Pain management experts fear giant step backward’ due to OxyContin controversy

Pain management specialists and advocates for chronic-pain patients say they are worried by recent attempts at the state level to restrict availability of the tablet form of the popular painkiller, oxycodone, better know by its trade name, OxyContin.

Efforts by state law enforcement officials have made it difficult for pain patients to get the needed drug, and medical professionals need to be more active in protecting legitimate access to the medication, experts warn.

"There have been reports that, even when appropriately prescribed by a licensed physician, patients are having difficulty in obtaining the medication," says Michael Ashburn, MD, MPH, president of the American Pain Society and a professor of anesthesiology at the University of Utah in Salt Lake City.

"Some pharmacies are no longer carrying the medication — due to fears of robbery — and there have been efforts by policy-makers to restrict the availability of the drug," he said.

Released by Purdue Pharma in 1996, OxyContin has become a popular pain-relief medication for cancer patients and other chronic-pain sufferers because it delivers a higher dose of oxycodone than Tylox and Percocet, and its controlled-released mechanism allows patients to take fewer tablets per day. But in recent years, law enforcement officials at the state and federal level have documented dramatic increases in the illegal diversion and abuse of the drug.1

Several cities nationwide have reported armed robberies targeting pharmacies that stocked the medication. Additionally, more than 120 overdose deaths have been linked to OxyContin in the United States.2

Across the country, different cities and states are taking drastic actions to halt the spread of OxyContin abuse. In August, Vermont Gov. Howard Dean announced that physicians would have to get state approval in order to prescribe OxyContin to patients enrolled in Medicaid and other state-funded health programs. Previously, the governor asked that physicians find alternatives to prescribing the drug and asked pharmacies to stop stocking the medication.

Other states have also removed OxyContin from their Medicaid formularies. And police in the small town of Pulaski, VA, recently announced that people who want to buy OxyContin at the town’s six pharmacies will have to be fingerprinted to receive the drug.3

The result of these efforts is that patients who desperately need the medication are prevented from obtaining it, says Mr. Ashburn. Policy-makers need to be encouraged to reasonably regulate access to opioids like OxyContin, but efforts to essentially make the medication "illegal" need to be strongly resisted.

"Asking Medicaid not to cover the medication, and asking pharmacies not to stock it, is a particularly egregious action, I feel," he says. "It denies access to a legitimate drug for an appropriate medical use."

Physicians reluctant to prescribe

In addition to state restrictions on coverage of OxyContin and pharmacies refusing to carry the medication, some physicians are becoming very reluctant to prescribe it. Furthermore, patients are afraid to take the drug due to the increased scrutiny, says Russell K. Portenoy, MD, chairman of the department of pain medicine and palliative care at St. Luke-Roosevelt Hospital Center in New York City.

"Although we can’t really quantify this, we sense that the country has taken a step back in being able to provide effective long-term opioid therapy to appropriately selected patients with chronic pain," Mr. Portenoy says. "The intense media attention on OxyContin appears to have re-ignited a climate of fear about the prescribing, dispensing, and taking of opioid drugs."

In 1996, the American Pain Society (APS) and the American Academy of Pain Medicine (AAPM) issued a consensus statement on the appropriate use of opioids to treat chronic pain. These guidelines were endorsed at the time by the U.S. Federation of Medical Boards, which then released guidelines similar to the consensus statement, Mr. Ashburn explains.

Health policy-makers recognized that opioids had a legitimate medical use and established practice guidelines for clinicians to use, he adds. Now, although there has been no report of medical boards changing their policies, Mr. Ashburn says he’s concerned that the medical community is not advocating more strongly for continued access.

Pain specialists, in particular, need to be sure that misinformation and misconceptions about OxyContin are corrected, and to ask policy makers to develop regulations that protect pain patients’ access to opioids.

As an example, Mr. Ashburn cites the Vermont governor’s request that physicians try to prescribe medications other than OxyContin.

"There have been patients who have fairly good pain relief with OxyContin that have not experienced relief using other opioid compounds," he says. "There are patients who report better pain relief with one compound vs. another. As a pain physician, I want access to as many options as possible to allow me a better chance to meet the patient’s needs. I need more options, not less."

Who should be responsible?

Both society and health care providers have a responsibility to make sure that drugs with addictive potential are not used inappropriately, both Mr. Portenoy and Mr. Ashburn say.

"There may be an increase in vigilance to make sure that physicians are appropriately prescribing these medications, and that is not all bad," Mr. Ashburn says. "But there is a fundamental difference between appropriate vigilance and inappropriate vigilance."

The U.S. Food and Drug Administration (FDA) has formed an advisory panel to recommend what actions, if any, need to be taken to further regulate OxyContin, and Purdue Pharma, the manufacturer of OxyContin, is responding to requests to develop a new formulation of the drug that will make it more difficult for the medication to be misused.

Mr. Portenoy, a member of the FDA panel, says it is likely the panel will examine possible enhancements to the labeling of OxyContin and increasing physician education about pain management and issues of chemical dependency.

At the same time, it is still essential that the drug continue to be available to patients who need it now, says Mr. Ashburn.

"Clearly, Purdue Pharma feels that they can move forward with research to make the product less likely to be diverted — clearly, that is something I support," he says. "But such development is very expensive and takes lots of time. Even if they had a product right now that they were ready to enter into clinical trials — and I don’t think they do — it is likely to still be five to seven years before that product will be available. While they are developing a new product to roll out, we still must have access to the old one."

References

1. National Drug Intelligence Center. Information Bulletin: OxyContin Diversion and Abuse. January 2001. Accessed on the Web at: http://www.usdoj.gov/ndic/pubs/651/index.htm#Contents.

2. Sneyd R. Vermont won’t pay for OxyContin. Associated Press. July 20, 2001. Accessed on the Web at:
http://www.tcpalm.com/news/national/20v424.shtml.

3. White J. Town’s OxyContin buyers to be fingerprinted. Washington Post. July 11, 2001; B:4.