Depression screening for prescribed medications with mental health risk: Considerations for clinical decision support, workflow redesign, and health information exchange arrangements.

OBJECTIVE: Depression screening should be increased when prevailing knowledge underscoring medication-associated mental health risk is highest. Depression screening in primary care practices when medications with mental health risk were prescribed was estimated while considering the absence and presence of clinical decision support systems. MATERIALS AND METHODS: A cross-sectional, descriptive study using the National Ambulatory Medical Care Survey (NAMCS) data from 2008 to 2010 was conducted. Primary care physician visits were classified based on whether a medication prescribed had a contraindication, severe warning, moderate warning, adverse event only, or no documented mental health risk. Adjusted odds of depression screening for each risk warning level were estimated while controlling for important sociodemographic factors and presence of computerized systems for medication warnings and guideline recommendations. RESULTS: Depression screening at primary care practice visits when medications were prescribed was 2.1% and increased to 2.8% or higher when medications had a moderate or severe mental health risk warning or medication-disease contraindication. Depression screening was increased at visits when at least one medication was prescribed that had a contraindication (AOR = 6.31, P < 0.001), severe warning (AOR = 2.04, P = 0.003), or moderate warning (AOR = 2.50, P = 0.012) for mental health risk, but not for mental health adverse event only warnings alone (AOR = 1.54, P = 0.074). DISCUSSION: Depression screening is increased when medications were prescribed with a documented mental health risk. Presence of clinical decision support systems may help discern between minor and major medication-associated mental health risks. CONCLUSIONS: Appropriately, positioned warning systems with targeted content, workflow redesign, and health information exchange may improve depression screening in at-risk patients.

Clinical gene therapy for nonmalignant disease.

Gene therapy is envisioned as a potentially definitive treatment for a variety of diseases that have a genetic etiology. We reviewed trials of clinical gene therapy for nonmalignant, single-gene, and multifactorial disorders and infectious diseases, and found limited evidence suggesting that gene therapy may benefit patients who have severe, combined, immunodeficiency disorder; cystic fibrosis; coronary artery disease or peripheral arterial disease; or hemophilia. Effective gene therapy requires the targeted transfer of exogenous genetic material into human cells and the subsequent regulated expression of the corresponding gene product. Because no phase 3 randomized controlled trials have been completed that fulfill these criteria, it is difficult to correlate signs of clinical benefit with the administration of gene therapy in any disease. Additional clinical and basic research is needed to determine the future role of gene therapy.

Sulfonamide cross-reactivity: is there evidence to support broad cross-allergenicity?

PURPOSE: Published and manufacturer-provided data regarding potential cross-reactivity between antibacterial and nonantibacterial sulfonamide agents are reviewed. SUMMARY: An estimated 3-6% of the general population is allergic to sulfonamides and thus at risk for type I and other hypersensitivity reactions to sulfamethoxazole and other sulfonamide antibacterial agents. Concerns have been raised that a history of sulfa allergy may be associated with an increased risk of adverse reactions to a wide range of nonantibacterial sulfonamides, including certain antivirals, carbonic anhydrase inhibitors, cyclooxygenase-2- selective nonsteroidal antiinflammatory drugs, loop and thiazide diuretics, and sulfonylureas; concerns have also been raised that patients who have experienced an allergic reaction to one nonantibacterial sulfonamide may be at risk for an adverse reaction to others. Structurally, none of the nonantibiotic sulfonamides exhibit both of the features shown to be responsible for sulfonamide reactions (i.e., an N-containing ring attached to the N1 nitrogen of the sulfonamide group and an arylamine group at the N4 position), and only two agents (amprenavir and fosamprenavir) have the latter characteristic. A comprehensive literature search (1966-December 2011) identified nine case reports indicating possible cross-reactivity to sulfonamide medications; however, in most cases, adequate patient testing was not conducted to firmly establish either sulfa allergy or sulfonamide cross-sensitivity. The weight of evidence suggests that withholding nonantibacterial sulfonamides from patients with prior reactions to antibacterial sulfonamides or other nonantibacterial sulfonamides is not clinically justified. CONCLUSION: A review of the professional literature and manufacturer-provided data did not find convincing evidence of broad cross-reactivity between antibacterial and nonantibacterial sulfonamide agents.

Unlabeled uses of intravenous immune globulin.

PURPOSE: The unlabeled uses of intravenous immune globulin (IVIG) were reviewed. SUMMARY: A literature review was conducted to identify studies examining the unlabeled uses of IVIG. A review of 138 clinical trial abstracts identified 10 trials examining 2 labeled uses (635 patients) and 128 trials examining 61 different off-label uses (6781 patients). The most common off-label indications included multiple sclerosis, graft-versus-host disease in transplant patients, prevention of antiphospholipid syndrome in miscarriage, Guillain-Barré syndrome, and progression of human immunodeficiency virus after delivery. The studies appeared to support many of the acceptable off-label uses cited by various guideline groups. A total of 276 case reports were identified, with 268 reports representing 156 different off-label uses (362 patients). Seven meta-analyses were identified, evaluating recurrent miscarriage, in vitro fertilization failure, infection in preterm infants, multiple sclerosis, immune thrombocytopenic purpura, and pemphigoid. With the exception of recurrent miscarriage and infection in preterm infants, the off-label use of IVIG for these indications was associated with positive outcomes. An examination of IVIG guidelines by specialty society, payer, and other review organizations revealed that the biomedical evidence supporting off-label uses is being interpreted in different ways. Health care institutions are strongly urged to approve and closely monitor specific uses of IVIG to reserve dwindling supplies for the "best-evidence" uses. Clinicians should be aware of the limits of knowledge in many off-label uses and exercise restraint in prescribing for unproven indications. CONCLUSION: A literature review identified more than 150 unlabeled uses of IVIG. The evidence for these uses is being interpreted in different ways by various reviewing organizations.

Physician factors as an indicator of technological device adoption.

This paper analyzes a sample interventional cardiologist's demographic, academic, and professional characteristics to provide an understanding of their technological device adoption styles. The study sample consisted of 15 physicians from two large Midwestern hospitals, one an academic medical center and the other a medium-sized community hospital. Interventional cardiologists were identified through their online physician profile and respective departments. A questionnaire was developed to assess each physician's self-perceived adoption style, their awareness of the new technology, their participation in clinical trials, organizational support, and how various factors influence their adoption of new technology. Lastly, a database of bare metal and drug eluting stents was examined to document the number of stents used by each physician. Pragmatic and observational findings are presented from the questionnaire, physician profile, to database on stent use. The paper concludes with a discussion of the managerial and forecasting implications and methods to promote technology adoption.