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Around the nation: FDA to require stronger warnings for opioids


FDA recently announced that it will require opioid manufacturers to update their product labeling to include long-term safety risks, in today's bite-sized hospital and health industry news from Illinois, Maryland, and New York.

  • Illinois: In new clinical guidelines, the Alzheimer's Association said specialists may use certain blood tests to help diagnose patients who have cognitive impairments instead of having to rely on more complex and invasive tests like PET scans and cerebrospinal fluid tests. According to the Alzheimer's Association, blood biomarker tests that have over 90% sensitivity and specificity can be used to diagnose patients while tests that have over 90% sensitivity and 75% specificity can be used to triage patients. Positive results on tests used to triage patients should be confirmed with standard diagnostic methods. According to Rebecca Edelmayer, one of the authors of the guidelines and VP of scientific engagement at the Alzheimer's Association, the organization will keep track of available tests and their accuracy in an online portal, which will be regularly updated. Although the guidelines are expected to be updated over time, the initial recommendations could help more patients get tested and diagnosed, especially in rural areas where accessing scans and spinal fluid tests may be more difficult. "I think this is reasonable," said Joseph Quinn, a professor of neurology at Oregon Health & Science University. "They've really thought through this very carefully in terms of making a diagnosis." (Chen, STAT, 7/29)
  • Maryland: FDA recently announced that it will require opioid manufacturers to update their product labeling to include long-term safety risks. Going forward, manufacturers will be required to add that higher doses of opioids are associated with an increased risk of serious harm, which persists over time, to prescribing information. "The death of almost one million Americans during the opioid epidemic has been one of the cardinal failures of the public health establishment," said FDA Commissioner Marty Makary. "This long-overdue labeling change is only part of what needs to be done -- we also need to modernize our approval processes and postmarket monitoring so that nothing like this ever happens again." Opioid manufacturers have been given 30 days to submit their updated labels to FDA for review. (Lou, MedPage Today, 7/31)
  • New York: Last week, KKR acquired a majority stake in HealthCare Royalty Partners (HCRx), furthering the investment firm's push into the healthcare industry. HCRx acquires pharmaceutical royalty rights for drugs that are already generating sales or are in later stages of development. Currently, the company has around $3 billion in assets under management. "We're just trying to play our part in advancing growth and innovation in healthcare," said Ali Satvat, cohead of KKR's Americas healthcare group. Because the deal is being conducted by KKR's management company and not one of its buyout funds, HCRx will become part of KKR after the deal is completed. After the acquisition is complete, HCRx CEO and cofounder Clarke Futch will have a minority stake in the company and continue to lead the HCRx team. (Glickman, Wall Street Journal, 7/30)

How Advocate Aurora Health created a supportive opioid wean program

Leveraging pharmacy expertise, Advocate Aurora Health created a supportive opioid wean program to minimize patient risk and help PCPs manage patients' pain.


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