JDPA Winter 2017

DPA J

V o l u m e 1 1 • n u m b e r 1 • w i n t e r 2 0 1 7 • www.jdpa.org

Journal of Dermatology for Physician Assistants

Dermatology PA News & Notes DPAF News 13 __________________________________

CLINIcal dermatology Dermatology Case Report

29

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surgical dermatology Surgical Wisdom 33 _________________________________

cosmetic dermatology Cosmetic Pearls 40 __________________________________

professional development Judicial & Ethical Affairs

42

›› Earn CME credit with this issue CME Biologic Agents for Psoriasis Where Are We Now?

15

Official Journal of the Society of Dermatology Physician Assistants

Volume 11 • number 1 • winter 2017

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Have you been thinking about hiring a DermPA? The demand for dermatological services has never been higher, from patient care and education, to skin surgery, treatment of chronic skin conditions, and cosmetic procedures, a PA will be a dynamic addition to your healthcare team.

844-DERMPAS (844-337-6727) • dermpa.org

Volume 11 • number 1 • winter 2017

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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 Lauren Zajac, MHS, PA-C Michelle DiBaise, MPAS, 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, PhD, 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 Travis Hayden, MPAS, PA-C Prof Dev Department Editor Abby Jacobson, MS, PA-C

2016-17 SDPA Board of Directors PRESIDENT Jennifer Conner, MPAS, PA-C PRESIDENT-ELECT Jane Mast, MPAS, PA-C IMMEDIATE PAST PRESIDENT Matthew Brunner, MHS, PA-C VICE PRESIDENT Jacki Kment, MPAS, PA-C SECRETARY / TREASURER Joleen Volz, MPAS, PA-C DIRECTORS AT LARGE Matt Dohlman, MHS, PA-C Gina Mangin, MPAS, PA-C Mark Hyde, MMS, PA-C Archana Sangha, MMS, 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 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 To read the JDPA publication’s Ethics and Malpractice Statement, please visit www.jdpa.org/write.html. 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 11, Number 1, Winter 2017. 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. © 2017 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., 8400 Westpark Drive, 2nd Floor, McLean, VA 22102 1-800-380-3992., email SDPA@dermpa.org, www.dermpa.org.

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Journal of Dermatology for Physician Assistants

Editor’s Message

I

n a world that offers bigger, better, and faster of just about anything and everything, I believe that simpler is oftentimes better. Making a conscience effort to slow down and simplify can be of great benefit. This ‘simpler is better’ approach can be applied to many aspects of our profession ranging from our treatment approaches for various dermatological conditions (such as atopic dermatitis) to our understanding of the recent AAPA Full Practice Authority and Responsibility (FPAR) proposal and how we go about discussing it with our colleagues and supervising physicians.

Recently in my office we had a very productive discussion regarding an article published in JAMA Pediatrics about the cost-effectiveness of prophylactic moisturization for newborns with atopic dermatitis. As many of us know, atopic dermatitis is a major health burden to our patients/families and is a significant expense to the US health care system. One recent study showed that adults with eczema paid more than $29.3 billion in out-of-pocket health care costs (an average of $489 per person-year).1 The JAMA Pediatrics article our provider staff was discussing had conducted a cost-effectiveness study using several different moisturizers for the prevention of atopic dermatitis in high-risk newborns. The study concluded that the prophylactic use of moisturizers was cost-effective across the board, but the least expensive product (petroleum jelly) demonstrated the best, overall cost-benefit ratio.2 Think about that; a simple recommendation to have our young patients use a widely available and inexpensive product for daily moisturizing will help their families to significantly reduce the burden (both emotionally and financially) of atopic dermatitis. Certainly there are cases that fall outside of the realm of being able to use this much simpler approach, but by and large it is a good one to consider when the factors are right.

Another area that would benefit from a simpler approach is communicating with our colleagues and supervising physicians about the AAPA FPAR proposal (recently renamed "Optimal Team Practice" by the AAPA FPAR Task Force). The SDPA is an excellent resource when these sensitive topics are in the media. All SDPA members should take the time to familiarize themselves with this subject and utilize the SDPA’s resources (online and in print) to do so. The SDPA Board of Directors has helped our members understand this recent proposal and has given us important, clear, and simple discussion points when we talk to our supervising physicians and colleagues about this delicate topic. As you will read in this issue’s message from SDPA President Jennifer Conner, MPAS, PA-C, there is a less complicated way to discuss this pressing issue. The simple message of reassurance is what we need to use when discussing “Optimal Team Practice,” and convey that we are not abandoning our team-based practice and collaboration between PAs and dermatologists. A simple and clear approach that can be of great benefit for our profession and our patient’s. J

REFERENCE: 1. Jonathan I. Silverberg. Healthcare Utilization, Patient Costs, and Access to Care in US Adults With Eczema. JAMA Dermatology, 2015; DOI: 10.1001/jamadermatol.2014.5432 2. JAMA Pediatr. 2017;171(2):e163909. doi:10.1001/jamapediatrics.2016.3909

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

Volume 11 • number 1 • winter 2017

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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.

15

Biologic Agents for Psoriasis Where Are We Now?

By Suzanne M. Sachsman, MD and Paul Yamauchi, MD, PhD

›› CME 11 Derm PA News & Notes – part one • Certification Review • DPAF News

15 Clinical Dermatology

Departments 04 Editorial Board 05 Editor’s Message 08 SDPA News & Current Affairs 11 Dermatology Market Watch 27 From The Patient’s Perspective 28 Clinical Snapshots 33 Surgical Wisdom 40 Cosmetic Pearls 45 Notes from your Office Manager 54 Listening to Patients 60 AAD Camp Discovery 2017 65 Now Showing on Dermcast.tv 66 Professional Opportunities and Development

• CME Article: Biologic Agents for Psoriasis Where Are We Now? • Dermatology Case Report: Erythema Ab Igne “Toasted Skin Syndrome"

30 Surgical Dermatology • Surgical Case Report: Nail Apparatus Melanoma Initially Diagnosed as Nail Matrix Blue Nevus

38 Cosmetic Dermatology • Act Your Age When it Comes to Skin Care

42 Professional Development • Judicial and Ethical Affairs: The Ethics of Self-Care • Outside & Inside the 9 to 5…

50 Derm PA News & Notes – part two

Go Green & Read On the Go 6

Journal of Dermatology for Physician Assistants

• Workplace Excellence • From the Desk of…

• Collaborating Physician Corner: An Interview with Joseph C. English III, MD

dermpa.org

Register Today!

Join us for the SDPA’s Annual Summer Dermatology Conference 2017 in beautiful San Diego, California June 1 – 4 at the Mancheter Grand Hyatt.

Attend and you’ll have an opportunity to earn over 24 CME credits while learning about the latest dermatological developments and procedures, gaining pearls of wisdom and new tips and tricks — all from industry thought-leaders and experts.

We are honored to have Dr. Ted Rosen guiding the Summer conference program as Medical Director.

Aesthetics & Corrective Pre-Conference Program: Space is limited, don’t miss out! Earn an additional day of CME with our popular pre-conference day program, May 31 featuring an esteemed panel of experts in this ever changing field. Just $99!

Register at: sdpaconferences.org

SDPA Annual Summer Dermatology Conference MANCHESTER GRAND HYATT | SAN DIEGO, CA PRE-CONFERENCE: MAY 31, 2017 | CONFERENCE: JUNE 1-4, 2017

Volume 11 • number 1 • winter 2017

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FROM THE SDPA

News & Current Affairs

CALENDAR OF EVENTS 2017 JUNE SDPA Summer Dermatology Conference June 1 – 4, 2017 Manchester Grand Hyatt San Diego, CA JULY AAD Summer Meeting July 27 – 30, 2017 New York City, NY NOVEMBER SDPA 15th Annual Fall Dermatology Conference November 8 – 11, 2017 Caribe Hilton San Juan Puerto Rico

The PA profession has grown exponentially in my short eleven years of practice and we are approaching a time of rapid evolution in our national healthcare landscape, for both healthcare providers and patients alike. The SDPA recently released a position statement on full practice authority in response to a proposal set forth by the AAPA. At this time, it is vital for dermatology PAs to fully understand the context and intention of our position statement as you discuss it with your colleagues. Included in this issue of the JDPA is a copy of the article from the SDPA Board of Directors that was recently printed in the publication Practical Dermatology (please see the From the Desk of article published in this JDPA issue titled Clarifying the SDPA Position on FPAR). Since the Practical Dermatology article was written, the AAPA FPAR Task Force has responded to suggestions from the SDPA Board of Directors and other constituents calling for a name change to the terms "Full Practice Authority and Responsibility." Despite our ongoing dedication to teambased practice with physicians, the name of the proposal suggests otherwise. In response, the AAPA FPAR Task Force has agreed to change the name of the proposal to "Optimal Team Practice" to better reflect their intentions.

The SDPA has always been, and will continue to be, an advocate for teambased practice and collaboration between PAs and dermatologists. The knowledge and skills we gain from working alongside our collaborating physicians is essential to our continued growth and ability to provide the best care for our patients.

Despite concerns from the dermatologist community, the SDPA does not support independent or autonomous practice for PAs, but rather a mutually agreeable team approach to providing dermatologic care that recognizes both the capabilities and limitations of our education and experience.

Our position statement on full practice authority and responsibility stems from a trending development in medicine that reaches far beyond our small world of dermatology. In nearly half of the country, nurse practitioners do possess full practice authority and responsibility. The unfortunate consequence of this difference between our otherwise similar professions is in the job market we share. The rise of corporate medicine and recent VA regulations have made it increasingly more difficult for PAs to compete for positions they are well qualified for, simply because our licensure requires a physician to agree to a varied degree of supervisory terms and liability for the care we provide. Hiring a PA, in these situations, has become more cumbersome, and frankly, less beneficial for physicians. The viability marketplace is being threatened in a time when we should be thriving. One solution to this problem, as outlined by the AAPA proposal, is to consider state licensing regulations that do not require an agreement with a collaborating physician for the PA license to be issued. However, PA practice, with physician collaboration, should not change. The goal is to expedite the PA licensure process, make it less cumbersome for employers, and allow for a more efficient transition into patient care. The bottom line is that change needs to occur in our licensing process, while maintaining the integrity of our collaboration with physicians and other healthcare providers.

Please take the time to provide your feedback to the AAPA by emailing fparfeedback@aapa.org, and encourage your colleagues to do the same as we work together to provide a solution that preserves our role in the workforce and commitment to team-based care. Our patients deserve nothing but the best care from PAs and dermatologists, working together towards our common goal of providing access to quality dermatologic care. J

Jennifer Conner, MPAS, PA-C SDPA President, Diplomate 8

Journal of Dermatology for Physician Assistants

TREATMENT WITH A WHOLE NEW FORMULATION SERNIVO. A UNIQUE FORMULATION FOR MILD-TO-MODERATE PLAQUE PSORIASIS. • The Sernivo formulation features a new, versatile oil-in-water emulsion1 • Effectively treats extensive moderate plaque psoriasis1 Learn more and register for updates at sernivo.com

INDICATION AND USAGE SERNIVO Spray is indicated for the treatment of mild–to–moderate plaque psoriasis in patients 18 years of age or older.

IMPORTANT SAFETY INFORMATION SERNIVO Spray can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. Systemic effects of topical corticosteroids may also manifest as Cushing’s syndrome, hyperglycemia or unmasking of latent diabetes mellitus, and glucosuria. These events are rare and generally occur after prolonged exposure to larger than recommended doses, particularly with high-potency topical corticosteroids. Do not use if atrophy is present at the treatment site. Do not use with occlusive dressings. Avoid use on the face, scalp, axilla, groin or other intertriginous areas. Use of SERNIVO Spray is not recommended in pediatric patients as they are more susceptible to systemic toxicity. Allergic contact dermatitis may occur. The most common adverse reactions (≥ 1%) were application site pruritus, burning and/or stinging, pain, and atrophy. Local reactions and skin atrophy are more likely to occur with occlusive use, prolonged use, or use of higher potency corticosteroids. These are not all the possible side effects of SERNIVO Spray.

Please see brief summary of the Full Prescribing Information on the reverse side.

To report SUSPECTED SIDE EFFECTS, call Promius Pharma at 1-888-966-8766 or contact the FDA at 1-800-FDA-1088.

Reference: 1. Sernivo Prescribing Information. Promius Pharma, LLC. Princeton, NJ. February 2016.

Sernivo™ is a trademark of Promius Pharma, LLC. ©2016 Promius Pharma, LLC. All rights reserved.

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Minimize the unwanted risks from endocrine effects by mitigating the risk factors favoring increased systemic bioavailability and by using the product as recommended [see Dosage and Administration].

Rx Only BRIEF SUMMARY OF PRESCRIBING INFORMATION INDICATIONS AND USAGE SERNIVO Spray is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older.

DOSAGE AND ADMINISTRATION Apply SERNIVO Spray to the affected skin areas twice daily and rub in gently.

Use SERNIVO Spray for up to 4 weeks of treatment. Treatment beyond 4 weeks is not recommended.

Avoid use on the face, scalp, axilla, groin, or other intertriginous areas.

SERNIVO Spray is for topical use only. It is not for oral, ophthalmic, or intravaginal use.

CONTRAINDICATIONS None.

WARNINGS AND PRECAUTIONS Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression and Other Unwanted Systemic Glucocorticoid Effects SERNIVO Spray can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during or after withdrawal of treatment.

Factors that predispose to HPA axis suppression include the use of high-potency corticosteroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age.

Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test.

In a study including 48 evaluable subjects 18 years of age or older with moderate to severe plaque psoriasis, abnormal ACTH stimulation test results suggestive of adrenal suppression were identified in 5 out of 24 (20.8%) subjects after treatment with SERNIVO Spray twice daily for 15 days. No subject (0 out of 24) had abnormal ACTH stimulation test results after treatment with SERNIVO Spray twice daily for 29 days [see Clinical Pharmacology].

If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid. If signs and symptoms of steroid withdrawal occur, supplemental systemic corticosteroids may be required.

Systemic effects of topical corticosteroids may also manifest as Cushing’s syndrome, hyperglycemia, and glucosuria. These events are rare and generally occur after prolonged exposure to larger than recommended doses, particularly with high-potency topical corticosteroids.

Pediatric patients may be more susceptible to systemic toxicity due to their larger skin surface to body mass ratios. Use of SERNIVO Spray is not recommended in pediatric patients [see Use in Specific Populations].

Allergic Contact Dermatitis Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation.

Corroborate such an observation with appropriate diagnostic patch testing. If irritation develops, discontinue the topical corticosteroid and institute appropriate therapy.

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

In two randomized, multicenter, prospective vehicle-controlled clinical trials, subjects with moderate plaque psoriasis of the body applied SERNIVO Spray or vehicle spray twice daily for 4 weeks. A total of 352 subjects applied SERNIVO Spray and 180 subjects applied vehicle spray.

Adverse reactions that occurred in at least 1% of subjects treated with SERNIVO Spray for up to 28 days are presented in Table 1.

Table 1: Adverse Reactions Occurring in ≥1% of Subjects Treated with SERNIVO Spray for up to Four Weeks SERNIVO Spray b.i.d.

(N=352)

Vehicle Spray b.i.d (N=180)

Application site pruritus

6.0%

9.4%

Application site burning and/or stinging

4.5%

10.0%

Application site pain

2.3%

3.9%

Application site atrophy

1.1%

1.7%

Less common adverse reactions (with occurrence lower than 1% but higher than 0.1%) in subjects treated with SERNIVO spray were application site reactions including telangiectasia, dermatitis, discoloration, folliculitis and skin rash, in addition to dysgeusia and hyperglycemia. These adverse reactions were not observed in subjects treated with vehicle.

Postmarketing Experience Because adverse 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.

10 Journal of Dermatology for Physician Assistants

Postmarketing reports for local adverse reactions to topical corticosteroids have also included striae, irritation, dryness, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, hypertrichosis, and miliaria.

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

Betamethasone dipropionate has been shown to be teratogenic in rabbits when given by the intramuscular route at doses of 0.05 mg/kg.

The abnormalities observed included umbilical hernias, cephalocele, and cleft palate.

Nursing Mothers Systemically administered corticosteroids appear in human milk and can suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids can result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when SERNIVO Spray is administered to a nursing woman.

Pediatric Use Safety and effectiveness of SERNIVO Spray in patients younger than 18 years of age have not been studied; therefore use in pediatric patients is not recommended. Because of a higher ratio of skin surface area to body mass, pediatric patients are at greater risk of systemic toxicity, including HPA axis suppression and adrenal insufficiency, when treated with topical drugs. [see Warnings and Precautions] Rare systemic effects such as Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients, especially those with prolonged exposure to large doses of high potency topical corticosteroids.

Local adverse reactions including skin atrophy have also been reported with use of topical corticosteroids in pediatric patients.

Geriatric Use Clinical studies of SERNIVO Spray did not include sufficient numbers of subjects who were 65 years of age or older to determine whether they respond differently from younger subjects.

Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215 Distributed by: Promius Pharma, LLC., Princeton, NJ 08540 Sernivo is a trademark of Promius Pharma, LLC. Issued: 02/2016

Dermatology PA news & notes

Dermatology Market Watch The Association of Certified Dermatology Techs (ACDT) has Launched Dermatologyspanish.com A Free Online Dermatology-Specific Resource

With the ever-increasing Hispanic population comes the challenge of communication. The ability to communicate effectively between a patient and his/ her healthcare provider is critical, and could be life threatening. With that point in mind, The Association of Certified Dermatology Techs (ACDT) has launched a new online resource that will no doubt assist in communication between Spanish speaking patients and their dermatology providers.

• Audiovisual ‘vignettes' which simulate typical patient encounters such as evaluation and treatment of acne, warts, rashes, and skin exams. Each vignette is subtitled and those subtitles are actively linked to the custom glossary and Google Translate.

Dermatologyspanish.com is designed to help dermatological providers and their staff to better communicate with their Spanish-speaking patients. The website features:

• A ‘Q & A' forum where visitors can submit suggestions and ask questions.

• An extensive glossary containing the most frequent nouns, verbs, and adjectives used when communicating with Spanish-speaking patients.

• Tooltip popups for each glossary item providing a thumbnail video, audio (for pronunciation), and a sample sentence using each term in a context which is familiar to those working in dermatology.

• Over twenty-five patient education handouts translated to Spanish. Each handout includes a subtitled video, allowing viewers to train their ear and practice pronunciation of the phrases spoken.

The Association of Certified Dermatology Techs (ACDT) was established in 2012 to provide education and certification to those working in the supportive roles of clinical dermatology. Since then, the ACDT has been offering an online 16-hour course for medical assistants.

Its focus is exclusively on providing the knowledge necessary to successfully assist in the setting of clinical dermatology. For complete information, please visit: dermatologyspanish.com. J

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Dermatology Market Watch

Medical Education Press has just published Alan Rockoff, MD’s second book, Act Like a Doctor, Think Like a Patient: Teaching Patient-Focused Medicine. Dr. Rockoff practices dermatology in Boston, MA and is board certified by both the American Board of Pediatrics and the American Board of Dermatology. He is a Fellow of the American Academy of Dermatology and a member of the Massachusetts Medical Society and the Massachusetts Academy of Dermatology. Dr. Rockoff is a Clinical Assistant Professor of Dermatology at Tufts University School of Medicine.

His second publication Act Like a Doctor, Think Like a Patient: Teaching PatientFocused Medicine is based on his experiences teaching senior medical students at the Tufts University School of Medicine in Boston and PA students at Northeastern University for the past thirty-five years. The book focuses on the need for medical providers to know not just how to diagnose and treat disease, but to personalize medicine by understanding illness and treatment through the eyes of their patients.

Act Like a Doctor, Think Like a Patient: Teaching Patient-Focused Medicine is available on-line through Amazon and Barnes and Noble. J

Certification Review

All Those Things Inside the Skin You Might Have Forgotten

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

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

QUESTION: Blocking the serotonin and norepinephrine transporter is the mechanism of action of which one of the following medications?

A. Carbamazepine (Tegretol) B. Haloperidol (Haldol) C. Amitriptyline (Elavil) D. Diazepam (Valium) E. Phenelzine (Nardil) EXPLANATION: Amitriptyline, a tricyclic antidepressant, acts by inhibiting serotonin and norepinephrine reuptake leading to its use in the treatment of major depression. Carbamazepine stabilizes the inactivated voltage-gated sodium channels leading to its anticonvulsant effects and is a GABA receptor agonist leading to its use in the treatment of neuropathic pain and bipolar disorder. Haloperidol, a butyrophenone, is a dopamine receptor antagonist used in the treatment of psychosis. Diazepam, a benzodiazepine, promotes the 12 Journal of Dermatology for Physician Assistants

binding of GABA to its receptors leading to sedation and muscle relaxation and also bind to voltage-dependent sodium channels leading to some of its anticonvulsant effects. Phenelzine binds irreversibly monoamine oxidase mitigating its actions. J The correct answer is C.

DERmatology pa news & notes

“Act Like a Doctor, Think Like a Patient: Teaching PatientFocused Medicine” by dermatologist Alan Rockoff, MD

James A. Van Rhee, MS, PA-C, is the Program Director for the Yale University School of Medicine Physician Assistant Program. Mr. Van Rhee has been involved in physician assistant education for over 20 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 fifteen years he has been course director and presenter of the Physician Assistant Board Review, which is now being produced live online by Kaplan Medical.

The Dermatology PA Foundation (DPAF), the philanthropic arm of the SDPA, had an amazing inaugural year. Having officially kicked off the SDPA’s charitable arm in mid-2016, we quickly surpassed our goals and expectations with the help of many generous donors and volunteers! We are thrilled to announce that because of the support of our individual and corporate donors we were able to raise over $40,000 in 2016! Much of the money raised has already been put to good use: • $7,500 was contributed to the Melanoma Research Foundation (MRF) • $23,600 went towards sending children with skin disease to summer camp(s), along with two PAs as volunteer staff Looking ahead, in 2017, we have a number of events in the works, including holding our first ever

virtual run/walk this spring in support of the National Alopecia Areata Foundation (NAAF). We will be posting our registration information on the DPAF website very soon (see box). In addition to this the DPAF will be hosting our 2nd Annual DPAF Silent Auction in conjunction with the SDPA’s 15th Annual Fall Dermatology Conference in San Juan, Puerto Rico this coming November. Along with these two exciting events this year we plan to sponsor a complimentary extended education session focusing on the “how to’s” of clinical research at our SDPA’s Annual Summer Dermatology Conference in San Diego, on June 3rd, 2017. This informative session will feature an expert panel of PA researchers. Conference attendees can add this free education session to their schedule during registration for the summer conference. There is a thirty-person max, so be sure to sign up early! J

In the past, the DPAF/SDPA has gone the traditional route and hosted an in-person timed 5k run/walk. However, this year we will be hosting our first-ever virtual event! The event will coincide with the SDPA’s Annual Summer Dermatology Conference in San Diego, June 1 – 4, 2017 and will support the National Alopecia Areata Foundation (NAAF).

So what exactly is a virtual run/walk? Good question – here’s how it works. Those who want to participate and contribute to this worthy cause can register to run/walk 5k on their own time.

Registrants will be emailed a bib to print out and wear on their shirt whenever they choose to complete their race. In addition, each participant will receive a fantastic commemorative medal as well as other materials to help get them started.

Help the DPAF promote this unique event by taking an optional snapshot of yourself and sending it to admin@dermpafoundation.org, or post it to social media: Tweet us @DermPAsCare, or tag us in your Facebook and Instagram posts (or choose to do all of the above!). Just be sure to include the hashtag, #DPAFVirtualRun, in your social posts. We will be checking for posts and choosing random winners for raffles, including a chance to win a free sun protective running shirt. Then once you are ready to run/ walk you can …

• Complete your race outside, at the gym, or anywhere you would like.

• Enter your time on the DPAF website. Participants with the best time(s) and those who raise the most funds towards the NAAF will receive a great prize.

• Congratulate yourself for supporting a great cause!

Volume 11 • number 1 • winter 2017 13

DERmatology pa news & notes

N e ws

Don’t want to run/walk alone? Grab a friend or meet up with the group of fellow dedicated SDPA conference runners to complete the run together at the SDPA’s summer conference this June.

DERmatology pa news & notes

Remember, if you will be attending the conference in San Diego swing by the DPAF booth to pick up your medal and say hi. The SDPA Conference Running Group, which is an informal group of members who like to run and walk, will be organizing an informal get together to complete the race together in San Diego. We will be promoting the time, location and other details as we get closer to the conference.

Don’t want to run/walk? No problem! You can still show your support by contributing.

Stay tuned for more details including registration and contribution information. J

DPAF Welcomes Tom Fitzgerald The DPAF is pleased to announce pharmaceutical industry veteran Tom Fitzgerald has joined the Dermatology PA Foundation as a Trustee at Large. Tom Fitzgerald is the Vice President of Sales at Cynova Laboratories, a dermatology startup company. He joins Cynova after spending over twenty-seven years at Galderma Laboratories, managing dermatology sales teams and shaping Galderma’s branding and presence at medical conventions. He holds a Bachelor’s Degree in Marketing from Rockhurst University in Kansas City, MO. Tom is committed to giving back to the dermatology community as well. He is a volunteer and fundraiser for Camp Wonder, a summer camp for children with rare skin diseases. He is honored to begin his work as a Board Trustee for the Dermatology PA Foundation. He currently resides in the Dallas-Fort Worth area with his wife and three daughters.

Help the DPAF keep the momentum going! Please consider making a charitable contribution this year. Remember, If you contributed at the Chairman’s Circle Level in 2016 – you will need to continue to contribute at this level again each year to maintain your Founders Circle status. Together we will continue making a difference!

Let them know they’re not alone...

Share a story with your patients.

Visit the Patient’s Perspective library of articles at www.jdpa.org/advocacy.html

JDPA Journal of Dermatology for Physician Assistants

If you know a patient who would like to share his/her story, please contact us at editor@jdpa.org

14 Journal of Dermatology for Physician Assistants

Clinic al Dermatology

Biologic Agents for Psoriasis Where Are We Now?

By Suzanne M. Sachsman, MD and Paul Yamauchi, MD, PhD

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 March 2017. 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:

• Outline the approved and upcoming biologic agents available for the treatment of moderate-to-severe plaque psoriasis.

• Understand the mechanisms of action, dosing, and efficacy of each of these biologic agents.

• Review the safety and potential adverse events of each biologic agent class.

Volume 11 • number 1 • winter 2017 15

Biologic Agents for Psoriasis - Where Are We Now?

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.

16 Journal of Dermatology for Physician Assistants

Biologic Agents for Psoriasis - Where Are We Now?

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.

Volume 11 • number 1 • winter 2017 17

Biologic Agents for Psoriasis - Where Are We Now?

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.

18 Journal of Dermatology for Physician Assistants

Biologic Agents for Psoriasis - Where Are We Now?

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.

Volume 11 • number 1 • winter 2017 19

Biologic Agents for Psoriasis - Where Are We Now?

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.

20 Journal of Dermatology for Physician Assistants

Biologic Agents for Psoriasis - Where Are We Now?

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.

Volume 11 • number 1 • winter 2017 21

Biologic Agents for Psoriasis - Where Are We Now?

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.

22 Journal of Dermatology for Physician Assistants

Biologic Agents for Psoriasis - Where Are We Now?

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.

Volume 11 • number 1 • winter 2017 23

Biologic Agents for Psoriasis - Where Are We Now?

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.

24 Journal of Dermatology for Physician Assistants

Biologic Agents for Psoriasis - Where Are We Now?

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.

Volume 11 • number 1 • winter 2017 25

Biologic Agents for Psoriasis - Where Are We Now?

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.

Suzanne M. Sachsman, MD graduated from the Keck School of Medicine of USC and is currently a resident in dermatology at UCLA. She has indicated no relationships to disclose relating to the content of this article.

Paul S. Yamauchi, MD, PhD is a Clinical Assistant Professor of Dermatology at David Geffen School of Medicine at UCLA and Harbor-UCLA Medical Center Division of Dermatology.

He is a Principal Investigator, Consultant, and Speaker for Abbvie, Amgen, Novartis, Lilly, Janssen, and Celgene. He is a Consultant and Principal Investigator for Valeant. He is also a Consultant for Sun Pharmaceutical Industries.

26 Journal of Dermatology for Physician Assistants

From The Patient’s Perspective Regina Villemure, Children could use her own talent and experience to give back.

With Hair Loss (CWHL) founder, a She has taken it as her personal mission to “Cover mother and grandmother, a hairstylist, Young Heads to Heal Young Hearts.” Since opening cosmetology instructor, hair replacement in 2000, CWHL has helped thousands of children specialist and former salon owner, brings with hair loss at no cost to the family. over thirty years of experience to the Children With Hair Loss opened in September non-profit organization. Regina started 2000. After researching, Regina didn’t find any other Regina Villemure the CWHL organization after her niece, organizations that were giving human hair replacements Sarah, a 33-year survivor, was diagnosed to children at no cost. CWHL’s mission and goals were with Acute Lymphoblastic Leukemia at the tender age of to never charge a family at a time when they need the three. most help. After years of intense fund raising, CWHL Sarah underwent chemotherapy for five years. During was able to purchase their first building in 2005. The her treatment’s, Regina had seen so many children that headquarters resides in South Rockwood, Michigan in either didn’t have hair or an old renovated fire were wearing outdated station. Originally, “It is our mission to empower these children to synthetic wigs. Being in CWHL’s focus was the hair industry, Regina become whole again by making hair replacement on children fighting knew that hair pieces cancer, until they available to those who may be financially were very expensive and found out that there challenged and might otherwise not have a most families could were a lot of other not afford human hair. reasons why children means of obtaining the hair they want and need.”

She recognized a strong lost hair including need to provide children alopecia, burns, who have medically related hair loss with human hair trichotillomania, and other rare diseases and disorders. replacements. Throughout the years Regina’s dream To this day, CWHL has never charged a family in evolved into a mission. need of hair replacement. Currently, they provide a customized human hair replacement and a care kit to Giving was always an important part of her life and over 500 children a year. after her niece’s treatment it was all about seeing how she Children With Hair Loss was created as a resource for all children who have medically-related hair loss.

“It is our mission to empower these children to become whole again by making hair replacement available to those who may be financially challenged and might otherwise not have a means of obtaining the hair they want and need. Our goal is to assist as many of these children as possible in changing their lives by Please visit www.childrenwithhairloss.us for more improving their outlook and empowering them with a information about Children With Hair Loss, directions degree of self-confidence that will allow them to face for donating hair, and stories and pictures of some of the world with renewed self-esteem,” says Regina. the many children who have helped and have been helped through the efforts of this amazing organization.

There are so many ways healthcare providers can The goal of Children With Hair Loss is to assist as many become involved with CWHL. You can refer patients of these children as possible in changing their lives by who are in need of a human hair replacement and improving their outlook and empowering them with a educate the families about the resources available at degree of self-confidence that will allow them to face the CWHL, you can talk to your hairdresser about joining world with renewed self-esteem. the network of salons that provide free hair styling and services to CWHL recipients, you can donate your Children With Hair Loss own hair to be made into a hair piece, you can inform Contact Information: www.childrenwithhairloss.us patients who are interested in donating their hair 12776 Dixie Hwy, South Rockwood, MI 48179 about CWHL, or you can make a monetary donation Facebook: Children With Hair Loss to help CWHL with hard costs for manufacturing the Twitter: @CWHL_org Phone: (734) 379-4400 hair pieces. J Volume 11 • number 1 • winter 2017 27

CLINIC AL Dermatology

Children With Hair Loss

SURGIC AL Dermatology

Clinical snapshots Dermcast.tv Blog - IL-17 May Play a Role Linking Pathogenesis of Psoriasis to Metabolic Disease

By Martha L. Sikes, MS, RPh, PA-C

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.

Image: Wikimedia Commons (By James Heilman, MD - Own work, CC BY-SA 3.0)

Dermcast.tv is the official online media resource of the SDPA and is your free source for the latest SDPA-related audio podcasts, current dermatology news and research, and videos featuring thought-leaders, procedures, conference highlights, and much more. In addition, Dermcast is the #1 dermatology-related podcast on iTunes! To read more Dermcast.tv Blogs and/or to follow the next live blog from an upcoming SDPA dermatology conference, please visit the Dermcast.tv website at www.dermcast.tv and subscribe today.

28 Journal of Dermatology for Physician Assistants

Dermatology Case Report Erythema Ab Igne “Toasted Skin Syndrome”

By Ruth Pierre-Louis, PA-C and Mary E. Showstark, MS, PA-C

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 - Hot bottle rash in a patient with chronic abdominal pain who found some relief from the application of heat.

(Image source: Wikimedia Commons)

Ruth Pierre-Louis, PA-C completed her undergraduate studies at Hofstra University of New York and graduated from Touro College Physician Assistant Program. She has indicated no relationships to disclose relating to the content of this article.

Mary E. Showstark, MS, PA-C completed her undergraduate studies at University of Florida. She went on to complete her PA studies and master's degree at University of Florida in 2004 and worked at Touro College Physician Assistant Program teaching and mentoring students. She has indicated no relationships to disclose relating to the content of this article.

Volume 11 • number 1 • winter 2017 29

SURGIC AL Dermatology Nail Apparatus Melanoma Initially Diagnosed as Nail Matrix Blue Nevus: A Case Report with Dermatoscopy And Dermatopathology

By Bengu Nisa Akay, MD, Aylin Okcu Heper, Luc Thomas, MD, PhD, Brigitte Balme, MD, Simon Clark, and Cliff Rosendahl, PhD

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.

30 Journal of Dermatology for Physician Assistants

A

Figure 1

B

Clinical (a) image of the right thumbnail of a 50-year-old woman.

The pigmented stripe has appeared and progressed over three years. Dermatoscopy (b) displays melanonychia striata with lines parallel varying in width, but not interval or color. ŠCopyright 2017 Akay et al.

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 2

A B C D

H&E staining (a) of the matrix biopsy specimen from the lesion in Figure 1 displays heavy pigmentation over both the epidermis and dermis, which compromised assessment of architecture and cytology. A bleached section (b) revealed an apparent epidermal melanocytic proliferation, but this was initially interpreted as keratinocytes modified by bleaching.

Interpretation of sections stained with Melan A (c) and Ki-67 (d) was compromised by heavy melanin pigmentation substantially obscuring DAB chromagen. ©Copyright 2017 Akay et al.

SURGIC AL Dermatology

SDPA Members Only Content

Bengu Nisa Akay, MD works at the Department of Dermatology, Ankara University Faculty of Medicine, Ankara, Turkey. Aylin Okcu Heper works at the Department of Pathology, Ankara University Faculty of Medicine, Ankara, Turkey. Luc Thomas, MD, PhD works at the Dermatology and Dermatopathology Centre, Hospitalier Lyon Sud, Pierre Bénite, France. Brigitte Balme, MD works at the Dermatology and Dermatopathology Centre, Hospitalier Lyon Sud, Pierre Bénite, France. Simon Clark is a dermatopathologist at DHM Pathology, Macquarie Park, NSW, Australia, and Cliff Rosendahl, PhD works at the School of Medicine, The University of Queensland, Australia. The authors have all contributed significantly to this publication and have indicated no conflicts of interest to disclose relating to the content of this article.

This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author (©2017 Akay et al) and source (Nail Apparatus Melanoma Initially Diagnosed as Nail Matrix Blue Nevus: A Case Report with Dermatoscopy and Dermatopathology. Dermatol Pract Conc. 2017;7(1):13) are credited.

Volume 11 • number 1 • winter 2017 31

GOING 80 MPH DOWNHILL -

EXTREME? NOT WEARING SUNSCREEN,

NOW THAT’S CRAZY

I’m Julia Mancuso, Olympic medalist and professional skier, and I apply sunscreen every day. I’m wearing orange to help put a spotlight on skin cancer.

Did you know snow reflects and intensifies the damaging rays of the sun?

Sun exposure is the most preventable risk factor for skin cancer.

To protect your skin apply sunscreen, seek shade, and wear protective clothing. Visit SpotSkinCancer.org. © 2012 American Academy of Dermatology. Use of this poster does not imply product or service endorsement by the American Academy of Dermatology.

32 Journal of Dermatology for Physician Assistants

SURGICAL wisdom Dermcast.tv Blog -

Ouch! What to Do About Needlesticks and Sharps Injuries

By Martha L. Sikes, MS, RPh, PA-C

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.

Image: Wikimedia Commons

Dermcast.tv is the official online media resource of the SDPA and is your free source for the latest SDPA-related audio podcasts, current dermatology news and research, and videos J featuring thought-leaders, procedures, conference highlights, and much more. In addition, Dermcast is the #1 dermatology-related podcast on iTunes! To read more Dermcast.tv Blogs and/or to follow the next live blog from an upcoming SDPA dermatology conference, please visit the Dermcast.tv website at www.dermcast.tv and subscribe today.

Volume 11 • number 1 • winter 2017 33

EMBRACE THE OPPORTUNITY TO GIVE

COMPLETELY CLEAR SKIN

IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Taltz is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients.

WARNINGS AND PRECAUTIONS Infections Taltz may increase the risk of infection. The Taltz group had a higher rate of infections than the placebo group (27% vs 23%). Serious infections have occurred. Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a serious infection develops, discontinue Taltz until the infection resolves.

Pre-Treatment Evaluation for Tuberculosis Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with Taltz. Do not administer to patients with active TB infection. Initiate treatment of latent TB prior to administering Taltz. Patients receiving Taltz should be monitored closely for signs and symptoms of active TB during and after treatment.

Hypersensitivity Serious hypersensitivity reactions, including anaphylaxis, angioedema and urticaria, have been reported with Taltz. If a serious hypersensitivity reaction occurs, discontinue Taltz immediately and initiate appropriate therapy.

34 Journal of Dermatology for Physician Assistants

Taltz is a humanized interleukin-17A (IL-17A) antagonist indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Taltz is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients.

QUICK *: 90% of patients treated with Taltz 80 mg every 2 weeks achieved PASI 75 at week 12 vs 2% of 1

placebo-treated patients

EFFECTIVE *: 1

WEEK 12

71%

40%

vs 1%

vs 1%

PASI 90

83%

achieved clear or almost clear skin (sPGA 0,1)

PASI 100

vs 2%

1†

CONSISTENT : Of responders who achieved clear or almost clear skin (sPGA 0,1) at week 12,

75% of those receiving Taltz 80 mg every 4 weeks in the maintenance period maintained clear or almost clear skin at week 60 compared to 7% of those switched to placebo Taltz

Placebo

*Trial 2 data (Taltz 80 mg every 2 weeks n=351; placebo n=168). † Results from integrated Trials 1 and 2 (Taltz n=181; placebo n=203).

ADDITIONAL WEEK 12 RESULTS In Trial 1 (Taltz n=433; placebo n=431) and Trial 3 (Taltz n=385; placebo n=193), Taltz patients achieved similar results: 89% and 87% of Taltz patients achieved PASI 75 vs 4% and 7% for placebo. Additionally, 71% and 68% of Taltz patients achieved PASI 90 vs 1% and 3% for placebo, and 35% and 38% achieved PASI 100 vs 0% and 0% for placebo. Also, 82% and 81% of Taltz patients achieved sPGA 0,1 vs 3% and 7% for placebo.

TRIAL DESIGN The Taltz clinical program included 3 randomized, double-blind, placebo-controlled trials to evaluate the efficacy and safety of Taltz. All patients were ≥18 years of age and had plaque psoriasis with a body surface area involvement of ≥10%, a static Physician’s Global Assessment (sPGA) score ≥3, and a Psoriasis Area Severity Index (PASI) score ≥12, and were candidates for phototherapy or systemic therapy. Participants were randomized to receive placebo or Taltz 80 mg every 2 weeks following a 160 mg starting dose. In Trials 2 and 3, an additional arm of US-approved etanercept (50 mg twice weekly) was included. Co-primary efficacy endpoints were proportion of patients with an sPGA 0,1 and at least a 2-point improvement from baseline and proportion of patients achieving PASI 75 (at least a 75% reduction in the PASI composite score) at week 12. Nonresponder imputation (NRI) methods were used for categorical efficacy analyses.

Patients originally randomized to Taltz who were responders at week 12 (ie, sPGA 0,1) in Trials 1 and 2 were re-randomized to either Taltz 80 mg every 4 weeks or placebo for an additional 48 weeks. Patients who relapsed (sPGA ≥3) at any time during the maintenance period were classified as nonresponders at week 60.

Help your patients save on Taltz at taltzsavings.com Inflammatory Bowel Disease Crohn’s disease and ulcerative colitis, including exacerbations, occurred at a greater frequency in the Taltz group (Crohn’s disease 0.1%, ulcerative colitis 0.2%) than in the placebo group (0%) during clinical trials. During Taltz treatment, monitor patients for onset or exacerbations of inflammatory bowel disease.

Immunizations Prior to initiating therapy with Taltz, consider completion of all age-appropriate immunizations according to current immunization guidelines. Live vaccines should not be given with Taltz.

ADVERSE REACTIONS Most common adverse reactions (≥1%) associated with Taltz treatment are injection site reactions, upper respiratory tract infections, nausea, and tinea infections.

Please see Brief Summary of Prescribing Information on the following pages. Please see Instructions for Use included with the device.

IX HCP ISI 18JAN2017 Reference: 1. Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2017.

Taltz® is a registered trademark of Eli Lilly and Company. PP-IX-US-1192 2/2017 © LILLY USA, LLC, 2017. ALL RIGHTS RESERVED.

Volume 11 • number 1 • winter 2017 35

Taltz® (ixekizumab) injection Brief Summary: Consult the package insert for complete prescribing information.

INDICATIONS AND USAGE Taltz is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

CONTRAINDICATIONS Taltz is contraindicated in patients with a previous serious hypersensitivity reaction such as anaphylaxis to ixekizumab or to any of the excipients.

WARNINGS AND PRECAUTIONS Infections—Taltz may increase the risk of infection. In clinical trials, the Taltz group had a higher rate of infections than the placebo group (27% vs 23%). Upper respiratory tract infection, oral candidiasis, conjunctivitis and tinea infections occurred more frequently in the Taltz group than in the placebo group (Adverse Reactions). Instruct patients treated with Taltz to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a serious infection or is not responding to standard therapy, monitor the patient closely and discontinue Taltz until the infection resolves.

Pre-treatment Evaluation for Tuberculosis—Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with Taltz. Do not administer to patients with active TB infection. Initiate treatment of latent TB prior to administering Taltz. Consider anti-TB therapy prior to initiating Taltz in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Patients receiving Taltz should be monitored closely for signs and symptoms of active TB during and after treatment.

Hypersensitivity—Serious hypersensitivity reactions, including anaphylaxis, angioedema and urticaria, have been reported with Taltz. If a serious hypersensitivity reaction occurs, discontinue Taltz immediately and initiate appropriate therapy.

Inflammatory Bowel Disease—Crohn’s disease and ulcerative colitis, including exacerbations, occurred at a greater frequency in the Taltz group (Crohn’s disease 0.1%, ulcerative colitis 0.2%) than in the placebo group (0%) during the 12-week, placebocontrolled period. During Taltz treatment, monitor for onset or exacerbation of inflammatory bowel disease.

Immunizations—Prior to initiating therapy with Taltz, consider completion of all age-appropriate immunizations according to current immunization guidelines.

Avoid use of live vaccines in patients treated with Taltz. No data are available on the response to live or inactive vaccines.

ADVERSE REACTIONS The following adverse drug reactions are discussed in greater detail in other sections of the label: • Infections (Warnings and Precautions) • Hypersensitivity Reactions (Contraindications and Warnings and Precautions) • Inflammatory Bowel Disease (Warnings and Precautions) Clinical Trials Experience—Because clinical trials are conducted under widely varying and controlled conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Weeks 0 to 12: Three placebo-controlled trials in subjects with plaque psoriasis were integrated to evaluate the safety of Taltz compared to placebo for up to 12 weeks.

A total of 1167 subjects (mean age 45 years; 66% men; 94% White) with plaque psoriasis received Taltz (160 mg at Week 0, 80 mg every two weeks [Q2W] for 12 weeks) subcutaneously. In two of the trials, the safety of Taltz (use up to 12 weeks) was also compared with an active comparator, U.S. approved etanercept.

In the 12-week, placebo-controlled period, adverse events occurred in 58% of the Taltz Q2W group (2.5 per subject-year of follow-up) compared with 47% of the placebo group (2.1 per subject-year of follow-up). Serious adverse events occurred in 2% of the Taltz group (0.07 per subject-year of follow-up), and in 2% of the placebo group (0.07 per subject-year of follow-up).

Table 1 summarizes the adverse reactions that occurred at a rate of at least 1% and at a higher rate in the Taltz group than the placebo group during the 12-week placebo-controlled period of the pooled clinical trials.

Table 1: Adverse Reactions Occurring in ≥1% of the Taltz Group and More Frequently than in the Placebo Group in the Plaque Psoriasis Clinical Trials through Week 12 Adverse Reactions Taltz 80 mg Placebo Etanerceptb Q2W (N=287) (n%) (N=791) (n%) (N=1167) (n%) Injection site reactions 196 (17) 32 (11) 26 (3) Upper respiratory tract 163 (14) 23 (8) 101 (13) infectionsa Nausea 23 (2) 1 (<1) 5 (1) Tinea infections a b

17 (2)

0

1 (<1)

Upper respiratory tract infections cluster includes nasopharyngitis and rhinovirus infection.

U.S. approved etanercept.

Taltz® (ixekizumab) injection

IX HCP BS 18JAN2017

36 Journal of Dermatology for Physician Assistants

Adverse reactions that occurred at rates less than 1% in the Taltz group and more frequently than in the placebo group during the 12-week induction period included rhinitis, oral candidiasis, urticaria, influenza, conjunctivitis, inflammatory bowel disease, and angioedema.

Weeks 13 to 60: A total of 332 subjects received the recommended maintenance regimen of Taltz 80 mg dosed every 4 weeks.

During the maintenance period (Weeks 13 to 60), adverse events occurred in 80% of subjects treated with Taltz (1.0 per subject-year of follow-up) compared to 58% of subjects treated with placebo (1.1 per subject-year of follow-up). Serious adverse events were reported in 4% of subjects treated with Taltz (0.05 per subjectyear of follow-up) and none in the subjects treated with placebo.

Weeks 0 to 60: Over the entire treatment period (Weeks 0 to 60), adverse events were reported in 67% of subjects treated with Taltz (1.4 per subject-year of follow-up) compared to 48% of subjects treated with placebo (2.0 per subject-year of follow-up).

Serious adverse events were reported in 3% of subjects treated with Taltz (0.06 per subject-year of follow-up), and in 2% of subjects treated with placebo (0.06 per subjectyear of follow-up).

Specific Adverse Drug Reactions: Injection Site Reactions The most frequent injection site reactions were erythema and pain. Most injection site reactions were mild-to-moderate in severity and did not lead to discontinuation of Taltz.

Infections In the 12-week, placebo-controlled period of the clinical trials in plaque psoriasis, infections occurred in 27% of subjects treated with Taltz (1.2 per subject-year of follow-up) compared to 23% of subjects treated with placebo (1.0 per subject-year of follow-up). Serious infections occurred in 0.4% of subjects treated with Taltz (0.02 per subject-year of follow-up) and in 0.4% of subjects treated with placebo (0.02 per subject-year of follow-up) [see Warnings and Precautions (5.1)].

During the maintenance treatment period (Weeks 13 to 60), infections occurred in 57% of subjects treated with Taltz (0.70 per subject-year of follow-up) compared to 32% of subjects treated with placebo (0.61 per subject-year of follow-up).

Serious infections occurred in 0.9% of subjects treated with Taltz (0.01 per subjectyear of follow-up) and none in the subjects treated with placebo.

Over the entire treatment period (Weeks 0 to 60), infections were reported in 38% of subjects treated with Taltz (0.83 per subject-year of follow-up) compared to 23% of subjects treated with placebo (1.0 per subject-year of follow-up). Serious infections occurred in 0.7% of subjects treated with Taltz (0.02 per subject-year of follow-up), and in 0.4% of subject treated with placebo (0.02 per subject-year of follow-up).

Laboratory Assessment of Cytopenia Neutropenia—Over the entire treatment period (Weeks 0 to 60), neutropenia occurred in 11% of subjects treated with Taltz (0.24 per subject-year of follow-up) compared to 3% of subjects treated with placebo (0.14 per subject-year of follow-up).

In subjects treated with Taltz, the incidence rate of neutropenia during Weeks 13 to 60 was lower than the incidence rate during Weeks 0 to 12.

In the 12-week, placebo-controlled period, neutropenia ≥ Grade 3 (<1,000 cells/mm3) occurred in 0.2% of the Taltz group (0.007 per subject-year of follow-up) compared to 0.1% of the placebo group (0.006 per subject-year of follow-up). The majority of cases of neutropenia were either Grade 2 (2% for Taltz 80 mg Q2W versus 0.3% for placebo; ≥1,000 to <1,500 cells/mm3) or Grade 1 (7% for Taltz 80 mg Q2W versus 3% for placebo; ≥1,500 cells/mm3 to <2,000 cells/mm3).

Neutropenia in the Taltz group was not associated with an increased rate of infection compared to the placebo group.

Thrombocytopenia—Ninety eight percent of cases of thrombocytopenia were Grade 1 (3% for Taltz 80 mg Q2W versus 1% for placebo; ≥75,000 cells/mm3 to <150,000 cells/mm3). Thrombocytopenia in subjects treated with Taltz was not associated with an increased rate of bleeding compared to subjects treated with placebo.

Active Comparator Trials—In the two clinical trials that included an active comparator, the rate of serious adverse events during weeks zero to twelve was 0.7% for U.S.-approved etanercept and 2% for Taltz 80 mg Q2W, and the rate of discontinuation from adverse events was 0.7% for U.S. approved etanercept and 2% for Taltz 80 mg Q2W. The incidence of infections was 18% for U.S. approved etanercept and 26% for Taltz 80 mg Q2W. The rate of serious infections was 0.3% for both Taltz 80 mg Q2W and U.S. approved etanercept.

Immunogenicity—As with all therapeutic proteins there is the potential for immunogenicity with Taltz. By Week 12, approximately 9% of subjects treated with Taltz every 2 weeks developed antibodies to ixekizumab. Approximately 22% of subjects treated with Taltz at the recommended dosing regimen developed antibodies to ixekizumab during the 60-week treatment period. The clinical effects of antibodies to ixekizumab are dependent on the antibody titer; higher antibody titers were associated with decreasing drug concentration and clinical response.

Of the subjects who developed antibodies to ixekizumab during the 60-week treatment period, approximately 10%, which equates to 2% of subjects treated with Taltz at the recommended dosing regimen, had antibodies that were classified as neutralizing. Neutralizing antibodies were associated with reduced drug concentrations and loss of efficacy.

Taltz® (ixekizumab) injection

IX HCP BS 18JAN2017

However, the assay to test for neutralizing antibodies has limitations detecting neutralizing antibodies in the presence of ixekizumab; therefore, the incidence of neutralizing antibodies development could be underestimated.

The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of incidence of antibodies to Taltz with the incidences of antibodies to other products may be misleading.

Postmarketing Experience—The following adverse reactions have been identified during post-approval use of TALTZ. Because the 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 TALTZ exposure.

Immune system disorders: anaphylaxis DRUG INTERACTIONS Live Vaccinations—Avoid use of live vaccines in patients treated with Taltz (Warnings and Precautions).

Cytochrome P450 Substrates—The formation of CYP450 enzymes can be altered by increased levels of certain cytokines (e.g., IL-1, IL-6, IL-10, TNFα, IFN) during chronic inflammation. Thus, Taltz, an antagonist of IL-17A, could normalize the formation of CYP450 enzymes.

Therefore, upon initiation or discontinuation of Taltz in patients who are receiving concomitant drugs which are CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for effect (e.g., for warfarin) or drug concentration (e.g., for cyclosporine) and consider dosage modification of the CYP450 substrate.

USE IN SPECIFIC POPULATIONS Pregnancy Risk Summary—There are no available data on Taltz use in pregnant women to inform any drug associated risks. Human IgG is known to cross the placental barrier; therefore, Taltz may be transmitted from the mother to the developing fetus. An embryofetal development study conducted in pregnant monkeys at doses up to 19 times the maximum recommended human dose (MRHD) revealed no evidence of harm to the developing fetus. When dosing was continued until parturition, neonatal deaths were observed at 1.9 times the MRHD [see Data]. The clinical significance of these nonclinical findings is unknown.

The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Data Animal Data—An embryofetal development study was conducted in cynomolgus monkeys administered ixekizumab. No malformations or embryofetal toxicity were observed in fetuses from pregnant monkeys administered ixekizumab weekly by subcutaneous injection during organogenesis to near parturition at doses up to 19 times the MRHD (on a mg/kg basis of 50 mg/kg/week). Ixekizumab crossed the placenta in monkeys.

In a pre- and post-natal development toxicity study, pregnant cynomolgus monkeys were administered weekly subcutaneous doses of ixekizumab up to 19 times the MRHD from the beginning of organogenesis to parturition. Neonatal deaths occurred in the offspring of two monkeys administered ixekizumab at 1.9 times the MRHD (on a mg/kg basis of 5 mg/kg/week) and two monkeys administered ixekizumab at 19 times the MRHD (on a mg/kg basis of 50 mg/kg/week). These neonatal deaths were attributed to early delivery, trauma, or congenital defect. The clinical significance of these findings is unknown. No ixekizumab-related effects on functional or immunological development were observed in the infants from birth through 6 months of age.

Lactation Risk Summary—There are no data on the presence of ixekizumab in human milk, the effects on the breastfed infant, or the effects on milk production. Ixekizumab was detected in the milk of lactating cynomolgus monkeys. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Taltz and any potential adverse effects on the breastfed infant from Taltz or from the underlying maternal condition Pediatric Use—The safety and effectiveness of Taltz in pediatric patients (<18 years of age) have not been evaluated.

Geriatric Use—Of the 4204 psoriasis subjects exposed to Taltz, a total of 301 were 65 years or older, and 36 subjects were 75 years or older. Although no differences in safety or efficacy were observed between older and younger subjects, the number of subjects aged 65 and over is not sufficient to determine whether they respond differently from younger subjects.

OVERDOSAGE—In the event of an overdosage, monitor the patient for any signs or symptoms of adverse reactions and institute appropriate symptomatic treatment immediately.

PATIENT COUNSELING INFORMATION—Advise the patient/caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use) before the patient starts using Taltz and each time the prescription is renewed, as there may be new information they need to know.

Instructions on Self-Administration-Provide guidance to patients and caregivers on proper subcutaneous injection technique, including aseptic technique, and how to use the autoinjector or prefilled syringe correctly (Instructions for Use).

Infection: Inform patients that Taltz may lower the ability of their immune system to fight infections. Instruct patients of the importance of communicating any history of infections to the healthcare provider, and contacting their healthcare provider if they develop any symptoms of infection. (Warnings and Precautions).

Allergic Reactions: Advise patients to seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions. (Warnings and Precautions).

Taltz® (ixekizumab) injection

Taltz® (ixekizumab) injection

IX HCP BS 18JAN2017

Additional information can be found at www.Taltz.com.

Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA Copyright © 2016, 2017, Eli Lilly and Company. All rights reserved.

IX HCP BS 18JAN2017 IX HCP BS 18JAN2017

Volume 11 • number 1 • winter 2017 37

COSMETIC Dermatology

Act Your Age When It Comes To Skin Care Dermatologists Share Tips for Women in Their 20s, 30s, and 40s The JDPA will feature this three part series from the American Academy of Dermatology (AAD) about skin care tips for women in their twenties, thirties, and forties.

This first article will address those skin care issues faced by women in their twenties.

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.

38 Journal of Dermatology for Physician Assistants

SDPA Members Only Content

Nada Elbuluk, MD, MSc, FAAD, is an assistant professor of dermatology in the Ronald O. Perelman Department of Dermatology at the NYU School of Medicine in New York. Her clinical and research interests include skin of color and pigmentation disorders.

Dr. Elbuluk earned her medical degree from the University of Michigan in Ann Arbor, Mich., where she graduated with a distinction in research and also obtained a Master of Science in Clinical Research. She completed her dermatology residency at Johns Hopkins Hospital in Baltimore.

Reprinted with permission from the American Academy of Dermatology

Volume 11 â&#x20AC;˘ number 1 â&#x20AC;˘ winter 2017 39

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.

Cosmetic pearls

How to Safely Exfoliate At Home 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.

COSMETIC Dermatology

These tips are demonstrated in “How to Exfoliate at Home,” a video posted to the AAD website and YouTube channel. This video is part of the AAD’s “Video of the Month” series, which offers tips people can use to properly care for their skin, hair and nails. A new video in the series posts to the AAD website and YouTube channel each month.

40 Journal of Dermatology for Physician Assistants

SDPA Members Only Content

Rebecca Clare Tung, MD, FAAD is a dermatologist in La Grange Park, Illinois and is affiliated with multiple hospitals in the area, including Edward Hines, Jr. Veterans Affairs Hospital and Loyola University Medical Center. She received her medical degree from Northwestern University Feinberg School of Medicine. She is a member of the AAD Council on Communications, Co-Chair of the AAD Cutaneous Oncology Work Group, and Chair of the AAD Public Education Committee.

Reprinted with permission from the American Academy of Dermatology.

Mount Rainier National Park Suncadia Resort | Cle Elum, WA July 19-22, 2017

To register, visit americandermoscopy.com

Volume 11 â&#x20AC;˘ number 1 â&#x20AC;˘ winter 2017 41

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.

Professional development

Judicial and Ethical Affairs The Ethics of Self-Care

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 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.

A friend of mine, a family physician, had a brief but serious illness recently. She was able to return to work part-time after three weeks. However, she still had limited physical and emotional energy. She told me that at times she could not care for her patients, which was a shock to her since she had always had empathy for her patients. She felt that she should have been able to feel that same empathy and provide care for her patients as usual.

Our primary role as health care professionals is to care for our patients. This may be difficult and arguably without meaning if we do not care for ourselves.

Richard Cohen wrote that our ethical imperative in caring for patients “goes all the way to giving the very self of the self.”1 We cannot give ourselves if there is no self to give. My friend, the family physician, had no self to give while she was recuperating from her own illness.

We may find ourselves having no self to give because of burnout from the increasing demands of medical practice, resentment, ill health, and so on.

The practice of self-care should be an ethical obligation for health care practitioners. This may seem self-evident but it is frequently ignored. When I was in medical school I do not recall any instruction on self-care, let alone its ethical implications. I do recall being told that I was to take myself out of the equation; my feelings, in particular, were irrelevant, and, if expressed, were unprofessional in the clinical encounter. One could argue that this teaching and attitude helped foster a disconnection from the human experience, turning us away from both patient empathy and self-care. Introspection was discouraged, making it very challenging to address weaknesses, stresses, and exhaustion that we all experience in medicine.

Craig Irvine, in his chapter on The Ethics of SelfCare, talks about one way to approach self-care in 42 Journal of Dermatology for Physician Assistants

our clinical encounters with patients.2 It is through storytelling in which we engage in shared humanity with our patients. Storytelling helps us make sense of and convey the meaning of our lives. Stories contribute to both personal and interpersonal healing.

Storytelling gives rise to narrative bioethics.3 Narrative plays an important role in the way we form knowledge, interpret experience, and define right and goodness. The goal of narrative is to get the stories out in the open where we can examine their values, sort through their conflicts, and explore their effects on us. It should allow us to pause and reflect. One way to respect our obligation for self-care is to address our self-telling narratives. In this way, we along with our patients can voice our experience, and be heard and valued. J REFERENCES: 1. Cohen, R. Ethics, Exegesis and Philosophy: Interpretation after Levinas.

Cambridge: Cambridge University Press. 2001. P. 294 2. Irvine, Craig. The Ethics of Self-Care. Chapter 10. P. 127-145 in: Faculty Health in Academic Medicine Physicians, Scientists, and the Pressures of Success Cole, Thomas (et al.) (Eds.), ISBN 978-1-60327-451-7, 2009 PDF eBook 3. Ibid Karen Scully is a board-certified dermatologist in the United States and Canada. She had a private practice in the Toronto area for many years and then accepted a teaching position at the Johns Hopkins Medical Institutions where she practiced and taught dermatology residents and medical students. More recently she moved to Charlotte, North Carolina and completed a Master’s Degree in Ethics and Applied Philosophy at the University North Carolina at Charlotte.

SMASH

*

*For the treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes. mentagrophytes

LARGER mL

8

JUBLIA allows some patients to have clearer toenails grow back.

Individual results may vary.

size

INDICATION JUBLIA (efinaconazole) topical solution, 10% is indicated for the topical treatment of onychomycosis (tinea unguium) of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.

AVAILABLE Rx Only

IMPORTANT SAFETY INFORMATION • JUBLIA is for topical use only and is not for oral, ophthalmic, or intravaginal use.

• Patients should be instructed to contact their health care professional if a reaction suggesting sensitivity or severe irritation occurs.

• The most common adverse reactions (incidence >1%) were (vs vehicle): ingrown toenail (2.3% vs 0.7%), application-site dermatitis (2.2% vs 0.2%), application-site vesicles (1.6% vs 0%), and application-site pain (1.1% vs 0.2%).

• JUBLIA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, and should be used with caution in nursing women. The safety and effectiveness in pediatric patients have not been established.

Please see Brief Summary of full Prescribing Information on the adjacent page.

Reference: 1. JUBLIA [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC.

Find out more by visiting www.JubliaRx.com.

Jublia is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates. ©2016 Valeant Pharmaceuticals North America LLC. JUB.0146.USA.16 Printed in US

Volume 11 • number 1 • winter 2017 43

BRIEF SUMMARY OF PRESCRIBING INFORMATION This Brief Summary does not include all the information needed to use JUBLIA safely and effectively. See full prescribing information for JUBLIA.

during the period of organogenesis (gestational days 6-19) to pregnant female rabbits. In the presence of maternal toxicity, there was no embryofetal toxicity or malformations at 10 mg/kg/day (154 times the MRHD based on AUC comparisons).

In a pre- and post-natal development study in rats, subcutaneous doses of

JUBLIAÂŽ

organogenesis (gestation day 6) through the end of lactation (lactation day 20). In the presence of maternal toxicity, embryofetal toxicity (increased prenatal pup mortality, reduced live litter sizes and increased postnatal pup mortality) was noted at 25 mg/kg/day. No embryofetal toxicity was noted at 5 mg/kg/day (17 times the MRHD based on AUC comparisons). No effects on postnatal development were noted at 25 mg/kg/day (89 times the MRHD based on AUC comparisons).

For topical use Initial U.S. Approval: 2014 INDICATIONS AND USAGE for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.

DOSAGE AND ADMINISTRATION through brush applicator. When applying JUBLIA, ensure the toenail, the toenail folds, toenail bed, hyponychium, and the undersurface of the toenail plate, are completely covered.

JUBLIA is for topical use only and not for oral, ophthalmic, or intravaginal use.

CONTRAINDICATIONS None.

ADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly rates observed in practice.

In two clinical trials, 1227 subjects were treated with JUBLIA, 1161 for at least 24 weeks and 780 for 48 weeks. Adverse reactions reported within 48 weeks of treatment and in at least 1% of subjects treated with JUBLIA and those reported in subjects treated with the vehicle are presented in Table 1.

Table 1: Adverse Reactions Reported by at Least 1% of Subjects Treated for up to 48 Weeks Adverse Event, n (%)

JUBLIA N = 1227

Vehicle N = 413

Ingrown toenail

28 (2.3%)

3 (0.7%)

Application site dermatitis

27 (2.2%)

1 (0.2%)

Application site vesicles

20 (1.6%)

0 (0.0%)

Application site pain

13 (1.1%)

1 (0.2%)

DRUG INTERACTIONS In vitro studies have shown that JUBLIA, at therapeutic concentrations, neither inhibits nor induces cytochrome P450 (CYP450) enzymes.

Nursing Mothers

Because many drugs are excreted in human milk, caution should be exercised when JUBLIA is administered to nursing women.

Pediatric Use Safety and effectiveness of JUBLIA in pediatric subjects have not been established.

Geriatric Use Of the total number of subjects in clinical trials of JUBLIA, 11.3% were 65 and over, while none were 75 and over. No overall differences in safety and effectiveness were observed between these subjects and younger subjects, and between the elderly and the younger subjects, but greater sensitivity of some older individuals cannot be ruled out.

NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility A 2-year dermal carcinogenicity study in mice was conducted with daily topical noted at the treatment site in all dose groups, which was attributed to the vehicle group was terminated at week 34 due to severe skin reactions. No drug-related MRHD based on AUC comparisons). on the results of two in vitro genotoxicity tests (Ames assay and Chinese hamster lung cell chromosome aberration assay) and one in vivo genotoxicity test (mouse peripheral reticulocyte micronucleus assay).

No effects on fertility were observed in male and female rats that were the MRHD based on AUC comparisons) prior to and during early pregnancy.

5 mg/kg/day (56 times MRHD based on AUC comparisons).

PATIENT COUNSELING INFORMATION See FDA-Approved Patient Labeling (Patient Information).

USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C There are no adequate and well-controlled studies with JUBLIA in pregnant

Systemic embryofetal development studies were conducted in rats and administered during the period of organogenesis (gestational days 6-16) to pregnant female rats. In the presence of maternal toxicity, embryofetal toxicity (increased embryofetal deaths, decreased number of live fetuses, and placental effects) was noted at 50 mg/kg/day [559 times the Maximum Recommended Human Dose (MRHD) based on Area Under the Curve (AUC) comparisons]. No embryofetal toxicity was noted at 10 mg/kg/day (112 times the MRHD based on AUC comparisons). No malformations were observed at 50 mg/kg/day (559 times the MRHD based on AUC comparisons).

44 Journal of Dermatology for Physician Assistants

Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA Manufactured by: Valeant Pharmaceuticals International, Inc., Laval, Quebec H7L 4A8, Canada JUBLIA is a trademark of Valeant Pharmaceuticals International, Inc. or Š Valeant Pharmaceuticals North America LLC U.S. Patents 8,039,494; 7,214,506 Based on 9462903 JUB.0130.USA.16 Issued: 09/2016

Notes from your Office Manager The Risk: Healthcare professionals share responsibility for minimizing prescription drug abuse and drug diversion. The following tips are intended to provide guidance to healthcare providers when confronted by drug seeking patients. This type of patient can pose significant challenges.

Recommendations: 1. Obtain a complete review of the patient’s pertinent history, and conduct a thorough medical evaluation, addressing all objective signs and symptoms of pain.

2. Be cautious of patients who are not interested in having a physical examination, are unwilling to authorize release of prior medical records, or have no interest in a diagnosis or a referral, saying they want the prescription immediately. Be cautious if a new patient has an unusual knowledge of controlled substances, or when a new patient requests a specific controlled drug and is unwilling to try another medication.

3. Document a trial of non-narcotic medication and/or physical therapy before choosing to place the patient on a controlled substance.

4. Document the real source of the patient’s pain in the medical record.

5. Consult the I-STOP registry or similar registry pertinent to your state (effective August 27, 2013, New York state providers must consult the prescription monitoring program registry I-STOP). The duty to consult arises prior to prescribing any Schedule II, III, and IV controlled substance.

Healthcare providers should also access

their state’s department of health website, as soon as possible, to establish a health Commerce System account (if applicable).

6. Document informed consent and agreement for treatment. Consider a written pain management agreement when prescribing controlled substances for patients with chronic pain.

7. Specifically document drug treatment outcomes and the rationale for medication changes.

8. Assess whether further treatment for addiction or pain management is appropriate, and document this discussion with the patient. If necessary, refer the patient for consultation or to a pain management clinic.

9. Monitor and protect your official prescription pads.

10. When writing a prescription for controlled substances, write the quantity and the strength of drugs in both letters and numbers. If only a number is on the prescription, it is easy to alter. Never sign an incomplete prescription.

11. Report patients who are reasonably believed to be a habitual user or abuser of controlled substances to your state’s Bureau of Controlled Substances (this is required by New York State Public health Law § 3372).

12. Contact your practice’s legal team to discuss how to address the patient who you believe to be selling/diverting narcotics, or may have altered, forged, or stolen prescription pads. 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 ©2017 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 11 • number 1 • winter 2017 45

professional development

Managing Drug Seeking Patients

Outside & Inside the 9 to 5...

Getting To Know a PA Pioneer – Esther Cohen, PA-C

professional development

By J. Margaret Casey

When Esther Cohen, PA-C extremely rewarding work, “I graduated from PA school in 1974, the eagerly accept undergrad college NCCPA did not exist. She practiced students for a summer internship her first year as a PA without having after completing their third taken her boards for certification year of college. I am contacted because the National Commission on individually by students who Certification of Physician Assistants express an interest in learning the (NCCPA) was not created until 1975. role of a PA while obtaining real During the time that Ms. Cohen first life exposure to medicine. This is was practicing, the PA field consisted a win-win situation for both the of mainly men with prior military student and myself. They are able experience. When she first started to obtain the necessary hours of working in Maryland in 1974, there direct patient care required to Esther Cohen, PA-C was no legislative documentation for apply to PA programs and I have her to even work in the state. Ms. the unique pleasure of witnessing Cohen, along with five other PAs joined together their personal growth, enthusiasm, and a deep to form the Maryland Academy of Physician desire to commit to becoming a PA student.” She Assistants (MAPA), which was established in says that the students return back to school for 1977. Ms. Cohen served as President of MAPA in their senior year focused on joining the ranks of 1993. During her time as President, the Academy becoming a future PA. “Getting into a PA program submitted their first prescribing bill. It took five is challenging, but when I receive notice of their years to be approved through legislation. acceptance I know I have given back to the next generation of PAs.” In addition to helping future Ms. Cohen has been fortunate to be a part of PA students, Ms. Cohen also accepts PA students the evolution of the PA profession and has witnessed for six-week elective rotations in dermatology the acceptance of the PA profession by patients and anytime throughout their academic year. For this the medical community. In 1980, Johns Hopkins elective, each student receives his/her own personal was looking for a PA to work in dermatology and free dermatology textbook, graciously provided by she filled this role. She became one of the first Ms. Cohen, to begin the never-ending journey of PAs not only in Maryland but the country to learning skin diagnosis and treatment. specialize in dermatology. Ms. Cohen was honored Ms. Cohen has been a pioneer for the PA as the PA of the Year in 2013 by MAPA. She is profession since her graduation from the very first a founding member of the Maryland Association of Dermatology Physician Assistants (MADPA), PA program in the state of Maryland. She has been consistently involved in direct patient care for which started in 2014 and she served as their first President. In 2015, the NCCPA recognized Ms. forty-three years, with the last thirty-seven years working exclusively in dermatology. She is deeply Cohen as one of 223 PAs nationally who have committed to her patients and the betterment of consistently remained certified for forty years. the PA profession. We thank Ms. Cohen for her “I love my profession and feel responsible hard work in creating a path for future PAs within to share my knowledge with students.” Ms. our profession. J Cohen says that working with college students is

46 Journal of Dermatology for Physician Assistants

FOR MODERATE TO SEVERE INFLAMMATORY ACNE

HELP PUT ACNE OUT

Indication and Usage SOLODYN® is indicated to treat only inflammatory lesions of non-nodular • Pseudomembranous colitis has been reported with nearly all moderate to severe acne vulgaris in patients 12 years of age and older. antibacterial agents and may range from mild to life-threatening; therefore, it is important to consider this diagnosis in patients who SOLODYN did not demonstrate any effect on non-inflammatory acne present with diarrhea subsequent to the administration of lesions. Safety of SOLODYN has not been established beyond 12 weeks antibacterial agents of use. This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug-resistant • Dose adjustments may be necessary in patients with renal bacteria as well as to maintain the effectiveness of other antibacterial impairment to avoid liver toxicity drugs, SOLODYN should be used only as indicated.

• Central nervous system side effects, including light-headedness, dizziness, and vertigo, have been reported with minocycline therapy Important Safety Information for SOLODYN Tablets • This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines • MINOCYCLINE, LIKE OTHER TETRACYCLINE-CLASS DRUGS, CAN CAUSE FETAL HARM WHEN ADMINISTERED TO A PREGNANT WOMAN. Should not be used during pregnancy or by individuals of either gender who are attempting to conceive a child; concurrent use of tetracyclines with oral contraceptives may render oral contraceptives less effective.

• TETRACYCLINE DRUGS SHOULD NOT BE USED DURING TOOTH DEVELOPMENT (LAST HALF OF PREGNANCY AND UP TO 8 YEARS OF AGE) AS THEY MAY CAUSE PERMANENT DISCOLORATION OF TEETH.

• Pseudotumor cerebri (benign intracranial hypertension) and autoimmune syndromes have been associated with the use of tetracyclines • Cases of anaphylaxis, serious skin reactions, erythema multiforme, and drug rash with eosinophilia and systemic symptoms have been reported postmarketing with minocycline use. Discontinue SOLODYN immediately if symptoms occur. In rare cases, photosensitivity has been reported.

• The most commonly observed adverse reactions are headache, fatigue, dizziness, and pruritus

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

/TMs are trademarks of Valeant Pharmaceuticals International, Inc. or its affiliates.

All other product or brand names are trademarks of their respective owners. © 2016 Valeant Pharmaceuticals North America LLC. SDN.0055.USA.16 Printed in USA.

®

Visit solodyn.com

Volume 11 • number 1 • winter 2017 47

SUMMARY OF PRESCRIBING INFORMATION This Brief Summary does not include all the information needed to use SOLODYN safely and effectively.

See full Prescribing Information.

SOLODYNÂŽ (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. To reduce the development of drug resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, SOLODYN should be used only as indicated (see Warnings and Precautions).

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,

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 Pseudomembranous Colitis such as visual loss that may be Clostridium difficile associated diarrhea permanent or severe exists. Patients (CDAD) has been reported with nearly should be questioned for visual all antibacterial agents, including disturbances prior to initiation of minocycline, and may range in severity treatment with tetracyclines. If visual from mild diarrhea to fatal colitis. disturbance occurs during treatment, Treatment with antibacterial agents alters patients should be checked for the normal flora of the colon leading to papilledema. Concomitant use of overgrowth of C. difficile. isotretinoin and minocycline should be C. difficile produces toxins A and B which avoided because isotretinoin, a systemic contribute to the development of CDAD. retinoid, is also known to cause Hypertoxin producing strains of pseudotumor cerebri.

C. difficile cause increased morbidity and mortality, as these infections can be Autoimmune Syndromes Tetracyclines have been associated with refractory to antimicrobial therapy and the development of autoimmune may require colectomy. CDAD must be syndromes. The long-term use of considered in all patients who present minocycline in the treatment of acne has with diarrhea following antibiotic use. been associated with drug-induced Careful medical history is necessary since CDAD has been reported to occur lupus-like syndrome, autoimmune over two months after the administration hepatitis and vasculitis. Sporadic cases of serum sickness have presented of antibacterial agents. shortly after minocycline use. Symptoms If CDAD is suspected or confirmed, may be manifested by fever, rash, ongoing antibiotic use not directed arthralgia, and malaise. In symptomatic against C. difficile may need to be patients, liver function tests, ANA, CBC, discontinued. Appropriate fluid and and other appropriate tests should be electrolyte management, protein performed to evaluate the patients. Use supplementation, antibiotic treatment of of all tetracycline-class drugs should be C. difficile, and surgical evaluation should discontinued immediately. be instituted as clinically indicated.

Photosensitivity Hepatotoxicity Photosensitivity manifested by an Post-marketing cases of serious liver exaggerated sunburn reaction has been injury, including irreversible drug-induced observed in some individuals taking hepatitis and fulminant hepatic failure tetracyclines. This has been reported (sometimes fatal) have been reported with rarely with minocycline. Patients should minocycline use in the treatment of acne. minimize or avoid exposure to natural Metabolic Effects or artificial sunlight (tanning beds or UVA/B treatment) while using The anti-anabolic action of the minocycline. If patients need to be tetracyclines may cause an increase in BUN. While this is not a problem in those outdoors while using minocycline, they should wear loose-fitting clothes that with normal renal function, in patients protect skin from sun exposure and with significantly impaired function, higher serum levels of tetracycline-class discuss other sun protection measures with their physician. drugs may lead to azotemia, hyperphosphatemia, and acidosis. If Serious Skin/Hypersensitivity renal impairment exists, even usual oral Reaction or parenteral doses may lead to Cases of anaphylaxis, serious skin excessive systemic accumulations of the reactions (e.g. Stevens Johnson drug and possible liver toxicity. Under syndrome), erythema multiforme, and such conditions, lower than usual total drug rash with eosinophilia and systemic doses are indicated, and if therapy is symptoms (DRESS) syndrome have been prolonged, serum level determinations of reported postmarketing with minocycline the drug may be advisable. use in patients with acne. DRESS Central Nervous System Effects syndrome consists of cutaneous reaction (such as rash or exfoliative dermatitis), Central nervous system side effects eosinophilia, and one or more of the including light-headedness, dizziness following visceral complications such as: or vertigo have been reported with hepatitis, pneumonitis, nephritis, minocycline therapy. Patients who myocarditis, and pericarditis. Fever and experience these symptoms should be lymphadenopathy may be present. In cautioned about driving vehicles or some cases, death has been reported. If using hazardous machinery while on this syndrome is recognized, the drug minocycline therapy. These symptoms should be discontinued immediately. may disappear during therapy and usually rapidly disappear when the drug Tissue Hyperpigmentation is discontinued.

Tetracycline-class antibiotics are known Benign Intracranial Hypertension to cause hyperpigmentation. Tetracycline Pseudotumor cerebri (benign intracranial therapy may induce hyperpigmentation hypertension) in adults and adolescents in many organs, including nails, bone, skin, eyes, thyroid, visceral tissue, oral has been associated with the use of cavity (teeth, mucosa, alveolar bone), tetracyclines. Minocycline has been sclerae and heart valves. Skin and oral reported to cause or precipitate pigmentation has been reported to occur pseudotumor cerebri, the hallmark are found in fetal tissues, and can cause retardation of skeletal development on the developing fetus. Evidence of embryotoxicity has been noted in animals treated early in pregnancy (see Use in Specific Populations).

48 Journal of Dermatology for Physician Assistants

independently of time or amount of drug administration, whereas other tissue pigmentation has been reported to occur upon prolonged administration.

Skin pigmentation includes diffuse pigmentation as well as over sites of scars or injury.

Development of Drug Resistant Bacteria Bacterial resistance to the tetracyclines may develop in patients using SOLODYN, therefore, the susceptibility of bacteria associated with infection should be considered in selecting antimicrobial therapy. Because of the potential for 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 should be discontinued and appropriate therapy instituted.

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

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

The following table summarizes selected adverse reactions reported in clinical trials at a rate of â&#x2030;Ľ1% for SOLODYN. Selected Treatment-Emergent Adverse Reactions in at least 1% of Clinical Trial Subjects Adverse Reactions

SOLODYN PLACEBO (1 mg/kg) N=364 N=674 (%) (%)

At least one treatment-emergent 379 (56) 197 (54) event Headache 152 (23) 83 (23) Fatigue 62 (9) 24 (7) Dizziness 59 (9) 17 (5) Pruritus 31 (5) 16 (4) Malaise 26 (4) 9 (3) Mood alteration 17 (3) 9 (3) Somnolence 13 (2) 3 (1) Urticaria 10 (2) 1 (0) Tinnitus 10 (2) 5 (1) Arthralgia 9 (1) 2 (0) Vertigo 8 (1) 3 (1) Dry mouth 7 (1) 5 (1) Myalgia 7 (1) 4 (1) Postmarketing Experience Adverse reactions that have been reported with minocycline hydrochloride use in a variety of indications include: Skin and hypersensitivity reactions: fixed drug eruptions, balanitis, erythema multiforme, Stevens-Johnson syndrome, anaphylactoid purpura, photosensitivity, pigmentation of skin and mucous membranes, hypersensitivity reactions, angioneurotic edema, anaphylaxis, DRESS syndrome (see Warnings and Precautions).

placenta and may cause fetal harm when administered to a pregnant woman.

Rare spontaneous reports of congenital anomalies including limb reduction have been reported with minocycline use in pregnancy in post-marketing experience. Only limited information is available regarding these reports; therefore, no conclusion on causal association can be established.

Minocycline induced skeletal malformations (bent limb bones) in fetuses when administered to pregnant rats and rabbits in doses of 30 mg/kg/day and 100 mg/kg/day, respectively, (resulting in approximately 3 times and 2 times, respectively, the systemic exposure to minocycline observed in patients as a result of use of SOLODYN). Reduced mean fetal body weight was observed in studies in which minocycline was administered to pregnant rats at a dose of 10 mg/kg/day (which resulted in approximately the DRUG INTERACTIONS same level of systemic exposure to minocycline as that observed in patients Anticoagulants Because tetracyclines have been shown who use SOLODYN). to depress plasma prothrombin activity, Minocycline was assessed for effects on peri- and post-natal development patients who are on anticoagulant of rats in a study that involved oral therapy may require downward adjustment of their anticoagulant dosage. administration to pregnant rats from day 6 of gestation through the period Penicillin of lactation (postpartum day 20), at Since bacteriostatic drugs may interfere dosages of 5, 10, or 50 mg/kg/day. with the bactericidal action of penicillin, it In this study, body weight gain was is advisable to avoid giving tetracycline- significantly reduced in pregnant class drugs in conjunction with penicillin. females that received 50 mg/kg/day (resulting in approximately 2.5 times Methoxyflurane the systemic exposure to minocycline The concurrent use of tetracycline and observed in patients as a result of use methoxyflurane has been reported to of SOLODYN). No effects of treatment result in fatal renal toxicity. on the duration of the gestation period Antacids and Iron Preparations or the number of live pups born per Absorption of tetracyclines is impaired litter were observed. Gross external by antacids containing aluminum, anomalies observed in F1 pups calcium or magnesium and iron(offspring of animals that received containing preparations. minocycline) included reduced body size, improperly rotated forelimbs, Low Dose Oral Contraceptives and reduced size of extremities. No In a multi-center study to evaluate the effects were observed on the physical effect of SOLODYN on low dose oral development, behavior, learning ability, contraceptives, hormone levels over one or reproduction of F1 pups, and there menstrual cycle with and without was no effect on gross appearance of SOLODYN 1 mg/kg once-daily were F2 pups (offspring 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 LH plasma levels, of breakthrough excreted in human milk. Because of bleeding, or of contraceptive failure, cannot the potential for serious adverse effects be ruled out. To avoid contraceptive failure, on bone and tooth development in female patients are advised to use a nursing infants from the tetracyclinesecond form of contraceptive during class antibiotics, a decision should be treatment with minocycline. made whether to discontinue nursing or discontinue the drug, taking into account Drug/Laboratory Test Interactions False elevations of urinary catecholamine the importance of the drug to the mother levels may occur due to interference with (see Warnings and Precautions). the fluorescence test.

Pediatric Use SOLODYN is indicated to treat only USE IN SPECIFIC POPULATIONS inflammatory lesions of non-nodular Pregnancy moderate to severe acne vulgaris in Teratogenic Effects: Pregnancy category D patients 12 years and older. Safety and effectiveness in pediatric (see Warnings and Precautions) patients below the age of 12 has SOLODYN should not be used during not been established. pregnancy. If the patient becomes Use of tetracycline-class antibiotics below pregnant while taking this drug, the the age of 8 is not recommended due to patient should be apprised of the the potential for tooth discoloration (see potential hazard to the fetus and stop Warnings and Precautions). treatment immediately.

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 tetracycline-class drugs, crosses the aged 65 and over to determine whether Autoimmune conditions: polyarthralgia, pericarditis, exacerbation of systemic lupus, pulmonary infiltrates with eosinophilia, transient lupus-like syndrome.

Central nervous system: pseudotumor cerebri, bulging fontanels in infants, decreased hearing.

Endocrine: brown-black microscopic thyroid discoloration, abnormal thyroid function.

Oncology: thyroid cancer.

Oral: glossitis, dysphagia, tooth discoloration.

Gastrointestinal: enterocolitis, pancreatitis, hepatitis, liver failure.

Renal: reversible acute renal failure.

Hematology: hemolytic anemia, thrombocytopenia, eosinophilia.

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

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 OVERDOSAGE equivalent to 55 mg minocycline, In case of overdosage, discontinue supplied as follows: medication, treat symptomatically and Bottle of 30 institute supportive measures. Minocycline NDC 99207-465-30 is not removed in significant quantities by The 65 mg extended release tablets are hemodialysis or peritoneal dialysis. blue, unscored, coated, and debossed with “DYN-065” on one side. Each tablet NONCLINICAL TOXICOLOGY contains minocycline hydrochloride Carcinogenesis, Mutagenesis, equivalent to 65 mg minocycline, Impairment of Fertility supplied as follows: NDC 99207-463-30 Bottle of 30 Carcinogenesis—In a carcinogenicity study in which minocycline HCl was orally The 80 mg extended release tablets are administered to male and female rats once dark gray, unscored, coated, and daily for up to 104 weeks at dosages up debossed with “DYN-080” on one side. to 200 mg/kg/day, minocycline HCl was Each tablet contains minocycline associated in both genders with follicular hydrochloride equivalent to 80 mg cell tumors of the thyroid gland, including minocycline, supplied as follows: increased incidences of adenomas, NDC 99207-466-30 Bottle of 30 carcinomas and the combined incidence The 105 mg extended release tablets are of adenomas and carcinomas in males, purple, unscored, coated, and debossed and adenomas and the combined incidence with “DYN-105” on one side. Each tablet of adenomas and carcinomas in females. In contains minocycline hydrochloride a carcinogenicity study in which minocycline equivalent to 105 mg minocycline, HCl was orally administered to male and supplied as follows: female mice once daily for up to 104 weeks NDC 99207-467-30 Bottle of 30 at dosages up to 150 mg/kg/day, exposure The 115 mg extended release tablets are to minocycline HCl did not result in a green, unscored, coated, and debossed significantly increased incidence of with “DYN-115” on one side. Each tablet neoplasms in either males or females. contains minocycline hydrochloride Mutagenesis—Minocycline was not equivalent to 115 mg minocycline, mutagenic in vitro in a bacterial reverse supplied as follows: mutation assay (Ames test) or CHO/ NDC 99207-464-30 Bottle of 30 HGPRT mammalian cell assay in the Storage presence or absence of metabolic Store at 25ºC (77ºF); excursions are activation. Minocycline was not permitted to 15º-30ºC (59º-86ºF) clastogenic in vitro using human [See USP Controlled Room Temperature]. peripheral blood lymphocytes or in vivo in a mouse micronucleus test.

Handling Keep out of reach of children Impairment of Fertility—Male and female reproductive performance in rats Protect from light, moisture, and was unaffected by oral doses of excessive heat. minocycline of up to 300 mg/kg/day Dispense in tight, light-resistant (which resulted in up to approximately container with child-resistant closure.

40 times the level of systemic exposure Revised: 06/2016 to minocycline observed in patients as a U.S. Patents 5,908,838; 7,790,705; result of use of SOLODYN). However, oral 7,919,483; 8,252,776; 8,268,804; administration of 100 or 300 mg/kg/day and other Patents Pending* of minocycline to male rats (resulting in *55 mg, 80 mg, and 105 mg are also approximately 15 to 40 times the level covered by U.S. Patents 8,722,650 of systemic exposure to minocycline *65 mg and 115 mg are also covered by observed in patients as a result of use U.S. Patent 9,119,793 of SOLODYN) adversely affected Manufactured for: spermatogenesis. Effects observed at Valeant Pharmaceuticals 300 mg/kg/day included a reduced North America LLC number of sperm cells per gram of Bridgewater, NJ 08807 USA epididymis, an apparent reduction in the By: percentage of sperm that were motile, WellSpring Pharma Services Inc. and (at 100 and 300 mg/kg/day) Oakville, Ontario L6H 1M5 Canada increased numbers of morphologically Based on 9387301 abnormal sperm cells. Morphological abnormalities observed in sperm samples included absent heads, misshapen heads, and abnormal flagella. ®/TMs are trademarks of Valeant Pharmaceuticals International, Inc. Limited human studies suggest that or its affiliates. All other product or minocycline may have a deleterious brand names are trademarks of their effect on spermatogenesis. respective owners.

SOLODYN should not be used by individuals of either gender who are © 2016 Valeant Pharmaceuticals attempting to conceive a child.

North America LLC. SDN.0053.USA.16

they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy.

Volume 11 • number 1 • winter 2017 49

Dermatology PA news & notes

Workplace Excellence Creating a Culture of Trust, Truth, and Toughness

By Matthew Davidson, PhD 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.

If you want to truly understand something, try to change it. ~ Kurt Lewin As we have so often argued, knowledge and ideas are important, but rarely sufficient for changing behavior. The idea of what toughness is and why it matters are important. What matters most, however, is how we translate the knowledge into practice. In particular how we turn knowledge about a habit into the development of a stable disposition of individuals and organizations. Culture, a shared way of doing things, is one of the most powerful habit-shaping forces. It’s hard to create culture, and harder still to change it; but it’s almost impossible to fix or change an individual without changing the culture around them. Creating a culture of trust, truth, and toughness will not be easy, especially if you’re changing from a culture of distrust, dishonesty, softness and/or selfishness. But once established, culture is the most powerful and sustainable asset for optimal performance. So how do we do that?

Getting intentional is the first essential element of creating culture. You cannot leave it to chance that individuals will know your expectations or how you want things done. Saying to your staff, “okay, we’re going to create a culture of trust and truth” isn’t the kind of intentionality I’m talking about. You can say that, and they’re all likely to say or think “Fine, I know what that means,” but they don’t really know what you mean. So, we must identify and communicate the specific indicators that are needed for our vision.

These optimal performance indicators are essential

for defining what this value or habit looks, sounds, and feels like.

In the first paragraph of his book Toughness by Jay Bilas he states, “It requires a certain toughness to trust in others and to trust and believe in yourself. I believe trust is a choice. Trustworthy people deal in truth. They speak and accept the truth from those they trust and respect. If you expect a culture of trust, you have to build and foster a culture of truth.”

Toughness - Trust Indicators, as defined by Jay Bilas in the first chapter would include: 1. Hearing and accepting constructive criticism and difficult truths 2. Not being afraid to challenge a teammate (fellow staff member) 3. Holding self and others accountable 4. Accepting challenge and accountability from team (staff) members 5. Not worrying about failure or mistakes 6. Not rationalizing or making excuses 7. Speaking the truth in love 8. Being unselfish and willing to sacrifice for the common good and goals 9. Directly confronting difficult truths, feelings, and circumstances Just like sport performance, no staff member would be expected to be equally proficient in all skills, or to implement them with equal effectiveness ...continued on page 53

50 Journal of Dermatology for Physician Assistants

For the topical treatment of tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum and Epidermophyton floccosum in adults1

STRIKE NOW. TREAT FAST.

1 week, 7 doses for tinea cruris and tinea corporis; efficacy seen at 3 weeks post-treatment1 2 weeks, 14 doses for tinea pedis; efficacy seen at 4 weeks post-treatment1

Indications and Usage LUZU (luliconazole) Cream, 1% is indicated for the topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum and Epidermophyton floccosum in patients 18 years of age and older.

Important Safety Information LUZU is indicated for topical use only and is not indicated for ophthalmic, oral or intravaginal use.

LUZU should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Caution should be exercised when LUZU is prescribed for nursing mothers.

The most common adverse reactions in clinical trials were application site reactions, which occurred in less than 1% of subjects in both LUZU and vehicle arms. Most adverse reactions were mild in severity.

To report SUSPECTED ADVERSE REACTIONS contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or visit fda.gov/medwatch.

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

Reference: 1: LUZU [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC.

Luzu is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates. ©2017 Valeant Pharmaceuticals North America LLC. LUZ.0051.USA.16

Volume 11 • number 1 • winter 2017 51

BRIEF SUMMARY OF FULL PRESCRIBING INFORMATION FOR LUZU (luliconazole) This Brief Summary does not include all the information needed to use LUZU safely and effectively. See full Prescribing Information for LUZU.

noted at 25 mg/kg/day (3 times the MRHD based on BSA comparisons).

Increased incidences of skeletal variation (14th rib) were noted at 25 mg/kg/day. No treatment related effects on skeletal variation were noted at 5 mg/kg/day (0.6 times the MRHD based on BSA comparisons).

LUZU (luliconazole) Cream, 1% for topical use Initial U.S. Approval: 2013

Subcutaneous doses of 4, 20 and 100 mg/kg/day luliconazole were administered during the period of organogenesis (gestational days 6-18) to pregnant female rabbits. No treatment related effects on maternal toxicity, embryofetal toxicity or malformations were noted at 100 mg/kg/day (24 times the MRHD based on BSA comparisons).

Rx Only INDICATIONS LUZU (luliconazole) Cream, 1% is an azole antifungal indicated for the topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum and Epidermophyton floccosum, in patients 18 years of age and older.

DOSAGE AND ADMINISTRATION For topical use only. LUZU Cream, 1% is not for ophthalmic, oral, or intravaginal use.

When treating interdigital tinea pedis, a thin layer of LUZU Cream, 1% should be applied to the affected area and approximately 1 inch of the immediate surrounding area(s) once daily for two (2) weeks.

When treating tinea cruris or tinea corporis, LUZU Cream, 1% should be applied to the affected area and approximately 1 inch of the immediate surrounding area(s) once daily for one (1) week.

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

In three Phase 3 clinical trials, 616 subjects were exposed to LUZU Cream, 1%: 305 with interdigital tinea pedis and 311 subjects with tinea cruris.

Subjects with interdigital tinea pedis or tinea cruris applied LUZU Cream, 1% or vehicle cream once daily for 14 days or 7 days, respectively, to affected and adjacent areas. During clinical trials with LUZU Cream, 1% the most common adverse reactions were application site reactions which occurred in less than 1% of subjects in both the LUZU and vehicle arms. Most adverse reactions were mild in severity.

Post-Marketing Experience The following adverse reactions have been identified during postmarketing use of luliconazole cream, 1%: contact dermatitis and cellulitis. 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 The potential of luliconazole to inhibit cytochrome P-450 (CYP) enzymes 1A2, 2C9, 2C19, 2D6, and 3A4 was evaluated in vitro. Based on in vitro assessment, luliconazole at therapeutic doses, particularly when applied to patients with moderate to severe tinea cruris, may inhibit the activity of CYP2C19 and CYP3A4. However, no in vivo drug interaction trials have been conducted to evaluate the effect of luliconazole on other drugs that are substrates of CYP2C19 and CYP3A4.

Luliconazole is not expected to inhibit CYPs 1A2, 2C9 and 2D6 based on in vitro assessment. The induction potential of luliconazole on CYP enzymes has not been evaluated.

USE IN SPECIFIC POPULATIONS Pregnancy: Pregnancy Category C. There are no adequate and well-controlled studies of LUZU Cream, 1% in pregnant women. LUZU Cream, 1% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

The animal multiples of human exposure calculations were based on daily dose body surface area (BSA) comparisons (mg/m2) for the reproductive toxicology studies described in this section and in Section 13.1 of the prescribing information. The Maximum Recommended Human Dose (MRHD) was set at 8 g 1% cream per day (1.33 mg/kg/day for a 60 kg individual which is equivalent to 49.2 mg/m2/day).

Systemic embryofetal development studies were conducted in rats and rabbits.

Subcutaneous doses of 1, 5 and 25 mg/kg/day luliconazole were administered during the period of organogenesis (gestational days 7-17) to pregnant female rats. No treatment related effects on maternal toxicity or malformations were

In a pre- and post-natal development study in rats, subcutaneous doses of 1, 5 and 25 mg/kg/day luliconazole were administered from the beginning of organogenesis (gestation day 7) through the end of lactation (lactation day 20). In the presence of maternal toxicity, embryofetal toxicity (increased prenatal pup mortality, reduced live litter sizes and increased postnatal pup mortality) was noted at 25 mg/kg/day. No embryofetal toxicity was noted at 5 mg/kg/day (0.6 times the MRHD based on BSA comparisons). No treatment effects on postnatal development were noted at 25 mg/kg/day (3 times the MRHD based on BSA comparisons).

Nursing Mothers It is not known whether luliconazole is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when LUZU Cream, 1% is administered to women who are breastfeeding.

Pediatric Use The safety and effectiveness of LUZU Cream, 1% in pediatric patients have not been established. The number of pediatric patients â&#x2030;Ľ12 years of age were too small to adequately assess safety and efficacy.

Geriatric Use Of the total number of subjects in clinical studies of LUZU Cream, 1%, 8 percent were 65 and over, while 1.4 percent were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies to evaluate the carcinogenic potential of LUZU Cream, 1% have not been conducted.

Luliconazole revealed no evidence of mutagenic or clastogenic potential based on the results of two in vitro genotoxicity tests (Ames assay and Chinese hamster lung cell chromosomal aberration assay) and one in vivo genotoxicity test (mouse bone marrow micronucleus test).

In a fertility study in rats, subcutaneous doses of 1, 5 and 25 mg/kg/day luliconazole were administered prior to and during mating and through early pregnancy. Treatment related effects on reproductive function were noted in females (decreased live embryos and decreased corpus luteum) at 5 and 25 mg/kg/day and males (decreased sperm counts) at 25 mg/kg/day. No treatment related effects on fertility or reproductive function were noted at 1 mg/kg/day (0.1X MRHD based on BSA comparisons).

PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information) Inform patients that LUZU Cream, 1% is for topical use only. LUZU Cream, 1% is not intended for intravaginal or ophthalmic use.

Manufactured for: Medicis, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807

Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215 Product of Japan Issued: 8/2014 9386401 DM/LUZ/15/0007

52 Journal of Dermatology for Physician Assistants

001_0116a_LUZU_HCP_Ad_10-5x13_Prepped_r24.indd 2

1/30/15

Workplace Excellence ...continued from page 50

1. Perform Regular Self-Study on the Indicators.

Using an optimal performance self-study is essential for measuring and monitoring.

Strengths and areas for improvement must be at the forefront of my mind on these indicators in the same way that my performance goals are.

Could be daily or weekly, but if I’m not regularly self-assessing how I’m doing on these indicators I will always have a vague notion, “Yeah, I do this stuff.” What gets measured matters. Self-study is essential.

optimal performance practices, practices that avoid excess or deficiency relative to the mission, vision, and/or goals. Toughness-trust practices, as defined

by Jay Bilas in the first chapter include: 1. Clearly and truthfully communicating expectations and intentions 2. Telling the absolute truth, both positive and negative 3. Not telling people what they want to hear 4. Honestly and authentically communicating feelings and emotions 5. Holding team members accountable to one another 6. Intentionally teaching standards for the “little things” (e.g., body language, dress, decorum, and overall professionalism)

2. Provide Other-Study Examples.

We must have good examples and models of what these indicators look, sound, and feel like. Use video or roleplaying scenarios to show examples to model (or ones to avoid). Teach these indicators with as much intentionality as the other expected skills.

7. Communicating in a way that instills confidence

3. Provide Deliberate Practice on the Indicators.

We understand the importance of deliberate practice for daily skills; it’s just as, if not more important for these emotional skills. You don’t become great at toughness-trust behaviors like the ones we are targeting from feedback that is not general in nature (“get tough”), or from feedback that demeans, insults, or embarrasses.

Deliberate practice means specific feedback: do this, not this; look her in the eye when you say that; don’t take it personal, etc. Focus on using “I” statements not “You” statements.

Character strengths, like toughness and trust, are not unlike athletic ability. We want to recruit for those with great potential, but we must develop that potential; they will not evolve into a person of character. Character potential is taught deliberately and with great intentionality and caught through intentional culture. J

4. Provide Accountability and Support.

We practice expected skills in pairs, small groups, and as a whole group. On character skills we often work alone, and that’s often because character goals make us feel pretty vulnerable.

Support and challenge from one another makes us vulnerable at first, but incredibly tight-knit thereafter. Goal partners, accountability pairs, small groups, and the like are needed to create a culture that embodies these skills and habits.

For the development of toughness-trust practices, managers/leaders will need to implement certain

8. Communicating feedback in a way that is truthful, but fair and doesn’t embarrass or browbeat 9. Establishing standards and rituals for both personal and collective responsibility.

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.

Volume 11 • number 1 • winter 2017 53

DERmatology pa news & notes

in every circumstance or situation. We are striving to more consistently see optimal performance relative to an individual’s capabilities, team and individual goals/expectations, and within circumstances faced.

Around these indicators there are four essential things we can do to intentionally shape these into stable habits.

Listening to Patients Look Out Below How Often Should You Examine Your Groin?

DERmatology pa news & notes

By Alan Rockoff, MD Practicing clinical medicine gives you the chance to ask many questions you never thought you’d have to consider such as the one that gives this essay its title. Frank came to the office the other day, had an itchy rash on his penis, and was very worried. For more than a month he had tried antifungal creams, both over-the-counter and prescribed by his primary physician, but the rash was still there.

“I’m happy to tell you that this is not a fungus,” I told him. “It is just eczema, sensitive skin. Maybe someone in your family has it, but it doesn’t matter. It’s not contagious, you didn’t pick it up from someone, and you can’t transmit it to anybody else. I’ll give you a cream that should clear it up in a couple of days. It may come back once in a while, but if it does, you can make it go away in a day or two.”

Frank looked relieved, but only a little. “What about this blue line in my groin?” he asked. I answered, “That’s just a blood vessel,” I said, “near the surface of the skin.”

“It wasn’t there before,” he said. “I think it probably was,” I said. “Maybe you never noticed.” “But how about these little white bumps near the blue line?” he asked. “Those are small cysts,” I said. “They’re common in the groin area.

See, you have some on your scrotum too.” “I never had them before,” he said. “They were probably there,” I said.

“You just never noticed.” “But I never saw them till now,” said Frank.

I sighed a little to myself. I’ve lived this scenario before.

I’ll bet you have too. If you haven’t, you surely will. “It’s only natural that you wouldn’t notice them,” I told him.

“Who looks at their groin? You don’t until you get a rash or something that draws your attention to the area. Then you look all the time. Am I right?” Frank nodded, a little sheepishly. “How often do you look down there now?” I asked him. “A dozen times a day?” “At least,” he said, finally smiling a little.

You don’t have to be neurotic or obsessive to stare compulsively at a part of your body. All you have to be is scared. Then you can’t stop looking at whatever you’re scared about, and when you look that often, you start seeing things. Not things that aren’t there, things that are there. They’ve been there for who knows how long, but how would you know if you’ve never looked? And why would you look?

This may sound obvious, but there’s nothing obvious about it when you’re worried about something. Many kinds of symptoms will do that to people, but rashes in groins, for reasons too obvious to explain, are a prime example. In dermatology examples are endless. That 54 Journal of Dermatology for Physician Assistants

mole - was it always there looking that way or did it change? That rash - I can’t remember having it before. That bruise - I don’t remember hitting myself or anything. That lump under the skin - did I have that before? The same is true for other kinds of symptoms including aches, pains, cramps, and itches. Once you notice them, it’s as hard to get them out of your mind as it is to not smile when somebody tells you not to.

The fancy term for this is “hypervigilance.” Deciding which vigilance is “hyper” and how much is too much depends on the diagnosis, the symptoms, a person’s natural temperament, and other things. Sometimes watching out carefully is an important thing to do. Other times it’s counterproductive such as PSA screening. I am perpetually amazed at the kinds of symptoms and fears our brains can invent to scare the daylights out of us once we are worried enough to focus on something.

Medical practitioners are often challenged to to figure out what makes people examine themselves too much and to then convince them that they don’t need to. Some patients are hard to convince. After all, I don’t have access to a time-lapse video of Frank’s groin to prove to him that his bumps have been there forever. Frank seemed to be calming down with my reassurance, and I told him what I like to say under these circumstances when I think I can get away with it. “Don’t look down,” I said. “What you’ve got down there belongs down there. From now on Frank, look up!” Frank grinned. A relief for both of us. J Alan Rockoff, MD practices dermatology in Boston, MA. He graduated with his medical degree in 1972 from the Albert Einstein College of Medicine in New York and then completed a pediatric internship and residency at Bronx Municipal Hospital Center. Continuing his education, Dr. Rockoff completed a dermatology residency program at the combined program at Boston University and Tufts University. Dr. Rockoff is a Clinical Assistant Professor of Dermatology at Tufts University School of Medicine. He has taught senior medical students and other trainees for over thirty-five years.

Dr. Rockoff has been named one of Boston’s Top Doctors by Boston Magazine for five years. Dr. Rockoff is board certified by the American Board of Pediatrics and the American Board of Dermatology. Dr. Rockoff is a Fellow of the American Academy of Dermatology and a member of the Massachusetts Medical Society and the Massachusetts Academy of Dermatology.

Dr. Rockoff’s publications have appeared in a number of journals.

He writes a monthly column for his dermatologic colleagues in Dermatology News as well as a blog for the magazine Psychology Today. His first book, “Under My Skin: A Dermatologist Looks at His Profession and His Patients” is available on Amazon and is his second book, “Act Like a Doctor, Think Like a Patient: Teaching Patient-focused Medicine” is available on Amazon and Barnes and Noble.

For your patients with corticosteroid-responsive dermatoses...

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Topicort® (desoximetasone cream USP) 0.05% and Topicort® (desoximetasone ointment USP) 0.05% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Topicort® (desoximetasone cream USP) 0.05% and Topicort® (desoximetasone ointment USP) 0.05% are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

IMPORTANT SAFETY INFORMATION 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, and miliaria. Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression.

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

Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of pediatric patients.

Before prescribing, please see brief Prescribing Information on reverse side.

References: 1. Topicort® Cream 0.05% Prescribing Information. Taro Pharmaceuticals U.S.A., Inc. 2. Topicort® Ointment 0.05% Prescribing Information. Taro Pharmaceuticals U.S.A., Inc. 3. Jacob SE, Steele T. Corticosteroid classes: A quick reference guide including patch test substances and cross-reactivity. J Am Acad Dermatol. 2006;54:723-727. 4. National Psoriasis Foundation.

Topical Steroids Potency Chart. https://www.psoriasis.org/page.aspx?pid=469. Accessed 9/3/15. 5. Baeck M, Chemelle J-A, Rasse C, Terreux R, Goossens A. et al. C16-methyl corticosteroids are far less allergenic than the non-methylated molecules. Contact Dermatitis. 2011;64:305-312. 6. Scheuer E, Warshaw E. Allergy to corticosteroids: Updated and review of epidemiology, clinical characteristics, and structural cross-reactivity. Am J Contact Derm. 2003;14(4):179-187. ©2016 Taro Pharmaceuticals U.S.A., Inc. TaroPharma® and Topicort® are registered trademarks of Taro Pharmaceuticals U.S.A., Inc. AD1000055D August 2016

Volume 11 • number 1 • winter 2017 55

RxRx only only RxRx only only

AsAs with with other other corticosteroids, corticosteroids, therapy therapy should should bebe discontinued discontinued when when control control is is achieved. achieved.

If no If no improvement improvement is seen is seen within within 4 weeks, 4 weeks, contact contact thethe physician. physician.

Brief Brief Summary Summary of Prescribing of Prescribing Information.

Information.

ForFor complete complete prescribing prescribing information information

Laboratory Laboratory Tests Tests The The following following tests tests may may bebe helpful helpful in in evaluating evaluating thethe hypothalamic-pituitaryhypothalamic-pituitaryadrenal adrenal (HPA) (HPA) axis axis suppression: suppression: Urinary Urinary free free cortisol cortisol test test ACTH ACTH stimulation stimulation test test

® ® Topicort Topicort (Desoximetasone (Desoximetasone Cream Cream USP) USP) 0.05% 0.05% ® ® Topicort Topicort (Desoximetasone (Desoximetasone Ointment Ointment USP) USP) 0.05% 0.05%

ForFor topical topical use use only. only.

Not Not forfor oral, oral, ophthalmic, ophthalmic, or or intravaginal intravaginal use. use.

INDICATIONS INDICATIONS AND AND USAGE USAGE ® ® ® ® Topicort Topicort (desoximetasone (desoximetasone cream cream USP) USP) 0.05% 0.05% and and Topicort Topicort (desoximetasone (desoximetasone manifestations manifestations of of corticosteroid-responsive corticosteroid-responsive dermatoses. dermatoses.

CONTRAINDICATIONS CONTRAINDICATIONS Topical Topical corticosteroids corticosteroids areare contraindicated contraindicated in in those those patients patients with with a history a history of of hypersensitivity hypersensitivity to to anyany of of thethe components components of of thethe preparation. preparation.

WARNINGS WARNINGS Keep Keep outout of of reach reach of of children. children.

PRECAUTIONS PRECAUTIONS General General Systemic Systemicabsorption absorptionof oftopical topicalcorticosteroids corticosteroidscan canproduce producereversible reversible hypothalamic-pituitary-adrenal hypothalamic-pituitary-adrenal (HPA) (HPA) axis axis suppression suppression with with thethe potential potential forfor upon upon withdrawal withdrawal of of thethe topical topical corticosteroid. corticosteroid.

Because Because of of thethe potential potential forfor systemic systemic absorption, absorption, useuse of of topical topical corticosteroids corticosteroids may may require require that that patients patients bebe periodically periodically evaluated evaluated forfor HPA HPA axis axis suppression. suppression.

Factors Factors that that predispose predispose a patient a patient using using a topical a topical corticosteroid corticosteroid to to HPA HPA axis axis suppression suppression include include thethe useuse of of more more potent potent steroids, steroids, useuse over over large large surface surface areas, areas, useuse over over prolonged prolonged periods, periods, useuse under under occlusion, occlusion, useuse onon anan altered altered skin skin barrier, barrier, and and useuse in patients in patients with with liver liver failure. failure.

Carcinogenesis, Carcinogenesis, Mutagenesis, Mutagenesis, and and Impairment Impairment of of Fertility Fertility Long-term Long-term animal animal studies studies have have notnot been been performed performed to evaluate to evaluate thethe carcinogenic carcinogenic Desoximetasone Desoximetasone was was nonmutagenic nonmutagenic in the in the Ames Ames test. test.

Corticosteroids Corticosteroids have have been been shown shown to to bebe teratogenic teratogenic in laboratory in laboratory animals animals when when administered systemically relatively dosage levels.

Some corticosteroids administered systemically at at relatively lowlow dosage levels.

Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. have been shown to be teratogenic after dermal application in laboratory animals.

Desoximetasone been shown teratogenic and embryotoxic in mice, Desoximetasone hashas been shown to to bebe teratogenic and embryotoxic in mice, rats, and rabbits when given subcutaneous or dermal routes of administration rats, and rabbits when given byby subcutaneous or dermal routes of administration ® ® in doses 150 times human dose Topicort(desoximetasone in doses 1515 to to 150 times thethe human dose of of Topicort (desoximetasone cream cream ® ® USP) 0.05%, Topicort USP) 0.05%, or or Topicort (desoximetasone (desoximetasone ointment ointment USP) USP) 0.05%.

0.05%.

There There areare nono adequate adequate and and well-controlled well-controlled studies studies in in pregnant pregnant women women onon ®

®

® ® (desoximetasone (desoximetasone cream cream USP) USP) 0.05% 0.05% or or Topicort Topicort (desoximetasone (desoximetasone ointment ointment

thethe potential potential riskrisk to the to the fetus. fetus.

Drugs Drugs of this of this class class should should notnot bebe used used extensively extensively onon pregnant patients, in large amounts, or or forfor prolonged periods of time. pregnant patients, in large amounts, prolonged periods of time.

Nursing Mothers Nursing Mothers It isIt not known whether topical administration of of corticosteroids could result in in is not known whether topical administration corticosteroids could result

AnAn ACTH ACTH stimulation stimulation test test may may bebe helpful helpful in in evaluating evaluating patients patients forfor HPA HPA axis axis suppression. suppression.

If HPA If HPA axis axis suppression suppression is is documented, documented, anan attempt attempt should should bebe made made to to gradually gradually withdraw withdraw thethe drug, drug, to to reduce reduce thethe frequency frequency of of application, application, or or

Systemically Systemically administered administered corticosteroids corticosteroids areare secreted secreted intointo breast breast milk milk in quantities in quantities

require require supplemental supplemental systemic systemic corticosteroids. corticosteroids.

Recovery Recovery of HPA of HPA axis axis function function is is generally generally prompt prompt and and complete complete upon upon discontinuation discontinuation of of topical topical corticosteroids. corticosteroids.

Pediatric Pediatric Use Use Pediatric Pediatricpatients patientsmay maydemonstrate demonstrategreater greatersusceptibility susceptibilityto totopical topical corticosteroid-induced HPA axis suppression and Cushing’s syndrome than corticosteroid-induced HPA axis suppression and Cushing’s syndrome than mature patients because a larger skin surface area body weight ratio. mature patients because of of a larger skin surface area to to body weight ratio.

Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, and intracranial hypertension have been reported in pediatric patients receiving and intracranial hypertension have been reported in pediatric patients receiving topicalcorticosteroids. corticosteroids.Manifestations Manifestationsof ofadrenal adrenalsuppression suppressionin inpediatric pediatric topical patients include linear growth retardation, delayed weight gain, plasma patients include linear growth retardation, delayed weight gain, lowlow plasma cortisol levels, and absence of response ACTH stimulation.

Manifestations cortisol levels, and absence of response to to ACTH stimulation.

Manifestations of of intracranial hypertension intracranial hypertension include bulging fontanelles, headaches, and bilateral include bulging fontanelles, headaches, and bilateral papilledema. papilledema.

Administration topical corticosteroids pediatric patients should limited Administration of of topical corticosteroids to to pediatric patients should bebe limited

Cushing’s Cushing’s syndrome, syndrome, hyperglycemia, hyperglycemia, and and unmasking unmasking of latent of latent diabetes diabetes mellitus mellitus can can also also result result from from systemic systemic absorption absorption of of topical topical corticosteroids. corticosteroids.

Use Use of of more more than than one one corticosteroid-containing corticosteroid-containing product product at at thethe same same time time may may increase increase thethe total total systemic systemic corticosteroid corticosteroid exposure. exposure.

Pediatric Pediatric patients patients may may bebe more more susceptible susceptible to to systemic systemic toxicity toxicity from from useuse of of topical topical corticosteroids. corticosteroids.

Local Local Adverse Adverse Reactions Reactions with with Topical Topical Corticosteroids Corticosteroids Local Local adverse adverse reactions reactions may may bebe more more likely likely to occur to occur with with occlusive occlusive use, use, prolonged prolonged useuse or use or use of higher of higher potency potency corticosteroids. corticosteroids.

Reactions Reactions may may include include atrophy, atrophy, striae, striae, telangiectasias, telangiectasias, burning, burning, itching, itching, irritation, irritation, dryness, dryness, folliculitis, folliculitis, acneiform acneiform eruptions, eruptions, hypopigmentation, hypopigmentation,perioral perioraldermatitis, dermatitis,allergic allergiccontact contactdermatitis, dermatitis,secondary secondary infection, infection, and and miliaria. miliaria.

Some Some local local adverse adverse reactions reactions may may bebe irreversible. irreversible.

Allergic Allergic Contact Contact Dermatitis Dermatitis with with Topical Topical Corticosteroids Corticosteroids Allergic Allergic contact contact dermatitis dermatitis to to anyany component component of of topical topical corticosteroids corticosteroids is is usually usually diagnosed diagnosed byby a failure a failure to to heal heal rather rather than than a clinical a clinical exacerbation. exacerbation.

Clinical Clinical Concomitant Concomitant Skin Skin Infections Infections Concomitant Concomitant skin skin infections infections should should bebe treated treated with with anan appropriate appropriate antimicrobial antimicrobial ® ® agent. agent.

If the If the infection infection persists, persists, Topicort Topicort (desoximetasone (desoximetasone cream cream USP) USP) 0.05% 0.05% ® ® or or Topicort Topicort(desoximetasone (desoximetasone ointment ointment USP) USP) 0.05% 0.05% should should bebe discontinued discontinued until until thethe infection infection hashas been been adequately adequately treated. treated.

Information Information forfor thethe Patient Patient Patients Patients using using topical topical corticosteroids corticosteroids should should receive receive thethe following following information information and and instructions: instructions: 1. 1.

This This medication medication is to is to bebe used used as as directed directed byby thethe physician. physician.

It isIt for is for external external useuse only. only.

Avoid Avoid contact contact with with thethe eyes. eyes.

2. 2.

Patients Patients should should bebe advised advised notnot to to useuse thisthis medication medication forfor anyany disorder disorder other other than than forfor which which it was it was prescribed. prescribed.

3. 3.

The The treated treated skin skin area area should should notnot bebe bandaged bandaged or or otherwise otherwise covered covered or or wrapped wrapped as as to to bebe occlusive occlusive unless unless directed directed byby thethe physician. physician.

4. 4.

Patients Patients should should report report anyany signs signs of of local local adverse adverse reactions, reactions, especially especially under under occlusive occlusive dressings. dressings. ® ® 5. 5.

Other Other corticosteroid-containing corticosteroid-containing products products should should notnot bebe used used with with Topicort Topicort ® ® (desoximetasone (desoximetasone cream cream USP) USP) 0.05% 0.05% or Topicort or Topicort (desoximetasone (desoximetasone ointment ointment Issued: Issued: April April 2014 2014

56 Journal of Dermatology for Physician Assistants

bebe exercised exercised when when topical topical corticosteroids corticosteroids areare administered administered to a tonursing a nursing woman. woman.

corticosteroid corticosteroid therapy therapy may may interfere interfere with with thethe growth growth and and development development of of pediatric patients. pediatric patients.

ADVERSE REACTIONS ADVERSE REACTIONS The following local adverse reactions reported infrequently with topical The following local adverse reactions areare reported infrequently with topical corticosteroids, may occur more frequently with occlusive corticosteroids, butbut may occur more frequently with thethe useuse of of occlusive dressings.

These reactions listed approximate decreasing order dressings.

These reactions areare listed in in anan approximate decreasing order of of occurrence: occurrence: Burning,itching, itching,irritation, irritation,dryness, dryness,folliculitis, folliculitis,hypertrichosis, hypertrichosis,acneiform acneiform Burning, eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration skin, secondary infection, skin atrophy, striae, and miliaria. maceration of of thethe skin, secondary infection, skin atrophy, striae, and miliaria.

In controlled clinical studies incidence adverse reactions were 0.8% In controlled clinical studies thethe incidence of of adverse reactions were lowlow 0.8% ® ® Topicort forfor Topicort (desoximetasone (desoximetasone cream cream USP) USP) 0.05% 0.05% and and included included pruritus, pruritus, erythema, vesiculation, and burning sensation.The The incidence erythema, vesiculation, and burning sensation. incidence adverse of of adverse ® ® reactions was lowlow (0.2%) forfor Topicort reactions was (0.2%) Topicort (desoximetasone (desoximetasone ointment ointment USP) USP) 0.05% 0.05% and included mild burning sensation application. and included mild burning sensation at at thethe sitesite of of application.

OVERDOSAGE OVERDOSAGE PRECAUTIONS).

PRECAUTIONS).

Mfd. Mfd. by:by: Taro Taro Pharmaceuticals Pharmaceuticals Inc., Inc., Brampton, Brampton, Ontario, Ontario, Canada Canada L6T L6T 1C1 1C1 Dist.

Dist. by:by: TaroPharma TaroPharma a division a division of of Taro Taro Pharmaceuticals Pharmaceuticals U.S.A., U.S.A., Inc., Inc., Hawthorne, Hawthorne, 10532 NYNY 10532 ® ® ® ® Topicortand Topicort and TaroPharma TaroPharmaareare registered registered trademarks trademarks of of Taro Taro Pharmaceuticals Pharmaceuticals

FDA. FDA. Visit Visit www.fda.gove/Safery/MedWatch/default.htm, www.fda.gove/Safery/MedWatch/default.htm, or call or call 1-800-FDA-1088.

1-800-FDA-1088.

From the Desk of...

Clarifying the SDPA Position on FPAR

The PA profession was built on a team-based approach to medical practice, which the SDPA and the Task Force proposal continue to recognize as foundational to our goal of providing patients better access to care as a part of a healthcare team.

The SDPA has always been, and will continue to be, an advocate for team-based practice and collaboration between PAs and dermatologists.

The knowledge and skills we gain from working alongside our collaborating physicians is essential to our continued growth and ability to provide the best care for our patients. Contrary to what a few have misinterpreted, the SDPA does not support independent or autonomous practice for PAs, but rather a mutually agreeable team approach to providing dermatologic care that recognizes both the capabilities and limitations of each individual PA’s education and experience.

Our commitment to maintaining the integrity of the physician-PA team is best demonstrated

by our membership requirements and bylaws, which require Fellow members of the SDPA to be working with a board-certified or board-eligible dermatologist.

The SDPA’s response to AAPA’s proposal stems from a trending development in medicine that reaches far beyond our small world of dermatology. Model legislation for nurse practitioners (NP), which has already been adopted in 21 states and the District of Columbia (www.aanp.org/legislation-regulation/statelegislation/state-practice-environment), provides full practice authority to NPs and has seemingly been less controversial in the dermatology community. Though it is important to note that the goal is not to achieve independent practice as some states allow for NPs, we do need reform in the licensure and regulatory processes that currently serve as a barrier to timely transition to PA practice.

The unfortunate consequence of current PA practice regulations versus that of NPs is in the job market we share. The rise of corporate medicine and recent VA regulations have made it increasingly more difficult for PAs to compete for positions they are well qualified to fill, simply because our licensure requires a physician to agree to a varied degree of supervisory terms and liability for the care we provide. Hiring a PA, in these situations, has become more cumbersome than hiring an NP for some physicians.

Additionally, the rapid rise of corporate owned medical practices has affected the willingness by physicians, who are now employees of the practice, to accept PA collaboration/supervision agreements and the liability they imply.

Physicians who are employees, rather than owners or stakeholders, in a practice are less likely to accept the liability of PA supervision because the corporation reaps the majority of the

Volume 11 • number 1 • winter 2017 57

DERmatology pa news & notes

The SDPA recently released a position statement in response to the American Academy of Physician Assistants (AAPA) Task Force’s proposal to pursue Full Practice Authority and Responsibility (FPAR) for the PA profession. In light of discussions that have followed the release of the proposal and our position statement, the SDPA has made a recommendation to AAPA to consider changing the name of the proposal to “PA Practice Reform” to more accurately reflect the intention of the proposal to simplify the PA licensure and regulatory process while maintaining PA commitment to team-based practice with physicians. We encourage every SDPA member, dermatologist, and others with vested interest in PA practice to take the time to fully understand the significance of the proposal as it relates to licensure, viability of PA job opportunities, and inclusion in the ever increasing numbers of corporate owned and managed medical practices.

DERmatology pa news & notes

benefits from adding a PA to the clinic staff. As a result, the viability of the PA profession in the job marketplace is being threatened in a time when we should be thriving.

Collectively, these issues pose a serious threat to PA opportunities in the workforce when compared to our NP colleagues, in all disciplines of medicine including dermatology. A prime example of this issue revolves around the Department of Veterans Affairs’ December 2016 rule to allow for NPs to exercise full practice authority in order to allow veterans to have direct access to care provided by NPs within the VA system. Though the ruling uses the terms “full practice authority,” NPs in the VA setting will still be practicing alongside physicians to maintain collaborative relationships with them.

The ruling will undoubtedly provide a larger set of healthcare providers to offer more timely care for our nation’s veterans, which is long overdue. Unfortunately, the regulation was not inclusive of PAs (whose practice is governed under a different title in the law), and has great potential to negatively affect the ability for PAs to secure employment in the VA system until a new ruling is passed. The difference in practice guideline semantics for PAs, in this instance, has created a clear gap in the ability of PAs to contribute equally to increased access to care for veterans. This same scenario can be applied to any healthcare system or corporate practice to demonstrate how regulations play a vital role in our ability to join forces with our physician and NP colleagues to meet the rapidly changing needs of our patients.

It is important to note that the SDPA has also suggested an edit to the proposed FPAR language from AAPA to make clear that we remain committed to “team-based practice, rather than autonomous care.” Another goal of the FPAR proposal is to establish state PA licensing boards with a voting membership that includes PAs to allow for involvement in licensure, regulations, and disciplinary action for our own profession.

This model mirrors that of NPs, which are governed by state nursing boards with the best understanding of NP education, training, and legislation. Physicians are similarly governed by medical boards comprised of physicians. Several

58 Journal of Dermatology for Physician Assistants

states do include a percentage of PAs on their medical board, and the goal is to ensure that PAs are represented on medical boards nationwide.

We recognize the issues within state PA licensure protocol, which require a varying degree of time-consuming and unnecessary steps for PAs to obtain a license, practice, or prescribe medication. Simply put, we believe the PA licensure and regulatory process should be simplified, while maintaining the collaborative relationship with physicians in clinical practice.

The FPAR proposal, as defined for individual PAs, asserts that PAs should continue to practice as part of a team with physicians and other providers, practice to the highest level of their education and training, and most importantly, recognize the limits of their knowledge and abilities. It also seeks to place liability and responsibility on each PA for the care they provide, rather than requiring a physician to accept that undue burden under the current “supervising physician” rules (www.news-center.aapa.org/fpar/), while still maintaining collaboration with physicians in day to day practice. Some states require an in-person meeting between the medical board, physician, and PA before the PA may begin seeing patients, which obviously causes unintended delays in patient access to care. Others require approval from the state medical board for PAs to perform a procedure they are trained on in the clinic beyond that which is listed in the initial supervisory terms. Ideally, PA scope of practice should be defined at the practice level between the PA and collaborating physicians, rather than by an overarching state or federal regulation that has no regard for individual training and skills.

A recent example of legislative action similar to the FPAR proposal occurred with Michigan House Bill 5533, which was enacted in December 2016. The updated legislation removed the requirement for physicians to sign on as a supervisor for PA licensure. However, it does require that PAs maintain a practice agreement with a physician, which is much different than independent practice. This agreement defines the communication and decision making process by which the PA and the participating physician provide medical care to their patients and may place conditions on specific duties, procedures or

The SDPA, as a whole, has the responsibility to advocate for the practice of PAs in dermatology, both today and in the future. Our support of FPAR reflects the need to support the evolution

of PA practice as it relates to the healthcare team and protect the viability of our profession, not a desire to practice apart from the dermatologists whom we learn from at all stages of our careers and with whom we share our passion for excellence in dermatologic patient care. We fully recognize the value of the dermatologist-PA team in providing more timely access to care, ongoing collaboration, and lifelong learning as all members of the healthcare team seek to better the lives of the patients we serve. J Sincerely,

The SDPA Board of Directors

Editor’s note: This article has also been submitted to Practical Dermatology and The Dermatologist to help expand the reach of our message on this important topic.

Volume 11 • number 1 • winter 2017 59

DERmatology pa news & notes

prescriptions based on individual knowledge and training. It also removed the limitation on the number of PAs that may practice with a physician, which allows for physicians to build their healthcare team to meet the needs of the patient population they serve within the capabilities of their specific healthcare team. These changes are essentially technical and involve a shift in the mechanism by which PA practice is defined.

Camp Discovery 2017

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Camp Discovery was founded in 1993 and offers a summer camp experience like no other. Every summer, the American Academy of Dermatology sponsors six weeks of camp in five locations where everyone can experience activities such as fishing, swimming, archery, horseback riding, nature trails, and just plain fun!

Under the expert care of dermatologists and dermatology healthcare professionals, Camp Discovery offers campers the opportunity to spend a week among other young people who have similar skin conditions. Many of the counselors have chronic skin conditions as well, and can provide support and advice to campers.

There is no fee for camp. All costs, including transportation, are provided by the American Academy of Dermatology through generous donations from its members, other organizations, and individuals. The American Academy of Dermatology is proud to offer this experience to about 380 children each year.

The success of AAD's Camp Discovery depends on dedicated dermatology healthcare providers and counselors who volunteer their time to ensure that the medical needs of each camper are met.

• Volunteers can select the week that is most convenient for them.

• There is no cost for volunteers to attend. All fees, including transportation, are provided by the American Academy of Dermatology.

• Each location accepts a number of cabin counselors and medical staff.

LV

60 Journal of Dermatology for Physician Assistants

CLASS 1 STRENGTH WITH A WELL-TOLERATED SPRAY FORMULATION1,2 Topicort® Topical Spray is a topical corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age or older.

Important Safety Information • Topicort® Topical Spray is a topical corticosteroid that has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis.

• Systemic absorption of topical corticosteroids can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid.

• Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression.

• Local adverse reactions may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Reactions may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. Some local reactions may be irreversible.

• Safety and effectiveness of Topicort® Topical Spray in patients younger than 18 years of age have not been studied; therefore use in pediatric patients is not recommended.

References: 1. National Psoriasis Foundation. Topical Steroids Potency Chart. https://www.psoriasis.org/sublearn03_mild_ potency. Accessed on 9/1/15. 2. Topicort® Topical Spray Prescribing Information. Taro Pharmaceuticals U.S.A., Inc. See brief summary of Prescribing Information on reverse side. © 2016 Taro Pharmaceuticals U.S.A., Inc. TaroPharma® and Topicort® are registered trademarks of Taro Pharmaceuticals U.S.A., Inc. AD1000047M August 2016

Volume 11 • number 1 • winter 2017 61

TOPICORT® (desoximetasone) Topical Spray, 0.25% Rx Only

Table 1. Number (%) of Subjects with Adverse Reactions Occurring in ≥ 1% Topicort® Topical Spray, 0.25% b.i.d. (N = 149)

Vehicle spray b.i.d.

(N = 135)

Number of Subjects with Adverse Reactions

13 (8.7%)

18 (13.3%)

4 CONTRAINDICATIONS None

Application site dryness

4 (2.7%)

7 (5.2%)

Application site irritation

4 (2.7%)

5 (3.7%)

5 WARNINGS AND PRECAUTIONS 5.1 Effect on Endocrine System Topicort® Topical Spray is a topical corticosteroid that has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis.

Application site pruritus

3 (2.0%)

5 (3.7%)

BRIEF SUMMARY 1 INDICATIONS AND USAGE Topicort® Topical Spray is a corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age or older.

Systemic absorption of topical corticosteroids can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid.

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Teratogenic Effects: Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. Topicort® Topical Spray should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

In a study including 21 evaluable subjects 18 years of age or older with moderate to severe plaque psoriasis, adrenal suppression was identified in 1 out of 12 subjects having involvement of 10-15% of body surface area (BSA) and 2 out of 9 subjects having involvement of >15% of BSA after treatment with Topicort® Topical Spray twice a day for 28 days. [see Clinical Pharmacology (12.2)]

Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels.

Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of high potency steroids, larger treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure and young age.

8.3 Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Because many drugs are excreted in human milk, caution should be exercised when Topicort® Topical Spray is administered to a nursing woman.

An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression.

If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.

Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids.

Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids.

Cushing’s syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids.

Use of more than one corticosteroid-containing product at the same time may increase the total systemic corticosteroid exposure.

Pediatric patients may be more susceptible to systemic toxicity from use of topical corticosteroids. [see Use in Specific Populations (8.4)] 5.2 Local Adverse Reactions with Topical Corticosteroids Local adverse reactions may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Reactions may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. Some local adverse reactions may be irreversible.

5.3 Allergic Contact Dermatitis with Topical Corticosteroids Allergic contact dermatitis to any component of topical corticosteroids is usually diagnosed by a failure to heal rather than a clinical exacerbation. Clinical diagnosis of allergic contact dermatitis can be confirmed by patch testing.

5.4 Concomitant Skin Infections Concomitant skin infections should be treated with an appropriate antimicrobial agent.

If the infection persists, Topicort® Topical Spray should be discontinued until the infection has been adequately treated.

5.5 Flammable Contents Topicort® Topical Spray is flammable; keep away from heat or flame.

ADVERSE REACTIONS 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In randomized, multicenter, prospective vehicle-controlled clinical trials, subjects with moderate to severe plaque psoriasis of the body applied Topicort® Topical Spray or vehicle spray twice daily for 4 weeks. A total of 149 subjects applied Topicort® Topical Spray.

Adverse reactions that occurred in ≥ 1% of subjects treated with Topicort® Topical Spray were application site dryness (2.7%), application site irritation (2.7%) and application site pruritus (2.0%).

Another less common adverse reaction (<1% but >0.1%) was folliculitis.

Desoximetasone has been shown to be teratogenic and embryotoxic in mice, rats, and rabbits when given by subcutaneous or dermal routes of administration at doses 3 to 30 times the human dose of Topicort® Topical Spray based on a body surface area comparison.

If used during lactation, Topicort® Topical Spray should not be applied on the chest to avoid accidental ingestion by the infant.

8.4 Pediatric Use Safety and effectiveness of Topicort® Topical Spray in patients younger than 18 years of age have not been studied; therefore use in pediatric patients is not recommended. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing’s syndrome when they are treated with topical corticosteroids. They are therefore at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children. [see Warnings and Precautions (5.1)] HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids.

Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. [see Warnings and Precautions (5.1)] 8.5 Geriatric Use Clinical studies of Topicort® Topical Spray did not include sufficient numbers of subjects aged 65 years 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. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

10 OVERDOSAGE Topicort® Topical Spray can be absorbed in sufficient amounts to produce systemic effects. [see Warnings and Precautions (5.1)] 17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information and Instructions for Use) Inform patients of the following: • Use this medication as directed by the physician.

• Topicort® Topical Spray is for external use only. Avoid use on the face, axilla or groin.

• Do not use this medication for any disorder other than that for which it was prescribed.

• Do not bandage or otherwise cover or wrap the treated skin so as to be occlusive.

• Report any signs of local or systemic adverse reactions to the physician.

• Do not use other corticosteroid-containing products with Topicort® Topical Spray without first consulting with the physician.

• Discontinue therapy when control is achieved. If no improvement is seen within 4 weeks, contact the physician.

• This medication is flammable; avoid heat, flame, or smoking when applying this product.

• Discard this product 30 days after dispensed by pharmacist.

Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1 Dist. by: TaroPharma® a division of Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532 Revised: April 2013 AD100-0030

62 Journal of Dermatology for Physician Assistants

Collaborating Physician CORNER An Interview with the New SDPA Fall Conference Educational Planning Committee’s CME Medical Director – Joseph C. English III, MD The SDPA’s Fall Conference Educational Planning Committee would like to welcome the new SDPA CME Medical Director. The creation of this position was a result of the Committee thoughtfully listening to feedback from our members and using their recommendations to help continually improve our conference and the SDPA overall. Dr. English will be serving as the SDPA CME Medical Director for the 2017 SDPA Fall Dermatology Conference. As the CME Medical Director, Dr. English will be providing the planning committee with guidance and direction to help improve the quality of the conferences. We had an opportunity to interview Dr. English and learn more about his experience volunteering with the SDPA in his new role as CME Medical Director and what he foresees for future conferences.

JDPA: How do you view your new role with the SDPA?

JDPA: What do you see as your mission in this position?

Dr. English: I have provided educational lectures at SDPA conferences for over seven years and don’t believe my role is the focal point. I will work closely with the SDPA Conference Educational Planning Committee on providing a high quality academic dermatology experience to all the participants.

Dr. English: My goal as the SDPA CME Medical Director is to help provide a well-rounded dermatology educational experience to those members attending the conference. The conference should review for those attending a wide range of dermatologic topics including skin, hair, nails, and mucous membranes.

JDPA: What special skills and/or experiences do you have that will lend to your new role?

JDPA: Are there any changes or new features that SDPA members can expect to see at the conference?

Dr. English: The planning committee has secured five Dr. English: Throughout my career I have trained out of seven faculty presenters for the conference who innumerable physicians and PAs in skin disease, and are new to the SDPA conferences. We have focused believe these experiences have prepared me for my new on involving clinicians role as SDPA CME who not only teach for Medical Director. a living, but who are “We should not let the internet beat us.

I was active duty also active clinicians. in the US Army We do not want patients getting their latest We believe that Medical Corp from information from ‘GoogleMD,’ we need to be this combination of 1988 to 1999 and experiences will lead to had the pleasure aware of the latest, most current information so a more enriched lecture of working with that we can educate our patients properly.” experience for SDPA and training many members. We are also exceptional PAs. This looking to incorporate has carried over into new topics including tele-dermatology, heatlh care my academic career (1999 to present). We have a large literacy, and the future of US health care. cadre of PAs that we have trained and work closely with at the University of Pittsburgh. I know their clinical JDPA: What do you hope to gain from this experience and educational needs firsthand. In addition, working with the SDPA? and educating others in academia helps to keep you up to date on the latest advances in dermatology and we Dr. English: During my time as SDPA CME Medical will be sure to highlight these current areas of interest Director I look forward to developing relationships to our conference audience. with new people who have a passion for dermatology.

Volume 11 • number 1 • winter 2017 63

DERmatology pa news & notes

By J. Margaret Casey

It is always exciting to meet new people and learn about their experiences within the field of dermatology.

JDPA: Do you see the role of dermatology PAs changing in the future, and if so how?

Dr. English: I believe that we will continue to see more practices/organizations become more open to utilizing PAs in dermatology. In my opinion, supervising physicians will continue to have a supervisory role and will still allow for autonomy within appropriate situations.

DERmatology pa news & notes

JDPA: Do you have any advice that you would like to share with fellow dermatologists who are considering volunteering their time to help educate dermatology PAs? Dr. English: I would suggest fellow dermatologists to be mindful of the growing physician shortage in the US health care system. One person surely cannot see the high volume of patient demands. If a physician is overwhelmed, PAs can help lighten the burden and free up the physician to have more time to focus on the more complex cases. Investing our time as dermatologists to help educate and the PA community will improve this team approach to health care and ultimately improve patient outcomes.

JDPA: Is there any additional information that you would like to share with the SDPA members?

Dr. English: I believe it is important to continue to expand upon your education regardless of your title in medicine and where you are at in your career. It is critical that we stay current regarding dermatology trends. I would encourage everyone in medicine to stay up to date on the latest treatments and topics and continuously read dermatology journals. We should not let the Internet beat us. We do not want patients getting their latest information from “GoogleMD,” we need to be aware of the latest, most current information so that we can educate our patients properly. J Joseph C. English III, MD is currently a Professor of Dermatology at the University Of Pittsburgh Department Of Dermatology. He graduated from St. Bonaventure University with a Bachelors of Science in 1987 and obtained his medical degree from the Pennsylvania State University College of Medicine in 1991.

His dermatology residency was performed al Brooke Army Medical Center from 1994-1997. He was on faculty at the University of Virginia from 1999 to 2003 and has been at the University of Pittsburgh since. He has a broad range of interests in medical dermatology and has over 160 various publications in the field of dermatology. His current focus is on expanding the department’s tele-dermatology platforms/capabilities for the patients of the UPMC Health Plan.

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

Share your content ideas today.

Email them to editor@jdpa.org

64 Journal of Dermatology for Physician Assistants

JDPA Journal of Dermatology for Physician Assistants

Now Showing on Dermcast.tv The Official Online Media Resource of the SDPA

Dermcast.tv is the official online media resource of the Society for Dermatology Physician Assistants (SDPA) and is your free source for the latest SDPA-related audio podcasts, current dermatology news and research, and videos featuring thought-leaders, procedures, conference highlights, and much more. In addition, Dermcast is the #1 dermatology-related podcast on iTunes – subscribe today!

Image: DermNet New Zealand

Infantile Hemangiomas: What Happens After They Resolve?

Link: http://bit.ly/2hmrrVa Image: Shutterstock

“... for the most part, all IH shrink, but they do often leave a permanent mark of some kind, and the ability to predict how disfiguring that might be could dictate the type of treatment that is indicated...”

UV-B Phototherapy Plus Tacrolimus for Childhood Vitiligo Combination narrowband UVB phototherapy with topical tacrolimus ointment 0.03% is an effective treatment for childhood vitiligo. “... The results showed that there was a significantly higher percentage of repigmentation in the patches treated with combination therapy than in those treated with NBUVB alone at the end of 4 and 6 months of therapy...”

Link: http://bit.ly/2j4tajC Image: Shutterstock

Anogenital Warts Carry Higher Risk of High-Grade Dysplasia in HIV+ Men Classically appearing anogenital warts in HIV positive men who have sex with men may contain high-grade dysplasia or invasive cancer. “... A recent study sought to answer the question of whether anogenital lesions of HIV-positive men that clinically appear as benign warts contain areas of dysplasia, and if so, to determine the virological characteristics of those lesions...”

Link: http://bit.ly/2i8ZT2k Image: Shutterstock

Topical Anticholinergics May Be Effective for Hyperhidrosis Topical glycopyrrolate spray may be a safe and effective treatment for axillary hyperhidrosis.

Link: http://bit.ly/2joPCUk

“... The authors state that due to the minimal and inferior effect 1% glycopyrrolate spray has on managing the physical and psychological effects of axillary hyperhidrosis, they would not recommend its use. However, this study demonstrates that 2% topical glycopyrrolate spray is a safe and effective treatment for axillary hyperhidrosis in the short-term, while also reducing the influence of psychological associated factors...” J Volume 11 • number 1 • winter 2017 65

DERmatology pa news & notes

Detection of early morphological changes suggestive a risk of significant sequelae can help guide clinicians in choosing appropriate therapy before unfavorable clinical features develop.

Professional Opportunities and Development

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• Eli Lilly – Taltz............................ Pages 34-37 • Valeant – Jublia............................Pages 43, 44 • Valeant – Solodyn..........................Pages 47-49 • Valeant – Luzu............................. Pages 51, 52 • Taro Pharma – Topicort 0.05%.....Pages 55, 56 • Taro Pharma – Topicort Spray....... Pages 61, 62 • Valeant – Onexton....................... Pages 67, 68 For more information on advertising opportunities in the JDPA, please log on to www.jdpa.org

The National Eczema Association (NEA) offers resources for you and your patients, all in one place.

InformatIon you can trust.

• Patient education materials • The Advocate, quarterly newsletter • eInsights, electronic newsletter • Tips from leading eczema experts • The latest eczema research and treatment news • National Eczema Association Seal of Acceptance products support for your patIents.

• Support groups nationwide • Facebook • Online Support Community: private and confidential • National Patient Conference & Kids Camp • NEA Itching for a Cure Walks you can count on us.

• Web: nationaleczema.org • Phone: 415.499.3474 or 800.818.7546 • Email: info@nationaleczema.org • Facebook: facebook.nationaleczema.org • Online support community: community.nationaleczema.org

nationaleczema.org

PROFESSIONAL

ALPINE SKIER. OLYMPIC MEDALIST.

SUNSCREEN USER. Being a professional skier requires a lot of hard work, intense training, and time outside on the mountain. But taking care of my skin is super easy. Every day, I apply sunscreen and wear sun protective gear because protecting my skin will help prevent skin cancer and avoid wrinkles. My name is Julia Mancuso and I’m wearing orange to help put a spotlight on skin cancer.

Did you know snow reflects and intensifies the damaging rays of the sun? Sun exposure is the most preventable risk factor for skin cancer. To protect your skin, apply sunscreen, seek shade and wear protective clothing. Visit SpotSkinCancer.org. © 2013 American Academy of Dermatology. Use of this poster does not imply product or service endorsement by the American Academy of Dermatology.

66 Journal of Dermatology for Physician Assistants

BRIEF SUMMARY OF FULL PRESCRIBING INFORMATION

Neuromuscular Blocking Agents

This Brief Summary does not include all the information needed to use ONEXTON Gel safely and effectively. See full prescribing information for ONEXTON Gel.

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

ONEXTON™ (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/3.75%, for topical use Initial U.S. Approval: 2000 CONTRAINDICATIONS Hypersensitivity ONEXTON Gel is contraindicated in those individuals who have shown hypersensitivity to clindamycin, benzoyl peroxide, any components of the formulation, or lincomycin.

Anaphylaxis, as well as allergic reactions leading to hospitalization, has been reported in postmarketing use with ONEXTON Gel [see Adverse Reactions] Colitis/Enteritis ONEXTON Gel is contraindicated in patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis [see Warnings and Precautions] WARNINGS AND PRECAUTIONS Colitis/Enteritis 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. If significant diarrhea occurs, ONEXTON 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 antibiotic-associated colitis. The colitis is usually characterized by severe persistent diarrhea and severe abdominal cramps and may be associated with the passage of blood and mucus. Stool cultures for Clostridium difficile and stool assay for C. difficile toxin may be helpful diagnostically.

Ultraviolet Light and Environmental Exposure Minimize sun exposure (including use of tanning beds or sun lamps) following drug application [see Nonclinical Toxicology].

ADVERSE REACTIONS The following adverse reaction is described in more detail in the Warnings and Precautions section of the label: Colitis [see Warnings and Precautions].

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

These adverse reactions occurred in less than 0.5% of subjects treated with ONEXTON Gel: burning sensation (0.4%); contact dermatitis (0.4%); pruritus (0.4%); and rash (0.4%).

During the clinical trial, subjects were assessed for local cutaneous signs and symptoms of erythema, scaling, itching, burning and stinging. Most local skin reactions either were the same as baseline or increased and peaked around week 4 and were near or improved from baseline levels by week 12. The percentage of subjects that had symptoms present before treatment (at baseline), 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.

Results from the Phase 3 Trial of ONEXTON Gel 1.2%/3.75% (N = 243) Before Treatment (Baseline)

Maximum During Treatment

End of Treatment (Week 12)

Mild Mod.* Severe

Mild Mod.* Severe

Mild Mod.* Severe

Erythema

20

6

0

28

5

<1

15

2

0

Scaling

10

1

0

19

3

0

10

<1

0

Itching

14

3

<1

15

3

0

7

2

0

Burning

5

<1

<1

7

1

<1

3

<1

0

Stinging

5

<1

0

7

0

<1

3

0

<1

*Mod. = Moderate

Postmarketing Experience Because postmarketing adverse 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.

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

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

Concomitant Topical Medications Concomitant topical acne therapy should be used with caution since a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents. If irritancy or dermatitis occurs, reduce frequency of application or temporarily interrupt treatment and resume once the irritation subsides. Treatment should be discontinued if the irritation persists.

USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women treated with ONEXTON Gel. ONEXTON 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 ONEXTON 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 ONEXTON 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 ONEXTON Gel while nursing, taking into account the importance of the drug to the mother.

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

Geriatric Use Clinical trials of ONEXTON 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 ONEXTON 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 15000 mg/kg/day (1.8, 5.4, and 30 times amount of clindamycin and 2.4, 7.2, and 40 times amount of benzoyl peroxide in the highest recommended adult human dose of 2.5 g ONEXTON Gel based on mg/m2, respectively) did not cause any increase in tumors. However, topical treatment with a different gel formulation containing 1% clindamycin and 5% benzoyl peroxide at doses of 100, 500, and 2000 mg/kg/day caused a dose-dependent increase in the incidence of keratoacanthoma at the treated skin site of male rats in a 2-year dermal carcinogenicity study in rats. In an oral (gavage) carcinogenicity study in rats, treatment with the gel formulation at doses of 300, 900 and 3000 mg/kg/day (1.2, 3.6, and 12 times amount of clindamycin and 1.6, 4.8, and 16 times amount of benzoyl peroxide in the highest recommended adult human dose of 2.5 g ONEXTON Gel based on mg/ m2, respectively) for up to 97 weeks did not cause any increase in tumors. In a 52-week dermal photocarcinogenicity study in hairless mice, (40 weeks of treatment followed by 12 weeks of observation), the median time to onset of skin tumor formation decreased and the number of tumors per mouse increased relative to controls following chronic concurrent topical administration of the higher concentration benzoyl peroxide formulation (5000 and 10000 mg/kg/day, 5 days/week) and exposure to ultraviolet radiation.

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

Fertility studies have not been performed with ONEXTON 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 ONEXTON 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 Issued 11/2014 9389300 ONX.0088.USA.16

Volume 11 • number 1 • winter 2017 67

l e G N e” O T X c E a F N r O ou GE Y w “Sho ALLEN t of CH men y reat mator t y l i -da flam Once onal & in ons ed lesi e n com c a

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INDICATION

ONEXTON (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/3.75% is indicated for the topical treatment of acne vulgaris in patients 12 years of age or older.

IMPORTANT SAFETY INFORMATION

• ONEXTON Gel is contraindicated in patients with a known hypersensitivity to clindamycin, benzoyl peroxide, any component of the formulation, or lincomycin.

• ONEXTON 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.

ONEXTON Gel should be discontinued if significant diarrhea occurs.

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

• Anaphylaxis, as well as other allergic reactions leading to hospitalizations, has been reported in postmarketing use of products containing

•

• •

• •

Visit Onexton.com for savings offers

clindamycin/benzoyl peroxide. If a patient develops symptoms of an allergic reaction such as swelling and shortness of breath, they should be instructed to discontinue use and contact a physician immediately.

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

ONEXTON Gel should not be used in combination with erythromycin-containing products because of its clindamycin component.

ONEXTON Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. A decision should be made whether to use ONEXTON Gel while nursing, taking into account the importance of the drug to the mother.

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

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

*This offer is only valid for patients with commercial insurance. Eligible uninsured patients will pay more. This offer is not valid for any person eligible for reimbursement of prescriptions, in whole or in part, by any federal, state, or other governmental programs, including, but not limited to, Medicare (including Medicare Advantage and Part A, B, and D plans), Medicaid, TRICARE, Veterans Administration or Department of Defense health coverage, CHAMPUS, the Puerto Rico Government Health Insurance Plan, or any other federal or state health care programs. This offer is good only in the U.S. at retail pharmacies owned and operated by Walgreen Co. (or its affiliates) or other participating independent retail pharmacies. This offer is not valid in Massachusetts or Minnesota or where otherwise prohibited, taxed or otherwise restricted. Visit www.valeantaccessprogram.com for full terms and conditions.

Please see Brief Summary of full Prescribing Information on the following page. ® /TMs are trademarks of Valeant Pharmaceuticals International, Inc. or its affiliates. All other product or brand names are trademarks of their respective owners. © 2016 Valeant Pharmaceuticals North America LLC. ONX.0075.USA.16 Printed in USA.

68 Journal of Dermatology for Physician Assistants