Pain treatment and opioid use

Pact aims to balance benefits with risks of controlled substances

WEST HAVEN >> As the nation deals with an epidemic of opioid addiction and millions of people cope with chronic pain, it’s important for doctors and their patients to have a clear understanding of the risks and benefits of taking opioids long term.

That’s the thinking behind a new, comprehensive “controlledsubstance agreement” that clearly outlines the responsibilities of both doctors and their patients who are taking addictive drugs such as oxycodone.

The agreement was published recently in an article in the Cleveland Clinic Journal of Medicine. Two of the authors are Summer McGee, a bioethicist and director of the University of New Haven’s master’s in health care administration program, and Dr. Daniel Tobin, medical director of the primary care center at Yale New Haven Hospital’s St. Raphael Campus.

Doctors have long used what are known as “pain contracts” or “opioid contracts,” whose purpose has been mainly “to shield them from legal liability (and) to document that the patient had been informed of risks and responsibili-

ties,” said McGee. “It is very easy to just write a prescription and to hand that to the patient,” she said.

She said that, according to medical literature, most patients don’t even realize they’re signing the traditional contracts, which often are written at too high a reading level and serve to protect the doctor, not the patient.

“The bias had previously been on creating a list of the things that a patient should not do,” McGee said. “We felt that it was very stigmatizing” and that “it is just as much the role of the physician” to be sure the patient understands the risks.

The agreements are not legally binding or even required in Connecticut, though some states do mandate their use, said Tobin. The agreement the authors propose promotes “shared decision-making” after close consultation.

The patient and doctor should “talk together first about what the goals of the patient are,” McGee said, such as being able to ride a bicycle or being pain-free for several hours a day. “The checklist we proposed is really a tool for providers to say, ‘We discussed all these things,’” she said.

Tobin said chronic pain and the abuse of opioids are “competing epidemics” in the United States. Connecticut’s chief medical examiner has estimated more than 800 residents would die this year from opioid overdoses.

And McGee said one issue underlying opioid dependence is a national shortage of pain specialists — there are just four for every 100,000 patients with chronic pain, according to the article. So most addictive drugs are prescribed by primary care physicians.

“One of the challenges that all providers face,” McGee said, is that in medical school, “you might get a day at best, eight hours, in how to treat pain. It’s an area that many physicians feel very uncomfortable dealing with and talking about.”

Adding to the opioid crisis is the tendency to overprescribe, although a Connecticut law, which went into effect in July, limits prescriptions to a sevenday supply. The action was meant to cut down on overdoses and theft of unused medications.

But while opioids are abused, they are also needed by many people to control chronic pain, McGee said. “The bioethical issue to me (is) finding the right balance between protecting the public on the one hand and ensuring that patients can get the medications that they need.

Traditional “pain contracts” include points such as giving the doctor the right to demand a urine test at any time. Tobin said even the word “narcotic” is stigmatizing because it is associated with criminal activity. It’s also not accurate; the federal government classifies cocaine as a narcotic, but it is not an opioid.

“We felt that it was stigmatizing and really draconian to say if you don’t do these eight things I have the right to pull you off this medication. … It was much more punitive,” McGee said.

“Our approach actually would reduce opioid use because we put emphasis right up front about talking to patients about alternatives to opioid therapy and also discussing right up front about the risks, the benefits and the cost of using opioids.”

Patient-doctor agreements are recommended by the Federation of State Medical Boards, McGee said. The controlled-substance agreement that the authors came up with is a checklist of statements that both doctor and patient are asked to discuss and initial. For example:

• “We talked about other treatment choices. We decided together to use opioids, but my doctor also recommends starting or continuing the following,” which may include physical therapy, talk therapy, exercise, counseling, massage, chiropractor treatment, acupuncture or other pain medications.

• “We agreed that I would take only the number and type of pills prescribed to me. We will work together to change them if they are not meeting our agreedupon goals.”

• “I agree to take my pills the way the doctor tells me. If I do not understand the directions, I will ask questions.”

“A checklist like this should be used by every provider for every patient and should be used across the board,” McGee said. “I think it does provide a certain amount of protection or security for the provider that we’re having these discussions with everyone.”

Using the agreement may help guide doctor and patient to avoid the use of opioids altogether, she said. “It’s OK to say, ‘I don’t think this is adequately controlling your pain or working for you. We need to look at other strategies,” she said.

In fact, she added, “I think that there is enough data now to show that longterm opioid therapy is marginally effective at treating chronic pain.”

As evidence grows for using alternative, non-pharmaceutical treatments, McGee said, “I also think patients don’t want to be on opioids either. … Patients would prefer other treatments as well.” Besides being addictive, opioids carry side effects such as fatigue, constipation and short-term memory loss. “They are also often expensive for patients, which is another big issue,” she said.

While the Cleveland Clinic article was just published last month, McGee said she’s put it out on social media and “I’ve had positive feedback from clinicians.”

Tobin said that while he doesn’t necessarily prescribe opioids less often than he used to, “I prescribe them more thoughtfully.”

The agreement “forces me to be more deliberate about risks and benefits for my patients. It forces me to slow down, pause and, in a very careful way, make sure we’re prescribing in the safest way we can be.”