“In the past couple of years, it’s just been exponential,” says Diane Ginsburg, president of the American Society of Health-System Pharmacists and clinical professor and assistant dean for student affairs at the University of Texas’ College of Pharmacy in Austin.
According to the FDA, 77% of the shortages in 2010 involved sterile injectable drugs.
“There are fewer and fewer firms making these older sterile injectables, and they are often discontinued for newer, more profitable agents,” FDA spokeswoman Yolanda Fultz-Morris said in an email. “When one firm has a delay or a manufacturing problem, it is extremely difficult for the remaining firms to quickly increase production.”
The biggest cause for the shortages in those drugs has been product quality issues, namely microbial contamination and newly identified impurities, according to the FDA. From January to October of 2010, 42% of drug shortages were due to quality problems.
Eighteen percent were due to product discontinuation by the manufacturer and another 18% were due to delays and capacity problems. Nine percent were due to difficulties getting raw materials, and 4% of the sterile injectable shortages were due to increased demand because there was a shortage of another injectable medication. In other words, one shortage led directly to another.
Kevin Schweers, a spokesman for the National Community Pharmacists Association, says generic drugs, especially Schedule II substances, have been in short supply. But there can be problems even when one generic is available to replace another generic.
An example, he says, is when a “new generic substituted in place of the old one is made by a different manufacturer and may come in a different color or shape. That can leave patients”—including those just released from hospitals—“wondering and asking the pharmacist why their medication is different or if a mistake was made.”