Flu vaccine shortage elicits FDA guidance

January 21, 2013

The spike in flu cases over the past month, along with limited supplies of influenza vaccine and Tamiflu across the United States, has led FDA Commissioner Margaret Hamburg to issue guidance to pharmacists and other healthcare providers.

The spike in flu cases over the past month, along with limited supplies of influenza vaccine and Tamiflu across the United States, has led FDA Commissioner Margaret Hamburg to issue guidance to pharmacists and other healthcare providers.

"Some locations may experience intermittent, temporary shortages of the oral suspension form of the anti-viral, Tamiflu, which is the liquid version often prescribed for children, for the remainder of the flu season," FDA Commissioner Hamburg said during a press conference late last week.

 “Tamiflu has been reported on the drug shortages list, and some pharmacies have begun compounding liquid dosage Tamiflu to meet demand,” a statement from the National Association of Boards of Pharmacy (NABP) announced.

Meanwhile, FDA has been working with Tamiflu’s manufacturer, Genentech, to increase supply. “I want to assure patients also that Tamiflu 30 mg and 40 mg capsules remain available, and pediatric patients age one and older can be dosed correctly using the 30 mg and 40 mg capsules,” Hamburg said.

Still the rapid spread of influenza this season is alarming. 48 states are reporting widespread flu activity, and the City of Boston recently responded to the upsurge in flu cases by declaring a health emergency.

According to new data from the Centers for Disease Control (CDC), of the 5,249 influenza-associated hospitalizations that have been reported this season, 49.6% have occurred among patients who are 65 and older.

In addition, the proportion of deaths attributed to pneumonia and influenza increased sharply for the week of January 6-12, remaining above the “epidemic” threshold for the second consecutive week, the CDC reported.

At the same time, the CDC found that the number of people seeing their healthcare providers for flu-like illnesses decreased from 4.8% to 4.6% for the week of January 6-12, although it remains above the national baseline for the sixth consecutive week. In addition, the number of respiratory specimens testing positive for influenza in the United States dropped to 29.4% for the week of January 6-12, down from 34% the prior week.

For more information or assistance with the flu outbreak, contact RX Response at 866-247-2694.