Today’s Top Story
Senate approves new FDA commissioner.
Medpage Today reports that the U.S. Senate has approved the nomination of Robert M. Califf, MD, MACC, as commissioner of the U.S. Food and Drug Administration (FDA). Some critics had argued that Dr. Califf should not be confirmed, due to past ties with the pharmaceutical industry. However, the Senate approved his appointment in an 89-4 vote. Read more…(registration may be required)

Other News

Societies release new consensus definitions for sepsis and septic shock.
At the Society for Critical Care Medicine (SCCM) 45th Critical Care Congress, SCCM and the European Society of Intensive Care Medicine have released the Third International Consensus Definitions for Sepsis and Septic Shock. As reported in MedPage Today, the new definition for sepsis includes evidence for infection, plus life-threatening organ dysfunction, which is clinically characterized by an acute change of two points or greater on the Sequential [Sepsis-related] Organ Failure Assessment (SOFA) score. The project was led by a 19-member task force of experts in sepsis pathobiology, clinical trials, and epidemiology. The complete definitions are published in the Feb. 23 issue of The Journal of the American Medical Association. Read more…
Read “The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3)”…
Read “Developing a New Definition and Assessing New Clinical Criteria for Septic Shock”…
Read “Assessment of Clinical Criteria for Sepsis”…
Read “New Sepsis Diagnostic Guidelines Shift Focus to Organ Dysfunction”…

Study: Treatment with pulsed electromagnetic fields may not improve return to sports after arthroscopic débridement and microfracture of talar OCD.
According to a study published online in The American Journal of Sports Medicine, use of pulsed electromagnetic fields (PEMFs) may not be associated with an increased likelihood of return to sports in patients who underwent arthroscopic débridement and microfracture of talar osteochondral defects (OCDs). The authors conducted a randomized, controlled trial of 68 patients treated with either PEMF (n = 36) or placebo (n = 32) after arthroscopic treatment of an OCD of the talus. They found that almost all outcome measures improved significantly across both cohorts. However, there was no significant difference between cohorts in percentage of sport resumption or median time to sport resumption. In addition, there were no significant between-group differences with regard to the secondary functional outcomes and computed tomography results. Read the abstract…

Experts say combining opioids and benzodiazepines can be dangerous; request FDA “black box” warning.
The Washington Post reports that 41 signatories from various governmental health departments and universities have petitioned FDA to add a “black box” warning to opioids and benzodiazepines regarding potential dangers of taking such drugs in combination. The petitioners argue that taking the two types of drugs together can severely depress the respiratory system, and request that an FDA warning state that taking the drugs in combination “reduces the margin of safety for respiratory depression and contributes to the risk of fatal overdose, particularly in the setting of misuse.” Read more…

Study: Drug manufacturers may submit incomplete information on adverse events.
Findings from a study published online in the journal Pharmacoepidemiology & Drug Safety suggest that some drug manufacturers may submit incomplete information on certain adverse events to the FDA. The researchers reviewed information on 528,192 new case reports linked to a serious or fatal outcome that were submitted to FDA during 2014. Overall, 25,038 (4.7 percent) were submitted directly from health professionals and consumers, and 503,154 (95.3 percent) were submitted by drug manufacturers. They found that 21,595 (86.2 percent) of serious reports submitted directly to FDA provided data for all four completeness variables, compared with 271,022 (40.4 percent) of manufacturer-expedited reports and 24,988 (51.3 percent) of periodic reports. Among manufacturer serious reports, 37.9 percent lacked age and 46.9 percent had no event date. The researchers state that performance by 25 manufacturers that submitted 5,000 or more reports varied from 24.4 percent to 67 percent complete on all variables. They note that cases in which a patient died had the lowest completeness scores in all categories. Read more…
Read the abstract…

AAHKS and ACR seek comment on recommendations for perioperative management of rheumatic disease medications in TJA patients.
The American Association of Hip and Knee Surgeons (AAHKS) and the American College of Rheumatology (ACR) are accepting public comment as part of an initiative to develop recommendations for perioperative management of rheumatic disease medications in patients undergoing total joint arthroplasty (TJA) of the hip and knee. Goals of the project include:

  • Developing recommendations for the perioperative use of glucocorticoids, disease-modifying anti-rheumatic drugs (DMARDs), and immunosuppressant medications
  • Analyzing the optimal timing of discontinuation and resumption of DMARDs pre-/postoperatively
  • Developing recommendations for “rescue” medication use for postoperative flares
  • Considering perioperative management decisions to decrease the risk of 90-day readmissions
  • Identifying knowledge gaps and areas for future research in perioperative medication management

The deadline for comment submission is March 24, 2016. Read more…
View the management plan (PDF)…
Submit comments…

FDA accepting comments on draft guidance on UHMWPE in orthopaedic devices.
FDA has made available a draft guidance on the characterization of ultrahigh molecular weight polyethylene (UHMWPE) used in orthopaedic devices. The guidance identifies the types of UHMWPE currently in use in orthopaedic implants, and includes recommended information and testing that the agency argues should be included in premarket submissions for such devices. FDA is currently accepting comments on the draft guidance. The agency notes that interested parties can comment on any guidance at any time, but encourages stakeholders to submit their comments by May 12, 2016, so they may be considered before work on the final version of the guidance begins. Read more…

Call for volunteers: NQF expert panel on certification of decision aids.
AAOS seeks experts to serve on a new National Quality Forum (NQF) panel to develop national standards for the certification of decision aids that support shared decision-making among patients, their families, and healthcare providers. NQF will conduct an environmental scan of existing measures that assess the quality of shared decision-making, commission a white paper on existing standards, and develop a potential business model for NQF decision-aid certification. These efforts will inform the work of the expert panel. The initiative builds upon work conducted by the International Patient Decision Aid Standards Collaboration and the Washington State Health Authority to specify standards for patient decision-support interventions. For more information, or to volunteer or recommend an expert to serve on the pane, contact Andrew Anderson, NQF project manager by Thursday, Feb. 25, at 202-783-1300, or via email at: decisionaids@qualityforum.org