Promoting Adherence

Clinicians should adopt a universal precautions approach toward their patients who have chronic noncancer pain (CNCP) (Exhibit 4-1). The term universal precautions first emerged in the context of infectious disease treatment and referred to using infection control procedures with all patients. In the context of pain treatment, a universal precautions approach refers to a minimum standard of care applied to all patients who have CNCP, whatever their assessed risk (Gourlay, Heit, & Almahrezi, 2005). A universal precautions approach improves care and shows due diligence in an era of increasing illegal use of prescription opioids.

Exhibit 4-1

Ten Steps of Universal Precautions. Make a diagnosis with appropriate differential. Perform a psychological assessment, including risk of addictive disorders.

Clinicians can help patients adhere to treatment plans by:

• Employing treatment agreements.
• Regulating visit intervals.
• Controlling medication supply.
• Conducting urine drug testing (UDT).
• To the degree possible, including the patient’s support network in monitoring efforts.

Medication Supply

The Drug Enforcement Administration’s (DEA’s) “do not fill until” option allows clinicians to write a 3-month prescription that can be filled in spaced intervals (Exhibit 4-2). However, only rarely should a patient with an SUD history be seen as infrequently as every 3 months. Patients who find it difficult to adhere to treatment plans may be better served by more frequent visits during which prescriptions for smaller amounts of medication are provided. In this case, clinicians can use the “do not fill until” strategy to divide a month’s supply into, for example, three 10-day prescriptions for patients who cannot handle a month’s worth of medication.

Exhibit 4-2

Issuance of Multiple Prescriptions for Schedule II Controlled Substances. 71 Federal Register 52724 allows clinicians to write multiple prescriptions—to be filled sequentially—for the same Schedule II controlled substance. The multiple (more...)

Clinicians also can promote adherence through pill counts or by recruiting (with the patient’s consent) a pharmacist or trusted family member to dispense medication daily. Patients who require tighter-than-weekly dispensing of medication also probably require a higher level of care and will often benefit from comanagement with an addiction specialist. Exhibit 4-3 presents a scenario regarding medication supply.

Exhibit 4-3

Talking With Patients About Medication Supply.

Urine Drug Testing

UDT can detect the presence of some prescribed and unprescribed substances and, therefore, can be a useful tool for improving patient care (Cone & Caplan, 2009; Heit & Gourlay, 2004; McMillin & Urry, 2007). Couto, Romney, Leider, Sharma, and Goldfarb (2009) studied data from the urine tests of more than 900,000 patients on chronic opioid treatment. The researchers found that 75 percent of the patients showed at least one sign of nonadherence to opioid regimens (e.g., having no detectable levels of the prescribed medication in their urine, having evidence of an illicit drug). As when using other tools, the clinician must understand the limitations of UDT and interpret results in light of other clinical findings.

There are two common kinds of urine drug tests:

• Immunoassay (IA) screens, which use antibodies to detect a drug or metabolite (e.g., opioids) in urine
• Specific substance identification tests, such as GC/MS (gas chromatography/mass spectroscopy) or HPLC (high-performance liquid chromatography), which use more sophisticated methods to detect the presence of specific substances

Immunoassays

Heit and Gourlay (2004) recommend testing for the following substances during routine screening: cocaine, amphetamines/methamphetamine, opioids, methadone, marijuana, and benzodiazepines.

Although IA screens are sensitive to natural opioids, they have limited ability to detect synthetic and semisynthetic opioids (e.g., hydrocodone, fentanyl, oxycodone, methadone). If an IA screen fails to detect the presence of expected opioids, the results can be confirmed with a more specific substance identification test.

IA screens can be conducted at the point of care (POC) or in a laboratory. Exhibit 4-4 lists the benefits and limitations of POC testing. POC results that are positive for an illicit substance or negative for the prescribed substance class can be verified with a confirmatory test.

Exhibit 4-4

POC Testing Benefits and Limitations.

Urine Drug Testing Results

UDT is subject to false-positive and false-negative results. The clinician must interpret results carefully and explore the possible causes of unexpected findings before taking action. For example, prescribed medication may not show up in a UDT result because (Gourlay et al., 2006):

• The patient did not use medications or did not use them recently.
• The patient excretes medications or metabolites at a rate different from normal.
• The test was not sufficiently sensitive to detect the medications at the concentrations present.
• There was a clerical error.

If the results of UDT are unexpected, the clinician may want to take the following steps, recommended by Gourlay and Heit (2009):

• Contact the laboratory to confirm there was no clerical error.
• Discuss with the laboratory what type of followup test or confirmatory test should be conducted.
• Discuss the results with the patient and document the UDT results and discussion in the patient’s medical record.
• Confirm disputed results with the recommended laboratory test.

An unexpected result should be discussed face-to-face with the patient (Exhibit 4-5). The presence of unprescribed or illicit substances does not render a patient’s pain complaints illegitimate, but it may suggest abuse or addiction. Repeated unexpected results suggest the need for evaluation by an addiction specialist. If a patient with CNCP is diagnosed with a comorbid SUD, the patient must be willing to accept treatment for both disorders. It is reasonable for the clinician, without getting into a dispute about patients’ rights to use substances or the benefits of medical marijuana, to make access to opioid therapy contingent on the patient’s willingness to relinquish use of illicit substances. This can be presented simply as a way to ensure the patient’s access to treatment and the clinician’s continued ability to prescribe. If the person is unwilling to relinquish recreational use, the pain problem may not warrant chronic opioid therapy. If the patient is unable to relinquish the drugs, then addiction treatment is indicated (Covington, 2008).

Exhibit 4-5

Talking With Patients About Aberrant Urine Drug Testing Results.

Intervals for UDT depend on the degree of oversight the patient requires. The tests can be scheduled or random, depending on the patient’s risk level; however, if patients are tested selectively, there is a risk of overtesting minorities and other marginalized groups and failing to detect substance abuse in patients whose ethnicity and socioeconomic status mirror those of the clinician.

Clinicians should help patients understand that UDT helps protect their recovery, their access to analgesia, and the clinician’s ability to prescribe and that urine drug tests are neither punitive nor discriminatory because they are expected of all patients who receive chronic opioid therapy. Exhibit 4-6 presents sample scenarios for addressing UDT with patients.

Exhibit 4-6

Talking With Patients Who Are Resistant to Urine Drug Testing.

Inclusion of Family, Friends, and Others

With support from others, the patient may be better able to comply with pain treatment. Just as important, the inclusion of others enables the clinician to obtain a clearer picture of the patient’s response to treatment, including his or her ability to adhere to an opioid medication regimen, any loss of function, or development of aberrant behaviors that may indicate relapse. When a patient has a history of an SUD, it is crucial that the prescribing clinician obtain collateral information from household members, physical therapists, pharmacists, and other members of the patient’s healthcare team. Given that patients may not always realize or disclose their problems with drugs, safety considerations require that prescriptions for addictive substances be contingent on the clinician’s unrestricted access to collateral information.

Nonadherence

At some point in the treatment of chronic pain, patients are likely to fail to adhere to their treatment agreement. Behavior that suggests substance misuse, abuse, or addiction is known as aberrant drug-related behavior (ADRB). ADRB includes:

• Being more interested in opioids (especially immediate-release and nongeneric) than in other medications or in any other aspect of treatment.
• Taking doses larger than those prescribed or increasing dosage without consulting the clinician.
• Insisting that higher doses are needed.
• Resisting UDT, referrals to specialists, and other aspects of treatment.
• Resisting changes to opioid therapy.
• Repeatedly losing medications or prescriptions or seeking early refills.
• Making multiple phone calls about prescriptions.
• Attempting unscheduled visits, typically after office hours or when the clinician is unavailable.
• Appearing sedated.
• Misusing alcohol or using illicit drugs.
• Showing deteriorating functioning and beginning to experience adverse consequences from medications (e.g., problems at home or on the job).
• Injecting (having track marks) or snorting oral formulations.
• Obtaining medications illegally (e.g., from multiple clinicians, street dealers, family members, the Internet, forged prescriptions).
• Behaving in an intimidating or threatening manner.
• Having urine drug tests that do not show the presence of prescribed opioids.
• Not adhering to nonpharmacological components of treatment.

Patient behavior is highly variable and dependent on circumstances, and the evidence base does not decisively implicate any single behavior or set of drug-related behaviors as being indicative of addiction. ADRB can be driven by other causes, including:

• Misunderstanding instructions.
• Seeking euphoria.
• Using medications to deal with fear, anger, stress, sleep problems, or other issues.
• Diverting medications for profit.
• Coping with untreated mental disorders.
• Coping with undertreated pain, also known as pseudoaddiction (Exhibit 4-7).
• General nonadherence.

Exhibit 4-7

Pseudoaddiction. Patients sometimes display ADRB in response to undertreated pain. This phenomenon has been termed pseudoaddiction (Weissman & Haddox, 1989). It is often unclear how to determine the presence of pseudoaddiction in a patient, and (more...)

ADRBs that clinicians are most likely to observe (or that patients are most likely to report) are often the behaviors that are most ambiguous (e.g., not following a medication regimen precisely, running out of a prescription early). The extreme behaviors that are easier to interpret (e.g., selling prescriptions, altering the medication’s delivery mode) are ones that may elude observation during an office visit. The development of a strong therapeutic relationship facilitates these often difficult conversations when and if ADRBs occur.

Tools To Assess Aberrant Drug-Related Behaviors

Tools exist to help clinicians assess ADRBs in patients on chronic opioid therapy. However, evidence for their validity is limited (Chou, Fanciullo, Fine, Miaskowski, et al., 2009). The Addiction Behaviors Checklist (Wu et al., 2006) helps determine whether opioids have become a problem for the patient (Exhibit 4-8). It is for ongoing evaluation and can flag addiction problems as they develop. The tool can be quickly administered at each office visit; three or more “yes” responses should trigger more careful monitoring or intervention.

Exhibit 4-8

Addiction Behaviors Checklist.

The Current Opioid Misuse Measure (Butler et al., 2007) asks patients about their behavior in the 30 days before the appointment (Exhibit 4-9). Butler and colleagues recommend a conservative cutoff score of 9, which yields some false-positive results, but misses fewer patients who may be misusing medications.

Exhibit 4-9

Current Opioid Misuse Measure. (Measured on a Scale of 0=Never to 4=Very Often) How often have you had trouble with thinking clearly or had memory problems?

Documenting Care

Meticulous documentation of chronic opioid therapy is essential. It is both a Federal and State requirement, and the quality of documentation can determine whether a clinician is judged to be practicing medicine or trafficking in drugs. In addition, longitudinal documentation is essential to permit a determination over time of the extent to which treatment is an asset or a liability to the patient. Documentation also provides protection for the clinician if drug enforcement authorities conduct an investigation.

The practitioner must be familiar with the requirements of the State in which he or she practices; however, generally there must be documentation of an adequate medical workup of the condition being treated, an evaluation for psychiatric comorbidity including SUD, a plan of care, amounts of scheduled medications prescribed, and instructions for use of medications. Some States require that chronic opioid therapy be used only if other treatments are ineffective or ill-advised. The University of Wisconsin’s Pain and Policy Studies Group maintains a Web site that describes the regulations of different States regarding opioid prescribing (http://www.painpolicy.wisc.edu/).

Like other treatments, opioid therapy should be continued only so long as it is effective. Many clinicians have found it useful to monitor and document opioid response using the “4As” of Passik and colleagues (2004): analgesia, activities of daily living, adverse events, and ADRBs.

Managing Difficult Conversations

Patients who have CNCP can be especially difficult to treat because their condition often eludes diagnosis and because unremitting pain itself can affect their ability to be civil. When an SUD or other co-occurring disorder is overlaid onto the pain, the likelihood of difficult behavior from the patient increases. Such a patient has complex and intense needs that are best served by a treatment team approach that allows for frequent assessment and care of the patient without overburdening any one member of the team (see Chapter 3).

The following activities can help build a therapeutic relationship between the treatment team and the patient:

• Listening actively
• Asking open-ended, nonjudgmental questions
• Restating a patient’s report to make sure it has been understood
• Using clarification statements (“It sounds as if the pain is worse than usual for you”)
• Demonstrating empathy
• Using feeling statements (“This must be very difficult for you”)

One strategy for demonstrating empathy is to specifically acknowledge the effort required simply to cope with pain daily. The clinician should not promise overly optimistic results and should educate patients so that they form reasonable expectations about outcomes. It may also help to suggest that patients focus on improvements in functioning and avoid defining their lives by their pain.

Patients who have chronic pain, as well as those with SUDs, and perhaps especially those with both, can elicit strong negative responses from treatment providers. These negative reactions impede efforts to experience and communicate empathy. It is useful, first of all, for the clinician to recognize these reactions and to seek to understand them. Frequently, they are simply a result of the frustration attendant on treating difficult or intractable problems. They may result from feelings that the clinician is working harder for the patient’s wellness than is the patient. It may help for the clinician to remind himself or herself that, no matter how lacking in motivation the patient seems, no one would ever wish for a typical life of a person with comorbid pain and addiction.

Workplace Safety

Clinicians and their patients must be protected from violence in the workplace. Clinic staff members should be encouraged to be proactive and aware of their surroundings, report suspicious activity, and use common sense to make good decisions about aggressive patients or family members. Clinicians should plan for occasional disruptive or aggressive behavior and position themselves in the examination room between the patient and the door. If a patient becomes threatening, security personnel or law enforcement may be needed. The consensus panel recommends that clinicians develop crisis management policies and plans and ensure that staff members are trained and drilled on their implementation. A plan should be developed for contacting public safety officials (discreetly, if necessary) in urgent or emergent situations. The plan should include a distress signal to alert all staff members. Contact information for public safety officials should be readily available.

Drug Diversion

Some patients sell or trade their medications, and sometimes patients give their medications to family or friends for various reasons. Medications taken by people other than for whom they are prescribed are said to be “diverted.”

Unequivocal evidence of diversion is rare, although patients often acknowledge it when confronted. All members of the treatment team should be alert to the patient who:

• Is known to have contact with people with active SUDs.
• Cannot produce the remainder of a partially used prescription when asked for a pill or patch count.
• Has attempted to alter or forge prescriptions.
• Has been “doctor shopping” to obtain additional medications.
• Does not comply with the nonpharmacological components of recommended treatment.
• Strongly prefers brand name drugs or drugs with high street value.
• Fails to demonstrate the presence of prescribed opioids in appropriate UDT results.

Clinicians should know which drugs are popular in their communities and be vigilant when prescribing medications that have high street value (Exhibit 4-10). Many clinicians scrupulously avoid prescribing medications with high marketability to patients who have an addiction disorder or histories of diversion.

Exhibit 4-10

Resources for Information on Drug Use Trends.

Clinicians should remind patients of their responsibility to protect their medications against theft and diversion (see Chapter 5). Clinicians must understand and comply with State laws regarding prescribing practices. State laws on the amount of opioids prescribed and prescription expiration may be more restrictive than Federal laws. State laws can be found at the Federation of State Medical Boards Web site (http://www.fsmb.org).

Some clinicians have inordinately restricted their prescribing because of a false belief that there has been a “crackdown” on clinicians prescribing opioids for pain. DEA’s policy statement on dispensing scheduled medications for the treatment of pain, which includes a response to concerns of a crackdown, is found at http://www.deadiversion.usdoj.gov/fed_regs/notices/2006/fr09062.htm.

Strict boundaries should be placed around a patient who pushes for medications that the clinician believes are unwise choices. In this situation, the clinician’s responsibility is to prescribe what is indicated and not what the patient desires. Although all diversion is unlawful, there are degrees of seriousness; for example, a patient who gives a hydrocodone tablet to a spouse who sustained a back sprain should not be treated in the same way as a “pseudo-patient” who seeks medications to resell. If diversion is suspected, treatment monitoring must be tightened. Clinicians should not tolerate any serious diversion, which is a breach of trust that usually calls for cessation of opioid therapy or even ending the clinician–patient relationship. Evidence of diversion should be documented.

State prescription monitoring programs, which currently operate in 38 States, may be useful to clinicians who suspect a patient of “doctor shopping,” that is, obtaining scheduled medications from multiple clinicians (Wang & Christo, 2009). Information regarding programs and a list of States that have active programs are at http://www.namsdl.org/presdrug.htm.

Discontinuation of Opioid Therapy

The best reason to discontinue opioid therapy is that the pain has resolved, but that is often not the case. Other likely reasons for discontinuation include the following:

• Opioids are no longer effective.
• Opioids no longer stabilize the patient or improve function.
• The patient loses control over the medication.
• The patient is diverting the medication.
• The patient is using alcohol, benzodiazepines, or illicit drugs.
• Adverse effects are unmanageable.

When the benefits of opioid therapy are outweighed by its harms, therapy should be discontinued. Of course, this statement applies to all medications, of whatever category. Exhibit 4-11 presents an algorithm for discontinuing chronic opioid therapy.

Exhibit 4-11

Exit Strategy. Note: This algorithm does not indicate a maximum trial dose, as none has been established by research. However, it can be said that doses above 200 mg morphine equivalents per day have not been studied systematically, and higher doses are (more...)

Patients tapering off opioids may experience both short-term withdrawal (which occurs immediately) and protracted withdrawal. Short-term withdrawal begins when the level of opioid in the blood falls below the accustomed level for the patient. It usually abates after a few days or a week (depending on the half-life of the medication). Patients may experience increased pain and withdrawal hyperalgesia. Symptoms and signs of opioid withdrawal are as follows.

Symptoms include:

• Abdominal cramps, nausea, vomiting, diarrhea
• Bone and muscle pain
• Anxiety
• Insomnia
• Increased pain sensitivity in the original painful site

Signs include:

• Tachycardia
• Hypertension
• Fever
• Mydriasis
• Hyperreflexia
• Diaphoresis
• Piloerection
• Lacrimation, yawning
• Rhinorrhea
• Myoclonus

Protracted withdrawal from opioids includes anxiety, depression, sleep disturbances, fatigue, dysphoria, and irritability, which can last for weeks or months following withdrawal from short- and long-acting opioids (Collins & Kleber, 2004; Satel, Kosten, Schuckit, & Fischman, 1993). These symptoms can be attenuated with tricyclic antidepressants, gabapentin, and other nonaddicting agents. Discomfort may develop at any time during the weaning process, so patients should be monitored until the process is complete and any symptoms addressed. Cognitive–behavioral therapy may help with cravings. Not all patients experience protracted withdrawal.

For patients whose active addiction necessitates discontinuation of opioid therapy, referral for specialized addiction treatment is crucial.

There are many reasons for discontinuing scheduled medications but very few for discontinuing care of the patient. When opioids are a liability, whether because of poor analgesic efficacy or patient ADRB, the clinician should usually offer to continue to provide non-opioid therapies and treatment; that is, stopping opioids does not mean stopping treatment.

The clinician who elects to discharge a patient from his or her practice should inform the patient in writing. To avoid charges of abandonment, the clinician should provide the patient with contact information for other clinicians, along with a written tapering schedule and prescriptions for the medications that require a taper. In cases in which the clinician–patient relationship is hostile or dangerous or in which the patient presents a danger to the clinician, a letter alone can suffice.

Key Points

• Patients on chronic opioid therapy should be monitored closely for signs of benefit, harm, and ADRBs.
• All ADRBs should be documented, investigated, and acted on.
• Difficult conversations should be managed with compassion and empathy.
• Clinicians should establish and respectfully maintain strict limits with patients who insist on opioids.
• Clinicians should establish relationships with drug-testing laboratory staff and addiction specialists.
• When it is necessary to discontinue chronic opioid therapy, a conscientious tapering plan should be provided.