Medicine • Federal legislation is pending, but no remedies are on immediate horizon.
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A record nationwide drug shortage is worsening, delaying the delivery of life-saving medicines to patients and distracting pharmacists who must spend more of their time rationing supplies and hunting for alternative therapies.
Utah hospitals have resorted to hoarding drugs for existing patients. Shrinking stockpiles have derailed clinical trials and caused delays in treatment. And doctors are turning to less preferred medicines as the first drugs of choice, from cancer treatments to surgical sedatives, run low or run out.
"No one has been denied therapy. I'm just grateful that our pharmacy has been so proactive in anticipating problems. But that doesn't mean we're not sweating," said John Ward, chief of the Department of Internal Medicine's oncology division at the Huntsman Cancer Institute.
Trouble with a drug shipment forced delays in Huntsman's participation in a large breast-cancer clinical trial, Ward said. The hospital this year also faced tough decisions due to dwindling supplies of cytarabine, considered critical for acute-leukemia treatment because without it patients generally don't survive.
"We were to a point where we couldn't accept patients from elsewhere because we only had enough drugs for our own patients," Ward said.
With chemotherapy agents, deciding which to prescribe isn't always a matter of a provider's personal preferences. Some patients are better able to tolerate certain formulas than others, he said.
"It seems we shouldn't be having to face this in modern society," said Ward, noting that a scarce therapy for colon cancer has been around for 40 years.
Federal recalls, manufacturing glitches and corporate decisions to discontinue less profitable medicines are most commonly cited as the causes for shortages.
The supply-chain pinch is affecting hospital workhorse staples: antibiotics, electrolytes used in life support, and injectable drugs used for sedation and in emergencies to prevent strokes and treat heart attacks and allergic reactions.
The shortage is reaching a crisis, said Erin Fox, manager of the nation's alert system, the University of Utah's Drug Information Service. The service monitors and verifies shortages for reporting to the American Society of Health-System Pharmacists and U.S. Food and Drug Administration.
Fox recorded 211 drug shortages last year up from 166 in 2009 and 70 in 2006.
And Fox said, "We're on track to exceed that." As of July 31, seven months into 2011, Fox had tallied 180 shortages.
"We've been able to find alternatives. When those disappear is when we start to worry," she said.
New ethical dilemmas stemming from the shortage are vexing doctors, such as drug companies getting into the business of dispensing treatment. Johnson & Johnson is asking providers to apply for its Doxil cancer drug.
"We sent out a list of patients earlier this month and got the drug just yesterday," said Fox.
The injectable is used to treat ovarian cancer and multiple myeloma. Information on Johnson & Johnson's website states applications are considered on a first-come, first-served basis and suggests rationing aims to ensure that patients already taking Doxil can complete their therapy.
There's also been an increase in distributors charging exorbitant prices for drugs known to be in short supply.
The U. won't purchase from such small, middle-man brokerages for ethical reasons.
Fox will participate in a national summit next month where federal officials, hospital chiefs and manufacturers hope to explore solutions.
Meanwhile, several bills pending in Congress would require manufactures to give the FDA six months notice of products they plan to stop making and immediate notice of unplanned production problems.
"The legislation doesn't fix everything, but it does capitalize on a strategy that we know works," said Fox, explaining that voluntary disclosures have helped the FDA head off 30 shortages. The agency is sometimes able to find raw materials in other countries or speed up approval for generics and new manufacturing plants.