Top 10 Focus stories from 2016
In order, these are the stories that interested readers the most in 2016
In July, FDA issued a notice announcing that they are changing procedures for inspections of human drug compounders. FDA only gave about a month from the announcement—August 1—for the notice to be effective. APhA government affairs identified troubling language in the notice as follows:
- FDA will still undertake inspections of 503A facilities, rather than complying with current statute.
- FDA still intends to include CGMPs on Form FDA-483s, potentially for 503A pharmacies.
Good sleep is a must. In March, the National Sleep Foundation (NSF) revised all recommended sleep ranges, which are age-specific and based on a systematic review of the current scientific literature. Overall, wider appropriate sleep ranges for most age groups are recommended by NSF.
Updated vaccine recommendations for the 2016–17 influenza season included the continuation to have everyone aged 6 months and older without any contraindications receive a routine annual influenza vaccine. In addition, only injectable inactivated influenza vaccine and recombinant influenza vaccine should be used. In the recommendations, two new influenza vaccines were approved since last season and finally, a few of the recommendations for administering influenza vaccine in those with a history of egg allergy have been modified.
Zika virus disease was on everyone’s minds this year, including pharmacists. Here were some frequently asked questions from February as the disease was beginning to emerge.
In a study published in the Archives of Disease in Childhood, Dutch researchers found that adverse reactions from second-generation antihistamines can occur in children—a finding that gave many pause since these second-generation antihistamines were developed in an attempt to decrease adverse effects from first-generation antihistamines.
In October, FDA put out a striking announcement to ban 19 active ingredients in antibacterial soaps and body washes, including triclosan and triclocarban—the two most commonly used ingredients. The reason: These active ingredients have little science to back up their effectiveness and could actually do more harm than good.
The Department of Labor issued a final rule that took effect on December 1. It stated that employers must increase minimum salary for certain employees to keep them exempt from wage regulations, such as those related to overtime pay. The final rule does not exempt pharmacy residents, meaning they could see a bigger paycheck going forward.
FDA decided to change the brand name for vortioxetine. Starting in June, Brintillex switched its labeling to Trintellix in order to avoid errors associated with the similar-sounding name of the medication Brilinta.
Back in February when flu season was just beginning to hit, CDC issued a health advisory stating that severe influenza illnesses were reported. They also took the opportunity to encourage clinicians to continue with efforts to vaccinate patients against the influenza virus.
President Barack Obama signed legislation in July to provide a much-needed framework for opioid abuse prevention and treatment. The legislation, called the Comprehensive Addiction and Recovery Act of 2016, also recognized pharmacists as key players in the fight against the opioid epidemic.