December 2016 Clinical Advisor by The Clinical Advisor

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NEWSLINE

■■Breastfeeding intervention ■■New diabetes guidelines ■■SIDS recommendations FEATURE Drone-delivered health care

Medication delivered by drone in rural Appalachia LEGAL ADVISOR

Chest pain in a woman leads to a misdiagnosis

n Dermatologic Look-Alikes

AN ULCERATION ON THE KNEE PAGE 44

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n Feature

TYPE 2 DIABETES COMORBIDITIES PAGE 24

DECEMBER 2016

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DIABETIC PERIPHERAL

NEUROPATHY Diabetic peripheral neuropathy is implicated in 50% to 75% of nontraumatic amputations.

Editor Colby Stong, editor@clinicaladvisor.com Senior editor Sandhya George Associate editor Lauren Grygotis Assistant editor Madeline Morr Contributing editors Mark P. Brady, PA-C; Philip R. Cohen, MD; Deborah L. Cross, MPH, CRNP, ANP; Sharon Dudley-Brown, PhD, FNP; Abimbola Farinde, PharmD; Laura A. Foster, CRNP, FNP; Abby A. Jacobson, PA; Maria Kidner, DNP, FNP; Joan W. Kiely, MSN, CRNP; Debra August King, PhD, PA; Ann W. Latner, JD; Mary Newberry, CNM, MSN; Claire Babcock O’Connell, MPH, PA; Kathy Pereira, DNP, FNP; Sherril Sego, DNP, FNP; Ann Walsh, PA-C, SCT(ASCP); Kim Zuber, PA-C Production editor Kim Daigneau Group art director, Haymarket Medical Jennifer Dvoretz Production director Ada Figueroa Circulation manager Paul Silver National accounts manager Alison McCauley, 973.224.6414 alison.mccauley @ haymarketmedical.com Publisher Kathleen Hiltz, 201.774.1078 kathleen.hiltz@haymarketmedia.com Editorial director Kathleen Walsh Tulley Senior vice president, digital products and medical magazines Jim Burke, RPh CEO, Haymarket Media, Inc. Lee Maniscalco All correspondence to: The Clinical Advisor 275 7th Avenue, 10th Floor, New York, NY 10001 For advertising sales, call 646.638.6085. For reprints, contact Wright’s Reprints at 877.652.5295. Persons appearing in photographs in “Newsline,” “The Legal Advisor,” and “Clinical Challenge” are not the actual individuals mentioned in the articles.They appear for illustrative purposes only. The Clinical Advisor ® (USPS 017-546, ISSN 1524-7317), Volume 19, Number 12, is published 12 times a year, monthly, for $75.00 per year in the United States; $85.00 in Canada; $110.00 for all other foreign, in U.S. dollars, by Haymarket Media, Inc., 275 7th Avenue, 10th Floor, New York, NY 10001. Single copy: $20 U.S.; $30 foreign. www.ClinicalAdvisor.com. To order or update your paid subscription, call 800.436.9269. Periodicals postage rate paid at New York, NY, and additional mailing offices. POSTMASTER: Send address change to DMD Data Inc., 10255 W. Higgins Rd, Suite 280, Rosemont, IL 60018. Subscription inquiries: call 800.430.5450 to change your address or make other subscription inquiries. Requests for subscriptions from outside the United States must be accompanied by payment. All rights reserved. Reproduction in whole or in part without permission is prohibited. Copyright © 2016

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EXPERTS If a patient has you stumped, write us and we’ll forward your query to one of our consultants and publish the response in Advisor Forum.You can also use this space to contribute a clinical pearl of your own or comment on another letter.

Advisor Forum These are letters from practitioners around the country who want to share their clinical problems and successes, observations, and pearls with their colleagues. Responding consultants are identified below. We invite you to participate.

CLINICAL PEARLS

It cannot be beat.—TERRI JORDAN, ARNP, Daytona Beach, Fla. (202-2)

NEUTROPHILS AND LYMPHOCYTES In interpreting a complete blood count with differential, anytime the neutrophils and lymphocytes are numerically close, it is a viral cause; when the neutrophils and lymphocytes are numerically distant, it is a bacterial cause. This is very helpful in determining treatment.—DONNA CARTER, FNP-C, Scottsburg, Ind. (202-1) GENERIC “CAINE” IS EFFECTIVE FOR WOUND CARE For pain relief, most pharmacies offer a “caine” at 2-510%, and basically nothing higher, for between $5 and $30 per tube. I work in wound care and use Walmart’s

INTRA-ARTICULAR INJECTIONS FOR SEVERE OSTEOARTHRITIS Patients with severe osteoarthritis in the knees seem to do better with intra-articular injections if you have them sit up and dangle their legs off the examination table and distract the knee slightly when administering the injection.—ROSEMARY LEDBETTER, PhD, PA, Troy, Ill. (202-3)

YOUR COMMENTS SLIPPED CAPITAL FEMORAL EPIPHYSIS IN OBESE ADOLESCENTS I just read the CME/CE article by Marilou Shreve, DNP, APRN, entitled, “Assessing and treating pediatric obesity” [ June 2015]. I was concerned regarding the oversight of a critical issue in obese adolescents: the increased risk of slipped capital femoral epiphysis (SCFE). This was not addressed in the article. The case study (p. 55) gave incomplete advice regarding the evaluation of an obese adolescent male with knee pain. The most common etiology of the insidious onset of knee pain in children is the hip, due to referred pain from the

Equate brand—vagicaine 20% benzocaine. When using this before debriding a wound, give it three minutes to sedate the nerves, then perform the procedure. I get good results, as patients say. It relieves pain and burning for $1.88.

Advisor F

Send us your letters with questions and comments to: Advisor Forum, The Clinical Advisor, 114 West 26th Street, 4th Floor, New York, NY 10001. You may contact us by e-mail at editor@ clinicaladvisor.com. If you are writing in response to a published letter, please indicate so by including the number in parentheses at the end of each item. Letters are edited for length and clarity. The Clinical Advisor’s policy is to print the author’s name with the letter. No anonymous contributions will be accepted.

orum

These are lette and successe rs from practitioners s, observat around the below. We ions, and country who OUR CONSULTANTS pearls with invite you want to shar to participa their colle e their clinic agues. Resp te. al problems onding cons ultants are identified CON SULTAT IONS

TREATM ENT FOR INFECT URINAR ION SGLT2 REC MALE CHI S IN THE UNC Y TRACT IRCUMCI LD FOR DIA EPTOR BLOCKE If a male SED child conti Deborah L. Cross, MPH, CRNP, Laura A.BET Foster,ES CRNP, FNP, Abby A. Jacobson, PA-C, RS Abimbola Farinde, PhD, PharmD, With the nues toassociate ANP-BC, is practices family medicine is a physician assistant is a professor redevprogram adven t ofPrimary circu SGLT2 recep at Delaware Valley urinaryattract director, Gerontology NP elop Program, mcisi Columbia Southern moda litywith Palmetto on be perfo for type tor infecPhysicians Dermatology University of Pennsylvania School blockersGroup University 2 diabe rmed? regarding inCare as a treatm in Wilmington, Del. in Orange Beach, Ala. useCharleston, S.C. tes, is there ent urology is of Nursing, Philadelphia. any evide NATHAN in patients with to protect the is well advise nce or data type 1 diabe GARDNE d tes mellitus?— R, PA-C, continues to to recommend a circum upper tracts, the kidne CPAAPA, ys. develo cision It p recurr•ent 44 THE ADVISOR AUGUST 2015 •on www.ClinicalAdvisor.com Castleton, severaCLINICAL l consideration urinary tract the male child who As it currently stands N.Y. , SGLT2 s that infections. for glycemic impede the receptor blocke There are control in ability to cleansenter into this decisio rs are FDA adults with n. Poor hygien should the e and quell -approved child have e may appro diet and exercise, but with type 2 diabetes phimosis, simpl infection potential. appropriate the in ved conjun FDA for use in patien Moreover, AdvisorForum_CA0815.indd urine 44 9/29/15ction 2:38 PM e cathet culture can ts with type has stated that they ketoacidosi steroid cream be a challenge. erization to obtain s, or those are not may tempo an FAR with severe 1 diabetes, patients with Having a short tion of the rarily solve renal functi diabetic steroid the trial of informINDE, PhD, Pharm these issues tenden , though after for infection D (See bottom on.—ABIMBOL ation about once again.—C cy redevelops, placin cessaA Dr. Farinde.) of this page Milwaukee g (203-2) for more , Wis. (203- OLEEN ROSEN, the child at risk 1) DNP, FNP -C, CLI Philip R. Cohen, MD,

is clinicaltions associate professor , shou ld of dermatology, University a of Texas Medical Center, The focus of Houston.

NICAL

Send us your letter Advisor Forum, The s with questions New York, and comm Clinical Advisor ents to: , 114 clinicaladvisoNY 10001. You may contacWest 26th Street , please indicatr.com. If you are writing in t us by e-mail at 4th Floor, each item. e so by including response editor@ to a the Letters are policy is edited for number in parent published letter, to heses at length and contribution print the author ’s name with clarity. The Clinicathe end of s will be accepted. l Advisor the letter. No anonym ’s ous

Write us today.

OUR CO

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PEARLS

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VAGINA L RESULT DISCHARGE AND ING FRO If a female M TAMPON ODOR patient has USE a ask if she uses tamp history of vaginal disch ons. If she the pelvic arge with says “yes,” exam when cond odor, that you woul , do not enter ucting the rotating of d to take a pap smea vagina in the same the specu way r. Instead, the cervix. lum Most retain from side to side start shallow until reach ed tampons ing are lodge d in the fold

Philip R.

Cohen, MD, is clinical associa te profess of dermat or ology, of Texas MedicaUniversity l Center, Houston.

SEND TO The Clinical Advisor 275 7th Avenue, 10th floor New York, NY 10001

62 THE CLINI

Deborah L. Cross, MPH, ANP-B

CRNP, C, is associa te program director, Geronto logy NP Program University of Pennsyl vania School , of Nursing , Philadelphia.

CAL ADVI

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Abimbo la Farinde

, PhD,

is a profess PharmD, or at Columb ia Souther n Univers in Orange ity Beach, Ala.

• www.Clinic

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Laura A.

Foster,

practices familyCRNP, FNP, with Palmett medicine o Primary Care Physicia ns in Charles ton, S.C.

Abby A.

Jacobso

is a physicia n, PA-C, n at Delawa assistant re Dermatology Valley in Wilmington,Group Del.

.indd 62

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CONTENTS DECEMBER 2016

NEWS AND COMMENT 9

24 CME A 55-year-old obese African American man with T2DM Absorption of high volumes of insulin may be unpredictable. Concentrated insulins help clinicians tailor regimens for patients who require large daily doses.

Newsline ■■Breastfeeding support interventions

in primary care are recommended by the USPSTF ■■The ADA releases new diabetes guidelines for physical activity and exercise ■■Obesity screening is recommended in children and adolescents ■■New clinical practice guidelines for red blood cell transfusion ■■Recommendations for SIDS and a safe infant sleeping environment ■■Long-term oxygen is not beneficial for patients with COPD and moderate desaturation ■■The CDC approves the HPV vaccine in 2 doses for preteens

31 CME Feature posttest

New guidelines for RBC transfusion 10

18 Drone-delivered health care in rural Appalachia Nurse practitioners make history with the first Federal Aviation Administration–approved drone delivery of medications in the United States. Is there a future for drones in health care?

MAKING CONTACT

TOC_CA1216.indd 4

Web Roundup A summary of our most recent opinion, news, and multimedia content from ClinicalAdvisor.com

34 Dermatology Clinic n Rapidly extending lesions originating in the perianal area n Two well-defined 6-mm nodules on a teenager’s arm

FEATURES 12 Diabetic peripheral neuropathy: an overview Often underreported and undertreated, diabetic peripheral neuropathy is a significant source of morbidity and mortality.

DEPARTMENTS

Medication delivered by drone in Appalachia 18

44 Dermatologic Look-Alikes An ulceration on the knee 58 Legal Advisor Chest pain leads to a misdiagnosis Continues on page 6

Chest pain in a woman becomes fatal 58

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CONTENTS 61

Alternative Meds Update Clove oil may be used as an effective antimicrobial.

DEPARTMENTS cont’d

ADVISOR FORUM 32

Your Comments ■ Diagnosing Lyme disease in the early clinical stages

Clinical Pearls ■ Monitoring vital signs and exercise ■ Educating patients on the proper use of contraception

Case Files ■ Premature thelarche in a young girl ■ Picking cherries leads to a case of pseudohyperglycemia

“Sorry I’m late. I hit every traffic light coming home.”

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PERIPHER

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Diabetic peripher al neuropat hy implicated is in 50% to 75% of non trau amputations matic .

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EXCLUSIVE TO THE WEB AT

ClinicalAdvisor.com Web Exclusives

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Effects of maternal age on the decline of preterm birth The CDC examined the effects of maternal age on the decline of preterm birth in the United States between 2007 and 2014. Edible seeds becoming major food allergens The inclusion of seeds in food and food products may be a contributing factor in the increase of seed allergies. Excessive energy drink consumption leads to acute hepatitis case A 50-year-old man presents to the emergency department with abdominal pain, nausea, jaundice, and dark urine.

Starting a physician assistant program in Liberia Physician assistants (PAs) have been present in Liberia since the 1960s and have made huge contributions to the health of the Liberian people. Steve Trexler, an American PA with more than 30 years of experience, discusses the development of a PA program in Liberia. Listen to the podcast here: ClinicalAdvisor.com/LiberiaPAProgram Prevalence of pulmonary embolism in first episode of syncope Data published in the New England Journal of Medicine found that pulmonary embolism occurs in about 1 in 6 patients hospitalized for a first episode of syncope. Watch the video here: ClinicalAdvisor.com/FirstSyncopeVideo

The Waiting Room Official Blog of The Clinical Advisor ClinicalAdvisor.com/WaitingRoom Jillian Knowles, MMS, PA-C Implementing prescription drug monitoring programs Prescription drug monitoring programs allow prescribers to perform a statewide search to determine when a patient last had a controlled substance prescribed.

Sharon M. O’Brien, MPAS, PA-C Melatonin use in children with a neurodevelopmental illness Melatonin has been studied across patient populations, has few side effects, and could be a good alternative for those who have insomnia.

Sharon M. O’Brien, MPAS, PA-C Using caffeine to promote alertness Caffeine can help many clinicians stay alert throughout the day if used appropriately, but it can also cause unwanted side effects at high doses.

Jillian Knowles, MMS, PA-C Telecommunicating with patients Patient evaluations performed through teleconferencing may lack the accuracy of a physical exam but could be beneficial for patients without immediate access to a primary care office. See more on page 8

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INTERACT WITH YOUR PEERS by viewing the images and offering your diagnosis and comments. To post your answer, obtain more clues, or view similar cases, visit ClinicalAdvisor.com/AdvisorDx. Learn more about diagnosing and treating these conditions, and see how you compare with your fellow colleagues.

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Thumb pain occurring with repeated lifting A 57-year-old woman presents with a 3-week history of thumb pain. She started babysitting her 1-year-old granddaughter a month previously, and lifting the toddler seems to aggravate the pain. The woman has tried oral nonsteroidal anti-inflammatory drugs, with minimal relief. CAN YOU DIAGNOSE THIS CONDITION?

• Stenosing tenosynovitis • De Quervain tenosynovitis • Basal joint arthritis • Flexor tenosynovitis ● See the full case at ClinicalAdvisor.com/OrthoDx_Dec16

Derm Dx A farmer’s rash that worsened with topical corticosteroids A 76-year-old man presents for an evaluation of a moderately pruritic rash on his chest. When the rash first appeared, he was prescribed triamcinolone cream, which he used for 3 weeks and which resulted in gradual worsening of dermatitis. CAN YOU DIAGNOSE THIS CONDITION?

• Tinea incognito • Eczema • Impetigo • Lupus erythematosus ● See the full case at ClinicalAdvisor.com/DermDx_Dec16

8 THE CLINICAL ADVISOR •DECEMBER 2016 • www.ClinicalAdvisor.com

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Newsline D E C E M B E R 2 016

Screening for obesity advised in children page 10

Guidelines for red blood cell transfusion page 10

A guideline for a safe infant sleep environment page 11

THE U.S. Preventive Services Task Force (USPSTF) found evidence confirming that breastfeeding support interventions are linked to increased rates of breastfeeding, according to the updated evidence report published in JAMA. The researchers reviewed 211 clinical trials with concurrent controls that evaluated breastfeeding interventions relevant to primary care among mothers of full-term or near-term infants. Fifty-two studies (n=66,757) met the inclusion criteria, including 6 trials that

reported on the inconsistent effects of infant health outcomes. “Most studies indicated that there was a good level of breastfeeding support within the birthing facility at or around the time of delivery from hospital staff, including support from lactation care providers, but failed to fully describe the minimal support for breastfeeding during the prenatal and postpartum periods” the study authors wrote. Estimates from the meta-analysis from 26 studies (n=11,588) revealed a beneficial association between individual-level breastfeeding

Breastfeeding support interventions recommended in primary care by USPSTF Support interventions are linked to higher rates of breastfeeding, benefitting mothers and infants, according to the USPSTF.

interventions and any breastfeeding for less than 3 months (RR, 1.07). The results were consistent for any breastfeeding between 3 and 6 months (RR, 1.11) and for exclusive breastfeeding between 3 and 6 months (RR, 1.20). The pooled risk ratio also demonstrated a positive association between individual-level breastfeeding interventions and exclusive breastfeeding at 6 months (RR, 1.16).

New diabetes guidelines for physical activity and exercise THE AMERICAN DIABETES Association (ADA) has issued updated guidelines for all patients with diabetes regarding regular, structured physical exercise. The report, published in Diabetes Care, includes a recommendation of 3 or more minutes of light activity, such as walking, leg extensions, or overhead arm stretches, every 30 minutes during prolonged sedentary activities to improve blood sugar management, particularly for patients with type 2 diabetes. “These updated guidelines are intended to ensure everyone continues to physically move around throughout the day—at least every 30 minutes—to improve blood glucose management,” stated Sheri R. Colberg-Ochs, PhD, FACSM. “This movement should be in addition to regular exercise, as it is highly recommended for people with diabetes to be active. Since incorporating more daily physical activity can mean different things to different people with diabetes, these guidelines offer excellent suggestions on what to do, why to do it, and how to do it safely.”

The ADA’s position statement is based on a review of more than 180 papers of the most recent diabetes research and includes input from leaders in diabetes and exercise physiology from the United States, Canada, and Australia. The benefits of and recommendations for reduced sedentary time are as follows: • All adults, particularly those with type 2 diabetes, should decrease the amount of time spent in daily sedentary behavior. Grade B • Prolonged sitting should be interrupted with bouts of light activity every 30 minutes for blood glucose benefits, at least in adults with type 2 diabetes. Grade C • The above 2 recommendations are additional to, and not a replacement for, increased structured exercise and incidental movement. Grade C u For

more detailed information about these recommendations, please see our expanded coverage at www.ClinicalAdvisor.com

www.ClinicalAdvisor.com • THE CLINICAL ADVISOR • DECEMBER 2016 9

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Newsline CHILDREN and adolescents older than age 6 years should be screened for obesity, according to a draft recommendation statement from the U.S. Preventive Services Task Force (USPSTF). The USPSTF gave a B grade to the recommendation, and note that clinicians should refer children to intensive behavioral interventions to improve weight status. Screening and intensive behavioral interventions for obesity in children and adolescents older than 6 years of age could lead to improvements in weight status and related cardiometabolic factors after 6 to 12 months. In addition, pharmacotherapy interventions such as orlistat and metformin showed small amounts of weight loss, but the clinical significance of this benefit is still uncertain.

The USPSTF recommends that all children aged 6 years and older be screened for obesity.

The task force notes several risk factors for obesity, including parental obesity, poor nutrition, low levels of physical activity, inadequate sleep, sedentary behaviors, and low family income. Risk factors for obesity in younger children include maternal diabetes, maternal smoking, gestational weight gain, and rapid infant growth.

The recommended screening test for obesity is a BMI measurement, which should be plotted on a growth chart such as the ones developed by the CDC. Obesity is defined as an age-specific and sexspecific BMI in the 95th percentile. There is no evidence regarding screening intervals for obesity in children in adolescents, but height and weight are measured during health maintenance visits and can be used to calculate BMI. The USPSTF found that BMI is an adequate screening measure for obesity, and the task force found no direct evidence that assessed the harms of screening for obesity in this patient population. Intensive behavioral interventions with at least 26 contact hours or more for a period of weeks or months were shown to improve weight loss.

Obesity screening recommended in children

THE AMERICAN Association of Blood Banks (AABB) recommends use of the restrictive red blood cell transfusion threshold, in which transfusions are not indicated until hemoglobin levels are 7 g/dL or 8 g/dL. The AABB also recommends the use of standardissue blood in current blood banking practices, according to updated guidelines published in JAMA. The AABB examined evidence from 12,587 participants in 31 randomized clinical trials that evaluated either hemoglobin thresholds for red blood cell transfusion (1950 through May 2016)

or red blood cell storage duration (1948 through May 2016). The investigators compared restrictive thresholds, defined as a transfusion not indicated until the hemoglobin levels are 7 g/dL to 8 g/dL, with liberal thresholds, defined as a transfusion not indicated until hemoglobin levels are 9 g/dL to 10 g/dL. The restrictive threshold was not associated with a higher risk of adverse outcomes, including 30-day mortality, myocardial infarction, cerebrovascular events, pneumonia, or thromboembolism. The researchers also examined 13

Use of fresher blood did not improve clinical outcomes.

trials that included 5515 participants randomly assigned to receive fresher blood or standard-issue blood. They found that fresher blood did not improve clinical outcomes. The AABB recommends using the restrictive threshold over the liberal threshold in adult patients who are hemodynamically stable. In addition, among patients who are undergoing orthopedic surgery, cardiac surgery, or who have preexisting cardiovascular disease, the AABB recommends using the restrictive threshold where transfusions are not indicated until hemoglobin levels are 8 g/dL.

New clinical practice guidelines for red blood cell transfusion

10 THE CLINICAL ADVISOR • DECEMBER 2016 • www.ClinicalAdvisor.com

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Long-term Recommendations for SIDS prevention oxygen therapy and a safe infant sleeping environment for COPD • Avoid smoke exposure during THE AMERICAN Academy of Pediatrics (AAP) has released updated recommendations for a safe infant sleeping environment, which were published in Pediatrics. The recommendations include the following: • Back to sleep for every sleep. To reduce the risk of SIDS, infants should be placed for sleep completely on their back until the child reaches 1 year old. • Use a firm sleep surface. Infants should be placed on a mattress in a safety-approved crib with a fitted sheet and no other bedding or soft objects. • Breastfeeding is recommended. • Infants should sleep in the parents’ room, close to the parents’ bed, but on a separate surface designed for infants, ideally for the first year of life. • Keep soft objects and loose bedding away from the sleep area. • Consider offering a pacifier at nap time and bedtime.

The AAP recommends a supine sleeping position and a firm sleep surface.

pregnancy and after birth. • Avoid alcohol and illicit drug use during pregnancy and birth • Avoid overheating and head covering in infants. Infants should be dressed appropriately for the environment in which they are sleeping. • Pregnant women should obtain regular prenatal care. • Infants should be immunized in accordance with recommendations of the AAP and CDC. • Avoid the use of commercia l dev ices that are inconsistent with safe sleep recommendations. • Do not use home cardiorespiratory monitors as a strategy to reduce the risk of SIDS. • There is no evidence to recommend swaddling as a strategy to reduce the risk of SIDS. • Healthcare professionals should endorse the SIDS risk-reduction recommendations from birth.

CDC approves HPV vaccine in 2 doses for preteens CHILDREN WHO ARE vaccinated for human papillomavirus (HPV) before age 15 now need only 2 doses instead of 3, according to the CDC. The agency accepted the recommendation by the Advisory Committee on Immunization Practices. “Safe, effective, and long-lasting protection against HPV cancers with 2 visits instead of 3 means more Americans will be protected from cancer,” stated Tom Frieden, MD, MPH, director of the CDC,

in a statement. “This recommendation will make it simpler for parents to get their children protected in time.” The HPV vaccine is recommended for boys and girls at age 11 or 12. The CDC had previously recommended 3 doses of the vaccine for all ages. Now, children younger than 15 may be given 2 doses instead of 3, and the shots should be spaced at least 6 months apart. Teens and young adults who receive their first HPV dose at age 15 and older will still need 3 doses, according to the CDC. n

LONG-TERM supplemental oxygen does not provide any benefit regarding time to death or first hospitalization in patients with stable chronic obstructive pulmonary disease (COPD) and resting or exercise-induced moderate desaturation, according to a study in the New England Journal of Medicine. Participants were randomly assigned to receive long-term supplemental oxygen or no longterm supplemental oxygen. In the supplemental-oxygen group, patients with resting desaturation were given 24-hour oxygen, and those with desaturation only during exercise were given oxygen during exercise and sleep. The researchers followed 738 patients at 42 centers for 1 to 6 years. They found no significant difference between the supplemental-oxygen group and the nosupplemental-oxygen group in the time to death or first hospitalization (hazard ratio, 0.94), nor in the rates of all hospitalizations (rate ratio, 1.01), COPD exacerbations (rate ratio, 1.08), and COPD-related hospitalizations (rate ratio, 0.99). “We found no effect on the primary outcome in subgroups of patients defined according to desaturation type, prescription type, or adherence to the regimen,” the authors continued. “Long-term supplemental oxygen in patients with stable COPD and resting or exercise-induced moderate desaturation has no benefit with regard to the multiple outcomes measured.”

www.ClinicalAdvisor.com • THE CLINICAL ADVISOR • DECEMBER 2016 11

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FEATURE: JENNIFER A. GRENELL, APRN, CNP, AND ANNE E. TURNER, PA-C

Diabetic peripheral neuropathy: an overview Often underreported and undertreated, diabetic peripheral neuropathy is a significant source of morbidity and mortality.

Frontal x-ray of the foot of a patient with diabetes, showing a prior amputation.

iabetic peripheral neuropathy is a common complication of both type 1 and type 2 diabetes. The overall annual incidence of this condition is approximately 2%, according to the Diabetes Control and Complications Trial.1 Another study estimated that 7% of patients had neuropathy at the time they received a diagnosis of diabetes and that 50% of patients with diabetes for longer than 25 years had peripheral neuropathy.2 A later American study revealed similar findings, estimating that 47% of patients with diabetes eventually develop some sort of peripheral neuropathy.3 Diabetic peripheral neuropathy is a significant source of morbidity and mortality and is implicated in approximately 50% to 75% of nontraumatic amputations.4 It has been defined as “the presence of symptoms and/or signs of peripheral nerve dysfunction in people with diabetes after the exclusion of other causes.”5 This article presents an overview of diabetic peripheral neuropathy, but it is important to remember that diabetes is not always the cause of nerve dysfunction in patients with diabetes in whom it develops. This article reviews the entities to be considered in the differential diagnosis when a patient with diabetes undergoes an evaluation for peripheral neuropathy; in addition, we review the risk factors for this condition, as well as pathophysiology, signs and symptoms, diagnosis, screening, and treatment of diabetic peripheral neuropathy. Differential diagnosis

In making a diagnosis of diabetic peripheral neuropathy, it is important that the examiner 12 THE CLINICAL ADVISOR • DECEMBER 2016 • www.ClinicalAdvisor.com

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consider a variety of entities because in 10% to 26% of patients with diabetes who experience peripheral neuropathy, another underlying cause may be present.6 Making the proper diagnosis requires a careful clinical evaluation and laboratory testing. Electrodiagnostic studies or nerve biopsy may be needed if the diagnosis remains unclear. Potential nondiabetic causes of peripheral neuropathy are listed in Table 1; however, this list is not exhaustive. Pathophysiology

Mechanisms underlying the development of diabetic peripheral neuropathy commonly cited in the literature include the polyol pathway, advanced glycation end products, and oxidative stress. In this section, each of these mechanisms is described briefly. Polyol pathway. With prolonged hyperglycemia, excess glucose moves into the polyol pathway, where it is converted to sorbitol and fructose. The accumulation of sorbitol and fructose contributes to the structural breakdown of nerves, leading to the development of peripheral neuropathy.7 Advanced glycation end products. Also with prolonged hyperglycemia, the reaction of excess glucose with proteins, nucleotides, and lipids results in the production of advanced glycation end products. These play a role in disrupting nerve cell metabolism, leading to the development of peripheral neuropathy.8 Oxidative stress. Oxidative stress and the production of free radicals also are involved in the development of peripheral neuropathy. Free radicals may damage blood vessels, leading to ischemia in the nerve cells, and facilitate the production of advanced glycation end products, which in turn contribute to the development of peripheral neuropathy.9

TABLE 1. Differential diagnosis of diabetic peripheral neuropathy Etiology

Condition

Alcohol abuse

Inherited neuropathy

Neurotoxic medications

Chronic inflammatory demyelinating neuropathy

Renal disease and related uremic neuropathy

Spinal cord tumors

Vitamin B12 deficiency

Vasculitis

TABLE 2. Signs and symptoms of diabetic peripheral neuropathy Decreased knee and ankle reflexes Diminished vibratory perception Feet and legs often affected first, followed by hands and arms (stocking-and-glove distribution) Foot problems, such as ulcers, infections, and deformities; bone and joint pain Frequent worsening of signs and symptoms at night Loss of balance and coordination Muscle weakness Numbness or reduced ability to feel pain or temperature changes, sometimes described as a sensation similar to that of a foot asleep or a sock bunched up under the toes Reduced protective sensations, such as those of pressure, heat and cold, and pain Sharp pains or cramps Tingling or burning sensations

Signs and symptoms

The peripheral nervous system can be damaged by diabetes in numerous ways. Most commonly, patients with diabetes experience peripheral neuropathy. Symptoms typically include lower-extremity weakness, in addition to tingling, pain, burning, and electrical and stabbing sensations with or without numbness. Patients may describe a sensation that feels like socks bunching up in their shoes. These symptoms usually begin in the feet and move proximally (stockingand-glove distribution). The symptoms present symmetrically and appear sensory in nature. Over time, allodynia (painful sensations in response to innocuous stimuli) and hyperalgesia (increased sensitivity to painful stimuli) may develop.10 Diabetic peripheral neuropathy is insidious in nature and can lead to foot ulceration. These ulcerations

Unusual sensitivity or tenderness when feet are touched (allodynia); some report that the weight of a bed sheet can be agonizing

can be slow to heal, become infected, and lead to amputation. Unfortunately, patients with peripheral neuropathy may not report their symptoms, and often, fewer than half of patients are treated for their pain. Table 2 provides an overview of some of the common signs and symptoms of diabetic peripheral neuropathy. Risk factors

A variety of risk factors for the development of diabetic neuropathy are known (Table 3). According to the Diabetes Control and Complications Trial,1 hyperglycemia is one of the

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DIABETIC PERIPHERAL NEUROPATHY: AN OVERVIEW

most significant risk factors. Others include a long duration of diabetes, large total exposure to hyperglycemia, male sex, advanced age, elevated lipid levels, elevated blood pressure, kidney disease, cigarette smoking, overweight, increased height, and a high level of exposure to other potentially neurotoxic agents, such as ethanol. Genetic factors, such as the HLA-DR3/4 phenotype and apolipoprotein E genotype, are also associated with a risk for diabetic peripheral neuropathy. Screening

There are many important physical examination components to consider in the evaluation of a patient with diabetes. According to the American Diabetes Association 2016 Standards of Medical Care in Diabetes,11 patients with type 2 diabetes should undergo screening for peripheral neuropathy at the time of diagnosis, and patients with type 1 diabetes should be screened 5 years after diagnosis. Following the initial screening, all patients with diabetes should be monitored on an annual basis for this condition. Screening should focus on sensory function, including pinprick, temperature, and vibratory perception (128-Hz tuning fork), or pressure sensation (10-g monofilament at distal halluces).12 Two simple screening tests, including the Michigan neuropathy screening instrument and the United Kingdom screening test, are available for routine clinical practice.13 Patients with diabetes should be educated regarding the importance of vigilant examination and care of their lower extremities. They should be taught to perform daily foot checks and note the development of calluses, ulcers, or deformation. Proper footwear, including socks, should be reviewed in an effort to prevent calluses or ulcers. Additionally, these patients should be taught about proper toenail trimming and dry skin management. Referral to a podiatrist should be considered if lower-extremity deformities are present or if assistance with toenail trimming is needed.

TABLE 3. Risk factors for the development of diabetic peripheral neuropathy Advanced age

Hyperlipidemia

Alcohol (high level of exposure)

Hypertension

Apolipoprotein E genotype

Increased height

Cigarette smoking

Kidney disease

Diabetes mellitus (long duration)

Male sex

HLA-DR3/4 phenotype

Overweight

Hyperglycemia (especially, large total exposure)

TABLE 4. Diagnostic tests used to evaluate diabetic peripheral neuropathy Test

Purpose

Autonomic tests

In patients with symptoms of autonomic neuropathy, to evaluate their blood pressure in different positions and their ability to sweat

Electromyography

To measure the electrical discharge in muscles

Monofilament testing

To determine sensitivity to touch

Nerve conduction studies

To measure how quickly nerves in the upper and lower extremities conduct electrical signals

Quantitative sensory testing

To assess how nerves respond to vibration and changes in temperature

TABLE 5. Level A and level B recommendations from the American Academy of Neurology for the treatment of painful diabetic neuropathy15 Recommended drugs and doses and other treatments

Drugs and other treatments not recommended

Diagnosis

Level A

Pregabalin, 300–600 mg/d

Oxcarbazepine

A diagnosis of diabetic peripheral neuropathy is commonly considered on the basis of a patient’s presenting signs and symptoms, medical history, and physical examination findings. A diagnosis of diabetic peripheral neuropathy can be confirmed after electrodiagnostic, sensory, and autonomic function testing. Diagnostic tests commonly performed during an evaluation for diabetic peripheral neuropathy are summarized in Table 4.

Level B

• Gabapentin, 900–3600 mg/d • Sodium valproate, 500–1200 mg/d • Venlafaxine, 75–225 mg/d • Duloxetine, 60–120 mg/d • Amitriptyline, 25–100 mg/d • Dextromethorphan, 400 mg/d • Morphine sulfate, titrated to 120 mg/d • Tramadol, 210 mg/d • Oxycodone, mean of 37 mg/d, maximum of 120 mg/d • Capsaicin cream, 0.075% 4 times daily • Isosorbide dinitrate spray • Electrical stimulation, percutaneous nerve stimulation, 3–4 wk

• Lamotrigine • Lacosamide • Clonidine • Pentoxifylline • Mexiletine • Magnetic field treatment • Low-intensity laser therapy • Reiki therapy

Treatment

Diabetic peripheral neuropathy can be difficult to treat. At the current time, adequate glycemic control and pain 14 THE CLINICAL ADVISOR • DECEMBER 2016 • www.ClinicalAdvisor.com

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management are the only effective treatment strategies.10 Observational studies have shown that neuropathic symptoms are mitigated with glucose optimization but may not necessarily be reversed.12 Diligent adjustment of diabetes medications is vital in the treatment of peripheral neuropathy. To manage the chronic pain associated with diabetic peripheral neuropathy, practitioners should consider a variety of antidepressants and anticonvulsants, including amitriptyline, duloxetine, venlafaxine, gabapentin, valproate, and pregabalin, as well as opioid therapy. The US Food and Drug Administration has approved duloxetine and pregabalin for the treatment of pain associated with diabetic peripheral neuropathy; however, there is no defined treatment of choice. Direct comparisons of agents have not been conducted, and a patient’s therapy should be switched if the pain does not decrease.14 In addition to maintaining glycemic control and managing pain, practitioners should attempt to control factors that may increase the likelihood of peripheral neuropathy. Therefore, patients with diabetes are encouraged to maintain a healthy body weight, exercise as tolerated,

eliminate cigarette smoking and alcohol consumption, and treat blood pressure and lipids to goal. The American Academy of Neurology provides guidelines regarding the pharmacologic and nonpharmacologic treatment of painful diabetic neuropathy.15 These level A and level B recommendations for the treatment of painful diabetic neuropathy are summarized in Table 5. As previously mentioned in the section on pathophysiology, hyperglycemia-related oxidative stress and the production of free radicals can contribute to the development of peripheral neuropathy. Alpha-lipoic acid, an antioxidant, has been shown to be a powerful scavenger of free radicals in peripheral nerves. Studies have examined the use of alpha-lipoic acid in treating the symptoms of diabetic peripheral neuropathy, and some have found that patients with diabetic peripheral neuropathy who were given 600 mg of intravenous alphalipoic acid daily for 3 weeks experienced a decrease in pain, numbness, and paresthesia.16-18 More research is needed to determine the efficacy of alpha-lipoic acid in reducing the symptoms of diabetic neuropathy.

Case study History and presentation A patient, aged 79 years, was given a diagnosis of type 2 diabetes approximately 20 years ago. Her condition was originally managed with oral agents, but she was transitioned to a regimen of multiple daily injections of insulin glargine and insulin aspart approximately 8 years ago. Her hemoglobin A1c level has ranged from 7.9% to 8.2% over the last few years. Diabetes-related comorbidities and complications include retinopathy, obesity with a body mass index (BMI) of 39, hypertension, hyperlipidemia, chronic kidney disease (stage 3A), sleep apnea, and diabetic peripheral neuropathy. Between visits with her endocrinologist, she has worked closely with a diabetes educator for assistance with adjusting her insulin dose. The patient has a history of hypoglycemia unawareness but notes that since she has been participating in insulin education and having regular contact with her diabetes educator, her episodes of hypoglycemia have become less frequent. Her husband has been educated regarding the use of glucagon. The patient’s main concern at today’s visit is increased sensations of burning and pain in her lower extremities, which she notes have worsened in the last 2 to 3 months. Her primary care provider has referred her to a neurologist to confirm the diagnosis of diabetic peripheral neuropathy. Previously,

she preferred nonpharmacologic methods, including ice/ heat and exercise, to relieve her symptoms. After the pain and burning sensations worsened, she tried topical capsaicin cream at the recommendation of her pharmacist but found that to be of minimal benefit. She denies issues with lowerextremity ulcerations and states that she assesses her feet on a daily basis, using lotion to manage dry skin. Today, she is inquiring about additional treatment options for improving the management of her diabetic peripheral neuropathy. Assessment and plan For this patient, the importance of glycemic control and adherence to her schedule of multiple daily insulin injections was stressed. She was referred to a diabetes educator, who provided ongoing support and showed her how to adjust her insulin doses to achieve her glycemic goal. It was recommended that the patient initiate gabapentin at a dosage of 300 mg by mouth once daily. She was instructed to take this medication at bedtime because of its common side effect of drowsiness. She also received written instructions to increase the dose gradually to 1800 mg, to be divided into 3 doses taken throughout the day. The patient was reminded that this medication can take up to 12 weeks to take effect.

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Which of the following do you most frequently recommend for managing chronic pain associated with diabetic peripheral neuropathy?

POLL POSITION

n=807 ■ Antidepressants and anticonvulsants

of various types of diabetic neuropathy, retinopathy, and nephropathy in a population-based cohort: the Rochester Diabetic Neuropathy Study. Neurology. 1993;43(4):817-824. 4. Vinik AI, Park TS, Stansberry KB, Pittenger GL. Diabetic neuropathies. Diabetologia. 2000;43(8):957-973. 5. Boulton AJ, Gries FA, Jervell JA. Guidelines for the diagnosis and outpatient management diabetic peripheral neuropathy. Diabet Med. 1998;15(6):508-514.

35.56%

■ Maintaining healthy body weight and exercise

3. Dyck PJ, Kratz KM, Karnes JL, et al. The prevalence by staged severity

62.58%

6. Vinik AI. New methods to assess diabetic neuropathy for clinical research. Paper presented at: 60th Scientific Sessions of the American Diabetes Association; June 9-13, 2000; San Antonio, TX.

■ Opioids 1.86%

For more polls, visit ClinicalAdvisor.com/Polls.

7. Carrington AL, Litchfield JE. The aldose reductase pathway and nonenzymatic glycation in the pathogenesis of diabetic neuropathy: a critical review for the end of the 20th century. Diabetes Rev. 1999;7: 275-299. 8. Ryle C, Donaghy M. Nonenzymatic glycation of peripheral nerve pro-

Summary

teins in human diabetics. J Neurol Sci. 1995;129(1):62-68.

Diabetic peripheral neuropathy is a prevalent disorder that is hard to treat. It is often underreported and undertreated. The costs associated with diabetic peripheral neuropathy are high. Potentially 25% of the cost of diabetes care in the United States is associated with neuropathy, ranging from $4.6 billion to $13.7 billion annually.10 To improve outcomes, patients with diabetes should be screened for peripheral neuropathy on an annual basis. A diagnosis of diabetic peripheral neuropathy is often suspected on the basis of symptoms, medical history, and physical examination findings. It is important to consider a variety of conditions in the differential diagnosis because a patient’s neuropathy may have an underlying cause other than diabetes. Glycemic control and pain management are the cornerstones of treatment, with several classes of drugs considered effective in the treatment of diabetic peripheral neuropathy. ■

9. Figueroa-Romero C, Sadidi M, Feldman EL. Mechanisms of disease: the oxidative stress theory of diabetic neuropathy. Rev Endocr Metab Disord. 2008;9(4):301-314. 10. Callaghan BC, Cheng HT, Stables CL, Smith AL, Feldman EL. Diabetic neuropathy: clinical manifestations and current treatments. Lancet Neurol. 2012;11(6):521-534. 11. American Diabetes Association. Standards of medical care in diabetes-2016. Diabetes Care. 2016;39(suppl 1):S1-S112. 12. Boulton AJ, Vinik AI, Arezzo JC, et al.. Diabetic neuropathies: a statement by the American Diabetes Association. Diabetes Care. 2005;28(4):956-962. 13. Feldman EL. Clinical manifestations and diagnosis of diabetic polyneuropathy. UpToDate website. http://www.uptodate.com/contents/clinicalmanifestations-and-diagnosis-of-diabetic-polyneuropathy. Updated March 24, 2015. Accessed October 28, 2016. 14. Powers AC. Diabetes mellitus: complications. In: Kasper D, Fauci A, Hauser S, Longo D, Jameson J, Loscalzo J (eds). Harrison’s Principles of Internal Medicine. 19th ed. New York, NY: McGraw-Hill;

Jennifer A. Grenell, APRN, CNP, and Anne E. Turner, PA-C, practice in the Department of Endocrinology at the Mayo Clinic in Rochester, Minn., and specialize in diabetes management.

2015:chap 419. 15. American Academy of Neurology (AAN). Treatment of painful diabetic neuropathy. https://www.aan.com/Guidelines/home/ GetGuidelineContent/480. Published 2011. Accessed October 28, 2016.

References

16. Ziegler D, Gries FA. Alpha-lipoic acid in the treatment of diabetic

1. Diabetes Control and Complications Trial Research Group. The effect

peripheral and cardiac autonomic neuropathy. Diabetes. 1997;46(suppl

of intensive treatment of diabetes on the development and progression of

2):S62-S66.

long-term complications in insulin-dependent diabetes mellitus. N Engl

17. Morelli V, Zoorob RJ. Alternative therapies: part I. Depression,

J Med. 1993;329(14):977-986.

diabetes, obesity. Am Fam Physician. 2000;62(5):1051-1060.

2. Pirart J. Diabetes mellitus and its degenerative complications: a prospec-

18. Ziegler D, Nowak H, Kempler P, Vargha P, Low PA. Treatment of

tive study of 4400 patients observed between 1947 and 1973. Diabetes

symptomatic diabetic polyneuropathy with the antioxidant alpha-lipoic

Metab. 1977;3(2):97-107.

acid: a meta-analysis. Diabetic Med. 2004;21(2):114-121.

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B:8” T:7.75” S:7”

You see recovery. Your patients may see OINV. Opioid-Induced Nausea and Vomiting

*Survey study used a hypothetical experimental design to assess relative preferences. Reference: 1. Gregorian RS Jr, Gasik A, Kwong WJ, Voeller S, Kavanagh S. Importance of side effects in opioid treatment: a trade-off analysis with patients and physicians. J Pain. 2010;11(11):1095-1108.

learn more at KnowOINV.com

B:10.75”

S:10”

Is OINV disrupting more recoveries than you realize?

T:10.5”

In a survey study, patients were willing to give up about 2 points of pain relief on a 0 to 10 pain scale for reduced nausea and vomiting1*

FEATURE: TERESA GARDNER, DNP, MSN, FNP-BC, FANNP

Drone-delivered health care in rural Appalachia Nurse practitioners make history with the first FAA-approved drone delivery of medications in the US. Is there a future for drones in health care?

Medication is delivered by drone to an outreach clinic in rural Virginia.

urse-managed health clinics provide care to some of the most vulnerable and disadvantaged populations in the United States. The Health Wagon is one such clinic that serves southwest Virginia in the impoverished rural Appalachian region with the innovative use of mobile healthcare delivery. Ninety-eight percent of the Health Wagon’s patients are uninsured, and 78% have an income of less than $20,000 annually, despite working multiple jobs. Most make too much money to qualify for Medicaid but not enough to afford private insurance. The mobility of our clinic allows us to fill in the gaps and bring health care to the people living in Appalachia. Innovation in healthcare delivery has been a mainstay of the Health Wagon not only where mobile health services are concerned, but most recently with the delivery of medications by a drone at a Remote Area Medical (RAM) Wise County, Virginia, outreach, which is spearheaded annually by the Health Wagon. The event is the largest medical outreach in the country and was started by Sister Bernie Kenny, a nurse practitioner, and myself more than 17 years ago. This outreach program provides free eye, dental, and medical care during a summer weekend every year with the help of more than 1,400 volunteers. The clinic provides care at the local fairgrounds, and people camp out days in advance to receive desperately needed health care. The field clinic serves more than 6,000 patients during the 3-day weekend. Continues on page 21

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DRONE-DELIVERED HEALTH CARE IN RURAL APPALACHIA

Humanitarian relief can be aided with the emerging technology of drones.The locus of care is moved closer to the patient where care can be optimized. such as insulin. The use of a drone to deliver medications to patients or to take supplies from our stationary clinics out to our mobile unit would be very beneficial and meet crucial needs. Embracing this technology would give rural communities such as ours distinct advantages in the delivery of health care. Medication delivered by drone

A 6-rotor drone delivered medication to the rural outreach clinic on July 17, 2015, after the medication was flown to the Lonesome Pine Airport in Wise, Virginia, by a remotely operated NASA fixed-wing aircraft. From that point, the drone delivered 20 smaller packages of medications from the airport to the clinic located at the neighboring fairgrounds, making multiple trips throughout the day. The drone made the delivery by lowering the packages of medications, in a controlled manner, while it hovered above the ground. The packages were received by a pharmacist and given to patients in need of critical medications who were identified during the event by a healthcare provider. Safety was maintained with built-in features that included return-to-safe-location in the event of a low battery or communication loss. The event proved that drones have a future in the healthcare arena, as

The patients present with a variety of disorders, including hypertension, diabetes, coronary artery disease, chronic obstructive pulmonary disease, chronic kidney disease, and mental health issues such as depression and anxiety. Stan Brock, founder of RAM, and I had discussed the potential use of drones in health care. I believed that medication delivery would be a highly innovative concept that would meet the crucial needs of patients living in rural areas. The idea was soon embraced by other partners, including Flirty, an Australian-based drone delivery service; NASA Langley Research Center; Virginia Tech’s Institute for Critical Technology and Applied Science; the Business and Economic Development Office of Wise County; MidAtlantic Aviation Partnership; and the Appalachian College of Pharmacy, among others. The use of drones for medication delivery provides a great opportunity to address the medical needs of underserved communities. Living in a rural, mountainous area with frequent heavy snowfalls in the winter presents a number of hardships, and patients often run out of much-needed medications. Last winter, southwest Virginia had a recordbreaking 42 inches of snow, and the National Guard had to travel into rural areas and deliver life-saving medications

The Remote Area Medical Wise County, Virginia, outreach clinic provides free health care to over 6,000 uninsured people living in Appalachia during a 3-day weekend each summer. More than 1,400 volunteers help with the event, which began in 1999. www.ClinicalAdvisor.com • THE CLINICAL ADVISOR • DECEMBER 2016 21

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DRONE-DELIVERED HEALTH CARE IN RURAL APPALACHIA

the fully autonomous machines use their preprogrammed delivery schedule and post to delivery. The drone has now been accepted by the Smithsonian Institution’s National Air and Space Museum. The successful endeavor allowed the group of partners to demonstrate how an unmanned aircraft can assist healthcare professionals in providing care more efficiently and allowing the gap in healthcare access to be closed between those who can offer medical care and those who are most in need. The event also demonstrated the trials of delivering health care in rural areas and how this evolving technology can be used to overcome challenges that healthcare providers face in delivering care in these areas. According to Dr. Paula Meade, DNP, MSN, FNP-BC, PNP-BC, clinical director of the Health Wagon who also worked on the project, “This is a great accomplishment for our nurse-managed clinic and carries on our concepts of innovation.”

be able to deliver crucial supplies. Most of the Health Wagon’s service revolves around mobile health, and being able to deliver supplies such as sutures, dressings, and others out to the field where our mobile clinic is set up would be highly beneficial. Some of the mobile sites that the Health Wagon visits are more than 2.5 hours away, and it is impossible to anticipate all needed items for each trip. In the future, I would like to have a drone pilot on our staff who would coordinate air-to-ground deliveries of medications and supplies to mobile field clinics and patients alike. This is where the future will take us. The technology is here, and this will be just one more part of the arsenal that can be used to reduce healthcare disparities. I have also seen concepts in which drones deliver automatic external defibrillators to provide stat defibrillation for ventricular fibrillation. It may

History of the Health Wagon

The Health Wagon, a free and charitable clinic, began with Sister Bernie, who came to the Appalachian region more than 30 years ago at the request of the Catholic Richmond Diocese to treat the poor and marginalized. Sister Bernie was one of the earliest nurse practitioners in the region. She previously had been a midwife in Tanzania before returning to the states. She began giving care from the back of a Volkswagen Beetle, which became known as the “Health Wagon.” The Health Wagon quickly evolved into a 501c3 nonprofit clinic. Today, it serves patients at 11 different locations via mobile health clinics and 2 stationary clinics that are located in some of Virginia’s poorest areas. The 6 counties that the Health Wagon serves are designated as federal Health Professional Shortage Areas and Medically Underserved Areas/Populations. In the region, 43% of the population is below 200% of the federal poverty level. “The Affordable Care Act has done little to help our patient population,” said Dr. Meade. “Our patients are still too poor to afford the monthly premiums, and even if a perfect payer was implemented today, there are still not enough providers in the region to see the patients. The needs and healthcare disparities here are alarming, and we have to look at different delivery formats to optimize care and bring additional resources to the patients in need.”

The Health Wagon has delivered health care to people living in the central Appalachian region for more than 30 years.

The future of drones in health care

The sky is the limit with drone technology. We may be able to deliver not only medications via drones, but we may also

About 98% of patients who come to the mobile clinic are uninsured, and 78% of them have an annual income of less than $20,000.

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be difficult to find an automatic external defibrillator in a prompt manner. In the future, one may be able to summon the defibrillator by an app on a smartphone. The biggest obstacle for drone usage is currently the regulatory environment. The Federal Aviation Administration has banned all drone commercial uses in the United States. This test flight allowed the only freight exemption that permitted a real delivery. The FAA continues to work on guidelines that will address safety issues related to drone usage. However, other countries are embracing the technology in rapid fashion, and the United States lags behind in policing the safety of drone activity. To the FAA’s credit, airspace in the United States is the safest in the world, and progress toward the goal of full use of drones continues to be monitored and evaluated.

“No thanks, I’m fine.”

Merging humanitarian relief with technology

As demonstrated by the Health Wagon and its partners, humanitarian relief can be addressed with this emerging technology, which can be used to improve health outcomes. The locus of care is moved closer to the patient where health care can be optimized. In rural areas such as Appalachia where mountainous terrain and transportation are barriers for patients, using drones will be a transforming idea that will improve healthcare access. On another positive note, southwest Virginia is holding to the promise that this may be an answer to the coal counties’ economic struggle to recover from mining job losses, which have been catastrophic for the region. This unprecedented drone delivery has been the impetus for leaders to strategize on how drone technology can be used to promote economic development. The type of testing that occurred was ideal, given the rural, unpopulated geography. This could translate into job creation with health insurance and go a long way to alleviate the mounting burden that the Health Wagon faces on a daily basis in seeing patients without insurance. The lack of healthcare access is multifaceted, and changing the dynamic at this level would be great for all involved. To know that it all started with a nurse-managed clinic would be another testament to the creative nature of nurses. n Teresa Gardner, DNP, MSN, FNP-BC, FANNP, is a family nurse practitioner who maintains a nurse-managed clinical practice caring for the uninsured in the rural Appalachian Mountains of Virginia. If you would like more information on volunteering or on the Health Wagon, please visit our website: thehealthwagon.org.

“I was reading the anti-texting billboard.”

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CME FEATURED COURSE

n EDUCATIONAL OBJECTIVES At the conclusion of this activity, participants should be better able to: • Identify patients with diabetes who may be severely insulin-resistant to develop an appropriate antihyperglycemic treatment regimen that may include concentrated insulins • Recognize the differences between available concentrated insulins and their related U-100 formulations and among each other based on clinically relevant characteristics, such as PK/PD profiles and bioavailability • Evaluate clinical trial data on concentrated insulins to individualize treatment plans for patients with high-dose insulin requirements • Implement effective strategies for minimizing risk of error and avoiding confusion when developing treatment plans that include concentrated insulins • Counsel patients with high-dose insulin requirements to ensure safe and proper use of concentrated insulins as a part of their treatment regimen n COMPLETE THE POST-TEST: Page 31

Release Date: September 30, 2016 Expiration Date: December 31, 2017 Estimated Time to Complete: 30 minutes Accredited Provider: This educational activity is provided by Haymarket Medical Education. Commercial Supporter: This activity is supported by an educational grant from Lilly USA, LLC. Program Description: Managing the care of patients with diabetes who are highly insulin-resistant remains a challenge for many clinicians. Patients who require more than 200 units (U) per day of insulin face difficulties administering the amounts necessary for managing their blood glucose levels effectively. Besides the inconvenience and discomfort of multiple insulin injections to meet the needs for glycemic control, absorption of high volumes of insulin may be unpredictable, making diabetes management particularly challenging for clinicians and patients alike. Concentrated insulins provide a way for clinicians to tailor insulin regimens for patients who require large daily doses. To allay fears and misunderstandings that can lead to clinical inertia on the part of prescribers who are reluctant to intensify antihyperglycemic therapy with these agents, clarity is needed about the characteristics of available concentrated insulins, including their pharmacokinetic and pharmacodynamic (PK/PD) profiles, how bioequivalence plays a role in determining the activity of these agents when compared with their U-100–parent agents, and their modes of administration and dosing, which will lead to more appropriate use in clinical practice. This case is the second of 2 companion case studies discussing the use of concentrated insulins and features a 55-year-old obese man with type 2 diabetes mellitus (T2DM) who presents to the endocrinology clinic with concerns about the frequency of his insulin injections. Intended Audience: Endocrinologists, diabetologists, primary care physicians, nurse practitioners (NPs), and physician assistants (PAs) Conflict of Interest Disclosure Policy: In accordance with the ACCME Standards for Commercial Support, HME requires that individuals in a position to control the content of an educational activity disclose all relevant financial relationships with any commercial interest. HME resolves all conflicts of interest to ensure independence, objectivity, balance, and scientific rigor in all its educational programs. Faculty Wendy Lane, MD Mountain Diabetes and Endocrine Center Asheville, NC

CA_CME_12.16_v5.indd 24

Faculty Disclosure: Dr. Lane has received consulting fees from Insulet Corp., Novo Nordisk, and Thermalin Diabetes, LLC. Accredited Provider Disclosure: The Haymarket Medical Education staff involved in the planning and content review of this activity have no relevant financial relationships to disclose. Accreditation Statement: Haymarket Medical Education is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. Designation Statement: Haymarket Medical Education designates this enduring material for a maximum of 0.50 AMA PRA Category 1 CreditTM. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Disclosure of Unlabeled Use: This educational activity may contain discussion of approved and/or investigational uses of agents that are not indicated by the FDA. Haymarket Medical Education and Lilly USA, LLC, do not recommend the use of any agent outside of the labeled indications. Disclaimer: The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of Haymarket Medical Education and Lilly USA, LLC. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings. If you have any questions relating to the accreditation of this activity, please contact cmequestions@haymarketmedical.com. Instructions: There are no fees for participating in and receiving CME credit for this activity. During the period September 30, 2016 through December 31, 2017, participants must: 1) read the learning objectives and faculty disclosures; 2) complete the pre-assessment test; 3) study the educational activity; 4) complete the poll questions; and 5) complete the post-test and submit it online. A statement of credit will be issued only upon receipt of the above elements and a post-test score of 70% or higher. All components must be completed and submitted online at ClinicalAdvisor.com/Dec16feature.

Provided by

11/22/16 4:04 PM

CME

FEATURED COURSE: WENDY LANE, MD

A 55-year-old obese African American man with T2DM Absorption of high volumes of insulin may be unpredictable. Concentrated insulins help clinicians tailor regimens for patients who require large daily doses.

Obesity is a key driver for insulin resistance in patients with T2DM.

pproximately 90% of type 2 diabetes mellitus (T2DM) patients in the United States are overweight or obese and are insulin-resistant.1,2 The rising prevalence of both obesity and diabetes creates unique challenges in managing the increasing numbers of patients who require high doses of insulin. 3 Approximately 30% of patients with T2DM globally use more than 60 units (U) of basal insulin daily.1,2 Patients who require more than 200 U per day of insulin are considered severely insulin-resistant.1,4 These patients face difficulties administering their required amounts of daily insulin. If vials and syringes are used, they may have to inject themselves 5 to 10 times throughout the day to successfully administer their required doses.5,6 As for those patients using available insulin pens or pumps, proper dosing can be significantly restricted by the cartridge or reservoir size and/or the administration limits of the devices.2 Concentrated insulins allow for the delivery of smaller volumes that reduce the discomfort associated with high insulin volumes and can increase adherence among these patients.2 Case presentation

Bob is a 55-year-old obese man with a body mass index (BMI) of 35 kg/m 2 who presents to the endocrinology clinic for T2DM management. He has recently moved to the area from out of state. He is 6 feet tall and weighs 258 lb. He currently uses 100 U of U-100 glargine twice daily (bid) and 30 U of U-100 insulin lispro 3 times a day (tid). www.ClinicalAdvisor.com • THE CLINICAL ADVISOR • DECEMBER 2016 25

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CME

FEATURED COURSE

Bob is also taking 850 mg of metformin tid with meals. His hemoglobin A1C (HbA1c, or A1C) is 10.2%. Bob’s fasting plasma glucose (FPG) is 200 to 250 mg/dL and his postprandial plasma glucose (PPG) is 300 mg/dL. He regularly takes his medication and insulin, but he complains about the frequency of insulin injections. Addressing obesity

According to the Centers for Disease Control and Prevention (CDC), more than 33% of US adults are obese.7,8 Obesity is a key driver of insulin resistance1,3 and a primary risk factor for T2DM.9,10 For type 1 diabetes mellitus (T1DM), obesity may be an independent cause for insulin resistance.11 As insulin resistance increases, the secretion of insulin declines and patients require increased doses of insulin.1,11 Severe insulin resistance is associated with other conditions and syndromes, including insulin-receptor defects, insulinreceptor autoantibodies (ie, type B insulin-resistance syndrome), gestational diabetes with severe insulin resistance, lipodystrophy, Cushing syndrome, acromegaly, nonalcoholic fatty liver disease, hemochromatosis, genetic abnormalities, leptin deficiency, and requirements for high titers of immunoglobulin G (IgG) insulin-binding antibodies or high-dose glucocorticoid therapy.12-15 Nevertheless, obesity remains by far the most prominent driver of the need for high-dose insulin. Regardless of etiology, severely insulin-resistant patients represent a clinical challenge.1 According to the American Diabetes Association (ADA), modest weight loss—defined as a 5% reduction of initial body weight—improves glycemic control and triglyceride levels and reduces the need for glucose-lowering medication(s) for patients with diabetes who are obese. The ADA also recommends that a sustained weight loss of at least 7% is optimal for patients to see benefits in glycemic control and to lessen the need for antihyperglycemic therapies.16 It is recommended that clinicians document BMI at each patient visit as well as encourage proper diet, physical activity, and behavioral therapy in patients with the goal of achieving a decrease in weight of at least 5%.16 Insulin considerations

The increased prevalence of obesity in T2DM patients has led to the need for increased insulin requirements in a sizable percentage of these patients.1,6,11 Patients with severe insulin resistance associated with diabetes and obesity require 2 or more U of insulin per kilogram of body weight daily, or more than 200 U of insulin daily, to meet their insulin needs.1,6,17 With the increasing prevalence

of obesity in the United States, the frequency of severe insulin resistance and the use of concentrated insulins appear to be growing as well.18 Severe insulin resistance poses clinical challenges in patient management,13,19,20 some of which may undermine good glycemic control. As the dose of insulin increases, so does the volume that is injected subcutaneously (SC).11 For severely insulin-resistant patients, delivering the prescribed dosage of insulin often requires the injection of more than 100 U (per 1.0 mL) of a U-100 insulin formulation at a time.19 Increased volumes due to high dosage requirements result in unpredictable absorption as well as increased pain, discomfort, and leakage—which can all impact adherence.10 This variable absorption due to the large volumes also leads to suboptimal glycemic control.21,22 Patients with T2DM who are obese and have severe insulin resistance are good candidates for concentrated insulins.1,13 Additional candidates for concentrated insulins include other patients with T2DM who require high insulin doses, patients with genetic defects of insulin action, patients with gestational diabetes and severe insulin resistance, and patients with immune-mediated diabetes.13 Based on data from a post hoc meta-analysis of 5 trials examining patients with T2DM on basal insulin, more than 30% of those analyzed required a maintenance dose of basal insulin of 60 U per day or more.17 In a treat-to-target basal insulin trial involving insulin-naïve patients with T2DM, 21% of subjects required more than 80 U of basal insulin per day at the end of the trial.23 As of September 2016, there were 4 concentrated insulins available: human regular insulin U-500 (referred to as U-500 or U-500R), insulin glargine U-300, insulin degludec U-200, and insulin lispro U-200. Table 1 provides a list of the currently US Food and Drug Administration (FDA)approved concentrated insulins and summarizes some basic characteristics of each. Potential advantages to concentrated insulins include improved insulin absorption from a smaller injection volume, which may lead to improved glycemic control and more predictable insulin action; fewer and lower-volume injections, which may enhance patient comfort and enhance compliance; and potentially prolonged insulin action.12,24 Pharmacokinetic/pharmacodynamic (PK/PD) profiles of concentrated insulins

Human insulin U-500. U-500 has a similar onset but a longer duration of action as compared with U-100 insulin.4,11,13,25 U-500 peaks at around 30 minutes, and the

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glucose-lowering effect and insulin action are prolonged (~7 hours). The longer duration of action is attributed to the concentration.11 Bioequivalence was measured in a randomized, double-blind, crossover study that analyzed the PK/PD profiles of 50-U and 100-U bolus doses of U-500R vs U-100 in 24 healthy obese subjects.26 Although overall insulin exposure and overall effect were comparable between the U-500R and U-100 products at both doses, peak concentration and effect were lower and the duration of action following peak was greater with both doses of U-500R. Therefore, U-500R and U-100 formulations are not bioequivalent, meaning that the glucodynamic profiles of these 2 agents differ when used clinically. U-200 insulin degludec. U-200 degludec is bioequivalent to U-100 degludec. When comparing U-100 degludec and U-200 degludec, the mean degludec 24-hour concentration–time profiles, glucose infusion rate (GIR) at steady-state, total insulin area under the curve (AUC), and maximum drug concentration (Cmax) were found to be similar.11 Additionally, the glucose-lowering effects of both are evenly distributed over 24 hours after dosing.

Both U-200 and U-100 degludec peak at 9 hours and achieve steady-state after 48 to 72 hours of once-a-day dosing. U-200 degludec is detectable for at least 120 hours after the last dose.11 Noninferiority studies demonstrate that glycemic control with U-200 degludec and U-300 glargine is similar to U-100 glargine.11 U-300 insulin glargine. A study compared U-100 glargine (0.4 U/kg) with U-300 glargine (0.4 U/kg or 0.6 U/kg) for 8 days in a 2-sequence crossover study.27 U-300 glargine was detected at 32 hours after the injections compared with 28 hours after U-100 glargine dosing. The insulin exposure for U-300 was evenly distributed during the study interval. Additional studies, including studies using euglycemic clamps, have demonstrated that U-300 insulin glargine has a different PK/PD profile than U-100 insulin glargine.11 U-200 insulin lispro. U-200 insulin lispro is bioequivalent to U-100 insulin lispro, as demonstrated by a phase 1, openlabel, 2-sequence, 4-period crossover, randomized, 8-hour euglycemic clamp study. PK/PD profiles and intrasubject variability estimates were similar for both formulations, which were both well tolerated.28

TABLE 1. Characteristics of FDA-approved concentrated insulins Insulin

Unit formulation

Administration

Bioequivalence

MIXED BASAL/PRANDIAL U-500 human regular insulin

500 U/mL

1. Dedicated syringe, available by prescription only 2. Disposable pen containing 3 mL (1500 U); dose increments: 5-300 U 3. 20-mL vial Note: Patients may use a U-100 syringe and refer to a dosage-conversion chart or use a tuberculin syringe. However, the manufacturer plans to remove the dosage-conversion chart from the vial label 4. Off-label use in an insulin pump

U-300 insulin glargine

300 U/mL

Disposable pen containing 1.5 mL (450 U); dose increments: 1-80 U

U-200 insulin degludec

200 U/mL

Disposable pen containing 3 mL (600 U); dose increments: 2-160 U

Yes

200 U/mL

Disposable pen containing 3 mL (600 U); dose increments: 1-60 U

Yes

BASAL

PRANDIAL U-200 insulin lispro

FDA, US Food and Drug Administration. Sources: US Food and Drug Administration. FDA approves a dedicated syringe to be used with Humulin R U-500 insulin. http://www.fda.gov/Drugs/DrugSafety/ucm510318. htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Published July 8, 2016. Drugs at FDA. http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018780s135s152lbl.pdf. Drugs at FDA. http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206538s000lbl.pdf. Drugs at FDA. http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203314lbl.pdf. Drugs at FDA. http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020563s163lbl.pdf.

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Moreover, with the concentrated insulins, similar glycemic control is achieved and nocturnal hypoglycemia is reduced.11 The newer concentrated insulins also have the advantage of a lower risk of weight gain when compared with U-100 or U-500R.11 The PK/PD profiles and clinical advantages for the concentrated insulins are summarized in Table 2. Insulin delivery options

Patients with severe insulin resistance require high-dose and high-volume insulin, and concentrated insulin formulations are beneficial, for the most part, if the delivery device can administer more than 60 to 80 U of insulin (for current conventional pen devices), or more than 100 U (for vial/1-mL insulin syringe) in a single injection. Reducing the number of daily injections is associated with improved patient adherence,29,30 contributing to better glycemic control. A lower injection volume can also reduce injection-site discomfort. Of the currently available delivery devices, the only ones that offer higher singledose insulin injections as compared with conventional pens or syringes are the U-500 vial + syringe, the newly available U-500 pen, and the U-200 insulin degludec pen. The U-300 insulin glargine pen can deliver only up to 80 U, and the lower bioavailability of this product compared with its parent formulation requires an uptitration of the insulin dose. U-500 is available as a 20-mL vial containing 10,000 U of insulin, and there is now a dedicated U-500 insulin syringe that was recently approved by the FDA.31 This will allow patients who prefer to use a vial + syringe to do so without the need for dose conversion.32 For patients who may have problems using a syringe, U-500 is also available

as a pen prefilled with 3 mL of U-500, for a total of 1500 U.33 The prefilled pen contains a dial that allows for doses of 5 to 300 U in 5-unit increments, with the potential of reducing the chance for dosage errors. There is no dose conversion needed with the pen; therefore, the patient can simply “dial in” the dose needed. U-200 insulin degludec, U-200 insulin lispro, and U-300 insulin glargine do not need dose conversions because they are available only as disposable pens. Patients can simply dial in the units (dosage) required and inject themselves accordingly. There are no special needles or dose-conversion tables needed. Therefore, doses can be safely converted using a direct unit-to-unit conversion.11 Management of T2DM with concentrated insulins: Bob’s case presentation, continued

The endocrinologist recommends that Bob start a concentrated insulin regimen so he can reduce the number of his daily insulin injections. She prescribes U-200 insulin degludec at 150 U daily plus U-200 insulin lispro at 50 U tid to better balance basal and prandial insulin doses. Bob’s total daily dose (TDD) of insulin will be 300 U per day, and he will now take 4 daily injections. The endocrinologist also counsels Bob on the importance of exercise and diet. She recommends that he see a dietitian who can counsel him on an appropriate “diabetes diet.” She asks him to return in 4 weeks. Visit 2 (4 weeks after initial visit)

Bob reports that he is happy with his new insulin regimen. His blood glucose meter logs show average glucose levels of 140 mg/dL in the morning (fasting) and 120 mg/dL prior to dinner; his A1C is 8.6%. His body weight has decreased

TABLE 2. Select PK/PD parameters for insulins providing basal and mixed basal/prandial activity11 PK/PD parameter Duration of action

Half-life

Steady-state

HbA1c reduction from baseline

Weight gain

6 to 10 hours

4 hours

—

-1.6% (T2DM)

+4.9 kg

Degludec U-200

42 hours

25 hours

2 to 3 days

-1.3% (T2DM)a; -0.4% (T1DM)a

-0.11 kg (T2DM)b; +0.2 kg (T1DM)b

Glargine U-300

>30 hours

18 to 19 hours

5 days

-0.8% (T2DM)a; -0.4% (T1DM)a

+0.2 kg (T2DM)b; -0.6 kg (T1DM)c

U-500R

HbA1c, hemoglobin A1C; PD, pharmacodynamic; PK, pharmacokinetic; T1DM, type 1 diabetes mellitus; T2DM, type 2 diabetes mellitus. a Noninferior to insulin glargine U-100. bNonsignificant mean difference between comparator and insulin glargine U-100. cSignificant mean difference between comparator and insulin glargine U-100.

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and he now weighs 248 lb. After consulting with Bob about further improving his glucose control, the endocrinologist decides to prescribe a once-weekly GLP-1 RA, and she also reduces his insulin dosage by 20% to reduce the risk of Bob’s experiencing hypoglycemia. Using oral therapies in combination with concentrated insulins

According to the ADA’s 2016 guidelines, if metformin monotherapy is not able to achieve or maintain A1C target levels, a second oral (eg, sulfonylurea, thiazolidinedione, dipeptidyl peptidase 4 [DPP-4] inhibitor, SGLT-2 inhibitor) or injectable (eg, GLP-1 RA, basal insulin) agent should be added.16 Using a patient-centered approach, clinicians need to consider efficacy, cost, and side effects as well as weigh comorbidities, hypoglycemia risk, and patient preference when deciding upon treatment choices.16 Weight gain is a major concern for patients on insulin. The new pharmacologic therapies including GLP-1 RAs,34 DPP-4 inhibitors,35 and SGLT-2 inhibitors35,36 have been shown to be weight-neutral or to reduce the amount of weight gain in patients on insulin therapy. These agents also allow for the reduction of total insulin dosages.34,37-40

insulin may be unpredictable, making diabetes management particularly challenging in these patients. Because concentrated insulins can deliver doses high enough to achieve glycemic control, yet with smaller volumes, they are an effective solution for patients with severe insulin resistance who require more than 200 U of insulin daily. Regimens that include concentrated insulins can not only improve patient comfort, but also enhance patient adherence to therapy. However, the optimal use of concentrated insulins requires considerations of compliance, PK/PD, and delivery methods to prevent dosing errors, improve patient quality of life, and better serve the needs of the growing population of individuals with severe insulin resistance. ■ References 1. Lane WS, Cochran EK, Jackson JA, et al. High dose insulin therapy: is it time for u-500 insulin? Endocr Pract. 2009;15(1):71-79. 2. Segal AR, El Sayed N. Are you ready for more insulin concentrations? J Diabetes Sci Technol. 2015;9(2):331-338. 3. Jones P, Idris I. The use of U-500 regular insulin in the management of patients with obesity and insulin resistance. Diabetes Obes Metab. 2013;15(10):882-887. 4. Distiller LA. The use of highly concentrated U-500 regular insulin

Visit 3 (2 weeks after last visit)

for the severely insulin resistant patient with type 2 diabetes.

Bob returns in 2 weeks with complaints of nausea, and he is not comfortable with his current regimen. Both Bob and the endocrinologist decide to switch the GLP-1 RA to an SGLT-2 inhibitor because of his complaints of nausea. She asks him to come back for a follow-up visit in 3 months.

AACE Clin Case Rep. 2015;1(1):e79-e80. 5. Ali MK, Bullard KM, Saaddine JB, et al. Achievement of goals in U.S. diabetes care, 1999-2010. N Engl J Med. 2013;368(17):1613-1624. 6. Segal AR, Brunner JE, Burch FT, et al. Use of concentrated insulin human regular (U-500) for patients with diabetes. Am J Health Syst Pharm. 2010;67(18):1526-1535.

Visit 4 (3 months after last visit)

7. Ogden CL, Carroll MD, Kit BK, et al. Prevalence of childhood and adult

Bob returns after 3 months and reports that he is happy with his regimen and that the nausea resolved within a few days of his starting the adjusted regimen. His blood work shows an HbA1c of 6.6%. His endocrinologist discusses the importance of following his new regimen. Bob is advised to return in 3 months for routine laboratory testing to assess his progress in maintaining the improved results seen with his current treatment regimen.

obesity in the United States, 2011-2012. JAMA. 2014;311(8):806-814. 8. Centers for Disease Control and Prevention. Overweight & obesity: adult obesity facts. http://www.cdc.gov/obesity/data/adult.html. Updated September 1, 2016. Accessed September 20, 2016. 9. Chan JM, Rimm EB, Colditz GA, et al. Obesity, fat distribution, and weight gain as risk factors for clinical diabetes in men. Diabetes Care. 1994;17(9):961-969. 10. Colditz GA, Willett WC, Rotnitzky A, et al. Weight gain as a risk factor for clinical diabetes mellitus in women. Ann Intern Med.

Summary

1995;122(7):481-486.

Obesity is a key driver for insulin resistance in patients with T2DM. These patients are often severely insulinresistant and require high doses of insulin. They often complain of the inconvenience and discomfort of multiple insulin injections to meet the needs for glycemic control. Additionally, the absorption of high volumes of

11. Lamos EM, Younk LM, Davis SN. Concentrated insulins: the new basal insulins. Ther Clin Risk Manag. 2016;12:389-400. 12. Lane W. High dose insulin therapy: the case for CONCENTRATED insulin. Presented at: Twenty-First Annual Diabetes Fall Symposium for Primary Health Care Professionals; September 18, 2015; North Charleston, SC. http://clinicaldepartments.musc.edu/medicine/divisions/

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endocrinology/dsc/21st%20Symposium/Lane_High_Dose_Insulin_

27. Becker RH, Dahmen R, Bergmann K, et al. New insulin glargine

Therapy_2015.pdf.

300 units·mL−1 provides a more even activity profile and prolonged

13. Cochran E, Musso C, Gorden P. The use of U-500 in patients with

glycemic control at steady state compared with insulin glargine

extreme insulin resistance. Diabetes Care. 2005;28(5):1240-1244.

100 units·mL−1. Diabetes Care. 2015;38(4):637-643.

14. Garg R, Johnston V, McNally PG, et al. U-500 insulin: why, when and

28. de la Peña A, Seger M, Soon D, et al. Bioequivalence and comparative

how to use in clinical practice. Diabetes Metab Res Rev. 2007;23(4):265-268.

pharmacodynamics of insulin lispro 200 U/mL relative to insulin lispro

15. Cusi K. Nonalcoholic fatty liver disease in type 2 diabetes mellitus.

(Humalog ®) 100 U/mL. Clin Pharmacol Drug Dev. 2016;5(1):69-75.

Curr Opin Endocrinol Diabetes Obes. 2009;16(2):141-149.

29. Eby EL, Zagar AJ, Wang P, et al. Healthcare costs and adherence

16. American Diabetes Association. Standards of medical care in diabetes-2016

associated with human regular U-500 versus high-dose U-100 insulin

abridged for primary care providers. Clin Diabetes. 2016;34(1):3-21.

in patients with diabetes. Endocr Pract. 2014;20(7):663-670.

17. Rodbard HW, Gough S, Lane W, et al. Reduced risk of hypoglycemia with

30. Eby EL, Wang P, Curtis BH, et al. Cost, healthcare resource utilization,

insulin degludec versus insulin glargine in patients with type

and adherence of individuals with diabetes using U-500 or U-100 insulin:

2 diabetes requiring high doses of basal insulin: a meta-analysis

a retrospective database analysis. J Med Econ. 2013;16(4):529-538.

of 5 randomized begin trials. Endocr Pract. 2014;20(4):285-292.

31. US Food and Drug Administration. FDA approves a dedicated

18. Institute for Safe Medication Practices. Acute Care: ISMP Medication

syringe to be used with Humulin R U-500 insulin. http://www.fda.gov/

Safety Alert. As U-500 insulin safety concerns mount, it’s time to rethink safe

Drugs/DrugSafety/ucm510318.htm. Published July 8, 2016. Accessed

use of strengths above U-100. http://www.ismp.org/Newsletters/acutecare/

September 20, 2016

showarticle.asp?id=62. Published October 31, 2013. Accessed June 21, 2016.

32. Abraham K, Patail B, Wurth D. Usability testing of a U-500 insulin

19. Reutrakul S, Wroblewski K, Brown RL. Clinical use of U-500 regular

syringe: a human factors approach. Patient Saf Qual Healthc. September/

insulin: review and meta-analysis. J Diabetes Sci Technol. 2012;6(2):412-420.

October 2013:38-43. http://www.patientsafety.va.gov/docs/Usability_

20. Ballani P, Tran MT, Navar MD, et al. Clinical experience with U-500

Testing_of_a_U-500_Insulin_Syringe.pdf.

regular insulin in obese, markedly insulin-resistant type 2 diabetic patients.

33. Humulin U-500R [package insert]. Indianapolis, IN: Eli Lilly and

Diabetes Care. 2006;29(11):2504-2505.

Company; 2015.

21. Binder C, Lauritzen T, Faber O, Pramming S. Insulin pharmacokinetics.

34. Vanderheiden A, Harrison L, Warshauer J, et al. Effect of adding

Diabetes Care. 1984;7(2):188-199.

liraglutide vs placebo to a high-dose insulin regimen in patients with

22. Saryusz-Wolska M, Szymańska-Garbacz E, Pawłowski M, et al. Splitting

type 2 diabetes: a randomized clinical trial. JAMA Intern Med.

high dose of insulin and injecting it in two sites improves blood glucose

2016;176(7):939-947.

control. Presented at: 47th Annual Meeting of the European Association

35. Cefalu WT, Riddle MC. SGLT2 inhibitors: the latest “new kids on

for the Study of Diabetes (EASD); September 14, 2011; Lisbon, Portugal.

the block”! Diabetes Care. 2015;38(3):352-354. http://dx.doi.org/10.2337/

Abstract 109. http://www.abstractsonline.com/Plan/ViewAbstract.

dc14-3048.

aspx?sKey=08b28006-c219-493e-aaca-29c081981abe&cKey=b35687af-

36. Nauck MA. Update on developments with SGLT2 inhibitors in the

b7ba-4bba-8a08-118077612a5e&mKey=%7bBAFB2746-B0DD-4110-

management of type 2 diabetes. Drug Des Devel Ther. 2014;8:1335-1380.

8588-E385FAF957B7%7d.

37. Lane W, Weinrib S, Rappaport J, et al. The effect of addition of liraglutide

23. Gough SC, Bhargava A, Jain R, et al. Low-volume insulin degludec 200

to high-dose intensive insulin therapy: a randomized prospective trial.

units/mL once daily improves glycemic control similarly to insulin glargine

Diabetes Obes Metab. 2014;16(9):827-832.

with a low risk of hypoglycemia in insulin-naïve patients with type 2 diabetes:

38. Wilding JP, Woo V, Soler NG, et al. Long-term efficacy of dapagliflozin

a 26-week, randomized, controlled, multinational, treat-to-target trial: the

in patients with type 2 diabetes mellitus receiving high doses of insulin:

BEGIN LOW VOLUME trial. Diabetes Care. 2013;36(9):2536-2542.

a randomized trial. Ann Intern Med. 2012;156(6):405-415.

24. Sindelka G, Heinemann L, Berger M, et al. Effect of insulin concentration,

39. Rosenstock J, Jelaska A, Frappin G, et al. Improved glucose control

subcutaneous fat thickness and skin temperature on subcutaneous insulin

with weight loss, lower insulin doses, and no increased hypoglycemia with

absorption in healthy subjects. Diabetologia. 1994;37(4):377-380.

empagliflozin added to titrated multiple daily injections of insulin in obese

25. Manno N, Naliboff A. A managed care organization’s initiative to

inadequately controlled type 2 diabetes. Diabetes Care. 2014;37(7):1815-

improve patient safety in the use of concentrated insulin. J Manag Care

1823. http://dx.doi.org/10.2337/dc13-3055.

Pharm. 2011;17(1):70-71.

40. Rosenstock J, Jelaska A, Zeller C, et al. Impact of empagliflozin added

26. de la Pena A, Riddle M, Morrow LA, et al. Pharmacokinetics and

on to basal insulin in type 2 diabetes inadequately controlled on basal

pharmacodynamics of high-dose human regular U-500 insulin versus

insulin: a 78-week randomized, double-blind, placebo-controlled trial.

human regular U-100 insulin in healthy obese subjects. Diabetes Care.

Diabetes Obes Metab. 2015;17(10):936-948. http://onlinelibrary.wiley.com/

2011;34(12):2496-2501.

doi/10.1111/dom.12503/epdf.

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CME

POST-TEST Expiration date: December 31, 2017

Credit Designation: Haymarket Medical Education designates this enduring material for a maximum of 0.50 AMA PRA Category 1 CreditTM. Physicians should claim only the credit commensurate with the extent of their participation in the activity. A statement of credit will be issued only upon receipt of a completed pre-assessment test, polling questions, activity evaluation form, and post-test with a score of 70% or higher. All components must be completed and submitted online at ClinicalAdvisor.com/Dec16feature. CREDITS: 0.50 | A 55-year-old obese African American man with T2DM

1. When counseling a patient who is severely insulin-resistant, which of the following would not be used as a reason for changing his/her insulin regimen from U-100 to a more concentrated insulin formulation? a. Concentrated insulins that are available as disposable pens do not need dose conversions. b. Decreased injection volumes result in less predictable insulin absorption. c. Lower injection volumes may result in reduced injection-site discomfort. d. Nocturnal hypoglycemia has been shown in studies to be lower when using concentrated insulins. 2. Severe insulin resistance is associated with all of the following conditions except: a. Acromegaly b. Hemochromatosis c. Hypoandrogenism d. Nonalcoholic fatty liver disease 3. According to the American Diabetes Association (ADA), what percentage reduction of initial body weight is considered to improve glycemic control, triglyceride levels, and the need for antihyperglycemic medications in patients who are obese with type 2 diabetes mellitus (T2DM)? a. 3% c. 10% b. 5% d. 12%

4. Which of the following statements about the pharmacokinetics/pharmacodynamics (PK/PD) of available concentrated insulin formulations is true? a. Both insulin U-300 glargine and insulin U-100 glargine have been shown in studies to be detected after 40 hours of an initial once-daily injection dose. b. Both insulin U-200 degludec and insulin U-100 degludec peak at 9 hours after a once-daily dose. c. Insulin U-500 peaks at about 1 hour, with a glucose-lowering effect and an insulin action of approximately 4 hours. d. Intrasubject variability estimates for insulin U-100 lispro and insulin U-200 lispro are not similar. 5. Which concentrated insulins have been shown in studies to be bioequivalent to their U-100 parent formulations? a. Insulin U-200 lispro and insulin U-200 degludec b. Insulin U-200 lispro and insulin U-500 (also referred to as U-500R [regular]) c. Insulin U-300 glargine and insulin U-200 degludec d. Insulin U-500 and insulin U-300 glargine e. No concentrated insulin has been shown to be bioequivalent to its parent formulation.

TO TAKE THE POST-TEST please go to: ClinicalAdvisor.com/Dec16feature

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YOUR COMMENTS DIAGNOSING LYME DISEASE IN THE EARLY CLINICAL STAGES Most patients with Lyme borreliosis do not recall a tick bite. The saliva of ticks contains a local anesthetic that helps mask their presence while taking a blood meal, and the ticks are also often in the groin, armpit, or nape of the neck and therefore not noticed [“Derm Dx: Is this Lyme disease?” ClinicalAdvisor.com]. The negative blood test is irrelevant. When clinical symptoms of early Lyme disease present, only about one-third of patients have positive serology. With treatment, about another one-third seroconvert, even with successful antibiotic treatment. Another one-third never seroconvert, as the antibiotics eradicate the infection before measurable IgM or IgG levels are present. The lesson to be learned is that early Lyme disease is a clinical diagnosis. There is no indication for serology unless you are also drawing blood to check for coinfection with anaplasma or babesia. A negative Send us your letters with questions and comments to: Advisor Forum, The Clinical Advisor, 275 7th Avenue, 10th Floor, New York, NY 10001.You may contact us by e-mail at editor@clinicaladvisor.com. If you are writing in response to a published letter, please indicate so by including the number in parentheses at the end of each item. Letters are edited for length and clarity. The Clinical Advisor’s policy is to print the author’s name with the letter. No anonymous contributions will be accepted.

blood test does not rule out Lyme disease. By the same logic, there is no indication for repeat blood testing, and generally no blood testing is indicated for Lyme disease unless there are symptoms of late disease (eg, neurologic symptoms, arthritis, or cardiac conduction abnormalities).—VIJAY SIKAND, MD, New London, Conn. (218-1)

CLINICAL PEARLS MONITORING VITAL SIGNS AND EXERCISE Vital signs are essential to each healthcare visit because they aid in monitoring and detecting health problems. When you are taking a patient’s vital signs, it is a good time to ask about and document his or her exercise regimen and treat this information as a vital sign. Lack of exercise is a modifiable health risk, and clinicians can then easily identify lack of exercise as a health risk. Also, if patients know that they will be asked about exercise during each visit, this may increase their awareness about exercise as well as their accountability.— DEANA GOLDIN, DNP, ARNP, FNP-BC, Miami (218-2) EDUCATING PATIENTS ON THE PROPER USE OF CONTRACEPTION A number of years ago I worked for a busy OB/GYN practice. We had several unplanned pregancies, all due to patients’ misunderstanding of the proper use of their chosen method

OUR CONSULTANTS

Philip R. Cohen, MD,

is clinical associate professor of dermatology, University of Texas Medical Center, Houston.

Deborah L. Cross, MPH, CRNP, ANP-BC, is associate program

director, Gerontology NP Program, University of Pennsylvania School of Nursing, Philadelphia.

Abimbola Farinde, PhD, PharmD,

is a professor at Columbia Southern University in Orange Beach, Ala.

Laura A. Foster, CRNP, FNP,

Abby A. Jacobson, MS, PA-C,

practices family medicine with Palmetto Primary Care Physicians in Charleston, S.C.

is an assistant professor at Thomas Jefferson University and a dermatology PA at Family Dermatology of Reading, Pa.

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of contraception. One patient became pregnant while using a diaphragm that had developed a small hole, so she had “repaired” the hole with a Band-Aid. Another patient was taking oral contraceptives in a vertical fashion, rather than horizontally, which resulted in her taking a placebo pill every 4 days. Another patient became pregant using contraceptive OTC foam. (I take responsibility for that one.) I had a vaginal/uterine plastic model in front of the patient as I demonstrated to her how to fill the vaginal applicator and insert it into the vagina, and then I pushed the plunger (into my palm) to show her how the applicator worked. Later, she explained, “And I put the foam into my palm, just as the nurse showed me. I rubbed it in well, too.” And lastly, a patient became pregnant while “on the pill.” Our office had not prescribed the oral contraceptive to her, so when questioned further she revealed that she was not on an oral contraceptive at all. She thought a woman would not get pregant if she was taking any pill, so she was taking a daily aspirin! Funny stories, but not really. These are all examples of not taking the time to educate patients and making sure they understand before they leave the office.—RHONDA McKANNA, RN, Canadian, Texas (218-3)

CASE FILES PREMATURE THELARCHE IN A YOUNG GIRL Contributed by Sherril Sego, FNP-C, DNP (See photo at bottom of this page for more information about Dr Sego.) A mother brought in her 2-year-old daughter, noting a “lump” in her left nipple. She said the child was healthy, current on vaccinations, and appeared in no distress. On examination, the left nipple itself appeared normal. There

Debra August King, PhD, PA,

is senior physician assistant at New York-Presbyterian Hospital, New York City.

Mary Newberry, CNM, MSN,

provides well-woman gynecologic care as a midwife with Prima Medical Group, Greenbrae, Calif.

was no discharge or discoloration. However, palpation revealed a 2- to 3-cm mass in the retro-areolar area. It was mildly tender, smooth, and slightly mobile. The axillary nodes were not enlarged, and the opposite nipple and areola were normal. She was referred to the local children’s hospital for further evaluation. Ultrasound confirmed a diagnosis of premature thelarche. This condition is often confused with precocious puberty. However, in cases of children this young, it typically resolves over time without intervention. Further interventions such as biopsy are discouraged, as this can cause damage to the breast bud structure and lead to irregularities when the child begins normal breast development. The child’s breast enlargement was monitored by her pediatric specialist, and it slowly resolved within the next 4 to 6 months. (218-4)

PICKING CHERRIES LEADS TO A CASE OF PSEUDOHYPERGLYCEMIA A 76-year-old patient with type 1 diabetes received emergency attention after becoming comatose shortly after picking cherries. The first capillary blood glucose measurement collected from a finger showed a concentration higher than the reference limits (Derkenne et al. BMJ Case Reports. 2016). After symptomatic treatment was started, a second blood glucose measurement was taken at the earlobe. It revealed profound hypoglycemia (0.89 mmol/L), which prompted the administration of appropriate treatment. The elevated initial capillary blood glucose measurement was associated with the presence of fructose on the patient’s fingers from picking cherries. After receiving an IV administration of glucose, the patient regained normal consciousness and had no sequelae despite the severity of the hypoglycemia and delayed diagnosis. Pseudohyperglycemia is rare, and delayed diagnosis frequently results in severe sequelae or death. (218-5) n

Claire O’Connell, MPH, PA-C,

Katherine Pereira, DNP, FNP,

teaches in the PA Program at the New Jersey Medical School and Rutgers University, Piscataway, N.J.

is assistant professor, Duke University School of Nursing, Durham, N.C.

Sherril Sego, FNP-C, DNP,

is an independent consultant in Kansas City, Mo.

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Dermatology Clinic CASE #1

Rapidly extending lesions originating in the perianal area MELINDA LIU, BA, AND MAURA HOLCOMB, MD

A 60-year-old man presents with rapidly growing lesions on his face, trunk, axillae, flexural areas, and groin. The lesions appeared 3 months earlier in his perianal area and extended rapidly to other areas. Previously, he was treated with topical agents for atopic dermatitis and seborrheic dermatitis without improvement. Examination reveals disseminated violaceous papules and plaques on the face, trunk, axillae, and perianal area. Yellowish-red to skin-colored papules are present on the scalp. He has no palpable lymphadenopathy or organomegaly. What is your diagnosis? Turn to page 41.

CASE #2

Two well-defined 6-mm nodules on a teenager’s arm ESTHER STERN, NP

A 13-year-old girl presents with a cystic lesion that has been on her forearm for several years. It may have grown slightly larger in the past year and is intermittently painful. More recently, a second similar lesion has appeared in close proximity. Physical examination reveals two well-defined 6-mm nodules that are rubbery, slightly tender, and pink on the right proximal ventral forearm. The overlying skin is intact, and there is no associated adenopathy. What is your diagnosis? Turn to page 42. 34 THE CLINICAL ADVISOR • DECEMBER 2016 • www.ClinicalAdvisor.com

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Dermatology Clinic CASE #1

Cutaneous Langerhans cell histiocytosis

Langerhans cell histiocytosis (LCH) is a rare inflammatory neoplasia characterized by the accumulation of clonal CD207-positive myeloid dendritic cells.1,2 It presents most commonly in infants and young children, with an estimated incidence of two to nine cases per million per year, compared with the incidence rate in adults, which is one to two cases per million per year.1,2 In addition, LCH has a slight predominance in boys and men.1,2 LCH is differentiated into two major categories based on the extent of disease, according to the Reclassification Working Group of the Histiocyte Society: single system (SS-LCH), in which a single organ system is involved, and multisystem (MS-LCH), in which two or more organ systems are involved.2 The skin is the second most commonly involved organ in SS-LCH disease after bone.3 Although the pathogenesis is unclear, two main hypotheses exist.2 The first hypothesis is that LCH is an inflammatory reaction elicited by antigenic stimulation that causes a cytokine storm, and the second is that LCH is a neoplastic condition resulting from BRAF-V600E pathway overactivation.2 Skin lesions are a classic feature of LCH; however, cutaneous LCH lesions have a highly variable clinical appearance.1,2 Cutaneous LCH can present with yellowish-red to skincolored papules or a seborrheic dermatitis-like eruption, commonly affecting the scalp, trunk, flexural, intertriginous areas, glabrous skin, and external genitalia.4-6 It can also present with erosive intertriginous eruptions, mimicking deficiency dermatitis and xanthomatous eruptions.3 Cutaneous LCH can also present with pruritic papules and nodules, mimicking prurigo nodularis.6 It can also present with petechiae, pustules, and vesicles, although this is less common.4 The presence of petechiae in the setting of seborrheic dermatitis should raise suspicion for LCH.4 In addition, the extent of cutaneous involvement may predict response to treatment.4 For example, patients younger than 3 months who have few and isolated lesions and patients with necrotic lesions and hypopigmented macules are more likely to have self-limited disease.4 However, patients with more extensive involvement, especially involving intertriginous and perineal areas, are less likely to have disease resolution without chemotherapy.4

Cutaneous LCH is diagnosed through a combination of clinicohistopathologic features and immunohistochemical stains for the S100 and CD1a proteins.4 Histopathologic findings of the lesions should show diffuse infiltration of large tumor cells with grooved kidney bean nuclei and a moderate amount of eosinophilic cytoplasm in the dermis.6 Equivocal cases can be diagnosed via electron microscopy demonstrating Birbeck granules or through immunohistochemical stains for Langerin (CD207), a monoclonal antibody that is associated with Birbeck granules.4 The differential includes seborrheic dermatitis, prurigo nodularis, eczema, and nutritional deficiency dermatitis, which may be distinguished from cutaneous LCH via histology and immunohistochemistry. No standardized treatment protocols exist for isolated cutaneous LCH.7 In cases of MS-LCH, providers should follow LCH treatment protocols.2 In patients with isolated noduloulcerative or papulonecrotic cutaneous LCH Take-away points for cutaneous Langerhans cell histiocytosis Clinical presentation

• Extremely variable presentation with many mimics, including seborrheic dermatitis, prurigo nodularis, atopic dermatitis, and deficiency dermatitis • Most commonly involving scalp, trunk, flexural areas, intertriginous areas, glabrous skin, and external genitalia

Differential diagnosis

Seborrheic dermatitis, prurigo nodularis, atopic derma titis, deficiency dermatitis

Diagnosis

• Definitive diagnosis requires clinicohistopathologic examination, which reveals a diffuse infiltrate of large tumor cells with grooved kidney bean nuclei and a moderate amount of eosinophilic cytoplasm in the dermis • Stains for S100, CD1a, and CD207 on immuno histochemistry • Birbeck granules present on electron microscopy

Management

• No standardized treatment protocol exists for iso lated cutaneous Langerhans cell histiocytosis; cases of multisystem Langerhans cell histiocytosis should be treated according to existing protocols; all patients require lifelong follow-up • Isolated noduloulcerative or papulonecrotic lesions: watchful waiting • Eczematous lesions: topical medium- to high-potency corticosteroids are first-line treatments; second-line treatments include nitrogen mustard and tacrolimus • Widespread cutaneous disease: oral prednisone with vinblastine, methotrexate, or thalidomide • Extensive cutaneous disease resistant to oral therapies: phototherapy with psoralen and ultraviolet A light

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Dermatology Clinic lesions, providers should pursue watchful waiting because spontaneous healing may occur.2,7 For eczematous lesions, topical medium- to high-potency corticosteroids are the first-line treatment.2,7 Unfortunately, recurrence is common following treatment discontinuation.7 Other topical agents include nitrogen mustard and tacrolimus.2,7 In widespread cutaneous disease, systemic agents such as oral prednisone combined with vinblastine, methotrexate, and thalidomide are recommended.2,7 In extensive cutaneous disease that is resistant to oral therapies, phototherapy with psoralen and ultraviolet A light may be an effective option.2,7 All patients with cutaneous LCH require life-long follow-up because they may develop systemic involvement years after resolution of their skin lesions.4 In our case, because the patient was diagnosed with widespread cutaneous LCH, he was treated with a course of oral prednisone along with methotrexate. After this single course of therapy, the patient achieved nonactive disease, which continued through his 3-year follow-up visit. Melinda Liu, BA, is a medical student and Maura Holcomb, MD, is a dermatology resident at the Baylor College of Medicine in Houston. References 1. Simko SJ, Garmezy B, Abhyankar H, et al. Differentiating skin-limited and multisystem Langerhans cell histiocytosis. J Pediatr. 2014;165(5):990-996. 2. Morren MA, Vanden Broecke K, Vangeebergen L, et al. Diverse cutaneous presentations of Langerhans cell histiocytosis in children: a retrospective cohort study. Pediatr Blood Cancer. 2016;63(3):486-492. 3. Subramaniyan R, Ramachandran R, Rajangam G, Donaparthi N. Purely cutaneous Langerhans cell histiocytosis presenting as an ulcer on the chin in an elderly man successfully treated with thalidomide. Indian Dermatol Online J. 2015;6(6):407-409. 4. Ng SS, Koh MJ, Tay YK. Cutaneous Langerhans cell histiocytosis: study of Asian children shows good overall prognosis. Acta Paediatr. 2013;102(11):e514-e518. 5. Langerhans Cell Histiocytosis Treatment (PDQ®)–Patient Version. National Cancer Institute website. https://www.cancer.gov/types/langerhans/patient/langerhans-treatment-pdq Updated October 3, 2016. Accessed November 3, 2016. 6. Sun WG, Zhong LS, Chen H. A case of adult generalized cutaneous Langerhans cell histiocytosis. Ann Dermatol. 2016;28(2):262-264. 7. Dodd E, Hook K. Topical imiquimod for the treatment of childhood cutaneous Langerhans cell histiocytosis. Pediatr Dermatol. 2016;33(3):e184-e185. .

CASE #2

Spiradenoma

Spiradenoma, also known as eccrine spiradenoma, spiroma, and cystic epithelioma of the sweat gland, is an uncommon, yet mostly benign, skin tumor of eccrine sweat gland origin. The benign lesion of spiradenoma typically presents as a single deep, gray, pink, or blue dermal nodule, approximately 1 cm in size. The head, neck, and trunk are the most common sites of presentation; spiradenomas may also appear on the extremities, in which case they are typically on the ventral aspect.1 Although it usually appears as a solitary lesion, occasionally—as was the case with our patient—two or more lesions may appear. Multiple lesions may present in a linear, grouped, or Blaschkoid distribution. Although a spiradenoma can occur at any age, the most frequent population affected is young adults aged 15 to 35 years.2 Many patients describe a history of slow growth and intermittent pain associated with the lesion. Malignant transformation of spiradenoma is extremely rare,3 but when it occurs, it can be aggressive, with a high mortality rate. In addition, malignancy usually develops from a long-standing existing lesion.4 The cause of this eccrine sweat gland tumor is not well known, although it seems to be caused by a defective tumor suppressor gene. In rare cases, it can present in association with Brooke-Spiegler syndrome, an autosomal dominant condition involving the appearance of multiple skin tumors starting in early adulthood.5 Patients with Brooke-Spiegler syndrome also manifest with trichoepitheliomas and cylindromas, and they are at risk for salivary gland tumors. The differential diagnosis is vast and often varies based on area of involvement. Painful tumors to consider include neuroma, glomus tumor, leiomyoma, angiolipoma, neurilemmoma, and dermatofibroma.6 Other clinical entities that may mimic spiradenoma include pilar cyst, pseudolymphoma, and metastatic carcinoma. Skin biopsy, ideally a punch biopsy, is necessary for a correct diagnosis. Histologically, a spiradenoma appears as a well-circumscribed dermal nodule with sharply marginated lobules and a delicate fibrous capsule that is not connected to the epidermis. Nests of basophilic cells with small dark nuclei are observed, and sometimes large pale cells and

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duct-like differentiation are present in the center of the lesion. Often a lymphocytic infiltrate is present. The only known acceptable treatment for spiradenoma at this time is surgical excision of the lesion. Recurrence after complete excision is rare. If patients choose not to have the lesion excised, it must be closely observed to detect any signs of malignant transformation. In addition, patients with the diagnosis of spiradenoma should undergo a full skin check to evaluate for other skin tumors and to rule out the presence of Brooke-Spiegler syndrome. One study has described carbon dioxide laser for treatment of multiple lesions.7 In the rare scenario of malignancy, treatment consists of chemotherapy and radiation.

Patients who have been diagnosed with spiradenoma should undergo a full skin check to evaluate for other skin tumors. For the patient in our case, a punch biopsy specimen sent for histopathologic examination revealed the diagnosis of spiradenoma. The patient, with consent from her mother, chose to undergo excision of both lesions. In addition, she had a full skin examination that did not identify any other suspicious skin lesions. Excision of the lesion with adequate margins was performed without complications. n Esther Stern, NP, is a family nurse practitioner at Advanced Dermatology & Skin Surgery, P.C., in Lakewood, N.J. References

“Hey, I’m not asking for a ‘handout.’ A ‘stipend’ or ‘honorarium’ would be just fine.”

1. James WD, Berger TG, Elston DM. Andrews’ Diseases of the Skin: Clinical Dermatology. 11th ed. Philadelphia, PA: Saunders-Elsevier; 2011. 2. Sahin MT, Öztürkcan S, Bilaç C, Tan A. Dermoscopy of eccrine spiradenoma: a case report. J Am Acad Dermatol. 2015;72(5 suppl 1):AB88. 3. Chow W, Griffiths M. A malignant eccrine spiradenoma of the scalp. BMJ Case Rep. 2014. doi: 10.1136/bcr-2013-202524 4. Jesús Fernández-Aceñero M, Manzarbeitia F, José Mestre de Juan M, Requena L. Malignant spiradenoma: report of two cases and literature review. J Am Acad Dermatol. 2001;44(2):395-398. © Harley Schwadron 2016

5. Paller AS, Mancini AJ. Hurwitz Clinical Pediatric Dermatology. 4th ed. Philadelphia, PA: Saunders-Elsevier; 2011. 6. Naversen DN, Trask DM, Watson FH, Burket JM. Painful tumors of the skin: “LEND AN EGG.” J Am Acad Dermatol. 1993;28(2 Pt 2):298-300. 7. Martins C, Bártolo E. Brooke-Spiegler syndrome: treatment of cylindromas with CO2 laser. Dermatol Surg. 2000;26(9):877-880; discussion 881.

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Dermatologic Look-Alikes An ulceration on the knee EMILY GUO, BA, AND MAURA HOLCOMB, MD

CASE #1

CASE #2

A previously healthy 24-year-old man from Honduras presents with a 2-month history of a progressively growing skin lesion on his left knee. He arrived to the United States 1 month earlier and had previously received a 2-week course of unknown antibiotics in Honduras with no improvement. The lesion first appeared after he cut his knee while swimming in a river. It has grown slowly in size. On examination, he has a 7-cm × 6-cm irregularly shaped dark, crusted plaque with central depression and yellowing, and surrounding erythema on his left knee.

A 28-year-old woman presents with a draining wound on her right knee. The lesion was the result of a fall that took place 2 days earlier while she was jogging. She has otherwise been healthy. The wound and surrounding area are tender, and she has not applied any treatments to the area. She denies having any constitutional symptoms. On examination, she is afebrile and has a 5-cm × 2.5-cm ulceration with yellow purulent drainage and surrounding erythema on her right knee. There is no fluctuance.

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Dermatologic Look-Alikes CASE #1

Atypical mycobacteria infection

Atypical mycobacteria are mycobacterial species other than Mycobacterium tuberculosis and M leprae. Atypical mycobacterial organisms are ubiquitous in the environment and can be isolated from vegetation, soil, animals, birds, and (especially) water.1 Tap water is the main reservoir for most atypical mycobacterial pathogens that affect humans.2 No evidence of person-to-person spread has been reported with atypical mycobacteria.3 Nonmotile acid-fast bacilli (AFB) can be categorized into rapidly growing mycobacteria (RGM) and slowly growing mycobacteria, based on culture characteristics. Runyon4 classified groups based on pigment-forming properties when cultured. Recent technologic advances have also allowed the bacteria to be grouped according to genotypic characteristics.4,5 Clinical syndromes that occur due to atypical mycobacterial infections include pulmonary disease, superficial lymphadenitis, disseminated disease in the severely immunocompromised, and skin and soft tissue infections (SSTIs). Atypical mycobacterial SSTIs primarily occur after trauma, surgery, or cosmetic procedures as a consequence of direct inoculation by M marinum, M ulcerans, or RGM species, including M fortuitum, M chelonae, and M abscessus.6 Because the organisms are relatively low in virulence, they typically require a break in the skin barrier to cause infection. The prevalence is small, with an estimated rate of 0.9 cases per 100,0007; however, data exist that cutaneous mycobacterial infection may be more prevalent than previously recognized.6,8,9 Skin findings with these infections include abscesses, sporotrichoid nodules, cellulitis, or ulcers; however, morphology can be variable. Two distinctive well-defined species-specific clinical disorders exist: fish-tank granuloma and Buruli ulcer, caused by M marinum and M ulcerans, respectively.10 The majority of cutaneous atypical mycobacterial infections in Europe and the United States are M marinum and the RGM species,2,11 whereas the majority of cases of M ulcerans occur in West and Central Africa.12 Atypical mycobacterial SSTIs are frequently underdiagnosed. Infection by an atypical mycobacterial organism should be considered in all patients with SSTIs resistant to treatment with typical antibacterial medications, particularly

those with a history of recent trauma, surgery, or immunosuppression. In immunosuppressed individuals, the infection tends to be more disseminated and may not be associated with trauma.2 Frequently, coinfection with bacteria, including Staphylococcus species, can occur, delaying identification of the atypical mycobacterial infection.13 The differential diagnosis for atypical mycobacterial SSTI includes bacterial infection by S aureus or Streptococcus pyogenes, sporotrichosis, cryptococcosis, blastomycosis, coccidioidomycosis, and cutaneous leishmaniasis. Typically, skin biopsy with culture is required to establish an accurate diagnosis. Polymerase chain reaction (PCR) can also be used to screen for mycobacterium, with DNA sequencing to identify the exact subtype.9,14 Diagnosis is often delayed due to the lengthy time required for tissue culture. Frequently, acid-fast staining of lesion exudates and skin biopsy are unable to reveal the diagnosis due to small numbers of organisms.2,15 On histopathologic examination, suppurative granulomas are the most characteristic of cutaneous atypical mycobacterial infections, but other patterns have been described and may be more prevalent in immunosuppressed patients.15 The treatment of SSTIs by atypical mycobacterium species has not been well established. Treatment is often guided by recommendations for management of pulmonary infections.8,9 Tetracycline antibiotics, macrolides, quinolones, and antitubercular drugs are the most commonly used drugs, and surgery is a possible adjunct.2,10,16 Combination therapy is often given to minimize development of resistance.16 Susceptibility testing for isolates should be performed16; however, results may be delayed due to the prolonged time culture requires. Length of treatment is not well defined, but it is suggested that antimicrobial therapy be continued for 4 to 8 weeks after the resolution of lesions.2,16 In 10% to 20% of cases, depending on the causative organism, the infection may be self-limiting and resolve over an average period of 8 months.17 For the patient in our case, two 4-mm punch biopsies were performed for hematoxylin and eosin staining and AFB smear and culture, and deep fungal and bacterial cultures. The biopsies showed a suppurative granulomatous dermatitis with neutrophils, lymphocytes, plasma cells, and histiocytes in the dermis. Results of gram, AFB, periodic acid-Schiff, and Giemsa stains were negative for microorganisms. Tissue bacterial cultures showed skin flora. PCR was performed and revealed M marinum. Clarithromycin and rifampin was initiated. At a follow-up visit 6 months later, the lesion had resolved.

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CASE #2

Methicillin-resistant Staphylococcus aureus infection

Methicillin-resistant Staph yl oc occus aureus (M RSA) infections are common and represent a major cause of nosocomial and communit y-acquired infections. Healthcare-associated MRSA (HA-MRSA) infections are defined as MRSA infections that occur at least 48 hours following hospitalization, in the presence of an invasive device such as a vascular catheter at time of admission, or that occur with exposure to healthcare risks such as surgery, hospitalization, dialysis or residence in a long-term care facility within 12 months of exposure to healthcare.18

HA-MRSA is typically associated with severe invasive diseases including bloodstream infections, pneumonia, and skin and soft tissue infections (SSTIs).18 Communityacquired MRSA (CA-MRSA) often causes SSTIs in otherwise healthy individuals, particularly in children and young adults.19 In surveillance of CA-MRSA, 77% were categorized as SSTIs, most commonly as abscesses (59%) or cellulitis (42%).20 Over the years, CA-MRSA has been increasing in incidence.21 Transmission of CA-MRSA resulting in skin infection has been reported to occur due to trauma resulting in disruption of skin integrity, including lacerations and microabrasion from shaving and from direct contact in person-to-person spread.22,23 Populations at risk include illicit drug users, prisoners, military trainees, athletes, and children.22-26 Individuals

Atypical mycobacteria versus MRSA skin infections Atypical mycobacteria

MRSA

Dermatologic presentation

• Abscesses, sporotrichoid nodules, cellulitis, or ulcers • Morphology can be variable.

Most commonly presents as abscesses or cellulitis

Epidemiology

• Prevalence is low, with an estimated rate of 0.9 cases per 100,000. • Cutaneous mycobacterial infection may be more prevalent than previously recognized.

• Healthcare-associated MRSA occurs at least 48-hours following hospitalization, in the presence of an invasive device, or with exposure to healthcare risks • Community-acquired MRSA often causes skin and soft tissue infections in otherwise healthy individuals, particularly children and young adults • At-risk populations include illicit drug users, prisoners, military trainees, athletes, and children

Etiology

• Ubiquitous in the environment • Tap water is the main reservoir for most atypical mycobacterial pathogens among humans.

Individuals colonized with MRSA, commonly in the nares, can serve as a reservoir for transmission

Characteristic location

Occurs in areas of trauma, surgery, or cosmetic procedures

Occurs due to trauma resulting in disruption of skin integrity, including lacerations and microabrasion from shaving

Diagnosis

• Skin biopsy with culture • Diagnosis often delayed • Acid-fast staining and skin biopsy often unable to reveal diagnosis due to small number of organisms • PCR can be used • Histology shows suppurative granulomas

• History and risk factors can lead to high clinical suspicion for MRSA infection • Purulent material can be obtained for gram stain, culture, and susceptibility testing to confirm diagnosis

Treatment

• Treatment is often guided by recommendations for management of pulmonary infections. • Combination therapy to minimize resistance • Tetracycline, macrolides, quinolones, and antitubercular drugs are most commonly used. • Surgery is a possible adjunctive therapy.

• Susceptibility of MRSA can vary depending on location. • Important to keep in mind local antibiotic susceptibility patterns and susceptibility testing • Minor infections: mupirocin • Abscesses: surgical drainage and antibiotics

MRSA, Methicillin-resistant Staphylococcus aureus; PCR, polymerase chain reaction

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Dermatologic Look-Alikes colonized with MRSA, commonly in the nares, can serve as a reservoir for transmission and are also at increased risk for subsequent MRSA infection.27 Purulent material can be obtained from the lesion for gram stain, culture, and susceptibility testing, which is useful in guiding therapy.19 By definition, MRSA organisms are not susceptible to β-lactam antibiotics. Susceptibility of MRSA skin infections to antibiotics can vary depending on location, emphasizing the importance of local antibiotic susceptibility patterns and susceptibility testing. The differential diagnosis for MRSA skin infections depends on the type of skin infection. The differential for a MRSA cellulitis includes abscess, contact dermatitis, arthropod-reactive dermatitis, panniculitis, and necrotizing fasciitis.

and susceptibility testing, which came back confirming the diagnosis of MRSA. After completion of 5 days of clindamycin therapy, the patient’s wound resolved. n Emily Guo, BA, is a medical student and Maura Holcomb, MD, is a dermatology resident at the Baylor College of Medicine in Houston. References 1. van Ingen J, Blaak H, de Beer J, et al. Rapidly growing nontuberculous mycobacteria cultured from home tap and shower water. Appl Environ Microbiol. 2010;76(17):6017-6019. 2. Lamb RC, Dawn G. Cutaneous nontuberculous mycobacterial infections. Int J Dermatol. 2014;53(10):1197-1204. 3. Falkinham JO. The changing pattern of nontuberculous mycobacterial disease. Can J Infect Dis. 2003;14(5):281-286. 4. Runyon EH. Anonymous mycobacteria in pulmonary disease. Med Clin

For very minor skin infections, mupirocin can be used topically. For abscesses, surgical drainage is recommended.

North Am. 1959;43(1):273-290. 5. Brown-Elliott BA, Wallace RJ Jr. Clinical and taxonomic status of pathogenic nonpigmented or late-pigmenting rapidly growing mycobacteria. Clin Microbiol Rev. 2002;15(4):716-746. 6. Phillips MS, von Reyn CF. Nosocomial infections due to nontuberculous mycobacteria. Clin Infect Dis. 2001;33(8):1363-1374. 7. Cassidy PM, Hedberg K, Saulson A, et al. Nontuberculous mycobacterial

The differential for a MRSA abscess includes folliculitis, hidradenitis suppurativa, atypical mycobacterial infection, leishmaniasis, myiasis, and sporotrichosis. The differential for a MRSA folliculitis includes gram-negative folliculitis from Pseudomonas aeruginosa, acne vulgaris, keratosis pilaris, Grover disease, hidradenitis suppurativa, and scabies. In terms of bacterial etiology, methicillin-susceptible S aureus and Group A β-hemolytic streptococcus are also common bacteria that manifest in the same types of skin infections as MRSA. For very minor skin infections, mupirocin can be used topically.28 For abscesses, surgical drainage is recommended, with addition of antibiotics for severe or extensive disease, systemic illness, comorbidities or immunosuppression, extremes of age, and difficult to drain areas.20,28 Empiric coverage for outpatient CA-MRSA includes clindamycin, trimethoprim-sulfamethoxazole, tetracycline antibiotics, and linezolid.28 Patients with complicated SSTI may require intravenous antibiotics, such as vancomycin, linezolid, daptomycin, or clindamycin.28 For the patient in our case, oral clindamycin was initiated empirically for presumed MRSA cellulitis. A swab of the purulent drainage was sent for gram stain, culture,

disease prevalence and risk factors: a changing epidemiology. Clin Infect Dis. 2009;49(12):e124-e129. 8. Brown-Elliott BA, Griffith DE, Wallace RJ Jr. Newly described or emerging human species of nontuberculous mycobacteria. Infect Dis Clin North Am. 2002;16(1):187-220. 9. Griffith DE, Aksamit T, Brown-Elliott BA, et al. An official ATS/IDSA statement: diagnosis, treatment, and prevention of nontuberculous mycobacterial diseases. Am J Respir Crit Care Med. 2007;175(4):367-416. 10. Gonzalez-Santiago TM, Drage LA. Nontuberculous mycobacteria: skin and soft tissue infections. Dermatol Clin. 2015;33(3):563-577. 11. Wagner D, Young LS. Nontuberculous mycobacterial infections: a clinical review. Infection. 2004;32(5):257-270. 12. Buruli ulcer (Mycobacterium ulcerans infection). World Health Organization website. http://www.who.int/mediacentre/factsheets/fs199/ en/ Updated February 2016. Accessed November 1, 2016. 13. Spicer T, Beer K. Cutaneous nontuberculous mycobacterial infections in the outpatient setting: presentation of a case, review of the literature, and therapeutic considerations. J Drugs Dermatol. 2014;13(12):1495-1497. 14. Ngan GJ, Ng LM, Jureen R, et al. Development of multiplex PCR assays based on the 16S-23S rRNA internal transcribed spacer for the detection of clinically relevant nontuberculous mycobacteria. Lett Appl Microbiol. 2011;52(5):546-554.

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15. Bartralot R, Pujol RM, García-Patos V, et al. Cutaneous infections due to nontuberculous mycobacteria: histopathological review of 28 cases. Comparative study between lesions observed in immunosuppressed patients and normal hosts. J Cutan Pathol. 2000;27(3):124-129. 16. Jogi R, Tyring SK. Therapy of nontuberculous mycobacterial infections. Dermatol Ther. 2004;17(6):491-498. 17. Woods GL, Washington JA 2nd. Mycobacteria other than mycobacterium tuberculosis: review of microbiologic and clinical aspects. Rev Infect Dis. 1987;9(2):275-294. 18. Klevens RM, Morrison MA, Nadle J, et al; Active Bacterial Core surveillance (ABCs) MRSA Investigators. Invasive methicillin-resistant Staphylococcus aureus infections in the United States. JAMA. 2007;298(15):1763-1771. 19. Daum RS. Skin and soft tissue infections caused by methicillin-resistant Staphylococcus aureus. N Engl J Med. 2007;357(4):380-390. 20. Fridkin SK, Hageman JC, Morrison M, et al; Active Bacterial Core

“It’s mostly sweater weight.”

Surveillance Program of the Emerging Infections Program Network. Methicillin-resistant Staphylococcus aureus disease in three communities. N Engl J Med. 2005;352(14):1436-1444. 21. Hersh AL, Chambers HF, Maselli JH, Gonzales R. National trends in ambulatory visits and antibiotic prescribing for skin and soft-tissue infections. Arch Intern Med. 2008;168(14):1585-1591. 22. Begier EM, Frenette K, Barrett NL, et al; Connecticut Bioterrorism Field Epidemiology Response Team. A high-morbidity outbreak of methicillin-resistant Staphylococcus aureus among players on a college football team, facilitated by cosmetic body shaving and turf burns. Clin Infect Dis. 2004;39(10):1446-1453. 23. Campbell KM, Vaughn AF, Russell KL, et al. Risk factors for communityassociated methicillin-resistant Staphylococcus aureus infections in an outbreak of disease among military trainees in San Diego, California, in 2002. J Clin Microbiol. 2004;42(9):4050-4053. 24. Gilbert M, MacDonald J, Gregson D, et al. Outbreak in Alberta of

“I can’t wait until I’m old enough to dress myself.”

in people with a history of drug use, homelessness, or incarceration. CMAJ. 2006;175(2):149-154. 25. Herold BC, Immergluck LC, Maranan MC, et al. Community-acquired methicillin-resistant Staphylococcus aureus in children with no identified predisposing risk. JAMA. 1998;279(8):593-598. 26. Lowy FD, Aiello AE, Bhat M, et al. Staphylococcus aureus colonization and infection in New York State prisons. J Infect Dis. 2007;196(6):911-918. 27. Davis KA, Stewart JJ, Crouch HK, et al. Methicillin-resistant Staphylococcus aureus (MRSA) nares colonization at hospital admission and its effect on subsequent MRSA infection. Clin Infect Dis. 2004;39(6):776-782. 28. Liu C, Bayer A, Cosgrove SE, et al. Clinical practice guidelines by the Infectious Diseases Society of America for the treatment of methicillinresistant Staphylococcus aureus infections in adults and children. Clin Infect Dis. 2011;52(3):285-292.

“I’m going to need to make multiple stops.”

community-acquired (USA300) methicillin-resistant Staphylococcus aureus

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Writers’ Guidelines The Clinical Advisor welcomes submissions from its readers. Writing for us is an opportunity to share your knowledge and experience with your colleagues — and to collect a fee in the bargain! We pay an honorarium for every submission we accept. We’ll be glad to work with you to develop your ideas into compelling articles. As for length, that depends on which kind of article you submit. CLINICAL FEATURES update our readers on the latest information about conditions seen in everyday practice. Running approximately 2,500 to 5,000 words, including the references, features can be written either as regular narratives or as a series of questions and answers. Topics should be selected with the busy primary-care clinician in mind; specialists should review specialty topics from the primary-care point of view. If at all possible, articles should be accompanied by clinical photos. Charts, tables, and algorithms are also encouraged. Please include your title and affiliation. CLINICAL CHALLENGE is our popular department comprising histories of difficult cases. Each case is presented as a step-by-step, chronological account, revealing the author’s thought processes along the way. It is divided into sections in this order: the patient presentation; the patient history; the twists and turns eventually leading to a diagnosis; the treatment and outcome; and a discussion of the lessons learned or of the condition in general. The length should be about 1,500 words, and accompanying images are encouraged. Please include your title and affiliation. DERMATOLOGY CLINIC is a department that presents photos of actual cases and asks readers to identify the condition. Each case opens with one or two color photos and a 75-to-100-word description of the patient presentation, without giving away the diagnosis. This is followed by a 750-to-1,000-word summary that includes a fuller description of the ailment, an explanation of how the correct diagnosis was reached, a general review of the condition along with a differential diagnosis, and a description of the patient’s treatment and outcome. Topics must be approved by the editor prior to submission. Please include your title and affiliation. COMMENTARY is our guest editorial page. It gives you the opportunity to sound off on an issue of importance to your colleagues nationwide. A typical Commentary runs about 600 words in length. Please include your title and affiliation. To discuss your editorial ideas, contact us by phone at 646.638.6078; by e-mail to editor@ClinicalAdvisor.com; or by mail to The Clinical Advisor, 275 7th Avenue, 10th Floor, New York, NY 10001. 56 THE CLINICAL ADVISOR • DECEMBER 2016 • www.ClinicalAdvisor.com

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LEAD YOUR PATIENTS To Safer Opioid Therapy

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Accreditation Boston University School of Medicine is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. Boston University School of Medicine designates this activity for a maximum of 2 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Continuing Nursing Education Provider Unit, Boston University School of Medicine is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation. CNE Contact Hours: 2, all of which is pharmacology credit worthy. Disclosure This educational activity is supported by an independent educational grant from the ER/LA Opioid Analgesic REMS Program Companies. Please see http://ce.er-la-opioidrems.com/IwgCEUI/ rems/pdf/List_of_RPC_Companies. pdf for a listing of the member companies. This activity is intended to be fully compliant with the ER/ LA Opioid Analgesic REMS education requirements issued by the US Food & Drug Administration.

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LEGAL ADVISOR CASE

Chest pain in a woman

A woman has a myocardial infarction after her chest symptoms are misdiagnosed as acid reflux.

ANN W. LATNER, JD

Mr N, aged 38 years, was a nurse practitioner working in a small primary care medical practice with a physician, Dr F. Mr N had been working with Dr F, aged 60 years, for the past year and enjoyed the challenges of working in a busy office. Dr F took her supervisory role seriously and would take a half hour at the end of every day to go over Mr N’s charts with him and discuss any issues that had occurred during the day. One morning, one of the practice’s patients, Mrs G, aged 47 years, came in to see Mr N. “I’ve been getting heartburn a lot lately,” the patient said. “I get a burning feeling in my chest after I eat. It happened yesterday after lunch as well. And it’s just been more than usual over the last few weeks.” The patient was obese and admitted to smoking and drinking alcohol socially. Mr N suspected that poor food choices might be part of her problem but did not say so. A review of Mrs G’s medical record showed elevated blood pressure during the past six months and an elevated cholesterol level of 237 mg/dL.

The patient’s ECG indicating a left bundle branch block should have triggered further testing or referral to a cardiologist.

A heart examination revealed a normal rate and rhythm. Mr N noted in the patient’s chart that the patient was sweating heavily but was not in acute distress and that she was pain-free during the examination. An electrocardiogram (ECG) revealed a left bundle branch block, but prior ECGs were not available for comparison. Mr N questioned the patient about whether there was any history of coronary artery disease in her family, and she answered that she was unaware of any. He also asked Mrs G what she had eaten that day, before the burning sensation began. She replied that she had eaten a hamburger and French fries from a fast-food restaurant. Suspecting acid reflux, Mr N advised the patient to take an antacid and try to make better food choices. He told her to return to the office if the symptoms continued. Continues on page 60

Cases presented are based on actual occurrences. Names of participants and details have been changed. Cases are informational only; no specific legal advice is intended. Persons pictured are not the actual individuals mentioned in the article.

58 THE CLINICAL ADVISOR • DECEMBER 2016 • www.ClinicalAdvisor.com

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LEGAL ADVISOR At the end of the day, Mr N and Dr F went over Mrs G’s file together. The physician was familiar with the patient, and, like Mr N, also suspected that poor food choices, obesity, and alcohol use could be contributing to her discomfort. Dr F suggested to Mr N that next time he saw the patient he should counsel her on not eating large meals late at night, not lying down immediately after eating, and other techniques to help manage her heartburn. The doctor also suggested doing a follow-up ECG at the next check-up. Two days later, Mrs G called the doctor’s office after lunch, complaining that the burning sensation in her chest was continuing. Both Dr F and Mr N were completely booked that afternoon, but Mr N called the patient on the phone, advised her to continue taking the antacid, and scheduled an office appointment for the next day. He advised the patient to go to the emergency department of the hospital if she developed chest pain. Late that night, Mrs G woke up with chest pain, nausea, and vomiting. Her husband called 911, and she was transported to the hospital for an emergency coronary angiography. Unfortunately, the patient died shortly after arrival at the hospital.

Heart disease is the leading cause of death among women in the United States, responsible for 1 in 4 deaths. Mr N was deeply upset when he heard the news about Mrs G. He felt guilty for not squeezing her in for an appointment the afternoon that she had called. He felt guilty for not advising her to go straight to the emergency department, but he really had thought it was a gastrointestinal issue. He felt even worse when he was notified that the practice was being sued by the patient’s husband for her wrongful death. Mr N had never been involved in a lawsuit before and was extremely anxious about the proceedings, particularly his own deposition. Speaking to the lawyer assigned by the practice’s insurance company did not reassure him. Instead, he became even more frightened as he was told that what he said at the deposition would be used by the plaintiff to try to impeach his testimony at trial. Fortunately for Mr N, the case settled early in the discovery phase, prior to the taking of depositions. Both sides realized that settling was the better option.

Legal background

In preparation for trial, both sides engage in the process called “discovery,” the formal process of exchanging information between the parties about the witnesses and information they plan to present at trial. The purpose of discovery is to allow the parties to learn what evidence may be presented at a trial and to avoid last-minute surprise evidence or witnesses when there would be no time for the other party to obtain contradictory evidence. Discovery may include subpoenaing documents, requesting physical exams, and depositions. Depositions are oral statements, given out of court but under oath, by a person who is involved in the case. Depositions enable a party to preview what witnesses will say at trial, and they provide that party a chance to impeach the witnesses’ credibility if they say something different at trial than what they had said during the deposition. Protecting yourself

According to the Centers for Disease Control and Prevention (CDC), heart disease is the leading cause of death for women in the United States, responsible for about 1 in 4 deaths. Statistics indicate that almost two-thirds of women who die suddenly from coronary heart disease have no previous symptoms. Even when women do have symptoms, they often present differently than men do, and the symptoms are more likely to mimic common problems such as indigestion or anxiety, making heart disease sometimes tricky to diagnose. Because heart disease in women can mimic other issues (such as heartburn), it is important to rule out myocardial infarction before making a gastrointestinal-related diagnosis. Always consider cardiac risk factors such as family history, obesity, smoking, hypertension, and hyperlipidemia. In this particular case, the patient’s ECG indicating a left bundle branch block should have triggered further testing or referral to a cardiologist in light of her other symptoms. The patient’s diaphoresis might also have been a clue. To further reduce the risks of misdiagnosing heart disease, consider developing a written chest pain protocol, and if possible, offer patients same-day appointments when they complain of continued symptoms for which they were recently seen. If this is not possible, send the patient directly to the emergency department and note this in the patient’s medical record. n Ms Latner, a former criminal defense attorney, is a freelance medical writer in Port Washington, NY.

60 THE CLINICAL ADVISOR • DECEMBER 2016 • www.ClinicalAdvisor.com

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ALTERNATIVE MEDS UPDATE

What you should know about the herbs and supplements patients use By Sherril Sego, FNP-C, DNP Ms. Sego is an independent consultant in Kansas City, Mo.

Cloves

When we think of this fragrant spice, we usually see it as studded artfully in a beautifully baked ham or flavoring a delicious cup of spiced tea. While food products comprise the largest and most well-known uses of cloves, its use in folk medicine is older and more established. The small, dark brown, odd-shaped spice that we know is the dried flower bud of the clove tree, or Syzygium aromaticum. In contrast to the tiny half-inch structure of its dried flower bud, the clove tree grows as tall as 12 meters with large leaves and reddish flowers.1 The trees can live to be 100 years old.

Background For medicinal purposes, cloves are used in either whole or expressed oil forms. Harvested mostly in Indonesia, cloves are a huge cash crop industry for the country, accounting for nearly one quarter of a billion dollars annually in exports.2 Cloves have been prized for their properties for centuries, with the spice being found in vessels of the Roman Empire dating back to over 1,700 BC. When Magellan’s ships returned from their circumnavigation of the world, one of the ships was carrying a cargo of cloves. At that time, cloves were more valuable than gold due to their lack of availability and wide range of use.

Science The main compound found in cloves that is believed to be responsible for most of its medicinal action is the essential oil eugenol.2 Eugenol is a phenolic compound and a potent anti-inflammatory, as well as antimicrobial agent. Clove oil

is categorized as ‘Generally Recognized to be Safe’ in oral doses up to 2.5 mg/kg in humans.3 Probably the most exciting use of clove oil is as an antimicrobial. This action has been studied extensively as it applies to oral health. Growing attention is being paid to the role of oral health in overall health and well-being. In the United States alone, tooth decay remains the most common chronic disease of school-aged children and up to 90% of adults.4 With the high cost of professional dental care, self-care agents are increasingly attractive. The main bacterium causing gingivitis and tooth decay is Streptococcus mutans.5 In an in-vitro study of various essential oils including clove against erythromycin as a positive control, clove oil inhibited the growth of S mutans as well as the adherence of the bacteria to the gingival and tooth surfaces.5 Researchers have found that the main mechanism of action of clove oil is cell membrane damage, which results in cell death and lack of proliferation.6 With the known inhibitory action on S mutans, clove oil has also been studied for its

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ALTERNATIVE MEDS UPDATE antibacterial effect on other enteropathogens. In another in-vitro study comparing clove extract’s action with chloramphenicol and ampicillin against four common enteropathogens, clove oil was up to 70% as effective at preventing growth of these pathogens as the positive control ampicillin.6,7 Another more traditional use of clove oil is for pain relief. Holding a clove seed in the mouth next to an aching tooth is an age-old home remedy. The mechanism of action for pain relief appears to be linked to the activation of calcium and chloride channels in ganglion cells.8 Additional research indicates inhibition of prostaglandin synthesis, cyclooxygenase, and lipoxygenase, which are all known to increase pain perception.9 Other very early in-vitro studies indicate promising anti-mutagenic action of clove oil. In a laboratory animal study examining clove oil’s effect on melanoma growth, treatment showed a very significant retardation of tumor growth, as well as an almost 40% reduction in actual tumor size.10

How supplied, dose, cost Cloves may be purchased in a wide variety of forms. The intended use typically drives the form chosen. The whole spice and the essential oil are the most common forms and can be found in grocery or health food stores. The cost is minimal, at usually $5 or less. As a topical treatment for pain, especially in the oral cavity, one to five drops of essential oil on a small piece of gauze or cotton as needed is usually sufficient.9

Summary There appears to be no downside to the use of clove oil or spice. In underserved healthcare areas, addition of daily oral rinses with clove oil mouthwash may improve dental health and help prevent the known health problems associated with gum disease and dental caries. Future studies examining the potential in fighting certain malignant conditions are ongoing. Recommending the use of cloves for patients should be considered safe and helpful when added to current health regimens. n Clove oil can be used as a topical treatment for pain in the oral cavity.

The mechanism of action for pain relief may be linked to the activation of calcium and chloride channels in ganglion cells.

Safety, interactions, side effects

References 1. Clove characteristics. Botanical-online website. http://www. botanical-online.com/english/clove.htm. Accessed November 14, 2016. 2. Agrawal M, Agrawal S, Rastogi R, Singh P, Adyanthaya BR, Gupta HL. A review on uses of clove in oral and general health. Indian Journal of Research in Pharmacy and Biotechnology. 2014;2(4):1321-1324. 3. Gülçin I, Elmastas M, Aboul-Enein HY. Antioxidant activity of clove oil—a powerful antioxidant source. Arab J Chem. 2012;5(4):489-499. 4. Hygiene-related diseases: dental caries (tooth decay). Centers for Disease Control and Prevention website. http:// www.cdc.gov/healthywater/hygiene/disease/dental_caries. html. Updated September 22, 2016. Accessed November 14, 2016. 5. Chaiya A, Saraya S, Chuakul W, Temsiririrkkul R. Screening for dental caries: Preventive activities of medicinal plants against Streptococcus mutans. Mahidol University Journal of Pharmaceutical Sciences. 2013;40(1):9-17. 6. Dua A, Garg G, Nagar S, Mahajan R. Methanol extract of clove (Syzygium aromaticum Linn.) damages cells and inhibits growth of enteropathogens. J Innov Biol. 2014;1(4):200-205. 7. Shah A, Jani M, Shah H, Chaudhary N, Shah A. Antimicrobial effect of clove oil (Luang) extract on Enterococcus faecalis. Journal of Advanced Oral Research. 2014;5(3):36-38. 8. Li HY, Lee BK, Kim JS, Jung SJ, Oh SB. Eugenol inhibits ATP—induced P2X currents in trigeminal ganglion neurons. Korean J Physiol Pharmacol. 2008;12(6):315-321. 9. Skidmore-Roth L. Mosby’s Handbook of Herbs & Natural Supplements. 3rd ed. St. Louis: Elsevier Health Sciences; 2005. 10. Ghosh R, Nadiminty N, Fitzpatrick JE, Alworth WL, Slaga TJ, Kumar AP. Eugenol causes melanoma growth suppression through inhibition of E2F1 transcriptional activity. J Biol Chem. 2005;280(7):5812-5819.

As with any essential oil, there may be allergic reactions. Careful skin patch testing should be performed if topical use is planned. For oral use, due to the highly aromatic nature of clove oil, bronchospasm has been noted, along with tissue irritation.9 There are no known interactions. However, due to its anti-inflammatory activity, the oil should be used with caution in conjunction with any other medication that possesses prostaglandin inhibitory action. 62 THE CLINICAL ADVISOR • DECEMBER 2016 • www.ClinicalAdvisor.com

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COMMENTARY Virginia Carreira, DNP, RN, APN, CDE, CCRN, is a family nurse practitioner in Long Branch, NJ.

Teen pregnancy prevention program Although teen births have declined significantly in the United States, disparities by race, ethnicity, and geography persist, emphasizing the ongoing need for teen pregnancy prevention efforts. According to the CDC, non-Hispanic black youth, Hispanic youth, and socioeconomically disadvantaged youth of any race or ethnicity have the highest rates of teen pregnancy and childbirth. Teen childbearing can have negative health, economic, and social consequences for mothers and their children, with related costs about $9.4 million annually in the US. In 2012, a total of 305,388 babies were born to teenage mothers in US. The teen pregnancy birth rates in the US are substantially

The program strives to modify teen attitudes toward sexuality and bring about life-changing behavior.

higher compared with those of other Western industrialized nations. Teen pregnancy and births are significant factors for dropping out of high school. Peer pressure and attitudes regarding teen pregnancy can influence students on whether to become sexually active. In an attempt to reduce teen pregnancies, the Baby Think It Over (BTIO) program was presented to 8th grade students in Long Branch, New Jersey, as a pilot study in 2001. After the first year, the physical education teachers requested that it become part of the students’ curriculum in school. All the 8th grade health classes took part in the program. Students who had a signed consent form from a parent or legal guardian took the baby simulator home on Friday after school and returned it the following Monday morning. They had to provide total care for the baby for the entire weekend (feed, change diapers, burp, etc). The purpose of this exercise was to educate the students about the realities and responsibilities of pregnancy and infant care. With the assistance of a licensed clinical social worker at the school, the BTIO program can be integrated in health class education regarding abstinence, STD prevention, and pregnancy delay. By implementing this educational program in the middle school, we planned to educate the students before they make the decision to become sexually active without protection. This

has created a dramatic decrease in pregnancies (from 26 pregnancies in 2001 to 1 in the past 2 years). Providing close to a real experience with infant simulators and having teen moms speak to peers about their day-to-day challenges can bring about life-changing behavior. Making the BTIO real case parenting program an integral part of our health classes has brought about positive results. It breaks the cycle of teenage motherhood by having the students comprehend the consequences of their actions. Teen mom peers in their class give them a shocking reality check. The teen moms share their stories to students about the financial impact of having a child as a teen, along with the resulting immediate and long-term impact on their lifestyle. The BTIO approach strives to modify teen attitudes toward sexuality and parenting requirements. This interactive curriculum lets them hear their peers’ opinions on sexuality and parenting as a teenager. Our curriculum called for a class in which teen moms from our high school volunteered their experiences of parenting and the issues affecting the delivery of a child at their ages. Teaching becomes more effective when students are presented with the actual consequences of having unprotected sex and when having a baby becomes a startling reality. The program has had a positive impact in delaying sex and giving our students time to mature and make better decisions in a safer way. n

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