Upcoming Product-Specific Guidances for Complex Generic Drug Product Development: This FDA announcement is not important to the general reader for its specifics. It is a reminder that although general parameters are in place for generic definition and compliance, the Agency still can issue product-specific guidance (PSG) for individual drugs.
As off-label use spreads for lifesaving niche drugs, supplies grow scarce, leaving patients in the lurch: Off-label use of medications not only increases costs and may cause serious side effects, but, as the article points out, can cause shortages for patients who really need the medication. What can be done to address this problem? One missing IT app is connecting the prescription drug code with diagnosis codes to monitor appropriateness.
A Painful Pill to Swallow: U.S. vs. International Prescription Drug PricesThe U.S. could save $49 billion annually on Medicare Part D alone by using average drug prices for comparator countries: This report from the House Ways and means Committee concluded that “The U.S. could save $49 billion annually on Medicare Part D alone by using average drug prices for comparator countries.”
New CRISPR approach could improve gene and cell therapies: “The most commonly used gene editing technology, CRISPR-Cas9, uses just one Cas protein to cut DNA. In the CRISPR field, this is known as a ‘class 2’ system. Class 1 systems, by contrast, are more complicated because they rely on multiple proteins to bind to DNA and then recruit a Cas3 protein to cut it. That network of proteins is called Cascade (CRISPR-associated complex for antiviral defense).” However, “Class 1 CRISPR–Cas systems represent about 90% of all CRISPR systems in nature [and] remain largely unexplored for genome engineering applications.” This new technique allows access to that 90%. Further, it allows modification of epigenomic changes, which control the gene function. This method is a real scientific breakthrough.
About healthcare quality and patient safety
NCQA Health Insurance Plan Ratings 2019-2020- Summary Report (Private /Commercial): The geographic distribution of these plans is very uneven. 38 scored 4.5/5 or above. Read the methods as well as the actual rankings.
About healthcare IT
California Looks to Expand Coverage for Telehealth Services: “A bill awaiting Governor Gavin Newsom's signature would require payers to cover telehealth services 'on the same basis and to the same extent' that providers are reimbursed for the same care delivered in person.”
Types of Information Compromised in Breaches of Protected Health Information (Annals of Internal Medicine- subscription required for full article):”Our analyses of 1461 PHI breaches over the past 10 years indicated that 71% of the breaches affecting 159 million patients (94%) compromised sensitive demographic or financial information that could be exploited for identity or financial fraud. Two percent of the breaches affecting 2.4 million patients (1%) compromised sensitive medical information, potentially threatening their clinical privacy.”
New robot offers in-home monitoring, medication dispensing: “Black+Decker has partnered with tech company Pillo Health to launch a new robot assistant named Pria to help with in-home adherence to medication.” This device is a far cry from the plastic pill pack strips now in common use. Check the Pria website to see how it works.
Amazon plans Alexa wireless earbuds with fitness-tracking built in, bigger Echo with better sound, source says: The healthcare part of this announcement is the wireless earbuds that will act as a fitness-tracker- competition for Fitbit and Apple.
New consortium works on mixing in IT to improve care outcomes: “The Object Management Group has launched BPM+ Health to aid healthcare stakeholders in leveraging health information technology to improve the quality of clinical care…Founding members include providers, vendors, universities, specialty societies and the Department of Veterans Affairs. Among those groups include the Agency for Healthcare Research and Quality, the Healthcare Information and Management Systems Society, HL7, the Healthcare Services Platform Consortium, the National Committee for Quality Assurance. The goal is to advance the consistency, efficiency and quality of care by improving the sharing of health practice patterns, workflows and clinical pathways among vendors and institutions.”
About the public’s health
UN welcomes ‘most comprehensive agreement ever’ on global health: Read about the UN’s commitment to achieving Universal Health Coverage by 2030. What is the US doing to help?
About healthcare professionals
Walmart announces plan to build healthcare workforce, offering education for $1 a day: Walmart announced today that “its 1.5 million associates will be able to apply for one of seven bachelor’s degrees and two career diplomas in health-related fields for $1 a day through Live Better U, Walmart’s education benefit program…The health and wellness courses include career diploma programs for pharmacy technicians and opticians through Penn Foster and seven bachelor’s degrees in health science, health and wellness and healthcare management/administration offered through Purdue University Global, Southern New Hampshire University, Bellevue University and Wilmington University.” The benefit is aimed at increasing personnel for Walmart’s expanding in-store healthcare services.