Many doctors around the country are now asking patients with chronic pain to sign a document agreeing to certain conditions before they’ll prescribe an opioid pain medication.
As part of these “opioid contracts” or “pain contracts,” patients agree to random urine drug screens, opioid pill counts, and other conditions. Violation of the terms can result in patients no longer being prescribed opioids by that medical professional.
The contracts, also known as “opioid treatment agreements,” are one tool among many aimed at reducing the misuse of prescription opioids such as oxycodone, hydrocodone, and codeine.
They’re also intended as a way to inform patients of the risks of prescription opioids.
“It is really meant to be used as a clear way to establish an understanding of [opioid] treatment guidelines and expectations of the patient and physician,” said Dr. Kavita Sharma, a board-certified pain physician with New York-based Manhattan Pain & Sports Associates.
But critics say the agreements are coercive and damage the doctor-patient relationship.
Research also suggests they do little to reduce misuse or diversion of prescription opioid pills.
Stigmatizing a group
Many patients with chronic pain who have been taking opioid pain medications for years — with no issues — say the agreements have made them feel mistrusted by their doctor.
“I’d never done anything wrong, but somehow the contract made me feel like I already had several strikes against me,” said Lynn Julian Crisci, a survivor of the Boston Marathon bombing attack and a patient advocate for the U.S. Pain Foundation.
Some doctors see a mix of reactions from patients.
“There are a variety of responses, but generally patients either say yes, of course, or they are clearly offended, refuse, and decline to continue their care with me,” said Dr. Britt Ehlert, a general internist practicing with Allina Health in Minnesota.
Opioid treatment agreements vary.
The American Academy of Pain Medicine, one of several professional groups to recommend their use, offers a template agreement.
The conditions for receiving a prescription opioid outlined in this template include agreeing to urine drug screening for controlled or illegal substances, or the absence of a prescription opioid in their system — a sign that a person may be selling their pills.
These random checks can increase a patient’s stress level.
“I knew I wasn’t doing anything wrong,” Crisci told Healthline, “but I was always worried that somehow they would find something in the random urine test, and my medication would be taken away from me.”
Patients also agree to obtain prescriptions for all controlled substances from the doctor listed on the agreement. Any exceptions require written approval from that doctor.
This can cause problems for patients with chronic pain who are treated in the emergency department, as Crisci was when she went to the hospital because of a migraine.
“I was in so much pain that I needed medication to deal with it, but I have brain injuries and memory problems,” she said. “If I forgot to tell my doctor that I was given some other medication, I could have my pain medication taken away from me.”
Patients who violate the agreement may have their opioid medication tapered off — to avoid withdrawal symptoms — and eventually discontinued.
Many concerns, little evidence
Critics have raised several concerns about opioid treatment agreements.
One is a lack of evidence showing that they’re effective.
A 2010 review of previous studies, published in the Annals of Internal Medicine, found “weak evidence” that opioid treatment agreements reduce opioid misuse by patients with chronic pain.
Some critics are also concerned that the agreements are “coercive,” because patients with chronic pain will “sign anything” just to get relief from their pain.
“You’re basically saying to a patient: ‘You are in pain and there’s an indicated treatment for you. But I’m only going to give you that treatment if you sign this contract,’” Dr. Peter Schwartz, an associate professor of medicine at Indiana University School of Medicine, told Healthline.
This is exactly how Crisci felt when her doctor handed her the agreement.
“I was willing to sign whatever needed to be signed so that I could have my independence back and be functional and get out of bed and meet my own needs,” she said.
The agreements may also negatively affect the doctor-patient relationship, especially for patients who have been with a doctor for years and are suddenly asked to sign an agreement.
But some doctors see the agreements as helping the relationship.
“The contract does not interfere with the doctor-patient relationship,” Dr. Mark Malone, a board-certified pain specialist and medical director of Advanced Pain Care in Texas, told Healthline.
“Quite the contrary,” he added, “it supports the relationship by clarifying the rules and conditions under which we can prescribe opioids. Like other written agreements, this helps us avoid any misunderstandings.”
Opioid agreements are not contracts
While these documents are often referred to as “contracts,” technically that’s not what they are.
“We call it an opioid agreement because it is not a legally binding contract that would be enforceable in a court of law,” said Malone.
In a paper published in The Hastings Center Report, Schwartz and a colleague argue that the key role of these agreements is to “disclose” to patients the monitoring that will happen while they’re receiving prescription opioids.
“It’s a way of telling the patient what to expect if they start on this medication,” Schwartz said, “and to prepare them for the consequences stemming from surveillance if they take certain actions and violate what the doctor is expecting.”
This is similar to the kind of disclosure that happens when you start on any new treatment, such as a new cholesterol-lowering drug. Your doctor will explain the benefits and risks of the drug and tell you of any follow-up monitoring that’s needed.
But you may not always sign a paper saying that you heard and understood what a doctor told you.
In the case of opioid treatment agreements, though, the signature serves as a record — for doctor and patient — that the conversation took place.
“A signed written agreement is essential to set the ground rules in a fair and unbiased way so each patient has a clear understanding of how they are expected to behave,” Malone said. “Without these rules in place, it would be much riskier to prescribe opioids.”
Schwartz said that in the case of prescription opioids, the monitoring that happens is justified ethically as a public health, or population health, issue — as a way of reducing the number of people who become addicted to these drugs.
Patients with chronic pain, though, sometimes feel like they’re being penalized for what happens to others.
“There are people who become addicted to prescription drugs and have overdosed, and that is undeniably tragic,” said Crisci. “But the solution is not, ‘Let’s take away everyone’s medication and punish you all.’ The solution should be addiction treatment, not punishing patients.”
Improving treatment agreements
Whatever you call them, opioid treatment agreements don’t eliminate the dilemmas that doctors face when they prescribe opioids.
For example, if a patient on a prescription opioid tests positive for cocaine once, should they be cut off? Or given a second chance?
Schwartz said that deciding to take the step of discontinuing a patient’s pain medication can be a “hard call,” but it must be done in a fair, nondiscriminatory way.
He added that in situations like this, doctors should be careful not to treat patients differently just because of their race, ethnicity, or social status.
Used correctly, he said, opioid treatment agreements can help healthcare providers prescribe controlled medications in a “more compassionate and fair way.”
There is, however, room for improvement with these agreements and the way they’re used.
One study found that many agreements are written at too high of a reading level for the average patient to fully understand the information.
Also, how the agreement is used is just as important as the language.
“I speak honestly about the opioid epidemic,” Sharma told Healthline, “and tell patients that this is a piece of paper to confirm that they understand all of the issues around using opiates.”
Ehlert said that rather than focusing solely on the medication, she takes time to ask patients about their pain, explain the underlying cause of their pain, and discuss treatment options.
“It is key to treat the patient with respect and to actually take very good care of them clinically,” she told Healthline. “Over time, patients learn to trust you, and that becomes more important to them than the agreement you asked them to sign.”
Schwartz said that the debate over these agreements would be more difficult if prescription opioids worked for chronic pain. But the evidence that they reduce pain and improve function over long periods is “quite poor.”
Even as debate over these agreements continues, the prescribing of opioids has decreased in recent years.
After peaking in 2010, opioid prescriptions in the United States dropped each year through 2015, reports the Centers for Disease Control and Prevention (CDC). But the level is still about three times higher than in 1999.
The country, though, isn’t just battling an opioid epidemic. It’s also struggling to find the best way to respond to pain.
“We have to confront the fact that we have people in pain who do not benefit from these medications or cannot comply with the requirements of these contracts,” said Schwartz. “We have to find a new way to balance our responsibility to use these medications appropriately with our commitment to compassionately treat pain.”
This article first appeared on HealthLine.com.