Many Drugs Made Available Via FDA Expanded Access Programs

Over the past two decades, close to 100 FDA-approved drugs and biologics were made available before FDA approval through expanded access programs, a study in JAMA Network Open suggests. Researchers evaluated the timing and duration of expanded access and compassionate use programs for investigational medicines initiated before FDA approval. “[T]hese findings suggest that the FDA and pharmaceutical industry have established a balance between investigational new drug access and protection of patients from therapies without established safety,” the authors write.

Wed, 20 Jun 2018 BREAKING NEWS
CDC: Death Rate for American Youth Up in Recent Years

For persons aged 10 to 19 years, there was a 33% decrease in the total death rate from 1999 to 2013, followed by a 12% increase between 2013 and 2016, according to the CDC’s National Vital Statistics Report. The increase from 2013 to 2016 was due to an increase in injury deaths for 10- to 19-year-olds. All three leading injury intents (unintentional, suicide, and homicide), increased from 2013 to 2016, with unintentional injury increasing 13%.

Mon, 04 Jun 2018 BREAKING NEWS
Tighter Alcohol Policies Cut Alcohol-Related Crash Deaths

Strengthening state alcohol policies can reduce alcohol-related crash fatalities, according to a study published in JAMA Internal Medicine. The researchers found that over the study period there were 505,614 adult motor vehicle crash fatalities in the United States, of which 35.4% were alcohol related. For each 10-percentage point increase in the Alcohol Policy Scale score (more restrictive state policies) there was a reduced individual-level odds of alcohol involvement in a crash fatality (adjusted odds ratio, 0.90).

Wed, 30 May 2018 BREAKING NEWS
Congress Approves Bill Expanding Private Care for VA Patients

Patients served by the beleaguered Veterans Affairs health system may have wider access to private care, thanks to a bill approved by the Senate. President Donald Trump is known to support the bill, which awaits his signature. The Senate passed the bill 92 to 5 vote, thereby avoiding a shutdown of the VA’s Choice private-sector program, the AP said. That program was expected to run out of funding next week, which would have necessitated cutbacks in care to veterans.

Fri, 25 May 2018 BREAKING NEWS
Novel Purchasing Strategy Could Cut Medicaid Costs for HCV Meds

A novel purchasing strategy could dramatically reduce the costs of medications for hepatitis C virus (HCV), according to the Annals of Internal Medicine. Noting that new treatments could reduce HCV by 90% by 2030, but that these treatments are unaffordable for most, the authors suggest a strategy whereby the state makes a lump-sum payment deal with a drug manufacturer. In return, the manufacturer would provide a 100% rebate on drug purchases for the state’s Medicaid recipients.

Wed, 16 May 2018 BREAKING NEWS
Regulatory Requirements Drive Dissatisfaction with EHRs

Regulatory requirements are an important aspect of physician dissatisfaction with electronic health records (EHRs), according to an opinion piece in the Annals of Internal Medicine. The authors note that physicians abroad who use the same vendor software as the U.S. were more likely to report satisfaction with EHRs. The EHR tends to be much briefer in other countries, omitting much of the compliance and reimbursement documentation. Simplifying regulations around documentation and billing would likely benefit the health care system and patients.

Wed, 09 May 2018 BREAKING NEWS