Reciprocal Tears

Prevention of Shingles: Better Protection and Better Value With Recombinant Vaccine

Fournier Gangrene Associated With Sodium–Glucose Cotransporter-2 Inhibitors: A Review of Spontaneous Postmarketing Cases: Annals of Internal Medicine: Vol 170, No 11

Background: Use of sodium–glucose cotransporter-2 (SGLT2) inhibitors has been associated with Fournier gangrene (FG), a rare urologic emergency characterized by necrotizing infection of the external genitalia, perineum, and perianal region. Objective: To describe and compare reported cases of FG in diabetic adults receiving treatment with SGLT2 inhibitors or other antiglycemic agents. Design: Descriptive case series. Setting: U.S. Food and Drug Administration (FDA) Adverse Event Reporting System and published case reports. Patients: Adults receiving SGLT2 inhibitors or other antiglycemic agents. Measurements: Clinical and laboratory data. Results: The FDA identified 55 unique cases of FG in patients receiving SGLT2 inhibitors between 1 March 2013 and 31 January 2019. The patients ranged in age from 33 to 87 years; 39 were men, and 16 were women. Time to onset after initiation of SGLT2-inhibitor therapy ranged from 5 days to 49 months. All patients had surgical debridement and were severely ill. Reported complications included diabetic ketoacidosis (n = 8), sepsis or septic shock (n = 9), and acute kidney injury (n = 4). Eight patients had fecal diversion surgery, 2 patients developed necrotizing fasciitis of a lower extremity that required amputation, and 1 patient required a lower-extremity bypass procedure because of gangrenous toes. Three patients died. For comparison, the FDA identified 19 FG cases associated with other antiglycemic agents between 1984 and 31 January 2019: metformin (n = 8), insulin glargine (n = 6), short-acting insulin (n = 2), sitagliptin plus metformin (n = 2), and dulaglutide (n = 1). These patients ranged in age from 42 to 79 years; 12 were men, and 7 were women. Two patients died. Limitation: Inability to establish causality or incidence, variable quality of reports, possible underreporting, and confounding by indication. Conclusion: FG is a newly identified safety concern in patients receiving SGLT2 inhibitors. Physicians prescribing these agents should be aware of this possible complication and have a high index of suspicion to recognize it in its early stages. Primary Funding Source: None.

Policy Recommendations for Public Health Plans to Stem the Escalating Costs of Prescription Drugs: A Position Paper From the American College of Physicians

The increasing price of prescription drugs is an ongoing concern for Medicare and Medicaid, particularly for patients with chronic health conditions who are using multiple medications and patients in these programs taking high-priced brand-name specialty drugs. Shifts in benefit design, including higher deductibles and a movement away from copayments to coinsurance, have increased patient out-of-pocket costs and put pressure on program budgets. In this paper, the American College of Physicians expands on its position paper from 2016 and offers additional recommendations to decrease out-of-pocket costs for patients, enhance the government's purchasing power, and address existing policies that add costs to the health care system.

Selective Use of Coronary Artery Calcium Testing for Shared Decision Making: Guideline Endorsed and Ready for Prime Time

Ominous Reversal of Health Gains in the United States: Time to Rethink Research Priorities?

Recommended Adult Immunization Schedule, United States, 2019*

Hepatitis C Virus Screening and Care: Complexity of Implementation in Primary Care Practices Serving Disadvantaged Populations

Background: Hepatitis C virus (HCV) disproportionately affects disadvantaged communities. Objective: To examine processes and outcomes of Screen, Treat, Or Prevent Hepatocellular Carcinoma (STOP HCC), a multicomponent intervention for HCV screening and care in safety-net primary care practices. Design: Mixed-methods retrospective analysis. Setting: 5 federally qualified health centers (FQHCs) and 1 family medicine residency program serving low-income communities in diverse locations with largely Hispanic populations. Patients: Persons born in 1945 through 1965 (baby boomers) who had never been tested for HCV and were followed through May 2018. Intervention: The Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) model guided implementation and evaluation. Test costs were covered for uninsured patients. Measurements: All practices tested patients for anti-HCV antibody (anti-HCV) and HCV RNA. For uninsured patients with chronic HCV in 4 practices, quantitative data also enabled assessment of HCV staging, specialist teleconsultation, direct-acting antiviral (DAA) treatment, and sustained virologic response (SVR). Implementation fidelity and adaptation were assessed qualitatively. Results: Anti-HCV screening was done in 13 334 of 27 700 baby boomers (48.1%, varying by practice from 19.8% to 71.3%). Of 695 anti-HCV–positive patients, HCV RNA was tested in 520 (74.8%; 48.9% to 92.9% by practice), and 349 persons (2.6% of those screened) were diagnosed with chronic HCV. In 4 FQHCs, 174 (84.9%) of 205 uninsured patients with chronic HCV had disease staging, 145 (70.7%) had teleconsultation review, 119 (58.0%) were recommended to start DAA therapy, 82 (40.0%) initiated free DAA therapy, 74 (36.1%) completed therapy (27.8% to 60.0% by practice), and 70 (94.6% of DAA completers) achieved SVR. Implementation was promoted by multilevel practice engagement, patient navigation, and anti-HCV screening with reflex HCV RNA testing. Limitation: No control practices were included, and data were missing for some variables. Conclusion: Despite a similar framework for STOP HCC implementation, performance varied widely across safety-net practices, which may reflect practice engagement as well as infrastructure or cost challenges beyond practice control. Primary Funding Source: Cancer Prevention & Research Institute of Texas and Centers for Medicare & Medicaid Services.

Pharmacovigilance in the Real World

How Would You Treat This Patient With Gallstone Pancreatitis?: Grand Rounds Discussion From Beth Israel Deaconess Medical Center: Annals of Internal Medicine: Vol 170, No 3

Acute pancreatitis, a common cause of hospitalization in the United States, is often the result of biliary tract disease. In 2016, the American Gastroenterological Association released a guideline that addresses the practical considerations in managing acute pancreatitis within the first 72 hours after the patient presents. The guideline specifically recommends goal-directed hydration therapy, early enteral feeding, judicious use of endoscopic retrograde cholangiopancreatography (ERCP), and gallbladder surgery during the index admission for patients with mild pancreatitis. The authors discuss their approach to these interventions in the context of a patient with recurrent acute pancreatitis who chooses to delay surgery until after hospital discharge. They address hydration and timing of surgery, as well as how they would manage the patient's preferences in the face of existing guidelines.