Volume 5 number 3 SUMMER 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. 3 SUMMER 2011
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 Keri Holyoak, MPH, PA-C PrESiDEnT-ElECT John Notabartolo, MPAS, PA-C iMMEDiATE PAST PrESiDEnT Abby Jacobson, MS, PA-C ViCE PrESiDEnT Jacki Kment, MPAS, PA-C SECrETAry / TrEASurEr Casey Croes, MPAS, PA-C DirECTors AT lArGE Susan Hammerling, MPAS, PA-C Kristine Kucera, DHS, MPAS, PA-C Vicki Roberts, MPAS, PA-C Jennifer Winter, PA-C Society of Dermatology Physician Assistants, Inc
4111 W. Alameda Ave. Suite 412 Burbank, CA 91505 1-800-380-3992 SDPA@dermpa.org www.dermpa.org
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 3, Summer 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., 4111 W. Alameda Ave. Suite 412, Burbank, CA 91505, 1-800-380-3992. THIS ISSUE IS SPONSORED BY
Journal of Dermatology for Physician Assistants
Editor’s Message
Summer Reading Journal of Dermatology for Physician Assistants
The Official Journal of the SDPA
E
arly each summer I look forward to teaching the incoming class of new PA students. It had been a while since I last taught, and I had to remind myself to simplify my presentation. It was not because the students lacked knowledge, quite the opposite. I found them to be very sharp and intelligent at what they had learned thus far. Instead, I realized that the major change that had occurred since the last time I taught was how much more experienced at practicing dermatology I now was. When we begin our careers we see things very differently, very simply. A similar situation is a child looking at a book for the first time. To the child who has not learned to read, he or she sees only a mass of individual letters on a page. For a beginning PA student, he or she sees only individual papules, plaques, and scale. As time passes, a child learns to assemble letters and these letters begin to resemble words; so too does a novice PA student begin to become more proficient at grouping individual lesions into recognizable rashes. Eventually a child is able to assemble words into sentences, and the sentences begin to tell a story. A PA who has years of experience is able to look at a rash and see an entire story unfold. The story leads the PA to ask very directed questions, which elicit responses from a patient such as, “Why yes, how did you know that I swim in a chlorinated pool and have allergies and asthma?” The PA is able to read the story after piecing together the presence of eczema, recognizing the attributes of an atopic individual, and detecting the smell of chlorine in the air from the patient’s morning water aerobics workout. Like any other profession, with years of experience we begin to master our craft. Work begins to become less tedious as we enjoy the good stories our patients share with us each and every day. J
The Diplomate Countdown is Underway
Travis Hayden, MPAS, PA-C Editor in chief
Visit dermpa.org/diplomate today to read up on all current Diplomate requirements and deadlines.
Vol. 5, No. 3 SUMMER 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.
18
Rubber Allergens as a Cause of Allergic Contact Dermatitis By J. Desiree Douglas, MPA, PA-C
CME
10 Derm PA News & Notes – part one
• New FDA Rules for Sunscreen Labeling - Important Information for Dermatology Providers and Their Patients • Certification Review – All Those Things Inside the Skin You Might Have Forgotten
18 Clinical Dermatology
• CME Article – Rubber Allergens as a Cause of Allergic Contact Dermatitis • Dermatology Case Report - Larval Tick Infestation • Dermatology Evidence Based Medicine - A Modified CAGE Questionnaire for Tanning Addiction • Drugs in Dermatology - Coal Tar - A Brief History and Overview of Its Uses in Dermatology
Departments
04 Editorial Board 05 Editor’s Message 09 SDPA News & Current Affairs 10 Dermatology Market Watch 24 From The Patient’s Perspective 27 Dermoscopy 36 Clinical Snapshots 43 Surgical Wisdom 46 Cosmetic Pearls 52 Notes from your Office Manager 55 Outside & Inside the 9 to 5... 59 The Difference We Make 62 Professional Opportunities and Development
38 Surgical Dermatology
• Mohs Surgery - An Interview with Shelley Sekula-Gibbs, MD
44 Cosmetic Dermatology
• Emerging Technologies Light The Way For Better Sunscreens
50 Professional Development
56 Derm PA News & Notes – part two
Go Green - Read Online
• Dermatology Billing & Coding – Destruction of Malignant Lesions (CPT codes 17260 to 17286) - Do You Measure Up? • Judicial and Ethical Affairs - Conflicts of Interest
Journal of Dermatology for Physician Assistants
• From the Desk of… • First Foundations - You’re Trained, What Now? • Supervising Physician Corner
dermPA.org
Vol. 5, No. 3 SUMMER 2011
Journal of Dermatology for Physician Assistants
Calendar
FROM THE SPDA News & Current Affairs
of events
2011
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
2012
MARCH 70th AAD Annual Academy Meeting March 16 - 20, 2012 San Diego, CA JULY SDPA Summer Dermatology Conference July 11 - 15, 2012 The Westin Hotel Seattle, WA
A
s I sat in the back of the room as a new PA-C at my first SDPA conference, I remember thinking, “I’m just a new PA-C. I lack clinical experience. Why would the SDPA need me to get involved?” From the outside looking in, the SDPA seemed like a well-oiled machine, bustling with purpose-driven people focused and determined to uphold and advance our profession. However, after attending four or five conferences, the message started sinking in. Protecting my career and profession was my responsibility. I never imagined that I would eventually become part of the SDPA Board of Directors and now President. We are engaged in remarkable things in the SDPA, which are made possible by members who, despite being too busy and tired, have stepped forward. They have a desire to improve your world and our world; the world our young members and future members will inherit. There is no need to hesitate about getting involved. In fact, now is the time to step up and serve the SDPA. Ultimately, you will benefit from whatever effort you make. If you have criticisms, bring them forward and back them up with solutions. We need new minds to help us span the generational and cultural separations within our profession. According to an old Spanish proverb “A little spark kindles a great fire.” I hope to create a small spark in each of you and by doing so continue the great fire of the SDPA in 2012. J
Calendar of Events Submissions Send information to: Editor@jdpa.org
Keri Holyoak, MPH, PA-C President Society of Dermatology Physician Assistants
Vol. 5, No. 3 SUMMER 2011
9
Dermatology PA news & notes
Dermatology Market Watch miraDry by Miramar Labs
Novel technology treats axillary hyperhidrosis Miramar Labs announced that it has received FDA 510(k) clearance for the new miraDry System for the treatment of primary axillary hyperhidrosis. miraDry is a noninvasive, quick, outpatient procedure that provides a lasting solution for primary axillary hyperhidrosis. Millions of Americans suffer from primary axillary hyperhidrosis, and many suffer silently— ashamed, frustrated and embarrassed because excessive underarm sweat can interfere with nearly every aspect of life. The miraDry procedure takes approximately one hour per office visit, and is typically conducted in two visits. It requires only a local anesthetic, causes little to no downtime, and provides a lasting
solution. This is in stark contrast to previously available alternatives. A robust, randomized, blinded clinical study that involved 120 people across 7 sites and followed patients 12-months post treatment demonstrated the efficacy and safety of miraDry. The miraDry procedure entails delivering electromagnetic energy to the area beneath the axillary skin where the sweat glands reside, resulting in thermolysis of the sweat glands. The effect can be seen almost immediately. The miraDry procedure will be available later this year through miraDrycertified dermatologists.
HylatopicPlus-Aurstat™ Kit
A Convenient Approach to Treating Patients with Atopic Dermatitis and Skin Susceptible to S. aureus Colonization Onset Dermatologics announced the launch of the HylatopicPlus-Aurstat™ Kit, now available in the U.S. by prescription only. The kit provides two products within one package: HylatopicPlus™ Emollient Foam indicated to manage and relieve burning, itching and pain that can accompany skin dermatoses such as atopic dermatitis and Aurstat™ Skin & Wound HydroGel, which is used to relieve skin irritation, minor abrasions and lacerations—and also can be used on intact skin. HylatopicPlus™ Emollient Foam is formulated to rapidly hydrate the stratum corneum and provide a semi-permeable barrier that protects against irritants and excessive water loss through the skin. 10 Journal of Dermatology for Physician Assistants
HylatopicPlus™ incorporates hyaluronic acid to deliver a blend of physiologic lipids, including ceramide, to restore healthy barrier function. HylatopicPlus™ has been clinically proven to improve the symptoms of atopic dermatitis. Aurstat™ HydroGel is intended for over-thecounter use on minor skin abrasions and lacerations— and for use on intact skin. Aurstat™ contains a unique shelfstable formulation of hypochlorous acid in hydrogel form. In a laboratory setting, Aurstat™ killed 99.99% of Staphylococcus aureus (S. aureus) within 30 seconds post-application. Aurstat™ HydroGel is non-irritating and can be safely used around the eyes, nose and mouth.
...continued on page 13
CLODERM CREAM Not a cookie-cutter topical steroid ®
Different by Design • Unique molecular structure provides midstrength efficacy with an excellent safety profile1-3 • Only Cloderm Cream offers the versatility of both a tube and pump To request samples or for further information, contact Promius Pharma at 888.384.6929 Indication and Important Safety Information Cloderm Cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. The most common adverse events with Cloderm Cream include burning, itching, irritation, dryness, and folliculitis. Cloderm Cream is contraindicated in patients who are hypersensitive to any of the ingredients of this product. As with all topical corticosteroids, systemic absorption can produce reversible HPA-axis suppression. See full prescribing information on reverse side. For more information see www.Cloderm.com. References: 1. Bikowski J, Pillai R, Shroot B. The position not the presence of halogen in corticosteroids influences potency and side effects. J Drug Dermatol. 2006;5(2):125-130. 2. Del Rosso J, Friedlander S. Corticosteroids: options in the era of steroid-sparing therapy. J Am Acad Dermatol. 2005;53(1 Suppl 1):S50-58. 3. Data on file. Promius Pharma, LLC: Bridgewater, NJ. Cloderm® is a trademark of Coria Laboratories, Ltd.
Vol. 5, No. 3 SUMMER 2011 11
RxOnly Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results. FOR TOPICAL DERMATOLOGIC USE ONLY– NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE. WARNING: KEEP OUT OF REACH OF CHILDREN DESCRIPTION: Cloderm Cream 0.1% contains the medium potency topical corticosteroid, clocortolone pivalate, in a specially formulated water-washable emollient cream base consisting of purified water, white petrolatum, mineral oil, stearyl alcohol, polyoxyl 40 stearate, carbomer 934P, edetate disodium, sodium hydroxide, with methylparaben and propylparaben as preservatives. Chemically, clocortolone pivalate is 9-chloro-6_-fluoro-11`, 21-dihydroxy-16_ methylpregna-1, 4-diene-3, 20-dione 21-pivalate. Its structure is as follows: CLINICAL PHARMACOLOGY: Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man. Pharmacokinetics: The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses. (See DOSAGE AND ADMINISTRATION). Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile. INDICATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. CONTRAINDICATIONS: Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. PRECAUTIONS: General: Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients. Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.
Pregnancy Category C: Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time. Nursing Mothers: It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman. Pediatric Use: Pediatric patients may demonstrate greater susceptibility to topical corticosteroidinduced HPA axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface area body weight ratio. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children. ADVERSE REACTIONS: The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: Burning, Itching, Irritation, Dryness, Folliculitis, Hypertrichosis, Acneiform eruptions, Hypopigmentation, Perioral dermatitis, Allergic contact dermatitis, Maceration of the skin, Secondary infection, Skin atrophy, Striae, Miliaria OVERDOSAGE: Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS). DOSAGE AND ADMINISTRATION: Apply Cloderm (clocortolone pivalate) Cream 0.1% sparingly to the affected areas three times a day and rub in gently. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted. HOW SUPPLIED: Cloderm (clocortolone pivalate) Cream 0.1% is supplied in 30 gram and 75 gram pump bottles, 45 gram and 90 gram tubes. Store Cloderm Cream between 15° and 30° C (59° and 86° F). Avoid freezing. Distributed by:
Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity. (See PRECAUTIONS-Pediatric Use). If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled. Information for the Patient: Patients using topical corticosteroids should receive the following information and instructions: 1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes. 2. Patients should be advised not to use this medication for any disorder other than for which it was prescribed. 3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician. 4. Patients should report any signs of local adverse reactions especially under occlusive dressing. 5. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings. Laboratory Tests: The following tests may be helpful in evaluating the HPA axis suppression: Urinary free cortisol test ACTH stimulation test
12 Journal of Dermatology for Physician Assistants
XXX QSPNJVTQIBSNB DPN Promius Pharma, LLC 200 Somerset Corporate Blvd., Bridgewater, NJ 08807 Manufactured by: DPT LABORATORIES, LTD. San Antonio, Texas 78215 ClodermÂŽ is a trademark of Coria Laboratories, Ltd. Reorder No.13548-031-30 (30g) pump bottle Reorder No.13548-031-45 (45g) tube Reorder No.13548-031-75 (75g) pump bottle Reorder No.13548-031-90 (90g) tube Rev.Date June 2011
Dermatology Market Watch
...continued from page 10
TriAcnéal - A breakthrough acne treatment designed to combat major symptoms A clinically-proven trio of acne-fighting ingredients, including patented Retinaldehyde with proven anti-aging benefits, Glycolic Acid and the new patented Efectiose®, formulated with soothing thermal spring water to help eliminate breakouts, abnormal keratinization, acnerelated inflammation and residual scarring without irritation. Indications: • Oily, blemish-prone skin • Adolescent to adult acne Benefits: • Used alone or in conjunction with other acne treatments and protocols • Hypoallergenic, noncomedogenic and paraben-free
Contains: • Efectiose® (0.1%) - is a bio-available patented ingredient clinically proven to treat the inflammation, abnormal keratinization/cell build-up and scarring associated with acne • Glycolic Acid (6%) - exfoliates the skin to offer deep-pore cleansing while helping to improve the penetration of TriAcnéal’s acne-fighting ingredients • Patented Retinaldehyde (0.1%) - works to normalize abnormal keratinization by encouraging cell renewal and stimulating elastin and collagen synthesis while working to eliminate acne breakouts and minimize scarring as well as minimize the appearance of lines and wrinkles • Avène Thermal Spring Water (5%) - soothes and softens the skin while minimizing irritation Directions for Use: • After cleansing, apply TriAcnéal on dry skin to the affected areas once at night or as directed • Do not apply to wounds, irritated or broken skin
The clock is ticking...
1. Must be enrolled by June 30, 2011 to be Diplomate 2. After June 30, 2011 if Fellow members are not currently enrolled they will not be considered Diplomates until all 10 modules are completed. 3. June 2012: all members who complete 10 modules will hold Diplomate status, those who have not completed all 10 modules will lose Diplomate status - (No Grace Periods will be allowed) www.dermpa.org/diplomate
Vol. 5, No. 3 SUMMER 2011 13
DERmatology pa news & notes
associated with breakouts and signs of aging with little or no irritation.
New FDA Rules for Sunscreen Labeling
Dermatology PA news & notes
Important Information for Dermatology Providers and Their Patients On June 14th, 2011 the U.S. Food and Drug Administration (FDA) issued long-awaited modifications to requirements for sunscreen labeling. These new sunscreen labeling regulations will help patients reduce their risk for skin cancer by guiding them to the most effective sunscreens and advising them about other sun protection measures. Sunscreens must have new labels by the summer of 2012, but some products may have new labels sooner. These changes will provide patients with more information about what a sunscreen can do. The American Academy of Dermatology (AAD) provided scientific information to the FDA as it was developing these rules. The AAD submitted extensive, evidence-based recommendations to the proposed FDA sunscreen regulations in 2007 and was among nearly 2,900 individuals and organizations that provided If used as directed with other sun protection measures, this product reduces the risk of skin cancer and early skin aging, as well as helps prevent sunburn. Only products labeled with both “Broad Spectrum” AND SPF 15 or higher have been shown to provide all these benefits.
comments to the FDA. Dermatology providers believe that these new rules will help Americans reduce their risk for skin cancer. The following are some key changes you and your patients will see.
Skin Cancer Prevention vs. Sunburn Protection On the label, you will see whether a sunscreen can: help prevent skin cancer and sunburn or only help prevent sunburn. For a label to claim that a sunscreen can help prevent skin cancer and sunburn, it will have to pass two FDA tests. The first test is the broad-spectrum test. This test shows whether a sunscreen can protect your skin from the sun’s UVA and UVB rays. Both rays can cause skin cancer. The second test is the sun protection factor (SPF) test. This test shows how well a sunscreen protects you from sunburn. Like today, you will see the SPF as a number, such as SPF 30. All sunscreens must offer some level of SPF (with the minimum being SPF 2). New Warning: For a sunscreen to claim that it can prevent skin cancer and sunburn, it must offer both: 1) broadspectrum coverage and 2) an SPF of 15 or higher (see Figure 1). If the sunscreen does not offer both, the label will have to carry this warning: “This product has been shown only to help prevent sunburn, not skin cancer or early skin aging” (see Figure 2).
Water Resistance The FDA will ban companies from claiming that a sunscreen is “waterproof” or “sweat proof.” You will now see the term “water resistant” since no sunscreen is truly water or sweat proof. To make this claim, the product must pass another test. This test shows how long a sunscreen keeps its SPF when a person
Figure 1
Courtesy US Food and Drug Administration
14 Journal of Dermatology for Physician Assistants
...continued on page 17
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. 3 SUMMER 2011 15
Output @ 100% Giant Creative Strategy 260665gi301DPA_PI
Fine facial wrinkles and hyperpigmentation were scored at baseline and at Week 24 by the investigator using a 10-point scale on which 0 represents no damage, 2-3=mild, 4-5=moderate, 6-7=moderate/ severe and 8-9=severe. The change was calculated as baseline minus the Week 24 evaluations.* ++ Please note: The clinical data in the package insert are from Ortho Dermatologics original clinical trials for Renova® 0.05% as required for FDA approval. *Data on File, CORIA Pharmaceuticals. CONTRAINDICATIONS This drug is contraindicated in individuals with a history of sensitivity reactions to any of its components. It should be discontinued if hypersensitivity to any of its ingredients is noted. WARNINGS TRETINOIN CREAM, USP (EMOLLIENT) is a dermal irritant, and the results of continued irritation of the skin for greater than 48 weeks in chronic, long term use are not known. Safety and effectiveness of TRETINOIN CREAM, USP (EMOLLIENT) in individuals with moderately or heavily pigmented skin have not been established. Refissa® [TRETINOIN CREAM, USP (EMOLLIENT)] should not be administered if the patient is also taking drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of augmented phototoxicity. Because of heightened burning susceptibility, exposure to sunlight (including sunlamps) should be avoided or minimized during use of Refissa®. Patients must be warned to use sunscreens (minimum of SPF of 15) and protective clothing when using Refissa®. Patients
ADVERSE REACTIONS (See WARNINGS and PRECAUTIONS sections.) Local reactions such as peeling, dry skin, burning, stinging, erythema, and pruritus were reported by almost all subjects during therapy. These signs and symptoms were usually of mild to moderate severity and generally occurred early in therapy. OVERDOSAGE Application of larger amounts of medication than recommended has not been shown to lead to more rapid or better results, and marked redness, peeling, or discomfort may occur. Oral ingestion of the drug may lead to the same side effects as those associated with excessive oral intake of Vitamin A. DOSAGE AND ADMINISTRATION Refissa® [TRETINOIN CREAM, USP (EMOLLIENT)] should be applied to the face once a day before retiring using only enough to cover the entire affected area lightly. Patients should gently wash their face with a mild soap, pat the skin dry, and wait 20 to 30 minutes before applying. The patient should apply a pea-sized amount of cream to cover the entire face lightly. Special caution should be taken when applying the cream to avoid the eyes, ears, nostrils, and mouth. With discontinuation of therapy, a majority of patients will lose most mitigating effects on fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin; however, the safety and effectiveness of using TRETINOIN CREAM, USP (EMOLLIENT) daily for greater than 48 weeks have not been established. Manufactured by DPT Laboratories, San Antonio, TX 78215 Distributed by CORIA Laboratories, a division of Valeant Pharmaceuticals North America, Fort Worth, TX 76107 (800-321-4576) Refissa is a registered trademark of Spear Pharmaceuticals, Inc. Renova® is a registered trademark of Ortho Dermatologics, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
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.
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© 2010 CORIA Laboratories REF-0610-0004
16 Journal of Dermatology for Physician Assistants
Certification Review
All Those Things Inside the Skin You Might Have Forgotten By James A. Van Rhee, MS, PA-C
Explanation: Acute pericarditis, most commonly due to infectious agents (such as coxsackie or cytomegalovirus), presents with chest pain and fever. The chest pain radiates to the back and is relieved with
James A. Van Rhee, MS, PA-C, is the Program Director for the Northwestern University Feinberg School of Medicine Department of Family Medicine Physician Assistant Program. Mr. Van Rhee has been involved in physician assistant education for over 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.
New FDA Rules for Sunscreen Labeling ...continued from page 14 goes in the water or sweats. The label must state how long the water resistance lasts, either 40 or 80 minutes. New Warning: If a sunscreen is not water resistant, the label must carry a warning telling you to use a water resistant sunscreen if you are likely to sweat or be in water.
These products have not been shown to protect against skin cancer and early skin aging. They have been shown only to help prevent sunburn.
Makeup and Moisturizers You will see the new claims on makeup and moisturizers, provided the product undergoes and passes the FDA tests. J
Figure 2
Courtesy US Food and Drug Administration
Pass it Along! This article is available to SDPA members in the SDPA Member Document Library. Download your copy today and share it with your colleagues and patients Vol. 5, No. 3 SUMMER 2011 17
Dermatology PA news & notes
Question: A 50 year-old male presents with fever and chest pain. The chest pain radiates to the back and is made worse with leaning forward. On physical examination a friction rub is noted over the heart. Which of the following is the expected EKG finding in this patient? A. Prolonged QT interval B. Presence of Q waves C. Diffuse ST elevations D. Abnormal U waves
leaning forward and worsens with lying down or with deep breathing. On physical examination the most common finding is a pericardial friction rub. EKG findings include ST elevations and PR depression in all leads except aVR and V1. Treatment consists of nonsteroidal anti-inflammatory drugs, antibiotics, or possible pericardiocentesis. J
The correct answer is C.
Are you recertifying soon? Don’t worry – the JDPA is committed to helping you pass your boards. Issues of the JDPA will feature one board question accompanied by a brief explanation of the answer along with any pertinent test taking tips. Best of luck!
Clinical Dermatology
Rubber Allergens as a Cause of Allergic Contact Dermatitis By J. Desiree Douglas, MPA, PA-C
SDPA Members Only Content A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.
CME
This program has been reviewed and is approved for a maximum of .5 hours of AAPA Category I CME credit by the Physician Assistant Review Panel.
Approval is valid for 1 year from the issue date of JULY 2011. Participants may submit the self-assessment exam at any time during that period. This program was planned in accordance with AAPA’s CME Standards for Enduring Material Programs and for Commercial Support of Enduring Material Programs.
SDPA members may access the posttest at www.jdpa.org
Learning Objectives: 1. Define allergic contact dermatitis. 2. Identify and describe multiple rubber allergens. 3. Recognize and understand how hand dermatitis can be associated with rubber allergen exposure. 4. Recognize and understand how foot dermatitis can be associated with rubber allergen exposure. 5. Describe allergen avoidance methods when faced with an allergic contact dermatitis caused by rubber allergens. 18 Journal of Dermatology for Physician Assistants
Rubber Allergens as a Cause of Allergic Contact Dermatitis SDPA Members Only Content
CLINICAL Dermatology
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Vol. 5, No. 3 SUMMER 2011 19
Rubber Allergens as a Cause of Allergic Contact Dermatitis SDPA Members Only Content
CLINICAL Dermatology
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20 Journal of Dermatology for Physician Assistants
Rubber Allergens as a Cause of Allergic Contact Dermatitis SDPA Members Only Content
CLINICAL Dermatology
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Vol. 5, No. 3 SUMMER 2011 21
Rubber Allergens as a Cause of Allergic Contact Dermatitis SDPA Members Only Content
CLINICAL Dermatology
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22 Journal of Dermatology for Physician Assistants
Rubber Allergens as a Cause of Allergic Contact Dermatitis SDPA Members Only Content
J. Desiree Douglas, MPA, PA-C has been a physician assistant for eleven years and has worked in dermatology for four years. She is Co-Director of the Occupational and Allergic Contact Dermatitis Clinic at the University of Pittsburgh Medical Center. She has indicated no relationships to disclose relating to the content of this article.
&
Dermoscopy Q A By John Burns, PA-C
A
B
Figure 1 - Clinical presentation of a linear scale located on the ventral right wrist (A) and immersion, polarized, contact, dermoscopic presentation of a similar lesion (B).
Questions: 1. What is the diagnosis? 2. Can you circle the exact cause of the patient’s problem in Figure 1(A)? 3. What is the name for the linear scale shown in Figure 1(A)? 4. Can you circle the exact cause of the patient’s problem in Figure 1(B)? 5. What is the dermoscopic phrase for the finding shown in Figure 1(B)?
Answer on page 27 Vol. 5, No. 3 SUMMER 2011 23
CLINICAL Dermatology
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From The Patient’s Perspective It’s Complicated
CLINICAL Dermatology
By Brittany Alba I define myself by my loving family, lasting friendships, and passion for helping children with special medical conditions NOT by the only complicated part about me: my medical history. I rarely discuss the fact that for as long as I can remember, through every stage of my life, my body has always given me a bit of a hard time. Consider this perspective: a reflective twentytwo year recap of what it is like to “wear” two chronic incurable conditions daily. My brother sent me the song, Shine On by Eric Bibb, which I adore. The following lyrics summarize how I currently feel about living with these conditions, “I know what you’ve been through, I see, but it’s time to leave it behind and let it be. Hard earned wisdom is something you can’t buy, it’s the wings of experience that make you fly high…Baby, you’ve got to shine on, it’s what you were born to do.”
My story starts on June 19, 1988, Father’s Day
myself, a perfectly healthy tenpound baby boy with one visible difference, his skin. Doctors now knew our condition was genetic.
At Yale, we were finally diagnosed with CIE ichthyosis 2 years old
Talking
Matt & Brittany
I have “50 cents” worth of CIE ichthyosis (congenital ichthyosiform erythroderma) while my brother has a “nickel’s worth.” CIE is a rare genetic recessive skin disorder characterized by redness, minor scaling, and heat intolerance. At the age of two, my finger swelled and my mother took me to the pediatrician; tests revealed that I also had juvenile rheumatoid arthritis (JRA). My JRA would hurt between intervals of medication, so daily I was more consumed with managing that pain rather than my skin. As a child I did not comprehend how much care my skin required because my mother seemed to effortlessly manage it. She took care of every doctor’s visit, bath, lotion application, scalp treatment, and vacuum cleanup that my condition required for thirteen+ years. Her daily dose of unconditional love was, and still is, the best medicine.
I was born six weeks prematurely with one very noticeable difference, bright red skin. At the time of my birth, doctors were uncertain The unexpected allergic of the cause and condition that reactions affected my skin. They sent me Each year around the home to be carefully cared for holidays I got very ill. My skin by my loving, attentive family. would turn the brightest shade of However, when I was four red, large scales fell off my body months old my delicate skin because my skin was reproducing developed a staph infection. I Graduation Day at such a rapid rate, and I stayed was admitted to the Children’s under three blankets at all times. Hospital of Philadelphia where At the age of five, while walking doctors still did not have an around a Christmas tree farm with my mother and explanation for my rare condition. No one would have grandmother, hives spread to my face. It was then clear thought a clue to this complicated medical puzzle would I was allergic to pine trees. My whole family invested in arrive in the form it did: my brother, Matthew. He fake trees and I have been healthy during the holidays literally was a “Gift of God,” born 15 months later than 24 Journal of Dermatology for Physician Assistants
Treatments As a child I cried any time my parents applied a lotion with acid, so it somehow ended up that my brother and I coated ourselves in plain old vaseline petroleum jelly. Today, I prefer the Walgreens petroleum jelly with shea butter. I shampoo with T-Sal twice a week to reduce the buildup in my scalp. On my palms and feet I use Hydro 35 foam. To calm allergic reactions, I recently found that a hydrocortisone compound works if applied daily for a week or two. When I am fed up with dedicating so much time to topical treatments, I turn to Accutane. For years, my parents resisted allowing me to try the medication because they were so fearful of all the side effects. I completely understand the dangers that come along with Accutane, but it cleared my skin for high school dances, proms, and summer trips. Speaking of trips, when I studied abroad in England during my junior year of college the water completely cleared up my skin.
Turning the pain into a passion I do have painful memories of what it feels like to be “different.” Classmates did not want to hold my hand during circle time, customers in the grocery store stared, comments of, “look at that girl” floated out of a crowd in Disney World, and most recently a guy at a bar asked me if I was holding a piece of sandpaper when I shook his hand. When moments like these happen, I smile, take a deep breath, and remove myself from the situation. I would rather not waste my time or energy on ignorant people. Instead I have discovered my passion lies in helping children who are also affected with special medical conditions. One day I hope to facilitate programs for children with these medical conditions and to organize discussions about how their conditions make them feel. For many years I internalized the painful comments and “covered up” my conditions to appear as normal as possible. I am not convinced this was the best way to deal with the psychological effects of “wearing” two chronic incurable conditions because when I initially meet people they can barely tell anything is wrong with my skin. However I am currently struggling with the elephant in the room canundrum of when to address and acknowledge the only visibly complicated part about me, my medical history. J Brittany Alba is twenty-three years old and lives in Worcester, PA. Last May Brittany graduated cum laude from the Catholic University of America with a Bachelor of Arts in Media Studies. She is currently a project associate at Dunleavy and Associates, a consulting firm that provides services for charitable organizations in the Philadelphia region. Through this work Brittany is able to help advocate for the missions of organizations that serve children with complicated medical conditions. She is involved with F.I.R.S.T. (the Foundation for Ichthyosis and Related Skin Types), Vibrant Lives (the patient support group for Enbrel), and Gwynedd Mercy Academy High School.
Take Home points for derm pas: By Steven K. Shama, MD, MPH 1. Brittany is on a lifelong journey, clearly a messenger for all of us. Could we live our lives with two significant diseases, an erythroderm and arthritis? One message for me is that I need to listen more and learn more from my patients about what it is like to live with any dermatologic disorder, especially one that is visible and can be, at times, debilitating. 2. It is said that, “Love conquers all.” For Brittany, the love of her family and especially of her mother soothed her so beautifully. As health care practitioners, our love for our patients can be expressed in many ways such
as by simply being there for them, with unconditional acceptance, and with the deep recognition that we are witnessing a beautiful soul expressing itself through pain and struggles, yearning to be free. 3. Brittany turns her pain into passion by wanting to help children who have significant skin diseases express their feelings. How do Brittany’s words inspire you to make this world a more compassionate place to live? We must all take a breath and allow ourselves to be inspired and changed for good.
Vol. 5, No. 3 SUMMER 2011 25
CLINICAL Dermatology
ever since. Although that allergy has been figured out for a few years, my list of allergies seems to grow every two years evidenced by horrific allergic reactions that happen when I least expect them. In high school, right before my uncle’s wedding, I took Sudafed for a cold, and forty-five minutes later I had a fever, was vomiting, and my skin turned two shades from purple. I am sure that all of the guests were wondering if I had been burned, but only one guest (who had too much to drink) actually asked me about my appearance. During my senior year of college, I came off of Accutane too quickly, which caused a painful rash to cover my body and left me confined to my room and unable to walk. My dermatologist prescribed a sulfa drug, which caused everything to get worse. I was in so much pain one day that I went over to the health clinic where the attending physician thought I had StevensJohnson syndrome.
Dermatology Case Report Larval Tick Infestation By W. Stephen Steiner, PA-C
SDPA Members Only Content
CLINICAL Dermatology
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Figure 1
Figure 2
26 Journal of Dermatology for Physician Assistants
W. Stephen Steiner, PA-C is a 2000 graduate of the Saint Louis University Physician Assistant program. He has 11 years of dermatology experience and currently works at Gwinnett Dermatology, PC and Gwinnett Clinical Research Center, Inc.
& Figure 2 Scabies mite denoted by solid arrow and eggs by stars viewed with light microscopy at 10x magnification.
A
B
Figure 3 - Scabies mite from Figure 1(A) & (B) circled and burrow denoted by squiggly lines.
SDPA Members Only Content A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.
John Burns, PA-C is a graduate of the Physician Assistant Program at Louisiana State University Health Science Center Shreveport, Louisiana, and completed a fellowship in dermatology at the University of Texas Southwestern Medical Center. He is a Diplomate of the Society of Dermatology Physician Assistants. He presently resides in Frisco, Texas where he works in dermatology with Dr. Eric Weisberg. He has indicated no relationships to disclose relating to the content of this article.
Vol. 5, No. 3 SUMMER 2011 27
CLINICAL Dermatology
Dermoscopy Q A
28 Journal of Dermatology for Physician Assistants
Vol. 5, No. 3 SUMMER 2011 29
Dermatology Evidence Based Medicine A Modified CAGE Questionnaire for Tanning Addiction By Darin Franceschini, MMS, PA-C and Mark E. Archambault, DHSc, PA-C
SDPA Members Only Content
CLINICAL Dermatology
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30 Journal of Dermatology for Physician Assistants
SDPA Members Only Content
CLINICAL Dermatology
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Vol. 5, No. 3 SUMMER 2011 31
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.
Darin Franceschini, MMS, PA-C is a recent graduate of the Physician Assistant Program at the Wake Forest School of Medicine. He currently resides in Newmarket, NH and will be working at Elliot Hospital in Manchester, NH in the Pediatric Intensive Care Unit. Mark Archambault, DHSc, PA-C is a graduate of the Lock Haven University PA and Nova Southeastern University Doctor of Health Science programs. He resides in Winston-Salem, NC and is the founding Chair and Program Director at Elon University. He also serves as the editor for JAAPA’s Critically Appraised Topic department. Both authors have indicated no relationships to disclose relating to the content of this article.
32 Journal of Dermatology for Physician Assistants
Understanding Evidence Based Medicine Writing Clinical Questions By Karen Graham, MPAS, PA-C JDPA Clinical Department Editor
Benefits Built on Science
The #1 Most Prescribed #SBOEFE .FEJDBUJPO JO %FSNBUPMPHZ
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SOLODYN is indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. SOLODYN did not demonstrate any effect on non-inflammatory acne lesions. Safety of SOLODYN has not been established beyond 12 weeks of use. This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, SOLODYN should be used only as indicated.
Important Safety Information for SOLODYN Tablets t 5IF NPTU DPNNPOMZ PCTFSWFE BEWFSTF reactions are headache, fatigue, dizziness, and pruritus.
t .JOPDZDMJOF MJLF PUIFS UFUSBDZDMJOF DMBTT ESVHT can cause fetal harm when administered to a pregnant woman. t 5FUSBDZDMJOF ESVHT TIPVME OPU CF VTFE EVSJOH tooth development (last half of pregnancy and up to 8 years of age) as they may cause permanent discoloration of teeth. t 1TFVEPNFNCSBOPVT DPMJUJT IBT CFFO SFQPSUFE with nearly all antibacterial agents and may range from mild to life-threatening; therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. t $FOUSBM OFSWPVT TZTUFN TJEF FGGFDUT JODMVEJOH light-headedness, dizziness, and vertigo, have been reported with minocycline therapy. t *O SBSF DBTFT QIPUPTFOTJUJWJUZ IBT CFFO SFQPSUFE
t 4IPVME OPU CF VTFE EVSJOH QSFHOBODZ PS by individuals of either gender who are attempting to conceive a child; concurrent use of tetracyclines with oral contraceptives may render oral contraceptives less effective. t 5IJT ESVH JT DPOUSBJOEJDBUFE JO QFSTPOT XIP IBWF shown hypersensitivity to any of the tetracyclines. t 4BGFUZ CFZPOE XFFLT PG VTF IBT OPU been established. t $BTFT PG BOBQIZMBYJT TFSJPVT TLJO SFBDUJPOT erythema multiforme, and drug rash with eosinophilia and systemic symptoms have been reported postmarketing with minocycline use. Discontinue SOLODYN immediately if symptoms occur.
40-0%:/ 5BCMFUT NH NH BOE NH BSF BMTP BWBJMBCMF
Reference: 1. *.4 )FBMUI /BUJPOBM 1SFTDSJQUJPO "VEJU /1" %BUB UISPVHI .BSDI %BUB PO m MF .FEJDJT 1IBSNBDFVUJDBM $PSQPSBUJPO
See following pages for Brief Summary of Full Prescribing Information. 40-0%:/ JT B SFHJTUFSFE USBEFNBSL PG .FEJDJT 1IBSNBDFVUJDBM $PSQPSBUJPO 40-
Vol. 5, No. 3 SUMMER 2011 33
BRIEF SUMMARY (see package insert for full prescribing information) SOLODYN® (minocycline HCl, USP) Extended Release Tablets Rx Only KEEP OUT OF REACH OF CHILDREN INDICATIONS AND USAGE Indication SOLODYN is indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. Limitations of Use SOLODYN did not demonstrate any effect on non-inflammatory acne lesions. Safety of SOLODYN has not been established beyond 12 weeks of use. This formulation of minocycline has not been evaluated in the treatment of infections.
animals treated early in pregnancy (see Use in Specific Populations). Pseudomembranous Colitis Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of “antibiotic-associated colitis”.
After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to discontinuation of To reduce the development of drugthe drug alone. In moderate to severe resistant bacteria as well as to maintain the cases, consideration should be given to effectiveness of other antibacterial drugs, management with fluids and electrolytes, SOLODYN should be used only as indicated protein supplementation, and treatment (see Warnings and Precautions). with an antibacterial drug clinically effective against Clostridium difficile colitis. CONTRAINDICATIONS This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines. WARNINGS AND PRECAUTIONS Teratogenic Effects A. MINOCYCLINE, LIKE OTHER TETRACYCLINE-CLASS DRUGS, CAN CAUSE FETAL HARM WHEN ADMINISTERED TO A PREGNANT WOMAN. IF ANY TETRACYCLINE IS USED DURING PREGNANCY OR IF THE PATIENT BECOMES PREGNANT WHILE TAKING THESE DRUGS, THE PATIENT SHOULD BE APPRISED OF THE POTENTIAL HAZARD TO THE FETUS. SOLODYN should not be used during pregnancy or by individuals of either gender who are attempting to conceive a child (see Nonclinical Toxicology & Use in Specific Populations). B. THE USE OF DRUGS OF THE TETRACYCLINE CLASS DURING TOOTH DEVELOPMENT (LAST HALF OF PREGNANCY, INFANCY, AND CHILDHOOD UP TO THE AGE OF 8 YEARS) MAY CAUSE PERMANENT DISCOLORATION OF THE TEETH (YELLOW-GRAY-BROWN). This adverse reaction is more common during long-term use of the drug but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. TETRACYCLINE DRUGS, THEREFORE, SHOULD NOT BE USED DURING TOOTH DEVELOPMENT. C. All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in fibula growth rate has been observed in premature human infants given oral tetracycline in doses of 25 mg/kg every 6 hours. This reaction was shown to be reversible when the drug was discontinued. Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can cause retardation of skeletal development on the developing fetus. Evidence of embryotoxicity has been noted in
Hepatotoxicity Post-marketing cases of serious liver injury, including irreversible drug-induced hepatitis and fulminant hepatic failure (sometimes fatal) have been reported with minocycline use in the treatment of acne. Metabolic Effects The anti-anabolic action of the tetracyclines may cause an increase in BUN. While this is not a problem in those with normal renal function, in patients with significantly impaired function, higher serum levels of tetracycline-class drugs may lead to azotemia, hyperphosphatemia, and acidosis. If renal impairment exists, even usual oral or parenteral doses may lead to excessive systemic accumulations of the drug and possible liver toxicity. Under such conditions, lower than usual total doses are indicated, and if therapy is prolonged, serum level determinations of the drug may be advisable. Central Nervous System Effects Central nervous system side effects including light-headedness, dizziness or vertigo have been reported with minocycline therapy. Patients who experience these symptoms should be cautioned about driving vehicles or using hazardous machinery while on minocycline therapy. These symptoms may disappear during therapy and usually rapidly disappear when the drug is discontinued. Benign Intracranial Hypertension Pseudotumor cerebri (benign intracranial hypertension) in adults and adolescents has been associated with the use of tetracyclines. Minocycline has been reported to cause or precipitate pseudotumor cerebri, the hallmark of which is papilledema. Clinical manifestations include headache and blurred vision. Bulging fontanels have been associated with the use of tetracyclines in infants. Although signs and symptoms of pseudotumor cerebri resolve after discontinuation of treatment, the possibility for permanent sequelae such as visual loss that may be permanent or severe exists. Patients should be questioned for visual
34 Journal of Dermatology for Physician Assistants
disturbances prior to initiation of treatment with tetracyclines. If visual disturbance occurs during treatment, patients should be checked for papilledema. Concomitant use of isotretinoin and minocycline should be avoided because isotretinoin, a systemic retinoid, is also known to cause pseudotumor cerebri.
drug-resistant bacteria to develop during the use of SOLODYN, it should be used only as indicated.
Superinfection As with other antibiotic preparations, use of SOLODYN may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, SOLODYN Autoimmune Syndromes should be discontinued and appropriate Tetracyclines have been associated with the therapy instituted. development of autoimmune syndromes. Laboratory Monitoring The long-term use of minocycline in the Periodic laboratory evaluations of organ treatment of acne has been associated systems, including hematopoetic renal with drug-induced lupus-like syndrome, and hepatic studies should be performed. autoimmune hepatitis and vasculitis. Appropriate tests for autoimmune syndromes Sporadic cases of serum sickness have should be performed as indicated. presented shortly after minocycline ADVERSE REACTIONS use. Symptoms may be manifested by fever, rash, arthralgia, and malaise. In Clinical Trial Experience symptomatic patients, liver function tests, Because clinical trials are conducted under ANA, CBC, and other appropriate tests prescribed conditions, adverse reaction should be performed to evaluate the rates observed in the clinical trial may not patients. Use of all tetracycline-class drugs reflect the rates observed in practice. should be discontinued immediately. The following table summarizes selected adverse reactions reported in clinical trials Photosensitivity at a rate of ≥1% for SOLODYN. Photosensitivity manifested by an exaggerated sunburn reaction has been Selected Treatment-Emergent Adverse observed in some individuals taking Reactions in at least 1% of Clinical tetracyclines. This has been reported Trial Subjects rarely with minocycline. Patients should Adverse Reactions SOLODYN PLACEBO minimize or avoid exposure to natural or (1 mg/kg) N=364 artificial sunlight (tanning beds or UVA/B N=674 (%) (%) treatment) while using minocycline. If At least one treatment- 379 (56) 197 (54) patients need to be outdoors while using minocycline, they should wear loose-fitting emergent event 152 (23) 83 (23) clothes that protect skin from sun exposure Headache 62 (9) 24 (7) and discuss other sun protection measures Fatigue Dizziness 59 (9) 17 (5) with their physician. Pruritus 31 (5) 16 (4) Serious Skin/Hypersensitivity Malaise 26 (4) 9 (3) Reaction Mood alteration 17 (3) 9 (3) Cases of anaphylaxis, serious skin reactions 13 (2) 3 (1) (e.g. Stevens Johnson syndrome), erythema Somnolence 10 (2) 1 (0) multiforme, and drug rash with eosinophilia Urticaria 10 (2) 5 (1) and systemic symptoms (DRESS) syndrome Tinnitus Arthralgia 9 (1) 2 (0) have been reported postmarketing with Vertigo 8 (1) 3 (1) minocycline use in patients with acne. Dry mouth 7 (1) 5 (1) DRESS syndrome consists of cutaneous Myalgia 7 (1) 4 (1) reaction (such as rash or exfoliative dermatitis), eosinophilia, and one or more Postmarketing Experience of the following visceral complications Adverse reactions that have been reported such as: hepatitis, pneumonitis, nephritis, with minocycline hydrochloride use in a myocarditis, and pericarditis. Fever and variety of indications include: lymphadenopathy may be present. In some Skin and hypersensitivity reactions: cases, death has been reported. If this fixed drug eruptions, balanitis, erythema syndrome is recognized, the drug should be multiforme, Stevens-Johnson syndrome, discontinued immediately. anaphylactoid purpura, photosensitivity, Tissue Hyperpigmentation pigmentation of skin and mucous Tetracycline-class antibiotics are known membranes, hypersensitivity reactions, to cause hyperpigmentation. Tetracycline angioneurotic edema, anaphylaxis, DRESS therapy may induce hyperpigmentation in syndrome (see Warnings and Precautions). many organs, including nails, bone, skin, Autoimmune conditions: polyarthralgia, eyes, thyroid, visceral tissue, oral cavity pericarditis, exacerbation of systemic lupus, (teeth, mucosa, alveolar bone), sclerae and pulmonary infiltrates with eosinophilia, heart valves. Skin and oral pigmentation transient lupus-like syndrome. has been reported to occur independently Central nervous system: pseudotumor of time or amount of drug administration, cerebri, bulging fontanels in infants, whereas other tissue pigmentation has decreased hearing. been reported to occur upon prolonged administration. Skin pigmentation includes Endocrine: brown-black microscopic thyroid diffuse pigmentation as well as over sites discoloration, abnormal thyroid function. of scars or injury. Oncology: thyroid cancer. Development of Drug Resistant Oral: glossitis, dysphagia, tooth Bacteria discoloration. Bacterial resistance to the tetracyclines may develop in patients using SOLODYN, Gastrointestinal: enterocolitis, pancreatitis, therefore, the susceptibility of bacteria hepatitis, liver failure. associated with infection should be Renal: reversible acute renal failure. considered in selecting antimicrobial Hematology: hemolytic anemia, therapy. Because of the potential for thrombocytopenia, eosinophilia.
Preliminary studies suggest that use of minocycline may have deleterious effects on human spermatogenesis (see Nonclinical Toxicology). DRUG INTERACTIONS Anticoagulants Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.
systemic exposure to minocycline observed in patients as a result of use of SOLODYN). Reduced mean fetal body weight was observed in studies in which minocycline was administered to pregnant rats at a dose of 10 mg/kg/day (which resulted in approximately the same level of systemic exposure to minocycline as that observed in patients who use SOLODYN).
Minocycline was assessed for effects on peri- and post-natal development of rats in a study that involved oral administration to Penicillin pregnant rats from day 6 of gestation Since bacteriostatic drugs may interfere through the period of lactation (postpartum with the bactericidal action of penicillin, it is day 20), at dosages of 5, 10, or 50 advisable to avoid giving tetracycline-class mg/kg/day. In this study, body weight gain drugs in conjunction with penicillin. was significantly reduced in pregnant females that received 50 mg/kg/day Methoxyflurane (resulting in approximately 2.5 times the The concurrent use of tetracycline and methoxyflurane has been reported to result systemic exposure to minocycline observed in patients as a result of use of SOLODYN). in fatal renal toxicity. No effects of treatment on the duration of Antacids and Iron Preparations the gestation period or the number of live Absorption of tetracyclines is impaired by pups born per litter were observed. Gross antacids containing aluminum, calcium external anomalies observed in F1 pups or magnesium and iron-containing (offspring of animals that received preparations. minocycline) included reduced body size, improperly rotated forelimbs, and reduced Low Dose Oral Contraceptives size of extremities. No effects were In a multi-center study to evaluate the observed on the physical development, effect of SOLODYN on low dose oral behavior, learning ability, or reproduction contraceptives, hormone levels over one of F1 pups, and there was no effect on menstrual cycle with and without gross appearance of F2 pups (offspring SOLODYN 1 mg/kg once-daily were of F1 animals). measured. Based on the results of this trial, minocycline-related changes in Nursing Mothers estradiol, progestinic hormone, FSH and Tetracycline-class antibiotics are excreted LH plasma levels, of breakthrough in human milk. Because of the potential for bleeding, or of contraceptive failure, can serious adverse effects on bone and tooth not be ruled out. To avoid contraceptive development in nursing infants from the failure, female patients are advised to use tetracycline-class antibiotics, a decision a second form of contraceptive during should be made whether to discontinue treatment with minocycline. nursing or discontinue the drug, taking into account the importance of the drug to the Drug/Laboratory Test Interactions mother (see Warnings and Precautions). False elevations of urinary catecholamine levels may occur due to interference with Pediatric Use the fluorescence test. SOLODYN is indicated to treat only inflammatory lesions of non-nodular USE IN SPECIFIC POPULATIONS moderate to severe acne vulgaris Pregnancy in patients 12 years and older. Teratogenic Effects: Pregnancy category D Safety and effectiveness in pediatric (see Warnings and Precautions) patients below the age of 12 has not been established. SOLODYN should not be used during pregnancy. If the patient becomes pregnant Use of tetracycline-class antibiotics below while taking this drug, the patient should be the age of 8 is not recommended due to apprised of the potential hazard to the fetus the potential for tooth discoloration (see and stop treatment immediately. Warnings and Precautions). There are no adequate and well-controlled Geriatric Use studies on the use of minocycline in Clinical studies of SOLODYN did not pregnant women. Minocycline, like other include sufficient numbers of subjects aged tetracycline-class drugs, crosses the 65 and over to determine whether they placenta and may cause fetal harm when respond differently from younger subjects. administered to a pregnant woman. Other reported clinical experience has not
NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility
The 65 mg extended release tablets are blue, unscored, coated, and debossed with “DYN-065” on one side. Each tablet contains minocycline hydrochloride equivalent to 65 mg minocycline, supplied as follows:
Carcinogenesis—Long-term animal studies have not been performed to evaluate the carcinogenic potential of minocycline. A structurally related compound, oxytetracycline, was found to produce adrenal and pituitary tumors in rats.
NDC 99207-463-30
Mutagenesis—Minocycline was not mutagenic in vitro in a bacterial reverse mutation assay (Ames test) or CHO/HGPRT mammalian cell assay in the presence or absence of metabolic activation. Minocycline was not clastogenic in vitro using human peripheral blood lymphocytes or in vivo in a mouse micronucleus test. Impairment of Fertility—Male and female reproductive performance in rats was unaffected by oral doses of minocycline of up to 300 mg/kg/day (which resulted in up to approximately 40 times the level of systemic exposure to minocycline observed in patients as a result of use of SOLODYN). However, oral administration of 100 or 300 mg/kg/day of minocycline to male rats (resulting in approximately 15 to 40 times the level of systemic exposure to minocycline observed in patients as a result of use of SOLODYN) adversely affected spermatogenesis. Effects observed at 300 mg/kg/day included a reduced number of sperm cells per gram of epididymis, an apparent reduction in the percentage of sperm that were motile, and (at 100 and 300 mg/kg/day) increased numbers of morphologically abnormal sperm cells. Morphological abnormalities observed in sperm samples included absent heads, misshapen heads, and abnormal flagella.
Bottle of 30
The 80 mg extended release tablets are gray, unscored, coated, and debossed with “DYN-080” on one side. Each tablet contains minocycline hydrochloride equivalent to 80 mg minocycline, supplied as follows: NDC 99207-466-30
Bottle of 30
The 90 mg extended release tablets are yellow, unscored, coated, and debossed with “DYN-090” on one side. Each tablet contains minocycline hydrochloride equivalent to 90 mg minocycline, supplied as follows: NDC 99207-461-30 NDC 99207-461-10
Bottle of 30 Bottle of 100
The 105 mg extended release tablets are purple, unscored, coated, and debossed with “DYN-105” on one side. Each tablet contains minocycline hydrochloride equivalent to 105 mg minocycline, supplied as follows: NDC 99207-467-30
Bottle of 30
The 115 mg extended release tablets are green, unscored, coated, and debossed with “DYN-115” on one side. Each tablet contains minocycline hydrochloride equivalent to 115 mg minocycline, supplied as follows: NDC 99207-464-30
Bottle of 30
The 135 mg extended release tablets are Limited human studies suggest that pink (orange-brown), unscored, coated, minocycline may have a deleterious effect and debossed with “DYN-135” on one on spermatogenesis. side. Each tablet contains minocycline SOLODYN should not be used by individuals hydrochloride equivalent to 135 mg minocycline, supplied as follows: of either gender who are attempting to conceive a child. NDC 99207-462-30 Bottle of 30 NDC 99207-462-10 Bottle of 100 HOW SUPPLIED/STORAGE AND HANDLING Storage How Supplied Store at 25ºC (77ºF); excursions are SOLODYN (minocycline HCl, USP) Extended permitted to 15º-30ºC (59º-86ºF) Release Tablets are supplied as aqueous [See USP Controlled Room Temperature]. film coated tablets containing minocycline hydrochloride equivalent to 45 mg, 55 mg, Handling Keep out of reach of children 65 mg, 80 mg, 90 mg, 105 mg, 115 mg Protect from light, moisture, and or 135 mg minocycline, are supplied excessive heat. as follows.
The 45 mg extended release tablets are gray, unscored, coated, and debossed with “DYN-045” on one side. Each tablet contains minocycline hydrochloride identified differences in responses between equivalent to 45 mg minocycline, supplied Rare spontaneous reports of congenital the elderly and younger patients. In general, as follows: anomalies including limb reduction have dose selection for an elderly patient should been reported with minocycline use in NDC 99207-460-30 Bottle of 30 be cautious, usually starting at the low end pregnancy in post-marketing experience. NDC 99207-460-10 Bottle of 100 of the dosing range, reflecting the greater Only limited information is available frequency of decreased hepatic, renal, or regarding these reports; therefore, no The 55 mg extended release tablets are cardiac function, and concomitant disease pink, unscored, coated, and debossed conclusion on causal association can or other drug therapy. be established. with “DYN-055” on one side. Each tablet contains minocycline hydrochloride Minocycline induced skeletal malformations OVERDOSAGE equivalent to 55 mg minocycline, supplied (bent limb bones) in fetuses when In case of overdosage, discontinue as follows: administered to pregnant rats and rabbits in medication, treat symptomatically and doses of 30 mg/kg/day and 100 mg/kg/day, institute supportive measures. Minocycline NDC 99207-465-30 Bottle of 30 respectively, (resulting in approximately is not removed in significant quantities by 3 times and 2 times, respectively, the hemodialysis or peritoneal dialysis.
Dispense in tight, light-resistant container with child-resistant closure. U.S. Patent 5,908,838, U.S. Patent 7,790,705 and Patents Pending* *90 mg is also covered by U.S. Patents 7,541,347 and 7,544,373 Manufactured for: Medicis, The Dermatology Company Scottsdale, AZ 85256 03/2011 17110203
Vol. 5, No. 3 SUMMER 2011 35
Clinical snapshots Sign of Leser-TrĂŠlat By Susan Hammerling, MPAS, PA-C and Meghan Ryan, PA-S
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.
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. She has indicated no relationships to disclose relating to the content of this article. Meghan Ryan, PA-S is a second year PA student at the SUNY Upstate Medical University Physician Assistant Program. She has indicated no relationships to disclose relating to the content of this article.
36 Journal of Dermatology for Physician Assistants
Drugs in Dermatology
Coal Tar - A Brief History and Overview of Its Uses in Dermatology By Scott Tomerlin, PharmD
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, PharmD, 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 patients’ specific needs. He has indicated no relationships to disclose relating to the content of this article.
Vol. 5, No. 3 SUMMER 2011 37
SURGICAL Dermatology
Mohs Surgery
An Interview with Shelley Sekula-Gibbs, MD SDPA Members Only Content A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.
Dr. Sekula-Gibbs has owned and operated her dermatology practice in Webster, TX for over twenty years. She served three terms on the Houston City Council and represented Texas District 22 in the 109th U.S. House of Representatives. A fifth generation Texan, Shelley graduated summa cum laude with a degree in chemistry from Our Lady of the Lake University in San Antonio. She received her medical degree from the University of Texas Medical Branch in Galveston and completed residencies in family practice at the University of Florida in Gainesville and in dermatology at Baylor College of Medicine in Houston. In addition to seeing patients in her private practice, Dr. Sekula-Gibbs is a Clinical Assistant Professor of dermatology at Baylor College of Medicine where she treats patients and teaches medical students and residents at Ben Taub General Hospital. Dr. Sekula-Gibbs is a Diplomate of the American Board of Dermatology, a Fellow of the American Academy of Dermatology, member of the American Society for Dermatologic Surgery, the American Society for Laser Surgery and Medicine, and the American Society of Phlebology. She has served on the Board of Directors of the American Society for Mohs Surgery, was president of the Texas Dermatological Society and the Houston Dermatological Society. She currently serves on the AAD Advisory Board and the AAD Leadership Advisory Board. Dr. Sekula-Gibbs also serves on the Bay Area Transportation Partnership, the Tourette Syndrome Association of Texas, the Healthy Houston Foundation, the Sylvan Rodriguez Foundation, and the Friends of the Texas Medical Center Library Advisory Board.
38 Journal of Dermatology for Physician Assistants
SDPA Members Only Content
SURGICAL Dermatology
A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.
Vol. 5, No. 3 SUMMER 2011 39
SDPA Members Only Content
SURGICAL Dermatology
A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.
40 Journal of Dermatology for Physician Assistants
For moderate to severe plaque psoriasis
Take scalp psoriasis head on
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.
Vol. 5, No. 3 SUMMER 2011 41
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
© 2011 Galderma Laboratories, L.P. GALDERMA and CLOBEX are registered trademarks. Galderma Laboratories, L.P., 14501 N. Freeway, Fort Worth, TX 76177 CLO-717 Printed in USA 02/11
42 Journal of Dermatology for Physician Assistants
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
SURGICAL wisdom
Biopsy Site Identification Utilizing Tangential Lighting SDPA Members Only Content
Figure 1 – Biopsy scar without tangential lighting (A). Biopsy scar with tangential lighting using a penlight (B).
A B:12.5 in
LT:12.25 in
ST:10.75 in
S:9.5 in
B
Vol. 5, No. 3 SUMMER 2011 43
SURGICAL Dermatology
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cosmetic Dermatology
Emerging Technologies Light The Way For Better Sunscreens 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.
44 Journal of Dermatology for Physician Assistants
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?
Vol. 5, No. 3 SUMMER 2011 45
COSMETIC Dermatology
SDPA Members Only Content
Zoe Diana Draelos, MD, is a practicing board-certified dermatologist and a Fellow of the American Academy of Dermatology with a research interest in cosmetics, toiletries, and biologically active skin medications. She is in solo private practice in High Point, North Carolina, and a Consulting Professor of Dermatology at Duke University. In 1988, she founded Dermatology Consulting Services to provide education, develop formulations, and conduct clinical studies in association with industry. Prior to pursuing a medical career, Dr. Draelos completed an undergraduate degree in Mechanical Engineering and was elected a Rhodes Scholar. A member of Sigma Xi research honorary and Alpha Omega Alpha medical honorary, she is author of the textbooks Cosmetics in Dermatology and Hair Cosmetics, as well as the editor of Cosmeceuticals, now in its second edition and translated into 5 languages. She has contributed chapters to 32 textbooks, served as the principle investigator on 274 studies, written 270 published papers, serves on 8 journal editorial boards, functions as the editor-in-chief of the Journal of Cosmetic Dermatology, and was a past member of the Board of Directors of the American Academy of Dermatology and the American Society for Dermatologic Surgery. She is Vice-President Elect of the American Academy of Dermatology. She received a lifetime achievement award from Health Beauty America for her research and the 2008 DermArts award for her contributions to dermatology. In 2010, she received the Albert Kligman Innovation Award.
Cosmetic pearls Results from the AAD’s “2011 Indoor Tanning: Teen and Young Adult Women” Survey SDPA Members Only Content
COSMETIC Dermatology
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46 Journal of Dermatology for Physician Assistants
Vol. 5, No. 3 SUMMER 2011 47
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 Michelle A Campbell MPAS, PA-C / Samantha Carter MD Rebecca L Caudle PA-C / Keith Haar MD Lisa Greenan PA-C / Mary Fredenberg MD Melinia J Honjo MPAS, PA-C / Gary A. McCraken MD Kathlynn H Hurt PA-C / Keith Haar MD Elizabeth J Jacobsen PA-C / William Ko MD Beth B Lopez MPAS, PA-C / Bogna Nowak MD Anngela Park MPAS, PA-C / Glenn Brown MD John C Rimer PA-C / Keith Haar MD Yuliya S Schoenling MPAS, PA-C / Kristine Romine MD Annie Sullivan 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 Devon N Updegraff-Day PA-C / Bryan Updegraff 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 / Lawrence F. Eichenfield MD Annie W Coots PA-C / Bruce Maltz 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 Sarah E Frazier MPAS, PA-C / Jonathan Baron MD Aaron A Furey PA-C / Valantina Sosa 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 Anette J Lecair PA-C / elissa gropen MD Mui Lee PA-C / Don King MD Steven D Leon MPAS, PA-C / Jasbir Sandhu MD Kenneth J Meehan PA-C / E. Victor Ross MD Melissa S Montes PA-C / Michael Lin MD Brett l Moore PA-C / Hubert Greenway MD 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 Jim L Reith MPAS, PA-C / David Lipman MD Jason L Roddick MPAS, PA-C / Robert Peppercorn MD Mary C Rozelle PA-C / Hayes Gladstone MD Laura A Rummel PA-C / Michael Moats MD Kerry A Schlosser MPAS, PA-C / Debra Luftman 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 Brian C Sutton PA-C / Walter Nahm MD Gary M Westbrock PA-C / Charles Fishman MD Katherine D Wilkens PA-C / Ruben Anders MD Doug M Williams MPAS, PA-C / Bradley Kurgis MD ColoRADo Sheree S Beddingfield PA-C / Anthony Timko MD John M Hoffstetter MPAS, PA-C / James V Twede MD Amy J Huber PA-C / Kimberly Stone MD Brooke W Lewis MPAS, PA-C / John Steinbaugh MD Catherine W Pacocha PA-C / Diane Kallgren MD Kristin E Pogue MPAS, PA-C / Mark Gaughan MD Susan L Rancis MPAS, PA-C / Patrick Lillis MD David J Seitz 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 Erica Scarrone PA-C / Richard Berry MD DiStRiCt oF ColumBiA Nicole Keeter PA-C / Martin A. Braun MD Adrian B Thompson PA-C / Karla Gayer 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 Kristy L Chatham PA-C / Ralph Massullo MD Scott A Clark MPAS, PA-C / Michael Bond MD Makesha H Curd PA-C / MICHAEL SPICER MD Audrey F Ford PA-C / Amy Simon Ross MD Noreen M Godfrey PA-C / Melvin Lu MD Susan Hammerling PA-C / Ruben Moreno MD Anna Iskandar PA-C / Theodore Schiff MD Jeffrey N Johnson PA-C / Ted Schiff MD Jennifer L Kallio PA-C / Adam S. Greenberg MD Amanda Kowalski PA-C / Joseph Yohn MD Gina D Mangin MPAS, PA-C / Michael Bond MD Pamela F Miller PA-C / Tory Sullivan MD Laura E Millns PA-C / John Millns MD Beth P Mitchell PA-C / Theodore Schiff MD E. Sarah Mowery MPAS, PA-C / John Long MD Emily S Neel PA-C / Larry Bishop MD Brenda L O’Hair MPAS, PA-C / William Roth MD Brenda L OHair MPAS, PA-C / William Roth MD Lindsay A Pelchen PA-C / Jere Mammino DO Miladys S Perez PA-C / Flor Mayoral MD Karen E Rosochowicz PA-C Richard Miller MD Rosa M Singleton MPAS, PA-C / Farooq Lateef MD Elleanor S Swartz MPAS, PA-C / Jennifer Vesper MD
Do you know A Nathaniel A Swartz MPAS, PA-C / Adam Greenberg MD Debbie A Wallace PA-C / Joel F. Waltzer MD 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 MHS, PA-C / Neville Pereyo MD Laura P Bush PA-C / James Sandwich MD Leah J Calder MPAS, PA-C / John Kayal MD Tomas J Chao MPAS, PA-C / Alan Gardner MD Jason M Cheyney MPAS, PA-C / David Cohen MD Katie B Covington PA-C / Holly Edmonds MD Tracy L Crockett PA-C / Karen Maffei MD Nancy T Duong PA-C / Tiffani Hamilton MD Christi G Gibson PA-C / Michael Sharkey MD Michael S Kelleher PA-C / Michelle Futral MD Heather Kitchens PA-C / Avis Yount MD Dawn Paletta PA-C / G. Anthony Slagel DO Delano Parker PA-C / Michael Sharkey MD Beverly Ringuette PA-C / Jonathan S, Weiss MD Myrtle H Sanders MPAS, PA-C / Mark Bonner MD Christin T Smith MPAS, PA-C / Jason L. Smith MD Justin R Smith PA-C / Margaret Kopchick MD Mark M Spatz PA-C / Joshua Lane MD Wm. Stephen Steiner PA-C / Jonathan Weiss MD John M Tolbert PA-C / David Schoenfeld MD Laurel M Whitmer MPAS, PA-C / Sylvia Wright MD HAwAii Helen M Petros PA-C / Julie Kenner MD iowA Mary M Heatley MPAS, PA-C / Martin Sands MD Jody K McKee PA-C / Kimberly Schulz MD Julie Truman MPAS, PA-C / Kathi Madison MD iDAHo Lura A Brown MPAS, PA-C / Stephen Craig MD Richard A Flygare PA-C / Stephen Craig MD Richard A Flygare PA-C / Stephen Craig MD Brian D Friedt PA-C / Randall Burr MD Ryan McCulloch PA-C / Earl Stoddard MD
illinoiS Jennifer Adams MPAS, PA-C / Sheldon Shore MD Christopher R Arico MPAS, PA-C / Jeffrey Hsu MD Kristine Bennett MPAS, PA-C / Fred Kemp MD Renata M Block PA-C / Kevin Pinski MD Karie M Hall PA-C / Kenneth Bielinski MD Bernice Ik-Jang Mi Johnson PA-C / Steven Mandrea MD Amber Kelley PA-C / Debra Babich MD Eric D King PA-C / Jeffrey Altman MD Dawn C Roman PA-C / Paula Lapinski 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 Rex E Stombaugh MPAS, PA-C / George Nahass MD Judy Valkenburg PA-C / Cheuk Yung MD inDiAnA Andrew M Burns PA-C / Lori Swan MD Mitzi L Carter MPAS, PA-C / Duane Banet MD 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 Christina L Race PA-C / Kenneth Dawes 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 kentuCky Delicia A Garner MPAS, PA-C / Teresa Bentley MD Dana N Jennings MPAS, PA-C / Michael Crowe MD MD mASSACHuSettS Jessica L Bahros PA-C / Ramzi Saad MD Holly B Chandler PA-C / Mark Blumberg 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 Blair Maerowitz PA-C / Seth Kates MD Elizabeth J McLeish PA-C / Ramzi Saad MD Kelly L Mead PA-C / Thomas Cahn MD Sneha R Patel Campanella MPAS, PA-C / M Grevelink MD Kathleen M Rose PA-C / Seth Kates MD
48 Journal of Dermatology for Physician Assistants
Jeffrey M Soares PA-C / Kenneth Reed MD Christine M David PA-C / Nina Blumenthal MD mARylAnD Beverly D Connolly PA-C / Michael Del Torto MD Christina L Dolinar PA-C / Risa Jampel MD Lauren M Fisher PA-C / Ronald Prussick MD Amy Gawler PA-C / Roberta Palestine MD Mary M Hoke PA-C / Robert Berger MD Edgar F Peithman PA-C / Kenneth Judd MD Brenda Schneider PA-C / Diane Orlinsky MD Kristina R Trunnell PA-C / Elizabeth Liotta MD Melissa A Veneracion PA-C / Allan Hartley MD mAine Alison J Ravis MPAS, PA-C / Peter Bouman MD miCHiGAn Matthew Adler MPAS, PA-C / Howard Lipkin MD Jennifer Anderson PA-C / David Spurlin MD Lisa K Bowersox PA-C / Murray Cotter MD PhD Terenia A Custer PA-C / Brian Sandler MD Molly R Duiven MPAS, PA-C / Jack Dekkinga MD Jeffry S Freeman PA-C / David Semler MD Laura K Ginoza PA-C / Stephen Guthrie MD Jason C Hui PA-C / Kimball Silverton MD Amber E Kintigh MPAS, PA-C / Jack Dekkinga MD Nicole Luszczyk PA-C / Wendy McFalda MD Jessica M MacDougall MPAS, PA-C / Ann Hern MD Leah M MacMartin MPAS, PA-C / Brian Sandler MD Mary R Proctor PA-C / Mark Saunders MD Ronald W Reusch PA-C / Jack Dekkinga MD Emily Roberts PA-C / Stephanie Neider MD Thomas D Till PA-C / Donn LaTour MD Kurt J Vander Veen PA-C / Jack Dekkinga MD Jared P Wilson PA-C / Donn LaTour MD minneSotA Jacalyn J Beiler MPAS, PA-C / Patrick Carney MD Heather R Haberman MPAS, PA-C / Cynthia Vehe MD Katherine R Larson PA-C / Patrick Carney MD Nicole T Manecke PA-C / Paul Lundstrom MD Deborah A Steinbar PA-C Natalie Roholt MD Larry D Weidell PA-C Patrick Carney MD
www.dermpa.org/diplomate miSSouRi Lindsay Delmont PA-C Melody Stone MD Christine B Edwards PA-C Jeffery Reed MD Scott K Maury PA-C Jacquelyn Garrett MD Julie D Medlin PA-C Angela Spray MD miSSiSSiPPi Alan G Crawford MPAS, PA-C Thomas Garrott MD Ron F Marascalco MPAS, PA-C John Marascalco MD noRtH CARolinA Melinda R Asfaw PA-C Jean Kois MD Timothy E August MPAS, PA-C Currie Custer MD English B Black PA-C / Beth Goldstein MD Katherine C Caggiano MPAS, PA-C / Stan Whittaker MD Adele Clark PA-C / Alan Fleischer MD Samantha B Conner PA-C / Amy Devore MD Julie S Dodge MPAS, PA-C / Audrey Echt MD David J Dorenfeld PA-C / John Reid 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 Ann Rankin PA-C / Joeseph Huppmann MD Della Sue Reynolds MPAS, PA-C / Dan Zivony MD Victoria F Rhodes PA-C / Dan Henshaw MD Angela F Richardson MED, MHS, PA-C / Navjeet Sidhu-Malik MD Kimberly H Rikard PA-C / James Polo MD Michael E Sabol PA-C / Dennis Polley DO 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 noRtH DAkotA Brooke K Schmidt PA-C / Thomas Matzke 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 Kerri S Otto PA-C / Rodney Basler MD Rebecca A Reinke 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 Giudice MD Jennifer L Krasovic PA-C / Christine Kannler MD George H Lewis PA-C / Robert Posnick MD 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 Guthrie MPAS, PA-C / Daniel Kessel MD Beth A Hellstern PA-C / Roderick Kaufmann MD Patricia A McTaggart PA-C / Patricia McCormack MD Kimberly A Newhook PA-C / Warren Kurnick MD Lauralee M Pakozdi PA-C / Lisa Coppa Breslauer MD Jenna N Rogers MPAS, PA-C / Christine Papa DO Gerard W Stroup PA-C / Coyle Connolly DO Antonella F Viterbo PA-C / Coyle Connolly DO Sarah Wasser PA-C / Mathias Zemel MD Jennifer Zimbalist MPAS, PA-C / David Wrone MD Genet M DeFazio PA-C / Dmitry Khasak MD nevADA Isaac Gier MPAS, PA-C / Elizabeth Langford MD Daniel B Hickey PA-C / Martin J. Safko MD John V Notabartolo MPAS, PA-C / Linda Woodson MD new yoRk Dawn M Barilli PA-C / Joseph Tuchman MD
Nicole J Cassara MPAS, PA-C / Joseph Onorato MD Elizabeth Choe PA-C / John F. Romano MD Kelly A Christman PA-C / Steven Simon MD Tania D Cohen MPAS, PA-C / Hendrik I. Uyttendaele MD Maria A DeRosa MPAS, PA-C / Joseph Wojciechowski MD Elizabeth M Femenia PA-C / david Cooper MD Ari J Fisher PA-C / Robert Shoss MD Ari J Fisher PA-C / Robert Shoss MD Patrick A Franck PA-C / Steven Resnick MD Travis M Hayden MPAS, PA-C / John Tu MD Susan B Hirsch PA-C / Mary Ruth Buchness MD Kelly T Joyce PA-C / Nathalie Zeitouni MD Patricia Kennedy PA-C / Daniel Cuozzo MD Karl Kruszynski PA-C / Marie-Louise Johnson MD Gary A Levine PA-C / Patricia McCormack MD Sandra S Mamis PA-C / Henry A. Greenblatt MD Mary Ann Pelzer PA-C / Jordan Zuckerman MD Matthew F Rossano PA-C / Richard Urbanek MD Allison C Santhouse PA-C / Debra Jaliman MD Timothy P Smith PA-C / Stephen Presser MD Avraham Sokoloff PA-C / Joseph Tuchman MD Melissa A Spencer-Winker MPAS, PA-C / Michelle L. Bennett MD Anna Stassiy PA-C / Josiane Lederman MD Jamie Sturm PA-C / Stephen Presser MD oHio Michelle E Bodie PA-C / Thomas Fleming MD John A France MPAS, PA-C / David Knox MD 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 Nina N Rettig PA-C / Mounir Boutros 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 Kelly J Walworth PA-C / Mark A. Dawkins MD
SDPA DiPlomAte? oReGon Laurie A Leece PA-C / Todd Knapp MD Kris J Miller MPAS, PA-C / Greg Richterich MD Nathan B Smith MPAS, PA-C / Cynthia Dreyer MD Erik S Zenger PA-C / Bernard Gasch MD PennSylvAniA Desiree A Antonacci PA-C / Bruce Brod MD Cheryl Bessoir PA-C / Michael O’Donnell MD Jocelyn M Confino MPAS, PA-C / Rochelle Weiss MD Greg S Forsyth MPAS, PA-C / Ira Berman MD Chantelle K Gastinger MPAS, PA-C / Scott Gottlieb MD Kristen M Grippe MPAS, PA-C / David Benjamin MD Abby A Jacobson MS, PA-C / Bruce Brod MD Amy L Jones PA-C / Jonathan Wolfe MD Katie B Joshi PA-C / Grace Lee MD Nicole A Koci MPAS, PA-C / Jean Braun MD Gina B Kuloszewski PA-C / Joanne Zenker MD Barbara A Lozada PA-C / Joann Zenker MD Lucia Y Martin MPAS, PA-C / Christine Stanko MD Jason D Oberdick PA-C / George Francis MD Michelle D Ramsberger PA-C / David Vasily MD Jessica S Rein PA-C / Christine Mackley MD Maria H Ressler MPAS, PA-C / Rebecca Caserio MD Dawn M Sanzotti PA-C / Sara Ferguson MD Ashley R Serena PA-C / Robin Scheiner MD Caitlyn W Smith PA-C / Kimberly Rau MD Carly R Soda PA-C / Daniel Shrager MD Barbara S Stein PA-C / Mark Marsili MD Jil K Swanson MPAS, PA-C / Justin Vujevich MD Debora M Szafran PA-C / Jonathan Wolfe MD Kimberly A Tacconi PA-C / Susan Kucirka MD Michael J Wassel JR MPAS, PA-C / Marc Levin MD Lauren R Zajac MPAS, PA-C / David Amato DO RHoDe iSlAnD Graciette DaSilva PA-C / Gwenn Vittimberga MD Mark A Trott PA-C / Raymond Welch MD SoutH CARolinA Peter B Gray MPAS, PA-C / Dr. Richard DeAngelis MD Michael D Overcash MPAS, PA-C / Hudson Rogers MD Rebecca L Repaire PA-C / Todd Schlesinger MD Edward R Reynolds PA-C / Phillip Latham MD Vicki S Roberts MPAS, PA-C / Fred McElveen MD
SoutH DAkotA S. Darlene Shafer PA-C / Marc Boddicker MD Karen K Zepp PA-C / Roger Knutsen MD tenneSSee Amy Bonner PA-C / Mark Fairhurst MD Tammie M Campanali PA-C / Chris Robb MD Jennifer H Hall PA-C / Michael Bell MD Angela M Heikes PA-C / Ronald Nelson MD Andrew W Hull PA-C / Robert Clemons MD Daniel L Kachelmyer PA-C / Julie Pena MD Waynette M Kingman PA-C / Robert Paul Unkefer MD Darrell R Millsap PA-C / James Patrick Rash MD Kathrin K Nunes PA-C / Samuel Banks MD Melissa K Taylor PA-C / Paul Benson MD texAS Piipar S Allen PA-C / Christopher Jones MD Karla J Blixt PA-C / Martha McCollough MD Cathleen Y Chidester PA-C / Ronald Grimwood MD 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 Kirk F Gautier PA-C / William Grabski MD Bethany L Grubb MPAS, PA-C / Kent Aftergut MD Sheryl L Gyr MPAS, PA-C / Mark Ray MD April L Harrison MPAS, PA-C / Suzanne Bruce MD Lindsay A Hayler PA-C / Dr. Shelley Sekula-Gibbs MD Jennifer J Jordan PA-C / Michael Coverman MD Kristine Kucera DHS, MPAS, PA-C / Kelly Warren MD Denise Marquez PA-C / Paul Friedman MD Allison L Martin PA-C / Vincent Quintero MD Lisa Moody PA-C / Jeannine Hoang MD Gabriel R Nanagas PA-C / Matthew Barrows MD Erin M Nulf MPAS, PA-C / Forrest C Brown MD Kristie Obranovich PA-C / Lisa Rhodes MD Lisa M Ostrowski PA-C / M.G. Mullanax MD Michelle B Purtle PA-C / Steven Smith MD Jill H Hude-Ray MPAS, PA-C / Dana Jeng MD Diana Reyes MPAS, PA-C / Bryan Selkin MD Katie C Rose PA-C / Forrest C. Brown 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 Joleen M Volz MPAS, PA-C / Alan Menter MD Teresa M Willis PA-C / D. Scott Miller MD
utAH Stephen T Anderson PA-C / Cheryl Lee Eberting MD 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 Kent B Whitaker PA-C / Bradley Summers 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 Kevin S Koch Sr PA-C / Calvin McCall MD Cecilia D Ross PA-C / Frances Slade Rotter 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 William R Bies PA-C / Eric Rasmussen 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 Matt Furber PA-C / Amber Fowler MD James L Garcia PA-C / William, Philip Werschler MD Megan E Landis Ferestien PA-C / John Headley MD Corey R Richardson MPAS, PA-C / Theresa Mah Zhen Qian MD Kurt Schlecht PA-C / Zheng Qian MD David Sprouse 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 Bauer MD wiSConSin Gregory D Buttolph MPAS, PA-C / Karl Noll MD Kurt S Holst PA-C / Vernon Casterline MD Courtney A Papp PA-C / Kathleen Stokes MD weSt viRGiniA Johnathan M Pierson MPAS, PA-C / Thomas Karrs MD
Vol. 5, No. 3 SUMMER 2011 49
Professional development
Dermatology Billing & Coding
Destruction of Malignant Lesions (CPT codes 17260 to 17286) Do You Measure Up? By Inga Ellzey, MPA, RHIA, CDC
SDPA Members Only Content A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.
Ms. Ellzey, President/CEO of the Inga Ellzey Practice Group, Inc., in Casselberry, FL, is an expert on dermatology coding, documentation and reimbursement. She has more than 35 years of experience in the field of dermatology and is the CEO and founder of two nationwide dermatology billing services. You can reach her at the following number: (800) 318-3271, or email her at: inga@iepg.com.
50 Journal of Dermatology for Physician Assistants
Judicial and Ethical Affairs Conflicts of Interest By Karen Scully, MD, FRCPC, MA Ethics
SDPA Members Only Content
professional development
A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.
Vol. 5, No. 3 SUMMER 2011 51
SDPA Members Only Content A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.
professional development
Karen Scully is a board-certified dermatologist in the United States and Canada. She had a private practice in the Toronto area for many years and then accepted a teaching position at the Johns Hopkins Medical Institutions where she practiced and taught dermatology residents and medical students. More recently she moved to Charlotte, North Carolina and completed a Master’s Degree in Ethics and Applied Philosophy at the University North Carolina at Charlotte.
If you have an ethical dilemma that you have encountered or a topic that you would like discussed, please pass it along to: Editor@jdpa.org
Notes from your Office Manager Communicating With Your Patients SDPA Members Only Content A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.
J
52 Journal of Dermatology for Physician Assistants
Proven effective in moderate to severe acne1,2
Power To treat
To please
In studies with more than 2800 patients with moderate to severe acne, Acanya®Gel demonstrated:
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●
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64% median reduction in inflammatory lesion counts at 12 weeks (34% for vehicle)1,2 49% median reduction in noninflammatory lesion counts at 12 weeks (26% for vehicle)1,2
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With ease!
No patient treated with Acanya Gel discontinued treatment due to erythema, scaling, burning, stinging, or itching in pivotal trials1
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Neat and simple: No jar, no mess
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No pharmacy admixing: Pump now replaces the Acanya Gel jar
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Measured dose: Consistent delivery
Low potential for cutaneous irritation may lead to increased adherence to treatment
Indication and Important Safety Information Acanya Gel is indicated for the topical treatment of acne vulgaris in patients 12 years of age or older. Acanya Gel is contraindicated in patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis. Discontinuation is recommended if significant diarrhea develops. In controlled clinical trials, the following application-site adverse reactions occurred in less than 0.2% of patients treated with Acanya Gel: applicationsite pain (0.1%), application-site exfoliation (0.1%), and application-site irritation (0.1%). Of the patients who experienced cutaneous symptoms of erythema, scaling, itching, burning, and/or stinging, regardless of the relationship to therapy, the majority of cases were mild to moderate in severity, occurred early in treatment, and decreased thereafter.
To learn more, please visit www.AcanyaGel.com Please see the following page for references and brief summary of full prescribing information.
Now
in a ready-to-use 50g pump for your patients’ convenience
Acanya Gel Disp: 50g Sig: Apply to affected area once daily ®
4
refills ACAN-1010-0002
© 2010 CORIA Laboratories ACAN-0510-6004
Vol. 5, No. 3 SUMMER 2011 53
USE IN SPECIFIC POPULATIONS Pregnancy Category C There are no well-controlled trials in pregnant women treated with ACANYA Gel. It also is not known whether ACANYA Gel can cause fetal harm when administered to a pregnant woman. ACANYA Gel should be used during pregnancy only if the potential benefi t justifies the potential risk to the fetus. ACANYA® (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/2.5% Brief summary. Please see full prescribing information for complete product information. INDICATIONS AND USAGE ACANYA Gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older. The safety and efficacy of this product in the treatment of any other disorders have not been evaluated. DOSAGE AND ADMINISTRATION Apply a pea-sized amount of ACANYA Gel to the face once daily. Use of ACANYA Gel beyond 12 weeks has not been evaluated. ACANYA Gel is not for oral, ophthalmic, or intravaginal use. CONTRAINDICATIONS ACANYA Gel is contraindicated in patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis. WARNINGS AND PRECAUTIONS Colitis Systemic absorption of clindamycin has been demonstrated following topical use of clindamycin. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin. When significant diarrhea occurs, ACANYA Gel should be discontinued.
Animal reproductive/developmental toxicity studies have not been conducted with ACANYA Gel or benzoyl peroxide. Developmental toxicity studies of clindamycin performed in rats and mice using oral doses of up to 600 mg/kg/day (240 and 120 times amount of clindamycin in the highest recommended adult human dose based on mg/m2, respectively) or subcutaneous doses of up to 200 mg/kg/day (80 and 40 times the amount of clindamycin in the highest recommended adult human dose based on mg/m2, respectively) revealed no evidence of teratogenicity. Nursing Mothers: It is not known whether clindamycin is excreted in human milk after topical application of ACANYA Gel. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to use ACANYA Gel while nursing, taking into account the importance of the drug to the mother. Pediatric Use: Safety and effectiveness of ACANYA Gel in pediatric patients under the age of 12 have not been evaluated. Clinical trials of ACANYA Gel included patients 12-17 years of age. Geriatric Use Clinical studies of ACANYA Gel did not include sufficient numbers of patients aged 65 and older to determine whether they respond differently from younger patients. NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity, mutagenicity and impairment of fertility testing of ACANYA Gel have not been performed.
Severe colitis has occurred following oral and parenteral administration of clindamycin with an onset of up to several weeks following cessation of therapy. Antiperistaltic agents such as opiates and diphenoxylate with atropine may prolong and/or worsen severe colitis. Severe colitis may result in death.
Benzoyl peroxide has been shown to be a tumor promoter and progression agent in a number of animal studies. Benzoyl peroxide in acetone at doses of 5 and 10 mg administered topically twice per week for 20 weeks induced skin tumors in transgenic Tg.AC mice. The clinical significance of this is unknown.
Studies indicate toxin(s) produced by Clostridia is one primary cause of antibiotic-associated colitis. The colitis is usually characterized by severe persistent diarrhea and severe abdominal cramps and may be associated with the passage of blood and mucus. Stool cultures for Clostridium difficile and stool assay for C. difficile toxin may be helpful diagnostically.
Carcinogenicity studies have been conducted with a gel formulation containing 1% clindamycin and 5% benzoyl peroxide. In a 2-year dermal carcinogenicity study in mice, treatment with the gel formulation at doses of 900, 2700, and 15000 mg/kg/day (1.8, 5.4, and 30 times amount of clindamycin and 3.6, 10.8, and 60 times amount of benzoyl peroxide in the highest recommended adult human dose of 2.5 g ACANYA Gel based on mg/m2, respectively) did not cause any increase in tumors. However, topical treatment with a different gel formulation containing 1% clindamycin and 5% benzoyl peroxide at doses of 100, 500, and 2000 mg/kg/ day caused a dose-dependent increase in the incidence of keratoacanthoma at the treated skin site of male rats in a 2-year dermal carcinogenicity study in rats. In an oral (gavage) carcinogenicity study in rats, treatment with the gel formulation at doses of 300, 900 and 3000 mg/kg/day (1.2, 3.6, and 12 times amount of clindamycin and 2.4, 7.2, and 24 times amount of benzoyl peroxide in the highest recommended adult human dose of 2.5 g ACANYA Gel based on mg/m2, respectively) for up to 97 weeks did not cause any increase in tumors. In a 52-week dermal photocarcinogenicity study in hairless mice, (40 weeks of treatment followed by 12 weeks of observation), the median time to onset of skin tumor formation decreased and the number of tumors per mouse increased relative to controls following chronic concurrent topical administration of the higher concentration benzoyl peroxide formulation (5000 and 10000 mg/kg/day, 5 days/week) and exposure to ultraviolet radiation.
Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug clinically effective against C. difficile colitis. Ultraviolet Light and Environmental Exposure Minimize sun exposure following drug application. (See NONCLINICAL TOXICOLOGY.) ADVERSE REACTIONS Clinical Studies Experience Because clinical trials are conducted under prescribed conditions, adverse reaction rates observed in the clinical trial may not reflect the rates observed in practice. Because clinical trials are also conducted under widely varying conditions, adverse reactions observed in the clinical trials of a drug cannot always be directly compared to rates in the clinical trials of another drug. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse reactions that appear to be related to drug use and for approximating rates. The following selected adverse reactions occurred in less than 0.2% of patients treated with ACANYA Gel: application site pain (0.1%); application site exfoliation (0.1%); and application site irritation (0.1%). During clinical trials, patients were assessed for local cutaneous signs and symptoms of erythema, scaling, itching, burning and stinging. Most local skin reactions increased and peaked around week 4 and continually decreased over time reaching near baseline levels by week 12. The percentage of patients that had symptoms present before treatment, the maximum value recorded during treatment, and the percent with symptoms present at week 12 are shown below. Local Skin Reactions—Percent Patients with Symptoms Present. Combined Results from the Two Phase 3 Trials (N = 773) Before Treatment (Baseline)
Maximum During Treatment
Clindamycin phosphate was not genotoxic in the human lymphocyte chromosome aberration assay. Benzoyl peroxide has been found to cause DNA strand breaks in a variety of mammalian cell types, to be mutagenic in S. typhimurium tests by some but not all investigators, and to cause sister chromatid exchanges in Chinese hamster ovary cells. Fertility studies have not been performed with ACANYA Gel or benzoyl peroxide, but fertility and mating ability have been studied with clindamycin. Fertility studies in rats treated orally with up to 300 mg/kg/day of clindamycin (approximately 120 times the amount of clindamycin in the highest recommended adult human dose of 2.5 g ACANYA Gel, based on mg/m2) revealed no effects on fertility or mating. HOW SUPPLIED ACANYA Gel is supplied as a 50 g pump (NDC 13548-132-50). Dispensing instructions for the pharmacist Dispense ACANYA Gel with a 10 week expiration date. Specify “Store at room temperature up to 25°C (77°F). Do not freeze.”
End of Treatment (Week 12)
Storage and Handling PHARMACIST: Prior to dispensing, store in a refrigerator, 2°C to 8°C (36°F to 46°F).
Mild
Mod*
Severe
Mild
Mod*
Severe
Mild
Mod*
Severe
Erythema
22
4
0
25
5
<1
15
2
0
Scaling
8
<1
0
18
3
0
8
1
0
Keep out of the reach of children.
Itching
10
2
0
15
2
0
6
<1
0
Keep container tightly closed.
Burning
3
<1
0
8
2
0
2
<1
0
RX Only
Stinging
2
<1
0
6
1
0
1
<1
0
Distributed by CORIA Laboratories, a division of Valeant Pharmaceuticals North America, Fort Worth, TX 76107
*Mod=Moderate
DRUG INTERACTIONS Erythromycin ACANYA Gel should not be used in combination with topical or oral erythromycin-containing products due to its clindamycin component. In vitro studies have shown antagonism between erythromycin and clindamycin. The clinical significance of this in vitro antagonism is not known.
PATIENT: Store at room temperature at or below 25°C (77°F). Protect from freezing.
Manufactured by Contract Pharmaceuticals Limited Niagara, Buffalo, NY 14213 © 2010 CORIA Laboratories
Concomitant Topical Medications Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents. Neuromuscular Blocking Agents Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, ACANYA Gel should be used with caution in patients receiving such agents.
54 Journal of Dermatology for Physician Assistants
References: 1. Pivotal studies, data on file, CORIA Laboratories. 2. Gold M. A new, once daily, optimized, fi xed combination of clindamycin phosphate 1.2% and low-concentration benzoyl peroxide 2.5% gel for the treatment of moderate-to-severe acne. J Clin Aesthet Derm. 2009;5:44-48.
LASERS PRINTED AT
100%
Outside & Inside the 9 to 5...
Sarah Kurts, PA-C of Denver, Colorado was recently and expertise on the Board. He said that she has “a appointed to the National Psoriasis Foundation Board tremendous passion for our cause and will bring of Trustees in recognition of her longtime service invaluable knowledge to our Board of Trustees.” to the National Psoriasis Foundation Sarah is a member of the American as a member and a volunteer. Noe Academy of Physician Assistants (AAPA), Baker, Public Relations Manager for the Colorado Association of Physician the National Psoriasis Foundation said, Assistants (CAPA), and the Society of “We wanted to add diversity to our Dermatology Physician Assistants (SDPA); leadership and bring people like Sarah she is the treasurer of the Colorado with a lot of direct experience working Society of Dermatology Professionals (PAs with people affected by psoriasis and and NPs). Sarah is a 1999 graduate of the psoriatic arthritis.” As a PA working in Child Health Associate/Physician Assistant dermatology, Sarah has participated Program at the University of Colorado in numerous research studies of Health Sciences Center in Denver, she new drugs in development for skin was the recipient of scholarships from Sarah Kurts, PA-C conditions, including psoriasis, and she both the Physician Assistant Foundation has helped lead the National Psoriasis and the Colorado Academy of Physician Foundation’s affiliated support network in Denver Assistants Student Sarah, who has also worked as a since 2008. Sarah was instrumental in starting the PA in pediatrics, has been a PA in dermatology since National Psoriasis Foundation’s Walk to Cure Psoriasis 2001. She has worked with the Dermatology & Laser in Denver, serving as its chair for 2009 and 2010. The Institute of Colorado in Lone Tree, outside of Denver National Psoriasis Foundation president and CEO, since 2005. J Randy Beranek, is delighted to have her leadership
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S, PA-C, and Alan PAD. ased), and ey, Jim Leka Sue Rancis, Beck, Society now call the Kurti s, Richa Joe Mon ated from DHS, MPA rd Sarto s roe. , PA-C gradu in Physicia of Dermatolog Patricia ri, al Branch Ferrer, MPAS Patricia sity of Texas Medic rs Degree from the Univ Ferrer, MPA during face-to-f n Assistants mety S, the her Maste the Univer 1998 andersity of Texa PA-C graduate New Orle February 2003 (SDPA first timeace for the obtained s 1998 and sity of Nebraska in ate member of 1995 AAD the Univ obtained her Medical Bran d from in ans. ch the Univer She is an Associ has been working annual one room scholarshersity of Nebr Masters Degr in In the aska in ee from meeting scholarship). the AAPA. She and is currently the SDPA ip). She is an 2003 disallow 1990s thro and in Associate (SDPA ent, nine years the SDPA PA for ugh to Fello She has and Presid mem w memiate tology for a dermatology Row: attende ed the “PA-C” the early been as in derma ber of the ber of and in to Front work years me Immed e Row locally m; bad desi ing 200 part-ti and Back outsi AAPA. in derm ges, thus gnation 0s identifyi working VA and volunteers ry to disclose. currently ittee Robert isHigha Patritociaright, on con the AAD ons Comm on sabbz; atology for nine relationsh wouldent-elect, dery 2007 - Left the Tucson nships with indust article and ; Presid ference attend ng fellow PAs reducing the those like to Swart atical. She ips with Indust Relati Hickeywho e; than e relatio to this chan the Danielwho Monro who indu has no Nancy all who, Sharon ent stry to contributed instrumen k asurer ent, Joewere has no outsid physicia conference . The AAD allow ces of the SDPA contrPresid disclose. not have Secretary/Tre Vice Past Presid may Mexico. She like to thank all who development of tal ;inand ibutedatolog y n Day; the early Derm to been sessions. ns and PAs coulonly with thei ed PAs to Gordo y Grubb ental in the mentionel CME ces for Bethan ChairSour developmthis article and Patricia would r 2006 this artic 6th Annua at Large, corre were instrum ned. d. or spon ent of the from July the Mon At the 1995 d only attend supervising y le inclu Direct mentio those who 2007esSDPA newsletters e Kucera, Bethan New Orle SDPA de: Kurtiat the denc the have been D.C. with s Opp, displayin roes sat outs ngton, Primo may not Linda phone inter view Kristin include: SDPA 2010 35 ans AAD plenary Washi inPA-C correspon ces with FAll ide phone , Jim Page Findley, PA-C this article 4 g sium s and for the onden and s a No. and sign Sympo AAD exhi conferen email introduce Source , PA-CVol. 4, , Sue asking and Mary dences with Arnold; email Gordon Day, email corresp ce Tom Hoka , and Rick Sato Rancis, PA-C Monroe. – June 2010; Hayden, and Terry Greg Buttolph, that seve themselves. dermatology bit hall , nson, PA-C ri, PA-C Grubb, Travis s with Nancy Primo, , Joe Mon . Email were offe ral dermatolo Both of them PAs to stop roe, PA-C conversation m. and , practices ring their servgists stopped were surprised Robert Higha to them that, to find out ices to help findask if they they had more abou PAs for t PAs thei PAs wor king in , and to info r rm their prac tices. Vol.4,
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Vol. 5, No. 3 SUMMER 2011 55
professional development
CORAC6957–JAAD, PEDIATRIC DERMATOLOGY, CUTIS DERMATOLOGY DEMO, DERMATOLOGY WORLD, ARCHIVES OF DERMATOLOGY Colors: BW + live/trim_DO NOT PRINT Bleed: 8.5"w x 11.125"h Trim: 7.75"w x 10.75"h Live: 6.75"w x 9.75"h Output @ 100% 262676gi302_Jrnl_PI Giant Creative Strategy
We congratulate Sarah Kurts, PA-C on her appointment to the National Psoriasis Foundation Board of Trustees. Sarah was elected to the Board of Trustees in February 2011. She has been a member of the National Psoriasis Foundation since 2007 and a volunteer since 2008. Sarah is the first and only PA to be named to the National Psoriasis Foundation Board of Trustees. To learn more about the National Psoriasis Foundation and how to get involved, please send an email to education@psoriasis.org or visit the Foundation’s website at www.psoriasis.org.
Dermatology PA news & notes
From the Desk of... Casey Croes, MPAS, PA-C SDPA Secretary/Treasurer
Educating Patients About the PA Profession We have all been there. We walk into an exam room, introduce ourselves to a new patient and hear, “Will the doctor be seeing me after you?” Or after you have taken a patient’s history, reviewed his/her complaints, examined the patient, told him/her your diagnosis and treatment, they then ask, “Why don’t we have the doctor take a look?” And last but not least, they ask, “When will you be a doctor?” These are difficult situations we have all found ourselves in at one time or another. How can we make the most out of such situations without losing our cool? Here are a few of my suggestions. First and foremost, your first line of defense is to be proactive. When your front office staff schedules a patient to see you, ensure that they tell the patient that he/she will be seeing, for example, Sally Smith, a physician assistant. I find that spelling it out gives the patient time to digest that you are not a resident or a nurse. We all know that patients can be hurried or distracted and may miss that information when it is given to them on the phone as they are scheduling the appointment. After your nurse or medical assistant has taken the patient to the exam room and gathered the patient’s history, upon leaving he/she can say, “Sally Smith, the physician assistant will be right with you.” That is yet again another opportunity to ensure that the patient knows whom he/she is seeing. At this point, if the patient has any questions or concerns, you will hopefully know this upon entering the exam room and can Casey Croes, MPAS, PA-C graduated from Chatham College in 2006. She currently works for the Dermatology Group in northern New Jersey and serves as the Secretary/Treasurer for the SDPA.
56 Journal of Dermatology for Physician Assistants
address any of these concerns immediately. These preventive measures are meant to allow the patient and physician assistant to begin the exam prepared and informed after addressing any concerns up front. The next issue is the patient who asks if the doctor will be seeing him/her after you. Even if the doctor is available, I offer to take a look first myself. I often find that once I have interviewed the patient, examined him/her, given my diagnosis and treatment plan, the patient will excitedly say, “No need for the doctor, you have answered all of my questions!” Simply suggesting that he/she could see the doctor after seeing me makes the patient more comfortable, and I am usually able to win the patient over. In fact, this is how I have developed a following of patients who only want to see me because I have made them comfortable and taken the time to answer their questions. Finally, my favorite question that patients ask is, “When will you be a doctor?” I love to tell them I do not have any plans to become a doctor because I am already doing what I love, taking care of patients! I then use this as an opportunity to educate patients about physician assistants and discuss the following: how our profession started, what comprises our education, what we are allowed to do, and how I work with my supervising physician. I find that many patients are reassured by my education. Often, patients will say that one of their children is interested in the profession, and I ask them to send that person my way. This conversation opens many doors. What I would like to do is challenge each of you to use these difficult situations as opportunities to educate your patients and spread the good word about our wonderful profession! J
FOR THE TREATMENT OF ACNE VULGARIS
Dive in
with Atralin
®
Optimized for efficacy with minimal irritation
mean reduction in inflammatory • 36% lesions at 12 weeks* mean reduction in noninflammatory • 41% lesions at 12 weeks* • Low irritation profile • Moisturizing and hydrating agents 1
1
1
† 2-4
*Combined results of two 12-week, prospective, multicenter, randomized, vehicle-controlled studies of patients with mild to moderate acne vulgaris of the face.1 †The contribution of individual components to efficacy has not been evaluated.
Indication and Important Safety Information: Atralin Gel is indicated for the treatment of acne vulgaris. The most common adverse reaction was mild to moderate irritation of the skin (ie, dry skin, skin burning, erythema, and exfoliative dermatitis), which occurred during the first few weeks of treatment with Atralin Gel. To prevent aggravating the skin, protect it from sun, tanning lights, extreme wind or cold, and harsh skincare products. Use of sunscreen products of at least SPF 15 and protective clothing over treated areas are recommended when exposure cannot be avoided. Atralin Gel should not be used on eczematous or sunburned skin due to potential for severe irritation. References: 1. Data on file, CORIA Laboratories. 2. Weindl G, Schaller M, Schäfer-Korting M, Korting HC. Hyaluronic acid in the treatment and prevention of skin diseases: molecular, biological, pharmaceutical and clinical aspects. Skin Pharmacol Physiol. 2004;17(5):207-213. 3. Morganti P. Skin hydration. In: Magdassi S, Touitou E, eds. Novel Cosmetic Delivery Systems. New York, NY. Marcel Dekker, Inc; 1999:71-98. 4. Kraft JN, Lynde CW. Moisturizers: what they are and a practical approach to product selection. Skin Therapy Lett. 2005;10(5):1-8.
AtralinGel.com
Please see brief summary of prescribing information on next page.
© 2010 CORIA Laboratories, a division of Valeant Pharmaceuticals North America COR-137791-1210
Vol. 5, No. 3 SUMMER 2011 57
Vehicle Gel (n = 487)
Dry Skin Peeling/Scaling/Flaking Skin Skin Burning Sensation Erythema Pruritus Pain of Skin Sunburn
109 (16%) 78 (12%) 53 (8%) 47 (7%) 11 (2%) 7 (1%) 7 (1%)
8 (2%) 7 (1%) 8 (2%) 1 (<1%) 3 (1%) 0 (0%) 3 (1%)
Marketed by:
Manufactured by: DPT LABORATORIES, LTD. San Antonio, Texas 78215 Patent No.: 5,670,547 Revised: 11/2009 137623-1109
df
CORIA Laboratories, a division of Valeant Pharmaceuticals North America, Aliso Viejo, CA 92656
58 Journal of Dermatology for Physician Assistants
263100gi301PI_JDPA
Atralin Gel (n = 674)
K
Event
Bleed: N/A Live: 6.75"w x 9.75"h Output @ 100% Giant Creative Strategy
Table 1. Number of Subjects with Selected Adverse Reactions (Occurring in At Least 1% of Subjects)
DRUG INTERACTIONS When treating with Atralin Gel, caution should be exercised with the use of concomitant topical medication, medicated or abrasive soaps and cleansers, products that have a strong drying effect, and products with high concentrations of alcohol, astringents, spices, or lime. Particular caution should be exercised with the concomitant use of topical over-the-counter acne preparations containing benzoyl peroxide, sulfur, resorcinol, or salicylic acid. Allow the effects of such preparations to subside before use of Atralin Gel is begun. USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C. There are no well-controlled trials in pregnant women treated with Atralin Gel. Atralin Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Atralin Gel at doses of 0.1, 0.3 and 1 g/kg/day was tested for maternal and developmental toxicity in pregnant Sprague-Dawley rats by dermal application. The dose of 1 g/kg/day was approximately 4 times the clinical dose assuming 100% absorption and based on body surface area comparison. Possible tretinoin-associated teratogenic effects (craniofacial abnormalities [hydrocephaly], asymmetrical thyroids, variations in ossification, and increased supernumerary ribs) were noted in the fetuses of Atralin Gel treated animals. These findings were not observed in control animals. Other maternal and reproductive parameters in the Atralin Gel treated animals were not different from control. For purposes of comparison of the animal exposure to human exposure, the clinical dose is defined as 2 g of Atralin Gel applied daily to a 50-kg person. Oral tretinoin has been shown to be teratogenic in rats, mice, rabbits, hamsters and nonhuman primates. Tretinoin was teratogenic in Wistar rats when given orally in doses greater than 1 mg/kg/day (approximately 8 times the clinical dose based on body surface area comparison). In the cynomolgus monkey, fetal malformations were reported for doses of 10 mg/kg/day, but none were observed at 5 mg/kg/day (approximately 80 times the clinical dose based on body surface area comparison), although increased skeletal variations were observed at all doses. Dose-related increases in embryolethality and abortion also were reported. Similar results have also been reported in pigtail macaques. Topical tretinoin in a different formulation has generated equivocal results in animal teratogenicity tests. There is evidence for teratogenicity (shortened or kinked tail) of topical tretinoin in Wistar rats at doses greater than 1 mg/kg/day (approximately 8 times the clinical dose assuming 100% absorption and based on body surface area comparison). Anomalies (humerus: short 13%, bent 6%, os parietal incompletely ossified 14%) have also been reported when 10 mg/kg/day (approximately 160 times the clinical dose assuming 100% absorption and based on body surface area comparison) was topically applied. Supernumerary ribs have been a consistent finding in rats when dams were treated topically or orally with retinoids. With widespread use of any drug, a small number of birth defect reports associated temporally with the administration of the drug would be expected by chance alone. Cases of temporally associated congenital malformations have been reported with use of other topical tretinoin products. The significance of these spontaneous reports in terms of risk to the fetus is not known. Nonteratogenic effects on fetuses: Oral tretinoin has been shown to be fetotoxic in rats when administered in doses 20 times the clinical dose based on a body surface area comparison. Topical tretinoin has been shown to be fetotoxic in rabbits when administered in doses 8 times the clinical dose based on a body surface area comparison. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Atralin Gel is administered to a nursing woman. Pediatric Use Safety and effectiveness in children below the age of 10 have not been established. A total of 381 pediatric subjects (aged 10 to 16 years), treated with Atralin Gel were enrolled into the two clinical studies. Across these two studies, comparable safety and efficacy were observed between pediatric and adult subjects. Geriatric Use Safety and effectiveness in a geriatric population have not been established. Clinical studies of Atralin Gel did not include any subjects over age 65 to determine whether they respond differently than younger subjects.
100%
BRIEF SUMMARY (see package insert for full prescribing information) For topical use only INDICATIONS AND USAGE Atralin Gel is a retinoid indicated for topical treatment of acne vulgaris. Important Limitations of Use The safety and efficacy of the use of this product in the treatment of any other disorders have not been evaluated. CONTRAINDICATIONS None WARNINGS AND PRECAUTIONS Skin Irritation The skin of certain individuals may become dry, red, or exfoliated while using Atralin Gel. If the degree of irritation warrants, patients should be directed to temporarily reduce the amount or frequency of application of the medication, discontinue use temporarily, or discontinue use altogether. Efficacy at reduced frequencies of application has not been established. If a reaction suggesting sensitivity occurs, use of the medication should be discontinued. Mild to moderate skin dryness may also be experienced; if so, use of an appropriate moisturizer during the day may be helpful. Tretinoin has been reported to cause severe irritation on eczematous or sunburned skin and should be used with caution in patients with these conditions. Topical over-the-counter acne preparations, concomitant topical medication, medicated cleansers, topical products with alcohol or astringents, when used with Atralin Gel, should be used with caution [see Drug Interactions (7)]. Ultraviolet Light and Environmental Exposure Unprotected exposure to sunlight, including sunlamps, should be minimized during the use of Atralin Gel. Patients who normally experience high levels of sun exposure, and those with inherent sensitivity to sun, should be warned to exercise caution. Use of sunscreen products of at least SPF 15 and protective clothing over treated areas is recommended when exposure cannot be avoided. Weather extremes, such as wind or cold, also may be irritating to patients under treatment with tretinoin. Fish Allergies Atralin Gel contains soluble fish proteins and should be used with caution in patients with known sensitivity or allergy to fish. Patients who develop pruritus or urticaria should contact their health care provider. ADVERSE REACTIONS Clinical Studies Experience Because clinical trials are conducted under prescribed conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. In two randomized, controlled trials, 674 subjects received treatment for up to 12 weeks with Atralin Gel [see Clinical Studies (14)]. In these studies, 50% of the subjects who were treated with Atralin Gel reported one or more adverse reactions; 30% of the subjects reported treatment-related adverse reactions. In the vehicle group, 29% of the 487 randomized subjects reported at least one adverse reaction; 5% of the subjects reported events that were treatment-related. There were no serious, treatment-related adverse reactions reported by subjects in any of the treatment groups. Selected adverse reactions that occurred in at least 1% of subjects in the two studies combined, are shown in Table 1 (below). Most skin-related adverse reactions first appear during the first two weeks of treatment with Atralin Gel, and the incidence rate for skin-related reactions peaks around the second and third week of treatment. In some subjects the skin-related adverse reactions persist throughout the treatment period.
The Difference We Make My One Regret
Recently, one of my colleagues, knowing that I was passing my thirty-year milestone in dermatology, asked me if I had thought about anything that I would have done differently in my practice. It didn’t take me more than a moment to start telling him what I have been thinking for a long time. “Time” was my answer, “more time with patients.” He then listened as I explained. I wish I had spent more time with patients... ● To BE with them...to simply BE with them. To honor their time and their lives. To have taken a deep breath and said, “So, what can I do for you today?”, and then wait for their responses...simply wait. ● To be in the moment, thinking only of them. To give them 100% of my attention. To make them feel special. ● To wonder with them, to find out the real reason “why” they came in for a visit, to hear their story. I remember one young woman in her early 30’s who came in concerned about a changing mole. Before she could say a word, I had already looked at the spot, confirmed that it was a benign growth, and told her so. I realized later that I had never really reassured her nor tried to soften or dissolve away slowly her worry. I just told her point blank that she was ok. I never listened to her story. Was she worried about the spot being a melanoma causing her sickness and death or about leaving her young children and husband alone in the world? I never allowed for her to tell me any of her story. Perhaps she would have told me how appreciative she was of our office making a very timely appointment after her “worried” call. What else might she have said or been thinking? Should I have waited perhaps for her to shed tears of relief? You see, I thought that my quick Dr. Steve Shama has been practicing general dermatology for 30 years in Boston, Massachusetts. Dr. Shama has been a professional speaker for 20 of those years and enjoys speaking on many topics, some of which include: “Dealing With Difficult People and Looking Forward To It!” and “Rediscovering The Joys of Medicine and of Life.” He gives these talks at medical meetings and for the general public throughout the country. He also travels to private offices to present his workshops and talks. You can reach Dr. Shama at www.steveshama.com.
and accurate diagnosis was all that was necessary. I never thought of hearing the rest of her story. I just assumed I knew. How many stories have I missed? ● To focus on them, to leave my “baggage” at the consultation door, to not be thinking of the last patient I saw, or the next one I would see, and to not wonder if I were on time. Time was all I had and should value, and I would have as much as I needed if I believed it so. ● To be more empathetic and to try to see from the patients’ perspectives; could I really stand in the patient shoes? Did I really give myself the time to imagine what it was like to live with generalized eczema, or a small patch of psoriasis in a visible area, or severe acne as a young person? Did I ever try to understand or was I too busy feeling good about making diagnoses and prescribing treatments, assuming that was enough? Did I ever ask patients what was it like to have a skin disorder or how it felt to live with a skin disorder that could not be cured? ● To make eye contact when I said something important for the patients to hear and to show the patients, by that eye contact, that I cared. ● To touch, not only physically, but with carefully chosen gestures, words, and the tonality that goes along with those words. ● To enter an exam room with the intention of first finding all of those things that were “working” for patients and then, and only then, looking for the “broken” parts. To first look for the loveliest parts of patients. ● To say “I’m sorry” for the fact that they have a serious skin disorder that they have to live with and to have those words come from a deep place within me. ● To always give hope, no matter what the circumstances. Even when all seems lost and there is no real hope, to be able to say, “I am here for you.” ● To set boundaries with patients about what I can and cannot do and while setting these boundaries to be caring, gentle, and not dismissive. If patients wanted drugs that had serious side effects
Vol. 5, No. 3 SUMMER 2011 59
DERmatology pa news & notes
By Steven K. Shama, MD, MPH
Dermatology PA news & notes
for seemingly innocent conditions, had I explained my reasons for a more benign approach, had I listened to their reasons, and had I “met” them somewhere in between? Was I true to myself, did I do the best for others, following my ethical compass, no matter what? ● To do the best I can to understand the angry patient. To embrace their anger, whatever the reason, and to find the deep source of it, and to do whatever I
can to make things better. ● To use both my heart and a scientific perspective to help patients. ● To do the best I can to express kindness, compassion, and my truth. On my wall in my office is calligraphy, expressing the condensed words of a poem by Nadine Stair:
“If I had my life to live over again... I would relax, I would limber up, I would be sillier than I have been this go-around. I would take more trips, watch more sunsets, climb more mountains, swim more rivers. I would eat more ice cream and fewer beans. I would start barefoot earlier in the spring and stay that way later in the fall. I wouldn’t work so hard. And I’d pick more daisies.” I would now add my own words: And I would spend more time with patients. J
“
”
First Foundations - You’re Trained, What Now? By Emily B. Massey, PA-C
When beginning a career in dermatology, you rely in part on those around you for training and advice. In appreciation of others investing time, money, and effort to make you a fabulous PA, you will eventually be able to “give back.” Keep this end in mind when you are training and start to forge these relationships early. • Seek leadership opportunities within the local, state, and national dermatology PA community • Train new dermatology PAs • Become an adjunct faculty at a PA program • Precept PA students • Consider medical missions, domestic or abroad • Provide inservices for your staff on subjects such as medical documentation, wound care, CLIA, OSHA, CPR/BLS, skin photography, iPLEDGE, etc.
60 Journal of Dermatology for Physician Assistants
• Consider becoming an expert in one facet of dermatology (psoriasis, acne, laser treatment, hair loss, etc.) • Do research or join an ongoing clinical trial • Give lectures to your local PA societies or at national conferences • Volunteer for career day at a high school or university • Be available for career counseling to students at all levels These ideas will provide you with a sense of personal satisfaction and enable you to “give back” in a meaningful way. The benefits of these actions will help advance the dermatology PA profession and may even make you a better PA. Please feel free to provide feedback (ah-ha moments, challenges, helpful hints, etc.) on your first year in dermatology to emily.massey@alumni.musc.edu. J
Supervising Physician CORNER Phototherapy for Psoriasis – Help the National Psoriasis Foundation and Your Patients Lower These Copayments
O
ur goal as medical providers in dermatology is to provide the highest quality care to our patients in the safest and most efficient manner possible. Unfortunately, there are sometimes barriers to care that have little to do with medicine and more to do with bureaucracy. A particularly topical example of this type of obstruction is the high copayment (co-pay) that is often required for each phototherapy treatment. As we all know, phototherapy is a safe, effective, and cost-efficient treatment for a wide variety of skin diseases, particularly psoriasis, eczema, vitiligo, and mycosis fungoides. Co-pays have been steadily rising across the country for the last 15 years and, despite the proven effectiveness of this treatment modality, these co-pays are now often applied to each phototherapy visit. Since psoriasis patients usually begin phototherapy with three visits a week, the pervisit co-pays between $20-50 can lead to monthly out-of-pocket costs of $600 or more. Many patients, especially in this difficult economy, cannot even approach affording treatment when their co-pay is applied to each visit. Since psoriasis is a life long and chronic disease, these patients generally move on to some other form of treatment. While a course of phototherapy may cost $1,200-1,500 yearly overall to the system, the large portion of this cost placed on the patient means that many go on to more aggressive and expensive systemic treatments. As biologic treatments for psoriasis can cost $15,000-25,000 yearly, it turns out that the insurance company and the medical system bear ten times the cost in order to put patients on a more expensive treatment with more side effects. For some patients such as children, pregnant women, or those with hepatitis C, there may be limited other options and high phototherapy co-pays may cut off their access to care completely. You might wonder how such disparity can exist and the answer is the most powerful force known to the modern world: bureaucracy. Insurance companies often disperse money in different “silos,” so savings on medications (covered by the pharmacy benefit side of the business) may not be important to the section of the company responsible for office visits. Six hundred dollars a month is a forbidding amount of money to most patients. By that patient moving on to a biologic,
the insurer incurs thousands of dollars in additional cost. Yet this is so buried in organizational bureaucracy and sacred insurance business models, that insurers will not bother trying to improve the situation – unless there is encouragement from our patients and us. There are several important steps we can take to help solve this burdensome problem for our patients: ♦ Write to your congressperson, senator, insurance commissioner, and state representatives about this problem to stress the burden it places not only on patients, but also on state and federal budgets as large amounts of money are needlessly spent on more aggressive treatment. Encourage your patients to do the same when this issue affects them. ♦ Discuss co-pays with your local insurance companies’ executives to encourage them to save money by offering more and better care through eliminating phototherapy co-pays. ♦ Join the National Psoriasis Foundation, which is fighting for change with both the government and the insurance companies. ♦ If you have patients faced with this issue who cannot receive the care they need and wish to get involved, have them share their story at www.psoriasis.org. Patient stories are often more powerful and effective than any financial data. Certainly, phototherapy is only one of the important weapons in the arsenal used to treat psoriasis and it is not for every patient. It is nonetheless a critical tool that is safe, effective, and relatively inexpensive. If we sit by and allow it to be abandoned in our practices because of unreasonable co-pays, we will fail in our mission to offer our patients the best possible care. J Colby Evans, MD was elected to the National Psoriasis Foundation Board of Trustees in 2010. Dr. Evans, a Foundation member since 2003 and a volunteer since 2008, currently chairs the Psoriasis Foundation’s National Phototherapy Copayment Task Force, a group of physicians and patients working to address rising copayments for phototherapy treatments. Dr. Evans also helped develop the Foundation’s advocacy work regarding phototherapy legislation in Illinois. Dr. Evans is married with two young sons and is a private-practice dermatologist with Evans Dermatology in Austin, Texas.
Vol. 5, No. 3 SUMMER 2011 61
DERmatology pa news & notes
By Colby Evans, MD
Professional Opportunities and Development
Advert iser INDE X OrthoDermatologics – Retin-A Micro......Pages 2, 3 Ranbaxy - Kenalog Spray........................... Pages 7, 8 Promius - Cloderm................................ Pages 11, 12 Coria - Refissa........................................ Pages 15, 16 Allergan - Aczone...................................Pages 28, 29 Medicis – Solodyn............................Pages 33, 34, 35 Galderma - Clobex Spray.......................Pages 41, 42 Dermatology Billing Associates................... Page 47 Coria - Acanya.......................................Pages 53, 54 Coria - Atralin....................................... Pages 57, 58 Stiefel - Duac.........................................Pages 63, 64 For more information on advertising opportunities in the JDPA, please log on to www.jdpa.org
CICATRICIAL ALOPECIA RESEARCH FOUNDATION
Cicatricial Alopecia Research Symposium 2011 Current Progress and Future Challenges Thursday, October 27 - Friday, October 28
The Cicatricial Alopecia Research Foundation (CARF) invites hair biologists, immunologists, dermatology providers, environmental toxicologists, and hair-transplant surgeons to attend the Cicatricial Alopecia Research Symposium 2011: Current Progress and Future Challenges, a twoday educational event. The symposium will help to facilitate the exchange of ideas and information between laboratory and clinical researchers as well as accelerate the translation of basic scientific discoveries into clinical applications. The event will take place Thursday, October 27 – Friday, October 28, 2011 at the Bethesda Marriott located in Bethesda, Maryland. For reservations, please call 301-897-9400. For additional information please visit www.carfintl.org/2011_symposium.html.
www.carfintl.org/2011_ symposium.html 62 Journal of Dermatology for Physician Assistants
BRIEF SUMMARY DUAC Topical Gel (clindamycin, 1% - benzoyl peroxide, 5%) ®
The following is a brief summary only; see full prescribing information for complete product information. For Dermatological Use Only. Not for Ophthalmic Use. Rx Only INDICATIONS AND USAGE DUAC Topical Gel is indicated for the topical treatment of inflammatory acne vulgaris. DUAC Topical Gel has not been demonstrated to have any additional benefit when compared to benzoyl peroxide alone in the same vehicle when used for the treatment of non-inflammatory acne. CONTRAINDICATIONS DUAC Topical Gel is contraindicated in those individuals who have shown hypersensitivity to any of its components or to lincomycin. It is also contraindicated in those having a history of regional enteritis, ulcerative colitis, pseudomembranous colitis, or antibiotic-associated colitis. WARNINGS ORALLY AND PARENTERALLY ADMINISTERED CLINDAMYCIN HAS BEEN ASSOCIATED WITH SEVERE COLITIS WHICH MAY RESULT IN PATIENT DEATH. USE OF THE TOPICAL FORMULATION OF CLINDAMYCIN RESULTS IN ABSORPTION OF THE ANTIBIOTIC FROM THE SKIN SURFACE. DIARRHEA, BLOODY DIARRHEA, AND COLITIS (INCLUDING PSEUDOMEMBRANOUS COLITIS) HAVE BEEN REPORTED WITH THE USE OF TOPICAL AND SYSTEMIC CLINDAMYCIN. STUDIES INDICATE A TOXIN(S) PRODUCED BY CLOSTRIDIA IS ONE PRIMARY CAUSE OF ANTIBIOTIC-ASSOCIATED COLITIS. THE COLITIS IS USUALLY CHARACTERIZED BY SEVERE PERSISTENT DIARRHEA AND SEVERE ABDOMINAL CRAMPS AND MAY BE ASSOCIATED WITH THE PASSAGE OF BLOOD AND MUCUS. ENDOSCOPIC EXAMINATION MAY REVEAL PSEUDOMEMBRANOUS COLITIS. STOOL CULTURE FOR Clostridium difficile AND STOOL ASSAY FOR Clostridium difficile TOXIN MAY BE HELPFUL DIAGNOSTICALLY. WHEN SIGNIFICANT DIARRHEA OCCURS, THE DRUG SHOULD BE DISCONTINUED. LARGE BOWEL ENDOSCOPY SHOULD BE CONSIDERED TO ESTABLISH A DEFINITIVE DIAGNOSIS IN CASES OF SEVERE DIARRHEA. ANTIPERISTALTIC AGENTS SUCH AS OPIATES AND DIPHENOXYLATE WITH ATROPINE MAY PROLONG AND/OR WORSEN THE CONDITION. DIARRHEA, COLITIS AND PSEUDOMEMBRANOUS COLITIS HAVE BEEN OBSERVED TO BEGIN UP TO SEVERAL WEEKS FOLLOWING CESSATION OF ORAL AND PARENTERAL THERAPY WITH CLINDAMYCIN. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug clinically effective against Clostridium difficile colitis. PRECAUTIONS General: For dermatological use only; not for ophthalmic use. Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents. The use of antibiotic agents may be associated with the overgrowth of nonsusceptible organisms, including fungi. If this occurs, discontinue use of this medication and take appropriate measures. Avoid contact with eyes and mucous membranes. Clindamycin and erythromycin containing products should not be used in combination. In vitro studies have shown antagonism between these two antimicrobials. The clinical significance of this in vitro antagonism is not known. Information for Patients: Patients using DUAC Topical Gel should receive the following information and instructions: 1.
DUAC Topical Gel is to be used as directed by the physician. It is for external use only. Avoid contact with eyes, and inside the nose, mouth, and all mucous membranes, as this product may be irritating.
2.
This medication should not be used for any disorder other than that for which it was prescribed.
3.
Patients should not use any other topical acne preparation unless otherwise directed by their physician.
4.
Patients should report any signs of local adverse reactions to their physician. Patients who develop allergic symptoms such as severe swelling or shortness of breath should discontinue use and contact their physician immediately.
5.
DUAC Topical Gel may bleach hair or colored fabric.
6.
DUAC Topical Gel can be stored at room temperature up to 25°C (77°F) for up to 2 months. Do not freeze. Keep tube tightly closed. Keep out of the reach of small children. Discard any unused product after 2 months.
7.
Before applying DUAC Topical Gel to affected areas, wash the skin gently, rinse with warm water, and pat dry.
8.
Excessive or prolonged exposure to sunlight should be limited. To minimize exposure to sunlight, a hat or other clothing should be worn.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Benzoyl peroxide has been shown to be a tumor promoter and progression agent in a number of animal studies. Benzoyl peroxide in acetone at doses of 5 and 10 mg administered twice per week induced squamous cell skin tumors in transgenic TgAC mice in a study using 20 weeks of topical treatment. The clinical significance of this is unknown. In a 2-year dermal carcinogenicity study in mice, treatment with DUAC Topical Gel at doses up to 8000 mg/kg/day (16 times the highest recommended adult human dose of 2.5 g DUAC Topical Gel, based on mg/m2) did not cause an increase in skin tumors. However, topical treatment with another formulation containing 1% clindamycin and 5% benzoyl peroxide at doses of 100, 500, or 2000 mg/kg/day caused a dose-dependent increase in the incidence of keratoacanthoma at the treated skin site of male rats in a 2-year dermal carcinogenicity study in rats. In a 52-week photocarcinogenicity study in hairless mice (40 weeks of treatment followed by 12 weeks of observation), the median time to onset of skin tumor formation decreased and the number of tumors per mouse increased relative to controls following chronic concurrent topical treatment with DUAC Topical Gel and exposure to ultraviolet radiation. Genotoxicity studies were not conducted with DUAC Topical Gel. Clindamycin phosphate was not genotoxic in Salmonella typhimurium or in a rat micronucleus test. Benzoyl peroxide has been found to cause DNA strand breaks in a variety of mammalian cell types, to be mutagenic in Salmonella typhimurium tests by some but not all investigators, and to cause sister chromatid exchanges in Chinese hamster ovary cells. Studies have not been performed with DUAC Topical Gel or benzoyl peroxide to evaluate the effect on fertility. Fertility studies in rats treated orally with up to 300 mg/kg/day of clindamycin (approximately 120 times the amount of clindamycin in the highest recommended adult human dose of 2.5 g DUAC Topical Gel, based on mg/m2) revealed no effects on fertility or mating ability. Pregnancy: Teratogenic Effects: Pregnancy Category C: Animal reproduction studies have not been conducted with DUAC Topical Gel or benzoyl peroxide. It is also not known whether DUAC Topical Gel can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. DUAC Topical Gel should be given to a pregnant woman only if clearly needed. Developmental toxicity studies performed in rats and mice using oral doses of clindamycin up to 600 mg/kg/day (240 and 120 times the amount of clindamycin in the highest recommended adult human dose based on mg/m2, respectively) or subcutaneous doses of clindamycin up to 250 mg/kg/day (100 and 50 times the amount of clindamycin in the highest recommended adult human dose based on mg/m2, respectively) revealed no evidence of teratogenicity. Nursing Women: It is not known whether DUAC Topical Gel is secreted into human milk after topical application. 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. Pediatric Use: Safety and effectiveness of this product in pediatric patients below the age of 12 have not been established. ADVERSE REACTIONS During clinical trials, all patients were graded for facial erythema, peeling, burning, and dryness on the following scale: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. The percentage of patients that had symptoms present before treatment (at baseline) and during treatment were as follows: Local reactions with use of DUAC Topical Gel % of patients using DUAC Topical Gel with symptom present Combined results from 5 studies (n = 397) Before Treatment (Baseline) During Treatment Mild Moderate Severe Mild Moderate Severe Erythema 28% 3% 0 26% 5% 0 Peeling
6%
<1%
0
17%
2%
0
Burning
3%
<1%
0
5%
<1%
0
Dryness
6%
<1%
0
15%
1%
0
(Percentages derived by # subjects with symptom score/# enrolled DUAC Topical Gel subjects, n = 397). Anaphylaxis, as well as allergic reactions leading to hospitalization, has been reported in post-marketing use with DUAC Topical Gel. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. ©2010 Stiefel Laboratories, Inc. DUA:2BRS January 2011
©2011 Stiefel Laboratories, Inc. All rights reserved. Printed in USA. DUA063R0 March 2011
Vol. 5, No. 3 SUMMER 2011 63
cy… Delivers on effica
Handles Patients With Care
the topical l is indicated for DUAC Topic al Ge ammator y acne vulgaris. ve any infl treatment of mons trated to ha l has not been de in the same ne alo ide DUAC Topic al Ge rox pe d with benzoyl tor y acne. fit when compare t of noninflamma additional bene d for the treatmen vehicle when use
DUAC Topical Gel is the once-daily clindamycin/benzoyl peroxide combination with a patented formula containing both glycerin and dimethicone The contribution to efficacy by individual components of the vehicle has not been established. • No therapeutically equivalent generic substitute1 • More than 6 million prescriptions of DUAC Topical Gel dispensed since launch2
PLEASE NOTE: The soap-free cleanser is no longer included in the package. Please prescribe DUAC Topical Gel 45 g.
DUAC 45 g
Apply once daily Dispense as written
Important Safety Information for DUAC Topical Gel • DUAC Topical Gel is contraindicated in patients who have shown hypersensitivity to any of its components or lincomycin • DUAC Topical Gel is contraindicated in patients with a history of regional enteritis, ulcerative colitis, pseudomembranous colitis, or antibiotic-associated colitis • Orally and parenterally administered clindamycin has been associated with severe colitis which may result in patient death. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin. The colitis is usually characterized by severe persistent diarrhea and severe abdominal cramps and may be associated with the passage of blood and mucus • For dermatologic use only; not for ophthalmic use • Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents • The use of antibiotic agents may be associated with the overgrowth of nonsusceptible organisms, including fungi. If this occurs, discontinue use of this medication and take appropriate measures • Clindamycin- and erythromycin-containing products should not be used in combination. In vitro studies have shown antagonism between these two antimicrobials. The clinical significance of this in vitro antagonism is not known • DUAC Topical Gel may bleach hair and colored fabrics • Excessive or prolonged exposure to sunlight should be limited. To minimize exposure to sunlight, a hat or other clothing should be worn • DUAC Topical Gel should be given to a pregnant woman only if clearly needed • It is not known whether DUAC Topical Gel is secreted into human milk after topical application. 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 • Safety and effectiveness of this product in pediatric patients below the age of 12 have not been established • Adverse reactions may include erythema, peeling, burning, and dryness • Anaphylaxis, as well as allergic reactions leading to hospitalization, has been reported in postmarketing use with DUAC Topical Gel. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure Please see brief summary of Prescribing Information on following page. References: 1. Electronic Orange Book. US Food and Drug Administration Web site. http://www.accessdata.fda.gov/scripts/cder/ob/docs/tempai.cfm. Accessed February 25, 2011. 2. SDI. VectorOne: National (VONA). October 2009.
64 Journal of Dermatology for Physician Assistants