Drug shortage dilemma: The problem
Thu, 28 Feb 2013 02:31:16 GMT —
WASHINGTON, DC (Ivanhoe Newswire) --- In the 80s, the war on drugs focused on ridding the U.S. of illegal narcotics like crack, cocaine and heroin. Today, doctors say the country is in the midst of a different kind of drug war, fighting to get the ones many people need.
"I think the public has a right to be dismayed and outraged," RADM Sandra Kweder, M.D., deputy director of CDRR's FDAâ?? s office of new drugs, told Ivanhoe.
Doctor Kweder heads the FDAâ??s office of new drugs. She says quality control in manufacturing plants is causing nationwide recalls and massive drug shortages. A lack of raw materials, closures and consolidations among drug-makers and low profit margins on certain drugs have also added to the problem.
According to the American Society of Healthcare System-Pharmacists shortages have nearly quadrupled from 74 in 2005 to 267 in 2011.
"We are in the midst of what we see as a crisis," Dr. Kweder said.
Pharmacists and the FDA have websites to help healthcare professionals monitor the situation. Almost everyday, more drugs show up in short supply.
The problem has hit every drug class, but mainly generic sterile injectables. Those medications are used in everything from giving sick babies the nutrition they need to surgical anesthesia.
A government report finds while the injectables make up only a small percentage of the overall prescription drug market, in 2011, they accounted for 74% of drug shortages.
"We really saw it spike in the last 12-18 months," Gene Rhea, Pharmd, manager: procurement, distribution and repackaging of the department of pharmacy at Duke University Hospital, explained.
Rhea says some of his colleagues compare it to working in a third world country.
"On a daily basis, we probably only get in about 60 to 70% of the products that we order," Dr.Rhea said. "I probably spend more than 50 percent of my time managing drug shortages."
A recent survey found shortages cost U.S. hospitals $216 million a year as theyâ??re forced to buy more expensive alternatives
"It's kind of the new norm," Dr. Rhea said.
Doctor Rhea says for many patients, including ovarian cancer patients on Doxil, itâ??s led to rationing. "Patients were put on waiting lists and it was a very difficult situation," Dr. Rhea said.
Reports attribute the drug shortage to only 15 deaths in the U.S including one man who died because the only antibiotic he responded to wasn't available.
Dr. Kweder also says it's hard to figure out how many have been impacted by the shortages. She guesses the number to be in the hundreds of thousands if not millions.