Drug Shortages: New prevention methods

Hundreds of drugs in the U.S. are unavailable to those who need them most. And after years of watching the situation get worse and worse, something is finally being done about it. Without the drugs they need, paramedics in Oregon have resorted to using expired medicines to save lives.

One out of four surveyed providers across the country say that drug shortages have resulted in a medication error. Dr. Joseph M. Hill, of the American Society of Health-System Pharmacists notes the problems of searching for drugs, “our members are scrambling to try to find the product and often times they're spending more time trying to find the product than they are caring for the patients."

According to Dr. Sandra Kweder the problem is with the drug manufacturers, "Really, drugs go into shortage because companies have difficulty making them.”

The F.D.A does not have the power to do anything about these issues. Now, a presidential executive order, followed by the Congress’ approval of the Prescription Drug User Fee Act is changing that.

Dr. Joseph M. Hill, "A company producing prescription drugs in the United States must notify the FDA as soon as possible whenever they shut down due to a quality issue. If they're discontinuing a product they must notify the FDA within six months of that discontinuation."

The F.D.A has been able to prevent more than 100 drug shortages because of these new measures, which Dr. Kweder says has led to a six-fold increase in reports.

Some hospitals are creating their own solutions to cope with the ongoing issue. Duke Hospital adopted an approach based on organ donation models, while a South Texas hospital system opened its own multi-million dollar distribution center. Now it can pack, label and distribute drugs to its hospitals safely, and even fill prescriptions in a much faster time frame.

The question still remains as to whether the new law will prevent more hospitals from taking such measures.

“We’re not out of the woods yet,” says Dr. Hill.

Two generic drug companies say that they are expanding to help with the drug shortages. Under the new law review time of generic drug applications could be cut down from three years to less than one. That decrease could help many drugs get approved faster, and help decrease the number of medications found in short supply.


REPORT: MB # 3533

USAGE OF EXPIRED DRUGS: When paramedics ran out of a critical drug used to treat irregular heartbeats, the Bend Fire Department in Central Oregon resorted to using expired medications. Medications are only guaranteed to work as intended until their expiration date. When stored properly, most expired drugs won't be harmful to patients but will become less effective with time, according to medical professionals and according to the Associated Press, Oregon health officials began allowing ambulances to carry expired drugs, and southern Nevada has extended the expiration dates for drugs in short supply. Arizona has stopped penalizing ambulance crews for running out of mandated medications.
THE PROGRESS: While there are still drug shortages in affect, the United States government and the FDA has begun to play an active role in trying to help the drug shortage problem. New acts signed into law by Barack Obama will speed up the review process of new drugs that could be used in the place of others not currently available. The act will also increase the communication between the drug manufacturing companies and the FDA so that the FDA is ready to help these companies avoid shortages. Furthermore, the FDA has begun to import drugs from abroad that were not yet available in the United States. With these continued efforts it is hoped that the drug shortages will begin to lower. (Source: www.cnn.com)
PRESCRIPTION USER FEE ACT: The Prescription User Fee Act was first passed in 1992 and has been renewed several times and was renewed most recently this year in the hopes that it would help to alleviate the drug shortage problem in the United States. The act allows the Food and Drug Administration to collect fees from companies that produce particular drugs and biological products in the hopes that it will speed up reviews of new drugs and therapies. In 2012 the act was renewed for another five years and an early warning system for possible drug shortages was also added to the legislation. Under the early warning system, manufacturing companies will have to notify the FDA at least six months before discontinuing a drug or if there are any foreseeable disruptions in the manufacturing process that might make a particular drug be in short supply. Hopefully with warning the FDA will be able to prevent a drug shortage by either helping the company rectify the issue or finding another source of the drug. (Source: www.ama-assn.org)
For more Information on drug shortages go to the ASHP website http://www.ashp.org/shortages or the FDA website at www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm
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Sarah Clark-Lynn
FDA Office of Public Affairs
Drug Shortages Notification and Updates:

Joseph M. Hill
Director, Federal Legislative Affairs
American Society of Health-System Pharmacists

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