Preventing drug shortages
There are hundreds of drugs unavailable to those who need them most right here in the United States. 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 resort to using expired drugs to save lives. One out of four surveyed providers across the United States said drug shortages have resulted in a medication error. America makes and uses the most medications in the world, but supplies are drying up.
"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," said Joseph M. Hill, Director of Federal Legislative Affairs at the American Society of Health-System Pharmacists.
Drug shortage expert Joseph Hill said injectable drugs used in everything from pain management to cancer treatments remain the hardest hit. That's partly because making them is a meticulous process.
"You have to be 99 percent right because it's going into someone's vein," Hill said.
The FDA'S Dr. Sandra Kweder said several large facilities closed in the last few years because quality problems.
"Really, drugs go into shortage because companies have difficulty making them, pure and simple,"said RADM Sandra Kweder, M.D., deputy director of CDRR's FDA' s office of new drugs, said.
And the FDA didn't have the power to do anything about it. A presidential executive order followed by congress's approval of the prescription drug user fee act is changing that.
"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," Hill said.
That will help the FDA work with other makers to ramp up production, expedite approval of new drugs and allow temporary supplies from other countries.
"Try to prevent shortages in the first place. That is number one," Kweder said.
Kweder said the FDA has been able to prevent more than 100 drug shortages because of the new measures.
"We've seen a six fold increase in reports about potential shortages," Kweder said.
Still, some hospitals are creating their own solutions to deal with the ongoing issue. Duke Hospital adopted an approach based on models used in organ donations. Key drugs for cancer and other diseases are distributed to patients with the greatest need and to those who stand to benefit the most. Patients not given a certain drug because of shortages can appeal the decision.
To help avoid shortages, a South Texas Hospital system has opened its own multi-million dollar distribution center that allows it to buy drugs in bulk. Now it can pack, label and distribute drugs to its hospitals safely and fill prescriptions in a fraction of the time. Still the question remains, will the new law prevent more hospitals from taking such measures?
"We're not out of the woods yet," Hill said.
For now, there's still a chance the drugs you need, might not be available. Two generic drug companies said they're expanding to help with the shortages. Under the new law, review time of generic drug applications could be cut from three years to less than one year. That could help many generic drugs get approved faster and cut down on the number of medications in short supply.
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