Pain in Primary Care

Posted on Jul 5, 2010 in Expired CME | 3 comments

Optimizing Pain Management in the Primary Care Setting

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Best Practice Pearls

• Assess risk for opioid misuse, abuse, or diversion prior to initiating opioid therapy to prevent potentially harmful outcomes to both the patient and the patient-clinician relationship
• Develop an opioid agreement with patients to clearly establish expectations and responsibilities
• Reassess patients on opioid therapy periodically and as warranted by changing circumstances

 

Learning Objectives

On completion of this activity, participants should be better able to
1. Utilize evidence- and guideline-based strategies for risk assessment, management, and monitoring of opioid therapy in patients with chronic pain
2. Identify clinical and pharmacologic strategies designed to reduce aberrant drug-related behaviors

Overview

Chronic pain is a serious medical problem in the United States, affecting millions of Americans and costing the healthcare system billions of dollars.[1] According to the National Center for Health Statistics, more than 25% or 1 in 4 Americans reported pain persisting for more than 24 hours with 1 in 3 Americans indicating their pain was “disabling.”[1] Although opioids have proven useful in treating patients with moderate-to-severe chronic noncancer pain, in general, chronic pain is often inadequately treated.

According to research, opioids are prescribed to fewer than 1 in 5 patients reporting pain as a complaint in an acute care setting.[2] Moreover, 84% of primary care clinicians have concerns regarding abuse of prescription opioids.[3] These concerns are grounded in data indicating that misuse, abuse, and diversion of prescription opioids have escalated in recent years. More than 6 million American adults report the use of prescription drugs for nonmedical reasons, a trend that appears to be on the rise in the United States.[4,5] The result is often a disturbing lack of treatment of pain in legitimate patients.

Common reasons cited by clinicians in response to the burden of inadequately treated pain include fear of creating addiction, lack of awareness of state and federal laws governing opioid use, worry over scrutiny by state licensing boards and law enforcement, and misunderstanding that addiction, tolerance, and physical dependence are not the same thing.[6,7] There is a clear need for education that dispels clinicians’ fears and misconceptions and emphasizes that adequate pain relief can be achieved while minimizing the risk of aberrant drug-related behaviors. This program will review recently updated guidelines for chronic pain care and examine clinical strategies, including opioid formulations designed to deter abuse. The goal is to provide clinicians with pain management tools that optimize the care of their patients with chronic pain.

Scope of the Problem

The use of nonmedical psychotherapeutic drugs has steadily increased over recent years, with pain relievers comprising the most misused class of drug.[8] In particular, the nonmedical use of opioids has risen in past decades—with misuse of hydrocodone, oxycodone, and morphine most prevalent.[9] All regions of the United States appear to be affected by this phenomenon according to the Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System, which is active in 94% of ZIP codes in the United States.[10] Reports indicate that 97% of all RADARS System surveyed ZIP codes have reported at least 1 case of prescription opioid abuse, misuse, or diversion. Furthermore, the source of pain relievers that are used nonmedically is not predominantly clinicians as one might suspect, but is the diversion of these medications from family members and friends (60%) (Figure 1).

Figure 1

Moreover, healthcare costs associated with opioid misuse and abuses are not insignificant. As seen in Figure 2, opioid abusers exceed nonabusers for hospitalizations, outpatient visits, medication, and other associated costs.[11]

Figure 2

Common Terms, Commonly Misinterpreted

Various confusing terms have been used to describe prescription opioid abuse. For the purposes of this article, the following terms from the 2009 American Pain Society/American Academy of Pain Medicine’s Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain (APS/AAPM guidelines) are applicable.[12]

• Addiction is a primary, chronic, and neurobiological disease with genetic, psychosocial, and environmental factors influencing its development and manifestations; it is characterized by behaviors that include 1 or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving.
• Aberrant drug-related behavior is a phrase to describe a behavior outside the boundaries of the agreed on treatment plan which is established as early as possible in the clinician-patient relationship.
• Abuse is any use of an illegal drug, or the intentional self-administration of a medication for a nonmedical purpose such as altering one’s state of consciousness: for example, getting high.
• Diversion is the intentional transfer of a controlled substance from legitimate distribution and dispensing channels.
• Misuse is the use of medication (for a medical purpose) other than as directed or as indicated, whether willful or unintentional, and whether harm results or not.
• Tolerance is a state of adaptation in which exposure to a drug induces changes that result in a diminution of 1 or more opioid effects over time.

In treating pain patients, it is important to understand that abuse is a distinct phenomenon, separate from the problem of addiction. As shown in Figure 3, addiction, a rare event, occurs in 2% to 5% of the total pain population which is consistent with its prevalence in the general population. Abuse is more common and occurs in 20% of pain patients and any aberrant behaviors in 40% of pain patients.[13]

Figure 3

Aberrant drug-related behaviors may be more likely in patients with a family history of abuse, a personal history of abuse, a history of preadolescent sexual abuse, psychological disease, and/or smoking.

These definitions come into play as valuable guides when distinguishing between drug-seeking behavior and a legitimate need for a treatment. In doing so, it is important to determine the nature of the pain, take a patient history with a validated screener, schedule frequent visits, rule out comorbid conditions that might put the patient at risk, and carefully select and evaluate prescribed medication.[14] Moreover, differential diagnoses should be considered and causes for underlying pain should be identified and treated directly. If no finding is evident, symptoms can and should be treated. Comorbid conditions, including substance use disorders and psychiatric illness, must also be addressed.[15]

Guidelines for Risk Assessment

The APS/AAPM guidelines support a Universal Precaution approach to the treatment of pain with chronic opioid therapy. As such, proper patient selection is critical and requires a comprehensive benefit-to-harm evaluation weighing the potential positive effects of opioids against potential risks. Thorough risk assessment and stratification is appropriate in every case.[12] A Universal Precaution approach to the treatment of chronic pain for making proper risk assessments includes diagnosing with appropriate differentials and psychological assessment, including evaluating every patient for risk of potential addictive disorders or aberrant drug-taking behaviors, and keeping orderly, up-to-date documentation on any and all patients under pain management care.[15]

All patients with pain should be assessed for pain through the use of a detailed history including the assessment of psychosocial issues and a focused examination.[12] Pain history taken prior to initiation of treatment must include onset, duration, quality, provoking factors, and patient rating if possible. An initial assessment of type and intensity by prompting patient descriptions and rating of pain is important to proper management and control.[12] Patients and their caregivers can be taught to use an appropriate pain scale for further monitoring and management. Before initiating opioid therapy, it is recommended to conduct a risk assessment for opioid misuse, abuse, and diversion.[12]

Risk assessment screening tools can be utilized to successfully assess the potential risks associated with chronic opioid therapy based on patient characteristics likely to be helpful in risk stratification.[12] Validated tools include The Screener and Opioid Assessment for Patients with Pain (SOAPP) {available for download from PainEdu.org} and its revised iteration (SOAPP-R), the Opioid Risk Tool (ORT), and the Diagnosis Intractability, Risk, Efficacy (DIRE) Instrument. DIRE is clinician-administered and is designed to assess potential efficacy as well as harm.[12] The SOAPP, SOAPP-R, and ORT are patient-report questionnaires that may aid in evaluating risk of aberrant drug-related behaviors.[12] The resultant stratification of risk can be categorized according to low, moderate, and high, as detailed in Figure 4.[15]

Figure 4

Candidates for treatment with chronic opioid therapy are patients with moderate-to-severe chronic noncancer pain whose pain negatively affects function or quality of life.[12] For these patients, careful assessment indicates that benefits are likely to outweigh harm and that there is no alternative therapy likely to offer as favorable a benefit to harm ratio. The impact of common opioid side effects including constipation, nausea or vomiting, sedation, and/or clouded mentation should be considered.[12] Less common side effects may include hormonal deficiencies, respiratory depression, pruritus, and/or myoclonus. The nature of pain pathways, as well as chemical dependency, is complex. The plan of care should emphasize an individualized approach that is carefully structured.[12]

Structuring Opioid Therapy for Pain Patients

When introducing chronic opioid therapy into pain management, clinicians should inform every patient about the risks and benefits associated with chronic opioid therapy before initiating a trial of therapy.[15] The use of informed consent and written treatment agreements is further recommended for all patients (sample 1, sample 2, or sample 3). Counseling should be provided on common side effects. Clinicians should discuss goals, expectations, risks, and alternatives to opioid therapy. The goal of the consent process is to allow patients to make medical decisions consistent with their preferences and values. Pre- and post-intervention pain level and function assessments are also recommended.[15] Appropriate trials of opioid therapy include adjunctive medicines as needed and routine reassessments of pain score and level of function.[15] Documentation of these activities remains essential throughout the patient’s management.

Whether in writing or verbally agreed upon, expectations and obligations of the patients and the treating practitioners need to be clearly articulated and understood.[16] The opioid agreement (see samples above), combined with informed consent, forms the basis of the initial therapeutic trial. A carefully worded treatment agreement will help to clarify boundaries and limits and create a forum for early identification and intervention concerning aberrant behavior.[15] It is important to discuss an opioid management plan before initiating a course of treatment. The APS/AAPM guidelines recommend using written management plans to clarify the plan with the patient, the patient’s family, and other clinicians who may become involved in the patient’s care.[12]

A paradigm for structuring therapy according to risk assessment is further detailed in Figure 5. Most importantly is to assess what has been termed the 4 A’s in opioid management; analgesia, activities of daily living, adverse events, and aberrant drug-taking behaviors. Use of the 4 A’s reinforces the fact that a successful outcome in pain therapy encompasses more than the lowering of pain intensity scores. This approach may offer pain relief as well as stabilization or improvement of psychosocial functioning, manageable side effects that do not compromise important areas of functioning, and an intact mechanism to assess and control aberrant behaviors. To monitor patients by way of the 4 A’s, the Pain Assessment and Documentation Tool (PADT) was developed and field tested.

Figure 5

Case Study

Initial Visit
Ted M. is a 33-year-old male suffering from chronic pain following a herniorrhaphy. A landscaper with his own business in charge of grounds maintenance at a local university, Ted presents complaining of shooting pain from groin to abdomen since surgery 8 months ago. Ted reports that after work, he suffers for hours and can’t get or stay to sleep. Out of oxycodone, which has been prescribed by a previous clinician, Ted reports that he fears he is taking more medication than he’s supposed to because he already needs a refill. His medication does not last as long as needed, and he takes an extra pill about 4 times a week to get to sleep.

Physical Examination
On the pain scale from 1 to 10, Ted rates the pain at an 8 on average. On examination, his abdomen is tender to the touch, but his function and sensitivity are intact. The clinician diagnoses the patient with post-herniorrhaphy pain syndrome.

Risk Assessment With the ORT Chart

The clinician reviews Ted’s history and physical examination; after administering the ORT, the clinician finds a family history of alcoholism, a history of the patient taking medications differently than prescribed, but no apparent addiction or psychiatric problems in the patient’s past. Ted’s ORT score is 4, placing him as a moderate risk for aberrant behavior.

Treatment and Structured Therapy
The clinician changes the patient’s medication to an extended-release oxycodone for around the clock pain control. The patient is referred to physical therapy to increase flexibility and break up some of the scar tissue causing the pain. The patient is told that regular appointments will be necessary, as well as pill counting and random urine drug tests. A written treatment plan is presented and an agreement outlining the responsibilities and expectations for pain management is signed.

Initiating Opioid Therapy

Opioid selection, initial dosing, and titration call for individualization according to thorough patient assessment and diagnosis. Additional nonpharmacologic approaches are often helpful in conjunction with opioid therapy. A multimodal approach to care may include education, immobilization, physical therapy, cognitive/behavioral therapy, and exercise in addition to initiating an opioid.[12] According to the APS/AAPM guidelines, in patients who are opioid-naïve or who have modest previous opioid exposure treatment should be started at a low dose and titrated slowly as a method of decreasing risk of adverse effects.[12] No data exist to demonstrate that any one opioid is superior to another for initial therapy. Additionally, there is insufficient evidence to recommend short-acting versus long-acting opioids or as needed versus around the clock therapy.[12] Dose, frequency, and duration of long- versus short-acting opioids is presented in Table 1.

Monitoring Opioid Therapy

The APS/AAPM guidelines support reassessment of pain score and level of function on follow-up visits.[15] Presence of adverse events and adherence to prescribed therapies should be noted as well. A regular assessment of the 4 A’s of pain management is recommended for all chronic pain management patients.[17] Additional precautions include periodic review of pain diagnosis, comorbid conditions and addictive disorders, and using appropriately thorough documentation throughout the treatment. In patients on chronic opioid therapy at high risk or with prior aberrant behaviors, drug screens or other information should be obtained to confirm adherence. Patients not at high risk and with no known aberrant drug-related behaviors may be considered for periodic drug screening or other methods to confirm adherence. Other monitoring strategies may include continual screening and risk stratification, use of prescription monitoring programs, urine drug testing, and pill or patch counts.[18-21] Psychosocial therapy and highly structured approaches employing Universal Precaution recommendations may also be useful strategies.[18-21]

Evidence for accurate assessment of long-term opioid therapy is limited.[12] Research demonstrates that benefits are most applicable to patients with moderate or more severe pain who have not responded to other therapies.[12] The use of intravenous opioid trials for predicting benefits of chronic opioid therapy is not currently recommended.[12]

Case Study: 4-Week Follow-Up

Returning after 4 weeks on the new pain regimen, Ted M. reports that his current pain level at rest is 3 to 4 out of 10 and 5 out of 10 when walking or working.

The pain has improved around the clock and most nights the patient has been able to sleep. On functional assessment, the clinician determines that Ted is able to work with his current pain level and does not feel the need to take additional medication for pain relief. The patient reports attending physical therapy once a week and adding regular stretches and exercises at home.

The patient’s urine drug test is positive for the prescribed opioid and the pill count is consistent with the prescribed amount.

Pharmacologic Strategies to Deter Opioid Abuse and Misuse

A variety of innovative physical and pharmacologic strategies are under investigation to test a number of abuse deterrent opioid formulations (ADFs). Categories for ADFs are shown in Figure 6 and include a variety of options attempting to protect against misuse, abuse, and diversion in the use of opioid pain therapy. These are formulations that explore packaging modifications, adjustments to the physical ability to crush or extract opioids from pills, aversive components, deterring pharmacologic manipulation, as well as alternative methods of opioid administration.[22]

Figure 6

Recently approved abuse-deterrent therapies include a formulation with controlled release morphine combined with an embedded opioid antagonist naltrexone that is released in the event of crushing, a controlled release, osmotic delivery formulation of hydromorphone, and a reformulated version of oxycodone that resists extraction when crushed or tampered with.[23,24] In agonist-antagonist combinations, antagonists such as naltrexone can be sequestered within the core of the pill, remaining inactive during normal use, but becoming active if the pill is crushed or extracted.[23] Controlled-release formulations of morphine/naltrexone have tested as mainly neutral among nonopioid-dependent recreational opioid users.[24] Another recently approved novel deterrent therapy is the osmotic delivery system hydromorphone, which delivers a steady release of hydromorphone, avoiding peaks and troughs associated with immediate release formulations.[25,26] This technique has been proven effective in chronic pain of moderate-to-severe intensity. Once daily hydromorphone provided pain relief similar to twice-daily extended release oxycodone in patients with knee or hip osteoarthritis. Tolerability was comparable. ADFs that are approved or in development are described in Table 2.

ADFs may be an important component of a chronic pain patient’s management plan in the future. This does not preclude the need for continuous evaluation for aberrant behaviors, substance disorders, and psychiatric comorbidities. However, ADFs may lower patient risk and relieve clinician concern. Appropriate use of these novel strategies will be based on risk factors and careful assessment.

Conclusions

Recent trends suggest that while the legitimate use of opioids for medical purposes has increased the use of these therapies for nonmedical use has also increased. This has prompted an evaluation current clinical practice, optimal management, and alternative abuse deterrent strategies. The problem of nonmedical opioid use appears to be widespread, growing in many parts of the country, and includes all available opioid drugs. On the other hand inadequately treated pain remains a major healthcare burden in today’s society due to several reasons including the fear by clinicians to prescribe opioid therapy. Treatment decisions should be individualized to the patient and be based on reported pain as well as their risk for aberrant drug-related behaviors. Monitoring and continual reassessment of treatment progress and changes in patients’ lives will aid in the success of a chronic pain management plan. Abuse deterrent formulations of opioids offer clinicians a new approach that may potentially reduce opioid abuse in patients with chronic pain. Long-term studies are needed to elucidate their benefits.

Bill H. McCarberg, MD
Published on July 6, 2010

References

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