CLEVELAND, Ohio-- Almost all chronic pain patients who now take prescription opioids for relief are asked by their doctors to sign a document in which they agree to submit to random urine drug screens, pill counts and other conditions in order to receive their medication.

The "opioid contracts," or "pain contracts," were designed to deter abuse and the sale of prescription painkillers amid the heroin and fentanyl overdose epidemic. There is little solid evidence that they are effective, according to research on the topic

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Many patients with chronic pain who have been taking the medications for years and feel victimized by the increasing restrictions on opioid prescribing, say the contracts often contain threatening and coercive language and have made them feel mistrusted by their doctors.

"It becomes a very unhealthy dynamic right away," when the contracts are introduced, said Stephen Newman, 32, who for years managed two conditions, ankylosing spondylitis and common variable immunodeficiency, in part with opioid medications. "It's a moral shaky ground. It's definitely not a mentally healthy relationship."

Good intentions, little evidence

Opioid contracts have been around since the 1980's, when they were known as "narcotic contracts" and used more selectively for patients thought to be at higher risk of addiction when using controlled substances. As deaths due to heroin overdose and synthetic, illicit opioids such as fentanyl have skyrocketed in the past decade, the contracts have become increasingly popular.

In Ohio, the Governor's Cabinet Opiate Action Team in 2013 strongly suggested, but did not require, the use of pain management contracts in its chronic pain guidelines. The contracts are also recommended by The Federation of State Medical Boards, the American Academy of Pain Medicine, the American Pain Society and Physicians for Responsible Opioid Prescribing, among others.

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In at least six states, patients seeking opioid medication for chronic pain are required by law to sign the contracts: Delaware, Georgia, Indiana, Minnesota, New Hampshire, and Rhode Island.

The contract's purpose is to provide complete information about the risks and benefits of the medication, deter abuse and improve safety, and mitigate the legal risk to the doctor or other healthcare provider prescribing the medication, said Dr. Daniel Tobin, Medical Director for the Adult Primary Care Center at Yale New Haven Hospital and an expert on opioid safety.

It's this last motivation that rubs many patients the wrong way. Many said they felt they had little choice but to sign the contracts, and that their doctors were looking for infractions as an excuse to terminate their care.

"Doctors will drop you at the drop of a hat because they need to protect their license and the medical board will suspend their license during an investigation," said Newman, who now controls his pain with acupuncture. "Who are they looking out for, then?"

Paul Ford, director of the NeuroEthics program at the Cleveland Clinic, said that formal guidelines like those recommending pain contracts "quickly become adopted when there are fears of risk of things like criminal prosecution or malpractice."

According to the National Practitioner Data Bank, adverse actions by the Drug Enforcement Administration (DEA) against physicians quadrupled from 88 to 371 cases from 2011 to 2014. In January, U.S. Attorney General Jeff Sessions announced that a "surge" of DEA agents and investigators would intensify their efforts to identify doctors and pharmacies who may be responsible for dispensing too much opioid medication.

A small 2014 survey of family doctors found that the majority believed pain contracts don't reduce opioid abuse but do offer some protection against liability.

Despite their near universal implementation and perceptions of their effectiveness, "there are very few studies as to how using these documents affect care," said Tobin, who wrote a 2016 review article in the Cleveland Clinic Journal of Medicine discussing the shortcomings of the contracts and how to improve them. "It's an area that needs more research."

A problem of language

Dr. Tim Lahey, an infectious disease doctor and bioethicist who practices in New Hampshire at Dartmouth Hitchcock Medical Center, felt compelled in 2016 to write about one of his patients he believed was harmed by an opioid contract. The young woman with a history of addiction was dropped by doctors who had prescribed her pain medication for a nerve condition once after a relapse and once when she was accused of selling the medication.

She died of a heroin overdose a few days after the second doctor stopped prescribing to her, Lahey said.

"I think it's really difficult to know if that was a cause and effect relationship... but there were certainly moments when I heard very legalistic terms coming out of the mouths of [doctors] who I know are very compassionate people," said Lahey, including terms such as "contract violation."

"When a doctor who is hoping to be in a healing relationship is using words like that, I start to worry there's something wrong with the relationship or that something has become polarized in the conversation," he said.

Tobin said using the term "contract" for the documents patients sign is in itself a problem. "It implies it's a legally binding document that lays out a set of conditions that must be followed and if they're not, you're essentially fired or we can't treat you."

"That's not what this is supposed to be, but that's the experience of many patients in the community."

Many of the more than 20 opioid contracts reviewed by The Plain Dealer contained inflammatory and threatening language instructing patients that deviations from the contract would be grounds for the prescriber to stop prescribing opioids "at any time." A template contract provided by the American Academy of Pain Medicine includes the bolded line: "You understand and agree that failure to adhere to these policies will be considered noncompliance and may result in cessation of opioid prescribing by your physician and possible dismissal from this clinic."

76-year-old Sandy Morris, of Painesville Township, said the pain contract she signed with a Mentor pain management doctor was used as an excuse to end her care when she used extra pills on a rainy day when the arthritis in her feet and hands was bad.

"I hurt really bad when it's raining. I told him that, and he wouldn't listen," she said. "For two years before that I'd had no problems. It seemed he was overjoyed to catch me doing something wrong."

Communication breakdown

Ford said that when used well, pain contracts can increase transparency and help doctors talk to patients about using a potentially dangerous medication. But he and fellow Clinic bioethicist Jane Jankowski said that the way a doctor presents the contract is key to how it is received.

"Simply being handed a document without the concurrent discussion, I can see where a patient might feel that this was intended only as a punitive measure, rather than a collaborative measure to responsibly use these strong medications," Jankowski said. "One ought not replace the other."

Elliott Ingersoll, a Cleveland State University professor and psychologist, said signing a contract with his general practitioner didn't bother him. Ingersoll, 56, of Kent, is weaning off of prescribed opioid medications for chronic low back pain caused by disc degeneration and arthritis.

"I signed one with [my current doctor], but he didn't treat me like a criminal," he said. "He explained it and I really liked him... If you don't have a history of addiction, why start out a relationship with suspicion? I didn't have a problem signing it, but I also didn't feel like he was Jim Rockford looking for holes in my story."

Unfortunately, said Ford, despite their widespread use, "I suspect there's almost no or very little guidance on how to have that conversation once [doctors] implement the contract."

Dr. Ali Mchaourab, chief of pain medicine at the Louis Stokes Cleveland VA Medical Center, said his institution calls the contracts "opioid treatment agreements" and that while none of his patients have expressed unhappiness with signing them, he understands why some would.

"I don't disagree with how patients feel, and I can mostly blame physicians for not doing the job they are capable of doing," in explaining the agreements, he said.

But he added that signing such an agreement, even if it's uncomfortable, is just part of life now.

"This is our society today, and that's what's required," Mchaourab said. "If you were in Germany you probably wouldn't experience that because they don't have an epidemic."

A better tool?

Still, some doctors are pushing for a more patient-friendly solution to the contracts, one that emphasizes the relationship between doctor and patient over the consequences of breaking rules.

In 2012, a Food and Drug Administration working group of pain and addiction specialists, primary care doctors, research organizations, professional groups, government agencies and patient advocacy groups came up with a patient-focused document that could replace current pain contracts. When tested among FDA employees, the agreement was found by more than 60 percent to be neutral in tone, and by 90 percent to be easy or very easy to read. Similar results were later replicated in a university setting.

Many pain contracts are difficult to understand, said Yale's Tobin. A 2007 study of more than 160 contracts found that they were written, on average, at a college level. The American Academy of Family Physicians recommends all patient materials be written at a sixth-grade reading level or lower.

"Many patients are experiencing these agreements written in a way that they just wouldn't understand," Tobin said. "And that's counterproductive. It actually needs to be something that's understandable, or why use it?"

Like the FDA's patient-friendly agreement, there are other pain contract alternatives available to doctors who want to use them, Tobin said.

Still, there are no uniform guidelines on which contracts are best, what to include in them, what language to avoid, or research on how different contracts affect patients and their care.

"I think it's just a low priority for a lot of states and policy makers to tackle this," Tobin said. "But when it's done wrong, which it often is, it leads to issues of trust and problems dealing with patients who are really suffering."