Long-Term Opioid Therapy: Safety and Healthcare Outcomes

Introduction and Literature Review Methodology

This chapter conducts a comprehensive literature review on safety and improvement of healthcare outcomes for long-term opioid therapy use. The study evaluates literature relating to opioids for pain management using Cochrane review criteria. A comprehensive literature search was conducted across the Cochrane Library, EMBASE, PubMed, and FDA (Food and Drug Administration) databases. The paper incorporates systematic reviews, clinical trials, and cross-references of systematic reviews. The research hypothesis was developed to test the safety and healthcare outcome improvements for long-term opioid therapy.

H1: Clinicians are required to scrutinize carefully for evidence of past substance abuse, which will assist in identifying patient risk of addiction or misuse. Physicians should also avoid prescribing opioid dosages greater than 100 mg of MED (morphine equivalent daily).

Long-Term Opioid Therapy: Safety Foundations and Clinical Evidence

H0: Clinicians are not required to scrutinize carefully for evidence of past substance abuse, which will assist in identifying patient risk of addiction or misuse. Physicians should also avoid prescribing opioid dosages greater than 100 mg of MED.

H2: Patient education is very critical for long-term opioid therapy use to educate patients about adherence to therapy, remove fear of opioid therapy, and enhance pain management.

H0: Patient education is not critical for long-term opioid therapy use to educate patients about adherence to therapy, remove fear of opioid therapy, and enhance pain management.

Pain is an unpleasant emotional and sensory experience caused by potential or actual tissue damage. Pain can be influenced by psychological, physical, cultural, social, and hereditary factors. Pain that persists beyond three months is widely viewed as chronic pain. As Cheatle and Baker (2014) note, "Chronic pain is complex and the patient suffering from chronic pain frequently experiences concomitant medical and psychiatric disorders, including mood and anxiety disorders" (p. 301).

In the United States, pain is the most common factor that leads patients to seek medical attention. Chronic pain incurs significant costs both nationally and globally. Costs are estimated at $150 billion yearly in the United States and $235 billion per year in Europe. Based on the enormous costs associated with pain management, the use of opioids continues to increase in the United States and Canada.

Risk Stratification, Patient Selection, and Monitoring Protocols

A systematic review of literature conducted by the Agency for Health Research and Quality (2013) shows that "there has been a dramatic increase over the past 10 to 20 years in the prescription of opioid medications for chronic pain, despite limited evidence showing long-term beneficial effects" (p. 1). Moreover, accumulated evidence reveals many side effects associated with opioid prescriptions, including addiction, abuse, accidental overdose, and diversion. Based on current evidence of long-term opioid therapy effects, Burgess et al. (2014) suggest that there is a need to reduce opioid medication prescriptions at or below 100 mg of MED daily. Prescriptions exceeding 100 mg of MED daily lead to a 1.7% annual overdose risk.

Physicians intending to prescribe long-term opioids should follow their state prescription guidelines to prevent patients from receiving opioids from multiple pharmacies or prescribers. Clinicians are required to scrutinize carefully for evidence of past substance abuse, which will assist in identifying patient risk of addiction or misuse. Identification of addiction history should necessitate close monitoring. Importantly, physicians should avoid prescribing opioid dosages greater than 100 mg of MED, as high dosages can lead to diversion, overdose, and abuse.

Franklin (2014) suggests that patients with no history of substance addiction or abuse can achieve long-term pain relief if proper opioid management is implemented. Healthcare practitioners should use publicly available tools to screen for evidence of current and past substance abuse, significant depression, and alcohol abuse using urine tests before prescribing opioids. This strategy assists physicians in calculating appropriate dosages, which enhance long-term opioid use without side effects. For example, Washington legislature recently passed landmark legislation creating new rules for opioid prescription, including dosing criteria and guidelines to track clinical progress. The Washington statute provides evidence-based practice aimed at reducing potential harm from opioid therapy for CNCP (chronic non-cancer pain).

Cheung, Qiu, Choi, et al. (2014) recommend different strategies for long-term chronic opioid therapy (COT). The first strategy is risk stratification and patient selection. Before physicians initiate chronic opioid therapy, appropriate testing is needed that includes assessment for substance misuse, abuse, or addiction. Physicians should perform a benefit-to-harm evaluation using appropriate diagnostic testing and physical examination. These tests should be documented before opioid prescription for chronic opioid therapy.

Special Populations and Patient Education Strategies

Monitoring is another critical therapeutic option suggested by the authors, which involves reassessing "patients on COT periodically and as warranted by changing circumstances" (Cheung et al., 2014, p. 403). A clinician should include documentation relating to pain intensity, body physiology level, progress toward therapeutic goals, adherence to prescribed therapies, and presence of adverse events. It is critical for clinicians to periodically obtain urine samples of patients not at high risk for drug screening or other information confirming adherence to the COT plan of care.

For high-risk patients, such as those with a history of drug abuse or serious drug-related behaviors, clinicians should prescribe opioids only if they can implement more stringent and frequent monitoring parameters. Additionally, clinicians should consider consultation with addiction and mental health specialists. During treatment, clinicians should constantly evaluate patients' drug-related behaviors to determine whether to restructure or discontinue opioid therapy.

Some patients on COT may require high doses of opioids. For this category of patients, clinicians should reassess opioid adverse effects and changes in patient health status. Clinicians should consider opioid rotation if patients experience intolerable adverse effects with dose increases or inadequate benefits from dose increases. It is important for clinicians to educate patients about adverse effects, risks, potential benefits, and complications related to opioid misuse. A clinician may request patients to sign a treatment agreement if they demonstrate higher risks of opioid misuse.

Cheung et al. (2014) suggest that clinicians should treat specific populations differently to improve healthcare and safety "outcomes for individuals on long-term opioid therapy" (p. 406). Opioid therapy for elderly patients can be effective and safe if appropriate precautions are implemented, including more frequent monitoring, longer dosing intervals, slower titration, lower starting doses, and tapering of benzodiazepines.

Clinicians should implement appropriate caution when prescribing opioid therapy for adolescents. Opioids can present health hazards for this population. Thus, it is critical to implement well-defined neuropathic or somatic pain conditions for adolescent patients when close monitoring is available, possible risk of misuse is low, and effective consultation is integrated in the treatment plan. Clinicians should prescribe the lowest possible dose for pregnant women taking opioids for extended periods, and therapy can be discontinued if possible.

Efficacy, Adverse Effects, and Integrated Pain Management

The U.S. Department of Veterans Affairs (2013) provides comprehensive guidelines for managing long-term opioid therapy. The report suggests appropriate steps when opioids are contraindicated. For example, clinicians should avoid initiating long-term opioid therapy for patients experiencing severe respiratory instability. Moreover, patients demonstrating uncontrolled suicide risk or acute psychiatric instability should not receive long-term opioid therapy.

The U.S. Department of Veterans Affairs (2013) also supports patient education as an important strategy for enhancing safe and improved healthcare outcomes for long-term opioid therapy. Given the prevalent misinformation regarding opioid use, repeated education is necessary because many patients harbor fear of opioid therapy, believing opioids cause more harm than benefit. These unwarranted beliefs can retard pain alleviation or increase dysfunction. Patients and families should be informed about adherence to therapy and pain management. Patient education regarding opioid therapy is critical for all patients with chronic pain because it enhances understanding of possible adverse effects, expected health outcomes, and the nature of treatment. The Veterans Affairs guidelines further recommend that clinicians ask patients to sign an OPCA (Opioid Pain Care Agreement) before initiating long-term opioid therapy. The OPCA is an agreement between patients and healthcare providers regarding long-term opioid therapy provision, also referred to as an Opioid Agreement or Treatment Agreement.

While opioids have continued to be used for post-surgical pain, acute pain, and palliative care, considerable debate remains about long-term effectiveness. Burgess, Siddiqui, and Burgess (2014) argue that opioid efficacy for pain treatment is limited to the short term, with limited evidence of long-term duration. No concrete evidence demonstrates the safety and effectiveness of opioids for long-term pain treatment. A Cochrane Review evaluating long-term management of chronic non-cancer pain reveals that long-term opioid use leads to 0.27% opioid addition rate. High risk of abuse or addiction is one side effect of long-term opioid use for pain management. Burgess et al. (2014) support this argument by noting that patients using opioids long-term have records of opioid abuse approaching 50% compared to patients without prior opioid use.

A Cochrane review of 26 studies evaluating the efficacy of long-term opioid use for CNCP found that "a significant percentage of these patients discontinued opioids due to adverse effects (22.9%, 95% CI 15.3–32.8) or insufficient pain relief (10.3%, 95% CI 7.6–13.9)" (Cheatle & Baker, 2014, p. 302). Moreover, weak evidence exists that patients using opioids for more than six months experience significant pain relief.