WASHINGTON -- The following information was released by New York Senator Charles Schumer:
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, And Drug Companies' Production Choices All Contributing To Shortages At Hudson Valley 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 throughout the Hudson Valley 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, increasing 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 the Hudson Valley 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 the continuity across the supply chain to make sure that doctors are equipped with the drugs they need to fight today's illnesses.'
'Hospitals tell us that commonly used drugs that have been available for over a decade are suddenly in short supply across the nation,' remarked Kevin Dahill, President and CEO of NorMet and the Nassau Suffolk Hospital Council. Dahill, who also serves as the Executive VP of HANYS, also asked, 'In a time when healthcare costs are under more scrutiny than ever, we wonder who is holding national suppliers and pharmaceutical companies accountable for their role in cost containment and healthcare effectiveness? The bill that Senator Schumer support would be a major step in the right direction here.'
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. The Hospital Association of New York State notes that in the past year in particular, shortages in the Hudson Valley have increased dramatically.
S. 226, 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 Kevin Dahill, President and CEO of NorMet, Jon. B. Schandler, President and CEO of White Plains Hospital Center, and the hospital's Director of Pharmacies as he pointed out that recently a number of Hudson Valley hospitals have reported shortages of anesthetics.
Physicians in the Hudson Valley have been working to deal with shortages of a variety of drugs including:
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Digoxen, a widely used drug in the treatment of various heart conditions, such as atrial fibrillation, atrial flutter and sometimes heart failure. Because of these shortages, hospitals in the Hudson Valley have been forced to prescribe more expensive, and less desirable drugs to patients.
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Fentanyl (a transdermal opioid pain patch) used to administer pain medication to cancer patients have been in short supply recently, so doctors are forced to administer the medication to patients who are unable to swallow or digest through injection, a less ideal approach.
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Dexamethazone injections, commonly used to combat neurologic injuries including head trauma and strokes, have been in short supply in the Hudson Valley, forcing doctors to use the alternative, methylprednisolone.
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Medication to calm patients' nerves so that ventilators can fully function has also been in short supply. Without these Ativan injections, some patients experience severe panic that could lead to actions that would worsen their medical condition, or put the safety of medical personnel at risk.
In addition, Schumer noted that several Hudson Valley hospitals have reported nearly cancelling elective surgeries, which were only allowed to go forward when substitute drugs were located. The Northern Metropolitan Hospital Association reports that its members have noted that shortages of essential medications have 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. 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), the Northern Metropolitan Hospital Association, 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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