Assessing The Drug Shortage

Although more than 100 companies supply the 168 drugs currently in short supply, 51% of these products have only one or two suppliers. That’s one of the findings of an analysis of the supply chain dynamics in the shortfall of critical medicines by the IMS Institute for Healthcare Informatics.

The study also finds that 13 companies have stopped supplying drugs in short supply over the past two years. While the total monthly supply of all the drugs involved has increased by 4% over the past five years, IMS found a decline of more than 20% in supply in recent months for 75 drugs.

The Food & Drug Administration uses market information to determine whether a drug shortage exists. The drugs in short supply are primarily generic injectable products treating cancer, cardiovascular disease, central nervous system disorders, and other diseases.

“Patients throughout the U.S., including hundreds of thousands being treated for cancer, may be at risk of treatment disruption,” says Murray Aitken, executive director of the institute, a division of IMS Health.

The pharmaceutical intelligence firm recommends that FDA and the drug industry develop an “early warning system” with a supply volatility index, demand forecasting, and risk identification mechanisms.

In an Oct. 31 report, however, FDA said many of the “root causes and potential solutions” to the shortage lie beyond its purview. “The agency is also limited in its current authorities as it formulates a response to the problem,” the agency said.

President Barack Obama signed an executive order last month that more than doubles FDA staff devoted to drug shortages and puts pressure on drugmakers to notify the agency of anticipated supply problems (C&EN, Nov. 7, page 10). The order does not include mandatory reporting.

Harry M. Lever, medical director of the hypertrophic cardiomyopathy clinic at the Cleveland Clinic, told C&EN at a conference on drug safety earlier this year that shortages have become a near crisis. “It’s bad enough that at the clinic we’ve hired a pharmacist whose job it is strictly to keep up with drug shortages,” he said. “I never used to worry about it. Now it’s a major problem.”