JDPA winter 2014

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DPA J

V o l u m e 8 • n u m b e r 1 • w i n t e r 2 0 1 4 • www.jdpa.org

Journal of Dermatology for Physician Assistants

dermatology Pa news & notes

Certification Review 13 __________________________________

clinical dermatology Clinical Snapshots 27 __________________________________

Surgical dermatology Surgical Wisdom

32

_________________________________

Cosmetic dermatology Journal Club

34

_____________________________

›› Earn CME credit with this issue

professional development

CME Alopecia Areata: Diagnosis and Treatment

Workplace Excellence

48

16

Official Journal of the Society of Dermatology Physician Assistants

Volume 8 • number 1 • wiinter 2014

1


Help Manage Winter Flares For

80%

of eczema patients*, ELIDEL® Cream may fit.

Winter’s cold air, low humidity and indoor heating can all contribute to damaging the skin’s protective barrier1, often resulting in skin dryness and eczema flares. For patients with mild to moderate eczema, ELIDEL Cream may provide the help they need.

*Population-based studies report ~80% of the eczema populations have mild eczema.2,3 INDICATION AND IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING ELIDEL (pimecrolimus) Cream 1% is indicated as second-line therapy for the shortterm and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable. WARNING: Long-term Safety of Topical Calcineurin Inhibitors Has Not Been Established. Although a causal relationship has not been established, rare cases of malignancy (e.g., skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including ELIDEL Cream. Therefore: • Continuous long-term use of topical calcineurin inhibitors, including ELIDEL Cream, in any age group should be avoided, and application limited to areas of involvement with atopic dermatitis. • ELIDEL Cream is not indicated for use in children less than 2 years of age. ELIDEL Cream is contraindicated in individuals with a history of hypersensitivity to pimecrolimus or any of the components of the cream. Patients should be reevaluated by their healthcare provider if signs and symptoms of atopic dermatitis do not improve within 6 weeks. Treatment should be discontinued upon resolution of signs and symptoms (e.g., itch, rash and redness) for atopic dermatitis. The safety of ELIDEL Cream has not been established beyond one year of non-continuous use. Application should be limited to areas of involvement with atopic dermatitis.

ELIDEL Cream may cause local symptoms such as skin burning (burning sensation, stinging, soreness) or pruritus. Localized symptoms are most common during the first few days of application and typically improve as the lesions of atopic dermatitis resolve. Before commencing treatment with ELIDEL Cream, bacterial or viral infections at treatment sites should be resolved. The most common adverse events seen in clinical studies included applicationsite burning, headache, pharyngitis, nasopharyngitis, cough, influenza, pyrexia, and viral infection. The most common local adverse event seen in clinical studies was application-site burning, which occurred in 8% to 26% of patients treated with ELIDEL Cream. In clinical studies, skin papillomas or warts were observed in 1% of ELIDEL patients. If patients have lymphadenopathy that is unresolved or of unclear etiology, discontinuation should be considered. ELIDEL Cream should not be used with occlusive dressings. ELIDEL Cream should not be applied to areas of active cutaneous infections. During the course of treatment, patients should minimize or avoid natural or artificial sunlight exposure, even while ELIDEL Cream is not on the skin. The potential effects of ELIDEL on skin response to ultraviolet damage are unknown.

Please See Brief Summary of Full Prescribing Information on adjacent page. References: 1. Harding CR. The stratum corneum: structure and function in health and disease. Dermatol Ther. 2004;17:6–15. 2. Larsen FS, Hanifin JM. Epidemiology of atopic dermatitis. Immunol Allergy Clin North Am. 2002;22(1):1–24. 3. Beltrani VS, Boguniewicz M. Atopic dermatitis. Dermatol Online J. 2003;9(2):1–27. Available at: http://dermatology.cdlib.org/92/reviews/atopy/beltrani.html.

© 2013 Valeant Pharmaceuticals North America LLC November 2013 US/DDD/13/0008 ELIDEL® is a registered trademark of Meda Pharma S.A.R.L. and is used under license by Valeant.


BRIEF SUMMARY

(see package insert for Full Prescribing Information)

® Elidel (pimecrolimus) Cream 1% FOR DERMATOLOGIC USE ONLY NOT FOR OPHTHALMIC USE Rx Only See WARNINGS, boxed WARNING concerning long-term safety of topical calcineurin inhibitors. INDICATIONS AND USAGE ELIDEL (pimecrolimus) Cream 1% is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in nonimmunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable. ELIDEL Cream is not indicated for use in children less than 2 years of age (see WARNINGS, boxed WARNING, and PRECAUTIONS, Pediatric Use). CONTRAINDICATIONS ELIDEL (pimecrolimus) Cream 1% is contraindicated in individuals with a history of hypersensitivity to pimecrolimus or any of the components of the cream. WARNINGS WARNING Long-term Safety of Topical Calcineurin Inhibitors Has Not Been Established Although a causal relationship has not been established, rare cases of malignancy (e.g., skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including ELIDEL Cream. Therefore: • Continuous long-term use of topical calcineurin inhibitors, including ELIDEL Cream, in any age group should be avoided, and application limited to areas of involvement with atopic dermatitis. • ELIDEL Cream is not indicated for use in children less than 2 years of age. Prolonged systemic use of calcineurin inhibitors for sustained immunosuppression in animal studies and transplant patients following systemic administration has been associated with an increased risk of infections, lymphomas, and skin malignancies. These risks are associated with the intensity and duration of immunosuppression. Based on this information and the mechanism of action, there is a concern about a potential risk with the use of topical calcineurin inhibitors, including ELIDEL Cream. While a causal relationship has not been established, rare cases of skin malignancy and lymphoma have been reported in patients treated with topical calcineurin inhibitors, including ELIDEL Cream. Therefore: • ELIDEL Cream should not be used in immunocompromised adults and children. • If signs and symptoms of atopic dermatitis do not improve within 6 weeks, patients should be re-examined by their healthcare provider and their diagnosis be confirmed (see PRECAUTIONS). • The safety of ELIDEL Cream has not been established beyond one year of non-continuous use. (See CLINICAL PHARMACOLOGY, WARNINGS, boxed WARNING, PRECAUTIONS, INDICATIONS AND USAGE, and DOSAGE AND ADMINISTRATION.) PRECAUTIONS General The use of ELIDEL Cream should be avoided on malignant or pre-malignant skin conditions. Malignant or pre-malignant skin conditions, such as cutaneous T-cell lymphoma (CTCL), can present as dermatitis. ELIDEL Cream should not be used in patients with Netherton’s Syndrome or other skin diseases where there is the potential for increased systemic absorption of pimecrolimus. The safety of ELIDEL Cream has not been established in patients with generalized erythroderma. The use of ELIDEL Cream may cause local symptoms such as skin burning (burning sensation, stinging, soreness) or pruritus. Localized symptoms are most common during the first few days of ELIDEL Cream application and typically improve as the lesions of atopic dermatitis resolve (see ADVERSE REACTIONS). Bacterial and Viral Skin Infections: Before commencing treatment with ELIDEL Cream, bacterial or viral infections at treatment sites should be resolved. Studies have not evaluated the safety and efficacy of ELIDEL Cream in the treatment of clinically infected atopic dermatitis. While patients with atopic dermatitis are predisposed to superficial skin infections including eczema herpeticum (Kaposi’s varicelliform eruption), treatment with ELIDEL Cream may be independently associated with an increased risk of varicella zoster virus infection (chicken pox or shingles), herpes simplex virus infection, or eczema herpeticum. In clinical studies, 15/1,544 (1%) cases of skin papilloma (warts) were observed in patients using ELIDEL Cream. The youngest patient was age 2 and the oldest was age 12. In cases where there is worsening of skin papillomas or they do not respond to conventional therapy, discontinuation of ELIDEL Cream should be considered until complete resolution of the warts is achieved. Patients with Lymphadenopathy: In clinical studies, 14/1,544 (0.9%) cases of lymphadenopathy were reported while using ELIDEL Cream. These cases of lymphadenopathy were usually related to infections and noted to resolve upon appropriate antibiotic therapy. Of these 14 cases, the majority had either a clear etiology or were known to resolve. Patients who receive ELIDEL Cream and who develop lymphadenopathy should have the etiology of their lymphadenopathy investigated. In the absence of a clear etiology for the lymphadenopathy, or in the presence of acute infectious mononucleosis, ELIDEL Cream should be discontinued. Patients who develop lymphadenopathy should be monitored to ensure that the lymphadenopathy resolves.

Sun Exposure: During the course of treatment, it is prudent for patients to minimize or avoid natural or artificial sunlight exposure, even while ELIDEL is not on the skin. The potential effects of ELIDEL Cream on skin response to ultraviolet damage are not known. Immunocompromised Patients: The safety and efficacy of ELIDEL Cream in immunocompromised patients have not been studied. Information for Patients (See Medication Guide.) Drug Interactions Potential interactions between ELIDEL and other drugs, including immunizations, have not been systematically evaluated. Due to low blood levels of pimecrolimus detected in some patients after topical application, systemic drug interactions are not expected, but cannot be ruled out. The concomitant administration of known CYP3A family of inhibitors in patients with widespread and/or erythrodermic disease should be done with caution. Some examples of such drugs are erythromycin, itraconazole, ketoconazole, fluconazole, calcium channel blockers and cimetidine. Pregnancy Teratogenic Effects: Pregnancy Category C There are no adequate and well-controlled studies of topically administered pimecrolimus in pregnant women. The experience with ELIDEL Cream when used by pregnant women is too limited to permit assessment of the safety of its use during pregnancy. Pimecrolimus was transferred across the placenta in oral rat and rabbit embryofetal developmental studies. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used only if clearly needed during pregnancy. Nursing Mothers It is not known whether this drug is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from pimecrolimus, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use ELIDEL Cream is not indicated for use in children less than 2 years of age. The long-term safety and effects of ELIDEL Cream on the developing immune system are unknown (see WARNINGS, boxed WARNING, and INDICATIONS AND USAGE). Three Phase 3 pediatric studies were conducted involving 1,114 patients 2-17 years of age. Two studies were 6-week randomized vehicle-controlled studies with a 20-week open-label phase and one was a vehicle-controlled (up to 1 year) safety study with the option for sequential topical corticosteroid use. Of these patients 542 (49%) were 2-6 years of age. In the short-term studies, 11% of ELIDEL patients did not complete these studies and 1.5% of ELIDEL patients discontinued due to adverse events. In the one-year study, 32% of ELIDEL patients did not complete this study and 3% of ELIDEL patients discontinued due to adverse events. Most discontinuations were due to unsatisfactory therapeutic effect. The most common local adverse event in the short-term studies of ELIDEL Cream in pediatric patients ages 2-17 was application site burning (10% vs. 13% vehicle); the incidence in the long-term study was 9% ELIDEL vs. 7% vehicle (see ADVERSE REACTIONS). Adverse events that were more frequent (>5%) in patients treated with ELIDEL Cream compared to vehicle were headache (14% vs. 9%) in the short-term trial. Nasopharyngitis (26% vs. 21%), influenza (13% vs. 4%), pharyngitis (8% vs. 3%), viral infection (7% vs. 1%), pyrexia (13% vs. 5%), cough (16% vs. 11%), and headache (25% vs. 16%) were increased over vehicle in the 1-year safety study (see ADVERSE REACTIONS). In 843 patients ages 2-17 years treated with ELIDEL Cream, 9 (0.8%) developed eczema herpeticum (5 on ELIDEL Cream alone and 4 on ELIDEL Cream used in sequence with corticosteroids). In 211 patients on vehicle alone, there were no cases of eczema herpeticum. The majority of adverse events were mild to moderate in severity. Two Phase 3 studies were conducted involving 436 infants age 3 months-23 months. One 6-week randomized vehicle-controlled study with a 20-week open-label phase and one safety study, up to one year, were conducted. In the 6-week study, 11% of ELIDEL and 48% of vehicle patients did not complete this study; no patient in either group discontinued due to adverse events. Infants on ELIDEL Cream had an increased incidence of some adverse events compared to vehicle. In the 6-week vehicle-controlled study these adverse events included pyrexia (32% vs. 13% vehicle), URI (24% vs. 14%), nasopharyngitis (15% vs. 8%), gastroenteritis (7% vs. 3%), otitis media (4% vs. 0%), and diarrhea (8% vs. 0%). In the open-label phase of the study, for infants who switched to ELIDEL Cream from vehicle, the incidence of the above-cited adverse events approached or equaled the incidence of those patients who remained on ELIDEL Cream. In the 6 month safety data, 16% of ELIDEL and 35% of vehicle patients discontinued early and 1.5% of ELIDEL and 0% of vehicle patients discontinued due to adverse events. Infants on ELIDEL Cream had a greater incidence of some adverse events as compared to vehicle. These included pyrexia (30% vs. 20%), URI (21% vs. 17%), cough (15% vs. 9%), hypersensitivity (8% vs. 2%), teething (27% vs. 22%), vomiting (9% vs. 4%), rhinitis (13% vs. 9%), viral rash (4% vs. 0%), rhinorrhea (4% vs. 0%), and wheezing (4% vs. 0%). Geriatric Use Nine (9) patients ≥65 years old received ELIDEL Cream in Phase 3 studies. Clinical studies of ELIDEL did not include sufficient numbers of patients aged 65 and over to assess efficacy and safety. ADVERSE REACTIONS No phototoxicity and no photoallergenicity were detected in clinical studies with 24 and 33 normal volunteers, respectively. In human dermal safety studies, ELIDEL (pimecrolimus) Cream 1% did not induce contact sensitization or cumulative irritation. In a one-year safety study in pediatric patients age 2-17 years old involving sequential use of ELIDEL Cream and a topical corticosteroid, 43% of ELIDEL patients and 68% of vehicle patients used corticosteroids during the study. Corticosteroids were used for more than 7 days by 34% of ELIDEL patients and 54% of vehicle patients. An increased incidence of impetigo, skin infection, superinfection (infected atopic dermatitis), rhinitis, and urticaria were found in the patients that had used ELIDEL Cream and topical corticosteroid sequentially as compared to ELIDEL Cream alone. In 3 randomized, double-blind vehicle-controlled pediatric studies and one active-controlled adult study, 843 and 328 patients respectively, were treated with ELIDEL Cream. In these clinical trials, 48 (4%) of the 1,171 ELIDEL patients and 13 (3%) of 408 vehicle-treated patients discontinued therapy due to adverse events.

Discontinuations for AEs were primarily due to application site reactions, and cutaneous infections. The most common application site reaction was application site burning, which occurred in 8%-26% of patients treated with ELIDEL Cream. The following table depicts the incidence of adverse events pooled across the 2 identically designed 6-week studies with their open label extensions and the 1-year safety study for pediatric patients ages 2-17. Data from the adult active-controlled study is also included in this table. Adverse events are listed regardless of relationship to study drug. Two cases of septic arthritis have been reported in infants less than one year of age in clinical trials conducted with ELIDEL Cream (n = 2,443). Causality has not been established. Treatment Emergent Adverse Events ( ≥1%) Pediatric Pediatric Pediatric Adult Patients* Patients* Patients* Active VehicleOpenVehicleComControlled Label Controlled parator (6 Weeks) (20 Weeks) (1 Year) (1 Year) Elidel VeElidel Elidel Ve- Elidel Cream hicle Cream Cream hicle Cream (N= (N= (N= (N= (N= (N= 267) 136) 335) 272) 75) 328) % % % % % % 68 71 72 85 75 78 At Least 1 AE Infections and Infestations Upper Respiratory 14 13 19 5 8 4 Tract Infection NOS Nasopharyngitis 10 7 20 27 21 8 Skin Infection 3 5 5 2 4 6 NOS Influenza 3 1 7 13 4 10 Ear Infection 2 2 6 3 1 1 NOS Otitis Media 2 1 3 3 5 1 Impetigo 2 2 4 4 5 2 Bacterial 2 2 1 1 0 2 Infection Folliculitis 1 1 1 2 4 6 Sinusitis 1 1 3 2 1 1 Pneumonia NOS 1 1 2 0 1 <1 Pharyngitis NOS 1 2 1 8 3 1 Pharyngitis 1 2 3 0 <1 0 Streptococcal Molluscum 1 0 1 2 0 0 Contagiosum Staphylococcal <1 4 2 0 <1 1 Infection Bronchitis NOS <1 2 1 11 8 2 Herpes Simplex <1 0 1 3 3 4 Tonsillitis NOS <1 0 1 6 0 1 Viral Infection 1 1 <1 7 1 0 NOS Gastroenteritis 0 2 1 7 3 2 NOS Chickenpox 1 0 1 3 4 <1 Skin Papilloma <1 0 1 3 <1 0 Tonsillitis Acute 0 0 0 3 0 0 NOS Upper Respiratory <1 0 1 2 0 <1 Tract Infection Viral NOS Herpes Simplex 0 0 <1 2 0 1 Dermatitis Bronchitis 0 0 0 2 0 0 Acute NOS Eye Infection 0 0 0 1 <1 <1 NOS General Disorders and Administration Site Conditions Application Site 10 13 2 9 7 26 Burning Pyrexia 8 9 12 13 5 1 Application Site 3 5 2 3 3 15 Reaction NOS Application Site 3 6 1 <1 4 6 Irritation Influenza Like <1 0 1 2 3 2 Illness Application Site <1 0 0 2 0 2 Erythema Application Site 1 2 1 2 0 6 Pruritus Respiratory, Thoracic and Mediastinal Disorders 12 8 9 16 11 2 Cough Nasal 3 2 2 2 1 1 Congestion Rhinorrhea Asthma Aggravated Sinus Congestion Rhinitis

2

1

1

<1

1

0

2

2

4

1

1

0

1

1

1

<1

<1

1

<1

0

2

4

7

2

Wheezing <1 1 1 1 <1 Asthma NOS 1 1 3 4 3 Epistaxis 0 1 0 3 1 Dyspnea NOS 0 0 0 2 1 Gastrointestinal Disorders Abdominal Pain 4 4 3 6 7 Upper Sore Throat 3 4 5 8 5 Vomiting NOS 3 4 4 7 8 Diarrhea NOS 1 1 1 8 5 Nausea <1 2 1 4 7 Abdominal Pain <1 1 2 4 4 NOS Toothache <1 1 1 3 1 Constipation <1 0 1 4 <1 Loose Stools 0 1 1 <1 <1 Reproductive System and Breast Disorders Dysmenorrhea 1 0 2 1 1 Eye Disorders Conjunctivitis 1 1 2 2 4 NEC Skin and Subcutaneous Tissue Disorders 1 0 <1 <1 <1 Urticaria Acne NOS 0 1 <1 2 <1 Immune System Disorders Hypersensitivity 4 4 5 5 1 NOS Injury and Poisoning 1 1 <1 <1 1 Accident NOS Laceration 1 1 2 <1 <1 Musculoskeletal, Connective Tissue and Bone Disorders <1 2 <1 <1 0 Back Pain Arthralgias 0 0 <1 1 1 Ear and Labyrinth Disorders 1 1 0 3 3 Earache Nervous System Disorders Headache 14 9 11 25 16

0 2 <1 1 <1 4 1 2 2 <1 1 0 0 1 3 1 2 3 0 0 2 2 0 7

*Ages 2-17 years

POST-MARKETING EVENTS The following adverse reactions have been reported in patients using ELIDEL Cream. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. General: Anaphylactic reactions, ocular irritation after application of the cream to the eye lids or near the eyes, angioneurotic edema, facial edema, skin flushing associated with alcohol use, skin discoloration Hematology/Oncology: Lymphomas, basal cell carcinoma, malignant melanoma, squamous cell carcinoma OVERDOSAGE There has been no experience of overdose with ELIDEL (pimecrolimus) Cream 1%. If oral ingestion occurs, medical advice should be sought. DOSAGE AND ADMINISTRATION • The patient or care giver should apply a thin layer of ELIDEL (pimecrolimus) Cream 1% to the affected skin twice daily. The patient or caregiver should stop using when signs and symptoms (e.g., itch, rash and redness) resolve and should be instructed on what actions to take if symptoms recur. • If signs and symptoms persist beyond 6 weeks, patients should be re-examined by their health care provider to confirm the diagnosis of atopic dermatitis. • Continuous long-term use of ELIDEL Cream should be avoided, and application should be limited to areas of involvement with atopic dermatitis. The safety of ELIDEL Cream under occlusion, which may promote systemic exposure, has not been evaluated. ELIDEL Cream should not be used with occlusive dressings. Manufactured by: Novartis Pharma Produktions GmbH Wehr, Germany Distributed by: Valeant Pharmaceuticals North America, LLC Bridgewater, NJ 08807 REV. 06/2011 ELD 13-014

*Ages 2-17 years

Volume 8 • number 1 • wiinter 2014

3


Journal of Dermatology for Physician Assistants

EDITORIAL BOARD

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

DEPARTMENT EDITORS

Clinical Department Editors Susan E. King-Barry, MPAS, PA-C Karen Graham, MPAS, PA-C Dermatology Grand Rounds Editor Cynthia F. Griffith, MPAS, PA-C Dermoscopy Editor John Burns, MSPA, PA-C Drugs in Dermatology Editor Stephen Wolverton, MD Surgical Department Editor Christy Kerr, MPAS, PA-C Cosmetic Department Editor Nancy Primo, MPAS, PA-C Prof Dev Department Editor Abby Jacobson, MS, PA-C

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

editorial missioN: The JDPA is the official clinical journal of the Society of Dermatology Physician Assistants. The mission of the JDPA is to improve dermatological patient care by publishing the most innovative, timely, practiceproven educational information available for the physician assistant profession. PUBLISHED CONTENT IN THE JDPA: Statements and opinions expressed in the articles and communications herein are those of the authors and not necessarily those of the Publisher or the Society of Dermatology Physician Assistants (SDPA). The Publisher and the SDPA disclaim any responsibility or liability for such material, including but not limited to any losses or other damage incurred by readers in reliance on such content. Neither Publisher nor SDPA verify any claims or other information appearing in any of the advertisements contained in the publication and cannot take responsibility for any losses or other damage incurred by readers in reliance on thereon. Neither Publisher nor SDPA guarantees, warrants, or endorses any product or service advertised in this publication, nor do they guaranty any claim made by the manufacturer of such product or service. This Issue: The JDPA includes articles that have been reviewed and approved for Category I (Preapproved) CME credit by the American Academy of Physician Assistants. Approval is valid for 1 year from the issue date, and participants may submit the self-assessment at any time during that period. Category I CME articles included in JDPA are planned and developed in accordance with AAPA’s CME Standards for Journal Articles and for Commercial Support of Journal Articles. going green: Since its inception, the JDPA has utilized eco-friendly printing practices. The JDPA is printed on paper obtained from sustainable forests that meet strict environmental standards. Soy-based inks that have a low environmental impact are used during printing of the journal and the journal is printed using 100% renewable energy. SDPA members may join us in our efforts and opt to receive the JDPA in digital format. Publishing Staff Publisher Travis Hayden, MPAS, PA-C Managing Editor Jennifer M. Hayden, M.Ed Copy Editor Douglas Morris Art Director Angela Simiele Website Design Terry Scanlon SALES Office Physician Assistant Communications, LLC P.O. Box 416, Manlius NY 13104-0416 Phone (315) 663-4147 PAC@pacommunications.org www.pacommunications.org keep current:

JDPA/Journal of Dermatology for Physician Assistants (ISSN 1938-9574) is published quarterly (4 issues per volume, one volume per year) by Physician Assistant Communications, LLC, P.O. Box 416, Manlius NY 13104-0416. Volume 8, Number 1, Winter 2014. One year subscription rates: $40 in the United States and Possessions. Single copies (prepaid only): $10 in the United States (Include $6.50 per order plus $2 per additional copy for US postage and handling). Periodicals postage rate paid at New York, NY 10001 and additional mailing offices. Š 2014 Physician Assistant Communications, LLC. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including by photocopy, recording, or information storage and retrieval system, without permission in writing from the publisher. Postmaster: Send address changes to Society of Dermatology Physician Assistants, Inc., 4111 W. Alameda Ave. Suite 412, Burbank, CA 91505, 1-800-380-3992., email SDPA@dermpa.org, www.dermpa.org. THIS ISSUE IS SPONSORED BY

4

Journal of Dermatology for Physician Assistants


Editor’s Message

T

his morning we awoke to another blast of Arctic air that made for very cold hands and first breathes taken outside. This frigid start to the day seemed to make for easy conversation with patients as we all were sharing in the same bitterly cold experiences. In the next exam room was a very pleasant elderly woman, her husband sitting next to her. As we exchanged pleasentries and stories about the extremely cold morning, she very abruptly became upset about something that we couldn’t quite seem to follow or understand. It took us a few moments to get our bearings as we struggled to think of something to say. Then a reassuring, warm hand took her hand, and a calm voice that was familiar and settling to her slowly began to calm her nerves. “But you’re ok now,” he said, visably melting the fear that had so quickly invaded her being. A glance down at her chart showed a note from the nurse that read: “patient has dementia.” Her sole caretaker, her husband, knew exactly what she needed, and it worked instantly to bring her comfort in that moment of unrest. “I’m glad I kept you,” she said to him, smiling as she looked into his warm eyes. He gently patted her hand and simply smiled back at her. This clearly was an experience that he has shared with her many times. We frequently look for common ground such as weather, sports, or current news to make conversation and connections with our patients. On occassion however, in the quieter moments of simply observing our patients, we can learn even more. J

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

Volume 8 • number 1 • wiinter 2014

5


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.

16 Alopecia Areata: Diagnosis and Treatment By Natasha Atanaskova Mesinkovska, MD, PhD and Wilma F. Bergfeld, MD

›› CME 10 Derm PA News & Notes – part one • Certification Review • Student Corner

16 Clinical Dermatology • CME Article – Alopecia Areata: Diagnosis and Treatment

31 Surgical Dermatology • Journal Club: Practice Changing Articles for

Departments

04 Editorial Board 05 Editor’s Message 09 SDPA News & Current Affairs 10 Dermatology Market Watch 23 From The Patient’s Perspective 26 Dermatopathology Q & A 27 Clinical Snapshots 32 Surgical Wisdom 35 Cosmetic Pearls 39 Outside & Inside the 9 to 5… 41 Notes from your Office Manager 47 The Difference We Make 52 Dermatology in Art 53 JDPA Information for Authors 54 Professional Opportunities and Development

Dermatology PAs

34 Cosmetic Dermatology • Journal Club: Practice Changing Articles for

Dermatology PAs

37 Professional Development • Dermatology Billing & Coding • Judicial and Ethical Affairs

46 Derm PA News & Notes – part two

Go Green - Read Online 6

Journal of Dermatology for Physician Assistants

• From the Desk of… • Workplace Excellence • Supervising Physician Corner

dermpa.org


your patients’

problems are

NO-TOUCH RELIEF The Only Mid-Potency Topical Steroid Aerosol Spray 1

INDICATIONS AND USAGE: Kenalog® Spray (Triamcinolone Acetonide Topical Aerosol, USP) is indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. CONTRAINDICATIONS: Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations. For external use only. Please see full Prescribing Information on reverse and also at KenalogSpray.com. REFERENCE: 1. Fowler J, Fowler L. Physician and patient assessment of triamcinolone acetonide spray for steroid-responsive dermatoses. J Clin Aesthet Dermatol. 2010;3:27-31. Kenalog® is a licensed trademark of Bristol-Myers Squibb Company. KNGJI1 09/13

Volume 8 • number 1 • wiinter 2014

7


KENALOG® SPRAY

Rx only

Triamcinolone Acetonide Topical Aerosol, USP (0.147 mg/g) For dermatologic use only Not for ophthalmic use

DESCRIPTION The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone acetonide is designated chemically as 9-fluoro-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17- acetal with acetone. The structural formula is:

C24H31FO6, MW 434.50 A two-second application, which covers an area approximately the size of the hand, delivers an amount of triamcinolone acetonide not exceeding 0.2 mg. After spraying, the nonvolatile vehicle remaining on the skin contains approximately 0.2% triamcinolone acetonide. Each gram of spray provides 0.147 mg triamcinolone acetonide in a vehicle of isopropyl palmitate, dehydrated alcohol (10.3%), and isobutane propellant. CLINICAL PHARMACOLOGY Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man. Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile. INDICATIONS AND USAGE Kenalog Spray (Triamcinolone Acetonide Topical Aerosol, USP) is indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. CONTRAINDICATIONS Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations. PRECAUTIONS General Systemic absorption of topical corticosteroids has produced reversible hypothalamicpituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients. Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Therefore, patients receiving a large dose of any potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests, and for impairment of thermal homeostasis. If HPA axis suppression or elevation of the body temperature occurs, an attempt should be made to withdraw the drug, to reduce the frequency of application, substitute a less potent steroid, or use a sequential approach. Recovery of HPA axis function and thermal homeostasis are generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see PRECAUTIONS, Pediatric Use). If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled. Information for the Patient Patients using Kenalog Spray should receive the following information and instructions: 1. This medication is to be used as directed by the physician. It is for external use only; avoid contact with the eyes and inhalation of the spray. 2. Patients should be advised not to use this medication for any disorder other than for which it was prescribed. 3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician. 4. Patients should report any signs of local adverse reactions. 5. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings. 6. Do not use Kenalog Spray on the underarms or groin areas unless directed by your physician. 7. If no improvement is seen within 2 weeks, contact your physician. 8. Do not use other corticosteroid-containing products while using Kenalog Spray without first

consulting your physician. 9. Kenalog Spray is flammable. Avoid heat, flames or smoking when applying Kenalog Spray. Laboratory Tests A urinary free cortisol test and ACTH stimulation test may be helpful in evaluating HPA axis suppression. Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. Studies to determine mutagenicity with prednisolone and hydrocortisone showed negative results. Pregnancy: Teratogenic Effects Category C. Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and wellcontrolled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time. Nursing Mothers It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman. Pediatric Use Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface area to body weight ratio. HPA axis suppression, Cushing’s syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children. ADVERSE REACTIONS The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings (reactions are listed in an approximate decreasing order of occurrence): burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria. OVERDOSAGE Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS, General). DOSAGE AND ADMINISTRATION Directions for use of the spray can are provided on the label. The preparation may be applied to any area of the body, but when it is sprayed about the face, care should be taken to see that the eyes are covered, and that inhalation of the spray is avoided. Spray is flammable; avoid heat, flame or smoking when using this product. Three or four applications daily of Kenalog Spray (Triamcinolone Acetonide Topical Aerosol) are generally adequate. HOW SUPPLIED Kenalog Spray (Triamcinolone Acetonide Topical Aerosol, USP) 63 g (NDC 10631-093-62) aerosol can. 100 g (NDC 10631-093-07) aerosol can. Storage and Handling Store at room temperature; avoid excessive heat. Contents under pressure; do not puncture or incinerate. Keep out of reach of children. To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. RANBAXY Jacksonville, FL 32257 USA

Revised August 2011

©Ranbaxy Pharmaceuticals, Inc.

8

Journal of Dermatology for Physician Assistants

Printed in the USA

DERM-3567-1212


FROM THE SDPA

News & Current Affairs

CALENDAR OF EVENTS 2014 MARCH 72nd AAD Annual Academy Meeting March 21 - 25, 2014 Denver, CO MAY/JUNE SDPA Summer Dermatology Conference May 28 – June 1, 2014 Marriott Downtown Indianapolis, IN AUGUST AAD Summer Academy Meeting August 6 - 10, 2014 Chicago, IL NOVEMBER SDPA 12th Annual Fall Dermatology Conference November 12 - 15, 2014 Manchester Grand Hyatt San Diego, CA

I

t is the end of the holiday season, the end of the year, and the beginning of a brand new year. It is a time for reflection on what has been and an opportunity to consider what we want for the coming year. Every day I am thankful for being able to care for my patients. I am honored and humbled by the trust they place in me. None of it would be possible without my mentor. Years ago Dr. Mark Bauer recognized that I had a knack for dermatology and encouraged me to go to PA school. My life would be very different if he had not taken the time to mentor me. Each one of you is in a position to have the same impact on others. I encourage you to offer your expertise to teach PA students, but don’t fail to recognize potential in your staff or even your patients. Let your passion show, and be the mentor you had or wish you had. Don’t forget to thank those who helped you get where you are. Thanks Mark; coming to work is a pleasure, and I am grateful to have the opportunity to still be able to learn from you every day. Because of you I enjoy teaching and maybe some day someone will consider me his or her mentor. J

Jennifer Winter, PA-C

SDPA President, Diplomate

Volume 8 • number 1 • wiinter 2014

9


Dermatology PA news & notes

Dermatology Market Watch GSK Gains Accelerated FDA Approval for First Combination Therapy for Advanced Melanoma The US Food and Drug Administration (FDA) has approved the first-ever combination therapy of trametinib (Mekinist), a MEK inhibitor, and dabrafenib (Tafinlar), a BRAF inhibitor, for the treatment of patients with unresectable or metastatic melanoma and BRAF V600E or V600K mutations (mutations that must be detected with an FDA-approved test). Both drugs had been approved in 2013 for single-agent use. Accelerated FDA approval was granted based on response rate and duration in a randomized, phase 2, open-label study, in which patients who received combination treatment had an overall response rate of 76%, compared with 54% for those who received only dabrafenib. Median duration of response was longer with combination treatment (10.5 vs. 5.6 months). These results, reported by the investigators, were superior to those reported by a blinded independent radiologic review committee.1,2 References: 1. US Food and Drug Administration. FDA approves Mekinist in combination with Tafinlar for advanced melanoma. FDA. Available at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ ucm381159.htm. Accessed January 24, 2014. 2. Mulcahy N. FDA Approves First Combination Therapy for Melanoma. Medscape [serial online]. Available at http://www.medscape.com/viewarticle/818930. Accessed January 24, 2014.

Valeant Pharmaceuticals Receives FDA approval of Luliconazole The US Food and Drug Administration (FDA) recently approved the azole antifungal luliconazole 1% cream (Luzu, Valeant Pharmaceuticals), the first topical azole antifungal agent with a 1-week (rather than 2-week), once-daily treatment regimen for the management of tinea cruris and tinea corporis in adults aged 18 years or older. Luliconazole was also approved for the treatment of interdigital tinea pedis in adults, a regimen that requires a 2-week treatment period. Approval was based on 3 clinical trials conducted on a total of 679 adults with either tinea pedis or tinea cruris, in which luliconazole was found to be effective against Trichophyton rubrum and Epidermophyton floccosum. J

10 Journal of Dermatology for Physician Assistants


CLODERM CREAM

®

Not a cookie-cutter corticosteroid. Unique clocortolone pivalate molecule enhances lipid solubility.1,2

Indication and Important Safety Information Cloderm Cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. The most common adverse events with Cloderm Cream include burning, itching, irritation, dryness, and folliculitis. Cloderm Cream is contraindicated in patients who are hypersensitive to any of the ingredients of this product. As with all topical corticosteroids, systemic absorption can produce reversible HPA-axis suppression. See full prescribing information on reverse side. For more information see www.Cloderm.com. References: 1. Siddiqui O, Roberts MS, Polack AE. Percutaneous absorption of steroids: relative contributions of epidermal penetration and dermal clearance. J Pharmacokinet Biopharm. 1989;17(4):405-424. 2. Royal Society of Chemistry website. Chem Spider, the free chemical database. Available at http://www.chemspider.com. Accessed June 6, 2011. Cloderm® is a trademark of Coria Laboratories, Ltd. ©2013 Promius Pharma, LLC. All rights reserved.

CDM-0413-071

Volume 8 • number 1 • wiinter 2014 11


RxOnly

5. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings. Laboratory Tests: The following tests may be helpful in evaluating the HPA axis suppression: Urinary free cortisol test ACTH stimulation test

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

Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.

DESCRIPTION: Cloderm Cream 0.1% contains the medium potency topical corticosteroid, clocortolone pivalate, in a specially formulated water-washable emollient cream base consisting of purified water, white petrolatum, mineral oil, stearyl alcohol, polyoxyl 40 stearate, carbomer 934P, edetate disodium, sodium hydroxide, with methylparaben and propylparaben as preservatives.

Pregnancy Category C: Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

Chemically, clocortolone pivalate is 9-chloro-6α-fluoro-11β, 21-dihydroxy-16α methylpregna-1, 4-diene-3, 20-dione 21-pivalate. Its structure is as follows: CLINICAL PHARMACOLOGY: Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man. Pharmacokinetics: The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses. (See DOSAGE AND ADMINISTRATION). Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile. INDICATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. CONTRAINDICATIONS: Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. PRECAUTIONS: General: Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients. Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity. (See PRECAUTIONS-Pediatric Use). If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled. Information for the Patient: Patients using topical corticosteroids should receive the following information and instructions: 1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes. 2. Patients should be advised not to use this medication for any disorder other than for which it was prescribed.

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

Nursing Mothers: It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman. Pediatric Use: Pediatric patients may demonstrate greater susceptibility to topical corticosteroidinduced HPA axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface area body weight ratio. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children. ADVERSE REACTIONS: The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: Burning, Itching, Irritation, Dryness, Folliculitis, Hypertrichosis, Acneiform eruptions, Hypopigmentation, Perioral dermatitis, Allergic contact dermatitis, Maceration of the skin, Secondary infection, Skin atrophy, Striae, Miliaria. OVERDOSAGE: Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS). DOSAGE AND ADMINISTRATION: Apply Cloderm (clocortolone pivalate) Cream 0.1% sparingly to the affected areas three times a day and rub in gently. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted. HOW SUPPLIED: Cloderm (clocortolone pivalate) Cream 0.1% is supplied in 30 gram and 75 gram pump bottles, 45 gram and 90 gram tubes. 30 gram pump bottle 75 gram pump bottle 45 gram tube 90 gram tube

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

STORAGE: Store Cloderm Cream between 15° and 30° C (59° and 86° F). Avoid freezing. Distributed by:

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

3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician. 4. Patients should report any signs of local adverse reactions especially under occlusive dressing.

12 Journal of Dermatology for Physician Assistants

Issued 0711

004158


Certification Review

All Those Things Inside the Skin You Might Have Forgotten By James A. Van Rhee, MS, PA-C

Test

Patient Result

Normal range

AST

480 U/L

0-40 U/L

ALT

540 U/L

0-40 U/L

4.5 mg/dl

0.3-1.0 mg/dl

Alkaline phosphatase

260 U/L

30-120 U/L

GGT

160 U/L

5-95 U/L

Bilirubin

Ceruloplasmin Ferritin

32 ng/dl

27-37 ng/dl

105 ng/ml

15-200 ng/ml

Which of the following is the most likely diagnosis? A. Crigler-Najjar syndrome B. Gilbert’s syndrome C. Hemochromatosis D. Wilson’s disease E. Viral hepatitis EXPLANATION: All of the disorders listed above can present with abdominal tenderness and jaundice. Liver function tests and other laboratory tests can assist in identifying the underlying cause. Viral hepatitis presents with marked elevations in AST and ALT, typically ten

times the normal range; alkaline phosphatase and GGT will be mildly elevated, typically two to three times normal; bilirubin will also be elevated. Hepatitis testing would confirm the diagnosis. Crigler-Najjar syndrome and Gilbert’s syndrome are hereditary disorders with a defect in bilirubin conjugation. The bilirubin will be elevated, but the remainder of the liver function tests will be normal. Wilson’s disease is an inherited disorder of copper metabolism. Patients present with liver, neurologic, and ocular (Kayser-Fleischer rings) symptoms. In Wilson’s disease the ceruloplasmin level, a copper carrying protein, will be decreased. Hemochromatosis is an inherited disorder of iron metabolism, patients present with fatigue, weakness, and abdominal pain. Serum iron or ferritin levels will be elevated. J

The correct answer is E

QUESTION: A patient presents with fatigue and jaundice. On physical examination, tenderness is noted in the right upper quadrant and the sclera are icteric. Laboratory results are noted below:

James A. Van Rhee, MS, PA-C, is the Program Director for the Yale University School of Medicine Physician Associate Program. Mr. Van Rhee has been involved in physician assistant education for over 17 years. He has served as project director and test item writer for the Physician Assistant Education Association’s (PAEA) Physician Assistant Clinical Knowledge Rating Assessment Tool (PACKRAT) and is the author of the Physician Assistant: Certification and Re-certification Review Book, published by Elsevier. For the last ten years he has been course director and presenter of the Physician Assistant Board Review, which is now being produced live online by Kaplan Medical.

Student Corner

Precepting PA Students in Dermatology It is important for SDPA members to recognize their crucial role in helping to successfully train our next generation of knowledgeable, clinically competent dermatology PAs. SDPA members should consider becoming clinical preceptors. We thank you if you are currently listed in our database as a preceptor site, and would encourage you to please be sure to update your information if you have not done so already by contacting sdpa@dermpa.org.

If you are interested in becoming a clinical preceptor please send your information to sdpa@dermpa.org. This is yet another great way members can help better our profession and make a difference. J Stephanie Palazzolo, PA-S1 SDPA Student Affairs Committee Junior Student Coordinator

Marc Kawohl, PA-S2 SDPA Student Affairs Committee Senior Student Coordinator Volume 8 • number 1 • wiinter 2014 13

DERmatology pa news & notes

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


Dermatology PEARLS

is a three day medical education program designed as a comprehensive training for Physician Assistants working in the dermatology specialty. Available Workshops:

Cobb Galleria Centre Atlanta, GA April 3-5, 2014 Offering 26.5 hours of Category I CME* Registration from $275 for Early Bird before February 12, 2014 Accomodations at Renaissance Waverly Hotel Register Now at www.gadermpa.org *This program is not yet approved for CME Credit. Conference Organizers plan to request for 26.5 hours of Category I CME from AAPA.

Sclerotherapy and Venous Reflux Disease Neurotoxins and Fillers Intermediate Surgical Skills Featured Faculty: Hilary Baldwin MD Lorie Gottwald MD Ashfaq Marghoob MD Gayla Sylvain MD

Terry Arnold PA-C Susan Coker PA-C Douglas DiRuggiero PA-C Abby Jacobson PA-C

*You won't want to miss our Dermoscopy lectures taught by Dr. Ashfaq Marghoob!

Provided by

Georgia Dermatology Physician Assistants

The P for D

D D Kasey D Ris

S D PA M

I H S R E EMB

P

Offe Registration f Accomodation Regis

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

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

1 14RAMC_6.75x4.75.indd Journal of Dermatology for Physician Assistants

1/31/13 12:49 PM


DO YOU KNOW A SDPA DIPLOMATE? The SDPA wishes to congratulate all of our Physician Assitant members who have completed the rigorous Distance Learning Initiative.

For For more more information information on achieving on achieving DIPLOMATE DIPLOMATE status status in in your s yourvisit state, dermpa.org/diplomate visit dermpa.org/diplomate Current diplomates effective as of 20132013 Current listlist ofofdiplomates effective asDec of Dec Volume 8 • number 1 • wiinter 2014 15


Clinic al Dermatology

Alopecia Areata: Diagnosis and Treatment By Natasha Atanaskova Mesinkovska, MD, PhD and Wilma F. Bergfeld, MD

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

›› CME

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

Approval is valid for 1 year from the issue date of January 2014. Participants may submit the self-assessment exam at any time during that period. This program was planned in accordance with AAPA’s CME Standards for Enduring Material Programs and for Commercial Support of Enduring Material Programs.

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

Learning Objectives: 1. To describe the clinical, dermatoscopic, and histopathologic findings of alopecia areata 2. Recognize the autoimmune processes associated with alopecia areata 3. Develop treatment algorithms for alopecia areata

16 Journal of Dermatology for Physician Assistants


Alopecia Areata: Diagnosis and Treatment 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 8 • number 1 • wiinter 2014 17


Alopecia Areata: Diagnosis and Treatment 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


Alopecia Areata: Diagnosis and Treatment 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 8 • number 1 • wiinter 2014 19


Alopecia Areata: Diagnosis and Treatment SDPA Members Only Content

CLINIC AL Dermatology

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

20 Journal of Dermatology for Physician Assistants


Alopecia Areata: Diagnosis and Treatment 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 8 • number 1 • wiinter 2014 21


Alopecia Areata: Diagnosis and Treatment 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.

Natasha Atanaskova Mesinkovska, MD, PhD works at the Departments of Dermatology and Dermatopathology, Cleveland Clinic, Cleveland, OH. She has indicated no relationships to disclose relating to the content of this article. Wilma F. Bergfeld, MD is Senior Dermatologist and Co-Director of the Departments of Dermatology and Dermatopathology, Cleveland Clinic, Cleveland, OH. She is the Past President of the American Academy of Dermatology and is currently a member of the National Alopecia Areata Foundation Scientific Advisory Committee. She has indicated no relationships to disclose relating to the content of this article.

&

Dermatopathology Q A By Dipti Anand, MD

Q: A 65 year-old Caucasian male presents with a one-year history of a slowly enlarging, scaly, nodular lesion measuring 0.6cm and located on his left cheek. The clinical impression is squamous cell carcinoma versus basal cell carcinoma. The histologic diagnosis is well-differentiated invasive squamous cell carcinoma. Which one of the two histologic findings did the biopsy from his left cheek show?

A

B Under the microscope [H&E stain (400x)]

Answer on page 26 22 Journal of Dermatology for Physician Assistants


From The Patient’s Perspective A Tiny Part of Who I Am My name is Vanessa. I was born with lamellar ever could, my entire life changed. Eventually at the age ichthyosis fifty-six years ago in Brooklyn, New York. of fifty, I decided to attend graduate school and there I When I was born, there was a gelatinous sac around me, met many people who accepted me for who I am. That’s which some cultures call a veil when I decided to totally (also known as a collodion accept myself for who I am as “On the outside we may have skin membrane). When the sac well! This change in attitude was broken and removed, the was an important step in of different colors or textures, but hospital staff saw that my skin my personal growth and has was scaly and I was transferred diminished (but not on the inside we are all people with greatly to the intensive care unit. erased) my self-consciousness. Eventually my parents were feelings, dreams, desires, and hopes Getting my Master’s degree allowed to bring me home, afforded me the opportunity trying to reach our fullest potential.” to work part-time in a although at that time there were no effective treatments for teaching position, which has the condition. They managed given me a lot of personal and the best they could, worked hard, and sacrificed to give my professional satisfaction. brother and me a parochial school education. When I finally was able to relax about my condition My earliest recollection of being “different” was and have more pride in myself, I met a wonderful man, fell when I was about five years old. in love, and moved to his state in order to be with him. People would point, laugh, or He’s an incredible partner who cares for me. One way he whisper to their companion(s) demonstrates it is by helping me manage my skin disorder. while staring at me. Once, while He makes thoughtful and encouraging suggestions like standing at a bus stop, a woman installing a steam shower and he’s always asking me what asked my mother if my condition I would like to drink, since hydration is so critical to me. was contagious and then she and He never complains about the flakes or the time I spend her children moved away from on personal care regimens. Lamellar ichthyosis is a tiny us. We lived in public housing part of who I am according to him. It is an organ with a for about fifteen years and the disorder, nothing more. Every human has seventy-eight children there could be very cruel organs in their body, so an affliction of at least one of them with their teasing and ostracizing. I got into a lot of fights! is inevitable. Although I was very self-conscious, I was not always timid. The desire to have positive attention made me a vociferous and gregarious (albeit moody) young person. In retrospect, my self-esteem was low and this led to some negative life experiences. I attended college and my experiences there with co-eds were much more positive than in grade and high school. Eventually I married and had a daughter (who has The Foundation for Ichthyosis & Related Skin Types, Inc.® (FIRST) is the only national non-profit organization a bit of eczema, but skin that is otherwise “normal”). The dedicated to helping families with the genetic skin disorders marriage did not last, but my daughter is, quite honestly, collectively called the ichthyoses. Our mission is to educate, my best friend. Mistakenly believing that I was never going inspire, and connect those touched by ichthyosis and to be in a healthy relationship due to my skin condition related disorders through emotional support, information, was the basis for many disastrous (romantic and otherwise) advocacy, and research funding for better treatments and eventual cures. relationships. Contact Information: www.firstskinfoundation.org One of the psychological and emotional aspects of 2616 North Broad Street, Colmar, PA 18915 being seen as an outsider is that of self-loathing. When I Phone: (800) 545-3286 • Fax: (215) 997-9403 E-mail: info@firstskinfoundation.org made the decision to love myself more than anyone else Volume 8 • number 1 • wiinter 2014 23

CLINIC AL Dermatology

By Vanessa Jennings


CLINIC AL Dermatology

From The Patient’s Perspective Very few doctors even knew what my condition was in the 1960’s, and sometimes even now they are unfamiliar with the condition. Doing my own research led me to the Foundation for Ichthyosis & Related Skin Types (FIRST) and helped me to discover the products that make my skin look close to normal, and contributed to making me feel more comfortable with myself. When I bathe, I add salts from the Dead Sea to the water, lathering with Dead Sea salt shower gel (imported from Israel), and scrub off scales with a ceramic pumice stone/sponge. Another topical product that has made a remarkable difference is 100% natural, unrefined African Shea Nut Butter. The smell of it is not appealing; I mix it with lotions of my favorite perfume scents or essential oils. However, I’m now utilizing much less expensive over-thecounter products to manage this disorder and rarely rely on expensive prescription medications, which have cost me thousands of dollars over my lifetime. On special occasions I go to a local day spa and treat myself to an exfoliating body scrub comprised of an oil and salt combination that is followed by a deep tissue massage with an emolliating cream. If I’m early enough for my spa appointment, I get to utilize the dry sauna and steam-room, which seems to help as well.

I am very grateful to FIRST for promoting research and sharing profiles of other people with this same disorder. When you look different from the general public it can be very lonely. Now I feel like I have a huge community of people who understand what I’ve experienced and how I feel. I hope to attend FIRST conferences in the future to give support to parents and encourage confidence in those children who are affected. On the outside we may have skin of different colors or textures, but on the inside we are all people with feelings, dreams, desires, and hopes trying to reach our fullest potential. We express ourselves through art, science, and sharing the love in our hearts with family, friends, and strangers. J Vanessa Jennings resides in Hackensack, NJ and works in New York City. She holds a BA in Economics from the City College of New York (CCNY) and a Master of Policy and Administration from the Metropolitan College of New York. A ten-year employee of the Sophie Davis School of Biomedical Education at the CCNY, she has risen from a secretarial function – Assistant to the Dean, to management – Director of Academic Affairs and Medical Education. Ms. Jennings is also an instructor for the CCNY School of Continuing and Professional Studies. Her hobbies include reading historical based fiction, jogging, collecting cookbooks, cooking, indoor and outdoor gardening, and attending a variety of cultural performances when time allows. She and her life-partner enjoy traveling and hope to revisit Europe together again soon. Her best friend is her daughter who recently obtained her MBA and is engaged to be married this spring. Vanessa is also fortunate to have a wonderful set of parents who will celebrate their 60th wedding anniversary this fall.

Take Home Points for Derm PAs: By Steven K. Shama, MD, MPH 1. Imagine Vanessa's parents' fear when their child was transferred to the intensive care unit at birth. When we do hospital consults with newborns, infants, or for that matter any child brought in by his or her parents, it is our responsibility to know enough about the skin condition as well as the future of this condition to make sure that parents are well counseled and that they are given hope, no matter how small it might seem to you, the clinician. The skin is simply our outer “wrapping,” but as Vanessa says, “on the inside we are all people with feelings, dreams, desires, and hopes of trying to reach our fullest potential.” 24 Journal of Dermatology for Physician Assistants

2. You must also realize that even young children can feel deep emotions. At the age of five, Vanessa can recall feeling “different” and being stared at and whispered about. Let us remember empathy and compassion. 3. My how Vanessa has been challenged in her life! She has been amazingly brave because of her deep belief of feeling that she was important in this life. She has got to be one of our teachers. Learn her message and tell her story to others who need your embracing words.


Volume 8 • number 1 • wiinter 2014 25


&

Dermatopathology Q A 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.

A

B

Dipti Anand, MD is a board-certified dermatopathologist specializing in the diagnosis of various inflammatory and neoplastic diseases of the skin. She is an associate dermatopathologist at SkinPath Solutions in Atlanta, GA. Dr. Anand received her medical degree from M.S. Ramaiah Medical College in India. She then successfully completed internships at Dr. Ram Manohar Lohia Hospital and Handa Medical Center and Diagnostic Laboratory in New Delhi. She then moved to Philadelphia, PA in 2004 and completed an internship in internal medicine at Albert Einstein Medical Center and a pathology residency at the Hospital of University of Pennsylvania. She attended a fellowship in dermatopathology at the University of Texas Southwestern under the training of Clay Cockerell, MD. Dr. Anand is board certified in pathology as well as dermatopathology. She enjoys teaching dermatopathology to dermatologists, residents, and physician assistants. She is active in the education of residents at the Medical College of Georgia and Emory University Medical School. Dr. Anand is an active member of the Atlanta Dermatology and Dermatologic Surgery Society, the Georgia Society of Dermatology and Dermatologic Surgery, the American Academy of Dermatology, and the American

26 Journal of Dermatology for Physician Assistants


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

Figure 2 - Following unroofing of the lesion with a #22-gauge needle, five black, coiled, beard hairs can be seen nestled deep into the dermis.

Figure 3 - The longest of the coiled hairs measured 6 cm in diameter.

REFERENCES: 1. Bolognia JL, Jorizzo JL, Schaffer JV. Dermatology. 3rd ed. New York: Saunders, 2012. 2. Perry PK, Cook-Bolden FE, Rahman Z, Jones E, Taylor SC. Defining pseudofolloculitis barbae in 2001: a review of the literature and current trends. J Am Acad Dermatol. 2002;46:S113-9. 3. Weismann K, Lorentzen HF. Dermoscopic color perspective. Arch Dermatol. 2006;142(9):1250.

(©Copyright 2013 Ladizinski et al.)

Barry Ladizinski, MD, works at the Department of Dermatology, Duke University Medical Center, Durham, NC; Marigdalia Ramirez-Fort, MD, works at the Center for Clinical Studies, Houston, TX; Yoon K. Cohen, DO, works at Alta Dermatology, Phoenix, AZ; Cliff Rosendahl, MBBS, Ph.D., works at the School of Medicine, University of Queensland, Brisbane, Queensland, Australia; and David J. Elpern, MD works at the Skin Clinic, Williamstown, MA. They have all indicated no conflicts of interest to disclose relating to the content of this article. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author (©2013 Ladizinski et al) and source (Case report: Pseudofolliculitis barbae: a dermatoscopic correlate. Dermatol Pract Conc. 2013;3(2):7) are credited.

Volume 8 • number 1 • wiinter 2014 27

CLINIC AL Dermatology

Figure 1 - Dermatoscopy showing a structureless pattern with a gray-blue, thick, curved line and adjacent red lines.


Simulated image based on patient with locally advanced BCC at Week 24.

BOXED WARNING AND ADDITIONAL IMPORTANT SAFETY INFORMATION Embryo-Fetal Death and Severe Birth Defects • Erivedge capsule can cause fetal harm when administered to a pregnant woman based on its mechanism of action • Verify pregnancy status prior to the initiation of Erivedge. Advise male and female patients of these risks. Advise female patients of the need for contraception during and after treatment and advise male patients of the potential risk of Erivedge exposure through semen • Advise patients to contact their healthcare provider immediately if they suspect they (or, for males, their female partner) may be pregnant 28 Journal of Dermatology for Physician Assistants

• Immediately report exposure to Erivedge during pregnancy and encourage women who may have been exposed to Erivedge during pregnancy, either directly or through seminal fluid, to participate in the Erivedge pregnancy pharmacovigilance program by contacting the Genentech Adverse Event Line at (888) 835-2555 Blood Donation • Advise patients not to donate blood or blood products while receiving Erivedge and for at least 7 months after the last dose of Erivedge Nursing Mothers • Inform female patients of the potential for serious adverse reactions in nursing infants from Erivedge, taking into account the importance of the drug to the mother


TRANSFORM THE TREATMENT OF DIFFICULT ADVANCED BASAL CELL CARCINOMA (aBCC) ERIVEDGE IS A UNIQUE ORAL THERAPY E (Not act actual ctual ual size size))

• Due to the nature of aBCC and its clinical factors (ie, lesion recurrence, location/size, and invasiveness) some patients may not be candidates for surgery or radiation1,2 • Erivedge is an oral treatment option dosed as a 150-mg capsule once daily until disease progression or unacceptable toxicity3 • Erivedge reduced lesions in patients with aBCC1,3 Objective response rates (ORR) by IR from ERIVANCE1,3* laBCC (n=63)

mBCC (n=33)

43% (n=27) (30.5-56.0)

30% (n=10) (15.6-48.2)

Complete response

21% (n=13)

0%

Partial response

22% (n=14)

30% (n=10)

7.6 (5.7-9.7)

7.6 (5.6-NE)

ORR (95% CI)

Median duration of response (months) (95% CI)

Indication Erivedge® (vismodegib) capsule is a hedgehog pathway inhibitor indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation. *Patients received at least 1 dose of Erivedge with independent pathologist-confirmed diagnosis of BCC. Response in laBCC: absence of disease progression and either ≥30% reduction in lesion size (sum of the longest diameter) from baseline in target lesions by radiography or in externally visible dimension (including scar tissue); or complete resolution of ulceration in all target lesions. Complete responders also had no residual BCC on sampling biopsy and partial responders had residual BCC on sampling biopsy. Response in mBCC: assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. IR=Independent Review; laBCC=locally advanced BCC; ORR=objective response rate; CI=confidence interval; NE=not estimable; mBCC=metastatic BCC.

Adverse Reactions • The most common adverse reactions (≥10%) were muscle spasms, alopecia, dysgeusia, weight loss, fatigue, nausea, diarrhea, decreased appetite, constipation, arthralgias, vomiting, and ageusia • In clinical trials, a total of 3 of 10 premenopausal women developed amenorrhea while receiving Erivedge • Treatment-emergent grade 3 laboratory abnormalities observed in clinical trials were hyponatremia in 6 patients (4%), hypokalemia in 2 patients (1%), and azotemia in 3 patients (2%) You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555. Please see Brief Summary of Prescribing Information on following page.

See what you can offer your patients with aBCC at www.Erivedge.com References: 1. Sekulic A, Migden MR, Oro AE, et al. N Engl J Med. 2012;366:2171-2179. 2. Walling HW, et al. Cancer Metastasis Rev. 2004;23:389-402. 3. Erivedge® (vismodegib) capsule Prescribing Information. Genentech, Inc. January 2012. © 2013 Genentech USA, Inc. All rights reserved. HED0001655400 Printed in USA.

Volume 8 • number 1 • wiinter 2014 29


Table 1: Adverse Reactions Occurring in ≥ 10% of Advanced BCC Patients (cont) All aBCC Patients (N = 138) Grade 3 Grade 4 All Grades 3 (%) (%) (%) 1

MedDRA Preferred Term2 Metabolism and nutrition disorders Decreased appetite Musculoskeletal and connective tissue disorders Muscle spasms Arthralgias Nervous system disorders Dysgeusia Ageusia Skin and subcutaneous tissue disorders Alopecia

ERIVEDGE (vismodegib) capsule Initial U.S. Approval: 2012 This is a brief summary of information about ERIVEDGE. Before prescribing, please see full prescribing information. WARNING: EMBRYO-FETAL DEATH AND SEVERE BIRTH DEFECTS ERIVEDGE (vismodegib) capsule can result in embryo-fetal death or severe birth defects. ERIVEDGE is embryotoxic and teratogenic in animals. Teratogenic effects included severe midline defects, missing digits, and other irreversible malformations. Verify pregnancy status prior to the initiation of ERIVEDGE. Advise male and female patients of these risks. Advise female patients of the need for contraception and advise male patients of the potential risk of ERIVEDGE exposure through semen [see Warnings and Precautions (5.1), Use in Specific Populations (8.1, 8.6)]. 1 INDICATIONS AND USAGE ERIVEDGE capsule is indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation. 2 DOSAGE AND ADMINISTRATION The recommended dose of ERIVEDGE is 150 mg taken orally once daily until disease progression or until unacceptable toxicity [see Clinical Studies (14)]. ERIVEDGE may be taken with or without food. Swallow capsules whole. Do not open or crush capsules. If a dose of ERIVEDGE is missed, do not make up that dose; resume dosing with the next scheduled dose. 4 CONTRAINDICATIONS None. 5 WARNINGS AND PRECAUTIONS 5.1 Embryo-Fetal Death and Severe Birth Defects ERIVEDGE capsules can cause fetal harm when administered to a pregnant woman based on its mechanism of action. Vismodegib is teratogenic, embryotoxic, and fetotoxic in rats at maternal exposures lower than the human exposures at the recommended dose of 150 mg/day. In rats, malformations included craniofacial anomalies, open perineum, and absent or fused digits. Fetal retardations and variations were also observed. Verify pregnancy status prior to the initiation of ERIVEDGE. Advise male and female patients of the risks of embryo-fetal death and severe birth defects and the need for contraception during and after treatment. Advise patients to contact their healthcare provider immediately if they suspect they (or, for males, their female partner) may be pregnant. Female and male patients of reproductive potential should be counseled regarding pregnancy prevention and planning. If ERIVEDGE is used during pregnancy or if a patient becomes pregnant while taking (or for a male patient, if his female partner is exposed to) ERIVEDGE, the patient should be apprised of the potential hazard to the fetus. Report immediately exposure to ERIVEDGE during pregnancy to the Genentech Adverse Event Line at 1-888-835-2555. Encourage women who may have been exposed to ERIVEDGE during pregnancy, either directly or through seminal fluid, to participate in the ERIVEDGE pregnancy pharmacovigilance program by contacting the Genentech Adverse Event Line at 1-888-835-2555 [see Boxed Warning, Use in Specific Populations (8.1, 8.6)]. 5.2 Blood Donation Advise patients not to donate blood or blood products while receiving ERIVEDGE and for at least 7 months after the last dose of ERIVEDGE. 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. ERIVEDGE capsule was administered as monotherapy at doses ≥ 150 mg orally daily in four open-label, uncontrolled, dose-ranging or fixed single dose clinical trials enrolling a total of 138 patients with advanced basal cell carcinoma (BCC). The median age of these patients was 61 years (range 21 to 101), 100% were White (including Hispanics), and 64% were male. The median duration of treatment was approximately 10 months (305 days; range 0.7 to 36 months); 111 patients received ERIVEDGE for 6 months or longer. The most common adverse reactions (≥ 10%) were muscle spasms, alopecia, dysgeusia, weight loss, fatigue, nausea, diarrhea, decreased appetite, constipation, arthralgias, vomiting, and ageusia (Table 1). Table 1: Adverse Reactions Occurring in ≥ 10% of Advanced BCC Patients All aBCC1 Patients (N = 138) MedDRA Preferred Term2 Gastrointestinal disorders Nausea Diarrhea Constipation Vomiting General disorders and administration site conditions Fatigue Investigations Weight loss

All Grades 3 (%)

Grade 3 (%)

Grade 4 (%)

42 (30.4%) 40 (29.0%) 29 (21.0%) 19 (13.8%)

1 (0.7%) 1 (0.7%) -

-

55 (39.9%)

7 (5.1%)

1 (0.7%)

62 (44.9%)

10 (7.2%)

-

35 (25.4%)

3 (2.2%)

-

99 (71.7%) 22 (15.9%)

5 (3.6%) 1 (0.7%)

-

76 (55.1%) 15 (10.9%)

-

-

88 (63.8%)

-

-

aBCC = Advanced Basal Cell Carcinoma. MedDRA = Medical Dictionary for Regulatory Activities. 3 Grading according to NCI-CTCAE v3.0. Amenorrhea: In clinical trials, a total of 3 of 10 pre-menopausal women developed amenorrhea while receiving ERIVEDGE [see Non-Clinical Toxicology (13.1)]. Laboratory Abnormalities: Treatment-emergent Grade 3 laboratory abnormalities observed in clinical trials were hyponatremia in 6 patients (4%), hypokalemia in 2 patients (1%), and azotemia in 3 patients (2%). 1 2

7 DRUG INTERACTIONS 7.1 Effects of Other Drugs on Vismodegib Drugs that Inhibit or Induce Drug Metabolizing Enzymes Vismodegib elimination involves multiple pathways. Vismodegib is predominantly excreted as an unchanged drug. Several minor metabolites are produced by multiple CYP enzymes. Although vismodegib is a substrate of CYP2C9 and CYP3A4 in vitro, CYP inhibition is not predicted to alter vismodegib systemic exposure since similar steady-state plasma vismodegib concentrations were observed in patients in clinical trials concomitantly treated with CYP3A4 inducers (i.e., carbamazepine, modafinil, phenobarbital) and those concomitantly treated with CYP3A4 inhibitors (i.e., erythromycin, fluconazole). Drugs that Inhibit Drug Transport Systems In vitro studies indicate that vismodegib is a substrate of the efflux transporter P-glycoprotein (P-gp). When ERIVEDGE is coadministered with drugs that inhibit P-gp (e.g. clarithromycin, erythromycin, azithromycin), systemic exposure of vismodegib and incidence of adverse events of ERIVEDGE may be increased. Drugs that Affect Gastric pH Drugs that alter the pH of the upper GI tract (e.g. proton pump inhibitors, H2-receptor antagonists, and antacids) may alter the solubility of vismodegib and reduce its bioavailability. However, no formal clinical study has been conducted to evaluate the effect of gastric pH altering agents on the systemic exposure of vismodegib. Increasing the dose of ERIVEDGE when coadministered with such agents is not likely to compensate for the loss of exposure. When ERIVEDGE is coadministered with a proton pump inhibitor, H2-receptor antagonist or antacid, systemic exposure of vismodegib may be decreased and the effect on efficacy of ERIVEDGE is unknown. 7.2 Effects of Vismodegib on Other Drugs Results of a drug-drug interaction study conducted in cancer patients demonstrated that the systemic exposure of rosiglitazone (a CYP2C8 substrate) or oral contraceptives (ethinyl estradiol and norethindrone) is not altered when either drug is co-administered with vismodegib. In vitro studies indicate that vismodegib is an inhibitor of CYP2C8, CYP2C9, CYP2C19 and the transporter BCRP. Vismodegib does not induce CYP1A2, CYP2B6, or CYP3A4/5 in human hepatocytes. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category D ERIVEDGE capsule can cause fetal harm when administered to a pregnant female based on its mechanism of action. Vismodegib is teratogenic in rats at doses corresponding to an exposure of 20% of the exposure at the recommended human dose (estimated AUC 0-24hr steady-state exposure). In rats, malformations included craniofacial anomalies, open perineum, and absent or fused digits. Fetal retardations and variations were also observed. Vismodegib is embryolethal in rats at exposures within the range achieved at the recommended human dose. If ERIVEDGE is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the embryo or fetus. Report immediately exposure to ERIVEDGE during pregnancy to the Genentech Adverse Event Line at 1-888-835-2555. Encourage women who may have been exposed to ERIVEDGE during pregnancy, either directly or through seminal fluid, to participate in the ERIVEDGE pregnancy pharmacovigilance program by contacting the Genentech Adverse Event Line at 1-888-835-2555 [see Boxed Warning, Warnings and Precautions (5.1)]. In an embryo-fetal developmental toxicity study, pregnant rats were administered oral vismodegib at doses of 10, 60, or 300 mg/kg/day during the period of organogenesis. Pre- and post-implantation loss were increased at doses of ≥ 60 mg/kg/day (approximately ≥ 2 times the systemic exposure (AUC) in patients at the recommended human dose), which included early resorption of 100% of the fetuses. A dose of 10 mg/kg/day (approximately 0.2 times the AUC in patients at the recommended dose) resulted in malformations (including missing and/or fused digits, open perineum and craniofacial anomalies) and retardations or variations (including dilated renal pelvis, dilated ureter, and incompletely or unossified sternal elements, centra of vertebrae, or proximal phalanges and claws). 8.3 Nursing Mothers It is not known whether vismodegib is excreted in human breast milk. Because many drugs are excreted in human milk and because

30 Journal of Dermatology for Physician Assistants

of the potential for serious adverse reactions in nursing infants from ERIVEDGE, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. 8.4 Pediatric Use The safety and effectiveness of ERIVEDGE capsule have not been established in pediatric patients. In repeat-dose toxicology studies in rats, administration of oral vismodegib resulted in toxicities in bone and teeth. Effects on bone consisted of closure of the epiphyseal growth plate when oral vismodegib was administered for 26 weeks at ≥ 50 mg/kg/day (approximately ≥ 0.4 times the systemic exposure (AUC) in patients at the recommended human dose). Abnormalities in growing incisor teeth (including degeneration/ necrosis of odontoblasts, formation of fluid-filled cysts in the dental pulp, ossification of the root canal, and hemorrhage resulting in breakage or loss of teeth) were observed after administration of oral vismodegib at ≥ 15 mg/kg/day (approximately ≥ 0.2 times the AUC in patients at the recommended human dose). 8.5 Geriatric Use Clinical studies of ERIVEDGE capsule did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. 8.6 Females of Reproductive Potential and Males ERIVEDGE capsule can cause harm to the embryo or fetus when administered during pregnancy. Counsel female and male patients regarding pregnancy prevention and planning. Advise patients to contact their healthcare provider immediately if they suspect they (or, for males, their female partner) may be pregnant [see Boxed Warning, Warnings and Precautions (5.1), Use in Specific Populations (8.1)] Female patients Determine pregnancy status within 7 days prior to initiation of treatment in females of reproductive potential. For females with a negative pregnancy test, initiate a highly effective form of contraception (failure rate of less than 1%) prior to the first dose. Continue highly effective contraception during therapy and for 7 months after the last dose of ERIVEDGE. If a patient becomes pregnant while taking ERIVEDGE, or during the 7 months after the last dose of treatment, report the pregnancy to the Genentech Adverse Event Line at 1-888-835-2555. Encourage pregnant females to participate in the ERIVEDGE pregnancy pharmacovigilance program by calling the Genentech Adverse Event Line at 1-888-835-2555. Counsel pregnant females about the teratogenic risk to the fetus. Amenorrhea has been observed in clinical trials in females of reproductive potential. Reversibility of amenorrhea is unknown [see Adverse Reactions (6), Nonclinical Toxicology (13.1)]. Male patients Male patients should use condoms with spermicide, even after a vasectomy, during sexual intercourse with female partners while being treated with ERIVEDGE capsule and for 2 months after the last dose to avoid exposing an embryo or fetus to vismodegib. 8.7 Hepatic Impairment The safety and effectiveness of ERIVEDGE capsule have not been established in patients with hepatic impairment [see Clinical Pharmacology (12.3)]. 8.8 Renal Impairment The safety and effectiveness of ERIVEDGE capsule have not been established in patients with renal impairment [see Clinical Pharmacology (12.3)]. 10 OVERDOSAGE There is no information on overdosage in humans. In clinical trials, ERIVEDGE capsule was administered at 540 mg orally once daily; exposure did not increase between 150 mg and 540 mg daily. 17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Medication Guide). t "EWJTF QBUJFOUT UIBU &3*7&%(& FYQPTVSF EVSJOH QSFHOBODZ DBO cause embryo-fetal death or severe birth defects. t *OTUSVDU GFNBMF QBUJFOUT PG SFQSPEVDUJWF QPUFOUJBM UP VTF B IJHIMZ effective form of contraception (failure rate of less than 1%) while taking ERIVEDGE and for at least 7 months after the last dose of ERIVEDGE. t *OTUSVDU BMM NBMF QBUJFOUT FWFO UIPTF XJUI QSJPS WBTFDUPNZ UP VTF condoms with spermicide, during sexual intercourse with female partners while taking ERIVEDGE and for at least 2 months after the last dose of ERIVEDGE. t *OTUSVDU QBUJFOUT UP JNNFEJBUFMZ DPOUBDU UIFJS IFBMUIDBSF QSPWJEFS if they (or, for males, their female partner) become pregnant or if pregnancy is suspected following exposure to ERIVEDGE. t *OTUSVDU QBUJFOUT UP JNNFEJBUFMZ SFQPSU BOZ QSFHOBODZ FYQPTVSF UP ERIVEDGE and encourage participation in the ERIVEDGE pregnancy pharmacovigilance program by calling the Genentech Adverse Event Line at 1-888-835-2555. t *OGPSN GFNBMF QBUJFOUT PG UIF QPUFOUJBM GPS TFSJPVT BEWFSTF reactions in nursing infants from ERIVEDGE, taking into account the importance of the drug to the mother. t "EWJTF QBUJFOUT OPU UP EPOBUF CMPPE PS CMPPE QSPEVDUT XIJMF UBLJOH ERIVEDGE and for at least 7 months after the last dose of ERIVEDGE. t "EWJTF QBUJFOUT UP TXBMMPX &3*7&%(& DBQTVMFT XIPMF BOE OPU UP crush or open the capsules.

ERIVEDGE ® [vismodegib] capsule Manufactured by: Patheon, Inc. Mississauga, Canada Distributed by: Genentech USA, Inc. ERIVEDGE is a registered trademark A Member of the Roche Group of Genentech, Inc. © 2013 2012 Genentech, Inc. 1 DNA Way South San Francisco, CA 94080-4990 1013 5 4 9 3 HED0000832301


SURGIC AL Dermatology Journal Club: Practice Changing Articles for Dermatology PAs Cutaneous squamous cell carcinomas of the lower extremity: A distinct subset of squamous cell carcinomas J Am Acad Dermatol. 2014 Jan;70(1):70-4. doi: 10.1016/j.jaad.2013.09.026. Epub 2013 Nov 5. Kim C, Ko CJ, Leffell DJ. Department of Dermatology, Yale University, New Haven, Connecticut. Department of Pathology, Yale University, New Haven, Connecticut.

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

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

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 8 • number 1 • wiinter 2014 31


SURGICAL wisdom American Academy of Dermatology Joins the Choosing Wisely速 Campaign 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.

32 Journal of Dermatology for Physician Assistants


SURGIC AL Dermatology Reprinted with permission from the American Academy of Dermatology.

Volume 8 • number 1 • wiinter 2014 33


COSMETIC deRMATOLOGY Journal Club: Practice Changing Articles for Dermatology PAs Laser Treatment of Traumatic Scars With an Emphasis on Ablative Fractional Laser Resurfacing JAMA Dermatol. Published online December 11, 2013. doi:10.1001/jamadermatol.2013.7761. Anderson RR, Donelan MB, Hivnor C, Greeson E, Ross EV, Shumaker PR, Uebelhoer NS, Waibel JS. Wellman Center for Photomedicine, Massachusetts General Hospital, Boston, MA; Department of Plastic Surgery, Shriner's Hospital for Children, Boston, MA; San Antonio Uniformed Health Education Consortium, Lackland Air Force Base, TX; Scripps Clinic Laser and Cosmetic Dermatology Center, San Diego, CA; Department of Dermatology, Naval Medical Center, San Diego, CA; Miami Dermatology and Laser Institute, Miami, FL.

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

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

34 Journal of Dermatology for Physician Assistants


Cosmetic pearls

Skin Care on a Budget SDPA Members Only Content

More expensive skin care products are not necessarily more effective.

Volume 8 • number 1 • wiinter 2014 35

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.


SDPA 2014 SUMMER DERMATOLOGY CONFERENCE

INDIANAPOLIS, INDIANA

MAY 29th - JUNE 1st

EARLY BIRD REGISTRATION NOW OPEN!

Join Us for our 20th Anniversary Gala! In Indianapolis – Marriott Downtown. SAVE THE DATE Who: Indianapolis Conference registrants When: 7:00pm on Friday, May 30th, 2014 The evening will include dinner, live music & a special guest speaker. Attire is Semi-Formal, suggestions include: Women – Cocktail Dress (mid length) or Dressy Pants and Blouse Men – Dark Business Suit

36 Journal of Dermatology for Physician Assistants


Professional development

Dermatology Billing & Coding Security Reminder By Inga C. Ellzey, MPA, RHIA, CDC

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

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

Volume 8 • number 1 • wiinter 2014 37


For eczema-prone skin

TWO ADVANCED TECHNOLOGIES.

ONE REPLENISHING REGIMEN. Cetaphil® RestoraDerm® products are the first and only regimen with advanced ceramide and Filaggrin technology™ To help restore the skin barrier in dry, eczema-prone skin, recommend the Cetaphil® RestoraDerm® regimen.1

Reference: 1. Simpson E, Trookman NS, Rizer RL, et al. Safety and tolerability of a body wash and moisturizer when applied to infants and toddlers with a history of atopic dermatitis: results from an open-label study. Pediatr Dermatol. 2012. doi:10.1111/j.1525-1470.2012.01809.x.

cetaphil.com Galderma, Cetaphil and RestoraDerm are registered trademarks. © 2013 Galderma Laboratories, L.P. Galderma Laboratories, L.P., 14501 N. Freeway, Fort Worth, TX 76177 CETA-619B Printed in USA 06/13

38 Journal of Dermatology for Physician Assistants


Outside & Inside the 9 to 5...

JDPA: What first interested you in becoming involved with the SDPA?

Volunteering is a great way to network and build your resume.

Mrs. Mangin: The SDPA has been a great organization in representing leadership and providing excellent dermatological education. Volunteering was a way to give back to my profession and fellow dermatology colleagues.

JDPA: As an SDPA Diplomate yourself, any suggestions or insights that you would like to share with SDPA members who are considering becoming a Diplomate?

Mrs. Mangin: I believe becoming a SDPA Diplomate is an extra way to boost your resume and set yourself apart Gina Mangin, MPAS, PA-C from other dermatology PAs. Mrs. Mangin: The most I feel it is a way to show dedication to our rewarding aspect has been the thank yous I have profession as dermatology PAs as well as to our received on the DLI forum, simply for answering SDPA organization that works closely with the a question and assisting fellow members in American Academy of Dermatology (AAD). completing the DLI. It has also been rewarding LT:12”

B:12.25”

S:9.875”

ST:10.75”

JDPA: What has been the most rewarding aspect of volunteering with the SDPA? Most challenging?

meeting and developing business relationships with fellow dermatology PAs across the nation. There have been no challenges for me in terms of volunteering.

JDPA: Having received the Outstanding Committee Member award for 2013, why do you think it is important for members to volunteer with the SDPA?

JDPA: What have you learned through volunteering with the SDPA committees?

Mrs. Mangin: The Society’s Board of Directors is completely run by our colleagues who volunteer their time. In order for our Society to continue to strive and provide excellent opportunities for you, we need volunteers. If there were no volunteers there would be no SDPA.

Mrs. Mangin: Volunteering really has not taken as much time out of my life as I anticipated. The SDPA allows you to be involved a little or a lot depending on your schedule and availability. JDPA: Any advice for members who have not yet volunteered on an SDPA committee? Mrs. Mangin: To get involved it only takes a simple email to the SDPA Leadership Development and Professional Growth Committee Chair, Abby Jacobson, MS, PA-C at ajacobson@dermpa.org.

JDPA: You have served in many leadership roles within the FSDPA. How did you first become involved with the FSDPA and what inspired you to take on these leadership roles? Mrs. Mangin: I attended a Florida state chapter meeting at the Annual SDPA Fall Dermatology

Volume 8 • number 1 • wiinter 2014 39

professional development

Gina Mangin, MPAS, PA-C has been a physician assistant for thirteen years. She has been practicing dermatology for five years and is currently working at Sand Lake Dermatology Center in Orlando, Florida. She has been active in the Society of Dermatology Physician Assistants (SDPA) as a past committee member of the Conference Educational Planning Committee and a current member of the Distance CME Committee (as well as being a Diplomate herself). Mrs. Mangin also is currently serving as the President of the Florida Society of Dermatology Physician Assistants (FSDPA) and has held the previous positions of Secretary, Director at Large, and Vice President of the FSDPA. Her passion for volunteering and educating PAs in dermatology is evident throughout her work with these great organizations, committees, and time spent precepting PA students in her office. The JDPA had the opportunity to interview Mrs. Mangin and learn about her passion for education as well as her experiences in giving back to her profession through her volunteer work on both the local and national levels.


professional development

know that my patients are in excellent hands. Conference and simply expressed that I wanted to get involved, it was that easy. I have always JDPA: Please share your insights on your enjoyed leadership roles ever since I was in college, experiences being involved with the SDPA on especially in things I both the larger scale as am passionate about. I a committee volunteer, started as an orientation “If there were no volunteers as well as on the State leader in college and Affiliate level, as President there would be no SDPA.” have continued to be a of the FSDPA. leader in my career. I love Mrs. Mangin: This dermatology and most has been a very rewarding experience for me. I importantly I love being a PA and want to share have enjoyed becoming a mentor for students my passion for my profession with everyone. and networking with JDPA: What changes colleagues. I have in the dermatology PA learned how much profession have you seen of a “team” effort it during your time with the takes from ALL of the FSDPA? volunteers to continue to keep these great Mrs. Mangin: organizations running PAs are becoming and providing services more independent to their members. As and advancing their the healthcare market skills in areas such as is changing, these dermatologic surgery and organizations have cosmetics. PAs are not allowed a pathway only seeing those patients for me to give back with acne, but are also to the profession and seeing patients with more community. complex diagnoses. The number of dermatology JDPA: Any additional PAs in Florida continues information you would to grow on a daily basis. like to share with the The industry is paying readers? more attention to PAs and SDPA President Jennifer Winter, PA-C presenting Mrs. Mangin Mrs. Mangin: As realizing the huge impact with the 2013 Outstanding Committee Member award at the I was growing up, my we have on patient care 11th Annual SDPA Fall Dermatology Conference in Atlanta, GA. mom worked as a Mary and patient education. Kay Consultant and JDPA: What value do you see in becoming always preached the importance of wearing involved with a SDPA State Affiliate? Any thoughts sunscreen and taking good care of your skin. Little to share with members who do not have a State did I know that I would follow in her footsteps Affiliate available in their state? and preach the same message from a medical standpoint. I practice what I preach every day as Mrs. Mangin: This could be a great stepping I apply sunscreen on my red-headed, blue-eyed stone to getting involved in the SDPA. Being a part little girl. My daughter lovingly states that I am her of an SDPA State Affiliate is a great networking hero because I take care of her skin. To me that is tool as it allows you to meet your local colleagues. priceless! J As a result of this type of networking, when I have patients moving within my state I can provide them with the name of a colleague to follow up with regarding their dermatology concerns and

40 Journal of Dermatology for Physician Assistants


Notes from your Office Manager Safely Caring for Obese Patients in the Office Practice Setting SDPA Members Only Content

professional development

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

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

Volume 8 • number 1 • wiinter 2014 41


Expand your Expertise…

at the largest dermatology event of the year! The AAD’s 72nd Annual Meeting offers Physician Assistants: • Full access to over 325 educational sessions covering a wide variety of topics

Registration begins Wednesday, December 4th 12 p.m. (CT).

REGISTER NOW!

• A look at the latest products and services from hundreds of exhibitors • A variety of networking events to help build professional relationships Don’t miss your chance to attend! For information regarding registration requirements for Physician Assistants, please visit www.aad.org/AM14/nonmembers

Visit www.aad.org/meetings for more information

13-785_Physician_Assist_Journal_Ad_cmyk.indd 1

9/17/2013 9:10:10 AM

The SDPA is celebrating 20 years! As part of the celebration, we will be making a 20th Anniversary photo and video montage that will play at our 2014 Summer Conference in Indianapolis. Please upload any photos or videos you have from SDPA Conferences & related events (i.e. Miles for Melanoma 5K, Diplomate Receptions, etc.). To get started, go to MEDIACOURIER.COM and type in sdpa20years as the password. Learn more about uploading here! http://bit.ly/1eDFv1B

42 Journal of Dermatology for Physician Assistants


Dermatology PA news & notes

Camp Discovery 2014

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in Crosslake, Minnesota (ages 10 – 14) ♦ June 23 – 27, Camp Reflection in Carnation, Washington (ages 8 – 16) ♦ July 6 – 11, Camp Big Trout in Crosslake, Minnesota (ages 14 – 16) ♦ August 10 – 16, Camp Liberty in Hebron, Connecticut (ages 8-16) ♦ August 10 – 15, Camp Dermadillo, in Burton, Texas (ages 9 – 15) ♦ August 9 – 15, Camp Horizon, in Millville, Pennsylvania (ages 8 – 13)

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CAMP DISCOVERY 2014 Dates: ♦ June 22 – 27, Camp Little Pine

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Camp Discovery was founded in 1993 and offers a summer camp experience like no other. Every summer, the American Academy of Dermatology sponsors six weeks of camp in five locations where everyone can experience activities such as fishing, swimming, archery, horseback riding, nature trails, and just plain fun! Under the expert care of dermatologists and dermatology healthcare professionals, Camp Discovery offers campers the opportunity to spend a week among other young people who have similar skin conditions. Many of the counselors have chronic skin conditions as well, and can provide support and advice to campers. There is no fee for camp. All costs, including transportation, are provided by the American Academy of Dermatology through generous donations from its members, other organizations, and individuals. The American Academy of Dermatology is proud to offer this experience to about 380 children each year.

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For more information about attending or volunteering, please visit the Camp Discovery website at www.aad.org/dermatology-ato-z/for-kids/camp-discovery/about-camp-discovery or contact Janine Mueller at (847) 240-1737 or jmueller@aad.org. Volume 8 • number 1 • wiinter 2014 43


We are pleased to announce that as of January 1, 2014 all DLI modules are now AAPA approved to be used for the new “self assessment” category I CME requirement. Visit the AAPA or NCCPA websites for complete details on the new CME requirements being implemented in 2014.

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

44 Journal of Dermatology for Physician Assistants


Now Showing on Dermcast.tv

The Official Online Media Resource of the SDPA Did you know that Dermcast is the #1 iTunes Podcast in dermatology? Dermcast.tv is your source for audio podcasts, the most current dermatology news and research, procedural videos, conference highlights, and much, much more. As members of the SDPA, everything on Dermcast.tv is not only tailored precisely for you and your needs, it is available to you FREE!

Read More: bit.ly/1g1R9ZB

Pain Free Remedy for Molluscum Contagiosum Donald Richey, MD Discover the pain free remedy for molluscum contagiosum Donald Richey, MD introduced at the 2013 SDPA Fall Conference in Atlanta.

Dermatology Clinic First to Accrue Fine For HIPAA Violation A dermatology clinic has been the first medical practice to be fined under new HIPAA rules. The clinic will be required to pay a fine of $150,000 and implement comprehensive HIPAA programs because of a 2011 data breach.

Read More: bit.ly/1jBjOme

2014 Diplomate and SDPA Leadership Reception Rewind SDPA Diplomates and leaders were recently treated to an exclusive event at the 2013 SDPA Fall Dermatology Conference in Atlanta, GA. The evening event, themed "Willy Wonka and the Chocolate Factory," was full of games, prizes, and candy, and was a great way to honor our hard working Diplomates.

Read More: bit.ly/KIIbl4

Florida Sees Increase in Tanning Facilities and Melanoma A recent study sought to classify indoor tanning facilities in order to “facilitate more directed health or regulatory interventions.” At the time of the study, October 2012, 1,261 facilities were licensed for indoor tanning. There was 1 tanning salon per 15,113 people and 1.16 tanning facilities per every 50 square miles. J Volume 8 • number 1 • wiinter 2014 45

DERmatology pa news & notes

Watch the Video on Dermcast: bit.ly/1dwImXG


From the Desk of... The SDPA Board of Directors

Recently the SDPA Board of Directors was asked to respond to an article published in the November 2013 issue of Practical Dermatology that contained incomplete information regarding the education of dermatology physician assistants. The following letter was submitted to Practical Dermatology in response to this oversight and is printed here for SDPA members to be fully aware of the role the SDPA Board of Directors plays in educating the public and/or other healthcare providers about our profession.

DERmatology pa news & notes

To Whom it May Concern, In the November 2013 issue of Practical Dermatology Dr. Joel Schlessinger wrote an article primarily on physician recertification titled "Is It Worth It to Recertify?" When discussing physician assistants (PAs), Dr. Schlessinger failed to mention that there is a standardized program for PA specific dermatology competency beyond the "judgment of their supervising physician." The program is called the Distance Learning Initiative (DLI). Completion of this program awards the PA Diplomate status within the Society of Dermatology Physician Assistants (SDPA). To maintain this status PAs must continue to complete additional modules, CME, dermatology-specific conference attendance, journal reading, and continued supervision by a board certified dermatologist. The DLI program not only answers the need for a standardized dermatology content but also provides evidencebased learning and testing required to pass each module. The DLI also incorporates many aspects of patient care including patient education, dermatopathology, emphasis on the team approach to healthcare that includes involvement of the supervising physician and appropriate referral to other medical specialties, and cost analysis of procedures, tests, and treatments. Some feel the program is an ideal hybrid of proven competencies and may even be superior to the typical standard multiple choice question

46 Journal of Dermatology for Physician Assistants

system of test taking at an expensive national testing center. The typical standardized test that is used for most healthcare professionals (including PAs) for test taking is expensive, time consuming, may contain questions and medical content that are often out of date, can unfairly punish those who are poor test takers or have test taking anxiety, and provide no real feedback or opportunity to learn from what questions were answered correctly or incorrectly. In summary, PAs who are Diplomates of the SDPA have completed dermatology specific competencies and have passed multiple tests to complete each module of the DLI. Each dermatologist who employs PAs should encourage them to achieve this highest level of proven competency. Encouragement can start with showing them this article, as well as providing them time to complete the program and shoulder the minimal costs (the SDPA has provided hundreds of thousands of dollars to develop and sustain this program at cost for dermatology PAs and their supervising dermatologists). Physicians considering the addition of a PA should highly consider Diplomates of the SDPA as superior employment candidates. A list of current SDPA Diplomates can be found at: http://www. dermpa.org/dlis/index/id/13. J Sincerely, The SDPA Board of Directors


The Difference We Make Individuals and Types

In a retrospective review of the origins of Antoine Saint-Exupéry’s Little Prince, Edward Rothstein observes that the children’s book might be ultimately “less about individuals and more about types.” It is an aviator’s perspective, sweeping across the landscape, only mildly hampered by earthly ties and human requirements, being guided by the stars. On the other hand, the message of the character of the fox is “far more grounded, empathetic, more concerned with others.” “Saint-Exupéry may have often been caught between these two perspectives,” Rothstein writes. “He fought against detachment but also relished it, fleeing for atmospheric vistas whenever possible.” There, briefly stated, you have the same dilemma faced daily by thousands of clinicians in medical practice. At the outset medical education consists largely of learning how to recognize and diagnose illness. Students are taught to look for disease patterns, clinical signs that when taken together as a whole point to one specific medical malady. Unfortunately this method cultivates an attitude toward human beings as disease entities. Students, residents and even attending physicians are apt to refer to “the cholecystectomy in Room 508,” “the schizophrenic in 212,” “the diabetic in ketoacidosis in the ED.” Such shorthand nomenclature provides a synopsis of the clinical condition and by implication, a plan for treating it. Yet if we are not careful, referring to patients as diagnostic entities or classifying them as types allows us to dehumanize them. If we come to regard patients

as mere disease entities, we are less likely to suffer emotional attachment, more likely to maintain our clinical objectivity; but at what cost? Patients who perceive that their providers are not interested in them tend to linger longer in the throes of illness than those who feel validated and nurtured as individuals. It has been shown that providing terminally ill patients with good palliative care dramatically improves the quality of life during their waning months. At some point in their medical education it would behoove clinicians to move toward an attitude of empathy, to take a compassionate stance in dealing with patients entrusted to their care. Perhaps that is what Saint-Exupéry’s Little Prince has to teach us grownup clinicians who have chosen a career in medical practice. In the words of the fox: “Here is my secret. It is very simple. One only sees rightly with the heart. The essential is invisible to the eye.” J Brian T. Maurer has practiced pediatric medicine as a physician assistant for thirty years. Over the past two decades Mr. Maurer has explored the illness narrative as a tool to cultivate an appreciation for the delivery of humane medical care. He has published numerous vignettes, editorials, and essays in both national and international journals. Mr. Maurer has been a contributing author to the online open-access journal Dermanities (www.dermanities. com) since its inception. Readers can visit the author on the web at http://briantmaurer.wordpress.com. This article was reprinted with permission from the author. Originally published at Wordpress at http://briantmaurer.wordpress.com/2014/01/24/individuals-andtypes/ : January 24th, 2014.

Write for the JDPA! Are you a PA who... • Is interested in writing? • Has a paper you want to get published? Share your knowledge today. Contact editor@jdpa.org

JDPA Journal of Dermatology for Physician Assistants

Volume 8 • number 1 • wiinter 2014 47

DERmatology pa news & notes

By Brian T. Maurer, PA-C


Workplace Excellence

Creating a Mistake-Resilient Culture of Excellence By Matthew Davidson, PhD

DERmatology pa news & notes

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

M

istakes happen - even in a culture of excellence. A truism and somewhat ironic to admit, given that our work at the Institute for Excellence & Ethics (IEE) is dedicated to developing a culture of excellence, which seems to convey “mistake-free.” However, excellence is really a standard beyond success and failure. Excellence is a realistic goal; perfection is not. Conceding the reality of mistakes seemingly removes accountability, which for many feels like a slippery slope whereby we encourage sloppiness and inadvertently reinforce low standards. However, a cavalier “mistakes happen” philosophy (which really conveys a “mistakes happen by me/us so you need to just deal with them”) isn’t the same as “we strive for excellence but when mistakes happen we deal with them in an excellent way” (that is intentionally, proactively with a sense of fairness to the maker(s) of the mistake(s) and the individual(s) affected). A culture that embraces mistakes in pursuit of excellence simply acknowledges that when you aspire to high standards and have a commitment to excellence, you are bound to fall short of those standards. For many this means lower the standard; under promise and over deliver; don’t put the bull’s-eye on your back by setting the expectations high. However, as the saying goes, “nobody ever rose up to low standards.” Setting the bar low isn’t the answer. Workplace excellence combines a complex combination of technical skills and human conditions. We develop a culture of excellence by embracing the reality of mistakes, and then proactively defining our shared way for 1) making the occurrence of mistakes rare, and 2) effectively

48 Journal of Dermatology for Physician Assistants

handling mistakes in a way that supports growth, improvement, and the experience of excellence for those we serve. A culture of excellence might be best described as a mistake-resilient environment: that is, an environment where mistakes are rare because of intentional habits and protocols, but an environment that handles and learns from mistakes when they do happen. In our work we advocate for the creation of “intentional culture” where what we do and how we do it are not left to chance. Every facet of the life of the organization is important; every habit either contributes to or detracts from the core values of the organization. Therefore, intentionally defining routines and rituals proactively ensures alignment between espoused values and the lived reality. For example, we want you to feel welcomed when you arrive; therefore, we DO certain things a certain way, and we DON’T do other things. If this routine is defined and executed, unintentional things creep into the experience. One person does it one way, another person does it another way. Mistakes often happen simply because we haven’t defined the ideal. If we have defined the ideal and fall short, it’s really a “miss-take” (i.e., we know what and how to do it, we just didn’t pull it off). There’s a big difference between an unforeseen mistake and a poorly executed protocol, or miss-take. In our work at IEE we utilize Excellence & Ethics Tools/Checklists, which provide a working protocol that defines a standard to guide behavior. We use checklists to ensure consistent results when performance challenges and pressures are high, and


An intentional culture with defined expectations and protocols creates an environment resilient to mistakes because the haphazard guesswork has been replaced with clear guidelines, which are especially important when new staff is added, and under times of fatigue and stress when mistakes often occur. However, mistakes will still happen, and when they do a different kind of resilience is needed: the strength needed to acknowledge and respond to the mistake. A mistake-resilient environment is a culture of safety, trust, and integrity where a foundation of personal and collective responsibility has been created by making clear the organization’s approach to reducing mistakes and handling them with integrity when they occur. A mistakeresilient culture is one where clear norms have been established, including the acknowledgement that, if in spite of clear norms and best efforts a mistake has happened, we will support one another in making it right. There must be a sense of compassion for and fairness to the maker of the mistake. A culture of fear will likely increase the occurrence of mistakes and encourage defensiveness and denial, which interfere with responsiveness and restitution.

with excellence, which requires an intentional guide. As you review or create your own checklist, consider the following mistake expectation template and sample responses: When we make a mistake we…. 1. Own it. 2. Make up for it. 3. Learn from it. 4. Move on from it. Owning it means accepting responsibility, not making excuses or blaming the victim. Making up for it means taking every reasonable step to make restitution. These first two steps must also be timely in their responsiveness. As the famous quote says, “Justice delayed is justice denied.” Learning from the mistake is essential to prevent future mistakes, to ensure that protocols are as good as they can be, and to make certain that human expectations for implementation are realistic. If we’ve done the first three steps, we can indeed move on knowing that we are a stronger, more mistake-resilient culture of excellence. J REFERENCE: 1. Gawande, A. The Checklist Manifesto: How to get things right. New York, Henry Holt. 2009. 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.

Most importantly, a mistake-resilient culture of excellence must have compassion (suffer with) and justice (give their due) for those affected by a mistake. All of the steps above fortify the organization from making a mistake that would cause pain to those being served. But if in spite of all of these efforts a mistake has been made, then it must be handled

Volume 8 • number 1 • wiinter 2014 49

DERmatology pa news & notes

when clear thinking and effective execution need to be ensured. In The Checklist Manifesto, surgeon Atul Gawande lays out compelling, real-world evidence that the use of checklists reduces failure and increases the consistent and efficient achievement of results. A familiar checklist is a valuable guide especially when pressures and tensions mount and it needs to be done right. An intentional organization defines the norms by saying to those in the organization and those the organization serves, “Here’s how we do things; this is our way; these are our expectations.” This applies to the important but low-risk routines and especially to high-risk routines. A mistake can still happen even if the standard or expectation has been defined through a checklist, but these instances become rare, and it becomes much easier to diagnose the root causes of the mistakes. For example, do we have a checklist for this? If no, then create one. If yes, then why wasn’t it followed, and how do we ensure it will be followed next time?


Supervising Physician CORNER An Interview with the New SDPA Conference Educational Planning Committee’s CME Medical Director - Whitney High, MD, JD, M.Eng By J. Margaret Casey

DERmatology pa news & notes

The SDPA’s Conference Educational Planning Committee has recently established the first ever SDPA CME Medical Director position. The addition of this position is a result of the Committee thoughtfully listening to feedback from our members and using their recommendations to help continually improve our conference and the SDPA overall. Dr. Whitney High will be serving as the Medical Director for the 2014 SDPA Summer Dermatology Conference. As the CME Medical Director, Dr. High will be providing the Committee with guidance and direction to help improve the quality of the conferences. We had an opportunity to interview Dr. High and learn more about his experience volunteering with the SDPA in his new role as Medical Director and what he foresees for future conferences. JDPA: How do you view your new role with the SDPA? Dr. High: I am helping those involved with the SDPA’s Conference Educational Planning Committee by putting them in contact with physicians and other thought leaders within the field who can serve as quality speakers. I am providing guidance and direction to the Committee, as opposed to a more dictatorial role. We are working closely and well together in establishing more user-friendly and pedagogic conferences. JDPA: What do you see as your mission in this role? Dr. High: Our overarching goal is to provide a wellstructured and informative conference. Based upon past feedback, the Committee will be creating a more logical flow with regard to the lectures, with complimentary topics arranged in a single block of time. This type of scheduling should make it more convenient for a member to maximize learning about topics that are truly germane to his or her dermatology practice. For example, if you practice exclusively in a surgical setting and do not treat pediatric patients, it may be of greater utility to have the surgical lectures grouped, for maximal learning. This type of block scheduling should make it easier for members to choose topics that they are interested in and should allow for more convenient travel to and from conferences. JDPA: What special skills and/or experiences do you have that you think will lend to your new role? Dr. High: Given that I am a dermatopathologist, as well as a board-certified dermatologist, I understand clinical concerns. I am a patient centered and patient focused provider. Therefore, in my new role I will be encouraging the Committee to try new things in order to teach the “fringes” of the subject matter. For example, this year we are going to have microscopes and slides available at the SDPA Summer Dermatology Conference. The purpose of this exercise is to show members what goes on behind the scenes when a specimen is submitted for histologic analysis. Of course, the goal of this session is not to train PAs to 50 Journal of Dermatology for Physician Assistants

become dermatopathologists; rather, it is to provide them with the “flavor” of what it is like to analyze skin under the microscope. This will make PAs better educated consumers with regard to dermatopathology services, and thereby improve care for patients. JDPA: What has been your experience thus far in working with and/or educating dermatology PAs? Dr. High: I currently practice in a university setting, and there are both PAs and NPs practicing alongside me in our department. I often have the opportunity to speak at the Colorado Society of Physician Assistant meetings. This will be my seventh year being involved with PA/NP conferences both locally and nationally, and I greatly enjoy helping people at all levels learn about the subject. JDPA: What do you hope to gain from this experience with the SDPA? Dr. High: For me, I always gain something from attending the SDPA conferences. The dermatology experience of PAs is often varied and may be different from that of physicians. As an SDPA educator, this breadth of varied experiences challenges me to be an entertaining and effective teacher. My interactions with seasoned dermatology PAs at these conferences provide me with insight into patient care experiences that differ from my own. JDPA: How do you see the role of dermatology PAs changing in the future? Dr. High: We have all seen dermatology practices that openly advertise that they do not utilize PAs and/or NPs. While I can respect their right to fashion a practice that conforms to their own beliefs, I do not believe this is likely to be a sustainable model. Utilizing PAs and NPs allows for better access to care and more affordable healthcare for a larger number of patients. The secret to still practicing safe and effective medicine is helping PAs and NPs grow in their knowledge, but still respect where their knowledge ends and when it is appropriate to refer


JDPA: What advice would you share with fellow dermatologists who are considering volunteering their time to helping educate dermatology PAs? Dr. High: I am certain that many of us have seen speakers come to SDPA conferencess and give a clearly “canned” lecture, which has not been customized at all for the target audience. Customization does not mean simply doing a find and replace search in Powerpoint, with the word “physician” changed to “physician assistant.” In fact, the types of patients seen and the topics covered by PAs in their daily practices differ somewhat from what physicians see. Presenters of lectures given to PAs should be mindful of this difference. Moreover, we all can recognize an industry-sponsored lecture that is so heavily influenced by the pharmaceutical company footing the bill that it verges upon being jaded, biased, or at best simply incomplete or uninformed. In my opinion, these types of lectures should be avoided – by the speaker, by the sponsor, and by the SDPA. JDPA: Any additional facts or information that you would like to share with the SDPA readers? Dr. High: We ask for SDPA members to be patient in regards to the implementation of these major changes that we are making to the format of the SDPA conferences;

think baby steps. The upcoming summer conference will be the first time we “try out” these new ideas. Some changes may not be “smooth” out of the gate; some may need a bit of polishing and refinement. We thank SDPA members in advance for their patience and continued feedback as we work out the details. We look forward to sharing these new improvements with you at the 2014 SDPA Summer Dermatology Conference. J Whitney A. High, MD, JD, M.Eng, is the first appointed CME Medical Director for the SDPA’s Conference Educational Planning Committee. He is a native of Colorado and is an Associate Professor of Dermatology and Pathology. He currently serves as Director of Dermatopatholgy (Dermatology) at the University of Colorado School of Medicine, in Denver. Dr. High is board-certified in dermatology and dermatopathology. He received his medical degree from the Mayo Clinic School of Medicine, and completed his dermatology residency training at the University of Texas Southwestern Medical Center, serving as Chief Resident. His dermatopathology fellowship was completed at the University of Colorado. Dr. High has studied tropical medicine in Central and South America, and has a certificate in Tropical Medicine and Hygiene from the Gorgas Institute, in Lima, Peru. His multidisciplinary research team was the first to discover gadolinium in the tissue of patients with nephrogenic systemic fibrosis. Dr. High also has a law degree from the University of Denver. He has authored 4 textbooks, more than 20 chapters, and more than 65 medical papers. Dr. High currently serves as an Assistant Editor of the Journal of the American Academy of Dermatology, and he is an editor/editorial board member of other medical journals as well. Dr. High often speaks nationally and internationally on a variety of topics in dermatology and dermatopathology, and he is considered an authority in both fields.

ATTENTION Student Members of the SDPA! Publishing an article in a peer-reviewed journal is a great way to enhance your dermatology education, share knowledge with your peers, and improve upon your resume. If you have written dermatology related papers and are interested in publishing your work, the JDPA staff is available to assist you through this process. Please contact the JDPA at editor@jdpa.org.

Volume 8 • number 1 • wiinter 2014 51

DERmatology pa news & notes

to a medical provider with a more detailed or specialized knowledge base. This holds true even for physicians. PAs and NPs should be utilized through collaborative efforts with their supervising physicians to provide both better care, as well as more care for our society.


Dermatology in Art By W. Stephen Steiner, PA-C

Dr. Bernard Ackerman likened the study of dermatology to art history. The parallels between appreciation of art and the evaluation of skin are many. A neophyte describes a painting in regards to color, brushstroke, content, and structure. A skilled art historian assimilates these details unconsciously and may declare, “It looks like a Monet.” Each description is equally valid, and each serves a unique purpose. Similarly, one may describe the violaceous polygonal papules arising on the volar wrist; another may describe it simply as lichen planus. While blood work and biopsies are critical to our specialty, it is what we appreciate on the surface of the skin that largely influences decisions in clinical practice. This series explores the depictions of dermatologic conditions in classic artwork. The condition may be the focus of the painting, but often it is a quiet detail, only for the discerning and trained eye. If you know of a piece of art that you would like to share with the JDPA readers, please contact us at editor@jdpa.org.

DERmatology pa news & notes

Entitled "Pau de Wandelaer,” this portrait was crafted in 1730 by Pieter Vanderlyn, an American colonial painter. The defined hyperpigmentation of this individual’s cheeks is consistent with melasma. While the etiology of melasma is unclear, it is clearly influenced by external and internal factors. The intensity and duration of exposure to ultraviolet radiation worsens the hyperpigmentation. Hormonal imbalances due to either natural sources or exogenous sources such as oral contraceptives play a role as well. High SPF sunblock can diminish worsening of hyperpigmentation, especially when applied frequently and liberally. Hydroquinone is the mainstay of treatment for melasma. Over-thecounter versions contain 2% hydroquinone, and commercially available prescription versions available in the US contain 4%. Retail pharmacies can compound much higher concentrations. Tretinoin has been demonstrated to work as a sole agent; however, tretinoin combined with hydroquinone is my preferred regimen. Other topical agents include azelaic acid and kojic acid. Intense pulsed light (IPL) and glycolic acid chemical peels are procedures that can supplement at home treatments. J

Portrait of Pau de Wandelaer by Pieter Vanderlyn circa 1730.

W. Stephen Steiner, PA-C is employed by Marietta Dermatology Associates. He has worked in dermatology for the past twelve years. Outside of work, he enjoys woodworking and spending time with his wife and boys.

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 52 Journal of Dermatology for Physician Assistants

JDPA Journal of Dermatology for Physician Assistants


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

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

From The Desk Of…

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

Clinical Dermatology CME articles

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

Dermatology Case Report

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

Journal Club: Dermatology PA Perspectives

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

From the Patient’s Perspective

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

Clinical Snapshots

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

Drugs in Dermatology

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

Dermatology Evidence-Based Medicine (derm EBM)

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

Surgical Dermatology Feature Articles

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

Surgical Wisdom

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

Surgical Dermatology Case Report

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

Journal Club: Dermatology PA Perspectives

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

Cosmetic Dermatology Feature Articles

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

Cosmetic Pearls

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

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

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

Professional Development Feature Articles

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

Outside & Inside the 9 to 5

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

Judicial and Ethical Affairs

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

Volume 8 • number 1 • wiinter 2014 53


Professional Opportunities and Development

A dver t iser INDE X • Valeant Pharmaceuticals - Elidel........ Pages 2, 3 • Ranbaxy - Kenalog Spray.....................Pages 7, 8 • Promius - Cloderm..........................Pages 11, 12 • Ferndale - DerMend...............................Page 25 • Genentech - Erivedge.....................Pages 28 - 30 • Galderma - Cetaphil Restoraderm............Page 38 • Taro Pharma - Topicort Spray..........Pages 55, 56 For more information on advertising opportunities in the JDPA, please log on to www.jdpa.org

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54 Journal of Dermatology for Physician Assistants


TOPICORT® (desoximetasone) Topical Spray, 0.25% Rx Only BRIEF SUMMARY 1 INDICATIONS AND USAGE Topicort® Topical Spray is a corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age or older. 4 CONTRAINDICATIONS None 5 WARNINGS AND PRECAUTIONS 5.1 Effect on Endocrine System Topicort® Topical Spray is a topical corticosteroid that has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Systemic absorption of topical corticosteroids can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid. In a study including 21 evaluable subjects 18 years of age or older with moderate to severe plaque psoriasis, adrenal suppression was identified in 1 out of 12 subjects having involvement of 10-15% of body surface area (BSA) and 2 out of 9 subjects having involvement of >15% of BSA after treatment with Topicort® Topical Spray twice a day for 28 days. [see Clinical Pharmacology (12.2)] Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of high potency steroids, larger treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure and young age. An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression. If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids. Cushing’s syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids. Use of more than one corticosteroid-containing product at the same time may increase the total systemic corticosteroid exposure. Pediatric patients may be more susceptible to systemic toxicity from use of topical corticosteroids. [see Use in Specific Populations (8.4)] 5.2 Local Adverse Reactions with Topical Corticosteroids Local adverse reactions may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Reactions may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. Some local adverse reactions may be irreversible. 5.3 Allergic Contact Dermatitis with Topical Corticosteroids Allergic contact dermatitis to any component of topical corticosteroids is usually diagnosed by a failure to heal rather than a clinical exacerbation. Clinical diagnosis of allergic contact dermatitis can be confirmed by patch testing. 5.4 Concomitant Skin Infections Concomitant skin infections should be treated with an appropriate antimicrobial agent. If the infection persists, Topicort® Topical Spray should be discontinued until the infection has been adequately treated. 5.5 Flammable Contents Topicort® Topical Spray is flammable; keep away from heat or flame. ADVERSE REACTIONS 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In randomized, multicenter, prospective vehicle-controlled clinical trials, subjects with moderate to severe plaque psoriasis of the body applied Topicort® Topical Spray or vehicle spray twice daily for 4 weeks. A total of 149 subjects applied Topicort® Topical Spray. Adverse reactions that occurred in ≥ 1% of subjects treated with Topicort® Topical Spray were application site dryness (2.7%), application site irritation (2.7%) and application site pruritus (2.0%). Another less common adverse reaction (<1% but >0.1%) was folliculitis.

Table 1. Number (%) of Subjects with Adverse Reactions Occurring in ≥ 1%

Number of Subjects with Adverse Reactions

Topicort® Topical Spray, 0.25% b.i.d. (N = 149)

Vehicle spray b.i.d. (N = 135)

13 (8.7%)

18 (13.3%)

Application site dryness

4 (2.7%)

7 (5.2%)

Application site irritation

4 (2.7%)

5 (3.7%)

Application site pruritus

3 (2.0%)

5 (3.7%)

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Teratogenic Effects: Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. Topicort® Topical Spray should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Desoximetasone has been shown to be teratogenic and embryotoxic in mice, rats, and rabbits when given by subcutaneous or dermal routes of administration at doses 3 to 30 times the human dose of Topicort® Topical Spray based on a body surface area comparison. 8.3 Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Because many drugs are excreted in human milk, caution should be exercised when Topicort® Topical Spray is administered to a nursing woman. If used during lactation, Topicort® Topical Spray should not be applied on the chest to avoid accidental ingestion by the infant. 8.4 Pediatric Use Safety and effectiveness of Topicort® Topical Spray in patients younger than 18 years of age have not been studied; therefore use in pediatric patients is not recommended. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing’s syndrome when they are treated with topical corticosteroids. They are therefore at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children. [see Warnings and Precautions (5.1)] HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. [see Warnings and Precautions (5.1)] 8.5 Geriatric Use Clinical studies of Topicort® Topical Spray did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. 10 OVERDOSAGE Topicort® Topical Spray can be absorbed in sufficient amounts to produce systemic effects. [see Warnings and Precautions (5.1)] 17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information and Instructions for Use) Inform patients of the following: • Use this medication as directed by the physician. • Topicort® Topical Spray is for external use only. Avoid use on the face, axilla or groin. • Do not use this medication for any disorder other than that for which it was prescribed. • Do not bandage or otherwise cover or wrap the treated skin so as to be occlusive. • Report any signs of local or systemic adverse reactions to the physician. • Do not use other corticosteroid-containing products with Topicort® Topical Spray without first consulting with the physician. • Discontinue therapy when control is achieved. If no improvement is seen within 4 weeks, contact the physician. • This medication is flammable; avoid heat, flame, or smoking when applying this product. • Discard this product 30 days after dispensed by pharmacist. Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1 Dist. by: TaroPharma® a division of Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532 Revised: April 2013 AD100-0030

Volume 8 • number 1 • wiinter 2014 55


A CLASS 1, SUPER-POTENT SPRAY For plaque psoriasis

Important Safety Information • Topicort® Topical Spray is a topical corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age or older. • Topicort® Topical Spray is a topical corticosteroid that has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis. • Systemic absorption of topical corticosteroids can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid. • Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. • Local adverse reactions may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Reactions may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. Some local reactions may be irreversible. • Safety and effectiveness of Topicort® Topical Spray in patients younger than 18 years of age have not been studied; therefore use in pediatric patients is not recommended. ®

See brief summary of Prescribing Information on reverse side. © 2013 Taro Pharmaceuticals U.S.A., Inc. TaroPharma® and Topicort® are registered trademarks of Taro Pharmaceuticals U.S.A., Inc.

56 Journal of Dermatology for Physician Assistants

AD100-0033

July 2013


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