|Michael J. Alkire, COO of Premier--Courtesy of Premier|
A presidential order in 2011 required drugmakers to notify the FDA of anything, like a manufacturing interruption, that might affect the supply of any of their drugs. This has allowed the agency to head off some drug shortages or attack them when they occur. But hospitals say the sense of urgency is still not great enough and that the FDA and drugmakers should loop in hospitals and group purchasing organizations to attack shortages the way police would attack a hostage situation.
"We need a 'SWAT team' mentality by all, including the FDA, the manufacturers, the distribution channel, the GPOs and the hospitals," said Michael J. Alkire, chief operating officer of supply chain and healthcare consulting group Premier. His statement accompanied a survey Premier released last week on how hospitals are dealing with drug shortages.
It acknowledged that the FDA's efforts to get in front of shortages had improved the situation, but said medical procedures are still being delayed because drugs are unavailable, creating risk for patients and expense for the medical system. Premier estimates that drug shortages are adding $230 million a year to the nation's bills for hospital care.
It said hospitals are currently finding it particularly difficult to lay their hands on cardiovascular drugs like nitroglycerin solution, anesthesia and sedation products like propofol used in surgeries and intravenous solutions. For several months, the FDA has been working with Baxter International ($BAX)--which recently had to recall four lots of saline--Hospira ($HSP) and Braun to boost production of that product and other IV solutions. U.S. hospitals go through millions of units of the products a week. The FDA no longer includes propofol on its drug shortages list after Hospira and Teva ($TEVA) both ramped up production of the anesthesia following manufacturing interruptions.
The FDA has tackled drug shortages with a special urgency in recent years, and the efforts have been paying off: A recent report on shortages from the FDA said it was able to ward off 140 potential drug shortages during the first 9 months of last year. The agency said only 38 new shortages were reported in that period, which is a huge decline from 2012 when there were 117 new shortages during the full year. On average, the 38 tallies up to less than half the number reported in 9 months of 2012.
Premier reports that the improvements have been noted at its client hospitals, where the number of patients facing a canceled or delayed medical procedure because of a drug shortage in the past 6 months is half what it was in 2010. Still, as a recent Government Accountability Office report shows, while the growth in drug shortages has slowed, the total number of ongoing drug shortages has gotten larger every year since 2007. It reached 288 through June of last year.
- read the Premier release
- here's the survey