Pain can be debilitating, as an 80-year-old Washington County woman who has spent the past 10 years suffering from serious leg neuropathy can attest.
But the Peters woman, asking that her name not be published, faces additional battles in getting the drug that best controls her pain. Without oxycodone, she once suggested half jokingly to her doctor, "just cut the legs off."
"That's how severe the pain is," she said. "Oxycodone would solve my problems."
A nationwide shortage of oxycodone, a widely prescribed opium-based pain medication, is causing some patients to panic, pharmacists to scramble, and doctors to spend additional time altering medication regimens for desperate patients.
The cutbacks in production by Ethex Corp., have contributed to the shortage. Tighter restrictions on the potentially addictive opioid drug are further aggravating the problem that's begun to affect patients in southwestern Pennsylvania and beyond.
The federal Drug Enforcement Administration's strict annual quotas on how much oxycodone manufacturers can produce restrict their ability to overcome shortfalls.
The situation is paining a nation.
"There is a shortage of oxycodone," said Dr. Till Conermann, a pain-management specialist and anesthesiologist at the Institute for Pain Medicine at West Penn Hospital. "There have been several incidents where we have prescribed oxycodone and the patient has taken the prescription to the pharmacy, and it is not available."
Because of the shortage, Dr. Conermann said, his institute has been prescribing Percocet, an analgesic that combines oxycodone and the over-the-counter pain medication acetaminophen.
"There are different options, but in most instances we have been able to replace oxycodone with Percocet with a moderate degree of success," Dr. Conermann said.
But a steady dose of acetaminophen can cause liver disease, especially if Percocet is used to replace higher doses of oxycodone, he said.
The Peters woman with neuropathy said her doctor prescribed Percocet and a new opioid pain reliever known as Opana to replace her oxycodone. But their effects, she said, don't come close to providing her the relief she realized from oxycodone.
"The pain never goes away," she said.
Adding to her problems, she also had used OxyContin, a brand-name long-lasting pain medication containing oxycodone that many insurance companies no longer pay for because of its price. Its high cost forced the Peters woman to discontinue using OxyContin.
With so many patients switching to Percocet, Diane Silverman, a pharmacist at the Medicine Shoppe in Penn Hills, said she's starting to encounter shortages of Percocet.
"The problems in the last few months with drug shortages have been more than I've ever seen in my entire career," Ms. Silverman said, describing "a ripple effect."
Current drug shortages include two popular cardiac drugs, Toprol XL and Indur, causing cardiologists and heart patients to scramble in recent months to find alternatives.
For doctors, the oxycodone shortage requires repeat visits from patients to establish new drug regimens that will keep their pain in check.
Dr. Doris Cope, a specialist in the University of Pittsburgh Medical Center Pain Program, agreed that an oxycodone shortage exists and warned that it could get worse.
The shortage of any major drug forces patients to go back to their doctors for new medications, which might or might not work as well.
"My practice saw 32,000 patients and many are on this medication, so it's a big patient population," Dr. Cope said. "If you have to put everyone on a new regimen, then get them back on their original regimen when the shortage ends, that's a world of trouble."
Oxycodone is one of the two or three most commonly prescribed pain medications, she said, heightening the impact of the shortage.
Oxycodone and OxyContin, known as "hillbilly heroin" due to its abuse in rural areas, hold significant potential for addiction.
Along with DEA-established quotas on oxycodone production, the Food and Drug Administration on Feb. 6 notified manufacturers that drugs including oxycodone and OxyContin will "be required to have a Risk Evaluation and Mitigation Strategy," known as REMS, "to ensure that the benefits of the drugs continue to outweigh the risks."
REMS requires federal and non-government institutions, patients and consumer advocates and representatives of pain and addiction treatment programs, among other health care professionals, to discuss the pros and cons of the drug.
"Opioid drugs have benefits when used properly and are a necessary component of pain management for certain patients," the FDA states. "Opioid drugs have serious risks when used improperly."
"Opioids used in appropriate clinical settings in appropriate patients can have a significant positive impact on quality of life by reducing levels of pain and improving levels of functioning," Dr. Conermann said. "It is one of the tools in our arsenal that includes other medications, physical therapy and interventional procedures to control pain.
"It is useful in the right patient, and we have to take certain steps to make sure they are not being misused," he said
The FDA requires warnings on product labels and other measures to reduce abuse.
"Despite these efforts, the rates of misuse and abuse and of accidental overdose of opioids have risen over the past decade," the FDA said, noting that establishing a REMS for opioids "will reduce these risks, while still ensuring that patients with legitimate need for these drugs will continue to have appropriate access."
Access is the key word.
Already the DEA is seeking to reduce quotas for oxycodone.
In 2009, the quota was set at 77,560,000 grams of the drug, but the DEA noted a proposed reduction in the quota to 70 million grams per year. That would represent about a 10 percent reduction in supply of oxycodone.
Because of DEA restrictions, Ms. Silverman said, pharmacies receive only enough drugs to fill actual prescriptions. She said she currently has three patients on the drug. So when a new patient walks into the pharmacy with a prescription for oxycodone, she cannot fill it.
"For now, oxycodone products are unavailable," she said.