"Addressing A Shortage Of Critical Drugs"
Physicians, pharmacists, and patients in Maine and throughout the country are struggling to cope with a surge in shortages of drugs that is causing significant disruptions in care and putting patients at risk. According to the U.S. Food and Drug Administration (FDA), the number of drug shortages has nearly tripled over the last six years, jumping from 61 products in 2005 to a record 178 in 2010. And the pace is accelerating, with more than 150 shortages reported already this year.
Many of the drugs in short supply are vital, used in hospitals and cancer centers for anesthesia, chemotherapy, and infections. There also are continuing shortages of drugs used in emergency rooms and intensive-care units.
I have met with several doctors and other medical professionals in Maine who are very concerned about this issue. They said these shortages are causing serious problems around the country, including forcing some medical centers to ration drugs or postpone elective surgeries. Oncologists have told me of situations where they are forced to change a patient's chemotherapy regime midcourse because they suddenly encounter a shortage of a particular drug. For some drugs, such as the leukemia drug cytarabine, there are no effective substitutes.
And substitution raises a host of other issues. In most cases, the original drug was chosen because it was deemed the most effective for that particular patient. In addition, a substitute may present interaction problems with other drugs the patient is taking that the original drug would have avoided.
This crisis is widespread. In a survey by the American Hospital Association, more than 80 percent of hospitals reported that have had to delay treatment due to shortages, and nearly 70 percent said patients received less effective substitutes. Pharmacists and technicians can each spend about 17 hours a week managing drug shortages, increasing labor costs by $216 million a year.
This is not solely an American problem - similar shortages are occurring worldwide. Last year, 94 percent of Canadian pharmacists reported dealing with at least one drug shortage per week. In Great Britain this year, stocks of 56 critical drugs, including treatments for cancer, Parkinson's disease, schizophrenia, depression, kidney disease, high blood pressure, and epilepsy have run low.
The causes of drug shortages vary but generally fall into four main categories: 1) shortages of raw materials or manufacturing difficulties, such as contamination problems or equipment failures; 2) reduced factory capacity due to industry consolidations; 3) companies dropping older, less profitable drugs, leaving manufacturing in the hands of fewer companies; and 4) regulatory and legislative factors such as the absence of FDA authority to require manufacturers to provide notice of an anticipated withdrawal of a drug from the market.
As a member of the Special Committee on Aging and founder of the Senate Diabetes Caucus, I am very concerned about the effect these shortages are having on all Americans of all ages. I have cosponsored legislation to provide the FDA with tools to better manage, and hopefully prevent, shortages of life-saving medications. First and foremost, the bill requires pharmaceutical manufacturers to notify the FDA of the discontinuance, interruption or other adjustment of the manufacture of a drug that would likely lead to a shortage.
Requiring manufacturers to give the FDA advance warning when a drug will not be available will help both doctors and patients. This builds on a successful model - the FDA's Drug Shortage Program -- which encourages manufacturers to report potential or existing shortages so that problems can be addressed or other manufacturers can ramp up production. Through this voluntary approach, the FDA was able to avert 38 drug shortages last year.
In addition to giving the FDA the ability to require early notification when a shortage arises, the legislation would also direct the FDA to provide up-to-date public notification of any shortage situation and the actions the agency is taking to address it. The bill also directs the FDA to work with the drug manufacturers to establish contingency plans to address drug shortages due to manufacturing interruptions, such as a shortage of raw materials or a reduction in production capabilities.
This legislation, titled the Preserving Access to Life-Saving Medications Act, would give the FDA the information and tools needed to help address and prevent drug shortages. This would help ensure that health-care professionals are able to provide the best care medical science allows. Most important, it would help ensure that patients have access to the medications that they need to treat their conditions.
Many of the drugs in short supply are vital, used in hospitals and cancer centers for anesthesia, chemotherapy, and infections. There also are continuing shortages of drugs used in emergency rooms and intensive-care units.
I have met with several doctors and other medical professionals in Maine who are very concerned about this issue. They said these shortages are causing serious problems around the country, including forcing some medical centers to ration drugs or postpone elective surgeries. Oncologists have told me of situations where they are forced to change a patient's chemotherapy regime midcourse because they suddenly encounter a shortage of a particular drug. For some drugs, such as the leukemia drug cytarabine, there are no effective substitutes.
And substitution raises a host of other issues. In most cases, the original drug was chosen because it was deemed the most effective for that particular patient. In addition, a substitute may present interaction problems with other drugs the patient is taking that the original drug would have avoided.
This crisis is widespread. In a survey by the American Hospital Association, more than 80 percent of hospitals reported that have had to delay treatment due to shortages, and nearly 70 percent said patients received less effective substitutes. Pharmacists and technicians can each spend about 17 hours a week managing drug shortages, increasing labor costs by $216 million a year.
This is not solely an American problem - similar shortages are occurring worldwide. Last year, 94 percent of Canadian pharmacists reported dealing with at least one drug shortage per week. In Great Britain this year, stocks of 56 critical drugs, including treatments for cancer, Parkinson's disease, schizophrenia, depression, kidney disease, high blood pressure, and epilepsy have run low.
The causes of drug shortages vary but generally fall into four main categories: 1) shortages of raw materials or manufacturing difficulties, such as contamination problems or equipment failures; 2) reduced factory capacity due to industry consolidations; 3) companies dropping older, less profitable drugs, leaving manufacturing in the hands of fewer companies; and 4) regulatory and legislative factors such as the absence of FDA authority to require manufacturers to provide notice of an anticipated withdrawal of a drug from the market.
As a member of the Special Committee on Aging and founder of the Senate Diabetes Caucus, I am very concerned about the effect these shortages are having on all Americans of all ages. I have cosponsored legislation to provide the FDA with tools to better manage, and hopefully prevent, shortages of life-saving medications. First and foremost, the bill requires pharmaceutical manufacturers to notify the FDA of the discontinuance, interruption or other adjustment of the manufacture of a drug that would likely lead to a shortage.
Requiring manufacturers to give the FDA advance warning when a drug will not be available will help both doctors and patients. This builds on a successful model - the FDA's Drug Shortage Program -- which encourages manufacturers to report potential or existing shortages so that problems can be addressed or other manufacturers can ramp up production. Through this voluntary approach, the FDA was able to avert 38 drug shortages last year.
In addition to giving the FDA the ability to require early notification when a shortage arises, the legislation would also direct the FDA to provide up-to-date public notification of any shortage situation and the actions the agency is taking to address it. The bill also directs the FDA to work with the drug manufacturers to establish contingency plans to address drug shortages due to manufacturing interruptions, such as a shortage of raw materials or a reduction in production capabilities.
This legislation, titled the Preserving Access to Life-Saving Medications Act, would give the FDA the information and tools needed to help address and prevent drug shortages. This would help ensure that health-care professionals are able to provide the best care medical science allows. Most important, it would help ensure that patients have access to the medications that they need to treat their conditions.
