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American Medical News

 
PROFESSION

OxyContin crackdown raises physician, patient concerns

Doctors struggle to treat patients without drawing the ire of the Drug Enforcement Agency or state medical boards.

By Tanya Albert and Damon Adams, amednews staff. June 25, 2001.

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OxyContin, a timed-release painkiller introduced in 1995, has been a miracle drug for people with severe pain. But it also has become an illicit street drug, and the ramifications of a crackdown on its street abuse are causing some doctors to think twice about prescribing the pill.

Doctors, especially in states where OxyContin diversion is a big problem, fear they will lose their license or face federal investigation into their prescribing habits.

Licensing boards say few doctors have lost their license over OxyContin so far, but they are getting the word out to doctors to closely follow pain management guidelines to avoid being caught in the web of enforcement actions surrounding the drug, oxycodone hydrochloride controlled-release tablets made by Purdue Pharma. Meanwhile, doctors are still worried.

"They're afraid the DEA will march into their office and cause them grief," said Edward David, MD, chair of the Maine Board of Licensure in Medicine. "If you do a good job and document what you're doing, [boards] have no problem with opioids."

A big splash

Doctors' fears began after OxyContin made a splash on the cover of Newsweek this spring. It has since been the subject of countless stories in newspapers and on television that focus on its diversion to a street drug that can be crushed and snorted, or dissolved and injected, giving the user a powerful high and sometimes causing death. Eastern states, including Kentucky, Maine, Maryland and Florida, have been hardest hit by the epidemic.

Authorities have stepped up education and enforcement efforts to slow the drug's diversion, while others are using lawsuits in hopes of curbing its illicit use. Among the most notable actions so far:

  • The DEA has announced it is using a four-point action plan to target areas where OxyContin has been a problem, including concentrating investigations. It's the first time the agency has used the program to target a specific drug. "We've taken extra steps in this case because of the explosive pattern," a DEA official said through a spokesperson.
  • The National Assn. of Attorneys General is assembling a prescription drug abuse task force to develop strategies to stop abuse, particularly of OxyContin.
  • In May, two West Virginia men filed a class action lawsuit against OxyContin maker Purdue Pharma and Abbott Laboratories, co-promoter and co-marketer of the drug, and two physicians who prescribed them the drugs. The men claim the companies encouraged physicians to prescribe the drug to patients who had moderate pain. The lawsuit claims that the drug should be used to treat only severe pain.
  • Earlier this month, the West Virginia Attorney general's office filed its own suit against the drug companies, claiming they knew the dangers of the misuse of OxyContin but marketed the drug in a coercive and deceptive manner to make more money.

Pain management strides threatened

All this activity has left physicians who specialize in pain management worried that strides they've made to get other doctors to treat patients' chronic pain will be lost.

Traditionally, physicians have been hesitant to prescribe opioids to the more than 50 million Americans who live with chronic pain because of DEA and licensure fears, and those fears are growing in light of the OxyContin controversy.

Eastern states have been hardest hit by the trafficking of OxyContin as a street drug.

"The war on drugs shouldn't affect the war on pain," said Joseph J. Fins, MD, medical ethics director at the Weill Medical College of Cornell University at New York Presbyterian Hospital. "We made progress in treating pain, and this could have an undue negative effect."

"What's happened recently is tragic for those working in pain management, because OxyContin is a wonderful arrow in our quiver for treating pain," added Ira Byock, MD, director of Palliative Care Service in Missoula, Mont. "Now there is a chill in the environment."

Some doctors who once prescribed pain medications no longer do so as frequently. They fear they could be targets of lawyers looking to sue doctors who are prescribing a "dangerous drug," Byock said.

Some patients in Eastern states report having to drive 100 miles to find a physician who is willing to prescribe OxyContin. While that is a considerable inconvenience, patients' biggest concern is that they won't be able to get the drug at all.

California resident Patricia Kerbs' chronic pain from a spinal condition is so bad she can't get out of bed without OxyContin. She's tried other opioids, but they either didn't knock it out or had side effects that made it difficult for her to concentrate.

"My whole life has changed," said Kerbs, who has written letters to Congress and the DEA asking them not to take the drug off the market or make it impossible for doctors to prescribe. "Although my doctor has been understanding and compassionate about my pain, I have sensed a concern in the medical community about prescribing OxyContin."

In May, Purdue Pharma stopped manufacturing the 160-mg OxyContin tablet because it was concerned about the possibility of illicit use in a dose of that magnitude. That tablet made up only 1% of the prescriptions written last year, Purdue spokesman James W. Heins said.

In other efforts to stop illegal OxyContin use, the company is giving tamper-resistant prescription pads, opioid documentation kits and mailing brochures that offer advice on how to stop drug diversion to nearly 500,000 physicians.

A DEA spokeswoman said the agency had met with Purdue Pharma executives and had no plans to take the drug off the market. DEA officials also talked to pain management physician groups about the drug's legitimate uses.

"There shouldn't be any fear," a DEA official said through spokeswoman Rogene Waite. "We're not changing the rules or regulations."

Reason to be nervous?

Still, many doctors are nervous, especially when they hear about colleagues being disciplined for prescribing the drug.

Benjamin R. Moore, DO, was swept into the OxyContin controversy this month when the DEA suspended his DEA number. The agency claims Dr. Moore's prescribing habits, in conjunction with other doctors' prescriptions, contributed to addiction, overdoses and the deaths of two patients.

The suspension stems from an investigation of the Comprehensive Care & Pain Management Center in Myrtle Beach, S.C., where Dr. Moore has worked the past year.

The DEA order against Dr. Moore said he routinely prescribed OxyContin to most of the clinic's patients -- writing prescriptions for the drug and other controlled substances "in many cases during the patients' first visit without any medical testing or complaint validation."

Investigators said he had written prescriptions based on questionable and inaccurate tests and kept incomplete records. Many patients traveled 100 miles or more to the clinic, bypassing other closer physicians.

Dr. Moore, 43, disputes the claims, saying the DEA had a vendetta against the clinic, which had been investigated previously. He said he was using OxyContin in an appropriate way for pain management.

"I never prescribed the stuff until I came to a pain clinic, but that's what you do at a pain clinic," said Dr. Moore, previously a family physician in North Carolina and California.

Dr. Moore said he confirmed most patients' histories with records or tests within several office visits. He said he sent away patients he suspected of feigning pain for drugs. He added that he had not always been aware of the distance traveled by patients, and that some patients had told him they knew of no other clinic.

Of the two patients who died, Dr. Moore said he never treated one and did not know the other had a drug problem. "I'll put my record against anything and it will shine," he said.

But he worries that the damage is done. He had hoped to return to California to practice. "I cannot do so now, because no one will hire a physician who has had their DEA number revoked or suspended," he said.

In Gadsden, Ala., Pascual Herrera Jr., MD, lost his license in April. The Alabama State Board of Medical Examiners said Dr. Herrera had wrongly dispensed controlled substances. Algert Agricola Jr., Dr. Herrera's attorney, said the doctor's license had been revoked amid teenage overdoses of OxyContin and a public outcry that physicians refrain from prescribing the drug. Dr. Herrera had a long patient-doctor relationship in the case reviewed by the board, Agricola said.

"This is not someone who walked in off the street and said, 'I want some pain medication,' and [I] never saw him again," he said.

Dr. Herrera plans to appeal.

"He's hearing from his patients now who say, 'Nobody wants me, nobody will treat me because they're scared what happened to you will happen to them,' " Agricola said.

Despite what happened to Dr. Herrera, Larry Dixon, executive director of the Alabama board, said physicians should not worry about being disciplined if they have a physician-patient relationship and documentation of sound medical judgment. Those who don't, watch out.

"It takes a doctor who is prone to writing large amounts of controlled substances, and it takes a 'drug shopper,' " Dixon said. "You get those two together and you've got a good relationship until we get you."

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 ADDITIONAL INFORMATION: 

How to protect yourself

Some tips from Purdue Pharma on how physicians can stop diversion and protect their practice:

  • Never sign an incomplete prescription.
  • Use tamper-resistant pads that can't be photocopied.
  • Write the quantity and strength of drugs in letters and numbers, like you would on a check. If just a number is on the prescription, it is easy to alter.
  • Be wary of people who are not interested in having a physical examination, are unwilling to authorize release of prior medical records or have no interest in a diagnosis or a referral, saying they want the prescription now.
  • Be cautious if a new patient has an unusual knowledge of controlled substances or when a new patient who requests a specific controlled drug is unwilling to try another medication.
  • Stick to principles and take a complete history and perform a thorough physical examination.
  • Look for drug abuse signs, such as inflamed nares, skin tracks and perforated nasal septum.
  • Call police if you believe someone is trying to divert prescription medication.

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Weblink

U.S. Dept. of Justice and DEA Diversion Control Program (http://www.deadiversion.usdoj.gov/)

Purdue Pharma's statements on OxyContin (http://www.purduepharma.com/news/)

American Academy of Pain Medicine (http://www.painmed.org/)

American Academy of Pain Management (http://www.aapainmanage.org/)

CSAT Advisory on OxyContin from the Substance Abuse and Mental Health Services' Center for Substance Abuse Treatment (http://www.health.org/govpubs/ms726/index.htm)

OxyContin information from the National Clearinghouse for Alcohol and Drug Information (http://www.health.org/promos/cbs-oxy.htm)

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Copyright 2001 American Medical Association. All rights reserved.
 
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