What We're Reading: Biosimilar Rituximab; Turning Back Time on EHRs; OTC Cough Products for Kids

November 5, 2018

Sandoz announced it will no longer pursue FDA approval for its proposed biosimilar rituximab; when it comes time to set the clocks back an hour for daylight saving time, hospitals opt for paper records during the night shift to compensate for challenges with electronic health records; new research on the effectiveness of over-the-counter (OTC) medicines finds little evidence that these products will relieve a child’s symptoms when sick.

Sandoz Abandoning Biosimilar Rituximab in the United States

After receiving a Complete Response Letter from the FDA for its proposed biosimilar rituximab, Sandoz has re-evaluated the environment and decided it will no longer pursue FDA approval for GP2013. The American Journal of Managed Care®’s The Center for Biosimilars® reported that Sandoz does not believe it can generate the data required before “patient and market place needs” in the United States are “satisfied.” Celltrion’s CT-P10 has already received a recommendation from an FDA advisory panel to be approved.

Setting the Clocks Back Challenges EHRs

It happens every year, and yet when it comes time to set the clocks back an hour for daylight saving time, hospitals opt for paper records during the night shift to compensate for challenges with electronic health records. According to Kaiser Health News, information entered from 1 am to 2 am will likely be deleted when the clock sets back to 1 am and hospitals avoid software glitches by turning the software off and using paper charts for an hour. Care delivery also slows down during the hour.

Questioning the Use of OTC Products in Sick Children

New research on the effectiveness of over-the-counter (OTC) cough and cold medicines finds little evidence that these products will relieve a child’s symptoms when sick. According to The New York Times, a review in The BMJ highlighted that there are actually risks in using OTC medications in young children. The American Academy of Pediatrics recommends against using OTC cough and cold preparations in children under age 6. The FDA only recommends against use in children under age 2. Instead, pediatricians recommend offering plenty of fluids, ibuprofen or acetaminophen, and honey (for children older than 1 year).