Tuesday, March 14, 2023
FDA Announces End of COVID-19 PHE Policies
Substance Use Treatment Hospital Grants Available
FDA Approves Migraine Nasal Spray
Illinois COVID-19 Data
Briefly Noted
FDA Announces End of COVID-19 PHE Policies
Twenty-two COVID-19-related polices issued by the Food and Drug Administration (FDA) will end on May 11 when the federal public health emergency (PHE) sunsets, the agency announced yesterday. Another 22 policies will continue for 180 days, to allow for “an additional wind-down period…to allow for an orderly transition.” Temporary policies impacted by this wind-down period apply to outsourcing facilities compounding certain drugs for hospitalized patients and non-standard personal protective equipment practices for sterile compounders not registered as outsourcing facilities.
The FDA said it has identified another 24 COVID-19-related policies it intends to retain “with appropriate changes” after the PHE expires, and four additional FDA guidance documents, which supported COVID-19 response efforts, but which aren’t tied to the COVID-19 PHE declaration, that will remain in effect after May 11.
IHA’s COVID-19 PHE sunset webpage is frequently updated with information and updates on federal and state guidance documents and additional resources for hospitals and healthcare facilities preparing for the end of COVID-19 as a PHE. Click here to access links to current guidance on waivers, vaccine and masking, telehealth, Medicaid unwinding, and bed and service flexibilities.
Substance Use Treatment Hospital Grants Available
The Illinois Dept. of Human Services has funded the Southern Illinois University School of Medicine to provide grants to healthcare organizations, including hospitals, that submit an application for Medication-Assisted Recovery (MAR) service implementation by May 2023. Ten grants of $20,000 each are available for facilities. MAR is primarily used in opioid use disorder treatment to help people sustain recovery. To submit an application and MAR implementation plan for Fiscal Year 2023, click here. For more information, email mar@siumed.edu.
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FDA Approves Migraine Nasal Spray
Pfizer announced that the Food and Drug Administration (FDA) approved its nasal spray for the treatment of acute migraine in adults. According to the statement, the drug, Zavzpret, demonstrated pain relief as quickly as 15 minutes after use and a return to normal function two hours after use.
FDA approval hinged on the results of a Phase 3 study, which were published in The Lancet Neurology. Media reports indicate the drug is expected to become available in July. Pfizer has not disclosed the estimated cost of the medication, though reportedly said it will be priced comparably to other migraine treatments.
Pfizer noted that according to the Migraine Research Foundation nearly 40 million people in the U.S. suffer from migraine, which is “characterized by debilitating attacks lasting four to 72 hours with multiple symptoms, including pulsating headaches of moderate to severe pain intensity often associated with nausea or vomiting, and/or sensitivity to sound (phonophobia) and sensitivity to light (photophobia).”
Illinois COVID-19 Data
The Illinois Dept. of Public Health (IDPH) is following the lead of the Centers for Disease Control and Prevention with weekly reporting of new COVID-19 cases and deaths. IDPH reports weekly data on Wednesday of each week for the previous week ending Sunday. IDPH will continue daily reporting of ICU bed availability and hospital admission data.
Briefly Noted
Insufficient sleep around the time of vaccinations reduces antibody response, according to a study in Current Biology. The study found that sleeping less than six hours the night before you are vaccinated could limit antibody response to the vaccine. However, the study noted that the impact of poor sleep on the vaccine immune response was only scientifically relevant in men, prompting study authors to say more data is needed in women to determine why only a man’s immunity would be affected.
A study of over 1 million Korean women found that those with increased breast density or persistent dense breasts are also more likely to have a family history of breast cancer. The study published in JAMA Network Open found that women with a family history of breast cancer were 22% more likely to have dense breasts than those without the family history of breast cancer. Women whose mother or sister had a history of breast cancer were 64% more likely to have dense breasts.