April 14, 2011 -- Alison Goldsmith got her first lesson in the potential dangers of using opioid painkillers at the age of 13, when she was diagnosed with a chronic pain disorder called reflex sympathetic dystrophy.
Her doctor agreed to prescribe opioids, which have some of the same properties as opiate narcotics, to help her manage her intense pain, but only under one condition: She had to sign an agreement that set forth guidelines for using the painkillers while under his care.
"He wanted to make sure I thoroughly understood everything about the medication, like how dangerous they could be and that I understood ... when to use them, not to share them and to store them in a safe place," said Goldsmith, who is now 22.
The agreement, she said, made it clear that the consequences of misusing these drugs could be serious.
"Being so young, there were a lot of people around me offering me drugs and abusing medications, but I never wanted to use them that way."
Goldsmith was one of an increasing number of patients required to sign pain agreements, and doctors who use them say the documents are an effective way to communicate what the expectations are for the treatment of chronic pain using opioids, and how patients can use these medications safely. Critics of the agreements, sometimes called contracts, say they undermine the patient-provider relationship.
Pain agreements vary from provider to provider, but in general, they outline conditions patients must meet to continue treatment for chronic pain.
"For example, the agreement may say patients have to keep the medication out of of other people's reach, the medication has to be kept in a locked container, there are no early refills, no sharing of medication, they may be required to submit to random tests to determine whether there's compliance and so forth," said Dr. Melvin Gitlin, chairman of the Department of Anesthesiology, Perioperative and Pain Management Medicine at the University of Miami's Miller School of Medicine.
In addition to random testing, doctors may require patients to have their pills counted to make sure they're the only ones taking them, or require them to use only one pharmacy.
Debate Over Who Really Benefits From Opioid Agreements
Dr. Joel Saper, founder and director of the Michigan Headache and Neurological Institute in Ann Arbor, said he rarely uses opioids to treat chronic headaches, but whenever he does, he requires his patients to sign an agreement.
"We must realize that opioids can be lethal, and that people do become physiologically dependent, and that people who become dependent get desperate if they don't get them," he said. "It's a lot different than any other set of circumstances with other medications. We don't feel that way aobut antidepressants or beta-blockers, for example."
The American Academy of Pain Medicine, the American Pain Society and the Federation of State Medical Boards all recommend the use of opioid agreements in certain circumstances. They started recommending the use of agreements in the late 1990s, according to Gitlin.
But the Center for Practical Bioethics, a Kansas City, Mo., nonprofit policy institute, believes these agreements can create an adversarial relatiionship between patients and providers.
Last November, a panel of pain and policy experts, including some from the Center for Practical Bioethics, published an in-depth discussion of pain contracts.
One criticism was that the contracts put chronic sufferers, often in a weakened and vulnerable state, at the mercy of providers, shifting the balance in the patient-provider relationship.
Another concern is that the language could offend patients.
"They often conclude with a statement that if you do not abide by these conditions, you will be fired from our practice, and that language is inappropriate in a health care relationship," said Myra Christopher, president and CEO of the Center for Practical Bioethics.
"In a professional context, clinicians are bound to put the interests of the patient ahead of their own and frequently, when I see the locus of concern shift form the patient to the provider, then I have concerns. I'm a bit suspicious about what's going on and why," she said.
She also said that while she agreed with the need to take special precautions with opioids and carefully communicate the risks of these drugs, standardized forms are not the best way to accomplish that.
Doctors who use opioid agreements argue that the documents protect both patients and providers. According to the Substance Abuse and Mental Health Administration, 12.5 million Americans age 12 and older reported recreational use of prescription pain medications in 2009, an increase from 11 million in 2002. In addition, there have recently been a number of physicians prosecuted for overprescribing pain medications.
"My experience has shown that these agreements are necessary to protect patients from overuse and misuse and other consequences from opioid use," said Saper. "They also protect the doctor and show that we are taking due diligence. In the event there is an issue with a patient's misuse or overuse, we can say that we have signed these contracts."
"There's an exchange of information that is helpful to the patient, and I don't belive that the intention of these is to be punitive to anybody," said Gitlin.
Some patients have complained in online support groups and blogs that their doctors refused to continue treating them anymore after the patients received opioids or other drugs in emergency rooms, which violated the terms of their agreement.
Gitlin, however, said most agreements have special stipulations for medical emergencies.
"Usually, there's a provision in the agreement that speaks to the fact that whenever possible, opioid medications are to be prescribed by a single physican, but these agreements account for the fact that emergencies may occur and allow for treatment," he said.
While there's ongoing debate about the benefits of pain contracts among chronic pain sufferers and health professionals, Alison Goldsmith believes her agreement has served her well.
"If you haven't grown up with one or are tempted to sell or abuse medications, I can understand why people are opposed to them. But I think it's very important," she said, "and it's like a safeguard to me."