Today’s Top Story
FDA announces class-wide safety labeling changes for opioids; considers ban on powdered gloves.
The U.S. Food and Drug Administration (FDA) has announced required class-wide safety labeling changes for immediate-release (IR) opioid pain medications. Among the changes, the agency is requiring a new boxed warning about the serious risks of misuse, abuse, addiction, overdose and death. The updated indication clarifies that IR opioids should be reserved for pain severe enough to require opioid treatment and for which alternative treatment options (e.g., non-opioid analgesics or opioid combination products, as appropriate) are inadequate or not tolerated. The dosing information also provides clearer instructions regarding patient monitoring and drug administration, including initial dosage, dosage changes during therapy and a warning not to abruptly stop treatment in a physically dependent patient. Further, FDA now requires a precaution that chronic maternal use of opioids during pregnancy can result in neonatal opioid withdrawal syndrome. Additionally, FDA is requiring updated labeling for all opioids, to include safety information about potentially harmful drug interactions with other medicines that may result in serotonin syndrome. Read more…
In unrelated news, FDA has proposed a ban on most powdered medical gloves, stating that they pose an unreasonable and substantial risk of illness or injury to healthcare providers, patients, and other individuals, which cannot be corrected through new or updated labeling. Read more…
Other News
House legislation would delay implementation of CJR payment model.
Legislation has been introduced in the U.S. House of Representatives to delay implementation of the U.S. Centers for Medicare & Medicaid Services Comprehensive Care for Joint Replacement (CJR) bundled payment model. Under the model, all eligible hospitals in 67 select geographic areas will be accountable for all costs associated with hip and knee arthroplasty procedures, from the time of surgery through 90 days postoperative. If enacted, the Healthy Inpatient Procedures (HIP) Act would delay CJR implementation until Jan. 1, 2018. The American Association of Orthopaedic Surgeons (AAOS) and others have advocated in favor of delaying implementation of CJR to allow hospitals and providers more time to prepare. Read more…
Study: Autologous iliac crest bone graft may be more effective than OP-1 for certain spinal fusion procedures.
Findings published in the March 16 issue of The Journal of Bone & Joint Surgery suggest that autologous iliac crest bone graft may be more effective than osteogenic protein-1 (OP-1, also known as BMP-7) with a collagen carrier for certain spinal fusion procedures. The authors conducted a randomized, controlled trial of 113 patients who underwent a single-level instrumented posterolateral fusion of the lumbar spine for degenerative or isthmic spondylolisthesis with symptoms of neurological compression. Patients received either OP-1 combined with local bone or autologous bone graft from the iliac crest combined with local bone. At 1-year follow-up, they noted success rates (defined as a combination of clinical success and evidence of fusion on computed tomography scans) of 40 percent in the OP-1 group and 54 percent in the autograft group. Overall, fusion rates were 54 percent in the OP-1 cohort and 74 percent in the autograft cohort. Read the abstract…
ED may be a prime venue to identify elder abuse.
Two articles published online in the Annals of Emergency Medicine look at the issue of identifying elder abuse and neglect in the emergency department (ED). The first profiles opportunities to identify elder abuse, starting with paramedics and emergency medical technicians and carrying through to ED triage, injury patterns, and the social support system. The writers state that fewer than 5 percent of elder abuse cases are reported to authorities, noting that delays in detection and intervention contribute to abuse-related morbidity and mortality. Read more…
A companion article presents two case studies of older patients who presented at the ED with severe malnutrition, contractures, and decubitus ulcers, and were nonverbal, with histories of dementia and end-stage disease. The writers illustrate an approach to the assessment of possible elder neglect in ED settings and how to intervene to ensure patient safety. Read more…
Growth in Medicare spending slowed in recent years.
The U.S. Department of Health and Human Services (HHS) has released a report on Medicare spending growth. The report notes a decreasing trend in Medicare spending growth, stating that Medicare spent $473.1 billion less on personal healthcare expenditures during the period 2009 to 2014, compared to projected rates of increase based on the period from 2000 to 2008. The agency projects that if trends continue through 2015, $648.6 billion will have been saved compared to the 2000 to 2008 time frame. The report states that overall national personal healthcare spending increased 4.3 percent per person during 2014. Read more…
Read the complete report (PDF)…
PCORI seeks to fund comparative research into efficacy of lumbar fusion versus nonsurgical approaches for treatment of chronic low back pain
The non-profit Patient-Centered Outcomes Research Institute (PCORI) has announced a funding opportunity of up to $22 million to study ways to improve treatment of chronic low back pain. The organization seeks to fund one or more randomized clinical trials to compare effectiveness of surgical and nonsurgical interventions for the management of chronic non-specific low back pain in adults. In particular, the goal of this announcement is to support patient-centered comparative effectiveness research into the efficacy of lumbar fusion versus optimized, multidisciplinary nonsurgical approaches. PCORI states that research proposals should carefully account for the noted risk of selection bias that may occur in such trials; have sufficient sample sizes to adequately address the priority research question, including in subgroups of interest; and should generate information that is readily generalizable to the broader population. In particular, the organization is interested in studies with no greater than a 5-year study period, including a 2-year post-intervention follow-up. Read more…
Oregon.
The Portland Business Journal reports that the Oregon Health Authority is contacting various medical and academic organizations in the state to solicit participants for a statewide task force to develop guidelines for opioid prescribing. The agency is seeking 20-25 participants from the Oregon Medical Association, ED physicians, primary care providers and other medical groups, and coordinated care organizations. Read more…
Call for volunteers: AMA ACGME Review Committee.
The American Medical Association (AMA) is soliciting AMA member candidates to serve as a member of the Accreditation Council for Graduate Medical Education (ACGME) Clinical Learning Environment Review (CLER) Evaluation Committee. Applicants for this position must be AMA members at the time of nomination and maintain AMA member status throughout the term of appointment. In addition, all applicants must submit an electronic Application for AMA Nomination for External Leadership Position, a current abbreviated curriculum vitae [not to exceed three pages], and a current full curriculum vitae. All supporting materials must be submitted to Mary O’Leary (at AMA) by March 28, 2016. Request a copy of the nomination form and submit supporting materials to: mary.oleary@ama-assn.org Learn more and download the application…
