Breaking the pain contract: A better controlled-substance agreement for patients on chronic opioid therapy
ABSTRACT“Pain contracts” for patients receiving long-term opioid therapy, though well-intentioned, often stigmatize the patient and erode trust between patient and physician. This article discusses how to improve these agreements to promote adherence, safety, trust, and shared decision-making.
KEY POINTS
- Both chronic pain and opioid therapy impose costs and risks. Though controversial, long-term opioid therapy will probably have a role for the foreseeable future.
- The term “controlled-substance agreement” is preferable to “pain contract” or “narcotic contract.”
- Controlled-substance agreements should be used only in the context of personalized patient counseling and shared decision-making.
- Objectives of controlled-substance agreements are to improve adherence, obtain informed consent, outline the prescribing policies of the practice, and mitigate risk.
Improving adherence
Many authors say that the primary goal of the controlled-substance agreement is to promote the use of the medication as prescribed, without variance, and from one physician only.35–38 This goal seems reasonable. However, many other classes of medications are also risky when used aberrantly, and we do not ask the patient to sign an agreement when we prescribe them. This double standard may reflect both the inherently higher risks associated with controlled substances and physician ambivalence regarding their use.
Regardless, the efficacy of controlledsubstance agreements in improving safe-use adherence and reducing aberrant medication-taking behaviors is uncertain. A 2010 systematic review based on observational and largely poor-quality studies concluded that using treatment agreements along with urine drug testing modestly reduced opioid misuse,39 while other reports have called their efficacy into question.40 We remain optimistic that well-written controlled-substance agreements can advance this objective, and that absence of evidence is not evidence of absence—ie, lack of efficacy. However, the data are not yet clear.
Interestingly, a 2014 survey found that most primary care physicians thought that controlled-substance agreements do not meaningfully reduce opioid misuse but do give a sense of protection against liability.41 Additionally, these documents are associated with a greater sense of physician satisfaction and mastery,42 and for some physicians these reasons may be enough to justify their use.
Somewhat alarmingly though, one study suggests that many patients do not even know that they signed a treatment agreement.43 Using a controlled-substance agreement without the full awareness and engagement of the patient cannot promote adherence and is likely counterproductive.
Obtaining informed consent
It is essential to discuss possible benefits and risks so that informed and shared decision-making can occur.
Controlled-substance agreements may advance this aim if carefully written, although medical practices often design them for use across a spectrum of patients with varying indications, contraindications, and risks, making these documents inherently inflexible. A one-size-fits-all document does not allow for meaningful personalization and is insufficient without patient-centered counseling.
We strongly recommend that treatment agreements complement but not replace personalized patient-centered counseling about individual risks and benefits. Well-written controlled-substance agreements may reduce the chance of overlooking key risks and launch further customized discussion. Additionally, they can be written in a manner that allows patients and physicians to agree on and document personalized goals (Table 2).
Furthermore, when crafted within a risk-benefit framework, a controlled-substance agreement can help to clarify an ethically important concept, ie, that the physician is judging the safety and appropriateness of the treatment, not the character of the patient.44 The prescriber can focus on evaluating the risks and benefits of treatment choices, not being a police officer or a judge of how “deserving” of opioid therapy the patient is.
Importantly, for patients to provide meaningful informed consent, the agreement must be understandable. A study of 162 opioid treatment agreements found that on average, they were written at a 14th grade level, which is beyond the reading comprehension of most patients.45 Another study evaluated patients’ ability to understand and follow instructions on labels for common prescriptions; even though 70% of the patients could read the labels, only 34.7% could demonstrate the instructions “take two tablets by mouth twice daily.”46
We recommend analyzing all controlled- substance agreements for readability by assessing their Flesch-Kincaid grade level or a similar literacy assessment, using readily available computer apps. The average education level of the patients cared for in each practice will vary based on the demographic served, and the controlled-substance agreement can be modified accordingly, but typically writing the document at the 6th- to 7th-grade reading level is suggested.
Outlining practice policies
Opioids are federally controlled substances with prescribing restrictions that vary based on the drug’s Drug Enforcement Agency schedule. State laws and regulations also govern opioid prescribing and are constantly evolving.47
Refilling opioid prescriptions should be a deliberate process during which the prescriber reviews the appropriateness of the medication and issues the prescription as safely as possible.
To promote practice consistency and to share expectations transparently with patients, we recommend spelling out in the agreement your policies on:
- Who can manage this patient’s opioid therapy
- How to handle refill requests after hours and on weekends
- When and how patients should request opioid refills
- Which pharmacies patients will use
- Whether the practice allows others to pick up refills for the patient.
This not only serves as a reference for patients, who keep a copy for their records, it also reduces the risk of inconsistent processes within the office, which will quickly lead to chaos and confusion among patients and physicians alike. Inconsistent prescription and refill practices can give the impression that a double standard exists and that some patients get more leeway than others, without apparent justification.
There is little evidence that this approach truly improves practice efficiency,34,48 but we believe that it may avert future confusion and conflict.
Mitigating the prescriber’s risk
Most licensing boards and clinical guidelines recommend controlled-substance agreements as part of opioid risk mitigation. These documents are now the standard of care, with many bodies recommending or mandating them, including the Federation of State Medical Boards,49 many states,50 Physicians for Responsible Opioid Prescribing,51 the American Academy of Pain Management,52 and the American Pain Society along with the American Academy of Pain Medicine.53
Historically, primary care physicians have used controlled-substance agreements inconsistently and primarily for patients believed to be at high risk of misuse.54 However, because physicians cannot accurately predict who will misuse or divert medications,25 controlled-substance agreements should be used universally, ie, for all patients prescribed controlled substances.
A controlled-substance agreement can serve as documentation. The patient can keep a copy for future reference, and a cosigned document is evidence that a discussion took place and may lower the risk of malpractice litigation.55 Further, if a state requires physicians to check their prescription monitoring database before prescribing opioids, the controlled-substance agreement can serve to both inform patients about this obligation and to obtain their consent when required.
At a minimum, we recommend that prescribers learn about the regulatory framework in their state and use controlled-substance agreements as legislatively mandated.
A CHECKLIST FOR THE PHYSICIAN AND PATIENT
To facilitate the development and use of ethically appropriate controlled-substance agreements with a focus on shared decision-making, we offer a sample tool in the form of a checklist (Table 2). It can be modified and implemented instead of a traditional controlled-substance agreement or can be used alongside other more comprehensive documents to facilitate discussion.
The model presents critical information for the patient and physician to discuss and acknowledge (initial) in writing. It is divided into three sections: shared responsibilities, patient responsibilities, and physician responsibilities. Each contains an approximately equal number of items; this is deliberate and visually conveys the notion of equivalent and shared responsibilities for patient and physician. The patient, physician, or both should initial each item to indicate their agreement.
The document is customizable for the specific treatment prescribed. It is written at a Flesch-Kincaid grade level of 6.8, consistent with current health literacy recommendations, and avoids medical jargon and complex compound sentences as much as possible.
We indicate key elements of shared decision-making27,30,31 in parentheses in Table 2 and cross-reference them with Table 1, which describes them more fully.
A BETTER TOOL
Both chronic pain and prescription drug abuse are highly prevalent and carry serious consequences. These overlapping epidemics put the prescriber in the difficult position of trying to prevent misuse, abuse, and diversion while simultaneously adequately treating pain.
Physicians and policy makers look to controlled-substance agreements as tools to help them balance the benefits and risks, but frequently at the expense of eroding trust between the patient and physician, stigmatizing the patient, using pejorative and coercive language, not adhering to health literacy guidelines, and failing to share decisions.
We believe a better tool is possible and suggest that controlled-substance agreements be universally applied, use deliberate and understandable language, be framed in terms of safety, and be implemented according to the principles of shared decision-making.
