Important pharmacy news and late-breaking industry information updated daily.
FDA on Friday approved an estrogen and progestin combination product consisting of elagolix, estradiol and norethindrone acetate (Oriahnn—AbbVie) capsules, co-packaged for oral use, for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.
[UPDATE: Maryland has also taken steps to allow pharmacists to bill Medicaid for specimen collection. More to come.]
The U.S. Department of Health and Human Services (HHS) has made clear that federal orders allowing pharmacists to order and administer FDA-authorized COVID-19 tests supersede state limits on scope of practice, and in at least one case has instructed a state pharmacy association to stop preventing pharmacists from testing for COVID-19. Now states are taking the baton, making widespread testing a possibility by creating pathways for pharmacists to bill for these services. Lack of avenues for payment has been a major barrier to increased access to COVID-19 testing at pharmacies.
In January, the Surgeon General released the first report on smoking cessation in 30 years. The report updates the latest findings on smoking cessation in the United States and highlights the important role pharmacists play in cessation efforts.
FDA reported Thursday that agency laboratory testing has identified levels of the nitrosamine impurity N-Nitrosodimethylamine (NDMA) above the agency's acceptable intake limit in several lots of extended-release (ER) metformin.
FDA said Wednesday it has found high levels of a potentially cancer-causing impurity in some versions of the diabetes drug metformin.
U.S. pharmacy chains are preparing a major push for influenza vaccinations when the season begins in October, hoping to curb tens of thousands of serious cases that could coincide with a second wave of coronavirus infections.
Your state prohibits pharmacists from ordering and administering COVID-19 tests? Think again, said the U.S. Department of Health and Human Services (HHS) Office of the General Counsel on Wednesday, May 20. An advisory opinion clarified that licensed pharmacists may order and administer COVID-19 tests even in states or localities that prohibit or effectively prohibit it.
It’s a popular question these days: Do people generate an antibody response to COVID-19?
The COVID-19 pandemic has put a spotlight on pharmaceutical companies' drug pricing decisions. Gilead Sciences has promised to give away its first production run of the antiviral therapy remdesivir and allow poor countries to make generics. Johnson & Johnson said it would sell its vaccine, now in trials, on a not-for-profit basis.
Heads up, pharmacy employers: the Occupational Safety and Health Administration (OSHA) has issued an alert listing safety tips to protect essential workers at pharmacies. Released May 14, 2020, it is OSHA’s first alert specifically recognizing pharmacy employees—but the recommendations are not binding.