- HHS Withdraws Advisory Opinion on 340B Drug Discount Program (biospace.com)Drugmakers dig in and signal fight over HRSA's demands to reverse 340B contract pharmacy policies (fiercehealthcare.com)Transparency in Drug Pricing Can Start With 340B (drugtopics.com)
On December 30, 2020, the Department of Health and Human Services issued an advisory opinion on the 340B Program...This program limits the prices drug manufacturers can charge for therapies sold to specific healthcare facilities, including public hospitals and community health centers. The opinion was designed to address whether drugmakers could refuse to sell drugs to those pharmacies at the “ceiling price.”...AstraZeneca, Eli Lilly, Novo Nordisk and Sanofi turned around and sued HHS over the issue...HHS responded saying it “never intended to do what plaintiffs in those suits allege: to create new, binding obligations on plaintiffs or to serve as the predicate for enforcement against those plaintiffs.”...READ MORE
- ‘We’re Not Gonna Take It’—Bayer and Twisted Sister rocker join nonprofit to push back on prostate cancer (fiercepharma.com)
Heavy metal band Twisted Sister urged '80s teens to stand up and say, “We’re not gonna take it.” Now, founding band member Jay Jay French is teaming up with Bayer to convince the now grown-up teens to take the same stance against prostate cancer…French, a guitarist who also managed Twisted Sister, knows from personal experience why it’s important. His father died from prostate cancer, and French himself was diagnosed in 2018… French and Bayer, along with prostate cancer patient organization Zero – the End of Prostate Cancer, are working together on the social media and digital We’re Not Gonna Take It campaign…READ MORE
- EXCLUSIVE: The 340B Program Soared to $38 Billion in 2020—Up 27% vs. 2019 (drugchannels.net)
Discounted purchases under the program reached at least $38 billion in 2020. That figure is an astonishing 27% higher than its 2019 counterpart—and more than quadruple the value of discounted purchases in 2014…The 340B program’s size now exceeds the Medicaid program’s outpatient drug sales—and accounts for nearly 20% of the total rebates and discounts that manufacturers provide for brand-name drugs. Alas, many elements of the 340B program—including its controversial contract pharmacy component—lack a comprehensive regulatory infrastructure…READ MORE
- Medicaid’s warning on government healthcare (washingtonexaminer.com)
One reason why Medicaid isn't so good is that many doctors won't actually accept Medicaid patients...If you rely upon the health insurance system for the poor, you'll likely not be able to get medical treatment in many places. Seeing as medical coverage is designed to provide access to treatment when needed, the system doesn't seem to work all that well. This is not a good thing. After all, a bit of bad luck, and one of us could be relying on Medicaid...READ MORE
- Johnson & Johnson among companies excluding Colorado residents from remote job openings after new state law (fiercepharma.com)90 Companies are avoiding hiring in Colorado (coloradoexcluded.com)
A senior manager in operations at Johnson & Johnson. A sales specialist at McKesson. A manager for international tax planning at Cardinal Health...What do these recent postings for remote jobs have in common?...All specify that those who live in Colorado need not apply...The issue, it seems, is Colorado’s Equal Pay for Equal Work Act, which requires companies to disclose the pay range for job openings. The goal of the new law, which went into effect on Jan. 1, is to narrow gender wage disparities by in part forcing salary transparency. Instead, companies that prefer not to disclose pay are barring remote workers from the state...READ MORE
- Top 10 Errors Related To COVID-19 Vaccination (pharmacypracticenews.com)
Many of the underlying causes of vaccine-related errors are ongoing issues, so health care providers who plan to stock and/or administer COVID-19 vaccines should anticipate the types of errors that can and do happen and take the necessary steps to prepare and mitigate the risk for COVID-19 vaccine–related errors…A recent analysis of more than 160 COVID-19–related event reports submitted to the Institute for Safe Medication Practices National Vaccine Errors Reporting Program from December 14, 2020, through April 17, 2021, underscores that more needs to be done to reduce the risk for vaccination errors because they can lead to inadequate immunity, increased cost, and reduced confidence in the health care delivery system…READ MORE
1. Shoulder injury related to vaccine administration.
2. Not checking/documenting administration in the immunization information system.
3. Wrong diluent.
4. Wrong diluent volume.
5. Errors related to vaccine storage.
7. Administration of air in empty vaccine syringe.
8. Wrong dose.
9. Age-related events.
10. Vaccine competency. - EU Hits AstraZeneca Vaccine with Another Blood Condition for Side Effect List (biospace.com)
The AstraZeneca COVID-19 vaccine takes another hit to its safety profile as the European Medicines Agency adds a new side effect to the label of its shot...The EMA identified a rare blood condition, capillary leak syndrome, as a potential side effect of AstraZeneca’s Vaxzevria. The condition causes plasma leaks from blood vessels into neighboring body cavities and muscles. Blood pressure experiences a sharp drop as a result, and, left untreated, the disorder can lead to organ failure and death...READ MORE
- Key senator calls for Woodcock’s removal as FDA fallout from Biogen Alzheimer’s approval heats up (fiercepharma.com)
The FDA’s fallout from its controversial approval of Biogen’s Alzheimer’s drug Aduhelm is rolling on with one pivotal Democratic lawmaker calling on the administration to dethrone the agency’s top decision-maker...Sen. Joe Manchin called on President Joe Biden in a letter...to oust the FDA’s interim commissioner Dr. Janet Woodcock...The moderate Democrat took aim at the FDA’s decision last week to approve Biogen’s Aduhelm, also known as aducanumab, for Alzheimer’s patients despite intense controversy over whether the treatment actually helps with cognitive decline...READ MORE
- EU Hits AstraZeneca Vaccine with Another Blood Condition for Side Effect List (biospace.com)
The AstraZeneca COVID-19 vaccine takes another hit to its safety profile as the European Medicines Agency adds a new side effect to the label of its shot…The EMA identified a rare blood condition, capillary leak syndrome, as a potential side effect of AstraZeneca’s Vaxzevria. The condition causes plasma leaks from blood vessels into neighboring body cavities and muscles. Blood pressure experiences a sharp drop as a result, and, left untreated, the disorder can lead to organ failure and death…READ MORE
- Drug Diversion On Radar of the Joint Commission (pharmacypracticenews.com)
Consultants at Joint Commission Resources are urging hospitals to double down on efforts to keep controlled substances safe. This is in light of a Joint Commission finding that 10% of hospitals surveyed in 2019 did not meet medication security standards, including those meant to prevent diversion...Jeannell Mansur...PharmD, the principal consultant for medication management and safety at JCR..pointed to a range of medication management and storage gaps that leave controlled substances open to diversion in health systems...READ MORE