Volume 5 number 1 WINTER 2011
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. 5, No. 1 WINTER 2011
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RETIN-A MICRO® (tretinoin gel) microsphere, 0.04% and 0.1% are indicated for topical application in the treatment of acne vulgaris. Important Safety Information: RETIN-A MICRO (tretinoin gel) microsphere, 0.04% and 0.1% is contraindicated in individuals with a history of sensitivity reactions to any of its components. The skin of certain individuals may become excessively dry, red, swollen or blistered. If warranted, these individuals should temporarily reduce the amount or frequency of application, or discontinue use temporarily or altogether. Patients should be encouraged to minimize exposure to sunlight, including sunlamps, and to use a sunscreen with a SPF of 15 or higher and protective clothing. The most common adverse reactions to RETIN-A MICRO 0.04% and 0.1% were limited to mild or moderate irritation of the skin. 1.3% of patients using RETIN-A MICRO 0.04% and 6% of patients using RETIN-A MICRO 0.1% discontinued due to irritation. RETIN-A MICRO 0.04% and 0.1% showed a visible reduction in total mean lesion count in as little as 2 weeks with full benefits seen after 7 weeks. Please see brief summary of prescribing information on the next page. *Reported at the end of the 12-week P.U.M.P. Study. † Data based on a consumer preference study designed to evaluate preference of Pump versus tube delivery. 104 male and female acne sufferers between the ages of 13 and 36 completed the study.3 References: 1. RETIN-A MICRO 0.04%/0.1% [prescribing information]. Los Angeles, Calif: Ortho Dermatologics; May 2006. 2. Eichenfield LF, Nighland M, Rossi AB, et al; PUMP Study Group. Phase 4 study to assess tretinoin pump for the treatment of facial acne. J Drugs Dermatol. 2008;7(12):1129-1136. 3. Data on file, Ortho Dermatologics. 4. Embil K, Nacht S. The Microsponge ® Delivery System (MDS): a topical delivery system with reduced irritancy incorporating multiple triggering mechanisms for the release of actives. J Microencapsul. 1996;13(5):575-588. RETIN-A MICRO ® is a brand of Ortho Dermatologics division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. © Ortho Dermatologics division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. 2009 09DD0217 10/09 Printed in the USA
FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE. Brief Summary Retin-A Micro® (tretinoin gel) microsphere, 0.1% and 0.04% is a formulation containing 0.1% or 0.04%, by weight, tretinoin for topical treatment of acne vulgaris. This formulation uses patented methyl methacrylate/glycol dimethacrylate crosspolymer porous microspheres (MICROSPONGE® System) to enable inclusion of the active ingredient, tretinoin, in an aqueous gel. IMPORTANT NOTE: This information is a BRIEF SUMMARY of the complete prescribing information provided with the product and therefore should not be used as the basis for prescribing the product. This summary has been prepared by deleting information from the complete prescribing information such as certain text, tables, and references. The physician should be thoroughly familiar with the complete prescribing information before prescribing the product. INDICATIONS AND USAGE: Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%, is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the use of this product in the treatment of other disorders have not been established. CONTRAINDICATIONS: This drug is contraindicated in individuals with a history of sensitivity reactions to any of its components. It should be discontinued if hypersensitivity to any of its ingredients is noted. PRECAUTIONS: General: • The skin of certain individuals may become excessively dry, red, swollen, or blistered. If the degree of irritation warrants, patients should be directed to temporarily reduce the amount or frequency of application of the medication, discontinue use temporarily, or discontinue use all together. Efficacy at reduced frequencies of application has not been established. If a reaction suggesting sensitivity occurs, use of the medication should be discontinued. Excessive skin dryness may also be experienced; if so, use of an appropriate emollient during the day may be helpful. • Unprotected exposure to sunlight, including sunlamps, should be minimized during the use of Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%, and patients with sunburn should be advised not to use the product until fully recovered because of heightened susceptibility to sunlight as a result of the use of tretinoin. Patients who may be required to have considerable sun exposure due to occupation and those with inherent sensitivity to the sun should exercise particular caution. Use of sunscreen products (SPF 15) and protective clothing over treated areas are recommended when exposure cannot be avoided. • Weather extremes, such as wind or cold, also may be irritating to patients under treatment with tretinoin. • Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%, should be kept away from the eyes, the mouth, paranasal creases of the nose, and mucous membranes. • Tretinoin has been reported to cause severe irritation on eczematous skin and should be used with utmost caution in patients with this condition. Information for Patients: A Patient Information Leaflet has been prepared and is included with each package of Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%. Drug Interactions: Concomitant topical medication, medicated or abrasive soaps and cleansers, products that have a strong drying effect, products with high concentrations of alcohol, astringents, or spices should be used with caution because of possible interaction with tretinoin. Avoid contact with the peel of limes. Particular caution should be exercised with the concomitant use of topical over-the-counter acne preparations containing benzoyl peroxide, sulfur, resorcinol, or salicylic acid with Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%. It also is advisable to allow the effects of such preparations to subside before use of Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%, is begun. Carcinogenesis, Mutagenesis, Impairment of Fertility: In a 91-week dermal study in which CD-1 mice were administered 0.017% and 0.035% formulations of tretinoin, cutaneous squamous cell carcinomas and papillomas in the treatment area were observed in some female mice. These concentrations are near the tretinoin concentration of these clinical formulations (0.04% and 0.1%). A dose-related incidence of liver tumors in male mice was observed at those same doses. The maximum systemic doses associated with the administered 0.017% and 0.035% formulations are 0.5 and 1.0 mg/kg/day, respectively. These doses are two and four times the maximum human systemic dose applied topically, when normalized for total body surface area. The biological significance of these findings is not clear because they occurred at doses that exceeded the dermal maximally tolerated dose (MTD) of tretinoin and because they were within the background natural occurrence rate for these tumors in this strain of mice. There was no evidence of carcinogenic potential when 0.025 mg/kg/day of tretinoin was administered topically to mice (0.1 times the maximum human systemic dose, normalized for total body surface area). For purposes of comparisons of the animal exposure to systemic human exposure, the maximum human systemic dose applied topically is defined as 1 gram of Retin-A Micro (tretinoin gel) microsphere, 0.1% applied daily to a 50 kg person (0.02 mg tretinoin/kg body weight). Dermal carcinogenicity testing has not been performed with Retin-A Micro (tretinoin gel) microsphere, 0.04% or 0.1%. Studies in hairless albino mice suggest that concurrent exposure to tretinoin may enhance the tumorigenic potential of carcinogenic doses of UVB and UVA light from a solar simulator. This effect has been confirmed in a later study in pigmented mice, and dark pigmentation did not overcome the enhancement of photocarcinogenesis by 0.05% tretinoin. Although the significance of these studies to humans is not clear, patients should minimize exposure to sunlight or artificial ultraviolet irradiation sources. The mutagenic potential of tretinoin was evaluated in the Ames assay and in the in vivo mouse micronucleus assay, both of which were negative. The components of the microspheres have shown potential for genetic toxicity and teratogenesis. EGDMA, a component of the excipient acrylates copolymer, was positive for induction of structural chromosomal aberrations in the in vitro chromosomal aberration assay in mammalian cells in the absence of metabolic activation, and negative for genetic toxicity in the Ames assay, the HGPRT forward mutation assay, and the mouse micronucleus assay. In dermal Segment I fertility studies of another tretinoin formulation in rats, slight (not statistically significant) decreases in sperm count and motility were seen at 0.5 mg/kg/day (4 times the maximum human systemic dose applied topically, and normalized for total body surface area), and slight (not statistically significant) increases in the number and percent of nonviable embryos in females treated with 0.25 mg/kg/day (2 times the maximum human systemic dose applied topically and normalized for total body surface area) and above were observed. In oral Segment I and Segment III studies in rats with tretinoin, decreased survival of neonates and growth retardation were observed at doses in excess of 2 mg/kg/day (17 times the human topical dose normalized for total body surface area). Dermal fertility and perinatal development studies with Retin-A Micro (tretinoin gel) microsphere, 0.1% or 0.04%, have not been performed in any species. Pregnancy: Teratogenic Effects: Pregnancy Category C. In a study of pregnant rats treated with topical application of Retin-A Micro (tretinoin gel) microsphere, 0.1%, at doses of 0.5 to 1 mg/kg/day on gestation days 6-15 (4 to 8 times the maximum human systemic dose of tretinoin normalized for total body surface area after topical administration of Retin-A Micro (tretinoin gel) microsphere, 0.1%) some alterations were seen in vertebrae and ribs of offspring. In another study, pregnant
New Zealand white rabbits were treated with Retin-A Micro (tretinoin gel) microsphere, 0.1%, at doses of 0.2, 0.5, and 1.0 mg/kg/day, administered topically for 24 hours a day while wearing Elizabethan collars to prevent ingestion of the drug. There appeared to be increased incidences of certain alterations, including domed head and hydrocephaly, typical of retinoid-induced fetal malformations in this species, at 0.5 and 1.0 mg/kg/day. Similar malformations were not observed at 0.2 mg/kg/day, 3 times the maximum human systemic dose of tretinoin after topical administration of Retin-A Micro (tretinoin gel) microsphere, 0.1%, normalized for total body surface area. In a repeat study of the highest topical dose (1.0 mg/kg/day) in pregnant rabbits, these effects were not seen, but a few alterations that may be associated with tretinoin exposure were seen. Other pregnant rabbits exposed topically for six hours to 0.5 or 0.1 mg/ kg/day tretinoin while restrained in stocks to prevent ingestion, did not show any teratogenic effects at doses up to 17 times (1.0 mg/kg/day) the maximum human systemic dose after topical administration of Retin-A Micro (tretinoin gel) microsphere, 0.1%, adjusted for total body surface area, but fetal resorptions were increased at 0.5 mg/kg. In addition, topical tretinoin in non Retin-A Micro (tretinoin gel) microsphere formulations was not teratogenic in rats and rabbits when given in doses of 42 and 27 times the maximum human systemic dose after topical administration of Retin-A Micro (tretinoin gel) microsphere, 0.1%, normalized for total body surface area, respectively, (assuming a 50 kg adult applied a daily dose of 1.0 g of 0.1% gel topically). At these topical doses, however, delayed ossification of several bones occurred in rabbits. In rats, a dose-dependent increase of supernumerary ribs was observed. Oral tretinoin has been shown to be teratogenic in rats, mice, rabbits, hamsters, and subhuman primates. Tretinoin was teratogenic in Wistar rats when given orally or topically in doses greater than 1 mg/kg/day (8 times the maximum human systemic dose normalized for total body surface area). However, variations in teratogenic doses among various strains of rats have been reported. In the cynomolgus monkey, which metabolically is more similar to humans than other species in its handling of tretinoin, fetal malformations were reported for doses of 10 mg/kg/day or greater, but none were observed at 5 mg/kg/day (83 times the maximum human systemic dose normalized for total body surface area), although increased skeletal variations were observed at all doses. Dose-related increases in embryolethality and abortion also were reported. Similar results have also been reported in pigtail macaques. Topical tretinoin in animal teratogenicity tests has generated equivocal results. There is evidence for teratogenicity (shortened or kinked tail) of topical tretinoin in Wistar rats at doses greater than 1 mg/kg/day (8 times the maximum human systemic dose normalized for total body surface area). Anomalies (humerus: short 13%, bent 6%, os parietal incompletely ossified 14%) have also been reported when 10 mg/kg/day was topically applied. Supernumerary ribs have been a consistent finding in rats when dams were treated topically or orally with retinoids. There are no adequate and well-controlled studies in pregnant women. Retin-A Micro should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. With widespread use of any drug, a small number of birth defect reports associated temporally with the administration of the drug would be expected by chance alone. Thirty human cases of temporally associated congenital malformations have been reported during two decades of clinical use of Retin-A. Although no definite pattern of teratogenicity and no causal association has been established from these cases, five of the reports describe the rare birth defect category holoprosencephaly (defects associated with incomplete midline development of the forebrain). The significance of these spontaneous reports in terms of risk to the fetus is not known. Non-Teratogenic Effects: Topical tretinoin has been shown to be fetotoxic in rabbits when administered 0.5 mg/kg/day (8 times the maximum human systemic dose applied topically and normalized for total body surface area), resulting in fetal resorptions and variations in ossification. Oral tretinoin has been shown to be fetotoxic, resulting in skeletal variations and increased intrauterine death in rats when administered 2.5 mg/kg/day (21 times the maximum human systemic dose applied topically and normalized for total body surface area). There are, however no adequate and well-controlled studies in pregnant women. Animal Toxicity Studies: In male mice treated topically with Retin-A Micro (tretinoin gel) microsphere 0.1%, at 0.5, 2.0, or 5.0 mg/kg/day tretinoin (2, 8, or 21 times the maximum human systemic dose after topical administration of Retin-A Micro (tretinoin gel) microsphere, 0.1%, normalized for total body surface area) for 90 days, a reduction in testicular weight, but with no pathological changes were observed at the two highest doses. Similarly, in female mice there was a reduction in ovarian weights, but without any underlying pathological changes, at 5.0 mg/kg/day (21 times the maximum human dose). In this study there was a dose-related increase in the plasma concentration of tretinoin 4 hours after the first dose. A separate toxicokinetic study in mice indicates that systemic exposure is greater after topical application to unrestrained animals than to restrained animals, suggesting that the systemic toxicity observed is probably related to ingestion. Male and female dogs treated with Retin-A Micro (tretinoin gel) microsphere, 0.1%, at 0.2, 0.5, or 1.0 mg/kg/day tretinoin (5, 12, or 25 times the maximum human systemic dose after topical administration of Retin-A Micro (tretinoin gel) microsphere, 0.1%, normalized for total body surface area, respectively) for 90 days showed no evidence of reduced testicular or ovarian weights or pathological changes. Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Retin-A Micro (tretinoin gel) microsphere, 0.1% or 0.04%, is administered to a nursing woman. Pediatric Use: Safety and effectiveness in children below the age of 12 have not been established. Geriatric Use: Safety and effectiveness in a geriatric population have not been established. Clinical studies of Retin-A Micro did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. ADVERSE REACTIONS: The skin of certain sensitive individuals may become excessively red, edematous, blistered, or crusted. If these effects occur, the medication should either be discontinued until the integrity of the skin is restored, or the medication should be adjusted to a level the patient can tolerate. However, efficacy has not been established for lower dosing frequencies. True contact allergy to topical tretinoin is rarely encountered. Temporary hyper- or hypopigmentation has been reported with repeated application of tretinoin. Some individuals have been reported to have heightened susceptibility to sunlight while under treatment with tretinoin. OVERDOSAGE: Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%, is intended for topical use only. If medication is applied excessively, no more rapid or better results will be obtained and marked redness, peeling, or discomfort may occur. Oral ingestion of large amounts of the drug may lead to the same side effects as those associated with excessive oral intake of Vitamin A. Rx only. Patent Nos.: 4,690,825; 5,145,675 & 5,955,109
Distributed by: OrthoNeutrogena DIVISION OF ORTHO-MCNEIL PHARMACEUTICAL, INC. Los Angeles, CA 90045 © OMP 2006 06DD0123 7/06 RETIN-A MICRO® is a registered trademark of Ortho-McNeil Pharmaceutical, Inc. MICROSPONGE® is a registered trademark of Cardinal Health, Inc., Dublin, OH.
EDITORIAL BOARD
Travis Hayden, MPAS, PA-C, Editor in chief Joe R. Monroe, MPAS, PA-C Patricia Ferrer, MPAS, PA-C Gordon Day, R.Ph., PA-C Nancy Primo, MPAS, PA-C Lauren Zajac, MHS, PA-C Michelle DiBaise, MPAS, PA-C P. Eugene Jones, Ph.D., PA-C Kristine Kucera, DHS, MPAS, PA-C Mark Hyde, MMS, PA-C Jeffrey LaDuca, Ph.D., MD Alan Menter, MD
DEPARTMENT EDITORS
Clinical Department 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 Abby Jacobson, MS, PA-C PrESiDEnT-ElECT Keri Holyoak, MPH, PA-C iMMEDiATE PAST PrESiDEnT Kristine Kucera, DHS, MPAS, PA-C ViCE PrESiDEnT CaSondra Soto, MPAS, PA-C SECrETAry / TrEASurEr Casey Croes, MPAS, PA-C DirECTors AT lArGE Mark Hyde, MMS, PA-C John Notabartolo, MPAS, PA-C Jennifer Winter, PA-C Jason Roddick, MS, MSPAS, PA-C Society of Dermatology Physician Assistants, Inc P.O. Box 701461 San Antonio, Texas 78270 1-800-380-3992 SDPA@dermpa.org www.dermpa.org
Publishing Staff
Publisher Travis Hayden, MPAS, PA-C Managing Editor Jennifer M. Hayden, M.Ed Copy Editor Douglas Morris Art Director Angela Simiele Website Design Terry Scanlon
SALES Office
Physician Assistant Communications, LLC P.O. Box 416, Manlius NY 13104-0416 Phone (315) 663-4147 PAC@pacommunications.org www.pacommunications.org editorial missioN: The JDPA is the official clinical journal of the Society of Dermatology Physician Assistants. The mission of the JDPA is to improve dermatological patient care by publishing the most innovative, timely, practiceproven educational information available for the physician assistant profession. PUBLISHED CONTENT IN THE JDPA: Statements and opinions expressed in the articles and communications herein are those of the authors and not necessarily those of the Publisher or the Society of Dermatology Physician Assistants (SDPA). The Publisher and the SDPA disclaim any responsibility or liability for such material, including but not limited to any losses or other damage incurred by readers in reliance on such content. Neither Publisher nor SDPA verify any claims or other information appearing in any of the advertisements contained in the publication and cannot take responsibility for any losses or other damage incurred by readers in reliance on thereon. Neither Publisher nor SDPA guarantees, warrants, or endorses any product or service advertised in this publication, nor do they guaranty any claim made by the manufacturer of such product or service. This Issue: of JDPA includes articles that have been reviewed and approved for Category I (Preapproved) CME credit by the American Academy of Physician Assistants. Approval is valid for 1 year from the issue date, and participants may submit the self-assessment at any time during that period. Category I CME articles included in JDPA are planned and developed in accordance with AAPA’s CME Standards for Journal Articles and for Commercial Support of Journal Articles. Since its inception, the JDPA has utilized eco-friendly printing practices. The JDPA is printed on paper obtained from sustainable forests that meet strict environmental standards. Soy-based inks that have a low environmental impact are used during printing of the journal and the journal is printed using 100% renewable energy. SDPA members may join us in our efforts and opt to receive the JDPA in digital format.
JDPA/Journal of Dermatology for Physician Assistants (ISSN 1938-9574) is published quarterly (4 issues per volume, one volume per year) by Physician Assistant Communications, LLC, P.O. Box 416, Manlius NY 13104-0416. Volume 5, Number 1, Winter 2011. One year subscription rates: $40 in the United States and Possessions. Single copies (prepaid only): $10 in the United States (Include $6.50 per order plus $2 per additional copy for US postage and handling). TM Periodicals postage rate paid at New York, NY 10001 and additional mailing offices. Š 2011 Physician Assistant Communications, LLC. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including by photocopy, recording, or information storage and retrieval system, without permission in writing from the publisher. Postmaster: Send address changes to Society of Dermatology Physician Assistants, Inc. P.O. Box 701461, San Antonio, Texas 78270; 1-800-380-3992. THIS ISSUE IS SPONSORED BY
Journal of Dermatology for Physician Assistants
Editor’s Message
Investing Time and Talent Journal of Dermatology for Physician Assistants
The Official Journal of the SDPA
Explore Your Benefits Did you know… Physicians who currently supervise Fellow members of the SDPA may join for FREE!
A
s we begin this new year, many of us may have made a resolution or two. As is the case with any new endeavor, we may need to invest a bit more of our time and talents in order to achieve these new goals. I too have set out to accomplish a few new things this year, and I have especially decided to invest more time and talent into the future of our dermatology physician assistant profession. I am sure that we all take great pride in the fact that we work hard to provide our patients with the optimum in dermatological healthcare. But can we say that we do the same within our own profession - have we invested enough of our time and talents into improving our role as healthcare providers within dermatology? I believe that the SDPA has offered us an opportunity to make such an investment by participating in the Distance Learning Initiative (DLI). This is our chance to showcase to our peers, supervising physicians, and to our patients that we are fully invested in our profession. Completing the modules and acquiring the designation of Diplomate affirms that we value our profession and take seriously the importance of obtaining the highest level of education currently available for dermatology physician assistants in order to better the lives of our patients. In addition to the DLI, there are many other ways that we can invest our time and talents in the future of our profession. Dermatology physician assistants are showing their commitment to the profession by participating in healthcare missions, volunteering within the SDPA or local SDPA State Affiliates, providing dermatological care for the uninsured, teaching/precepting physician assistant students, as well as through other commendable activities. It is certainly an exciting time to be a dermatology physician assistant. I wish everyone all the best in the new year that lies ahead and would encourage all of us to embrace the amazing opportunities that are available to us by investing our time and talents in the future of our great profession. J
Travis Hayden, MPAS, PA-C Editor in chief
Encourage your physician to join the SDPA today! Vol. 5, No. 1 WINTER 2011
table of contents SDPA Members Only Content A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.
17
Dermoscopic Features of Seborrheic Keratoses By John Burns, PA-C
CME
10 Derm PA News & Notes – part one
• Certification Review - All Those Things Inside the Skin You Might Have Forgotten
17 Clinical Dermatology
• CME Article – Dermoscopic Features of Seborrheic Keratoses • Drugs in Dermatology – The A, B, C, and Ds of Groups A-D Corticosteroids • Dermatology Case Report – Lichen Striatus
Departments
04 Editorial Board 05 Editor’s Message 09 SDPA News & Current Affairs 10 Dermatology Market Watch 23 From The Patient’s Perspective 25 Dermatoscopy 26 Clinical Snapshots 35 Surgical Wisdom 38 Cosmetic Pearls 48 Notes from your Office Manager 51 Outside & Inside the 9 to 5... 53 The Difference We Make 58 Professional Opportunities and Development
34 Surgical Dermatology
• Surgical Subtleties for Dermatology PAs
36 Cosmetic Dermatology
• Is It All In Their Heads? – The Cosmetic Patient and Body Dysmorphic Disorder
41 Professional Development
• Dermatology Billing & Coding – EMR Decision Making • Five Great IT Tools Under $100
52 Derm PA News & Notes – part two
Check it out!
Journal of Dermatology for Physician Assistants
• From the Desk of… • Supervising Physician Corner
dermPA.org
Vol. 5, No. 1 WINTER 2011
Journal of Dermatology for Physician Assistants
Calendar
FROM THE SPDA News & Current Affairs
of events
2011 FEBRUARY 69th AAD Annual Academy Meeting February 4 - 8, 2011 New Orleans, LA june SDPA 2nd Annual Summer Dermatology Conference June 2 - 5, 2011 JW Marriott Hotel Washington, DC August AAD Summer Academy Meeting August 3 - 7, 2011 JW Marriott Hotel New York, NY NOVEMBER SDPA 9th Annual Fall Conference November 9 - 12, 2011 Loews Portofino Bay Hotel Orlando, FL
A Commitment to Dermatology: Physicians, PAs, and Patients
T
he SDPA has made a commitment to our members to help support the dermatology PA/physician team, which in turn will help create increased patient access to care. Studies have shown that dermatology practices that employ a PA can offer patients quicker appointments for chief complaints such as a changing mole. As part of this commitment to our members, dermatologists, and patients, the SDPA developed the Diplomate status. The term “Diplomate� is used by thousands of professional organizations to denote a member who has had additional training. Becoming a SDPA Diplomate indicates that you have achieved the highest honor available as a dermatology PA. Diplomates are SDPA Fellow members who have worked with a board certified dermatologist for at least one year before completing the rigorous online distance learning training. The online content is delivered on the UTTeleCampus and users have 24/7 access to course content and technical support, as well as biomedical library databases and repositories for any necessary reference documents. The modules include a rich assortment of sharply focused color digital images. The educational content has been approved for 70 hours of Continuing Medical Education (CME) Category I credit. Demonstrate your commitment to dermatology, the SDPA, your supervising physician, and your patients by becoming a SDPA Diplomate today! To learn more about the SDPA Diplomate Program visit www. dermpa.org/diplomate J
Calendar of Events Submissions Send information to: Editor@jdpa.org
Abby Jacobson, MS, PA-C President Society of Dermatology Physician Assistants
Vol. 5, No. 1 WINTER 2011
9
Dermatology PA news & notes
Dermatology Market Watch Avène Cold Cream Lip Cream Intensely rich formula provides immediate, long-lasting first aid and protection for severely dry, cracked, chapped and flaky lips. The quickly absorbing new Avène Cold Cream Lip Cream offers healing, nourishing, restoring and protective benefits in one-easy-to-use, soothing formula. Benefits: • Extra-strength formula provides intense treatment for severely dry lip conditions • Remains on lips to insure long-lasting benefits • Travel-friendly, convenient tube • Quickly absorbing • Hypoallergenic and non-comedogenic Contains: • Avène Thermal Spring Water - (1%) soothes and softens the skin • Sucralfate - helps heal damaged lips and restore skin barrier • Lipid Cocktail - including Avène Cold Cream formula, Linoleic acid, and Shea butter to nourish, protect and re-balance while making lips more comfortable • Remainance agent - to maintain long-lasting benefits Directions for Use: • Apply to lips as often as desired/necessary • May be applied under lipsticks
SanovaWorks, formerly Physicians’ Continuing Education (PCE), was founded in 2002 by the renowned Dr. Perry Robins. SanovaWorks is a healthcare communications company, offering unique and quality educational resources to medical providers. With a flagship enterprise in dermatology, SanovaWorks produces several educational tools for this specialty’s practitioners—many of which are complimentary to both dermatologists and dermatology physician assistants. SanovaWorks’ collective educational offerings in dermatology include the Journal of Drugs in Dermatology (JDD) (JDDonline. com), eJDD (JDDonline.com/eJDD), DermPearls (dermpearls.com), The Derm Directy (TheDermDirectory.com), Dermatology In-Review (DermatologyInReview.com/ Galderma), the Comprehensive Review Notes in Dermatology for the Physician Assistant (derm. cme.etasonline.com), Discussions in Dermatology (discussionsindermatology.com), the Orlando Dermatology Aesthetic and Clinical (ODAC) conference (orlandoderm.org), and the Skin of Color Seminar Series (skinofcolorseminars.com). If you would like to know more about SanovaWorks and the educational opportunities available to dermatology PAs, please contact info@sanovaworks.com or visit the website sanovaworks.com.
AIM at Melanoma Patient & Caregiver Symposiums Leading melanoma experts will discuss emerging therapies, the importance of clinical trials, and innovations in research. In 2011, AIM at Melanoma will continue to host free educational symposiums at major cancer centers throughout the country for patients and their caregivers. The topics to be covered include the importance of clinical trials, emerging therapies, and innovations in research. The first symposium is scheduled to take place at Emory Winship Cancer Institute on February 26, 2011 in Atlanta, GA and will be followed by other symposiums in Santa Monica, CA; Los Angeles, CA; Ann Arbor, MI; and Chicago, IL. To obtain information on the symposiums or to view 2010 symposium videos, please visit our website at www.AIMatMelanoma.org and click on Patient & Caregiver Symposiums. For additional information, please contact Samantha Guild at sguild@AIMatMelanoma.org or call 916-706-0599. 10 Journal of Dermatology for Physician Assistants
Expectations
Reformulated
A tretinoin re-invented for success • Delivered within a unique aqueous gel with a smart combination of ingredients that are known to moisturize and hydrate skin* • Efficacy you can expect only from a tretinoin1 • Low irritation profile1
Important Safety Information: • The most common adverse reactions were mild to moderate irritation of the skin and occurred during the first few weeks of treatment with ATRALIN® Gel. • To prevent aggravating the skin, protect it from sun, tanning lights, extreme wind or cold, and harsh skincare products. • Use of sunscreen products of at least SPF 15 and protective clothing over treated areas is recommended when exposure cannot be avoided. • Please see next page for Brief Summary of Prescribing Information. *The contribution to efficacy of individual components has not been evaluated.
www.atralingel.com Reference: 1. Data on file. CORIA Laboratories. ATRALIN and CORIA are registered trademarks of CORIA Laboratories. ©2008 CORIA Laboratories ATR–10011–0908
Vol. 5, No. 1 WINTER 2011 11
BRIEF SUMMARY
(see package insert for full prescribing information)
For topical use only INDICATIONS AND USAGE Atralin Gel is a retinoid indicated for topical treatment of acne vulgaris. Important Limitations of Use The safety and efficacy of the use of this product in the treatment of any other disorders have not been evaluated. CONTRAINDICATIONS None WARNINGS AND PRECAUTIONS Skin Irritation The skin of certain individuals may become dry, red, or exfoliated while using Atralin Gel. If the degree of irritation warrants, patients should be directed to temporarily reduce the amount or frequency of application of the medication, discontinue use temporarily, or discontinue use altogether. Efficacy at reduced frequencies of application has not been established. If a reaction suggesting sensitivity occurs, use of the medication should be discontinued. Mild to moderate skin dryness may also be experienced; if so, use of an appropriate moisturizer during the day may be helpful. Tretinoin has been reported to cause severe irritation on eczematous or sunburned skin and should be used with caution in patients with these conditions. Topical over-the-counter acne preparations, concomitant topical medication, medicated cleansers, topical products with alcohol or astringents, when used with Atralin Gel, should be used with caution [see Drug Interactions (7)]. Ultraviolet Light and Environmental Exposure Unprotected exposure to sunlight, including sunlamps, should be minimized during the use of Atralin Gel. Patients who normally experience high levels of sun exposure, and those with inherent sensitivity to sun, should be warned to exercise caution. Use of sunscreen products of at least SPF 15 and protective clothing over treated areas is recommended when exposure cannot be avoided. Weather extremes, such as wind or cold, also may be irritating to patients under treatment with tretinoin. Fish Allergies Atralin Gel contains soluble fish proteins and should be used with caution in patients with known sensitivity or allergy to fish. Patients who develop pruritus or urticaria should contact their health care provider. ADVERSE REACTIONS Clinical Studies Experience Because clinical trials are conducted under prescribed conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. In two randomized, controlled trials, 674 subjects received treatment for up to 12 weeks with Atralin Gel [see Clinical Studies (14)]. In these studies, 50% of the subjects who were treated with Atralin Gel reported one or more adverse reactions; 30% of the subjects reported treatment-related adverse reactions. In the vehicle group, 29% of the 487 randomized subjects reported at least one adverse reaction;
5% of the subjects reported events that were treatment-related. There were no serious, treatment-related adverse reactions reported by subjects in any of the treatment groups. Selected adverse reactions that occurred in at least 1% of subjects in the two studies combined, are shown in Table 1 (below). Most skin-related adverse reactions first appear during the first two weeks of treatment with Atralin Gel, and the incidence rate for skin-related reactions peaks around the second and third week of treatment. In some subjects the skin-related adverse reactions persist throughout the treatment period. Table 1. Number of Subjects with Selected Adverse Reactions (Occurring in At Least 1% of Subjects) Event
Atralin Gel (n = 674)
Vehicle Gel (n = 487)
Dry Skin
109 (16%)
8 (2%)
78 (12%)
7 (1%)
53 (8%)
8 (2%)
Erythema
47 (7%)
1 (<1%)
Pruritus
11 (2%)
3 (1%)
Pain of Skin
7 (1%)
0 (0%)
Sunburn
7 (1%)
3 (1%)
Peeling/Scaling/ Flaking Skin Skin Burning Sensation
DRUG INTERACTIONS When treating with Atralin Gel, caution should be exercised with the use of concomitant topical medication, medicated or abrasive soaps and cleansers, products that have a strong drying effect, and products with high concentrations of alcohol, astringents, spices, or lime. Particular caution should be exercised with the concomitant use of topical over-the-counter acne preparations containing benzoyl peroxide, sulfur, resorcinol, or salicylic acid. Allow the effects of such preparations to subside before use of Atralin Gel is begun. USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C. There are no wellcontrolled trials in pregnant women treated with Atralin Gel. Atralin Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Atralin Gel at doses of 0.1, 0.3 and 1 g/kg/day was tested for maternal and developmental toxicity in pregnant Sprague-Dawley rats by dermal application. The dose of 1 g/kg/day was approximately 4 times the clinical dose assuming 100% absorption and based on body surface area comparison. Possible tretinoin-associated teratogenic effects (craniofacial abnormalities [hydrocephaly], asymmetrical thyroids, variations in ossification, and increased supernumerary ribs) were noted in the fetuses of Atralin Gel treated animals. These findings were not observed in control animals. Other maternal and reproductive parameters in the Atralin Gel treated animals were not different from control. For purposes of comparison of the animal exposure to human exposure, the clinical dose is defined as 2 g of Atralin Gel applied daily to a 50-kg person. Oral tretinoin has been shown to be teratogenic in rats, mice, rabbits, hamsters and nonhuman primates. Tretinoin was teratogenic in Wistar rats when given orally in doses greater than 1 mg/kg/day (approximately 8 times the clinical dose based on body surface area comparison). In the cynomolgus monkey, fetal malformations were reported for doses of 10 mg/kg/day, but none were observed at 5 mg/kg/day (approximately 80 times the clinical dose
12 Journal of Dermatology for Physician Assistants
based on body surface area comparison), although increased skeletal variations were observed at all doses. Dose-related increases in embryolethality and abortion also were reported. Similar results have also been reported in pigtail macaques. Topical tretinoin in a different formulation has generated equivocal results in animal teratogenicity tests. There is evidence for teratogenicity (shortened or kinked tail) of topical tretinoin in Wistar rats at doses greater than 1 mg/kg/day (approximately 8 times the clinical dose assuming 100% absorption and based on body surface area comparison). Anomalies (humerus: short 13%, bent 6%, os parietal incompletely ossified 14%) have also been reported when 10 mg/kg/day (approximately 160 times the clinical dose assuming 100% absorption and based on body surface area comparison) was topically applied. Supernumerary ribs have been a consistent finding in rats when dams were treated topically or orally with retinoids. With widespread use of any drug, a small number of birth defect reports associated temporally with the administration of the drug would be expected by chance alone. Cases of temporally associated congenital malformations have been reported with use of other topical tretinoin products. The significance of these spontaneous reports in terms of risk to the fetus is not known. Nonteratogenic effects on fetuses: Oral tretinoin has been shown to be fetotoxic in rats when administered in doses 20 times the clinical dose based on a body surface area comparison. Topical tretinoin has been shown to be fetotoxic in rabbits when administered in doses 8 times the clinical dose based on a body surface area comparison. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Atralin Gel is administered to a nursing woman. Pediatric Use Safety and effectiveness in children below the age of 10 have not been established. A total of 381 pediatric subjects (aged 10 to 16 years), treated with Atralin Gel were enrolled into the two clinical studies. Across these two studies, comparable safety and efficacy were observed between pediatric and adult subjects. Geriatric Use Safety and effectiveness in a geriatric population have not been established. Clinical studies of Atralin Gel did not include any subjects over age 65 to determine whether they respond differently than younger subjects. Marketed by:
CORIA Laboratories, a division of Valeant Pharmaceuticals North America, Aliso Viejo, CA 92656 Manufactured by: DPT LABORATORIES, LTD. San Antonio, Texas 78215 Patent No.: 5,670,547 Revised: 11/2009 137623-1109
Certification Review
All Those Things Inside the Skin You Might Have Forgotten By James A. Van Rhee, MS, PA-C
Explanation: Crohn’s disease presents between ages 15 to 25 and 55 to 65. Major presenting symptoms include abdominal pain, diarrhea, and weight loss. On physical examination aphthous ulcers may be noted on the buccal mucosa and the abdomen is tender. Diagnosis is made by noting aphthous ulcers on the colonic mucosa, giving it a cobblestone appearance. The inflammation may or may not involve the rectum (the rectum is always involved in ulcerative colitis) and will show areas of normal colon interspersed with areas of inflammation. The white
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.
JDPA...Your Journal, Your Life.
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The Journal of Dermatology for Physician Assistants (JDPA) is the first PA specialty publication dedicated specifically to serving the needs of the dermatology PA community. The journal is a peer-reviewed publication that delivers innovative clinical, surgical, cosmetic and professional content exclusively for dermatology PAs. The JDPA serves as a printed forum in which dermatology PAs can share clinical information, practice tips and other relevant professional insights with an already established network of their colleagues.
WRITE FOR THE JDPA
We are looking for dermatology PAs who are interested in contributing to our profession by writing for the JDPA. There are a variety of subjects to write about in the JDPA. To the right is a list of the sections and their respective topics that are featured in each issue. You can find more detailed information regarding these topics online at: www.jdpa.org.
News and Notes • From the Desk of... • The Difference We Make Clinical Dermatology • CME Articles • Derm Case Reports • From the Patient’s Perspective (Have your patient’s story published, in their own words)
• Clinical Snapshots • Journal Club (Review an article)
• Drugs in Dermatology Surgical Dermatology • Feature Articles • Journal Club
Cosmetic Dermatology • Feature Articles • Journal Club (Review an article)
• Cosmetic Pearls Professional Development • Feature Articles • Outside & Inside the 9 to 5
(Share the story of the work you do outside of your daily dermatology profession)
• Notes from your Office Manager • Judicial & Ethical Affairs
(Review an article)
• Surgical Wisdom
Vol. 5, No. 1 WINTER 2011 13
Dermatology PA news & notes
Question: A 25 year-old presents with a history of abdominal pain and diarrhea. On physical examination, aphthous ulcers are noted in the mouth and the abdomen is tender. Laboratory testing reveals an elevated white blood cell count and sedimentation rate of 50 mm/hour. Endoscopic exam reveals inflammation involving the terminal ileum. Which of the following is the treatment of choice for this patient? A. Metronidazole (Flagyl) B. Naltrexone (ReVia) C. Sulfasalazine (Azulfidine) D. Azathioprine (Imuran)
blood cell count and sedimentation rate will be elevated. Treatment consists of nutritional support and control of inflammation. Inflammation can be controlled by corticosteroids (prednisone), aminosalicylates (sulfasalazine), immunomodulators (azathioprine), and TNF-antibodies (infliximab). The cornerstone of therapy for mild to moderate disease is sulfasalazine and other 5-aminosalicylic acid drugs; they are both antiinflammatory and anti-bacterial. Metronidazole has no role in mild to moderate disease. Azathioprine is used in severe, steroid dependent Crohn’s disease. Naltrexone has been used in clinical trials for the treatment of Crohn’s disease but results are preliminary. J The correct answer is C.
Are you recertifying soon? Start your board review early. Each issue of the JDPA features one board question accompanied by a brief explanation of the answer along with any pertinent test taking tips. Best of luck!
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
14 Journal of Dermatology for Physician Assistants
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%)
Mild n=46 (14%)
Moderate n=30 (9%)
Severe n=5 (2%)
Burning/ stinging/ tingling
71 (16%)
42 (9%)
17 (4%)
8 (2%)
6 (2%)
2 (1%)
Pruritus
29 (6%)
18 (4%)
5 (1%)
9 (3%)
6 (2%)
0 (0%)
Scaling/dry skin/xerosis
21 (5%)
10 (2%)
5 (1%)
31 (9%)
14 (4%)
1 (<1%)
Erythema/ irritation
6 (1%)
7 (2%)
2 (<1%)
8 (2%)
4 (1%)
2 (1%)
Contact dermatitis
2 (<1%)
3 (1%)
0 (0%)
1 (<1%)
0 (0%)
0 (0%)
Edema
3 (1%)
2 (<1%)
0 (0%)
3 (1%)
0 (0%)
0 (0%)
Acne
3 (1%)
1 (<1%)
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
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® *myfinaceaskinsavvy.com – a website for patient support and education Finacea 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. 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. Please see brief summary of full Prescribing Information on following page. References: 1. Draelos ZD, Kayne AL. Implications of azelaic acid’s multiple mechanisms of action: therapeutic versatility. Poster presented at: 66th Annual Meeting of the American Academy of Dermatology; February 1-5, 2008, San Antonio, TX. 2. 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. FINACEA was only studied in clinical trials for 12 weeks. 3. Elewski BE, Fleischer AB, Pariser DM. A comparison of 15% azelaic acid gel and 0.75% metronidazole gel in the topical treatment of papulopustular rosacea: results of a randomized trial. Arch Dermatol. 2003;139: 1444-1450. 4. Thiboutot DM, Fleischer AB, Del Rosso JQ, Rich P. A multicenter study of topical azelaic acid 15% gel in combination with oral doxycycline as initial therapy and azelaic acid 15% gel as maintenance monotherapy. J Drugs Dermatol. 2009;8(7):639-648. ©2009 Intendis, Inc. All rights reserved.
09-JA-004
October 2009
Vol. 5, No. 1 WINTER 2011 15
The SDPA congratulates all Diplomate Physician Assistants! ALABAMA
Miranda P Frith MPAS PA-C Christopher Harmon MD
ARIZONA
Kenan Arkawi PA-C / Kristine Romine MD Jason W Arnett MPAS PA-C / Mark Rosenberg DO Michelle A Campbell MPAS PA-C / Samantha Carter MD Rebecca L Caudle PA-C / Keith Haar MD LisaGreenan PA-C / Mary Fredenberg MD Melinia J Honjo MPAS PA-C / Gary A. McCrakenMD Beth B Lopez MPAS PA-C / Bogna Nowak MD John C Rimer PA-C / Keith HaarMD Yuliya S Schoenling MPAS PA-C / Kristine Romine MD AnnieSullivan MPAS PA-C / Burrell Wolk MD Wendy A Thompson MPAS PA-C / Catherine P. Chen-Tsai MD Francisco J Trejo MPAS PA-C / Katherine Orlick MD
CALIFORNIA
Irene G Bayer PA-C / Bente Berman MD Roger T Bellamy PA-C / Timothy Richardson MD Raylene M Blandino PA-C Peter Webb MD Rae Calamia MPAS PA-C John Maddox MD Carolyn S Calma PA-C Vince Afsahi MD Judy W Cheng MPAS PA-C / Lawrence Rivkin MD Renee Christenson PA-C / Donald Richey MD Yvonne Clark PA-C / Larry Eichenfield MD Lara A Clayton PA-C / Larry Eichenfield MD Annie W Coots PA-C / Bruce Maltz MD CA Sandra I Diaz PA-C / Radwan Badawi MD Kasey Drapeau DAmato MPAS PA-C / Lauren Reager MD Tiara Esani MPAS PA-C / Larry Eichenfield MD April S Ethridge PA-C / Pamela Broska MD Christina Hampton PA-C / Ronald Chappler MD Robert C Higham MPAS PA-C / Allan Wirtzer MD Mark J Hollis PA-C / R. Jeffrey Herten MD Erin M Jensen PA-C / Jeffery Rebish MD Helene S Jolly MPAS PA-C / Paul Dean MD Christy L Kerr MPAS PA-C / Hubert Greenway MD
Steven D Leon MPAS PA-C Jasbir Sandhu MD Melissa S Montes PA-C / Michael Lin MD Brett l Moore PA-C / HubertGreenwayMD Heather L Pastor MPAS PA-C / Amelia Kaymen MD Robert E Phillips PA / Randy Jacobs MD Daniell Pollack PA-C / Michelle Pelle MD Nancy Primo MPAS PA-C / Martin Kay MD Brian A Reber PA-C / Craig Kraffert MD Jason L Roddick MPAS PA-C / Robert Peppercorn MD Fariba Seraj PA-C / William Wickwire MD Nicole R Smith MPAS PA-C / Ezra Kest MD Brooke M Stidham MPAS PA-C / Edward Rohaly MD Debra M Stock PA-C / John Geisse MD Gary M Westbrock PA-C / Charles Fishman MD Doug M Williams MPAS PA-C / Bradley Kurgis MD
COLORADO
Amy J Huber PA-C / Kimberly Stone MD Brooke W Lewis MPAS PA-C / John Steinbaugh MD Kristin E Pogue MPAS PA-C / Mark Gaughan MD Susan L Rancis MPAS PA-C / Patrick Lillis MD Robin Sproule MPAS PA-C / Robert Wright MD
CONNECTICUT
Gail M Fowler MHP PA-C / Andrew Atton MD Darlene M Haviland MPAS PA-C / Steve Franks MD
DELAWARE
Nicole M Wotus-Silvestri PA-C / Scott Panzer MD
FLORIDA
Debra L Babcock PA-C / Cynthia Halcin MD Randy G Banks MPAS PA-C / J. Kevin Poitras MD Terri A Beck PA-C David Dorton DO Noreen M Godfrey PA-C / Melvin Lu MD Susan Hammerling PA-C / Ruben Moreno MD Pamela F Miller PA-C / Tory Sullivan MD Beth P Mitchell PA-C / Theodore Schiff MD
E. Sarah Mowery MPAS PA-C / John Long MD Brenda L OHair MPAS PA-C / William Roth MD Allan J Snyder PA-C / Brad Glick DO Elleanor S Swartz MPAS PA-C / Jennifer Vesper MD Nathaniel A Swartz MPAS PA-C / Adam Greenberg MD Michelle Thomas PA-C / Martin Yungmann DO Denise M West MPAS PA-C / Monica Bedi MD Thomas Wildes PA-C / Catherine Clayton MD Jennifer K Winkleman PA-C / Russell Metz MD Rosemary Woolfe PA-C / Adam Plotkin MD
GEORGIA
Matthew Brunner PA-C / Neville PereyoMD Laura P Bush PA-C / James SandwichMD Tomas J Chao MPAS PA-C / AlanGardner MD Jason M Cheyney MPAS PA-C / David Cohen MD Michael S Kelleher PA-C / Michelle Futral MD HeatherKitchens PA-C / Avis Yount MD Myrtle H Sanders MPAS PA-C / Mark Bonner MD Justin R Smith PA-C / Margaret Kopchick MD Mark M Spatz PA-C / Joshua Lane MD Wm. StephenSteiner PA-C / Jonathan Weiss MD Laurel M Whitmer MPAS PA-C / Sylvia Wright MD
IOWA
Angela M Buttjer PA-C / BryanSands DO Mary M Heatley MPAS PA-C / Martin SandsMD Jody K McKee PA-C / Kimberly Schulz MD JulieTruman MPAS PA-C / Kathi Madison MD
ILLINOIS
Christopher R Arico MPAS PA-C / Jeffrey Hsu MD Kristine Bennett MPAS PA-C / Fred Kemp MD Bernice Ik-Jang MiJohnson PA-C / Steven Mandrea MD Amber Kelley PA-C / Debra Babich MD Eric D King PA-C / Jeffrey Altman MD Leigh A Ruelo MPAS PA-C / Jeff Bakal MD Corey D Schneeman PA-C / Paula Lapinski MD
Marilyn J Stombaugh PA-C / George Nahass MD Judy Valkenburg PA-C / Cheuk Yung MD
INDIANA
Mitzi L Carter MPAS PA-C / Duane Banet MD A. Michelle Ferguson PA-C / Jeffrey Sassmannshausen MD Elizabeth A Golden MPAS PA-C / Scott Fretzin MD
KANSAS
Kristin K Bowen PA-C / Frank Koranda MD Judy Ky PA-C / Christopher Moeller MD Erin E Thornton PA-C / David Harden MD
MASSACHUSETTS
Jessica L Bahros PA-C / Ramzi Saad MD Christine M David PA-C / Nina Blumenthal MD Stefanie L Delaney MPAS PA-C / Robert O’Brien MD Stefanie A Goodrich MPAS PA-C / Seth Kates MD Nathan K Hand PA-C / Rafael Pupo MD Melissa Lemiech PA-C / Rachel A. Ivker MD Elizabeth J McLeish PA-C / Ramzi Saad MD
MARYLAND
Beverly D Connolly PA-C / Michael Del Torto MD Mary M Hoke PA-C / Robert Berger MD Brenda Schneider PA-C / Diane Orlinsky MD Melissa A Veneracion PA-C / Allan Harrington MD
MICHIGAN
MatthewAdler MPAS PA-C / Howard Lipkin MD Lisa K Bowersox PA-C / Murray Cotter MD PhD Jeffry S Freeman PA-C / David Semler MD Laura K Ginoza PA-C / Stephen Guthrie MD Nicole Luszczyk PA-C / Wendy McFalda MD Leah M MacMartin MPAS PA-C / Brian Sandler MD Mary R Proctor PA-C / Mark Saunders MD
DO YOU KNOW A SDPA DIPLOMATE? MINNESOTA
Lindsay Delmont PA-C / Melody Stone MD Christine B Edwards PA-C / Jeffery Reed MD
Beth A Hellstern PA-C / Roderick Kaufmann MD Patricia A McTaggart PA-C / Patricia McCormack MD Kimberly A Newhook PA-C / Warren KurnickMD Lauralee M Pakozdi PA-C / Lisa Coppa Breslauer MD Jenna N Rogers MPAS PA-C / Christine Papa MD Gerard W Stroup PA-C / Coyle Connolly DO Amanda Tirado PA-C / Alexander Doctoroff DO Antonella F Viterbo PA-C / Coyle Connolly DO Sarah Wasser PA-C / Mathias Zemel MD Jennifer Zimbalist MPAS PA-C / David Wrone MD
MISSISSIPPI
NEVADA
Jacalyn J Beiler MPAS PA-C / Patrick Carney MD Katherine R Larson PA-C / Patrick Carney MD Nicole T Manecke PA-C / Paul Lundstrom MD Larry D Weidell PA-C / Patrick Carney MD
MISSOURI
Alan G Crawford MPAS PA-C / Thomas Garrott MD
NORTH CAROLINA
Melinda R Asfaw PA-C / Jean Kois MD Timothy E August MPAS PA-C / Currie CusterMD Katherine C Caggiano MPAS PA-C / Stan Whittaker MD Adele Clark PA-C / Alan FleischerMD Samantha B Conner PA-C / Amy Devore MD Julie S Dodge MPAS PA-C / Audrey Echt MD Dan R Ecclestone PA-C / Robert E. Clark MD Debbie A Hauser MHS PA-C / Christine Yuengel-Bienenfeld MD Erica A Kelly MMS PA-C / Stephen B. Scheibner MD Beth AnnRankin PA-C / Joeseph Huppmann MD Angela F Richardson MEd MHS PA / Navjeet Sidhu-Malik MD Charlene M Snyder PA-C / Jonathan Crane DO Sharon M Swartz PA-C / Christopher Snyder MD Michael D Walker MPAS PA-C / Wesley Hawfield MD Elyshia M Warden MPAS PA-C / Stuart Tafeen MD Sallie S White PA-C / Paul Kostuchenko MD
NEBRASKA
Saundra D Brennan MPAS PA-C / Jill Nelson MD Laura A Fox MPAS PA-C / Jennifer Alberts MD Jacklynn A Kment MPAS PA-C / Margaret Sutton MD Michelle R Sitzman MPAS PA-C / Margaret Sutton MD
NEW HAMPSHIRE
Stacy L Filion MPAS PA-C / Robert Posnick MD Jacqueline A Fournier PA-C / Stephen Del GiudiceMD Jennifer L Krasovic PA-C / Christine Kannler MD George H Lewis PA-C / Robert Posnick M.D.
NEW JERSEY
Shari B Ashton PA-C / Patricia McCormack MD Janet Clarkson PA-C / Daniel Groisser MD Casey R Croes MPAS PA-C / Daniel Groisser MD Allison R Ginsberg PA-C / Cheryl Fialkoff MD Savy GuthrieMPAS PA-C / Daniel Kessel MD
Isaac Gier MPAS PA-C / Elizabeth Langford MD Daniel B Hickey PA-C / Martin J. Safko MD John V Notabartolo MPAS PA-C / Jonathan Woodson MD
NEW YORK
Dawn M Barilli PA-C / Joseph Tuchman MD ElizabethChoe PA-C / John F. Romano MD Kelly A Christman PA-C / Steven Simon MD Maria A DeRosa MPAS PA-C / Joseph Wojciechowski MD Ari J Fisher PA-C / Robert ShossMD Patrick A Franck PA-C / Steven ResnickMD Travis M Hayden MPAS PA-C / John Tu MD Susan B Hirsch PA-C / Mary Ruth Buchness MD Karl Kruszynski PA-C / Marie-Louise Johnson MD Gary A Levine PA-C / Patricia McCormack MD Sandra S Mamis PA-C / Henry A. GreenblattMD Timothy P Smith PA-C / Stephen Presser MD Melissa A Spencer-Winker MPAS PA-C / Michelle L. Bennett MD Jamie Sturm PA-C / Stephen Presser MD
OHIO
Shannon K Hammond PA-C / Christy Lorton MD Sarah J Kudelko PA-C / Patrick Shannon MD Amy M Lauer MPAS PA-C / Brian Adams MD Sherri L Whitcomb PA-C / Christy Lorton MD
OKLAHOMA
Randy R Bluethman PA-C / Craig Abbott MD Tara D Linville PA-C / John Ashley MD
OREGON
Laurie A Leece PA-C / Todd Knapp MD Nathan B Smith MPAS PA-C / Cynthia Dreyer MD Erik S Zenger MPAS PA-C / Bernard Gasch MD
PENNSYLVANIA
Desiree A Antonacci PA-C / Bruce Brod MD
Cheryl Bessoir PA-C / Michael O’Donnell MD Greg S Forsyth MPAS PA-C / Ira Berman MD Chantelle K Gastinger MPAS PA-C / Scott Gottlieb MD Richard D Graper PA-C / Jeffrey Weaver DO Kristen M Grippe MPAS PA-C / David Benjamin MD Abby A Jacobson MSPA-C / Bruce Brod MD Amy L Jones PA-C / Jonathan Wolfe MD Gina B Kuloszewski PA-C / Joanne Zenker MD Barbara A Lozada PA-C / Joann Zenker MD Jason D Oberdick PA-C / George Francis MD Maria H Ressler MPAS PA-C / Rebecca Caserio MD Caitlyn W Smith PA-C / Kimberly Rau MD Carly R Soda PA-C / Daniel Shrager MD Barbara S Stein PA-C / Mark MarsiliMD Jil K Swanson MPAS PA-C / Justin Vujevich MD Debora M Szafran PA-C / Jonathan WolfeMD Lauren R Zajac MPAS PA-C / David Amato DO
RHODE ISLAND
GracietteDaSilva PA-C / Gwenn Vittimberga MD Mark A Trott PA-C / Raymond Welch MD
SOUTH CAROLINA
Rebecca L Repaire PA-C / Todd Schlesinger MD Edward R Reynolds PA-C / Phillip Latham MD
SOUTH DAKOTA
Karen K Zepp PA-C / Roger Knutsen MD
TENNESSEE
Jennifer H Hall PA-C / Michael Bell MD Darrell R Millsap PA-C / James Patrick Rash MD Kathrin K Nunes PA-C / Samuel Banks MD Melissa K Taylor PA-C / Paul BensonMD
TEXAS
Piipar S Allen PA-C / Christopher JonesMD Karla J Blixt PA-C / Martha McCollough MD Joseph L Capasso PA-C / David Grice DO Jennifer M Conner MPAS PA-C / Paula Vogel MD Heidi B Cook MPAS PA-C / Forrest Brown MD Carol Fields PA-C / Larry Becker MD Bethany L Grubb MPAS PA-C / Kent Aftergut MD April L Harrison MPAS PA-C / Suzanne Bruce MD Jennifer J Jordan PA-C / Michael Coverman MD Kristine Kucera DHS MPAS PA-C / Kelly WarrenMD Denise Marquez PA-C / Paul Friedman MD Allison L Martin PA-C / Vincent Quintero MD Lisa Moody PA-C / Jeannine Hoang MD
16 Journal of Dermatology for Physician www.dermPA.org/diplomate Assistants
Gabriel R Nanagas PA-C / Matthew Barrows MD Erin M Nulf MPAS PA-C / Forrest C Brown MD KristieObranovich PA-C / Lisa Rhodes MD Lisa M Ostrowski PA-C / M.G. Mullanax MD Michelle B Purtle PA-C / Steven Smith MD Jill H Ray MPAS PA-C / Dana Jeng MD Jennifer K Scheiderich MPAS PA-C / Lori Stetler MD Toni L Smith PA-C / Kelly Herne MD Cynthia J Trickett PA-C / Dan McCoy MD Ray C Vaughn MPAS PA-C / Isaac Perez MD Teresa M Willis PA-C / D. Scott MillerMD
UTAH
Lynn A Birrell MPAS PA-C / C David Hansen MD Keri L Holyoak PA-C / Joseph D.Jensen MD Mark A Hyde MPAS PA-C / Glen Bowen MD
VIRGINIA
Kelly G Barriault MPAS PA-C / Michael Gross MD Jennifer D Bauer MPAS PA-C / Georgia Seely MD Kevin K Charles MPAS PA-C / Steve Cronquist MD Lauran R Glover PA-C / Leslie Coker MD Amanda M Waggoner MPAS PA-C / David Pariser MD
VERMONT
Phoebe E Pelkey MPAS PA-C / MitchellSchwartz MD
WASHINGTON
Scott B Ahrndt MPAS PA-C / Joel Sears MD Stacey L Bryant MPAS PA-C / Walter Williams MD Christine V Carpenter PA-C / Robert Hopp MD Gina M Fragione MPAS PA-C / Nicole Kageyama MD Megan E Landis Ferestien PA-C / John Headley MD Corey R Richardson MPAS PA-C / Theresa Mah MD Kurt Schlecht PA-C / Zheng Qian MD DavidSprouse PA-C / Maureen Mooney MD Heidi A Tate PA-C / Dr. Russell Johnson MD Dan W Walkowski PA-C / Claire Haycox MD Jennifer E Winter PA-C / Mark BauerMD
WISCONSIN
Gregory D Buttolph MPAS PA-C / Karl Noll MD James Baumgaertner MD MD Kurt S Holst PA-C / Vernon Casterline MD Michelle M Lipke MPAS PA-C / Gregg Taylor MD Courtney A Papp PA-C / Kathleen Stokes MD
WEST VIRGINIA
Allison L Cook MPAS PA-C / Gregory Lagos DO
Clinical Dermatology
Dermoscopic Features of Seborrheic Keratoses By John Burns, 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 2011. Participants may submit the self-assessment exam at any time during that period. This program was planned in accordance with AAPAâ&#x20AC;&#x2122;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) Acknowledge the utility of dermoscopy in discerning skin tumors other than melanoma. 2) Review the dermoscopic findings of seborrheic keratoses. 3) Review clear examples of the dermoscopic findings of seborrheic keratoses. 4) Recognize that dermoscopy is a complement to the clinical and historical identification of a skin tumor. Vol. 5, No. 1 WINTER 2011 17
Dermoscopic Features of Seborrheic Keratoses SDPA Members Only Content
CLINICAL Dermatology
A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.
18 Journal of Dermatology for Physician Assistants
Dermoscopic Features of Seborrheic Keratoses 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. 5, No. 1 WINTER 2011 19
Dermoscopic Features of Seborrheic Keratoses SDPA Members Only Content
CLINICAL Dermatology
A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.
20 Journal of Dermatology for Physician Assistants
Dermoscopic Features of Seborrheic Keratoses 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. 5, No. 1 WINTER 2011 21
Dermoscopic Features of Seborrheic Keratoses 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.
John Burns, PA-C is a graduate of the Physician Assistant Program at Louisiana State University Health Science Center Shreveport, Louisiana. He is a Diplomate of the Society of Dermatology Physician Assistants. He presently resides in Frisco, Texas where he works in dermatology with Dr. Eric Weisberg. He has indicated no relationships to disclose relating to the content of this article.
&
Dermatoscopy Q A Q: What is it?
Under Dermatoscopy
Answer on page 25 22 Journal of Dermatology for Physician Assistants
From The Patient’s Perspective The True Measure of Beauty
I never knew how attached I was to my hair define me anymore. The threat was not to my life, but to my self-esteem. I had to find a path to serenity until I began to lose it. I recognize that in the by accepting the things I could not change and big scheme of things if you have to get diagnosed finding the courage to change the things I could. with a rare autoimmune disease, not having a lifethreatening situation is the most important factor. For several years now I have learned to live At the tender age of twenty-five, I began my journey happily as a bald woman. I have accepted this with alopecia areata. Emotionally, it felt like a lifecondition and myself but have secretly hoped that threatening situation. I was married and we had a one day my hair would return. one-year-old daughter. I always In 2009, I decided to see wore my hair very short, which a dermatologist again and “I’m stronger, I’m wiser, and made the bald islands that was diagnosed with central surfaced on my scalp impossible centrifugal cicatricial alopecia I’m better - bald, bold, and to hide. I immediately had as well. With the reality of to start wearing a wig. Since more beautiful than I ever having cicatricial (scarring) it was not by choice, having alopecia, which causes knew I was with hair.” to wear a wig felt as if I were permanent hair loss, my hope waving a red flag on my head of hair regrowth was shattered. and everyone was watching. If I suffer occasional itching, I got an honest compliment on my hairstyle, I could which is one of the typical symptoms of cicatricial not receive it; I only wanted to run and hide. What alopecia, and the color of my beautiful, baldhead I would not have given to be invisible during those is compromised of blotchy discoloration. This is days. nothing that a little MAC makeup cannot fix. My dermatologist suggested I begin treatments Experiencing hair loss has changed me in many of cortisone injections and topical ointments. None ways and even though the process was painful at of these worked for me, and within the first six times, I am grateful for the invaluable life lessons months of discovering my first bald spot, I had lost it has taught me and for the amazing people I have nearly 50% of the hair on my head. Discouraged been able to meet while on this path. I am not the and finding the injections painful, I decided to woman I used to be. I’m stronger, I’m wiser, and I’m stop treatments and just let it be. Within a year my better - bald, bold, and more beautiful than I ever hair began to grow back on its own and so did my knew I was with hair. No one ever signs up to go shattered confidence. When at least 95% of my hair through a life-changing traumatic experience. We had grown back, I thought the battle was over and live and learn that in life there are many things that that I had won. will be out of our control. We each have personal challenges along our path that are designed to It was all good until a year later, after I gave teach us and shape us into who we are meant to be. birth to my second daughter. The hair loss began Whining and wondering, “Why me?” is an effort in again and was more aggressive. This time my futility because no one person deserves emotional condition progressed to alopecia universalis, and pain over another, and yet we each will have our own I lost all the hair on my body. I held on to every unique share of it. strand that I could until the last moment. I had to ask myself, “Who was I kidding?” The hair was gone Being challenged by unwanted changes in our and holding on to a few strands would not make self-image provides us with a unique opportunity other hair decide to come back. The most liberating to learn a deeper lesson about our identity. We pick thing I could do for myself was to take control of the apart what we thought made us who we are and get situation and shave my whole head bald. No longer to the root (no pun intended) of our true identity. was I a victim waiting for the sting of alopecia to We are forced to learn this lesson if we are going strike; I was fighting back by deciding not to let hair to survive. Dare we believe that our greatness and Vol. 5, No. 1 WINTER 2011 23
CLINICAL Dermatology
By Sandra Dubose
CLINICAL Dermatology
beauty exists in our external attributes alone? We can no longer allow hair to define us, or our weight, or our skin, or even our limbs if they are taken away. At some point we have to find a way to turn it around and make it a positive. I learned that if you dig deeper, you can stand taller than you ever knew you could. Find a way to give back, even when you feel you have nothing to give. There is always someone in need of a kind word of encouragement. Through it all, I have realized that the true way to measure my beauty is not counted by the hair follicles on my head but by the smiles I can put on the faces of others. J Sandra Dubose knows firsthand what it is like to struggle with low self-esteem and a lack of confidence as a result of hair loss. She has lived as a completely bald woman for the past eight years due to alopecia universalis and in 2009 was diagnosed with central centrifugal cicatricial alopecia as well. Sandra is the Founder and President of the Alopecia Community of the Triangle, a support group for people living with medically related hair loss in and around Raleigh, NC. Sandra was the inspirational patient speaker at the Cicatricial Alopecia Research Foundation’s (CARF) Fourth International Patient Doctor Conference in 2010 and is a leader of CARF’s patient support group in Winston-Salem, North Carolina. As an advocate for alopecia awareness, Sandra has become a leader in the alopecia community, speaking out to educate others by sharing her song and story on television, radio, and at speaking events all over the US. Sandra is an inspirational speaker, recording artist, actress, and independent filmmaker. Her self-documentary film entitled, “Project Liberation; My Alopecia Experience” is available on DVD as an educational tool in libraries throughout the US, as well as through Amazon.com. The accompanying music soundtrack has songs she wrote and performed that uplift and inspire both those with hair and without. It is currently available on iTUNES and other online record stores. For more information visit: www.SandraDubose.com.
Sandra uses all of her creative talents to inspire and encourage others to liberate themselves from the pain of hair loss and reclaim the joy in their lives by uncovering the origin of their true beauty. She says that her mission in life is to live her song and make manifest the glory of God that is within her in spite of the challenges of life. Her hope is that as she is continually liberated from her own fear, her very presence will automatically liberate others.
Take Home points for derm pas: By Steven K. Shama, MD, MPH 1. I only wish I could use the inspirational thoughts contained within this article initially with all patients. There is a time and a place for us to introduce to patients the concept of, ”It is not a threat to your life but to your self-esteem.” All patients may one day embrace those feelings, but we need to be sensitive about when we might introduce these and other perspectives. 2. Our author mentions that while she has accepted her condition and herself, she still “secretly” hoped her hair would return one day. If we are conscious of this secret wish that many patients probably have, we might be even more sensitive to how they express their expressed emotional adjustment, wondering if they ever do completely adjust. 3. What can we learn about our own personal body image and how we would feel if it changed? I have said this before in my writings in our journal - patients are messengers from the universe trying to teach us a lesson. We need to listen.
Let them know they’re not alone... Share a story with your patients. Visit the Patient’s Perspective library of articles at www.jdpa.org/advocacy.html If you know a patient who would like to share his/her story, please contact us at editor@jdpa.org 24 Journal of Dermatology for Physician Assistants
&
Dermatoscopy Q A
CLINICAL Dermatology
A: Seborrheic keratosis
Under Dermatoscopy
SDPA Members Only Content A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.
Vol. 5, No. 1 WINTER 2011 25
Clinical snapshots Thickened Nerves in Leprosy By Prahlad K Sethi, MD, Nitin K Sethi, MD, Josh Torgovnick, MD, and Edward Arsura, 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: showing infiltrated plaque over the ear lobule, hypopigmented patch over the left forehead and a thickened left supraorbital nerve.
Figure 2: showing cord like thickening of the left greater auricular nerve.
1 26 jdpa_std_summer2011_a.indd Journal of Dermatology for Physician Assistants
12/16/10 12:52 PM
When it comes to fine facial wrinkles and hyperpigmentation,
Refissa meets her needs ®
The only tretinoin that is: • 0.05% concentration for effective strength • Emollient base for gentle hydration • Fragrance-free formulation to reduce the potential for allergic reactions
Important Safety Information: Refissa 0.05% is indicated as an adjunctive agent for mitigation (palliation) of fine facial wrinkles, mottled hyperpigmentation, and tactile roughness in patients who use a comprehensive skin care and sunlight-avoidance program (including sunscreen). Refissa does not eliminate wrinkles, repair sun-damaged skin, reverse photoaging, or restore more youthful or younger skin. Do not use if the patient is taking drugs known to be photosensitizers, pregnant, attempting pregnancy, or nursing. Refissa, early in treatment, may cause redness, itching, burning, stinging, and peeling. If the degree of irritation warrants, patients should be advised to use less medication and decrease the frequency of application. If still significant, patient should be advised to discontinue use. Please see reverse for brief summary of full prescribing information.
Refi 40g / ssa 0.05 % Use a s dire cted 2 refi lls
Contact a CORIA® representative for samples, or call customer service at 1-800-556-1937 Vol. 5, No. 1 WINTER 2011 27
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Fine facial wrinkles and hyperpigmentation were scored at baseline and at Week 24 by the investigator using a 10-point scale on which 0 represents no damage, 2-3=mild, 4-5=moderate, 6-7=moderate/ severe and 8-9=severe. The change was calculated as baseline minus the Week 24 evaluations.* ++ Please note: The clinical data in the package insert are from Ortho Dermatologics original clinical trials for Renova® 0.05% as required for FDA approval. *Data on File, CORIA Pharmaceuticals. CONTRAINDICATIONS This drug is contraindicated in individuals with a history of sensitivity reactions to any of its components. It should be discontinued if hypersensitivity to any of its ingredients is noted. WARNINGS TRETINOIN CREAM, USP (EMOLLIENT) is a dermal irritant, and the results of continued irritation of the skin for greater than 48 weeks in chronic, long term use are not known. Safety and effectiveness of TRETINOIN CREAM, USP (EMOLLIENT) in individuals with moderately or heavily pigmented skin have not been established. Refissa® [TRETINOIN CREAM, USP (EMOLLIENT)] should not be administered if the patient is also taking drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of augmented phototoxicity. Because of heightened burning susceptibility, exposure to sunlight (including sunlamps) should be avoided or minimized during use of Refissa®. Patients must be warned to use sunscreens (minimum of SPF of 15) and protective clothing when using Refissa®. Patients
ADVERSE REACTIONS (See WARNINGS and PRECAUTIONS sections.) Local reactions such as peeling, dry skin, burning, stinging, erythema, and pruritus were reported by almost all subjects during therapy. These signs and symptoms were usually of mild to moderate severity and generally occurred early in therapy. OVERDOSAGE Application of larger amounts of medication than recommended has not been shown to lead to more rapid or better results, and marked redness, peeling, or discomfort may occur. Oral ingestion of the drug may lead to the same side effects as those associated with excessive oral intake of Vitamin A. DOSAGE AND ADMINISTRATION Refissa® [TRETINOIN CREAM, USP (EMOLLIENT)] should be applied to the face once a day before retiring using only enough to cover the entire affected area lightly. Patients should gently wash their face with a mild soap, pat the skin dry, and wait 20 to 30 minutes before applying. The patient should apply a pea-sized amount of cream to cover the entire face lightly. Special caution should be taken when applying the cream to avoid the eyes, ears, nostrils, and mouth. With discontinuation of therapy, a majority of patients will lose most mitigating effects on fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin; however, the safety and effectiveness of using TRETINOIN CREAM, USP (EMOLLIENT) daily for greater than 48 weeks have not been established. Manufactured by DPT Laboratories, San Antonio, TX 78215 Distributed by CORIA Laboratories, a division of Valeant Pharmaceuticals North America, Fort Worth, TX 76107 (800-321-4576) Refissa is a registered trademark of Spear Pharmaceuticals, Inc. Renova® is a registered trademark of Ortho Dermatologics, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
100%
Refissa ® [Tretinoin Cream, USP (Emollient) 0.05%] Brief Summary of Full Prescribing Information DESCRIPTION Tretinoin is available as Refissa® [Tretinoin Cream, USP (Emollient)] at a concentration of 0.05% w/w in a water-in-oil emulsion formulation consisting of light mineral oil, sorbitol solution, hydroxyoctacosanyl hydroxystearate; methoxy PEG-22/dodecyl glycol copolymer, PEG45/dodecyl glycol copolymer, stearoxytrimethylsilane and stearyl alcohol, dimethicone 50 cs, methylparaben, edetate disodium, propylparaben, butylated hydroxytoluene, citric acid monohydrate, and purified water. INDICATIONS AND USAGE Refissa® is indicated as an adjunctive agent for use in the mitigation (palliation) of fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin in patients who do not achieve such palliation using comprehensive skin care and sun avoidance programs alone. Neither the safety nor the effectiveness of Tretinoin Cream, USP (Emollient) for the prevention or treatment of actinic keratoses or skin neoplasms has been established. (Please see third bullet point in this section of the full prescribing information for additional populations in which effectiveness has not been established.) Refissa® DOES NOT ELIMINATE WRINKLES, REPAIR SUN DAMAGED SKIN, REVERSE PHOTO-AGING, or RESTORE A MORE YOUTHFUL or YOUNGER DERMAL HISTOLOGIC PATTERN. Refissa® should only be used under medical supervision as an adjunct to a comprehensive skin care and sun avoidance program that includes the use of effective sunscreens (minimum SPF of 15) and protective clothing when desired results on fi ne wrinkles, mottled hyperpigmentation, and roughness of facial skin have not been achieved with a comprehensive skin care and sun avoidance program alone. Neither the safety nor the efficacy of using TRETINOIN CREAM, USP (EMOLLIENT) daily for greater than 48 weeks has been established, and daily use beyond 48 weeks has not been systematically and histologically investigated in adequate and well-controlled trials. CLINICAL TRIALS DATA The Spear Refissa® bioequivalence 6-month study of 382 patients revealed Refissa® and Renova® 0.05% products are bioequivalent.++ In effect, Refissa® and Renova® 0.05% demonstrated no statistical difference from one another, neither product being superior to the other, but both proved superior to placebo. Refissa® Results: Improvement No Improvement Fine Facial Wrinkles 71% 29% Mottled Hyperpigmentation 83% 17%
with sunburn should be advised not to use until fully recovered. Patients who may have considerable sun exposure due to their occupation and those patients with inherent sensitivity to sunlight should exercise particular caution when using and assure that the precautions outlined in the Patient Package Insert are observed. Refissa® should be kept out of the eyes, mouth, angles of the nose, and mucous membranes. Topical use may cause severe local erythema, pruritus, burning, stinging, and peeling at the site of application. If the degree of local irritation warrants, patients should be directed to use less medication, decrease the frequency of application, discontinue use temporarily or discontinue use altogether. Tretinoin has been reported to cause severe irritation on eczematous skin and should be used only with utmost caution in patients with this condition. PRECAUTIONS General: If a drug sensitivity, chemical irritation, or a systemic adverse reaction develops, use should be discontinued. Drug Interactions: Concomitant topical medication, medicated or abrasive soaps, shampoos, cleansers, cosmetics with a strong drying effect, products with high concentration of alcohol, astringents, spices or lime, permanent wave solutions, electrolysis, hair depilatories or waxes, and products that may irritate the skin should be used with caution in patients being treated because they may increase irritation with use. Refissa® should not be administered if the patient is also taking drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of augmented phototoxicity. Carcinogenesis, Mutagenesis, Impairment of Fertility There was no evidence of carcinogenic potential when tretinoin was administered topically at a dose 5 times the average recommended human topical clinical dose. The mutagenic potential of tretinoin was valuated in the Ames assay and in the in vivo mouse micronucleus assay, both of which were negative. Pregnancy: Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. Refissa® should not be used during pregnancy. Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when administered to nursing women. Pediatric Use: Safety and effectiveness in patients less than 18 years of age have not been established. Geriatric Use: Safety and effectiveness in individuals older than 50 years of age have not been established.
df
© 2010 CORIA Laboratories REF-0610-0004
28 Journal of Dermatology for Physician Assistants
Drugs in Dermatology The A, B, C, and Ds of Groups A-D Corticosteroids
By Scott Tomerlin, PharmD and Michael Sheehan, 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.
Scott Tomerlin, Pharm.D, is the Compounding Pharmacy Manager at Walgreens Pharmacy in West Melbourne, FL. He is a 2006 graduate of the Mercer University College of Pharmacy. Currently, he serves as the President of the Brevard County Pharmacy Association in Florida. He was named the Distinguished Young Pharmacist of the Year by the Florida Pharmacy Association in 2007. His interests include compounding various dermatological medications based on patientsâ&#x20AC;&#x2122; specific needs. He has indicated no relationships to disclose relating to the content of this article. Michael Sheehan, MD, is a chief resident in the Department of Dermatology at Indiana University School of Medicine. His interests include medical dermatology and contact dermatitis. He is a member of the American Society of Contact Dermatitis as well as the winner of the first National Contact Allergen Bee for Dermatology Residents hosted by the American Society of Contact Dermatitis.
Vol. 5, No. 1 WINTER 2011 29
Dermatology Case Report Lichen Striatus By Kristen Grippe, PA-C
SDPA Members Only Content
Fig. 1
CLINICAL Dermatology
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Fig. 2
Kristen Grippe, PA-C is a 2005 graduate from Gannon University Physician Assistant Program and has worked in dermatology for five years at Dermatology Associates of Erie, in Erie, PA. She has indicated no relationships to disclose relating to the content of this article. 30 Journal of Dermatology for Physician Assistants
THE #1 MOST PRESCRIBED
BRANDED MEDICATION1
IN DERMATOLOGY
SOLODYN is indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. SOLODYN did not demonstrate any effect on non-inflammatory lesions. Safety of SOLODYN has not been established beyond 12 weeks of use. This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, SOLODYN should be used only as indicated.
Important Safety Information for SOLODYN Tablets t 5IF NPTU DPNNPOMZ SFQPSUFE TJEF FGGFDUT XFSF headache, fatigue, dizziness, and pruritus.
t .JOPDZDMJOF MJLF PUIFS UFUSBDZDMJOFT DBO DBVTF 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 *O SBSF DBTFT QIPUPTFOTJUJWJUZ IBT CFFO reported. t 4IPVME OPU CF VTFE EVSJOH QSFHOBODZ OPS 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 have shown hypersensitivity to any of the tetracyclines. t 4BGFUZ CFZPOE XFFLT PG VTF IBT not been established.
t Central nervous system side effects, including light-headedness, dizziness, and vertigo, have been reported with minocycline therapy.
Reference: 1. IMS Health. National Prescription Audit (NPA). Data through September 2010. Data on file, Medicis Pharmaceutical Corporation.
See following pages for Brief Summary of Full Prescribing Information. SOLODYN is a registered trademark of Medicis Pharmaceutical Corporation. SOL 10-038 12/31/11
Vol. 5, No. 1 WINTER 2011 31
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.
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 ANTIBIOTICS, CAN CAUSE FETAL HARM WHEN ADMINISTERED TO A PREGNANT WOMAN. IF ANY TETRACYCLINE IS USED DURING PREGNANCY OR IF THE PATIENT BECOMES PREGNANT WHILE TAKING THESE DRUGS, THE PATIENT SHOULD BE APPRISED OF THE POTENTIAL HAZARD TO THE FETUS.
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 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.
visual disturbances prior to initiation of treatment with tetracyclines and should be routinely checked for papilledema while on treatment. Concomitant use of isotretinoin and minocycline should be avoided because isotretinoin, a systemic retinoid, is also known to cause pseudotumor cerebri. Autoimmune Syndromes Tetracyclines have been associated with the development of autoimmune syndromes. The long-term use of minocycline in the treatment of acne has been associated with drug-induced lupus-like syndrome, autoimmune hepatitis and vasculitis. Sporadic cases of serum sickness have presented shortly after minocycline use. 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.
32 Journal of Dermatology for Physician Assistants
ADVERSE REACTIONS Clinical Trial 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. The following table summarizes selected adverse reactions reported in clinical trials at a rate of ≥1% for SOLODYN.
Selected Treatment-Emergent Adverse Reactions in at least 1% of Clinical Trial Subjects Adverse Reactions SOLODYN PLACEBO (1 mg/kg) N=364 N=674 (%) (%) At least one treatment- 379 (56) 197 (54) emergent event Photosensitivity Headache 152 (23) 83 (23) Photosensitivity manifested by an Fatigue 62 (9) 24 (7) exaggerated sunburn reaction has been Dizziness 59 (9) 17 (5) observed in some individuals taking Pruritus 31 (5) 16 (4) tetracyclines. This has been reported Malaise 26 (4) 9 (3) rarely with minocycline. Patients should minimize or avoid exposure to natural or Mood alteration 17 (3) 9 (3) artificial sunlight (tanning beds or UVA/B Somnolence 13 (2) 3 (1) treatment) while using minocycline. If Urticaria 10 (2) 1 (0) patients need to be outdoors while using Tinnitus 10 (2) 5 (1) minocycline, they should wear loose-fitting Arthralgia 9 (1) 2 (0) clothes that protect skin from sun exposure Vertigo 8 (1) 3 (1) and discuss other sun protection measures Dry mouth 7 (1) 5 (1) with their physician. Myalgia 7 (1) 4 (1) Postmarketing Experience Serious Skin/Hypersensitivity Reaction Adverse reactions that have been reported Post-marketing cases of anaphylaxis with minocycline hydrochloride use in a and serious skin reactions such as variety of indications include: Stevens-Johnson syndrome and erythema Skin and hypersensitivity reactions: multiforme have been reported with fixed drug eruptions, balanitis, erythema minocycline use in treatment of acne. multiforme, Stevens-Johnson syndrome,
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 B. THE USE OF DRUGS OF THE heart valves. Skin and oral pigmentation Central Nervous System Effects TETRACYCLINE-CLASS DURING has been reported to occur independently TOOTH DEVELOPMENT (LAST HALF OF Central nervous system side effects of time or amount of drug administration, PREGNANCY, INFANCY, AND CHILDHOOD including light-headedness, dizziness or vertigo have been reported with minocycline whereas other tissue pigmentation has UP TO THE AGE OF 8 YEARS) MAY been reported to occur upon prolonged therapy. Patients who experience these CAUSE PERMANENT DISCOLORATION administration. Skin pigmentation includes OF THE TEETH (YELLOW-GRAY-BROWN). symptoms should be cautioned about diffuse pigmentation as well as over sites driving vehicles or using hazardous This adverse reaction is more common of scars or injury. machinery while on minocycline therapy. during long-term use of the drug but These symptoms may disappear during Development of Drug Resistant has been observed following repeated therapy and usually rapidly disappear Bacteria short-term courses. Enamel hypoplasia when the drug is discontinued. Bacterial resistance to the tetracyclines has also been reported. TETRACYCLINE may develop in patients using SOLODYN, Benign Intracranial Hypertension DRUGS, THEREFORE, SHOULD NOT BE therefore, the susceptibility of bacteria Pseudotumor cerebri (benign intracranial USED DURING TOOTH DEVELOPMENT. associated with infection should be hypertension) in adults and adolescents C. All tetracyclines form a stable calcium considered in selecting antimicrobial has been associated with the use complex in any bone-forming tissue. A therapy. Because of the potential for of tetracyclines. Minocycline has decrease in fibula growth rate has been been reported to cause or precipitate drug-resistant bacteria to develop during observed in premature human infants the use of SOLODYN, it should be used only pseudotumor cerebri, the hallmark given oral tetracycline in doses of 25 as indicated. of which is papilledema. Clinical mg/kg every 6 hours. This reaction was manifestations include headache and Superinfection shown to be reversible when the drug blurred vision. Bulging fontanels have been As with other antibiotic preparations, use was discontinued. associated with the use of tetracyclines of SOLODYN may result in overgrowth of Results of animal studies indicate that in infants. Although signs and symptoms nonsusceptible organisms, including fungi. tetracyclines cross the placenta, are of pseudotumor cerebri resolve after If superinfection occurs, the antibiotic found in fetal tissues, and can cause discontinuation of treatment, the possibility should be discontinued and appropriate retardation of skeletal development for permanent sequelae such as visual therapy instituted. on the developing fetus. Evidence of loss that may be permanent or severe embryotoxicity has been noted in animals exists. Patients should be questioned for 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).
Laboratory Monitoring 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.
anaphylactoid purpura, photosensitivity, pigmentation of skin and mucous membranes, hypersensitivity reactions, angioneurotic edema, anaphylaxis.
Autoimmune conditions: polyarthralgia, pericarditis, exacerbation of systemic lupus, pulmonary infiltrates with eosinophilia, transient lupus-like syndrome. Central nervous system: pseudotumor cerebri, bulging fontanels in infants, decreased hearing. Endocrine: thyroid discoloration, abnormal thyroid function. Oncology: papillary thyroid cancer. Oral: glossitis, dysphagia, tooth discoloration. Gastrointestinal: enterocolitis, pancreatitis, hepatitis, liver failure. Renal: reversible acute renal failure. Hematology: hemolytic anemia, thrombocytopenia, eosinophilia. Preliminary studies suggest that use of minocycline may have deleterious effects on human spermatogenesis (see 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.
Penicillin Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin. Methoxyflurane The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity. Antacids and Iron Preparations Absorption of tetracyclines is impaired by antacids containing aluminum, calcium or magnesium and iron-containing preparations. Low Dose Oral Contraceptives In a multi-center study to evaluate the effect of SOLODYN on low dose oral contraceptives, hormone levels over one menstrual cycle with and without SOLODYN 1 mg/kg once-daily were measured. Based on the results of this trial, minocycline-related changes in estradiol, progestinic hormone, FSH and LH plasma levels, of breakthrough bleeding, or of contraceptive failure, can not be ruled out. To avoid contraceptive failure, female patients are advised to use a second form of contraceptive during treatment with minocycline. Drug/Laboratory Test Interactions False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test. USE IN SPECIFIC POPULATIONS Pregnancy Teratogenic Effects: Pregnancy category D (see Warnings and Precautions) SOLODYN should not be used during pregnancy. If the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus and stop treatment immediately. There are no adequate and well-controlled studies on the use of minocycline in pregnant women. Minocycline, like other tetracycline-class drugs, crosses the placenta and may cause fetal harm when administered to a pregnant woman. Rare spontaneous reports of congenital anomalies including limb reduction have been reported with minocycline use in pregnancy in post-marketing experience. Only limited information is available regarding these reports; therefore, no conclusion on causal association can be established. Minocycline induced skeletal malformations (bent limb bones) in fetuses when administered to pregnant rats and rabbits in doses of 30 mg/kg/day and 100 mg/kg/day, respectively, (resulting in approximately 3 times and 2 times, respectively, the systemic exposure to minocycline observed in patients as a result of use of SOLODYN). Reduced mean fetal body weight was observed in studies in which minocycline was administered to pregnant rats at a dose of 10 mg/kg/day (which resulted in approximately the same level of systemic exposure to minocycline as that observed in patients who use SOLODYN).
Minocycline was assessed for effects on peri- and post-natal development of rats in a study that involved oral administration to pregnant rats from day 6 of gestation through the period of lactation (postpartum day 20), at dosages of 5, 10, or 50 mg/kg/day. In this study, body weight gain was significantly reduced in pregnant females that received 50 mg/kg/day (resulting in approximately 2.5 times the systemic exposure to minocycline observed in patients as a result of use of SOLODYN). No effects of treatment on the duration of the gestation period or the number of live pups born per litter were observed. Gross external anomalies observed in F1 pups (offspring of animals that received minocycline) included reduced body size, improperly rotated forelimbs, and reduced size of extremities. No effects were observed on the physical development, behavior, learning ability, or reproduction of F1 pups, and there was no effect on gross appearance of F2 pups (offspring of F1 animals).
evaluate the carcinogenic potential of minocycline. A structurally related compound, oxytetracycline, was found to produce adrenal and pituitary tumors in rats.
contains minocycline hydrochloride equivalent to 65 mg minocycline, supplied as follows:
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.
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 99207-463-30
NDC 99207-466-30
Bottle of 30
Bottle of 30
The 90 mg extended release tablets are Impairment of Fertility—Male and yellow, unscored, coated, and debossed female reproductive performance in with “DYN-090” on one side. Each tablet rats was unaffected by oral doses of contains minocycline hydrochloride minocycline of up to 300 mg/kg/day (which equivalent to 90 mg minocycline, supplied resulted in up to approximately 40 times the as follows: level of systemic exposure to minocycline observed in patients as a result of use of NDC 99207-461-30 Bottle of 30 SOLODYN). However, oral administration of NDC 99207-461-10 Bottle of 100 100 or 300 mg/kg/day of minocycline to The 105 mg extended release tablets are male rats (resulting in approximately 15 to 40 times the level of systemic exposure to purple, unscored, coated, and debossed minocycline observed in patients as a result with “DYN-105” on one side. Each tablet contains minocycline hydrochloride Nursing Mothers of use of SOLODYN) adversely affected Tetracycline-class antibiotics are excreted spermatogenesis. Effects observed at 300 equivalent to 105 mg minocycline, supplied as follows: in human milk. Because of the potential for mg/kg/day included a reduced number serious adverse effects on bone and tooth of sperm cells per gram of epididymis, NDC 99207-467-30 Bottle of 30 development in nursing infants from the an apparent reduction in the percentage tetracycline-class antibiotics, a decision The 115 mg extended release tablets are of sperm that were motile, and (at 100 should be made whether to discontinue green, unscored, coated, and debossed and 300 mg/kg/day) increased numbers nursing or discontinue the drug, taking into of morphologically abnormal sperm cells. with “DYN-115” on one side. Each tablet account the importance of the drug to the Morphological abnormalities observed in contains minocycline hydrochloride mother (see Warnings and Precautions). equivalent to 115 mg minocycline, sperm samples included absent heads, supplied as follows: misshapen heads, and abnormal flagella. Pediatric Use SOLODYN is indicated to treat only NDC 99207-464-30 Bottle of 30 Limited human studies suggest that inflammatory lesions of non-nodular minocycline may have a deleterious effect The 135 mg extended release tablets are moderate to severe acne vulgaris on spermatogenesis. pink (orange-brown), unscored, coated, in patients 12 years and older. SOLODYN should not be used by individuals and debossed with “DYN-135” on one Safety and effectiveness in pediatric of either gender who are attempting to side. Each tablet contains minocycline patients below the age of 12 has not conceive a child. hydrochloride equivalent to 135 mg been established. minocycline, supplied as follows: Use of tetracycline-class antibiotics below HOW SUPPLIED/STORAGE AND HANDLING NDC 99207-462-30 Bottle of 30 the age of 8 is not recommended due to How Supplied NDC 99207-462-10 Bottle of 100 the potential for tooth discoloration (see SOLODYN (minocycline HCl, USP) Extended Warnings and Precautions). Storage Release Tablets are supplied as aqueous Geriatric Use film coated tablets containing minocycline Store at 25ºC (77ºF); excursions are Clinical studies of SOLODYN did not hydrochloride equivalent to 45 mg, 55 mg, permitted to 15º-30ºC (59º-86ºF) [See USP Controlled Room Temperature]. include sufficient numbers of subjects aged 65 mg, 80 mg, 90 mg, 105 mg, 115 mg 65 and over to determine whether they or 135 mg minocycline, are supplied Handling respond differently from younger subjects. as follows. Keep out of reach of children Other reported clinical experience has not Protect from light, moisture, and identified differences in responses between The 45 mg extended release tablets are excessive heat. the elderly and younger patients. In general, gray, unscored, coated, and debossed dose selection for an elderly patient should with “DYN-045” on one side. Each tablet Dispense in tight, light-resistant container be cautious, usually starting at the low end contains minocycline hydrochloride with child-resistant closure. equivalent to 45 mg minocycline, supplied of the dosing range, reflecting the greater as follows: U.S. Patent 5,908,838* and Patents Pending frequency of decreased hepatic, renal, or *90 mg is also covered by U.S. Patents cardiac function, and concomitant disease NDC 99207-460-30 Bottle of 30 7,541,347 and 7,544,373 or other drug therapy. NDC 99207-460-10 Bottle of 100 OVERDOSAGE In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures. Minocycline is not removed in significant quantities by hemodialysis or peritoneal dialysis. NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis—Long-term animal studies have not been performed to
The 55 mg extended release tablets are pink, unscored, coated, and debossed with “DYN-055” on one side. Each tablet contains minocycline hydrochloride equivalent to 55 mg minocycline, supplied as follows: NDC 99207-465-30
Manufactured for: Medicis, The Dermatology Company Scottsdale, AZ 85256 August 2010 17110163
Bottle of 30
The 65 mg extended release tablets are blue, unscored, coated, and debossed with “DYN-065” on one side. Each tablet
Vol. 5, No. 1 WINTER 2011 33
SURGICAL Dermatology
Surgical Subtleties for Dermatology PAs By 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.
34 Journal of Dermatology for Physician Assistants
SDPA Members Only Content
Mark Hyde, MMS, PA-C is a graduate of the Physician Assistant Program at Midwestern University in Glendale, Arizona. He is a Diplomate of the Society of Dermatology Physician Assistants. He presently resides in Salt Lake City, Utah where he works with the Melanoma and Cutaneous Oncology Program for the Huntsman Cancer Institute at the University of Utah.
SURGICAL wisdom
Qualities of the Ideal Surgical Needle 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.
Content for Surgical Wisdom provided by Ethicon, Inc.
Vol. 5, No. 1 WINTER 2011 35
SURGICAL Dermatology
A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.
cosmetic Dermatology
Is It All In Their Heads?
The Cosmetic Patient and Body Dysmorphic Disorder By Risha Bellomo, MPAS, PA-C
SDPA Members Only Content A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.
Risha Bellomo, MPAS, PA-C has practiced dermatology for 9 years. She currently works at Advanced Dermatology & Cosmetic Surgery in Orlando, Florida and has been their Director of PA/NP Cosmetic Training for the last 3 years. She has indicated no relationships to disclose relating to the content of this article. 36 Journal of Dermatology for Physician Assistants
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.
Vol. 5, No. 1 WINTER 2011 37
Cosmetic pearls Tips for Keeping Skin Healthy During The Winter Months SDPA Members Only Content
COSMETIC Dermatology
A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.
38 Journal of Dermatology for Physician Assistants
For moderate to severe plaque psoriasis
A real sharpshooter Spray nozzle more precisely hits a range of plaques on the body and scalp • Efficacy of Clobex® Spray confirmed in multiple clinical trials totaling more than 2000 patients1-3 —An average of 80% of patients clear or almost clear at 4 weeks1,2
SPRAY NOZZLE! Important Safety Information CLOBEX® (clobetasol propionate) Spray, 0.05%, is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older. Clobetasol propionate has been shown to suppress the HPA axis at the lowest doses tested. Clobetasol propionate spray should not be used in the treatment of rosacea or perioral dermatitis and should not be used on the face, groin or axillae. In controlled clinical trials, the following adverse reactions have been reported: burning, pruritus, hyperpigmentation, infections and infestations, nasopharyngitis, upper respiratory tract infection, and skin and subcutaneous tissue disorders. Treatment should be limited to 4 weeks. Treatment beyond 2 weeks should be limited to localized lesions of moderate to severe plaque psoriasis that have not sufficiently improved after the initial 2 weeks of treatment with CLOBEX® Spray, 0.05%. CLOBEX® Spray, 0.05%, should not exceed 50 g (59 mL or 2 fl oz) per week. CLOBEX® Spray, 0.05%, is not recommended for use on anyone younger than 18 years of age. Pregnancy Category C. Please see adjacent page for brief summary of Prescribing Information.
Log on to www.psoriasispro.com Vol. 5, No. 1 WINTER 2011 39
CLOBEX
®
(clobetasol propionate) Spray, 0.05% Rx Only BRIEF SUMMARY
INDICATIONS AND USAGE: CLOBEX® (clobetasol propionate) Spray, 0.05% is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older (see PRECAUTIONS). Treatment should be limited to 4 consecutive weeks. The total dosage should not exceed 50 g (59 mL or 2 fl. oz.) per week. Before prescribing for more than 2 weeks, any additional benefits of extending treatment to 4 weeks should be weighed against the risk of HPA axis suppression. Patients should be instructed to use CLOBEX® (clobetasol propionate) Spray, 0.05% for the minimum amount of time necessary to achieve the desired results (see PRECAUTIONS). Use in patients under 18 years of age is not recommended because safety has not been established and because numerically high rates of HPA axis suppression were seen with other clobetasol propionate topical formulations (see PRECAUTIONS: Pediatric Use). CONTRAINDICATIONS: CLOBEX® (clobetasol propionate) Spray, 0.05% is contraindicated in patients who are hypersensitive to clobetasol propionate, to other corticosteroids, or to any ingredient in this preparation. PRECAUTIONS: General: Clobetasol propionate is a highly potent topical corticosteroid that has been shown to suppress the HPA axis at the lowest doses tested. In studies evaluating the potential for hypothalamic-pituitary-adrenal (HPA) axis suppression, using the Cosyntropin Stimulation Test, CLOBEX® (clobetasol propionate) Spray, 0.05% demonstrated rates of suppression that were comparable after 2 and 4 weeks of twice-daily use (19% and 15-20%, respectively), in adult patients with moderate to severe plaque psoriasis (≥ 20%BSA). In these studies, HPA axis suppression was defined as serum cortisol level ≤18 �g/dL 30-min post cosyntropin stimulation. (See CLINICAL PHARMACOLOGY). Patients with acute illness or injury may have increased morbidity and mortality with intermittent HPA axis suppression. Patients should be instructed to use CLOBEX® (clobetasol propionate) Spray, 0.05% for the minimum amount of time necessary to achieve the desired results (see INDICATIONS AND USAGE). Systemic absorption of topical corticosteroids has caused reversible adrenal suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment. HPA axis suppression has not been evaluated in psoriasis patients treated with CLOBEX® (clobetasol propionate) Spray, 0.05% who are less than 18 years old. Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios (see PRECAUTIONS: Pediatric Use). The potential increase in systemic exposure does not correlate with any proven benefit, but may lead to an increased potential for hypothalamic-pituitary-adrenal (HPA) axis suppression. Conditions which increase systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Therefore, patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of adrenal suppression (see laboratory tests below). If adrenal suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products. If irritation develops, CLOBEX® (clobetasol propionate) Spray, 0.05% should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noting a clinical exacerbation, as with most topical products not containing corticosteroids. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, use of CLOBEX® (clobetasol propionate) Spray, 0.05% should be discontinued until the infection has been adequately controlled. CLOBEX® (clobetasol propionate) Spray, 0.05% should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae. Information for Patients: Patients using topical corticosteroids should receive the following information and instructions: • This medication is to be used as directed by the physician and should not be used longer than the prescribed time period. • This medication should not be used for any disorder other than that for which it was prescribed. • The treated skin area should not be bandaged, otherwise covered, or wrapped so as to be occlusive unless directed by the physician. • Patients should wash their hands after applying the medication. • Patients should report any signs of local or systemic adverse reactions to the physician. • Patients should inform their physicians that they are using CLOBEX® (clobetasol propionate) Spray, 0.05% if surgery is contemplated. • This medication is for external use only. It should not be used on the face, underarms, or groin area. Also avoid contact with the eyes and lips. • As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician. • Patients should not use more than 50 g (59 mL or 2 fl. oz.) per week of CLOBEX® (clobetasol propionate) Spray, 0.05%. Instructions to the Pharmacist: 1. Remove the spray pump from the wrapper 2. Remove and discard the cap from the bottle 3. Keeping the bottle vertical, insert the spray pump into the bottle and turn clockwise until well-fastened 4. Dispense the bottle with the spray pump inserted Laboratory Tests: The cosyntropin stimulation test may be helpful in evaluating patients for HPA axis suppression. Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term animal studies have not been performed to evaluate the carcinogenic potential of clobetasol propionate. Clobetasol propionate was negative in the in vitro mammalian chromosomal aberration test and in the in vivo mammalian erythrocyte micronucleus test. The effect of subcutaneously administered clobetasol propionate on fertility and general reproductive toxicity was studied in rats at doses of 0, 12.5, 25, and 50 �g/kg/day. Males were treated beginning 70 days before mating and females beginning 15 days before mating through day 7 of gestation. A dosage level of less than 12.5 �g/kg/day clobetasol propionate was considered to be the no-observed-effect-level (NOEL) for paternal and maternal general toxicity based on decreased weight gain and for male reproductive toxicity based on increased weights of the seminal vesicles with fluid. The female reproductive NOEL was 12.5 �g/kg/day (ratio of animal dose to proposed human dose of 0.03 on a mg/m2/day basis) based on reduction in the numbers of estrous cycles during the pre-cohabitation period and an increase in the number of nonviable embryos at higher doses. Pregnancy: Teratogenic effects: Pregnancy Category C. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application to laboratory animals. Clobetasol propionate is absorbed percutaneously, and when administered subcutaneously it was a significant teratogen in both the rabbit and the mouse. Clobetasol propionate has greater teratogenic potential than steroids that are less potent. The effect of clobetasol propionate on pregnancy outcome and development of offspring was studied in the rat. Clobetasol propionate was administered subcutaneously to female rats twice daily (0, 12.5, 25, and 50 �g/kg/day) from day 7 of presumed gestation through day 25 of lactation or day 24 presumed gestation for those rats that did not deliver a litter. The maternal NOEL for clobetasol propionate was less than 12.5 �g/kg/day due to reduced body weight gain and feed consumption during the gestation period. The reproductive NOEL in the dams was 25 �g/kg/day (ratio of animal dose to proposed human dose of 0.07 on a mg/m2/day basis) based on prolonged delivery at a higher dose level. The no-observed-adverse-effect-level (NOAEL) for viability and growth in the offspring was 12.5 �g/kg/day (ratio of animal dose to proposed human dose of 0.03 on a mg/m2/day basis) based on incidence of stillbirths, reductions in pup body weights on days 1 and 7 of lactation, increased pup mortality, increases in the incidence of umbilical hernia, and increases in
the incidence of pups with cysts on the kidney at higher dose levels during the preweaning period. The weights of the epididymides and testes were significantly reduced at higher dosages. Despite these changes, there were no effects on the mating and fertility of the offspring. There are no adequate and well-controlled studies of the teratogenic potential of clobetasol propionate in pregnant women. CLOBEX® (clobetasol propionate) Spray, 0.05% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers: Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Because many drugs are excreted in human milk, caution should be exercised when CLOBEX® (clobetasol propionate) Spray, 0.05% is administered to a nursing woman. Pediatric Use: Use in patients under 18 years of age is not recommended, because safety has not been established and because numerically high rates of HPA axis suppression were seen with other clobetasol propionate topical formulations. Safety and effectiveness in pediatric patients treated with CLOBEX® (clobetasol propionate) Spray, 0.05% have not been established (see PRECAUTIONS: General). Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing’s syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of glucocortisteroid insufficiency during and/or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children. HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Geriatric Use: Clinical studies of CLOBEX® (clobetasol propionate) Spray, 0.05% did not include sufficient numbers of patients aged 65 and over to adequately determine whether they respond differently than younger patients. In the two Phase 3 studies, 21 of the 240 patients (9%) were over the age of 65. In general, dose selection for an elderly patient should be made with caution, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. ADVERSE REACTIONS: In controlled, clinical trials with CLOBEX® (clobetasol propionate) Spray, 0.05%, the most common adverse reaction was burning at the site of application [40% of subjects treated with CLOBEX® (clobetasol propionate) Spray, 0.05% and 47% of subjects treated with Spray Vehicle]. Other commonly reported adverse reactions for CLOBEX® (clobetasol propionate) Spray, 0.05% and Spray Vehicle, respectively, are noted in Table 2. Table 2 - Commonly Occurring Adverse Events Adverse Reaction
Clobetasol Propionate 0.05% Spray (N=120)
Vehicle Spray (N=120)
50 (42%)
56 (47%)
System Organ Class General disorders and administration site conditions Application site atrophy
0 (0%)
1 (1%)
Application site burning
48 (40%)
56 (47%)
Application site dryness
2 (2%)
0 (0%)
Application site irritation
1 (1%)
0 (0%)
Application site pain
1 (1%)
2 (2%)
Application site pigmentation changes
1 (1%)
0 (0%)
Application site pruritus
4 (3%)
3 (3%)
17 (14%)
12 (10%)
Infections and infestations Influenza
0 (0%)
2 (2%)
Nasopharyngitis
6 (5%)
3 (3%)
Pharyngitis streptococcal
1 (1%)
0 (0%)
10 (8%)
2 (2%)
4 (3%)
2 (2%)
2 (2%)
0 (0%)
Upper respiratory tract infection Skin and subcutaneous tissue disorders Eczema asteatotic
Other adverse events occurred at rates less than 1.0%. Most local adverse events were rated as mild to moderate and they are not affected by age, race or gender. The following additional local adverse reactions have been reported with topical corticosteroids. They may occur more frequently with the use of occlusive dressings and higher potency corticosteroids, including clobetasol propionate. These reactions are listed in an approximate decreasing order of occurrence: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae and miliaria. Systemic absorption topical corticosteroids has produced hypothalamic-pituitary-adrenal (HPA) axis suppression manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients. OVERDOSAGE: Topically applied CLOBEX® (clobetasol propionate) Spray, 0.05% can be absorbed in sufficient amount to produce systemic effects. (See PRECAUTIONS). DOSAGE AND ADMINISTRATION: CLOBEX® (clobetasol propionate) Spray, 0.05% should be sprayed directly onto the affected skin areas twice daily and rubbed in gently and completely. (See INDICATIONS AND USAGE). CLOBEX® (clobetasol propionate) Spray, 0.05% contains a super-high potent topical corticosteroid; therefore treatment should be limited to 4 weeks. Treatment beyond 2 weeks should be limited to localized lesions of moderate to severe plaque psoriasis that have not sufficiently improved after the initial 2 weeks of treatment with CLOBEX® (clobetasol propionate) Spray, 0.05%. The total dosage should not exceed 50 g (59 mL or 2 fluid ounces) per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Use in pediatric patients younger than 18 years is not recommended because of the potential for HPA axis suppression (see PRECAUTIONS: Pediatric Use). Unless directed by physician, CLOBEX® (clobetasol propionate) Spray, 0.05% should not be used with occlusive dressings. HOW SUPPLIED: CLOBEX® (clobetasol propionate) Spray, 0.05% is supplied in a white HDPE bottle with a white polypropylene cap and white LDPE liner in the following sizes: 2 fl oz/59 mL NDC 0299-3849-02 4.25 fl oz/125 mL NDC 0299-3849-04 Store under controlled room temperature conditions of 20˚C - 25˚C (68˚F - 77˚F) with excursions permitted between 15˚C and 30˚C (59˚F and 86˚F). Do not freeze, refrigerate or store above 30˚C. Spray is flammable; keep away from heat or flame. US Patent Nos: 5,972,920; 5,990,100 and foreign patents pending. Marketed by: GALDERMA LABORATORIES, L.P., Fort Worth, Texas 76177 USA Manufactured by: CPL, Mississauga, Ontario, Canada L5N 6L6, Made in Canada. GALDERMA is a registered trademark. www.psoriasispro.com 2003739-0906 Revised: September 2006
References: 1. Clobex® Spray Prescribing Information. September 2006. Galderma Laboratories, L.P. 2. Koo JYM. Relevance of the COBRA Trial in current psoriasis practice. Cutis. 2007;80(suppl 5):4-11. 3. Menter A, Abramovits W, Colón LE, Johnson LA, Gottschalk RW. Comparing clobetasol propionate 0.05% spray to calcipotriene 0.005% betamethasone dipropionate 0.064% ointment for the treatment of moderate to severe plaque psoriasis. J Drugs Dermatol. 2009;8:52-57. © 2010 Galderma Laboratories, L.P. GALDERMA and CLOBEX are registered trademarks. Galderma Laboratories, L.P., 14501 N. Freeway, Fort Worth, TX 76177 CLO-604A Printed in USA 11/10
40 Journal of Dermatology for Physician Assistants
Professional development
Dermatology Billing & Coding EMR Decision Making 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.
Vol. 5, No. 1 WINTER 2011 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.
...continued on page 45
42 Journal of Dermatology for Physician Assistants
In the treatment of actinic keratosis
What will your patients pay for significant lesion reduction?
$ The Zyclara Zero Program Zyclara Patient Savings Card RxBIN:
610524
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• 36% of patients had complete clearance vs 6% for placebo (P<.001)1 • 59% had partial clearance vs 23% for placebo (P<.001)1 Zyclara Cream is indicated for the topical treatment of clinically typical visible or palpable actinic keratoses (AK) of the full face or balding scalp in immunocompetent adults. In clinical studies, the most common side effects involved skin reactions in the application area. These reactions included erythema, scabbing or crusting, flaking, scaling or dryness, edema, erosion or ulceration, and weeping or exudate. Most skin reactions were rated as mild to moderate. Intense local inflammatory reactions and/or flu-like systemic signs and symptoms can occur. Dosing interruptions may be required. Exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) should be avoided or minimized during use of Zyclara Cream. Please see Brief Summary of Full Prescribing Information on adjacent page. Visit us at www.ZyclaraCream.com *Patient not eligible if: (1) prescriptions are paid in part or full by any state or federally funded programs including but not limited to Medicare or Medicaid, Medigap, VA, DOD, or TriCare; (2) patient does not have any prescription drug benefits; (3) patient is a resident of MA; where prohibited by law; patient is under the age of 18. LoyaltyScript® is not an insurance card. For questions regarding setup, claim transmission, patient eligibility, or other issues, call the ZYCLARA Patient Savings Card Program at 1-877-264-2440 (8:00 am through 8:00 pm EST, Monday through Friday). Reference: 1. Swanson N, Abramovits W, Berman B, et al. Imiquimod 2.5% and 3.75% for the treatment of actinic keratoses: results of 2 placebo-controlled studies of daily application to the face and balding scalp for two 2-week cycles. J Am Acad Dermatol. 2010;62(4):582-590. ©2010 Graceway Pharmaceuticals, LLC, Bristol, TN
www.gracewaypharma.com
www.ZyclaraCream.com
ZYC0910179a
Vol. 5, No. 1 WINTER 2011 43
44 Journal of Dermatology for Physician Assistants
Dermatology Billing & Coding
...continued from page 42
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.
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. 5, No. 1 WINTER 2011 45
Five Great IT Tools Under $100 By Rosemarie Nelson, MS
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.
Rosemarie Nelson is a principal with the MGMA healthcare consulting group. She conducts educational seminars and provides keynote speeches on a variety of healthcaretechnology and operational topics. Drawing upon her diverse experience, Nelson provides practical solutions to help medical groups succeed in their practices. She may be reached via physicianspractice@cmpmedica.com.
46 Journal of Dermatology for Physician Assistants
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Physician matolog y nty years from ety of Der of the Soci tion as it marks twe n from less the history and articles on year for our organiza profession has grow mem k ricia Fery t series of 0 By Patbers PA rer, MP in a four-parsand ten is a landmaron. The dermatology ently has over 1,80 high-qualit d AS, PAthir uni C A curr refined, This is the Two thou chairs; its formal y. The SDP A has two (SDPA). Thtee is is the en years from e than 2200 toda nizations. The SDP (BOD) and commit Assistants tants, wesecond in on and fifte to mor orga Assista n assis Directors sicia of a fou its concepti in the early 1990s constituent AAPA nts rd phy atology king Boa all its concep (SDPA). Two r-part series of than 25 PAs most organized of icated and hard wor nizations. As derm thousand articles tio n an orga than 25 on d le society. is one of the E meetings and a ded other constituent PAs into befifteen years fro ten is a landm the history of formidab for this el is the tee CM ark yea the Soc one m its for blish esta of mit annual ed a mod r for iety the mo ratioear n ly 199 irs Com ma is consider to those who helped Ethical Affaann uaing our opest organized 0s to more tha l union. The our organizat of Dermatolog n the SDPA icial and s der ion as it y Physic n 2200 E ncie and keep l CM of appreciatio etin and the Jud for interpreting the ian SDPA today. Th matology PA ma discisrepame gs and all constituen owe much any g lvin profession rks twenty yea a t AA sible consid e SDPA ded reso owe mu “respon rs from has gro curren ch apprec ered a model icated and har PA organizat current and nts wn fro ume ion g d for iat doc s. The SD tly has over 06 working other more e now beinion to those 1800 me m less them.” 2004-20 PA has century withed who hel constituent org Board of Di between ferences wer nson, and mb 21st Part iii: two refi con the E rector ped esta and anization A CM Pah,rtGloria Joh ned, hig ers and A entered blish thi The SDP g Buttolp mittees, exptions with ii: 1999 s. As der s (BOD) an g h-quality The SDP com atin s sed rdin d for ma Gre midable t coo -2004ker). le rela by tology phy committee and focu From even planned society. 199 e Haw chairs; organized education, acceptabsupport of the sician ass Simple (an Ros formale and 0 to de t the 199 Ma men ogy and organizat to exp 8 istants, Events by Mik ion and improve dermatol SDPA ers ion wit the we PA ass managed SDand his offic evolve full recognit continued were in great creating h offi by company ed media suppor ess the AA D, ical industry, and Mr. Day s and ch comd to become collected y,cerwhi atology onaland from s, a edutcati olog fees, This allowed atology the phamat inform pharmaceut services. PAs in derm increase revenue received mittees. The in Der contrib ally rec rmaceuti of derm pre iew es ogn to hou uti financ society’s calrs sence.Not izered of member ause of our ability care, and easing the d by40 became ng newsletter s offe ensive Rev Anote the mik.industry, and ial SDPA bec and 6. Compreh in 200 the work incThe to patient D new by DerAA wa demand d slet the formathe official SD articles. Jud ludedspon sore ter was for our organi s sicians. All y Reese e derma accessibility PA new t nts, wer and was released me Joe sen , tolo and zat improve our supervising phy dividends in the der for aes E t to the sletter edi Day gy CM ion’s mally thetics Mr. I CMinform matolo E con Un gy ted tor of our offi category D invi and conJones to attend memb atioAA burden for 04 would pay big n rela booth at der the leaders the cial pub and improved tract pea ference announership Th ted Eugene 200 e 5new 9-20 lication slet rls, and 4-2005 In Aprilopp cefrom 199 Galderm the AAD An hip of Jim Sot ter, and to PAs in ham . five years. t from 200 ary unities also published dermatology any RobertortHig and a booa provided funnual Meeting ack the SDPA upcoming A Presiden list. Monroe, and the hig was SDP Day’s prim con ding for th was In 1999 yhly cov the SDPA. Mr. Sot starte the SD tinued to thr Gordon Day President-elect. Mr. son position to Jim Sot rmatolog Mamis Deack becam 04-2006eted job nroe he PA Liai on dermaack encourage d at the AAPA PA newslet ive. bec amof ty inc d e and Joe Mo to initiate an AA by the AA PA and Day cie An Sec tolo der e lud 20 Pre so nual Me ter retary/ matolo gy sub ed volunteer ts: was ded tan Treasu sident and . Mr. Pag and Joe nJim sis and par jects at PA CMgy PAs to lect eting. objective e, Sue as Sandra rer. The ted and fun the first Liaison Sot por Mo cia Ra tici ack sup ure nro SDPA ysis hel pat E ’s e. Derm ncis, Kurits Phthu ham as ional and er the AA D the SD tenure the AA e at all SDPA meetings and atolog inted as .theOpp, Lo BOD also Robert Hig tees: Profess pap PA and inv ping to incrtrea am appo AAD ra Gurul the wer appointed three new commit develop a position Discov to volunteer D Allied He venues. Durinto se then toists olv Robe High e hir e, ation ery alth Co Joe Mo ement AAPA liaiso SDPA 2005 ing more . No first resolution . The AAD at the Specia n-Pved mmitte g Mr. nroe) and established irs Committee to stituent Organiz PAs, As Ma the AAPAmembers l Board Randy hip Con d ry Mo Marecei Awar SDPA of AdvisoOlympics ande asked at the res for PAs to rti Ullation Ull nroe (for numbers Clinical Affa , Member and st members’ needs, ic Educ end reg inform endorfPubl sion mer for dermaident rate. Mr ister at the AArs began dra Camp ation via ) helped in orf (wife of on supervi to evaluate and assi deceasedwife of Kalin, collecting . Sotack d from tology D Annua fting a the Thom the SDPA graduate PA PA arr Committee
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Patrici others tology The 5 ere a certifi of a Fer200 started 1998 and PAs. rer, of Nebraska member cation in the 199SDPA succes the . versity MPAS, PA- C sfu the University She is an Associate 0s. Ou 2004 1998Uni of gra of the AAPA PA-C, ip). r websi lly embraced and scholarsh w member atology for nine bec ts obt Texas Medical Braduated from ensive thestan and Fello Univers ained her Ma and tho ame a hub te, maintain the evolving Com n Assi nchpreh in derm has no the SDPA in Notes in ity of Neb of sters Deg w working y Physicia scholarshi By Pat atical. She ose. Revie was to be invse new to derma resources for ed by Steve Pri internet raskrici ree from She has beencurrently on sabb stry of atology a in itstheand a Fer Derm Dermatolog s from Day to discl Gregp). She is is SDP induety 3 MP in d and an Ass 200rer, withSoci A AAD behind olved with the tology. Mary dermatology ce, plete years and ionsh PAAS, and Fell nty year Gordonlph less ips the le and ociate (SD than of com d the PAtwe r, MPAS, PA-C She SDPA artic ory ks joine in all C -th PA ow Ferre relat this has to me hist Mo we FDA mar to ide from yea mb ed as it SDPA who grownButto bsite con nroe con s re the offer on the Our list e-scenes con ered n won.rkin member of By Patricia befo of tion onetinoi cles outs isbee ying and rs and bers. n has nizaribut ten the AAP of the tin testifbers g inisder all who mem kour orgacont is ma is curren Th series of arti lopment professio Patricia 0 mem of oral isotre A. the firs Dermato of free journa tributions to t along with ued for ntal like to than ual in the deve woulddefenseoutside four-part Patricia wou the SD gy tly gyt in on sab tolo atology PA has2004 rela ls grew her (SD logy (no for a fou y ann atolo marldk year over tion tho1,40 like bat PA final of a se who high instrume Ne shipds withPA to alit -qu a land ical. She nin ). Tw 2004 thaDerm on. Thed.derm Aslette complete ite. nk ally wh wereThe fromyJuly ma who wereal uni and Co longer a pubto include Cro newsletter. currrsentl o thohas e r-partanserws, This is the sand ten is thoseits mentione instrum y noted, theSDPA force form ra, refin SDP owebsconcepind new smetic rs;entStud y to disc usano Work Kucetwo nd ten artiesicleof art have tee have been today.de: Two thou years from tioustr SDPA A has al the contribute n an Kristine icle Ran beenchai Dermato lication), Ski ss Section in and may not posted on 0 le inclu The is a lan for Ski withSDP s on the dycom (SDPA). d fiftlose me 220 Ullemit and develop Arnold,and artic 25 medsto this tha ntio dencs.esThe wein. owe s, ned een. article e thanthis spontion and fifteen 0s to mor historlog en, Terry D) impo,orta ndo y. Dr. Jay n & Allergy rf are now tant niza ark n & All il corre Sadly, Jim PA and years fro t “PAdm nt in Sources for s Hayd erg theSDP emaorga of the nt n assis Travi ectors (BO conception y Neywsof the Nancy Prim physicia Ninmeteits s are theyeabes r for earAlywh ise, Herbst Dir AA;PA ber ofersat early 199 theack ent2006 Soc our Sources building blocksdeceased but of Sot rd 199 ions with atology elle Diba t en for in the – Octo titu kep iety mo wro , Boa Mich Bru in org wh ma o nin 0s cons b, t secretanizat ich he of De te their con st org ce ani king e convtions.am. toCla etyl -ni for the unne As derm 1999 – for this article 25 PAs morkregat d of all Bethand any Grub d wor ionend n,zed in derion claimerm SDPA. CM and tributio Kali har il and phonRobe . Th thaher E me nizart High Octobe as it ma include t organize dedicated matolo n ing ede wit d atolog y ns becam of all con roe; ema ent orga der 22 etin for ety. Day, Mon Mic r 00 ma sur : ts 200 on SDP gy. soci h Joe a g rks of the mos titu hele a veyay. tod JoetolMo and e 3; email stitpos ” A newcon cons, Gord twenty Physician Ass ogynro r olph idablesician Assistan uentert AA datTh presen sletsid othe PAe and a fro Butt tings and corresp with Buttolp DiBaise, and Dermato tersere istants years fro e SD Greg d aJanmo a dedicated this form profess ked m SD PAtati from ondenc y for Phy wor h and Gor PAPA CME mee idered a model for orgon Adele has ry Mo keyesrec and har estaofblish logy” for curfell GrubbMa ter app uardel ren with Dermatolog Cen helpednal y for other owtlymemb ion iatKris e. Pho grown m its d wo the anionzatthe ion“Th Day. icalnro iontine ct Bethany donMed s. Th e Uti ne constit toKuc SDPA is cons ation to those who Byuen from less ove ers thoera 34 Jour e lization has the tyea rkingMa se, who con Borch President-ele as Southwestern director of the PAconversations with ard200 reci 0 AADSDPA tha of aPAs r 1600 memb orgr ani has 2000 of Di helpedtinued of Tex (now a), Tom much app Greg ers and n ionSD Mulitalo , Australi s annual refiinned, University hel establigrowth zatthe s. PA rectorAn ),
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PA in at the anhassistants, 90 -1998 Chaidea of PA t happen we owe s the SD coneeceived Knight (wh Jones (UTSW tions Committ ings wer -C, became At the much nded goal ming pres Laboratinorie 1990 bec PA as an org and Eugene A Industrial Rela orters Cor e taking praiactic and his inte to initial inco I). inThe ing anization SDP l supp place: (DL aus Higham’s A accomplishments AAD, allow PAs ng e Vo as ncia e l. iativ well of fina der 4, the ing ma Th a desire Noe 2 SPR and wa rning Init con8,grecon r supervisi gatsum recent SDP d relations with t ste to have s e tothesha tology ING other PA. firs Gordon Daythe Distance Lea mer of 200 p in goo without theicategory for exp 201 n ces PA re for erie 0 off ntai it eren lop s s mai 33ng get nces, com in the Sum energy to deve bership accompli practicing mi ding AAD conf knto D owledge, launched in der the PA D wa n of the mon attend the create an AAD mem ban on PAs atten He shed by inceptio DLI was ous amount of BO . Thecam and to the placing matology. Th s to identify build ible referred aralyder physicians, atology, and lift at AAD conferences. of ads in a tremend smoothly as poss was prev Joes to hadious fourie.year severa is was PAs in derm cosmetic courses ent of the Journal SDPA’s nroe ng ide to of Mo ground as in 2004 (when it ion)gro , takithe cem seeking l PA journals gatthe surgical and ced the commen stants (JDPA), the ions and updofexamaple her DLI began ance Learning Opt 8; a goo s this dermatolto find other madtol focu and hele-mder also announ y for Physician Assicreated by Publicat and ogy PA as the Dist e to fruition in 200and sing andinde to s stepped ogy PA s. Six y his , wif ssar com no Dermatolognal. The JDPA was Chair Travis Hayden LLC. e, was nece w Mary finally organization that Sartori, for ward: Ric Monro former official jour ons Committee t Communications,A was rmination, with the projectcol lab k e, dete ora icati ted in ma aged lved Watts, Jim Page, He Commun by Physician Assistan l issue of the JDP the SDPA project. this thougChair, of all invo manking idi Oj this huge Hokan ay On, Tom developed of 2007, the inauguramembers, making own peer mittee ht aerea In 199 complete Com litys . year son A thre old, CME connces2,forthe Opp. In , and Kurtis In the Fall and sent to all SDP nizations with its rd of the Momitt ee nroes sidere Com Terr y Arn CME Confere published few specialty PA orgading Editorial Boa itor in the firs December 199 Fall to the CMdE variou t newslet recrsuitm nament, 4 the SDPA duties of call thi lty es s The facu one of the lication. The foun MPAS, PA-C (Ed MPAS, new the ter for The firs ent, 08). of der PA D group pub er, t ma (2005-20 developm reviewed ded: Travis Hayden, C, Patricia Ferr Orlean SDPA memb this tim went out and program settled tology PA s and MPAS, PAs, ers me included on eting at RosemarieFebruary 6, JDPA inclu Monroe, MPAS, C, Nancy Primo, era, PA s had e 23 dermatol by Assistant Physician 199 ogy Opp. Bac Palting, Nan 5. From left the AAD Con Chief), Joe don Day, R.Ph, PA- PA-C, Kristine Kuc founding responded. Th fere with the s in Dermato ., Jerry Dav k: Pat Zanolli, cy Heller, Mary to right – Front: nce in New PA-C, Gor ene Jones, Ph.D Menter, MD. log acrony Lind what we members of e Mo idson (de Terr Eug m of PA y and Alan ceased a Findley, Jim nroe, Sue Ran i Beck, PA-C, P. D. ), and Joe Society now call the Lekas, Rich cis, Kurtis AS, PA-C, uated from Mo of DHS, MP grad ard nroe. Sartori, S, PA-C in Physicia Dermatolog Patrici Ferrer, MPA s Medical Branch from a Ferrer, n Assist y Patricia ee the Texa du MP fac of Degr ant Uni ring the AS, e-to-face ters vers s met the University ined her Mas 2003 (SDPA 1998 and ity of Texas PA- C gradua for New Or February obta in ted of 1998 and 1995 AAfirst time in one the the Uni obtained her Medical Branch from leans. of Nebraska ciate member versity D annual roo the University She is an Asso has been working of Neb Masters Deg in schola ip). In the rask rshi ree meeting m . She ntly scholarsh the SDP p). She is an a in 2003 (SD from disallowe 1990s throu and the AAPA years and is currefor in A Ass,ocia PA the SDPA dent Fell She has and te gy for nine : Presi ow me atology PA attendee d the “PA-C gh to the ear t Row bee mberteof member of n workinImm edia in dermatolo -time as a derm locally and in yeators Fron ly ” Row the AAP am; g in der ee rs part and rt isHigh identifyi badges, thus designation 2000s the AA working VA and voluntee stry to disclose. right, Back out currently A. ma to mitt Robe Pat t, tolo Left side Com ricia on -elec gy relationtions on sab D wo dent conferenc 2007 tho ey; Presi the Tucson ionships with indu batical for nine attend ng fellow PA reducing the ships with article and Swartz; Industry Rela se who uld like Hick to tha . She has e cha the ide relat s. ed to this SDPA who , Sharon Danielwh Monroe; nk allsurer wer indNan ustr ycyto no contribut wh con President has no outs physicia conference The AA D allo nces of odent,yJoe e instetary the disclose ental inandoVice not ;hav Secr rum/Trea Past Presi ma tribute Mexico. She like to thank all who development of . on Day datology e beeGru the earE Derm ld sessions. ns and PA s couonly with the wed PA s to in the Gord n mebb; rces for e, Bethany ly developto this article ChairSou ntioual Patricia wouwere instrumental d. ir nedCM and July 2006 at Largthis articleA 6th Ann ment of . resp ctor the Mo At the 1995 ld only attend supervising Direcor ondenc7 SDP include . any mentione those who the SDP sletters from Ne nro KurotisatOpp the 200 es withton, D.C: phone have been A SDPA new Kristine Kucera, Beth displayin es sat outsid w Orleans the plenar y Prim may not hing Linda Find intervie FAll 2010 35 le include: , PAe Was corposiu C, Jim AA D con m in this artic 4ws and respond e the AA dences with g a sign and phon ley,. PANo. Page, PA- Vol 4, Sym em int Sources for ; email correspon Arnold; email Gordon Day, and enc C, fer ail rod ask Sue and D exh ence C, and , uce ing Ran Mary Mo es with Tom – June 2010 s Hayden, and Terryo, Greg Buttolph Hokans Rick Satori, cis, PA- C, nroe. that sev themselves. dermatology ibit hall PAon, PAera Grubb, Travi with Nancy Prim C, Joe Mo C. Email were off l dermatol Both of them PA s to stop ions nroe, PAconversat am. ogi and C, practic ering their ser sts stopped were surprised Robert High es, to ask if vices to them tha to find out the hel t they had more abo p find PA s for y their PA s wo ut PA s, and rking in to their pra inform ctices.
sent Robert 2007-Pre ip Summit, outlined Part iV: SDPA 2007 Leadershiden tial message s:
Vol.4,
No. 1 WIN
Know Your SDPA History… Visit the JDPA Past Issues located in the members only section of the SDPA website at www.dermpa.org A sincere thank you to Patricia Ferrer, MPAS, PA-C for all of her hard work and dedication in researching and writing the four History of the SDPA articles that were published in 2010, JDPA Volume 4, Numbers 1, 2, 3, 4. We greatly appreciate her contribution to the SDPA in providing this thorough and detailed historical record.
TER 201 0 35
Vol. 5, No. 1 WINTER 2011 47
professional development
iO n al
SDPA ry of the The Histo
Pr O fE ss
Notes from your Office Manager Management and Documentation of After-Hours Telephone Calls From Patients 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.
J These Risk Management Tips have been reprinted with permission from: MLMIC Dateline, published by Medical Liability Mutual Insurance Company, 2 Park Avenue, Room 2500, New York, NY 10016. Copyright Š2010 by Medical Liability Mutual Insurance Company. All Rights Reserved. No part of this article may be reproduced or transmitted in any form or by any means, electronic, photocopying, or otherwise, without the written permission of MLMIC.
48 Journal of Dermatology for Physician Assistants
DIFFERIN® (adapalene) LOTION, 0.1% — THE ONLY RETINOID IN A LOTION FORMULATION
ON THE JOB WITH GENTLE EFFICACY1
58.2% MEDIAN TOTAL LESION COUNT REDUCTION BY WEEK 121* TOLERABILITY PROFILE SIMILAR TO DIFFERIN® (adapalene) CREAM, 0.1%1† AVAILABLE IN AN EASY-TO-USE PUMP DISPENSER
RESULTS PATIENTS WANT IN A FORMULATION THAT DOES THE WORK—
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A 12-week, multicenter, randomized, double-blind, parallel-group study of patients 12 to 18 years of age with acne vulgaris (N=1075). The most frequent adverse event reported was dryness. Erythema, stinging/burning, and scaling may also occur.1
* †
Important Safety Information Differin® Lotion, 0.1% is indicated for the topical treatment of acne vulgaris in patients 12 years and older. A thin film of Differin® Lotion, 0.1% should be applied once per day to the face and other areas of the skin affected by acne. In clinical trials, the most common adverse event (>1%) reported with use of Differin® Lotion, 0.1% was mild to moderate skin dryness. Erythema, scaling, stinging and burning may also occur. Excessive exposure to sunlight and sunlamps should be avoided during treatment, and use of sunscreen products and protective clothing is recommended. Concomitant use of drying or irritating topical products (like products containing resorcinol, salicylic acid or sulfur) should be used with caution. Instruct patients to avoid the eyes, lips and mucous membranes when applying Differin® Lotion, 0.1%, and not to apply to areas that have been depilated with wax products. Differin® Lotion, 0.1% has not been tested in pregnant or nursing women, or with the elderly. Pregnancy Category C. www.differin.com/HCP Please see Brief Summary of Prescribing Information on adjacent page.
Vol. 5, No. 1 WINTER 2011 49
DIFFERIN®
Rx only
(adapalene) Lotion 0.1% For Topical Use Only Not For Oral, Ophthalmic, or Intravaginal Use. BRIEF SUMMARY INDICATIONS AND USAGE DIFFERIN Lotion is a retinoid product indicated for the topical treatment of acne vulgaris in patients 12 years and older. CONTRAINDICATIONS None. WARNINGS AND PRECAUTIONS Ultraviolet Light and Environmental Exposure: Avoid exposure to sunlight and sunlamps. Wear sunscreen when sun exposure cannot be avoided. Erythema, scaling, dryness, and stinging/burning may occur with use of DIFFERIN Lotion. ADVERSE REACTIONS Dry skin of mild to moderate severity was the most frequently reported (≥ 1%) treatment related adverse event. Erythema, scaling, dryness, burning/stinging were also seen during treatment. DRUG INTERACTIONS Concomitant use of topical products with a strong drying effect can increase skin irritation. Use with caution, especially in using preparations containing sulfur, resorcinol, or salicylic acid in combination with DIFFERIN Lotion. Wax depilation should not be performed on treated skin. Pregnancy Pregnancy Category C. There are no well-controlled trials in pregnant women treated with DIFFERIN Lotion. Therefore, DIFFERIN Lotion should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal reproduction studies have not been conducted with DIFFERIN Lotion. Furthermore, such studies are not always predictive of human response. Human Data In clinical trials involving DIFFERIN Lotion, 0.1% in the treatment of acne vulgaris, women of childbearing potential initiated treatment only after a negative pregnancy test. Two women became pregnant while using DIFFERIN Lotion, 0.1%. One patient delivered a healthy full term baby and the other patient electively terminated her pregnancy. Animal Data No teratogenic effects were observed in rats treated with oral doses of 0.15 to 5.0 mg adapalene/kg/day, up to 25 times (mg/m2/day) the maximum recommended human dose (MRHD) of 2 grams of DIFFERIN Lotion. However, teratogenic changes were observed in rats and rabbits when treated with oral doses of ≥ 25 mg adapalene/kg/day representing 123 and 246 times MRHD, respectively. Findings included cleft palate, microphthalmia, encephalocele and skeletal abnormalities in rats; and umbilical hernia, exophthalmos and kidney and skeletal abnormalities in rabbits. Dermal teratology studies conducted in rats and rabbits at doses of 0.66.0 mg adapalene/kg/day [25-59 times (mg/m2) the MRHD] exhibited no fetotoxicity and only minimal increases in supernumerary ribs in both species and delayed ossification in rabbits. Systemic exposure (AUC 0-24h) to adapalene at topical doses (6.0 mg/kg/day) in rats represented 101 times the exposure to adapalene in patients with acne treated with DIFFERIN Lotion applied to the face, chest and back (2 grams applied to 1000 cm² of acne-involved skin). Nursing Mothers It is not known whether adapalene is excreted in human milk following use of DIFFERIN Lotion. Because many drugs are excreted in human milk, caution should be exercised when DIFFERIN Lotion is administered to a nursing woman. Pediatric Use Safety and effectiveness of DIFFERIN Lotion in pediatric patients under the age of 12 have not been established. Geriatric Use Clinical studies of DIFFERIN Lotion did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Carcinogenesis, Mutagenesis, Impairment of Fertility No carcinogenicity, mutagenicity and impairment of fertility studies were conducted with DIFFERIN Lotion. Carcinogenicity studies with adapalene have been conducted in mice at topical doses of 0.4, 1.3, and 4.0 mg/kg/day (1.2, 3.9, and 12 mg/m²/day),
50 Journal of Dermatology for Physician Assistants
and in rats at oral doses of 0.15, 0.5, and 1.5 mg/kg/day (0.9, 3.0, and 9.0 mg/m2/day). In terms of body surface area, the highest dose levels are 9.8 (mice) and 7.4 times (rats) the MRHD of 2 grams of DIFFERIN Lotion. In the rat study, an increased incidence of benign and malignant pheochromocytomas in the adrenal medulla of male rats was observed. No photocarcinogenicity studies were conducted with adapalene. However, animal studies have shown an increased tumorigenic risk with the use of pharmacologically similar drugs (e.g. retinoids) when exposed to UV irradiation in the laboratory or sunlight. Although the significance of these findings to humans is not clear, patients should be advised to avoid or minimize exposure to either sunlight or artificial irradiation sources. Adapalene did not exhibit mutagenic or genotoxic effects in vitro (Ames test, Chinese hamster ovary cell assay, mouse lymphoma TK assay) or in vivo (mouse micronucleus test). In rat oral studies, 20 mg adapalene/kg/day (120 mg/m2/day; 98 times the MRHD based on mg/m2/day comparison) did not affect the reproductive performance and fertility of F0 males and females, or growth, development and reproductive function of F1 offspring. PATIENT COUNSELING INFORMATION • Apply a thin film of DIFFERIN Lotion to the affected areas of the skin once daily, after washing gently with a mild soapless cleanser. Dispense a nickel size amount of DIFFERIN Lotion (3-4 actuations of the pump) to cover the entire face. Avoid application to the areas of skin around eyes, lips and mucous membranes. DIFFERIN Lotion may cause irritation such as erythema, scaling, dryness, stinging or burning. • Advise patients to cleanse the area to be treated with a mild or soapless cleanser; pat dry. Apply DIFFERIN Lotion to the entire face or other acne affected areas as a thin layer, avoiding the eyes, lips and mucous membranes. • Exposure of the eye to this medication may result in reactions such as swelling, conjunctivitis and eye irritation. • Patients should be advised not to use more than the recommended amount and not to apply more than once daily as this will not produce faster results, but may increase irritation. • Advise patients to minimize exposure to sunlight including sunlamps. Recommend the use of sunscreen products and protective apparel (e.g., hat) when exposure cannot be avoided. • Moisturizers may be used if necessary; however, products containing alpha hydroxy or glycolic acids should be avoided. • This medication should not be applied to cuts, abrasions, eczematous, or sunburned skin. • Wax depilation should not be performed on treated skin due to the potential for skin erosions. • This product is for external use only. Marketed by: GALDERMA LABORATORIES, L.P., Fort Worth, Texas 76177 USA Manufactured by: Galderma Production Canada Inc., Baie d’Urfé, QC, H9X 3S4 Canada Made in Canada. GALDERMA is a registered trademark. P51503-0 Revised: March 2010
Reference: 1. Data on file. Galderma Laboratories, L.P. Galderma is a registered trademark. ©2010 Galderma Laboratories, L.P. Galderma Laboratories, L.P. 14501 N. Freeway Fort Worth, TX 76177 DIFF-113 Printed in USA 09/10
www.differin.com/HCP
Outside & Inside the 9 to 5...
We recently had the pleasure of interviewing April Harrison, MPAS, PA-C, one of the first SDPA Fellow members to complete the Distance Learning Initiative (DLI). April graduated from the University of Texas Medical Branch in 2000 and obtained her Masters Degree from the University of Nebraska in 2004. She has been a dermatology PA for ten years and currently practices at Suzanne Bruce and Associates in Houston, TX where her primary focus is cosmetic dermatology. In 2010, April completed all ten modules of the DLI and earned Diplomate status. She was awarded the first DLI certificate of completion at the SDPA 8th Annual Fall Conference in Grapevine, TX. For this installment of the Outside & Inside the 9 to 5, April shares with us her experiences and insights relating to her completion of the DLI.
What are your hopes for the future of all SDPA Diplomates?
As PAs we are trained as generalists. If we specialize, it is even more important to thoroughly understand the area in which we practice. I was impressed with the breadth and depth of material offered in the DLI. I am always interested in furthering my knowledge and education and felt that the DLI provided that opportunity.
What did you like best about the DLI?
I think as an organization, the SDPA is at the forefront. Other specialty organizations are modeling themselves after us. We should continue to set the bar high by offering quality continuing education programs that set us apart from the rest. In doing so, our members will continue to have the opportunity to excel in their work, making them even more valuable to their patients and employers. I hope all SDPA members embrace the opportunity to become Diplomates April Harrison, MPAS, PA-C (left) after receiving and solidify our dedication to the PA profession through pursuing the first awarded SDPA DLI certificate of completion pictured with Kasey Drapeauthe completion of this vigorous Dâ&#x20AC;&#x2122;Amato, MPAS, PA-C, SDPA Distance CME educational program.
The broad range of cases and increasing difficulty in Committee Chair (right). the modules is what I liked What would you like to share best about the DLI. The with other SDPA members about the DLI? difference between a standard CME program and the DLI is that the DLI was designed to be more Stick with it! It is challenging and can be difficult, challenging than traditional CME programs. The but help is out there. Visit the dermpa.org forums material presented in the modules is at a higher and search for the modules that are giving you level of education. You should grow even more as difficulty. Chances are you are not the first with a dermatology PA after completing it. questions on a particular module and help is out there. There are several moderators of the DLI The DLI was developed as an educational tool in forum on the SDPA website that are there to help. response to concerns from the American Academy of Just ask! J Dermatology regarding specific dermatology training for dermatology physician assistants. The DLI is an innovative program that promotes the dermatology physician assistant, the SDPA, and the profession as a whole. The DLI demonstrates that dermatology PAs are well educated, motivated, and willing to go the extra mile for our patients and our supervising physicians. Be sure to view With this program, everybody wins. Congratulations April Harrisonâ&#x20AC;&#x2122;s to April and all other SDPA Fellow members who interview on have worked hard to complete the DLI modules dermcast.tv and obtain Diplomate status. Vol. 5, No. 1 WINTER 2011 51
professional development
Why was it important for you to participate in the DLI?
Dermatology PA news & notes
From the Desk of... Susan Hammerling, MPAS, PA-C
SDPA Legislative Affairs Committee Chair
POLITICS 101 What would you do if you went to work as a PA one day and found out that a law had been passed where you are now only able to take a patient into an exam room and take their history? What if you couldn’t perform a shave biopsy, freeze a wart, or write a prescription for a patient with acne? Have you ever wondered how a bill gets passed through the legislature? One way to get a bill passed through the legislature involves the process of writing the legislation and getting a sponsor who will help the bill through the committees and votes on the floor. I think it is important to recognize that most legislators are interested in getting elected or reelected. Keep in mind that legislators believe that they are doing good for their communities and the best way to continue to do so and carry out their mission is to get reelected. Once you understand this fact, the next obvious fact is that if you help legislatures with their campaigns, they are more likely to help you get a bill through the legislature. Since all legislation has people for or against it, how do legislatures decide whether to support it or not? Remember legislators are interested in getting reelected and legislators often will side with those who will help them get reelected! As dermatology PAs we should seize such opportunities and align ourselves with local legislatures in order to promote our needs and continue to pursue positive growth for our profession. Dermatology PAs can play a unique role in creating change within the healthcare system. We not only understand various facets of the healthcare system, but we also understand the day-to-day issues that affect patients and their families. So, what can dermatology PAs do to affect real change within the Susan Hammerling, MPAS, PA-C is a 2001 graduate of the Nova Southeastern University Physician Assistant Program and has practiced dermatology for 10 years. She currently works at Florida Dermatology Associates with Ruben Moreno, MD in Palm Bay, Florida.
52 Journal of Dermatology for Physician Assistants
political world? The answer is a lot! Below is a list of political activities in which PAs can participate. 1. Become a member of the SDPA. 2. Contact local political leaders. You can contact political leaders in your area to learn about current local issues. This may lead to you becoming involved in activities that will support important local healthcare and PA legislation. 3. If you identify an important healthcare issue, start a letter writing or petition campaign in your healthcare organization. Letters and petitions supporting important legislation can be sent to local, state, and/or federal leaders. 4. Write a letter to the editor of a local or national newspaper. Use this forum to “spread the word” about issues important to PAs. 5. Call local or national radio talk shows. This is a great way to let the public know about important issues. 6. Talk with the manager or administrator of your own healthcare agency about issues that directly affect patient care and your practice as a PA. Sometimes starting right in your “own backyard” is the best way to initiate change. 7. Research issues or policies that are important to your practice. Provide a summary of your findings to your coworkers to educate them about the issues you have explored. 8. Educate others. PAs know that educating others is a great way to affect change. For those of you who do not have the time to participate in “lengthy” legislative activities, simply find a legislative bill or advocacy organization that interests you and send an email about your findings to coworkers, friends, and family. Ask them to pass the information on to others. Not all political activities require a visit to Capitol Hill; many only require you to get involved at some level. J
The Difference We Make
Delivering Bad News - Sacred Conversations In the Spring 2010 issue of the JPDA I discussed the have a way of curing it. Unfortunately, despite what issue of hope in relationship to delivering bad news. I know will be your loving and caring for him, at the Hope is defined as a belief in a positive outcome as present time and with the medical understanding that related to events or circumstances in one’s life. Bad we have, his life expectancy is no more than five years. I news can be defined as information, which changes am so sorry.” in a negative way a person’s perception of the future. As she told her story to us, we were all hushed. Then Therefore, bad news is defined by the recipient, the she told us the ‘end’ of the story. She met the mother patient. It cannot be defined or during a well baby hospital visit anticipated absolutely by the about ten years after the birth of “I truly believe that delivering deliverer. mother’s son who had died bad news is a caregivers’ greatest the Delivering bad news, at the age of four and a half. The opportunity to show how much depending upon how it is mother had delivered a healthy phrased, can be a “gift” to a daughter a year after her son they can express compassion, patient. It is an opportunity had passed away. The mother kindness, and caring to those to truly shine as a healthcare recalled the geneticist’s exact they take care of.” practitioner and as a person words about how her son was a with true compassion. Is there a “beautiful, sweet, and innocent best place, a best time, and are there special words that child” and those words were with her during the difficult we can use for these sacred conversations? times when her son became more and more ill. The mother told the geneticist that she had given her an Patients may never forget how they were told such image of a beautiful child and the hope for a possible news and the memory of this “delivery” of bad news cure. Her words had truly lasted the lifetime of her child may live with them for their entire lives. I remember a and many years after; they were truly words of peace geneticist telling a group of us a story about how she and hope. These are what sacred conversations are all first told the mother of a two week old that her child about. had an incurable genetic syndrome, which would take her baby’s life within five years. She told us that What general lessons can be learned from the she asked the mother and father to come to her office geneticist’s story? Whether we are talking about the one week after she had performed some genetic HPV or HSV virus, the diagnosis of psoriasis, or any other testing on their baby. “Mr. and Mrs. Harris,” she said, news that we believe might be considered bad news, “you have a beautiful, sweet, and innocent child, who we should deliver this information in person if it is at I can see has you and your husband’s wonderful joy all possible. We should also perhaps consider inviting and peacefulness.” She paused and then continued, a family member or an advocate for the patient to be “After performing and completing all the tests on your present. Sometimes if we believe that the results of a son I have something to tell you that is difficult for biopsy or culture may be positive, we might suggest me to express. Your son was born with the inability to this to the patient during the initial visit letting them digest fats in his diet. We do not have any cure for this know that more likely than not, all will be well. This condition at the present time. Perhaps as he gets older initial conversation is also an opportunity to discuss any we will understand more about this condition and will worries the patient may have before the actual diagnosis is made. Dr. Steve Shama has been practicing general dermatology for 30 years in Boston, Massachusetts. Dr. Shama has been a professional speaker When you anticipate delivering bad news, find for 20 of those years and enjoys speaking on many topics, some of a quiet place that is respectful of what is happening. which include: “Dealing With Difficult People and Looking Forward To Check with your staff to make sure that you are not It!” and “Rediscovering The Joys of Medicine and of Life.” He gives these interrupted. Ensure that you, as the deliverer of this talks at medical meetings and for the general public throughout the news, have adequate time to discuss the issue and for country. He also travels to private offices to present his workshops and talks. You can reach Dr. Shama at www.steveshama.com.
...continued on page 57
Vol. 5, No. 1 WINTER 2011 53
DERmatology pa news & notes
By Steven K. Shama, MD, MPH
Supervising Physician CORNER Note-o-Penia
DERmatology pa news & notes
By Michael Sherling, MD
“No one has ever died from ‘note-o-penia,’” a Originally, medical notes were meant as a venerable Boston physician told me as I began my communication between health care professionals. training, essentially instructing his interns to worry Only the pertinent information needed to be about patient care first and documentation later. included. Now of course, what we charge is not based on how much we do for the patient, but by how Now that seems like a lifetime ago. A lot has much we document what we did. In a ten-minute changed in medicine, and the need for documentation patient visit, five of those minutes may be devoted to always seems to be increasing. “If it isn’t in the chart, documentation. Though it didn’t happen,” has been we only need what could be the refrain ever since that day “We sacrifice the personal connection scribbled down in a minute in internship. I have heard or less, the insurers want once so highly valued in medicine… to it from lawyers, mentors, more. So we sacrifice the and billing specialists alike. hurry patients out as quickly as possible personal connection once so Every question and physical highly valued in medicine in order to finish our notes. Patients are finding has to be preserved such as asking about kids and for posterity or perhaps some not happy and neither are we.” grandkids or joking about future audit. sports team rivalries to hurry If you were to look patients out as quickly as possible in order to finish our at a medical dermatology note from twenty years notes. Patients are not happy and neither are we. ago for a simple condition like eczema, it might As physicians try to see more and more patients read something like, “S: Patient complains of itchy to make up for declining reimbursements, much rash for a few months. Worse in winter. O: Scaly, of the documentation burden seems to be falling erythematous patches on arms and legs. A: Eczema. on the shoulders of physician assistants. “They P: Triamcinolone x 2 weeks.” Now, that same note (physician assistants) are often the only ones writing might carry on for two pages and include all negative in the charts,” says James Kennedy, MD, in a widely and positive answers to questions pertinent or not. circulated health information management periodical.1 A medication list would be included, as would a This makes the over documentation situation all the past medical and surgical history. Perhaps a social more frustrating for the physician assistant who wants and family history would be included as well. Such to spend time with his or her patient. documentation does not further patient care and would not be particularly helpful to a referring physician. Since insurance companies and government But without all the extra information, a visit would be regulations aren’t going anywhere and if anything, barely billable, and a practice could indeed die from promise to become more onerous in the future, how note-o-penia. do we make the third party payers, our patients, and maybe even ourselves happy too? The answer lies in Michael Sherling, MD l is a board certified emerging so-called touch technology. Look at your dermatologist and the Chief Medical Officer own touch screen device, you know, the one your four of Modernizing Medicine, Inc. (www. modernizingmedicine.com), a software company year-old likes to use or notice the one the cashier is that designs mobile and web-based solutions to placing your order on in the quick-service restaurant. save physicians and physician assistants time. He Now picture such a hand-held device in your office. practices in Florida and is an expert in medical, With a few taps on a male or female figure on the surgical, and cosmetic dermatology. Prior to relocating to Florida, screen and a few more taps for the diagnosis and plan, he was the Associate Director of Laser Medicine and Skin Health at Brigham and Women’s Hospital and the Associate Residency the note is done in less than a minute. The computer Program Director for Harvard Medical School’s Department of can fill in all the extra words so you don’t have to. Dermatology. He has several publications in peer reviewed medical Basically, you are entering an old-fashioned short and literature. He obtained his B.S. in Biology at Brown University with sweet SOAP note, but generating a nice long billable honors in 1996, his M.D. from Yale School of Medicine with honors in 2002, and his MBA from Yale School of Management in 2002. He note for the third party payers. received his clinical training at Harvard Medical School, where he served as chief resident in dermatology.
54 Journal of Dermatology for Physician Assistants
...continued on page 57
A clear message for external genital and perianal warts (EGW)...
“I don’t want to see you again.” VEREGEN® Delivers Complete Clearance With Low Recurrence • Demonstrated complete clearance in 53.6% of all patients studied1
• Only 6.8% rate of recurrence among patients with complete clearance 12 weeks posttreatment1
• Proven effective in clearing both baseline and newly emerging EGW in male and female patients1
The FIRST
BOTANICAL DRUG approved for prescription use in the United States2
VEREGEN
®
(sinecatechins) Ointment,15%
Get out and stay out. VEREGEN® is indicated for the topical treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older. Important Selected Safety Information
VEREGEN® has not been evaluated to treat urethral, intra-vaginal, cervical, rectal, or intra-anal human papilloma viral disease and should not be used to treat these conditions. Avoid use of VEREGEN® on open wounds. Avoid exposure of VEREGEN®-treated areas to sun/UV-light because VEREGEN® has not been tested under these circumstances. Safety and efficacy of VEREGEN® have not been established in immunosuppressed or pediatric patients, or pregnant women, or for the treatment of external genital and perianal warts beyond 16 weeks or for multiple treatment courses. The most common adverse reactions are local skin and application site reactions including (incidence ≥ 20%) erythema, pruritus, burning, pain/discomfort, erosion/ulceration, edema, induration, and rash vesicular. References: 1. VEREGEN® Ointment, 15% [Prescribing Information, 2008]. Melville, NY: PharmaDerm, a division of Nycomed US Inc. 2. Data on file, PharmaDerm. Please see adjacent page for Brief Summary of full Prescribing Information.
VEREGEN is a registered trademark of MediGene AG, D-82152 Planegg/Martinsried, Germany. ©2010 PharmaDerm, a division of Nycomed US Inc. Melville, NY 11747. All rights reserved. 98NVE400910
Vol. 5, No. 1 WINTER 2011 55
Brief Summary of Prescribing Information–See Package Insert for Full Prescribing Information at www.pharmaderm.com
Veregen
USE IN SPECIFIC POPULATIONS
®
Pregnancy
(sinecatechins)
Pregnancy Category C: There are no adequate and well controlled studies in pregnant women. Veregen® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Ointment, 15%
Nursing Mothers
Rx Only
It is not known whether topically applied Veregen® is excreted in breast milk.
Pediatric Use
For Topical Dermatologic Use Only
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use INDICATIONS AND USAGE Veregen® is indicated for the topical treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older. The safety and effectiveness of Veregen® have not been established for treatment beyond 16-weeks or for multiple treatment courses. The safety and effectiveness of Veregen® in immunosuppressed patients have not been established.
CONTRAINDICATIONS None
CLINICAL STUDIES Two randomized, double-blind, vehicle-controlled studies were performed to investigate the safety and efficacy of Veregen® in the treatment of immunocompetent patients 18 years of age and older with external genital and perianal warts. The subjects applied the ointment 3 times daily for up to 16 weeks or until complete clearance of all warts (baseline and new warts occurring during treatment). Over both studies the median baseline wart area was 51 mm2 (range 12 to 585 mm2), and the median baseline number of warts was 6 (range 2 to 30). The primary efficacy outcome measure was the response rate defined as the proportion of patients with complete clinical (visual) clearance of all external genital and perianal warts (baseline and new) by week 16, presented in Tables 1 and 2 for all randomized subjects dispensed medication.
Table 1: Efficacy by Region Complete Clearance All Countries (includes the United States) Veregen® 15% (N = 397)
213 (53.6%)
Vehicle (N = 207)
73 (35.3%)
United States Veregen® 15% (N = 21)
5 (23.8%)
Vehicle (N = 9)
0 (0.0%)
Table 2: Efficacy by Gender Complete Clearance Males Veregen® 15% (N = 205)
97 (47.3%)
Vehicle (N = 118)
34 (28.8%)
Females Veregen® 15% (N = 192)
116 (60.4%)
Vehicle (N = 89)
39 (43.8%)
Median time to complete wart clearance was 16 weeks and 10 weeks, respectively, in the two phase 3 clinical trials. The rate of recurrence of external genital and perianal warts 12 weeks after completion of treatment in subjects with complete clearance is 6.8% (14/206) for those treated with Veregen® and 5.8% (4/69) for those treated with vehicle.
WARNINGS AND PRECAUTIONS Veregen® has not been evaluated for the treatment of urethral, intra-vaginal, cervical, rectal, or intra-anal human papilloma viral disease and should not be used for the treatment of these conditions. Use of Veregen® on open wounds should be avoided. Patients should be advised to avoid exposure of the genital and perianal area to sun/ UV-light as Veregen® has not been tested under these circumstances.
56 Journal of Dermatology for Physician Assistants
Seven patients (1.4%), older than 65 years of age were treated with Veregen® in clinical studies. This, however, is an insufficient number of subjects to determine whether they respond differently from younger subjects.
ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In Phase 3 clinical trials, a total of 397 subjects received Veregen® three times per day topical application for the treatment of external genital and perianal warts for up to 16 weeks. Serious local adverse events of pain and inflammation were reported in two subjects (0.5%), both women. In clinical trials, the incidence of patients with local adverse events leading to discontinuation or dose interruption (reduction) was 5% (19/397). These included the following events: application site reactions (local pain, erythema, vesicles, skin erosion/ulceration), phimosis, inguinal lymphadenitis, urethral meatal stenosis, dysuria, genital herpes simplex, vulvitis, hypersensitivity, pruritus, pyodermitis, skin ulcer, erosions in the urethral meatus, and superinfection of warts and ulcers. Local and regional reactions (including adenopathy) occurring at >1% in the groups treated with Veregen® (N=397) or vehicle (N=207), respectively, were: erythema (70%, 32%), pruritus (69%, 45%), burning (67%, 31%), pain/discomfort (56%, 14%), erosion/ulceration (49%, 10%), edema (45%, 11%), induration (35%, 11%), rash vesicular (20%, 6%), regional lymphadenitis (3%, 1%), desquamation (5%, <1%), discharge (3%, <1%), bleeding (2%, <1%), reaction (2%, 0%), scar (1%, 0%), irritation (1%, 0%), and rash (1%, 0%). A total of 266/397 (67%) of subjects in the Veregen® group had either a moderate or a severe reaction that was considered probably related to the drug, of which 120 (30%) subjects had a severe reaction. Severe reactions occurred in 37% (71/192) of women and in 24% (49/205) of men. The percentage of subjects with at least one severe, related adverse event was 26% (86/328) for subjects with genital warts only, 42% (19/45) in subjects with both genital and perianal warts and 48% (11/23) of subjects with perianal warts only. Phimosis occurred in 3% of uncircumcised male subjects (5/174) treated with Veregen® and in 1% (1/99) in vehicle. The maximum mean severity of erythema, erosion, edema, and induration was observed by week 2 of treatment. Less common local adverse events included urethritis, perianal infection, pigmentation changes, dryness, eczema, hyperesthesia, necrosis, papules, and discoloration. Other less common adverse events included cervical dysplasia, pelvic pain, cutaneous facial rash, and staphylococcemia. In a dermal sensitization study of Veregen® in healthy volunteers, hypersensitivity (type IV) was observed in 5 out of 209 subjects (2.4%) under occlusive conditions.
DOSAGE AND ADMINISTRATION Veregen® is to be applied three times per day to all external genital and perianal warts. Treatment with Veregen® should be continued until complete clearance of all warts, however no longer than 16 weeks.
HOW SUPPLIED/STORAGE AND HANDLING Veregen® is a brown ointment and is supplied in an aluminum tube containing 15 grams (NDC # 10337-450-15) of ointment per tube. Prior to dispensing to the patient, store refrigerated 2°C to 8°C (36°F to 46°F). After dispensing, store refrigerated or up to 25°C (77°F). Do not freeze.
Manufactured by: C.P.M. Contract Pharma GmbH & Co. KG Frühlingstrasse 7 D-83620 Feldkirchen-Westerham Germany U.S. Patent Nos. 5795911 and 5968973
Manufactured for:
www.pharmaderm.com
Melville, NY 11747 USA
98NVE390210
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the patient to ask questions. Invite the patient back at the end of your morning or afternoon, so that if you should need more time the conversation can always extend into your lunch hour or at the end of the day if necessary. Another option, when more time is needed, is to invite the patient back for a continuation of the discussion, or to offer them the option of continuing the discussion with a phone conversation. Remember, these options should be discussed with the patient to make sure that the patient is in agreement. At the end of any discussion check with the patient to make sure he/she has the information needed and is okay with the way you have presented the facts. Asking the simple question, “Is there anything else I can say or do to make this better or to help in any way?” is a wonderful way of summarizing. Always make yourself available for further questions after the patient has left your office and let the patient know that you are there for him/her. If the bad news is something that you feel can be delivered by someone else in your office, such as the diagnosis of a basal cell carcinoma, make sure that the
patient knows that you have delegated this person to speak with him/her and that, if the patient has any further questions, you personally are available. Your delegate should preferably be someone who is known to the patient, is knowledgeable, and has a kind voice. The words that are used to explain the diagnosis, treatment, and the significance of the diagnosis should be simple words, not technical ones, and should leave the patient with hope. We can never totally and completely understand how our words affect another, either in a positive or a negative way. Let us always try to find words that embrace, support, and give hope. I truly believe that delivering bad news is a caregivers’ greatest opportunity to show how much they can express compassion, kindness, and caring to those they take care of. Let our words to our patients be like the words of the geneticist that were never forgotten by the mother and gave that mother beautiful, sweet, and innocent moments with her child. May our kind words be able to last a lifetime and make a positive difference in the lives of those we care for. J
Supervising Physician CORNER Touch screen technology can be more than just a note-generation tool; it can finally bring the decisionsupport long promised by medical informatics out of the classroom and into the exam room. No physician or physician assistant can be expected to remember all aspects of dermatology at a moment’s notice. Combing through a textbook while patients are waiting is a luxury few have outside of training. The American Informatics Association has asserted that, “The need for clinical decision support (CDS) arises from a significant gap that exists between what is known to medical science and the care that many patients actually receive.”2 The American Informatics Association article goes on to say that, “by providing the right information to the right people at the right point in the clinical workflow, CDS interventions can be highly effective at addressing this crisis in care quality.” Touch screen technology can help to provide “the right information” by generating a point-of-service differential diagnosis. Described by some as a “magical device,” the iPad makes decision support a feasible
...continued from page 54
idea for busy medical professionals.3 Tap a few keys to create a description and common and not so common suggestions can appear on the screen. Think of it as a Fitzpatrick’s atlas for the 21st century, on the screen for you to view in real time as your taps generate a note, and you never break eye contact with your patient. If this sounds like some theoretical futuristic dream, it isn’t. I am already using this type of technology in my office. There is no stack of paperwork at the end of the day, and I even get to see a few pictures of my patients’ grandkids. What was told to me so many years ago gets to be true again: no one ever dies from note-o-penia, my practice included. J REFERENCES: 1. Chavis S. Chart a course for better documentation. For the record. 2008;20(20):30. 2. Kawamoto K, Lobach D. Proposal for fulfilling strategic objectives of the US roadmap for national action on decision support through a serviceoriented architecture leveraging. HL 7 Services. J Am Med Inform Assoc. 2007;14(2):146-155. 3. Tedeschi B. 10 apps that make magic on your iPad. NY Times. Dec. 8, 2010.
Vol. 5, No. 1 WINTER 2011 57
DERmatology pa news & notes
The Difference We Make
Professional Opportunities and Development
Advertiser INDE X OrthoDermatologics – Retin-A Micro......Pages 2, 3 Ranbaxy – Kenalog Spray...........................Pages 7, 8 Coria – Atralin.......................................Pages 11, 12 Intendis – Finacea..................................Pages 14, 15 Coria – Refissa....................................... Pages 27, 28 Medicis – Solodyn............................ Pages 31, 32, 33 Galderma – Clobex Spray...................... Pages 39, 40 Graceway – Zyclara...............................Pages 43, 44 Galderma – Differin Lotion................... Pages 49, 50 PharmaDerm – Veregen........................ Pages 55, 56 Stiefel – Veltin....................................... Pages 59, 60 For more information on advertising opportunities in the JDPA, please log on to www.jdpa.org
CICATRICIAL ALOPECIA RESEARCH FOUNDATION The Cicatricial Alopecia Research Foundation (CARF) is the world center for those with cicatricial alopecia. The Foundation ■ Provides funds for research to find effective treatments and a cure ■ Supports education and advocacy ■ Raises public awareness
P.O. Box 64158 Los Angeles, CA 90064 310.475.2419 info@carfintl.org
www.carfintl.org
Speakers Include: James Del Rosso D.O. Hilary Baldwin M.D. Leon Kircik M.D.
May 12-14, 2011 at the Cobb Galleria Centre in Atlanta, GA Offering 21 hours of Category I CME Registration $300 for Early Bird and $375 starting March 1 Conference Hotel from $119 a night For more information visit: www.GaDermPA.com and click on CME Conference Sponsored by the Georgia Dermatology Physician Assistants
58 Journal of Dermatology for Physician Assistants
BRIEF SUMMARY VELTIN™ (clindamycin phosphate and tretinoin) Gel 1.2%/0.025% The following is a brief summary only; see full prescribing information for complete product information. 1 INDICATIONS AND USAGE VELTIN Gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older. 4 CONTRAINDICATIONS VELTIN Gel is contraindicated in patients with regional enteritis, ulcerative colitis, or history of antibiotic-associated colitis. 5 WARNINGS AND PRECAUTIONS 5.1 Colitis Systemic absorption of clindamycin has been demonstrated following topical use. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical clindamycin. If significant diarrhea occurs, VELTIN Gel should be discontinued. Severe colitis has occurred following oral or 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. Studies indicate a toxin(s) produced by clostridia is one primary cause of antibioticassociated colitis. 5.2 Ultraviolet Light and Environmental Exposure Exposure to sunlight, including sunlamps, should be avoided during the use of VELTIN Gel, and patients with sunburn should be advised not to use the product until fully recovered because of heightened susceptibility to sunlight as a result of the use of tretinoin. Patients who may be required to have considerable sun exposure due to occupation and those with inherent sensitivity to the sun should exercise particular caution. Daily use of sunscreen products and protective apparel (e.g., a hat) are recommended. Weather extremes, such as wind or cold, also may be irritating to patients under treatment with VELTIN Gel. 6 ADVERSE REACTIONS 6.1 Adverse Reactions in Clinical Studies The safety data reflect exposure to VELTIN Gel in 1,104 patients with acne vulgaris. Patients were 12 years or older and were treated once daily in the evening for 12 weeks. Observed local treatment-related adverse reactions (≥1%) in clinical studies with VELTIN Gel were application site reactions, including dryness (6%), irritation (5%), exfoliation (5%), erythema (4%), pruritus (2%), and dermatitis (1%). Sunburn (1%) was also reported. Incidence of skin reactions peaked at week 2 and then gradually decreased. Local skin reactions were actively assessed at baseline and at the end of 12 weeks of treatment in patients exposed to VELTIN Gel. At baseline (N=476), local skin reactions included erythema (24%), scaling (8%), dryness (11%), burning (8%), and itching (17%). At 12 weeks of treatment (N=409), local skin reactions included erythema (21%), scaling (19%), dryness (22%), burning (13%), and itching (15%). During the 12 weeks of treatment, each local skin reaction peaked at week 2 and gradually reduced thereafter. 7 DRUG INTERACTIONS 7.1 Erythromycin VELTIN Gel should not be used in combination with erythromycin-containing products due to possible antagonism to the clindamycin component. In vitro studies have shown antagonism between these 2 antimicrobials. The clinical significance of this in vitro antagonism is not known. 7.2 Neuromuscular Blocking Agents Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, VELTIN Gel should be used with caution in patients receiving such agents. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category C. There are no well-controlled studies in pregnant women treated with VELTIN Gel. VELTIN Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. A limit teratology study performed in Sprague Dawley rats treated topically with VELTIN Gel or 0.025% tretinoin gel at a dose of 2 mL/kg during gestation days 6 to 15 did not result in teratogenic effects. Although no systemic levels of tretinoin were detected, craniofacial and heart abnormalities were described in drug-treated groups. These abnormalities are consistent with retinoid effects and occurred at 16 times the recommended clinical dose assuming 100% absorption and based on body surface area comparison. For purposes of comparison of the animal exposure to human exposure, the recommended clinical dose is defined as 1 g of VELTIN Gel applied daily to a 50 kg person. Tretinoin: Oral tretinoin has been shown to be teratogenic in mice, rats, hamsters, rabbits, and primates. It was teratogenic and fetotoxic in Wistar rats when given orally at doses greater than 1 mg/kg/day (32 times the recommended clinical dose based on body surface area comparison). However, variations in teratogenic doses among various strains of rats have been reported. In the cynomologous monkey, a species in which tretinoin metabolism is closer to humans than in other species examined, fetal malformations were reported at oral doses of 10 mg/kg/day or greater, but none were observed at 5 mg/kg/day (324 times the recommended clinical dose based on body surface area comparison), although increased skeletal variations were observed at all doses. Dose-related teratogenic effects and increased abortion rates were reported in pigtail macaques.
With widespread use of any drug, a small number of birth defect reports associated temporally with the administration of the drug would be expected by chance alone. Thirty cases of temporally associated congenital malformations have been reported during two decades of clinical use of another formulation of topical tretinoin. Although no definite pattern of teratogenicity and no causal association have been established from these cases, 5 of the reports describe the rare birth defect category, holoprosencephaly (defects associated with incomplete midline development of the forebrain). The significance of these spontaneous reports in terms of risk to fetus is not known. 8.3 Nursing Mothers It is not known whether clindamycin is excreted in human milk following use of VELTIN 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 discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. It is not known whether tretinoin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when VELTIN Gel is administered to a nursing woman. 8.4 Pediatric Use Safety and effectiveness of VELTIN Gel in pediatric patients below the age of 12 years have not been established. Clinical trials of VELTIN Gel included 2,086 patients 12-17 years of age with acne vulgaris. [See Clinical Studies (14) of full prescribing information.] 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential of VELTIN Gel or the effect of VELTIN Gel on fertility. VELTIN Gel was negative for mutagenic potential when evaluated in an in vitro Ames Salmonella reversion assay. VELTIN Gel was equivocal for clastogenic potential in the absence of metabolic activation when tested in an in vitro chromosomal aberration assay. Clindamycin: Once daily dermal administration of 1% clindamycin as clindamycin phosphate in the VELTIN Gel vehicle (32 mg/kg/day, 13 times the recommended clinical dose based on body surface area comparison) to mice for up to 2 years did not produce evidence of tumorigenicity. Tretinoin: In two independent mouse studies where tretinoin was administered topically (0.025% or 0.1%) three times per week for up to two years no carcinogenicity was observed, with maximum effects of dermal amyloidosis. However, in a dermal carcinogenicity study in mice, tretinoin applied at a dose of 5.1 μg (1.4 times the recommended clinical dose based on body surface area comparison) three times per week for 20 weeks acted as a weak promoter of skin tumor formation following a single application of dimethylbenz[]anthracene (DMBA). In a study in female SENCAR mice, papillomas were induced by topical exposure to DMBA followed by promotion with 12-O-tetradecanoyl-phorbol 13-acetate or mezerein for up to 20 weeks. Topical application of tretinoin prior to each application of promoting agent resulted in a reduction in the number of papillomas per mouse. However, papillomas resistant to topical tretinoin suppression were at higher risk for pre-malignant progression. Tretinoin has been shown to enhance photoco-carcinogenicity in properly performed specific studies, employing concurrent or intercurrent exposure to tretinoin and UV radiation. The photoco-carcinogenic potential of the clindamycin tretinoin combination is unknown. Although the significance of these studies to humans is not clear, patients should avoid exposure to sun. 17 PATIENT COUNSELING INFORMATION [See FDA-approved Patient Labeling]. 17.1 Instructions for Use • At bedtime, the face should be gently washed with a mild soap and water. After patting the skin dry, apply VELTIN Gel as a thin layer over the entire affected area (excluding the eyes and lips). • Patients should be advised not to use more than a pea sized amount to cover the face and not to apply more often than once daily (at bedtime) as this will not make for faster results and may increase irritation. • A sunscreen should be applied every morning and reapplied over the course of the day as needed. Patients should be advised to avoid exposure to sunlight, sunlamp, ultraviolet light, and other medicines that may increase sensitivity to sunlight. • Other topical products with a strong drying effect, such as abrasive soaps or cleansers, may cause an increase in skin irritation with VELTIN Gel. 17.2 Skin Irritation VELTIN Gel may cause irritation such as erythema, scaling, itching, burning, or stinging. 17.3 Colitis In the event a patient treated with VELTIN Gel experiences severe diarrhea or gastrointestinal discomfort, VELTIN Gel should be discontinued and a physician should be contacted. STIEFEL and STIEFEL & Design are registered trademarks of Stiefel Laboratories, Inc. VELTIN is a trademark of Astellas Pharma Europe B.V. VEL:2BRS Issued July 2010 ©2010 Stiefel Laboratories, Inc.
©2010 Stiefel Laboratories, Inc. All rights reserved. Printed in USA. VEL015R0 September 2010
Vol. 5, No. 1 WINTER 2011 59
Introducing VELTIN Gel—A New Topical Treatment for Patients �� Years or Older With Acne Vulgaris Once-daily application in the evening
VELTIN Gel
Combines the acne-fighting properties of tretinoin and clindamycin Contains tretinoin, solubilized in an aqueous-based gel Combats inflammatory and noninflammatory acne
Important Safety Information for VELTIN Gel VELTIN Gel is contraindicated in patients with regional enteritis, ulcerative colitis, or history of antibiotic-associated colitis Systemic absorption of clindamycin has been demonstrated following topical use. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical clindamycin. VELTIN Gel should be discontinued if significant diarrhea occurs. Severe colitis has occurred following oral or parenteral clindamycin administration. Severe colitis may result in death Avoid exposure to sunlight and sunlamps when using VELTIN Gel. Patients with sunburn should be advised not to use VELTIN Gel until fully recovered. Daily use of sunscreen products and protective apparel are recommended. Weather extremes (eg, wind and cold) also may be irritating to patients using VELTIN Gel Observed local treatment-related adverse reactions (≥�%) in clinical studies with VELTIN Gel were application site reactions, including dryness, irritation, exfoliation, erythema, pruritus, and dermatitis. Sunburn was also reported. Incidence of skin reactions peaked at week � and then gradually decreased VELTIN Gel should not be used in combination with erythromycincontaining products due to possible antagonism to the clindamycin component Please see brief summary of Prescribing Information on the next page.
60 Journal of Dermatology for Physician Assistants
Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. VELTIN Gel should be used with caution in patients receiving such agents VELTIN Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus It is not known whether either clindamycin or tretinoin is excreted in human milk following use of VELTIN Gel. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. Due to possible serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or the drug. Exercise caution if administering VELTIN Gel to a nursing woman The efficacy and safety have not been established in pediatric patients below the age of �� years VELTIN Gel is not for oral, ophthalmic, or intravaginal use