JDPA Fall 2014

DPA J

V o l u m e 8 • n u m b e r 4 • F A LL 2 0 1 4 • www.jdpa.org

Journal of Dermatology for Physician Assistants

dermatology Pa news & notes

Certification Maintenance 16 __________________________________

clinical dermatology Dermatology Case Report 26 __________________________________

Surgical dermatology Surgical Wisdom

33

_________________________________

Cosmetic dermatology Cosmetic Pearls

47

_____________________________ professional development Judicial and Ethical Affairs: Ethical Issues in Cosmetic Dermatology 51

›› Earn CME credit with this issue CME Cosmetic Dermatology Complications 42 A Review of Common Procedures

Official Journal of the Society of Dermatology Physician Assistants

Volume 8 • number 4 • FALL 2014

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Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936-1080

Š2014 Novartis

4/14

XDP-1301721

I’M TIRED OF BEING STARED AT. BUT WORSE, I DON’T EVEN WANT TO SEE MYSELF. Many patients with moderate to severe psoriasis (PsO) have trouble expressing how they’re doing. You probably have patients in your practice who still suffer from embarrassment, poor self-image, and social isolation but aren’t talking to you about it.1-4 But with just 1 revealing question, you can uncover the dissatisfaction your patients may have trouble expressing, and help make a real difference in managing their PsO.

MAKE A CONNECTION. MAKE A DIFFERENCE. Find out how you can help at PSOMUCHMORE.COM References: 1. Data on file. Kantar Health 2013. Novartis Pharmaceuticals Corp; 2014. 2. Gupta MA, Gupta AK, Watteel GN. Perceived deprivation of social touch in psoriasis is associated with greater psychologic morbidity: an index of the stigma experience in dermatologic disorders. Cutis.

1998;61(6):339-342. 3. Schmid-Ott G, Jaeger B, Kuensebeck HW, Ott R, Lamprecht F. Dimensions of stigmatization in patients with psoriasis in a ‘‘Questionnaire on Experience with Skin Complaints.’’ Dermatology. 1996;193(4):304-310. 4. Armstrong AW, Schupp C, Wu J, Bebo B. Quality of life and work productivity impairment among psoriasis patients: findings from the National Psoriasis Foundation survey data 2003-2011.

PLoS One. 2012;7(12):e52935.

Volume 8 • number 4 • FALL 2014

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Journal of Dermatology for Physician Assistants

EDITORIAL BOARD

Travis Hayden, MPAS, PA-C, Editor in Chief Joe R. Monroe, MPAS, PA 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, PhD, 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, PhD, MD Alan Menter, MD

DEPARTMENT EDITORS

Clinical Department Editors Susan E. King-Barry, MPAS, PA-C Karen Graham, MPAS, PA-C Dermatology Grand Rounds Editor Cynthia F. Griffith, MPAS, PA-C Dermoscopy Editor John Burns, MSPA, 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

2014-15 SDPA Board of Directors PRESIDENT Vicki Roberts, MPAS, PA-C PRESIDENT-ELECT Matthew Brunner, MHS, PA-C IMMEDIATE PAST PRESIDENT Jennifer Winter, MSPAS, PA-C VICE PRESIDENT Jacki Kment, MPAS, PA-C SECRETARY / TREASURER Joleen Volz, MPAS, PA-C DIRECTORS AT LARGE Scott B. Ahrndt, MPAS, PA-C Jennifer Conner, MPAS, PA-C Jang Mi Johnson, PA-C Jane Mast, PA-C

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: The 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. going green: Since its inception, the JDPA has utilized eco-friendly printing practices. The JDPA is printed on paper obtained from sustainable forests that meet strict environmental standards. Soy-based inks that have a low environmental impact are used during printing of the journal and the journal is printed using 100% renewable energy. SDPA members may join us in our efforts and opt to receive the JDPA in digital format.

Publishing Staff Publisher Travis Hayden, MPAS, PA-C Managing Editor Jennifer M. Hayden, M.Ed Copy Editor Douglas Morris Art Director Angela Simiele Website Design Terry Scanlon SALES Office Physician Assistant Communications, LLC P.O. Box 416, Manlius NY 13104-0416 Phone (315) 663-4147 PAC@pacommunications.org www.pacommunications.org keep current with the SDPA:

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 8, Number 4, Fall 2014. 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).

Periodicals postage rate paid at New York, NY 10001 and additional mailing offices. Š 2014 Physician Assistant Communications, LLC. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including by photocopy, recording, or information storage and retrieval system, without permission in writing from the publisher.

Postmaster: Send address changes to Society of Dermatology Physician Assistants, Inc., 4111 W. Alameda Ave. Suite 412, Burbank, CA 91505, 1-800-380-3992., email SDPA@dermpa.org, www.dermpa.org.

THIS ISSUE IS SPONSORED BY

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Journal of Dermatology for Physician Assistants

Editor’s Message

A

s many of us read this article in print, we may find ourselves relieved and perhaps happy to be reading something other than a computer screen. Yes, believe it or not, I said print. A healthy number of our readers continue to actually prefer to receive and read their JDPA in print. I know I have been finding greater relaxation in reading words on the printed page even more so since my practice has transitioned into using its first electronic medical record system. Don’t get me wrong, I acknowledge the purpose and value behind the use of such systems in our practice of medicine. However, I must admit that I did not foresee the problems of adapting to such a system, especially the mental fatigue I have experienced from the excessive screen time that I now find myself logging in during clinic hours.

Recently, I came across an interview with best-selling author and neuroscientist Daniel Levitin, PhD who wrote The Organized Mind. In the interview Dr. Levitin discusses our brain’s ability to process (or to not process) the high volume of information that is coming at us in this age of seemingly never-ending digital information, and he shares tips on how busy healthcare providers can be more efficient. One such suggestion is to try, when possible, to avoid multitasking and rather to focus on “unitasking.” This concept involves becoming absorbed in one activity for a certain period of time before moving on to the next task.

By exercising unitasking we can better avoid the constant distraction of emails, texts, and other digital communications. Dr. Levitin also stresses the importance of taking a mental break from time to time. He explains that our brain needs an opportunity to consolidate and process all of the information that it has been presented with. He refers to this break as our brain’s opportunity to function in “day-dreaming mode” (the time when our brain is processing the information we have been presented with while we are not actively working on another task). Throughout our busy clinic workdays, whenever possible, we should attempt to focus on unitasking and allow ourselves periodic mental breaks. Doing so will enable us to more accurately diagnose conditions without the distractions of other work related items that may take up our thought processes and will permit our brain the much deserved rest it needs so that we are not as mentally fatigued when we see our last few patients at day’s end.

Keeping our minds focused and refreshed in this digital information age can only result in positive outcomes for the work that we do. Technology is here to stay, and how we choose to interact with it will not only directly impact our own health but the health of our patients as well. J

Travis Hayden, MPAS, PA-C JDPA Editor in Chief editor@jdpa.org

Volume 8 • number 4 • FALL 2014

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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.

42 Cosmetic Dermatology Complications: A Review of Common Procedures

By Maggie Leonard Rivera, PA-C and Michelle DiBaise, DHSc, PA-C, DFAAPA

›› CME 10 Derm PA News & Notes – part one

• Certification Review & Maintenance • Student Corner: Dermatology PA Preceptors Needed • Dermatology Market Watch: Managing Rosacea

20 Clinical Dermatology

• Dermatology Case Report: Case of Self-Inflicted Dermatitis in a Patient Participating in “Salt and Ice Challenge” • Journal Club: Practice Changing Articles for Dermatology

Departments

04 Editorial Board 05 Editor’s Message 09 SDPA News & Current Affairs 10 Dermatology Market Watch 19 Now Showing on Dermcast.tv 20 From The Patient’s Perspective 28 Clinical Snapshots 33 Surgical Wisdom 47 Cosmetic Pearls 53 Outside & Inside the 9 to 5…

55 Notes from your Office Manager 56 The Difference We Make 68 Dermatology in Art 69 JDPA Information for Authors 70 Professional Opportunities and Development

32 Surgical Dermatology • Journal Club: Practice Changing Articles for Dermatology

42 Cosmetic Dermatology

• CME Article – Cosmetic Dermatology Complications: A Review of Common Procedures

51 Professional Development

• Judicial and Ethical Affairs: Ethical Issues in Cosmetic Dermatology

56 Derm PA News & Notes – part two

• From the Desk of…

• Workplace Excellence • Supervising Physician Corner: An Interview with David Pariser, MD

Omission from JDPA Summer 2014

In the Summer 2014 issue of the JDPA, the photo used on the front cover as well as on the table of contents page was provided courtesy of Adelaide Hebert, MD. © Photo courtesy of Adelaide Hebert, MD Univ of Texas c/o International Hyperhidrosis Society. All rights reserved.

Go Green & Read On the Go 6

Journal of Dermatology for Physician Assistants

dermpa.org

HALOG Cream and Ointment are designed for a difference your patients can truly feel.

BIPHASIC CREAM for sustained relief.1,2 PLASTIBASE® OINTMENT for enhanced spreadability and appeal.3

INDICATIONS AND USAGE: HALOG (Halcinonide, USP) 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

For topical use only.

For Important Safety Information, please see Brief Summary on reverse. For full Prescribing Information see Product Package Insert at HalogRx.com REFERENCES: 1. Blecker, J. Double-blind comparison between two new topical steroids, halcinonide 0.1% and clobetasol propionate cream 0.05%. Curr Med Res Opin. 1975;3:225-228. 2. Bagatell FK. Halcinonide: a new potent anti-inflammatory drug. Cutis. 1974:14:459-462.

3. Thau P, Fox C. A new procedure for the preparation of polyethylenemineral oil gels. J Soc Cosmet Chem. 1965;16:359-363.

HALOG ® is a registered trademark of Ranbaxy Laboratories Inc. All other trademarks are property of their respective owners.

HLGJI1Ba 01/14

Volume 8 • number 4 • FALL 2014

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8

Journal of Dermatology for Physician Assistants

FROM THE SDPA

News & Current Affairs

CALENDAR OF EVENTS 2014

NOVEMBER SDPA 12th Annual Fall Dermatology Conference November 12 - 15, 2014 Manchester Grand Hyatt San Diego, CA

2015

MARCH 73rd AAD Annual Academy Meeting March 20 - 24, 2015 San Francisco, CA

JUNE SDPA Summer Dermatology Conference June 4 – 7, 2015 Caesars Palace Las Vegas, NV NOVEMBER SDPA 13th Annual Fall Dermatology Conference November 12 - 15, 2015 Loews Portofino Bay Hotel Orlando, FL

I

n the fourteen years that I have been with my current practice, I have had two supervising physicians (SP). The relationship I developed with each was very different. The first SP was an older, experienced physician. Since he hired me straight out of school, our relationship was very similar to a fatherdaughter relationship. In the beginning, I shadowed and trained right by his side helping him with biopsies and surgeries. As I moved on to my own schedule, he still required me to be available whenever he needed me, even if it meant leaving the patient on my schedule for a few minutes to help him. I realize this was not ideal, but in turn, he protected me and was loyal to me and the PA profession. One example of his loyalty was when a pathologist refused to speak to me because I was a PA. My SP decided that we would no longer send pathology to this particular pathologist. After about a week, the pathologist started talking to me about my patients.

When my first SP retired he sold the practice to a dermatologist who was right out of residency. Given that I had over ten years of experience and was a few years older than my new SP, I knew that this relationship would not be like the father-daughter relationship I had with my former SP. However, my new SP’s positive experience with PAs during residency helped us to develop a more collaborative relationship. His show of support for me and the PA profession became apparent when he bought local ads to announce my accomplishments, participated in the SDPA’s recent video about dermatology PAs, and as he helped guide me whenever I wanted to respond to negative legislation or articles that incorrectly defined PAs. How PAs are viewed within the medical community is formed to a large degree by our relationships with our SPs. As they share their experiences of being SPs with their peers, they can become strong advocates for our profession. Our SPs are the members of the AAD, read dermatological journals, converse with state medical boards, and sometimes are the ones writing journal articles. It is important that we keep our SPs informed about issues affecting PAs, the PAs who they depend on day in and day out. Keeping our SPs informed may result in them writing positive articles pertaining to our profession or discussing the benefits of our team-based profession with the AAD and/or their state societies.

We all obviously discuss clinical concerns with our SPs, but we also should be having discussions about legislation, articles in the popular press, and journal articles that deal with the SP/PA relationship. By allowing them insight into the obstacles that might be facing PAs, informed dermatologists with positive PA experiences are more likely to be in our corner when we need them - both in every day discussions with other physicians and when critical issues arise. J

Vicki Roberts, MPAS, PA-C SDPA President, Diplomate

Volume 8 • number 4 • FALL 2014

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Dermatology PA news & notes

Dermatology Market Watch Keytruda for Injection The U.S. Food and Drug Administration granted accelerated approval to Keytruda (pembrolizumab) for treatment of patients with advanced or unresectable melanoma who are no longer responding to other drugs.

Melanoma accounts for approximately 5 percent of all new cancers in the United States. According to the National Cancer Institute, an estimated 76,100 Americans will be diagnosed with melanoma and 9,710 will die from the disease this year.

Keytruda is the first approved drug that blocks a cellular pathway known as PD-1, which restricts the body’s immune system from attacking melanoma cells.

Keytruda is intended for use following treatment with ipilimumab, a type of immunotherapy. For melanoma patients whose tumors express a gene mutation called BRAF V600, Keytruda is intended for use after treatment with ipilimumab and a BRAF inhibitor, a therapy that blocks activity of BRAF gene mutations.

“Keytruda is the sixth new melanoma treatment approved since 2011, a result of promising advances in melanoma research,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Many of these treatments have different mechanisms of action and bring new options to patients with melanoma.” The five prior FDA approvals for melanoma include: ipilimumab (2011), peginterferon alfa-2b (2011), vemurafenib (2011), dabrafenib (2013), and trametinib (2013).

The FDA granted Keytruda breakthrough therapy designation because the sponsor demonstrated through preliminary clinical evidence that the drug may offer a substantial improvement over available therapies. It also received priority review and orphan product designation.

Priority review is granted to drugs that have the potential, at the time the application was submitted, to be a significant improvement in safety or effectiveness in the treatment of a serious condition. Orphan product designation is given to drugs intended to treat rare diseases.

The FDA action was taken under the agency’s accelerated approval program, which allows approval of a drug to treat a serious or life-threatening disease based on clinical data showing the drug has an effect on a surrogate endpoint reasonably likely to predict clinical benefit to patients. This program provides earlier patient access to promising new drugs while the company conducts confirmatory clinical trials. An improvement in survival or diseaserelated symptoms has not yet been established.

Keytruda’s efficacy was established in 173 clinical trial participants with advanced melanoma whose disease progressed after prior treatment. All participants were treated with Keytruda, either at the recommended dose of 2mg/kg or at a higher dose of 10mg/kg. In the half of the participants who received Keytruda at the recommended dose of 2mg/kg, approximately 24 percent had their tumors shrink. This effect lasted at least 1.4 to 8.5 months and continued beyond this period in most patients.

A similar percentage of patients had their tumor shrink at the 10mg/kg dose.

Keytruda’s safety was established in the trial population of 411 participants with advanced melanoma. The most common side effects of Keytruda were fatigue, cough, nausea, itchy skin (pruritus), rash, decreased appetite, constipation, joint pain (arthralgia) and diarrhea. J

KerydinTM (tavaborole) Topical Solution, 5% Sandoz, through its branded dermatology business, PharmaDerm, announced the US launch of KerydinTM (tavaborole) topical solution, 5%, developed by Anacor Pharmaceuticals, Inc. KerydinTM is the first oxaborole antifungal indicated for the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes, a fungal infection of the nail and nail bed that affects approximately 35 million people in the US, according to Podiatry Today. J

10 Journal of Dermatology for Physician Assistants

Cloderm Cream for dry, cracked, and inflamed skin ®

CLODERM® CREAM AND ITS AUTHORIZED GENERIC MAY EXPAND PATIENT ACCESS BY DELIVERING: P Enhanced formulary access P Fewer insurance challenges P Reduced pharmacy callbacks Cloderm® Cream demonstrated better skin hydration and moisturization than both Locoid Lipocream® (hydrocortisone butyrate, 0.1%) and Locoid® Lotion (hydrocortisone butyrate, 0.1%).1,2

Same formulation Same manufacturer Learn more at www.clodermcream.com

Indication and Important Safety Information Cloderm Cream and Clocortolone pivalate Cream, 0.1% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. The most common adverse events with Cloderm Cream and Clocortolone pivalate Cream, 0.1% include burning, itching, irritation, dryness, and folliculitis. Cloderm Cream and Clocortolone pivalate Cream, 0.1% are contraindicated in patients who are hypersensitive to any of the ingredients of these products. As with all topical corticosteroids, systemic absorption can produce reversible HPA-axis suppression.

Please see Brief Summary of Prescribing Information.

Not a cookie-cutter topical steroid

Locoid Lipocream® and Locoid® Lotion are registered trademarks of Astellas Pharma Europe B.V. licensed to Onset Dermatologics References: 1. Data on file. Study #CDC1303. Bridgewater, NJ: Promius Pharma, LLC; 2013.

2. Data on file. Study #CDC1304. Bridgewater, NJ: Promius Pharma, LLC; 2013.

Cloderm® is a trademark of Coria Laboratories, Ltd. ©2014 Promius, Pharma, LLC. All rights reserved. CDM-0414-106

Volume 8 • number 4 • FALL 2014 11

RxOnly

5. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.

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

FOR TOPICAL DERMATOLOGIC USE ONLY– NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE. WARNING: KEEP OUT OF REACH OF CHILDREN

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.

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.

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.

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.

CONTRAINDICATIONS: Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

PRECAUTIONS: General: Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.

Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings.

Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.

Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

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.

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

Nursing Mothers: It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

Pediatric Use: Pediatric patients may demonstrate greater susceptibility to topical corticosteroidinduced HPA axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface area body weight ratio.

Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.

ADVERSE REACTIONS: The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: Burning, Itching, Irritation, Dryness, Folliculitis, Hypertrichosis, Acneiform eruptions, Hypopigmentation, Perioral dermatitis, Allergic contact dermatitis, Maceration of the skin, Secondary infection, Skin atrophy, Striae, Miliaria.

OVERDOSAGE: Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

DOSAGE AND ADMINISTRATION: Apply Cloderm (clocortolone pivalate) Cream 0.1% sparingly to the affected areas three times a day and rub in gently.

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

HOW SUPPLIED: Cloderm (clocortolone pivalate) Cream 0.1% is supplied in 30 gram and 75 gram pump bottles, 45 gram and 90 gram tubes.

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:

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

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.

Issued 0711

004158

12 Journal of Dermatology for Physician Assistants Cloderm PI.indd 1

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Dermatology Market Watch

...continued from pg. 10

Innocutis Holdings, LLC announced the introduction into the North American markets of Sitavig® (acyclovir) 50mg Muco-Adhesive Buccal Tablets, licensed from BioAlliance Pharma. Sitavig® 50mg represents a treatment breakthrough in the herpes labialis category, because of its unique vehicle and delivery system.

Sitavig® uses a proprietary Lauriad® delivery technology which consists of a tablet that sticks to the gum, above the canine tooth on the side of the lip that is infected with a cold sore.

8mm in diameter and 2.2 – 2.6mm in thickness, this tablet is tasteless and odorless. It dissolves to provide a sustained release of medicine.

A Phase III study demonstrated that a single low dose of Sitavig® 50mg improved all clinical parameters of labial herpes, in particular, it increased the percentages of blocked lesions and delayed by about 105 days the recurrence of the

next herpes episodes. It is well known that the standard of care, systemic antiviral drugs, are typically prescribed at high doses in the treatment of labial herpes. However, Acyclovir Lauriad® mucoadhesive buccal tablet (Sitavig®) is an innovative drug delivery system that provides a high sustained-release local exposure of acyclovir in oral mucosa, supporting its evaluation as single low dose in herpes labialis.

In summary, Sitavig® 50mg provided clinical benefit to patients independently of the lesion stage. It reduced the occurrence of vesicular lesions, primary or non-primary, which is the most important burden of the disease. It also prevented and delayed the recurrence of the next herpes episode. Sitavig® 50mg buccal tablet is an alternative option to systemic antiviral treatment for patients with recurrent herpes labialis when applied within one hour after the occurrence of prodromal symptoms. J

S D PA M

I H S R E EMB

P

RECEIVE A $20 AMAZON GIFT CARD FOR EVERY PERSON YOU REFER TO BECOME A MEMBER OF THE SDPA.

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_6.75x4.75.indd 1

1/31/13 12:49 PM

Volume 8 • number 4 • FALL 2014 13

DERmatology pa news & notes

Sitavig® 50mg Acyclovir Muco-Adhesive Buccal Tablet for Relief From Herpes Labialis

Certification Review

All Those Things Inside the Skin You Might Have Forgotten

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

QUESTION: A 40-year-old female presents with a three-week history of fatigue, shortness of breath, fever, and ten-pound weight loss. The patient also notes a two-week history of a non-productive cough. On physical examination, lungs are clear to auscultation and no lymphadenopathy or hepatosplenomegaly is noted. Laboratory studies reveal a hemoglobin of 11.0mg/dl and chest X-ray shows bilateral hilar lymphadenopathy. Angiotensin-converting enzyme level is elevated. Which of the following is the most likely diagnosis?

A. Tuberculosis B. Histoplasmosis C. Hodgkin’s lymphoma D. Sarcoidosis E. Berylliosis EXPLANATION: Sarcoidosis is an inflammatory disease characterized by the presence of non-caseating granulomas. The disease affects multiple systems (lung, liver, skin, and eyes are most commonly affected).

Sarcoidosis is more common in young females; presenting symptoms include cough, dyspnea, fatigue, fever, night sweats, and weight loss. Physical exam findings may include lymphadenopathy, hepatosplenomegaly, and skin involvement. Laboratory testing reveals bilateral hilar lymphadenopathy on chest X-ray, elevated angiotensinconverting enzyme (ACE) levels, and anemia. Histoplasmosis

is due to Histoplasma capsulatum, a dimorphic fungi.

Typically found in the Ohio and Mississippi river valley areas, patients present with fever, chills, fatigue, and a non-productive cough. A chest X-ray reveals a patchy or multi-lobed infiltrate. Hodgkin’s lymphoma presents with localized lymphadenopathy, fever, weight loss, and night sweats. ACE levels would be normal. Tuberculosis is due to Mycobacterium tuberculosis. Patients present with fever, hemoptysis, and night sweats. A chest X-ray typically reveals a cavitary lesion in the upper lung fields.

Berylliosis is secondary to chronic exposure to beryllium, which is found in foundries and nuclear reactors. Patients present with chronic productive cough and dyspnea. A chest X-ray reveals diffuse interstitial infiltrates and hilar lymphadenopathy. ACE levels would be normal. J The correct answer is D.

DERmatology pa news & notes

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

James A. Van Rhee, MS, PA-C, is the Program Director for the Yale University School of Medicine Physician Associate Program. Mr. Van Rhee has been involved in physician assistant education for over 17 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 and on-demand by Kaplan Medical.

Student Corner

Dermatology PA Preceptors Needed It is important for SDPA members to recognize their crucial role in helping to successfully train our next generation of knowledgeable, clinically competent dermatology PAs. SDPA members should consider becoming clinical preceptors.

We thank you if you are currently listed in our database as a preceptor site, and would encourage you to please be sure to update your information if you have not done so already by contacting sdpa@dermpa.org.

If you are interested in becoming a clinical preceptor please send your information to sdpa@dermpa.org. This is 14 Journal of Dermatology for Physician Assistants

yet another great way SDPA members can help better our profession and make a difference.

Stephanie Palazzolo, PA-S2 SDPA Student Affairs Committee Senior Student Coordinator

Maria Kelly, PA-S1 SDPA Student Affairs Committee Junior Student Coordinator

Marc Kawohl, PA-C SDPA Student Affairs Committee Recent Graduate Advisor J

Prescribe

Finacea first ®

© 2014 Bayer HealthCare Pharmaceuticals Inc. Bayer, the Bayer Cross, Finacea and the Finacea logo are registered trademarks of Bayer. All rights reserved.

PP-825-US-0202 | September 2014

Volume 8 • number 4 • FALL 2014 15

Certification Maintenance - Frequently Asked Questions

DERmatology pa news & notes

The year 2014 marks the beginning of the physician assistant profession's transition to a 10-year certification maintenance process. Physician assistants who pass PANCE, regain certification, or wrap up a six-year certification maintenance cycle in 2014 will be the first to begin the new 10-year process.

SDPA members can log into their NCCPA accounts and review their dashboards to confirm when they will move into this new 10-year cycle.

Only programs approved for AAPA Category 1 PI-CME credit qualify. Visit www.aapa.org/picme for a complete list of approved PI-CME activities.

AAPA will continue to add more activities as they are identified and approved.

This new process requires new types of CME activities; self-assessment (SA) and performance improvement (PI) CME. To learn more about the new requirements, SDPA members are encouraged to visit www.nccpa.net/CertMain. Below are some of the most frequently asked questions by SDPA members pertaining to these new changes in certification maintenance.

Here's a practical example: the American Academy of Family Physicians' METRIC program includes modules on asthma, diabetes, geriatrics, and hypertension. Participants select 10-15 patient charts, enter data into an online interface, and receive a report showing how their patients are doing relative to national standards or norms. The report also suggests areas where changes may make a positive difference.

Participants implement the change(s) over the course of several months, and then enter another set of sample charts for a final report on the impact of the change.

PAs can participate in a METRIC module and fulfill the 20-credit requirement for just $125. Of course, that is just one example.

Q: What is “performance improvement (PI) CME,” and where will I find it?

Q: Will I be required to do a performance improvement “project?”

A: PI-CME is active learning and the application of learning to improve your practice. And this can be done in partnership with your supervising physician and others in your practice; everyone can work on and get credit for PI-CME together. PI-CME involves a three-step process:

A: That depends on what you mean by “project.”

While NCCPA was initially considering a less structured performance improvement requirement that would have required PAs to design and implement their own improvement project, since then the concept of PI-CME has emerged as a simpler way to accomplish the same goal. PI-CME will generally involve the review of a sample of patient charts, implementation of some change in your practice, and then a follow-up review of a sample of charts to assess the impact of the change. It will be structured; you will not have to conceptualize and design a unique improvement project and find ways to measure impact. You will be able to focus your time on the actual effort of making a positive change in your practice. J

1. Compare some aspect of practice to national benchmarks, performance guidelines, or other established evidence-based metric or standard.

2. Based on the comparison, develop and implement a plan for improvement in that area.

3. Evaluate the impact of the improvement effort by comparing the results of the original comparison with the new results or outcomes.

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 16 Journal of Dermatology for Physician Assistants

JDPA Journal of Dermatology for Physician Assistants

Dermatology Market Watch

...continued from pg. 13

Managing Rosacea

Rosacea is a complex disease of unknown etiology with multiple pathogenic factors. Several treatment options exist for rosacea although no one agent effectively treats the total spectrum of the disease completely. A brief review of current treatment strategies and options for managing rosacea is presented in this article.

Table: Common Factors That Can Trigger Rosacea

Avoidance of Rosacea Triggers

A thorough discussion with patients should seek to Emotional stress identify agents or conditions that trigger or exacerbate their Hot weather rosacea.1 Once identified, Wind (cold or hot) patients should be counseled Exercise to avoid these trigger factors.

Common rosacea triggers are Alcohol consumption listed in the Table. Cosmetic (especially red wine) and skincare products may Hot baths be irritating to rosacea patients due to their sensitive Cold weather skin. Patients should choose Spicy foods and temperature hot noncomedogenic, fragrance foods (soup) and soap free products, and Humidity avoid products that contain alcohol, methanol, eucalyptus Certain skincare products (scrubbing or exfoliating washes oil, clove oil, peppermint, and devices) witch hazel, or sodium lauryl sulfate.2 A broad-spectrum Hot beverages sunscreen with a SPF of at least 30 should be used that is formulated with inorganic UV filters and a simethicone or dimethicone base.

Sun exposure

application of azelaic acid can reduce the cutaneous side effects and enhance penetration.

Retinoids have also been used to successfully treat PPR. A clinical study compared adapalene gel 0.1% to metronidazole gel 0.75%.5 Both were well tolerated and produced a significant reduction in papules and pustules. Another study compared a combination product containing clindamycin phosphate 1.2% and tretinoin 0.025% gel against its vehicle for the treatment of papules and pustules associated with PPR.6 The number of papules and pustules was reduced in the active group whereas the number increased in the vehicle group.

While these studies were limited by their size of enrollment, they do suggest that retinoids may be a viable alternative to topical metronidazole or azelaic acid for the treatment of papules and pustules of rosacea.

Oral Antibiotics

Tetracyclines (tetracycline, doxycycline, and minocycline) have been traditional therapies for decades to treat PPR and ocular rosacea (OcR).2 Recent research has suggested their mechanism of action is likely related to their anti-inflammatory properties and not their antibiotic properties.7 The most common doses used are 250mg to 1000mg per day for tetracycline, 40mg to 200mg per day for doxycycline, and 100mg to 200mg per day for minocycline.8 A subantimicrobial-dose doxycycline is the only oral therapy approved by the FDA to treat the inflammatory lesions (papules and pustules) associated with PPR (OraceaÂŽ, Galderma Laboratories, L.P.). Multiple clinical trials have demonstrated its safety and efficacy.9-11 In the pivotal trials, the most common reported adverse events were nasopharyngitis, diarrhea, and headache.9

Topical Therapies

Metronidazole and azelaic acid are currently approved by the FDA for the treatment of inflammatory lesions (papules and pustules) associated with papulopustular rosacea (PPR).

Metronidazole is available in several concentrations and formulations and is indicated for once-daily or twice-daily use. Multiple studies have demonstrated that metronidazole is significantly superior to placebo in reducing the number of papules and pustules associated with PPR.3 Metronidazole formulations are generally well tolerated; the most commonly reported adverse events are cutaneous reactions such as dryness, scaling, pruritus, and stinging/burning. Sulfa based medications (washes, creams, lotions, pads) are frequently helpful as adjuvant therapeutic agents, provided the patient has no known sulfa allergy.

Clinical studies investigating the safety and efficacy of azelaic acid gel 15% have demonstrated it is effective in reducing papules and pustules and like metronidazole is generally well tolerated.4 The most common adverse events reported with azelaic acid gel 15% are burning/stinging/ tingling, pruritus, scaling/dry skin/xerosis, and erythema/ irritation. Counseling patients to apply moisturizer before

Figure: Rhinophyma before treatment (A) and five

weeks after treatment with a carbon dioxide laser (B).

Laser and Light Treatment

Laser and light therapy are frequently used to treat erythema, telangiectasias, and rhinophyma associated with rosacea.12,13 Short and long wavelength pulsed dye lasers, Volume 8 • number 4 • FALL 2014 17

DERmatology pa news & notes

By Cynthia Trickett, MPAS, PA-C, Alan Menter, MD, and Alison E. Harvey, PhD, MS

potassium-titanyl-phosphate lasers, and intense pulsed light therapies have all been used to successfully treat erythema and telangiectasias. Rhinophyma can be treated with argon lasers, carbon dioxide lasers, erbium:yttrium-aluminumgarnet lasers, and neodymium:yttrium-aluminum-garnet lasers.13 The Figure provided shows a patient with rhinophyma pretreatment and five weeks after treatment using a carbon dioxide laser. It is recommended that patients be in remission or on maintenance therapy with their rosacea appropriately controlled before initiating laser therapy. Most side effects are transient or mild. Discomfort during the procedure is tolerable without anesthesia for most patients unless the phymatous condition is severe.

DERmatology pa news & notes

New Treatments

Brimonidine 0.33% gel was recently approved by the FDA to treat persistent (nontransient) facial erythema of rosacea (MirvasoÂŽ Gel, Galderma Laboratories, L.P.).

Brimonidine is a selective alpha-2 adrenergic receptor agonist that causes vasoconstriction upon receptor binding.14,15 Clinical trials have demonstrated that brimonidine 0.33% gel is significantly more effective at reducing facial erythema compared to vehicle and is well tolerated.16,17 Oxymetazoline is another adrenergic receptor agonist that is in development for the treatment of facial erythema. Oxymetazoline is an alpha-1 adrenergic receptor agonist and partial alpha-2 adrenergic receptor agonist, and also causes vasoconstriction upon receptor binding.14,18 Oxymetazoline is currently in the phase 2 trial of development (clinicaltrials.gov identifier: NCT01735201).

Alternative Treatments

Systemic isotretinoin is extremely helpful for patients with granulomatous rosacea, as well as rosacea fulminans, with reductions in both the rhinophyma and the associated multiple sebaceous hyperplastic papules on the face.19 Antihistamines can be used to reduce the severity of flushing episodes.20 Oral antihypertensives (beta-blockers such as propranolol) also reduce facial flushing unresponsive to antihistamines, or facial flushing associated with exercise.19 Clonidine may be helpful for stress induced flushing, but can also cause rebound flushing.

Summary

A number of agents are available to treat rosacea. Topical medications and oral antibiotics are indicated to treat papules and pustules associated with rosacea. A newly approved topical medication has been approved to treat persistent erythema, which is usually unresponsive to traditional therapies or systemic agents. Laser and light treatments are effective for the erythema, telangiectasias, and rhinophyma. Understanding the current treatment options for rosacea can better prepare clinicians for managing their patients’ rosacea. J REFERENCES: 1. Chauhan N, Ellis DA. Rosacea: pathophysiology and management principles. Facial Plast Surg Clin North Am. Feb 2013;21(1):127-136.

2. Goldgar C, Keahey DJ, Houchins J. Treatment options for acne rosacea. Am Fam Physician. Sep 1 2009;80(5):461-468.

3. McClellan KJ, Noble S. Topical metronidazole. A review of its use in rosacea. Am J Clin Dermatol. May-Jun 2000;1(3):191-199.

4. Thiboutot D, Thieroff-Ekerdt R, Graupe K. Efficacy and safety of azelaic acid (15%) gel as a new treatment for papulopustular rosacea: results from two vehicle-controlled,

18 Journal of Dermatology for Physician Assistants

randomized phase III studies. J Am Acad Dermatol. Jun 2003;48(6):836-845.

5. Altinyazar HC, Koca R, Tekin NS, Esturk E. Adapalene vs. metronidazole gel for the treatment of rosacea. Int J Dermatol. Mar 2005;44(3):252-255.

6. Freeman SA, Moon SD, Spencer JM. Clindamycin phosphate 1.2% and tretinoin 0.025% gel for rosacea: summary of a placebo-controlled, double-blind trial. J Drugs Dermatol.

Dec 2012;11(12):1410-1414.

7. Korting HC, Schollmann C. Tetracycline actions relevant to rosacea treatment. Skin Pharmacol Physiol. 2009;22(6):287-294.

8. Baldwin HE. Systemic therapy for rosacea. Skin Therapy Lett. Mar 2007;12(2):1-5, 9.

9. Del Rosso JQ, Webster GF, Jackson M, et al. Two randomized phase III clinical trials evaluating anti-inflammatory dose doxycycline (40-mg doxycycline, USP capsules) administered once daily for treatment of rosacea. J Am Acad Dermatol. May 2007;56(5):791-802.

10. Webster GF. An open-label, community-based, 12-week assessment of the effectiveness and safety of monotherapy with doxycycline 40 mg (30-mg immediaterelease and 10-mg delayed-release beads). Cutis. Nov 2010;86(5 Suppl):7-15.

11. Del Rosso JQ, Schlessinger J, Werschler P. Comparison of anti-inflammatory dose doxycycline versus doxycycline 100 mg in the treatment of rosacea. J Drugs Dermatol.

Jun 2008;7(6):573-576.

12. Butterwick KJ, Butterwick LS, Han A. Laser and light therapies for acne rosacea. J Drugs Dermatol. Jan 2006;5(1):35-39.

13. Laube S, Lanigan SW. Laser treatment of rosacea. J Cosmet Dermatol. Dec 2002;1(4):188-195.

14. Guimaraes S, Moura D. Vascular adrenoceptors: an update. Pharmacol Rev. Jun 2001;53(2):319-356.

15. Rahman MQ, Ramaesh K, Montgomery DM. Brimonidine for glaucoma. Expert Opin Drug Saf. May 2010;9(3):483-491.

16. Fowler J, Jarratt M, Moore A, et al. Once-daily topical brimonidine tartrate gel 0.5% is a novel treatment for moderate to severe facial erythema of rosacea: results of two multicentre, randomized and vehicle-controlled studies. Br J Dermatol. Mar 2012;166(3):633-641.

17. Fowler J, Jr., Jackson M, Moore A, et al. Efficacy and Safety of Once-Daily Topical Brimonidine Tartrate Gel 0.5% for the Treatment of Moderate to Severe Facial Erythema of Rosacea: Results of Two Randomized, Double-blind, and Vehicle-Controlled Pivotal Studies. J Drugs Dermatol. Jun 1 2013;12(6):650-656.

18. Shanler SD, Ondo AL. Successful treatment of the erythema and flushing of rosacea using a topically applied selective alpha1-adrenergic receptor agonist, oxymetazoline.

Arch Dermatol. Nov 2007;143(11):1369-1371.

19. Culp B, Scheinfeld N. Rosacea: a review. P T. Jan 2009;34(1):38-45.

20. Drake L. Women May Need Added Therapy 2008; http://www.rosacea.org/rr/2008/ winter/article_2.php. Accessed July 29, 2013.

Cynthia Trickett, MPAS, PA-C practices dermatology at Texas Dermatology Associates. Ms. Trickett has sat on two advisory boards for acne vulgaris with Galderma Laboratories, L.P. in the past 5 years. Ms. Trickett was not compensated for her contributions to this manuscript.

Alan Menter, MD is Chief of Dermatology at Baylor University Medical Center in Dallas, TX and Director of the Dermatology Residency Program. Dr. Menter has sat on an advisory board, has been a consultant and a speaker, and has received honoraria from Galderma Laboratories, L.P. Dr. Menter was not compensated for his contributions to this manuscript.

Alison E. Harvey, PhD, MS is a Medical Science Liaison at Galderma Laboratories, L.P. Acknowledgement: Matthew H. Meckfessel, PhD (Galderma Laboratories, L.P.) assisted with the preparation of this manuscript. Galderma Laboratories, L.P. provided funding/support for activities pertaining to this manuscript.

Now Showing on Dermcast.tv

The Official Online Media Resource of the SDPA We are very proud that Dermcast is the #1 iTunes Podcast in dermatology. Dermcast.tv is your source for audio podcasts, the most current dermatology news and research, procedural videos, conference highlights, and much, much more.

As members of the SDPA, everything on Dermcast.tv is not only tailored precisely for you and your needs, it is available to you FREE!

SDPA Replies to The New York Times Article About PAs Recently the New York Times published an in-depth article about PAs called "The Physician Assistant Will See You." The article covered the type of education that a PA receives, discussed the collaborative nature of the PA/Physician relationship, and mentioned many positive aspects of PAs working in healthcare. However, the article did have some misconceptions and mistakes.

SDPA Immediate Past President, Jennifer Winter, MSPAS, PA-C, wrote a letter to the New York Times to address some of the errors and speculations of the article.

Negotiating for a Raise? PA Salaries Continue to Rise Read More: http:// bit.ly/SDPAraise

Good news for all the PAs out there. According to the a survey held by The Clinical Advisor called the 2014 National Salary Survey, yearly take-home pay for PAs is on the up-and-up. This survey agrees with past studies showing that PAs, and particularly those in the dermatology profession, continue to enjoy high job satisfaction and quality pay and benefits.

SDPA Rebuts Inaccurate JAMA Article About PA Billing Practices and Education Read More on Dermcast: http://bit. ly/SDPAjama

On August 11, 2014, the Journal of the American Medical Association Dermatology (JAMA) published an original investigation into the billing practices of mid-level providers such as PAs and NPs. Unfortunately, the article, called "Scope of Physician Procedures Independently Billed by Mid-Level Providers in the Office Setting" was filled with inaccurate information about PA education levels and proper incident-to billing standards.

Immediate Past President of the SDPA, Jennifer Winter, MSPAS, PA-C, with support of the Board of Directors of the SDPA, wrote and submitted a thorough rebuttal to JAMA and the author, Dr. Brett Coldiron, President of the American Academy of Dermatology (AAD).

Ms. Winter carefully laid out the erroneous arguments of the article and provided detailed corrections to the mistakes. J

Volume 8 • number 4 • FALL 2014 19

DERmatology pa news & notes

Read More: http:// bit.ly/SDPANYT

Clinic al Dermatology

From The Patient’s Perspective

Traveling Far and Wide to Better Understand, Care For, and Cope With Hyperhidrosis

By Samantha Spenser

I

do not remember when I first heard the word hyperhidrosis, but I’ve been aware of my sweaty hands and feet for my entire life. My mother recalls having to ring out my socks as an infant. When I played sports, racquets and bats would fly out of my hands unless I wore gloves or had an extra grip. In school I had trouble holding onto a pen and would lay a towel atop my notebook so as not to moisten the paper or smudge the ink. After years of misunderstandings and trial and error with innumerable treatments, I am finally on a path to better understand, care for, and cope with hyperhidrosis.

In my case, hyperhidrosis affects the palms of my hands, soles of my feet, and underarms. Excessive sweating can occur at any time, even when I’m not hot, exercising, or in a stressful situation. Heat and humidity are also triggers. When I am without treatment, sweat may literally drip off of my hands in visible sweat beads.

In circumstances where a healthy person would sweat normally, my sweat glands are overactive; they produce more sweat and often work longer than is necessary.

While there is research suggesting that hyperhidrosis is caused by a genetic trait, neither of my parents suffers from the condition. My father recalls having some symptoms in his youth, but none are present today.

Since hyperhidrosis only affects a small percentage of the population and complications are rarely medically serious, the condition is often dismissed, even by healthcare providers. However, the annoyance of excessive sweating can be immeasurable. It has caused me to be frustrated and anxious in social situations and has provoked distress when meeting new people. For example, it is uncomfortable to shake someone’s hand, especially in a professional environment, when your hand is drenched in sweat. Do you warn the person in advance? Apologize after he or she has had to wipe their own hand after touching yours? Or pretend you didn’t realize?

Regardless of which kind of antiperspirant I use, I always have a concern about body odor, both in the underarm and genital areas. I have learned that it is not the sweat that smells bad, but the substances skin bacteria create when they come in contact with sweat. Foot odor, 20 Journal of Dermatology for Physician Assistants

caused by sweaty feet constricted in tight shoes, is also a concern. One summer while working at a camp I developed warts on my hands and feet caused by a skin infection, which flourished from sweat. This induced severe physical pain and emotional embarrassment, leading me to hide my hands whenever possible. When I was young, I remember disfavoring games and activities where I would have to hold hands with other children

International Hyperhidrosis Society (IHHS) is the only independent, non-profit, global organization that strives to improve the quality of life of those affected by excessive sweating. The IHHS knows no boundaries; it is composed of people from all over the world, making it a true global network of support, resources, and understanding.

The IHHS is committed to reducing the symptoms, anxiety, and social stigma associated with excessive sweating by offering education, support, and medical resources to millions of affected children, teens, and adults worldwide. It is our mission to promote hyperhidrosis research, educate healthcare professionals in optimal diagnosis and care, raise awareness about the condition's emotional and economic impacts, and advocate for patient access to effective treatments while increasing public understanding of this debilitating medical condition.

As part of our mission, we continuously build programs that connect those who suffer from hyperhidrosis with those who provide care, while increasing public understanding of excessive sweating.

Contact Information: www.SweatHelp.org & www.SweatOmeter.org Phone: (610) 346-6008 Email: Info@SweatHelp.org Twitter: @SweatHelpOrg

had to offer.

primary focal hyperhidrosis, with excessive sweating of the hands, feet, and underarms. The training would take place outside of Boston and if selected, I decided that I would make the four-hour drive to participate. Family and friends asked, “Why would you travel so far to get treatment when you can go to a doctor nearby in New York?” However, I was determined to see what IHHS, an organization specializing in this medical condition,

Since working with IHHS I have a greater acceptance of what this condition means for me and have honed in on the best methods for managing hyperhidrosis when treatment is minimized or not available. I have employed tactics in both my personal and professional life to help me get by. That means traveling with disposable/refreezable ice packs, taking cars with air conditioning whenever possible instead of riding on public transportation, and

I went with trepidation, not knowing what to expect from the medical professionals, the treatment, or the other As a child and young adult, I was treated by numerous patients. I had been on the organization’s mailing list and doctors who prescribed treatments for hyperhidrosis. knew of them peripherally, but was unaware of what an We tried Drysol, an aluminum chloride roll-on (to incredible resource they are for patients suffering from be followed by other aluminum chloride products hyperhidrosis. The treatment in Boston was a success. throughout the years); Iontophoresis, a treatment device Not only did the providers and staff, led by Dr. Dee where hands or feet (or both) are immersed in a shallow Anna Glaser and Dr. David Pariser, administer treatment tray of water while a low electrical current travels through using techniques I the water; and Robinul, had never before seen, an oral anticholinergic “As a patient, it is deeply reassuring but they also took a drug, which is supposed completely hands on to reduce the secretions to know that my physician approach with patients, of certain organs in truly understanding their the body. I even tried understands hyperhidrosis and is individual needs and herbal remedies such as IHHS offered schisandra and sage tea, equipped with the latest practices to concerns. me the opportunity to but ultimately none of meet other individuals these treatments worked. diagnose and treat the condition.” with hyperhidrosis, to About a decade ago, swap stories and tips, and a dermatologist suggested treating palmar hyperhidrosis to finally realize that my condition is not unique and with Botox injections. At the time I was not eligible for that I am not suffering alone! insurance so the amount used was minimal and therefore, After the effective care in Boston, I kept in touch with did not make a substantive difference. However, this IHHS knowing that I wanted to further my relationship opened up a new path and for the next several years I and participate in future events. My treatment in Boston would experiment on and off with Botox injections in had been so successful that I did not experience any my hands (and later my feet and underarms). I saw many post-treatment muscle weakness or pain. However, since doctors who administered treatment, but the effects Botox is not a “cure” and symptoms eventually return, were never ideal. More than once, the dose was too low; it was soon time for another treatment. This past June I other times the injections were so deep that I had severe participated in my second IHHS patient volunteer session muscle weakness and pain, often more debilitating than in Atlanta, which proved to be even more successful the excessive sweat. I also had successes and failures with than the first. Again, everyone thought it was needless to insurance authorizations and reimbursements - for years travel so far for treatment, but I was determined. There, I was covered, then suddenly not covered, only to be in addition to injections for palmar hyperhidrosis, I covered again the following year. In between treatments, experimented with Botox injections in my underarms, excessive sweat would return - often a dull sweat for which were life changing. The team performed a starchseveral hours, which would cause my fingers and toes to iodine test to identify the affected area; this was a first swell and lead me to feel an overall discomfort and chill for me. I had such a rewarding experience with the throughout the body.

IHHS team that I have decided, against the bemusement I was discouraged until one day last summer I opened of many, to become a patient at Dr. Pariser’s office in my email to find a newsletter from the International Virginia for Botox treatment going forward. Although it Hyperhidrosis Society (IHHS) seeking patient is a far distance to travel, I am willing to make the effort volunteers for a healthcare professionals’ training for the to go where I need to go in order to receive the treatment treatment of hyperhidrosis. It was as if they had sought I feel that I need. me out directly since I fit all of the criteria: patient with

Volume 8 • number 4 • FALL 2014 21

CLINIC AL Dermatology

because I always had to explain or apologize for my hands being “wet.”

CLINIC AL Dermatology

knowing where to stand in the subway to minimize the heat, especially in the summer months. At work I have a strong desktop fan, and I make sure I have access to very cold water, ice packs, and a change of clothing in case my outfit becomes wet or sweat stained. Fortunately my job keeps me in an air-conditioned environment for most of the day; however, when I do go out during the day, at night, or on the weekends, I am sure to travel with a supply kit containing various kinds of wipes including face, body, and feminine wipes, as well as Cool Off™ wipes which refresh and bring a chill to the body. I carry a small deodorant, a washcloth, and extra underwear and socks. Wearing certain types of shoes can be difficult, which means no flip flops and no shoes with light colored bottoms as sweat will turn them brown! I place ultra-absorbent Summer Soles® insoles in my shoes and often wear thin no-show sock liners to lock in the moisture.

I encourage healthcare professionals - those who have experience with hyperhidrosis as well as those who are not familiar with the condition - to connect with IHHS. The organization’s website (www.sweathelp. org) provides comprehensive diagnostic and treatment information as well as the latest research and tools available to both patients and providers. IHHS affords healthcare professionals the opportunity to further their

education by participating in up-to-date training for excessive sweating. As a patient, it is deeply reassuring to know that my physician understands hyperhidrosis and is equipped with the latest practices to diagnose and treat the condition.

Throughout my journey I have met wonderful, brave individuals. They too have traveled far and wide to participate in IHHS events. I am no longer as embarrassed as I once was, and I am looking forward to exploring new and updated treatments for hyperhidrosis.

There is a great community available for support! J The IHHS plans to hold its 2015 Master Class in Hyperhidrosis Patient Care and Practice Efficiency in Seattle, WA on Saturday July 25th, 2015. Please save the date. This Master Class will allow all medical professionals to gain a deeper understanding of hyperhidrosis diagnosis, employ the nuances of best in class treatment, and gain insights into billing and coding. The IHHS encourages all members of practices to attend and learn as a team. To receive Open Registration advance notice, simply subscribe to the IHHS alert newsletter via their web site www.

SweatHelp.org today.

Take Home Points for Derm PAs:

By Steven K. Shama, MD, MPH, FAAD 1. As we have often read in the JDPA Patient Perspective section, this particular article expresses the emotions of yet another patient who is reporting on her suffering with a skin condition that takes over her life. It reminds me once again that we cannot stop reading and listening to patients’ stories, for this is one major way for us to maintain our empathy.

In this instance, think how often we shake hands with another person and how it is a way for us to meet someone new and to begin a relationship. Just think about how we may very well take this simple act for granted, while any patient with a skin condition affecting the hands will anticipate this simple greeting with much anxiety. As I read this story I realized it was one powerful way of reminding me of the 22 Journal of Dermatology for Physician Assistants

privilege of being in dermatology and hearing our patients' stories. All of these stories keep us human and make us better clinicians.

2. Once again we read about how helpful support organizations can be as the International Hyperhidrosis Society is in the life of the author. Let us remember that when we believe we have nothing else to give a patient, referring the patient to one of these support organizations may be helpful. Such groups may not only provide scientific information that is helpful, but may also offer a patient a way to share his/her pain, sorrows, and joys with others who are affected with a similar skin disease. These groups also offer hope, which is one "treatment" we as clinicians should always offer.

When first-line therapy is either inappropriate or ineffective in managing mild-to-moderate eczema,

HELP BREAK THE ECZEMA CYCLE itc

h

• Helps manage the progression of mild-to-moderate flares1

• Significantly reduces pruritus and clears the visible signs and symptoms of eczema2* • ELIDEL is available in 30g, 60g, and 100g tubes2 • ELIDEL is not indicated for use in children less than 2 years of age or for long-term use (see Boxed Warning below)

Not an actual patient.

Image for representation only.

ELIDEL (pimecrolimus) Cream 1% is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments or when those treatments are not advisable.

ELIDEL Cream is not indicated for use in children less than 2 years of age.

WARNING:

Long-term Safety of Topical Calcineurin Inhibitors Has Not Been Established.

Although a causal relationship has not been established, rare cases of malignancy (e.g., skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including ELIDEL Cream.

Therefore: • Continuous long-term use of topical calcineurin inhibitors, including ELIDEL Cream, in any age group should be avoided, and application limited to areas of involvement with atopic dermatitis.

• ELIDEL Cream is not indicated for use in children less than 2 years of age.

IMPORTANT SAFETY INFORMATION ELIDEL Cream is contraindicated in individuals with a history of hypersensitivity to pimecrolimus or any of the components of the cream.

Patients should be reevaluated by their healthcare provider if signs and symptoms of atopic dermatitis do not improve within 6 weeks. Treatment should be discontinued upon resolution of signs and symptoms (e.g., itch, rash and redness) for atopic dermatitis.

Before commencing treatment with ELIDEL Cream, bacterial or viral infections at treatment sites should be resolved.

The most common adverse events seen in clinical studies included application-site burning, headache, pharyngitis, nasopharyngitis, cough, influenza, pyrexia, and viral infection.

The most common local adverse event seen in clinical studies was application-site burning, which occurred in 8% to 26% of patients treated with ELIDEL Cream. In clinical studies, skin papillomas or warts were observed in 1% of ELIDEL patients.

If patients have lymphadenopathy that is unresolved or of unclear etiology, discontinuation should be considered.

ELIDEL Cream should not be used with occlusive dressings.

ELIDEL Cream should not be applied to areas of active cutaneous infections.

During the course of treatment, patients should minimize or avoid natural or artificial sunlight exposure, even while ELIDEL Cream is not on the skin. The potential effects of ELIDEL on skin response to ultraviolet damage are unknown.

*In an investigator’s global assessment, 57% of Elidel-treated patients had mild-to-no pruritus vs 34% with vehicle; 35% of ELIDEL-treated patients were rated clear or almost clear at Day 43 vs 18% with vehicle. Pooled results from two 6-week, randomized, double-blind, multicenter studies investigating the efficacy and safety of ELIDEL in pediatric patients with predominantly moderate atopic dermatitis (n=403).

References: 1. Data on file, Valeant Pharmaceuticals North America LLC. 2. Elidel Cream Package Insert. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC; 2010.

Please see Brief Summary of full Prescribing Information on following pages.

ELIDEL is a registered trademark of Meda Pharma S.A.R.L. and is used under license by Valeant. Except as otherwise indicated, all product names, slogans and other marks are trademarks of the Valeant family of companies. © 2014 Valeant Pharmaceuticals North America LLC DM/ELD/14/0015

Volume 8 • number 4 • FALL 2014 23

BRIEF SUMMARY (see package insert for Full Prescribing Information) ® (pimecrolimus) Cream 1%

Elidel

FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE. Rx Only.

See WARNINGS and boxed WARNING concerning long-term safety of topical calcineurin inhibitors.

CONTRAINDICATIONS ELIDEL (pimecrolimus) Cream 1% is contraindicated in individuals with a history of hypersensitivity to pimecrolimus or any of the components of the cream.

WARNINGS WARNING Long-term Safety of Topical Calcineurin Inhibitors Has Not Been Established Although a causal relationship has not been established, rare cases of malignancy (e.g., skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including ELIDEL Cream.

Therefore: • Continuous long-term use of topical calcineurin inhibitors, including ELIDEL Cream, in any age group should be avoided, and application limited to areas of involvement with atopic dermatitis.

• ELIDEL Cream is not indicated for use in children less than 2 years of age.

Prolonged systemic use of calcineurin inhibitors for sustained immunosuppression in animal studies and transplant patients following systemic administration has been associated with an increased risk of infections, lymphomas, and skin malignancies. These risks are associated with the intensity and duration of immunosuppression.

Based on this information and the mechanism of action, there is a concern about a potential risk with the use of topical calcineurin inhibitors, including ELIDEL Cream. While a causal relationship has not been established, rare cases of skin malignancy and lymphoma have been reported in patients treated with topical calcineurin inhibitors, including ELIDEL Cream.

Therefore: • ELIDEL Cream should not be used in immunocompromised adults and children.

• If signs and symptoms of atopic dermatitis do not improve within 6 weeks, patients should be re-examined by their healthcare provider and their diagnosis be confirmed (see PRECAUTIONS).

• The safety of ELIDEL Cream has not been established beyond one year of non-continuous use. (See CLINICAL PHARMACOLOGY, WARNINGS, boxed WARNING, PRECAUTIONS, INDICATIONS AND USAGE, and DOSAGE AND ADMINISTRATION.) PRECAUTIONS General: The use of ELIDEL Cream should be avoided on malignant or pre-malignant skin conditions. Malignant or pre-malignant skin conditions, such as cutaneous T-cell lymphoma (CTCL), can present as dermatitis. ELIDEL Cream should not be used in patients with Netherton’s Syndrome or other skin diseases where there is the potential for increased systemic absorption of pimecrolimus. The safety of ELIDEL Cream has not been established in patients with generalized erythroderma. The use of ELIDEL Cream may cause local symptoms such as skin burning (burning sensation, stinging, soreness) or pruritus. Localized symptoms are most common during the first few days of ELIDEL Cream application and typically improve as the lesions of atopic dermatitis resolve (see ADVERSE REACTIONS).

Bacterial and Viral Skin Infections: Before commencing treatment with ELIDEL Cream, bacterial or viral infections at treatment sites should be resolved. Studies have not evaluated the safety and efficacy of ELIDEL Cream in the treatment of clinically infected atopic dermatitis. While patients with atopic dermatitis are predisposed to superficial skin infections including eczema herpeticum (Kaposi’s varicelliform eruption), treatment with ELIDEL Cream may be independently associated with an increased risk of varicella zoster virus infection (chicken pox or shingles), herpes simplex virus infection, or eczema herpeticum. In clinical studies, 15/1,544 (1%) cases of skin papilloma (warts) were observed in patients using ELIDEL Cream. The youngest patient was age 2 and the oldest was age 12.

In cases where there is worsening of skin papillomas or they do not respond to conventional therapy, discontinuation of ELIDEL Cream should be considered until complete resolution of the warts is achieved.

Patients with Lymphadenopathy: In clinical studies, 14/1,544 (0.9%) cases of lymphadenopathy were reported while using ELIDEL Cream. These cases of lymphadenopathy were usually related to infections and noted to resolve upon appropriate antibiotic therapy. Of these 14 cases, the majority had either a clear etiology or were known to resolve. Patients who receive ELIDEL Cream and who develop lymphadenopathy should have the etiology of their lymphadenopathy investigated. In the absence of a clear etiology for the lymphadenopathy, or in the presence of acute infectious mononucleosis, ELIDEL Cream should be discontinued. Patients who develop lymphadenopathy should be monitored to ensure that the lymphadenopathy resolves.

Sun Exposure: During the course of treatment, it is prudent for patients to minimize or avoid natural or artificial sunlight exposure, even while ELIDEL is not on the skin. The potential effects of ELIDEL Cream on skin response to ultraviolet damage are not known.

Immunocompromised Patients: The safety and efficacy of ELIDEL Cream in immunocompromised patients have not been studied.

Information for Patients (See Medication Guide.)

Drug Interactions: Potential interactions between ELIDEL and other drugs, including immunizations, have not been systematically evaluated. Due to low blood levels of pimecrolimus detected in some patients after topical application, systemic drug interactions are not expected, but cannot be ruled out. The concomitant administration of known CYP3A family of inhibitors in patients with widespread and/or erythrodermic disease should be done with caution. Some examples of such drugs are erythromycin, itraconazole, ketoconazole, fluconazole, calcium channel blockers and cimetidine.

Carcinogenesis, Mutagenesis, Impairment of Fertility: In a 2-year rat dermal carcinogenicity study using ELIDEL Cream, a statistically significant increase in the incidence of follicular cell adenoma of the thyroid was noted in low, mid and high dose male

24 Journal of Dermatology for Physician Assistants

animals compared to vehicle and saline control male animals. Follicular cell adenoma of the thyroid was noted in the dermal rat carcinogenicity study at the lowest dose of 2 mg/kg/day [0.2% pimecrolimus cream; 1.5× the Maximum Recommended Human Dose (MRHD) based on AUC comparisons]. No increase in the incidence of follicular cell adenoma of the thyroid was noted in the oral carcinogenicity study in male rats up to 10 mg/kg/day (66× MRHD based on AUC comparisons). However, oral studies may not reflect continuous exposure or the same metabolic profile as by the dermal route.

In a mouse dermal carcinogenicity study using pimecrolimus in an ethanolic solution, no increase in incidence of neoplasms was observed in the skin or other organs up to the highest dose of 4 mg/kg/day (0.32% pimecrolimus in ethanol) 27x MRHD based on AUC comparisons.

However, lymphoproliferative changes (including lymphoma) were noted in a 13 week repeat dose dermal toxicity study conducted in mice using pimecrolimus in an ethanolic solution at a dose of 25 mg/kg/day (47x MRHD based on AUC comparisons). No lymphoproliferative changes were noted in this study at a dose of 10 mg/kg/day (17x MRHD based on AUC comparison). However, the latency time to lymphoma formation was shortened to 8 weeks after dermal administration of pimecrolimus dissolved in ethanol at a dose of 100 mg/kg/day (179-217x MRHD based on AUC comparisons).

In a mouse oral (gavage) carcinogenicity study, a statistically significant increase in the incidence of lymphoma was noted in high dose male and female animals compared to vehicle control male and female animals. Lymphomas were noted in the oral mouse carcinogenicity study at a dose of 45 mg/kg/day (258-340x MRHD based on AUC comparisons). No drugrelated tumors were noted in the mouse oral carcinogenicity study at a dose of 15 mg/kg/day (60-133x MRHD based on AUC comparisons). In an oral (gavage) rat carcinogenicity study, a statistically significant increase in the incidence of benign thymoma was noted in 10 mg/kg/day pimecrolimus treated male and female animals compared to vehicle control treated male and female animals. In addition, a significant increase in the incidence of benign thymoma was noted in another oral (gavage) rat carcinogenicity study in 5 mg/kg/day pimecrolimus treated male animals compared to vehicle control treated male animals.

No drug-related tumors were noted in the rat based on AUC comparisons) and at a dose of 5 mg/kg/day for female animals (21x MRHD based on AUC comparisons). In a 52-week dermal photo-carcinogenicity study, the median time to onset of skin tumor formation was decreased in hairless mice following chronic topical dosing with concurrent exposure to UV radiation (40 weeks of treatment followed by 12 weeks of observation) with the ELIDEL Cream vehicle alone. No additional effect on tumor development beyond the vehicle effect was noted with the addition of the active ingredient, pimecrolimus, to the vehicle cream.

A 39-week oral monkey toxicology study was conducted with pimecrolimus doses of 15, 45 and 120 mg/kg/day. A dose dependent increase in expression of immunosuppressive-related lymphoproliferative disorder (IRLD) associated with lymphocryptovirus (a monkey strain of virus related to human Epstein Barr virus) was observed. IRLD in monkeys mirrors what has been noted in human transplant patients after chronic systemic immunosuppressive therapy, post transplantation lymphoproliferative disease (PTLD), after treatment with chronic systemic immunosuppressive therapy. Both IRLD and PTLD can progress to lymphoma, which is dependent on the dose and duration of systemic immunosuppressive therapy. A dose dependent increase in opportunistic infections (a signal of systemic immunosuppression) was also noted in this monkey study.

An oral fertility and embryofetal developmental study in rats revealed estrus cycle disturbances, post-implantation loss and reduction in litter size at the 45 mg/kg/day dose (38× MRHD based on AUC comparisons). No effect on fertility in female rats was noted at 10 mg/kg/day (12× MRHD based on AUC comparisons). No effect on fertility in male rats was noted at 45 mg/kg/day (23× MRHD based on AUC comparisons), which was the highest dose tested in this study (see full Prescribing Information for additional Carcinogenesis, Mutagenesis and Impairment of Fertility data).

Pregnancy Teratogenic Effects Pregnancy Category C: There are no adequate and well-controlled studies of topically administered pimecrolimus in pregnant women. The experience with ELIDEL Cream when used by pregnant women is too limited to permit assessment of the safety of its use during pregnancy. Pimecrolimus was transferred across the placenta in oral rat and rabbit embryofetal developmental studies. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used only if clearly needed during pregnancy.

Nursing Mothers: It is not known whether this drug is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from pimecrolimus, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use: ELIDEL Cream is not indicated for use in children less than 2 years of age.

The long-term safety and effects of ELIDEL Cream on the developing immune system are unknown (see WARNINGS, boxed WARNING, and INDICATIONS AND USAGE).

Three Phase 3 pediatric studies were conducted involving 1,114 patients 2-17 years of age. Two studies were 6-week randomized vehicle-controlled studies with a 20-week openlabel phase and one was a vehicle-controlled (up to 1 year) safety study with the option for sequential topical corticosteroid use. Of these patients 542 (49%) were 2-6 years of age. In the short-term studies, 11% of ELIDEL patients did not complete these studies and 1.5% of ELIDEL patients discontinued due to adverse events. In the one-year study, 32% of ELIDEL patients did not complete this study and 3% of ELIDEL patients discontinued due to adverse events. Most discontinuations were due to unsatisfactory therapeutic effect.

The most common local adverse event in the short-term studies of ELIDEL Cream in pediatric patients ages 2-17 was application site burning (10% vs. 13% vehicle); the incidence in the long-term study was 9% ELIDEL vs. 7% vehicle (see ADVERSE REACTIONS). Adverse events that were more frequent (>5%) in patients treated with ELIDEL Cream compared to vehicle were headache (14% vs. 9%) in the short-term trial. Nasopharyngitis (26% vs. 21%), influenza (13% vs. 4%), pharyngitis (8% vs. 3%), viral infection (7% vs. 1%), pyrexia (13% vs. 5%), cough (16% vs. 11%), and headache (25% vs. 16%) were increased over vehicle in the 1-year safety study (see ADVERSE REACTIONS). In 843 patients ages 2-17 years treated with ELIDEL Cream, 9 (0.8%) developed eczema herpeticum (5 on ELIDEL Cream alone and 4 on ELIDEL Cream used in sequence with corticosteroids). In 211 patients on vehicle alone, there were no cases of eczema herpeticum. The majority of adverse events were mild to moderate in severity.

Two Phase 3 studies were conducted involving 436 infants age 3 months-23 months. One 6-week randomized vehicle-controlled study with a 20-week open-label phase and one safety study, up to one year, were conducted. In the 6-week study, 11% of ELIDEL and 48% of vehicle patients did not complete this study; no patient in either group discontinued due to adverse events. Infants on ELIDEL Cream had an increased incidence of some adverse events compared to vehicle. In the 6-week vehicle-controlled study these adverse events included pyrexia (32% vs. 13% vehicle), URI (24% vs. 14%), nasopharyngitis (15% vs. 8%), gastroenteritis (7% vs. 3%), otitis media (4% vs. 0%), and diarrhea (8% vs. 0%). In the open-label phase of the study, for infants who switched to ELIDEL Cream from vehicle, the incidence of the above-cited adverse events approached or equaled the incidence of those patients who remained on ELIDEL Cream. In the 6 month safety data, 16% of ELIDEL and 35% of vehicle patients discontinued early and 1.5% of ELIDEL and 0% of vehicle patients discontinued due to adverse events. Infants on ELIDEL Cream had a greater incidence of some adverse events as compared to vehicle. These included pyrexia (30% vs. 20%), URI (21% vs. 17%), cough (15% vs. 9%), hypersensitivity (8% vs. 2%), teething (27% vs. 22%), vomiting (9% vs. 4%), rhinitis (13% vs. 9%), viral rash (4% vs. 0%), rhinorrhea (4% vs. 0%), and wheezing (4% vs. 0%).

Geriatric Use: Nine (9) patients ≥65 years old received ELIDEL Cream in Phase 3 studies.

Clinical studies of ELIDEL did not include sufficient numbers of patients aged 65 and over to assess efficacy and safety.

ADVERSE REACTIONS No phototoxicity and no photoallergenicity were detected in clinical studies with 24 and 33 normal volunteers, respectively. In human dermal safety studies, ELIDEL (pimecrolimus) Cream 1% did not induce contact sensitization or cumulative irritation.

In a one-year safety study in pediatric patients age 2-17 years old involving sequential use of ELIDEL Cream and a topical corticosteroid, 43% of ELIDEL patients and 68% of vehicle patients used corticosteroids during the study. Corticosteroids were used for more than 7 days by 34% of ELIDEL patients and 54% of vehicle patients. An increased incidence of impetigo, skin infection, superinfection (infected atopic dermatitis), rhinitis, and urticaria were found in the patients that had used ELIDEL Cream and topical corticosteroid sequentially as compared to ELIDEL Cream alone.

In 3 randomized, double-blind vehicle-controlled pediatric studies and one active-controlled adult study, 843 and 328 patients respectively, were treated with ELIDEL Cream. In these clinical trials, 48 (4%) of the 1,171 ELIDEL patients and 13 (3%) of 408 vehicle-treated patients discontinued therapy due to adverse events. Discontinuations for AEs were primarily due to application site reactions, and cutaneous infections. The most common application site reaction was application site burning, which occurred in 8%-26% of patients treated with ELIDEL Cream.

The following table depicts the incidence of adverse events pooled across the 2 identically designed 6-week studies with their open label extensions and the 1-year safety study for pediatric patients ages 2-17. Data from the adult active-controlled study is also included in this table. Adverse events are listed regardless of relationship to study drug.

Two cases of septic arthritis have been reported in infants less than one year of age in clinical trials conducted with ELIDEL Cream (n = 2,443). Causality has not been established.

Treatment Emergent Adverse Events ( ≥1%) Pediatric Pediatric Patients* Patients* Vehicle-Controlled Open-Label (20 (6 Weeks) (1 Year) Weeks) Elidel Elidel Elidel Elidel Elidel Cream Cream Cream Cream Cream (N=267) (N=136) (N=335) (N=272) (N=75) % % % % % At Least 1 AE 68 71 72 85 75 Infections and Infestations Upper Respiratory 14 13 19 5 8 Tract Infection NOS Nasopharyngitis 10 7 20 27 21 Skin Infection NOS 3 5 5 2 4 Influenza 3 1 7 13 4 Ear Infection NOS 3 5 5 2 4 Otitis Media 2 1 3 3 5 Impetigo 2 2 4 4 5 Bacterial Infection 2 2 1 1 0 Folliculitis 1 1 1 2 4 Sinusitis 1 1 3 2 1 Pneumonia NOS 1 1 2 0 1 Pharyngitis NOS 1 2 1 8 3 Pharyngitis 1 2 3 0 <1 Streptococcal Molluscum 1 0 1 2 0 Contagiosum Staphylococcal <1 4 2 0 <1 Infection Bronchitis NOS <1 2 1 11 8 Herpes Simplex <1 0 1 3 3 Tonsillitis NOS <1 0 1 6 0 Viral Infection NOS 1 1 <1 7 1 Gastroenteritis NOS 0 2 1 7 3 Chickenpox 1 0 1 3 4 Skin Papilloma <1 0 1 3 <1 Tonsillitis Acute NOS 0 0 0 3 0 Pediatric Patients* Vehicle-Controlled

*Ages 2-17 years

Adult Active Comparator (1 Year) Elidel Cream (N=328) % 78 4 8 6 10 6 1 2 2 6 1 <1 1 0 0 1 2 4 1 0 2 <1 0 0

Upper Respiratory Tract <1 0 1 Infection Viral NOS Herpes Simplex 0 0 <1 Dermatitis Bronchitis Acute NOS 0 0 0 Eye Infection NOS 0 0 0 General Disorders and Administration Site Conditions Application Site 10 13 2 Burning Pyrexia 8 9 12 Application Site 3 5 2 Reaction NOS Application Site 3 6 1 Irritation Influenza Like Illness <1 0 1 Application Site <1 0 0 Erythema Application Site 1 2 1 Pruritus Respiratory, Thoracic and Mediastinal Disorders Cough 12 8 9 Nasal Congestion 3 2 2 Rhinorrhea 2 1 1 Asthma Aggravated 2 2 4 Sinus Congestion 1 1 1 Rhinitis <1 0 2 Wheezing <1 1 1 Asthma NOS 1 1 3 Epistaxis 0 1 0 Dyspnea NOS 0 0 0 Gastrointestinal Disorders Abdominal Pain Upper 4 4 3 Sore Throat 3 4 5 Vomiting NOS 3 4 4 Diarrhea NOS 1 1 1 Nausea <1 2 1 Abdominal Pain NOS <1 1 2 Toothache <1 1 1 Constipation <1 0 1 Loose Stools 0 1 1 Reproductive System and Breast Disorders Dysmenorrhea 1 0 2 Eye Disorders Conjunctivitis NEC 1 1 2 Skin and Subcutaneous Tissue Disorders Urticaria 1 0 <1 Acne NOS 0 1 <1 Immune System Disorders Hypersensitivity NOS 4 4 5 Injury and Poisoning Accident NOS 1 1 <1 Laceration 1 1 2 Musculoskeletal, Connective Tissue and Bone Disorders Back Pain <1 2 <1 Arthralgias 0 0 <1 Ear and Labyrinth Disorders Earache 1 1 0 Nervous System Disorders Headache 14 9 11

2

0

<1

2

0

1

2 1

0 <1

0 <1

9

7

26

13

5

1

3

3

15

<1

4

6

2

3

2

2

0

2

2

0

6

16 2 <1 1 <1 4 1 4 3 2

11 1 1 1 <1 7 <1 3 1 1

2 1 0 0 1 2 0 2 <1 1

6 8 7 8 4 4 3 4 <1

7 5 8 5 7 4 1 <1 <1

<1 4 1 2 2 <1 1 0 0

1

1

1

2

4

3

<1 2

<1 <1

1 2

5

1

3

<1 <1

1 <1

0 0

<1 1

0 1

2 2

3

3

0

25

16

7

*Ages 2-17 years

POST-MARKETING EVENTS The following adverse reactions have been reported in patients using ELIDEL Cream. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

General: Anaphylactic reactions, ocular irritation after application of the cream to the eye lids or near the eyes, angioneurotic edema, facial edema, skin flushing associated with alcohol use, skin discoloration Hematology/Oncology: Lymphomas, basal cell carcinoma, malignant melanoma, squamous cell carcinoma OVERDOSAGE There has been no experience of overdose with ELIDEL (pimecrolimus) Cream 1%. If oral ingestion occurs, medical advice should be sought.

Manufactured by: Novartis Pharma Produktions GmbH Wehr, Germany Distributed by: Valeant Pharmaceuticals North America, LLC. Bridgewater, NJ 08807 REV. 02/2014 (based on #2079799 06/11) DM/ELD/14/0010(1)

Volume 8 • number 4 • FALL 2014 25

Dermatology Case Report Case of Self-Inflicted Dermatitis in a Patient Participating in â&#x20AC;&#x153;Salt and Ice Challengeâ&#x20AC;?

By Racheal C. McMahon, PA-C and Roger I. Ceilley, MD

SDPA Members Only Content

CLINIC AL Dermatology

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

Figure 1

Figure 2

26 Journal of Dermatology for Physician Assistants

SDPA Members Only Content

Racheal C. McMahon, PA-C completed her bachelor’s degree from the University of Nebraska and earned a master’s degree in Physician Assistant Studies from University of Nebraska Medical Center. She has indicated no relationships to disclose relating to the content of this article.

Roger I. Ceilley, MD received his undergraduate education from the University of Northern Iowa, his medical degree from the University of Iowa, interned at the University of Colorado and completed his dermatology residency at the University of Iowa. He received training in Mohs surgery for skin cancer at the University of Wisconsin. Dr. Ceilley is board certified in Dermatology, Dermatopathology, and Mohs Micrographic Surgery and Cutaneous Oncology.

Dr. Ceilley is a Professor at the University of Iowa, Department of Dermatology, and is in private practice in Des Moines, Iowa specializing in skin cancer surgery and dermatologic surgery. He is director of a Mohs Surgery Fellowship program.

Dr. Ceilley has also served on the Board of Directors of the American Academy of Dermatology and numerous other task forces and committees such as the National Coalition of Sun Safety. He is the past president of the American Society for Dermatologic Surgery, Fellow of the American College of Mohs Micrographic Surgery and Cutaneous Oncology, and member of the American Dermatological Association, the Noah Worcester Dermatological Society and Society for Investigative Dermatology. He is a Fellow of the American Academy of Facial Plastic and Reconstructive Surgery and is also a member of the American Medical Association, Iowa Medical Society, and the Iowa Dermatologic Society.

Dr. Ceilley has authored and co-authored over 100 scientific publications, books, and chapters. He has indicated no relationships to disclose relating to the content of this article.

Volume 8 • number 4 • FALL 2014 27

CLINIC AL 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.

Clinical snapshots Pain Free Remedy for Molluscum Contagiosum

An Interview with Donald Richey, MD

CLINIC AL Dermatology

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

We are pleased to announce that as of January 1, 2014 all DLI modules are now AAPA approved to be used for the new “self assessment” category I CME requirement.

Visit the AAPA or NCCPA websites for complete details on the new CME requirements being implemented in 2014.

AAPA • www.aapa.org • 703.836.2272 NCCPA • www.nccpa.net • 678-417-8100

28 Journal of Dermatology for Physician Assistants

Once-a-day

Efficacy Tough on acne • Proven effective in the treatment of both inflammatory and noninflammatory lesions1 • 2.5% benzoyl peroxide (BPO) concentration exceeds the activity needed to inhibit P acnes growth2

With tolerance and convenience in mind Acanya (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/2.5%, is indicated for the topical treatment of acne vulgaris in patients 12 years or older.

• Contains no preservatives, parabens, or surfactants1 • Less than 0.2% of patients experienced cutaneous irritation1 • Use concomitant topical acne medications with caution due to the risk of cumulative irritancy • Available in a ready-to-use, premixed, 50g pump1

Important Safety Information • Acanya Gel is contraindicated in patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.

• Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin. Acanya Gel should be discontinued if significant diarrhea occurs.

• The most common local adverse reactions experienced by patients in clinical trials were mild and moderate erythema, scaling, itching, burning, and stinging.

• Acanya Gel should not be used in combination with erythromycincontaining products because of its clindamycin component.

• Use of Acanya Gel beyond 12 weeks has not been evaluated.

• Orally and parenterally administered clindamycin has been associated with severe colitis, which may result in death.

• Patients should be advised to avoid contact with the eyes or mucous membranes.

• 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 and shortness of breath, he or she should be instructed to discontinue use and contact a physician immediately.

• Patients should minimize exposure to natural and avoid artificial sunlight (tanning beds or UVA/UVB treatment) while using Acanya Gel. To minimize exposure to sunlight, protective clothing should be worn and a sunscreen with SPF 15 rating or higher should be used.

References: 1. Acanya Gel Package Insert. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC; 2013. 2. Data on file, Dow Pharmaceutical Sciences, Inc.

Please see Brief Summary of full Prescribing Information on following page.

Except as otherwise indicated, all product names, slogans and other marks are trademarks of the Valeant family of companies. © 2014 Valeant Pharmaceuticals North America LLC DM/ACY/14/0012

Volume 8 • number 4 • FALL 2014 29

BRIEF SUMMARY OF FULL PRESCRIBING INFORMATION This Brief Summary does not include all the information needed to use ACANYA Gel safely and effectively. See full prescribing information for ACANYA Gel. ACANYA速 (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/2.5%, for topical use Initial U.S. Approval: 2000

Revised: 02/2014 CONTRAINDICATIONS ACANYA Gel is contraindicated in patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.

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

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 including use of tanning beds or sun lamps following drug application [see Nonclinical Toxicology].

ADVERSE REACTIONS Clinical Trials 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 and may not reflect the rates observed in practice.

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, subjects 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 subjects that had symptoms present before treatment, the maximum value recorded during treatment, and the percent with symptoms present at week 12 are shown in Table 1.

Table 1: Local Skin Reactions - Percent of Subjects with Symptoms Present. Combined Results from the Two Phase 3 Trials (N = 773) Before Treatment (Baseline) Mild

Mod.* Severe

Maximum During Treatment Mild

Mod.* Severe

End of Treatment (Week 12) Mild

Mod.* Severe

Erythema

22

4

0

25

5

<1

15

2

0

Scaling

8

<1

0

18

3

0

8

1

0

Itching

10

2

0

15

2

0

6

<1

0

Burning

3

<1

0

8

2

0

2

<1

0

Stinging

2

<1

0

6

1

0

1

<1

0

*Mod. = Moderate

Postmarketing Experience Anaphylaxis, as well as allergic reactions leading to hospitalizations, has been reported in postmarketing use of products containing clindamycin/benzoyl peroxide.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

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.

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.

30 Journal of Dermatology for Physician Assistants

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

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

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

Pediatric Use Safety and effectiveness of ACANYA Gel in pediatric patients under the age of 12 have not been evaluated.

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

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

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 15,000 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 dosedependent 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 10,000 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 ability.

PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information).

Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 Manufactured by: Contract Pharmaceuticals Limited Mississauga, Ontario, Canada L5N 6L6 U.S. Patents 5,733,886 and 8,288,434 Rev. 02/2014 DM/ACY/14/0016(1)

2006787 9379500

Journal Club: Practice Changing Articles for Dermatology PAs Afamelanotide and Narrowband UV-B Phototherapy for the Treatment of Vitiligo: A Randomized Multicenter Trial

JAMA Dermatol. 2014 Sep 17. doi: 10.1001/jamadermatol.2014.1875. [Epub ahead of print] Lim HW1, Grimes PE2, Agbai O3, Hamzavi I1, Henderson M1, Haddican M4, Linkner RV4, Lebwohl M4.

1 Multicultural Dermatology Center, Department of Dermatology, Henry Ford Hospital, Detroit, Michigan.

2 Vitiligo and Pigmentation Institute of Southern California, Los Angeles.

3 Multicultural Dermatology Center, Department of Dermatology, Henry Ford Hospital, Detroit, Michigan.

Department of Dermatology, University of California, Davis, Sacramento.

4 Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York.

SDPA Members Only Content

CLINIC AL 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.

Journal clubs are a great way to review and critically evaluate the most current literature impacting the practice of dermatology. For physician assistants who are new to the practice of dermatology, journal clubs can assist them to become more familiar with advanced medical literature and improve their understanding of current issues within the field. The articles selected for the JDPA Journal Club are meant to be shared and discussed with your colleagues, peers, and supervising physicians. If you have any articles to recommend for the JDPA Journal Club, please email them to editor@jdpa.org.

Volume 8 â&#x20AC;˘ number 4 â&#x20AC;˘ FALL 2014 31

SURGIC AL Dermatology Journal Club: Practice Changing Articles for Dermatology PAs Merkel cell carcinoma: what makes a difference?

Am J Surg. 2014 Jul 30. pii: S0002-9610(14)00362-6. doi: 10.1016/j.amjsurg.2014.06.013. [Epub ahead of print] Tseng J1, Dhungel B1, Mills JK2, Diggs BS1, Weerasinghe R2, Fortino J2, Vetto JT3.

1 Department of Surgery, Oregon Health & Science University, Portland, OR, USA. 2 Division of Surgical Oncology, Oregon Health & Science University, Portland, OR, USA. 3 Department of Surgery, Oregon Health & Science University, Portland, OR, USA; Division of Surgical Oncology, Oregon Health & Science University, Portland, OR, USA.

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.

Journal clubs are a great way to review and critically evaluate the most current literature impacting the practice of dermatology. For physician assistants who are new to the practice of dermatology, journal clubs can assist them to become more familiar with advanced medical literature and improve their understanding of current issues within the field. The articles selected for the JDPA Journal Club are meant to be shared and discussed with your colleagues, peers, and supervising physicians. If you have any articles to recommend for the JDPA Journal Club, please email them to editor@jdpa.org.

32 Journal of Dermatology for Physician Assistants

SURGICAL wisdom Are You Reporting Cases of Melanoma to Your State Registry?

SDPA Members Only Content

SURGIC AL 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.

Volume 8 • number 4 • FALL 2014 33

34 Journal of Dermatology for Physician Assistants

On behalf of Amgen

Thank you for a decade of ongoing partnership in serving patients

• 10 years of postmarketing experience in plaque PsO with ENBREL1 • Evaluated in clinical studies over the past 20 years in rheumatoid arthritis (RA), with over 15 years of postmarketing experience in moderate to severe RA2,3* • Over 35,000 patient-years of therapy in clinical studies4

Turn page to learn more.

ENBREL is indicated for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. ENBREL is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis. ENBREL can be initiated in combination with methotrexate (MTX) or used alone.

Prescription ENBREL is administered by injection.

Selected Safety Information: ENBREL suppresses the immune system and has been associated with serious and sometimes fatal infections, including TB and other opportunistic infections. Other serious and sometimes fatal adverse events including malignancies, neurologic events, hematologic events, congestive heart failure, hepatitis B reactivation, allergic reactions, lupus-like syndrome and autoimmune hepatitis have also been reported. ENBREL is contraindicated in patients with sepsis.

Please see Important Safety Information on the following pages and the Brief Summary of the Prescribing Information at the end of this multi-page advertisement. *Initial clinical trials in RA began in 1993.

Volume 8 • number 4 • FALL 2014 35

When choosing a biologic for adult chronic moderate to severe plaque psoriasis

ENBREL is a Biological Place to Start

In moderate to severe plaque psoriasis (PsO):

Experience

ENBREL is indicated for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

• Evaluated in clinical studies over the past 20 years in rheumatoid arthritis (RA)2* - Over 15 years of postmarketing experience since approval for moderate to severe RA in 19983 - ENBREL is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis. ENBREL can be initiated in combination with methotrexate (MTX) or used alone

Efficacy • Efficacy established through 24 weeks in a worldwide pivotal trial5 - In medical studies, nearly half of patients saw 75% skin clearance in their moderate to severe plaque psoriasis in 3 months with ENBREL. Overall, 3 out of 4 patients saw 50% skin clearance in 3 months5,6

Established safety profile • Safety data from 7 PsO trials that included 4,410 patients7-14 • Consistent adverse event rates through 3 years of treatment in over 1,100 patients in clinical trials15-19

36 Journal of Dermatology for Physician Assistants

10 years of postmarketing experience since approval for moderate to severe plaque PsO in 20041 *Initial clinical research in RA patients began in 1993.

www.enbrel.com

Turn page to learn more.

IMPORTANT SAFETY CONSIDERATIONS SERIOUS INFECTIONS Patients treated with ENBREL are at an increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens.

ENBREL should be discontinued if a patient develops a serious infection or sepsis during treatment.

Perform test for latent TB; if positive, start treatment for TB prior to starting ENBREL. Monitor all patients for active TB during treatment, even if initial latent TB test is negative.

MALIGNANCIES

several-fold higher in RA and psoriasis patients. The role of TNF blocker therapy in the development of malignancies is unknown.

Cases of acute and chronic leukemia have been reported in association with postmarketing TNF blocker use in RA and other indications. The risk of leukemia may be higher in patients with RA (approximately 2-fold) than the general population.

Melanoma and non-melanoma skin cancer (NMSC) have been reported in patients treated with TNF blockers, including ENBREL. Periodic skin examinations should be considered for all patients at increased risk for skin cancer.

Please see additional Important Safety Information on the following page and Brief Summary of the Prescribing Information at the end of this advertisement.

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including ENBREL. In adult clinical trials of all TNF blockers, more cases of lymphoma were seen compared to control patients. The risk of lymphoma may be up to

Volume 8 â&#x20AC;˘ number 4 â&#x20AC;˘ FALL 2014 37

IMPORTANT SAFETY INFORMATION SERIOUS INFECTIONS Patients treated with ENBREL are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids or were predisposed to infection because of their underlying disease. ENBREL should not be initiated in the presence of sepsis, active infections, or allergy to ENBREL or its components.

ENBREL should be discontinued if a patient develops a serious infection or sepsis. Reported infections include: 1) Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent TB before ENBREL use and periodically during therapy. Treatment for latent infection should be initiated prior to ENBREL use, 2) Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric antifungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness, and 3) Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

The risks and benefits of treatment with ENBREL should be carefully considered prior to initiating therapy in patients 1) with chronic or recurrent infection, 2) who have been exposed to TB, 3) who have resided or traveled in areas of endemic TB or endemic mycoses, or 4) with underlying conditions that may predispose them to infections such as advanced or poorly controlled diabetes. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with ENBREL, including the possible development of TB in patients who tested negative for latent TB prior to initiating therapy.

MALIGNANCIES Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including ENBREL. In adult clinical trials of all TNF blockers, more cases of lymphoma were seen compared to control patients. The risk of lymphoma may be up to several-fold higher in RA and psoriasis patients. The role of TNF blocker therapy in the development of malignancies is unknown.

Cases of acute and chronic leukemia have been reported in association with postmarketing TNF blocker use in RA and other indications. The risk of leukemia may be higher in patients with RA (approximately 2-fold) than the general population.

Melanoma and non-melanoma skin cancer (NMSC) have been reported in patients treated with TNF blockers, including ENBREL. Periodic skin examinations should be considered for all patients at increased risk for skin cancer.

Pediatric Patients In patients who initiated therapy at ≤ 18 years of age, approximately half of the reported malignancies were lymphomas (Hodgkin’s and non-Hodgkin’s lymphoma).

Other cases included rare malignancies usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. Most of the patients were receiving concomitant immunosuppressants.

NEUROLOGIC EVENTS Treatment with TNF-blocking agents, including ENBREL, has been associated with rare (< 0.1%) cases of new onset or exacerbation of central nervous system demyelinating disorders, some presenting with mental status changes and some associated with permanent disability, and with peripheral nervous system demyelinating disorders. Cases of transverse myelitis, optic neuritis, multiple sclerosis, Guillain-Barré syndromes, other peripheral demyelinating neuropathies, and new onset or exacerbation of seizure disorders have been reported in postmarketing experience with ENBREL therapy. Prescribers should exercise caution in considering the use of ENBREL in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders.

HEMATOLOGIC EVENTS Rare cases of pancytopenia, including aplastic anemia, some fatal, have been reported. The causal relationship to ENBREL therapy remains unclear. Exercise caution when considering ENBREL in patients who have a previous history of significant hematologic abnormalities. Advise patients to seek immediate medical attention if they develop signs or symptoms of blood dyscrasias or infection.

Consider discontinuing ENBREL if significant hematologic abnormalities are confirmed.

HEPATITIS B REACTIVATION Reactivation of hepatitis B has been reported in patients who were previously infected with hepatitis B virus (HBV) and received concomitant TNF-blocking agents, including ENBREL. Most reports occurred in patients also taking immunosuppressive agents, which may contribute to hepatitis B reactivation.

Exercise caution when considering ENBREL in these patients.

ALLERGIC REACTIONS Allergic reactions associated with administration of ENBREL during clinical trials have been reported in < 2% of patients. If an anaphylactic reaction or other serious allergic reaction occurs, administration of ENBREL should be discontinued immediately and appropriate therapy initiated.

IMMUNIZATIONS Live vaccines should not be administered to patients on ENBREL. JIA patients, if possible, should be brought up to date with all immunizations prior to initiating ENBREL. In patients with exposure to varicella virus, consider temporary discontinuation of ENBREL and prophylactic treatment with Varicella Zoster Immune Globulin.

AUTOIMMUNITY Autoantibodies may develop with ENBREL, and rarely lupus-like syndrome or autoimmune hepatitis may occur. These may resolve upon withdrawal of ENBREL. Stop ENBREL if lupus-like syndrome or autoimmune hepatitis develops.

WEGENER’S GRANULOMATOSIS PATIENTS The use of ENBREL in patients with Wegener’s granulomatosis receiving immunosuppressive agents (eg, cyclophosphamide) is not recommended.

MODERATE TO SEVERE ALCOHOLIC HEPATITIS Based on a study of patients treated for alcoholic hepatitis, exercise caution when using ENBREL in patients with moderate to severe alcoholic hepatitis.

ADVERSE EVENTS The most commonly reported adverse events in RA clinical trials were injection site reaction, infection, and headache. In clinical trials of all other adult indications, adverse events were similar to those reported in RA clinical trials.

DRUG INTERACTIONS The use of ENBREL in patients receiving concurrent cyclophosphamide therapy is not recommended. The risk of serious infection may increase with concomitant use of abatacept therapy. Concurrent therapy with ENBREL and anakinra is not recommended. Hypoglycemia has been reported following initiation of ENBREL therapy in patients receiving medication for diabetes, necessitating a reduction in anti-diabetic medication in some of these patients.

References: 1. Data on file, Amgen; PsO Approval Letter: April 30, 2004. 2. Data on file, Amgen; Enbrel RA Clinical Trials Experience: December 13, 2012. 3. Data on file, Amgen; RA Approval Letter: November 2, 1998. 4. Data on file, Amgen; TB Labeling History: April 2, 2008. 5. Data on file, Amgen; 1642 Subanalysis: May 31, 2007. 6. Enbrel® (etanercept) Prescribing Information, Immunex Corporation, Thousand Oaks, Calif. November 2013. 7. Data on file, Amgen; CSR1632: April 7, 2003. 8. Data on file, Amgen; CSR1642: October 8, 2003. 9. Data on file, Amgen; CSR1639: October 8, 2003. 10. Data on file, Amgen; CSR117: February 24, 2006. 11. Data on file, Amgen; CSR20030190: November 18, 2005.

12. Data on file, Amgen; CSR115: November 28, 2005. 13. Data on file, Amgen; CSR20040216: March 6, 2008. 14. Pariser DM, Leonardi CL, Gordon K, et al. Integrated safety analysis: short- and long-term safety profiles of etanercept in patients with psoriasis. J Am Acad Dermatol. 2012;67:245-256.

15. Data on file, Amgen; Exposure-adjusted Rate of OI: October 5, 2010. 16. Data on file, Amgen; IPoD Safety Analysis of Malignancy: October 23, 2009. 17. Data on file, Amgen; Year 1 Summary of Adverse Events: October 14, 2010. 18. Data on file, Amgen; Year 2 Summary of Adverse Events: October 14, 2010.

19. Data on file, Amgen; Year 3 Summary of Adverse Events: October 14, 2010.

Please see Brief Summary of Prescribing Information on following pages.

CONGESTIVE HEART FAILURE Cases of worsening congestive heart failure (CHF) and, rarely, new-onset cases have been reported in patients taking ENBREL. Caution should be used when using ENBREL in patients with CHF. These patients should be carefully monitored.

78372-R1-V3

38 Journal of Dermatology for Physician Assistants

Enbrel® (etanercept) Brief Summary SEE PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION WARNINGS SERIOUS INFECTIONS AND MALIGNANCIES Patients treated with Enbrel are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions and Adverse Reactions]. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Enbrel should be discontinued if a patient develops a serious infection or sepsis.

Reported infections include: • Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before Enbrel use and during therapy. Treatment for latent infection should be initiated prior to Enbrel use.

• Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.

• Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

The risks and benefits of treatment with Enbrel should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.

Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with Enbrel, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.

MALIGNANCIES Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including Enbrel.

INDICATIONS AND USAGE Rheumatoid Arthritis Enbrel is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis (RA). Enbrel can be initiated in combination with methotrexate (MTX) or used alone.

Polyarticular Juvenile Idiopathic Arthritis Enbrel is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients ages 2 and older.

Psoriatic Arthritis Enbrel is indicated for reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with psoriatic arthritis (PsA). Enbrel can be used in combination with methotrexate (MTX) in patients who do not respond adequately to MTX alone.

Ankylosing Spondylitis Enbrel is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis (AS).

Plaque Psoriasis Enbrel is indicated for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.

CONTRAINDICATIONS Enbrel should not be administered to patients with sepsis.

WARNINGS AND PRECAUTIONS Serious Infections Patients treated with Enbrel are at increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death.

Opportunistic infections due to bacterial, mycobacterial, invasive fungal, viral, parasitic, or other opportunistic pathogens including aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, histoplasmosis, legionellosis, listeriosis, pneumocystosis, and tuberculosis have been reported with TNF blockers. Patients have frequently presented with disseminated rather than localized disease.

Treatment with Enbrel should not be initiated in patients with an active infection, including clinically important localized infections. Patients greater than 65 years of age, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants (such as corticosteroids or methotrexate), may be at greater risk of infection. The risks and benefits of treatment should be considered prior to initiating therapy in patients: with chronic or recurrent infection; who have been exposed to tuberculosis; with a history of an opportunistic infection; who have resided or traveled in areas of endemic tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis; or with underlying conditions that may predispose them to infection, such as advanced or poorly controlled diabetes [see Adverse Reactions].

Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with Enbrel.

Enbrel should be discontinued if a patient develops a serious infection or sepsis. A patient who develops a new infection during treatment with Enbrel should be closely monitored, undergo a prompt and complete diagnostic workup appropriate for an immunocompromised patient, and appropriate antimicrobial therapy should be initiated.

Tuberculosis Cases of reactivation of tuberculosis or new tuberculosis infections have been observed in patients receiving Enbrel, including patients who have previously received treatment for latent or active tuberculosis. Data from clinical trials and preclinical studies suggest that the risk of reactivation of latent tuberculosis infection is lower with Enbrel than with TNF-blocking monoclonal antibodies. Nonetheless, postmarketing cases of tuberculosis reactivation have been reported for TNF blockers, including Enbrel. Tuberculosis has developed in patients who tested negative for latent tuberculosis prior to

initiation of therapy. Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating Enbrel and periodically during therapy. Tests for latent tuberculosis infection may be falsely negative while on therapy with Enbrel.

Treatment of latent tuberculosis infection prior to therapy with TNF-blocking agents has been shown to reduce the risk of tuberculosis reactivation during therapy. Induration of 5 mm or greater with tuberculin skin testing should be considered a positive test result when assessing if treatment for latent tuberculosis is needed prior to initiating Enbrel, even for patients previously vaccinated with Bacille Calmette-Guerin (BCG).

Anti-tuberculosis therapy should also be considered prior to initiation of Enbrel in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent tuberculosis but having risk factors for tuberculosis infection. Consultation with a physician with expertise in the treatment of tuberculosis is recommended to aid in the decision whether initiating antituberculosis therapy is appropriate for an individual patient.

Tuberculosis should be strongly considered in patients who develop a new infection during Enbrel treatment, especially in patients who have previously or recently traveled to countries with a high prevalence of tuberculosis, or who have had close contact with a person with active tuberculosis.

Invasive Fungal Infections Cases of serious and sometimes fatal fungal infections, including histoplasmosis, have been reported with TNF blockers, including Enbrel. For patients who reside or travel in regions where mycoses are endemic, invasive fungal infection should be suspected if they develop a serious systemic illness. Appropriate empiric antifungal therapy should be considered while a diagnostic workup is being performed. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. When feasible, the decision to administer empiric antifungal therapy in these patients should be made in consultation with a physician with expertise in the diagnosis and treatment of invasive fungal infections and should take into account both the risk for severe fungal infection and the risks of antifungal therapy. In 38 Enbrel clinical trials and 4 cohort studies in all approved indications representing 27,169 patient-years of exposure (17,696 patients) from the United States and Canada, no histoplasmosis infections were reported among patients treated with Enbrel.

Neurologic Events Treatment with TNF-blocking agents, including Enbrel, has been associated with rare (< 0.1%) cases of new onset or exacerbation of central nervous system demyelinating disorders, some presenting with mental status changes and some associated with permanent disability. Cases of transverse myelitis, optic neuritis, multiple sclerosis, Guillain-Barré syndromes, other peripheral demyelinating neuropathies, and new onset or exacerbation of seizure disorders have been reported in postmarketing experience with Enbrel therapy. Prescribers should exercise caution in considering the use of Enbrel in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders [see Adverse Reactions].

Malignancies Lymphomas In the controlled portions of clinical trials of TNF-blocking agents, more cases of lymphoma have been observed among patients receiving a TNF blocker compared to control patients. During the controlled portions of Enbrel trials in adult patients with RA, AS, and PsA, 2 lymphomas were observed among 3306 Enbrel-treated patients versus 0 among 1521 control patients (duration of controlled treatment ranged from 3 to 36 months).

Among 6543 adult rheumatology (RA, PsA, AS) patients treated with Enbrel in controlled and uncontrolled portions of clinical trials, representing approximately 12,845 patient-years of therapy, the observed rate of lymphoma was 0.10 cases per 100 patient-years. This was 3-fold higher than the rate of lymphoma expected in the general US population based on the Surveillance, Epidemiology, and End Results (SEER) Database. An increased rate of lymphoma up to several-fold has been reported in the RA patient population, and may be further increased in patients with more severe disease activity.

Among 4410 adult PsO patients treated with Enbrel in clinical trials up to 36 months, representing approximately 4278 patient-years of therapy, the observed rate of lymphoma was 0.05 cases per 100 patient-years, which is comparable to the rate in the general population. No cases were observed in Enbrel- or placebo-treated patients during the controlled portions of these trials.

Leukemia Cases of acute and chronic leukemia have been reported in association with postmarketing TNF-blocker use in rheumatoid arthritis and other indications.

Even in the absence of TNF-blocker therapy, patients with rheumatoid arthritis may be at higher risk (approximately 2-fold) than the general population for the development of leukemia.

During the controlled portions of Enbrel trials, 2 cases of leukemia were observed among 5445 (0.06 cases per 100 patient-years) Enbrel-treated patients versus 0 among 2890 (0%) control patients (duration of controlled treatment ranged from 3 to 48 months).

Among 15,401 patients treated with Enbrel in controlled and open portions of clinical trials representing approximately 23,325 patient-years of therapy, the observed rate of leukemia was 0.03 cases per 100 patient-years.

Other Malignancies Information is available from 10,953 adult patients with 17,123 patient-years and 696 pediatric patients with 1282 patient-years of experience across 45 Enbrel clinical studies.

For malignancies other than lymphoma and non-melanoma skin cancer, there was no difference in exposure-adjusted rates between the Enbrel and control arms in the controlled portions of clinical studies for all indications. Analysis of the malignancy rate in combined controlled and uncontrolled portions of studies has demonstrated that types and rates are similar to what is expected in the general US population based on the SEER database and suggests no increase in rates over time. Whether treatment with Enbrel might influence the development and course of malignancies in adults is unknown.

Melanoma and Non-melanoma skin cancer (NMSC) Melanoma and non-melanoma skin cancer has been reported in patients treated with TNF antagonists including etanercept.

Among 15,401 patients treated with Enbrel in controlled and open portions of clinical trials representing approximately 23,325 patient-years of therapy, the observed rate of melanoma was 0.043 cases per 100 patient-years.

Among 3306 adult rheumatology (RA, PsA, AS) patients treated with Enbrel in controlled clinical trials representing approximately 2669 patient-years of therapy, the observed rate of NMSC was 0.41 cases per 100 patient-years vs 0.37 cases per 100 patient-years among 1521 control-treated patients representing 1077 patient-years. Among 1245 adult psoriasis patients treated with Enbrel in controlled clinical trials, representing approximately 283

patient-years of therapy, the observed rate of NMSC was 3.54 cases per 100 patient-years vs 1.28 cases per 100 patient-years among 720 control-treated patients representing 156 patient-years.

Postmarketing cases of Merkel cell carcinoma have been reported very infrequently in patients treated with Enbrel.

Periodic skin examinations should be considered for all patients at increased risk for skin cancer.

Pediatric Patients Malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with TNF-blocking agents (initiation of therapy at ≤ 18 years of age), including Enbrel. Approximately half the cases were lymphomas, including Hodgkin’s and non-Hodgkin’s lymphoma. The other cases represented a variety of different malignancies and included rare malignancies usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. The malignancies occurred after a median of 30 months of therapy (range 1 to 84 months). Most of the patients were receiving concomitant immunosuppressants. These cases were reported postmarketing and are derived from a variety of sources, including registries and spontaneous postmarketing reports.

In clinical trials of 1140 pediatric patients representing 1927.2 patient-years of therapy, no malignancies, including lymphoma or NMSC, have been reported.

Postmarketing Use In global postmarketing adult and pediatric use, lymphoma and other malignancies have been reported.

Patients With Heart Failure Two clinical trials evaluating the use of Enbrel in the treatment of heart failure were terminated early due to lack of efficacy. One of these studies suggested higher mortality in Enbrel-treated patients compared to placebo [see Adverse Reactions]. There have been postmarketing reports of worsening of congestive heart failure (CHF), with and without identifiable precipitating factors, in patients taking Enbrel. There have also been rare (< 0.1%) reports of new onset CHF, including CHF in patients without known preexisting cardiovascular disease. Some of these patients have been under 50 years of age. Physicians should exercise caution when using Enbrel in patients who also have heart failure, and monitor patients carefully.

Hematologic Events Rare (< 0.1%) reports of pancytopenia, including very rare (< 0.01%) reports of aplastic anemia, some with a fatal outcome, have been reported in patients treated with Enbrel. The causal relationship to Enbrel therapy remains unclear. Although no high-risk group has been identified, caution should be exercised in patients being treated with Enbrel who have a previous history of significant hematologic abnormalities. All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (eg, persistent fever, bruising, bleeding, pallor) while on Enbrel. Discontinuation of Enbrel therapy should be considered in patients with confirmed significant hematologic abnormalities.

Two percent of patients treated concurrently with Enbrel and anakinra developed neutropenia (ANC < 1 x 10 9/L). While neutropenic, one patient developed cellulitis that resolved with antibiotic therapy.

Hepatitis B Reactivation Reactivation of hepatitis B in patients who were previously infected with the hepatitis B virus (HBV) and had received concomitant TNF-blocking agents, including very rare cases (< 0.01%) with Enbrel, has been reported. In some instances, hepatitis B reactivation occurring in conjunction with TNF-blocker therapy has been fatal. The majority of these reports have occurred in patients concomitantly receiving other medications that suppress the immune system, which may also contribute to hepatitis B reactivation. Patients at risk for HBV infection should be evaluated for prior evidence of HBV infection before initiating TNF-blocker therapy. Prescribers should exercise caution in prescribing TNF blockers in patients previously infected with HBV. Adequate data are not available on the safety or efficacy of treating patients who are carriers of HBV with anti-viral therapy in conjunction with TNF-blocker therapy to prevent HBV reactivation. Patients previously infected with HBV and require treatment with Enbrel should be closely monitored for clinical and laboratory signs of active HBV infection throughout therapy and for several months following termination of therapy. In patients who develop HBV reactivation, consideration should be given to stopping Enbrel and initiating anti-viral therapy with appropriate supportive treatment. The safety of resuming Enbrel therapy after HBV reactivation is controlled is not known.

Therefore, prescribers should weigh the risks and benefits when considering resumption of therapy in this situation.

Allergic Reactions Allergic reactions associated with administration of Enbrel during clinical trials have been reported in < 2% of patients. If an anaphylactic reaction or other serious allergic reaction occurs, administration of Enbrel should be discontinued immediately and appropriate therapy initiated.

Caution: The following components contain dry natural rubber (a derivative of latex), which may cause allergic reactions in individuals sensitive to latex: the needle cover of the prefilled syringe and the needle cover within the needle cap of the SureClick® autoinjector.

Immunizations Live vaccines should not be given concurrently with Enbrel. It is recommended that pediatric patients, if possible, be brought up-to-date with all immunizations in agreement with current immunization guidelines prior to initiating Enbrel therapy [see Drug Interactions].

Autoimmunity Treatment with Enbrel may result in the formation of autoantibodies [see Adverse Reactions] and, rarely (< 0.1%), in the development of a lupus-like syndrome or autoimmune hepatitis [see Adverse Reactions], which may resolve following withdrawal of Enbrel. If a patient develops symptoms and findings suggestive of a lupus-like syndrome or autoimmune hepatitis following treatment with Enbrel, treatment should be discontinued and the patient should be carefully evaluated.

Immunosuppression TNF mediates inflammation and modulates cellular immune responses. TNFblocking agents, including Enbrel, affect host defenses against infections. The effect of TNF inhibition on the development and course of malignancies is not fully understood. In a study of 49 patients with RA treated with Enbrel, there was no evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector cell populations [see Adverse Reactions].

Use in Wegener’s Granulomatosis Patients The use of Enbrel in patients with Wegener’s granulomatosis receiving

Volume 8 • number 4 • FALL 2014 39

immunosuppressive agents is not recommended. In a study of patients with Wegener’s granulomatosis, the addition of Enbrel to standard therapy (including cyclophosphamide) was associated with a higher incidence of non cutaneous solid malignancies and was not associated with improved clinical outcomes when compared with standard therapy alone [see Drug Interactions].

Use with Anakinra or Abatacept Use of Enbrel with anakinra or abatacept is not recommended [see Drug Interactions].

compared to placebo-treated patients. In RA Study III, no pattern of increased autoantibody development was seen in Enbrel patients compared to MTX patients [see Warnings and Precautions].

Other Adverse Reactions Table 3 summarizes adverse reactions reported in adult RA patients. The types of adverse reactions seen in patients with PsA or AS were similar to the types of adverse reactions seen in patients with RA. Table 3. Percent of Adult RA Patients Experiencing Adverse Reactions in Controlled Clinical Trials

Use in Patients with Moderate to Severe Alcoholic Hepatitis In a study of 48 hospitalized patients treated with Enbrel or placebo for moderate to severe alcoholic hepatitis, the mortality rate in patients treated with Enbrel was similar to patients treated with placebo at 1 month but significantly higher after 6 months. Physicians should use caution when using Enbrel in patients with moderate to severe alcoholic hepatitis.

ADVERSE REACTIONS Across clinical studies and postmarketing experience, the most serious adverse reactions with Enbrel were infections, neurologic events, CHF, and hematologic events [see Warnings and Precautions]. The most common adverse reactions with Enbrel were infections and injection site reactions.

Clinical Studies Experience Adverse Reactions in Adult Patients With Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, or Plaque Psoriasis The data described below reflect exposure to Enbrel in 2219 adult patients with RA followed for up to 80 months, in 182 patients with PsA for up to 24 months, in 138 patients with AS for up to 6 months, and in 1204 adult patients with PsO for up to 18 months.

In controlled trials, the proportion of Enbrel-treated patients who discontinued treatment due to adverse events was approximately 4% in the indications studied.

Because clinical trials are conducted under widely varying conditions, adverse reactions 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 predict the rates observed in clinical practice.

Infections Infections, including viral, bacterial, and fungal infections, have been observed in adult and pediatric patients. Infections have been noted in all body systems and have been reported in patients receiving Enbrel alone or in combination with other immunosuppressive agents.

In controlled portions of trials, the types and severity of infection were similar between Enbrel and the respective control group (placebo or MTX for RA and PsA patients) in RA, PsA, AS and PsO patients. Rates of infections in RA and PsO patients are provided in Table 3 and Table 4, respectively.

Infections consisted primarily of upper respiratory tract infection, sinusitis and influenza.

In controlled portions of trials in RA, PsA, AS and PsO, the rates of serious infection were similar (0.8% in placebo, 3.6% in MTX, and 1.4% in Enbrel/ Enbrel + MTX-treated groups). In clinical trials in rheumatologic indications, serious infections experienced by patients have included, but are not limited to, pneumonia, cellulitis, septic arthritis, bronchitis, gastroenteritis, pyelonephritis, sepsis, abscess and osteomyelitis. In clinical trials in PsO, serious infections experienced by patients have included, but are not limited to, pneumonia, cellulitis, gastroenteritis, abscess and osteomyelitis. The rate of serious infections was not increased in open-label extension trials and was similar to that observed in Enbrel- and placebo-treated patients from controlled trials.

In 66 global clinical trials of 17,505 patients (21,015 patient-years of therapy), tuberculosis was observed in approximately 0.02% of patients. In 17,696 patients (27,169 patient-years of therapy) from 38 clinical trials and 4 cohort studies in the US and Canada, tuberculosis was observed in approximately 0.006% of patients. These studies include reports of pulmonary and extrapulmonary tuberculosis [see Warnings and Precautions].

Injection Site Reactions In placebo-controlled trials in rheumatologic indications, approximately 37% of patients treated with Enbrel developed injection site reactions. In controlled trials in patients with PsO, 15% of patients treated with Enbrel developed injection site reactions during the first 3 months of treatment. All injection site reactions were described as mild to moderate (erythema, itching, pain, swelling, bleeding, bruising) and generally did not necessitate drug discontinuation. Injection site reactions generally occurred in the first month and subsequently decreased in frequency. The mean duration of injection site reactions was 3 to 5 days. Seven percent of patients experienced redness at a previous injection site when subsequent injections were given.

Immunogenicity Patients with RA, PsA, AS or PsO were tested at multiple time points for antibodies to etanercept. Antibodies to the TNF receptor portion or other protein components of the Enbrel drug product were detected at least once in sera of approximately 6% of adult patients with RA, PsA, AS or PsO. These antibodies were all non-neutralizing. Results from JIA patients were similar to those seen in adult RA patients treated with Enbrel.

In PsO studies that evaluated the exposure of etanercept for up to 120 weeks, the percentage of patients testing positive at the assessed time points of 24, 48, 72 and 96 weeks ranged from 3.6%–8.7% and were all non-neutralizing.

The percentage of patients testing positive increased with an increase in the duration of study; however, the clinical significance of this finding is unknown.

No apparent correlation of antibody development to clinical response or adverse events was observed. The immunogenicity data of Enbrel beyond 120 weeks of exposure are unknown.

The data reflect the percentage of patients whose test results were considered positive for antibodies to etanercept in an ELISA assay, and are highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of any antibody positivity in an assay is highly dependent on several factors, including assay sensitivity and specificity, assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to etanercept with the incidence of antibodies to other products may be misleading.

Autoantibodies Patients with RA had serum samples tested for autoantibodies at multiple time points. In RA Studies I and II, the percentage of patients evaluated for antinuclear antibodies (ANA) who developed new positive ANA (titer ≥ 1:40) was higher in patients treated with Enbrel (11%) than in placebo-treated patients (5%). The percentage of patients who developed new positive antidouble-stranded DNA antibodies was also higher by radioimmunoassay (15% of patients treated with Enbrel compared to 4% of placebo-treated patients) and by Crithidia luciliae assay (3% of patients treated with Enbrel compared to none of placebo-treated patients). The proportion of patients treated with Enbrel who developed anticardiolipin antibodies was similarly increased

Placebo Controlleda (Studies I, II, and a Phase 2 Study) Placebo (N = 152) Reaction Infectiond (total) Upper Respiratory Infectionse Non-upper Respiratory Infections Injection Site Reactions Diarrhea Rash Pruritus Pyrexia Urticaria Hypersensitivity

Enbrelc (N = 349)

Percent of Patients

Active Controlledb (Study III) MTX (N = 217)

Enbrelc (N = 415)

Percent of Patients 81 65

39 30

50 38

86 70

15

21

59

54

11

37

18

43

9 2 1 – 1 –

8 3 2 3 – –

16 19 5 4 4 1

16 13 5 2 2 1

Includes data from the 6-month study in which patients received concurrent MTX therapy in both arms.

Study duration of 2 years. c Any dose. d Includes bacterial, viral, and fungal infections. e Most frequent Upper Respiratory Infections were upper respiratory tract infection, sinusitis, and influenza. a

b

In placebo-controlled PsO trials, the percentages of patients reporting adverse reactions in the 50 mg twice a week dose group were similar to those observed in the 25 mg twice a week dose group or placebo group.

Table 4 summarizes adverse reactions reported in adult PsO patients from Studies I and II. Table 4. Percent of Adult PsO Patients Experiencing Adverse Reactions in Placebo-Controlled Portions of Clinical Trials (Studies I & II) Placebo (N = 359)

Enbrela (N = 876)

Reaction

Percent of Patients

Infectionb (total) Non-upper Respiratory Infections Upper Respiratory Infectionsc Injection Site Reactions Diarrhea Rash Pruritus Urticaria Hypersensitivity Pyrexia

28 14

27 12

17

17

6

15

2 1 2 – – 1

3 1 1 1 1 –

Includes 25 mg SC QW, 25 mg SC BIW, 50 mg SC QW, and 50 mg SC BIW doses.

Includes bacterial, viral and fungal infections. c Most frequent Upper Respiratory Infections were upper respiratory tract infection, nasopharyngitis and sinusitis. a

b

Adverse Reactions in Pediatric Patients In general, the adverse reactions in pediatric patients were similar in frequency and type as those seen in adult patients [see Warnings and Precautions]. The types of infections reported in pediatric patients were generally mild and consistent with those commonly seen in the general pediatric population. Two JIA patients developed varicella infection and signs and symptoms of aseptic meningitis, which resolved without sequelae.

In open-label clinical studies of children with JIA, adverse reactions reported in those ages 2 to 4 years were similar to adverse reactions reported in older children.

Postmarketing Experience Adverse reactions have been reported during post approval use of Enbrel in adults and pediatric patients. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to Enbrel exposure.

Adverse reactions are listed by body system below: Blood and lymphatic pancytopenia, anemia, leukopenia, neutropenia, system disorders: thrombocytopenia, lymphadenopathy, aplastic anemia [see Warnings and Precautions] Cardiac disorders: congestive heart failure [see Warnings and Precautions] Gastrointestinal disorders: inflammatory bowel disease (IBD) General disorders: angioedema, chest pain Hepatobiliary disorders: autoimmune hepatitis, elevated transaminases, hepatitis B reactivation Immune disorders: macrophage activation syndrome, systemic vasculitis Musculoskeletal and lupus-like syndrome connective tissue disorders: Neoplasms benign, melanoma and non-melanoma skin cancers, malignant, and unspecified: merkel cell carcinoma [see Warnings and Precautions] Nervous system disorders: convulsions, multiple sclerosis, demyelination, optic neuritis, transverse myelitis, paresthesias [see Warnings and Precautions] Ocular disorders: uveitis, scleritis Respiratory, thoracic interstitial lung disease and mediastinal disorders:

40 Journal of Dermatology for Physician Assistants

Skin and subcutaneous tissue disorders:

cutaneous lupus erythematous, cutaneous vasculitis (including leukocytoclastic vasculitis), erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, subcutaneous nodule, new or worsening psoriasis (all sub-types including pustular and palmoplantar) Opportunistic infections, including atypical mycobacterial infection, herpes zoster, aspergillosis and Pneumocystis jiroveci pneumonia, and protozoal infections have also been reported in postmarketing use.

DRUG INTERACTIONS Specific drug interaction studies have not been conducted with Enbrel.

Vaccines Most PsA patients receiving Enbrel were able to mount effective B-cell immune responses to pneumococcal polysaccharide vaccine, but titers in aggregate were moderately lower and fewer patients had 2-fold rises in titers compared to patients not receiving Enbrel. The clinical significance of this is unknown. Patients receiving Enbrel may receive concurrent vaccinations, except for live vaccines. No data are available on the secondary transmission of infection by live vaccines in patients receiving Enbrel.

Patients with a significant exposure to varicella virus should temporarily discontinue Enbrel therapy and be considered for prophylactic treatment with varicella zoster immune globulin [see Warnings and Precautions].

Immune-Modulating Biologic Products In a study in which patients with active RA were treated for up to 24 weeks with concurrent Enbrel and anakinra therapy, a 7% rate of serious infections was observed, which was higher than that observed with Enbrel alone (0%) [see Warnings and Precautions] and did not result in higher ACR response rates compared to Enbrel alone. The most common infections consisted of bacterial pneumonia (4 cases) and cellulitis (4 cases). One patient with pulmonary fibrosis and pneumonia died due to respiratory failure. Two percent of patients treated concurrently with Enbrel and anakinra developed neutropenia (ANC < 1 x 10 9/L).

In clinical studies, concurrent administration of abatacept and Enbrel resulted in increased incidences of serious adverse events, including infections, and did not demonstrate increased clinical benefit [see Warnings and Precautions].

Cyclophosphamide The use of Enbrel in patients receiving concurrent cyclophosphamide therapy is not recommended [see Warnings and Precautions].

Sulfasalazine Patients in a clinical study who were on established therapy with sulfasalazine, to which Enbrel was added, were noted to develop a mild decrease in mean neutrophil counts in comparison to groups treated with either Enbrel or sulfasalazine alone. The clinical significance of this observation is unknown.

USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category B Pregnancy Surveillance Program There is a Pregnancy Surveillance Program that monitors outcomes in women exposed to Enbrel during pregnancy. Women who become pregnant during Enbrel treatment are encouraged to enroll. Patients or their physicians should call 1-800-77-AMGEN (1-800-772-6436) to enroll.

Risk Summary There are no adequate and well controlled studies in pregnant women.

Based on limited data, etanercept concentration in cord blood at the time of delivery showed that etanercept crossed the placenta in small amounts.

Developmental toxicity studies have been performed in rats and rabbits at doses ranging from 60- to 100-fold higher than the human dose and have revealed no evidence of harm to the fetus due to Enbrel. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Human Data Three case reports showed that cord blood levels of etanercept at delivery in infants, born to mothers administered etanercept during pregnancy, were between 3 and 32% of the maternal serum level.

Nursing Mothers Limited data from published literature show that etanercept is present in low levels in human milk and minimally absorbed by a breastfed infant. Caution should be exercised when Enbrel is administered to a nursing woman. The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for Enbrel and any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition.

Women who choose to continue Enbrel treatment while nursing are encouraged to enroll in Amgen’s Lactation Surveillance Program. Patients or their physicians should call 1-800-77-AMGEN (1-800-772-6436) to enroll.

Pediatric Use Enbrel has not been studied in children < 2 years of age with JIA. The safety and efficacy of Enbrel in pediatric patients with PsO have not been studied.

Rare (< 0.1%) cases of IBD have been reported in JIA patients receiving Enbrel, which is not effective for the treatment of IBD [see Adverse Reactions (6.2)].

The clinical significance of infant exposure to Enbrel in utero is unknown. The safety of administering live or live-attenuated vaccines in exposed infants is unknown. Risks and benefits should be considered prior to administering live or live-attenuated vaccines to exposed infants.

Geriatric Use A total of 480 RA patients ages 65 years or older have been studied in clinical trials. In PsO randomized clinical trials, a total of 138 out of 1965 subjects treated with Enbrel or placebo were age 65 or older. No overall differences in safety or effectiveness were observed between these patients and younger patients, but the number of geriatric PsO subjects is too small to determine whether they respond differently from younger subjects. Because there is a higher incidence of infections in the elderly population in general, caution should be used in treating the elderly.

Use in Diabetics There have been reports of hypoglycemia following initiation of Enbrel therapy in patients receiving medication for diabetes, necessitating a reduction in anti-diabetic medication in some of these patients.

Rx Only.

This brief summary is based on ENBREL prescribing information v.53: 11/2013 US License Number 1132 © 1998 – 2013 Immunex Corporation.

All rights reserved.

US Patent Nos. 7,915,225; 5,605,690; Re. 36,755.

For more information please call 1-888-436-2735 or visit www.enbrel.com © 2013 Amgen Inc., Thousand Oaks, CA 91320 All rights reserved.

60077-R5-V1

PMV53

Is this YOUR year to become a Diplomate?

Join your peers as an elite Derm PA! The SDPA wishes to congratulate all of our Physician Assistant members who have completed the rigorous Distance Learning Initiative.

For For more more information information on achieving on achieving DIPLOMATE DIPLOMATE status status in in your yourvisit state, dermpa.org/diplomate visit dermpa.org/diplomate Current list of diplomates effective as of Dec 2013 Volume 8 â&#x20AC;˘ number 4 â&#x20AC;˘ FALL 2014 41

070714

COSMETIC deRMATOLOGY

Cosmetic Dermatology Complications A Review of Common Procedures

By Maggie Leonard Rivera, PA-C and Michelle DiBaise, DHSc, PA-C, DFAAPA

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 October 2014. 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. Identify the common complications of botulinum toxin injections, soft-tissue fillers, chemical peels, and laser therapy.

2. Identify and treat serious adverse events of the aforementioned procedures.

3. Consider important patient selection factors and screening parameters for each of these procedures.

42 Journal of Dermatology for Physician Assistants

Cosmetic Dermatology Complications 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.

Volume 8 • number 4 • FALL 2014 43

Cosmetic Dermatology Complications 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.

44 Journal of Dermatology for Physician Assistants

Cosmetic Dermatology Complications 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.

Volume 8 • number 4 • FALL 2014 45

Cosmetic Dermatology Complications 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.

Maggie Leonard Rivera, PA-C graduated in 2014 from the inaugural class of the Northern Arizona University (NAU) PA Program in Phoenix, AZ. She has an interest in dermatology in addition to caring for our nationâ&#x20AC;&#x2122;s Veteran population.

She has indicated no relationships to disclose relating to the content of this article.

Michelle DiBaise, DHSc, PA-C, DFAAPA graduated from the University of Nebraska Medical Center (UNMC) PA Program in 1990. She practiced dermatology in Nebraska for ten years before moving to Phoenix and working in PA education. Michelle is currently a full-time Associate Clinical Professor and the Director of Admissions for the Northern Arizona University (NAU) PA Program in Phoenix, AZ. Michelle has served on the American Academy of Physician Assistant Board of Directors, the Student Academy of the AAPA as both a student and Graduate Advisor, as Vice President of the PA Foundation, and on the editorial board for the Journal of Dermatology for Physician Assistants. In addition, she has served as President of the Arizona State Association of PAs (ASAPA), the Nebraska Society of Dermatology PAs, Iowa Society of Dermatology PAs, and the national Society of Dermatology Physician Assistants (SDPA). She has indicated no relationships to disclose relating to the content of this article.

46 Journal of Dermatology for Physician Assistants

Cosmetic pearls Treatments For Cellulite, Excess Fat Now Produce Long-Lasting Results 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.

M. Christine Lee, MD, FAAD, is an assistant clinical professor of dermatologic surgery at the University of California, San Francisco and director of a private practice in Walnut Creek, California.

Volume 8 â&#x20AC;˘ number 4 â&#x20AC;˘ FALL 2014 47

IT STARTED SO SMALL BUT DESTROYED SO MUCH I WASN’T PREPARED FOR WHAT THIS WOULD TURN INTO Although basal cell carcinoma (BCC) is a common and treatable skin cancer, a few patients may progress to a more challenging form of disease—advanced BCC. One of the characteristics of advanced BCC is invasive growth.1 In complex anatomies such as the ear, BCC can infiltrate deeply into cartilage or through the auditory canal to internal structures.2,3 As BCC advances, the risk of disfigurement or loss of function can increase.4,5

HOW DOES ADVANCED BCC APPEAR IN YOUR PRACTICE?

References: 1. Walling HW, Fosko SW, Geraminejad PA, Whitaker DC, Arpey CJ. Cancer Metastasis Rev. 2004;23:389-402. 2. Jarell AD, Mully TW. J Am Acad Dermatol. 2012;66:780-784. 3. Sand M, Sand D, Brors D, Altmeyer P, Mann B, Bechara FG. Head Face Med. 2008;4:2.doi:10.1186/1746-160X-4-2.

4. Hauschild A, Breuninger H, Kaufmann R, et al. J Dtsch Dermatol Ges. 2008;6(suppl 1):S2-S4. 5. Leibovitch I, McNab A, Sullivan T, Davis G, Selva D. Ophthalmology. 2005;112:717-723.

To learn more about advanced BCC, visit www.LearnaboutaBCC.com At Genentech, we are passionate about dermatology. © 2012 Genentech USA, Inc. All rights reserved. HED0001489300 Printed in USA.

48 Journal of Dermatology for Physician Assistants

Volume 8 • number 4 • FALL 2014 49

A M E R I C A

THANKS

MEETING PATIENTS’ NEEDS IN A CHANGING HEALTHCARE SYSTEM IS A BIG JOB. AMERICA’S PAs SHOULD KNOW. THEY DO IT EVERY DAY.

50 Journal of Dermatology for Physician Assistants

PROFESSIONAL de VELOPMENT

Judicial and Ethical Affairs

Ethical Issues in Cosmetic Dermatology

By Karen Scully, MD, FRCPC, MA Ethics

The study of ethics has given me the opportunity to examine our day-to-day practice of dermatology with a critical lens. Issues such as informed consent, conflicts of interest, relations with pharmaceutical companies, research ethics, and ethical treatment of research subjects are some of the ethical matters I would like to address in this and upcoming issues of the JDPA. My aim is not to suggest what is right or wrong, but rather to raise awareness of ethical issues so that we can, to the best of our abilities, make sound decisions in caring for our patients.

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

Volume 8 â&#x20AC;˘ number 4 â&#x20AC;˘ FALL 2014 51

SDPA Members Only Content

professional development

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

Karen Scully is a board-certified dermatologist in is a board-certified dermatologist in the United States and Canada. She had a private practice in the Toronto area for many years and then accepted a teaching position at the Johns Hopkins Medical Institutions where she practiced and taught dermatology residents and medical students. More recently she moved to Charlotte, North Carolina and completed a Masterâ&#x20AC;&#x2122;s Degree in Ethics and Applied Philosophy at the University North Carolina at Charlotte.

The SDPA is proud to announce

5 NEW DLI Modules!

1. Acneiform Eruptions 2. Papulosquamous Disorders 3. Fungal Infections 4. Viral Infections 5. Skin Cancer

These new Distance Learning Initiative modules are available to ALL SDPA members, including students and NPs. These modules provide high quality interactive Category 1 CME accessible 24 hours a day!

www.dermpa.org/diplomate 52 Journal of Dermatology for Physician Assistants

Outside & Inside the 9 to 5...

JDPA: What inspired you to write children’s books?

Ms. Douse-Dean: I once had a little girl as a patient who had named her wart. She was an excellent patient and inspired me to write. The experience made me realize that if I can help children understand what dermatologic conditions they have and what needs to be done for treatment, they actually are more comfortable with the procedures that we have to perform on them. As I began to see more young patients for the same condition, I asked them to name their wart, and this seemed to make the visit more fun for them. As healthcare providers, we all know that eczema and warts are vey common concerns for children and adults. I wanted my patients’ visits to the dermatology office to be the best they could be despite the circumstances.

under the tree. I have to admit that I was a little disappointed that I didn't get the Walkman that I had put on my list. My favorite authors today are Danielle Steele, Terry McMillan, Suze Orman, and T.D. Jakes. These books have gotten me through my life with suspense, drama, financial disparity, and spiritual growth (in that order).

JDPA: Can you describe for us the process of publishing your first book?

Ms. Douse-Dean: When I got the idea to write a book, I first envisioned a coloring book so that young patients would have something to do while they waited in our office. I began to research how to write a book. I came to realize that in order for this process to happen, it would take time, dedication, and money. I also realized that because I wasn't a reality TV star, I would have to self publish my book.

I chose my publishing company based on what they had to offer. They made it easy for me; they provided me with a personal book consultant who kept in contact with me via e-mails and phone calls. Sometimes it became a little overwhelming because I work a full-time job, volunteer a lot in my community, serve as the Vice President with the ISDPA, and volunteer nationally with the SDPA, but it was all worth it.

Tracee Douse-Dean, PA-C

JDPA: As a child, did you have a favorite book or author?

Ms. Douse-Dean: As a child my parents always surrounded me with books and learning materials.

One Christmas, I woke up, and there were so many presents under the tree that I thought, "Wow, someone really loves me!" In fact, my mom individually wrapped the entire series of the BabySitters Club; I had around fifty books wrapped

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professional development

Tracee Douse-Dean, PA-C has been serving in the healthcare industry for the past fifteen years and has specialized as a PA in dermatology for the past eight years. She is currently the Co-Chair of the SDPA Public Relations Committee as well as the Vice President of the Illinois Society of Dermatology Physician Assistants (ISDPA). Most recently, she has had the privilege of adding children’s books author to her list of many accomplishments.

The two children’s books she has recently authored are “Wally The Wart” and “X-zema; A Children’s Guide to Happy Skin.” Both are available online through Amazon, Authorhouse.com, and Barnes & Noble. The JDPA had an opportunity to interview Ms. Douse-Dean and learn more about her work as an author and about the experience of getting her work published.

professional development

JDPA: How did you develop the storylines and characters for the books?

Ms. Douse-Dean: In developing the storyline, I pretty much thought of some of my own patients. They are all different ages and nationalities.

I wanted the characters in my books to be identifiable and relatable to the children who would be reading the books. I would write down certain parts from the conversations that I would have with my patients.

For follow-up visits, I would ask my patients to bring a drawing of their wart. Their imaginations are so vast. The inspiration that came from these interactions was awesome.

JDPA: What message do you hope readers take away from your books?

Ms. Douse-Dean: I would like my readers to have a good time reading the stories. It is also my hope that readers learn more about the conditions that they may have.

JDPA: Have you read your stories to young patients and/or school children? Do you have the books available at your practice?

Ms. Douse-Dean: I have had opportunities to present and market my book at community health fairs. I have not had the opportunity to read them aloud, but I imagine that will happen in the near future. My employer has purchased the books, and we have them in each exam room and waiting room of our three general dermatology offices. A local public elementary school has also purchased books for their students to read during their classroom reading time. I have recently developed a press release and website so that the books have more exposure and are more marketable.

JDPA: What type of feedback have you received from readers of the books?

Ms. Douse-Dean: The parents who have read my books have told me that they love the stories and that their children have read the books over and over again. I have had some patients purchase the books and bring them in for me to autograph.

This has made me feel like I am making a positive impact on someone’s life. I also had one of my

54 Journal of Dermatology for Physician Assistants

colleagues bring me into an exam room where she was seeing a young patient. He had seen my picture on the back of the book and didn’t believe that I was actually working in the office. His eyes lit up when I walked into the room, and he said, "Whoa!"

We all laughed. On a separate occasion, I did have one parent playfully try to throw out the "Wally The Wart" book because his name was Walter. The overall feedback has been extremely positive and encouraging.

JDPA: Any insights or tips you would share with others who are considering delving into the world of book authorship?

Ms. Douse-Dean: My advice would be to take about a six week vacation to allow enough time to start and finish (lol).

JDPA: Do you have any future plans for more books?

Ms. Douse-Dean: Absolutely! I have ideas for three more in my head. I just have to be off from work for six weeks to get them on paper.

JDPA: Could you please finish the following sentence,“I will consider my books a success if…”

Ms. Douse-Dean: I am able to get them to Oprah for her blessing. Just kidding. I will consider my books a success if I can get them into all of the dermatology and pediatric offices nationwide and if I can possibly have a cartoon series made from them.

JDPA: Any additional information about your books that you would like to share with our readers?

Ms. Douse-Dean: Not only are they books about common skin concerns, but I also made sure to highlight our profession as physician assistants.

I believe that I have the greatest career ever! We don't just see patients; we are here to educate the public and enhance our patients’ experiences in a medical setting. Thank you to everyone who has supported me in my endeavor, and I look forward to your ongoing support as I continue to pursue my passion as a writer and live out my dreams. J

Notes from your Office Manager Using Chaperones During Physical Examination The Risk:

Recommendations:

➊ A healthcare provider should always use

a chaperone when performing breast or pelvic examinations on patients. ➋ Consideration should also be given to the use of a chaperone for rectal and/or testicular examinations and in unusual situations where the provider is concerned that the patient, spouse, or family member seems uncomfortable, apprehensive, or otherwise heightens the provider’s concerns. Such situations include when a parent or spouse demands to be present, or when a patient acts seductively or otherwise inappropriately. ➌ The presence of a chaperone must always be documented in the patient’s medical record. The healthcare provider can simply document “chaperone in room for the entire exam” and the chaperone’s initials. Templates are available online

from which either a stamp or a form for your electronic medical records (EMR) for this documentation can be made by your office. Adding the name and title of the staff member who chaperoned the exam allows you to verify his/her presence at a later date, should the need arise. ➍ A chaperone should be provided even if the healthcare provider is the same gender as the patient. ➎ Chaperones must be educated about patient privacy and confidentiality. ➏ Unless specifically requested by the patient, family members should not be used as chaperones. ➐ Respect for the patient’s privacy can be maintained by speaking to the patient privately before and/or after the examination. 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.

Volume 8 • number 4 • FALL 2014 55

professional development

Healthcare providers must recognize that at any time a patient may make a complaint to the Office of Professional Medical Conduct alleging that he or she was the victim of a healthcare provider’s sexual misconduct. Having a chaperone present during intimate physical examinations may be beneficial to both the provider and patient. First, it may provide reassurance to a patient, demonstrating both respect for his or her concerns and an understanding of his or her vulnerabilities. Second, the use of a chaperone can provide legal protection for the healthcare provider in the event of a misunderstanding or false accusation of sexual misconduct on the part of the patient.

Dermatology PA news & notes

The Difference We Make The Wonder of It All

By Steven K. Shama, MD, MPH, FAAD All my life I've been accused of being a wonderer… and I'm so happy that I've been labeled that way. I've always considered my life wonder-full. Let’s see if I can convince you to enter this wonderland for the good of science and for the good of yourself.

As a clinician I'm supposed to be, and rewarded for being, that scientific person and that traditionally thought of left brained individual whose logical, analytical, linear, and objective way of thinking is the way of life. Any suggestion that I might be a right brain thinker, one who uses intuition, thoughtfulness, subjectivity, and creativity may be looked upon with concern at the least. I'm sure people have said about me, “Why doesn't he grow up?” or “Why doesn't he get serious?” or ”Why doesn't he stop dreaming?”

However, I am an adult, I am serious, and I don't always dream. I have found that when I am in that traditional right brain way of thinking I am most happy and terribly creative (humbly spoken). There are no smiles when I am in my left brain mode and no great joy. I am rather serious and methodical but I must say rather productive. In my left brain mode it’s always a numbers game. How many patients can I see, how many diagnoses can I make, and how can I stay on time? For me to have persevered through my long career in medicine, I have always felt that I needed to connect with my right brain way of thinking. I find no great joy in doing the left brain way. The greatest joys in my life are when I'm me - just wondering and being fascinated by what I see in the world, my right brain way.

I hasten to say that most patients come to clinicians for their left brain scientific knowledge and their ability to make the correct diagnosis and prescribe the proper treatment. I would suggest, however, that the things that keep these patients coming back and referring other patients are the clinicians’ right brain expressions (the caring part), the ability to recognize them as people, not as a disease, and the skill to add hope to every diagnosis.

I learned this essential “wonder of it all” lesson when I spent two years as a Clinical Associate at the National Institutes of Health in Bethesda, Maryland, almost thirty-five years ago. I was a research assistant working with some of the brightest scientific minds in medicine and in dermatology more specifically. These dermatologist were the ones who wrote the basic articles that allow all of us to understand the causes of certain skin diseases and the reasons why certain medications work or don't work.

Here's what I discovered while working with them. I saw them set up, in a very exacting way, the experiments that would prove many of their theories. I also noticed that when they were rigorously determining how to prove their findings that there were no smiles on their faces. They were very serious and were working from their left brain.

But then I saw them at lunch talking to their colleagues about how to improve their experiments; they would use words and phrases such as, “I have a hunch,” or “I was wondering about something,” or “I've been dreaming about this every 56 Journal of Dermatology for Physician Assistants

day.” Their faces were full of smiles and true, innocent, childlike excitement. I quickly realized that their lunchtime state of being had nothing to do with their left brain and that it was truly coming from the traditional right brain. Their brilliance was in their hunches and in their ability to set up rigorous experiments to prove their hypotheses. However, these experiments might not have ever occurred had they not had these hunches, had they not been wondering, had they not been dreaming. I soon realized that all great theories and all great experiments start from a hunch, a wonder.

These scientists begin their quest for discovery with the innocence of a child wondering about something he or she sees in their world, with the freedom to wonder sacredly preserved among the scientific community. They truly work for right brain satisfaction, yet we reward them for their left brain activity. Let us all look for those child like qualities in the scientists we observe and see if we can give ourselves the same freedom to bring out the child within us.

The practical application of this information has to do with asking the why of it all. Why do certain diseases affect the skin and in certain unique ways? It has to do with not being afraid or embarrassed to be fascinated by some occurrence, especially if you express it to a colleague or a patient. I recall being amazed that while I know how to diagnose psoriasis, I have always wondered about how the body makes psoriasis-form disorders.

In a similar way, I know how to diagnose lichen planus, but I'm amazed that there's something like lichen-oid eruptions. Why does the body do this? What does it mean? That's what keeps my mind stimulated. Asking questions that amaze me and that put me in a state of wonder is what I live for.

May I suggest that that's how you should embrace, as well as honor, both sides of your amazing brain, your amazing self.

You will rarely tire of seeing patients during your entire career if you periodically refresh yourself in activities and expressions, which engage your right brain, give you the freedom to wonder, and allow you to be amazed and fascinated. While it's not scientific, like your left brain, it's where it all begins.

Living in a scientific world as we do, we will constantly have to recognize that our left brain will be rewarded more often than our right brain. However, it is those right brain qualities that give each one of us the true joy of being a clinician. Always honor it. Never be ashamed of it. Develop it, culture it, and give it the freedom to express itself often and with great joy. Wishing you a wonder-full career. 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.

PROVEN

EFFICACY

CUSTOMIZED, WITH WEIGHT-BASED1,2

DOSING

• Significant reduction in inflammatory lesions at ~1 mg/kg/day in SOLODYN®-treated patients1,2 – In a dose-ranging study, a 56.8% reduction from baseline vs placebo (39.4%)* – In 2 phase 3 trials, mean percent improvement from baseline was 43% and 46% vs placebo (32% and 31%, respectively)† • Once-daily dosing, with or without food1 • No generic equivalent *Phase 2 study; N=233 subjects. † N=924 subjects.

Indication and Usage SOLODYN is indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older.

Important Safety Information for SOLODYN Tablets use of tetracyclines with oral life-threatening; therefore, it • The most commonly observed contraceptives may render oral adverse reactions are headache, is important to consider this contraceptives less effective diagnosis in patients who fatigue, dizziness, and pruritus present with diarrhea subsequent • This drug is contraindicated in • Minocycline like other to the administration of persons who have shown tetracycline-class drugs antibacterial agents hypersensitivity to any of the can cause fetal harm when tetracyclines • Central nervous system side administered to a effects, including lightpregnant woman • Safety beyond 12 weeks of use headedness, dizziness, and has not been established • Tetracycline drugs should not be vertigo, have been reported used during tooth development • Cases of anaphylaxis, serious with minocycline therapy (last half of pregnancy and up to skin reactions, erythema 8 years of age) as they may cause • In rare cases, photosensitivity multiforme, and drug rash with has been reported permanent discoloration of teeth eosinophilia and systemic symptoms have been reported • Pseudomembranous colitis has • Should not be used during pregnancy or by individuals of postmarketing with minocycline been reported with nearly all either gender who are attempting use. Discontinue SOLODYN antibacterial agents and may to conceive a child; concurrent immediately if symptoms occur range from mild to Please see Brief Summary of full Prescribing Information on the following pages.

References: 1. SOLODYN Tablets Package Insert. Scottsdale, AZ: Valeant Dermatology; February 2012.

2. Data on file, Valeant Pharmaceuticals.

Except as otherwise indicated, all product names, slogans and other marks are trademarks of the Valeant family of companies. ©2014 Valeant Pharmaceuticals North America LLC. DM/SDN/14/0005

Volume 8 • number 4 • FALL 2014 57

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Patients should be questioned for visual

58 Journal of Dermatology for Physician Assistants

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

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

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

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

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

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

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

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

Oncology: thyroid cancer.

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

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

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

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

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

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

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

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

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

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

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

Warnings and Precautions).

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

Other reported clinical experience has not

NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility

contains minocycline hydrochloride equivalent to 80 mg minocycline, supplied as follows:

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

NDC 99207-466-30

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

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

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

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

Limited human studies suggest that minocycline may have a deleterious effect on spermatogenesis.

Bottle of 30

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

Bottle of 30

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

Bottle of 30

Storage Store at 25ºC (77ºF); excursions are permitted to 15º-30ºC (59º-86ºF) [See USP Controlled Room Temperature].

Handling Keep out of reach of children Protect from light, moisture, and excessive heat.

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

U.S. Patents 5,908,838; 7,790,705; 7,919,483; and Patents Pending* *90 mg is also covered by U.S. Patents 7,541,347 and 7,544,373 Manufactured for: Medicis, The Dermatology Company Scottsdale, AZ 85256 02/2012 17110264

SOLODYN should not be used by individuals of either gender who are attempting to conceive a child.

HOW SUPPLIED/STORAGE AND HANDLING How Supplied SOLODYN (minocycline HCl, USP) Extended Release Tablets are supplied as aqueous film coated tablets containing minocycline hydrochloride equivalent to 55 mg, 65 mg, 80 mg, 105 mg or 115 mg minocycline, are supplied as follows.

The 55 mg extended release tablets are pink, unscored, coated, and debossed with “DYN-055” on one side. Each tablet contains minocycline hydrochloride equivalent to 55 mg minocycline, supplied identified differences in responses between as follows: Rare spontaneous reports of congenital the elderly and younger patients. In general, anomalies including limb reduction have Bottle of 30 dose selection for an elderly patient should NDC 99207-465-30 been reported with minocycline use in be cautious, usually starting at the low end The 65 mg extended release tablets are pregnancy in post-marketing experience. of the dosing range, reflecting the greater Only limited information is available blue, unscored, coated, and debossed frequency of decreased hepatic, renal, or regarding these reports; therefore, no with “DYN-065” on one side. Each tablet cardiac function, and concomitant disease contains minocycline hydrochloride conclusion on causal association can or other drug therapy. be established. equivalent to 65 mg minocycline, supplied as follows: Minocycline induced skeletal malformations OVERDOSAGE (bent limb bones) in fetuses when In case of overdosage, discontinue NDC 99207-463-30 Bottle of 30 administered to pregnant rats and rabbits in medication, treat symptomatically and doses of 30 mg/kg/day and 100 mg/kg/day, institute supportive measures. Minocycline The 80 mg extended release tablets are dark gray, unscored, coated, and debossed respectively, (resulting in approximately is not removed in significant quantities by with “DYN-080” on one side. Each tablet 3 times and 2 times, respectively, the hemodialysis or peritoneal dialysis.

Volume 8 • number 4 • FALL 2014 59

Workplace Excellence

Empathy: Not Just Caring FOR Me, Caring ABOUT Me

By Matthew Davidson, PhD

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.

E

xcellence with integrity: three words that describe the means and end-goal of our work at the Institute for Excellence & Ethics (IEE); three words that I believe describe the means and end-goal that most individuals desire - even if they can’t or don’t exactly explain it that simply. I want my kids to get a great education, but I want them to be well-rounded, whole persons who don’t lie, cheat, steal, or inflict physical and psychological harm to themselves in their quest for excellence. We want athletes who achieve greatness without lying or cheating to achieve it; so too in the workplace. We want individuals who have a moral conscience, decency, and respect, but who also do their work with a sort of “conscience of craft” - with excellence and care. In our work in educational, athletic, and workplace settings we work to identify the Optimal Performance Practices that avoid both excess and deficiency in the quest to achieve excellence with integrity.

In his recent book, Focus: The Hidden Driver of Excellence, bestselling author, Daniel Goleman identifies two interconnected optimal performance practices essential for achieving excellence with integrity - focus and empathy.1 Goleman’s main argument is that our ability to focus is being eroded by a complex set of factors that is basically leaving us stressed out, burned out, distracted, and divided. A famous quotation from the book asserts that, “Wherever you go, there you are.” However, our multi-tasking, over-committed, technologically driven world has left many of us feeling like, “Wherever we go, we’re somewhere else!” We’re at work thinking about home; at home doing work; in the car texting, eating, learning, and all sorts of other things! We’re rarely fully focused, fully present, with mind-body-soul concentrating on a single task at hand.

But isn’t focusing on lots of things a capacity we look for in the best and brightest? Multi-tasking is required for 60 Journal of Dermatology for Physician Assistants

surviving and thriving, isn’t it? Like most things in life, “Virtue is the means between excess and deficiency.”

However, Goleman argues that there is in fact a cost when our focus gets lost? One important thing that is lost, impacting both excellence and integrity, is our empathy—our ability to recognize or share the feelings of others.

Consider focus and empathy in this “Tale of Two You’s.” The- first you is the one I meet in your first appointment of the day. You’re rested, had an early workout, a good breakfast, and a stress-free commute to work on a sunny day with blue skies; your interpersonal exchanges around the office were friendly, and you chose not to look at your emails before this first appointment.

You come in and sit down, and you are FOCUSED. You see my chart, but you also see me. You notice I have running shoes on and ask if I’m still running and remind me to put sunscreen on my bald head. You notice the cut on my face that I got from shaving, but you still ask to make sure it’s just that. You are thorough, but efficient, explaining with clarity the what, so what, and now what of my treatment; you even paused to ask how I am feeling and tell me to email my questions if I get reading Web-MD online as I sometimes do.

The second you, is the one I meet at the end of a rainy day that began with you oversleeping, rushing out the door for a particularly stressful commute, arriving late to the office, to an empty coffee pot and getting a, “It must be nice to make your own schedule” comment from your colleague. It’s nearly four o’clock now, and it has been a doozy of a day with particularly tough patients and some very frustrating personal and professional emails that you happened to check on your smartphone as you ate lunch standing up. You’re focus is “anywhere but here” as you open the door reading the chart and stick your hand out while hardly making eye

being focused. And empathy and focus aren’t simply “customer service”; they’re also directly related to quality of care. For example, Goleman cites research showing that, “About half of all the medicines prescribed for patients are never taken. And, the strongest predictor of patients following such instruction is whether they feel their doctor is genuinely concerned with them.”

If I believe you care about me and understand me, I trust more deeply in your professional expertise and recommendations.

So how can we put this theory around focus and empathy into action? It’s important to remember that we’re seeking optimal performance - performance that avoids excess or deficiency for the circumstance and for the unique sensibilities and capacities of the specific individuals. The following are ten Optimal Performance Practices (drawn from Focus) for increasing focus and empathy: 1. Breathing mindfully to center oneself 2. Deliberately looking patients in the eye 3. Observing patients’ emotions including tone of voice, posture, and facial expressions 4. Maintaining meaningful eye contact while typing into the computer 5. Explaining to patients the information you are looking at or entering into the computer 6. Showing and explaining “like an engaged teacher” relevant information or results 7. Continually verifying patients’ levels of understanding (e.g., asking “Do you understand what I mean? Does that make sense? Do you have any questions?”)

8. Continually seeking to clarify patients’ emotional states (e.g., asking “How are feeling about all this? Has what I’ve shared upset you?”)

9. Explaining the rationale for your concerns or proposed course of action 10. Taking a bird’s eye view of setting and situation You can certainly further customize these items by looking for indicators that would resonate for certain patients (older, younger), types of illnesses, or certain aspects of the work flow such as at check-in or checkout.

Knowledge of these practices won’t necessarily lead to changes in your personal or collective habits. Here are four ways that you can ensure these practices are consistently implemented with fidelity: 1. Regularly conduct your own self-study on the above practices. It might be daily, weekly, monthly, or quarterly, but a regular self-study can reveal important patterns - both positive and negative.

Volume 8 • number 4 • FALL 2014 61

DERmatology pa news & notes

contact. I’m nervous acting and seem to be unsettled at the close of the appointment, which you didn’t see because you were typing your notes as I left.

In essence it’s a tale of the one you, in both cases you have the same professional and technical skills and experience, except that the first was a focused, fully present you who delivered focused compassionate care - excellence with integrity. The second you delivered a service that in all likelihood lacked both excellence and integrity. It’s unlikely that it was excellent care given that your mind was distracted and elsewhere. It’s equally unlikely that I left being clear on the what, so what, and now what of my treatment. And because I felt that you were distracted, didn’t really see or understand me and what I was feeling, and simply didn’t seem to care, I left questioning your expertise, your professionalism, and as a result, your integrity.

Healthcare isn’t the only place where caring and achievement go hand in hand. In a landmark study by Kathryn Wentzel, middle school students were asked two important questions: “How do you know when a teacher cares about you and how do you know when a teacher does not care about you?”2 Their responses were telling. They said that they knew a teacher cared about them if the teacher talked and listened to students; was honest, fair, and trusting; showed concern for students as individuals by asking whether they needed help; made sure students understood what was being taught; and asked students if something was wrong.

They knew a teacher did not care about them if the teacher was boring or off-task; continued teaching when students weren’t paying attention; ignored, interrupted, embarrassed, insulted, students; showed little interest in students by forgetting student’s names and not doing anything when they did something wrong; didn’t try to explain something when students didn’t understand.

Students are saying two things; they feel cared about when teachers treat them with respect and care, and they also feel cared about when teachers teach well - in a way that enables them to learn. The more students believe teachers “care” the better they do in school.

We might use these same two questions for the customers whom we serve. How might they answer the questions: “How do you know when they care about you and how do you know when they do not care about you?” Using the “Tale of Two You’s” from above, I knew the first you cared about me because you were focused on me, respected and understood me as a person, were thorough and knowledgeable, and simply provided me “compassionate care.” I probably walked away from the second you feeling that you did not care about me because you were distracted, disconnected, and not thorough or attentive to me and my feelings and needs. Excellence with integrity in healthcare requires “compassionate care” or “empathy” that comes from

DERmatology pa news & notes

2. Seek support and challenge from others. It might be a colleague, a supervisor, or even a patient, but the key is to compare your self-study data with those of others to intentionally seek out expertise, encouragement, and accountability.

3. Intentionally simulate the practices. We practice our technical skills; we need to practice our emotional skills. We sometimes call it “E-motions learning”; before it becomes a stable habit, you have to remind yourself, and at first you may be going through the motions. Eventually it will simply be how you act and at some point, who you are.

4. Look for examples you want to emulate (and avoid). Accumulate examples for your mind’s eye of times when you (or a colleague) put each of the above into action. Study those examples you want to emulate and those you want to avoid so you have clarity of what it looks like for when you face similar circumstances.

Nobody can expect to be perfect; everyone can expect to have less than optimal experiences. As the saying goes, “If it was easy anybody could do it.”

Providing focused, empathetic, compassionate care is a never-ending, ongoing quest; it is the means and

the end-goal we relentlessly pursue. We might never get there fully, but hopefully with a more intentional approach we can deliver excellence with integrity. J REFERENCES: 1. Daniel Goleman. Focus: The hidden driver of excellence. New York: Harper Collins; 2013.

2. Wentzel KR. Student motivation in middle school: The role of perceived pedagogical caring. Journal of Educational Psychology. Sept 1997;89(3):411-419.

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. 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. He has indicated no relationships to disclose relating to the content of this article. For additional information or to contact the IEE, please visit www.excellenceandethics.org.

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62 Journal of Dermatology for Physician Assistants

| 1-800-380-3922

AVAILABLE FROM VALEANT DERMATOLOGY: BENSAL HP®

Indications and Usage

An external treatment for the inflammation and irritation associated with many common forms of dermatitis, including certain eczematoid conditions. These conditions include complications associated with pyodermas.

Indicated also in the treatment of insect bites, burns, and fungal infections.

Important Safety Information

• BENSAL HP is contraindicated for use in those patients who are hypersensitive to topical polyethylene glycols.

• BENSAL HP is for external use only. Not to be used in eyes.

• It is not known if BENSAL HP interacts with other topical medications applied to the treatment area. Use with other topical agents has not been studied.

• A small percentage of patients may experience a temporary burning sensation upon application of the ointment.

• Safety and effectiveness in pediatric patients has not been established.

Please see full Prescribing Information on the following page.

Reference: BENSAL HP [prescribing information]. Easley, SC: 7 Oaks Pharmaceutical Corp; 2010.

The BENSAL HP trademark is used under license. Except where otherwise indicated, all other products, names, slogans, and other marks are trademarks of the Valeant family of companies. © 2014 Valeant Pharmaceuticals North America LLC. DM/BHP/14/0003(1) Printed in USA.

Volume 8 • number 4 • FALL 2014 63

Rx Only Prescribing Information DESCRIPTION: Bensal HP ® ointment contains 30 mg salicylic acid per gram in a base containing: Benzoic acid, polyethylene glycol 400, polyethylene glycol 3350 and oak bark extract (QRB-7).

CLINICAL PHARMACOLOGY: The mechanism of action of Bensal HP ® is not known. W hile the following animal data are available, their clinical significance is unknown. It has been demonstrated that Bensal HP ® significantly reduces methicillin-resistant Staphylococcus aureus (MRSA) protected by biofilms in wounds using porcine models. In addition, Bensal HP ® stimulates re-epithelialization of second-degree burns in porcine models.

CLINICAL STUDIES: A randomized, double-blind, placebo-controlled study evaluated the rate of wound re-epithelialization. Four partial-thickness wounds (2x2 cm & 0.2 mm deep) were created under local anesthesia on the thighs of 13 normal, healthy, male volunteers with an electrokeratome. Bensal HP ® substantially increased the rate of re-epithelialization by 63% over the vehicle alone (p<0.01) and 77% over untreated control (p<0.005).

INDICATIONS AND USAGE: An external treatment for the inflammation and irritation associated with many common forms of dermatitis, including certain eczematoid conditions. These conditions include complications associated with pyodermas. Indicated also in the treatment of insect bites, burns and fungal infections.

CONTRAINDICATIONS: Bensal HP ® is contraindicated for use in those patients who are hypersensitive to topical polyethylene glycols.

PRECAUTIONS: For external use only. Not to be used in eyes.

DRUG INTERACTIONS: It is not known if Bensal HP ® interacts with other topical medications applied to the treatment area. The use of Bensal HP ® with other topical drugs has not been studied.

ADVERSE REACTIONS: Bensal HP ® is generally well tolerated and non-irritating. A small percentage of patients may experience a temporary burning sensation upon application of the ointment.

DOSAGE AND ADMINISTRATION: Patients should be advised to follow these step-by-step instructions for application of Bensal HP ® Ointment:

Hands should be washed thoroughly.

W hen using tubes, the tip of the tube should not come into contact with the area to be treated; the tube should be recapped tightly after each application.

If applying with a cotton-tipped applicator, which is recommended, use once and discard.

Bensal HP ® Ointment should be applied twice a day for best results.

Gently rinse the area to be treated with saline or water and then pat dry. Bensal HP ® Ointment can be applied directly to the wound or placed on dry gauze and then placed on the wound. Wet-Packs or Wet-To-Dry Dressings are not recommended since they will dilute the ointment and decrease its effectiveness.

Bensal HP ® is designed to provide moisture to the wound.

Spread a generous quantity of Bensal HP ® Ointment evenly over the desired area to yield a thin continuous layer of approximately 1/8 of an inch of thickness. There may be a mild warming sensation, or slight burning, to the treated area for 3-5 minutes after application. If irritation occurs or symptoms persist after 10 days, discontinue use and consult your physician.

Try to keep the area being treated clean and exposed to air when possible. Apply an appropriate dressing to shield the area from clothes or exposure to water or dirt.

If there is no improvement in the wound within 7 days, consult your physician for further evaluation of the wound. If there is no response to the ointment at all, then the wound should be re-evaluated for other contributing factors to the wound healing process.

PEDIATRIC USE: Safety and effectiveness in pediatric patients has not been established.

HOW SUPPLIED: 15 g tube .................................. NDC 63801 - 0107 - 09 30 g tube .................................. NDC 63801 - 0107 - 01 4 g tube .................................. NDC 63801 - 0107 - 12 2 g sample packet .................................. NDC 63801 - 0107 - 13 10 count 2 g sample packet carton .................................. NDC 63801 - 0107 - 10 Store at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted between 15ºC and 30ºC (between 59ºF and 86ºF). Brief exposure to temperatures up to 40ºC (104ºF) may be tolerated provided the mean kinetic temperature does not exceed 25ºC (77ºF); however, such exposure should be minimized.

Bensal HP ® inhibited all tested microbial strains, both Gram negative and Gram positive, in a Minimum Inhibitory Concentration (MIC) test against the following 49 select pathogens.

Minimum Inhibitory Concentration Testing of QRB-7 The minimum inhibitory concentrations (MIC) of QRB-7 are listed below in parts per million (PPM)* .

Microorganism Microorganism

QRB-7

Microorganism

QRB-7

Parts Per Million

Microorganism

Parts Per Million

Staphylococcus aureus, ATCC 6538 Salmonella choleraesuis, ATCC 10708 * Enterococcus faecalis, ATCC 19433 Pseudomonas cepacia, ATCC 10856 Staphylococcus epidermidis, ATCC 17917 Alcaligenes faecalis, ATCC 8750 Streptococcus uberis ATCC 27958 Escherichia coli, ATC 25922 Klebsiella pneumoniae, ATCC 13883 Pseudomonas aeruginosa, ATCC 10145 Shigella flexneri type 1A ATTC 9199 Pseudomonas paucimobilis, ATCC 29837 Streptococcus sanguis, ATCC 10556 Acinetobacter lewoffii, ATCC 9957 Pseudomonas putida, HTB Isolate Aeromonas sobria, ATCC 9071 Staphylococcus hominus, ATCC 27844 Staphylococcus haemolyticus, ATCC 29970 Staphylococcus saprophyticus, ATCC 15305 Staphylococcus simulans, ATCC 27848 Micrococcus lylae, ATCC 27566 Streptococcus agalactiae ATCC 13813 Streptococcus equisimilis ATCC 9542 Pseudomonas alcaligenes, ATCC 14909 Klebsiella oxytoca, ATCC 15764

25,000 25,000 50,000 3,125 12,500 25,000 12,500 25,000 25,000 25,000 12,500 1,563 12,500 25,000 6,250 25,000 12,500 25,000 25,000 25,000 50,000 12,500 12,500 25,000 12,500

Pseudomonas stutzeri, ATCC 17588 Salmonella typhi, ATCC 6539 Enterobacter aerogenes, ATCC 15038 Group D enterococcus Trichophyton mentagrophytes CDC y68+ Rhodotorula rubra HTB Isolate Enterobacter cloacae, Hosp/Envi isolate Escherichia coli, Hosp/Envi isolate Pseudomonas cepacia, Hosp/Envi isolate Klebsiella pneumoniae, Hosp/Envi isolate Staphylococcus aureus, Hosp/Envi isolate Acinetobacter calcoaceticus, ATCC 17961 Alcaligenes faecalis, ATCC 337 Enterobacter cloacae, ATCC 23355 Achromobacter xylosoxidans, HTB isolate Salmonella typhi, ATCC 19430 Listeria monocytogenes, ATCC 15313 Serratia marcesans, ATCC 14756 Serratia marcesans, ATCC 13880 Candida albicans, ATCC 10231 Serratia marcensans, Hosp/Envi isolate Salmonella enteritidis, ATCC 13076 Escherichia coli, ATCC 11229 Proteus mirabilis, ATCC 9240

50,000 12,500 25,000 50,000 50,000 50,000 25,000 25,000 25,000 25,000 50,000 25,000 25,000 25,000 25,000 25,000 12,500 25,000 25,000 12,500 25,000 25,000 25,000 25,000

* Data on file: 7 Oaks Pharmaceutical Corp., Easley, SC

Manufactured by: Sonar Products Inc. • Carlstadt, NJ For: 7 Oaks Pharmaceutical Corp.

• Easley, SC

© 2010 7 Oaks Pharmaceuticals Corp.

64 Journal of Dermatology for Physician Assistants

• 877.723.6725 BHP-PI TD 1012

From the Desk of...

Jennifer Winter, MSPAS, PA-C SDPA Immediate Past President SDPA Diplomate

A recent article in the New York Times entitled, “The Physician Assistant Will See You” has the potential to raise awareness of the physician assistant (PA) profession. This increased awareness is a good thing because the PA profession is growing by leaps and bounds, and most patients are likely to encounter a PA at some point when seeking medical care. The more the public understands about those who care for them, the better. Accurate information is critical to the educational process.

One paragraph in the article references a survey commissioned by the American Academy of Family Physicians (AAFP). The article suggests that the survey indicates that PAs are not well embraced by patients. Clicking the link leads to the AAFP website and an announcement of the survey results in December 2013: www.aafp.org/news/practiceprofessional-issues/20131218ipsossurvey.html.

However, the actual survey found at http://ipsos-na. com/download/pr.aspx?id=13294 does not address the relationship between patients and PAs. The survey asks which type of provider people prefer to see and the results are as follows: Physician – strongly 56% Physician – not so strongly 16% NP – strongly 4% NP – not so strongly 3% No preference 16% Don’t know 5% To say that PAs are not embraced based on the results of this survey is speculation. The same question was asked again following a paragraph describing nurse practitioner (NP) training, to see if the responders changed their opinion. They did and the answers are as follows: Physician – strongly 49% Physician – not so strongly 17% NP – strongly 8% NP – not so strongly 6% No preference 14% Don’t know 5%

It is clear that education can change minds. However, education based on inaccurate information will lead to inaccurate opinions, which are not constructive in improving public health or in creating better patient/provider relationships.

The article goes on to suggest that PAs’ role in mental health care is one of the reasons misdiagnoses, underdiagnoses, and the over-prescription of antidepressants have flooded the mental health system. Unfortunately, the author does not provide any supporting documentation that PA practice is the cause of these changes versus other factors such as direct to consumer advertising or the influence of large numbers of military war veterans returning to civilian life. Unsupported speculation such as this is not helpful to the discussion and potentially unfairly damaging.

The Society of Dermatology Physician Assistants fully supports adequate training of any provider, physician, PA, or NP prior to autonomous practice. For the PA, this additional training occurs after graduation under the direction of a supervising physician whose duty it is to ensure that the PA is well trained before increasing his/her level of autonomy. It is in everyone’s best interest that accurate information is available to help the public better understand the roles of the many different providers whom they may encounter in the team sport that medicine now is. J Jennifer Winter, MSPAS, PA-C is a graduate of MEDEX NW Physician Assistant Program and has practiced dermatology for 14 years at Dermatology and Allergy Specialists of Olympia in Olympia, Washington. Jennifer currently serves as the SDPA Immediate Past President and is an SDPA Diplomate as well.

Volume 8 • number 4 • FALL 2014 65

DERmatology pa news & notes

Accurate Information Helps

Supervising Physician CORNER The Dermatology Care Team An Interview with David Pariser, MD

DERmatology pa news & notes

By J. Margaret Casey As a result of the Affordable Care Act (ACA), it is projected that there will be an increase in the number of new patients entering into the healthcare system. Examining ways to approach this patient increase and the subsequent heightened demand for dermatological care coupled with the shortage of dermatologists in many areas of the U.S. is on the forefront of the AAD’s Academy Workgroup on Dermatology Care Team Implementation.

Former AAD President, David M. Pariser, MD, chair of the Academy Workgroup on Dermatology Care Team Implementation has observed firsthand this increased demand on the dermatology workforce. Dr. Pariser began to incorporate PAs into his dermatology care team in 2005. His practice currently consists of eleven dermatologists and employs six PAs and one nurse practitioner.

“Without an increase in the number of physicians, particularly for dermatologists, it’s going to be more and more difficult to meet the demand of all the patients who need care,” Dr. Pariser said in an interview with the AAD’s Dermatology World. According to Dr. Pariser, “The team-based approach is the natural evolution of solutions dermatologists and practice managers have been experimenting with for years.”

“The idea of the care team is coming forth as a way to help meet the demand with the workforce that we have.

A group of people will work together under defined roles to provide care for the patient,” Dr. Pariser said. “The AAD Board has gone along with this concept, and the Academy is going to be including other people in the care team so that dermatologists will be able to maintain a high quality of care for all the patients that we treat.”

We had an opportunity to interview Dr. Pariser and learn more about the AAD’s establishment of the dermatology care team and the role PAs can play in educating and introducing this program to the public.

JDPA: What message does the AAD wish to communicate to dermatology PAs about the dermatology care team approach?

Dr. Pariser: As healthcare evolves and more patients need dermatological care, there are not enough dermatologists to meet these needs. PAs have been and will continue to be providers of healthcare. The AAD believes that the best way for PAs to provide care is for patients to be seen by dermatologists and by PAs who are functioning under appropriate supervision standards.

This approach will enable providers to extend more care to more patients through collaboration between dermatologists and PAs. The AAD’s position is to have a standardized appropriate degree of supervision.

Establishing an appropriate standard of care would hold dermatology PAs, as well as NPs, to the same standard.

PAs should not be treating or caring for patients without appropriate physician supervision.

JDPA: How can the SDPA help to educate its members who may be working within a state’s legal parameters but outside of what the AAD would consider as appropriate supervision?

Dr. Pariser: The SDPA can certainly help to educate their members about inappropriate care. For example, 66 Journal of Dermatology for Physician Assistants

working at a satellite clinic that the physician never comes to is not providing appropriate care. Taking care of the overall population is part of our goal, as is doing so within appropriate terms and standards.

JDPA: What is the AAD’s opinion of the SDPA’s DLI or the AAD’s Medical Student Core Curriculum program in regards to improving the quality of care provided to patients?

Dr. Pariser: These tools provide great educational value. However, they are haphazard to some extent.

The AAD would like to see a more universal method of educating dermatology providers, as opposed to several different methods that may not be at the same standard.

The AAD wants to tailor the content and manage the delivery of the education that non-physician providers working in dermatology receive. The AAD wants to have introductory educational materials through advanced training available. The AAD will be holding focus groups to see what kinds of specific programs they want to offer.

JDPA: In terms of helping to educate dermatology PAs, what access will they have to the AAD’s educational offerings?

Dr. Pariser: The AAD is still looking to share the electronic and print version of the JAAD. As for our

David M. Pariser, MD, FACP, FAAD is a Professor in the Department of Dermatology at Eastern Virginia Medical School in Norfolk, Virginia where he is also the senior physician in Pariser Dermatology Specialists, Ltd., a private group practice of eleven dermatologists, six PAs and one nurse practitioner with multiple locations in the southeastern Virginia Area.

He obtained his undergraduate degree from the University of Pennsylvania, medical degree from Medical College of Virginia and trained as a dermatology resident in Florida at the University of Miami. Dr. Pariser is Board Certified in both dermatology and dermatopathology.

Quite active in the affairs of the AAD of which he was President in 2009-2010, and was Assistant Secretary-Treasurer for three years, Secretary-Treasurer for three years, and was a Board member of the AAD for fourteen years. He is a long-time advocate for the dermatology care team approach and for education, training, and proper supervision of non-physician clinicians. He has co-authored twenty-two AAD publications on Guidelines of Care.

Dr. Pariser holds fellowships from the AAD, the American Society of Dermatopathology, and the American College of Physicians.

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Volume 8 • number 4 • FALL 2014 67

DERmatology pa news & notes

Annual Meeting, this year the AAD held focus groups of PAs to ask about their educational needs. From the information gathered there it now seems that a free standing program, planned by the AAD with significant input from the PA community, will be a good way to provide PAs with dermatological education. The remainder of the Annual Meeting will still have only a few areas that dermatologists alone will have access to, such as the advanced surgical and cosmetic training sessions.

JDPA: What do you see as the ideal future goal for the dermatology care team approach?

Dr. Pariser: The ideal future goal will be for the care team to provide better, higher quality care to patients. We plan on promoting the care team concept to the general public so that there is an awareness among patients about the provider they are seeing. Those who are a part of the care team program will wear a designated care team logo on their lab coats. It is our hope that this type of branding will provide patients with an identifiable truth in labeling. Patients will be readily able to recognize this distinction and will know that they are receiving their care from an AAD dermatology care team participating provider. J

Dermatology in Art Improving Diagnostic Skills Through the Observation of Fine Art

DERmatology pa news & notes

By Travis Hayden, MPAS, PA-C JDPA Editor in Chief

Historical Background – These 19th century illustrations come from a book written by French dermatologist Jean-Louis-Marie Alibert in 1833. The book was titled: Clinic of the Saint Louis Hospital, or, Complete Treatise of the Diseases of the Skin, Containing the Descriptions of These Diseases and of the Best Ways to Treat Them.

Look back at this painting now. Can you tell if this woman is febrile? Is she in the later “desquamation” stage of scarlet fever? Does she exhibit swollen glands in her neck, circumoral pallor, or Pastia lines? Did the artist intentionally paint her in a low cut nightshirt to accentuate the truncal spread of the rash?

Observations – The woman appears to be sleeping. She is in her nightclothes with her head resting on a pillow, and her eyes are shut. It appears that she has been well cared for. Her clothing is not soiled; it appears clean.

Her hair is not disheveled but rather is neatly tucked into her ornately ruffled bonnet with the exception of one escaping curl.

When observing this next piece, what do you see? What does the piece make you think, make you feel?

“Scarlatine Normale” Illustration by Jean-Louis-Marie Alibert, 1833.

Courtesy of The Lilly Library, Indiana University, Bloomington, Indiana.

Thoughts & Questions (Observe what you see in the painting to elicit answers to the following questions) – Is this women in pain? Is she asleep? Does she have a fever?

Could she be recovering? Is she at home or in a hospital?

Does she have family? Do you think they visit her? Did the rash just begin or is it on its way out?

Actual diagnosis – Scarlet Fever Observations pertaining to the diagnosis – The rash of scarlet fever is its most striking feature and appears like a severe sunburn with tiny bumps within 12 to 72 hours after the fever begins. The rash initially can appear on the neck and face, and often leaves a clear, unaffected area around the mouth (circumoral pallor). It may then begin to spread to the chest and back and finally to the rest of the body. In the body creases, especially around the axillae and elbows, the rash forms classic red streaks known as Pastia lines. By the sixth day of the infection the rash usually fades (after sore-throat symptoms begin), and the affected skin may begin to desquamate.2 Other symptoms that help to confirm a diagnosis of scarlet fever include a reddened and sore throat with a bright red tongue with a “strawberry” appearance, a fever at or above 101°F, and swollen glands in the neck.

An infected person may have malaise, chills, nausea, vomiting, and loss of appetite.2 68 Journal of Dermatology for Physician Assistants

Tell us what you see

Please take a moment to observe this issue’s artwork.

To view the piece in more detail, please visit www. jdpa.org/current. html where the artwork can be enlarged/ expa nded digitally and viewed in greater detail.

We invite readers to email us their initial thoughts, comments, questions, and observations (both general and detailed) as well as what you think the likely diagnoses may be. Send all observations to editor@jdpa.org.

Remember, there can be no wrong observations with this exercise. The point is to practice our ability to observe what is presented and fine-tune this skill to the point that we are observing both the big picture as well as the minute details. J REFERENCES: 1. Dolev JC, Friedlaender LK, and Braverman IM. Use of Fine Art to Enhance Visual Diagnostic Skills. JAMA. 2001;286(9):1020-1021.

2. Zabawski EJ, James WD, et al. Scarlet Fever. Available at http://emedicine. medscape.com/article/1053253-overview#. Accessed October 19, 2014.

Travis Hayden, MPAS, PA-C presently resides in upstate New York where he has enjoyed practicing dermatology since 2003 at Dermatology Associates of Rochester. He is an adjunct instructor and preceptor for both Le Moyne College Physician Assistant Program and SUNY Upstate Medical University Department of Physician Assistant Studies. He has indicated no relationships to disclose relating to the content of this article.

Journal of Dermatology for Physician Assistants Information for Authors – The JDPA is a peer-reviewed publication that delivers innovative clinical, surgical, cosmetic, and professional content exclusively for dermatology PAs. Submissions to the JDPA are peer-reviewed by a panel of experienced dermatology PAs, educational PAs, and dermatologists before articles are accepted for publication.

Manuscripts submitted for publication will be reviewed with the understanding that they are original and have not been submitted elsewhere nor are being considered by other journals. Electronic submissions are accepted and should be sent to editor@ jdpa.org.

The five main sections featured in each issue of the JDPA are listed below along with a brief description of the various topics that authors can contribute to. Regardless of the section, all articles must follow the following criteria: • Formatting - Times New Roman font, 12 point, double-spaced, left aligned.

• Article Order - Title, Author(s), Author bios (including disclosures), Text of Article, References, Tables, and Figures • Reference Citations - Utilize the AMA Manual of Style, 10th Edition.

Dermatology PA News and Notes Feature Articles

Write a review about a new or innovative dermatological procedure, device, and/or approach to patient care (500-1000 words).

From The Desk Of…

Write an opinion essay sharing your insight regarding a current “hot item” issue (e.g., specialty PA credentialing, dermatology access to care, supervising physician relationships, etc.) or any other topic regarding the field of dermatology (250-1000 words).

Clinical Dermatology CME articles

Content should be specific to the field of dermatology following any of the following formats: Study – Original research (clinical or basic science).

Professional issues or health policy papers.

Review – Scholarly review of a topic.

Content length: 6 pages (requires 4 self-assessment Q&A) = .5hr of Cat. I CME. 12 pages (requires 8 self-assessment Q&A) = 1hr of Cat. I CME. Article should include written learning objectives (3-4 required).

Dermatology Case Report

Write a report and discuss a case(s) that illustrate an important or interesting observation (500-1500 words).

Journal Club: Dermatology PA Perspectives

Write a review of an already published article from an established dermatology journal (e.g., JAAD, Cos Dermatol, Dermatol Surg, etc.), summarizing the practical thoughts and clinical issues (250-1000 words).

From the Patient’s Perspective

Patients’ stories published in their own words. JDPA staff can even assist patients with writing their stories (250-1000 words).

Clinical Snapshots

Write a brief written description and clinical facts about an interesting cutaneous anomaly (250-500 words).

Drugs in Dermatology

Write about the current information regarding a particular dermatological medication, drug interaction, or medication side effect/adverse reaction (250-1000 words).

Dermatology Evidence-Based Medicine (derm EBM)

Write a brief, evidence-based assessment of the one or two most relevant studies retrieved to answer a focused clinical question that may have arisen from a real-life situation. A derm EBM is not a comprehensive review of a subject or a synthesis of all the available knowledge (500–1500 words).

Surgical Dermatology Feature Articles

Write a review about a new or innovative surgical procedure, device, and/or approach to patient care (500-1000 words).

Surgical Wisdom

Write a brief article on a fact or pearl for the surgical setting (250-500 words).

Surgical Dermatology Case Report

Write a report and discuss a case(s) that illustrate an important or interesting observation (500-1500 words).

Journal Club: Dermatology PA Perspectives

Write a review of an already published article from an established dermatology journal (e.g., JAAD, Cos Dermatol, Dermatol Surg, etc.), summarizing the practical thoughts and clinical issues (250-1000 words).

Cosmetic Dermatology Feature Articles

Write a review about a new or innovative cosmetic procedure, device, and/or approach to patient care (500-1000 words).

Cosmetic Pearls

Write a brief article on a fact or pearl for the cosmetic setting (250500 words).

Cosmetic Dermatology Case Report Write a report and discuss a case(s) that illustrate an important or interesting observation (500-1500 words).

Journal Club: Dermatology PA Perspectives

Write a review of an already published article from an established dermatology journal (e.g., JAAD, Cos Dermatol, Dermatol Surg, etc.), summarizing the practical thoughts and clinical issues (250-1000 words).

Professional Development Feature Articles

Write an article that explores the professional issues dermatology PAs face such as reimbursement, education, medical trends, contracts, office management, etc. (500-1500 words).

Outside & Inside the 9 to 5

Allow us to share your story of the good work that you do either outside or inside your practice of dermatology. You can write this article yourself or the JDPA staff can interview you to write the article (250-1000 words). Notes From Your Office Manager Write a brief article on a fact or pearl for the office setting (250-500 words).

Judicial and Ethical Affairs

Write an article that explores the complex or multifaceted ethical or judicial professional issues that affect the practice of dermatology for PAs (250-1000 words).

Volume 8 • number 4 • FALL 2014 69

Professional Opportunities and Development

A dver t iser INDE X • Novartis Pharmaceuticals Corp. ........ Pages 2, 3 • Ranbaxy – Halog.................................Pages 7, 8 • Promius Pharma - Cloderm.............Pages 11, 12 • Bayer HealthCare – Finacea................... Page 15 • Valeant – Elidel............................. Pages 23 - 25 • Valeant – Acanya.............................Pages 29, 30 • Amgen – Enbrel............................ Pages 35 - 40 • Genentech...................................... Pages 48, 49 • Valeant – Solodyn.......................... Pages 57 - 59 • Valeant – Bensal HP....................... Pages 63, 64 • Aqua Pharmaceuticals – Acticlate.....Pages 71, 72 For more information on advertising opportunities in the JDPA, please log on to www.jdpa.org

Available Now! The SDPA’s First Ever Interactive Derm PA Resume The perfect resume building tool to assist the aspiring dermatology PA.

www.dermpa.org

70 Journal of Dermatology for Physician Assistants

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1-800-380-3922

BRIEF SUMMARY (see package insert for Full Prescribing Information)

ACTICLATE™ (doxycycline hyclate USP) Tablets Aqua Pharmaceuticals, an Almirall company This brief summary does not include all the information needed to use ACTICLATE™ Tablets safely and effectively.

See full prescribing information for ACTICLATE™ Tablets.

INDICATIONS ACTICLATE™ is a tetracycline-class antimicrobial indicated for: • Rickettsial infections • Sexually transmitted infections • Respiratory tract infections • Specific bacterial infections • Ophthalmic infections • Anthrax, including inhalational anthrax (post-exposure) • Alternative treatment for selected infections when penicillin is contraindicated • Adjunctive therapy in acute intestinal amebiasis and severe acne • Prophylaxis of malaria To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate and other antimicrobial drugs, ACTICLATE Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

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

WARNINGS AND PRECAUTIONS • The use of drugs of the tetracycline-class during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-graybrown). This adverse reaction is more common during long-term use of the drugs but it has been observed following repeated short-term courses. Enamel hypoplasia has also been reported.

Doxycycline should not be used in this age group, except for anthrax, including inhalational anthrax (post-exposure), unless other drugs are not likely to be effective or are contraindicated.

• Clostridium difficile-associated diarrhea: Evaluate patients if diarrhea occurs.

• Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Patients apt to be exposed to direct sunlight or ultraviolet light should be advised that this reaction can occur with tetracycline drugs, and treatment should be discontinued at the first evidence of skin erythema.

• Overgrowth of non-susceptible organisms, including fungi, may occur. Reevaluate therapy if superinfection occurs.

• Intracranial hypertension (IH, pseudotumor cerebri) has been associated with the use of tetracyclines including ACTICLATE. Women of childbearing age who are overweight or have a history of IH are at greater risk for developing tetracycline associated IH. Concomitant use of isotretinoin and ACTICLATE should be avoided because isotretinoin is also known to cause pseudotumor cerebri.

• All tetracyclines form a stable calcium complex in any bone-forming tissue. This reaction was shown to be reversible when the drug was discontinued.

• The antianabolic action of the tetracyclines may cause an increase in BUN. • Doxycycline offers substantial but not complete suppression of the asexual blood stages of Plasmodium strains. Doxycycline does not suppress P. falciparum’s sexual blood stage gametocytes. Subjects completing this prophylactic regimen may still transmit the infection to mosquitoes outside endemic areas.

• Prescribing ACTICLATE in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

• In long-term therapy, periodic laboratory evaluation of organ systems, including hematopoietic, renal and hepatic studies should be performed.

ADVERSE REACTIONS Due to oral doxycycline’s virtually complete absorption, side effects to the lower bowel, particularly diarrhea, have been infrequent. The following adverse reactions have been observed in patients receiving tetracyclines.

• Gastrointestinal: Anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, and inflammatory lesions (with monilial overgrowth) in the anogenital region. Hepatotoxicity has been reported. These reactions have been caused by both the oral and parenteral administration of tetracyclines. Instances of esophagitis and esophageal ulcerations have been reported in patients receiving capsule and tablet forms of drugs in the tetracyclineclass. Most of these patients took medications immediately before going to bed.

• Skin: Maculopapular and erythematous rashes, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, and erythema multiforme have been reported. Photosensitivity is discussed above (see Warnings and Precautions).

• Renal Toxicity: Rise in BUN has been reported and is apparently dose-related (see Warnings and Precautions).

• Hypersensitivity Reactions: Urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, serum sickness, pericarditis, and exacerbation of systemic lupus erythematosus.

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

• Intracranial Hypertension: Intracranial hypertension (IH, pseudotumor cerebri) has been associated with the use of tetracyclines (see Warnings and Precautions).

• Thyroid Gland Changes: When given over prolonged periods, tetracyclines have been reported to produce brown-black microscopic discoloration of thyroid glands. No abnormalities of thyroid function are known to occur.

to outweigh the risks such as for anthrax, or when other drugs are not likely to be effective or are contraindicated (see Warnings and Precautions).

Geriatric Use Clinical studies of doxycycline hyclate tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

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

• Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracyclines in conjunction with penicillin.

• Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, and iron-containing preparations.

• Concurrent use of tetracycline may render oral contraceptives less effective.

• Barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline.

• The concurrent use of tetracycline and Penthrane® (methoxyflurane) has been reported to result in fatal renal toxicity.

• False elevations of urinary catecholamines may occur due to interference with the fluorescence test.

PATIENT INFORMATION Advise patients taking doxycycline for malaria prophylaxis: • that no present-day antimalarial agent, including doxycycline, guarantees protection against malaria.

• to avoid being bitten by mosquitoes by using personal protective measures that help avoid contact with mosquitoes, especially from dusk to dawn (for example, staying in well-screened areas, using mosquito nets, covering the body with clothing, and using an effective insect repellent).

• that doxycycline prophylaxis: – should begin 1 day to 2 days before travel to the malarious area, – should be continued daily while in the malarious area and after leaving the malarious area, – should be continued for 4 further weeks to avoid development of malaria after returning from an endemic area, – should not exceed 4 months.

Advise all patients taking doxycycline: • to avoid excessive sunlight or artificial ultraviolet light while receiving doxycycline and to discontinue therapy if phototoxicity (for example, skin eruptions, etc.) occurs. Sunscreen or sunblock should be considered (see Warnings and Precautions).

• to drink fluids liberally along with doxycycline to reduce the risk of esophageal irritation and ulceration (see Adverse Reactions).

• that the absorption of tetracyclines is reduced when taken with foods, especially those that contain calcium. However, the absorption of doxycycline is not markedly influenced by simultaneous ingestion of food or milk (see Drug Interactions).

• that the absorption of tetracyclines is reduced when taken with antacids containing aluminum, calcium or magnesium, bismuth subsalicylate, and iron-containing preparations (see Drug Interactions).

• that the use of doxycycline might increase the incidence of vaginal candidiasis.

Diarrhea is a common problem caused by antibacterials which usually ends when the antibacterial is discontinued. Sometimes after starting treatment with antibacterials, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of antibacterial. If this occurs, patients should contact their physician as soon as possible.

USE IN SPECIFIC POPULATIONS Pregnancy Teratogenic Effects. Pregnancy Category D There are no adequate and well-controlled studies on the use of doxycycline in pregnant women. The vast majority of reported experience with doxycycline during human pregnancy is short-term, first trimester exposure. There are no human data available to assess the effects of long-term therapy of doxycycline in pregnant women such as that proposed for the treatment of anthrax exposure.

Counsel patients that antibacterial drugs including ACTICLATE should only be used to treat bacterial infections. They do not treat viral infections (for example, the common cold). When ACTICLATE is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by ACTICLATE or other antibacterial drugs in the future.

Nursing Mothers Tetracyclines are excreted in human milk, however, the extent of absorption of tetracyclines including doxycycline, by the breastfed infant is not known. Short-term use by lactating women is not necessarily contraindicated. The effects of prolonged exposure to doxycycline in breast milk are unknown. Because of the potential for serious adverse reactions in nursing infants from doxycycline, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother (see Warnings and Precautions).

To report SUSPECTED ADVERSE REACTIONS, contact Aqua Pharmaceuticals at 1-866-665-2782 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Pediatric Use Because of the effects of drugs of the tetracycline-class on tooth development and growth, ACTICLATE should not be used in pediatric patients to the age of 8 years, unless the potential benefits are expected

For Aqua Pharmaceuticals, an Almirall Company West Chester, PA 19380 August 2014

Manufactured by Catalent Pharma Solutions, Winchester, KY 40391

Volume 8 • number 4 • FALL 2014 71

For adjunctive tHeraPY in severe acne

NEW

from AquA

THE NEXT

SMALL THING

Introducing ACTICLATE Tablets TM

150 mg and 75 mg film-coated tablets

Small enough for patients to take1

Functional score delivers a clean break for flexible and accurate dosing1,2

Easy for patients to break

Can be taken with or without food2

No generic equivalent (Actual Size) 150 mg tablet shown

For more information, please visit www.ACTICLATE.com

Important Safety Information Regarding ACTICLATE™ (doxycycline hyclate USP) Tablets, 150 mg and 75 mg

ACTICLATE™ is indicated for adjunctive therapy in severe acne.

• ACTICLATE™ should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

• ACTICLATE™ Tablets are contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

• The use of drugs of the tetracycline-class during tooth development (last half of pregnancy, infancy, and childhood to 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown).

• Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including ACTICLATE™, and may range in severity from mild diarrhea to fatal colitis. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against Clostridium difficile may need to be discontinued.

• Photosensitivity manifested by an exaggerated sunburn

Please see brief summary of Prescribing Information on next page.

References: 1. Data on file. Aqua Pharmaceuticals. West Chester, PA. 2013.

2. ACTICLATE™ (Doxycycline Hyclate USP) Tablets Prescribing Information. Aqua Pharmaceuticals. West Chester, PA. 2014.

aquapharm.com © 2014 Aqua Pharmaceuticals, West Chester, PA 19380 ACT - 014

72 Journal of Dermatology for Physician Assistants

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reaction has been observed in some individuals taking tetracyclines. Limit sun exposure.

Intracranial Hypertension (IH) has been associated with the use of tetracyclines. Women of childbearing age who are overweight or have a history of IH are at greater risk for developing tetracycline-associated IH. Adverse reactions observed in patients receiving tetracyclines include the following: anorexia, nausea, vomiting, diarrhea, rash, photosensitivity, urticaria and hemolytic anemia.

Additional adverse events identified after marketing doxycycline hyclate include: Stevens-Johnson syndrome, rise in BUN, angioneurotic edema, exacerbation of systemic lupus, thrombocytopenia, neutropenia and eosinophilia.

Concurrent use of tetracycline may render oral contraceptives less effective.

Pregnancy Category D. ACTICLATE™ use during nursing should be avoided, if possible.

Patients are advised to drink fluids liberally along with doxycycline to reduce the risk of esophageal irritation and ulceration.