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egulatory 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.
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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] [3] [4] [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.
■ PAIN AND ITS TREATMENT HAVE COSTS
; 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 vrussell@example.com. Diversion of prescription drugs for nonmedical use is common 11 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.
■ THE SPECIAL ROLE OF THE PRIMARY CARE PHYSICIAN
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.
■ THE SPECIAL ROLE OF THE PRIMARY CARE PHYSICIAN
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.
■ THE SPECIAL ROLE OF THE PRIMARY CARE PHYSICIAN
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.
■ A CONTROLLED-SUBSTANCE AGREEMENT INSTEAD OF A 'NARCOTIC CONTRACT'
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.
■ A CONTROLLED-SUBSTANCE AGREEMENT INSTEAD OF A 'NARCOTIC CONTRACT'
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] [21] [22] [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 paDrug overdose deaths exceed deaths from car crashes TOBIN AND COLLEAGUES tient 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.
■ STIGMATIZING THE PATIENT
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] [21] [22] [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 decisionmaking. 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.
■ SHARED DECISION-MAKING AND CHRONIC OPIOID THERAPY
To be consistent with shared decisionmaking, the controlled-substance agreement must: 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:
■ THE CONTROLLED-SUBSTANCE AGREEMENT: FOUR OBJECTIVES
• 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.
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] [36] [37] [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.
Improving adherence
Regardless, the efficacy of controlledsubstance agreements in improving safe-use adherence and reducing aberrant medicationtaking 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.
Improving adherence
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.
Improving adherence
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 decisionmaking can occur.
Obtaining informed consent
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.
Obtaining informed consent
We strongly recommend that treatment Some primary care physicians have stopped prescribing opioids altogether TOBIN AND COLLEAGUES 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 riskbenefit 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 Physicians are notoriously poor at predicting which patients will misuse opioids a) Pill counts, to be sure the number of pills used is correct b) Urine ("pee") or blood tests, to be sure I am taking my medication correctly and no unsafe drugs are present c) Checking the state "prescription monitoring program"to be sure the drugstore is filling pain pills only when they are due and only from this doctor's office.
Obtaining informed consent
7 We agreed that I would take only the number and type of pills prescribed to me. We will work together to change them if they are not meeting our agreed-upon goals. (Table 1 12 My doctor explained that opioids are even more dangerous when they are mixed with other drugs or alcohol or used in the wrong way. For safety, I understand that I should not: (Table 1, 13 I understand that my pills are for me only. I will keep them in a safe place away from children and other people. I will also get rid of leftover pills only in the way my doctor or pharmacist teaches me. (Table 1, 16 I will keep learning about how to treat pain and recognize when opioids are causing more harm than good. (Table 1, element 5) 17 I will make sure my patient has the right phone numbers for my office and the hospital. (Table 1, element 9) 18 My office and I will be available to my patients when they need help. (Table 1,  element 9) 19 I will make sure my patient knows my office rules about how and when to ask for refills. (Table 1, element 7) 20 I will teach my patients how to take their pills safely. I will have them show me to be sure they are doing it right. (Table 1, element 7) 21 If I believe opioids are no longer safe or helping my patient, I will carefully stop prescribing them and use other treatments. (Table 1 , elements 5 and 9)
Obtaining informed consent
TOBIN AND COLLEAGUES 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 controlledsubstance 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.
Outlining practice policies
To promote practice consistency and to share expectations transparently with patients, we recommend spelling out in the agreement your policies on:
Outlining practice policies
• 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.
Outlining practice policies
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.
Outlining practice policies
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 controlledsubstance agreements should be used universally, ie, for all patients prescribed controlled substances.
Mitigating the prescriber's risk
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.
Mitigating the prescriber's risk
At a minimum, we recommend that prescribers learn about the regulatory framework in their state and use controlled-substance agreements as legislatively mandated.
Mitigating the prescriber's risk
Many patients do not even know that they signed a treatment agreement ■ 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.
Mitigating the prescriber's risk
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.
Mitigating the prescriber's risk
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.
Mitigating the prescriber's risk
We indicate key elements of shared decision-making 27, 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.
■ A BETTER TOOL
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.
■ A BETTER TOOL
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. 

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