NEW ORLEANS – Five therapeutic areas account for two-thirds of the drug shortages in the United States, with oncology taking the hardest hit.
Those shortages may affect as many as a half-million cancer patients, according to a Nov. 14 report from the IMS Institute, a division of health care analytics firm IMS Health.
The ongoing problem was high on the agenda at the interim meeting of the American Medical Association House of Delegates. In response to reports by IMS and an AMA committee, the House of Delegates voted to encourage the AMA to push Congress and the Food and Drug Administration to require manufacturers to create contingency plans in case of shortage.
Some delegates sought to have the AMA back the rights of manufacturers to set prices and recover additional costs in the face of shortages, but the resolution was voted down.
The House-passed policy also urges support for recommendations from a Dec. 2010 summit sponsored by the American Society of Health System Pharmacists (ASHP), the American Society of Anesthesiologists, the American Society of Clinical Oncologists, and the Institute for Safe Medication Practices.
“Drug shortages can delay a patient’s treatment and may force physicians to use alternative drugs that aren’t optimal, leading to an increased potential for errors and adverse outcomes,” said AMA president-elect Jeremy A. Lazarus in a statement.
In its report, IMS reviewed information for 168 drug shortages reported to both the Food and Drug Administration and the American Society of Health System Pharmacists. The data give more of a real-time snapshot of what’s happening in the supply chain because they use invoice and purchasing data, said Bona Benjamin, ASHP director of medication use–quality improvement, who discussed the report at the interim meeting of the American Medical Association House of Delegates.
The company found that more than 80% of the 168 products in short supply are generics, and more than 80% are injectables. A total of 16% are oncology products; 15% are anti-infectives, 12% are cardiovascular products, 11% are central nervous system products, 9% are for pain, and 9% are vitamins and nutritionals.
There is no doubt that oncology is a problem area, said Ms. Benjamin. She is the liaison between ASHP and the FDA and her association’s point person for the public, physicians, hospitals, and others on shortages.
"Recently with the escalating oncology drug shortages, I’ve gotten many, many, very distressing calls from patients who are not able to get the drugs that they need," she told AMA meeting attendees.
Overall, 232 drugs have been in short supply this year, Ms. Benjamin said, adding that the number could reach 300 before year’s end. In oncology, there were few shortages for many years. The number jumped in 2010 to 24 shortages. There have been 20 so far in 2011, the vast majority injectables, she said.
Dr. Chris Nunnink, delegate to the AMA House from American Society of Clinical Oncology, said that shortages were not only threatening patient care, but also hastening the shift from office-based to hospital-based practices.
Profit margins are slim and declining; shortages are exacerbating that and making new physicians think twice about starting their practices, he said. "Just about every oncologist now is going to a hospital-based practice," said Dr. Nunnink of the Vermont Cancer Center in Colchester.
Patients often end up having to pay more out of pocket for the available alternatives, he said. And, sometimes standard chemotherapy drugs just aren’t available. "I have to say I don’t have Taxol," he said. "To have that conversation with a patient is just incredibly frustrating."
The IMS report concluded that manufacturing issues are largely responsible for the shortages. Companies that get into trouble with the FDA concerning their drug quality either have to suspend manufacturing or stop altogether. Also, many companies have not been prepared to meet the demand for their products, in particular the generic injectables.
Manufacturing and supply of many key products is concentrated in the hands of a few companies, the IMS report found. While there are 100 suppliers of the 168 products studied, half of those products have only 1 or 2 suppliers. Thirteen companies have stopped supplying products on the shortages lists within the past 2 years.
Ms. Benjamin said that 23 of the drugs have only two suppliers, and two-thirds have three or fewer suppliers. If one supplier is hobbled by a production issue, often the other two cannot meet the additional 30% demand, she said. This was the case for propofol; there were shortages for a year because one manufacturer ceased production. The FDA ended up allowing importation from Germany.