Winter 2012 Journal of Dermatology for Physician Assistants

Volume 6 number 1 WINTER 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. 1 WINTER 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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

Dermal 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

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Physician Assistant Communications, LLC P.O. Box 416, Manlius NY 13104-0416 Phone (315) 663-4147 PAC@pacommunications.org www.pacommunications.org editorial missioN: The JDPA is the official clinical journal of the Society of Dermatology Physician Assistants. The mission of the JDPA is to improve dermatological patient care by publishing the most innovative, timely, practiceproven educational information available for the physician assistant profession.

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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 1, Winter 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).

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Editor’s Message

Journal of Dermatology for Physician Assistants

The Official Journal of the SDPA

The time to move our profession forward is Now! If you are interested in running for office, please contact the elections committee at elections@dermpa.org

T

unnel vision can happen to the best of us. Whether it happens from lack of experience, a complicated case with multiple issues, or a busy and hectic day, we can easily fall into the trap of focusing only on the presenting concerns of our patients. In dermatology we are charged to care for an organ system that is exposed in front of us. This makes it feasible for us to allow our eyes to wander, while still maintaining an appropriate level of focus on the central areas of our patients’ concerns. I always encourage the students I precept and teach to “take a look around” whenever they are performing focused skin examinations. I remind students that it is important to remember that although patients are encouraged to perform monthly skin self-examinations, this often does not translate into them doing so. One recent study conducted in 2011 by Hull, et al. showed that among patients with histories of melanoma and atypical moles (high risk individuals for skin cancer), compliance with requested monthly skin self-examinations was minimal:1 Only 22% in the melanoma group and fewer than 10% of those with atypical moles performed a complete skin self-examination monthly.

Findings such as these highlight the importance that we dermatology providers should become the scouring eyes, screening whenever and wherever we have the opportunity. I know of many colleagues who have seen atypical appearing lesions on friends or family at poolside gatherings, picnics, days at the beach, or other social venues. While their intentions were to have a casual day of relaxation, this did not stop them from offering a comment such as, “That looks funny, have you had that checked out yet?”

For the trained and experienced professional, many dermatological conditions take only a minute or two to assess and diagnose. Meanwhile we have plenty of time for our eyes to wander and to peruse the landscape of our patients’ skin, in particular the “out of sight, out of mind” areas that are normally hidden from patients’ fields of vision (such as the posterior surfaces of backs, arms, legs, and ears). Often times surveying these areas can be done discretely as we carry on conversations with our patients about their histories or how they have been doing. Let me clarify that I am not advocating turning each and every follow-up patient encounter into a full body skin examination.

I am fully aware that with the extremely high demand for our services and the extended patient wait times in most of our offices, this would be unrealistic.

If a full body skin examination is indeed required, it can easily be arranged or scheduled. However, what I am saying is that if we have exposed skin in front of us, then by all means we should be looking at all of it. Finding new lesions that patients are unaware of does take some additional time to address and manage, potentially altering our schedules for the day. However, taking the necessary time to keep our focuses wide and out of the tunnel vision mode will more importantly help to save a life. J

Travis Hayden, MPAS, PA-C Editor in chief

REFERENCE: 1. Hull PR, Piemontesi NG, Lichtenwald J. Compliance with self-examination surveillance in patients with melanoma and atypical moles: an anonymous questionnaire study. J Cutan Med Surg. 2011;15(2):97-102.

Vol. 6, No. 1 WINTER 2012

table of contents

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14

Management of Cutaneous T-Cell Lymphoma – An Overview of Current Therapies with a Case Study

By Patrick C. Ford, Allison S. Felshaw, MS, PA-C, Kelly McNavish, MMS, PA-C, and Mark Hyde, MMS, PA-C

CME

© Therakos, Inc. 2011

SDPA Members Only Content

10 Derm PA News & Notes – part one • Certification Review – All Those Things Inside the Skin You Might Have Forgotten

14 Clinical Dermatology • CME Article – Management of Cutaneous T-Cell Lymphoma - An Overview of Current Therapies with a Case Study • Dermatology Case Report - The Muir-Torre Syndrome: An Opportunity for Colon Cancer Screening • Drugs in Dermatology - Spinosad

Departments

04 Editorial Board 05 Editor’s Message 09 SDPA News & Current Affairs 10 Dermatology Market Watch 19 From The Patient’s Perspective 23 Dermoscopy Q&A 28 Clinical Snapshots 35 Surgical Wisdom 38 Cosmetic Pearls 43 Outside & Inside the 9 to 5...

45 Notes from your Office Manager 48 The Difference We Make 53 JDPA Information for Authors 54 Professional Opportunities and Development

35 Surgical Dermatology

• Surgical Wisdom - Needle Stick Prevention

36 Cosmetic Dermatology • Moisturizer Selection for Dry Winter Skin

39 Professional Development

46 Derm PA News & Notes – part two

Go Green - Read Online

• Dermatology Billing & Coding – What to do for 2012 • Judicial and Ethical Affairs - Professionalism

Journal of Dermatology for Physician Assistants

• From the Desk of…

• First Foundations - New Employee Checklist • Supervising Physician Corner

dermPA.org

Vol. 6, No. 1 WINTER 2012

Journal of Dermatology for Physician Assistants

Calendar

FROM THE SPDA News & Current Affairs

of events

2012 MARCH 70th AAD Annual Academy Meeting March 16 - 20, 2012 San Diego, CA JULY SDPA Summer Dermatology Conference July 11 - 15, 2012 The Westin Hotel Seattle, WA AUGUST AAD Summer Academy Meeting August 15 - 19, 2012 Boston, MA OCTOBER/NOVEMBER SDPA 10th Annual Fall Conference October 31 - November 3, 2012 Caesars Palace Hotel Las Vegas, NV

T

he SDPA’s growth exemplifies the motto: “big gates move on small hinges.” Expanding from a handful of visionary leaders in 1994 to a nationally respected society with more than 2,000 members in 2012, the SDPA is a leader among PA specialty groups.

SDPA leaders are advocates for our patients and members. We educate policymakers and politicians and continually strive to move “big gates” through our passion to strengthen our great profession.

As steadfast ambassadors for our profession, our success “hinges” upon the insight, dedication, and teamwork of our members. At the start of 2012, I would like to challenge our members with two goals for the upcoming year: Attend at least one SDPA medical education conference.

Our sold-out conferences have a reputation among dermatology physician assistants as being premier events to attend. Attending a conference will provide you with unparalleled access to key dermatology leaders, enhance your education in dermatology, and allow you to show your support for the dermatologist/ physician assistant team.

Become a Diplomate of the SDPA. By enrolling in the Distance Learning Initiative (DLI) you will receive dermatology specific education that will increase your physician’s confidence and credibility in you as he/she entrusts you to care for patients.

Those who complete the DLI have the opportunity to participate in the DLI mentor program by contacting John Hoffstetter at hoff6080@yahoo.com.

Please make a commitment now to achieve these two goals in 2012 and to help to secure the future of PAs in dermatology. J

Keri Holyoak, MPH, PA-C SDPA President, Diplomate

Vol. 6, No. 1 WINTER 2012

9

Dermatology PA news & notes

Dermatology Market Watch New Vaniply Ointment

An advanced OTC skin protectant for dry, irritated, and sensitive skin From the makers of Vanicream Skin Cream, Vaniply Ointment is a gentle and effective ointment that forms a protective film on the skin, which helps to retain the skin’s natural moisture.

• A skin lubricant/ protectant/moisturizer that helps prevent water loss • Non-irritating, nongreasy, long-lasting • Spreads easily and smoothly, soothing dry, irritated, itchy skin • Non-comedogenic • Helps protect minor cuts, scrapes and burns and relieves dry, chapped, cracked lips

• Beneficial in skin problems such as atopic dermatitis, psoriasis, and ichthyosis • Helps protect from drying effects of wind and cold weather and prevents chafed skin associated with sports activities • Available in a 13 oz. (368 g) jar and a 2.5 oz.

(70 g) tube • Formulated without lanolin, dyes, fragrance, masking fragrance, parabens, formaldehyde, and other preservatives • Active Ingredients: dimethicone 1% Inactive Ingredients: C30-45 alkyl methicone, C3045 olefin, hydrogenated polydecene, microcrystalline wax, polyethylene, silica dimethyl silylate For more information or to order free samples call 1-800-325-8232 or visit www.psico.com.

New Glytone Rosacure® Kit

A new three-step treatment for redness-prone skin formulated to minimize the symptoms of intermittent to permanent redness Technical Information: • The innovative, nonirritating 3-Step regimen’s active ingredients work synergistically to reduce the appearance of redness and the severity of itching and stinging.

• Can be used alone or in combination with prescription products as directed by a medical provider • All products are paraben- and fragrance-free Contains: • Rosacure® Cleansing Milk: A soothing cleanser containing 3% Hyaluronic Acid to promote cell renewal and optimal hydration, and Methyl Sulfonyl Methane (MSM), clinically proven to reduce the appearance of redness and the severity of itching and stinging • Rosacure® Calming Tonic Lotion: A light, refreshing, hydrating toning lotion to help even skin’s 10 Journal of Dermatology for Physician Assistants

texture containing 3% Hyaluronic Acid to promote cell renewal and optimal hydration and Methyl Sulfonyl Methane (MSM), clinically proven to reduce the appearance of redness and the severity of itching and stinging • Rosacure® Cream Gel: An especially gentle cream gel for the management of Rosacea, containing 7.2 % Silibinin and Methyl Sulfonyl Methane (MSM), clinically proven to help reduce the appearance of redness and the severity of itching and stinging Direction for use: • Use Rosacure® Cleansing Milk twice daily to cleanse the skin or as directed by a medical provider • Saturate a cotton pad with Rosacure® Calming Tonic Lotion and apply after cleansing or as directed by a medical provider • Apply a thin layer of Rosacure® Cream Gel to affected areas after cleansing and toning or as directed by a medical provider • Before going outdoors, allow Rosacure® Cream Gel to dry, and then apply a sunscreen ...continued on page 13

CLODERM CREAM Not a cookie-cutter topical steroid ®

Different by Design • Unique molecular structure provides midstrength efficacy with an excellent safety profile1-3 • Only Cloderm Cream offers the versatility of both a tube and pump To request samples or for further information, contact Promius Pharma at 888.384.6929 Indication and Important Safety Information Cloderm Cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. The most common adverse events with Cloderm Cream include burning, itching, irritation, dryness, and folliculitis. Cloderm Cream is contraindicated in patients who are hypersensitive to any of the ingredients of this product. As with all topical corticosteroids, systemic absorption can produce reversible HPA-axis suppression. See full prescribing information on reverse side. For more information see www.Cloderm.com.

References: 1. Bikowski J, Pillai R, Shroot B. The position not the presence of halogen in corticosteroids influences potency and side effects. J Drug Dermatol.

2006;5(2):125-130. 2. Del Rosso J, Friedlander S. Corticosteroids: options in the era of steroid-sparing therapy. J Am Acad Dermatol. 2005;53(1 Suppl 1):S50-58.

3. Data on file. Promius Pharma, LLC: Bridgewater, NJ. Cloderm® is a trademark of Coria Laboratories, Ltd.

Vol. 6, No. 1 WINTER 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

Certification Review

All Those Things Inside the Skin You Might Have Forgotten disorders. Clinical manifestations include abdominal distention, anorexia, peripheral, periorbital, and facial edema, weight gain, ascites, and hypertension.

Laboratory studies reveal decreased serum albumin, hyperlipidemia, and urine positive for presence of protein and blood. Fatty casts and oval fat bodies may also be noted on microscopic exam of the urine.

Treatment consists of treating the underlying cause, dietary management, and avoidance of nephrotoxic drugs. Acute pyelonephritis would present with fever, flank pain, and urinalysis positive for white blood cells and white blood cell casts. IgA nephropathy (Berger’s disease) presents with hematuria and hypertension and is typically associated with an upper respiratory or flu-like infection. Glomerular IgA deposits are noted in the kidney and serum IgA levels are elevated. Acute renal failure would present with an elevated serum creatinine. J The correct answer is B.

Are you recertifying soon? Start your board review early. Each issue of the JDPA features one board question accompanied by a brief explanation about the answer along with any pertinent test taking tips. Best of luck!

QUESTION: A 58 year-old patient presents with a seven day history of an eight pound weight gain and facial swelling. On physical examination the blood pressure is 140/88 mmHg, and periorbital and lower extremity edema is noted. Laboratory testing reveals serum sodium 135 mEq/L, potassium 3.8 mEq/L, chloride 100 mEq/L, bicarbonate 23 mEq/L, BUN 12 mg/dl, and creatinine 1.2 mg/dl. Urinalysis reveals a specific gravity 1.030, protein 4+, trace glucose, 1-3 WBCs/HPF, and the presence of oval fat bodies. Which of the following is the most likely diagnosis?

A. Acute pyelonephritis B. Nephrotic syndrome C. Acute renal failure D. Berger’s disease EXPLANATION: Nephrotic syndrome is defined by the presence of more than 3.0 g/day of protein in the urine accompanied by hypoalbuminemia, edema, and hyperlipidemia.

Etiologies include idiopathic, secondary to systemic disease (diabetes, lupus), infections (poststreptococcal), medications (NSAIDS), neoplasms (lymphoma), and hereditary and metabolic

James A. Van Rhee, MS, PA-C, is the Program Director for the Northwestern University Feinberg School of Medicine Department of Family Medicine Physician Assistant Program.

Mr. Van Rhee has been involved in physician assistant education for over 13 years. He has served as project director and test item writer for the Physician Assistant Education Association’s (PAEA) Physician Assistant Clinical Knowledge Rating Assessment Tool (PACKRAT) and is the author of the Physician Assistant: Certification and Re-certification Review Book, published

by Elsevier. For the last ten years he has been course director and presenter of the Physician Assistant Board Review, which is now being produced live online by Kaplan Medical.

Dermatology Market Watch

...continued from page 10

Calling all Running/Walking Enthusiasts!

Mark your calenders for Saturday, July 14th and plan to participate in the SDPA’s inaugural Miles for Melanoma 5K Run/1 Mile Walk at the 2012 SDPA Summer Dermatology Conference in Seattle, WA. All proceeds will benefit the Melanoma Research Foundation. Sign-up will be available with conference registration on the SDPA website, so don’t miss out! Anyone who wishes to volunteer for the event may also contact Jennifer Conner, MPAS, PA-C, SDPA Public Relations Committee Co-Chair at jconner@dermpa.org. J Vol. 6, No. 1 WINTER 2012 13

DERmatology pa news & notes

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

Clinical Dermatology

Management of Cutaneous T-Cell Lymphoma An Overview of Current Therapies with a Case Study

By Patrick C. Ford, Allison S. Felshaw, MS, PA-C, Kelly McNavish, MMS, PA-C, and Mark Hyde, MMS, PA-C

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

CME

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

Approval is valid for 1 year from the issue date of JANUARY 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. Discuss the staging criteria of cutaneous T-cell lymphoma.

2. Provide an overview of cutaneous T-cell lymphoma management.

3. Become familiar with the current patient therapies for cutaneous T-cell lymphoma.

14 Journal of Dermatology for Physician Assistants

Management of Cutaneous T-Cell Lymphoma 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. 1 WINTER 2012 15

Management of Cutaneous T-Cell Lymphoma SDPA Members Only Content

CLINICAL Dermatology

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

16 Journal of Dermatology for Physician Assistants

Management of Cutaneous T-Cell Lymphoma 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. 1 WINTER 2012 17

Management of Cutaneous T-Cell Lymphoma 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.

Patrick C. Ford is a student of Salt Lake Community College and is currently preparing for physician assistant school. He has indicated no relationships to disclose relating to the content of this article.

Allison S. Felshaw, MS, PA-C is a graduate of the Utah Physician Assistant Program in Salt Lake City, Utah. She has indicated no relationships to disclose relating to the content of this article.

Kelly McNavish, MMS, PA-C is a graduate of the Midwestern University Physician Assistant Program in Glendale, Arizona. She has indicated no relationships to disclose relating to the content of this article.

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

18 Journal of Dermatology for Physician Assistants

From The Patient’s Perspective

My Personal Journey with Cutaneous Lymphoma It was at the fairly young age of thirty-one that my journey with cutaneous T-cell lymphoma (CTCL) began.

As so many CTCL patients do, I began with seeing several dermatologists over the course of a year. I was eventually fortunate enough to be referred to Dr. Eric Vonderheid, one of the few specialists treating cutaneous lymphoma at the time. It was 1991 and I was diagnosed with mycosis fungoides. With all that I was involved in at that time in my life, the hopes, dreams and life goals I was pursuing, this diagnosis stopped me cold. I was just thirty-one, how could I have cancer?

At first, this diagnosis was just devastating. So many tough emotions. It took a tremendous physical, mental, and emotional toll on me. Eventually, I wanted and needed to overcome these feelings of hopelessness because, despite this diagnosis, I wanted to live the best life I could. So, being a problem solver, I began to look at my cancer diagnosis in this light: how do I now begin to solve this problem?

Under Dr. Vonderheid’s watchful eye, I began PUVA treatment immediately. This treatment, along with many others, kept my CTCL under control for quite a few years. The itching was challenging at times, but different topical treatments provided some relief.

In 1997 the disease turned aggressive, and I found myself in stage IV looking at a bone marrow transplant as my only option. After a year of struggling, I began the preparatory process for the transplant by taking medications and entering into three months of radiation therapy to get the tumors under control. The summer of 1998 was spent traveling to downtown Philadelphia every day for radiation treatment that left me hairless. I learned that my head is quite a nice round shape!

Fortunately for me, the three months of steady radiation and medications did the trick, and by my 40th birthday in September, the CTCL was under control once again. To celebrate, I completed the Philadelphia Distance Run (a 1/2 marathon consisting of 13.1 miles) and threw myself a 40th birthday party, baldhead and all.

Feeling very lucky at this point, I responded to a Team in Training (TNT) flyer as I was thinking about

participating in my first triathlon. For those of you who may not be familiar with TNT, it is a program offered

by The Leukemia & Lymphoma Society that provides hands-on training for marathons, half-marathons, triathlons, hiking events, or 100-mile bike rides. The pull for me was very strong to give something back so I jumped into the TNT world by training for and finishing the Chicago Triathlon in the summer of 2001 while raising over $5,000 for leukemia and lymphoma research. One of my proudest accomplishments was finishing the 2004 Pacific Crest 1/2 Ironman Triathlon finishing in 8.5 hours and not last! Not bad for a 45 year-old!

I discovered the Cutaneous Lymphoma Foundation in 2007 when my new doctor, Stuart Lessin, who serves on the Board of Directors of the Foundation, suggested that I might be interested in becoming involved. It was an honor to be asked to join the Foundation Board in early 2008. In June 2011, I made a transition from the Board to become the Foundation’s new Management Consultant for Programs and Services, a full-time role that allows me to work closely with patients on an ongoing basis – I love it! I feel so blessed to be working directly with the Foundation each day to enhance its programs, which bring life-changing outcomes to CTCL patients.

The joy of living a full and wonderful life, in spite of being treated for CTCL, keeps me going. My message to every person reading this, whether you are a patient, caregiver, healthcare provider, or anyone interested in our mission, is this: First, thank you for being a part of the Cutaneous Lymphoma Foundation community.

Second, I encourage you to learn more about and become involved in all that we are doing to improve the lives of people affected by cutaneous lymphoma.

Getting involved and helping others is extraordinarily empowering and life enriching, which has certainly been the case for me. It gives you something to think about each day beyond the symptoms you may be experiencing, beyond the day-to-day frustrations that you are coping with. It helps you positively impact the lives of others while, at the same time, positively impacting your own. J

The joy of living a full and wonderful life, in spite of being treated for CTCL, keeps me going.

Vol. 6, No. 1 WINTER 2012 19

CLINICAL Dermatology

By Susan Thornton

CLINICAL Dermatology

Susan Thornton is a native of Philadelphia. She spent the last 27 years in the healthcare information technology field in various consulting, sales, and marketing positions. Susan holds a Marketing/Management degree from the University of Pennsylvania’s Wharton School, Certification in Fundraising from the University of Pennsylvania, and recently received her certificate as an Archetypal Consultant from the CMED Institute in Chicago.

Outside of her professional endeavors, Susan has been active in many non-profit organizations in the Philadelphia region, holding Board positions at the Eastern Pennsylvania Chapter of the Sierra Club, Leukemia & Lymphoma Society Eastern PA Chapter, and was one of the original members of the Tristate Multisport Association. Susan’s love of sports, and in particular triathlons, has given her the opportunity to coach with the local Team in Training triathlon teams, become Race Director for the Patriot’s Triathlon, and mentor many beginning triathletes.

In addition to her management-consulting role with the Cutaneous Lymphoma Foundation, Susan has launched a new venture, Let’s Live, dedicated to inspiring and empowering people to explore life beyond cancer. Her Adventure Quest courses, which fall under the Let’s Live umbrella, show cancer survivors how to live life worth jumping out of bed for. Adventure Quest is a series of programs for long-term cancer survivors and will be launched in 2012. You can learn more about Susan and her inspirational story at www.letslivetoday.com.

Take Home points for derm pas:

By Steven K. Shama, MD, MPH 1. I have often wondered, but truthfully not often enough, what a patient is feeling when I give them a diagnosis that is clearly bad news. Susan writes “... this diagnosis was just devastating.” She adds that it brought forth “many tough emotions” with feelings of hopelessness. How often are we truly “there” as healthcare practitioners when patients go through these emotions? How often do we ask these simple and innocent questions, “How are you doing?” and “Is there anything I can do to make things better?”

And how often do we really take the time to wait for a heartfelt answer? We need to “be there” more often, to listen more deeply, and to really mean it when we ask, “How can I help?”

2. Susan is an inspiration to us all. Her physical feats and emotional strengths should leave us in awe. While we cannot expect all of our patients to achieve as much as Susan, we must hope and believe that they all have such deep physical and emotional reserves. It is our obligation to encourage them to tap into these reserves as a complement to our formal treatments. We also need to be humbled in our patients’ presence, since they are messengers from the universe teaching us that we too have these powerful resources, should we ever need to use them to help heal ourselves.

&

Dermoscopy Q A

Under Dermoscopy

Questions: What is it?

Answer on page 23 20 Journal of Dermatology for Physician Assistants

NOW IN A

Proven effective in moderate to severe acne* 1 ,2

PUMP

Power Now

with ease!

in a ready-to-use 50g pump

●

Neat and simple: No jar, no mess

●

Measured dose: Consistent delivery

●

Longer shelf life: 10 weeks’ stability at room temperature

●

Convenience: Easily portable and meets TSA liquid carry-on limits

Indication and Important Safety Information Acanya Gel is indicated for the topical treatment of acne vulgaris in patients 12 years of age or older. Acanya Gel is contraindicated in patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.

Discontinuation is recommended if significant diarrhea, bloody diarrhea, severe abdominal cramping, or colitis (including pseudomembranous colitis) develops.

Clindamycin taken orally or through IV may result in severe colitis, which may result in death. Anaphylaxis, as well as other allergic reactions leading to hospitalizations, has been reported in postmarketing use of products containing clindamycin/benzoyl peroxide. If a patient develops symptoms of an allergic reaction such as swelling or shortness of breath, they should be instructed to discontinue use and contact a physician immediately. Patients should be advised to avoid contact with the eyes or mucous membranes and to minimize sun exposure following the application of Acanya Gel.

To learn more, please visit www.AcanyaGel.com Please see brief summary of prescribing information on adjacent page.

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. *Individual results may vary.

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

© 2011 CORIA Laboratories, a division of Valeant Pharmaceuticals North America LLC ACAN-0411-0002

Vol. 6, No. 1 WINTER 2012 21

USE IN SPECIFIC POPULATIONS Pregnancy Category C There are no well-controlled trials in pregnant women treated with ACANYA Gel. It also is not known whether ACANYA Gel can cause fetal harm when administered to a pregnant woman. ACANYA Gel should be used during pregnancy only if the potential benefi t justifies the potential risk to the fetus.

ACANYA® (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/2.5% Brief summary. Please see full prescribing information for complete product information.

INDICATIONS AND USAGE ACANYA Gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older.

The safety and efficacy of this product in the treatment of any other disorders have not been evaluated.

DOSAGE AND ADMINISTRATION Apply a pea-sized amount of ACANYA Gel to the face once daily. Use of ACANYA Gel beyond 12 weeks has not been evaluated.

ACANYA Gel is not for oral, ophthalmic, or intravaginal use.

CONTRAINDICATIONS ACANYA Gel is contraindicated in patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.

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

Animal reproductive/developmental toxicity studies have not been conducted with ACANYA Gel or benzoyl peroxide. Developmental toxicity studies of clindamycin performed in rats and mice using oral doses of up to 600 mg/kg/day (240 and 120 times amount of clindamycin in the highest recommended adult human dose based on mg/m2, respectively) or subcutaneous doses of up to 200 mg/kg/day (80 and 40 times the amount of clindamycin in the highest recommended adult human dose based on mg/m2, respectively) revealed no evidence of teratogenicity.

Nursing Mothers: It is not known whether clindamycin is excreted in human milk after topical application of ACANYA Gel. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to use ACANYA Gel while nursing, taking into account the importance of the drug to the mother.

Pediatric Use: Safety and effectiveness of ACANYA Gel in pediatric patients under the age of 12 have not been evaluated. Clinical trials of ACANYA Gel included patients 12-17 years of age.

Geriatric Use Clinical studies of ACANYA Gel did not include sufficient numbers of patients aged 65 and older to determine whether they respond differently from younger patients.

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

Severe colitis has occurred following oral and parenteral administration of clindamycin with an onset of up to several weeks following cessation of therapy. Antiperistaltic agents such as opiates and diphenoxylate with atropine may prolong and/or worsen severe colitis. Severe colitis may result in death.

Benzoyl peroxide has been shown to be a tumor promoter and progression agent in a number of animal studies. Benzoyl peroxide in acetone at doses of 5 and 10 mg administered topically twice per week for 20 weeks induced skin tumors in transgenic Tg.AC mice. The clinical significance of this is unknown.

Studies indicate toxin(s) produced by Clostridia is one primary cause of antibiotic-associated colitis. The colitis is usually characterized by severe persistent diarrhea and severe abdominal cramps and may be associated with the passage of blood and mucus. Stool cultures for Clostridium difficile and stool assay for C. difficile toxin may be helpful diagnostically.

Carcinogenicity studies have been conducted with a gel formulation containing 1% clindamycin and 5% benzoyl peroxide. In a 2-year dermal carcinogenicity study in mice, treatment with the gel formulation at doses of 900, 2700, and 15000 mg/kg/day (1.8, 5.4, and 30 times amount of clindamycin and 3.6, 10.8, and 60 times amount of benzoyl peroxide in the highest recommended adult human dose of 2.5 g ACANYA Gel based on mg/m2, respectively) did not cause any increase in tumors. However, topical treatment with a different gel formulation containing 1% clindamycin and 5% benzoyl peroxide at doses of 100, 500, and 2000 mg/kg/ day caused a dose-dependent increase in the incidence of keratoacanthoma at the treated skin site of male rats in a 2-year dermal carcinogenicity study in rats. In an oral (gavage) carcinogenicity study in rats, treatment with the gel formulation at doses of 300, 900 and 3000 mg/kg/day (1.2, 3.6, and 12 times amount of clindamycin and 2.4, 7.2, and 24 times amount of benzoyl peroxide in the highest recommended adult human dose of 2.5 g ACANYA Gel based on mg/m2, respectively) for up to 97 weeks did not cause any increase in tumors. In a 52-week dermal photocarcinogenicity study in hairless mice, (40 weeks of treatment followed by 12 weeks of observation), the median time to onset of skin tumor formation decreased and the number of tumors per mouse increased relative to controls following chronic concurrent topical administration of the higher concentration benzoyl peroxide formulation (5000 and 10000 mg/kg/day, 5 days/week) and exposure to ultraviolet radiation.

Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug clinically effective against C. difficile colitis.

Ultraviolet Light and Environmental Exposure Minimize sun exposure following drug application. (See NONCLINICAL TOXICOLOGY.) ADVERSE REACTIONS Clinical Studies Experience Because clinical trials are conducted under prescribed conditions, adverse reaction rates observed in the clinical trial may not reflect the rates observed in practice. Because clinical trials are also conducted under widely varying conditions, adverse reactions observed in the clinical trials of a drug cannot always be directly compared to rates in the clinical trials of another drug. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse reactions that appear to be related to drug use and for approximating rates.

The following selected adverse reactions occurred in less than 0.2% of patients treated with ACANYA Gel: application site pain (0.1%); application site exfoliation (0.1%); and application site irritation (0.1%).

During clinical trials, patients were assessed for local cutaneous signs and symptoms of erythema, scaling, itching, burning and stinging. Most local skin reactions increased and peaked around week 4 and continually decreased over time reaching near baseline levels by week 12. The percentage of patients that had symptoms present before treatment, the maximum value recorded during treatment, and the percent with symptoms present at week 12 are shown below.

Local Skin Reactions—Percent Patients with Symptoms Present. Combined Results from the Two Phase 3 Trials (N = 773) Before Treatment (Baseline)

Maximum During Treatment

Clindamycin phosphate was not genotoxic in the human lymphocyte chromosome aberration assay. Benzoyl peroxide has been found to cause DNA strand breaks in a variety of mammalian cell types, to be mutagenic in S. typhimurium tests by some but not all investigators, and to cause sister chromatid exchanges in Chinese hamster ovary cells.

Fertility studies have not been performed with ACANYA Gel or benzoyl peroxide, but fertility and mating ability have been studied with clindamycin. Fertility studies in rats treated orally with up to 300 mg/kg/day of clindamycin (approximately 120 times the amount of clindamycin in the highest recommended adult human dose of 2.5 g ACANYA Gel, based on mg/m2) revealed no effects on fertility or mating.

HOW SUPPLIED ACANYA Gel is supplied as a 50 g pump (NDC 13548-132-50).

Dispensing instructions for the pharmacist Dispense ACANYA Gel with a 10 week expiration date.

Specify “Store at room temperature up to 25°C (77°F). Do not freeze.”

End of Treatment (Week 12)

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

Mild

Mod*

Severe

Mild

Mod*

Severe

Mild

Mod*

Severe

Erythema

22

4

0

25

5

<1

15

2

0

Scaling

8

<1

0

18

3

0

8

1

0

Keep out of the reach of children.

Itching

10

2

0

15

2

0

6

<1

0

Keep container tightly closed.

Burning

3

<1

0

8

2

0

2

<1

0

RX Only

Stinging

2

<1

0

6

1

0

1

<1

0

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

*Mod=Moderate

DRUG INTERACTIONS Erythromycin ACANYA Gel should not be used in combination with topical or oral erythromycin-containing products due to its clindamycin component. In vitro studies have shown antagonism between erythromycin and clindamycin. The clinical significance of this in vitro antagonism is not known.

Concomitant Topical Medications Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents.

Neuromuscular Blocking Agents Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, ACANYA Gel should be used with caution in patients receiving such agents.

22 Journal of Dermatology for Physician Assistants

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

Protect from freezing.

Manufactured by Contract Pharmaceuticals Limited Niagara, Buffalo, NY 14213 © 2010 CORIA Laboratories

&

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

Vol. 6, No. 1 WINTER 2012 23

CLINICAL Dermatology

Dermoscopy Q A

Dermatology Case Report

The Muir-Torre Syndrome: An Opportunity for Colon Cancer Screening

By Jennifer Gloeckner Powers, MD, Mohammed A. Sharaf, MD, and Nellie Konnikov, MD

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 1 - Multiple lesions of sebaceous hyperplasia.

Figure 2 - Sebaceous adenoma of the neck.

Figure 3 - Dermoscopy of sebaceous adenoma.

24 Journal of Dermatology for Physician Assistants

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.

Jennifer Powers, MD and Mohammed A. Sharaf, MD are currently residents in the Department of Dermatology at Boston University.

Nellie Konnikov, MD is the distinguished Chief of Dermatology at the Jamaica Plain VA Hospital and holds appointments at multiple institutions in Boston, including Boston University and Harvard University Departments of Dermatology.

Vol. 6, No. 1 WINTER 2012 25

Vehicle Gel (n = 487)

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

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

Marketed by:

263100gi301PI_JDPA

Atralin Gel (n = 674)

K

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

Output @ 100% Giant Creative Strategy

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

DRUG INTERACTIONS When treating with Atralin Gel, caution should be exercised with the use of concomitant topical medication, medicated or abrasive soaps and cleansers, products that have a strong drying effect, and products with high concentrations of alcohol, astringents, spices, or lime. Particular caution should be exercised with the concomitant use of topical over-the-counter acne preparations containing benzoyl peroxide, sulfur, resorcinol, or salicylic acid. Allow the effects of such preparations to subside before use of Atralin Gel is begun.

USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C. There are no well-controlled trials in pregnant women treated with Atralin Gel. Atralin Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Atralin Gel at doses of 0.1, 0.3 and 1 g/kg/day was tested for maternal and developmental toxicity in pregnant Sprague-Dawley rats by dermal application.

The dose of 1 g/kg/day was approximately 4 times the clinical dose assuming 100% absorption and based on body surface area comparison. Possible tretinoin-associated teratogenic effects (craniofacial abnormalities [hydrocephaly], asymmetrical thyroids, variations in ossification, and increased supernumerary ribs) were noted in the fetuses of Atralin Gel treated animals. These findings were not observed in control animals. Other maternal and reproductive parameters in the Atralin Gel treated animals were not different from control. For purposes of comparison of the animal exposure to human exposure, the clinical dose is defined as 2 g of Atralin Gel applied daily to a 50-kg person.

Oral tretinoin has been shown to be teratogenic in rats, mice, rabbits, hamsters and nonhuman primates. Tretinoin was teratogenic in Wistar rats when given orally in doses greater than 1 mg/kg/day (approximately 8 times the clinical dose based on body surface area comparison). In the cynomolgus monkey, fetal malformations were reported for doses of 10 mg/kg/day, but none were observed at 5 mg/kg/day (approximately 80 times the clinical dose based on body surface area comparison), although increased skeletal variations were observed at all doses. Dose-related increases in embryolethality and abortion also were reported. Similar results have also been reported in pigtail macaques.

Topical tretinoin in a different formulation has generated equivocal results in animal teratogenicity tests. There is evidence for teratogenicity (shortened or kinked tail) of topical tretinoin in Wistar rats at doses greater than 1 mg/kg/day (approximately 8 times the clinical dose assuming 100% absorption and based on body surface area comparison). Anomalies (humerus: short 13%, bent 6%, os parietal incompletely ossified 14%) have also been reported when 10 mg/kg/day (approximately 160 times the clinical dose assuming 100% absorption and based on body surface area comparison) was topically applied. Supernumerary ribs have been a consistent finding in rats when dams were treated topically or orally with retinoids.

With widespread use of any drug, a small number of birth defect reports associated temporally with the administration of the drug would be expected by chance alone. Cases of temporally associated congenital malformations have been reported with use of other topical tretinoin products. The significance of these spontaneous reports in terms of risk to the fetus is not known.

Nonteratogenic effects on fetuses: Oral tretinoin has been shown to be fetotoxic in rats when administered in doses 20 times the clinical dose based on a body surface area comparison. Topical tretinoin has been shown to be fetotoxic in rabbits when administered in doses 8 times the clinical dose based on a body surface area comparison.

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Atralin Gel is administered to a nursing woman.

Pediatric Use Safety and effectiveness in children below the age of 10 have not been established.

A total of 381 pediatric subjects (aged 10 to 16 years), treated with Atralin Gel were enrolled into the two clinical studies. Across these two studies, comparable safety and efficacy were observed between pediatric and adult subjects.

Geriatric Use Safety and effectiveness in a geriatric population have not been established.

Clinical studies of Atralin Gel did not include any subjects over age 65 to determine whether they respond differently than younger subjects.

100%

BRIEF SUMMARY (see package insert for full prescribing information) For topical use only INDICATIONS AND USAGE Atralin Gel is a retinoid indicated for topical treatment of acne vulgaris.

Important Limitations of Use The safety and efficacy of the use of this product in the treatment of any other disorders have not been evaluated.

CONTRAINDICATIONS None WARNINGS AND PRECAUTIONS Skin Irritation The skin of certain individuals may become dry, red, or exfoliated while using Atralin Gel. If the degree of irritation warrants, patients should be directed to temporarily reduce the amount or frequency of application of the medication, discontinue use temporarily, or discontinue use altogether. Efficacy at reduced frequencies of application has not been established. If a reaction suggesting sensitivity occurs, use of the medication should be discontinued. Mild to moderate skin dryness may also be experienced; if so, use of an appropriate moisturizer during the day may be helpful.

Tretinoin has been reported to cause severe irritation on eczematous or sunburned skin and should be used with caution in patients with these conditions.

Topical over-the-counter acne preparations, concomitant topical medication, medicated cleansers, topical products with alcohol or astringents, when used with Atralin Gel, should be used with caution [see Drug Interactions (7)].

Ultraviolet Light and Environmental Exposure Unprotected exposure to sunlight, including sunlamps, should be minimized during the use of Atralin Gel. Patients who normally experience high levels of sun exposure, and those with inherent sensitivity to sun, should be warned to exercise caution.

Use of sunscreen products of at least SPF 15 and protective clothing over treated areas is recommended when exposure cannot be avoided.

Weather extremes, such as wind or cold, also may be irritating to patients under treatment with tretinoin.

Fish Allergies Atralin Gel contains soluble fish proteins and should be used with caution in patients with known sensitivity or allergy to fish. Patients who develop pruritus or urticaria should contact their health care provider.

ADVERSE REACTIONS Clinical Studies Experience Because clinical trials are conducted under prescribed conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In two randomized, controlled trials, 674 subjects received treatment for up to 12 weeks with Atralin Gel [see Clinical Studies (14)]. In these studies, 50% of the subjects who were treated with Atralin Gel reported one or more adverse reactions; 30% of the subjects reported treatment-related adverse reactions. In the vehicle group, 29% of the 487 randomized subjects reported at least one adverse reaction; 5% of the subjects reported events that were treatment-related. There were no serious, treatment-related adverse reactions reported by subjects in any of the treatment groups.

Selected adverse reactions that occurred in at least 1% of subjects in the two studies combined, are shown in Table 1 (below). Most skin-related adverse reactions first appear during the first two weeks of treatment with Atralin Gel, and the incidence rate for skin-related reactions peaks around the second and third week of treatment. In some subjects the skin-related adverse reactions persist throughout the treatment period.

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

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

df

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

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

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. 1 WINTER 2012 27

Clinical snapshots Twenty-Nail Dystrophy

By Travis Hayden, MPAS, RPA-C

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

Table: Cutaneous conditions associated with twenty-nail dystrophy.

Alopecia areata Atopic dermatitis Lichen planus Psoriasis Vitiligo

CLINICAL Dermatology

Figures

Travis Hayden, MPAS, PA-C practices dermatology with Lesley Loss, MD and John Tu, MD at Dermatology Associates of Rochester, New York. He has indicated no relationships to disclose relating to the content of this article.

28 Journal of Dermatology for Physician Assistants

Benefits Built on Science

The #1 Most Prescribed #SBOEFE .FEJDBUJPO JO %FSNBUPMPHZ

1

SOLODYN is indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. SOLODYN did not demonstrate any effect on non-inflammatory acne lesions. Safety of SOLODYN has not been established beyond 12 weeks of use. This formulation of minocycline has not been evaluated in the treatment of infections.

To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, SOLODYN should be used only as indicated.

Important Safety Information for SOLODYN Tablets t 5IF NPTU DPNNPOMZ PCTFSWFE BEWFSTF reactions are headache, fatigue, dizziness, and pruritus.

t .JOPDZDMJOF MJLF PUIFS UFUSBDZDMJOF DMBTT ESVHT can cause fetal harm when administered to a pregnant woman. t 5FUSBDZDMJOF ESVHT TIPVME OPU CF VTFE EVSJOH tooth development (last half of pregnancy and up to 8 years of age) as they may cause permanent discoloration of teeth. t 1TFVEPNFNCSBOPVT DPMJUJT IBT CFFO SFQPSUFE with nearly all antibacterial agents and may range from mild to life-threatening; therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. t $FOUSBM OFSWPVT TZTUFN TJEF FGGFDUT JODMVEJOH light-headedness, dizziness, and vertigo, have been reported with minocycline therapy. t *O SBSF DBTFT QIPUPTFOTJUJWJUZ IBT CFFO SFQPSUFE

t 4IPVME OPU CF VTFE EVSJOH QSFHOBODZ PS by individuals of either gender who are attempting to conceive a child; concurrent use of tetracyclines with oral contraceptives may render oral contraceptives less effective. t 5IJT ESVH JT DPOUSBJOEJDBUFE JO QFSTPOT XIP IBWF shown hypersensitivity to any of the tetracyclines. t 4BGFUZ CFZPOE XFFLT PG VTF IBT OPU been established. t $BTFT PG BOBQIZMBYJT TFSJPVT TLJO SFBDUJPOT erythema multiforme, and drug rash with eosinophilia and systemic symptoms have been reported postmarketing with minocycline use. Discontinue SOLODYN immediately if symptoms occur.

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See following pages for Brief Summary of Full Prescribing Information.

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Vol. 6, No. 1 WINTER 2012 29

BRIEF SUMMARY (see package insert for full prescribing information) SOLODYN® (minocycline HCl, USP) Extended Release Tablets Rx Only KEEP OUT OF REACH OF CHILDREN INDICATIONS AND USAGE Indication SOLODYN is indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older.

Limitations of Use SOLODYN did not demonstrate any effect on non-inflammatory acne lesions. Safety of SOLODYN has not been established beyond 12 weeks of use. This formulation of minocycline has not been evaluated in the treatment of infections.

animals treated early in pregnancy (see Use in Specific Populations).

Pseudomembranous Colitis Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.

Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia.

Studies indicate that a toxin produced by Clostridium difficile is a primary cause of “antibiotic-associated colitis”.

After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to discontinuation of To reduce the development of drugthe drug alone. In moderate to severe resistant bacteria as well as to maintain the cases, consideration should be given to effectiveness of other antibacterial drugs, management with fluids and electrolytes, SOLODYN should be used only as indicated protein supplementation, and treatment (see Warnings and Precautions). with an antibacterial drug clinically effective against Clostridium difficile colitis.

CONTRAINDICATIONS This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

WARNINGS AND PRECAUTIONS Teratogenic Effects A. MINOCYCLINE, LIKE OTHER TETRACYCLINE-CLASS DRUGS, CAN CAUSE FETAL HARM WHEN ADMINISTERED TO A PREGNANT WOMAN. IF ANY TETRACYCLINE IS USED DURING PREGNANCY OR IF THE PATIENT BECOMES PREGNANT WHILE TAKING THESE DRUGS, THE PATIENT SHOULD BE APPRISED OF THE POTENTIAL HAZARD TO THE FETUS. SOLODYN should not be used during pregnancy or by individuals of either gender who are attempting to conceive a child (see Nonclinical Toxicology & Use in Specific Populations).

B. THE USE OF DRUGS OF THE TETRACYCLINE CLASS DURING TOOTH DEVELOPMENT (LAST HALF OF PREGNANCY, INFANCY, AND CHILDHOOD UP TO THE AGE OF 8 YEARS) MAY CAUSE PERMANENT DISCOLORATION OF THE TEETH (YELLOW-GRAY-BROWN).

This adverse reaction is more common during long-term use of the drug but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. TETRACYCLINE DRUGS, THEREFORE, SHOULD NOT BE USED DURING TOOTH DEVELOPMENT. C. All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in fibula growth rate has been observed in premature human infants given oral tetracycline in doses of 25 mg/kg every 6 hours. This reaction was shown to be reversible when the drug was discontinued.

Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can cause retardation of skeletal development on the developing fetus. Evidence of embryotoxicity has been noted in

Hepatotoxicity Post-marketing cases of serious liver injury, including irreversible drug-induced hepatitis and fulminant hepatic failure (sometimes fatal) have been reported with minocycline use in the treatment of acne.

Metabolic Effects The anti-anabolic action of the tetracyclines may cause an increase in BUN. While this is not a problem in those with normal renal function, in patients with significantly impaired function, higher serum levels of tetracycline-class drugs may lead to azotemia, hyperphosphatemia, and acidosis.

If renal impairment exists, even usual oral or parenteral doses may lead to excessive systemic accumulations of the drug and possible liver toxicity. Under such conditions, lower than usual total doses are indicated, and if therapy is prolonged, serum level determinations of the drug may be advisable.

Central Nervous System Effects Central nervous system side effects including light-headedness, dizziness or vertigo have been reported with minocycline therapy. Patients who experience these symptoms should be cautioned about driving vehicles or using hazardous machinery while on minocycline therapy.

These symptoms may disappear during therapy and usually rapidly disappear when the drug is discontinued.

Benign Intracranial Hypertension Pseudotumor cerebri (benign intracranial hypertension) in adults and adolescents has been associated with the use of tetracyclines. Minocycline has been reported to cause or precipitate pseudotumor cerebri, the hallmark of which is papilledema. Clinical manifestations include headache and blurred vision. Bulging fontanels have been associated with the use of tetracyclines in infants. Although signs and symptoms of pseudotumor cerebri resolve after discontinuation of treatment, the possibility for permanent sequelae such as visual loss that may be permanent or severe exists.

Patients should be questioned for visual

30 Journal of Dermatology for Physician Assistants

disturbances prior to initiation of treatment with tetracyclines. If visual disturbance occurs during treatment, patients should be checked for papilledema. Concomitant use of isotretinoin and minocycline should be avoided because isotretinoin, a systemic retinoid, is also known to cause pseudotumor cerebri.

drug-resistant bacteria to develop during the use of SOLODYN, it should be used only as indicated.

Superinfection As with other antibiotic preparations, use of SOLODYN may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, SOLODYN Autoimmune Syndromes should be discontinued and appropriate Tetracyclines have been associated with the therapy instituted. development of autoimmune syndromes.

Laboratory Monitoring The long-term use of minocycline in the Periodic laboratory evaluations of organ treatment of acne has been associated systems, including hematopoetic renal with drug-induced lupus-like syndrome, and hepatic studies should be performed. autoimmune hepatitis and vasculitis.

Appropriate tests for autoimmune syndromes Sporadic cases of serum sickness have should be performed as indicated. presented shortly after minocycline ADVERSE REACTIONS use. Symptoms may be manifested by fever, rash, arthralgia, and malaise. In Clinical Trial Experience symptomatic patients, liver function tests, Because clinical trials are conducted under ANA, CBC, and other appropriate tests prescribed conditions, adverse reaction should be performed to evaluate the rates observed in the clinical trial may not patients. Use of all tetracycline-class drugs reflect the rates observed in practice. should be discontinued immediately.

The following table summarizes selected adverse reactions reported in clinical trials Photosensitivity at a rate of ≥1% for SOLODYN. Photosensitivity manifested by an exaggerated sunburn reaction has been Selected Treatment-Emergent Adverse observed in some individuals taking Reactions in at least 1% of Clinical tetracyclines. This has been reported Trial Subjects rarely with minocycline. Patients should Adverse Reactions SOLODYN PLACEBO minimize or avoid exposure to natural or (1 mg/kg) N=364 artificial sunlight (tanning beds or UVA/B N=674 (%) (%) treatment) while using minocycline. If At least one treatment- 379 (56) 197 (54) patients need to be outdoors while using minocycline, they should wear loose-fitting emergent event 152 (23) 83 (23) clothes that protect skin from sun exposure Headache 62 (9) 24 (7) and discuss other sun protection measures Fatigue Dizziness 59 (9) 17 (5) with their physician.

Pruritus 31 (5) 16 (4) Serious Skin/Hypersensitivity Malaise 26 (4) 9 (3) Reaction Mood alteration 17 (3) 9 (3) Cases of anaphylaxis, serious skin reactions 13 (2) 3 (1) (e.g. Stevens Johnson syndrome), erythema Somnolence 10 (2) 1 (0) multiforme, and drug rash with eosinophilia Urticaria 10 (2) 5 (1) and systemic symptoms (DRESS) syndrome Tinnitus Arthralgia 9 (1) 2 (0) have been reported postmarketing with Vertigo 8 (1) 3 (1) minocycline use in patients with acne.

Dry mouth 7 (1) 5 (1) DRESS syndrome consists of cutaneous Myalgia 7 (1) 4 (1) reaction (such as rash or exfoliative dermatitis), eosinophilia, and one or more Postmarketing Experience of the following visceral complications Adverse reactions that have been reported such as: hepatitis, pneumonitis, nephritis, with minocycline hydrochloride use in a myocarditis, and pericarditis. Fever and variety of indications include: lymphadenopathy may be present. In some Skin and hypersensitivity reactions: cases, death has been reported. If this fixed drug eruptions, balanitis, erythema syndrome is recognized, the drug should be multiforme, Stevens-Johnson syndrome, discontinued immediately. anaphylactoid purpura, photosensitivity, Tissue Hyperpigmentation pigmentation of skin and mucous Tetracycline-class antibiotics are known membranes, hypersensitivity reactions, to cause hyperpigmentation. Tetracycline angioneurotic edema, anaphylaxis, DRESS therapy may induce hyperpigmentation in syndrome (see Warnings and Precautions). many organs, including nails, bone, skin, Autoimmune conditions: polyarthralgia, eyes, thyroid, visceral tissue, oral cavity pericarditis, exacerbation of systemic lupus, (teeth, mucosa, alveolar bone), sclerae and pulmonary infiltrates with eosinophilia, heart valves. Skin and oral pigmentation transient lupus-like syndrome. has been reported to occur independently Central nervous system: pseudotumor of time or amount of drug administration, cerebri, bulging fontanels in infants, whereas other tissue pigmentation has decreased hearing. been reported to occur upon prolonged administration. Skin pigmentation includes Endocrine: brown-black microscopic thyroid diffuse pigmentation as well as over sites discoloration, abnormal thyroid function. of scars or injury.

Oncology: thyroid cancer.

Development of Drug Resistant Oral: glossitis, dysphagia, tooth Bacteria discoloration.

Bacterial resistance to the tetracyclines may develop in patients using SOLODYN, Gastrointestinal: enterocolitis, pancreatitis, therefore, the susceptibility of bacteria hepatitis, liver failure. associated with infection should be Renal: reversible acute renal failure. considered in selecting antimicrobial Hematology: hemolytic anemia, therapy. Because of the potential for thrombocytopenia, eosinophilia.

Preliminary studies suggest that use of minocycline may have deleterious effects on human spermatogenesis (see Nonclinical Toxicology).

DRUG INTERACTIONS Anticoagulants Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.

systemic exposure to minocycline observed in patients as a result of use of SOLODYN). Reduced mean fetal body weight was observed in studies in which minocycline was administered to pregnant rats at a dose of 10 mg/kg/day (which resulted in approximately the same level of systemic exposure to minocycline as that observed in patients who use SOLODYN).

Minocycline was assessed for effects on peri- and post-natal development of rats in a study that involved oral administration to Penicillin pregnant rats from day 6 of gestation Since bacteriostatic drugs may interfere through the period of lactation (postpartum with the bactericidal action of penicillin, it is day 20), at dosages of 5, 10, or 50 advisable to avoid giving tetracycline-class mg/kg/day. In this study, body weight gain drugs in conjunction with penicillin. was significantly reduced in pregnant females that received 50 mg/kg/day Methoxyflurane (resulting in approximately 2.5 times the The concurrent use of tetracycline and methoxyflurane has been reported to result systemic exposure to minocycline observed in patients as a result of use of SOLODYN). in fatal renal toxicity.

No effects of treatment on the duration of Antacids and Iron Preparations the gestation period or the number of live Absorption of tetracyclines is impaired by pups born per litter were observed. Gross antacids containing aluminum, calcium external anomalies observed in F1 pups or magnesium and iron-containing (offspring of animals that received preparations. minocycline) included reduced body size, improperly rotated forelimbs, and reduced Low Dose Oral Contraceptives size of extremities. No effects were In a multi-center study to evaluate the observed on the physical development, effect of SOLODYN on low dose oral behavior, learning ability, or reproduction contraceptives, hormone levels over one of F1 pups, and there was no effect on menstrual cycle with and without gross appearance of F2 pups (offspring SOLODYN 1 mg/kg once-daily were of F1 animals). measured. Based on the results of this trial, minocycline-related changes in Nursing Mothers estradiol, progestinic hormone, FSH and Tetracycline-class antibiotics are excreted LH plasma levels, of breakthrough in human milk. Because of the potential for bleeding, or of contraceptive failure, can serious adverse effects on bone and tooth not be ruled out. To avoid contraceptive development in nursing infants from the failure, female patients are advised to use tetracycline-class antibiotics, a decision a second form of contraceptive during should be made whether to discontinue treatment with minocycline. nursing or discontinue the drug, taking into account the importance of the drug to the Drug/Laboratory Test Interactions mother (see Warnings and Precautions).

False elevations of urinary catecholamine levels may occur due to interference with Pediatric Use the fluorescence test.

SOLODYN is indicated to treat only inflammatory lesions of non-nodular USE IN SPECIFIC POPULATIONS moderate to severe acne vulgaris Pregnancy in patients 12 years and older.

Teratogenic Effects: Pregnancy category D Safety and effectiveness in pediatric (see Warnings and Precautions) patients below the age of 12 has not been established.

SOLODYN should not be used during pregnancy. If the patient becomes pregnant Use of tetracycline-class antibiotics below while taking this drug, the patient should be the age of 8 is not recommended due to apprised of the potential hazard to the fetus the potential for tooth discoloration (see and stop treatment immediately.

Warnings and Precautions).

There are no adequate and well-controlled Geriatric Use studies on the use of minocycline in Clinical studies of SOLODYN did not pregnant women. Minocycline, like other include sufficient numbers of subjects aged tetracycline-class drugs, crosses the 65 and over to determine whether they placenta and may cause fetal harm when respond differently from younger subjects. administered to a pregnant woman.

Other reported clinical experience has not

NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility

The 65 mg extended release tablets are blue, unscored, coated, and debossed with “DYN-065” on one side. Each tablet contains minocycline hydrochloride equivalent to 65 mg minocycline, supplied as follows:

Carcinogenesis—Long-term animal studies have not been performed to evaluate the carcinogenic potential of minocycline. A structurally related compound, oxytetracycline, was found to produce adrenal and pituitary tumors in rats.

NDC 99207-463-30

Mutagenesis—Minocycline was not mutagenic in vitro in a bacterial reverse mutation assay (Ames test) or CHO/HGPRT mammalian cell assay in the presence or absence of metabolic activation.

Minocycline was not clastogenic in vitro using human peripheral blood lymphocytes or in vivo in a mouse micronucleus test.

Impairment of Fertility—Male and female reproductive performance in rats was unaffected by oral doses of minocycline of up to 300 mg/kg/day (which resulted in up to approximately 40 times the level of systemic exposure to minocycline observed in patients as a result of use of SOLODYN). However, oral administration of 100 or 300 mg/kg/day of minocycline to male rats (resulting in approximately 15 to 40 times the level of systemic exposure to minocycline observed in patients as a result of use of SOLODYN) adversely affected spermatogenesis. Effects observed at 300 mg/kg/day included a reduced number of sperm cells per gram of epididymis, an apparent reduction in the percentage of sperm that were motile, and (at 100 and 300 mg/kg/day) increased numbers of morphologically abnormal sperm cells.

Morphological abnormalities observed in sperm samples included absent heads, misshapen heads, and abnormal flagella.

Bottle of 30

The 80 mg extended release tablets are gray, unscored, coated, and debossed with “DYN-080” on one side. Each tablet contains minocycline hydrochloride equivalent to 80 mg minocycline, supplied as follows: NDC 99207-466-30

Bottle of 30

The 90 mg extended release tablets are yellow, unscored, coated, and debossed with “DYN-090” on one side. Each tablet contains minocycline hydrochloride equivalent to 90 mg minocycline, supplied as follows: NDC 99207-461-30 NDC 99207-461-10

Bottle of 30 Bottle of 100

The 105 mg extended release tablets are purple, unscored, coated, and debossed with “DYN-105” on one side. Each tablet contains minocycline hydrochloride equivalent to 105 mg minocycline, supplied as follows: NDC 99207-467-30

Bottle of 30

The 115 mg extended release tablets are green, unscored, coated, and debossed with “DYN-115” on one side. Each tablet contains minocycline hydrochloride equivalent to 115 mg minocycline, supplied as follows: NDC 99207-464-30

Bottle of 30

The 135 mg extended release tablets are Limited human studies suggest that pink (orange-brown), unscored, coated, minocycline may have a deleterious effect and debossed with “DYN-135” on one on spermatogenesis. side. Each tablet contains minocycline SOLODYN should not be used by individuals hydrochloride equivalent to 135 mg minocycline, supplied as follows: of either gender who are attempting to conceive a child.

NDC 99207-462-30 Bottle of 30 NDC 99207-462-10 Bottle of 100 HOW SUPPLIED/STORAGE AND HANDLING Storage How Supplied Store at 25ºC (77ºF); excursions are SOLODYN (minocycline HCl, USP) Extended permitted to 15º-30ºC (59º-86ºF) Release Tablets are supplied as aqueous [See USP Controlled Room Temperature]. film coated tablets containing minocycline hydrochloride equivalent to 45 mg, 55 mg, Handling Keep out of reach of children 65 mg, 80 mg, 90 mg, 105 mg, 115 mg Protect from light, moisture, and or 135 mg minocycline, are supplied excessive heat. as follows.

The 45 mg extended release tablets are gray, unscored, coated, and debossed with “DYN-045” on one side. Each tablet contains minocycline hydrochloride identified differences in responses between equivalent to 45 mg minocycline, supplied Rare spontaneous reports of congenital the elderly and younger patients. In general, as follows: anomalies including limb reduction have dose selection for an elderly patient should been reported with minocycline use in NDC 99207-460-30 Bottle of 30 be cautious, usually starting at the low end pregnancy in post-marketing experience.

NDC 99207-460-10 Bottle of 100 of the dosing range, reflecting the greater Only limited information is available frequency of decreased hepatic, renal, or regarding these reports; therefore, no The 55 mg extended release tablets are cardiac function, and concomitant disease pink, unscored, coated, and debossed conclusion on causal association can or other drug therapy. be established. with “DYN-055” on one side. Each tablet contains minocycline hydrochloride Minocycline induced skeletal malformations OVERDOSAGE equivalent to 55 mg minocycline, supplied (bent limb bones) in fetuses when In case of overdosage, discontinue as follows: administered to pregnant rats and rabbits in medication, treat symptomatically and doses of 30 mg/kg/day and 100 mg/kg/day, institute supportive measures. Minocycline NDC 99207-465-30 Bottle of 30 respectively, (resulting in approximately is not removed in significant quantities by 3 times and 2 times, respectively, the hemodialysis or peritoneal dialysis.

Dispense in tight, light-resistant container with child-resistant closure.

U.S. Patent 5,908,838, U.S. Patent 7,790,705 and Patents Pending* *90 mg is also covered by U.S. Patents 7,541,347 and 7,544,373 Manufactured for: Medicis, The Dermatology Company Scottsdale, AZ 85256 03/2011 17110203

Vol. 6, No. 1 WINTER 2012 31

Drugs in Dermatology Spinosad

By Sarah McBane, PharmD, CDE, BCPS

SDPA Members Only Content

CLINICAL Dermatology

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

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

32 Journal of Dermatology for Physician Assistants

Break the Cycle of Inflammatory Rosacea With Or acea ®

The only FDA-approved oral treatment—

Formulated for an effective anti-inflammatory response

*

*

t Results from a clinical study showed: —Almost a 50% reduction in total inflammatory lesion count by week 41 —5x less gastrointestinal upset vs doxycycline 100 mg1

Oracea® is the

#1

ROSACEA BRAND among dermatologists2

Important Safety Information Oracea is indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients.

In clinical trials, the most common adverse events reported were nasopharyngitis/pain, gastrointestinal upsets, hypertension, and nasal congestion/sinusitis. Oracea® should not be used to treat microbial infections, and should be used only as indicated. This drug is contraindicated in people who have shown hypersensitivity to any of the tetracyclines, and, like other tetracycline drugs, may cause fetal harm when administered to a pregnant woman.

Oracea® should not be used during pregnancy, by nursing mothers, or during tooth development (up to the age of 8 years). Although photosensitivity was not observed in clinical trials, Oracea® patients should minimize or avoid exposure to natural or artificial sunlight.

All contraindications, warnings, and precautions associated with tetracyclines must be considered before prescribing Oracea®. The efficacy of Oracea® beyond 16 weeks and safety beyond 9 months have not been established. ®

t Anti-inflammatory dose remains below the antimicrobial threshold 2 —No evidence of bacterial resistance in a long-term (9-month) safety study3

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.

References: 1. Del Rosso JQ, Schlessinger J, Werschler P. Comparison of anti-inflammatory dose doxycycline versus doxycycline 100 mg in the treatment of rosacea. J Drugs Dermatol. 2008;7(6):573-576. 2. Data on file. Galderma Laboratories, L.P. 3. Preshaw PM, Novak MJ, Mellonig J, et al. Modifiedrelease subantimicrobial dose doxycycline enhances scaling and root planing in subjects with periodontal disease. J Periodontol. 2008;79(3):440-452.

Please see brief summary of Prescribing Information on next page.

Oracea and Galderma are registered trademarks. ©2011 Galderma Laboratories, L.P. Galderma Laboratories, L.P. 14501 N. Freeway Fort Worth, TX 76177 ORA-668 Printed in USA 11/11

hcp.oracea.com

Vol. 6, No. 1 WINTER 2012 33

Rx Only

Keep out of reach of children.

Brief Summary of Full Prescribing Information INDICATIONS AND USAGE ORACEA is indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients.

The dosage of ORACEA differs from that of doxycycline used to treat infections. To reduce the development of resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, ORACEA should be used only as indicated.

CLINICAL PHARMACOLOGY Pharmacokinetics ORACEA capsules are not bioequivalent to other doxycycline products.

CONTRAINDICATIONS This drug is contraindicated in persons who have shown hypersensitivity to doxycycline or any of the other tetracyclines.

WARNINGS Teratogenic effects: 1) Doxycycline, like other tetracycline-class antibiotics, can cause fetal harm when administered to a pregnant woman. If any tetracycline is used during pregnancy or if the patient becomes pregnant while taking these drugs, the patient should be informed of the potential hazard to the fetus and treatment stopped immediately.

ORACEA should not be used during pregnancy (see PRECAUTIONS: Pregnancy).

2) The use of drugs of the tetracycline class during tooth development (last half of pregnancy, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). This adverse reaction is more common during long-term use of the drug but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. Tetracycline drugs, therefore, should not be used during tooth development unless other drugs are not likely to be effective or are contraindicated.

3) All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in fibula growth rate has been observed in premature human infants given oral tetracycline in doses of 25 mg/kg every 6 hours.

This reaction was shown to be reversible when the drug was discontinued.

Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can cause retardation of skeletal development on the developing fetus. Evidence of embryotoxicity has been noted in animals treated early in pregnancy (see PRECAUTIONS: Pregnancy section).

Gastrointestinal effects: Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.

Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia.

Studies indicate that a toxin produced by Clostridium difficile is a primary cause of “antibiotic-associated colitis”.

If a diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to discontinuation of the drug alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against Clostridium difficile colitis.

Metabolic effects: The anti-anabolic action of the tetracyclines may cause an increase in BUN. While this is not a problem in those with normal renal function, in patients with significantly impaired function, higher serum levels of tetracycline-class antibiotics may lead to azotemia, hyperphosphatemia, and acidosis. If renal impairment exists, even usual oral or parenteral doses may lead to excessive systemic accumulations of the drug and possible liver toxicity. Under such conditions, lower than usual total doses are indicated, and if therapy is prolonged, serum level determinations of the drug may be advisable.

Photosensitivity: Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Although this was not observed during the duration of the clinical studies with ORACEA, patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using ORACEA. If patients need to be outdoors while using ORACEA, they should wear loose-fitting clothes that protect skin from sun exposure and discuss other sun protection measures with their physician.

PRECAUTIONS General: Safety of ORACEA beyond 9 months has not been established.

As with other antibiotic preparations, use of ORACEA may result in overgrowth of non-susceptible microorganisms, including fungi. If superinfection occurs, ORACEA should be discontinued and appropriate therapy instituted. Although not observed in clinical trials with ORACEA, the use of tetracyclines may increase the incidence of vaginal candidiasis.

ORACEA should be used with caution in patients with a history of or predisposition to candidiasis overgrowth.

Bacterial resistance to tetracyclines may develop in patients using ORACEA. Because of the potential for drugresistant bacteria to develop during the use of ORACEA, it should be used only as indicated.

Autoimmune Syndromes: Tetracyclines have been associated with the development of autoimmune syndromes. Symptoms may be manifested by fever, rash, arthralgia, and malaise. In symptomatic patients, liver function tests, ANA, CBC, and other appropriate tests should be performed to evaluate the patients. Use of all tetracycline-class drugs should be discontinued immediately.

Tissue Hyperpigmentation: Tetracycline class antibiotics are known to cause hyperpigmentation. Tetracycline therapy may induce hyperpigmentation in many organs, including nails, bone, skin, eyes, thyroid, visceral tissue, oral cavity (teeth, mucosa, alveolar bone), sclerae and heart valves. Skin and oral pigmentation has been reported to occur independently of time or amount of drug administration, whereas other pigmentation has been reported to occur upon prolonged administration. Skin pigmentation includes diffuse pigmentation as well as over sites of scars or injury.

Pseudotumor cerebri: Bulging fontanels in infants and benign intracranial hypertension in adults have been reported in individuals receiving tetracyclines. These conditions disappeared when the drug was discontinued.

Laboratory Tests: Periodic laboratory evaluations of organ systems, including hematopoietic, renal and hepatic studies should be performed. Appropriate tests for autoimmune syndromes should be performed as indicated.

Drug Interactions: 1. Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.

2. Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin. 3. The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity. 4. Absorption of tetracyclines is impaired by bismuth subsalicylate, proton pump inhibitors, antacids containing aluminum, calcium or magnesium and ironcontaining preparations. 5. Doxycycline may interfere with the effectiveness of low dose oral contraceptives. To avoid contraceptive failure, females are advised to use a second form of contraceptive during treatment with doxycycline. 6. There have been reports of pseudotumor cerebri (benign intracranial hypertension) associated with the concomitant use of isotretinoin and tetracyclines. Since both oral retinoids, including isotretinoin and acitretin, and the tetracyclines, primarily minocycline, can cause increased intracranial pressure, the concurrent use of an oral retinoid and a tetracycline should be avoided.

34 Journal of Dermatology for Physician Assistants

MICROBIOLOGY The plasma concentrations of doxycycline achieved with ORACEA during administration (see DOSAGE AND ADMINISTRATION) are less than the concentration required to treat bacterial diseases. In vivo microbiological studies utilizing a similar drug exposure for up to 18 months demonstrated no detectable long-term effects on bacterial flora of the oral cavity, skin, intestinal tract, and vagina.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Doxycycline was assessed for potential to induce carcinogenesis in a study in which the compound was administered to Sprague-Dawley rats by gavage at dosages of 20, 75, and 200 mg/kg/day for two years. An increased incidence of uterine polyps was observed in female rats that received 200 mg/kg/day, a dosage that resulted in a systemic exposure to doxycycline approximately 12.2 times that observed in female humans who use ORACEA (exposure comparison based upon area under the curve (AUC) values). No impact upon tumor incidence was observed in male rats at 200 mg/kg/ day, or in either gender at the other dosages studied. Evidence of oncogenic activity was obtained in studies with related compounds, i.e., oxytetracycline (adrenal and pituitary tumors) and minocycline (thyroid tumors).

Doxycycline demonstrated no potential to cause genetic toxicity in an in vitro point mutation study with mammalian cells (CHO/HGPRT forward mutation assay) or in an in vivo micronucleus assay conducted in CD-1 mice. However, data from an in vitro assay with CHO cells for potential to cause chromosomal aberrations suggest that doxycycline is a weak clastogen.

Oral administration of doxycycline to male and female Sprague-Dawley rats adversely affected fertility and reproductive performance, as evidenced by increased time for mating to occur, reduced sperm motility, velocity, and concentration, abnormal sperm morphology, and increased pre-and post-implantation losses. Doxycycline induced reproductive toxicity at all dosages that were examined in this study, as even the lowest dosage tested (50 mg/kg/day) induced a statistically significant reduction in sperm velocity. Note that 50 mg/kg/day is approximately 3.6 times the amount of doxycycline contained in the recommended daily dose of ORACEA for a 60-kg human when compared on the basis of AUC estimates. Although doxycycline impairs the fertility of rats when administered at sufficient dosage, the effect of ORACEA on human fertility is unknown.

Pregnancy: Teratogenic Effects: Pregnancy Category D. (see WARNINGS section). Results from animal studies indicate that doxycycline crosses the placenta and is found in fetal tissues.

Nonteratogenic effects: (see WARNINGS section).

Labor and Delivery: The effect of tetracyclines on labor and delivery is unknown.

Nursing Mothers: Tetracyclines are excreted in human milk. Because of the potential for serious adverse reactions in infants from doxycycline, ORACEA should not be used in mothers who breastfeed. (see WARNINGS section).

Pediatric Use: ORACEA should not be used in infants and children less than 8 years of age (see WARNINGS section). ORACEA has not been studied in children of any age with regard to safety or efficacy, therefore use in children is not recommended.

ADVERSE REACTIONS Adverse Reactions in Clinical Trials of ORACEA: In controlled clinical trials of adult patients with mild to moderate rosacea, 537 patients received ORACEA or placebo over a 16-week period. The most frequent adverse reactions occurring in these studies are listed in the table below.

Incidence (%) of Selected Adverse Reactions in Clinical Trials of ORACEA (n=269) vs. Placebo (n=268)

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

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

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

Note: Percentages based on total number of study participants in each treatment group.

Adverse Reactions for Tetracyclines: The following adverse reactions have been observed in patients receiving tetracyclines at higher, antimicrobial doses: Gastrointestinal: anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, and inflammatory lesions (with vaginal candidiasis) in the anogenital region. Hepatotoxicity has been reported rarely. Rare instances of esophagitis and esophageal ulcerations have been reported in patients receiving the capsule forms of the drugs in the tetracycline class. Most of the patients experiencing esophagitis and/or esophageal ulceration took their medication immediately before lying down. (see DOSAGE AND ADMINISTRATION section).

Skin: maculopapular and erythematous rashes. Exfoliative dermatitis has been reported but is uncommon.

Photosensitivity is discussed above. (see WARNINGS section).

Renal toxicity: Rise in BUN has been reported and is apparently dose-related.(see WARNINGS section).

Hypersensitivity reactions: urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, serum sickness, pericarditis, and exacerbation of systemic lupus erythematosus.

Blood: Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia have been reported.

OVERDOSAGE In case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures.

Dialysis does not alter serum half-life and thus would not be of benefit in treating cases of overdose.

DOSAGE AND ADMINISTRATION THE DOSAGE OF ORACEA DIFFERS FROM THAT OF DOXYCYCLINE USED TO TREAT INFECTIONS. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS INCLUDING THE DEVELOPMENT OF RESISTANT MICROORGANISMS. One ORACEA Capsule (40 mg) should be taken once daily in the morning on an empty stomach, preferably at least one hour prior to or two hours after meals.

Efficacy beyond 16 weeks and safety beyond 9 months have not been established.

Administration of adequate amounts of fluid along with the capsules is recommended to wash down the capsule to reduce the risk of esophageal irritation and ulceration. (see ADVERSE REACTIONS section).

HOW SUPPLIED ORACEA (beige opaque capsule printed with CGPI 40) containing doxycycline, USP in an amount equivalent to 40 mg of anhydrous doxycycline. Bottle of 30 (NDC 64682-009-01).

Storage: All products are to be stored at controlled room temperatures of 15°C-30°C (59°F-86°F) and dispensed in tight, light-resistant containers (USP). Keep out of reach of children.

Patent Information: U.S. Patents 5,789,395; 5,919,775; 7,232,572; 7,211,267 and patents pending.

ORACEA is a registered trademark of CollaGenex Pharmaceuticals, Inc. Manufactured by: Marketed by: CardinalHealth Galderma Laboratories, L.P. Winchester, KY 40391 Fort Worth, TX 76177 7961-01 BPI 06/08

SURGICAL Dermatology

SURGICAL wisdom

Needle Stick Prevention 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.

In the next few issues, the JDPA will highlight the CDCâ&#x20AC;&#x2122;s remaining steps of the STOP STICKS campaign. For additional information on the STOP STICKS campaign please visit the CDC website at www.cdc.gov/niosh/stopstick.

Vol. 6, No. 1 WINTER 2012 35

cosmetic Dermatology

Moisturizer Selection for Dry Winter Skin

By Zoe Diana Draelos, 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.

36 Journal of Dermatology for Physician Assistants

Winter skin is exposed to a low humidity and low temperature environment in many areas of the United States and requires the use of skin care products to compensate for these conditions. The most important winter skin care product is a moisturizer. The name â&#x20AC;&#x153;moisturizerâ&#x20AC;? is a misnomer because moisturizers do not put water back in the skin. If you read the back of the lotion bottle you will see that water is the first ingredient in most lotions, although this water does not moisturize the skin. Water is the vehicle that spreads the skin conditioning ingredients over the stratum corneum while rapidly evaporating in the low humidity environment.

While the many moisturizers available for purchase differ subtly, there are some basic functions that all moisturizers provide. They include making the skin feel smooth and soft while increasing skin hydration.

Smooth and Soft

SAVE THE DATE

The most basic consumer need achieved by moisturizer application is smooth and soft skin. All moisturizers in the current marketplace make the skin smooth and soft. If you apply a sample of a moisturizing cream to the hand of a patient, his/her immediate inclination is to see how the product changes the tactile properties of the skin.

Vol. 6, No. 1 WINTER 2012 37

COSMETIC Dermatology

Zoe Diana Draelos, MD, is a practicing board-certified dermatologist and a Fellow of the American Academy of Dermatology with a research interest in cosmetics, toiletries, and biologically active skin medications. She is in solo private practice in High Point, North Carolina, and a Consulting Professor of Dermatology at Duke University. In 1988, she founded Dermatology Consulting Services to provide education, develop formulations, and conduct clinical studies in association with industry. Prior to pursuing a medical career, Dr. Draelos completed an undergraduate degree in Mechanical Engineering and was elected a Rhodes Scholar. A member of Sigma Xi research honorary and Alpha Omega Alpha medical honorary, she is author of the textbooks Cosmetics in Dermatology and Hair Cosmetics, as well as the editor of Cosmeceuticals, now in its second edition and translated into 5 languages. She has contributed chapters to 32 textbooks, served as the principle investigator on 274 studies, and written 270 published papers and she currently serves on 8 journal editorial boards, functions as the editor-in-chief of the Journal of Cosmetic Dermatology, and is a past member of the Board of Directors of the American Academy of Dermatology and the American Society for Dermatologic Surgery. She is Vice-President Elect of the American Academy of Dermatology. She received a lifetime achievement award from Health Beauty America for her research and the 2008 DermArts award for her contributions to dermatology. In 2010, she received the Albert Kligman Innovation Award.

Cosmetic pearls Categorizing Cosmetic Patients

By Risha Bellomo, MPAS, PA-C

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.

Risha Bellomo, MPAS, PA-C has practiced dermatology for 11 years. She currently works at Advanced Dermatology & Cosmetic Surgery in Orlando, Florida and has been their Director of PA/NP Cosmetic Training for the last 5 years. She has indicated no relationships to disclose relating to the content of this article.

38 Journal of Dermatology for Physician Assistants

Professional development

Dermatology Billing & Coding What to Do for 2012

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.

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

Vol. 6, No. 1 WINTER 2012 39

SDPA Members Only Content

professional development

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

40 Journal of Dermatology for Physician Assistants

Judicial and Ethical Affairs Professionalism

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 Masterâ&#x20AC;&#x2122;s Degree in Ethics and Applied Philosophy at the University North Carolina at Charlotte.

Vol. 6, No. 1 WINTER 2012 41

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.

42 Journal of Dermatology for Physician Assistants

Outside & Inside the 9 to 5...

As with any new experience, I arrived on the campus their daily activities and function as a traditional of Camp Horizon nervous, but very excited. I knew camp counselor. For those who are return campers, that I would be putting in a lot of work, even though and there are many, this is the best week of their year.

I was taking a week’s “vacation” from my job. I didn’t The reunions of campers as they arrived to Camp anticipate how much the were full of hugs, laughter, campers and staff would and smiles. At Camp, there feel like an extended family is no “normal,” and skin is to me so quickly. secondary. These kids are here to expend their entire Camp Discovery is a days’ energies having fun, collection of six sites around not wondering what a the country that provide schoolmate thinks of their children and teenagers red, scaly skin. with chronic and/or severe skin conditions the The staff is comprised opportunity to experience of medical professionals, an amazing week of camp. former campers, and those There is no fee for a camper who are afflicted with skin Caitlyn W. Smith, MHSc, PA-C enjoying some time with a camper and Alan Solter, MD at Camp Horizon to attend; the AAD offers conditions themselves. this past summer. scholarships, including The staff’s energy rivals transportation for all campers. Camp Horizon in that of the campers who they supervise. I cannot rural Millville, PA hosts children ages 8-13. Various appropriately describe the sense of belonging that activities are available for everyone, including I felt from day one. It truly felt like an extended archery, a rock climbing wall, fishing, swimming, family. tent camping, a talent show, and arts and crafts. However, truth be told, it wasn’t all hugs and kisses!

We also spent a day at Knoebel’s amusement park I was one of seven counselors in a cabin of eight with the campers. Campers are not limited by their 11-13 year old girls, so you can imagine the petty health conditions or their socioeconomic statuses; arguments and the occasional homesickness we they are only limited by how much fun they want had to deal with; all of which is to be expected at to have. any children’s camp. It was most remarkable seeing Initially, it was difficult to separate myself from my our girls come out of their shells and start to form clinical background, especially seeing these children friendships with other campers. and knowing what their prognoses were. That If you have a patient who you feel might benefit changed quickly because my role as a volunteer from a week of camp, I urge you to contact the didn’t require me to diagnose or treat the campers. AAD and visit Camp Discovery’s website at www.

As a counselor, my role was to take my campers to campdiscovery.org. Your patients do not need to Vol. 6, No. 1 WINTER 2012 43

professional development

Caitlyn W. Smith, MHSc, PA-C spent time this past summer as a volunteer at Camp Horizon, located in Millville, PA. Camp Horizon is one of several camps that make up the American Academy of Dermatology’s (AAD) Camp Discovery program. All of the AAD’s Camp Discovery camps are for young people with chronic skin conditions. Camp Discovery camps offer a summer camping experience unlike any they’ve had before. Every year, the AAD sponsors a week of fishing, boating, swimming, water skiing, arts and crafts, and just plain fun. Under the expert care of dermatologists, physician assistants, and nurses, Camp Discovery camps offer campers the opportunity to spend a week among other young people who have similar skin conditions. Many of the counselors have skin conditions as well, and can provide support and advice to campers. Fun, friendship, and independence are on the top of everyone’s agenda and everyone shares in the discovery of what it’s like to be included. Caitlyn kindly shares with us her experience and insight as a volunteer at Camp Horizon.

professional development

children and seeing how their eyes light up when they catch their first fish or laugh uncontrollably as they fly down the zip line will be one of the most rewarding experiences you will ever have. J

have the most severe or unusual skin conditions.

In fact, many of the campers had atopic dermatitis or some form of alopecia, and I know that it was comforting for the campers to know there are others (even adults!) like themselves.

If you are interested in volunteering with Camp Discovery, you can download an application through their website. Together with the physicians, residents, and medical students who volunteer their time, I think it would be incredible to have a greater presence of physician assistants.

I guarantee that volunteering your time with these

Caitlyn W. Smith, MHSc, PA-C is a 2009 graduate of the Lock Haven University Physician Assistant Program.

She received her Bachelors of Science Degree in Biology from Allegheny College. She practices dermatology with Kimberly A. Rau, MD in Pittsburgh, PA.

Are you interested in volunteering for Camp Discovery and would like to speak to a past volunteer?

Contact us at editor@jdpa.org

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.

44 Journal of Dermatology for Physician Assistants

Notes from your Office Manager

Schedule Smart

By Rosemarie Nelson, MS

Does your practice open early enough for your patients who want to come in and then head to their job, or to get their kids off to school? Do you stay open during the lunch hour when patients may have some flexible time in the middle of their day and can use an extended lunch hour to get into your office? Does your office offer any evening hours during the week? Think about creating an office scheduling template that provides some nontraditional office hours for your patients, such as the one below.

if you get 30% fewer incoming phone calls because 30% of your patients are using the web to make appointments!

How does smart web scheduling work? Patients will have a secure account and enter some preliminary information such as their preferred providers, the reason(s) for their appointment and even their preferred days of the week or times of day for their appointments.

In a smart scheduling practice, the patients’ requests are answered by one of your staff members who responds to patients with specific appointment dates and times via secure messages. Patients open emails that direct them via a URL link to the secure site where patients can accept the appointment or revise their requests.

With very smart scheduling, the application searches available appointment slots and presents patients with Monday 8am – 4pm No lunch break potential dates and times for Tuesday 8am – 6pm Lunch break 1:15 – 2:15 their selected providers, which patients can accept, reject, or Wednesday 10am – 1:30pm Mid-day break reschedule. Behind the scenes 1:30 – 3:00 and 3pm - 7pm you have identified specific Thursday 10am – 6pm Lunch break 1:15 – 2:15 appointment times available for patients using self-scheduling, so Friday 7am – 2pm No lunch break patients are presented with only those particular appointment Stagger staff hours to accommodate the longer days slots. Smart scheduling starts with a template that J without consistently paying overtime. Use the mid- is patient-centric and follows through with tools like day break to run errands or get through your inbox web-based scheduling for the convenience of your so you aren’t taking so much work home. patients. That’s smart business! J Consider how your patients get an appointment.

Rosemarie Nelson is a principal with the MGMA Can your patients actually go on your website and healthcare consulting group. She conducts educational find open slots for appointments? Can patients seminars and provides keynote speeches on a variety of send in a request for appointments? More and more healthcare-technology and operational topics. Drawing practices are offering patients the convenience of upon her diverse experience, Nelson provides practical using the web to schedule appointments at any solutions to help medical groups succeed in their hour of the day or night. Will all patients schedule practices. She may be reached via physicianspractice@ appointments this way? Not right away, but cmpmedica.com. imagine how differently your practice will function Are you a PA who has transitioned to using web based patient access scheduling? If so, we would like to hear from you. Please email editor@jdpa.org to share your experiences with us. Thank you.

Vol. 6, No. 1 WINTER 2012 45

professional development

How can you schedule smart? Start by thinking about the schedule from your patients’ perspectives.

When do patients want to come in? Are you available at hours that are convenient for your patients? If patients can obtain an appointment within hours or a day of requesting it, your no-show rate drops dramatically!

Dermatology PA news & notes

From the Desk of...

By Steven Leon, MS, PA-C

The SDPA Member Document Library Turning an Idea into Reality My mom is a lifelong teacher, and my dad is a published author of a how-to book, so I guess it is in my blood to have a desire to explain things to people. This makes patient education the favorite part of my job. I have had acne my entire life and I know the challenges of treating acne firsthand. As a provider I have found myself struggling to educate patients about the multiple parts of a successful acne treatment program. Since my attempts at educating patients were taking too much time and weren’t effective, I started creating patient handouts on acne as a means of organizing my own thoughts and transforming them into a patient friendly document.

These handouts led to better outcomes and more efficient office visits. Because of this success, I was motivated to design educational handouts for other dermatological conditions. I contacted the SDPA with an idea to create an internet forum where members could post all of their most useful documents. It turns out they were already discussing it, and the SDPA Member Document Library was born.

Since incorporating these educational tools into my practice, I have realized the following benefits.

They…

1. Let patients know that you are an expert with a plan - Having practice specific handouts that list everything your practice offers and reflect the medications and additional treatments and products that your practice uses, sends a powerful Steven Leon, MS, PA-C graduated in 2006 from Western University of the Health Sciences in Pomona, CA. He works with Daniel P. Taheri, MD at Advanced Dermatology in Palmdale, CA. Steve used to have hobbies such as hiking, but he now has two-year old twins.

46 Journal of Dermatology for Physician Assistants

message. It says that you are an expert (something vital for PAs to establish) with a well thought out treatment plan.

2. Save time and allows you to meet more patient needs - Have you ever had a patient say at the end of a long visit, “Oh, one more thing.

What can I do about these brown patches on my face?” If you have a handout ready you can simply say, “You have melasma and we have a really good treatment program for that. I would be more than happy to spend some time talking to you about it during your next visit. This handout tells you everything we offer. I’ve circled the treatments I think would be most helpful.” In less than thirty seconds you have solidly addressed this complicated condition, established that you are an expert with a plan to successfully treat it, and set up a productive and efficient follow-up.

3. Reinforce key information - I can’t tell you how many times I have had people tell me that they have used hydroquinone for one month and stopped because they don’t see a difference, or that they are so frustrated because they have had multiple skin cancer surgeries and cryodestruction but are still developing more actinic keratoses (AKs). Because patients forget half of what you tell them after they leave the room, they need the reinforcement of quality written information to remind them that hydroquinone takes one to two months to start working and that topical medicines may be required to gain better control of their AKs. 4. Increase awareness of additional products and services - For example, on my acne treatment sheet, cleansers, moisturizers, and sunscreens are all listed with a brief description and their prices.

Also listed are additional services such as chemical peels, kenalog injections, microdermabrasions, and CO2 laser for acne scars. The more things you offer the more important the patient handout

(see Figure). Looking through the examples and tailoring the handouts to meet the needs of your patients is a great way to start.

When developing a handout be sure to put yourself in the patientsâ&#x20AC;&#x2122; shoes, using only language and concepts that they can easily understand.

Start with an overview of what patients can expect in regards to results. Then, outline the critical components of the treatment program in a concise way. The format of the handout should allow you to quickly circle the recommended treatment options. If you offer a lot of treatment options you can put the prescription medications and medical procedures on the front of the handout and the cleansers, moisturizers, and other products or services (including lasers) on the back.

Good luck as you begin to create and tailor educational handouts to meet the needs of your patients. If your experience is like mine, once you start using them you wonâ&#x20AC;&#x2122;t be able to live without them. Please visit the SDPA website at www.dermpa. org and go to the Member Document Library to see examples of patient education handouts and other documents submitted by our members. There are currently over 40 documents. Be sure to submit your own and keep the library growing! J

Figure

EXAMPLE

Vol. 6, No. 1 WINTER 2012 47

DERmatology pa news & notes

becomes. The first step in increasing sales of products and additional services is making patients aware that you offer them! Simply circling the appropriate products and services on the handout and saying a few words is a low-pressure, educational, and effective way to promote these additional treatments.

Besides distributing these handouts to patients myself, there are two other effective ways of using them. I have my medical staff give appropriate handouts to patients before I enter the exam room if it is obvious why they are at our office. This gives patients time to become more familiar with their conditions, and formulate questions, thus making the visits more efficient. Handouts can be used in cosmetic consultations by your cosmetic coordinators, nurses, medical assistants, or estheticians. I have also found that making patient education handouts into pamphlets for display in treatment and waiting rooms is very beneficial as well.

You may be wondering how to create an effective educational handout. You will be relieved to know that you do not need to recreate the wheel.

Thanks to the SDPA, there are many examples of such handouts, from myself and others, available to members in the Member Document Library

The Difference We Make

When Patients Don’t Get Better… Are They Noncompliant?

Dermatology PA news & notes

By Steven K. Shama, MD, MPH

I truly believe that most of our patients get better. Of course, we generally attribute this to our making the right diagnosis and prescribing the most appropriate treatment. Over the years I have learned that some patients get better despite us. For example, we hear about rashes that clear up without us having seen the patient. This humbles us, since had we seen patients at the onset of their rashes, we might have attributed our treatments’ positive results to our “brilliance.”

But what about those patients who don’t get better despite the fact you are sure your diagnosis and treatment are correct? Why aren’t they better? Is it that they aren’t doing what we want them to do?

When I am faced with such a possibility I remember an article I read long ago that stated that as many as 30% of general medical patients don’t use prescribed medications as written by their clinicians.

There are a variety of reasons for this noncompliance; some people don’t fill their prescriptions, some use them less often than prescribed, or some stop too soon. All of which leads to so-called noncompliant patients. If only we knew that they weren’t following our instructions. But for a number of reasons, they don’t always tell us. Is there a way that we can increase the likelihood of our patients following our instructions or at least letting us know when they aren’t? Do patients actually not tell us the truth?

Steve Feldman, MD, PhD, (Professor of Dermatology, Wake Forest Medical Center, WinstonSalem, NC) performed a study, which revealed that patients don’t always tell us that they aren’t following our instructions. Dr. Feldman gave a lid-covered jar of a potent cream to a number of volunteers in Dr. Steve Shama was practicing general dermatology for 30 years in Boston, Massachusetts until last year. He retired at that time but continues in a 20 year career as a professional speaker and enjoys speaking on topics such as, “Dealing With Difficult People and Looking Forward To It!” and “Rediscovering The Joys of Medicine and of Life.” He gives these talks at medical meetings, in private practices, and to general audiences and youth throughout the country. You can reach Dr. Shama at www.steveshama.com.

48 Journal of Dermatology for Physician Assistants

order to clear a rash but also to examine the question of compliance. His simple instructions were to use the cream twice daily and to record for an entire month the number of applications they used. Some patients using this potent cream didn’t clear their rash. In order to explain this anticipated finding, he had installed (unbeknownst to the patient) a microchip in the lid of each jar that recorded every date and time the lid was removed. He found that for a number of patients who did not get better, the micro-chip indicated that many doses of medication were missed even though the patients’ personal recordings showed almost complete adherence to the twice daily schedule. Dr. Feldman’s conclusion was that some patients simply did not tell the truth. He offered no explanation as to why this occurred, but the facts were apparent; patients were noncompliant and this was accompanied by them not telling the truth.

In the face of these findings, how can we increase compliance and how can we get patients to tell us when they are noncompliant? Based on my own personal experience, on journal articles I have read, and on talks I have heard, the following suggestions may help increase compliance and honesty in patients.

1. Be convincing in your diagnosis and treatment.

If you need to express some doubt, make sure patients know that you are not thinking of another more serious diagnosis and always give hope.

2. You can convey the feeling that you truly care about them getting better by taking your time when presenting your treatment ideas. Sit, make eye contact with your patients, and speak in soft tones.

3. Involve your patients in the decision making process. State what needs to be treated, why, and what could happen if not treated; if there are side effects of the treatment, mention

The Difference We Make Even in the best of circumstances, patients may not get better despite the clinician following the five points above. Sometimes diseases don’t respond to treatments, and we need to learn more about the diseases and why they don’t clear up. Sometimes patients will be noncompliant and not tell us, even when we show them that we care. It is then that we have our chance to truly shine as clinicians, to show our patients that we really care about them, and to find some alternative treatment that will address the patients’ concerns while providing effective treatment of their diseases. Hopefully, it will be in that caring state, that we will either find a cure or we will find a way of staying together as a team, keeping open honest conversations, until a cure is found. J

First Foundations - New Employee Checklist

By Emily B. Massey, PA-C

C

ongratulations, it’s your first day at the clinic, and you are eager to start practicing dermatology. In addition to the massive amount of medical information you will be learning, there will be an overwhelming amount of new employee paperwork and other administrative tasks to complete. Use the list below as a helpful reminder.

• Pass NCCPA exam and have license available • Attain state licence(s) and have it (them) available • Receive prescribing license(s) and have it (them) available • Sign job contract • Meet with supervising physician to set your professional goals for the next 3, 6, 12 months • Have malpractice insurance in place • Receive hospital credentialing (if applicable) • Fill out human resource forms • Begin receiving a quarterly report on your billings/collections • Be sure your benefits are in place (health insurance, 401(k) or other pension program)

• Create your personal dermatology specific library (see First Foundation article in JDPA Vol.3, No.3, Summer 2009) • Ensure you are listed as a provider on your office’s insurance carriers • Join professional societies, especially SDPA and your local PA dermatology society • Subscribe to professional journals • Familiarize yourself with your reference tools • Familiarize yourself with the pharmaceutical sample closet • Order prescriptions pads • Order business cards Office managers may be in a position to help you complete these tasks, but remember that ultimately it is your responsibility. Please also note that there may be other job and state specific requirements that are not listed above.

Please feel free to provide feedback (ah-ha moments, challenges, and helpful hints) on your first year in dermatology to emily.massey@alumni.musc.edu. J Vol. 6, No. 1 WINTER 2012 49

DERmatology pa news & notes

alternative approaches and ask them about their treatment concerns.

4. Make sure you ask your patients whether what you have said makes sense to them and whether they have any other questions. You may find that what you thought was clear, is not and that your patients have important unanswered questions.

5. Always arrange for a follow-up, whether it is a formal office visit or a phone call within a reasonable period of time. Sometimes for an acute problem or when you see that your patients are worried, a reassuring phone call two or three days after the first visit does wonders for your patients’ confidence in their clinician.

Supervising Physician CORNER Dr. Alan Solter

By J. Margaret Casey, staff writer

Dermatology PA news & notes

A

lan Solter, MD practiced dermatology for thirty-three years and just retired this past year. For the past four years he has volunteered at the AAD sponsored Camp Horizon located in Millville, PA. We had the pleasure of interviewing Dr. Solter and talking about his experiences as a volunteer at Camp Horizon. We thank him for taking the time to share with us his experiences and insights.

JDPA: How did you first become involved with volunteering at a Camp Discovery camp?

Dr. Solter: The AAD prints a blurb about volunteering at the camps every year.

My summers were spent with my family and my young kids, going to t-ball games and various other activities. As my children got older the time seemed right for me to volunteer.

JDPA: How would you describe your first week volunteering?

Dr. Solter: I certainly did not know what to expect the first week I volunteered. I was impressed by the positive attitudes - both of staff and campers. Many volunteers do not have a medical background.

All volunteers are giving up a week of vacation from their respective jobs, and everyone pitches in and works hard. I assumed the kids would enjoy the camp, but was amazed by the courage I saw displayed by the campers. There were campers with some major physical disabilities who showed great amounts of courage. The campers were so 50 Journal of Dermatology for Physician Assistants

supportive and encouraging of one another. Kids who may not normally feel comfortable getting up in front of a group of peers would perform in the camp talent show, and all the other campers would cheer them on and support them.

JDPA: Can you explain briefly how the volunteers are organized?

Dr. Solter: There are three types of volunteering opportunities: counselors, activities crew members, and nursing staff.

People who volunteer as counselors are responsible for being with their assigned group of campers. Counselors stay with their campers for meals, daily activities, and sleep in the cabin with their group. I have volunteered on the activities staff. As an activities crew member, I was responsible for getting all of the necessary supplies ready for activities, setting up, running the activities, and cleaning up after the activities were completed. Activities crew members sleep in a cabin like everyone else, but arenâ&#x20AC;&#x2122;t assigned to a set group of campers. There is also a medical shed that is staffed by nurses.

This is where campers go for dressing changes, medications, and any other medical needs.

The counselors and camp staff meet every night to discuss any problems and the plans for the following day. The behind the scenes organization and hard work are what make the camp run so smoothly.

enjoy this too. Of course making s’mores and telling ghost stories around a campfire are also favorites. As an activity crew member, every night we get to walk through the cabins with Dr. Pride singing a Motown version of “Good Night Sweet Heart” to all of the campers.

JDPA: Anything you have taken away from your camp experience and implemented into your practice?

Dr. Solter: I have learned to appreciate even more what caregivers of the campers go through. I remember one medical student who was volunteering one of the weeks I was there.

At the end of the week he was talking about how exhausted he was. I looked at him and said, “You are tired from having these kids for one week, and can you imagine how tired their parents are who care for them 52 weeks out of the year?” I think volunteers leave with a greater sense of empathy and understanding for both the campers and what they endure as well as their caregivers.

JDPA: Are there any experiences that you have had that stand out in particular?

Dr. Solter: When you volunteer it changes you a bit. You gain an appreciation of things that you may have overlooked before. You are not there to get something for yourself; you are there for the kids, but you really do get a lot for yourself. I remember one camper in particular who had Olmsted Syndrome, a mutilating keratoderma of the palms and soles with hyperkeratotic plaques and many other signs. He was in a wheelchair and had no distinct fingers left. He kept two cups of water on either side of his chair to dunk his limbs in for some sort of relief. The camp has a day where they bring in bounce houses and things for campers to jump in. This boy was tired of being in his wheelchair. He got out of it and crawled on his stomach over to the bounce house. He got to the entrance and got in the bounce house. A group of fellow campers surrounded him and began jumping so he could bounce. The courage that he showed and the support that his fellow campers exhibited epitomizes what camp is all about. The courage that these campers exhibit really does bring tears to your eyes.

JDPA: Are there any camp traditions that you have come to cherish or look forward to yearly?

Dr. Solter: The campers love going to Knoebels Amusement Park. We take them one of the days during camp, and it is a highlight for many. It is an older, family run amusement park that is nestled in a beautiful setting with lots of trees. The campers also love carnival night, Vegas night, the camp dance, the camp talent show, and really all of the fun activities they participate in on a daily basis. Each night one cabin gets to sleep under the stars or in tents and the campers

JDPA: What are some of the misconceptions that providers may have in regards to what kinds of patients can be referred to the camps?

Dr. Solter: I would love to see more kids participate in the camps. I think that having brochures in waiting rooms would be a great reminder to providers to talk to their patients and caregivers about the camp opportunities.

Some providers might think that patients need to have very severe conditions to attend camp, and this is not the case. There are ranges of conditions. Some campers are physically affected

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DERmatology pa news & notes

JDPA: What type of orientation do volunteers need to go through prior to volunteering?

Dr. Solter: The screening process is intense.

There are a number of medical residents, medical students, physicians, physician assistants, and many non-medical volunteers. Dr. Howard Pride is the camp director, and he does a phenomenal job making the Camp a safe and fun environment for all. He has a great sense of humor, calm attitude, and effective discipline as needed. Before campers arrive all volunteers are required to watch a 10-12 subject video on how to manage kids at camp - including subjects ranging from homesickness, fraternization, bullying, etc. There is a test after each section that volunteers need to take.

Dermatology PA news & notes

by their conditions to the point of needing to be in a wheelchair, while others have fairly mild conditions. It is important to recognize that it may be difficult for an 8 year old with alopecia to have the confidence to stand up in front of his/her peers, and the camp experience provides him/her with a safe and accepting environment to be around others who are dealing with similar issues. The campers love camp because it provides them with this environment in which they are part of this family.

JDPA: What tips do you have for someone who is considering volunteering at one of the camps?

Dr. Solter: I would suggest contacting someone who has already volunteered. This would be a great place to start. You can ask any questions you may have. I encourage anyone thinking about volunteering to do so, and would be happy to talk with anyone interested in volunteering at Camp Horizon. It truly is a life changing experience. J

Alan Solter, MD completed his undergraduate studies at the University of North Carolina. He went to medical school at Yale Medical School, and completed his dermatology fellowship at the Cleveland Clinic. He practiced as a dermatologist in Pittsburgh, PA for over thirty years and just retired this past year. He is a member of the American Academy of Dermatology (AAD) and for the past four years he has volunteered at the AAD sponsored Camp Horizon located in Millville, PA.

If you are interested in volunteering for Camp Discovery and/ or would like to speak with Dr. Solter about his experiences, please contact us at editor@jdpa.org.

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

52 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 (250500 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 (250500 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. 1 WINTER 2012 53

Professional Opportunities and Development

Advertiser INDE X OrthoDermatologics â&#x20AC;&#x201C; Retin-A Micro... Pages 2, 3 Ranbaxy - Kenalog Spray........................Pages 7, 8 Promius - Cloderm.............................Pages 11, 12 Coria - Acanya...................................Pages 21, 22 Coria - Atralin ................................. Pages 26, 27 Medicis â&#x20AC;&#x201C; Solodyn........................Pages 29, 30, 31 Galderma - Oracea . ......................... Pages 33, 34 Intendis - Finacea . ............................Pages 55, 56 For more information on advertising opportunities in the JDPA, please log on to www.jdpa.org

The Premier Southeastern Conference for Dermatology Physician Assistants Speakers Include:

Dr. Vivian Bucay M.D. Dr. Amy McMichael M.D. Dr. Ted Rosen M.D.

May 3-5, 2012

Georgia World Congress Center in Atlanta, GA Offering 20 hours of Category I CME Registration from $300 for Early Bird before March 1 Accomodations at Embassy Suites Centennial Olympic Park For more information visit: www.GaDermPA.org and click on CME Conference Sponsored by the Georgia Dermatology Physician Assistants

54 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. 1 WINTER 2012 55

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.

56 Journal of Dermatology for Physician Assistants