Today’s Top Story
ABOS responds to ProPublica article regarding incorporation of scorecard ratings into recertification process.
On Oct. 13, ProPublica reported that the American Board of Orthopaedic Surgery (ABOS) planned to incorporate that publication’s surgeon scorecard ratings into its recertification process. In response to that article, ABOS has issued the following response: “To all diplomates and the orthopaedic community. You may have read certain information from an online publication, ProPublica. It should be known that the ABOS Board of Directors has not discussed nor considered the use of any ProPublica‘s scorecard or any data in any certification or credentialing process.” ProPublica has updated the article to include the following correction, which reads in part: “This story has been updated to clarify that the [ABOS] board of directors did not have a formal discussion or vote on the decision to use the Surgeon Scorecard when certifying or re-certifying doctors.” Read more…
Read the ProPublica article…

Other News

FDA issues safety alerts on mislabled acetaminophen; heater-cooler devices.
The U.S. Food and Drug Administration (FDA) states that Medline Industries, Inc. has announced a voluntary, nationwide recall of lot #45810 of acetaminophen tablets, 500mg, uncoated compressed tablets. The product has been found to have been mislabeled as “Acetaminophen 325mg” (OTC10101) instead of “Acetaminophen 500mg.” If the product is taken at the maximum labeled dose—every 4 hours or five doses a day—or with other medications containing acetaminophen, it may lead to liver toxicity or liver failure. Read more…
Read the manufacturer’s press release…
     FDA has issued a safety communication stating that the use of heater-cooler devices has been associated with nontuberculous Mycobacterium (NTM) infection. Heater-cooler devices are used during surgical procedures to warm or cool a patient to optimize medical care and improve patient outcomes. Between January 2010 and August 2015, FDA received 32 Medical Device Reports of patient infections associated with heater-cooler devices or bacterial heater-cooler device contamination. FDA has outlined a series of protocols for the use of heater-cooler devices to reduce risk to patients. Read more…
Read the FDA statement, including safety recommendations…

Study: How likely is reoperation for symptomatic nonuninon of ACDFs?
A study published in the Oct. 15 issue of the journal Spine examines reoperation rates for symptomatic nonunions for 1-level, 2-level, and 3-level anterior cervical discectomies and fusions (ACDFs). The researchers conducted a retrospective cohort study of 1,054 patients with minimum 2-year follow-up and found reoperation rates for nonunions to be 0.2 percent, 2.9 percent, and 6.5 percent for 1-level, 2-level, and 3-level ACDFs, respectively. “A large cohort of ACDF patients with more than 2 years of follow-up had reoperations for nonunion rates significantly lower than reported in the literature for radiographical nonunions,” the researchers write. Read the abstract…

Study: An increase in antibiotic resistance could threaten safety of surgical procedures.
Data from a study published online in the journal The Lancet Infectious Diseases suggest that an increase in antibiotic resistance could threaten the safety and efficacy of surgical procedures. The research team conducted a meta-analysis of published studies and estimated that 38.7 percent to 50.9 percent of pathogens causing surgical site infections (SSIs) and 26.8 percent of pathogens causing infections after chemotherapy may be resistant to standard prophylactic antibiotics in the United States. They project that a 30 percent reduction in the efficacy of antibiotic prophylaxis for such procedures would be associated with 120,000 additional SSIs and infections after chemotherapy per year, along with 6,300 infection-related deaths. Read more…
Read the abstract…

CDC report finds wide variation in drug prescribing patterns by state.
A multistate report released by the U.S. Centers for Disease Control and Prevention (CDC) and the FDA-funded Prescription Behavior Surveillance System (PBSS) finds wide variation in prescribing patterns by state for opioids, stimulants, and benzodiazepines. The authors looked at state-level data from the following eight states: California, Delaware, Florida, Idaho, Louisiana, Maine, Ohio, and West Virginia. Taken together, these states represent about a quarter of the U.S. population. Prescribing rates between states were found to vary twofold for opioids, fourfold for stimulants, and nearly twofold for benzodiazepines. In addition, the authors noted that:

  • A small minority of prescribers were responsible for most opioid prescriptions.
  • The top 1 percent of prescribers wrote 1 in 4 opioid prescriptions in Delaware, compared with 1 in 8 in Maine.
  • People who receive opioid prescriptions often receive benzodiazepine prescriptions as well, despite the risk for adverse drug interactions.
  • The percentage of controlled substance prescriptions paid for in cash varied almost threefold among five states reporting this measure.

Read more…
     The American Medical Association has posted a web page with information on preventing opioid abuse. Read more…
     The AAOS recently adopted an information statement on Opioid Use, Misuse, and Abuse in Orthopaedic Practice. Read more…

FTC document clarifies issues surrounding medical board regulation and antitrust law.
Modern Healthcare reports that the U.S. Federal Trade Commission (FTC) has issued guidance explaining how medical boards can regulate their own professions without violating antitrust law. The guidance follows a U.S. Supreme Court ruling in which the justices ruled that state licensing boards made up of active members of the professions they regulate are not immune from antitrust laws unless they are actively supervised by the state. The FTC document describes exactly what “active supervision” by the state means, who constitutes an active member of a profession, and what it means for active members of a profession to control such a board. Read more…(registration may be required)
Read the FTC guidance document (PDF)…

Massachusetts.
The Boston Globe reports that the governor of Massachusetts has proposed a bill that, if enacted, would place new limits on how many opioid painkillers doctors and dentists can prescribe to a patient. Under terms of the bill, healthcare providers would be limited to prescribing no more than a 72-hour first-time supply of opioids to patients, with exceptions only for certain limited emergencies. Critics of the bill say it would set an unrealistic limit on prescribing. Read more…

Call for volunteers: FDA Network of Experts Program.
AAOS seeks to nominate up to five candidates with experience in labeling for the Birmingham Hip Resurfacing system to participate in the FDA Network of Experts program. The Network of Experts is a vetted network of outside scientists, clinicians, and engineers who will provide staff from the FDA Center for Devices and Radiological Health with rapid access to scientific, engineering, and medical expertise when it is needed to supplement existing knowledge and expertise. 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. In addition all applicants must provide the following: an online AAOS CAP application, a current curriculum vitae, and a completed conflict of interest form. All supporting materials must be submitted by Sunday, Oct. 25, 2015 at 11:59 p.m. CT, to Kyle Shah, at: shah@aaos.org
Learn more and submit your application…