Ninety percent of hospitals experienced a drug shortage in the last half of 2010, and 80% said that the shortages had resulted in a delay or cancellation of a patient intervention as a result, according to a survey conducted by Premier Inc., a voluntary hospital and health care alliance and group purchasing organization.
Premier surveyed 311 pharmacy experts from hospitals; infusion centers; oncology and surgery centers; outpatient and retail pharmacies; and long-term care facilities about their experience with drug shortages during the period of July-Dec. 2010.
Not only did the vast majority report trouble accessing critical drugs, but at least a third reported experiencing access problem more than six times. According to Premier, shortages are at an all-time high. The Food and Drug Administration, the American Society of Health System Pharmacists, the American Society of Clinical Oncology, and other groups have been closely tracking the shortage problem over the last year and have been meeting to discuss potential solutions. The shortages have hit oncology particularly hard.
Over the second half of 2010, more than 240 drugs were in short supply or unavailable and more than 400 generic drugs were back ordered for 5 days or longer, according to Premier’s analysis. Many of those drugs still are not available. The major categories of drugs in short supply are anesthetic agents, other drugs used in emergency departments, and chemotherapy drugs.
The shortages are costing American hospitals at least $200 million a year, largely because the facilities have to buy more expensive alternatives or therapeutic equivalents. Hospitals are paying an average 11% more for these products, but sometimes more. The $200 million figure does not include additional labor for new dispensing systems and compounding, and the added expense for delays and disruptions in patient care, said Blair Childs, senior vice president of public affairs at Premier. These costs cannot be passed on to physicians, payers, or patients because of the nature of the hospitals’ purchasing contracts, so the facilities are absorbing the costs, he added.
There are multiple reasons for the shortages, according to Premier’s analysis, but one major problem is market consolidation. When the single supplier of a particular product has materials or manufacturing problems, no other manufacturers can take up the slack, Mr. Childs said.
Compounding the situation is the fact that many manufacturers, particularly of generic drugs, have ceased making products that are deemed no longer profitable. And, some distributors are buying up available supplies and instituting huge price increases, said Mike Alkire, president of Premier Purchasing Partners. He noted, for instance, that the diuretic furosemide previously sold for $1.21 a vial and is now being offered at $195 a vial.
Mr. Alkire said that the shortages were threatening patient safety. "It’s very, very important to understand that hospitals and other providers are doing unusual and unnatural activities to ensure the care of patients isn’t affected," he said. For instance, hospitals and pharmacists are purchasing drugs from distributors that may not have gone through the traditional vetting process used by Premier for vendors.
Martin Caponi, R.Ph., pharmacy director for Sacred Heart Medical Center in Eugene, Ore., said during the briefing that pharmacists and physicians are often the last to know of a shortage, leading to last-minute changes in dispensing and prescribing. Hospitals and providers are going to great lengths to ensure quality care, and yet, "Every step is being undermined by the drug shortages," said Mr. Caponi, chairman of Premier’s National Pharmacy Committee.
Premier and many other stakeholders are supporting legislation introduced by Sen. Amy Klobuchar (D-Minn.), the Preserving Access to Life-Saving Medications Act (S. 296).
During the briefing, Sen. Klobuchar characterized Premier’s findings as "disturbing." Among other things, her legislation would require a type of early-warning system from both manufacturers and the FDA. Drug makers would need to warn FDA at least 6 months in advance of discontinuing a product or give immediate notification if there was an unanticipated event that could lead to a potential shortage.
The FDA would be required to give the public and health providers faster notice too, Sen. Klobuchar said.
"Right now, pharmacists and physicians are about the last to know that a shortage is coming – sometimes they find out right before a patient’s treatment. That’s just not right," she said.