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Current and Emerging Options to Combat the Opioid Epidemic

Courtney Kominek, PharmD, BCPS, CPE

 
Today’s management of chronic pain presents a challenging clinical dilemma. Although clinicians wish to relieve a patient’s suffering, they must do so without undertreating the pain or contributing to the drug abuse problem. Following a steady rise in opioid prescription rates from 2006 to 2012, increased national attention for the obioid abuse epidemic likely contributed to the decline in prescribing rates from 2012 to 2016. Although opioids have helped many patients, they are also associated with adverse events and a growing national crisis of misuse, abuse, and overdose.
Am J Manag Care. 2018;24:-S0
Responses to the Opioid Overdose Public  Health Crisis

Responses to the opioid epidemic have included activities of law enforcement, government regulatory agencies, pharmaceutical companies, and healthcare providers. The Anti-Drug Abuse Act of 1988 created the Office of National Drug Control Policy (ONDCP) to combat drug abuse in the United States.1 Over the next several decades, reauthorizations of the policy expanded the mandate of the agency to address the prescription opioid and heroin epidemic. Former President Barack Obama strengthened insurance coverage for mental health and substance use disorders (SUDs) under the Affordable Care Act.2 In July 2016, he signed the Comprehensive Addiction and Recovery Act (CARA) of 2016 into law; it was the first major federal addiction legislation in 40 years.3 The law addresses the opioid epidemic through a coordinated and balanced strategy of grant programs to expand prevention and education efforts while also promoting treatment and recovery.

The ONDCP provides administrative and financial support to the President’s Commission on Combating Drug Addiction and the Opioid Crisis, established by an Executive Order in March 2017 by President Donald J. Trump.1 In October 2017, President Trump declared the opioid crisis a national public health emergency under federal law, which created policy, but not funding, for “the United States to use all lawful means to combat the drug demand and opioid crisis currently afflicting our country. . . and exercise all appropriate emergency authorities.”4 Unlike the declaration of a national emergency, President Trump’s directive does not on its own release any additional funds to deal with the opioid crisis, but it would allow for some grant money to be used to combat opioid abuse.5

As a response to the opioid crisis, the US Department of Health and Human Services (HHS) has developed strategies focusing on 5 major priorities6:
  • Improving access to treatment and recovery services
  • Strengthening understanding of the opioid epidemic through better public health surveillance
  • Advancing better pain management practices
  • Promoting the use of overdose-reversing drugs
  • Providing support for innovative research on pain and addiction
As a component of HHS, the National Institutes of Health is partnering with pharmaceutical companies and academic research centers to develop safe and effective strategies to manage chronic pain along with new medications and technologies to treat opioid use disorders (OUDs). Other research is being conducted to improve overdose prevention and reversal interventions to promote recovery.6

The FDA launched a comprehensive Opioids Action Plan in early 2016 to take concrete steps toward reducing the impact of opioid abuse on American families and communities.7 These steps include7:
  • Expanded use of advisory committees to provide advice from external experts before approving any new opioid that does not have abuse-deterrent properties or approving new pediatric opioid labeling
  • Updated warnings and safety information for immediate-release opioid labeling to provide better information for doctors on safe prescribing
  • Strengthened postmarketing requirements for pharmaceutical companies to provide data on the long-term impact of using extended-release/long-acting opioids
  • Updated risk evaluation and mitigation strategy programs to increase the number of prescribers who receive training on pain management and safe opioid prescribing
  • Expanded access to abuse-deterrent formulations (ADFs) of opioids to discourage abuse
  • Increased support for better overdose treatment, better opioid prescribing guidelines developed by the Centers for Disease Control and Prevention (CDC), and more research to develop safer pain medicines
  • Endorsed incorporation of the broader public health impact of opioid abuse in approval decisions7
As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of science on pain research, care, and education, as well as to identify actions that the FDA and others can take to respond to the opioid epidemic.8 In addition to recommending that access to treatment for OUDs be increased, the committee recommended a constellation of policies, interventions, and tools related to access to opioids and clinical decision making to reduce harms while also meeting the needs of patients requiring pain management. 

Practice Guidelines for Chronic Pain Management

In general, practice guidelines from the American Pain Society, the American Academy of Pain Medicine, the American Society of Interventional Pain Physicians, and the Office of Veterans Health Administration and Department of Defense Health Affairs (VA/DoD) recommend that opioids be prescribed only after the patient has received a thorough evaluation, including a pain history, assessment of the impact of pain, a directed physical examination, a review of previous treatments, a drug history, and an assessment of coexisting diseases or conditions.9-11 When appropriate, the patient should undergo baseline urine drug monitoring (UDM).

In March 2016, the CDC released a new set of opioid prescribing recommendations to guide primary care clinicians who write most prescriptions for opioid analgesics.12 These recommendations include using nonopioids for most cases of chronic pain, checking with the state’s prescription drug monitoring program (PDMP) before prescribing opioids, using the lowest effective dose when prescribing opioids, maintaining a dose ceiling, and ensuring that patients who are treated with opioids are closely monitored.12 Guidelines also suggest starting opioid therapy with an immediate-release opioid due to increased risk for opioid overdose associated with long-acting opioids in opioid-naïve patients.11,12

The CDC Guideline for Prescribing Opioids for Chronic Pain has received criticism related to the recommendations and the manner in which they were released to the public. Schatman and Ziegler note that the guideline, by failing to recognize the complexity of the issues involved in both reducing the harm from prescription drugs while ensuring appropriate access, impedes the ability of the public and policymakers to understand the complexity of the problem and to create solutions that are balanced and effective.13 According to these authors, drugs such as heroin and illicit fentanyl, and not prescription opioids and overprescribing, are the drivers of unintentional overdose deaths in the United States. Failure to make this distinction has far-reaching consequences for policy, pain treatment, substance abuse prevention, and reduction of intentional overdose.13

Despite its criticisms, the guideline includes recommendations that are intended to improve communication between providers and patients about the risks associated with long-term opioid therapy and overdose. Prescribers and pharmacists are encouraged to work collaboratively to optimize pain management and prevent opioid misuse.14 As members of the healthcare team, pharmacists must verify a prescriber’s Drug Enforcement Agency registration, check with the state’s PDMP, and contact the prescriber if questions arise (Table 1).14,15 In addition, pharmacists should advise patients on the proper use and storage of opioids and review common adverse events (AEs). To reduce harm, pharmacists should discuss the possibility of tolerance and abuse with patients and caretakers when filling opioid prescriptions and communicate any concerns about misuse or abuse to providers, including recommendations for addiction treatment if indicated.14,15

Mitigating Risks of Opioid Misuse and Abuse 

Risk assessment for all patients prior to opioid prescribing is recommended and includes the use of screening tools, treatment agreements, and regular UDM. Several factors have been identified that increase an individual’s risk of opioid overdose or addiction (Table 2).11,16 Additional factors have been shown to increase the likelihood of abuse as well as the likelihood of using a riskier route of abuse. These include past or current substance abuse, long duration of prior abuse, young age, untreated psychiatric disorder, male sex, and living in a rural setting or social or family environment that encourages misuse. Clinicians should consider these factors when prescribing an opioid analgesic in an individual patient.17,18 

Unfortunately, risk assessment strategies have not reduced overall rates of opioid misuse or overdose. Newer strategies for reducing opioid-related risks include more selective prescription and avoidance of co-prescription with sedative hypnotics. Ongoing monitoring using analgesia, AEs, activities of daily living, and aberrant behavior—collectively referred to as the “4As”—provide information about how the patient is responding to opioid therapy and whether treatment needs to be modified.19 Nevertheless, although the number of outpatient opioid prescriptions dropped 13% nationally between 2012 and 2015, the national overdose death rate surged 38% during those years, leading some to postulate that the opioid crisis is a manifestation of unfulfilled and complex physical and mental health needs.20

Informed Consent

Several guidelines discuss informed consent. The CDC Guideline and VA/DoD Guideline suggest that providers discuss the risks, benefits, and alternatives of chronic opioid therapy at the outset and throughout treatment.11,12 This reinforces the use of opioids when the benefits outweigh the risks. Also, it is recommended to discuss patient and provider responsibilities.12 This discussion is also a good time to establish realistic treatment goals.21 The VA/DoD Guideline intentionally moves away from the use of opioid treatment agreements or pain contracts as these were seen as detrimental to the therapeutic relationship and an intimidation tactic.11 Unfortunately, evidence for the use of opioid treatment agreements to reduce opioid misuse has been weak.11

Abuse-Deterrent Formulations

 
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