Abuse of the painkiller has put doctors, insurance firms and pharmacists on alert.
By Elisa Ung
INQUIRER STAFF WRITER
Kim Bondarenko says her insurance company is making it harder for her to get OxyContin, the drug that annihilated her severe neurological pain and let her go back to work.
Orthopedic surgeon Norman A. Johanson has shied away from prescribing it after hearing about the region's recent spike in deaths linked to abuse of the drug.
And pain specialists across the country are concerned that increased vigilance in administering OxyContin may be causing people to suffer needlessly.
As officials scramble to curb abuse of OxyContin - coveted for the heroin-like high it delivers when the 12-hour, time-release tablets are crushed - it has become more difficult for legitimate patients to get it. For those struggling with relentless cancer pain, the obstacles have been especially cruel.
"I would say my prescriptions for OxyContin are less than 50 percent of what they were three months ago, just because of the fear factor," said Johanson, chairman of the orthopedic surgery department at Hahnemann University Hospital. He said he was now much more likely to prescribe other, weaker painkillers.
Pain centers across the region, meanwhile, have been deluged with calls from patients whose doctors have stopped prescribing OxyContin altogether.
"The pool of physicians willing to prescribe [OxyContin] is dwindling," said Andrea Cheville, director of cancer rehabilitation at the University of Pennsylvania Medical Center.
Cheville has spent hours reassuring her OxyContin patients, many of whom fear becoming addicted or being stigmatized. She says pharmacists have winked at some of her patients, telling them: "Hang on, I'll get your fix."
OxyContin was formulated by drug maker Purdue Pharma of Stamford, Conn., to deliver, with one tablet covering 12 hours, a sustained amount of the painkiller oxycodone for patients suffering moderate to severe pain. The tablets come in strengths of 10, 20, 40, and 80 milligrams, corresponding to their amount of oxycodone, a narcotic derived from opium that works by blocking pain receptors in the brain.
OxyContin's time-release formulation has made it wildly successful as a legitimate painkiller - and as an abused drug. The amount that is time-released allows patients to sleep through the night, but it also gives abusers a high when they crush a tablet, getting the full hit of oxycodone by chewing, snorting or injecting.
That high can shut down respiration and kill, especially when OxyContin is crushed and taken with alcohol or other prescription drugs. Medical examiners in the Philadelphia region report a rising oxycodone-related death toll; in the city alone, oxycodone was linked to 39 deaths by late June of this year, compared with 41 in all of 2000. Four area medical professionals have been arrested this year for illegally prescribing the drug, including Richard G. Paolino of Bensalem, a physician who authorities said was the number-one source of OxyContin as the drug ravaged Fishtown, Port Richmond and Kensington.
With reports of OxyContin addiction, abuse and deaths rising nationally, officials - among them Pennsylvania Attorney General Mike Fisher - have insisted that Purdue Pharma halt what they consider aggressive marketing of the drug, introduced in 1996. The manufacturer estimates about one million people took the drug last year. There were $1.2 billion in sales from May 2000 to May 2001.
Purdue announced last month that it would reformulate the drug to be abuse-proof, with an additive, naltrexone, that would block the drug's narcotic effect if tablets were crushed. That new version will not be available for at least three years, since naltrexone must undergo safety trials.
Critics said the manufacturer, too slow to react to OxyContin abuse in the first place, should offer a redesigned drug much sooner. Late last month, Purdue's senior medical director, J. David Haddox, said the company would try a quicker solution, adding naloxone, a chemical already tested and used in other painkillers to help prevent intravenous abuse.
In an interview last week, Haddox said the company could not predict when any new formulation might be available because of Food and Drug Administration testing requirements. And though Purdue has known it could use naloxone, he said there were concerns that it would add a ceiling effect to OxyContin.
"Our primary goal here is to make safe, effective medications for patients with pain," Haddox said. "The secondary goal is to try to make these medications in a formulation that will be resistant to abuse.
"When you look at the number of people who have benefited and continue to benefit from OxyContin, it would have been unethical for us to just have sat on that until we worked on every last technical glitch to make the drug abuse-resistant," he said. "Our primary obligation is to patients with legitimate medical need."
Many of those legitimate patients, like Bondarenko, struggle to get their OxyContin prescriptions filled.
Bondarenko, 35, of Mayfair, has taken the drug for two years. She and her doctor say she needs the drug to function.
Bondarenko, who has fibromyalgia and herniated discs in her neck and back, says severe pain left her unable to care for her children. She was forced to hire someone to cook meals for her family. Her marriage was strained.
She went through a long list of medications before her doctor prescribed OxyContin. It was a godsend. She was able to return to her job as a carrier for The Inquirer. Now able to care for her 3-year-old daughter, she has also decorated her home.
To control her pain, Bondarenko's doctors at Albert Einstein Medical Center switched her this year to a high dosage of OxyContin - 80 milligrams three times a day. Five or six months ago, her insurance company, Keystone Mercy, began requiring letters of medical justification from all doctors who prescribe OxyContin for ailments other than sickle-cell anemia, chronic pain, cancer or HIV.
Ever since, Bondarenko's OxyContin has been limited and sometimes denied to her, despite calls and letters from her doctor.
But Keystone Mercy defends its policy. "We really don't see a need for primary-care doctors to prescribe OxyContin since there is already short-term medications like Percocet available in the market," said Mesfin Tegenu, vice president of pharmacy services for Keystone Mercy. "The whole idea is to control the diversion and abuse."
The company also weeds out over-prescribing doctors and "doctor-shoppers," patients who seek prescriptions from more than one doctor.
Bondarenko's family doctor, Jody Borgman, is frustrated with the hassles, yet acknowledges he, too, has stepped up his vigilance.
"I thought I was going to be above all that and know that I was doing the right thing," Borgman, a general internist at Einstein Medical Center, said. "But in the last two to three weeks, I certainly have become more concerned with reports of doctors being arrested.. . . I think a lot more about who's getting [OxyContin] and documenting the reasons they are getting it for."
Pharmacists across the country are also making greater efforts to call doctors to verify OxyContin prescriptions.
"When they see an OxyContin prescription, they raise that high level of vigilance even higher because of the . . . incidence of abuse with this drug," said Douglas Hoey, a vice president of the National Community Pharmacists Association.
One lung-cancer patient, Joseph Cassada, 41, a pipe worker from California, said he had found it nearly impossible to get his OxyContin prescription filled in Philadelphia, where he has worked for several months.
"I went to pharmacies all up and down Broad Street, and none of them would fill my prescription," Cassada said. "I say to the pharmacist, 'You know me. You know I have cancer. You know I need this.' But the pharmacist just looked at me and said, 'Can't do it, Joe. There's too much heat on us right now.' "
State legislators, meanwhile, have held hearings and are drafting legislation to crack down on doctor-shoppers and those who steal prescription pads. Last week, U.S. Rep. James C. Greenwood (R., Pa.) called for the creation of a national, computerized prescription-oversight program to identify abusing patients and doctors.
But the nation's pain specialists, who for years have worked to help doctors overcome the stigma of narcotic prescription, are especially worried that the controversy will overshadow the need for more education about painkillers.
"We've probably lost some ground," said Michael Ashburn, president of the American Pain Society and medical director for pain programs at the University of Utah. "Our concern is that the measures taken don't have the unintended consequence of causing people to suffer needlessly with pain."
Compounding the issue is the lack of education about painkillers in medical schools, said Sanjay Gupta, director of Einstein's pain center. He said many patients who came to him after doctors stopped their OxyContin prescriptions did not need such potent medication to begin with.
If more physicians were educated about the nuances of painkillers, Gupta said, their attitudes toward opioids would not be subject to such controversies as the OxyContin scare. And patients would not get mixed signals.
"They were suffering when we were over-prescribing," he said. "Now they're suffering as we're under-prescribing. There's a poor understanding of the real problem."
Elisa Ung's e-mail address is firstname.lastname@example.org
Jake Wagman of the Inquirer suburban staff contributed to this article.