Offer Informed Consent Instead of Opioid Treatment Contracts

NATIONAL HARBOR, Md. – In the ongoing climate the opioid abuse epidemic, many clinicians are hesitant to prescribe painkillers out of fear of legal repercussions. Pain management practitioners commonly ask patients to enter into treatment agreements that require patients to uphold a set of conditions. This approach raises ethical dilemmas, even when the intentions are made clear.

Richard Payne, MD, professor of medicine at the Duke University School of Medicine in Durham, North Carolina, examined the history of pain management agreements at the American Academy of Pain Management 2015 meeting.¹ 

During his keynote, Dr. Payne discussed the development of opioid contract agreements. He proposed informed consent as a more ethically justifiable option for pain management, contending that informed consent represents a paradigm shift in chronic pain policy. Dr. Payne also offered suggestions for how clinicians and institutions can make the right transformations to better meet the needs of patients. 

Chronic pain affects more than 100 million Americans and is the most common cause of long-term disability, accounting for billions of dollars of healthcare spending each year.² 

The first mention of opioid contracts in literature occurred in the 1980s, according to Dr. Payne, as a form of contingency contracting for substance use. Through the 1990s these agreements became more popular, finding their way into state medical boards, institutional policies, and professional guidelines. 

At least 10 states that have codified a mandate in relation to the use of opioid agreements, which the conditions of such contracts varying depending on the state. “The number of states requiring some kind of an opioid contract between clinician and patient will grow over the years,” said Dr. Payne.

The original clinical objectives of creating binding contracts for opioid use were as follows: 

• To create a tool to educate patients about treatment plan
• To inform patients of risks and benefits of treatment
• To clarify treatments goals, expectations, and mutual responsibility
• To promote adherence to treatment

Over the years, other purposes for agreements became relevant including minimizing the legal risk to clinicians/facilities; promoting medication adherence; curbing misuse, abuse, diversion; and controlling the medication supply. 

“Patients sometimes ask: ‘Why do I have to sign this? I take my medications the way they are prescribed, so why do I have to sign a contract to show I can be trusted?’” explained Dr. Payne.

There are several differences between a treatment contract and informed consent. Contracts show paternalism, unilateral responsibilities, imposed proscriptions, and a power differential, whereas informed consent revolves around autonomy, mutual responsibilities, negotiated goals, and equalizing, according to Dr. Payne.

Key elements of informed consent include providing information in a form the patient can understand; involving the patient in a decision-making capacity to communicate and reason regarding treatment choice; sufficient voluntarism on the part of the patient to  make choices consistent with his or her preferences and values without undue coercion.

In legal terms, opioid agreements are “adhesion contracts,” prepared by one party to be signed by a second party in a weaker position, usually a consumer who has little choice about the terms.³

Bioethicists have long questioned opioid agreements and proposed focusing on moving to informed consent instead of agreement contracts. Many patients have poor understanding what is entailed within a given opioid agreement as many are written beyond a high-school reading level.

There are other unintended adverse consequences of making pain patients sign opioid agreements. Pain patients are already stigmatized, distrustful of physicians, and vulnerable to coercion. These contracts may shame patients and intensify mutual suspicion, thereby leading to under-treatment of pain.⁴

In order to promote informed consent, there needs to be clear statement of the medical diagnosis, treatment goal, potential adverse effects of therapy, and clearly defined behavior expectations, emphasized Dr. Payne.

References

1. Payne R. “From Contracts to Consent: The Evolution of Opioid Ethics.” Presented at: AAPM 2015. Sept. 17-20; National Harbor, Maryland.
2. American Pain Society. “Pain assessment and treatment in the managed care environment. A position statement from the American Pain Society.” Case Manager. 2000; 11(5): 50-53.
3. Penko J. “Do patients know they are on pain medication agreements? Results from a sample of high-risk patients on chronic opioid therapy.” Pain Med. 2012;13(9):1174-80. 
4. Roskos SE. “Literacy demands and formatting characteristics of opioid contracts in chronic nonmalignant pain management.” J Pain. 2007;8(10):753-8.