The opioid epidemic in the United States is a critical public health issue that requires a multi-stakeholder, multi-pronged approach to mitigate its devastating outcomes.
The CDC has identified prescription drug abuse in the United States as an epidemic, and reported drug overdose as the leading cause of injury in this country.1,2 The occurrence of prescription drug abuse is surpassing that of illicit drug abuse. In 2009, this type of drug abuse or misuse resulted in 1.2 million emergency department visits, compared with 1 million visits related to illicit drugs, such as heroin and cocaine.3
Between 1999 and 2007, the rate of unintentional overdose death in the United States more than doubled—largely credited to the increase in prescription opioid overdoses.4-6 According to the National Vital Statistics System, the number of deaths per year attributed to prescription opioid medications reached 16,007 in 2012,7 and in 2013, more than 70% of prescription drug overdose deaths involved opioid medications.8 The increase in prescription opioid overdoses corresponds with a dramatic increase in the use of opioid analgesics; for example, the number of prescription opioids dispensed roughly doubled between 1999 and 2010, with an estimated 201.5 million opioid prescriptions dispensed in 2009.9
Problematic prescribing practices are often cited as chief drivers of this rise in opioid use. Inadequately managed pain among Americans led to an upsurge in the acceptance and use of prescription opioids for the treatment of chronic non-cancer pain, such as back pain or osteoarthritis.10 The lengthy application and approval process for prescription drugs by the FDA may allay the fears of many prescribers, increasing the likelihood of underestimating the significant safety concerns associated with these medications.
Leadership across the country is making strides to understand and diminish the harm caused by the widespread opioid abuse problem. On April 28, 2015, HHS Secretary Sylvia Burwell, Governor Charlie Baker of Massachusetts, and Marylou Sudders, Massachusetts’ top health official, participated in a roundtable discussion regarding the epidemic that has devastated families across the state of Massachusetts.11 As stated by Governor Baker, “This issue does not care about geography. It does not care about race. We have much work to do.”11
The nation’s intense focus in response to the pressing patient safety concerns posed by opioid abuse has facilitated communication and collaborations across HHS and other federal partners. The HHS National Action Plan for Adverse Drug Event Prevention (ADE Action Plan) highlights opioids as one of the 3 primary drug classes implicated in adverse drug events.12 Opioids are one of the primary targets of the ADE Action Plan because they account for a large number of measureable harms, their use can be effectively measured, and their misuse is considered largely preventable.12 The systematic efforts of federal agencies include surveillance, prevention, policy, and research around adverse drug event targets of high priority, such as opioid overdose.12 The ADE Action Plan recognizes that to ensure patient safety and tackle the complications of healthcare delivery, the quality of healthcare must be improved.12
There is currently bipartisan legislation in Congress authorizing Patient Review and Restriction (PRR) programs in Medicare, and the president’s 2016 fiscal year budget request proposes authorization to establish PRR programs in Medicare as well.
These are programs that are currently used by state Medicaid and private insurance plans. The intensity of the opioid epidemic in the Medicaid population originally incited a need to utilize PRR programs at the state level to identify and manage patients at risk for prescription drug abuse.
A plan can identify a patient receiving large quantities or duplicate opioids from multiple prescribers or pharmacies, and then require that the patient use a designated pharmacy and/or prescriber to obtain those opioid medications. The plan generally has broad discretion regarding criteria for patient identification and how the program is implemented.
PRR programs ensure that patients have access to pain medication while simultaneously lowering the risk of abuse and overdose. According to the 2012 CDC Expert Panel Meeting Report, these programs “have the potential to reduce opioid usage to lower, safer levels, and thus save lives and lower healthcare costs.”
Studies assessing the effect of Louisiana PRR programs have found that these efforts decrease the use of multiple medications and schedule II medications, the dosage of opioid medications, and the use of multiple pharmacies and physicians.
The House Energy and Commerce Subcommittee on Oversight and Investigations held a hearing on April 23, 2015, to continue the discussion on the growing problem of prescription drug and opioid abuse. The subcommittee, composed of representatives from the Drug Enforcement Administration, Office of National Drug Control Policy, CDC, National Institutes of Health, and Substance Abuse and Mental Health Services Administration, has been reviewing the opioid threat since 2014. The subcommittee participants centered their discussion on the best options for treatment and prevention, including medical-assisted treatment, reduction in the overprescribing of opioids, prescription drug monitoring programs, drug courts, and the importance of federal, state, and local laws focused on overdose prevention.19 According to Dr Anna Lembke, a physician at the Addiction Medicine Clinic at Stanford University School of Medicine, “We do not just have an opioid misuse epidemic, or an opioid overdose epidemic, we also have an opioid overprescribing epidemic. Congress can push back against the opioid epidemic by requiring revision of healthcare quality measures to reduce overprescribing, incentivizing use of Prescription Drug Monitoring Programs (PDMPs), and scrutinizing accreditation organizations and regulatory agencies.”19
The Pharmacy Quality Alliance (PQA)—a multi-stakeholder, consensus-based measure developer that focuses on promoting safe and appropriate use of medications—identified the opioid abuse epidemic as a necessary area for measure development in 2012. It has been documented that patients who take high dosages of opioid medications or obtain prescriptions from multiple providers are at a higher risk of overdose.14,20-22 As such, PQA developed and endorsed (on May 14, 2015) 3 new performance measures that assess the use of opioids from multiple providers or at high dosage in persons without cancer.23
The PQA measures target opioid overdose death prevention and are intended for health plans to examine the quality of use related to the dose of the medications over time, access to the medications, and the combination of both of these criteria.24 The first measure assesses populations that are receiving prescriptions for opioids at a high dose that could be inappropriate or could contribute to an adverse event. The second measure assesses populations that are receiving opioid prescriptions from multiple prescribers and multiple pharmacies, which may indicate uncoordinated care and/or doctor and pharmacy shopping. The third and last measure includes criteria of both high-dose opioids and populations receiving prescriptions from multiple providers, which may indicate misuse, abuse, or inappropriate and/or fragmented care. According to the 2016 CMS Call Letter, these newly endorsed PQA measures may be adopted as future display measures in the Medicare Star Rating System, or alternatively, used in the Overutilization Monitoring System (OMS).25
The OMS was developed as part of the new Medicare Part D policy implemented by CMS on January 1, 2013, for monitoring administrative prescription data to identify high-risk prescribing practices and eliminate fraud, waste, and abuse related to opioid medications.26 It requires plans to address potential overutilization of opioids more effectively through improved drug utilization controls and case management. The policy is flexible in accommodating different approaches to meeting its objectives. According to the 2016 CMS Call Letter, “The OMS provides quarterly reports to sponsors on beneficiaries with potential opioid or acetaminophen overutilization issues, as identified through prescription drug event data analyses from the previous 12 months and through CMS program integrity investigations; sponsors should respond to the OMS within 30 days on the status of their review for each beneficiary case.”25 A comparison of overutilization in 2011, 2013, and 2014 shows a significant reduction of opioid and acetaminophen overutilization in Part D since the policy went into effect.25 OMS has been found to be effective in identifying potentially unsafe and inappropriate use of opioids.24,26
The current opioid epidemic is a critical public health issue that will continue to require a multi-stakeholder, multi-pronged approach. The United States has the available resources to combat these devastating circumstances; now it is a matter of effective collaboration and continued surveillance to follow the progress that the nation is making toward minimization of opioid abuse.27