Diana W. Bartenstein

Extending Shelf Life Just Makes Sense

From The University of Texas Dell Medical School, Austin (D.G.D.); Tufts University School of Medicine, Boston, MA (D.W.B.); and Pharmacy, Northwest Hills Surgical Hospital, Austin, TX (D.R.C.). S ince 1979, the US Food and Drug Administration (FDA) has required pharmaceutical companies to provide rigorous proof that their medication is stable over the course of months when submitting a New Drug Application or an Abbreviated Drug Application. A medication’s shelf life, or expiration date, is the time frame in which a medication has been proven safe and effective despite exposure to various environmental factors including temperature, humidity, and light. Although expiration dates guarantee a certain length of stability, the FDA has no requirement for long-term testing. Many medications may have much longer shelf lives than labeled. The best evidence indicating that medications can last longer than their labeled expiration date comes from the Shelf Life Extension Program (SLEP). Rather than disposing of billions of dollars of the military’s stockpiled medications that were set to expire in the 1980s, the FDA tested various batches of the medications in their supplies to provide extensions in shelf life. In their studies of 122 different medication products, nearly 90% met the requirements for an extension. Table 1 includes medications for which all lots tested by SLEP when approaching their expiration dates met the criteria for initial shelf life extension, and Table 2 lists medications for which less than 50% of lots tested were initially extended. Whereas the shelf life of most medications in the United States is 1 to 5 years, the average additional extension length by SLEP was 5.5 years, and some lots were extended by more than 20 years. Cantrell et al, in another study, tested medications that had expired 28 to 40 years earlier that were discovered unopened and in their original containers at a retail pharmacy. Twelve of the 14 active ingredients were present in at least 90% of the labeled amount, meeting our standard of acceptable minimum potency. Given these data, it seems

Lipofibromatosis-like neural tumor: Case report of a unique infantile presentation

A 14-month-old boy presented with a slow-growing, asymptomatic back plaque, which was biopsied and found to have S100 positivity, sparse CD34 staining, and no significant mitotic activity, nuclear pleomorphism, or necrosis; genetic workup found LMNA-NTRK1 gene fusion, overall consistent with lipofibromatosis-like neural tumor (LPF-NT). LPF-NT is rare, with 14 cases previously reported, and our patient is the first report of this diagnosis in infancy. This case report and literature review includes comparison of similar diagnoses including lipofibromatosis, low-grade malignant peripheral nerve sheath tumor, infantile fibrosarcoma, and dermatofibrosarcoma protuberans and serves to aid detection of LPF-NT presenting in pediatric patients by highlighting similarities and differences that should prompt consideration. LPF-NT shows locally aggressive behavior only and should not be confused with conditions that have potential for distant spread. However, case reports of metastasizing LMNA-NTRK1 tumors draw into question whether growths with this gene fusion exist on a spectrum of disease severity. Our patient was treated with wide local excision and has developed no complications or evidence of recurrence with 6 months of follow-up time.

A Prospective, Randomized, Single-Blind Study Comparing Cyanoacrylate Adhesives to Sutures for Wound Closure in Skin Cancer Patients

BACKGROUND Cyanoacrylate tissue adhesives are not more likely to result in wound dehiscence or infection than sutured closures. However, suturing is the gold standard for optimal cosmetic appearance of scars. OBJECTIVE To determine whether cyanoacrylate tissue adhesives produce a cosmetic outcome equivalent to sutures at 3 months. Secondary outcomes include time for wound closure, time spent on wound care, and surgeon and patient satisfaction. MATERIALS AND METHODS Seventy-one patients scheduled for skin cancer excision at Beverly Hospital were included in this prospective, randomized, single-blind study. Cosmetic appearance was assessed by a masked panel of dermatologists and plastic surgeons who evaluated digital photographs. Secondary outcomes were assessed by nursing recordings and patient and surgeon evaluations. RESULTS There was no significant difference in wound appearance (Visual Analog Scale: p = .4693, modified Hollander Wound Evaluation Score: p = .6413) between adhesives and sutures. It was faster and easier for a surgeon to use adhesives, and subjects spent less time caring for and were more satisfied by wounds sealed with adhesives than sutures. CONCLUSION Cyanoacrylate tissue adhesives produce cosmetic outcomes that are not statistically significantly different than sutures; furthermore, they are associated with fast application, easy wound care, and patient satisfaction.

Indoor Tanning Devices in Student Apartment Complexes: A Study of 2 Texas University Communities

A better understanding of the US population’s interest and means of accessing information regarding skin cancer is essential to improving educational and preventive initiatives. The use of the Google Trends application provides a novel means for determining this interest. Because the US population seeks information regarding skin cancer at a greater level during the summer months, this might be the most efficient time for educational and public health initiatives.

Contrasting features of childhood and adolescent melanomas

Melanoma in children and adolescents is uncommon, and there are limited data on pediatric outcomes. Several studies have shown comparable survival rates in children and adults, but other research demonstrates that prepubescent children have more favorable outcomes. This study aims to compare childhood and adolescent melanoma.

Delayed-type hypersensitivity to vaccine aluminum adjuvant causing subcutaneous leg mass and urticaria in a child

A 3‐year‐old girl presented with a 7‐month history of a waxing and waning left thigh mass associated with pruritus and erythema at the site of two previous DTaP‐HepB‐IPV vaccinations. Patch testing was positive to aluminum chloride, supporting a diagnosis of vaccine granuloma secondary to aluminum allergy; her symptoms had been well controlled with antihistamines and topical steroids. Injection site granulomas are a benign but potentially bothersome reaction to aluminum‐containing immunizations that can be supportively managed, and we encourage strict adherence to the recommended vaccine schedule in this setting. Patch testing is a sensitive, noninvasive diagnostic tool for patients presenting with this clinical finding, and dermatologist awareness can prevent unnecessary medical examination and provide reassurance.

Pediatric Inpatient Dermatology: New Insights on Severe Eruptions and Cutaneous Adverse Reactions

Purpose of ReviewThis manuscript reviews important advances in our understanding of severe eruptions and cutaneous adverse reactions in children.Recent FindingsThe latest research provides significant insights regarding severe cutaneous eruptions including coxsackievirus eruptions, mycoplasma-induced rash and mucositis, urticaria multiforme, erythema multiforme, and severe cutaneous adverse reactions. Recent literature expands our understanding of the incidence and cost, pathophysiology, and management considerations for pediatric patients with Stevens-Johnson syndrome and toxic epidermal necrolysis.SummaryPediatric inpatient cutaneous eruptions, from infectious and inflammatory to adverse reactions are very burdensome diseases. It is important to recognize salient features to initiate appropriate workup and management, particularly for patients with severe cutaneous adverse reactions for which early recognition of complications of disease and consultation with colleagues may minimize sequelae.

Evolving Childhood Melanoma Monitored by Parental Photodocumentation

A 3-year-old girl presented with a left shin nodule that appeared 6 months previously, and her mother had taken serial photographs of the growth and evolution (Figure). The tumor was initially thought to be mollusca, part of her concurrent infection, and later a keloid scar. Examination revealed a 1.6-cm, red, slightly friable nodule with peripheral scale. Excisional biopsy showed a severely atypical compound Spitzoid melanocytic proliferation, consistent with Spitzoid melanoma, with a Breslow depth of 3.5 mm, level IV invasion, and mitotic index of 14/mm. Ulceration, lymphovascular invasion, and regression were not identified on histopathology. Sentinel lymph node biopsy revealed 4 of 4 positive nodes in both the inguinal and external iliac nodal basins. Subsequent completion lymphadenectomy showed no disease (0 of 15 nodes), and imaging was unremarkable. The patient is undergoing adjuvant interferon therapy, with no evidence of recurrence in 1 year of follow-up. Pediatric melanomas are rare, and can be challenging to diagnose owing to atypical clinical characteristics. The majority of melanomas presenting in children 0-10 years of age are amelanotic, and childhood and adolescent melanomas often lack border irregularity, color heterogeneity,or diameter >6 mm. Modified ABCD criteria (which conventionally represent Asymmetry, Border irregularity, Color heterogeneity, and Diameter >6 mm features of pigmented lesions that should prompt evaluation in adults) have been proposed for recognizing melanoma in children, and these include amelanosis, bleeding, “bumps,” uniform color, variable diameter, and de novo development. Evolution is also a predominant feature among childhood melanoma, and timely dermatologic referral is recommended for lesions of any color or shape that are reported to be rapidly growing, bleeding, or otherwise changing. We endorse home photodocumentation, which has been used previously to assess superficial infantile hemangioma growth, for monitoring and evaluating pediatric cutaneous conditions. This approach provides more information than can be obtained in office visits alone, and photographs demonstrating dramatic evolution over several months may prompt biopsy at an initial dermatology visit—leading to earlier diagnosis of aggressive tumors. In this case, parental photodocumentation meaningfully contributed to evaluation of a rare, challenging tumor. ■

Shelf life considerations as EpiPen price increases

www.thelancet.com Vol 388 December 10, 2016 2871 bringing life-saving health care to those who need it most. Worldwide, every year 1 billion people are denied medical care because they cannot aff ord to pay, while 100 million are pushed into poverty by health-care costs. The need for UHC couldn’t be more urgent, and the inclusion of a target to achieve UHC in the SDGs is a triumph of global decision making. UHC means that everyone can access the quality health services they need without being pushed, or pushed further, into poverty. There are two clear indicators required to measure UHC: one for coverage (indicator 3.8.1), and one that can measure effective financial risk protection (indicator 3.8.2). We are pleased to see both aspects of UHC refl ected in the framework and we congratulate you on agreeing on a robust indicator for health coverage (3.8.1). We are, however, very concerned that indicator 3.8.2 for fi nancial risk protection as it stands—coverage by health insurance or a public health system per 1000 population—will fail to measure the impoverishing eff ect of health spending meaningfully, and could undermine real progress towards UHC. Having a public health system or an insurance mechanism is, in itself, not a measure or guarantee of fi nancial risk protection. Moreover, this indicator will not produce data that can be disaggregated by income or gender. We endorse the WHO and World Bank-supported refinement to indicator 3.8.2: the proportion of the population with large household expenditures on health, as a total share of household expenditure or consumption. Data on household expenditure on health can be collected from existing household surveys, and this indicator allows for disaggregation, including by measures such as income and gender. As members of the academic and research community, we want to see an indicator of financial risk protection that is scientifi cally robust and neutral with regard to alternative responsibility becomes particularly compelling when soaring EpiPen prices are considered. If EpiPens can be used beyond their stated shelf life of 2 years, patients, schools, hospitals, and all other aff ected institutions would not have to replace devices and incur steep costs so frequently.

Seeing Is Believing: Images of Wound Healing for Patient Education.

Patient education is a cornerstone of dermatology care, increasing patient satisfaction, knowledge, adherence, and outcomes. To educate patients about wound care after surgical procedures in dermatology, providers traditionally give instructions orally and in a written handout. In the authors’ experience, many patients become concerned that a normal postprocedure wound is infected or otherwise not healing properly. They hypothesized that providing patientswith real images ofwoundhealing would assuage certain fears and promote patient satisfaction.