The drug shortage has become such a hot-button issue that President Barack Obama issued an executive order last month requiring the FDA to take action.
In the weeks after the executive order, a study conducted by the IMS Institute for Healthcare Informatics, a health research company based in Danbury, CT, shed some light on the pattern of drug shortages.
The shortages are primarily limited to generic injectables and a few key disease areas, but troublesome nevertheless, according to Murray Aitken, the institute's executive director.
In a webinar, Aitken noted that 16% of the products in short supply are oncology drugs, which may affect as many as 550,000 patients. Other affected disease areas include infections, cardiovascular disease, central nervous system, and pain. More than 80% of the products are generic and more than 80% are injectables, according to the report.
Over the last five years, White House data indicates that the demand for sterile injectable cancer treatments has increased by about 20%, without a corresponding increase in capacity. The FDA has developed a page on its website giving an overview of current drug shortages. (Healthcare professionals and patients are encouraged to notify the FDA about shortages at firstname.lastname@example.org.)
According to FDA estimates, about 42% of the 2010 drug shortages were caused by product quality issues. While ensuring safety standards is paramount, the FDA also needs to determine whether its evaluation of product quality is accurate, Solberg says.
The IMS Institute and other healthcare groups, such as the American Society of Hematology, have recommended that the FDA establish an early warning system to improve drug supply monitoring, which is being considered in legislation introduced in Congress. Lawmakers are also considering other plans, such as establishing economic incentives to produce medically necessary drugs in shortage. Some Democratic Senators are calling for hearings on the drug shortages, as well as seeking a General Accountability Office probe.
In the meantime, drug manufacturers say they are working together to examine and adjust their manufacturing schedules for "life-saving" drugs that could be susceptible to shortages.
Still, physicians and patients must be vigilant about drug shortages. Only a few weeks after Solberg was relieved to learn that cytarabine had returned to the market, he received a letter on November 21 from Janssen Products, LP, about delays in the availability of its cancer-fighting drug DOXIL.
"This suspension of manufacturing will impact the production and release of DOXIL, which remains in short supply," the pharmaceutical company wrote. "We are not able to estimate timing when DOXIL may return to market."
Unfortunately, Solberg, says, physicians like him will probably receive more letters like that from other drug manufacturers in the months ahead.