Painkiller shortage triggers concern
By Carol Gentry and David Gulliver
4/17/2009 © Health News Florida
A national shortage of opium-based painkillers triggered by a Food and Drug Administration order has forced some cancer patients to search frantically for pharmacies that have it in stock, doctors and pharmacists say.
One of the painkillers, quick-release oxycodone, hit the scarcity peak about a month ago, forcing doctors to prescribe alternatives. But now some of those substitutes – morphine, hydromorphone, and Dilaudid – are headed in the same direction.
“It’s probably going to get worse,” said pharmacist David Craig at H. Lee Moffitt Cancer Center in Tampa. “We deal with this every day.”
At the end of March, the FDA sent letters to manufacturers of many opium-based painkillers ordering them to halt production until their pills could go through a rigorous safety check. Information on the FDA Web site indicates the drugs were being marketed even though they had never been approved, and some contained stronger doses of narcotics than the label indicated. (FDA posted a Q&A for consumers.)
Ironically, the FDA orders do not apply to OxyContin, a well-known opiod that has become a favorite in the illicit prescription-drug trade, because that brand went through the FDA safety checks during its approval. OxyContin is a time-release capsule; those ordered out of production are traditional “immediate-release” tablets.
Oncologists and hospice workers were so concerned about the impending shortage of effective painkillers for terminally ill patients that they protested to FDA. On April 9, the agency modified its order to allow continued production and distribution of a concentrated morphine solution that can be squirted under the tongue and is used mainly by hospices.
Still, the concern and confusion are so great that Moffitt pharmacy students are updating and sending out charts showing which tablets are on the unapproved list, by manufacturer and code number, and where the approved drugs can be found.
Hospitals, which buy in bulk directly through wholesalers, tend to have less trouble with shortages than the individual pharmacies.
Craig said Moffitt has been fortunate in maintaining its supplies of oxycodone, which it can use in-house or dispense to outpatients. Those who live too far away from Tampa to come to the hospital – especially those in rural areas -- are having trouble finding pharmacies that can fill their prescriptions, he said.
A reporter for Health News Florida who made calls to several pharmacies along Florida’s Gulf Coast found about half had no oxycodone in stock and others with limited supplies.
Kim Chmielewski, who runs the non-profit Sarasota County Community Pharmacy, said she received about 20 phone calls and a dozen walk-in visits last week from people desperate for the drug -- some from as far as Clearwater. “They’ll drive two or three hours to get oxycodone,” she said. Her pharmacy has no federal narcotics permit and does not carry the drug.
It’s unclear whether the shortage has been made worse by diversion of supplies to “pill mills,” pain clinics that exchange controlled drugs for cash to addicts and drug runners who sell them throughout the Southeast.
Recent reports in the Miami Herald cited DEA data showing Florida ranks first in the country for oxycodone prescriptions. In Broward County, the number of pain clinics rose from 60 a year ago to 150 today, the Herald reported.
Some pain clinic doctors buy oxycodone and other drugs directly from manufacturers and dispense the tablets from their offices, but others send clients out with written prescriptions.
The shortage first appeared in late January, after a KV Pharmaceuticals subsidiary ceased production and recalled shipments of oxycodone and other drugs. The company said it discovered quality problems, including oversized pills with higher-than-labeled dosages. Other companies received stop-production orders in March.
Although oxycodone is a narcotic that can lead to addiction, under proper supervision it’s appropriate because it’s more effective than many painkillers and has fewer side effects, said Dr. Donald Erb of Sarasota Memorial Hospital’s Pain Care Center.
In February, he said, the shortage became so severe that he and other pain specialists switched to Dilaudid and morphine, the drugs that have joined the scarcity list. Switching drugs can trigger nausea, anxiety and flu-like symptoms, he said.
“For patients who are stable on the medicine, it is a nuisance for them, and there usually is an adjustment period where they are uncomfortable,” he said.
--Contact Carol Gentry by e-mail or at 727-410-3266.