JDPA Spring 2017 by Angela Simiele

DPA J

V o l u m e 1 1 • n u m b e r 2 • S P R I N G 2 0 1 7 • www.jdpa.org

Journal of Dermatology for Physician Assistants

Dermatology PA News & Notes Workplace Excellence 40 __________________________________

CLINIcal dermatology Clinical Snapshots

__________________________________

surgical dermatology Surgical Wisdom 30 _________________________________

cosmetic dermatology Cosmetic Pearls 34 __________________________________

professional development Notes From Your Office Manager

›› Earn CME credit with this issue CME Current Review of Perioral Dermatitis

Official Journal of the Society of Dermatology Physician Assistants

Volume 11 • number 2 • SPRING 2017

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Volume 11 â&#x20AC;˘ number 2 â&#x20AC;˘ SPRING 2017

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

2017-18 SDPA Board of Directors PRESIDENT Jane Mast, MPAS, PA-C PRESIDENT-ELECT Joleen Volz, MPAS, PA-C IMMEDIATE PAST PRESIDENT Jennifer Conner, MPAS, PA-C VICE PRESIDENT John Notabartolo, MPAS, PA-C SECRETARY / TREASURER Gina Mangin, MPAS, PA-C DIRECTORS AT LARGE Renata Block, MHS, PA-C Travis Hayden, MPAS, PA-C Archana Sangha, MMS, PA-C Martha Sikes, MS, RPh, 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 2, Spring 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.

Journal of Dermatology for Physician Assistants

Editor’s Message

here always seems to be new and exciting news to share about progress and innovations being made by the SDPA. The SDPA Diplomate Fellowship Program is one of the latest exciting programs. Launched on June 1st, 2017, this new program features an all-encompassing, online, didactic training program for PAs working in the field of dermatology. This program replaces the DLI, which was created in 2005 and was clinically formatted with case study based learning. SDPA members provided feedback about the original DLI format and areas they wanted to see improvements and/or changes. The SDPA Board of Directors and leaders listened and as a result of the feedback and after researching how to best serve our members, the SDPA Diplomate Fellowship Program was born. Yet another example of how important it is to let your voice be heard and share your input with your SDPA leaders. The SDPA Diplomate Fellowship Program includes approximately 65 hours of AAPA accredited Category 1 CME training, spread out across 22 modules. Each of the 22 modules contains sections (or presentations) providing detailed training on the topics related to that module. The program was created in conjunction with a core textbook, Dermatology Essentials – 1st Edition by Bolognia et. al. This text will be used and referenced throughout the program and you will be asked to read associated chapters. This new program is centered on one core text and all with a similar style and theme. Learners will be provided with all resources and information needed to complete the program and will walk away with improved skills, knowledge, and training. Thank you to all of those SDPA leaders who worked so diligently behind the scenes putting the Diplomate Fellowship Program together. Your time, energy, and hard work is greatly appreciated. I continue to be so proud to be a part of such a progressive organization that truly listens to its members and continues to make changes and improvements in order to better serve the needs of its members. Please continue to share your thoughts with our SDPA leaders and please consider volunteering with the SDPA, as this is an excellent way to make a difference in our field. When we all work together we can accomplish great things. J

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

Volume 11 • number 2 • SPRING 2017

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.

Current Review of Perioral Dermatitis By Mallory Aycock, MPA, PA-C, Henry Heard, DHSc, PA-C, Jill Mattingly, DHSc, PA-C

›› CME 12 Derm PA News & Notes – part one • Certification Review

14 Clinical Dermatology • CME Article: Current Review of Perioral Dermatitis • Tips To Prevent And Treat Bug Bites

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

Departments 04 Editorial Board 05 Editor’s Message 08 SDPA News & Current Affairs 12 Dermatology Market Watch 20 From The Patient’s Perspective 22 Clinical Snapshots 30 Surgical Wisdom 34 Cosmetic Pearls 36 Notes from your Office Manager 54 The Difference We Make 50 Professional Opportunities and Development

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

36 Professional Development • Outside & Inside the 9 to 5…

40 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: AAD Launches SkinSerious Campaign

dermpa.org

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feAtureD leCtureS InCluDe:

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This program in not yet approved for CME Credit. Conference organizers plan to request maximum of 27 hours (21maximum earnable by any attendee) of Category i CME Credit from AAPA.

feAtureD fACulty InCluDe: • Eileen Cheever PA-C • Whitney High MD • Pearl Kwong MD • Heather Roebuck NP • Ted Rosen MD • James Treat MD

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WoRKSHoPS 1 & 2 iNCLuDE: IntermeDIAte DermAtologIC Surgery

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TRACK #1 iNCLuDES: AESTHETiC & MEDiCAL uTiLizATioN oF LASER iN DERMAToLogy

We look forward to seeing you in Atlanta!

presented by Heather Roebuck, NP

presented by Suneel Chilukuri, MD

Volume 11 • number 2 • SPRING 2017

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

This has been an interesting and monumental year for the PA profession. We have witnessed progressive movement in the laws and regulations of PA career fields, as well as the controversy that inevitably comes with change. Awareness of the political landscape in which we practice is becoming increasingly critical for PAs. Over the past year, we have seen quite a bit of activity from the NCCPA and AAPA regarding the future of PA practice. Now, more than ever, I encourage you to be aware of legislation in your state that has the potential to affect the way you practice. Take note of those standing with the profession, as well as those running interference. Take the time to talk to your collaborating physician to discuss the issues that face that PA profession. Open and candid dialogue can go a long way towards strengthening your bond as a team and providing a deeper level of understanding about our role and commitment to the healthcare team. This summer also marks the launch of our much anticipated Diplomate Fellowship program, which has been in development for over a year. The program is meant to provide the fundamental knowledge that all PAs in dermatology should possess in order to best serve their patients. Both seasoned and new PAs will benefit from this robust educational opportunity, and it is our hope that all SDPA members will participate. There are a number of SDPA leaders, authors, staff, and volunteers who worked tirelessly to make our plan a reality. Please take some time to thank those who have dedicated their time, knowledge, and energy to provide us with the absolute best program for dermatology PA education. As this leadership year comes to a close, I would like to express my sincere thanks for the opportunity to serve as your President. It has been an honor to serve you and to work alongside such an amazing group of leaders who selflessly give to our organization. I look forward to continuing to be a part of the SDPA’s growth and success for years to come. J

Jennifer Conner, MPAS, PA-C

SDPA Immediate Past President, Diplomate

Journal of Dermatology for Physician Assistants

FOR MODERATE TO SEVERE INFLAMMATORY ACNE

MATCH THE POWER TO THE PATIENT TREAT INFLAMMATORY LESIONS WITH CUSTOMIZED DOSING1 FIVE CUSTOMIZED, WEIGHT-BASED STRENGTHS DELIVER ~1 MG/KG/DAY1

GIVE PATIENTS YOU SEE THE MOST ONLY WHAT THEY NEED1 Indication and Usage SOLODYN ® is indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. SOLODYN did not demonstrate any effect on non-inflammatory acne lesions. Safety of SOLODYN has not been established beyond 12 weeks of use. This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, SOLODYN should be used only as indicated.

Important Safety Information for SOLODYN Tablets • 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.

• Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range from mild to life-threatening; therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents • Dose adjustments may be necessary in patients with renal impairment to avoid liver toxicity • Central nervous system side effects, including light-headedness, dizziness, and vertigo, have been reported with minocycline therapy • 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 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 www.fda.gov/medwatch. Please see Brief Summary of Prescribing Information on the following pages.

Reference: 1. SOLODYN Tablets Package Insert. Valeant Pharmaceuticals North America LLC. Solodyn is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates. © 2017 Valeant Pharmaceuticals North America LLC. SDN.0029.USA.17

Volume 11 • number 2 • SPRING 9 Visit2017 Solodyn.com

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).

10 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).

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 the fluorescence test. Pediatric Use 300 mg/kg/day included a reduced North America LLC SOLODYN is indicated to treat only USE IN SPECIFIC POPULATIONS number of sperm cells per gram of inflammatory lesions of non-nodular epididymis, an apparent reduction in the Bridgewater, NJ 08807 USA Pregnancy By: moderate to severe acne vulgaris in percentage of sperm that were motile, WellSpring Pharma Services Inc. Teratogenic Effects: Pregnancy category D patients 12 years and older. Safety and (at 100 and 300 mg/kg/day) Oakville, Ontario L6H 1M5 Canada and effectiveness in pediatric (see Warnings and Precautions) increased numbers of morphologically Based on 9387301 patients below the age of 12 has SOLODYN should not be used during abnormal sperm cells. Morphological not been established. pregnancy. If the patient becomes abnormalities observed in sperm Use of tetracycline-class antibiotics below samples included absent heads, pregnant while taking this drug, the the age of 8 is not recommended due to patient should be apprised of the misshapen heads, and abnormal flagella. ®/TMs are trademarks of Valeant the potential for tooth discoloration (see potential hazard to the fetus and stop Pharmaceuticals International, Inc. Limited human studies suggest that Warnings and Precautions). treatment immediately. or its affiliates. All other product or minocycline may have a deleterious There are no adequate and well-controlled Geriatric Use brand names are trademarks of their effect on spermatogenesis. studies on the use of minocycline in respective owners. Clinical studies of SOLODYN did not SOLODYN should not be used by pregnant women. Minocycline, like other include sufficient numbers of subjects individuals of either gender who are © 2016 Valeant Pharmaceuticals tetracycline-class drugs, crosses the aged 65 and over to determine whether attempting to conceive a child. North America LLC. SDN.0053.USA.16 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). 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).

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 2 • SPRING 2017 11

Dermatology PA news & notes

Dermatology Market Watch Sun Pharma Introduces "Leave Acne Behind™" Patient Initiative Designed to Educate Patients About Severe Acne and its Long-term Effects Sun Pharma has introduced Leave Acne Behind™, a unique initiative dedicated to educate patients and create awareness of severe recalcitrant nodular acne (SRNA). Approximately 50 million people in the US suffer from acne breakouts and flare-ups. Out of all of the prescriptiontreated acne cases today, 20 percent represent severe acne conditions. Those who face such conditions often suffer embarrassment, low self-esteem and other negative emotions that impact their quality of life. Approximately, 90% of these cases are often teenagers. The Leave Acne Behind™ initiative comprises a suite of educational resources including a website LeaveAcneBehind. com and resources for the dermatology office including a book (both in hard copy and iBook) and patient brochure to help patients and caregivers navigate through topics that are often not addressed regarding severe acne. All of the program's resources are meant to open the lines of communication between patients and dermatology providers in hopes to reduce the long-term effects of acne. The website and book addresses cover a variety of topics such as: • Who gets acne and why • The different types of acne • The physical and emotional damage severe acne can cause • Treatments to help prevent acne from causing permanent skin damage/scars • Questions a patient or caregiver may want to ask during dermatology appointments Please visit LeaveAcneBehind.com for any additional information. J

Bavencio (avelumab) The First Drug Ever Approved for Merkel Cell Carcinoma The recent approval of avelumab (Bavencio, EMD Serono) by the US Food and Drug Administration (FDA) is the first for a treatment of Merkel cell carcinoma. According to the FDA’s Center for Drug Evaluation and Research Merkel cell carcinoma is diagnosed in some 1,600 people in the United States each year. Although most patients present with localized tumors that can be treated with surgical resection, approximately half of all patients will experience recurrence, and more than 30% will eventually develop 12 Journal of Dermatology for Physician Assistants

metastatic disease. Avelumab is a novel immunotherapy that acts an inhibitor of the programmed cell death pathway. Merkel cell carcinoma is the drug's first indication. It was granted an accelerated approval on the basis of response rates from a single-arm clinical trial conducted in 88 patients with chemotherapy-refractory MCC. The FDA notes that 33% of these 88 patients experienced complete or partial shrinkage of their tumors. The response lasted for more than 6 months in 86% of responding patients and more than 12 months in 45% of responding patients. The study, known as JAVELIN Merkel 2000, was published online September 1, 2016 in Lancet Oncology. 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!

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.

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 Volume 11 • number 2 • SPRING 2017 13

DERmatology pa news & notes

EXPLANATION: Coarctation of the aorta is a common cause of secondary hypertension. On physical examination a systolic murmur is noted that can be heard in the infraclavicular areas and there is a significant delay between the bounding radial and weak femoral pulses. Electrocardiogram (ECG) reveals left ventricular

hypertrophy. Aortic stenosis presents with systolic murmur with radiation to the neck. Peripheral pulses are normal and ECG reveals left ventricular hypertrophy. Renal artery hypertension presents with elevated blood pressure but not cardiac murmur. A renal artery bruit may be noted. Hypertrophic cardiomyopathy presents with a systolic murmur heard best at the left sternal edge with radiation to the apex, arterial pulses have a rapid upstroke and downstroke. J The correct answer is B.

QUESTION: A 44-year-old male is admitted for investigation of long-standing hypertension. On examination, his blood pressure is 210/102 mm Hg in both arms. There is a systolic ejection murmur best heard at the right second intercostal space and a reversed split of the second sound is present. The murmur is also heard in the left interscapular area. The femoral pulse is delayed and weak compared to the radial pulse. An electrocardiogram indicates normal sinus rhythm and left ventricular hypertrophy. Which of the following is the most likely diagnosis? A. Aortic stenosis B. Coarctation of the aorta C. Renal artery hypertension D. Hypertrophic cardiomyopathy

Clinic al Dermatology

Current Review of Perioral Dermatitis By Mallory Aycock, MPA, PA-C, Henry Heard, DHSc, PA-C, Jill Mattingly, DHSc, PA-C

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

›› CME

This program has been reviewed and is approved for a maximum of .5 hours of AAPA Category I CME credit by the Physician Assistant Review Panel.

Approval is valid for 1 year from the issue date of June 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:

1. Discuss the clinical and physical presentations of perioral dermatitis. 2. Review current treatment options for perioral dermatitis. 3. Outline management considerations and patient education pearls for patients with perioral dermatitis.

14 Journal of Dermatology for Physician Assistants

Current Review of Perioral Dermatitis

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 2 • SPRING 2017 15

Current Review of Perioral Dermatitis

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

Current Review of Perioral Dermatitis

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 2 • SPRING 2017 17

Current Review of Perioral Dermatitis

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

Current Review of Perioral Dermatitis

SDPA Members Only Content

Mallory Aycock, MPA, PA-C: Mallory is a graduate of Medical College of Georgia in Augusta, GA. She has practiced both in Dermatology and Surgery. Mallory is currently a Clinical Assistant Professor at Mercer University in the Department of Physician Assistant Studies. She has indicated no relationships to disclose relating to the content of this article. Henry Heard, DHSc, PA-C: Hank is a recent graduate of Nova Southeastern University Doctor of Health Science program and a graduate of Medical College of Georgia in Augusta, GA. Hank is currently a Clinical Assistant Professor at Mercer University in the Department of Physician Assistant Studies. He has indicated no relationships to disclose relating to the content of this article. Jill Mattingly, DHSc, PA-C: Jill is a recent graduate of Nova Southeastern University Doctor of Health Science program and a graduate of Emory University in Atlanta, GA. She has practiced both in Internal Medicine, Addiction Medicine, and Integrated Medicine. Jill is currently a Clinical Assistant Professor and Academic Coordinator at Mercer University in the Department of Physician Assistant Studies. She has indicated no relationships to disclose relating to the content of this article.

Volume 11 â&#x20AC;˘ number 2 â&#x20AC;˘ SPRING 2017 19

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.

From The Patient’s Perspective

Katie's Story

CLINIC AL Dermatology

My Ocular Melanoma Diagnosis Is My Opportunity To Spread Hope In May of 2013, on the way to my ophthalmologist I noticed a black line dancing across my windshield appointment, my left while driving a cobra strap unhooked. worker and myself to a "Because of organizations like the MRF, I said to myself, client meeting. When “ We l l … h o p e f u l l y she didn’t see the line, patients like me have a community, that’s the worst thing I decided to make an that happens to me appointment with my a voice and a hope for a cure." today.” I always visited eye doctor. I was given my ophthalmologist a worrisome referral to regularly, mostly to get my contacts prescription but a specialist after my ophthalmologist noticed a bump this time was different. I had noticed my lower left on my retina. I prayed that I didn’t have a retinal tear peripheral vision was disappearing. On top of that, or macular degeneration, which runs in my family. The news I would receive that day, unfortunately, would be very different. The specialist dilated my eyes - for the second time that day, and to his and my surprise, found ocular melanoma in my left eye. I was at a complete loss for words. The only thing I could think about was my mom, who I lost to pancreatic cancer when I was young. I knew that I could lean on my wonderful, supportive family during this difficult time, but there was no hiding the fact that I was scared. The Melanoma Research Foundation (MRF) is the largest independent organization devoted to melanoma. The Luckily, after further testing, my ocular melanoma MRF is a 501(c)(3) nonprofit organization. was classified as Stage 1A. I had caught it early. Committed to the support of medical research in finding Following a week of radiation therapy that left me effective treatments and eventually a cure for melanoma, blind in my left eye, I was considered cancer-free with the MRF also educates patients, caregivers, and physicians only a 2 percent chance of recurrence. After what was about the prevention, diagnosis, and treatment of the biggest whirlwind of my life, and even though I melanoma. The MRF's website is the premier source for melanoma information seekers. was grieving the loss of my eyesight, I couldn’t have The MRF is also an active advocate for the melanoma been more relieved. In just 22 days, I had become a community, helping to raise awareness of this disease cancer survivor. and the need for a cure. Its online forum - the Melanoma Fast forward to November of 2014. I had kept Patients Information Page (MPIP) - is the oldest and largest up with regular visits to my eye doctor, continued community of people affected by melanoma and is hosted through the MRF. It is designed to provide support working, and as luck would have it I met the love of and information to caregivers, patients, family, and friends. my life, Nick. That November, I went back in to the Melanoma Research Foundation doctor for a routine scan when they noticed something Contact Information: www.melanoma.org suspicious on my liver. My stomach dropped. Later 1411 K Street, NW Suite 800, Washington, DC 20005 that afternoon, just two days before Thanksgiving, my MRF Blog: www.melanoma.org/about-us/news-press-room/blog oncologist called to confirm my melanoma had spread Phone: (800) 673-1290 to my liver and was diagnosed as Stage IV. 20 Journal of Dermatology for Physician Assistants

their skin. However, ocular melanoma accounts for 5-12 percent of all melanoma cases. While it is a rare disease, it is still definitely more common than people think. Since my second diagnosis, I have entered three clinical trials and endured two liver embolization procedures that are aimed at shrinking tumors. While this process has been emotionally, physically, and mentally exhausting, I have so many reasons to stay positive. My amazing family and husband have kept me going when I didn’t think I could. May 16th 2007 will mark four years since my initial ocular melanoma diagnosis. I will be participating in Melanoma Awareness Month with the MRF and I encourage you all to join me! Because of organizations like the MRF, patients like me have a community, a voice, and a hope for a cure. J

Take Home Points for Derm PAs: By Steven K. Shama, MD, MPH, FAAD

1. I am always humbled with the brave and positive outlook that many of our patients who are diagnosed with very serious medical diagnoses have. Throughout my years as a provider, I have been absolutely convinced that these individuals are messengers for us as clinicians, sent as a reminder of the preciousness and vitality of our lives. 2. While most clinicians would assume that a 2% likelihood of recurrence is essentially a cure, it still means that two out of every 100 patients will develop a recurrence, and that is a fact that our patients must hear.

How we choose to incorporate into our conversation the raw facts versus the message of the pureness of the hope of a cure is up to each clinician. However, it must be done and it should be done with grace and compassion. 3. Katie reminds us that we are not, nor should we be, our patient’s main source of emotional support. Her family, friends, and her involvement in the Melanoma Research Foundation give her a reason to live a fulfilling life with the hope for a cure.

Volume 11 • number 2 • SPRING 2017 21

CLINIC AL Dermatology

On Thanksgiving, Nick proposed to me in front of my entire family. Since that moment, I have not stopped fighting. Over the next several weeks, I enrolled in a clinical trial in New York City, away from my friends and family in Denver. Oh, and I also planned a wedding. In February of 2015, Nick and I were married. For the next few months I continued to travel to New York for appointments. Then I found the Melanoma Research Foundation’s (MRF) #EyeGetDilated campaign that brings awareness to ocular melanoma. Knowing that there is a community of people who know what I’m going through and are working hard to bring attention to this rare form of melanoma is extremely comforting and motivating. It’s important for me to encourage my friends and family to get dilated eye exams because when most people think of melanoma, they think of

Clinical snapshots Dermcast.tv Blog

Biologics and Reactivating Hepatitis: What is the Risk? By Martha L. Sikes, MS, RPh, 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.

Image: Shutterstock

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.

22 Journal of Dermatology for Physician Assistants

Join us in Puerto Rico!

Exceptional Speakers!

Bring the whole family to San Juan for the SDPA’s first-ever destination event. Don’t miss the opportunity to gain training from nationally acclaimed dermatology experts while exploring all Puerto Rico has to offer.

more at: sdpaconferences.org Colorful architecture in Old San Juan, Puerto Rico.

Volume 11 • number 2 • SPRING 2017 23

Tips To Prevent And Treat Bug Bites By Dr. Lindsay Strowd

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.

Dr. Lindsay Strowd is a dermatologist with Wake Forest Baptist Health in Winston - Salem, North Carolina. Dr. Strowd graduated from Wake Forest University School of Medicine and completed her residency at Wake Forest Baptist Medical Center.

Repeated with permission from the American Academy of Dermatology

24 Journal of Dermatology for Physician Assistants

SURGIC AL Dermatology Journal Club: Practice Changing Articles for Dermatology PAs

Effectiveness and Safety of Surgical Excision in the Treatment of Digital Mucoid Cysts Dermatologic Surgery. 2017 July. Volume 43 – Issue 7 – pg 928-933. Balakirski, Galina MD1, Loeser, Christoph MD2, Baron, Jens M. MD1, Dippel, Edgar MD2, Schmitt, Laurenz MD1 1 Department of Dermatology and Allergology, University Hospital of RWTH Aachen, Aachen, Germany 2 Department of Dermatology, Ludwigshafen City Hospital, Ludwigshafen, Germany

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

Volume 11 • number 2 • SPRING 2017 25

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.

26 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%

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 2 • SPRING 2017 27

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)

1 (<1)

Upper respiratory tract infections cluster includes nasopharyngitis and rhinovirus infection. U.S. approved etanercept.

Taltz® (ixekizumab) injection

IX HCP BS 18JAN2017

28 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

IX HCP BS 18JAN2017

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

Volume 11 • number 2 • SPRING 2017 29

SURGICAL wisdom Dermcast.tv Blog -

Billing Code Confusion: How to Use Modifier -25 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.

Dermcast.tv is the official online media resource of the SDPA and is your free source for the latest SDPArelated 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.

30 Journal of Dermatology for Physician Assistants

in 5

Americans

will develop skin cancer in their lifetime.

DON’T BE THE 1.

Prevent. Detect. Live.

It’s easy to prevent and detect skin cancer. Learn more at SpotSkinCancer.org. © 2015 American Academy of Dermatology. Use of this poster does not imply product or service endorsement by the American Academy of Dermatology.

Volume 11 • number 2 • SPRING 2017 31

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 second article will address those skin care issues faced by women in their thirties.

32 Journal of Dermatology for Physician Assistants

SDPA Members Only Content

Lauren Eckert Ploch, MD, MEd, FAAD, is in private practice in Augusta, GA., where she practices general, medical and cosmetic dermatology. Dr. Ploch attended Tulane University in New Orleans, where she earned her medical degree before completing an internship in internal medicine and a residency in dermatology. She also received a master’s degree in education from Vanderbilt University in Nashville, Tenn.

Reprinted with permission from the American Academy of Dermatology

Volume 11 • number 2 • SPRING 2017 33

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

Dermcast.tv Blog Is Isotretinoin Use Safe Before and After Cosmetic Procedures? New Guidelines For Managing Use By Martha L. Sikes, MS, RPh, PA-C

COSMETIC Dermatology

Image: Shutterstock

34 Journal of Dermatology for Physician Assistants

Make Bensal HP® your first response. Excoriated/broken skin can be vulnerable to infection and slow to heal. Bensal HP® has a proven multi-action formula that helps rebuild damaged skin by offering1: Protection with broad-spectrum antimicrobial activity Reduced inflammation Faster healing by 63% vs. vehicle

IMPORTANT SAFETY INFORMATION • Bensal HP® is contraindicated in patients who are hypersensitive to topical polyethylene glycols. • Bensal HP® is for external use only. Not to be used in eyes. • It is not known if Bensal HP® interacts with other topical medications applied to the treatment area. Use with other topical agents has not been studied. • Bensal HP® has not been studied in pregnant women or in immunocompromised patients and no interaction studies have been performed. • The safety and effectiveness of Bensal HP® in pediatric patients have not been established. • Bensal HP® is a Pregnancy Category C product; it is unknown if Bensal HP® ointment is excreted in breast milk. • A small percentage of patients may experience a temporary burning sensation upon application of the ointment. For Full Prescribing Information, please visit www.bensalhp.com

You are encouraged to report negative side effects of prescription drugs to the FDA. Call 1-800-FDA-1088 or visit www.fda.gov/medwatch REFERENCE: 1. Bensal HP® (topical ointment) Prescribing Information. 7 Oaks Pharmaceutical Corp., Easley, SC, USA; 2010.

Volume 11 • number 2 • SPRING 2017 35

BHP-JDPA-0617

INDICATION Bensal HP® is indicated for the external treatment of inflammation and irritation associated with many common forms of dermatitis, including certain eczematoid conditions. These conditions include complications associated with pyodermas. Bensal HP® also is indicated in the treatment of insect bites, burns and fungal infections.

Professional development

Notes from your Office Manager Reducing the Risk of the “Copy and Paste” Function in Electronic Health Records The Risk: The “copy and paste” function of electronic health record systems (EHRs) allows users to easily duplicate information such as text, images, and other data within or between documents. While this function offers convenience and efficiency to healthcare providers, it also poses unique liability risks when the information copied and pasted is either inaccurate or outdated. Further, redundancy within the new entry may cause difficulty in identifying current information and may create overly lengthy progress notes. Recommendations: 1. Develop a comprehensive policy and procedure for the appropriate use of the copy and paste function. The policy should include a process to monitor and audit both the staffs’ and providers’ use of this function. 2. Educate all EHR users about: a. the importance of verifying that the copied and pasted information is correct and accurately describes the patient’s current condition; b. the risks to patient safety in the inappropriate use of this function; and c. the importance of adhering to all regulatory, legal, and compliance guidelines.

3. Determine what portions of the record should be copied and pasted. At a minimum, the healthcare provider’s signature(s) should not be copied and pasted. 4. Confirm that the source of information which has been copied and pasted can be readily identified and is available for review in the future. 5. Confirm that the history of the present illness is based upon the patient’s description during that visit. 6. Use the medical, social, or family history from a previous note only after it has been reviewed with the patient to confirm it is relevant to the current appointment. 7. Verify that the diagnoses in your assessment are only those addressed at that visit. Although some EHRs allow the copying of all diagnoses in the problem list, some may either have already been resolved or they are not the reason for this particular encounter. 8. Contact your EHR vendor as necessary to help you and your staff comply with established policies. This may include the vendor making modifications which disable the copy and paste function in designated fields, and assisting in performing audits of the use of the copy and paste function by staff and providers. 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.

36 Journal of Dermatology for Physician Assistants

Outside & Inside the 9 to 5... Denice Schwind, PA-C, Founder of Pūr Skin Clinic

Ms. Schwind Recognized As Top Dermatology Physician Assistant Two Years In A Row

SDPA member Denice Schwind, PA-C is a board certified physician assistant and founder of Pūr Skin Clinic. She graduated from the University of Washington School of Medicine, MEDEX Physician Assistant Program in 2000 and was awarded an Academic Excellence and Leadership Scholarship by Delta Epsilon Iota. Denice has specialized in medical and cosmetic dermatology since 2004 and has advanced cosmetic dermatology experience. Her medical activities include dermatologic skin exams, skin biopsies, and evaluation and treatment of various skin conditions including acne, rosacea, and eczema. She specializes in advanced cosmetic dermatology treatments including laser treatments, Botox, advanced dermal fillers, and anti-aging skincare. Denice is a certified medical laser safety officer and a nationally ranked faculty trainer for Allergan, the makers of BOTOX Cosmetic and Juvederm dermal fillers. She was named Top Dermatology Physician Assistant in the 2015 Seattle Met Magazine’s Top Doc Survey. She was also named the Top Dermatology Physician Assistant in 2015. 2016. The award is based on survey results. Over 1,500 providers were asked, “If you or a loved one needed medical care, whom would you choose?” The physicians, physician assistants, and nurses who received the highest number of votes were

named on Seattle Met’s 2015 and 2016 Top Doc list. The JDPA recently had the opportunity to interview Ms. Schwind and learn more about what inspired her to start her own business, what she attributes the clinic’s success to, and why giving back to the community is a cornerstone of her business model. JDPA: What inspired you to create Pūr Skin Clinic? Ms. Schwind: My inspiration for opening Pūr came about after specializing in medical and cosmetic dermatology for over a decade and wanting to deliver exceptional medical care in a pristine, tranquil, medical-boutique setting. I wanted to offer the kind of place/setting where beauty and cosmetic-dermatology go hand in hand. JDPA: What were the greatest challenges in creating the clinic? Greatest rewards? Ms. Schwind: The greatest challenge in opening a business and being a healthcare provider is balancing both responsibilities in a successful way. Time management and a clear vision is key, along with always remembering that quality patient care is the priority. The greatest reward is connecting with patients to ensure every step of their interaction with Pūr leaves them feeling special. The initial phone call, greeting at the front desk, patient treatments, and follow up appointments are all a part of the

Volume 11 • number 2 • SPRING 2017 37

professional development

By J. Margaret Casey

“patient experience” we pride ourselves on. JDPA: Any advice you have for PAs considering pursuing a similar path? Ms. Schwind: If you have an entrepreneurial spirit, I highly recommend opening a clinic that you believe in and one that offers the best patient care. JDPA: What do you think has most lent to the success of Pūr Skin Clinic?

professional development

Ms. Schwind: Our team at Pūr builds close, caring relationships with our patients, many of whom will be friends for a lifetime. Our team helps patients rediscover healthy, pure, glowing skin by customizing every single treatment. It's a results-driven strategy that makes them look as young as they feel both today and tomorrow. JDPA: Please share with our readers the significance of being recognized as TOP Dermatology PA of the Year two years in a row? Ms. Schwind: The biggest meaning behind this award for me is that over 1,500 providers were asked, “If you or a loved one needed medical care, whom would you choose?” The doctors, physician assistants and nurses who received the highest number of votes were named on the list. I am especially proud since the first year they included PAs was in 2015, and I received the award in 2015 and 2016.

JDPA: Please share any insights into the importance of giving back to the local and international causes that Pūr Skin Clinic supports? Ms. Schwind: At Pūr improving people's lives in every way possible is consistent with our brand values of caring and excellence and that means giving back to our community and the world around us whenever possible. We have donated and volunteered for dozens of local and international causes and will continue to do so. J Denice was born and raised in the Seattle area and enjoys spending time with her family and two dogs. She enjoys snow skiing, yoga, pilates, and travelling. Denice is actively involved in local and international medical volunteering and philanthropic causes including the local Boys and Girls Club, ONElife (devoted to bringing clean drinking water and sanitation to people in developing countries), Eastside Domestic Violence Program, Rise n’ Shine (dedicated to offering support to children and teens affected by HIV/AIDS), Flying Doctors of America (providing international medical assistance to the poor and needy), and Haiti Outreach. Pūr Skin Clinic is passionate about helping build better communities. They are devoted to establishing a positive presence in their local and extended communities and actively participate in helping those in need.

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

JDPA Journal of Dermatology for Physician Assistants

38 Journal of Dermatology for Physician Assistants

Now Approved! Learn more at our booth Visit www.EucrisaHCP.com Visit www.EucrisaHCP.com forfor moremore information information

Volume 11 • number 2 • SPRING 2017 39

Dermatology PA news & notes

Workplace Excellence The Integrity of Excellence: Why Doing Your Job Well Is All About Integrity 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. Integrity is often defined as consistency between our stated values and our lived behaviors. We often talk about integrity as a moral character value. Indeed integrity is an essential moral character value, one that is often put to the test when our competitiveness and drive for performance goals test our resolve to pursue excellence with integrity. Excellence with integrity: this is how I often translate the means and the end-goal of the IEE approach. In other words, win the right way by honoring your competitors and the game. The prize you gain isn’t worth it if you have to compromise your integrity to get it. I don’t for one instant mean to undermine the importance of and the very real challenges to the moral character value of integrity. If you look around the culture of athletics at every level of competition, threats to integrity are destroying individuals and organizations. On and off the field we see the very real costs that result when folks do not act with integrity, when they lie, cheat, and break the rules or the law, and when they violate norms of basic respect and human decency. The same observations can be made within the culture of healthcare. We must be vigilant in our efforts to develop the moral character value of integrity. However, here I want to shine a light on an equally important dimension of integrity, specifically the performance character aspects of integrity or what we might call the integrity of excellence Return for a moment to where we began: integrity means consistency between our stated values and lived behaviors. Now consider this idea from the performance character perspective. Performance

40 Journal of Dermatology for Physician Assistants

character is the values in action needed to develop our talents and abilities in order to achieve excellence. The greatest teams and organizations (including those in the healthcare profession) are built on a foundation of integrity because they consistently act according to the values they espouse. They don’t just talk about performance character values like communication, hard work, toughness, sacrifice, and leadership. They put these into action - always and everywhere. You can trust that you will get their best no matter the circumstances. This is what I mean by the integrity of excellence: with an individual, team, or organization that is truly excellent, you come to expect it, trust that it will be there, and are surprised if it’s not there. It’s not random or sporadic, it is the norm. In the same way you would trust a person with the moral character virtue of integrity to do the right thing, and you would trust a person of performance character integrity to perform his/her duties with excellence. Think about the greatest teams and organizations, and you immediately think about how consistently their excellence is evident in their actions. They don’t play great for one play or one game or one season. The greatest healthcare providers and practices do not provide excellent care for one office visit, one month, or one year. Over time, based on what they do again and again (even more than what they say), we come to expect them to perform at a high level for every play/ office visit, every game /follow-up visits, and every season/duration of care. This is why we define character as “values in action.” Who cares if you can define a value or if you care deeply about it, when you don’t put it in action? Mother Teresa, Gandhi, and Martin Luther King, Jr. were moral character exemplars who

1. Committing to our goals and to your role. 2. Doing your job well no matter how small, insignificant, or difficult. 3. Working hard and smart, giving the perfect effort for the play, for the situation, for your role, for the expectations. 4. Being where you are supposed to be when you are supposed to be there. 5. Implementing the strategy or plan with passion. 6. Recovering from mistakes quickly - learning, growing, improving, being accountable. 7. Training and preparing yourself for competition in mind, body, and spirit. 8. Communicating continuously, engaging in care-frontation: challenging one another to get closer to optimal. 9. Controlling the controllables and letting go of everything else. Moral character and performance character are a unified concept, a co-dependent force, which is all about integrity. At the line between performance character and moral character is where the magic happens. You have integrity and are trustworthy when you do your job well. In my opinion, even though you don’t lie, cheat, or steal, you will not have integrity if you do your job poorly and inconsistently. Abraham Lincoln said, “Whatever you are, be a good one.” Honest Abe was talking about performance character integrity. We must act with integrity; the questions are when, how, and why? J 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 2 • SPRING 2017 41

DERmatology pa news & notes

by their actions showed us their values. In the same way we know about the greatest athletes and performers in every walk of life because they consistently performed with excellence. They showed us their performance character values - hard work, discipline, toughness, perseverance, and courage - by their consistent actions. When we talk about integrity from a moral character perspective, we argue that it is built up or torn down one decision or one action at a time. It’s that simple and that difficult. You cannot just talk about it; you have to show it every moment, every day, and in every way. You show it in how you train, practice, eat, sleep, deal with prosperity, and suffer in adversity. If you put your performance character into action consistently, there’s integrity to it. It’s consistent and trustworthy. We love sports because it simulates life, especially some of the most demanding and difficult situations in life. Rightly or wrongly, many draw comparisons between war and athletic competition. Why? Because in battle you must be able to trust that your “teammate” will do his or her job consistently and with excellence, otherwise people die. Patients are depending on their healthcare team every day to be consistently excellent. In almost everything that is not about life and death, most individuals and organizations tend to adopt the, “It’s just a mindset. It’s just a bad day, a bad play, a simple mistake, a minor breakdown.” As we have so often argued, nobody’s perfect. High expectations, difficult circumstances, and vulnerable mental, emotional, and physical capacity virtually ensure that perfection is not reasonable to expect. However, too often we dismiss our inconsistencies, we resist accountability, and so these simple breakdowns in performance character gradually become our character. At that point our performance character lacks integrity and can no longer be trusted. Character in Greek means, “enduring or distinguishing mark.” One moral character advocate asked, “How many lies does it take until you’re a liar?” He knew that many people like to believe, “I lie, but I’m not a liar.” The first is something I do. The second is something I am. When we consider our performance character we should ask how many times do we have to be soft and selfish; to quit, give up, give in, or give less than our best; to drop our assignment, not do our job well; not communicate or be where we’re supposed to be? How many times before this is who we are and how we perform? Perhaps we should forget perfect, and find optimal. This can be true for moral character integrity and for performance character integrity. Here are some specific optimal performance indicators of the integrity of excellence and the consistency of our performance character:

Listening to Patients Preventive Medicine

DERmatology pa news & notes

By Ardeshir Ebn Alnassir, PA-C

issues. Shortly after turning 11, Alex stopped visiting the On my pediatrics rotation, I encountered the absolute clinic for a seventeen-month stretch. When he returned failure of adherence to primary, secondary, and tertiary to the clinic about eight-months ago, he had a blood preventions and their impact on health outcomes. I pressure of 142/94 mmHg, a hemoglobin A1C of 6.4, witnessed how lifestyle and compliance are influenced HDL of 32, Triglyceride of by the psychosocial 232, and a fasting glucose aspects that are part of of 119. He was suffering the human condition. My Primary Prevention: from bilateral knee pain patient, whom I will call Aims to prevent a disease before it even and had already begun Alex Smith, exemplifies develops. Typically accomplished with to exhibit signs of insulin the natural sequence of health promotion and by reducing the resistance, manifested events that many children risk factors associated with the disease.4 dermatologically as and adolescents face in acanthosis nigricans. the United States. Alex He was diagnosed is a 13 year-old Hispanic Secondary Prevention: with depressive mood male, who weighs three Aims to detect and screen early on while disorder, ADHD, and hundred and three pounds binge eating disorder in and has been diagnosed the disease is subclinical and there are no 4 the following months. with hypertension, symptoms. Reviewing his blood work morbid obesity, over the course of these acanthosis nigricans, Tertiary Prevention: past months, his fasting abnormal fasting glucose, glucose, triglycerides, dyslipidemia, depressive Aims to treat or minimize the negative HDL, and hemoglobin mood disorder, bingeimpact of a disease, which has already A1C have fluctuated only eating disorder, and knee been diagnosed.4 slightly. When I spoke with pain. The relationship him in person during one between these diagnoses of our visits, this almost is apparent to many in diabetic 13 year-old boy asked me what I ask you in this the medical field. Unfortunately, as has been repeated moment, “What am I supposed to do now?” several times during our first year in PA school, failing to get patients and in this case their families to adhere to To mention preventive strategies and medical medical advice and treatment can be very difficult, and treatment without addressing the psychosocial aspects can directly lead to the deterioration of their physical and of each individual would be neither fair nor realistic. mental health. More often than not, within the pediatric setting, the parents are the ones who are required to comply with Alex has been seen on and off by the same medical the implementation of lifestyle recommendations and practitioner for most of his life. His elevated BMI has medical treatment. Alex has been raised by a single mother been aggressively addressed many times in the past, of four children who works both a full-time and part-time starting when he was only 5 years-old. His mother has job to support her kids along with help from her sister. consistently dismissed it with what she considered the Neither of them has a high school diploma. They had endearing description of “gordito” (translating to mean been working on farms in Puerto Rico prior to moving to something along the lines of ‘plump one’). She stated the United States. Since immigrating about sixteen years that weight and health were almost synonymous to ago, they have had a series of blue-collar jobs. Because her throughout her childhood. At the ages of 9 and of their backgrounds, they have low health literacy, low 10, Alex’s BMI surpassed 35 and 40 respectively. By the socioeconomic status, and decreased access to medical age of 10, he had hypertriglyceridemia and two systolic care. Comprehension of medical advice and terminology blood pressure readings greater than 140 mmHg. He is integrated with and impressed upon cultural beliefs was already beginning to exhibit guilt and body image 42 Journal of Dermatology for Physician Assistants

and practices, faith, fatalism, and optimism. To the mother, Alex is simply “gordito,” and the intergenerational, familial incidence of diabetes is hereditary. Alex is not nearly as much at fault as his mother, and his mother, not nearly as much as her circumstance. My frustration expressed here should, thus, be taken with a grain of salt. What is supposed to be done in cases like Alex’s? Alex’s medical provider began primary intervention for weight gain, inappropriate eating habits, and hypertension almost at birth. Diets low in saturated and trans fats, sodium restriction, sugar restriction, food group diversity, and appropriate levels of physical activity are discussed at every well-child check up, and are often mentioned at routine follow-ups and sick visits. As presented in a literature review conducted by Sorof et al., obese children are at an approximately 3-fold increased risk for the development of hypertension when compared to nonobese children and the risk increases linearly with BMI.1 The review also states that there have been numerous observational and interventional studies demonstrating the benefits of weight loss on blood pressure, a secondary intervention relative to obesity in children and a primary intervention relative to hypertension. A study by Klein et al. reveals that a daily energy deficit of 500 to 1000 kcal yields an approximate loss of one to two pounds each week.2 The article also lists a BMI of greater than or equal to 25, family history of diabetes, impaired fasting glucose, habitual physical inactivity, Hispanic ethnicity, hypertension, and dyslipidemia (all of which apply to Alex) as significant risk factors for the development of type II diabetes. Attempts at designing meal plans for Alex to accomplish these weight loss goals have not been effective. Education offered to both mother and son about the complications listed above and probable future end-organ damage have not had any lasting effect. Appropriate patient and family education have been provided regarding the potential cardiovascular and psychological outcomes, including the imminent development of diabetes, to no avail. Attempts at tertiary prevention by encouraging Alex to lose weight have been largely unsuccessful. Alex states that his knee pain prevents him from exercising consistently, and he is only interested in playing football after which his knees are in rough shape for a few days. I have tried to encourage him to go for walks around the neighborhood as often as he is able, and to try to swim since swimming does not place too much strain on his knees. He apathetically nodded his head without making eye contact. Alex’s eating habits have been admittedly out of control. He says it’s the thing he enjoys doing most in his day and he does most of his eating late at night. At this point tertiary prevention of his binge eating has been the greatest practical goal and focus at the pediatric clinic. Several referrals have been submitted to pediatric

psychiatry and family counseling, but the family has missed all of the appointments. A recent study conducted, McElroy et al. has demonstrated the efficacy of lisdexamphetamine in the treatment of binge-eating in patients with ADHD, reducing both the number of episodes and total amount consumed weekly.3 About 4 months ago Alex was placed on Vyvanse in the hopes that a reduction in weight would impact his binge eating, help him lose some weight, inspire some confidence, and reduce the burden on his knees. This attempt is proving to be a struggle since his mother does a poor job of giving him his medication daily and he shrugs responsibility as well. When I saw him in the office, he explained that when he takes the lisdexamphetamine he eats less throughout the day and is generally happier and more active. He smiled at me and stated that he lost 2 pounds in a couple of weeks when he was taking it. When asked whether he had been taking it recently, he shrugged his shoulders and admitted he had not taken it for the last eight days. He stated that he simply forgets. The doctor reiterated suggestions she made at previous visits that he should set an alarm in the morning to take his pill and that his mom should ensure that he takes the pill before going to school. “All you gotta do is take the pill in the morning.” They nodded along, while breaking eye contact. We left the room after a forty-minute visit and looked at each other confused and disheartened. As I paint this bleak picture, I ask what am I supposed to do at this point? J REFERENCES 1. Sorof J, Daniels S. Obesity hypertension in children. Hypertension. 2002;40:441447. 2.Klein S, Sheard NF, Xavier P, et al. Weight management through lifestyle modification for the prevention and management of type 2 diabetes: rationale and strategies. Diabetes Care. 2004;27(8):2067-2073. 3. McElroy SL, Hudson JI, Mitchell JE, et al. Efficacy and safety of lisdexamphetamine for treatment of adults with moderate to severe binge eating disorder. JAMA Psychiatry. 2015;72(3):235-246 4.Starfield B, et al. The concept of prevention: a good idea gone astray? J Epidemiol Community Health 2008;62:580-580. Ardeshir Ebn Alnassir, PA-C is a recent graduate of the LeMoyne College Physician Assistant Program, class of 2016.

Volume 11 • number 2 • SPRING 2017 43

From the Desk of...

DERmatology pa news & notes

Summary of AAPA Leadership & Advocacy Summit 2017 We had the pleasure of attending the 2017 AAPA Leadership and Advocacy Summit (LAS) on behalf of the SDPA in Arlington, VA. This conference highlighted the many current and controversial issues affecting daily PA practice and was attended by PA leaders from across the country. Below is a synopsis of the main topics discussed.

1. Full Practice Authority Rights (FPAR) Passionate debate occurred discussing the potential pros and cons of FPAR. The overarching pro was that FPAR would keep PA practice relevant in a rapidly changing healthcare landscape. As physician owned practices are decreasing and corporations are increasing, FPAR would enable PA licensure to no longer be coupled to that of a physician, allowing for job mobility and reducing physician liability for PAs they supervise. Many argued that in 22 states NPs already have FPAR, and it’s only a matter of time until all states give NPs FPAR. In order to stay competitive, it was suggested that we need to move forward and pursue FPAR.

to help alleviate some anticipated fears from physicians. The AAPA made it clear that this discussion was intended to gather data, and the AAPA board has yet to decide whether they will be advocating for FPAR. The FPAR Task Force was to meet following the Leadership and Advocacy Summit and consider the comments submitted to date including those collected in the recent AAPA survey on FPAR. The final recommendation is expected to be submitted to the AAPA House of Delegates in May 2017 for consideration.

2. The future of PA recertification In regards to NCCPA’s previous threats to drastically modify the recertification structure for PAs, the AAPA stated that “they oppose exams without evidence that shows improved patient care.” They urged NCCPA to make evidencebased decisions and not opinion-based decisions.

The AAPA Board of Directors did commission a feasibility study for a replacement certification board The majority for PAs. The results agreed that the largest of that study were con to FPAR was From left to right: Matthew Brunner, MHS, PA-C, presented to all alienating ourselves Archana Sangha, MMS, PA-C, Martha Sikes, MS, those in attendance. RPh, PA-C, and Lindsay Martin from the physician While the potential relationships that we exists to set up a replacement certification, currently enjoy. Would physicians consider us there exists concern from ARC-PA, PAEA, and a threat? Many suggested changing the name some PA leaders that we may be fracturing the FPAR to something less intimidating in an effort profession. There still remains considerable

44 Journal of Dermatology for Physician Assistants

3. Changes in healthcare reimbursement and its effects on the PA profession The new quality based programs replacing meaningful use were discussed. These programs include the merit-incentive payment system (MIPS) and the advanced alternative payment models (Advanced APMs). Understanding the new programs is important for two main reasons: 1) Reimbursements- you will either be penalized or incentivized based on your enrollment and performance. 2) Reputation- you will be rated

on a website called “physician compare”, which scores providers based on how they perform within these programs. The government is still developing many of the components of these newly launched programs, and the programs themselves are in a constant state of change. Please refer to https:// qpp.cms.gov for up-to-date information. We were grateful to represent the SDPA at the 2017 LAS. It is clear that as the PA profession commemorates its fiftieth anniversary, the path before us gleams with infinite possibilities. We urge you to be a force for positive change by getting involved in leadership; please visit www. dermpa.org for a list of standing committees. J Sincerely, Matthew Brunner PA-C, Archana Sangha PA-C, and Martha Sikes PA-C

Volume 11 • number 2 • SPRING 2017 45

DERmatology pa news & notes

pressure from PAs to consider this as an alternative path or risk becoming subjected to further NCCPA certification requirements that are onerous and contribute to PA certification expenses with no evidence that they improve patient outcomes. The AAPA Board of Directors will be considering whether to move forward with the initiative or place it on hold at their next meeting.

RISKY BEHAVIOR... NO SUNSCREEN.

1 in 5 Americans will develop skin cancer. Donâ&#x20AC;&#x2122;t be the 1. Prevent. Detect. Live. SpotSkinCancer.org ÂŠ 2015 American Academy of Dermatology. Use of this poster does not imply product or service endorsement by the American Academy of Dermatology.

46 Journal of Dermatology for Physician Assistants

Collaborating Physician CORNER New Study Shows Significant Economic Burden Of Skin Disease In The United States AAD Launches SkinSerious Campaign The American Academy of Dermatology launches national SkinSerious campaign to raise awareness of impact of skin disease and highlight collaboration with other care providers.

“The impact of skin disease in this country is staggering, affecting one in every four Americans each year and taking a toll on lives, livelihood, and our economy,” said Henry W. Lim, MD, FAAD, incoming president of the AAD and chair of its Burden of Skin Disease Work Group. “We’re launching the SkinSerious campaign to raise awareness of the impact these diseases have on more than 85 million Americans a year, improve access to dermatologists’ expertise, and increase collaboration with our physician peers to ensure high-quality patient care.” The SkinSerious campaign is supported by data from the “Burden of Skin Disease in the United States” report. This report quantifies the economic burden of 24 skin disease categories on patients and the health care system in the United States, based on an analysis of medical claims in 2013. The report will be outlined in a series of manuscripts to be published in the Journal of the American Academy of Dermatology. It includes several key findings: ◗ Skin disease is serious and can be deadly. • Of the 24 skin disease categories analyzed in the study, half are associated with mortality.

• Nonmelanoma skin cancer and melanoma accounted for 60 percent of skin disease-related deaths. • Prevalence of skin disease is high and is likely to increase as the population ages. • The number of individuals with skin disease across the U.S. population in 2013 exceeds those with cardiovascular disease, diabetes or end-stage renal disease. • One in four Americans (26 percent) reported receiving treatment for at least one skin disease in 2013. • Nearly 50 percent of Americans over age 65 have skin disease, with an average of 2.2 skin diseases each. ◗ Skin disease burdens Americans, their families and employers. • Patients and caregivers with skin disease suffered $11 billion in lost productivity. (This does not include additional time for at-home care and treatment, which was not evaluated.) • $75 billion was spent on skin disease in 2013. The majority of this was for treatment costs, including $46 billion for health care provider costs from medical care. Building on the Burden of Skin Disease Report, the SkinSerious campaign includes a website, www. aad.org/skinserious, to share patient stories, practices for improving access, and facts about the serious impact of dermatologic conditions. Through the campaign, Volume 11 • number 2 • SPRING 2017 47

DERmatology pa news & notes

Citing a new study assessing the impact of skin disease on patients and the U.S. economy, the American Academy of Dermatology is launching a new campaign to raise awareness of the breadth of serious skin diseases that affect patients, as well as the critical role dermatologists play in an era of team-based health care. The SkinSerious campaign will launch at the 2017 AAD Annual Meeting.

the AAD will work to improve collaboration between dermatologists and their physician colleagues, and highlight the intersections between dermatology and other medical specialties. “In a 21st century health care system, it’s more important than ever that dermatologists work with colleagues across the house of medicine,” said Karen E. Edison, MD, FAAD, chair of the AAD’s Access to Dermatology Committee and the SkinSerious Campaign Work Group. “SkinSerious will highlight the ways dermatology and other medical specialties work together, while sharing best practices for ensuring patients and physicians can access dermatologic expertise when they need it.”

DERmatology pa news & notes

For more information about SkinSerious and the Burden of Skin Disease report, visit aad.org. J

48 Journal of Dermatology for Physician Assistants

Henry W. Lim, MD, FAAD President, American Academy of Dermatology Association Dr. Lim is chair emeritus of the department of dermatology and senior vice president for Academic Affairs at Henry Ford Health System in Detroit, Michigan. He previously served as Chief of Staff of the New York VA Medical Center. Karen E. Edison, MD, FAAD

Former Chair American Academy of Dermatology Access to Dermatology Committee

Dr. Edison is chair of the department of dermatology at the University of Missouri School of Medicine. She has served as a Robert Wood Johnson Health Policy Fellow, and from 19992001, served as a member of the majority health policy staff for the Senate Health Education Labor and Pensions (HELP) Committee.

Journal of Dermatology for Physician Assistants Information for Authors – The JDPA is a peer-reviewed publication that delivers innovative clinical, surgical, cosmetic, and professional content exclusively for dermatology PAs. Submissions to the JDPA are peer-reviewed by a panel of experienced dermatology PAs, educational PAs, and dermatologists before articles are accepted for publication. Manuscripts submitted for publication will be reviewed with the understanding that they are original and have not been submitted elsewhere nor are being considered by other journals. Electronic submissions are accepted and should be sent to editor@ jdpa.org. The five main sections featured in each issue of the JDPA are listed below along with a brief description of the various topics that authors can contribute to. Regardless of the section, all articles must follow the following criteria: • Formatting - Times New Roman font, 12 point, double-spaced, left aligned. • Article Order - Title, Author(s), Author bios (including disclosures), Text of Article, References, Tables, and Figures • Reference Citations - Utilize the AMA Manual of Style, 10th Edition. Dermatology PA News and Notes Feature Articles

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

From The Desk Of…

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

Clinical Dermatology CME articles

Content should be specific to the field of dermatology following any of the following formats: Study – Original research (clinical or basic science). Professional issues or health policy papers. Review – Scholarly review of a topic. Content length: 6 pages (requires 4 self-assessment Q&A) = .5hr of Cat. I CME. 12 pages (requires 8 self-assessment Q&A) = 1hr of Cat. I CME. Article should include written learning objectives (3-4 required).

Dermatology Case Report

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

Journal Club: Dermatology PA Perspectives

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

From the Patient’s Perspective

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

Clinical Snapshots

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

Drugs in Dermatology

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

Dermatology Evidence-Based Medicine (derm EBM)

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

Surgical Dermatology Feature Articles

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

Surgical Wisdom

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

Surgical Dermatology Case Report

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

Journal Club: Dermatology PA Perspectives

Cosmetic Dermatology Feature Articles

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

Cosmetic Pearls

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

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

Professional Development Feature Articles

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

Outside & Inside the 9 to 5

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

Judicial and Ethical Affairs

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

To read the JDPA publication’s Ethics and Malpractice Statement, please visit www.jdpa.org/write.html.

Volume 11 • number 2 • SPRING 2017 49

Professional Opportunities and Development

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50 Journal of Dermatology for Physician Assistants

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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

JUBLIA®

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).

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 © Valeant Pharmaceuticals North America LLC U.S. Patents 8,039,494; 7,214,506 Based on 9462903 Volume 11 • number JUB.0130.USA.16 Issued: 2 • SPRING 201709/2016 51

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

JUBLIA allows some patients to have clearer toenails grow back. Individual results may vary.

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.

LARGER mL

size

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.

52 Journal of Dermatology for Physician Assistants