Friday, January 21, 2011

The Trouble with Opioid Treatment Agreements

Pain-PourriAs the prescribing of opioid analgesics for pain has increased, so have fears about opioid misuse, abuse, and diversion. One measure often presumed to help stem such problems is the Opioid Treatment Agreement. However, a recent report suggests that these documents can be used indiscriminately and seriously harm rather than enhance practitioner-patient relationships.

In April 2010, the Center for Practical Bioethics convened a panel of pain-management professionals to consider the usefulness and the ethical propriety of what they called “Pain Contracts”; more commonly and appropriately known as Pain Treatment (or, Opioid Treatment) Agreements. The meeting focused on professional, patient, and policy issues regarding healthcare providers’ use of these documents when prescribing opioids and/or other medications for pain.

Writing in the November 2010 issue of the American Journal of Bioethics (AJOB) the panel debates whether the Agreements are used more for reducing potential risks of therapy to patients or managing perceived risks to prescribers from regulatory and law enforcement agencies. Many of the Agreements in use include text that is poorly understood by patients and contain adversarial or intimidating language that puts patients at the mercy of the prescribers; precluding a trusting relationship. Furthermore, there is little evidence from clinical research to confirm the benefits of these Agreements for improving therapeutic outcomes or for minimizing the abuse and diversion of prescription drugs by persons who are so inclined.

The panel concludes:
“…the lack of data about the benefit of pain agreements / contracts, concerns about increasing disparities and further stigmatization of pain patients, and other possible unintended consequences, coupled with the importance of preserving the integrity of medicine from inappropriate outside influence, are all very strong reasons why the authors of this paper cannot support the universal utilization of pain contracts / agreements at this time.”
COMMENTARY: The panel’s use of the phrase “Pain Contracts” is unfortunate; implying that patients are contracting for pain, and is perhaps suggestive of the confusing language sometimes surrounding this issue. We discussed problems and concerns with Opioid Treatment Agreements several years ago in an e-Briefing Newsletter [“Opioid Contracts: Good, Bad, or Useless?” PDF here] and more recently [here] — and we agree with the conclusions of the panel. Our position has been that these Agreements can be useful; however, as presently conceived and implemented they are often worse than useless, they may be damaging to the therapeutic milieu of pain management.

Similarly, in a news report about the panel’s deliberations and conclusions [see American Medical News], Myra Christopher, President/CEO of the Center for Practical Bioethics and a coauthor of the AJOB article, said, “It is not that any of us disagree with the notion that agreements can, in fact, be very helpful in certain circumstances, and patients with a history of substance abuse or mental illness may be aided by documents that inform them of the risks and benefits of opioids and set out a care plan.” However, “what is becoming common practice in many pain specialty clinics is using a preprinted, standardized form that says, ‘If we're going to treat or prescribe controlled substances to you, these are the conditions under which we'll do so — and sign this document, and if you fail to do so, then we'll fire you from our practice.’”

How healthcare providers discuss the Agreements with patients is critical, adds Will Rowe, CEO of the American Pain Foundation. “Just think about how it's presented — unless you sign this, you won't get your medications. That, to me, is crossing the line. It's basically a document that says, ‘You do this, or I've gotcha,’ and that interferes with what should be a trusting relationship between the patient and the practitioner.”

Our position at Pain Treatment Topics has been that, from a patient-centered perspective, patients (and loved ones who assist with their care) must be educated on the risks and benefits of the proposed therapy, whether opioids, other drugs, or another intervention. This is best presented in writing and using language that patients can easily understand for providing informed consent. Along with that, it seems appropriate to provide some ground rules to help ensure patient safety — in the best interests of what will be most beneficial for good patient care; rather than primarily for the convenience and protection of the prescriber.

At the Opioids911-Safety patient/caregiver education website (Opioids911.org) visitors are informed, “Your opioid prescriber may have you read and sign a ‘treatment agreement’ that lists the things you are expected to do. These are like ‘Rules of the Road’ for using opioid medicines. Even if you are not asked to sign a formal paper, for your own safety and the protection of others, you must agree to do the following...” and there is a list of directions that patients and their caregivers must be willing to follow [view list here].

The “Rules” are based on sound medical practice, easy to follow, and patient-centered. However, patients must be willing to accept responsibility for following safe practices; otherwise, it is only fair that there would be consequences. Hence, they are informed, “For safety’s sake, if you do not accept and follow the above rules your healthcare provider may not be willing to prescribe, or to continue prescribing, opioids for your pain. Not following the rules also could indicate that you have an opioid-use problem or addiction that requires separate treatment.”

A guiding principle of Treatment Agreements should be that they are used within the context of a trusting practitioner-patient relationship, without intimidation or coercion, and for purposes of promoting the health and well-being of the patient. From this perspective, an Agreement — which includes informed consent for the specific treatment — seems not only ethical but a prudent component of good medical practice.

ADDENDUM: For a further perspective, we recommend this editorial: Howard A. Heit and Douglas L. Gourlay. Tackling the Difficult Problem of Prescription Opioid Misuse. Ann Intern Med. 2010(Jun 1);152(11):747-748 [extract here].

REFERENCES:
> Payne R, Anderson E, Arnold R, Duensing L, Gilson A, Green C, Haywood C, Passik S, Rich B, Robin L, Shuler N, Christopher M. A Rose by Any Other Name: Pain Contracts/Agreements. Amer J Bioethics (AJOB). 2010;10(11):5-12 [
access by subscription here, no abstract].
> For additional information see: Center for Practical Bioethics. Pain Contracts [
access here].