTIONS Exercise caution in using preparations containing sulfur, resorcinol, or salicylic acid, medicated or abrasive soaps and cleansers and products with high concentrations of alcohol or astringents in combination with EPIDUO Gel. Concomitant use of topical products with a strong drying effect can increase irritation. Use with caution. Pregnancy Pregnancy Category C. There are no well-controlled trials in pregnant women treated with EPIDUO Gel. Animal reproduction studies have not been conducted with the combination gel or benzoyl peroxide. Furthermore, such studies are not always predictive of human response; therefore, EPIDUO Gel should be used during pregnancy only if the potential benefit justifies the risk to the fetus. No teratogenic effects were observed in rats treated with oral doses of 0.15 to 5.0 mg adapalene/kg/day, up to 25 times (mg/m2/day) the maximum recommended human dose (MRHD) of 2 grams of EPIDUO Gel. However, teratogenic changes were observed in rats and rabbits when treated with oral doses of * 25 mg adapalene/kg/day representing 123 and 246 times MRHD, respectively. Findings included cleft palate, microphthalmia, encephalocele and skeletal abnormalities in rats; and umbilical hernia, exophthalmos and kidney and skeletal abnormalities in rabbits. Dermal teratology studies conducted in rats and rabbits at doses of 0.6-6.0 mg adapalene/kg/day [25-59 times (mg/m2) the MRHD] exhibited no fetotoxicity and only minimal increases in supernumerary ribs in both species and delayed ossification in rabbits. Nursing Mothers It is not known whether adapalene or benzoyl peroxide is excreted in human milk following use of EPIDUO Gel. Because many drugs are excreted in human milk, caution should be exercised when EPIDUO Gel is administered to a nursing woman. Pediatric Use Safety and effectiveness of EPIDUO Gel in pediatric patients under the age of 12 have not been established. Geriatric Use Clinical studies of EPIDUO Gel did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Carcinogenesis, Mutagenesis, Impairment of Fertility No carcinogenicity, photocarcinogenicity, genotoxicity, or fertility studies were conducted with EPIDUO Gel.
Carcinogenicity studies with adapalene have been conducted in mice at topical doses of 0.4, 1.3, and 4.0 mg/kg/day (1.2, 3.9, and 12 mg/m²/day), and in rats at oral doses of 0.15, 0.5, and 1.5 mg/kg/day (0.9, 3.0, and 9.0 mg/m2/day). In terms of body surface area, the highest dose levels are 9.8 (mice) and 7.4 times (rats) the MRHD of 2 grams of EPIDUO Gel. In the rat study, an increased incidence of benign and malignant pheochromcytomas in the adrenal medulla of male rats was observed. No significant increase in tumor formation was observed in rodents topically treated with 15-25% benzoyl peroxide carbopol gel (6-10 times the concentration of benzoyl peroxide in EPIDUO Gel) for two years. Rats received maximum daily applications of 138 (males) and 205 (females) mg benzoyl peroxide/kg. In terms of body surface area, these levels are 27-40 times the MRHD. Similar results were obtained in mice topically treated with 25% benzoyl peroxide carbopol gel for 56 weeks followed by intermittent treatment with 15% benzoyl peroxide carbopol gel for rest of the 2 years study period, and in mice topically treated with 5% benzoyl peroxide carbopol gel for two years. The role of benzoyl peroxide as a tumor promoter has been well established in several animal species. However, the significance of this finding in humans is unknown. In a photocarcinogenicity study conducted with 5% benzoyl peroxide carbopol gel, no increase in UV-induced tumor formation was observed in hairless mice topically treated for 40 weeks. No photocarcinogenicity studies were conducted with adapalene. However, animal studies have shown an increased tumorigenic risk with the use of pharmacologically similar drugs (e.g., retinoids) when exposed to UV irradiation in the laboratory or sunlight. Although the significance of these findings to humans is not clear, patients should be advised to avoid or minimize exposure to either sunlight or artificial irradiation sources. Adapalene did not exhibit mutagenic or genotoxic effects in vitro (Ames test, Chinese hamster ovary cell assay, mouse lymphoma TK assay) or in vivo (mouse micronucleus test). Bacterial mutagenicity assays (Ames test) with benzoyl peroxide has provided mixed results, mutagenic potential was observed in a few but not in a majority of investigations. Benzoyl peroxide has been shown to produce single-strand DNA breaks in human bronchial epithelial and mouse epidermal cells, it has caused DNA-protein cross-links in the human cells, and has also induced a dose-dependent increase in sister chromatid exchanges in Chinese hamster ovary cells. In rat oral studies, 20 mg adapalene/kg/day (120 mg/m2/day; 98 times the MRHD based on mg/m2/day comparison) did not affect the reproductive performance and fertility of F0 males and females, or growth, development and reproductive function of F1 offspring. No fertility studies were conducted with benzoyl peroxide. PATIENT COUNSELING INFORMATION – Advise patients to cleanse the area to be treated with a mild or soapless cleanser; pat dry. Apply EPIDUO Gel as a thin layer, avoiding the eyes, lips and mucous membranes. – Advise patients not to use more than the recommended amount and not to apply more than once daily as this will not produce faster results, but may increase irritation. – EPIDUO Gel may cause irritation such as erythema, scaling, dryness, stinging or burning. – Advise patients to minimize exposure to sunlight, including sunlamps. Recommend the use of sunscreen products and protective apparel, (e.g., hat) when exposure cannot be avoided. – EPIDUO Gel may bleach hair and colored fabric. Marketed by: GALDERMA LABORATORIES, L.P. Fort Worth, Texas 76177 USA Manufactured by: G Production Inc. Baie d’Urfé, QC, H9X 3S4 Canada Made in Canada. GALDERMA is a registered trademark. Revised: December 2011 P51740-0-BS
References: 1. Wolters Kluwer Pharma Solutions, Source ® Pharmaceutical Audit Suite, May 2010-April 2011. 2. Subject preference survey CSR (US10184). Data on file. Galderma Laboratories, L.P.
Galderma and Epiduo are registered trademarks. ©2011 Galderma Laboratories, L.P. Galderma Laboratories, L.P. 14501 N. Freeway Fort Worth, TX 76177 EPI-797A Printed in USA 12/11
www.epiduo.com/hcp
44 Journal of Dermatology for Physician Assistants
Judicial and Ethical Affairs
The Ethics of Enhancement - “Is Better Always Good?” 1
By Karen Scully, MD, FRCPC, MA Ethics
SDPA Members Only Content
professional development
A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.
Karen Scully is a board-certified
dermatologist in the United States and Canada. She had a private practice in the Toronto area for many years and then accepted a teaching position at the Johns Hopkins Medical Institutions where she practiced and taught dermatology residents and medical students. More recently she moved to Charlotte, North Carolina and completed a Master’s Degree in Ethics and Applied Philosophy at the University North Carolina at Charlotte.
Vol. 6, No. 2 SPRING 2012 45
SDPA Members Only Content
professional development
A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.
ATTENTION Student Members of the SDPA! Publishing an article in a peer-reviewed journal is a great way to enhance your dermatology education, share knowledge with your peers, and improve upon your resume. If you have written dermatology related papers and are interested in publishing your work, the JDPA staff is available to assist you through this process. Please contact the JDPA at editor@jdpa.org.
46 Journal of Dermatology for Physician Assistants
Outside & Inside the 9 to 5...
Providing care to underserved patients is something I have always been drawn to. I have volunteered at various stateside migrant clinics treating pediatric patients as well as working in emergency medicine. Dermatology and dermatologic procedures have always been my passion. In my current role as a dermatology PA, I am able to help treat the underserved population in Sacramento, CA. My interest in dermatology coupled with my desire to help the underserved made the opportunity to volunteer with the Free The Children medical volunteer trip one I could not resist.
Kehli McCaskill, PA-C (fourth from the right) and the
inaugural Free The Children medical trip volunteers. I have always had an overwhelming desire to serve on a medical mission and have had a specific desire to provide quality medical care to underserved patients in Africa. This particular mission, supported by the Passion to Heal initiative, appealed to me because I was interested in working with other dermatology providers and saw it as an opportunity to increase my knowledge of treating patients of color in a third world country.
Working in Africa with the Free The Children medical volunteers was the most incredible learning experience of my career. Practicing medicine using basic clinical exam skills was amazing. I believe that practicing medicine is such a privilege, and this opportunity reminded me of why I fell in love with medicine in the first place. The people of Kenya are amazing. Their spirits are beautiful, caring, and so strong. Every moment was inspirational and a learning opportunity for me. I would strongly encourage other dermatology PAs who are considering volunteering with the Passion to Heal program to do so.
Kehli and Scott Drew, DO examine a patient at the Baraka Health Clinic
Local students waiting to be screened by the dermatology team
Kehli screening a local student.
Vol. 6, No. 2 SPRING 2012 47
professional development
Kehli McCaskill, PA-C was one of four PAs who volunteered for the inaugural Free The Children medical volunteer trip focused on dermatologic conditions, supported by the Medicis Passion to HealSM initiative. In January 2012, Kehli along with a group of fourteen dermatologists, dermatology residents, physician assistants, and nurses from across North America packed their bags and travelled to Africa to provide needed care to residents of the Maasai Mara region of Kenya. These Kenyans represent some of the most vulnerable segments of the African population. Many patients traveled 30 miles to seek treatment at the Free The Children Baraka Health Clinic. During her ten-day trip, Kehli and her group successfully treated 280 patients and screened 2,094 school children for various dermatologic conditions. The volunteers worked side by side with the local clinicians educating them so that they might serve as a bridge until the next medical volunteer trip arrives. The volunteers were completely immersed in the local communities, visiting schools and identifying ways to prevent skin conditions. All came away with a strong conviction that they made a difference in the lives of Kenyans who, without their care, might have suffered a lifetime with dermatologic conditions, some debilitating. Kehli shares with us her insights about her rewarding experience volunteering on this unforgettable inaugural medical trip.
Outside & Inside the
9 to 5...
Free The Children is the world’s largest network of children helping children through education, with more than one million youth involved in its innovative education and development programs in 45 countries. Founded in 1995 by international child rights activist Craig Kielburger, Free The Children is a charity and educational partner that believes in a world where all young people are free to achieve their fullest potential as agents of change. Its domestic programs educate, engage, and empower hundreds of thousands of youth in North America, the UK, and around the world. Its international projects have brought over 650 schools and school rooms to youth and provided clean water, health care, and sanitation to one million people around the world.
professional development
Since 1999, Free The Children has witnessed inspiring advancements in basic health care for rural communities in the Narok South District of Kenya. Specialized care, however, remains out of reach for millions of Kenyans. Skin conditions and wound complications, in particular, constitute ten percent of all clinical cases in this largely rural area. Without expertise in the field of dermatology, clinics struggle to diagnose and treat many patients who walk through their doors in desperate need of care. Thanks to Passion to Heal, an initiative of Medicis Pharmaceutical Corporation, Free The Children has developed a comprehensive program for advanced diagnosis and treatment of skin conditions in rural Kenya. The program is based in Free The Children’s Baraka Health Clinic, which provides medical care to over 40,000 people. The cornerstones of the program are medical volunteer trips, which bring North American dermatologists, residents, physician assistants, and nurses to the clinic to treat and educate community members while training local clinicians to create sustainable solutions. If you are interested in participating in a future medical volunteer trip, visit www.passiontoheal.com and learn how you can volunteer and embark on an experience of a lifetime. J
Free The Children Medical Volunteer Trips Scheduled for 2012 • May 27 - June 3, 2012
• September 9 - 16, 2012
• November 4 - 11, 2012
Passion to Heal is a service mark of Medicis Pharmaceutical Corporation
The clock is ticking...
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.
48 Journal of Dermatology for Physician Assistants
Notes from your Office Manager Eliminating the Use of Dangerous Abbreviations In 2001, The Joint Commission issued a Sentinel Event Alert on the subject of medical abbreviations, and just one year later, its Board of Commissioners approved a National Patient Safety Goal requiring accredited organizations to develop and implement a list of abbreviations not to use. In 2004, The Joint Commission created its “do not use” list of abbreviations as part of the requirements for meeting that goal. Currently, this requirement does not apply to preprogrammed health information technology systems (e.g., electronic medical records), but this application remains under consideration for the future. If your office is considering introducing or upgrading an EMR system, you should strive to eliminate the use of dangerous abbreviations, acronyms, symbols, and dose designations from the software. Below is a list of the Joint Commission’s “do not use” list of abbreviations. J
Do Not Use U, u (unit)
Potential Problem Mistaken for “0” (zero), the number “4” (four), or “cc”
Use Instead Write “unit”
IU (International Unit)
Mistaken for IV (intravenous) or the number 10 (ten)
Write “International Unit”
Q.D., QD, q.d., qd (daily) Q.O.D., QOD, q.o.d, qod (every other day)
Mistaken for each other Period after the Q mistaken for “I” and the “O” mistaken for “I”
Write “daily” Write “every other day”
Trailing zero (X.0 mg)* Lack of leading zero (.X mg)
Decimal point is missed
Write X mg Write 0.X mg
MS MSO4 and MgSO4
Can mean morphine sulfate or magnesium sulfate Confused for one another
Write “morphine sulfate” Write “magnesium sulfate”
1
Applies to all orders and all medication-related documentation that is handwritten (including free-text computer entry) or on pre-printed forms.
*Exception: A “trailing zero” may be used only where required to demonstrate the level of precision of the value being reported, such as for laboratory results, imaging studies that report size of lesions, or catheter/tube sizes. It may not be used in medication orders or other medication-related documentation.
Additional Abbreviations, Acronyms, and Symbols (For possible future inclusion in the Official “Do Not Use” List)
Do Not Use > (greater than) < (less than)
Potential Problem Misinterpreted as the number “7” (seven) or the letter “L” Confused for one another
Use Instead Write “greater than” Write “less than”
Abbreviations for drug names
Misinterpreted due to similar abbreviations for multiple drugs
Write drug names in full
Apothecary units
Unfamiliar to many practitioners Confused with metric units
Use metric units
@
Mistaken for the number “2” (two)
Write “at”
cc
Mistaken for U (units) when poorly written
Write “mL” or “ml” or “milliliters” (“mL” is preferred)
μg
Mistaken for mg (milligrams) resulting in one thousand-fold overdose
Write “mcg” or “micrograms”
Vol. 6, No. 2 SPRING 2012 49
professional development
Official “Do Not Use” List1
Now achieve harmony in acne management
Cetaphil® DermaControl™ Foam Wash and Moisturizer SPF 30 for patients with acne-prone skin CONTROL oil with a highly tolerable regimen formulated with advanced zinc technology1-4
PROTECT with an SPF 30 moisturizer and restore barrier function with ceramide technology5
BALANCE control of both acne symptoms and acne treatment effects1*
*Formulated to be used with acne treatments. References: 1. Data on file. Galderma Laboratories. 2. Bigotti C, Guala F, Merlo E, Gazzaniga G, Villa G. Zinc and its derivatives: their applications in cosmetic. J Appl Cosmetol. 2005;23:139-147. 3. Rigano L, Merlo E, Guala F, Villa G. Stabilized solutions of zinc coceth sulfate for skin cleansing and skin care. Cosmetics Toiletries. 2005;120:103-108. 4. Schwartz JR, Marsh RG, Draelos ZD. Zinc and skin health: overview of physiology and pharmacology. Dermatol Surg. 2005;31:837-847. 5. Castiel-Higounenc I, Chopart M, Ferraris C. Stratum corneum lipids: specificity, role, deficiencies and modulation. OCL. 2004;11(6):401-406.
cetaphil.com © 2012 Galderma Laboratories, L.P. Galderma is a registered trademark. Galderma Laboratories, L.P., 14501 N. Freeway, Fort Worth, TX 76177 CETA-393R Printed in USA 02/12
50 Journal of Dermatology for Physician Assistants
Dermatology PA news & notes
From the Desk of...
By Michelle DiBaise, DFAAPA, MPAS, PA-C
The Risks of Specialty Certification The PA profession has traditionally been one of generalist training but one that provides ease of mobility into different areas of practice as desired. PAs currently practice in almost every area of medicine. It is our generalist certification that allows the mobility that makes this profession quite attractive to new students. PAs early on in their career tend to frequently switch jobs until they find their ideal job. PAs may be required to move later in their career based on various family issues. Despite this, there are a number of PAs who settle into a specialty field for the duration of their practice. These specialty PAs have become experts in their field and are recognized as such by their peers in the community, their state and specialty organizations, and the Academy. They are called on to provide specialty CME lectures, serve as adjunct instructors in PA programs, and be a referral source for their primary care colleagues. Some have sought additional recognition through specialty certification in particular through the NCCPA. Other PAs have felt pressure from the physician specialty boards to demonstrate their expertise via a test designating their specialized skill. The NCCPAâ&#x20AC;&#x2122;s certificate of added qualifications (CAQ) has several steps to accomplish including years of experience in the specialty, additional CME, documentation of procedures and patient case experiences, and a specialty exam. The danger of specialty recognition, especially as provided by the NCCPA, is that it implies that to be able to practice in that particular specialty one must complete the CAQ. The unintended consequence of specialty recognition is that state legislation could be passed requiring specialty certification to practice. This could impede PAs entering a specialty and ultimately eliminate one of the attractive aspects of the profession, mobility. Some physician specialty groups have already considered asking that their physician members hire only specialty recognized PAs. Another risk is an effect on reimbursement for services rendered by PAs, if payment becomes tied to specialty certification. There is a possibility that PAs could be refused credentialing
in a hospital if they do not hold specialty recognition. PAs who work in specialties should be recognized for their focused knowledge base and expertise. Since the NCCPA is the certification body on which licensure rests, specialty recognition should preferably be conferred by a separate body. The better venue would be from the specialty constituencies of the AAPA. For example, the SDPA offers Diplomate status to its qualified members that indicate they have achieved the highest honor available as a dermatology PA. It is recognized by the physician specialty organization but does not bring with it the risks of loss of reimbursement, credentialing, or a decrease in mobility within the profession. The Academy should continue to uphold its policy against specialty certification. At the same time we should encourage our specialty organizations to recognize and reward the expertise of specialty PAs. I would be happy to speak with anyone who has additional questions about my position regarding specialty certification. I can be reached at mdibaise@ cox.net. J Michelle DiBaise, DFAAPA, MPAS, PA-C is a graduate of the Physician Assistant Program at the University of Nebraska Medical Center in Omaha, Nebraska. She is a current member and past President (2003-2004) of the SDPA. She has had the opportunity of serving in various leadership positions, including: AAPA committees (Chapter Relations, Public Education, and Awards); Student Academy (Vice President, Chief Delegate, and Graduate Advisor); AAPA House of Delegates with nearly twenty-two years of experience; and AAPA Board of Directors for three years. She has served as a President of four constituent organizations including: Nebraska Academy of PAs, Iowa PA Society, Arizona State Association of PAs, and the SDPA. During this time she has spent over ten years in the field of education in Nebraska and Arizona, and is currently an Associate Professor at the newly developed Northern Arizona University PA Program. Michelle is currently running for Presidentelect of the AAPA Board of Directors. Articles written by candidates are provided as information for our readers. The publishing of articles about candidates neither implies nor infers a specific endorsement of any candidate by any individual on the SDPA Board of Directors (BOD) or by the SDPA BOD collectively as an organization.
Vol. 6, No. 2 SPRING 2012 51
Student Scoop - Pay it Forward By Stephanie Cohen, PA-S SDPA Student Affairs Coordinator
Dermatology PA news & notes
T
hree months into my first year of PA school, I was finally feeling adjusted to the fast-paced, demanding curriculum. In an attempt to access what for some may be distant memories, I would like to remind you of the nagging feeling of inadequacy when you realize how little you actually know about medicine. As your fragile confidence is constantly being tested, you start to realize just how important the clinical year will be to your education. Having completed the hematology, pulmonary, and cardiology units in my program’s organ system approach, I find myself constantly wondering if I have truly learned all that I need to know about each system as we move onto the next. The answer is obviously NO! Moving through each of these units at the speed with which all PA programs do, our only comfort comes from knowing that we will have repeated exposure to these topics during our clinical year. Students are filled with excitement, along with the obvious overwhelming fear, at the prospect of testing and further expanding our knowledge during our second (or third) years. Knowledge obtained during the didactic year holds little value unless it is applied to clinical scenarios. It is vitally important that our didactic year be complemented with clinical experiences so that we can ultimately provide the best care to our future patients.
The clinical year is especially important for training students who wish to work in a specialty such as dermatology. The first year curriculum in many PA programs does not include the depth of knowledge that most hospitals or clinics would expect of a dermatology PA. Therefore, it is incumbent on current dermatology providers to share their knowledge with students who may one day become their future colleagues. Dermatology providers should recognize their crucial role in successfully training knowledgeable, clinically competent dermatology PAs and should consider becoming clinical preceptors. If you are interested in becoming a dermatology PA preceptor, please email sdpa@dermpa.org for more information. If you are already listed on the SDPA’s student website as a preceptor, thank you for volunteering your time and talents to help the next generation of dermatology PAs. If you need to update or make a change to your information, please email sdpa@ dermpa.org. J Stephanie Cohen, PA-S is currently enrolled at the Northwestern University Feinberg School of Medicine Physician Assistant Program in Chicago, IL. She currently holds the position of Student Affairs Coordinator for the SDPA. She will be graduating in May 2013 and plans to practice in dermatology.
Let them know they’re not alone... Share a story with your patients. Visit the Patient’s Perspective library of articles at www.jdpa.org/advocacy.html If you know a patient who would like to share his/her story, please contact us at editor@jdpa.org
52 Journal of Dermatology for Physician Assistants
Workplace Excellence
Creating an Intentional Culture of Excellence in the Workplace By Matthew Davidson, Ph.D.
G
reetings! It is my great pleasure to contribute this inaugural article as part of the new Workplace Excellence column of the JDPA. A journal dedicated to excellence in dermatological patient care through the PA profession must clearly address the science of disease and treatment. And yet that in itself is insufficient for excellence in dermatological patient care when you consider that PAs carry out their craft with and for human beings nested in a very complex human ecology. In fact, my experience suggests that it is often our failures and inadequacies as human beings and human organizations, more so even than deficiencies in medical knowledge, that detracts from excellence in patient care. This Workplace Excellence column will be used as a forum to draw out critical issues within the human ecology of dermatological patient care including PA-patient relationships, PA-supervising physician (and staff) relationships, as well as the PA relationship to self. I will present theoretical, empirical, and practical insights on how each of these layers in the ecology of patient care can contribute to or detract from patient care. For example, this column will discuss the PA’s ability to communicate effectively, to give and receive feedback, to balance competing priorities and stakeholder needs, to maintain passion and motivation for work while also achieving life-balance, and to be an effective member of a professional and ethical community. In the busy, bottom-line world in which we live and work, individuals and organizations too often focus on the “urgent over the important.” We become adept at looking at details without ever seeing the larger picture. We forge ahead with our work with little time to ask ourselves the all-important question: “How’s that working for you?” and for us and for the
patients we serve? PAs need to see the larger picture of the culture and competencies needed to enhance their ability to do the following: • Develop positive and productive relationships • Communicate and collaborate with efficiency and effectiveness • Manage priorities and reduce stress • Commit to high standards and continuous improvement • Demonstrate emotional intelligence, integrity, and responsibility • Exhibit creativity and innovation as well as critical thinking and problem solving • Lead and serve others • Live a balanced, purposeful, and healthy life Aristotle famously observed, “We are what we repeatedly do. Excellence, then, is not an act, but a habit.” This statement is true for the individual and for the organization. Random acts of excellence or pockets of excellence can be achieved by any individual or organization. But consistent excellent patient care that is experienced as a stable norm or as a distinguishing mark of your practice will come only as the result of an intentional culture where excellence is repeatedly, consistently, and pervasively practiced. This is why our organizational culture - that is, our shared values, beliefs, and operational norms - must be intentional. We cannot leave any aspect of the work experience too unstructured or allow for unintentional norms, norms that simply emerge. Unintentional culture can be described as a “it’s just a…” mindset; it’s just a staff meeting, it’s just an acne follow-up, it’s just an appointment reminder. We must know what we do and why we do it. For it is Vol. 6, No. 2 SPRING 2012 53
DERmatology pa news & notes
In my work as President of the Institute for Excellence & Ethics (IEE) I have had the opportunity to work with diverse individuals and organizations in their quest to achieve excellence. This column dedicated to Workplace Excellence will explore the organizational, interpersonal, and ethical issues that contribute to (or detract from) individual or organizational excellence within the physician assistant profession. If you have any workplace topics you would like to see covered in the JDPA please feel free to share them with us. Email editor@jdpa.org with any topic ideas or questions concerning the workplace.
The Difference We Make Facing Our Mistakes
Dermatology PA news & notes
By Brian T. Maurer, PA-C Nowadays, the popular press focuses on medical errors from the perspective of the patient. Pick up any current patient-focused periodical, and you’re apt to find a Doctor So-and-so did me wrong article. Many times the patient has a valid gripe. In his recent TED talk Doctors make mistakes: Can we talk about that? (www.ted.com/talks/brian_goldman_ doctors_make_mistakes_can_we_talk_about_that.html), Canadian physician Brian Goldman offers a viewpoint from the opposite camp: How do clinicians react when confronted with the oft-times detrimental effects of errors in clinical judgement? We know that Sir William Osler made at least one attempt to address this issue head on when he called his residents to the morgue to witness his error in diagnosis. “Once in a ward class there was a big colored man whom he demonstrated as showing all the classical symptoms of croupous pneumonia. The man came to autopsy later. He had no pneumonia, but a chest full of fluid. Dr. Osler seemed delighted, sent especially for all those in his ward class, showed them what a mistake he had made, how it might have been
Workplace Excellence ...continued from page 53
through our words and actions that we communicate to all those we serve and interact with that, “This is who we are. These are our values.” We must continue to audit our practices to determine which are supportive of and which diminish our mission of excellent patient care. When it comes to achieving excellence, regardless of your field of work, there are simply no universally benign practices; all have the potential to turn into an organizational malignancy. What do we do? Why do we do it that way? Are we intentional? Does this routine, practice, protocol, or ritual contribute to excellent patient care? Is there a better way to interact with patients and colleagues? How can I become an excellent PA serving my patients, my practice, and myself with integrity? Stay tuned to future Workplace Excellence columns for further insights on these pressing questions. J 54 Journal of Dermatology for Physician Assistants
avoided and how careful they should be not to repeat it. In 30 years of practice since then…I remember that case.” Over the course of my career I’ve tried to get at such issues by writing about them. I recall one of my early pieces published in the premier issue of Dermanities, titled Abdominal Pain. Although revisiting it still leaves me feeling a bit queasy, it offers a lesson that I shall never forget. Or in Doctor Goldman’s words, “Yes, I remember…” Facing our mistakes is one of the most effective tools that we clinicians have to improve our clinical diagnostic acumen. What a pity that more of us don’t take advantage of it. J Brian T. Maurer has practiced pediatric medicine as a physician assistant for thirty years. Over the past two decades Mr. Maurer has explored the illness narrative as a tool to cultivate an appreciation for the delivery of humane medical care. He has published numerous vignettes, editorials, and essays in both national and international journals. Mr. Maurer has been a contributing author to the online open-access journal Dermanities (www.dermanities.com) since its inception. Readers can visit the author on the web at http:// briantmaurer.wordpress.com.
Matthew L. Davidson, Ph.D. is the Founder, President, and Director of Education for the Institute for Excellence & Ethics (IEE), a 501(c)3 nonprofit corporation dedicated to helping individuals and organizations achieve excellence. Previously he was the Research Director at the Center for Respect & Responsibility at the State University of New York College at Cortland. He has been on staff at the Family Life Development Center at Cornell University, the Values Program at LeMoyne College, and the Mendelson Center for Sport, Character, and Culture at the University of Notre Dame where he was also an Adjunct Professor of Education. He is a National Spokesperson for the Business Bureau National Center for Character Ethics. The IEE specializes in the development and dissemination of researchbased tools for developing the culture and competencies of excellence and ethics in schools, athletics, the workplace, and the home; this is done through professional development workshops & academies, teaching & learning resources, assessment, and consulting services. He is a frequent national presenter and is available for keynote lectures, professional development, retreats, and organizational consulting. For additional information or to contact the IEE, please visit www.excellenceandethics.org.
FOR THE TREATMENT OF ACNE VULGARIS
Dive in
with Atralin
®
Optimized for efficacy with minimal irritation
mean reduction in inflammatory • 36% lesions at 12 weeks* mean reduction in noninflammatory • 41% lesions at 12 weeks* • Low irritation profile • Moisturizing and hydrating agents 1
1
1
† 2-4
*Combined results of two 12-week, prospective, multicenter, randomized, vehicle-controlled studies of patients with mild to moderate acne vulgaris of the face.1 †The contribution of individual components to efficacy has not been evaluated.
Indication and Important Safety Information: Atralin Gel is indicated for the treatment of acne vulgaris. The most common adverse reaction was mild to moderate irritation of the skin (ie, dry skin, skin burning, erythema, and exfoliative dermatitis), which occurred during the first few weeks of treatment with Atralin Gel. To prevent aggravating the skin, protect it from sun, tanning lights, extreme wind or cold, and harsh skincare products. Use of sunscreen products of at least SPF 15 and protective clothing over treated areas are recommended when exposure cannot be avoided. Atralin Gel should not be used on eczematous or sunburned skin due to potential for severe irritation. References: 1. Data on file, CORIA Laboratories. 2. Weindl G, Schaller M, Schäfer-Korting M, Korting HC. Hyaluronic acid in the treatment and prevention of skin diseases: molecular, biological, pharmaceutical and clinical aspects. Skin Pharmacol Physiol. 2004;17(5):207-213. 3. Morganti P. Skin hydration. In: Magdassi S, Touitou E, eds. Novel Cosmetic Delivery Systems. New York, NY. Marcel Dekker, Inc; 1999:71-98. 4. Kraft JN, Lynde CW. Moisturizers: what they are and a practical approach to product selection. Skin Therapy Lett. 2005;10(5):1-8.
AtralinGel.com
Please see brief summary of prescribing information on next page.
© 2010 CORIA Laboratories, a division of Valeant Pharmaceuticals North America COR-137791-1210
Vol. 6, No. 2 SPRING 2012 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%)
Marketed by:
Manufactured by: DPT LABORATORIES, LTD. San Antonio, Texas 78215 Patent No.: 5,670,547 Revised: 11/2009 137623-1109
df
CORIA Laboratories, a division of Valeant Pharmaceuticals North America, Aliso Viejo, CA 92656
56 Journal of Dermatology for Physician Assistants
263100gi301PI_JDPA
Atralin Gel (n = 674)
K
Event
Output @ 100% Giant Creative Strategy
Table 1. Number of Subjects with Selected Adverse Reactions (Occurring in At Least 1% of Subjects)
DRUG INTERACTIONS When treating with Atralin Gel, caution should be exercised with the use of concomitant topical medication, medicated or abrasive soaps and cleansers, products that have a strong drying effect, and products with high concentrations of alcohol, astringents, spices, or lime. Particular caution should be exercised with the concomitant use of topical over-the-counter acne preparations containing benzoyl peroxide, sulfur, resorcinol, or salicylic acid. Allow the effects of such preparations to subside before use of Atralin Gel is begun. USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C. There are no well-controlled trials in pregnant women treated with Atralin Gel. Atralin Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Atralin Gel at doses of 0.1, 0.3 and 1 g/kg/day was tested for maternal and developmental toxicity in pregnant Sprague-Dawley rats by dermal application. The dose of 1 g/kg/day was approximately 4 times the clinical dose assuming 100% absorption and based on body surface area comparison. Possible tretinoin-associated teratogenic effects (craniofacial abnormalities [hydrocephaly], asymmetrical thyroids, variations in ossification, and increased supernumerary ribs) were noted in the fetuses of Atralin Gel treated animals. These findings were not observed in control animals. Other maternal and reproductive parameters in the Atralin Gel treated animals were not different from control. For purposes of comparison of the animal exposure to human exposure, the clinical dose is defined as 2 g of Atralin Gel applied daily to a 50-kg person. Oral tretinoin has been shown to be teratogenic in rats, mice, rabbits, hamsters and nonhuman primates. Tretinoin was teratogenic in Wistar rats when given orally in doses greater than 1 mg/kg/day (approximately 8 times the clinical dose based on body surface area comparison). In the cynomolgus monkey, fetal malformations were reported for doses of 10 mg/kg/day, but none were observed at 5 mg/kg/day (approximately 80 times the clinical dose based on body surface area comparison), although increased skeletal variations were observed at all doses. Dose-related increases in embryolethality and abortion also were reported. Similar results have also been reported in pigtail macaques. Topical tretinoin in a different formulation has generated equivocal results in animal teratogenicity tests. There is evidence for teratogenicity (shortened or kinked tail) of topical tretinoin in Wistar rats at doses greater than 1 mg/kg/day (approximately 8 times the clinical dose assuming 100% absorption and based on body surface area comparison). Anomalies (humerus: short 13%, bent 6%, os parietal incompletely ossified 14%) have also been reported when 10 mg/kg/day (approximately 160 times the clinical dose assuming 100% absorption and based on body surface area comparison) was topically applied. Supernumerary ribs have been a consistent finding in rats when dams were treated topically or orally with retinoids. With widespread use of any drug, a small number of birth defect reports associated temporally with the administration of the drug would be expected by chance alone. Cases of temporally associated congenital malformations have been reported with use of other topical tretinoin products. The significance of these spontaneous reports in terms of risk to the fetus is not known. Nonteratogenic effects on fetuses: Oral tretinoin has been shown to be fetotoxic in rats when administered in doses 20 times the clinical dose based on a body surface area comparison. Topical tretinoin has been shown to be fetotoxic in rabbits when administered in doses 8 times the clinical dose based on a body surface area comparison. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Atralin Gel is administered to a nursing woman. Pediatric Use Safety and effectiveness in children below the age of 10 have not been established. A total of 381 pediatric subjects (aged 10 to 16 years), treated with Atralin Gel were enrolled into the two clinical studies. Across these two studies, comparable safety and efficacy were observed between pediatric and adult subjects. Geriatric Use Safety and effectiveness in a geriatric population have not been established. Clinical studies of Atralin Gel did not include any subjects over age 65 to determine whether they respond differently than younger subjects.
100%
BRIEF SUMMARY (see package insert for full prescribing information) For topical use only INDICATIONS AND USAGE Atralin Gel is a retinoid indicated for topical treatment of acne vulgaris. Important Limitations of Use The safety and efficacy of the use of this product in the treatment of any other disorders have not been evaluated. CONTRAINDICATIONS None WARNINGS AND PRECAUTIONS Skin Irritation The skin of certain individuals may become dry, red, or exfoliated while using Atralin Gel. If the degree of irritation warrants, patients should be directed to temporarily reduce the amount or frequency of application of the medication, discontinue use temporarily, or discontinue use altogether. Efficacy at reduced frequencies of application has not been established. If a reaction suggesting sensitivity occurs, use of the medication should be discontinued. Mild to moderate skin dryness may also be experienced; if so, use of an appropriate moisturizer during the day may be helpful. Tretinoin has been reported to cause severe irritation on eczematous or sunburned skin and should be used with caution in patients with these conditions. Topical over-the-counter acne preparations, concomitant topical medication, medicated cleansers, topical products with alcohol or astringents, when used with Atralin Gel, should be used with caution [see Drug Interactions (7)]. Ultraviolet Light and Environmental Exposure Unprotected exposure to sunlight, including sunlamps, should be minimized during the use of Atralin Gel. Patients who normally experience high levels of sun exposure, and those with inherent sensitivity to sun, should be warned to exercise caution. Use of sunscreen products of at least SPF 15 and protective clothing over treated areas is recommended when exposure cannot be avoided. Weather extremes, such as wind or cold, also may be irritating to patients under treatment with tretinoin. Fish Allergies Atralin Gel contains soluble fish proteins and should be used with caution in patients with known sensitivity or allergy to fish. Patients who develop pruritus or urticaria should contact their health care provider. ADVERSE REACTIONS Clinical Studies Experience Because clinical trials are conducted under prescribed conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. In two randomized, controlled trials, 674 subjects received treatment for up to 12 weeks with Atralin Gel [see Clinical Studies (14)]. In these studies, 50% of the subjects who were treated with Atralin Gel reported one or more adverse reactions; 30% of the subjects reported treatment-related adverse reactions. In the vehicle group, 29% of the 487 randomized subjects reported at least one adverse reaction; 5% of the subjects reported events that were treatment-related. There were no serious, treatment-related adverse reactions reported by subjects in any of the treatment groups. Selected adverse reactions that occurred in at least 1% of subjects in the two studies combined, are shown in Table 1 (below). Most skin-related adverse reactions first appear during the first two weeks of treatment with Atralin Gel, and the incidence rate for skin-related reactions peaks around the second and third week of treatment. In some subjects the skin-related adverse reactions persist throughout the treatment period.
Supervising Physician CORNER Dr. Joseph Jorizzo
J
oseph Jorizzo, MD has been practicing dermatology for thirty-six years. He is currently a Professor, Former and Founding Chair in the Department of Dermatology at Wake Forest University School of Medicine in Winston-Salem, North Carolina, and is an Adjunct Professor of Dermatology at the Weill Cornell School of Medicine in New York City. Many dermatology PAs may recognize him as one of the editors of the textbook Dermatology by Bolognia, Jorizzo, and Rapini and from his many published works/ articles, several co-edited textbooks, and SDPA conference lectures where he enjoys sharing his passion for medical education with the dermatology PA audience. We had the pleasure of interviewing Dr. Jorizzo and talking with him about his influential role in the field of medical education, as well as his insights on how a supervising physician can help to educate his/her PA(s). We thank him for taking the time to share with us his experiences and insights. JDPA: Did you always know that dermatology was the specialty that you wanted to pursue? Dr. Jorizzo: I certainly grew up with the idea of pursuing a career in medicine. My father practiced dermatology in Italy. When he moved to the U.S. he had to start from scratch and pursued rehabilitation medicine. During eighth grade I had to interview someone who worked in a field that I would be interested in when I grew up, and I interviewed my fatherâ&#x20AC;&#x2122;s boss who was an internal medicine physician. When I was an intern in internal medicine at the University of North Carolina I had two consecutive dermatologists, who were my mentors, suggest that I pursue a career in dermatology. My father passed away when I was a freshman in college, and I think that subliminally this factored into my decision. Despite the fact that we had never discussed why he had pursued dermatology when in Italy, I think he influenced me in choosing dermatology.
JDPA: As the founder, former chair, and professor of the Wake Forest Dermatology Residency Program, you have had an important role in dermatology education. What inspired you to become involved in educating healthcare providers both in the written form through your books and articles and through lectures at conferences? Dr. Jorizzo: Part of my inspiration probably came during my physical chemistry class when I was a first year pre-medical student. During the class we were supposed to mix two chemicals together and end up with a white powder. I always ended up with gray, so it was obvious to me that laboratory research would not be my best career path! Giving advice, teaching, and seeing patients just came naturally to me. As an older brother in my family, I had already had years of practice giving unsolicited advice to my younger sister and brother. As a resident, I was patient and enjoyed teaching and giving advice. I had two mentors; Ben Smith from the University of Texas and Clayton Wheeler from the University of North Carolina. They were both personal and inspirational. Ben Smith taught me the importance of administration, and Clayton Wheeler taught me the value of running a family oriented department. I spent a year in London, and the people I met there taught me how to structure my career as a good teacher and a good dermatologist and to have a subspecialty interest. I have always tried to tie all three components (administration, personal attention, and structure) together. JDPA: Do you work with PAs? If so, how have you seen PAs evolve through the years? Dr. Jorizzo: Yes, I work with three PAs within the department of dermatology at Wake Forest. I speak at a number of meetings including one or two national PA meetings per year. The PAs who attend seem to be very receptive to these lectures. I have spoken for one to two hours Vol. 6, No. 2 SPRING 2012 57
DERmatology pa news & notes
By J. Margaret Casey, staff writer
Dermatology PA news & notes
on complex dermatology topics and have not lost the attention of my PA audience. I could present the same lecture to an audience of my peers and would loose the attention of some as they might be more interested in cosmetic or surgical topics, not complex medical dermatology. I am impressed with the level to which PAs are interested in learning more and expanding their knowledge base. JDPA: What are your thoughts regarding the role of PAs in dermatology? Dr. Jorizzo: In its current form, healthcare does not incentivize taking care of sick patients. Therefore, in the best-case scenario PAs should function independently while being supervised to the extent that is required through AAD guidelines. I do not like situations in which PAs function in complete isolation being required to primarily find and refer patients with cosmetic or dermatologic oncology problems. It is not good if the supervising dermatologist is never available. JDPA: What would you recommend to new dermatology PAs to help them expand their dermatology knowledge? Dr. Jorizzo: New PAs need to have a strong didactic experience to complement their clinical experiences. A new dermatology PA should look for a supervising physician who supports, values, and encourages attending CME conferences. PAs and dermatologists should work together to create a learning environment. It is important for a supervising physician to have an established recognition of the expanding skills new PAs are achieving. Dermatology is a constantly evolving specialty and new PAs want to be sure to keep up with the clinical changes. JDPA: Having presented at several SDPA conferences, what is your impression of them? Dr. Jorizzo: I am extremely impressed with the SDPA conferences I have attended. The SDPA really does its homework. When approached about presenting, I have been asked to present very specific topics as opposed to being asked to lecture on something I have presented several times before. The SDPA researches and requests content to meet the needs of their curriculum program rather than just taking old content and rehashing it. The conferences certainly present a more complete curriculum. I would also 58 Journal of Dermatology for Physician Assistants
encourage dermatology PAs to attend the AAD conferences as well. JDPA: What is the best way that a supervising physician can aid in the education of their PA(s)? Dr. Jorizzo: This may sound self-serving, but it really isnâ&#x20AC;&#x2122;t meant to be; I have seen offices do this, and it is very successful. Take a major dermatology textbook and go over the book together. This approach can work with both large and small offices. Assign a section each week and spend a year going over the book. Another approach is to choose topics based on relevance to your practice and cover them in that order. Communicating about the topics, how the office handles certain cases, and answering any questions the PA may have will be beneficial to the practice and to patients. J Joseph L. Jorizzo, MD is Professor, Former and Founding Chair in the Department of Dermatology at Wake Forest University School of Medicine in Winston-Salem, North Carolina and is an Adjunct Professor of Dermatology at the Weill Cornell School of Medicine in New York City. He received his undergraduate and medical degrees in a 6-year AB/MD program from the Boston University School of Medicine and completed his residency at the North Carolina Memorial Hospital (UNC Hospital) where he was Chief Resident in Dermatology. He was a fellow at the St Johnâ&#x20AC;&#x2122;s Hospital for Disease of the Skin - Dermatology Institute in London, England. Dr Jorizzo has participated on the editorial boards of major dermatology journals including: Archives of Dermatology, Journal of the American Academy of Dermatology, Journal of the European Academy of Dermatology and Venereology, and others. He has co-edited several books, including the 4 editions of Dermatological Signs of Internal Disease and Dermatology by Bolognia, Jorizzo and Rapini for Elsevier. Additionally, he has authored and/or co-authored more than 200 articles and abstracts in such specialty-targeted periodicals as the Archives of Dermatology, International Journal of Dermatology, the Journal of the American Academy of Dermatology, the Journal of Dermatological Treatment, the Journal of Investigative Dermatology, the British Journal of Dermatology, the Annals of Internal Medicine and the Journal of the European Academy of Dermatology and Venereology. He is also an active member of a number of professional dermatologic groups including the American Academy of Dermatology where he served as Vice President, the American Dermatological Association, the Association of Professors of Dermatology, the Dermatology Foundation, and the Society of Investigative Dermatology.
Dermatology in art By W. Stephen Steiner, PA-C
“An Old Man and his Grandson” hangs in the Louvre Museum in Paris, France. It was painted in the late 15th century by Domenico Ghirlandaio. An elderly man looks down with reassurance at the questioning eyes on the youngster. The rich color of the robes denotes their wealth; however, the love shared between the two is the timeless focus of the art. Maybe the grandson is seeking consolation after hearing bad news. Perhaps the lad is wondering if his nose will someday approach the size of his grandfather’s. The bulbous protrusion of the proboscis of this gentleman is clearly rhinophyma. Most regard phymatous changes as an advanced sequella of rosacea. The mainstay of treatment is laser resurfacing or other surgical management. J W. Stephen Steiner, PA-C is employed by Gwinnett Dermatology, PC and Gwinnett Clinical Research Center. He has worked in dermatology for the past twelve years. Outside of work, he enjoys woodworking and spending time with his wife and boys.
What Do You Want To Read About In The JDPA? We’re interested in knowing what kind of articles SDPA members would be interested in reading more about in order to help improve their practice of dermatology. Share your content ideas today. Email them to editor@jdpa.org
Vol. 6, No. 2 SPRING 2012 59
DERmatology pa news & notes
Dr. Bernard Ackerman likened the study of dermatology to art history. The parallels between appreciation of art and the evaluation of skin are many. A neophyte describes a painting in regards to color, brushstroke, content, and structure. A skilled art historian assimilates these details unconsciously and may declare, “It looks like a Monet.” Each description is equally valid, and each serves a unique purpose. Similarly, one may describe the violaceous polygonal papules arising on the volar wrist; another may describe it simply as lichen planus. While blood work and biopsies are critical to our specialty, it is what we appreciate on the surface of the skin that largely influences decisions in clinical practice. This series will explore the depictions of dermatologic conditions in classic artwork. The condition may be the focus of the painting, but often it is a quiet detail, only for the discerning and trained eye. If you have a piece of art that you would like to share with the JDPA readers, please contact us at editor@jdpa.org.
Camp Discovery 2012
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Dermatology PA news & notes
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In 1993, during his presidency, Dr. Mark Dahl founded Camp Discovery with the support of the American Academy of Dermatology (AAD), offering one week of camp to about 50 kids at Camp Knutson in Crosslake, Minnesota. Little did we know how much Camp would grow over the next 19 years. The Camp Discovery family now includes Camp Little Pine (Minnesota), Camp Big Trout (Minnesota), Camp Horizon (Pennsylvania), Camp Dermadillo (Texas), Camp Liberty (Connecticut) and Camp Reflection (Washington). This year the AAD is proud to offer six camping sessions for young people with chronic skin conditions who are between the ages of 8 and 16. Under the expert care of dermatologists, dermatology PAs, and nurses, Camp Discovery gives campers the opportunity to spend a week with other young people with skin conditions, while participating in everything from swimming and fishing to horseback riding to lots of camp games and just plain fun! There is no fee to attend this very special camp. Full scholarships, including transportation, are provided by the AAD through generous donations from its members, outside organizations, and individuals. All campers must be referred by their dermatology provider.
LV
in Crosslake, Minnesota (ages 10 – 14) ✦ June 25 – 29, Camp Reflection in Carnation, Washington (ages 8 – 16) ✦ July 8 – 13, Camp Big Trout in Crosslake, Minnesota (ages 14 – 16) ✦ August 12 – 17, Camp Liberty in Hebron, Connecticut (ages 8 – 16) ✦ August 5 – 10, Camp Dermadillo in Burton, Texas (ages 9 – 15) ✦ August 11 – 18, Camp Horizon in Millville, Pennsylvania (ages 8 – 13) For more information about attending or volunteering, please visit the Camp Discovery website at campdiscovery.org or contact Janine Mueller at (847) 240-1737 or jmueller@aad.org. J
60 Journal of Dermatology for Physician Assistants
JDPA Information for Authors The Journal of Dermatology for Physician Assistants (JDPA) is a peer-reviewed publication that delivers innovative clinical, surgical, cosmetic, and professional content exclusively for dermatology PAs. Submissions to the JDPA are peer-reviewed by a panel of experienced dermatology PAs, educational PAs, and dermatologists before articles are accepted for publication. Manuscripts submitted for publication will be reviewed with the understanding that they are original and have not been submitted elsewhere nor are being considered by other journals. Electronic submissions are accepted and should be sent to editor@jdpa.org. The five main sections featured in each issue of the JDPA are listed below along with a brief description of the various topics that authors can contribute to. Regardless of the section, all articles must follow the following criteria: • Formatting - Times New Roman font, 12 point, double-spaced, left aligned. • Article Order - Title, Author(s), Author bios (including disclosures), Text of Article, References, Tables, and Figures • Reference Citations - Utilize the AMA Manual of Style, 10th Edition.
Dermatology PA News and Notes • Feature Articles
Write a review about a new or innovative dermatological procedure, device, and/or approach to patient care (500-1000 words).
• From The Desk Of…
Write an opinion essay sharing your insight regarding a current “hot item” issue (e.g., specialty PA credentialing, dermatology access to care, supervising physician relationships, etc.) or any other topic regarding the field of dermatology (250-1000 words).
Clinical Dermatology • CME articles
Content should be specific to the field of dermatology following any of the following formats: Study – Original research (clinical or basic science). Professional issues or health policy papers. Review – Scholarly review of a topic. Content length: 6 pages (requires 4 self-assessment Q&A) = .5hr of Cat. I CME. 12 pages (requires 8 self-assessment Q&A) = 1hr of Cat. I CME. Article should include written learning objectives (3-4 required).
• Dermatology Case Report
Write a report and discuss a case(s) that illustrate an important or interesting observation (500-1500 words).
• Journal Club: Dermatology PA Perspectives
Write a review of an already published article from an established dermatology journal (e.g., JAAD, Cos Dermatol, Dermatol Surg, etc.), summarizing the practical thoughts and clinical issues (250-1000 words).
• From the Patient’s Perspective
Patients’ stories published in their own words. JDPA staff can even assist patients with writing their stories (250-1000 words).
• Clinical Snapshots
Write a brief written description and clinical facts about an interesting cutaneous anomaly (250-500 words).
• Drugs in Dermatology
Write about the current information regarding a particular dermatological medication, drug interaction, or medication side effect/adverse reaction (250-1000 words).
• Dermatology Evidence-Based Medicine (derm EBM)
Write a brief, evidence-based assessment of the one or two most relevant studies retrieved to answer a focused clinical question that may have arisen from a real-life situation. A derm EBM is not a comprehensive review of a subject or a synthesis of all the available knowledge (500–1500 words).
Surgical Dermatology • Feature Articles
Write a review about a new or innovative surgical procedure, device, and/or approach to patient care (500-1000 words).
• Surgical Wisdom
Write a brief article on a fact or pearl for the surgical setting (250-500 words).
• Surgical Dermatology Case Report
Write a report and discuss a case(s) that illustrate an important or interesting observation (500-1500 words).
• Journal Club: Dermatology PA Perspectives
Write a review of an already published article from an established dermatology journal (e.g., JAAD, Cos Dermatol, Dermatol Surg, etc.), summarizing the practical thoughts and clinical issues (250-1000 words).
Cosmetic Dermatology • Feature Articles
Write a review about a new or innovative cosmetic procedure, device, and/or approach to patient care (500-1000 words).
• Cosmetic Pearls
Write a brief article on a fact or pearl for the cosmetic setting (250-500 words).
• Cosmetic Dermatology Case Report Write a report and discuss a case(s) that illustrate an important or interesting observation (500-1500 words). • Journal Club: Dermatology PA Perspectives Write a review of an already published article from an established dermatology journal (e.g., JAAD, Cos Dermatol, Dermatol Surg, etc.), summarizing the practical thoughts and clinical issues (250-1000 words).
Professional Development • Feature Articles
Write an article that explores the professional issues dermatology PAs face such as reimbursement, education, medical trends, contracts, office management, etc. (500-1500 words).
• Outside & Inside the 9 to 5
Allow us to share your story of the good work that you do either outside or inside your practice of dermatology. You can write this article yourself or the JDPA staff can interview you to write the article (250-1000 words).
• Notes From Your Office Manager
Write a brief article on a fact or pearl for the office setting (250-500 words).
• Judicial and Ethical Affairs
Write an article that explores the complex or multifaceted ethical or judicial professional issues that affect the practice of dermatology for PAs (250-1000 words).
Vol. 6, No. 2 SPRING 2012 61
Professional Opportunities and Development
Advertiser INDE X Valeant – Retin-A Micro........................ Pages 2, 3 Ranbaxy - Kenalog Spray........................Pages 7, 8 Promius - Cloderm.............................Pages 11, 12 Leo – Picato.......................................Pages 27, 28 Medicis – Passion to Heal...................Pages 32, 33 Galderma - Metrogel..........................Pages 35, 36 Allergan – Aczone...............................Pages 39, 40 Galderma - Epiduo . ......................... Pages 43, 44 Galderma – Cetaphil DermaControl..........Page 50 Valeant - Atralin............................... Pages 55, 56 Bayer HealthCare - Finacea.............. Pages 63, 64 For more information on advertising opportunities in the JDPA, please log on to www.jdpa.org
We are excited to extend our Refer a Member Campaign!
Receive a $20 Amazon Gift Card for every person you refer to become a member of the SDPA.
SOCIETY OF DERMATOLOGY
PHYSICIAN ASSISTANTS Please note: Each referral will be counted only after the new member pays his/her dues and lists the referring member’s name on the application. Referral of supervising physicians will NOT qualify for this campaign, but is certainly encouraged.
62 Journal of Dermatology for Physician Assistants
Finacea
®�
(azelaic acid) Gel,15%
For Dermatologic Use Only–Not for Ophthalmic, Oral, or Intravaginal Use Rx only BRIEF SUMMARY CONSULT PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION INDICATIONS AND USAGE FINACEA Gel, 15%, is indicated for topical treatment of inflammatory papules and pustules of mild to moderate rosacea. Although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated. Patients should be instructed to avoid spicy foods, thermally hot foods and drinks, alcoholic beverages and to use only very mild soaps or soapless cleansing lotion for facial cleansing. CONTRAINDICATIONS FINACEA Gel, 15%, is contraindicated in individuals with a history of hypersensitivity to propylene glycol or any other component of the formulation. WARNINGS FINACEA Gel, 15%, is for dermatologic use only, and not for ophthalmic, oral or intravaginal use. There have been isolated reports of hypopigmentation after use of azelaic acid. Since azelaic acid has not been well studied in patients with dark complexion, these patients should be monitored for early signs of hypopigmentation. PRECAUTIONS General: Contact with the eyes should be avoided. If sensitivity or severe irritation develops with the use of FINACEA Gel, 15%, treatment should be discontinued and appropriate therapy instituted. In a transgenic mouse study, chronic use of FINACEA Gel led to an increased number of animals with papillomas at the treatment site (see PRECAUTIONS: Carcinogenesis, Mutagenesis, and Impairment of Fertility). The clinical relevance of the findings in animal studies to humans is not clear. Information for Patients: Patients using FINACEA Gel, 15%, should receive the following information and instructions: • FINACEA Gel, 15%, is to be used only as directed by the physician. • FINACEA Gel, 15%, is for external use only. It is not to be used orally, intravaginally, or for the eyes. • Cleanse affected area(s) with a very mild soap or a soapless cleansing lotion and pat dry with a soft towel before applying FINACEA Gel, 15%. Avoid alcoholic cleansers, tinctures and astringents, abrasives and peeling agents. • Avoid contact of FINACEA Gel, 15%, with the mouth, eyes and other mucous membranes. If it does come in contact with the eyes, wash the eyes with large amounts of water and consult a physician if eye irritation persists. • The hands should be washed following application of FINACEA Gel, 15%. • Cosmetics may be applied after FINACEA Gel, 15%, has dried. • Skin irritation (e.g., pruritus, burning, or stinging) may occur during use of FINACEA Gel, 15%, usually during the first few weeks of treatment. If irritation is excessive or persists, use of FINACEA Gel, 15%, should be discontinued, and patients should consult their physician (See ADVERSE REACTIONS). • Avoid any foods and beverages that might provoke erythema, flushing, and blushing (including spicy food, alcoholic beverages, and thermally hot drinks, including hot coffee and tea). • Patients should report abnormal changes in skin color to their physician. • Avoid the use of occlusive dressings or wrappings. Drug Interactions: There have been no formal studies of the interaction of FINACEA Gel, 15%, with other drugs. Carcinogenesis, Mutagenesis, Impairment of Fertility: Systemic long-term animal studies have not been performed to evaluate the carcinogenic potential of azelaic acid. In a 26-week dermal carcinogenicity study using transgenic (Tg.AC) mice, FINACEA Gel, 15%, and the gel vehicle, when applied once or twice daily, did not increase the number of female Tg.AC animals with papillomas at the treatment site. No statistically significant increase in the number of animals with papillomas at the treatment site was observed in male Tg.AC animals after once daily application. After twice daily application, FINACEA Gel, 15%, and the gel vehicle induced a statistically significant increase in the number of male animals with papillomas at the treatment site when compared to untreated males. This suggests that the positive effect may be associated with the vehicle application. The clinical relevance of the findings in animals to humans is not clear. Azelaic acid was not mutagenic or clastogenic in a battery of in vitro (Ames assay, HGPRT in V79 cells {Chinese hamster lung cells}, and chromosomal aberration assay in human lymphocytes) and in vivo (dominant lethal assay in mice and mouse micronucleus assay) genotoxicity tests. Oral administration of azelaic acid at dose levels up to 2500 mg/kg/day (162 times the maximum recommended human dose based on body surface area) did not affect fertility or reproductive performance in male or female rats. Pregnancy: Teratogenic Effects: Pregnancy Category B There are no adequate and well-controlled studies of topically administered azelaic acid in pregnant women. The experience with FINACEA Gel, 15%, when used by pregnant women is too limited to permit assessment of the safety of its use during pregnancy. Dermal embryofetal developmental toxicology studies have not been performed with azelaic acid, 15%, gel. Oral embryofetal developmental studies were conducted with azelaic acid in rats, rabbits, and cynomolgus monkeys. Azelaic acid was administered during the period of organogenesis in
all three animal species. Embryotoxicity was observed in rats, rabbits, and monkeys at oral doses of azelaic acid that generated some maternal toxicity. Embryotoxicity was observed in rats given 2500 mg/kg/day (162 times the maximum recommended human dose based on body surface area), rabbits given 150 or 500 mg/kg/day (19 or 65 times the maximum recommended human dose based on body surface area) and cynomolgus monkeys given 500 mg/kg/day (65 times the maximum recommended human dose based on body surface area) azelaic acid. No teratogenic effects were observed in the oral embryofetal developmental studies conducted in rats, rabbits and cynomolgus monkeys. An oral peri- and post-natal developmental study was conducted in rats. Azelaic acid was administered from gestational day 15 through day 21 postpartum up to a dose level of 2500 mg/kg/day. Embryotoxicity was observed in rats at an oral dose that generated some maternal toxicity (2500 mg/kg/day; 162 times the maximum recommended human dose based on body surface area). In addition, slight disturbances in the post-natal development of fetuses was noted in rats at oral doses that generated some maternal toxicity (500 and 2500 mg/kg/day; 32 and 162 times the maximum recommended human dose based on body surface area). No effects on sexual maturation of the fetuses were noted in this study. Because animal reproduction studies are not always predictive of human response, this drug should be used only if clearly needed during pregnancy. Nursing Mothers: Equilibrium dialysis was used to assess human milk partitioning in vitro. At an azelaic acid concentration of 25 µg/mL, the milk/plasma distribution coefficient was 0.7 and the milk/buffer distribution was 1.0, indicating that passage of drug into maternal milk may occur. Since less than 4% of a topically applied dose of azelaic acid cream, 20%, is systemically absorbed, the uptake of azelaic acid into maternal milk is not expected to cause a significant change from baseline azelaic acid levels in the milk. However, caution should be exercised when FINACEA Gel, 15%, is administered to a nursing mother. Pediatric Use: Safety and effectiveness of FINACEA Gel, 15%, in pediatric patients have not been established. Geriatric: Clinical studies of FINACEA Gel, 15%, did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. ADVERSE REACTIONS Overall, treatment related adverse events, including burning, stinging/ tingling, dryness/tightness/ scaling, itching, and erythema/irritation/ redness, were 19.4% (24/124) for FINACEA Gel, 15%, and 7.1% (9/127) for the active comparator gel at 15 weeks. In two vehicle controlled, and one active controlled U.S. clinical studies, treatment safety was monitored in 788 patients who used twice daily FINACEA Gel, 15%, for 12 weeks (N=333) or for 15 weeks (N=124), or the gel vehicle (N=331) for 12 weeks. Table 3. Cutaneous Adverse Events Occurring in ≥1% of Subjects in the Rosacea Trials by Treatment Group and Maximum Intensity* FINACEA Gel, 15% N=457 (100%)
Vehicle N=331 (100%)
Mild n=99 (22%)
Moderate n=61 (13%)
Severe n=27 (6%)
Burning/ stinging/ tingling
71 (16%)
42 (9%)
17 (4%)
Pruritus
29 (6%)
18 (4%)
5 (1%)
Scaling/dry skin/xerosis
21 (5%)
10 (2%)
5 (1%)
Erythema/ irritation
6 (1%)
7 (2%)
Contact dermatitis
2 (<1%)
Edema
3 (1%)
Acne
3 (1%)
1 (<1%)
Mild n=46 (14%)
Moderate n=30 (9%)
Severe n=5 (2%)
8 (2%)
6 (2%)
2 (1%)
9 (3%)
6 (2%)
0 (0%)
31 (9%)
14 (4%)
1 (<1%)
2 (<1%)
8 (2%)
4 (1%)
2 (1%)
3 (1%)
0 (0%)
1 (<1%)
0 (0%)
0 (0%)
2 (<1%)
0 (0%)
3 (1%)
0 (0%)
0 (0%)
0 (0%)
1 (<1%)
0 (0%)
0 (0%)
*Subjects may have >1 cutaneous adverse event; thus, the sum of the frequencies of preferred terms may exceed the number of subjects with at least 1 cutaneous adverse event. FINACEA Gel, 15%, and its vehicle caused irritant reactions at the application site in human dermal safety studies. FINACEA Gel, 15%, caused significantly more irritation than its vehicle in a cumulative irritation study. Some improvement in irritation was demonstrated over the course of the clinical studies, but this improvement might be attributed to subject dropouts. No phototoxicity or photoallergenicity were reported in human dermal safety studies. In patients using azelaic acid formulations, the following additional adverse experiences have been reported rarely: worsening of asthma, vitiligo depigmentation, small depigmented spots, hypertrichosis, reddening (signs of keratosis pilaris), and exacerbation of recurrent herpes labialis. Post-marketing safety-Skin: facial burning and irritation; Eyes: iridocyclitis on accidental exposure with FINACEA Gel, 15%, to the eye (see PRECAUTIONS). Distributed under license; U.S. Patent No 6,534,070 www.myfinacea.com ©2010, Intendis, Inc. All rights reserved, July 2010 Manufactured by Intendis Manufacturing S.p.A., Segrate, Milan, Italy Distributed by: Morristown, NJ 07962 Intendis is part of the Bayer Group
6706803BS
Vol. 6, No. 2 SPRING 2012 63
For patients with mild to moderate rosacea,
Deliver a spectrum of benefits with FINACEA
®
• The first and only gel approved to treat the inflammatory papules, pustules, and their associated erythema* • Continuous lesion reductions consistent across 12-week pivotal studies1 • Hydrogel formulation that’s nonsticky, alcohol- and fragrance-free2 • Maintains the skin barrier 3
INDICATION & USAGE
IMPORTANT SAFETY INFORMATION
FINACEA (azelaic acid) Gel, 15% is indicated for topical treatment of inflammatory papules and pustules of mild to moderate rosacea.
FINACEA is for dermatologic use only, and not for ophthalmic, oral, or intravaginal use. FINACEA is contraindicated in individuals with a history of hypersensitivity to propylene glycol or any other component of the formulation. In clinical trials, sensations of burning/stinging/tingling occurred in 29% of patients, and itching in 11%, regardless of the relationship to therapy. Post-marketing safety—Skin: facial burning and irritation; Eyes: iridocyclitis on accidental exposure to the eye. There have been isolated reports of hypopigmentation after use of azelaic acid. Since azelaic acid has not been well studied in patients with dark complexion, these patients should be monitored for early signs of hypopigmentation.
* Although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated.
Model used for illustrative purposes only. References: 1. Thiboutot D, Thieroff-Ekerdt R, Graupe K. Efficacy and safety of azelaic acid (15%) gel as a new treatment for papulopustular rosacea: results from two vehicle-controlled, randomized phase III studies. J Am Acad Dermatol. 2003;48(6):836-845. 2. Draelos ZD, Graupe K. A new topical formulation for the treatment of mild to moderate papulopustular rosacea: azelaic acid 15% gel. Poster presented at: 61st Annual Meeting of the American Academy of Dermatology; March 21-26, 2003; San Francisco, CA. 3. Draelos ZD. Effects of azelaic acid 15% gel on skin barrier in rosacea. Cosmet Derm. 2008;21(5):259-261.
Please see following page for Brief Summary of full Prescribing Information.
INTENDIS is now © 2012 Bayer HealthCare Inc. Bayer, the Bayer Cross and FINACEA are registered trademarks of Bayer HealthCare Inc. All rights reserved. FIN-10-0001-12 January 2012. Printed in USA.
64 Journal of Dermatology for Physician Assistants