The Food and Drug Administration has made strides in preventing new drug shortages but the agency is still struggling to address the glut of ongoing deficits.
The U.S. Government Accountability Office found that while new shortages have generally decreased since 2011, the number of ongoing shortages has remained high. In 2015, 291 ongoing shortages were reported. That's a 5% increase from 2014 and more than double from 2010. Providers and public health officials alike worry that persistent drug shortages can delay patient care or leave patients with less-effective alternatives.
Directed by Congress to study drug shortages, the auditing agency found that the FDA issued an increasing number of warning letters to the makers of sterile injectible drugs, like antibiotics, cancer medications and anesthetics. Sterile injectables represent some of the most persistent shortages. They are difficult to produce safely because of issues with sterility, bacterial or fungal contamination, visible particulates in the medication, or crystallization, among other reasons.
While the FDA has increased the amount of inspections it performs at manufacturer facilities, the GAO found that the overall number of warning letters resulting from those inspections – beyond sterile injectables – has remained relatively small. Only eight were delivered in 2013, the most recent year for which data is available. There weren't more than 11 warning letters between 2007 and 2013, and for every year besides 2007, there were at least five.
Those warning letters don't order a halt to production, so it's unlikely that they're contributing to supply disruption, and some of the warning letters were sent to repeat offenders. During the GAO review period between January 2010 and July 2014, seven of the establishments that received warnings letters had a previous history of compliance problems.
Group purchasing organizations and providers want the FDA to expedite the review of manufacturer applications to produce drugs that are frequently in shortage, especially for sterile injectables. GPOs have gotten creative in contracting and sourcing to make up for shortages, sometimes launching their own private generic drug labels or contracting with active-ingredient suppliers to ensure a steady supply.
The report notes that the FDA expedited the review of 383 drug applications and supplements between January 2010 and July 2014, the same period as the GAO review. That represents about 3% of all applications it received. Sixty-three percent of those expedited applications were for sterile injectables.
The GAO found that, among the 38 drugs for which applications were received, 15 drugs were associated with at least one expedited application that was approved before a shortage was resolved or prevented a potential shortage from occurring. The report cautions against drawing a causal link from this data, but this does suggest that the agency has followed up on its previous promises that it would work swiftly to ensure there are multiple producers for drugs that are prone to shortage.
Recognizing the difficulty of drug shortages and the affect they can have on hospital operations, some providers have gone outside of their GPO contract and forged direct relationships with manufacturers to buy drugs when the usual channels run scarce. These relationships often come at a premium cost, and aren't common.