Patient contracts help physicians track pain medications

Prescribing opioids for chronic pain is a delicate balance.

As a result, a patient could once again do the things he or she loves because the pain is no longer disabling. Or, that patient could become addicted. Some form of written care agreement or contract is among the tools most frequently used by physicians to try to guide the patient toward the more favorable outcome. Conclusive research is still lacking, but a recent study found that such contracts may have the desired effect, according to the April Journal of General Internal Medicine.

"This is a tool to be able to provide better care for patients who are on these drugs," said Dr. Jaishree Hariharan, lead author and associate professor of general internal medicine at the Medical College of Wisconsin.

Dr. Hariharan and her team followed for a five-year period 330 patients from a general internal medicine clinic who were in this situation. Out of the group, only 17% of the patients had their contracts cancelled, primarily because of substance abuse and other noncompliance problems. About 20% discontinued them voluntarily, and 63% were still following the rules laid out an average of nearly two years after signing.

Prescribing narcotics, particularly for those with chronic pain unrelated to cancer, has long been challenging for physicians. Legal and regulatory scrutiny are worries for doctors and are issues that have come up at numerous medical society meetings. The American Medical Association policy, for instance, supports balancing access to necessary pain medication with preventing drug abuse and diversion. The AMA's Council on Science and Public Health is also expected to issue a report on this subject at the organization's June meeting.

Legal issues aside, many primary care physicians also struggle to increase the likelihood that use of these drugs does not have significant medical consequences for the patient, or society, that contravene the original prescribing goals. "This is the one area of medicine where a doctor's therapeutic intent can be routinely subverted to harm the recipient and harm public health," said Paul Chelminski, MD, MPH, assistant professor of general internal medicine at the University of North Carolina.

These agreements, which have not been standardized, usually spell out obligations of all involved in pain care, including the patient. Contract use is suggested in several treatment guidelines and consensus statements, and samples are available on various Web sites, including that of the American Academy of Pain Medicine.

"The contract is a really good tool to help clinicians see the red flags when they come up, whether a patient needs a dosage adjustment or substance abuse treatment," said Meg Hayes, MD, assistant professor of family medicine at Oregon Health & Science University.

While this kind of document is well established, its actual impact is not well understood. Experts praised this study for attempting to measure its reach and said these findings support their continued use, although questions remain.

"There's been a fairly substantial shift in patients with chronic pain away from the specialty clinics into primary care. We have been scrambling to adapt, but at this point we don't yet have compelling medical science that helps to understand the best way to use these patient care agreements," said Matthew Hollon, MD, MPH, assistant professor of general internal medicine at the University of Washington. "There's not even a lot of literature on their use in pain clinics."

More questions

Experts called the study a good beginning, although much more work is needed. These data, while valuable, may not be generalizable to nonacademic settings, and this was not a randomized trial.

"These patients may have done just the same without the agreement," said Dr. Hollon. "We don't yet understand if these agreements serve patients in any way."

Many believe, though, that these documents, at the very least, make physicians more comfortable prescribing opioids.

Finding a means to determine which patients are more likely to adhere to the agreements remains elusive. This study suggested that men may be more likely to have their contracts cancelled than women, although the numbers were not compelling. Experts cautioned against drawing such conclusions from these data. Previous studies have suggested that patients who have had prior substance abuse problems may also be more likely to have trouble following the stipulations, but experts said this scenario called for more judicious monitoring rather than refusing these drugs to these patients.

"Don't deny the patient care. Use the tools you have to help you give the best care you can," said Dr. Hariharan.

Although identifying in advance the patients who are most likely to misuse these drugs may not be possible, there are also challenges for determining this risk during treatment. The authors and other experts are calling for moving away from random testing to policies that have more structure. This study found that only 42% of these patients received urine toxicology screening, and 38% of those tests came back positive for illicit substances.

"If you're going to have a comprehensive program, you cannot do anything randomly," said B. Todd Sitzman, MD, MPH, president of the American Academy of Pain Medicine. "Screen everyone, or you're going to miss somebody.