Summer 2012 Journal of Dermatology for Physician Assistants

Volume 6 number 3 SUMMER 2012

SDPA News and Current Affairs

dermatology pa news and notes

clinical dermatology

surgical dermatology

cosmetic dermatology

Professional development

Official Journal of the Society of Dermatology Physician Assistants

Vol. 6, No. 3 Summer 2012

1

FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE. Brief Summary Retin-A Micro® (tretinoin gel) microsphere, 0.1% and 0.04% is a formulation containing 0.1% or 0.04%, by weight, tretinoin for topical treatment of acne vulgaris. This formulation uses patented methyl methacrylate/glycol dimethacrylate crosspolymer porous microspheres (MICROSPONGE® System) to enable inclusion of the active ingredient, tretinoin, in an aqueous gel.

IMPORTANT NOTE: This information is a BRIEF SUMMARY of the complete prescribing information provided with the product and therefore should not be used as the basis for prescribing the product. This summary has been prepared by deleting information from the complete prescribing information such as certain text, tables, and references.

The physician should be thoroughly familiar with the complete prescribing information before prescribing the product.

INDICATIONS AND USAGE: Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%, is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the use of this product in the treatment of other disorders have not been established.

CONTRAINDICATIONS: This drug is contraindicated in individuals with a history of sensitivity reactions to any of its components. It should be discontinued if hypersensitivity to any of its ingredients is noted.

PRECAUTIONS: General: • The skin of certain individuals may become excessively dry, red, swollen, or blistered. If the degree of irritation warrants, patients should be directed to temporarily reduce the amount or frequency of application of the medication, discontinue use temporarily, or discontinue use all together. Efficacy at reduced frequencies of application has not been established.

If a reaction suggesting sensitivity occurs, use of the medication should be discontinued.

Excessive skin dryness may also be experienced; if so, use of an appropriate emollient during the day may be helpful.

• Unprotected exposure to sunlight, including sunlamps, should be minimized during the use of Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%, and patients with sunburn should be advised not to use the product until fully recovered because of heightened susceptibility to sunlight as a result of the use of tretinoin. Patients who may be required to have considerable sun exposure due to occupation and those with inherent sensitivity to the sun should exercise particular caution. Use of sunscreen products (SPF 15) and protective clothing over treated areas are recommended when exposure cannot be avoided.

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

• Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%, should be kept away from the eyes, the mouth, paranasal creases of the nose, and mucous membranes.

• Tretinoin has been reported to cause severe irritation on eczematous skin and should be used with utmost caution in patients with this condition.

Information for Patients: A Patient Information Leaflet has been prepared and is included with each package of Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%.

Drug Interactions: Concomitant topical medication, medicated or abrasive soaps and cleansers, products that have a strong drying effect, products with high concentrations of alcohol, astringents, or spices should be used with caution because of possible interaction with tretinoin. Avoid contact with the peel of limes. Particular caution should be exercised with the concomitant use of topical over-the-counter acne preparations containing benzoyl peroxide, sulfur, resorcinol, or salicylic acid with Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%. It also is advisable to allow the effects of such preparations to subside before use of Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%, is begun.

Carcinogenesis, Mutagenesis, Impairment of Fertility: In a 91-week dermal study in which CD-1 mice were administered 0.017% and 0.035% formulations of tretinoin, cutaneous squamous cell carcinomas and papillomas in the treatment area were observed in some female mice. These concentrations are near the tretinoin concentration of these clinical formulations (0.04% and 0.1%). A dose-related incidence of liver tumors in male mice was observed at those same doses. The maximum systemic doses associated with the administered 0.017% and 0.035% formulations are 0.5 and 1.0 mg/kg/day, respectively. These doses are two and four times the maximum human systemic dose applied topically, when normalized for total body surface area. The biological significance of these findings is not clear because they occurred at doses that exceeded the dermal maximally tolerated dose (MTD) of tretinoin and because they were within the background natural occurrence rate for these tumors in this strain of mice. There was no evidence of carcinogenic potential when 0.025 mg/kg/day of tretinoin was administered topically to mice (0.1 times the maximum human systemic dose, normalized for total body surface area). For purposes of comparisons of the animal exposure to systemic human exposure, the maximum human systemic dose applied topically is defined as 1 gram of Retin-A Micro (tretinoin gel) microsphere, 0.1% applied daily to a 50 kg person (0.02 mg tretinoin/kg body weight).

Dermal carcinogenicity testing has not been performed with Retin-A Micro (tretinoin gel) microsphere, 0.04% or 0.1%.

Studies in hairless albino mice suggest that concurrent exposure to tretinoin may enhance the tumorigenic potential of carcinogenic doses of UVB and UVA light from a solar simulator. This effect has been confirmed in a later study in pigmented mice, and dark pigmentation did not overcome the enhancement of photocarcinogenesis by 0.05% tretinoin. Although the significance of these studies to humans is not clear, patients should minimize exposure to sunlight or artificial ultraviolet irradiation sources.

The mutagenic potential of tretinoin was evaluated in the Ames assay and in the in vivo mouse micronucleus assay, both of which were negative.

The components of the microspheres have shown potential for genetic toxicity and teratogenesis.

EGDMA, a component of the excipient acrylates copolymer, was positive for induction of structural chromosomal aberrations in the in vitro chromosomal aberration assay in mammalian cells in the absence of metabolic activation, and negative for genetic toxicity in the Ames assay, the HGPRT forward mutation assay, and the mouse micronucleus assay.

In dermal Segment I fertility studies of another tretinoin formulation in rats, slight (not statistically significant) decreases in sperm count and motility were seen at 0.5 mg/kg/day (4 times the maximum human systemic dose applied topically, and normalized for total body surface area), and slight (not statistically significant) increases in the number and percent of nonviable embryos in females treated with 0.25 mg/kg/day (2 times the maximum human systemic dose applied topically and normalized for total body surface area) and above were observed. In oral Segment I and Segment III studies in rats with tretinoin, decreased survival of neonates and growth retardation were observed at doses in excess of 2 mg/kg/day (17 times the human topical dose normalized for total body surface area).

Dermal fertility and perinatal development studies with Retin-A Micro (tretinoin gel) microsphere, 0.1% or 0.04%, have not been performed in any species.

Pregnancy: Teratogenic Effects: Pregnancy Category C. In a study of pregnant rats treated with topical application of Retin-A Micro (tretinoin gel) microsphere, 0.1%, at doses of 0.5 to 1 mg/kg/day on gestation days 6-15 (4 to 8 times the maximum human systemic dose of tretinoin normalized for total body surface area after topical administration of Retin-A Micro (tretinoin gel) microsphere, 0.1%) some alterations were seen in vertebrae and ribs of offspring. In another study, pregnant

New Zealand white rabbits were treated with Retin-A Micro (tretinoin gel) microsphere, 0.1%, at doses of 0.2, 0.5, and 1.0 mg/kg/day, administered topically for 24 hours a day while wearing Elizabethan collars to prevent ingestion of the drug. There appeared to be increased incidences of certain alterations, including domed head and hydrocephaly, typical of retinoid-induced fetal malformations in this species, at 0.5 and 1.0 mg/kg/day. Similar malformations were not observed at 0.2 mg/kg/day, 3 times the maximum human systemic dose of tretinoin after topical administration of Retin-A Micro (tretinoin gel) microsphere, 0.1%, normalized for total body surface area. In a repeat study of the highest topical dose (1.0 mg/kg/day) in pregnant rabbits, these effects were not seen, but a few alterations that may be associated with tretinoin exposure were seen. Other pregnant rabbits exposed topically for six hours to 0.5 or 0.1 mg/ kg/day tretinoin while restrained in stocks to prevent ingestion, did not show any teratogenic effects at doses up to 17 times (1.0 mg/kg/day) the maximum human systemic dose after topical administration of Retin-A Micro (tretinoin gel) microsphere, 0.1%, adjusted for total body surface area, but fetal resorptions were increased at 0.5 mg/kg. In addition, topical tretinoin in non Retin-A Micro (tretinoin gel) microsphere formulations was not teratogenic in rats and rabbits when given in doses of 42 and 27 times the maximum human systemic dose after topical administration of Retin-A Micro (tretinoin gel) microsphere, 0.1%, normalized for total body surface area, respectively, (assuming a 50 kg adult applied a daily dose of 1.0 g of 0.1% gel topically).

At these topical doses, however, delayed ossification of several bones occurred in rabbits. In rats, a dose-dependent increase of supernumerary ribs was observed.

Oral tretinoin has been shown to be teratogenic in rats, mice, rabbits, hamsters, and subhuman primates. Tretinoin was teratogenic in Wistar rats when given orally or topically in doses greater than 1 mg/kg/day (8 times the maximum human systemic dose normalized for total body surface area). However, variations in teratogenic doses among various strains of rats have been reported. In the cynomolgus monkey, which metabolically is more similar to humans than other species in its handling of tretinoin, fetal malformations were reported for doses of 10 mg/kg/day or greater, but none were observed at 5 mg/kg/day (83 times the maximum human systemic dose normalized for total body surface area), although increased skeletal variations were observed at all doses. Dose-related increases in embryolethality and abortion also were reported. Similar results have also been reported in pigtail macaques.

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

There are no adequate and well-controlled studies in pregnant women. Retin-A Micro should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

With widespread use of any drug, a small number of birth defect reports associated temporally with the administration of the drug would be expected by chance alone. Thirty human cases of temporally associated congenital malformations have been reported during two decades of clinical use of Retin-A. Although no definite pattern of teratogenicity and no causal association has been established from these cases, five of the reports describe the rare birth defect category holoprosencephaly (defects associated with incomplete midline development of the forebrain). The significance of these spontaneous reports in terms of risk to the fetus is not known.

Non-Teratogenic Effects: Topical tretinoin has been shown to be fetotoxic in rabbits when administered 0.5 mg/kg/day (8 times the maximum human systemic dose applied topically and normalized for total body surface area), resulting in fetal resorptions and variations in ossification. Oral tretinoin has been shown to be fetotoxic, resulting in skeletal variations and increased intrauterine death in rats when administered 2.5 mg/kg/day (21 times the maximum human systemic dose applied topically and normalized for total body surface area).

There are, however no adequate and well-controlled studies in pregnant women.

Animal Toxicity Studies: In male mice treated topically with Retin-A Micro (tretinoin gel) microsphere 0.1%, at 0.5, 2.0, or 5.0 mg/kg/day tretinoin (2, 8, or 21 times the maximum human systemic dose after topical administration of Retin-A Micro (tretinoin gel) microsphere, 0.1%, normalized for total body surface area) for 90 days, a reduction in testicular weight, but with no pathological changes were observed at the two highest doses. Similarly, in female mice there was a reduction in ovarian weights, but without any underlying pathological changes, at 5.0 mg/kg/day (21 times the maximum human dose). In this study there was a dose-related increase in the plasma concentration of tretinoin 4 hours after the first dose. A separate toxicokinetic study in mice indicates that systemic exposure is greater after topical application to unrestrained animals than to restrained animals, suggesting that the systemic toxicity observed is probably related to ingestion. Male and female dogs treated with Retin-A Micro (tretinoin gel) microsphere, 0.1%, at 0.2, 0.5, or 1.0 mg/kg/day tretinoin (5, 12, or 25 times the maximum human systemic dose after topical administration of Retin-A Micro (tretinoin gel) microsphere, 0.1%, normalized for total body surface area, respectively) for 90 days showed no evidence of reduced testicular or ovarian weights or pathological changes.

Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Retin-A Micro (tretinoin gel) microsphere, 0.1% or 0.04%, is administered to a nursing woman.

Pediatric Use: Safety and effectiveness in children below the age of 12 have not been established.

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

Clinical studies of Retin-A Micro did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

ADVERSE REACTIONS: The skin of certain sensitive individuals may become excessively red, edematous, blistered, or crusted. If these effects occur, the medication should either be discontinued until the integrity of the skin is restored, or the medication should be adjusted to a level the patient can tolerate.

However, efficacy has not been established for lower dosing frequencies.

True contact allergy to topical tretinoin is rarely encountered. Temporary hyper- or hypopigmentation has been reported with repeated application of tretinoin. Some individuals have been reported to have heightened susceptibility to sunlight while under treatment with tretinoin.

OVERDOSAGE: Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%, is intended for topical use only. If medication is applied excessively, no more rapid or better results will be obtained and marked redness, peeling, or discomfort may occur. Oral ingestion of large amounts of the drug may lead to the same side effects as those associated with excessive oral intake of Vitamin A. Rx only.

Distributed by: Ortho Dermatologics Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., Los Angeles, CA 90045 © OMP 2011 11DD0126 07/11 RETIN-A MICRO ® is a registered trademark of Ortho-McNeil Pharmaceutical, Inc. MICROSPONGE ® is a registered trademark of AMCOL International Corporation.

Publishing Staff

EDITORIAL BOARD

Travis Hayden, MPAS, PA-C, Editor in chief Joe R. Monroe, MPAS, PA-C Patricia Ferrer, MPAS, PA-C Gordon Day, R.Ph., PA-C Nancy Primo, MPAS, PA-C Lauren Zajac, MHS, PA-C Michelle DiBaise, MPAS, PA-C P. Eugene Jones, Ph.D., PA-C Mark Archambault, DHSc, PA-C Kristine Kucera, DHS, MPAS, PA-C Jennifer Winter, PA-C Mark Hyde, MMS, PA-C Jennifer Conner, MPAS, PA-C Jeffrey LaDuca, Ph.D., MD Alan Menter, MD

DEPARTMENT EDITORS

Clinical Department Editors Susan E. King-Barry, MPAS, PA-C Karen Graham, MPAS, PA-C Drugs in Dermatology Editor Stephen Wolverton, MD Surgical Department Editor Christy Kerr, MPAS, PA-C Cosmetic Department Editor Nancy Primo, MPAS, PA-C Prof Dev Department Editor Abby Jacobson, MS, PA-C

SDPA Board of Directors

PrESiDEnT John Notabartolo, MPAS, PA-C PrESiDEnT-ElECT Jennifer Winter, PA-C iMMEDiATE PAST PrESiDEnT Keri Holyoak, MPH, PA-C ViCE PrESiDEnT Jacki Kment, MPAS, PA-C SECrETAry / TrEASurEr Joleen Volz, MPAS, PA-C DirECTors AT lArGE Matthew Brunner, MHS, PA-C Greg Buttolph, MPAS, PA-C Jennifer Conner, MPAS, PA-C Vicki Roberts, MPAS, PA-C

Society of Dermatology Physician Assistants, Inc.

4111 W. Alameda Ave. Suite 412 Burbank, CA 91505 1-800-380-3992 SDPA@dermpa.org www.dermpa.org

Publisher Travis Hayden, MPAS, PA-C Managing Editor Jennifer M. Hayden, M.Ed Copy Editor Douglas Morris Art Director Angela Simiele Website Design Terry Scanlon

SALES Office

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

PUBLISHED CONTENT IN THE JDPA: Statements and opinions expressed in the articles and communications herein are those of the authors and not necessarily those of the Publisher or the Society of Dermatology Physician Assistants (SDPA). The Publisher and the SDPA disclaim any responsibility or liability for such material, including but not limited to any losses or other damage incurred by readers in reliance on such content. Neither Publisher nor SDPA verify any claims or other information appearing in any of the advertisements contained in the publication and cannot take responsibility for any losses or other damage incurred by readers in reliance on thereon. Neither Publisher nor SDPA guarantees, warrants, or endorses any product or service advertised in this publication, nor do they guaranty any claim made by the manufacturer of such product or service.

This Issue: of JDPA includes articles that have been reviewed and approved for Category I (Preapproved) CME credit by the American Academy of Physician Assistants. Approval is valid for 1 year from the issue date, and participants may submit the self-assessment at any time during that period.

Category I CME articles included in JDPA are planned and developed in accordance with AAPA’s CME Standards for Journal Articles and for Commercial Support of Journal Articles.

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JDPA/Journal of Dermatology for Physician Assistants (ISSN 1938-9574) is published quarterly (4 issues per volume, one volume per year) by Physician Assistant Communications, LLC, P.O. Box 416, Manlius NY 13104-0416. Volume 6, Number 3, Summer 2012. One year subscription rates: $40 in the United States and Possessions. Single copies (prepaid only): $10 in the United States (Include $6.50 per order plus $2 per additional copy for US postage and handling).

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Editor’s Message Bridging the Gap Journal of Dermatology for Physician Assistants

The Official Journal of the SDPA

Exclusive PQRS Registry Access for SDPA Members Early SDPA adopters of NetHealth’s 1st Ascent Melanoma PQRS Registry will receive $100 off annual access.

Details and support regarding the measures reported, eligibility, how to report, and applicable deadlines can be found online at www.dermpa.org/nethealth_ information

I recently had a patient who was extremely distressed when he learned that he had been diagnosed with psoriasis. He explained that his concern stemmed from the fact that his brother had just passed away from the same condition. I shared my condolences for his recent loss but explained to him that I was quite surprised to hear of this. I informed him that in all my years of healthcare experience, I had yet to see anyone succumb to psoriasis. Yet he continued to be upset and was adamant that he had now been given the same death sentence as his brother who had just passed away from “psoriasis of the liver.” At that point, everything made perfect sense, and I had a better understanding of why he was so distraught.

George Bernard Shaw once said, “The single biggest problem in communication is the illusion that it has taken place.” Time and again I am reminded of the importance of effective communication when interacting with our patients. We often take for granted how much medical knowledge we have and at times forget that what seems like basic information to us is not part of the everyday vocabulary or scope of comprehension for many of our patients.

We must be sure that we give our patients enough time at their visits to process new information that they receive from us and to allow for questions and further explanations/discussions as may be needed. Slowing down enough to allow our patients to bridge the clinician-patient communication gap is critically important.

Our patients’ concerns about their health, the demands of our busy clinic schedules, cultural and language barriers, and even literacy all work together to create a gap between what we say and what patients may actually hear. I suggest that we consciously take the time to gauge our patients’ level of understanding when we provide them with a new diagnosis or treatment recommendation.

Using a “teach-back” method to confirm patients’ comprehension greatly assists in removing any misundertandings.1 For example, “The biopsy of the lesion on your back has found a basal cell carcinoma; a form of skin cancer that is not melanoma. We will need to schedule you for a type of surgery called an ED&C x3, a procedure that allows us to ‘scrape and burn’ the superficial layers of the skin in order to remove it. Do you understand what I have just explained?”

Ending with such a question allows for a conversation to unfold and we can then help to answer any questions or concerns that patients may have. Such as, possibly clarifying to this patient that an ED&C x3 does not mean that he/she will have to come back into the office for three different appointments but that all three steps will be done consecutively in a single appointment.

My patient was relieved to find out that psoriasis of the skin was much different from cirrhosis of the liver. He left our office relieved knowing that the treatments we had recommended would be able to help him and that he was not going to die from his newly diagnosed skin disease. I remember this experience each time I am explaining a new diagnosis to a patient. Communicating in terms that are easy to comprehend and slowing down to take the time to confirm that our patients understand the information that has been presented to them ultimately helps us to bridge the communication gap and leads to improved health outcomes. J

Travis Hayden, MPAS, PA-C Editor in chief

REFERENCES: 1. Health Literacy Universal Precautions Toolkit. Prepared for the Agency for Healthcare Research and Quality. AHRQ Publication No. 10-0046-EF, April 2010. http://nchealthliteracy.org/toolkit/. Accessed July 19, 2012.

Vol. 6, No. 3 Summer 2012

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

17

Dermoscopy For The Physician Assistant: Fundamentals of Dermoscopy

By Natalia Jaimes, MD and Ashfaq A. Marghoob, MD

CME

10 Derm PA News & Notes – part one

• SDPA State Affiliates Round Table Discussion – Should Your State Chapter Become Incorporated?

• Certification Review – All Those Things Inside the Skin You Might Have Forgotten

17 Clinical Dermatology Departments

04 Editorial Board 05 Editor’s Message 09 SDPA News & Current Affairs 10 Dermatology Market Watch 26 From The Patient’s Perspective 31 Dermoscopy Q&A 32 Clinical Snapshots 38 Surgical Wisdom 43 Cosmetic Pearls 54 Outside & Inside the 9 to 5...

55 Notes from your Office Manager 59 The Difference We Make 65 Dermatology in Art 66 Professional Opportunities and Development

• CME Article – Dermoscopy For The Physician Assistant: Fundamentals of Dermoscopy • Drugs in Dermatology – iPLEDGE Update • Dermatology Case Report – Cutaneous Leishmaniasis

38 Surgical Dermatology

• Surgical Wisdom – Needle Stick Prevention

41 Cosmetic Dermatology • Customer Service is Key When Serving the Cosmetic Patients

45 Professional Development

56 Derm PA News & Notes – part two

Go Green - Read Online 6

• Is There a Glass Ceiling for PAs? • Dermatology Billing & Coding – How to Correctly Measure Lesions to Assure Accurate Code Selection • Judicial and Ethical Affairs – Case-Based Compliance Scenarios

Journal of Dermatology for Physician Assistants

• From the Desk of…

• Workplace Excellence – You Can’t Give What You Don’t Have - Developing Rituals for Renewal • First Foundations – On The Job Training • Supervising Physician Corner

dermPA.org

Vol. 6, No. 3 Summer 2012

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Journal of Dermatology for Physician Assistants

Calendar

of events

2012 AUGUST AAD Summer Academy Meeting August 15 - 19, 2012 Boston, MA OCTOBER/NOVEMBER SDPA 10th Annual Fall Conference October 31 - November 3, 2012 Caesars Palace Hotel Las Vegas, NV

2013 MARCH 71st AAD Annual Academy Meeting March 1 - 5, 2013 Miami, FL JUNE SDPA Summer Dermatology Conference June 27 - 30, 2013 Hyatt Regency at the Arch St. Louis, MO

FROM THE SPDA News & Current Affairs

I

’m what is now becoming more and more of a rarity among PAs, someone who started in general medicine prior to going into a specialty. Now don’t get me wrong, I knew I was meant to be in dermatology (I was an SDPA student member) and was in family practice to gain a better understanding of “the basics.”

When I was a new PA, I attended the AAPA annual conference, and one of my first experiences in PA professional leadership was thrust upon me; I was seated in the House of Delegates (HoD), the decision making arm of the AAPA, as a representative for my constituent organization! “But wait, I’m a new PA, I don’t know anything!” But I learned. As a delegate, alternate, and even Chief Delegate for both the Society of Air Force PAs (SAFPA) and the SDPA, I spent twelve of the last fourteen years in the HoD. After seeing that I could have an influence on the way things were run, I stood up and told people how I KNEW things could work better!

I was hooked.

I was no longer content with someone else making all the decisions about my profession. I wanted an active role in the decision-making. I held office in SAFPA three times for over seven years. When it came time for my career long goal to change from part-time to full-time dermatology practice, the SDPA became my focus, and I immediately ran for office.

Not because I thought we were doing anything wrong, I just thought we could do things better. That will be the theme for my year as your President, asking ourselves the question, “How can we do that better?”

Many committees and their volunteers do the day-to-day work that keeps the SDPA running smoothly. These committees rely on the dedication and commitment of members just like you to make a stronger, better SDPA. Your time and effort are the most precious gifts that you can share; they are a finite commodity that we never seem to have enough of. So why not step away from Facebook, Twitter, or your own personal favorite time-waster and give five minutes a day to the SDPA? That equals about two and a half hours per month, enough time to begin to be involved with the committee of your choice.

You see, we already do many things well and some of them are even exemplary. For example, the Distant Learning Initiative (DLI) has been held up as a model for PA education by the NCCPA and AAPA and has even been mentioned in our discussions with the AAD! Since it is such a success, we’re done right? NO! We have moved the original DLI to a friendlier server and are releasing new modules. That’s how we make it better. How did we get here from the days of the Comprehensive Review Notes? Through hard work and dedication by your fellow SDPA members.

People who, just like you, have to juggle full-time jobs, family, exercise, and relaxation time, but still want to contribute to making the SDPA better for everyone. J

John Notabartolo, MPAS, PA-C SDPA President, Diplomate Vol. 6, No. 3 Summer 2012

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Dermatology PA news & notes

Dermatology Market Watch New FDA Rules for Sunscreen Labeling Now Pushed Back Until December 2012 The U.S. Food and Drug Administration (FDA) recently announced that they were pushing back the FDA label implementation date. Last year in June 2011, the FDA released new guidelines for sunscreen labeling.

These labels were to hit store shelves by June 2012, but have now been pushed back until December 2012; smaller companies with less than $25,000 in sales will have until June 2013 to update their labels. Sunscreen manufacturers and lobbyists for cosmetics and over-thecounter pharmaceutical industries requested that more than one year be provided for them to change the labels, and warned that there may be sunscreen shortages if the new labels were to go into effect as originally scheduled.

The long-awaited modifications to requirements for sunscreen labeling 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. These new sunscreen labeling regulations will also provide patients with more information about what a sunscreen can do. The following are some key changes you and your patients will see.

Figure

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) broad-spectrum coverage and 2) an SPF of 15 or higher (see Figure). 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.”

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 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.

Sunscreen Labeling According to 2011 Final Rule

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 SPF15 or higher have been shown to provide all these benefits.

10 Journal of Dermatology for Physician Assistants

Makeup and Moisturizers You will see the new claims on makeup and moisturizers, provided the product undergoes and passes the FDA tests.

Courtesy US Food and Drug Administration

...continued on page 13

CLODERM CREAM The difference is baked right in. ®

Cloderm Cream’s unique molecule, clocortolone pivalate, has no generic alternative • Provides Class IV efficacy with an excellent safety profile1-3 • The pivalate group enhances lipid solubility1 – Clocortolone pivalate is more lipophilic than other commonly used branded midpotent steroids4

Not a cookie-cutter corticosteroid

• Statistically significant improvement of symptoms at day 43

Make Cloderm Cream your 1st choice topical steroid • No age restriction • Available in 90 g tube and 75 g pump • To request samples or for further information, contact Promius Pharma at 888.384.6929 or visit www.Cloderm.com 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 the halogen in corticosteroids influences potency and side effects. J Drugs Dermatol. 2006;5(2):125-130. 2. Del Rosso J, Friedlander SF. 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. 4. Royal Society of Chemistry Website. Chem Spider, the free chemical database. Available at http://www.chemspider.com. Accessed June 1, 2011.

Cloderm® is a trademark of Coria Laboratories, Ltd.

Vol. 6, No. 3 Summer 2012 11

RxOnly

Laboratory Tests: The following tests may be helpful in evaluating the HPA axis suppression: Urinary free cortisol test ACTH stimulation test 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.

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-6α-fluoro-11β, 21-dihydroxy-16α 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.

Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.

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 corticosteroid-induced 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.

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 hypothalamicpituitary-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.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate anti-microbial 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.

30 gram pump bottle 75 gram pump bottle 45 gram tube 90 gram tube

NDC-67857-804-30 NDC-67857-804-51 NDC-67857-804-45 NDC-67857-804-90

STORAGE: 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.

12 Journal of Dermatology for Physician Assistants

www.promiuspharma.com Promius Pharma, LLC 200 Somerset Corporate Blvd., Floor 7, Bridgewater, NJ 08807 Cloderm® is a trademark of Coria Laboratories, Ltd. Manufactured by: DPT LABORATORIES, LTD. San Antonio, Texas 78215

Issued 0711

004158

Dermatology Market Watch ...continued from page 10 New Offering for Dermatology PAs Now Available on PsoriasisTX.com The National Psoriasis Foundation, International Psoriasis Council, Dermatology Nurses’ Association, Society of Dermatology Physician Assistants, University of Chicago, and Curatio CME Institute have launched a CME/CE-certified educational initiative consisting of a Biologic Bulletin, clinician educator, and iPhone app. The Biologic Bulletin has been designed to provide everyone involved in the care of psoriasis patients with an overview of treatment recommendations based on guidelines published by the American Academy of Dermatology. The clinician educator is a pocket reference guide designed for use in clinical practice and as a resource during consultations with patients. The iPhone app provides an algorithm to help guide treatment decisions and useful information about the traditional systemic and biologic agents used in the management of psoriatic disease.

This educational initiative was prepared with content expertise provided

by Alan Menter, MD, Jerry Bagel, MD, Kenneth B. Gordon, MD, Kristine Kucera, DHS, MPAS, PA-C, and Melodie Young, MSN, RN, A/GNP-C. To order your free copies of the Biologic Bulletin and clinician educator pocket guide, please visit www.PsoriasisTX.com today. To download the iPhone app, visit http:// www.curatiocme.com/psoriasis/iPhone.

Certification Review

All Those Things Inside the Skin You Might Have Forgotten

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

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

EXPLANATION: Acute glaucoma is due to an increase in intraocular pressure. Acute glaucoma presents with headache, sudden onset of eye pain, nausea and vomiting, and a red eye. Physical exam reveals a fixed, dilated pupil, a hazy cornea, and ciliary flush is noted.

Giant cell arteritis, or temporal arteritis, is a vasculitis of the temporal artery. Common in the elderly, giant cell arteritis is often associated with polymyalgia rheumatica.

Giant cell arteritis presents with headache, jaw claudication, transient or complete vision loss, and on examination a tender, enlarged temporal artery is noted. The erythrocyte sedimentation rate is also markedly elevated. Retinal

detachment is common in patients over age 50 and linked to severe myopia. Retinal detachment presents with blurry vision that progressively worsens. Patients often state it is like a “curtain coming down over the eye.” On physical examination the retina is noted hanging in the vitreous fluid. Central retinal artery occlusion is common in patients over age 50 and presents with sudden, painless monocular vision loss. The symptoms are often preceded by amaurosis fugax. On physical examination a cherry red spot is noted on the macula. J

The correct answer is A.

QUESTION: A 65 year-old female presents with a 24hour history of a headache and right eye pain. She states the pain is a throbbing, dull ache with nausea and vomiting.

On physical examination, the right eye is mildly dilated and nonreactive. The cornea is hazy and a ciliary flush is noted. Which of the following is the most likely diagnosis?

A. Acute glaucoma B. Giant cell arteritis C. Retinal detachment D. Central retinal artery occlusion

James A. Van Rhee, MS, PA-C, is the Program Director for the Northwestern University Feinberg School of Medicine Department of Family Medicine Physician Assistant Program. Mr. Van Rhee has been involved in physician assistant education for over 15 years. He has served as project director and test item writer for the Physician Assistant Education Association’s (PAEA) Physician Assistant Clinical Knowledge Rating Assessment Tool (PACKRAT) and is the author of the Physician Assistant: Certification and Re-certification Review Book, published by Elsevier.

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

Vol. 6, No. 3 Summer 2012 13

DERmatology pa news & notes

Advancing the Art and Science of Psoriasis and Psoriatic Arthritis Management

SDPA State Affiliates Round Table Discussion Should Your State Chapter Become Incorporated?

DERmatology pa news & notes

The purpose of this SDPA State Affiliates round table discussion is to provide state chapters guidance in determining if they should become incorporated and insights about the process. Leading the discussion panel is Joleen M Volz, MPAS, PA-C, SDPA Secretary/Treasurer and former SDPA Constituent Relations Committee Chair. She is joined at this round table by Matthew Brunner, MHS, PA-C, SDPA Director at Large and former President of Georgia Dermatology Physician Assistants (GDPA), Renata Block, MMS, PA-C, SDPA Constituent Relations Committee Chair and President of the Illinois Society of Dermatology Physician Assistants (ISDPA), and Vicki Roberts, MPAS, PA-C, SDPA Director at Large and Midlands Representative of the South Carolina Society of Dermatology Physician Assistants (SCSDPA).

Joleen M Volz, MPAS, PA-C SDPA Secretary/Treasurer Former SDPA Constituent Relations Committee Chair

Matthew Brunner, MHS, PA-C

Vicki Roberts, MPAS, PA-C

Renata M. Block, MMS, PA-C

SDPA Director at Large Former President of the Georgia Dermatology Physician Assistants

SDPA Director at Large Former President of the South Carolina Society of Dermatology Physician Assistants

SDPA Constituent Relations Committee Chair President of the Illinois Society of Dermatology Physician Assistants

JOLEEN - What does it mean to be incorporated and when should a state chapter become incorporated?

RENATA - To be incorporated with your state, a state chapter is licensed to operate as a non-profit organization and becomes recognized as a legal entity within your state.

If you are not incorporated then you are not considered a legal entity.

VICKI - Incorporation means the organization is now a legal and distinct entity in the eyes of the government.

Depending on the goals and activities of your particular state chapter, it may benefit the chapter to become incorporated. If your state will eventually want to obtain a non-profit status, incorporation will be a requirement.

Becoming incorporated will also protect the individual members from any potential lawsuits or debts accrued by the organization.

MATTHEW - The process of incorporation is when a state chapter becomes a legal entity separate from its members. State chapters do not necessarily need to incorporate; some groups may prefer to stay as a grassroots organization rather than to become an official legal entity as a corporation. For many years, the GDPA was simply an organization of PAs without incorporating. This works well for groups that are small or who do not plan to do a lot of fund raising or execution of contracts. However, if your state chapter is considering becoming a non-profit, it will become necessary.

14 Journal of Dermatology for Physician Assistants

JOLEEN - Does a state chapter have to be incorporated in order to become a State Affiliate chapter of the SDPA? MATTHEW - Not at all. You can achieve many of the same goals through running an organization that is not incorporated. These types of organizations operate with bylaws just as a corporation would, but without the legal responsibilities of a corporation.

RENATA - Incorporation is not required in order to become an affiliate chapter of the SDPA. Officially being recognized as a State Affiliate chapter of the SDPA may increase the level of professionalism perceived by the public and other organizations. Incorporation makes your state chapter a legally recognized entity by the individual state VICKI - No, the SDPA does not require a state chapter to be incorporated in order to become a state affiliate, but it is encouraged.

JOLEEN - What is an EIN and should a state chapter obtain one?

MATTHEW - EIN stands for Employer Identification Number; it is the way the IRS recognizes companies and corporations for purposes of enforcing the tax code.

Much as individuals have social security numbers, all corporations have an EIN number. In my experience, it was required in order for the GDPA to open a bank account and to apply for non-profit status. So, depending on whether your state chapter plans on handling funds or

the needs of the organization were growing and it was reasonable to ask our members to support those needs.

We made sure that members received a value back from paying the dues. We created a job board that is accessible to our members and members are eligible to vote in our elections. In addition, we offer our members a discount on registration at our annual CME conference. The GDPA Board felt that no one needed another $100 membership fee nor did the chapter really need that amount of money at the present time. We eventually settled on $25 as a starting place and have left it up to future leaders to adjust the membership fee based upon the needs of the organization’s operational expenses.

JOLEEN - What have been the pros and cons to being a non-profit organization?

MATTHEW - Non-profit status allows the GDPA to raise monies free from taxation and allows others such as pharmaceutical companies, labs, and device manufacturers to donate funds to the GDPA. There are many legal responsibilities that go along with being a non-profit.

The GDPA has to file annual forms with the IRS and make sure we follow the tax code. I would suggest anyone considering this for their state chapter to thoughtfully consider the responsibilities and legal ramifications before applying for non-profit status.

VICKI - Benefits to becoming a non-profit include no taxes (on assets or property), ability to receive public and private donations, protection from personal liability, lower postal rates, and free airtime on radio and television for public service announcements. Disadvantages include a great deal of time and paperwork, money for the application and/or the potential need for hiring a lawyer, no political campaigning or lobbying (if set up as a 501(c) (3), and if the chapter folds then the assets would need to be given to another non-profit.

RENATA - Let’s start with the pros; your state chapter will not have to pay income tax and donations made to a non-profit organization are tax deductible. The cons are that the chapter cannot make any interest on any of its investments. It is also important to note that a nonprofit organization can exist as a 501(c)(3) or as a 501(c) (6). A 501(c)(3) allows your state chapter to create public awareness about a cause and to provide education to both the public and its members. With this status, keep in mind that your chapter is not allowed to lobby for any particular cause, as a 501(c)(6) could. Individual members of a 501(c)(3) may lobby on their own accord, but not as a representative of the state chapter (doing so may cause a state chapter to lose its non-profit status with the IRS). As a 501(c)(3), the ISDPA is not allowed to make money donations for legislation or lobbying efforts.

Information and opinions are allowed and expressed through individual members. For example, as President of the ISDPA, I send out monthly updates to our members and encourage them to lobby for a cause on an individual basis by sending a letter to their local representatives as Vol. 6, No. 3 Summer 2012 15

DERmatology pa news & notes

not, I would think most chapters would find it a benefit to have an EIN. One of the most requested items GDPA has when it comes to raising funds is a disclosure of our EIN through completion of an IRS W-9 form. Also, if you plan to file for non-profit status with the IRS, an EIN will be necessary.

VICKI - I agree. An EIN will be required when setting up a bank account, incorporating, or applying for non-profit status. Obtaining an EIN is fairly easy and can be done through the IRS online, by telephone, or by mail.

RENATA - Yes, state chapters should obtain an EIN in order to operate as a non-profit organization, open a bank account, solicit donations, and file tax returns. Applying for an EIN is a free service offered by the IRS. JOLEEN - Should a state chapter set up a bank account?

VICKI - Opening up a bank account would be very beneficial to an individual state chapter. For the SCSDPA, opening a bank account helped us to keep track of our finances and expenditures and gave us somewhere to deposit our dues.

MATTHEW - Eventually all organizations will find this to their benefit. Even if your state chapter doesn’t plan to collect dues right away, you will need a safe place to store the chapter’s financial resources and from which to make payments.

RENATA - Yes, and I would recommend that the bank account be set up as “interest free.” The bank will require your state chapter’s federal EIN, which obligates nonprofits to pay taxes on account interest.

JOLEEN - How did you decide whether or not your state chapter should collect dues and how did you determine the amount to collect?

VICKI - For many years, the SCSDPA did not collect any dues. As the needs and goals of our organization grew, we needed to have some financial resources to be able to facilitate these goals. Our state chapter wanted to become an incorporated non-profit group; therefore, we needed funds to help get through the application processes. Since we had not collected dues for quite some time, the first year we decided to collect $10. We now decide annually what is needed for the organization to thrive. It really depends on what your membership decides is important for the state chapter.

RENATA- When deciding whether or not a state chapter should collect dues, I believe it should be based on a state chapter’s budget analysis. For example, the ISDPA is a 501(c)(3) chapter, which defines us as a non-profit organization that can only provide education and is not able to lobby. Therefore, having a free membership allows our members to allocate a voluntary membership fee, for which we encourage, to the Illinois Academy of Physician Assistants (IAPA) who lobby for all of our rights as PAs. MATTHEW – The GDPA waited over ten years before we started collecting dues. We eventually decided that

DERmatology pa news & notes

a dermatology PA. Bottom line, a 501(c)(3) organization is for educational and research purposes only. This particular tax-exempt status precludes any activity aimed at influencing legislation.

JOLEEN - How supportive have pharmaceutical companies been with your state chapter?

MATTHEW - Pharmaceutical companies have been very helpful, but it grows increasingly difficult for them to donate to organizations with the changes in corporate compliance codes. Anyone looking to raise funds should foster a relationship with the local and regional pharmaceutical leaders and inquire about grant applications. Be prepared to explain what the funds will be used for and discuss how many members are in your state chapter. Also, not having an EIN and a non-profit status may be a hindrance.

RENATA - All pharmaceutical companies have been very supportive, but we have members who are contracted not to participate in any pharmaceutical sponsored programs.

Therefore, it is best to raise funds via these companies and have programs sponsored by your state chapter. In the end, we could not survive without the support from pharmaceutical companies.

VICKI - The SCSDPA has not actively sought out pharmaceutical companies and they have yet to approach us. It has been something we have been considering pursuing now that we have achieved 501(c)(3) non-profit status.

JOLEEN - Do you have any learned advice regarding incorporation and/or the non-profit application process?

RENATA - Yes, protect your non-profit status. My suggested order-of-events are to write down your group’s interests and goals, set up your bylaws and then apply with the IRS for 501(c)(3) non-profit status. A lawyer can help you tailor your bylaws to your state’s needs and assist you in simultaneously contacting your Secretary of State and incorporating your state chapter as a nonprofit. The response and cost may vary by state. This application process must be precise because it can be rejected. An application fee can be around $750 and if rejected, you must resubmit another application and fee.

The turnaround can be two to six months. There may be other requirements that can vary by individual states. For example, for Illinois we also had to file with the Attorney General.

VICKI - If your state chapter has been productive collecting dues and has some finances on hand, it may be beneficial to hire a lawyer to help in the process. The SCSDPA did not have the funds, so we went through the process ourselves. In order to be incorporated though

the state, we needed to have our bylaws and articles of incorporation. We found some examples and were able to tailor them to meet our chapter’s needs. As far as the non-profit application, the most important thing you will need is patience. After filling out the very lengthy application, it took about three months to get an answer, which was just another list of items they wanted answers to. It took about one year before they were satisfied with all of our answers. The one good thing in all of this was that when you apply, you are assigned an IRS agent who knows your organization. You can call this person directly to ask questions regarding the additional information they are requiring. Our agent was very helpful and practically walked us through the process.

MATTHEW - The GDPA was fortunate to have a model on the Secretary of State’s website detailing the required elements to incorporate as a non-profit. State laws vary so be sure to check with your state to see what is required. We had to go back and amend our articles of incorporation to satisfy the IRS when we applied to become a non-profit so it may help to seek the advice of an attorney. I found that the IRS agent we were assigned was very helpful to us in providing feedback on amending our application and correcting our articles of incorporation. It turned out to be quite a detailed process, but it did seem as though the agent was genuinely interested in helping our chapter. It is not a requirement to have a lawyer, but I think many find it helpful. If funds are available, I recommend hiring an attorney. Early on many state chapters may find their resources stretched and should consider reaching out to their members to see if any of their spouses or relatives are attorneys willing to help pro bono.

JOLEEN - Are there any websites or helpful resources for state chapters to use?

VICKI - The SCSDPA used a resource from the Secretary of State’s website that offered some assistance in the incorporation process. We were even able to chat live with a person who answered our questions. As for the non-profit process, the IRS website does have some useful information to help in filling out the application. There are also some additional resources available online (CDs and/or books) that can help state chapters trying to do it on their own without the help of a lawyer.

RENATA - Yes, state chapters can visit www.sdpa.org, www.irs.gov, or contact me at rblock@dermpa.org.

MATTHEW - Definitely check with your Secretary of State’s website as it should have useful information. The IRS has a link to their instructions sheet on their website which has some very helpful information. In particular, pages 25 and 26 of the IRS instruction provide an example of a Conflict of Interest Policy, which is a requirement. J

Future topics that may be discussed at the round table include: steps to becoming affiliated with the SDPA, keeping your state affiliate active, and how to interact with your local state medical board. If you have any other topics that you would like to see covered, please feel free to share them with us. Email editor@jdpa.org with any topic ideas or state affiliate questions.

16 Journal of Dermatology for Physician Assistants

Clinical Dermatology

Dermoscopy For The Physician Assistant: Fundamentals of Dermoscopy

By Natalia Jaimes, MD and Ashfaq A. Marghoob, MD

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

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 2012.

Participants may submit the self-assessment exam at any time during that period.

This program was planned in accordance with AAPA’s CME Standards for Enduring Material Programs and for Commercial Support of Enduring Material Programs.

SDPA members may access the posttest at www.jdpa.org

Learning Objectives: 1. Review the basic concepts of dermoscopy including its history, physics, and techniques.

2. Recognize the advantages and limitations of dermoscopy.

3. Understand the indications for dermoscopy.

4. Identify the colors and structures seen under dermoscopy.

Vol. 6, No. 3 Summer 2012 17

Dermoscopy For The Physician Assistant SDPA Members Only Content

CLINICAL Dermatology

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

18 Journal of Dermatology for Physician Assistants

Dermoscopy For The Physician Assistant SDPA Members Only Content

CLINICAL Dermatology

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

Vol. 6, No. 3 Summer 2012 19

Dermoscopy For The Physician Assistant SDPA Members Only Content

CLINICAL Dermatology

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

20 Journal of Dermatology for Physician Assistants

Dermoscopy For The Physician Assistant SDPA Members Only Content

CLINICAL Dermatology

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

Vol. 6, No. 3 Summer 2012 21

Dermoscopy For The Physician Assistant SDPA Members Only Content

CLINICAL Dermatology

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

22 Journal of Dermatology for Physician Assistants

Dermoscopy For The Physician Assistant SDPA Members Only Content

CLINICAL Dermatology

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

Vol. 6, No. 3 Summer 2012 23

Dermoscopy For The Physician Assistant 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.

24 Journal of Dermatology for Physician Assistants

Dermoscopy For The Physician Assistant SDPA Members Only Content

Natalia Jaimes, MD is a dermatologist from Medellín, Colombia. She received training in skin cancer management at the Memorial Sloan-Kettering Cancer Center, Department of Dermatology, and is Assistant Professor of Dermatology at the Universidad Pontificia Bolivariana in Medellín, Colombia. Her research interests are pigmented lesions, melanoma, and imaging diagnostic techniques including dermoscopy. She has indicated no relationships to disclose relating to the content of this article.

Ashfaq A. Marghoob, MD is a board-certified dermatologist specializing in the diagnosis and treatment of cancers of the skin. He is the director of Memorial SloanKettering’s regional skin cancer clinic in Hauppauge, Long Island. Dr. Marghoob is very active in clinical research and has published numerous papers on topics related to skin cancer with an emphasis on melanoma, atypical/dysplastic nevi, and congenital melanocytic nevi. His research interests are focused on the use of imaging instruments such as photography, dermoscopy, and confocal laser microscopy to recognize skin cancer early in its development. He frequently lectures on these topics both nationally and internationally and was on faculty at this year’s inaugural American Dermoscopy Meeting. He has indicated no relationships to disclose relating to the content of this article Vol. 6, No. 3 Summer 2012 25

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.

From The Patient’s Perspective

CLINICAL Dermatology

Amber Paris: Not Alone in the Lone Star State Watauga, Texas, just outside the Dallas-Fort Worth Eight years ago, Amber Paris and her husband area. She’s active with the parent-teacher association at believed they would never be able to have children. her daughter’s school. She also volunteers a lot of her Amber has lived with scleroderma since she was a teen. time for the Scleroderma She had suffered through Foundation’s Texas renal crisis, digital ulcers “The picture for us is that Bluebonnet Chapter. and other complications it always gets better.

Amber’s goal is to jump-start from the disease. The couple No matter what we’re a juvenile support system discussed their options for younger scleroderma for starting a family with going through, it will patients and their family a rheumatologist, who always get better, and members, a service that classified their chances to we will have good times wasn’t around for her when conceive as high-risk. So, again.” she was diagnosed at 14. they decided to adopt.

At 13, Amber’s hands Soon after starting began to get horribly cold. the adoption paperwork, She tried to warm them under warm water, but it felt Amber had a big surprise. At a doctor’s appointment, she scalding hot. Amber and her parents knew something learned she was pregnant. “We were so concerned about was going on, and shortly thereafter, she was diagnosed the pregnancy being high-risk, we weren’t even trying to with Raynaud Phenomenon. Then, came the ulcers on her conceive,” Amber recalled. fingers and a scleroderma diagnosis.

Women living with scleroderma are at a higher risk As a teen growing for some complications during pregnancy, particularly up in Colorado, Amber renal crisis and cardiopulmonary issues. Some research tried to ignore the disease. indicates that women should delay conception until their She wouldn’t take her disease has stabilized. As is the case for many chronic medication and tried to live illnesses, especially autoimmune diseases, pregnancy the normal, teenage life. “I may relieve some of a woman’s symptoms (remember, was a cheerleader. I would each pregnancy is different. Be sure to check with your cheer out in snowstorms,” doctor about what your individual risks are as it relates to she remembered. “I don’t pregnancy and conception). Pregnancy, however, caused recommend it. But, it’s Amber’s system to go haywire.

Amber as a teen growing difficult having scleroderma up in Colorado “The pregnancy exacerbated as a teenager.

The hardest my symptoms. The doctors were thing when you’re growing up, especially at that age, is really worried about my kidneys that you don’t want to be different from anyone else.” since I had previous issues,” “I kept the disease to myself. I would tell a few close she said. “While my kidneys friends, and I remember one in particular. Her mom didn’t crash, my tests were all called my mom saying that she was crying uncontrollably. borderline during the entire She had looked up the disease online and it said that I pregnancy.” only had five years to live. My mom had to explain that Amber, along with her Amber’s doctors ordered her daughter, Jacelyn some of the information out there is old and that this to go on five weeks of bed rest disease isn’t a life sentence.” because her amniotic fluid was so low. “Our doctors were “Then, as I was getting older, I started to tell more afraid that the baby would sit on the [umbilical] cord and people, especially those who had other illnesses. It made suffocate,” she said. The amniotic fluid eventually started us feel less alone, and it helped me open up. I found that to rise again but it was a scary moment for the parents-toit was actually good to talk about the disease because I be when daughter Jacelyn, now eight years old, was born could let people know that there are others struggling nine weeks early. with scleroderma, and there’s hope. There is a way to live a “This Disease Isn’t a Life Sentence” normal, great life even with a chronic illness.”

Today, Amber is a stay-at-home mom living in 26 Journal of Dermatology for Physician Assistants

Hope for the Future Ahead “Amber was a normal teenager who had to sometimes deal with serious issues because of her disease,” said her mom Debbie Hinson. “Like a lot of other parents, we were told about support groups but were advised not to involve Amber in them because of the age difference. A lot of the patients were in the later stages of the disease, and it could be discouraging or frightening to her.”

“I talk with parents today, and doctors are still discouraging kids from support groups,” Amber said. “I felt alone and didn’t have anyone else to talk to about scleroderma.”

“During the past year, the Texas chapter has been contacted by several parents whose kids are suffering from the disease,” said Cindi Brannum, the chapter’s executive director. “These parents didn’t know where to turn to or how to find a place of support for their kids since the groups they had checked out were mostly geared towards adults. As a Amber, along with her mother, Debbie Hinson result, I started calling and sending emails to Amber and her mother.”

Together with her mom, Amber is heading the effort to form an innovative online support group for juvenile scleroderma patients and their families living in Texas.

“We want to give kids and their parents a sense of home. They are not alone. There are other patients who have grown up and gotten through scleroderma. We’ve had children, we’ve gotten married. I want to provide an environment where kids can talk to other kids about what they’re going through. There’s hope and a bright, wonderful future ahead for them,” said Amber. J Amber Jo Paris from Watauga, TX was diagnosed with scleroderma at the age of fourteen. She is now thirty-seven and has been married to her husband Eric for nearly fourteen years.

The couple has an eight year-old daughter, Jacelyn. Amber is a stay-at-home mom who previously worked as a high school English teacher and a mortgage loan processor. She has been a board member of the Scleroderma Foundation’s Texas Bluebonnet Chapter for two years and has led the Chapter’s Tarrant County Support Group for almost five years. She and her mother, Debbie Hinson, are in the process of beginning a Juvenile Scleroderma Outreach Program for the State of Texas.

This article originally was published in the Summer 2012 issue of “Scleroderma Voice,” a member magazine of the Scleroderma Foundation. The Scleroderma Foundation currently has 23 chapters and more than 150 support groups across the U.S. For more information, please visit www.scleroderma.org.

Take Home points for derm pas:

By Steven K. Shama, MD, MPH 1. I know I have said it once before and probably twice, and I will say it again. Our patients like Amber are messengers from the universe trying to teach us a lesson.

Perhaps the lesson is that, “Despite my disease beginning as a teenager when I most wanted to fit in with my friends and to look perfect, I must now live my life, to grow, to want to have children, to contribute to this world, to embrace others, and to give hope. And no one can tell me it cannot happen.”

2. Personal risks aside, Amber decided to continue her pregnancy. What a brave person, to want to be a mother, raise a child, and tell that child how beautiful life can be, even though she has a debilitating disease which could be life threatening.

3. Amber is giving the great gift of hope to young people with scleroderma by establishing a juvenile support group. She is a great example of why we should never give up on patients.

We can never place a value on our patients’ quality of life. We must always remember the anonymous 15th century expression: to cure sometimes, to relieve often, and to comfort always. To always believe in, to give hope, and to honor our patients might be other good lessons we can embrace.

&

Dermoscopy Q A Question: What is it?

Under Dermoscopy

Answer on page 31 Vol. 6, No. 3 Summer 2012 27

CLINICAL Dermatology

Amber went on to college and got married in 1998.

By then, her doctors began to question why she was still living in the cold Colorado climate. She and her husband decided to move to Texas for the lower elevation and warmer temperatures. That led to a slight reprieve in her symptoms for about seven years.

Indications and Usage Picato® (ingenol mebutate) gel, 0.015% and 0.05%, is indicated for the topical treatment of actinic keratosis.

Important Safety Information For topical use only; not for oral, ophthalmic, or intravaginal use. Eye disorders, including severe eye pain, eyelid edema, eyelid ptosis, periorbital edema can occur after exposure. Patients should wash hands well after applying Picato® gel, and avoid transfer of the drug to the periocular area during and after application. If accidental exposure occurs, flush eyes with water and seek medical care.

Severe skin reactions in the treated areas on the face/scalp and trunk/extremities, including erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration can occur after application. Administration of Picato® gel is not recommended until the skin is healed from any previous drug or surgical treatment. The most common adverse reactions observed in clinical trials on the face and scalp (≥2%) are local skin reactions (94%), application site pain (15%), application site pruritus (8%), application site infection (3%), periorbital edema (3%), and headache (2%).

28 Journal of Dermatology for Physician Assistants

Breakthrough Speed in AK Dosing Dosing Done in 2 or 3 Days Treat actinic keratosis (AK) on the face and scalp or the trunk and extremities with 3 or 2 days of once-daily dosing, respectively, to the affected area, up to 1 contiguous area of approximately 25 cm2. Efficacy was demonstrated at day 57.1

To learn more, visit www.Picato.com/HCP.

Important Safety Information (cont’d) The most common adverse reactions observed in clinical trials on the trunk and extremities (≥2%) are local skin reactions (92%), application site pruritus (8%), application site irritation (4%), nasopharyngitis (2%), and application site pain (2%). There are no adequate and well-controlled studies of Picato® gel in pregnant women. Picato® gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The safety and effectiveness of Picato® gel for actinic keratosis in patients less than 18 years of age have not been established.

Please see brief summary of full Prescribing Information on the following page.

Reference: 1. Picato [prescribing information]. Parsippany, NJ: LEO Pharma Inc.; 2012.

Picato is a registered trademark of LEO Laboratories Limited.

LEO and the LEO Lion Design are registered trademarks of LEO Pharma A/S. ©2012 LEO Pharma Inc. 3428-PI-12-373 All rights reserved. May 2012 Printed in USA.

Vol. 6, No. 3 Summer 2012 29

30 Journal of Dermatology for Physician Assistants

&

DermoscopyQ A SDPA Members Only Content

CLINICAL Dermatology

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

Vol. 6, No. 3 Summer 2012 31

Clinical snapshots Porokeratosis of Mibelli

By Larry Bishop, MD

SDPA Members Only Content

CLINICAL Dermatology

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

Figure: Clinical view of porokeratosis of Mibelli

Larry Bishop, MD attended medical school at Wright State University and completed a surgical internship at the University of Pennsylvania. He then went on to complete his residency in dermatology at Wilford Hall Medical Center in San Antonio, TX. While at Wilford Hall, Dr. Bishop was able to serve as an exchange resident at the world’s oldest hospital dedicated to dermatology, Hospital Saint-Louis in Paris, France.

Dr. Bishop landed in Melbourne, FL in 1995 and is currently in practice at MIMA Dermatology. His areas of special interest are cosmetic and surgical dermatology including Mohs Micrographic Surgery and nonsurgical rejuvenation of the face. Dr. Bishop’s practice has been named as one of the top dermatology practices in the US each year for the last twelve years.

Dr. Bishop has created the Derm Challenge, an email based trivia game designed for PAs and NPs practicing in dermatology. Answers (along with the question or clinical image) from previous daily challenges can be found archived in a blog at www.dermchallenge. blogspot.com. To sign up for the Derm Challenge, forward your name, position, name of your dermatology practice, and email address to delsol321@cfl.rr.com. Dr. Bishop has indicated no conflicts of interest to disclose relating to the content of this article.

Let them know they’re not alone...

Share a story with your patients.

Visit the Patient’s Perspective library of articles at www.jdpa.org/advocacy.html If you know a patient who would like to share his/her story, please contact us at editor@jdpa.org

32 Journal of Dermatology for Physician Assistants

Drugs in Dermatology iPLEDGE Update 2012

SDPA Members Only Content

CLINICAL Dermatology

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

Vol. 6, No. 3 Summer 2012 33

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.

iPLEDGE and Dermatology PAs When in Question, Do Not Act‌ Ask

By Abby A. Jacobson, MS, PA-C SDPA Leadership Development and Professional Growth Committee Chair Ipledge Scientific Committee Member

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

34 Journal of Dermatology for Physician Assistants

The Society of Dermatology Physician Assistants is proud to recognize our first 100 True Diplomates!

Arizona Courtney A Cahill MMS, PA-C / Lynn Juracek M.D.

Kansas Judy Ky PA-C / Christopher Moeller M.D.

California Anette Lecair PA-C / Elissa Gropen M.D. Mary C Rozelle MS, MPAS, PA-C / Greg Morganroth M.D. Melinia Honjo MPAS, PA-C / Gary A McCraken M.D. Nicole Smith PA-C / Ezra Kest M.D. Fariba Seraj PA-C / WilliamJ. Wickwire M.D. Christy Kerr MPAS, PA-C / Hubert T. Greenway M.D.

Kentucky Angela Mills MPAS, PA-C / Artis Truett III M.D.

Colorado Patrick J Galaska MPAS, PA-C / Larry W. Cole M.D. Amy J Huber PA-C / Kimberly Stone M.D. John Hoffstetter PA-C / James V. Twede M.D. Kristin E Pogue MPAS, PA-C / Mark D. Gaughan M.D. Angie Riddleberger PA-C / Steven Hong M.D. Kim Guthke PA-C / Steven Hong M.D. Robin Sproule PA-C / Robert Wright M.D. Dawn M Baird PA-C / Ronald Nadel M.D. Jessica Bahros PA-C / Ramzi Saad M.D. Stefanie Delaney M.S., PA-C / Robert O’Brien M.D.

Maryland Justin G Adrien PA-C / Allan Harrington M.D. Edgar F Peithman PA-C / Judd Kenneth M.D. Massachusetts Mark Trott PA-C / Raymond Welch M.D. Jennifer L Krasovic PA-C / Christine Kannler M.D. Bethany Foster PA-C, MPAS / Glenn Genest M.D. Darlene Haviland PA-C, MPAS / Steven Franks M.D. Greg Forsyth MPAS, PA-C / Ira Berman M.D. Barbara Stein PA-C / Mark Marsili M.D. PhD Dayna Hrovath MPAS, PA-C / Amy Norton M.D. Abby Jacobson PA-C / Bruce Brod M.D. Chantelle Gastinger MSPAS, PA-C / Scott Gottlieb M.D. Michigan Kurt Vander Veen PA-C / Jack Dekkinga M.D. Ronald W Reusch PA-C / Jack Dekkinga M.D. Molly Duiven PA-C / Jack Dekkinga M.D. Adam Gomoll MPAS, PA-C / Eric Seiger DO Sheli Tinkelman MS, PA-C / Barry Auster M.D.

Connecticut Kelly A Christman RPA-C / Stuart Zweibel M.D.

North Carolina Sallie S White PA-C / Paul Kostuchenko M.D. Adele Clark PA-C / Alan Fleischer M.D. Debbie A Hauser PA-C, MHS / Christine Bienenfeld M.D. North Dakota Judy Reese PA-C / David Flach M.D. Ohio Michelle Bodie PA-C / Thomas Fleming M.D. Oklahoma Randy Bluethman PA-C / Craig Abbott M.D. Oregon Mark D Williams PA-C / Russell Young III M.D. Laura Leece PA-C / Todd Knapp M.D. Pennsylvania Gina B Kuloszewski PA-C / Joanne Zenker M.D. Lauren R Zajac MHS, PA-C / David Amato DO Barbara Lozada PA-C / Joanne Zenker M.D. South Carolina Michael D Overcash MPAS, PA-C / Hudson Rogers M.D. Thy K Tran PA-C / Donald Baxter M.D. Vicki S Roberts MPAS, PA-C / Jeffrey K. Smith M.D.

DO YOU KNOW A SDPA DIPLOMATE? Florida Susan Hammerling PA-C / Ruben Moreno M.D. Michelle Thomas Snider PA-C / James M. Knight M.D. Gina Mangin PA-C / Michael Bond M.D. Stacey Klingbeil MCMS, PA-C / Daniel Rivlin M.D. Christine Kahlbaum MMS,PA-C / Daniel Rivlin M.D.

Minnesota Deborah Steinbar PA-C / Natalie Roholt M.D. Nadine Miller PA-C / Jaime Davis M.D.

Tennesee Andrew Hull PA-C / Robert Clemons M.D. Darrell Millsap PA-C / James Rash M.D.

Missouri Scott Maury PA-C / Jacquelyn Garrett M.D.

Georgia Michael Kelleher PA-C / Michelle Futral M.D. Wm. Stephen Steiner PA-C / Jonathan Weiss M.D. Huntley Sanders MPAS, PA-C / Mark Bonner M.D. Horace A Saunders MPAS, PA-C / Alexander Gross M.D. Delano Parker Ed.D.,PA-C / Michael Sharkey M.D. Beverly Conolly PA-C / Alan Gardner M.D. Laura Bush PA-C / James Sandwich M.D.

Nebraska Jacklynn A Kment MPAS, PA-C / Margaret Sutton M.D. Laura Fox PA-C / Jennifer Alberts M.D.

Texas April L Harrison MPAS, PA-C / Suzanne Bruce M.D. Jennifer J Jordan MS, PA-C / Eric Weisberg M.D. Jennifer Conner MPAS, PA-C / Steven Davis M.D. Joleen M Volz MPAS, PA-C / M. Alan Menter M.D. Joe Capasso PA-C / David Grice DO Bethany Grubb MPAS, PA-C / Kent Aftergut M.D. Ray Vaughn MPAS, PA-C / Isaac Perez M.D.

Illinois Rex E Stombaugh PA-C, MPAS / George Nahass M.D. Marilyn J Stombaugh PA-C / George Nahass M.D. Amber Kelley PA-C / Debra Babich M.D. Mark Moran PA-C / John Exner M.D. Indiana Meredith Woodard PA-C / C. William Hanke M.D. Iowa Rachae Jensen PA-C, MPAS / David Knutson M.D.

Nevada John V Notabartolo MPAS, PA-C / Linda Woodson M.D. New Hampshire Nathan Hand PA-C / Rafael Pupo M.D. George H Lewis PA-C / Robert Posnick M.D. Gale J Furey MS, PA-C / David Abels M.D. New Jersey Sevasti Guthrie MPAS, PA-C / Daniel Kessel M.D. Casey Croes MPAS, PA-C / David Groisser M.D. NewYork Timothy Smith PA-C / Stephen Presser M.D. Tania Cohen MPAS, PA-C / Cindy Hoffman DO Patrick Franck PA-C / Steven Resnick M.D. Gretchen E Thorner PA-C / Michael Eidelman M.D. Kurt H Schroeder RPA-C / Kenneth Kircher M.D. Michael Barton PA-C / Romeo Morales M.D. Maria A DeRosa MPAS, RPA-C / Joseph Wojciechowski M.D.

Vermont Phoebe Pelkey MPAS, PA-C / Mitchell Schwartz M.D. Virginia Stacy J Williams MPAS, PA-C / An Yen M.D. Washington James Garcia PA-C / Wm. Phillip Werschler Jr M.D. Jennifer Winter PA-C / Mark Bauer M.D. Wisconsin Kirsten J Antonneau PA-C, MPAS / Kenneth Katz M.D.

Vol. 6, No. 3 Summer 2012 www.dermPA.org/diplomate

35

Dermatology Case Report Cutaneous Leishmaniasis

By Jennifer L. Monna, 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.

Figure

36 Journal of Dermatology for Physician Assistants

SDPA Members Only Content

Jennifer L. Monna, PA-S is currently enrolled at the Le Moyne College Physician Assistant Program in Syracuse, NY. She is a student member of the SDPA and has served as the Newsletter Chair of student government at Le Moyne. She will be graduating in August 2012 and intends to practice in dermatology. She has indicated no relationships to disclose relating to the content of this article.

Vol. 6, No. 3 Summer 2012 37

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.

SURGICAL Dermatology

SURGICAL wisdom Needle Stick Prevention – Step 3: Message Delivery SDPA Members Only Content A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

Figure: Campaign Process

In the next issue, the JDPA will highlight Step 4: Evaluation of the CDC’s STOP STICKS campaign.

For additional information on the campaign please visit the CDC website at www.cdc.gov/ niosh/stopstick.

38 Journal of Dermatology for Physician Assistants

Proven effective in moderate to severe acne* 1 ,2

NOW IN A

PUMP

Power Now

with ease!

in a ready-to-use 50g pump

●

Neat and simple: No jar, no mess

●

Measured dose: Consistent delivery

●

Longer shelf life: 10 weeks’ stability at room temperature

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

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

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

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

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

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov /medwatch, or call 1-800-FDA-1088. *Individual results may vary.

References: 1. Pivotal studies, data on file, CORIA Laboratories. 2. Gold M. A new, once-daily, optimized, fi xed combination of clindamycin phosphate 1.2% and lowconcentration benzoyl peroxide 2.5% gel for the treatment of moderate-to-severe acne.

J Clin Aesthetic Dermatol. 2009;2(5):44-48.

© 2012 Valeant Dermatology ACAN-0112-0001

Vol. 6, No. 3 Summer 2012 39

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.

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.

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

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.

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

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.

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.

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.

Studies indicate toxin(s) produced by Clostridia is one primary cause of antibioticassociated 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.

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) Mod* Severe 4 0 <1 0 2 0 <1 0 <1 0

Mild Erythema 22 Scaling 8 Itching 10 Burning 3 Stinging 2 *Mod=Moderate

Maximum During Treatment Mod* Severe 5 <1 3 0 2 0 2 0 1 0

Mild 25 18 15 8 6

End of Treatment (Week 12) Mod* Severe 2 0 1 0 <1 0 <1 0 <1 0

Mild 15 8 6 2 1

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

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

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

40 Journal of Dermatology for Physician Assistants

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.

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.

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.”

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

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

Protect from freezing.

Keep out of the reach of children.

Keep container tightly closed.

RX Only Distributed by CORIA Laboratories, a division of Valeant Pharmaceuticals North America, Fort Worth, TX 76107 Manufactured by Contract Pharmaceuticals Limited Niagara, Buffalo, NY 14213 © 2010 CORIA Laboratories

COSMETIC deRMATOLOGY

Customer Service is Key When Serving the Cosmetic Patient

By Risha Bellomo, MPAS, PA-C

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

Vol. 6, No. 3 Summer 2012 41

COSMETIC Dermatology

Risha Bellomo, MPAS, PA-C has practiced dermatology for 11 years.

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

42 Journal of Dermatology for Physician Assistants

Cosmetic pearls Get The Most From Your Skin Care Products SDPA Members Only Content

COSMETIC Dermatology

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

Vol. 6, No. 3 Summer 2012 43

Now achieve harmony in acne management

Cetaphil® DermaControl™ Foam Wash and Moisturizer SPF 30 for patients with acne-prone skin CONTROL oil with a highly tolerable regimen formulated with advanced zinc technology1-4

PROTECT with an SPF 30 moisturizer and restore barrier function with ceramide technology5

BALANCE control of both acne symptoms and acne treatment effects1*

*Formulated to be used with acne treatments.

References: 1. Data on file. Galderma Laboratories. 2. Bigotti C, Guala F, Merlo E, Gazzaniga G, Villa G. Zinc and its derivatives: their applications in cosmetic. J Appl Cosmetol. 2005;23:139-147. 3. Rigano L, Merlo E, Guala F, Villa G. Stabilized solutions of zinc coceth sulfate for skin cleansing and skin care. Cosmetics Toiletries. 2005;120:103-108. 4. Schwartz JR, Marsh RG, Draelos ZD. Zinc and skin health: overview of physiology and pharmacology. Dermatol Surg. 2005;31:837-847. 5. Castiel-Higounenc I, Chopart M, Ferraris C. Stratum corneum lipids: specificity, role, deficiencies and modulation. OCL. 2004;11(6):401-406.

cetaphil.com © 2012 Galderma Laboratories, L.P. Galderma is a registered trademark.

Galderma Laboratories, L.P., 14501 N. Freeway, Fort Worth, TX 76177 CETA-393R Printed in USA 02/12

44 Journal of Dermatology for Physician Assistants

Professional development

Is There a Glass Ceiling for PAs?

By Kasey Drapeau-Dâ&#x20AC;&#x2122;Amato, MPAP, PA-C and Katherine Wilkens, MHIS, MPAP, 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.

Vol. 6, No. 3 Summer 2012 45

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

Kasey Drapeau-D’Amato, MPAP, PA-C is the President and founder of Certified Physician Assistant Consulting (www. certifiedpaconsulting.com). She received her Master’s degree in Physician Assistant Practice from the Keck School of Medicine’s Physician Assistant Program at the University of Southern California in 2003 and has been working as a Physician Assistant in Southern California since that time. She currently practices in one of the largest private practice dermatology groups in Los Angeles. Kasey achieved the status of SDPA Diplomate in 2011 and is very active in the SDPA. She has written and contributed to multiple medical journal publications on the topics of the PA profession and compensation.

She is also a regular contributor to the SDPA’s website public forum, where she provides guidance to her colleagues and peers.

Katherine Wilkens, MHIS, MPAP, PA-C is the Vice President of Certified Physician Assistant Consulting (www.certifiedpaconsulting. com). She received her first Master’s degree in medicine and Health Information Systems from Loma Linda University. She obtained her second Master’s degree from University of Southern California’s Keck School of Medicine’s Physician Assistant Program in 2003. Katherine currently practices dermatology in Northern California in a private practice setting. She serves as the Clinical Administrative Manager for three separate offices. Katherine has maintained additional clinical skills by continuing to work in the ER. She has also been an employee of CEP, California Emergency Physicians, since 2003.

46 Journal of Dermatology for Physician Assistants

Dermatology Billing & Coding How to Correctly Measure Lesions to Assure Accurate Code Selection

By Inga Ellzey, MPA, RHIA, CDC

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. 6, No. 3 Summer 2012 47

SDPA Members Only Content

professional development

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

...continued on page 51 48 Journal of Dermatology for Physician Assistants

In the first-line treatment of external genital and perianal warts (EGW)…

Put patients in the clear.

VEREGEN® Delivers Complete Clearance With Low Recurrence*1 • 53.6% of patients demonstrated complete clearance1 —Only 6.8% of patients with complete clearance experienced recurrence at 12 weeks posttreatment1 • Sinecatechins Ointment, 15% is now included in the Centers for Disease Control and Prevention (CDC) Sexually Transmitted Diseases Treatment Guidelines2 —Listed as a patient-applied treatment option for EGW

• The most common adverse reactions were local skin and application site reactions1 *At 12 weeks posttreatment in the two phase 3 studies.

VEREGEN® is indicated for the topical treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older.

Important Selected Safety Information VEREGEN® has not been evaluated to treat urethral, intra-vaginal, cervical, rectal, or intra-anal human papilloma viral disease and should not be used to treat these conditions. Avoid use of VEREGEN® on open wounds.

Avoid exposure of VEREGEN®-treated areas to sun/UV-light because VEREGEN® has not been tested under these circumstances. Safety and efficacy of VEREGEN® have not been established in immunosuppressed patients or patients under 18 years of age, or The FIRST pregnant women, or for the treatment BOTANICAL DRUG of external genital and perianal warts approved for prescription use in the United States beyond 16 weeks or for multiple treatment courses.

The most common adverse reactions are local skin and application site reactions including (incidence ≥ 20%) erythema, pruritus, burning, pain/ discomfort, erosion/ulceration, edema, induration, and rash vesicular.

3

References: 1. VEREGEN® Ointment, 15% [Prescribing Information, 2011]. Melville, NY: PharmaDerm, a division of Fougera Pharmaceuticals Inc. 2. Workowski KA, Berman S; Centers for Disease Control and Prevention.

Sexually transmitted diseases treatment guidelines, 2010. MMWR Recomm Rep. 2010;59(RR-12):1-110. 3. Data on file, PharmaDerm.

Please see adjacent page for Brief Summary of full Prescribing Information.

VEREGEN is a registered trademark of MediGene AG, D-82152 Planegg/Martinsried, Germany. ©2012 PharmaDerm, a division of Fougera Pharmaceuticals Inc. Melville, NY 11747. All rights reserved. 98NVE030212

Vol. 6, No. 3 Summer 2012 49

Brief Summary of Prescribing Information–See Package Insert for Full Prescribing Information at www.pharmaderm.com

Veregen

®

(sinecatechins)

Ointment, 15% Rx Only

For Topical Dermatologic Use Only

Nursing Mothers It is not known whether topically applied Veregen® is excreted in breast milk.

Pediatric Use Safety and effectiveness in pediatric patients have not been established.

Geriatric Use Seven patients (1.4%), older than 65 years of age were treated with Veregen® in clinical studies. This, however, is an insufficient number of subjects to determine whether they respond differently from younger subjects.

ADVERSE REACTIONS

INDICATIONS AND USAGE

Veregen® is a topical ointment indicated for the treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older.

Limitations of Use: Safety and effectiveness of Veregen® have not been established in immunosuppressed patients, in treatment of external genital and perianal warts beyond 16-weeks, or for multiple treatment courses.

CONTRAINDICATIONS None

CLINICAL STUDIES

Two randomized, double-blind, vehicle-controlled studies were performed to investigate the safety and efficacy of Veregen® in the treatment of immunocompetent patients 18 years of age and older with external genital and perianal warts. The subjects applied the ointment 3 times daily for up to 16 weeks or until complete clearance of all warts (baseline and new warts occurring during treatment).

Over both studies the median baseline wart area was 51 mm2 (range 12 to 585 mm2), and the median baseline number of warts was 6 (range 2 to 30).

The primary efficacy outcome measure was the response rate defined as the proportion of patients with complete clinical (visual) clearance of all external genital and perianal warts (baseline and new) by week 16, presented in Tables 1 and 2 for all randomized subjects dispensed medication.

Table 1: Efficacy by Region Complete Clearance All Countries (includes the United States) Veregen® 15% (N = 397) 213 (53.6%) Vehicle (N = 207) 73 (35.3%) United States Veregen® 15% (N = 21) 5 (23.8%) Vehicle (N = 9) 0 (0.0%) Table 2: Efficacy by Gender Complete Clearance Males Veregen® 15% (N = 205) 97 (47.3%) Vehicle (N = 118) 34 (28.8%) Females Veregen® 15% (N = 192) 116 (60.4%) Vehicle (N = 89) 39 (43.8%) Median time to complete wart clearance was 16 weeks and 10 weeks, respectively, in the two phase 3 clinical trials.

The rate of recurrence of external genital and perianal warts 12 weeks after completion of treatment in subjects with complete clearance is 6.8% (14/206) for those treated with Veregen® and 5.8% (4/69) for those treated with vehicle.

WARNINGS AND PRECAUTIONS

Veregen® should not be used to treat urethral, intra-vaginal, cervical, rectal, or intra-anal human papilloma viral disease.

Use of Veregen® on open wounds should be avoided.

Avoid exposure of Veregen® treated areas to sun/UV-light as Veregen® has not been tested under these circumstances.

USE IN SPECIFIC POPULATIONS

Pregnancy Pregnancy Category C: There are no adequate and well controlled studies in pregnant women. Veregen® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

50 Journal of Dermatology for Physician Assistants

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In Phase 3 clinical trials, a total of 397 subjects received Veregen® three times per day topical application for the treatment of external genital and perianal warts for up to 16 weeks.

Serious local adverse events of pain and inflammation were reported in two subjects (0.5%), both women.

In clinical trials, the incidence of patients with local adverse events leading to discontinuation or dose interruption (reduction) was 5% (19/397). These included the following events: application site reactions (local pain, erythema, vesicles, skin erosion/ulceration), phimosis, inguinal lymphadenitis, urethral meatal stenosis, dysuria, genital herpes simplex, vulvitis, hypersensitivity, pruritus, pyodermitis, skin ulcer, erosions in the urethral meatus, and superinfection of warts and ulcers.

Local and regional reactions (including adenopathy) occurring at >1% in the groups treated with Veregen® (N=397) or vehicle (N=207), respectively, were: erythema (70%, 32%), pruritus (69%, 45%), burning (67%, 31%), pain/discomfort (56%, 14%), erosion/ulceration (49%, 10%), edema (45%, 11%), induration (35%, 11%), rash vesicular (20%, 6%), regional lymphadenitis (3%, 1%), desquamation (5%, <1%), discharge (3%, <1%), bleeding (2%, <1%), reaction (2%, 0%), scar (1%, 0%), irritation (1%, 0%), and rash (1%, 0%).

A total of 266/397 (67%) of subjects in the Veregen® group had either a moderate or a severe reaction that was considered probably related to the drug, of which 120 (30%) subjects had a severe reaction. Severe reactions occurred in 37% (71/192) of women and in 24% (49/205) of men. The percentage of subjects with at least one severe, related adverse event was 26% (86/328) for subjects with genital warts only, 42% (19/45) in subjects with both genital and perianal warts and 48% (11/23) of subjects with perianal warts only.

Phimosis occurred in 3% of uncircumcised male subjects (5/174) treated with Veregen® and in 1% (1/99) in vehicle.

The maximum mean severity of erythema, erosion, edema, and induration was observed by week 2 of treatment.

Less common local adverse events included urethritis, perianal infection, pigmentation changes, dryness, eczema, hyperesthesia, necrosis, papules, and discoloration. Other less common adverse events included cervical dysplasia, pelvic pain, cutaneous facial rash, and staphylococcemia.

In a dermal sensitization study of Veregen® in healthy volunteers, hypersensitivity (type IV) was observed in 5 out of 209 subjects (2.4%) under occlusive conditions.

DOSAGE AND ADMINISTRATION

Veregen® is to be applied three times per day to all external genital and perianal warts.

Apply about an 0.5 cm strand of ointment to each wart using the finger(s), dabbing it on to ensure complete coverage and leaving a thin layer of the ointment on the warts.

Veregen® is not for ophthalmic, oral, intra-vaginal, or intra-anal use.

HOW SUPPLIED/STORAGE AND HANDLING

Veregen® is a brown ointment and is supplied in an aluminum tube containing 15 grams (NDC # 10337-450-15) of ointment per tube.

Prior to dispensing to the patient, store refrigerated 2°C to 8°C (36°F to 46°F).

After dispensing, store refrigerated or up to 25°C (77°F). Do not freeze.

Manufactured for:

Manufactured by: C.P.M. Contract Pharma GmbH & Co. KG Frühlingstrasse 7 D-83620 Feldkirchen-Westerham Germany U.S. Patent Nos. 5795911 and 5968973

98NVE060312

Dermatology Billing & Coding ...continued from page 48 SDPA Members Only Content

professional development

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

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

Vol. 6, No. 3 Summer 2012 51

Judicial and Ethical Affairs

Case-Based Compliance Scenarios

By Sarah Richardson, Chief Compliance Officer, Medicis Pharmaceutical Corporation

professional development

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

52 Journal of Dermatology for Physician Assistants

SDPA Members Only Content

Sarah Richardson is the Chief Compliance Officer for Medicis Pharmaceutical Corporation and is responsible for overseeing the companyâ&#x20AC;&#x2122;s corporate compliance program. Prior to joining Medicis, Mrs. Richardson was in private practice at Hunton & Williams, LLP and specialized in FDA regulatory law, healthcare fraud and abuse laws, and development of pharmaceutical/medical device company compliance programs. Mrs. Richardson is a graduate of Furman University, St. Andrews University, and Northwestern University School of Law.

ATTENTION Student Members of the SDPA! Publishing an article in a peer-reviewed journal is a great way to enhance your dermatology education, share knowledge with your peers, and improve upon your resume.

If you have written dermatology related papers and are interested in publishing your work, the JDPA staff is available to assist you through this process.

Please contact the JDPA at editor@jdpa.org.

Vol. 6, No. 3 Summer 2012 53

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.

Outside & Inside the 9 to 5...

professional development

Tracee Douse-Dean, PA-C was one of the SDPA Public Relations Committee member volunteers who assisted with the SDPA’s inaugural Miles for Melanoma 5K Run/1 Mile Walk that took place on July 14th at the 2012 SDPA Summer Dermatology Conference in Seattle, WA. With over 100 SDPA members registered for the inaugural event, it was a huge success. All proceeds raised were donated to the Melanoma Research Foundation. SDPA members who participated and those who volunteered their time to help coordinate the event did their part to help advance melanoma research, which is paramount for our patients. An event such as this takes a team of dedicated volunteers working hard behind the scenes to make it possible. Through the time, hard work, effort, and enthusiasm of volunteers like Tracee, dermatology PAs have continued to be represented in a positive light to our colleagues, the AAD, the AAPA, and to our patient communities. Tracee shares with us now what she has gained from volunteering with the Public Relations Committee and what her involvement with the inaugural 5K Run/1 Mile Walk meant to her.

I have been a member of of course some “curves in the SDPA Public Relations the road” (literally), but we Committee for two years. ended up on the straight Jang-Mi Johnson, PA-C, a and narrow path. I look colleague and good friend forward to helping the of mine, inspired me to committee make future become more involved and events even more successful. volunteer with the SDPA. She People often wonder if has played an integral role in it is difficult to balance recruiting members who can work, personal time, and positively represent the SDPA volunteering. I believe that and the committee. As a volunteering is a part of my volunteer, I have worked on job, so most of the time I am several SDPA public relations doing both simultaneously. projects including assisting Currently, I have some extra at the AAD meetings in order Tracee Douse-Dean, PA-C volunteering at the free time on my hands, as I inaugural Miles for Melanoma 5K Run/1 Mile to highlight the important have not been blessed with Walk that took place at the 2012 SDPA Summer role of PAs in dermatology. any children yet. Enjoying life Dermatology Conference in Seattle, WA I welcome any opportunity to the fullest is something I in which I am able to bring really like to do, so I don’t let just anything interfere awareness to an area I am most passionate about, with my personal time.

Anyone who is considering especially my profession as a dermatology PA. One volunteering with the SDPA should do so. Come of the aspects I like most about this committee one, come all!

More volunteers and more help are is being able to talk to and interact with so many always needed.

I encourage everyone to volunteer different people. at some point in time.

Working on the Public Relations Committee is The SDPA is already busy planning for the next 5K certainly rewarding. We are making a difference in Run/1 Mile Walk. Anyone who wishes to volunteer the world of dermatology. This impact is evident in for the event can contact the SDPA at sdpa@ how dermatology PAs and what we are capable of dermp.org. It would be great to see the spouses are viewed by dermatologists and our patients. The and children of SDPA members participate in inaugural 5K Run/1 Mile Walk was a great way to future events as well. We look forward to having demonstrate to the public that we as dermatology more volunteers, more participants, and even more PAs care about the health of our patients as well as enthusiasm for the next event! J our own health. The event went great. There were

54 Journal of Dermatology for Physician Assistants

Notes from your Office Manager Following Up Missed or Cancelled Appointments The Risk A missed or cancelled appointment, and the failure of a practice to follow up with or contact the patient, may result in a serious delay in diagnosis or treatment and a subsequent risk of liability for the provider.

➊ Develop policies and procedures in your

practice for following up with patients who have missed or cancelled appointments.

➋ Providers should be made aware of all missed or cancelled appointments. The staff should inform the provider(s) of these patients at the end of the day and have the medical records ready for the provider’s review.

➌ The provider should assess the clinical

importance of the appointment, the severity of the patient’s medical condition, and the risk(s) associated with the missed or cancelled appointment.

➍ A reminder telephone call from the office staff may suffice for patients at minimal risk. The time and date of the telephone call and the content of the message or conversation must be documented in the patient’s record.

➎ A telephone call from the provider may

be indicated for patients at higher risk. The provider should emphasize the importance of follow-up care and the risks inherent in failing to obtain it. This telephone conversation must also be documented in the medical record.

➏ If there is no response from the patient or the patient develops a pattern of not keeping or missing appointments, a certified letter, with

a return receipt requested, should be mailed to the patient to advise him/her of the risk of non-compliance. A copy of the letter and the signed receipt must be maintained in the patient’s chart.

➐ All efforts to contact the patient, either by

telephone or letter, must be documented in the medical record. This provides written evidence that the patient was clearly made aware of the importance of continuing medical care.

➑ Educate your staff about patient follow-up

policies and procedures in your practice.

Conduct periodic record reviews to determine staff compliance and to evaluate the effectiveness of the processes you have implemented.

➒ Continued failure of patients to keep

appointments may be deemed noncompliance with treatment. Consideration should be given to discharging the patient from your practice since patient noncompliance may increase a provider’s risk of liability. A legal consult should be considered to assist you in determining how and when to properly discontinue a provider-patient relationship due to patient non-compliance. J

These Risk Management Tips have been reprinted with permission from: MLMIC Dateline, published by Medical Liability Mutual Insurance Company, 2 Park Avenue, Room 2500, New York, NY 10016. Copyright ©2010 by Medical Liability Mutual Insurance Company. All Rights Reserved. No part of this article may be reproduced or transmitted in any form or by any means, electronic, photocopying, or otherwise, without the written permission of MLMIC..

Vol. 6, No. 3 Summer 2012 55

professional development

Recommendations

Dermatology PA news & notes

From the Desk of...

By Jennifer M. Conner, MPAS, PA-C

Serving the SDPA as a Director at Large As a newly elected SDPA Director at Large, my goal is to continue the mission I embarked upon as the SDPA Public Relations Committee Chair in educating the dermatology community and public about dermatology PAs. Physician awareness and understanding of dermatology PAs will grow job opportunities, improve PAs’ salaries, positively impact physician quality of life, ensure state regulations that help protect PAs’ scope of practice, and improve access to the quality, cost effective dermatology healthcare PAs provide. Over the past three years I have served as Chair of the Public Relations Committee and have witnessed firsthand the dedication required by our leaders to make this organization so successful. I am excited to accept this challenge and do my part to continue the success of the SDPA as Director at Large.

My PA career began in the military as a graduate of the Army’s Interservice Physician Assistant Program, and I have been practicing dermatology since 2006. I served over ten years in the Army National Guard as a medic, Platoon Leader, and Battalion Physician Assistant before becoming involved with the SDPA. Additionally, as an undergraduate student I served as President of my class and representative on the student Board of Directors at Marian University in Indianapolis, IN. The skills I have learned in both my academic and professional careers will undoubtedly prove beneficial as Director at Large for the SDPA. My position as Public Relations Committee Chair involved reaching out to dermatologists at the American Academy of Dermatology, American College of Mohs Surgery, and other dermatology organizations to educate them on the great impact dermatology PAs can

56 Journal of Dermatology for Physician Assistants

have on their practices. It also gave me the opportunity to facilitate a working relationship between the SDPA and the Melanoma Research Foundation, and I hope this relationship will increase opportunities for PAs to get involved in projects that expand awareness of our role in dermatology. I have also enjoyed serving as Chair of the sub-committee in planning for the inaugural SDPA Miles for Melanoma 5K Run/1 Mile Walk that took place at the SDPA Summer 2012 Conference in Seattle. Serving as Director at Large will allow me to continue fostering this program and see it grow along with the SDPA. A key mission for the SDPA needs to be educating the dermatology community, lawmakers, and the public about dermatology PAs. Through education we can ensure that the opportunities for PAs continue to increase to allow us to better serve our patients. I envision partnerships with other dermatology organizations that will allow our members to get involved and be a part of the growth of our profession in the years to come. Involvement of dermatology PAs, even on the local level, will have an immeasurable impact and serve to further our potential in dermatology. I look forward to working to make that possible for all SDPA members in my role as Director at Large. J Jennifer M. Conner, MPAS, PA-C is a graduate of the Interservice PA Program at Fort Sam Houston, TX. Jennifer is a SDPA Diplomate and was recently elected to serve as SDPA Director at Large. She has been a Co-Chair of the SDPA Public Relations Committee for the past three years. She practices at the Dermatology and Laser Center of San Antonio, TX with Steven Davis, MD. Jennifer is an Army wife and proud mother of a two and a half year old girl and a baby boy who was born in early June this year.

For mild to moderate plaque psoriasis

Enhance your current regimen with Vitamin D3—a topical treatment that normalizes keratinocyte function to help delay the recurrence of plaques in mild to moderate plaque psoriasis1-3 Important Safety Information for Vectical® Ointment Indication: VECTICAL® Ointment is indicated for the topical treatment of mild to moderate plaque psoriasis in adults 18 years and older. Adverse Events: In controlled clinical studies, the most commonly reported adverse reactions (≥ 3%) were lab test abnormality, urine abnormality, psoriasis, hypercalciuria, pruritus, and skin discomfort. Warnings/Precautions: The maximum weekly dose should not exceed 200 g. Avoid contact with eyes, lips and face. VECTICAL® Ointment should be used with caution in patients receiving medications known to increase the serum calcium level, such as

thiazide diuretics and in patients receiving calcium supplements or high doses of Vitamin D. If aberrations in parameters of calcium metabolism are noted discontinue VECTICAL® Ointment until these normalize. Avoid excessive exposure of VECTICAL® Ointment treated areas to either natural or artificial sunlight.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see adjacent page for brief summary of Prescribing Information.

Vol. 6, No. 3 Summer 2012 57

IMPORTANT INFORMATION ABOUT ®

VECTICAL OINTMENT 3mcg/g (calcitriol)

BRIEF SUMMARY This summary contains important information about VECTICAL Ointment. It is not meant to take the place of your doctor’s instructions.

Read this information carefully before you start using VECTICAL Ointment.

Ask your doctor or pharmacist if you do not understand any of this information or if you want to know more about VECTICAL Ointment. For full Prescribing Information and Patient Information please see the package insert.

WHAT IS VECTICAL OINTMENT? VECTICAL Ointment is a vitamin D analog indicated for the topical treatment of mild to moderate plaque psoriasis in adults 18 years and older.

WHO IS VECTICAL OINTMENT FOR? VECTICAL Ointment is for use in adults 18 years of age or older.

WHAT SHOULD I TELL MY DOCTOR BEFORE USING VECTICAL OINTMENT? Before you use VECTICAL Ointment, tell your doctor if you: • have any other medical conditions.

• are pregnant or plan to become pregnant. VECTICAL Ointment contains calcitriol which could harm your unborn baby.

• are breast-feeding or plan to breast-feed. It is not known if VECTICAL Ointment passes into your breast milk. Talk to your doctor about the best way to feed your baby if you use VECTICAL Ointment.

• are taking a medication that increases how often you urinate.

• are taking calcium or Vitamin D supplements, are on diuretics, or suffer from kidney disease.

The effects of VECTICAL Ointment on calcium metabolism following treatment durations greater than 52 weeks have not been evaluated.

Increased absorption may occur with occlusive use.

You are encouraged to report negative side effects of prescription drugs to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088. You may also contact GALDERMA LABORATORIES, L.P. AT 1-866-735-4137.

HOW SHOULD I USE VECTICAL OINTMENT? • Use VECTICAL Ointment exactly as your doctor tells you to use it.

• Apply VECTICAL Ointment to affected areas twice daily, morning and evening.

• Do not use more than 200 g in one week.

• VECTICAL Ointment is for external use on skin only. Do not get VECTICAL Ointment near or in your eyes, mouth, or vagina.

• Apply only enough VECTICAL Ointment to cover the affected skin area.

• Rub gently into the skin so that no medication remains visible.

• Wash your hands after using VECTICAL Ointment.

WHERE SHOULD I GO FOR MORE INFORMATION ABOUT VECTICAL OINTMENT? • Talk to your doctor or pharmacist • • Go to www.vectical.com or call 1-866-735-4137 • GALDERMA LABORATORIES, L.P., Fort Worth, Texas 76177 USA Revised: March 2012 P51460-2-BS

Tell your doctor about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

WHAT SHOULD I AVOID WHILE USING VECTICAL OINTMENT? • Avoid excessive exposure of the treated area to either natural or artificial sunlight, like tanning booths and sun lamps. Physicians may also wish to limit or avoid use of phototherapy in psoriasis patients who are using VECTICAL Ointment.

WHAT ARE THE MOST COMMON SIDE EFFECTS OF VECTICAL OINTMENT? The most common side effects with VECTICAL Ointment include: • lab test abnormality • urine abnormality • psoriasis • high levels of calcium in urine and blood • itching • skin discomfort

References: 1. Langner A, Verjans H, Stapór V, Mol M, Fraczykowska M. 1α,25-dihydroxyvitamin D3 (calcitriol) ointment in psoriasis. J Dermatol Treat. 1992;3:177-180. 2. Tanghetti EA. The role of topical vitamin D modulators in psoriasis therapy. J Drugs Dermatol. 2009;8(suppl 8):s4-s8. 3. Data on file. Galderma Laboratories.

58 Journal of Dermatology for Physician Assistants

© 2012 Galderma Laboratories, L.P. GALDERMA and VECTICAL are registered trademarks.

Galderma Laboratories, L.P. 14501 N. Freeway, Fort Worth, TX 76177 VEC-695 Printed in USA 06/12

The Difference We Make Reclaiming The Lost Art of Appreciation When was the last time you said thank you to someone and really meant it? Someone taught me years ago the lost art of appreciating someone’s efforts, and I do so whenever I can and look forward to it. I’m talking about a simple thank you, followed by an explanation of what you are thanking the person for. If nothing else is gained (for example, the person doesn’t seem to appreciate your thank you) at least it makes me feel good, and I like myself better for this act of recognition.

I am one of those weird people who thanks the Starbuck’s barista for being up at 5:30 AM on a holiday, no less, to serve me my cup of coffee. I am told that they are rarely thanked. I tell them how much I appreciate them while looking them in the eyes and with a tone that lets them know I mean it.

Of course, the first person I thank in the morning is myself. I don’t believe you can truly appreciate some else until you appreciate yourself. Your cup has to be overflowing with gratefulness for simply being alive, for the many blessings you have, and for being someone who is doing his/her very best to make this world a better place. You can then start by giving away some of that wonderful energy.

It was William James, the 20th century philosopher and psychologist, who said, “Perhaps the greatest human need is to be appreciated.” In surveys of the American worker, 65% feel that they are underappreciated. So what does this say for us and what we need to do, especially since we are the “captain of the ship” in our offices? In what ways can we appreciate those who visit and appreciate our staff members who work with us so intimately and in whom we place our trust?

We could start by giving a staff member a simple, “Thank you.” The person would of course say, “For what?”

And your reply would be something like, “For making my day so easy,” “For smiling all the time,” or “For always being on time.”

You might say to a patient, “Thanks for doing what I asked you to do because your rash has cleared so nicely,” or “For being you.” I love the explanation you can give someone when they want to know why you are so full of compliments, and your reply is, “Just because.” No other explanation needed. Just because.

“Just because” is what I said to a physician who I had called to thank for a great story he told at a recent meeting I attended. I had interrupted him during a busy day with my phone call, which he graciously answered. After I told him how appreciative of him I was for his touching story about how he missed his family while being away at the conference, he thanked me and then quickly asked, “So what did you call for?” I tried to tell him at least three times that my thanking him was the only reason for the call. When he

still could not believe that, I finally said, “Just because” and wished him a good day.

It is so unusual that we take the time to appreciate someone that when we do it people wonder what else is on our mind. They are typically wondering, “Why are you really saying what you are saying? What is your hidden agenda?”

If you want practice in finding ways to appreciate people and getting into the mood to appreciate others, may I suggest watching how people act when it is someone’s birthday. People often will say beyond the expected happy birthday wish, “It is lovely to have you on the staff ” or “It is a pleasure to have you as a patient.” A birthday is one special celebration that allows us to appreciate someone else without an explanation. We need to imagine it is everyone’s birthday every day and give ourselves permission to appreciate one another. Make others feel special, just because!

You may wonder what excuses people give for not appreciating others so often. Here are a few that I have heard: I’m too busy; they must know that they are already appreciated; my way of saying thank you is by paying them; I’m looking to correct, not compliment; I’m in a survival mode with no time to be nice; it makes me feel uncomfortable.

And when we do compliment, thank, or appreciate someone, we often do it in some impersonal, efficient way such as in an email, a short letter, or a phone call after hours, knowing full well that the person isn’t there and thus avoiding a personal interaction.

It was Mark Twain who said, “ I can live for two months on a good compliment.” By one simple compliment you can positively change someone’s day, week, month, year, or even a life! One simple “Thank you for being you.” When you decide to express an appreciative thought, practice saying it long enough so that you believe yourself saying it!

May I suggest that you make a promise to yourself that you will thank at least one person today for something.

It could be a family member, a friend, a colleague, a staff member, or a patient. Thank them for making someone else’s life sweeter because they have lived. And tonight, when you end your day, look in the mirror and thank yourself for making this world a better place. J Dr. Steve Shama was practicing general dermatology for 30 years in Boston, Massachusetts until last year. He retired at that time but continues in a 20 year career as a professional speaker and enjoys speaking on topics such as, “Dealing With Difficult People and Looking Forward To It!” and “Rediscovering The Joys of Medicine and of Life.” He gives these talks at medical meetings, in private practices, and to general audiences and youth throughout the country. You can reach Dr. Shama at www.steveshama.com.

Vol. 6, No. 3 Summer 2012 59

DERmatology pa news & notes

By Steven K. Shama, MD, MPH

Workplace Excellence

You Can’t Give What You Don’t Have Developing Rituals for Renewal

By Matthew Davidson, Ph.D.

Dermatology PA news & notes

In my work as President of the Institute for Excellence & Ethics (IEE) I have had the opportunity to work with diverse individuals and organizations in their quest to achieve excellence. This column dedicated to workplace excellence explores the organizational, interpersonal, and ethical issues that contribute to (or detract from) individual or organizational excellence within the physician assistant profession. If you have any workplace topics you would like to see covered in the JDPA please feel free to share them with us. Email editor@jdpa.org with any topic ideas or questions concerning the workplace.

I

was recently conducting a two-day organizational retreat with an organization to develop shared vision, staff connectedness, and to assist in identifying the drivers and preventers of individual and organizational excellence. Like many organizations, the stresses of day-to-day work had left them feeling tired and beat down.

Over time this led to the fractures and factions within the organization where individuals of one role banded together against individuals with another role, creating a palpable “us versus them” mindset. They were one organization in name only; they were in their own assessment, a house divided.

At one point, I structured an activity designed to help them to reconnect in their shared professional work and as human persons. The task was for them to reflect on their role in the organization and to identify 1) what they liked best about their jobs, 2) the most difficult part of their jobs, and 3) what they wished others knew about their jobs. This simple activity generated tangible intensity as they shared out loud their individual self-reflections in their mixed-role groups.

The groups were completely locked in to one another as soon as the sharing at their tables began. What stood out initially was the seriousness with which they engaged in this task.

They wanted and needed this opportunity to share. There wasn’t laughing, side conversations, or people getting up for refreshments or to take a call. As I mulled in between the tables, I could not identify status differences; whichever person was sharing had power and had everyone’s interest 60 Journal of Dermatology for Physician Assistants

and attention. I especially noticed the passion with which people shared what they loved about their jobs, with many sharing why they got into this field in the first place and their formative mentors and experiences. It seemed that through the process they began to understand their colleague performing the task, the person hidden behind the role. There was a sense that they were discovering or rediscovering somebody new, even though most had worked together in close physical proximity for many years.

They connected at an even deeper level as they shared thoughts on the most challenging parts of their jobs. There were certainly some shared themes of the more obvious variety—too much to do, too few resources, and the toll of the daily pressure and relentless grind. And while these were familiar, they were also significant, in part perhaps because these challenges represented a shared experience. I could see the “us versus them” divisions dissipating and solidarity emerging through true empathy for each other through their shared thoughts and experiences. They were so united in their shared experiences; they had been in the battle together but simply hadn’t had the forum to reflect upon the shared reality of their isolated sufferings.

Beyond empathy, I observed something deeper still, something closer to compassion, a word derived from the Latin root, compatior, meaning “to suffer with.” In particular, they were united in compassion as they shared regarding the most difficult parts of their jobs, during which time many in the group expressed how difficult it was for them to see the toll that their work was

As we strive to help organizations achieve excellence, we often must find ways to help them look beyond the technical aspects of performance.

Clearly essential knowledge and well honed skills matter deeply to peak performance. But time and again we see that one truly neglected aspect of workplace excellence involves living a balanced, purposeful, and healthy life. In a bottom-line world, many miss the direct contribution to productivity and work performance. Consider evidence from a 2005 study of Canadian CEO’s and employees which found that “stress, burnout, or other physical and mental health problems are the top issues that are negatively impacting productivity,” with 8 in 10 CEO’s saying they were either “very or somewhat concerned.”1 We encounter many different sectors of the workplace, and the reality is the same: stress, burnout, lack of balance, neglect of home is a major risk to peak performance in the workplace. PAs and others in health-service fields are particularly at risk. What is sometimes called “compassion fatigue,” the inability to identify with the patient, often begins with just good old-fashioned fatigue.

Recovering or discovering balance and passion for work takes more than good intentions.

It requires intentional routines, targeted for the reality of the rigors of your environment. A retreat is just one possible option. One organization we consulted went white water rafting and then had a salmon cookout together. Our own organization has developed a ritual of “mandatory fun,” so named because we know we should relax and reconnect, but unless we require it of each other, it won’t get done. These anchor practices are important, but by themselves insufficient.

Rejuvenation and refocus can’t be an annual event;

it must be a regular practice. Think for example about the routines of your day and look to better use them for self-reflection, for public presentation, for support, and challenge. How do you begin your day and end your day? Can you build in time to share “brick walls and breakthroughs?” Find time to celebrate one another, to share good news, and to recommit to shared goals and the collective good. Look for ways to incorporate personal and collective goal setting around work goals, personal development, and overall health. Brainstorm strategies for creating more and better time away from the office so that your team can reconnect to the deep, animating, and motivating forces in their lives.

Recovery is an essential and oft-neglected part of peak performance. So, as your performance coach, I beg of you physician assistants: heal thyself! Take time this summer to reconnect with your colleagues, to refocus your professional and personal life, to recover and rejuvenate. You need it; your patients deserve it. Remember, you can’t give what you don’t have. J Reference: 1. New Canadian Study Reveals Widespread Concern Over Employee Health And Workplace Productivity. HR.com. http://www.bit.ly/ MvOVzW. Accessed June 15, 2012.

Matthew L. Davidson, Ph.D. is the Founder, President, and Director of Education for the Institute for Excellence & Ethics (IEE), a 501(c)3 nonprofit corporation dedicated to helping individuals and organizations achieve excellence. Previously he was the Research Director at the Center for Respect & Responsibility at the State University of New York College at Cortland. He has been on staff at the Family Life Development Center at Cornell University, the Values Program at LeMoyne College, and the Mendelson Center for Sport, Character, and Culture at the University of Notre Dame where he was also an Adjunct Professor of Education. He is a National Spokesperson for the Business Bureau National Center for Character Ethics. The IEE specializes in the development and dissemination of research based tools for developing the culture and competencies of excellence and ethics in schools, athletics, the workplace, and the home; this is done through professional development workshops & academies, teaching & learning resources, assessment, and consulting services. He is a frequent national presenter and is available for keynote lectures, professional development, retreats, and organizational consulting. For additional information or to contact the IEE, please visit www.excellenceandethics.org.

Vol. 6, No. 3 Summer 2012 61

DERmatology pa news & notes

taking on their families. At one table in particular several individuals struggled to hold back their emotions as they talked about the time away from home, and how often work left them so tapped out they had nothing to offer when they were home. This toll on home and family turned out to be a double-edged sword: burnout from work affected home; struggles at home became baggage and burdens that impacted work performance.

Many wanted others to know that lapses in work performance—especially lapses in basic kindness, civility, and collegiality—weren’t because they didn’t love their jobs, it was because they resented the toll it was taking on their lives overall.

First Foundations - On The Job Training

By Emily B. Massey, PA-C

M

any dermatology PAs expect that they will receive on the job training during their first year of employment when their learning curve is the steepest.

Supervising physicians should be training new PAs in every subject area, including: • Medical dermatology • Cosmetic dermatology • Surgical dermatology

Dermatology PA news & notes

• Procedures • Coding and Billing • Microbiology • Pathology The interaction of PAs with their supervising physicians for on the job training can take many forms such as shadowing, case study presentation, and assigned

62 Journal of Dermatology for Physician Assistants

reading. It is also a good idea for PAs to summarize lectures they attend and review these lectures with their supervising physicians. The SDPA’s Distance Learning Initiative is another great educational resource for PAs to review with their supervising physicians. In addition, PAs who have patients with difficult diagnoses or treatment plans should involve their supervising physicians and benefit from these learning experiences.

PAs should keep notes on what they learn from their encounters with their supervising physicians. Some dermatology PAs keep notes electronically, while others keep their notes in a convenient index card file. Choose the system that works best for you (electronic or hand written) and go with it!

Please feel free to provide feedback (ah-ha moments, challenges, and helpful hints) on your first year in dermatology to emily.massey@alumni.musc.edu. J

Supervising Physician CORNER Dr. Larry Bishop

L

arry Bishop, MD has been practicing dermatology for 19 years. He is currently a board-certified dermatologist practicing in Melbourne, FL. Dr. Bishop practices as part of a multi-specialty group, Melbourne Internal Medicine Associates, and has two physician assistants and a nurse practitioner working with him. He has created the Derm Challenge, an email based trivia type of game designed for PAs and NPs practicing in dermatology. He posts a question daily, usually in the form of a clinical picture with occasional bonus questions added on. Answers (along with the question or clinical image) from previous daily challenges can be found archived in a blog at at www.dermchallenge.blogspot. com. Participants are awarded points for correct answers, and at the end of the month the winner is given a bottle of wine. The grand prize winner is the participant who has won the most monthly Derm Challenges and receives a bottle of Dom Perignon champagne. To sign up for the Derm Challenge forward your name, position, name of your dermatology practice, and email address to delsol321@cfl.rr.com.

We had the pleasure of interviewing Dr. Bishop and learning more about Derm Challenge and his motivation in creating it. We thank him for taking the time to share with us his experiences and insights relating to the role of supervising physicians in educating dermatology PAs. JDPA: Describe your current position. What does your typical week/month look like?

Dr. Bishop: My current position is Chief of Dermatology at Melbourne Internal Medicine Associates. Typically, I see patients and perform simple excisions Mondays and Tuesdays, seeing about 50 patients a day. My schedule Wednesdays, Thursdays, and Fridays is a combination of Mohs surgeries and simple excisions as well as cosmetic patients. I perform roughly sixteen or so Mohs surgeries a week.

JDPA: Why did you develop the Derm Challenge?

Dr. Bishop: I started the Derm Challenge because I happen to have a phenomenal collection

of clinical photos and decided to use those photos to help my PAs elevate their levels of knowledge while having a great time doing it. I also like wine and thought it would be fun to reward the victor each month with a nice bottle of wine. It has turned out to be fun and rewarding for those who are playing, and we are now up to forty-two players in three states.

JDPA: What is the greatest challenge of working on this project?

Dr. Bishop: Making the time to provide quality insight into the different clinical entities.

JDPA: What concern do you hear most often from dermatologists regarding PAs? Dr. Bishop: The concern that I hear most from dermatologists regarding PAs is that they are concerned that PAs are not as qualified to see patients as they should be. My response to them is to ask them why don’t they set up an educational system to bring their PAs up to speed?

The supervising physician needs to help establish a way of evaluating patients as well as establishing a knowledge base. Otherwise, it isn’t fair to the patients or the PAs. JDPA: What steps have you taken to address these concerns?

Dr. Bishop: My PAs spend an inordinate amount of time with me, discussing both general and surgical dermatology. Additionally, I make it a policy to never express exasperation or impatience when I am asked a question. That way, there is no negative incentive for learning and the delivery of excellent care. I believe if I am not welcoming to my PAs when they ask me questions, I am not doing my job.

JDPA: My favorite bit of advice for PAs working in dermatology is…

Dr. Bishop: Become your own brand and make your brand stand for excellence. Try to be the best at everything you do, and the world will beat a path to your door.

JDPA: What feedback have you had from your peers about the Derm Challenge project?

Vol. 6, No. 3 Summer 2012 63

DERmatology pa news & notes

By J. Margaret Casey, staff writer

Dermatology PA news & notes

Dr. Bishop: My peers seem to think I have too much time on my hands. They’re not threatened, though. My old colleagues in residency remember how focused I was on getting good clinical photos of different entities, so they know I always planned to be an educator down the road.

JDPA: What is your greatest source of inspiration?

Dr. Bishop: My greatest source of inspiration is my family. I have a very supportive and loving family, and that makes the rest of my life easier.

JDPA: Describe your ideal vision for the future of dermatology.

Dr. Bishop: Dermatology has undergone a fairly significant change in the last twenty years shifting from a primarily cognitive specialty to becoming both a cognitive and procedural one. As pressures from third parties move toward the medical home concept, I believe more dermatologists will integrate their practices with multispecialty groups, and with that, there will be an explosion of opportunity for physician assistants. I would like to see the Society of Dermatology Physician Assistants (SDPA) take the lead and continue to develop their Distance Learning Initiative (DLI) in order to educate dermatology PAs not only on the basics of dermatology but also introduce more procedural topics into the DLI curriculum. If that happens, I think those PAs who take the time to complete the DLI and become Diplomates of the SDPA will be more marketable, and will be able to command better pay. In my practice, my PAs perform a wide variety of surgeries as well as cosmetic procedures and do so at a very high skill level. They review pathology reports and go over histopathology slides prior to surgery in order to provide a higher standard of care on excisions. One day, I believe all offices using dermatology PAs will practice as we do. J

Larry Bishop, MD was born in Pasadena, CA and grew up in Westerville, OH near Columbus. He attended Miami University in Oxford, OH and earned a double major in both Zoology and Chemistry. Dr. Bishop attended medical school in Dayton, OH at Wright State University, where he graduated with honors (Alpha Omega Alpha). He then went on to the University of Pennsylvania, where he completed a surgical internship and followed that with his residency in Dermatology at Wilford Hall Medical Center in San Antonio, TX. While at Wilford Hall, Dr. Bishop was able to serve as an exchange resident at the world’s oldest hospital dedicated to dermatology, Hospital Saint-Louis in Paris, France.

Dr. Bishop spent nine spectacular years in the Air Force, where he served in California, Texas, and finally the panhandle of Florida. He was lucky enough to have traveled all the way around the world, go to all of the continents except Antarctica, serve as Bob Hope’s personal physician for one of his USO tours, and was selected as one of the top flight surgeons in the Air Force.

Dr. Bishop landed in Melbourne, FL in 1995, and each year has gotten better and better. He added his first physician assistant nearly ten years ago, and has added another PA as well as a nurse practitioner to his practice, receiving very positive feedback from his patients. In a recent survey, his practice received among the highest patient satisfaction grades in the nation; this he attributes to his high quality PAs and NPs. His practice has been named as one of the top dermatology practices in the US each year for the last twelve years.

Dr. Bishop’s areas of special interest are cosmetic and surgical dermatology, including Mohs Micrographic Surgery, and non-surgical rejuvenation of the face. In his spare time, he likes to run, bicycle, fish, and travel. He also enjoys water sports including wakeboarding and kite boarding, and plans to learn to surf in the near future.

What Do You Want To Read About In The JDPA? We’re interested in knowing what kind of articles SDPA members would be interested in reading more about in order to help improve their practice of dermatology.

Share your content ideas today. Email them to editor@jdpa.org

64 Journal of Dermatology for Physician Assistants

Dermatology in art

By W. Stephen Steiner, PA-C

Hans Holbein the Younger (1497–1543), a Northern Renaissance painter famous for painting portraits of English royalty of the 16th century, completed this work in 1523. This illustration was originally called “Portrait of a Leper” but now carries the title of “Head of a Young Man.” Holbein immediately focuses the viewer’s attention to the eyes of the young man. There is both questioning and conviction in his expression. Prior to the onset of his affliction, he was a handsome man, likely never giving a negative thought to his appearance. Now that his face and neck have numerous pustules and crusts, he must worry about first impressions. His hair is not disheveled and his clothing appears normal. It is only his skin that makes him different - just like many of our patients.

Conjecture about the nature of ailment is plentiful.

Syphilis, pox virus, and impetigo have been purposed.

Could the annular lesion on his chin be indicative of a superficial fungus? A skin scraping would be nice to have to supplement the diagnosis, but Leeuwenhoek did not establish the field of microbiology for another hundred years or so after this work. J W. Stephen Steiner, PA-C is employed by Gwinnett Dermatology, PC and Gwinnett Clinical Research Center. He has worked in dermatology for the past twelve years. Outside of work, he enjoys woodworking and spending time with his wife and boys.

Write for the JDPA! Are you a PA who...

• Is interested in writing?

• Has a paper you want to get published?

Share your knowledge today. Contact editor@jdpa.org Vol. 6, No. 3 Summer 2012 65

DERmatology pa news & notes

Dr. Bernard Ackerman likened the study of dermatology to art history. The parallels between appreciation of art and the evaluation of skin are many. A neophyte describes a painting in regards to color, brushstroke, content, and structure. A skilled art historian assimilates these details unconsciously and may declare, “It looks like a Monet.” Each description is equally valid, and each serves a unique purpose. Similarly, one may describe the violaceous polygonal papules arising on the volar wrist; another may describe it simply as lichen planus. While blood work and biopsies are critical to our specialty, it is what we appreciate on the surface of the skin that largely influences decisions in clinical practice.

This series will explore the depictions of dermatologic conditions in classic artwork. The condition may be the focus of the painting, but often it is a quiet detail, only for the discerning and trained eye. If you have a piece of art that you would like to share with the JDPA readers, please contact us at editor@jdpa.org

Professional Opportunities and Development

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Receive a $20 Amazon Gift Card for every person you refer to become a member of the SDPA.

Bayer HealthCare - Finacea...............Pages 67, 68 For more information on advertising opportunities in the JDPA, please log on to www.jdpa.org

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66 Journal of Dermatology for Physician Assistants

Please note: Each referral will be counted only after the new member pays his/her dues and lists the referring member’s name on the application. Referral of supervising physicians will NOT qualify for this campaign, but is certainly encouraged.

RAMC_Quarter_071712.indd 1

7/17/12 7:04 PM

Finacea

®

(azelaic acid) Gel,15% For Dermatologic Use Only–Not for Ophthalmic, Oral, or Intravaginal Use Rx only BRIEF SUMMARY CONSULT PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION INDICATIONS AND USAGE FINACEA Gel, 15%, is indicated for topical treatment of inflammatory papules and pustules of mild to moderate rosacea. Although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated. Patients should be instructed to avoid spicy foods, thermally hot foods and drinks, alcoholic beverages and to use only very mild soaps or soapless cleansing lotion for facial cleansing.

CONTRAINDICATIONS FINACEA Gel, 15%, is contraindicated in individuals with a history of hypersensitivity to propylene glycol or any other component of the formulation.

WARNINGS FINACEA Gel, 15%, is for dermatologic use only, and not for ophthalmic, oral or intravaginal use.

There have been isolated reports of hypopigmentation after use of azelaic acid. Since azelaic acid has not been well studied in patients with dark complexion, these patients should be monitored for early signs of hypopigmentation.

PRECAUTIONS General: Contact with the eyes should be avoided. If sensitivity or severe irritation develops with the use of FINACEA Gel, 15%, treatment should be discontinued and appropriate therapy instituted.

In a transgenic mouse study, chronic use of FINACEA Gel led to an increased number of animals with papillomas at the treatment site (see PRECAUTIONS: Carcinogenesis, Mutagenesis, and Impairment of Fertility). The clinical relevance of the findings in animal studies to humans is not clear.

Information for Patients: Patients using FINACEA Gel, 15%, should receive the following information and instructions: • FINACEA Gel, 15%, is to be used only as directed by the physician.

• FINACEA Gel, 15%, is for external use only. It is not to be used orally, intravaginally, or for the eyes.

• Cleanse affected area(s) with a very mild soap or a soapless cleansing lotion and pat dry with a soft towel before applying FINACEA Gel, 15%. Avoid alcoholic cleansers, tinctures and astringents, abrasives and peeling agents.

• Avoid contact of FINACEA Gel, 15%, with the mouth, eyes and other mucous membranes. If it does come in contact with the eyes, wash the eyes with large amounts of water and consult a physician if eye irritation persists.

• The hands should be washed following application of FINACEA Gel, 15%.

• Cosmetics may be applied after FINACEA Gel, 15%, has dried.

• Skin irritation (e.g., pruritus, burning, or stinging) may occur during use of FINACEA Gel, 15%, usually during the first few weeks of treatment. If irritation is excessive or persists, use of FINACEA Gel, 15%, should be discontinued, and patients should consult their physician (See ADVERSE REACTIONS).

• Avoid any foods and beverages that might provoke erythema, flushing, and blushing (including spicy food, alcoholic beverages, and thermally hot drinks, including hot coffee and tea).

• Patients should report abnormal changes in skin color to their physician.

• Avoid the use of occlusive dressings or wrappings.

Drug Interactions: There have been no formal studies of the interaction of FINACEA Gel, 15%, with other drugs.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Systemic long-term animal studies have not been performed to evaluate the carcinogenic potential of azelaic acid. In a 26-week dermal carcinogenicity study using transgenic (Tg.AC) mice, FINACEA Gel, 15%, and the gel vehicle, when applied once or twice daily, did not increase the number of female Tg.AC animals with papillomas at the treatment site. No statistically significant increase in the number of animals with papillomas at the treatment site was observed in male Tg.AC animals after once daily application. After twice daily application, FINACEA Gel, 15%, and the gel vehicle induced a statistically significant increase in the number of male animals with papillomas at the treatment site when compared to untreated males. This suggests that the positive effect may be associated with the vehicle application. The clinical relevance of the findings in animals to humans is not clear.

Azelaic acid was not mutagenic or clastogenic in a battery of in vitro (Ames assay, HGPRT in V79 cells {Chinese hamster lung cells}, and chromosomal aberration assay in human lymphocytes) and in vivo (dominant lethal assay in mice and mouse micronucleus assay) genotoxicity tests.

Oral administration of azelaic acid at dose levels up to 2500 mg/kg/day (162 times the maximum recommended human dose based on body surface area) did not affect fertility or reproductive performance in male or female rats.

Pregnancy: Teratogenic Effects: Pregnancy Category B There are no adequate and well-controlled studies of topically administered azelaic acid in pregnant women. The experience with FINACEA Gel, 15%, when used by pregnant women is too limited to permit assessment of the safety of its use during pregnancy.

Dermal embryofetal developmental toxicology studies have not been performed with azelaic acid, 15%, gel. Oral embryofetal developmental studies were conducted with azelaic acid in rats, rabbits, and cynomolgus monkeys. Azelaic acid was administered during the period of organogenesis in

all three animal species. Embryotoxicity was observed in rats, rabbits, and monkeys at oral doses of azelaic acid that generated some maternal toxicity. Embryotoxicity was observed in rats given 2500 mg/kg/day (162 times the maximum recommended human dose based on body surface area), rabbits given 150 or 500 mg/kg/day (19 or 65 times the maximum recommended human dose based on body surface area) and cynomolgus monkeys given 500 mg/kg/day (65 times the maximum recommended human dose based on body surface area) azelaic acid. No teratogenic effects were observed in the oral embryofetal developmental studies conducted in rats, rabbits and cynomolgus monkeys.

An oral peri- and post-natal developmental study was conducted in rats. Azelaic acid was administered from gestational day 15 through day 21 postpartum up to a dose level of 2500 mg/kg/day.

Embryotoxicity was observed in rats at an oral dose that generated some maternal toxicity (2500 mg/kg/day; 162 times the maximum recommended human dose based on body surface area). In addition, slight disturbances in the post-natal development of fetuses was noted in rats at oral doses that generated some maternal toxicity (500 and 2500 mg/kg/day; 32 and 162 times the maximum recommended human dose based on body surface area). No effects on sexual maturation of the fetuses were noted in this study.

Because animal reproduction studies are not always predictive of human response, this drug should be used only if clearly needed during pregnancy.

Nursing Mothers: Equilibrium dialysis was used to assess human milk partitioning in vitro. At an azelaic acid concentration of 25 µg/mL, the milk/plasma distribution coefficient was 0.7 and the milk/buffer distribution was 1.0, indicating that passage of drug into maternal milk may occur.

Since less than 4% of a topically applied dose of azelaic acid cream, 20%, is systemically absorbed, the uptake of azelaic acid into maternal milk is not expected to cause a significant change from baseline azelaic acid levels in the milk. However, caution should be exercised when FINACEA Gel, 15%, is administered to a nursing mother.

Pediatric Use: Safety and effectiveness of FINACEA Gel, 15%, in pediatric patients have not been established.

Geriatric: Clinical studies of FINACEA Gel, 15%, did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

ADVERSE REACTIONS Overall, treatment related adverse events, including burning, stinging/ tingling, dryness/tightness/ scaling, itching, and erythema/irritation/ redness, were 19.4% (24/124) for FINACEA Gel, 15%, and 7.1% (9/127) for the active comparator gel at 15 weeks.

In two vehicle controlled, and one active controlled U.S. clinical studies, treatment safety was monitored in 788 patients who used twice daily FINACEA Gel, 15%, for 12 weeks (N=333) or for 15 weeks (N=124), or the gel vehicle (N=331) for 12 weeks.

Table 3. Cutaneous Adverse Events Occurring in ≥1% of Subjects in the Rosacea Trials by Treatment Group and Maximum Intensity* FINACEA Gel, 15% N=457 (100%)

Vehicle N=331 (100%)

Mild n=99 (22%)

Moderate n=61 (13%)

Severe n=27 (6%)

Mild n=46 (14%)

Moderate n=30 (9%)

Severe n=5 (2%)

Burning/ stinging/ tingling

71 (16%)

42 (9%)

17 (4%)

8 (2%)

6 (2%)

2 (1%)

Pruritus

29 (6%)

18 (4%)

5 (1%)

9 (3%)

6 (2%)

0 (0%)

Scaling/dry skin/xerosis

21 (5%)

10 (2%)

5 (1%)

31 (9%)

14 (4%)

1 (<1%)

Erythema/ irritation

6 (1%)

7 (2%)

2 (<1%)

8 (2%)

4 (1%)

2 (1%)

Contact dermatitis

2 (<1%)

3 (1%)

0 (0%)

1 (<1%)

0 (0%)

0 (0%)

Edema

3 (1%)

2 (<1%)

0 (0%)

3 (1%)

0 (0%)

0 (0%)

Acne

3 (1%)

1 (<1%)

0 (0%)

1 (<1%)

0 (0%)

0 (0%)

*Subjects may have >1 cutaneous adverse event; thus, the sum of the frequencies of preferred terms may exceed the number of subjects with at least 1 cutaneous adverse event.

FINACEA Gel, 15%, and its vehicle caused irritant reactions at the application site in human dermal safety studies. FINACEA Gel, 15%, caused significantly more irritation than its vehicle in a cumulative irritation study. Some improvement in irritation was demonstrated over the course of the clinical studies, but this improvement might be attributed to subject dropouts. No phototoxicity or photoallergenicity were reported in human dermal safety studies.

In patients using azelaic acid formulations, the following additional adverse experiences have been reported rarely: worsening of asthma, vitiligo depigmentation, small depigmented spots, hypertrichosis, reddening (signs of keratosis pilaris), and exacerbation of recurrent herpes labialis.

Post-marketing safety-Skin: facial burning and irritation; Eyes: iridocyclitis on accidental exposure with FINACEA Gel, 15%, to the eye (see PRECAUTIONS).

Distributed under license; U.S. Patent No 6,534,070 www.myfinacea.com ©2010, Intendis, Inc. All rights reserved, July 2010 Manufactured by Intendis Manufacturing S.p.A., Segrate, Milan, Italy Distributed by: Morristown, NJ 07962 Intendis is part of the Bayer Group

6706803BS

Vol. 6, No. 3 Summer 2012 67

For patients with mild to moderate rosacea,

Deliver a spectrum of benefits with

• The first and only gel approved to treat inflammatory papules, pustules, and associated erythema** (See Indication & Usage below) • 61% of patients achievedd treatment success in 12-week clinical studies1 • Helps maintain the stratuum corneum barrier function2 • #1 dermatologist-prescribed topical brand for mild to moderate rosacea3

INDICATION & USAGE FINACEA® (azelaic acid) Gel, 15% is indicated for topical treatment of inflammatory papules and pusstules of mild to moderate rosacea. *Although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated.

IMPORTANT SAFETY INFORMATION FINACEA Gel, 15% is contraindicated in individuals with a history of hypersensitivity to propylene glycol or any other components of the formulation. There have been isolated reports of hypopigmentation after use of azelaic acid. Since azelaic acid has not been well studied in patients with dark complexion, these patients should be monitored for early signs of hypopigmentation. FINACEA and its vehicle caused irritant reactions at the application site in human dermal safety studies. Skin irritation (e.g. pruritus, burning or stinging) may occur during use with FINACEA, usually during the first few weeks of treatment. If sensitivity or severe irritation develops and/or persists during use with FINACEA, discontinue use and institute appropriate therapy.

In clinical trials with FINACEA, the most common local adverse events (AE’s) (inclusive of mild, moderate and severe categories) were: burning/stinging/ tingling (29%), (29%) pruritus (11%) (11%), scaling/dry skin/xerosis (8%) and erythema/ irritation (4%). Contact dermatitis, edema and acne were observed at frequencies of 1% or less.

Rarely reported AE’s included: worsening of asthma, vitiligo depigmentation, small depigmented spots, hypertrichosis, reddening (signs of keratosis pilaris) and exacerbation of recurrent herpes labialis. Post-marketing safety information: Skin (facial burning and irritation); Eyes (iridocyclitis on accidental exposure with FINACEA to the eyes). To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare at 1-866-463-3634 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

FINACEA is for topical use only. It is not for ophthalmic, oral or intravaginal use. In case of accidental eye exposure, wash eyes with large amounts of water and consult a physician if eye irritation persists. Wash hands following application of FINACEA. See following page for Brief Summary of full Prescribing Information.

Model used for illustrative purposes only.

References: 1. FINACEA [package insert]. Morristown, NJ: Intendis, Inc; 2010. 2. Draelos ZD. Effects of azelaic acid 15% gel on skin barrier in rosacea. Cosmet Derm. 2008;21(5):259-261. 3. Wolters Kluwer Pharma Solutions, Source® Pharmaceutical Audit Suite, July 2010-December 2011. Based on TRx counts, dermatology specialty, inclusive of listed products/strengths only. Wolters Kluwer Health makes no representations regarding the adequacy of its data for the purpose of substantiating

any advertising and promotional claims made by Bayer. Bayer remains solely responsible for full compliance with any and all applicable advertising and marketing laws and regulations. Provision of approval for data release for publication is contingent upon Bayer’s acknowledgement of sole responsibility for accuracy of the claim made, as well as for compliance with any and all applicable marketing and advertising laws.

© 2012 Bayer HealthCare Inc. Bayer, the Bayer Cross and FINACEA are registered trademarks of Bayer HealthCare Inc. All rights reserved. FIN-10-0002-12 May 2012. Printed in USA.

68 Journal of Dermatology for Physician Assistants