Durbin: Congressional Action Needed to Ease Drug Shortage

U.S. Sen. Dick Durbin, during his visit Wednesday to Advocate Condell Medical Center, called for the passage of a bill he said would help ease the drug-shortage problem.

The Preserving Access to Life-Saving Medications Act would require drug manufacturers to notify the Food and Drug Administration of a disruption to a drug supply six months in advance.

“This issue came as a big awakening to me. I really didn’t know how serious it was,” Durbin said. “I can’t go anywhere in the state, in Chicago, in Illinois, and here in Lake County, without hearing the same thing — hospitals are facing serious shortages.”

The senator first heard about the issue three months ago while in a committee meeting with Sen. Amy Kloburchar, D-Minn., who first introduced the bill in February 2011.

Drug Shortages Increase Health Care Costs, Risks

Durbin heard from North Shore health care providers during a panel discussion at Advocate Condell Medical Center.

Health care providers say the drug shortage is causing various issues, such as unnecessary increase in health care costs, risks, stockpiling of drugs, ethical dilemmas and strains on staff.

Bill Santulli, chief operating officer of Advocate Health Care, says disruptions in drug supplies have cost the company about $2 million in increased expenses. “You take that across the industry and that’s an incredible amount,” he said.

Donna Krueger, an administrator for Illinois Cancer Specialists, says the increase also trickles down to patients.

“One of the drugs we had a big shortage on last year was Leucovorin, which is used to treat colon cancer. For 12 cycles it cost $450 for Medicare but to switch to the alternative, which most people had to do, it was $24,000 for the course of this drug,” Krueger said during the discussion. “Not only does it affect the physicians and the hospital, that extra difference means more out of pocket for the patient.”

For the generic version of Leucovorin, patients paid $110 out of pocket, but due to the generic drug shortage, many had to switch to alternatives, which cost patients $6,000 out of pocket, Kreuger said.

Health care providers say drug shortages also force doctors to decide between which patients get the limited supply of a drug and which patients get alternative drugs that could lead to more health risks.

“This entire issue also encourages stockpiling,” Karen Lambert, president of Advocate Good Shepherd Hospital in Barrington said.

Hundreds of Drug Shortages in 2011

In 2011, there were 231 reports of lifesaving drug shortages, up from just 55 reports five years ago. Injectable drugs used for cancer treatment, anesthesia, antibiotics, or nutrition supplements represent almost 70 percent of the drug shortage. In the most extreme cases, drug shortages have forced patients to delay lifesaving treatments or use unproven, less-effective alternatives, according to a press release from Durbin.

“Shortages are happening mostly because drug companies don’t make generics — they are not viable for them,” said Krueger, a registered nurse with 30 years of experience.

That’s an issue Durbin hopes to address with the bipartisan Preserving Access to Life-Saving Medications Act, which he has co-sponsored.

The bill aims to give the FDA opportunity to prevent the shortage, notify providers, work with manufacturers to maintain a drug supply and develop a contingency plan. It also would require the Department of Health and Human Services to create criteria for identifying potential drug shortages and report to Congress the actions taken to address the issue.

“What we are trying to do is to collect the (issues) and come up with a way to solve the problem,” Durbin said.

The senator cited the Orphan Drug Act, passed in 1983, which makes it economically justifiable for manufactures to produce drugs that treat rare diseases. 

“If it’s a financial incentive for a generic drug company that’s missing, we’ve got to find ways to approach this to make sure the supplies are there,” he said.

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