Daniel G. Tobin, MD, FACP

As a medical student, I understood that dealing with death was part of the practice of medicine. I was prepared to help my patients face the end of life from disease and old age and had steeled myself against the inevitable losses I would see from trauma and infection. However, I had no sense of the incredible burden that opioid addiction and death from unintentional overdose would one day cause.

See related article

MORE DEATHS FROM OVERDOSE THAN FROM MOTOR VEHICLE ACCIDENTS

To highlight the point, unintentional overdose deaths in 2008 exceeded motor vehicle accidents as the leading cause of accidental death in the United States.¹ Since then, the problem has only worsened; by 2014 the US Centers for Disease Control and Prevention reported that 78 Americans were dying each day from unintentional opioid overdose.²

Yet the scourge of deaths from opioid overdose is only the most obvious way that opioid use disorder destroys the lives of patients suffering from addiction, as well as their friends and family. Among many other heartaches, opioid use disorder is associated with severely impaired social function, increased rates of hepatitis C and human immunodeficiency virus (HIV) infection, and serious legal consequences and incarceration.³ Sadly, opioid use disorder has torn apart countless families. Addiction may be a brain disease, but its scope of morbidity extends far beyond the individual with the affliction.

PLENTY OF BLAME TO GO AROUND

To some extent, physicians are culpable in propagating this epidemic, and not just in their obvious role as opioid suppliers. To be certain, opioid overprescribing is a tremendous problem; in 2014, more than 240 million prescriptions for opioids were issued, enough for every American adult to have his or her own bottle of pills.⁴

However, there is plenty of blame to go around in the medical system for the problems of overprescribing and inappropriate opioid use. Among other factors, medical schools have historically failed to teach young physicians how to treat pain or prescribe opioids safely,⁵ and pain specialists are often inaccessible to primary care providers.⁶ Additionally, pharmaceutical companies have been found guilty of marketing opioids to prescribers in misleading ways,⁷ and well-intentioned but misguided campaigns such as the “pain as a fifth vital sign” movement may have inadvertently contributed to opioid overprescribing as well.⁸

TACKLING THE CHALLENGE

Prescribers need to tackle these challenges by educating themselves about when and how to prescribe opioids for chronic pain. Breaking the cycle of overprescribing can be achieved by learning to prescribe opioids rationally, cautiously, and as part of a comprehensive multimodal pain management plan with a commitment to risk assessment and harm reduction. It also means having an exit strategy at the start of opioid therapy. This must include recognizing problematic opioid use when it occurs and having options to offer patients when opioid use disorder becomes the primary problem.

Recognizing the problem

Physicians are notoriously poor at predicting and detecting the presence of aberrant drug use behaviors and opioid use disorder. For example, in a study of patients clinicians thought were not at risk for misuse of medications, 60% had urine drug tests showing either the presence of illicit drugs or no evidence of the prescribed drug.⁹

The prevalence of problematic opioid use in patients on chronic opioid therapy for pain has been variably reported in the literature, but one systematic review found that misuse rates ranged from 21% to 29% (95% confidence interval 13%–38%) and addiction rates averaged 8% to 12% (3%–17%).¹⁰ These numbers are alarming, and prescribers need to know how to screen for and diagnose opioid addiction when they see it.

Importantly, there is a wide spectrum of opioid misuse behaviors, and the wise prescriber will thoughtfully consider each circumstance before assuming a patient has a substance use disorder. For example, one patient may skip doses and “hoard” unused pills for fear that he or she will run out of medication during a pain flare, while another may use opioids for nonmedical reasons such as to get high. Both examples represent aberrant drug use, but in the first case patient education may sufficiently address the problem, while the second may herald a more dangerous and less correctable problem.

Simply recognizing that a problem exists is not enough. Once we identify problematic opioid use, we also need to know how to address it.

Managing opioid misuse behaviors requires empathy, and prescribers should consider a patient’s motivation and emotive response to counsel. For instance, the patient who skips doses and hoards pills may fear that their well-controlled pain will suddenly worsen if their doctor’s opioid prescribing becomes more restrictive as new guidelines are released.

The lesson is that safe opioid prescribing may require a more restrictive approach than was understood in prior years, but rational prescribing also means careful consideration before arbitrarily tapering or discontinuing opioids in a patient who has demonstrated benefit without evidence of harm, even if new guidelines now recommend against starting opioid therapy for similar pain syndromes. For example, the American College of Physicians released a guideline earlier this year that recommended against opioids to treat low back pain, but it did not recommend stopping opioids if patients were already taking them and benefiting from their use.¹¹

Sometimes the best course of action is to discontinue opioid therapy. This decision may trigger a grief-like reaction in some patients and there can be distinct communication challenges during each coping phase.¹² The prescriber should frame opioid prescribing discussions on the changing balance of perceived benefits, risks, and harms; in some cases, the treatment may have “failed” or no longer be appropriate, but the patient may still be suffering from pain. Further, the patient may now need help with a newly recognized substance use disorder and may be particularly vulnerable during this time.

The wrong approach, in my opinion, is to discharge the patient from care because of addiction. This approach may seem justified to the provider who feels betrayed by a patient who has used a prescription differently than intended and has thus placed everyone at risk. However, providers should not take it personally; by definition, a patient with addiction has lost control over use of a drug and may have a stronger relationship with the drug than with you. Instead, we should attempt to intervene to protect a patient’s health and chances of survival. It is critical that physicians learn to leverage treatment resources to provide the support patients need to start the long process of recovery. This may involve detoxification and rehabilitation programs, but in many cases opioid agonist therapy also has a role.

Medication-assisted therapy

Medication-assisted therapy with methadone or buprenorphine can be an extremely important part of this process and is a strategy that Modesto-Lowe et al explore in this issue of the Journal.¹³ As they point out, patients and providers often misunderstand the use of opioid agonists to treat opioid use disorder; many perceive this as merely substituting one form of addiction for another. However, compelling data support this approach. Studies have shown that opioid agonist therapy is associated with decreased illicit opioid use, better retention in substance use treatment programs, reduced hepatitis C and HIV seroconversion, reduced rates of criminal activity and incarceration, decreased overdose risk, and improved survival.¹⁴

Opioid agonists are not a cure-all and come with their own challenges, but for many patients they can “create the space” needed to do the real work of recovery—healing their damaged relationships with themselves, their family, and their society.

Providers need to educate themselves regarding the options available and when and how to use them. They should familiarize themselves with methadone and buprenorphine treatment programs in their community. Better yet, with only 8 hours of additional training, primary care physicians can become waivered to prescribe buprenorphine to treat opioid addiction right in the office. Treating addiction is quickly becoming part of primary care, and clinicians in practice can no longer turn a blind eye toward this problem.

As a medical student, I understood that dealing with death was part of the practice of medicine. I was prepared to help my patients face the end of life from disease and old age and had steeled myself against the inevitable losses I would see from trauma and infection. However, I had no sense of the incredible burden that opioid addiction and death from unintentional overdose would one day cause.

See related article

MORE DEATHS FROM OVERDOSE THAN FROM MOTOR VEHICLE ACCIDENTS

To highlight the point, unintentional overdose deaths in 2008 exceeded motor vehicle accidents as the leading cause of accidental death in the United States.¹ Since then, the problem has only worsened; by 2014 the US Centers for Disease Control and Prevention reported that 78 Americans were dying each day from unintentional opioid overdose.²

Yet the scourge of deaths from opioid overdose is only the most obvious way that opioid use disorder destroys the lives of patients suffering from addiction, as well as their friends and family. Among many other heartaches, opioid use disorder is associated with severely impaired social function, increased rates of hepatitis C and human immunodeficiency virus (HIV) infection, and serious legal consequences and incarceration.³ Sadly, opioid use disorder has torn apart countless families. Addiction may be a brain disease, but its scope of morbidity extends far beyond the individual with the affliction.

PLENTY OF BLAME TO GO AROUND

To some extent, physicians are culpable in propagating this epidemic, and not just in their obvious role as opioid suppliers. To be certain, opioid overprescribing is a tremendous problem; in 2014, more than 240 million prescriptions for opioids were issued, enough for every American adult to have his or her own bottle of pills.⁴

However, there is plenty of blame to go around in the medical system for the problems of overprescribing and inappropriate opioid use. Among other factors, medical schools have historically failed to teach young physicians how to treat pain or prescribe opioids safely,⁵ and pain specialists are often inaccessible to primary care providers.⁶ Additionally, pharmaceutical companies have been found guilty of marketing opioids to prescribers in misleading ways,⁷ and well-intentioned but misguided campaigns such as the “pain as a fifth vital sign” movement may have inadvertently contributed to opioid overprescribing as well.⁸

TACKLING THE CHALLENGE

Prescribers need to tackle these challenges by educating themselves about when and how to prescribe opioids for chronic pain. Breaking the cycle of overprescribing can be achieved by learning to prescribe opioids rationally, cautiously, and as part of a comprehensive multimodal pain management plan with a commitment to risk assessment and harm reduction. It also means having an exit strategy at the start of opioid therapy. This must include recognizing problematic opioid use when it occurs and having options to offer patients when opioid use disorder becomes the primary problem.

Recognizing the problem

Physicians are notoriously poor at predicting and detecting the presence of aberrant drug use behaviors and opioid use disorder. For example, in a study of patients clinicians thought were not at risk for misuse of medications, 60% had urine drug tests showing either the presence of illicit drugs or no evidence of the prescribed drug.⁹

The prevalence of problematic opioid use in patients on chronic opioid therapy for pain has been variably reported in the literature, but one systematic review found that misuse rates ranged from 21% to 29% (95% confidence interval 13%–38%) and addiction rates averaged 8% to 12% (3%–17%).¹⁰ These numbers are alarming, and prescribers need to know how to screen for and diagnose opioid addiction when they see it.

Importantly, there is a wide spectrum of opioid misuse behaviors, and the wise prescriber will thoughtfully consider each circumstance before assuming a patient has a substance use disorder. For example, one patient may skip doses and “hoard” unused pills for fear that he or she will run out of medication during a pain flare, while another may use opioids for nonmedical reasons such as to get high. Both examples represent aberrant drug use, but in the first case patient education may sufficiently address the problem, while the second may herald a more dangerous and less correctable problem.

Simply recognizing that a problem exists is not enough. Once we identify problematic opioid use, we also need to know how to address it.

Managing opioid misuse behaviors requires empathy, and prescribers should consider a patient’s motivation and emotive response to counsel. For instance, the patient who skips doses and hoards pills may fear that their well-controlled pain will suddenly worsen if their doctor’s opioid prescribing becomes more restrictive as new guidelines are released.

The lesson is that safe opioid prescribing may require a more restrictive approach than was understood in prior years, but rational prescribing also means careful consideration before arbitrarily tapering or discontinuing opioids in a patient who has demonstrated benefit without evidence of harm, even if new guidelines now recommend against starting opioid therapy for similar pain syndromes. For example, the American College of Physicians released a guideline earlier this year that recommended against opioids to treat low back pain, but it did not recommend stopping opioids if patients were already taking them and benefiting from their use.¹¹

Sometimes the best course of action is to discontinue opioid therapy. This decision may trigger a grief-like reaction in some patients and there can be distinct communication challenges during each coping phase.¹² The prescriber should frame opioid prescribing discussions on the changing balance of perceived benefits, risks, and harms; in some cases, the treatment may have “failed” or no longer be appropriate, but the patient may still be suffering from pain. Further, the patient may now need help with a newly recognized substance use disorder and may be particularly vulnerable during this time.

The wrong approach, in my opinion, is to discharge the patient from care because of addiction. This approach may seem justified to the provider who feels betrayed by a patient who has used a prescription differently than intended and has thus placed everyone at risk. However, providers should not take it personally; by definition, a patient with addiction has lost control over use of a drug and may have a stronger relationship with the drug than with you. Instead, we should attempt to intervene to protect a patient’s health and chances of survival. It is critical that physicians learn to leverage treatment resources to provide the support patients need to start the long process of recovery. This may involve detoxification and rehabilitation programs, but in many cases opioid agonist therapy also has a role.

Medication-assisted therapy

Medication-assisted therapy with methadone or buprenorphine can be an extremely important part of this process and is a strategy that Modesto-Lowe et al explore in this issue of the Journal.¹³ As they point out, patients and providers often misunderstand the use of opioid agonists to treat opioid use disorder; many perceive this as merely substituting one form of addiction for another. However, compelling data support this approach. Studies have shown that opioid agonist therapy is associated with decreased illicit opioid use, better retention in substance use treatment programs, reduced hepatitis C and HIV seroconversion, reduced rates of criminal activity and incarceration, decreased overdose risk, and improved survival.¹⁴

Opioid agonists are not a cure-all and come with their own challenges, but for many patients they can “create the space” needed to do the real work of recovery—healing their damaged relationships with themselves, their family, and their society.

Providers need to educate themselves regarding the options available and when and how to use them. They should familiarize themselves with methadone and buprenorphine treatment programs in their community. Better yet, with only 8 hours of additional training, primary care physicians can become waivered to prescribe buprenorphine to treat opioid addiction right in the office. Treating addiction is quickly becoming part of primary care, and clinicians in practice can no longer turn a blind eye toward this problem.

As a medical student, I understood that dealing with death was part of the practice of medicine. I was prepared to help my patients face the end of life from disease and old age and had steeled myself against the inevitable losses I would see from trauma and infection. However, I had no sense of the incredible burden that opioid addiction and death from unintentional overdose would one day cause.

See related article

MORE DEATHS FROM OVERDOSE THAN FROM MOTOR VEHICLE ACCIDENTS

To highlight the point, unintentional overdose deaths in 2008 exceeded motor vehicle accidents as the leading cause of accidental death in the United States.¹ Since then, the problem has only worsened; by 2014 the US Centers for Disease Control and Prevention reported that 78 Americans were dying each day from unintentional opioid overdose.²

Yet the scourge of deaths from opioid overdose is only the most obvious way that opioid use disorder destroys the lives of patients suffering from addiction, as well as their friends and family. Among many other heartaches, opioid use disorder is associated with severely impaired social function, increased rates of hepatitis C and human immunodeficiency virus (HIV) infection, and serious legal consequences and incarceration.³ Sadly, opioid use disorder has torn apart countless families. Addiction may be a brain disease, but its scope of morbidity extends far beyond the individual with the affliction.

PLENTY OF BLAME TO GO AROUND

To some extent, physicians are culpable in propagating this epidemic, and not just in their obvious role as opioid suppliers. To be certain, opioid overprescribing is a tremendous problem; in 2014, more than 240 million prescriptions for opioids were issued, enough for every American adult to have his or her own bottle of pills.⁴

However, there is plenty of blame to go around in the medical system for the problems of overprescribing and inappropriate opioid use. Among other factors, medical schools have historically failed to teach young physicians how to treat pain or prescribe opioids safely,⁵ and pain specialists are often inaccessible to primary care providers.⁶ Additionally, pharmaceutical companies have been found guilty of marketing opioids to prescribers in misleading ways,⁷ and well-intentioned but misguided campaigns such as the “pain as a fifth vital sign” movement may have inadvertently contributed to opioid overprescribing as well.⁸

TACKLING THE CHALLENGE

Prescribers need to tackle these challenges by educating themselves about when and how to prescribe opioids for chronic pain. Breaking the cycle of overprescribing can be achieved by learning to prescribe opioids rationally, cautiously, and as part of a comprehensive multimodal pain management plan with a commitment to risk assessment and harm reduction. It also means having an exit strategy at the start of opioid therapy. This must include recognizing problematic opioid use when it occurs and having options to offer patients when opioid use disorder becomes the primary problem.

Recognizing the problem

Physicians are notoriously poor at predicting and detecting the presence of aberrant drug use behaviors and opioid use disorder. For example, in a study of patients clinicians thought were not at risk for misuse of medications, 60% had urine drug tests showing either the presence of illicit drugs or no evidence of the prescribed drug.⁹

The prevalence of problematic opioid use in patients on chronic opioid therapy for pain has been variably reported in the literature, but one systematic review found that misuse rates ranged from 21% to 29% (95% confidence interval 13%–38%) and addiction rates averaged 8% to 12% (3%–17%).¹⁰ These numbers are alarming, and prescribers need to know how to screen for and diagnose opioid addiction when they see it.

Importantly, there is a wide spectrum of opioid misuse behaviors, and the wise prescriber will thoughtfully consider each circumstance before assuming a patient has a substance use disorder. For example, one patient may skip doses and “hoard” unused pills for fear that he or she will run out of medication during a pain flare, while another may use opioids for nonmedical reasons such as to get high. Both examples represent aberrant drug use, but in the first case patient education may sufficiently address the problem, while the second may herald a more dangerous and less correctable problem.

Simply recognizing that a problem exists is not enough. Once we identify problematic opioid use, we also need to know how to address it.

Managing opioid misuse behaviors requires empathy, and prescribers should consider a patient’s motivation and emotive response to counsel. For instance, the patient who skips doses and hoards pills may fear that their well-controlled pain will suddenly worsen if their doctor’s opioid prescribing becomes more restrictive as new guidelines are released.

The lesson is that safe opioid prescribing may require a more restrictive approach than was understood in prior years, but rational prescribing also means careful consideration before arbitrarily tapering or discontinuing opioids in a patient who has demonstrated benefit without evidence of harm, even if new guidelines now recommend against starting opioid therapy for similar pain syndromes. For example, the American College of Physicians released a guideline earlier this year that recommended against opioids to treat low back pain, but it did not recommend stopping opioids if patients were already taking them and benefiting from their use.¹¹

Sometimes the best course of action is to discontinue opioid therapy. This decision may trigger a grief-like reaction in some patients and there can be distinct communication challenges during each coping phase.¹² The prescriber should frame opioid prescribing discussions on the changing balance of perceived benefits, risks, and harms; in some cases, the treatment may have “failed” or no longer be appropriate, but the patient may still be suffering from pain. Further, the patient may now need help with a newly recognized substance use disorder and may be particularly vulnerable during this time.

The wrong approach, in my opinion, is to discharge the patient from care because of addiction. This approach may seem justified to the provider who feels betrayed by a patient who has used a prescription differently than intended and has thus placed everyone at risk. However, providers should not take it personally; by definition, a patient with addiction has lost control over use of a drug and may have a stronger relationship with the drug than with you. Instead, we should attempt to intervene to protect a patient’s health and chances of survival. It is critical that physicians learn to leverage treatment resources to provide the support patients need to start the long process of recovery. This may involve detoxification and rehabilitation programs, but in many cases opioid agonist therapy also has a role.

Medication-assisted therapy

Medication-assisted therapy with methadone or buprenorphine can be an extremely important part of this process and is a strategy that Modesto-Lowe et al explore in this issue of the Journal.¹³ As they point out, patients and providers often misunderstand the use of opioid agonists to treat opioid use disorder; many perceive this as merely substituting one form of addiction for another. However, compelling data support this approach. Studies have shown that opioid agonist therapy is associated with decreased illicit opioid use, better retention in substance use treatment programs, reduced hepatitis C and HIV seroconversion, reduced rates of criminal activity and incarceration, decreased overdose risk, and improved survival.¹⁴

Opioid agonists are not a cure-all and come with their own challenges, but for many patients they can “create the space” needed to do the real work of recovery—healing their damaged relationships with themselves, their family, and their society.

Providers need to educate themselves regarding the options available and when and how to use them. They should familiarize themselves with methadone and buprenorphine treatment programs in their community. Better yet, with only 8 hours of additional training, primary care physicians can become waivered to prescribe buprenorphine to treat opioid addiction right in the office. Treating addiction is quickly becoming part of primary care, and clinicians in practice can no longer turn a blind eye toward this problem.

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.

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-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.

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.

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.

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-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.

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.

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.

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-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.

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.

In Reply: We thank Dr. Pettiway for his remarks. The intent of our article was to identify common challenges when prescribing opioids for chronic pain and offer tips to the provider struggling with how to do so safely. We hope these comments will offer additional clarity.

First, as general internists who are essentially “self-trained” in the management of chronic pain, we fully acknowledge the importance of practical experience in learning how to prescribe opioids safely and effectively. Dr. Pettiway is correct that a dedicated physician who keeps up with the medical literature, attends relevant continuing medical education courses, and strives to provide deliberate, rational, and evidence-based care to his or her patients can do so effectively. However, the medical literature suggests that medical school training in the management of chronic pain is sparse; one review found that in 2011 only 5 out of 133 US medical schools required coursework on pain management, and only 13 offered it as an elective.¹ Many primary care providers do feel unprepared to handle this challenge.

Additionally, Dr. Pettiway raises a good question about where misused prescription opioids originate and whether prescribers are responsible. The data show that the majority of misused prescription opioids are obtained from a family member or friend and not directly from a physician.^2,3 However, this supply does generally originate from a prescription. Providers need to educate their patients about the risk for diversion, the need to keep pills safely hidden and locked away, and the importance of safely discarding unused supplies. Responsible prescribers need to anticipate these concerns and educate patients about them.

In summary, we firmly believe that primary care providers are capable of safe, effective, and responsible opioid prescribing and hope that our paper provides additional guidance on how to do so.

In Reply: We thank Dr. Pettiway for his remarks. The intent of our article was to identify common challenges when prescribing opioids for chronic pain and offer tips to the provider struggling with how to do so safely. We hope these comments will offer additional clarity.

First, as general internists who are essentially “self-trained” in the management of chronic pain, we fully acknowledge the importance of practical experience in learning how to prescribe opioids safely and effectively. Dr. Pettiway is correct that a dedicated physician who keeps up with the medical literature, attends relevant continuing medical education courses, and strives to provide deliberate, rational, and evidence-based care to his or her patients can do so effectively. However, the medical literature suggests that medical school training in the management of chronic pain is sparse; one review found that in 2011 only 5 out of 133 US medical schools required coursework on pain management, and only 13 offered it as an elective.¹ Many primary care providers do feel unprepared to handle this challenge.

Additionally, Dr. Pettiway raises a good question about where misused prescription opioids originate and whether prescribers are responsible. The data show that the majority of misused prescription opioids are obtained from a family member or friend and not directly from a physician.^2,3 However, this supply does generally originate from a prescription. Providers need to educate their patients about the risk for diversion, the need to keep pills safely hidden and locked away, and the importance of safely discarding unused supplies. Responsible prescribers need to anticipate these concerns and educate patients about them.

In summary, we firmly believe that primary care providers are capable of safe, effective, and responsible opioid prescribing and hope that our paper provides additional guidance on how to do so.

In Reply: We thank Dr. Pettiway for his remarks. The intent of our article was to identify common challenges when prescribing opioids for chronic pain and offer tips to the provider struggling with how to do so safely. We hope these comments will offer additional clarity.

First, as general internists who are essentially “self-trained” in the management of chronic pain, we fully acknowledge the importance of practical experience in learning how to prescribe opioids safely and effectively. Dr. Pettiway is correct that a dedicated physician who keeps up with the medical literature, attends relevant continuing medical education courses, and strives to provide deliberate, rational, and evidence-based care to his or her patients can do so effectively. However, the medical literature suggests that medical school training in the management of chronic pain is sparse; one review found that in 2011 only 5 out of 133 US medical schools required coursework on pain management, and only 13 offered it as an elective.¹ Many primary care providers do feel unprepared to handle this challenge.

Additionally, Dr. Pettiway raises a good question about where misused prescription opioids originate and whether prescribers are responsible. The data show that the majority of misused prescription opioids are obtained from a family member or friend and not directly from a physician.^2,3 However, this supply does generally originate from a prescription. Providers need to educate their patients about the risk for diversion, the need to keep pills safely hidden and locked away, and the importance of safely discarding unused supplies. Responsible prescribers need to anticipate these concerns and educate patients about them.

In summary, we firmly believe that primary care providers are capable of safe, effective, and responsible opioid prescribing and hope that our paper provides additional guidance on how to do so.

Chronic pain affects an estimated 100 million Americans, at a cost of $635 billion each year in medical expenses, lost wages, and reduced productivity.¹ It is often managed in primary care settings with opioids by clinicians who have little or no formal training in pain management.^2,3 Some primary care providers may seek assistance from board-certified pain specialists, but with only four such experts for every 100,000 patients with chronic pain, primary care providers are typically on their own.⁴

Although opioids may help in some chronic pain syndromes, they also carry the risk of serious harm, including unintentional overdose and death. In 2009, unintentional drug overdoses, most commonly with opioids, surpassed motor vehicle accidents as the leading cause of accidental death in the United States.⁵ Additionally, nonmedical use of prescription drugs is the third most common category of drug abuse, after marijuana and alcohol.⁶

Unfortunately, clinicians cannot accurately predict future medication misuse.⁷ And while the potential harms of opioids are many, the long-term benefits are questionable.^8,9

For these reasons, providers need to understand the indications for and potential benefits of opioids, as well as the potential harms and how to monitor their safe use. Also important to know is how and when to discontinue opioids while preserving the therapeutic relationship.

This paper offers practical strategies to primary care providers and their care teams on how to safely initiate, monitor, and discontinue chronic opioid therapy.

STARTING OPIOID THERAPY FOR CHRONIC PAIN

Guidelines recommend considering starting patients on opioid therapy when the benefits are likely to outweigh the risks, when pain is moderate to severe, and when other multimodal treatment strategies have not achieved functional goals.¹⁰ Unfortunately, few studies have examined or demonstrated long-term benefit, and those that did examine this outcome reported reduction of pain severity but did not assess functional improvement.⁹ Meanwhile, data are increasingly clear that long-term use increases the risk of harm, both acute (eg, overdose) and chronic (eg, osteoporosis), especially with high doses.

Tools have been developed to predict the risk of misuse,^11–13 but few have been validated in primary care, where most opioids are prescribed. This limitation aside, consensus guidelines state that untreated substance use disorders, poorly controlled psychiatric disease, and erratic treatment adherence are contraindications to opioid therapy, at least until these other issues are treated.¹⁰

We are increasingly avoiding chronic opioid therapy in younger patients with chronic pain

Faced with the benefit-harm conundrum, we recommend a generally conservative approach to opioid initiation. With long-term functional benefit questionable and toxicity relatively common, we are increasingly avoiding chronic opioid therapy in younger patients with chronic pain.

Empathize and partner with your patient

Chronic pain care can be fraught with frustration and mutual distrust between patient and provider.¹⁴ Empathy and a collaborative stance help signal to the patient that the provider has the patient’s best interest in mind,¹⁵ whether initiating or deciding not to initiate opioids.

Optimize nonopioid therapy

In light of the risks associated with chronic opioid therapy, the clinician is urged to review and optimize nonopioid therapy before starting a patient on opioid treatment, and to maintain this approach if opioid therapy is started. Whenever possible, nonopioid treatment should include disease-modifying therapy and nondrug modalities such as physical therapy.

Judicious use of adequately dosed analgesics such as acetaminophen and nonsteroidal anti-inflammatory drugs may be sufficient to achieve analgesic goals if not contraindicated, and in some patients the addition of a topical analgesic (eg, diclofenac gel, lidocaine patches), a tricyclic or serotonin-norepinephrine reuptake inhibitor antidepressant, an anticonvulsant (eg, gabapentin), or a combination of the above can effectively address underlying pain-generating mechanisms.¹⁶ As with opioids, the risks and benefits of nonopioid pharmacotherapy should be reviewed both at initiation and periodically thereafter.

Frame the opioid treatment plan as a ‘therapeutic trial’

Starting an opioid should be framed as a “therapeutic trial.” These drugs should be continued only if safe and effective, at the lowest effective dose, and as one component of a multimodal pain treatment plan. Concurrent use of nonpharmacologic therapies (eg, physical therapy, structured exercise, yoga, relaxation training, biofeedback, cognitive behavioral therapy) and rational pharmacotherapy while promoting patient self-care is the standard of pain management called for by the Institute of Medicine.¹

Set functional goals

We recommend clearly defining functional goals with each patient before starting therapy. These goals should be written into the treatment plan as a way for patient and provider to evaluate the effectiveness of chronic opioid therapy. A useful mnemonic to help identify such goals is SMART, an acronym for specific, measurable, action-oriented, realistic, and time-bound. Specific goals will depend on pain severity, but examples could include being able to do grocery shopping without assistance, to play on the floor with grandchildren, or to engage in healthy exercise habits such as 20 minutes of moderately brisk walking 3 days per week.

Obtain informed consent, and document it thoroughly

Providers must communicate risks, potential benefits, and safe medication-taking practices, including how to safely store and dispose of unused opioids, and document this conversation clearly in the medical record. From a medicolegal perspective, if it wasn’t documented, it did not happen.¹⁷

From a medicolegal perspective, if it wasn’t documented, it didn’t happen

Informed consent can be further advanced with the use of a controlled substance agreement that outlines the treatment plan as well as potential risks, benefits, and practice policies in a structured way. Most states now either recommend or mandate the use of such agreements.¹⁸

Controlled substance agreements give providers a greater sense of mastery and comfort when prescribing opioids,¹⁹ but they have important limitations. In particular, there is a lack of consensus on what the agreement should say and relatively weak evidence that these agreements are efficacious. Additionally, a poorly written agreement can be stigmatizing and can erode trust.²⁰ However, we believe that when the agreement is written in an appropriate framework of safety at an appropriate level of health literacy and with a focus on shared decision-making, it can be very helpful and should be used.

Employ safe, rational pharmacotherapy

Considerations when choosing an opioid include its potency, onset of action, and half-life. Comorbid conditions (eg, advanced age,²¹ sleep-disordered breathing²²) and concurrent medications (eg, benzodiazepines, anticonvulsants, muscle relaxants) also affect decisions about the formulation, starting dose, rapidity of titration, and ceiling dose. Risk of harm  increases in patients with such comorbid factors, and it is prudent to start with lower doses of shorter-acting medications until patients can demonstrate safe use. Risk of unintentional overdose is higher with higher prescribed doses.²³ Pharmacologically there is no analgesic dose ceiling, but we urge caution, particularly in opioid-naive patients.

Try a less addictive agent such as tramadol or codeine before escalating to hydrocodone, oxycodone, or morphine

A patient’s response to any particular opioid is idiosyncratic and variable. There are more than 100 known polymorphisms in the human opioid mu-receptor gene, and thus differences in receptor affinity and activation as well as in metabolism make it difficult to predict which opioid will work best for a particular patient.²⁴ However, a less potent opioid receptor agonist with less addictive potential, such as tramadol or codeine, should generally be tried first before escalating to a riskier, more potent opioid such as hydrocodone, oxycodone, or morphine. This “analgesic ladder,” a concept introduced by the World Health Organization in 1986 to provide a framework for managing cancer pain, has been adapted to a variety of chronic pain syndromes.²⁵

Methadone deserves special mention. A strongly lipophilic molecule with a long and variable half-life, it accumulates in fat,²⁶ and long after the analgesic effect has worn off, methadone will still be present. Repeated dosing or rapid dose escalation in an attempt to achieve adequate analgesia may result in inadvertent overdose. Additionally, methadone can prolong the QT interval, and periodic electrocardiographic monitoring is recommended.²⁷ For these reasons, we recommend avoiding the use of methadone in most cases unless the provider has significant experience, expertise, or support in the safe use of this medication.

Table 1 summarizes these recommendations.

MONITORING AND SAFETY

Providers must periodically reassess the safety and efficacy of chronic opioid therapy to be sure that it is still indicated.¹⁰ Since we cannot accurately predict which patients will suffer adverse reactions or demonstrate aberrant behaviors,⁷ it is important to be transparent and consistent with monitoring practices for all patients on chronic opioid therapy.¹⁷ By framing monitoring in terms of safety and employing it universally, providers can minimize miscommunication and accidental stigmatization.

Prescription monitoring programs

In 2002, Congress appropriated funding to the US Department of Justice to support prescription monitoring programs nationally.²⁸ At the time of this writing, Missouri is the only state without an approved monitoring program.²⁹

Although the design and function of the programs vary from state to state, they require pharmacies to collect and report data on controlled substances for individual patients and prescribers. These data are sometimes shared across state lines, and the programs enhance the capacity of regulatory and law enforcement agencies to analyze controlled substance use.

Prescribers can (and are sometimes required to) register for access in their state and use this resource to assess the opioid refill history of their patients. This powerful tool improves detection of “doctor-shopping” and other common scams.³⁰

Additionally, recognizing that the risk of death from overdose increases as the total daily dose of opioids increases,²³ some states provide data on their composite report expressing the morphine equivalent daily dose or daily morphine milligram equivalents of the opioids prescribed. This information is valuable to the busy clinician; at a glance the prescriber can quickly discern the total daily opioid dose and use that information to assess risk and manage change. Furthermore, some states restrict further dose escalation when the morphine equivalent daily dose exceeds a predetermined amount (typically 100 to 120 morphine milligram equivalents).

Tamper-resistant prescribing

To minimize the risk of prescription tampering, simple techniques such as writing out the number of tablets dispensed can help, and use of tamper-resistant prescription paper has been required for Medicaid recipients since 2008.³¹

When possible, we recommend products with abuse-deterrent properties. Although the science of abuse deterrence is relatively new and few products are labeled as such, a number of opioids are formulated to resist deformation, vaporization, dissolving, or other physical tampering. Additionally, some abuse-deterrent opioid formulations contain naloxone, which is released only when the drug is deformed in some way, thereby decreasing the user’s response to an abused substance or resulting in opioid withdrawal.³²

Urine drug testing

Although complex and nuanced, guidelines recommend urine drug testing to confirm the presence or absence of prescribed and illicit substances in the body.¹⁰ There is no consensus on when or how often to test, but it should be done randomly and without forewarning to foil efforts to defeat testing such as provision of synthetic, adulterated, or substituted urine.

Providers underuse urine drug testing.³³ We recommend that it be done at the start of opioid therapy, sporadically thereafter, when therapy is changed, and whenever the provider is concerned about possible aberrant drug use.

Understanding opioid metabolism, cross-reactivity, and the types of tests available will help avoid misinterpretation of results.³⁴ For example, a positive “opiate” result in most screening immunoassay tests does not reflect oxycodone use, since tests for synthetic opioids often need to be ordered separately; the commonly used Cedia opiate assay cross-reacts with oxycodone at a concentration of 10,000 ng/mL only 3.1% of the time.³⁵ Immunoassay screening tests are widely available, sensitive, inexpensive, and fast, but they are qualitative, have limited specificity, and are subject to false-positive and false-negative results.³⁶  Table 2 outlines some common characteristics of substances on screening immunoassays, including reported causes of false-positive results.^37–39

Confirmatory testing using gas chromatography or mass spectroscopy is more expensive and slower to process, but is highly sensitive and specific, quantitative, and useful when screening results are difficult to interpret.

Knowing how and when to order the right urine drug test and knowing how to interpret the results are skills prescribers should master.

DISCONTINUING OPIOIDS

When opioids are no longer safe or effective, they should be stopped. The decision can be difficult for both the patient and provider, and a certain degree of equanimity is needed to approach it rationally.

Strong indications for discontinuation

Respiratory depression, cognitive impairment, falls, and motor vehicle accidents mean harm is already apparent. At a minimum, dose reduction is warranted and discontinuation should be strongly considered. Similarly, overdose (intentional or accidental) and active suicidal ideation contraindicate ongoing opioid prescribing unless the ongoing risk can be decisively mitigated.

Certain aberrant behaviors such as prescription forgery or theft, threats of violence to obtain analgesics, and diversion (transfer of the drug to another person for nonmedical use) also warrant immediate discontinuation. Continuing to prescribe an opioid while knowing diversion is taking place may be a violation of federal or state law or both.⁴⁰

Another reason to stop is failure to achieve the expected benefit from chronic opioid therapy (ie, agreed-upon functional goals) despite appropriate dose adjustment. In these cases, ongoing risk by definition outweighs observed benefit.

Relative indications for discontinuation

Opioid therapy has many potential adverse effects. Depending on the severity and duration of the symptom and its response to either dose reduction or adjunctive management, opioids may need to be discontinued.

For example, pruritus, constipation, urinary retention, nausea, sedation, and sexual dysfunction may all be reasons to stop chronic opioid therapy. Similarly, chronic opioid therapy may paradoxically worsen pain in some susceptible patients, a complication known as opioid-induced hyperalgesia; in these cases, tapering off opioids should be considered as well.⁴¹ Aberrant behaviors should prompt reconsideration of chronic opioid therapy; these include hazardous alcohol consumption, use of illicit drugs, pill hoarding, and use of opioids in a manner different than intended by the prescriber.

Another relative indication for discontinuation is receipt of controlled substances from other providers. A well-written controlled substance agreement and adequate counseling may help mitigate this risk; poor communication between providers, lack of integration of electronic medical record systems, urgent or emergency room care, and poor health literacy may all lead to redundant prescribing in some circumstances. While unintentional use of controlled substances from different providers is no less dangerous than intentional misuse, the specifics of each case need to be considered before opioids are reflexively discontinued.

How to discontinue opioids

In most cases, opioids should be tapered to reduce the risk and severity of withdrawal symptoms. Decreasing the dose by 10% of the original dose per week is usually well tolerated with minimal adverse effects.⁴² Tapering can be done much faster, and numerous rapid detoxification protocols are available. In general, a patient needs 20% of the previous day’s dose to prevent withdrawal symptoms.⁴³

Withdrawal symptoms are rarely life-threatening but can be very uncomfortable. Some providers add clonidine to attenuate associated autonomic symptoms such as hypertension, nausea, cramps, diaphoresis, and tachycardia if they occur. Other adjunctive medications include nonsteroidal anti-inflammatory drugs for body aches, antiemetics for nausea and vomiting, bismuth subsalicylate for diarrhea, and trazodone for insomnia.

It is unlawful for primary care physicians to use another opioid to treat symptoms of withdrawal in the outpatient setting unless it is issued through a federally certified narcotic treatment program or prescribed by a qualified clinician registered with the US Drug Enforcement Administration to prescribe buprenorphine-naloxone.⁴⁴

In some circumstances, it may be appropriate to abruptly discontinue opioids without a taper, such as when diversion is evident. However, a decision to discontinue opioids due to misuse should not equate to an automatic decision to terminate a patient from the practice. Instead, providers should use this opportunity to offer empathy and referral to drug treatment counseling and rehabilitation. A decision to discontinue opioids because they are no longer safe or effective does not mean that the patient’s pain is not real—it is “real” for them, even if caused by the pain of addiction—or that shared decision-making is no longer possible or appropriate.

Handling difficult conversations when discontinuing opioids

The conversation between patient and provider when discontinuing opioids can be difficult. Misaligned expectations of both parties, patient fear of uncontrolled pain, and provider concern about causing suffering are frequent contributing factors. Patients abusing prescription drugs may also have a stronger relationship with their medication than with their provider and may use manipulative strategies including overt hostility and threats to obtain a prescription. Providers need to maintain their composure to de-escalate these potentially upsetting confrontations.

Table 3 outlines some specific suggestions that may be helpful, including the following:

• Frame the discussion in terms of safety—opioids are being discontinued because the benefit no longer outweighs the risk
  

• Don’t debate your decision with the patient, but present your reasoning in a considered manner
• Focus on the appropriateness of the treatment and not on the patient’s character
• Avoid the use of labels (eg, “drug addict”)
• Emphasize your commitment to the patient’s well-being and an alternative treatment plan (ie, nonabandonment)
• Respond to emotional distress with empathy, but do not let that change your decision to discontinue opioids.

Finally, we strongly encourage providers to insist on being treated respectfully. When safety cannot be ensured, providers should remove themselves from the room until the patient can calm down or the provider can ask for assistance from colleagues.

Maintaining empathy by understanding grief

Discontinuing opioids may trigger in a patient an emotional response similar to grief. When considered in this framework, it may empower an otherwise frustrated provider to remain empathetic even in the midst of a difficult confrontation. Paralleling Kübler-Ross’s five stages of grief,⁴⁵ we propose a similar model we call the “five stages of opioid loss”; this model has been successfully used in the residency continuity clinic at the University of Connecticut as a training aid.

Hopelessness and helplessness. During the first stage of the discussion the patient struggles with how to move forward. This conversation is frequently characterized by tearfulness and explanations to account for aberrant behavior or willingness to continue to suffer side effects. Active listening, empathy, and a focus on the factors that led to discontinuation of opioids while still validating pain are important.

Some patients go through five stages of opioid loss when stopping these drugs

Demanding and indignant. During the second stage, patients frequently push the limits of “no.” Accusations of abandonment and lack of empathy may accompany this stage and can be quite upsetting for the unprepared provider. A novice clinician can use role-play as a tool to better prepare for this type of encounter. Patients should be allowed to express their frustration but ultimatums and threats of violence should not be tolerated. Reassuring patients that their pain will be addressed using nonopioid therapy can be helpful, and a simple offer of continued care can help to preserve the therapeutic relationship.

Bargaining, the third stage of this model, is characterized by attempts to negotiate continued prescribing. While it can be frustrating, this push and pull is the beginning of real conversation and identification of a treatment plan for the future.

Resignation. The fourth stage begins when the patient has resigned himself or herself to your decision, but may not have accepted the available treatment options. At this point the patient may return for care or seek out a new provider. Empathy is again the element most crucial to success; this stage carries an opportunity to develop mutual respect.

Acceptance. The patients who choose to continue care with you have progressed to the final phase. They begin to look toward the future, having chosen the better of the two paths: partnering with a caring provider to develop a shared therapeutic plan.

A CONSISTENT AND TRANSPARENT APPROACH

Opioids can be useful for selected patients when they are carefully prescribed, but the prescriber must fully consider the risks and benefits specific to each patient and mitigate risk whenever possible.

Collaborating with patients to use opioids rationally is easier when it is part of a multimodal pain management plan and is initiated with clear functional goals and parameters for discontinuation. Presenting risks and benefits in a framework of safety and educating patients will help to reduce the stigma that may otherwise accompany safety monitoring using tools such as controlled substance agreements and urine toxicology testing.

Despite these efforts, patients may become psychologically dependent on opioids and discontinuation may prove difficult. However, a consistent and transparent approach to prescribing with special efforts to empathize with suffering patients may empower providers to navigate this process effectively.

Chronic pain affects an estimated 100 million Americans, at a cost of $635 billion each year in medical expenses, lost wages, and reduced productivity.¹ It is often managed in primary care settings with opioids by clinicians who have little or no formal training in pain management.^2,3 Some primary care providers may seek assistance from board-certified pain specialists, but with only four such experts for every 100,000 patients with chronic pain, primary care providers are typically on their own.⁴

Although opioids may help in some chronic pain syndromes, they also carry the risk of serious harm, including unintentional overdose and death. In 2009, unintentional drug overdoses, most commonly with opioids, surpassed motor vehicle accidents as the leading cause of accidental death in the United States.⁵ Additionally, nonmedical use of prescription drugs is the third most common category of drug abuse, after marijuana and alcohol.⁶

Unfortunately, clinicians cannot accurately predict future medication misuse.⁷ And while the potential harms of opioids are many, the long-term benefits are questionable.^8,9

For these reasons, providers need to understand the indications for and potential benefits of opioids, as well as the potential harms and how to monitor their safe use. Also important to know is how and when to discontinue opioids while preserving the therapeutic relationship.

This paper offers practical strategies to primary care providers and their care teams on how to safely initiate, monitor, and discontinue chronic opioid therapy.

STARTING OPIOID THERAPY FOR CHRONIC PAIN

Guidelines recommend considering starting patients on opioid therapy when the benefits are likely to outweigh the risks, when pain is moderate to severe, and when other multimodal treatment strategies have not achieved functional goals.¹⁰ Unfortunately, few studies have examined or demonstrated long-term benefit, and those that did examine this outcome reported reduction of pain severity but did not assess functional improvement.⁹ Meanwhile, data are increasingly clear that long-term use increases the risk of harm, both acute (eg, overdose) and chronic (eg, osteoporosis), especially with high doses.

Tools have been developed to predict the risk of misuse,^11–13 but few have been validated in primary care, where most opioids are prescribed. This limitation aside, consensus guidelines state that untreated substance use disorders, poorly controlled psychiatric disease, and erratic treatment adherence are contraindications to opioid therapy, at least until these other issues are treated.¹⁰

We are increasingly avoiding chronic opioid therapy in younger patients with chronic pain

Faced with the benefit-harm conundrum, we recommend a generally conservative approach to opioid initiation. With long-term functional benefit questionable and toxicity relatively common, we are increasingly avoiding chronic opioid therapy in younger patients with chronic pain.

Empathize and partner with your patient

Chronic pain care can be fraught with frustration and mutual distrust between patient and provider.¹⁴ Empathy and a collaborative stance help signal to the patient that the provider has the patient’s best interest in mind,¹⁵ whether initiating or deciding not to initiate opioids.

Optimize nonopioid therapy

In light of the risks associated with chronic opioid therapy, the clinician is urged to review and optimize nonopioid therapy before starting a patient on opioid treatment, and to maintain this approach if opioid therapy is started. Whenever possible, nonopioid treatment should include disease-modifying therapy and nondrug modalities such as physical therapy.

Judicious use of adequately dosed analgesics such as acetaminophen and nonsteroidal anti-inflammatory drugs may be sufficient to achieve analgesic goals if not contraindicated, and in some patients the addition of a topical analgesic (eg, diclofenac gel, lidocaine patches), a tricyclic or serotonin-norepinephrine reuptake inhibitor antidepressant, an anticonvulsant (eg, gabapentin), or a combination of the above can effectively address underlying pain-generating mechanisms.¹⁶ As with opioids, the risks and benefits of nonopioid pharmacotherapy should be reviewed both at initiation and periodically thereafter.

Frame the opioid treatment plan as a ‘therapeutic trial’

Starting an opioid should be framed as a “therapeutic trial.” These drugs should be continued only if safe and effective, at the lowest effective dose, and as one component of a multimodal pain treatment plan. Concurrent use of nonpharmacologic therapies (eg, physical therapy, structured exercise, yoga, relaxation training, biofeedback, cognitive behavioral therapy) and rational pharmacotherapy while promoting patient self-care is the standard of pain management called for by the Institute of Medicine.¹

Set functional goals

We recommend clearly defining functional goals with each patient before starting therapy. These goals should be written into the treatment plan as a way for patient and provider to evaluate the effectiveness of chronic opioid therapy. A useful mnemonic to help identify such goals is SMART, an acronym for specific, measurable, action-oriented, realistic, and time-bound. Specific goals will depend on pain severity, but examples could include being able to do grocery shopping without assistance, to play on the floor with grandchildren, or to engage in healthy exercise habits such as 20 minutes of moderately brisk walking 3 days per week.

Obtain informed consent, and document it thoroughly

Providers must communicate risks, potential benefits, and safe medication-taking practices, including how to safely store and dispose of unused opioids, and document this conversation clearly in the medical record. From a medicolegal perspective, if it wasn’t documented, it did not happen.¹⁷

From a medicolegal perspective, if it wasn’t documented, it didn’t happen

Informed consent can be further advanced with the use of a controlled substance agreement that outlines the treatment plan as well as potential risks, benefits, and practice policies in a structured way. Most states now either recommend or mandate the use of such agreements.¹⁸

Controlled substance agreements give providers a greater sense of mastery and comfort when prescribing opioids,¹⁹ but they have important limitations. In particular, there is a lack of consensus on what the agreement should say and relatively weak evidence that these agreements are efficacious. Additionally, a poorly written agreement can be stigmatizing and can erode trust.²⁰ However, we believe that when the agreement is written in an appropriate framework of safety at an appropriate level of health literacy and with a focus on shared decision-making, it can be very helpful and should be used.

Employ safe, rational pharmacotherapy

Considerations when choosing an opioid include its potency, onset of action, and half-life. Comorbid conditions (eg, advanced age,²¹ sleep-disordered breathing²²) and concurrent medications (eg, benzodiazepines, anticonvulsants, muscle relaxants) also affect decisions about the formulation, starting dose, rapidity of titration, and ceiling dose. Risk of harm  increases in patients with such comorbid factors, and it is prudent to start with lower doses of shorter-acting medications until patients can demonstrate safe use. Risk of unintentional overdose is higher with higher prescribed doses.²³ Pharmacologically there is no analgesic dose ceiling, but we urge caution, particularly in opioid-naive patients.

Try a less addictive agent such as tramadol or codeine before escalating to hydrocodone, oxycodone, or morphine

A patient’s response to any particular opioid is idiosyncratic and variable. There are more than 100 known polymorphisms in the human opioid mu-receptor gene, and thus differences in receptor affinity and activation as well as in metabolism make it difficult to predict which opioid will work best for a particular patient.²⁴ However, a less potent opioid receptor agonist with less addictive potential, such as tramadol or codeine, should generally be tried first before escalating to a riskier, more potent opioid such as hydrocodone, oxycodone, or morphine. This “analgesic ladder,” a concept introduced by the World Health Organization in 1986 to provide a framework for managing cancer pain, has been adapted to a variety of chronic pain syndromes.²⁵

Methadone deserves special mention. A strongly lipophilic molecule with a long and variable half-life, it accumulates in fat,²⁶ and long after the analgesic effect has worn off, methadone will still be present. Repeated dosing or rapid dose escalation in an attempt to achieve adequate analgesia may result in inadvertent overdose. Additionally, methadone can prolong the QT interval, and periodic electrocardiographic monitoring is recommended.²⁷ For these reasons, we recommend avoiding the use of methadone in most cases unless the provider has significant experience, expertise, or support in the safe use of this medication.

Table 1 summarizes these recommendations.

MONITORING AND SAFETY

Providers must periodically reassess the safety and efficacy of chronic opioid therapy to be sure that it is still indicated.¹⁰ Since we cannot accurately predict which patients will suffer adverse reactions or demonstrate aberrant behaviors,⁷ it is important to be transparent and consistent with monitoring practices for all patients on chronic opioid therapy.¹⁷ By framing monitoring in terms of safety and employing it universally, providers can minimize miscommunication and accidental stigmatization.

Prescription monitoring programs

In 2002, Congress appropriated funding to the US Department of Justice to support prescription monitoring programs nationally.²⁸ At the time of this writing, Missouri is the only state without an approved monitoring program.²⁹

Although the design and function of the programs vary from state to state, they require pharmacies to collect and report data on controlled substances for individual patients and prescribers. These data are sometimes shared across state lines, and the programs enhance the capacity of regulatory and law enforcement agencies to analyze controlled substance use.

Prescribers can (and are sometimes required to) register for access in their state and use this resource to assess the opioid refill history of their patients. This powerful tool improves detection of “doctor-shopping” and other common scams.³⁰

Additionally, recognizing that the risk of death from overdose increases as the total daily dose of opioids increases,²³ some states provide data on their composite report expressing the morphine equivalent daily dose or daily morphine milligram equivalents of the opioids prescribed. This information is valuable to the busy clinician; at a glance the prescriber can quickly discern the total daily opioid dose and use that information to assess risk and manage change. Furthermore, some states restrict further dose escalation when the morphine equivalent daily dose exceeds a predetermined amount (typically 100 to 120 morphine milligram equivalents).

Tamper-resistant prescribing

To minimize the risk of prescription tampering, simple techniques such as writing out the number of tablets dispensed can help, and use of tamper-resistant prescription paper has been required for Medicaid recipients since 2008.³¹

When possible, we recommend products with abuse-deterrent properties. Although the science of abuse deterrence is relatively new and few products are labeled as such, a number of opioids are formulated to resist deformation, vaporization, dissolving, or other physical tampering. Additionally, some abuse-deterrent opioid formulations contain naloxone, which is released only when the drug is deformed in some way, thereby decreasing the user’s response to an abused substance or resulting in opioid withdrawal.³²

Urine drug testing

Although complex and nuanced, guidelines recommend urine drug testing to confirm the presence or absence of prescribed and illicit substances in the body.¹⁰ There is no consensus on when or how often to test, but it should be done randomly and without forewarning to foil efforts to defeat testing such as provision of synthetic, adulterated, or substituted urine.

Providers underuse urine drug testing.³³ We recommend that it be done at the start of opioid therapy, sporadically thereafter, when therapy is changed, and whenever the provider is concerned about possible aberrant drug use.

Understanding opioid metabolism, cross-reactivity, and the types of tests available will help avoid misinterpretation of results.³⁴ For example, a positive “opiate” result in most screening immunoassay tests does not reflect oxycodone use, since tests for synthetic opioids often need to be ordered separately; the commonly used Cedia opiate assay cross-reacts with oxycodone at a concentration of 10,000 ng/mL only 3.1% of the time.³⁵ Immunoassay screening tests are widely available, sensitive, inexpensive, and fast, but they are qualitative, have limited specificity, and are subject to false-positive and false-negative results.³⁶  Table 2 outlines some common characteristics of substances on screening immunoassays, including reported causes of false-positive results.^37–39

Confirmatory testing using gas chromatography or mass spectroscopy is more expensive and slower to process, but is highly sensitive and specific, quantitative, and useful when screening results are difficult to interpret.

Knowing how and when to order the right urine drug test and knowing how to interpret the results are skills prescribers should master.

DISCONTINUING OPIOIDS

When opioids are no longer safe or effective, they should be stopped. The decision can be difficult for both the patient and provider, and a certain degree of equanimity is needed to approach it rationally.

Strong indications for discontinuation

Respiratory depression, cognitive impairment, falls, and motor vehicle accidents mean harm is already apparent. At a minimum, dose reduction is warranted and discontinuation should be strongly considered. Similarly, overdose (intentional or accidental) and active suicidal ideation contraindicate ongoing opioid prescribing unless the ongoing risk can be decisively mitigated.

Certain aberrant behaviors such as prescription forgery or theft, threats of violence to obtain analgesics, and diversion (transfer of the drug to another person for nonmedical use) also warrant immediate discontinuation. Continuing to prescribe an opioid while knowing diversion is taking place may be a violation of federal or state law or both.⁴⁰

Another reason to stop is failure to achieve the expected benefit from chronic opioid therapy (ie, agreed-upon functional goals) despite appropriate dose adjustment. In these cases, ongoing risk by definition outweighs observed benefit.

Relative indications for discontinuation

Opioid therapy has many potential adverse effects. Depending on the severity and duration of the symptom and its response to either dose reduction or adjunctive management, opioids may need to be discontinued.

For example, pruritus, constipation, urinary retention, nausea, sedation, and sexual dysfunction may all be reasons to stop chronic opioid therapy. Similarly, chronic opioid therapy may paradoxically worsen pain in some susceptible patients, a complication known as opioid-induced hyperalgesia; in these cases, tapering off opioids should be considered as well.⁴¹ Aberrant behaviors should prompt reconsideration of chronic opioid therapy; these include hazardous alcohol consumption, use of illicit drugs, pill hoarding, and use of opioids in a manner different than intended by the prescriber.

Another relative indication for discontinuation is receipt of controlled substances from other providers. A well-written controlled substance agreement and adequate counseling may help mitigate this risk; poor communication between providers, lack of integration of electronic medical record systems, urgent or emergency room care, and poor health literacy may all lead to redundant prescribing in some circumstances. While unintentional use of controlled substances from different providers is no less dangerous than intentional misuse, the specifics of each case need to be considered before opioids are reflexively discontinued.

How to discontinue opioids

In most cases, opioids should be tapered to reduce the risk and severity of withdrawal symptoms. Decreasing the dose by 10% of the original dose per week is usually well tolerated with minimal adverse effects.⁴² Tapering can be done much faster, and numerous rapid detoxification protocols are available. In general, a patient needs 20% of the previous day’s dose to prevent withdrawal symptoms.⁴³

Withdrawal symptoms are rarely life-threatening but can be very uncomfortable. Some providers add clonidine to attenuate associated autonomic symptoms such as hypertension, nausea, cramps, diaphoresis, and tachycardia if they occur. Other adjunctive medications include nonsteroidal anti-inflammatory drugs for body aches, antiemetics for nausea and vomiting, bismuth subsalicylate for diarrhea, and trazodone for insomnia.

It is unlawful for primary care physicians to use another opioid to treat symptoms of withdrawal in the outpatient setting unless it is issued through a federally certified narcotic treatment program or prescribed by a qualified clinician registered with the US Drug Enforcement Administration to prescribe buprenorphine-naloxone.⁴⁴

In some circumstances, it may be appropriate to abruptly discontinue opioids without a taper, such as when diversion is evident. However, a decision to discontinue opioids due to misuse should not equate to an automatic decision to terminate a patient from the practice. Instead, providers should use this opportunity to offer empathy and referral to drug treatment counseling and rehabilitation. A decision to discontinue opioids because they are no longer safe or effective does not mean that the patient’s pain is not real—it is “real” for them, even if caused by the pain of addiction—or that shared decision-making is no longer possible or appropriate.

Handling difficult conversations when discontinuing opioids

The conversation between patient and provider when discontinuing opioids can be difficult. Misaligned expectations of both parties, patient fear of uncontrolled pain, and provider concern about causing suffering are frequent contributing factors. Patients abusing prescription drugs may also have a stronger relationship with their medication than with their provider and may use manipulative strategies including overt hostility and threats to obtain a prescription. Providers need to maintain their composure to de-escalate these potentially upsetting confrontations.

Table 3 outlines some specific suggestions that may be helpful, including the following:

• Frame the discussion in terms of safety—opioids are being discontinued because the benefit no longer outweighs the risk
  

• Don’t debate your decision with the patient, but present your reasoning in a considered manner
• Focus on the appropriateness of the treatment and not on the patient’s character
• Avoid the use of labels (eg, “drug addict”)
• Emphasize your commitment to the patient’s well-being and an alternative treatment plan (ie, nonabandonment)
• Respond to emotional distress with empathy, but do not let that change your decision to discontinue opioids.

Finally, we strongly encourage providers to insist on being treated respectfully. When safety cannot be ensured, providers should remove themselves from the room until the patient can calm down or the provider can ask for assistance from colleagues.

Maintaining empathy by understanding grief

Discontinuing opioids may trigger in a patient an emotional response similar to grief. When considered in this framework, it may empower an otherwise frustrated provider to remain empathetic even in the midst of a difficult confrontation. Paralleling Kübler-Ross’s five stages of grief,⁴⁵ we propose a similar model we call the “five stages of opioid loss”; this model has been successfully used in the residency continuity clinic at the University of Connecticut as a training aid.

Hopelessness and helplessness. During the first stage of the discussion the patient struggles with how to move forward. This conversation is frequently characterized by tearfulness and explanations to account for aberrant behavior or willingness to continue to suffer side effects. Active listening, empathy, and a focus on the factors that led to discontinuation of opioids while still validating pain are important.

Some patients go through five stages of opioid loss when stopping these drugs

Demanding and indignant. During the second stage, patients frequently push the limits of “no.” Accusations of abandonment and lack of empathy may accompany this stage and can be quite upsetting for the unprepared provider. A novice clinician can use role-play as a tool to better prepare for this type of encounter. Patients should be allowed to express their frustration but ultimatums and threats of violence should not be tolerated. Reassuring patients that their pain will be addressed using nonopioid therapy can be helpful, and a simple offer of continued care can help to preserve the therapeutic relationship.

Bargaining, the third stage of this model, is characterized by attempts to negotiate continued prescribing. While it can be frustrating, this push and pull is the beginning of real conversation and identification of a treatment plan for the future.

Resignation. The fourth stage begins when the patient has resigned himself or herself to your decision, but may not have accepted the available treatment options. At this point the patient may return for care or seek out a new provider. Empathy is again the element most crucial to success; this stage carries an opportunity to develop mutual respect.

Acceptance. The patients who choose to continue care with you have progressed to the final phase. They begin to look toward the future, having chosen the better of the two paths: partnering with a caring provider to develop a shared therapeutic plan.

A CONSISTENT AND TRANSPARENT APPROACH

Opioids can be useful for selected patients when they are carefully prescribed, but the prescriber must fully consider the risks and benefits specific to each patient and mitigate risk whenever possible.

Collaborating with patients to use opioids rationally is easier when it is part of a multimodal pain management plan and is initiated with clear functional goals and parameters for discontinuation. Presenting risks and benefits in a framework of safety and educating patients will help to reduce the stigma that may otherwise accompany safety monitoring using tools such as controlled substance agreements and urine toxicology testing.

Despite these efforts, patients may become psychologically dependent on opioids and discontinuation may prove difficult. However, a consistent and transparent approach to prescribing with special efforts to empathize with suffering patients may empower providers to navigate this process effectively.

Chronic pain affects an estimated 100 million Americans, at a cost of $635 billion each year in medical expenses, lost wages, and reduced productivity.¹ It is often managed in primary care settings with opioids by clinicians who have little or no formal training in pain management.^2,3 Some primary care providers may seek assistance from board-certified pain specialists, but with only four such experts for every 100,000 patients with chronic pain, primary care providers are typically on their own.⁴

Although opioids may help in some chronic pain syndromes, they also carry the risk of serious harm, including unintentional overdose and death. In 2009, unintentional drug overdoses, most commonly with opioids, surpassed motor vehicle accidents as the leading cause of accidental death in the United States.⁵ Additionally, nonmedical use of prescription drugs is the third most common category of drug abuse, after marijuana and alcohol.⁶

Unfortunately, clinicians cannot accurately predict future medication misuse.⁷ And while the potential harms of opioids are many, the long-term benefits are questionable.^8,9

For these reasons, providers need to understand the indications for and potential benefits of opioids, as well as the potential harms and how to monitor their safe use. Also important to know is how and when to discontinue opioids while preserving the therapeutic relationship.

This paper offers practical strategies to primary care providers and their care teams on how to safely initiate, monitor, and discontinue chronic opioid therapy.

STARTING OPIOID THERAPY FOR CHRONIC PAIN

Guidelines recommend considering starting patients on opioid therapy when the benefits are likely to outweigh the risks, when pain is moderate to severe, and when other multimodal treatment strategies have not achieved functional goals.¹⁰ Unfortunately, few studies have examined or demonstrated long-term benefit, and those that did examine this outcome reported reduction of pain severity but did not assess functional improvement.⁹ Meanwhile, data are increasingly clear that long-term use increases the risk of harm, both acute (eg, overdose) and chronic (eg, osteoporosis), especially with high doses.

Tools have been developed to predict the risk of misuse,^11–13 but few have been validated in primary care, where most opioids are prescribed. This limitation aside, consensus guidelines state that untreated substance use disorders, poorly controlled psychiatric disease, and erratic treatment adherence are contraindications to opioid therapy, at least until these other issues are treated.¹⁰

We are increasingly avoiding chronic opioid therapy in younger patients with chronic pain

Faced with the benefit-harm conundrum, we recommend a generally conservative approach to opioid initiation. With long-term functional benefit questionable and toxicity relatively common, we are increasingly avoiding chronic opioid therapy in younger patients with chronic pain.

Empathize and partner with your patient

Chronic pain care can be fraught with frustration and mutual distrust between patient and provider.¹⁴ Empathy and a collaborative stance help signal to the patient that the provider has the patient’s best interest in mind,¹⁵ whether initiating or deciding not to initiate opioids.

Optimize nonopioid therapy

In light of the risks associated with chronic opioid therapy, the clinician is urged to review and optimize nonopioid therapy before starting a patient on opioid treatment, and to maintain this approach if opioid therapy is started. Whenever possible, nonopioid treatment should include disease-modifying therapy and nondrug modalities such as physical therapy.

Judicious use of adequately dosed analgesics such as acetaminophen and nonsteroidal anti-inflammatory drugs may be sufficient to achieve analgesic goals if not contraindicated, and in some patients the addition of a topical analgesic (eg, diclofenac gel, lidocaine patches), a tricyclic or serotonin-norepinephrine reuptake inhibitor antidepressant, an anticonvulsant (eg, gabapentin), or a combination of the above can effectively address underlying pain-generating mechanisms.¹⁶ As with opioids, the risks and benefits of nonopioid pharmacotherapy should be reviewed both at initiation and periodically thereafter.

Frame the opioid treatment plan as a ‘therapeutic trial’

Starting an opioid should be framed as a “therapeutic trial.” These drugs should be continued only if safe and effective, at the lowest effective dose, and as one component of a multimodal pain treatment plan. Concurrent use of nonpharmacologic therapies (eg, physical therapy, structured exercise, yoga, relaxation training, biofeedback, cognitive behavioral therapy) and rational pharmacotherapy while promoting patient self-care is the standard of pain management called for by the Institute of Medicine.¹

Set functional goals

We recommend clearly defining functional goals with each patient before starting therapy. These goals should be written into the treatment plan as a way for patient and provider to evaluate the effectiveness of chronic opioid therapy. A useful mnemonic to help identify such goals is SMART, an acronym for specific, measurable, action-oriented, realistic, and time-bound. Specific goals will depend on pain severity, but examples could include being able to do grocery shopping without assistance, to play on the floor with grandchildren, or to engage in healthy exercise habits such as 20 minutes of moderately brisk walking 3 days per week.

Obtain informed consent, and document it thoroughly

Providers must communicate risks, potential benefits, and safe medication-taking practices, including how to safely store and dispose of unused opioids, and document this conversation clearly in the medical record. From a medicolegal perspective, if it wasn’t documented, it did not happen.¹⁷

From a medicolegal perspective, if it wasn’t documented, it didn’t happen

Informed consent can be further advanced with the use of a controlled substance agreement that outlines the treatment plan as well as potential risks, benefits, and practice policies in a structured way. Most states now either recommend or mandate the use of such agreements.¹⁸

Controlled substance agreements give providers a greater sense of mastery and comfort when prescribing opioids,¹⁹ but they have important limitations. In particular, there is a lack of consensus on what the agreement should say and relatively weak evidence that these agreements are efficacious. Additionally, a poorly written agreement can be stigmatizing and can erode trust.²⁰ However, we believe that when the agreement is written in an appropriate framework of safety at an appropriate level of health literacy and with a focus on shared decision-making, it can be very helpful and should be used.

Employ safe, rational pharmacotherapy

Considerations when choosing an opioid include its potency, onset of action, and half-life. Comorbid conditions (eg, advanced age,²¹ sleep-disordered breathing²²) and concurrent medications (eg, benzodiazepines, anticonvulsants, muscle relaxants) also affect decisions about the formulation, starting dose, rapidity of titration, and ceiling dose. Risk of harm  increases in patients with such comorbid factors, and it is prudent to start with lower doses of shorter-acting medications until patients can demonstrate safe use. Risk of unintentional overdose is higher with higher prescribed doses.²³ Pharmacologically there is no analgesic dose ceiling, but we urge caution, particularly in opioid-naive patients.

Try a less addictive agent such as tramadol or codeine before escalating to hydrocodone, oxycodone, or morphine

A patient’s response to any particular opioid is idiosyncratic and variable. There are more than 100 known polymorphisms in the human opioid mu-receptor gene, and thus differences in receptor affinity and activation as well as in metabolism make it difficult to predict which opioid will work best for a particular patient.²⁴ However, a less potent opioid receptor agonist with less addictive potential, such as tramadol or codeine, should generally be tried first before escalating to a riskier, more potent opioid such as hydrocodone, oxycodone, or morphine. This “analgesic ladder,” a concept introduced by the World Health Organization in 1986 to provide a framework for managing cancer pain, has been adapted to a variety of chronic pain syndromes.²⁵

Methadone deserves special mention. A strongly lipophilic molecule with a long and variable half-life, it accumulates in fat,²⁶ and long after the analgesic effect has worn off, methadone will still be present. Repeated dosing or rapid dose escalation in an attempt to achieve adequate analgesia may result in inadvertent overdose. Additionally, methadone can prolong the QT interval, and periodic electrocardiographic monitoring is recommended.²⁷ For these reasons, we recommend avoiding the use of methadone in most cases unless the provider has significant experience, expertise, or support in the safe use of this medication.

Table 1 summarizes these recommendations.

MONITORING AND SAFETY

Providers must periodically reassess the safety and efficacy of chronic opioid therapy to be sure that it is still indicated.¹⁰ Since we cannot accurately predict which patients will suffer adverse reactions or demonstrate aberrant behaviors,⁷ it is important to be transparent and consistent with monitoring practices for all patients on chronic opioid therapy.¹⁷ By framing monitoring in terms of safety and employing it universally, providers can minimize miscommunication and accidental stigmatization.

Prescription monitoring programs

In 2002, Congress appropriated funding to the US Department of Justice to support prescription monitoring programs nationally.²⁸ At the time of this writing, Missouri is the only state without an approved monitoring program.²⁹

Although the design and function of the programs vary from state to state, they require pharmacies to collect and report data on controlled substances for individual patients and prescribers. These data are sometimes shared across state lines, and the programs enhance the capacity of regulatory and law enforcement agencies to analyze controlled substance use.

Prescribers can (and are sometimes required to) register for access in their state and use this resource to assess the opioid refill history of their patients. This powerful tool improves detection of “doctor-shopping” and other common scams.³⁰

Additionally, recognizing that the risk of death from overdose increases as the total daily dose of opioids increases,²³ some states provide data on their composite report expressing the morphine equivalent daily dose or daily morphine milligram equivalents of the opioids prescribed. This information is valuable to the busy clinician; at a glance the prescriber can quickly discern the total daily opioid dose and use that information to assess risk and manage change. Furthermore, some states restrict further dose escalation when the morphine equivalent daily dose exceeds a predetermined amount (typically 100 to 120 morphine milligram equivalents).

Tamper-resistant prescribing

To minimize the risk of prescription tampering, simple techniques such as writing out the number of tablets dispensed can help, and use of tamper-resistant prescription paper has been required for Medicaid recipients since 2008.³¹

When possible, we recommend products with abuse-deterrent properties. Although the science of abuse deterrence is relatively new and few products are labeled as such, a number of opioids are formulated to resist deformation, vaporization, dissolving, or other physical tampering. Additionally, some abuse-deterrent opioid formulations contain naloxone, which is released only when the drug is deformed in some way, thereby decreasing the user’s response to an abused substance or resulting in opioid withdrawal.³²

Urine drug testing

Although complex and nuanced, guidelines recommend urine drug testing to confirm the presence or absence of prescribed and illicit substances in the body.¹⁰ There is no consensus on when or how often to test, but it should be done randomly and without forewarning to foil efforts to defeat testing such as provision of synthetic, adulterated, or substituted urine.

Providers underuse urine drug testing.³³ We recommend that it be done at the start of opioid therapy, sporadically thereafter, when therapy is changed, and whenever the provider is concerned about possible aberrant drug use.

Understanding opioid metabolism, cross-reactivity, and the types of tests available will help avoid misinterpretation of results.³⁴ For example, a positive “opiate” result in most screening immunoassay tests does not reflect oxycodone use, since tests for synthetic opioids often need to be ordered separately; the commonly used Cedia opiate assay cross-reacts with oxycodone at a concentration of 10,000 ng/mL only 3.1% of the time.³⁵ Immunoassay screening tests are widely available, sensitive, inexpensive, and fast, but they are qualitative, have limited specificity, and are subject to false-positive and false-negative results.³⁶  Table 2 outlines some common characteristics of substances on screening immunoassays, including reported causes of false-positive results.^37–39

Confirmatory testing using gas chromatography or mass spectroscopy is more expensive and slower to process, but is highly sensitive and specific, quantitative, and useful when screening results are difficult to interpret.

Knowing how and when to order the right urine drug test and knowing how to interpret the results are skills prescribers should master.

DISCONTINUING OPIOIDS

When opioids are no longer safe or effective, they should be stopped. The decision can be difficult for both the patient and provider, and a certain degree of equanimity is needed to approach it rationally.

Strong indications for discontinuation

Respiratory depression, cognitive impairment, falls, and motor vehicle accidents mean harm is already apparent. At a minimum, dose reduction is warranted and discontinuation should be strongly considered. Similarly, overdose (intentional or accidental) and active suicidal ideation contraindicate ongoing opioid prescribing unless the ongoing risk can be decisively mitigated.

Certain aberrant behaviors such as prescription forgery or theft, threats of violence to obtain analgesics, and diversion (transfer of the drug to another person for nonmedical use) also warrant immediate discontinuation. Continuing to prescribe an opioid while knowing diversion is taking place may be a violation of federal or state law or both.⁴⁰

Another reason to stop is failure to achieve the expected benefit from chronic opioid therapy (ie, agreed-upon functional goals) despite appropriate dose adjustment. In these cases, ongoing risk by definition outweighs observed benefit.

Relative indications for discontinuation

Opioid therapy has many potential adverse effects. Depending on the severity and duration of the symptom and its response to either dose reduction or adjunctive management, opioids may need to be discontinued.

For example, pruritus, constipation, urinary retention, nausea, sedation, and sexual dysfunction may all be reasons to stop chronic opioid therapy. Similarly, chronic opioid therapy may paradoxically worsen pain in some susceptible patients, a complication known as opioid-induced hyperalgesia; in these cases, tapering off opioids should be considered as well.⁴¹ Aberrant behaviors should prompt reconsideration of chronic opioid therapy; these include hazardous alcohol consumption, use of illicit drugs, pill hoarding, and use of opioids in a manner different than intended by the prescriber.

Another relative indication for discontinuation is receipt of controlled substances from other providers. A well-written controlled substance agreement and adequate counseling may help mitigate this risk; poor communication between providers, lack of integration of electronic medical record systems, urgent or emergency room care, and poor health literacy may all lead to redundant prescribing in some circumstances. While unintentional use of controlled substances from different providers is no less dangerous than intentional misuse, the specifics of each case need to be considered before opioids are reflexively discontinued.

How to discontinue opioids

In most cases, opioids should be tapered to reduce the risk and severity of withdrawal symptoms. Decreasing the dose by 10% of the original dose per week is usually well tolerated with minimal adverse effects.⁴² Tapering can be done much faster, and numerous rapid detoxification protocols are available. In general, a patient needs 20% of the previous day’s dose to prevent withdrawal symptoms.⁴³

Withdrawal symptoms are rarely life-threatening but can be very uncomfortable. Some providers add clonidine to attenuate associated autonomic symptoms such as hypertension, nausea, cramps, diaphoresis, and tachycardia if they occur. Other adjunctive medications include nonsteroidal anti-inflammatory drugs for body aches, antiemetics for nausea and vomiting, bismuth subsalicylate for diarrhea, and trazodone for insomnia.

It is unlawful for primary care physicians to use another opioid to treat symptoms of withdrawal in the outpatient setting unless it is issued through a federally certified narcotic treatment program or prescribed by a qualified clinician registered with the US Drug Enforcement Administration to prescribe buprenorphine-naloxone.⁴⁴

In some circumstances, it may be appropriate to abruptly discontinue opioids without a taper, such as when diversion is evident. However, a decision to discontinue opioids due to misuse should not equate to an automatic decision to terminate a patient from the practice. Instead, providers should use this opportunity to offer empathy and referral to drug treatment counseling and rehabilitation. A decision to discontinue opioids because they are no longer safe or effective does not mean that the patient’s pain is not real—it is “real” for them, even if caused by the pain of addiction—or that shared decision-making is no longer possible or appropriate.

Handling difficult conversations when discontinuing opioids

The conversation between patient and provider when discontinuing opioids can be difficult. Misaligned expectations of both parties, patient fear of uncontrolled pain, and provider concern about causing suffering are frequent contributing factors. Patients abusing prescription drugs may also have a stronger relationship with their medication than with their provider and may use manipulative strategies including overt hostility and threats to obtain a prescription. Providers need to maintain their composure to de-escalate these potentially upsetting confrontations.

Table 3 outlines some specific suggestions that may be helpful, including the following:

• Frame the discussion in terms of safety—opioids are being discontinued because the benefit no longer outweighs the risk
  

• Don’t debate your decision with the patient, but present your reasoning in a considered manner
• Focus on the appropriateness of the treatment and not on the patient’s character
• Avoid the use of labels (eg, “drug addict”)
• Emphasize your commitment to the patient’s well-being and an alternative treatment plan (ie, nonabandonment)
• Respond to emotional distress with empathy, but do not let that change your decision to discontinue opioids.

Finally, we strongly encourage providers to insist on being treated respectfully. When safety cannot be ensured, providers should remove themselves from the room until the patient can calm down or the provider can ask for assistance from colleagues.

Maintaining empathy by understanding grief

Discontinuing opioids may trigger in a patient an emotional response similar to grief. When considered in this framework, it may empower an otherwise frustrated provider to remain empathetic even in the midst of a difficult confrontation. Paralleling Kübler-Ross’s five stages of grief,⁴⁵ we propose a similar model we call the “five stages of opioid loss”; this model has been successfully used in the residency continuity clinic at the University of Connecticut as a training aid.

Hopelessness and helplessness. During the first stage of the discussion the patient struggles with how to move forward. This conversation is frequently characterized by tearfulness and explanations to account for aberrant behavior or willingness to continue to suffer side effects. Active listening, empathy, and a focus on the factors that led to discontinuation of opioids while still validating pain are important.

Some patients go through five stages of opioid loss when stopping these drugs

Demanding and indignant. During the second stage, patients frequently push the limits of “no.” Accusations of abandonment and lack of empathy may accompany this stage and can be quite upsetting for the unprepared provider. A novice clinician can use role-play as a tool to better prepare for this type of encounter. Patients should be allowed to express their frustration but ultimatums and threats of violence should not be tolerated. Reassuring patients that their pain will be addressed using nonopioid therapy can be helpful, and a simple offer of continued care can help to preserve the therapeutic relationship.

Bargaining, the third stage of this model, is characterized by attempts to negotiate continued prescribing. While it can be frustrating, this push and pull is the beginning of real conversation and identification of a treatment plan for the future.

Resignation. The fourth stage begins when the patient has resigned himself or herself to your decision, but may not have accepted the available treatment options. At this point the patient may return for care or seek out a new provider. Empathy is again the element most crucial to success; this stage carries an opportunity to develop mutual respect.

Acceptance. The patients who choose to continue care with you have progressed to the final phase. They begin to look toward the future, having chosen the better of the two paths: partnering with a caring provider to develop a shared therapeutic plan.

A CONSISTENT AND TRANSPARENT APPROACH

Opioids can be useful for selected patients when they are carefully prescribed, but the prescriber must fully consider the risks and benefits specific to each patient and mitigate risk whenever possible.

Collaborating with patients to use opioids rationally is easier when it is part of a multimodal pain management plan and is initiated with clear functional goals and parameters for discontinuation. Presenting risks and benefits in a framework of safety and educating patients will help to reduce the stigma that may otherwise accompany safety monitoring using tools such as controlled substance agreements and urine toxicology testing.

Despite these efforts, patients may become psychologically dependent on opioids and discontinuation may prove difficult. However, a consistent and transparent approach to prescribing with special efforts to empathize with suffering patients may empower providers to navigate this process effectively.