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Breaking the pain contract: A better controlled-substance agreement for patients on chronic opioid therapy

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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.


 

References

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.1

Opioid therapy for chronic noncancer pain is being called into question,2–5 and a 2016 guideline from the US Centers for Disease Control and Prevention has called for more limited and judicious use of opioids in primary care.6 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.7

Concerns about opioids include risks of overdose and death. Unintentional drug overdoses, typically with opioids, exceeded motor vehicle accidents in 2009 as the leading cause of accidental death in the United States8; by 2014, nearly one and a half times as many people were dying of a drug overdose than of a car accident.9 Even when used appropriately, opioids are associated with sedation, falls, motor vehicle accidents, addiction, and unintended overdose.10

The potential harm extends beyond the patient to the community at large. Diversion of prescription drugs for nonmedical use is common11 and, after marijuana and alcohol abuse, is the most common form of drug abuse in the United States.12 Misuse of prescription drugs costs health insurers an estimated $72.5 billion each year—a cost largely passed on to consumers through higher premiums.13 Most individuals who abuse prescription opioids get them from friends and family, sometimes by stealing them.14

THE SPECIAL ROLE OF THE PRIMARY CARE PHYSICIAN

Chronic pain is extremely prevalent in general internal medicine and primary care practice.15,16 It has tremendous associated medical, social, and economic costs.1

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.

Furthermore, access to board-certified pain specialists is limited. There are only four such specialists for every 100,000 patients with chronic pain,17 and those who are available often restrict the types of insurance they accept, disproportionately excluding Medicaid patients.

We encourage primary care physicians to undertake continuing medical education and professional development as needed to prescribe opioids as safely and effectively as possible.

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 1981.18 Since then, the term “narcotic contract” has become widely used, even as most professional guidelines have now moved away from using it. A Google search for the term on November 27, 2015, yielded 2,000 results, with numerous examples of the documents in clinical use.

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. For example, the US Controlled Substances Act lists cocaine as a narcotic.19 The word also carries a stigma, as law enforcement agencies and drug abuse programs commonly use phrases such as “narcotic task force” or “narcotic treatment program.” On the other hand, the more accurate term “opioid” may be unfamiliar to patients. 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.20–23

For these reasons, we encourage physicians to adopt the phrase “controlled-substance agreement” or something similar. This label accurately reflects the specificity of the treatment and connotes a partnership between patient and physician. Furthermore, it allows the physician to use the agreement when prescribing other controlled substances such as benzodiazepines and stimulants that also carry a risk of addiction, misuse, and adverse effects.

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.21,24 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 search.

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.20–23

Some physicians stigmatize inadvertently. Believing that they can identify which patients will misuse their prescriptions, they use controlled-substance agreements only in this subgroup. But in fact, physicians are notoriously poor at predicting which patients will misuse prescription opioids or suffer adverse effects.25 Therefore, it is important to be transparent and consistent with monitoring practices for all patients on chronic opioid therapy.26

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.

Shared decision-making promotes mutual respect between patients and physicians, is feasible to implement in primary care, and may improve health outcomes.27,28 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.29 Additionally, after learning about the risks, some patients may choose to forgo opioid therapy.

To be consistent with shared decision-making, the controlled-substance agreement must:

  • Engage the patient, emphasizing the shared, reciprocal obligations of physician and patient
  • Address goals of treatment that are personalized and mutually agreed-upon and that incorporate the patient’s values and preferences
  • Explain treatment options in a way that is understandable and informative for the patient.

Table 1 outlines other key elements in detail.27,30,31

Shared decision-making is especially useful when the balance between the risks and benefits of a treatment plan is uncertain. It is not a substitute for medical expertise, and a patient’s preferences do not override the physician’s clinical judgment. A physician should not offer or implement chronic opioid therapy if he or she believes it is not indicated or is contraindicated, or that the risks for that patient clearly outweigh the benefits.32

THE CONTROLLED-SUBSTANCE AGREEMENT: FOUR OBJECTIVES

Stigmatizing language in the controlled-substance agreement may result from physician ambivalence regarding its intent and objectives. For example, some may perceive the agreement as a way to facilitate communication, while others may use it in a possibly unethical manner to control patient behavior with the threat of cutting off access to pain medication.33

Controlled-substance agreements have four commonly identified objectives,34 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.

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