Have a Real Conversation: Informed Consent vs Contracts for Opioid Therapy
Opioid contracts, more properly known as patient-provider agreements (PPAs), emerged from the need to address the complex set of challenges surrounding opioid use in the United States. These medications are clearly essential for treating some people with chronic pain, but they also pose a risk for abuse and misuse. The Federation of State Medical Boards and several state departments of health have recommended the use of PPAs as part of their model policies.1
Drawbacks of Opioid PPAs
The drawbacks of opioid PPAs include a lack consistency and clarity in their use of terms, including abuse, misuse, and addiction.2 In addition, limited evidence is available to support the efficacy of PPAs in preventing opioid misuse, abuse, or diversion.3,4
Furthermore, experts have expressed concern that PPAs may undermine the prescriber-patient relationship and create an atmosphere of mistrust.2,5,6 When PPAs first became commonly used in clinical practice, most were written in ways that protected prescribers more than patients. Thus, many PPAs were written using language that demanded that the patient fulfill certain requirements, with the consequence for nonadherence being dismissal from the practice.
Presenting these PPAs at initial patient visits may suggest to patients that they are not to be trusted and may give the sense of an unnecessarily large power imbalance, which is not conducive to establishing a good therapeutic relationship. In fact, part of the argument against PPAs is the limited evidence that they work and growing evidence that they can cause harm to the prescriber-patient relationship.2
Fortunately, a paradigm shift has occurred, and PPAs are evolving into essentially an extension of informed consent and more of an agreement shared by prescriber and patient.
Incorporating PPAs Into Informed Consent
Informed consent is a patient-centered approach to educating patients, which promotes the safe prescribing and use of opioids. During the informed consent process, patients should be briefed on the anticipated benefits and risks of using opioids to treat pain, as well as precautions that will be implemented to keep patients safe. The US Department of Veterans Affairs implemented this approach in 2014.7
When bringing up the topic of PPAs, it is helpful to present this information in an open and honest way. For example, a prescriber might say, “Here are some things that I need you to do to keep you as safe as possible when taking these medications. In exchange for your agreement to do these things, I’m also going to agree to do some things.” In this way, the PPA becomes a two-way agreement, rather than conveying a level of mistrust, while also informing patients of the reasons why the PPA is used (i.e., to keep patients safe).
PPAs should be voluntary and as free from coercion as possible. Agreements that are written with draconian consequences for any violation, or that are entirely one-sided by obligating the patient but not prescriber to certain behaviors, serve only to reinforce the inherent power imbalance. It is far better for patients to understand the reasons for the terms of the PPA, and to adhere to them because of an understanding that doing so promotes safe opioid use. The alternative, in which the patient feels coerced into adherence, can lead to a sense of resentment and can threaten the openness of the prescriber-patient relationship.
Steps for Informed Consent With Opioid Prescribing
The informed consent process is an investment of time that pays off down the road. Patients who are well informed are less likely to have adverse effects or to misuse opioids, which would require extensive time to manage.
Clinicians are often concerned about the time constraints of these conversations. However, when a clinician connects with the patient as outlined below, the conversation can be surprisingly efficient and satisfying for both parties. Of course, there are some patients who require more time to process the information, and the prescriber should be prepared for that.
It is important to set the stage for the discussion and present the agreement as part of the informed consent process. The following steps may be used as guidance:
- Sit at eye level with the patient.
- Be mindful of your body language. Do not cross your arms or legs. Face the patient straight on and be open.
- Remove all distractions so that you are fully engaged. Give the patient a sense that this is an important conversation and that you have time to devote to having it.
- Do not look at computer screens or paperwork during the conversation. Electronic health records should be completed by a nurse or medical assistant during the conversation, if possible, or after the conversation if the prescriber is alone.
- Don’t speak fast or use “medicalese.”
- Educate the patient on the medication, including the associated risks and anticipated benefits.
- When explaining the need to keep opioids in a secure place, highlight that this requirement is not only to protect the patient but also to protect loved ones.
- Ask the patient to demonstrate his or her understanding of the risks and benefits of the medication, as well as his or her part of the agreement, by repeating back the information.
What to Do When a Patient Breaks an Agreement
For patients who do not fulfill their responsibilities as outlined in the agreement, a careful assessment of the reasons for this behavior is needed rather than automatic punishments for violations. Once that assessment is completed, it may be possible to continue treatment under new, generally more restrictive, terms. For patients whose pain continues to be inadequately treated, referral to a pain specialist may be appropriate.
For other patients, restructuring of the treatment plan may be necessary. For example, some patients who are given a month’s supply of medication will run out in 20 days. However, if you give those patients a 1-week supply at a time, they are able to take the medication as prescribed without running out early.
Importantly, if the patient engages in aberrant drug-related behavior, it also may be a sign of a substance use disorder (see Chapter 7). Discharging a patient who exhibits signs of a substance use disorder could be construed as unethical and be grounds for malpractice charges. If the patient is violating the terms of the agreement, and there is an indication of a substance use disorder, the patient needs to be referred to a substance abuse specialist or program.
Tools for Guiding PPAs
A sample PPA that details the terms and conditions of long-term opioid therapy for pain is shown in the figure below.8 The form, which is provided by the National Institute on Drug Abuse, is designed to help patients understand their role and responsibilities (e.g., how to obtain refills and conditions of medication use), the conditions under which treatment may be terminated, and the responsibilities of the health care provider.