Schumer: Rochester Hospitals & Others Throughout NY Suffering from Shortages of Life-Saving Medications - Pushes New Legislation to Ensure Patients Get the Medicine they Need
Press Release
Schumer Announces Support For New Legislation Requiring The FDA To Work With Drug Companies To Ensure Adequate Availability Of Life-Saving Drugs And Prevent Supply Chain Interruptions
Lack Of Raw Materials, Increase In Demand For Certain Drugs Like Shingles Vaccine, And Drug Companies' Production Choices All Contributing To Shortages At Rochester Hospitals
Schumer: This Bill Would Ensure That Doctors Have The Medicine They Need To Deliver Top-Notch Medical Care
Today, U.S. Senator Charles E. Schumer announced his support for new legislation that would create an early warning system within the Food and Drug Administration to help ward off shortages of life-saving drugs. The Preserving Access to Life-Saving Medications Act would require drug makers to immediately notify the FDA when a raw material shortage, manufacturing problem, or production decision is likely to cause a drug shortage. The early notification would allow the FDA to work with other manufacturers, both domestic and international, to find new sources and ensure that the supply chain is not interrupted. Schumer's support for the bill comes as a number of hospitals and doctors throughout the Rochester region and across the country have reported shortages of anesthetics and other medicine that is essential to patient care, according to the Healthcare Association of New York State (HANYS). Physicians have been forced to substitute therapeutically equivalent medicines because of drug shortages, which can increase costs to patients and the system and elevating the possibility of errors. One analysis suggested the increase in health care costs due to the need for substitutions could be as much as $200 million each year nationwide.
"With drug shortages on the rise, hospitals, physicians, pharmacists and patients cannot be the last to know when an important drug will be unavailable to them," said Schumer. "This common-sense solution will minimize that risk by creating an early warning system from drug makers to the FDA, so that hospitals in Rochester and all throughout New York will have the medicine they need to deliver top-notch medical care. Patients should never have to hear a doctor tell them they're out of medicine -- this bill would ensure continuity across the supply chain to make sure that doctors are equipped with the drugs they need to fight today's illnesses."??"Unanticipated drug shortages pose a serious, growing risk to patient safety and they drive health care costs," said Bradford C. Berk, M.D., Ph.D., CEO, University of Rochester Medical Center and University Vice President for Health Science. "We're immensely grateful to Senator Chuck Schumer for his support of legislation that will empower the FDA to ensure a reliable, sufficient supply of life-sustaining medications in our hospitals. That will allow our staff to focus on taking care of patients and free them from the worry that critical medications may not be on our shelves."
"Each drug shortage has cost us a minimum of 40 man hours trying to identify the substitute, inform staff, deploy the product and implement the computer system changes," said James Della Rocco, RPh, J.D. Director of Pharmacy Services for Unity Health System. "Multiply the fact that this is once or twice a week, and has been a recurrent event for the last several months of drug shortages, and you have an extraordinarily large drain on manpower usage which quite frankly should be spent directly on patient care."
This year, pharmacists and other health care providers have been reporting unprecedented shortages of prescription drugs. Experts cite a number of factors behind the shortages, including scarcity of some raw materials, manufacturing problems, and unexpected demand. Business decisions within the pharmaceutical industry are also a factor, such as cutting back on the production of low-cost generic drugs in favor of more profitable brand-name drugs. The frequency and impact of drug shortages have risen to critical levels, more than tripling since 2005, and affecting all segments of healthcare. According to a report from the Premier Health Alliance, in 2010, over 240 drugs were either in short supply or completely unavailable and more than 400 generic equivalents were backordered for greater than five days. From 2009 to 2010, the number of newly reported shortages rose from 166 to 211. Physicians in the Rochester area have noted that shortages of drugs in hospitals and clinics are occurring at an alarming rate, and have appealed directly to Schumer to cosponsor this potentially life-saving legislation.
S. 296, the Preserving Access to Life-Saving Medications Act, introduced by Senator Amy Klobuchar (D-MN), would give the FDA the ability to require early notification from pharmaceutical companies when a factor arises that may result in a shortage. These factors may include changes made to raw material supplies, adjustments to manufacturer production capabilities, and certain business decisions such as mergers, withdrawals, or changes in output. The bill would also direct the FDA to provide up-to-date public notification of any shortage situation and the actions the agency would take to address them. This bill shifts shortage reporting responsibility from providers to manufacturers; requires all manufacturers to report upcoming drug shortages to the FDA; increases manufacturer accountability by requiring them to anticipate and notify of future manufacturing stoppages, but does not impose fines or other sanctions for reporting; and allows providers to better anticipate impending shortages so both providers and patients can prepare for alterations in treatment regimens. This early warning system would allow the FDA more time to work with domestic and international manufacturers in order to provide increased availability of life-saving drugs.
Schumer was joined by Dr. Raymond Mayewski, Vice President and Chief Medical and Quality Officer at University of Rochester Medical Center, Dr. Joseph Salipante, Vice President of Medical Affairs at Unity Health Systems, James Della Rocco RPh, Pharmacy Director for Unity Health Systems, Dr. Anthony Fedullo, Medical Director at Rochester General Hospital, Doug Hosie, Pharmacy Director at Rochester General Hospital, Nancy Adams, Executive Director of the Monroe County Medical Society and Diane Ashley, President and CEO of the Rochester Regional Healthcare Association.
Physicians in the Rochester region have been working to deal with shortages of a variety of drugs including:
Zostavax - A vaccine for shingles, utilized to reduced the severity and duration of pain and discomfort associated with shingles. Approximately 1 in 3 people will experience shingles in their lifetime, and in March the FDA expanded the indication for Zostavax to patients over the age of 50. This increased demand has cut into the supply, and is often out of stock at hospitals and clinics that typically offer monthly clinics to patients in Rochester.
Ritalin -- A drug approved for treatment of Attention-Deficit Hyperactive Disorder (ADHD) in patients. Ritalin, Adderall and their generic counterparts have been abruptly unavailable, and often doctors and patients only become aware of shortages when attempting to fill prescriptions at pharmacy.
Retevase - A drug used to treat heart conditions by improving heart function and reducing long-term effects of a heart attack. Unavailability has forced changes in medical protocols in emergency rooms, and at one Ontario County hospital added approximately over $1300 to the cost of treating just a single heart attack patient.
Propofol -- A drug used by anesthesiologists during surgical procedures and is often the preferred agent for ambulatory surgery. Unavailability nearly forced one local hospital to cancel certain surgical procedures.
Other common drugs that are in short supply in this area and other parts of the state are also staples in trauma units, like morphine, dopemine, and norepinephrine, and all play crucial roles in stabilizing the critically ill.
Hospitals have also experienced a shortage of vasopressors, like Dopemine and Noripenephrine, that are vitally important to emergency departments to stabilize blood pressure in critically ill or injured patients.
In addition, Schumer noted that several Rochester hospitals have reported nearly cancelling elective surgeries, which were only allowed to go forward when substitute drugs were located. Shortages of essential medications have also led to longer hospital stays and slower recovery periods for patients. In many cases, the drugs in question have been on the market for several years, or even decades. Treatment plans have been created and established based on the availability of these drugs, making it extremely difficult for physicians to adjust to their absence.
Schumer states that these drug shortages require costly resources and time to alleviate, costing one Rochester Hospital?nearly $1 million last year alone and hundreds of hours in manpower to find alternatives. Because there is currently no warning system, pharmacists and physicians are forced to do work-arounds, substitutions, and occasionally must even secure the drug from an alternate source - the "gray market" -- due to the short supply or complete unavailability from wholesalers. Though not illegal, Pharmacy Directors aim to avoid using this alternate source, based on safety and cost concerns. The "gray market' is made up of distributors who purchase medicine and medical supplies and markup prices, sometimes by as much as 335% according to the Premier Health Alliance survey, before selling to hospitals and doctors. Schumer also notes that doctors believe these drug shortages can create longer stays in hospitals, and slower recoveries.
The legislation is endorsed by the Healthcare Association of New York State (HANYS), Greater New York Hospital Association, the American Hospital Association, the American Society of Clinical Oncologists, the Institute for Safe Medication Practices, the American Society of Health System Pharmacists, and the American Society of Anesthesiologists.
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