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.
Regulatory bodies and professional societies have encouraged or mandated written pain treatment agreements for over a decade as a way to establish informed consent, improve adherence, and mitigate risk.
Unfortunately, the content of these agreements varies, their efficacy is uncertain, and some are stigmatizing or coercive and jeopardize trust.
Additionally, many are written at reading levels beyond most patients’ understanding.
However, we believe a well-written agreement is still an important tool in chronic pain management.
In this article, we explore common limitations of current pain treatment “contracts” and propose strategies to improve their usefulness and acceptance.
PAIN AND ITS TREATMENT HAVE COSTS
Chronic pain affects 100 million US adults and is estimated to cost $635 billion each year in treatment, lost wages, and reduced productivity
Opioid therapy for chronic noncancer pain is being called into question, and a 2016 guideline from the US Centers for Disease Control and Prevention (CDC) has called for more limited and judicious use of opioids in primary care.
Nevertheless, long-term opioid therapy is probably helpful in some circumstances and will likely continue to have a role in chronic pain management for the foreseeable future.
THE SPECIAL ROLE OF THE PRIMARY CARE PHYSICIAN
In light of the risks and complexity of opioid use and the increasing regulatory requirements for safe prescribing, some primary care physicians have stopped prescribing opioids altogether and refer patients elsewhere for pain management
This does a disservice to patients.
Primary care physicians cannot entirely avoid chronic pain management or absolutely refuse to prescribe opioids in all circumstances and still provide quality care.
And although some primary care physicians may need more training in prescribing opioids, their comprehensive understanding of the patient’s other health issues enables them to address the psychosocial generators and consequences of the patient’s chronic pain more fully than a specialist can.
This is an important point I had not considered: I’ve known my PCP for over a decade and she is aware of all my multiple health issues. She has much more knowledge of and experience with me and can see how opioids fit into my general health maintenance.
Furthermore, access to board-certified pain specialists is limited. There are only four such specialists for every 100,000 patients with chronic pain, and those who are available often restrict the types of insurance they accept, disproportionately excluding Medicaid patients.
A CONTROLLED-SUBSTANCE AGREEMENT INSTEAD OF A ‘NARCOTIC CONTRACT’
To address the challenges of long-term opioid therapy, many state officials, medical licensing boards, professional societies, and other regulatory bodies recommend proactive monitoring and management of prescribing risks.
Often promoted and sometimes mandated is the use of a written pain treatment agreement, sometimes called a “pain contract” or “narcotic contract,” in which the patient and the physician ostensibly agree to various conditions under which opioids will be prescribed or discontinued
Although well-intentioned, these documents can cause several problems.
Contracts were being advocated in treating opiate addiction as early as 1981. Since then, the term “narcotic contract” has become widely used, even as most professional guidelines have now moved away from using it.
But the phrase is misleading, and we believe physicians should avoid using it. Clinically, the word “narcotic” is imprecise and can refer to substances other than opioids
The word also carries a stigma,
We recommend using the term “controlled substance” instead.
Similarly, the word “contract” can be perceived as coercive, can erode physician-patient trust,
…and implies that failure to agree to it will result in loss of access to pain medications.
Implies? That’s exactly what these contracts spell out: if you break the contract, you will be “fired” from the practice and receive no further help.
For these reasons, we encourage physicians to adopt the phrase “controlled-substance agreement” or something similar.
STIGMATIZING THE PATIENT
Although no studies have systematically assessed the style and tone of available treatment agreements, many of the agreements seem to stigmatize the patient, using language that is mistrustful, accusatory, and even confrontational and that implies that the patient will misuse or abuse the medications
This is exactly correct. After working with my PCP (who prescribes my opioids) for close to 10 years, she was forced by her clinic to give me such an agreement to sign.
Tears came to my eyes as I read the text, which was essentially an accusation of abuse and strict terms outlining the severe punishment I’d receive if I didn’t obey even the smallest stipulation of the “contract”.
I signed it only under the threat of losing access to my medication, and I wonder if this can be legal. The coercion is clear and blatant throughout the document.
For example, “Failure to comply with the terms of the contract will risk loss of medication or discharge from the medical practice” is inflammatory and coercive, but variations of this phrase appear in many of the results of the aforementioned Google searc
Such language defeats attempts to communicate openly and implies a deprecatory attitude towards patients.
Stigmatization may result in undertreatment of pain, physician refusal to prescribe opioids, and patient refusal to submit to the terms of a one-sided agreement perceived as unfair.
Therefore, poorly written opioid agreements impair the trust necessary for a therapeutic physician-patient relationship and can interfere with optimal pain management.
Framing the controlled-substance agreement in terms of safety and using it universally can minimize miscommunication and unintentional stigmatization
SHARED DECISION-MAKING AND CHRONIC OPIOID THERAPY
We recommend using controlled-substance agreements only in the context of personalized patient counseling and shared decision-making.
These one-sided contracts that threaten patients with loss of medical care run counter to any kind of personalization and make it risky for the patient to express themselves.
A study found that physicians who received 2 hours of training in shared decision-making for chronic opioid therapy were more likely to complete treatment agreements and set mutually agreed-upon functional goals with patients, and they felt more confident, competent, and comfortable treating chronic pain. Additionally, after learning about the risks, some patients may choose to forgo opioid therapy.
THE CONTROLLED-SUBSTANCE AGREEMENT: FOUR OBJECTIVES
Controlled-substance agreements have four commonly identified objectives, explored further below:
- To improve adherence with the safe use of controlled substances while reducing aberrant behaviors
- To obtain informed consent
- To outline the prescribing policies of the practice
- To mitigate the prescriber’s legal risk.
The last one is the true reason for these contracts, protecting the doctor from any consequences from the treatment they dole out.
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. 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.
…the efficacy of controlled substance 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, while other reports have called their efficacy into question.
Obtaining informed consent
It is essential to discuss possible benefits and risks so that informed and shared decision-making can occur.
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 benefit
Additionally, they can be written in a manner that allows patients and physicians to agree on and document personalized goals (Table 2).
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.
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.”
Outlining practice policies
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.
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.
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
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
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) [above].
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.
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.
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.
Another article about this: Yale doctor, UNH bioethicist develop ‘agreement’ to balance opioid use, pain management