Sen. Durbin Talks to Leaders at Condell about Prescription Drug Shortage
Hospitals, physicians, pharmacists and ambulance operators in Illinois are working hard on a daily basis to protect their patients from unprecedented shortages of important medications, U.S. Senator Dick Durbin (D-IL) learned while visiting Advocate Condell Medical Center on Wednesday.
During the visit, Durbin called for passage of the bipartisan Preserving Access to Life-Saving Medications Act, which he has co-sponsored. The bill would require drug manufacturers to notify the FDA of a disruption to a drug supply six months in advance—under threat of financial penalty—giving the FDA an opportunity to prevent the shortage, notify providers and develop a contingency plan; require HHS to create criteria for identifying potential drug shortages and require FDA to work with the manufacturer to maintain a drug supply; and require HHS to report to Congress actions taken to address the drug shortage.
“Over the past few years, hardworking doctors, nurses, pharmacists and EMS personnel have become all too familiar with this troubling scenario: their patient arrives in the hospital or ambulance only to discover that the critical drug needed to save their life is not available. This is a situation in which no patient should ever find themselves. Congress must work to pass a comprehensive solution to ease the burden on hospitals and pharmacies and to ensure that patients are receiving the best drug therapies available,” Durbin said.
“Illinois has been spared some of the worst case scenarios because our hospitals have been effective in managing the drug shortage and establishing alternative treatment plans. But the shortages are real and they are dangerous,” Durbin said.
Over the past five years the number of life-saving drugs in shortage has increased dramatically - from 55 to 231 reported drug shortages in 2011. 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 their lifesaving treatments or use unproven, less effective alternatives. Multiple factors contribute to the drug shortage including disruptions in the availability of raw supplies, manufacturing problems, limited manufacturing capability, delayed U.S. Food and Drug Administration (FDA) oversight, and business decisions to terminate manufacturing a drug, particularly generic drugs, due to low profit margins.
The drug shortage is affecting hospitals across Illinois and the country, including those in the northern suburbs. Currently, Advocate Condell is dealing with shortages of important narcotics, sedation, anti-seizure, and intravenous nutritional drugs. The hospital recently needed a sedation drug that was not available and paid a significantly marked up price to get it from a secondary distributor. Pharmacy staff spends large amounts of time trying to find drugs and alternative treatments.
“If these shortages continue, many patients will be put at risk for life-saving and even routine procedures,” said Dr. Ann Errichetti, President of Advocate Condell Medical Center. “Our supply changes weekly with often little or no notification.” Advocate Condell is Lake County's only Level I Trauma Center.
Illinois hospitals cite numerous consequences of the drug shortage including:
• Ethical dilemmas when doctors have to decide which patients get the limited supply of a drug and other patients get a less desirable alternative.
• Being forced to pay for drugs at a 200-500 percent mark up from secondary distributors, where there are concerns about the drug's integrity.
• Concern about patient safety as they use alternative drugs that have not been tested to treat a particular condition, have side effects, and require extra staff monitoring and procedures to ensure safety.
• Confusion caused by maintaining a drug in different concentrations, which requires extra attention to avoid dosing errors.
• Strain on resources and staff as the pharmacy works to keep drugs in stock, educate staff, and protect patient safety.
• Frustration by providers when they are unable to give patients the care they deserve.
In October of 2011, President Obama issued an executive order urging pharmaceutical companies to notify the FDA of impending prescription drug shortages. The FDA prevented nearly 200 drug shortages in 2011 due to voluntary early notifications from companies. Additionally, the FDA further expanded requirements on certain manufacturers of lifesaving, medically necessary drugs.