Today’s Top Story
FDA issues draft guidance to support development of generic versions of ADF opioids.
The U.S. Food and Drug Administration (FDA) has issued a draft guidance intended to support development of generic versions of approved opioids with abuse-deterrent formulations (ADFs). The agency states that, although ADFs are not failsafe and more data are needed, ADF opioids do have properties expected to deter abuse compared to non-ADFs. The draft guidance includes recommendations for studies that should be conducted to demonstrate that a generic opioid is no less abuse-deterrent than the brand name product, with respect to all potential routes of abuse. To encourage additional input from outside experts and the public, FDA will also hold a public meeting later this year to discuss the draft guidance and a broad range of issues related to the use of abuse-deterrent technology as one tool to reduce prescription opioid abuse. The FDA will take this feedback into consideration when developing its final guidance on the topic. Read more…
Read the draft guidance (PDF)…
Other News
Study: Modeling algorithm may simulate development of knee OA.
Data from a study conducted in Finland and published online in the journal Nature suggest that an algorithm combined with computational modeling may be used to simulate the development of knee osteoarthritis (OA). The researchers drew baseline data from 1,087 participants in the Osteoarthritis Initiative database and developed a cartilage degeneration algorithm to simulate knee OA progression among overweight patients. At 4-year follow-up, they compared representative subjects from two matched cohorts of patients younger than 65 years: mean body mass index [BMI]) 24 kg/m2 and no meniscus or knee injuries; mean BMI 35 kg/m2 and no meniscus or knee injuries). They found that the algorithm accurately simulated cartilage degeneration as compared to the Kellgren-Lawrence findings in the high-BMI cohort, while the healthy subject group’s joints remained intact. In addition, the algorithm followed the experimentally found trend of cartilage degeneration in the obese group, in which rapid degeneration immediately after initiation of OA was followed by slow or negligible degeneration. Read more…
Read the complete study…
Study: Not all pediatric patients with isolated skull fractures may require inpatient observation.
A study to be published in the April issue of the Journal of Pediatric Surgery suggests that certain pediatric patients with isolated skull fractures may be safely discharged from the emergency department (ED) without the need for inpatient observation. The authors conducted a retrospective review of 71 patients aged 12.4 years or younger who presented with acute, isolated skull fractures. Overall, 22.5 percent of patients were discharged from the ED following evaluation and 77.5 percent were admitted for neurological observation. The authors found that none of the patients required neurosurgical intervention, and that none of the patients underwent repeat head imaging during their index admission; repeat imaging was obtained only in three previously admitted patients who returned to the ED. A cost analysis revealed an average increase in charges of $4,291.50 for admitted patients. The authors emphasize that further studies should be conducted before changes to clinical practice are recommended. Read more…
Read the abstract…
Is a novel ACL repair technique safe?
An article in The New York Times reports on an experimental anterior cruciate ligament (ACL) reconstruction technique performed by physicians at a single center. The research team conducted a pilot safety trial of 20 patients, 10 of whom underwent standard ACL reconstruction and 10 of whom were treated using bridge-enhanced ACL repair. At maximum 1-year follow-up, they found no failed repairs, infections, or stiffness among patients in either cohort. Based on its findings, the research team plans to move forward with a larger, randomized trial. Read more…
CBO increases cost estimates for ACA.
A report from the U.S. Congressional Budget Office (CBO) projects that health insurance subsidies are expected to cost the federal government about $660 billion in 2016, with $136 billion of that total driven by higher than expected enrollment in Medicaid. CBO projects the cost of healthcare subsidies to grow about 5.4 percent annually as more people enroll in Medicaid. Over 10 years, the total cost of health subsidies is expected to rise to $1.1 trillion. The agency projects that the Affordable Care Act will cost an additional $28 billion due to recent legislation that postponed the so-called “Cadillac tax” on high-cost insurance plans. Read more…
Ohio.
Bloomberg BNA reports that the U.S. Court of Appeals for the Sixth Circuit has ruled that a joint venture agreement that combined healthcare and management functions for four Dayton-area hospitals did not necessarily create a single unit for antitrust law purposes. A physician-owned surgery center has argued that the hospitals are independent actors that conspired to keep the center from competing in the Dayton market. The appellate decision revives the surgery center’s claims which allege that the four hospitals breached federal antitrust laws by conspiring to keep it from opening. Observers say that the decision could affect many hospital joint operating agreements, in which the institutions sought to avoid liability under the Sherman Antitrust Act. In a dissenting opinion, one judge argues that the provisions of the hospital agreement made clear that the institutions were giving up much of their individual identities when they formed the joint venture, thus creating a single entity that was incapable of conspiring with itself to violate antitrust laws. Read more…
Read the ruling…
Call for volunteers: The Joint Commission technical advisory panel on fluoroscopy.
AAOS seeks to nominate one member to The Joint Commission technical advisory panel on fluoroscopy. The technical advisory panel will provide recommendations regarding processes that must be evaluated to ensure the safe delivery of fluoroscopy. Applicants for this position must be active fellows, candidate members, candidate members osteopathic, candidate member applicants for fellowship, or candidate member applicants for fellowship osteopathic with clinical and/or technical expertise in fluoroscopy. In addition, all applicants must provide the following: an online AAOS CAP application, a current curriculum vitae, a 100-word biosketch, and a letter of interest highlighting their expertise in the subject area. All supporting materials must be submitted by April 3, 2016 at 11:59 p.m. CT, to Kyle Shah, at: shah@aaos.org.
Learn more and submit your application…(member login required)
