Opioid Prescribing and Monitoring - (Second Edition)
Primary Care Models for Pain Management

What Do the CDC Guidelines Really Mean?

Understanding the CDC Guideline for Prescribing Opioids for Chronic Pain—Recommendations for Consideration by Primary Care Physicians for Clinical Practice

In 2011, the Institute of Medicine estimated that 100 million adults in the United States are burdened by chronic pain, with an annual economic toll of $560 billion to $635 billion.1 More recently, estimates have increased to 126 million adults living with pain—with the aging population, that number is only expected to rise.2 Primary care physicians (PCPs) are often the very first stations along a patient’s journey to pain care, treating 52% of chronic pain patients in the US.3 In fact, management of chronic pain has largely been relegated to PCPs working in health systems not designed or equipped for chronic pain management.4

In a retrospective study of Medicare Part D prescription drug claims in 2013, PCPs were the largest prescribers of analgesics containing hydrocodone, oxycodone, codeine, and other opioids.5 Family practice physicians issued 15.3 million prescriptions, while internal medicine specialists issued 12.8 million prescriptions, nurse practitioners issued 4.1 million prescriptions, and physician assistants issued 3.1 million prescriptions.5 Unfortunately, many clinicians prescribing pain medication have little training in pain management or prescription opioids, and management of chronic pain patients within primary care centers is seen as problematic.6

In 2016, the Centers for Disease Control and Prevention (CDC) issued guidelines for PCPs who prescribe opioids.7 The CDC based its rationale on the following concerns reported by PCPs: the misuse of prescription opioids, the stress of managing chronic pain patients, the rise of addiction, and inadequate training in prescribing opioids.8 The agency’s recommendations are tailored for PCPs who are prescribing opioids for chronic pain outside of active cancer treatment, palliative care, and end-of-life care. In particular, the guidelines aim to improve communication between clinicians and their patients about the risks and benefits of opioid therapy for chronic pain, to improve the safety and effectiveness of pain treatment, and to reduce the risks associated with long-term opioid therapy. As such, the CDC issued guidelines and not legal requirements. (See Chapter 2 for interview with Jennifer Bolen, JD, about legal interpretation of guidelines).

Table 1. 12 Recommendatons from the Centers for Disease Control and Prevention for Prescribing Opioids for Chronic Pain

The guidance includes 12 main recommendations (Table 1). These may be grouped into 3 main areas: determining when to initiate or continue opioid therapy for chronic pain; the selection, dosage, duration, follow-up, and discontinuation of opioids; and how to assess and address the potential harms of opioid use.7,8

This chapter aims to interpret the main points of guidance that would relate to an opioid-naïve patient seeking treatment from a PCP for chronic noncancer pain. Such pain is prevalent and can be challenging to treat.9 Chronic pain also differs from acute pain in its involvement of central sensitization and its occasional incorporation of a neuropathic component (multimechanistic pain).10,11

Nonopioid Alternatives

One of the most crucial takeaway messages from the new CDC opioid guidelines is that nonopioid analgesics (acetaminophen or nonsteroidal anti-
inflammatory drugs (NSAIDs)) should be considered frontline treatment for opioid-naïve patients with chronic noncancer pain. Care must be taken when prescribing these agents, since they carry their own associated risks and side-effect profiles. Acetaminophen is associated with hepatoxicity at high doses, and some evidence has associated it with hypertension among selected patients.12,13 NSAIDs can provide effective pain relief but may be associated with gastrointestinal (GI) symptoms, renal, and cardiovascular complications.14-18 Nevertheless, such nonopioid analgesics should be evaluated as first-line therapy for most patients with chronic noncancer pain.

Due to maladaptive central neuronal plasticity, long-term moderate to severe pain may often incorporate a neuropathic component, which is not effectively treated by conventional nonopioid analgesics.19 Multimodal management options that include adjuvant agents, such as anticonvulsants, muscle relaxers, and antidepressants, may be considered to help alleviate multimechanistic pain.20

When treating chronic noncancer pain patients who have not yet taken opioid analgesics, providers should first take a thorough history and attempt to diagnose the underlying painful condition. Patients may be asked to pinpoint their pain sites, which may be multiple (this may be more easily done using an anatomical diagram). For each site, patients should be asked to describe how the pain feels (sharp, dull, stabbing, burning, electrical, shooting, intermittent, tingling, etc), how often it occurs (continuous or intermittent), which factors may worsen or alleviate it (such as certain movements), and whether or not it migrates. The clinician should then measure the patient’s pain using a validated pain scale, such as a visual analog scale, for each pain site.

Note that acute pain is typically associated with a known cause and clear localization, while chronic pain can be more diffuse, vague, and variable in location. Additionally, it is not unusual for a chronic pain site to be distant from the original injury or to be unassociated with any injury at all.

During this discussion, physicians should make note of whether specific factors can lessen patients’ pain. For example, patients may report finding relief with movement, stretching, exercise, heating pads, ice packs, or other interventions. This can be a good time to bring up nonpharmacological pain treatments, which can be quite effective and may include physical therapy, occupational therapy, massage, stretching, exercise (including yoga, cardiovascular, and water-based exercises), meditation, guided relaxation, and biofeedback.

Healthful eating habits, adequate sleep, and weight loss also can contribute significantly to pain relief. Music therapy, aromatherapy, acupuncture, and complementary and alternative medicine also may be included in the mix of options, although evidence in support of these techniques is less than robust. Nevertheless, clinicians should initiate a conversation with patients that encourages a frank discussion of the wide range of available approaches to pain control.

Determining When to Initiate or Continue
Opioids for Chronic Pain

In some cases, nonpharmacological approaches and/or nonopioid analgesics may be ineffective at providing patients with reliable pain control. This uncontrolled pain, in turn, can interfere with patients’ ability to function and pursue normal daily activities. In such cases, opioid pain relievers may be considered. The CDC guidelines recommend an up-front discussion that makes patients aware of the potential risks and benefits of opioid therapy.7 In particular, patients should know that opioids are associated with side effects (constipation, somnolence, etc), that they can lead to tolerance and the need for increasingly high doses to maintain the same level of pain relief, and that they have a potential for abuse. Given the recent spate of news about opioid addiction, patients may want to discuss their own reservations.

If opioids are prescribed, patients should understand that they must take them only and exactly as directed. Prescribers also can explain why and when patients will be subjected to periodic urine drug tests, pill counts, or other forms of monitoring. Patients should be encouraged to talk to prescribers about the management of side effects (many of which can be managed), as well as the more dangerous potential adverse effects. A shared decision-making approach between patient and healthcare provider must be employed.

Selection, Dosage, Duration, and Follow-Up

The prescriber should select the appropriate analgesic for the patient. With so many products, formulations, and brands of opioid analgesics on the market, the selection process can be challenging. The CDC guidelines recommend prescribing short-acting opioids at the lowest effective dose. One important prescribing option for the opioid-naïve patient is a loose or fixed-dose combination that combines a small amount of opioid with a nonopioid analgesic (such as oxycodone plus acetaminophen or hydrocodone plus acetaminophen).

Some newer “atypical” opioids, such as tramadol and tapentadol, have both opioid and nonopioid mechanisms of analgesic action. Tramadol combines µ-opioid agonist action (residing primarily in its O-desmethyl metabolite) and inhibition of the reuptake of neuronal norepinephrine and serotonin (residing primary in the parent drug).21 Tapentadol combines µ-opioid agonist action and inhibition of neuronal reuptake of norepinephrine, both residing in the parent molecule.22 Such agents may offer synergistic analgesia while exposing the patient to relatively smaller opioid amounts.23,24

Some universal precautions can help prescribers discuss the potential risks of opioid therapy with their patients.25,26 In general, patients who are active substance abusers or who have abused drugs or alcohol in the recent past, as well as patients with mental health disorders such as depression, may be at elevated risk for self-medication through opioid misuse or for opioid abuse.27 In addition to asking patients about their history, physicians should inquire about their past drug-taking behaviors and mental health status, bearing in mind that not all patients may be forthcoming. Several validated instruments can help clinicians better assess the risk for opioid misuse and abuse.28-30 (See Chapter 4 for more on assessment tools). For patients at high risk for opioid misuse and abuse, PCPs may wish to refer them to a pain or addiction specialist.

Assessing Function and Halting Opioids

A sound strategy for concluding opioid therapy is just as important as a good plan for starting it. Patients should know that opioids may not be effective or well tolerated—and that other pain control options can be considered if opioids do not work. Patients should be alerted to both transient and more persistent side effects. After trying an opioid analgesic for a short period of time, physicians should monitor their patients for side effects and tolerability, and assess whether the opioids have reduced their pain.

While pain relief is essential, the CDC guidelines also mention that functional goals are likewise important. These functional goals, in fact, may actually be more relevant than numeric pain scales to typical chronic noncancer pain patients. For instance, patients may set goals of being able to walk to the mailbox or sit comfortably through a movie. In the initial days and weeks of opioid therapy, prescribers and patients should discuss whether opioids are helping the patients meet their goals.

Many patients do not like taking opioids and will want to discontinue them. In a meta-analysis of 26 studies on opioid pain control for patients with chronic noncancer pain, 22.9% of patients discontinued oral opioid analgesics because of adverse effects.31 Furthermore, opioids are not effective for all patients or all painful conditions; in that same study, 10.3% of patients stopped oral opioid therapy because they found it ineffective.31

When a given opioid analgesic is ineffective or intolerable, clinicians should determine whether another opioid might be more effective or better tolerated. Opioid rotation can be an important clinical strategy.32 In other cases, patients may decide to continue with nonopioid analgesics, nonpharmacological pain options, or other techniques such as interventional pain therapies and device-based therapies. Particularly challenging cases may be referred to a pain specialist.

If patients find opioid analgesia effective and tolerable, clinicians should closely monitor them and jointly discuss the goals of opioid therapy as well as potential risks and benefits at least every 3 months.

With prolonged opioid exposure, many patients normally develop tolerance to the analgesic effect but not to all of the adverse effects; tolerance requires increased doses to maintain equianalgesia. The CDC guidelines suggest that physicians should carefully reassess the evidence of benefits and risks when considering whether to increase a dosage to ≥ 50 morphine milligram equivalents (MME) per day, and that they should avoid escalation to ≥ 90 MME per day unless their decision to do so is carefully justified.

In some cases, a subset of patients may develop opioid-induced hyperalgesia (OIH), a paradoxical condition in which opioids lower the pain threshold. Both OIH and tolerance result in patients requesting higher doses. Patients with OIH should not receive more opioids, however, since the increased dose would only further decrease their pain thresholds. Instead, OIH patients should be offered adjuvant analgesics and either lower their dose or be tapered off opioids.

Assessing and Addressing the Potential Harms of Opioid Use

Physicians and their clinical teams should be aware of aberrant drug behaviors, which are well described in the literature.33-35 As much as possible, physicians should nurture a frank relationship with their pain patients so that issues relating to misuse and abuse can be openly discussed during treatment sessions.

Many chronic noncancer patients are on polypharmacy; their clinicians should try to avoid pharmacokinetic drug-drug interactions that can occur more frequently than commonly thought.36 The CDC guidelines also specify that patients on opioid therapy should not be prescribed concurrent benzodiazepines.7

The proportion of patients who receive appropriate opioid analgesic prescriptions for legitimate pain indications and subsequently become addicted isn’t clear; however, the majority of pain patients do not.37,38 Even so, clinicians may encounter patients who develop physical dependence on opioids over time. Such patients will suffer withdrawal symptoms if opioids are discontinued abruptly. Physical dependence is not the same as addiction, but rather a normal and expected result of long-term exposure that can be managed by gradually tapering patients off opioids.

Addiction is a biopsychosocial phenomenon in which patients intensely crave opioids and seek them out despite knowing the dangers. Patients who misuse opioids take them inappropriately, such as doubling up on a bad day. Patients who abuse opioids take them for nonmedical purposes, such as to get high or to cope with stress. People with opioid use disorder (addicts) take opioids compulsively and will seek ever-higher doses as their tolerance grows. Thus, all addicted patients are opioid dependent, but not all opioid-dependent patients are addicted.

Clinicians who observe aberrant drug-taking behaviors or who encounter patients who admit they are using medications inappropriately must be prepared to intervene. The CDC guidelines recommend that such patients be referred to evidence-based treatment. Such treatments are available through pain specialists, addiction medicine specialists, and rehabilitation centers. Buprenorphine or methadone maintenance programs are the 2 main evidence-based treatment options for opioid use disorder.

Conclusion

Opioids are increasingly in the news, with alarming reports of widespread abuse and misuse that have caused many clinicians to limit their prescribing of opioids or to make opioids “off limits” as a pain control option.39,40 In reality, opioid therapy is appropriate for a subset of pain patients. The role of opioid therapy for chronic noncancer pain patients is more controversial, and PCPs should be clinically prudent and weigh all pain control options.41

When opioids are judiciously prescribed and closely monitored, physicians should be able to offer effective pain control to patients who truly need it without inadvertently opening the door to abuse. Although PCPs are on the front lines of pain care, they have many important resources to care for their patients: an armamentarium of analgesic options, CDC guidance, and referral options to specialists in pain medicine and/or addiction.

Acknowledgement: The authors wish to thank Jo Ann LeQuang, who helped with editing and proofreading this manuscript.

Last updated on: April 29, 2019
Continue Reading:
A Legal Interpretation of the CDC Opioid Prescribing Guidelines
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