About medical devices
FDA Warns of Possible Failure of EpiPen Injectors: “The FDA issued an alert about the potential failure of EpiPen 0.3mg and EpiPen Jr 0.15mg auto-injectors and authorized generics.
Pfizer, the manufacturer of the EpiPen, and Mylan said the devices may activate prematurely if their blue safety release is removed using a sideways force. A limited number of devices may have a blue safety release that is slightly raised and this also could cause the device to activate prematurely.
Additionally, some of the devices may not slide out of their carrier tube easily, or potentially at all, due to a slight deformation on the rim of the carrier tube, the companies said.”
About the public’s health
National Health Expenditure Projections, 2019–28: Expected Rebound In Prices Drives Rising Spending Growth: This article from the CMS Office of the Actuary is issued pre-publication in Health Affairs (Subscription required). Here is the Abstract:
”National health expenditures are projected to grow at an average annual rate of 5.4 percent for 2019–28 and to represent 19.7 percent of gross domestic product by the end of the period. Price growth for medical goods and services is projected to accelerate, averaging 2.4 percent per year for 2019–28, which partly reflects faster expected growth in health-sector wages. Among all major payers, Medicare is expected to experience the fastest spending growth (7.6 percent per year), largely as a result of having the highest projected enrollment growth. The insured share of the population is expected to fall from 90.6 percent in 2018 to 89.4 percent by 2028.” Note the rates of increase will be greater than projected economic growth.
Symptoms & Testing: This CDC website is a good reference for personal information and “what to look for.”
Project N95: This site enables healthcare providers who need access to PPE to connect with manufacturers who can fill their orders.
Economic cost of the 'cure' is not worse than the disease — here's why: President Trump opined that the government’s current public health measures may cause worse harm to the economy than lesser actions. Read why this statement is false.
The Society for Critical Care medicine has developed a Tiered Staffing Strategy to care for critically ill patients.
CDC says traces of coronavirus found on cruise ship surfaces after two weeks: The headline speaks for itself. The traces of virus may not be infectious but it stresses the need for strict hand washing protocols.
FDA to allow COVID-19 treatments with blood from survivors: These treatments are not guaranteed to work and will be allowed on a case-by-case basis.
About healthcare IT
Telehealth visits up 312% in New York, causing major lag times: The good thing about telehealth is its availability. However, when “everyone” is using the technology, increased waiting lines mitigate this advantage.
About pharma
Gilead’s Remdesivir Gets Orphan Drug Status: “The FDA has granted Gilead’s remdesivir orphan drug designation as a potential treatment for COVID-19.
The investigational antiviral compound is currently in clinical trials around the world in severe COVID-19 patients, including the World Health Organization’s multinational SOLIDARITY trial.”
This designation is VERY strange. First, the treatment is unproved. More importantly, if it is found to be effective, the exclusive market advantage that accompanies Orphan Status is supposed to be limited to rare diseases- those with not more than 200,000 afflicted. Read, also: Gilead under fire for declaring remdesivir an orphan drug
4 more state pharmacy boards join Ohio in curbing prescriptions for experimental COVID-19 drugs: “Four more state pharmacy boards have followed Ohio's lead and taken steps to block pharmacists from excessively dispensing two drugs touted as possible COVID-19 treatments, as both drugs are already in shortage.
Utah, Idaho, Texas and Nevada have all moved to block unnecessary prescriptions of chloroquine and hydroxychloroquine, both designed to treat malaria but commonly used to treat autoimmune diseases such as lupus and rheumatoid arthritis.”
FDA Clarifies Criteria for Competitive Generic Therapy Designation: “The FDA has clarified its criteria for granting a competitive generic therapy (CGT) designation. The agency can designate a generic as a CGT if there is no more than one approved drug listed in the active section of the Orange Book.
Once designated, a generic will remain designated a CGT even if there is no longer inadequate generic competition for that drug prior to the ANDA’s approval, the agency said.”