Maria V. Scarlatos, PharmD, CPHQ

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.

 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.

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.

 According to the National Vital Statistics System, the number of deaths per year attributed to prescription opioid medications reached 16,007 in 2012,

 and in 2013, more than 70% of prescription drug overdose deaths involved opioid medications.

 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.

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.

 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.

 As stated by Governor Baker, “This issue does not care about geography. It does not care about race. We have much work to do.”

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.

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.

 The systematic efforts of federal agencies include surveillance, prevention, policy, and research around adverse drug event targets of high priority, such as opioid overdose.

 The ADE Action Plan recognizes that to ensure patient safety and tackle the complications of healthcare delivery, the quality of healthcare must be improved.

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.

 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.”

The Pharmacy Quality Alliance (PQA)—a multi-stakeholder, consensus-based measure developer that focuses on promoting safe and appropriate use of medications&mdash;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.

 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.

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.

 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).

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.

 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.”

 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.

 OMS has been found to be effective in identifying potentially unsafe and inappropriate use of opioids.

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.

Articles

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.

A Multi-Pronged Approach to Addressing the Opioid Epidemic

Medication-related problems among older adults represent a significant clinical and economic burden in the United States. Potentially inappropriate medications continue to be prescribed for and taken by older adults despite the recognition of increased likelihood of adverse drug events and evidence of poor outcomes in those patients.

 Studies have estimated that healthcare expenditures related to potentially inappropriate medication use in community-dwelling elderly patients totaled $7.2 billion in 2001,

 and that adverse drug events are preventable 27% to 42% of the time in primary care and long-term care settings, respectively.

	With the US healthcare system placing an ever-increasing emphasis on value-based delivery and payment,

 those accountable for improving the quality and affordability of healthcare seek to close care gaps such as that associated with the overuse of potentially inappropriate medications in older adults. The Pharmacy Quality Alliance’s (PQA’s) “Use of High-Risk Medications in the Elderly” (HRM) performance measure is often targeted for intervention by payers and providers, as it is a key safety measure in the CMS Star Rating System for Part D plans.

	CMS publishes the Star Ratings annually in order to measure quality of care provided to assist beneficiaries in selecting a plan and to determine Quality Bonus Payments for Medicare Advantage (MA) plans. MA plans with prescription drug coverage (MA-PD) contracts are rated on up to 44 performance measures; MA-only contracts (without prescription drug coverage) are rated on up to 33 measures; and stand-alone Part D contracts are rated on up to 13 measures. The HRM measure is included within those plans with prescription drug coverage, and as an intermediate outcome measure, it holds a triple weighting that contributes to the plan’s overall Star Rating. Considering the quality incentive structures put into place particularly for MA-PD plans focusing on the HRM measure can yield significant reward in the form of Quality Bonus Payments.

	The HRM measure is calculated using prescription claims data to measure “the percentage of patients 65 years and older who received 2 or more prescription fills for a high-risk medication during the measurement period.”

High-risk medications were designated based upon the Beers Criteria for Potentially Inappropriate Medication Use in Older Adults, a guideline for healthcare professionals first published in 1991 by a group of 12 clinicians with expertise in geriatrics, led by Mark Beers, MD. Since its original publication, the Beers Criteria have been updated 3 times, with the most recent revision performed in 2012 by the American Geriatric Society (AGS),

 and a fourth revision by the AGS slated for publication mid-2015. Numerous studies have demonstrated a strong association between the medications listed in the Beers Criteria and poor patient outcomes including adverse drug events, hospitalization, and mortality.

 According to the AGS, avoiding the use of potentially inappropriate medications is an important, simple, and effective strategy in reducing medication-related problems and adverse drug events in older adults.

	To this end, PQA and the National Committee for Quality Assurance (NCQA) developed and maintain performance measures in order to capture population-based trends in high-risk medication use among older adults. PQA’s HRM measure was adapted from NCQA’s Healthcare Effectiveness Data and Information Set (HEDIS) measure, originally known as “Drugs to be Avoided in the Elderly,” which is currently used inside the 2015 HEDIS measure set. PQA and NCQA have considered AGS recommendations and revisions to the Beers Criteria when updating these performance measures, and the 2 measures are jointly maintained.

	In adapting the Beers Criteria to fit the needs of a performance measure, PQA considered 4 guiding principles. The first is that, since the HRM measure is intended for prescription drug plans that may have access only to drug claims and not medical claims, the measure will only include medications from the Beers Criteria that should be avoided independent of diagnosis or condition. Certain medications listed in the Beers Criteria are not recommended for use in older adults with specific disease states, such as nondihydropyridine calcium channel blockers in patients with systolic heart failure. A prescription claim for verapamil will not capture the diagnosis code for systolic heart failure; therefore, the HRM measure cannot evaluate performance on that Beers Criteria recommendation. Similarly, benzodiazepines are medications commonly considered risky for older adults due to their ability to increase the likelihood of cognitive impairment, delirium, falls, fractures, and motor vehicle accidents.

 However, benzodiazepines are not included in the HRM measure, because they are deemed appropriate for treatment of generalized anxiety disorder, a condition from which patients over the age of 65 years often suffer; such a diagnosis cannot be verified through prescription claims.

	Second, PQA will only include products that are prescription drugs. While over-the-counter (OTC) drug products may be prescribed and may be adjudicated through third-party payers, this information cannot be consistently and reliably captured. First-generation prescription anti-histamines are included in the Beers Criteria and the HRM measure, as their anticholinergic effects pose a great risk of adverse drug events such as confusion, dry mouth, and constipation.

 Conversely, OTC products that contain first-generation antihistamines (eg, Benadryl) are not captured within the HRM measure.

	The third guiding principle is that PQA will only include products for which the AGS recommendation indicates “Avoid.” Several of the Beers Criteria recommendations include caveats that are not identifiable from prescription claims data, such as avoiding antispasmodic medications “except in short-term palliative care to decrease oral secretions.”

 There are instances in which phrases such as “short term” and “long term” are ambiguous and determined by professional judgment. On the other hand, non-benzodiazepine hypnotics such as zolpidem are only recommended for use that does not exceed 90 days. The HRM measure can therefore characterize performance for these medications, capturing inappropriate zolpidem use only if the cumulative days supply is greater than 90 days.

	Fourth and last, PQA will consider inclusion of products with caveats if the caveat can be measured efficiently and reliably from prescription drug claims data. For example, while the Beers Criteria recommend avoidance of estrogens (with or without progestins) in the oral and topical patch formulations, they allow for its use in topical creams. The HRM measure is able to capture inappropriate use of the topical patch and oral estrogens specifically, as claims data can easily distinguish routes of administration.

	Plans and providers seeking to decrease the use of potentially inappropriate medications in older adults have implemented a variety of interventions. No single strategy to improve performance on the HRM measure has proved superior; instead, several may lead to success. Predictors of high-risk prescribing among elderly patients vary, but one study that assessed a sample of 203 MA beneficiaries from 2006 to 2008 found that women, patients with poorer self-reported health, and those residing in the southern regions of the United States more frequently receive high-risk medications.16 Plans often conduct their own internal analyses to develop a targeted approach for HRM measure intervention. Some plans and health systems adapt their formularies to exclude payment or increase patient cost sharing for potentially inappropriate medications in older adults. Others require additional steps for those medications to be prescribed, such as prior authorization. Clinical decision trees used in the prior authorization process can be provided to frontline practitioners to help offer patients suitable alternatives, both pharmacological and nonpharmacological.

	Additionally, strategies may focus on the use of integrated care teams, in which multiple touch points along the spectrum of patient care can influence identification of potentially inappropriate medications and replacement with appropriate alternatives. For instance, several health and drug plans have partnered with community pharmacies to help drive increased performance on medication-use quality measures, including the HRM measure (

). More than 56,000 pharmacies, and many plans across the country, are utilizing the Electronic Quality Improvement Platform for Plans & Pharmacies (EQuIPP) in this effort, which lets plan administrators better understand the impact that pharmacy providers have on the quality of care delivered to their beneficiaries.

 It also gives pharmacies the opportunity to track their performance on quality metrics to help drive further improvements. Several of these partnerships employ pay-for-performance contracts, which provide added incentive for pharmacists to target patients for assessment and intervention.

	Regardless of the type of intervention or the individual who provides it, limiting potentially inap-propriate medications in older adults helps improve patient outcomes and ease the economic burden associated with the use of such medications. Tracking and evalu-ating population-based trends lends itself to a strengthened accountability for prescribing in older adults, and it stimulates value-driven healthcare.

Health Mart Pharmacies Utilize 3 Key Action Steps to Reduce HRM Use

Whether or not a patient takes any medication, including potentially high-risk medications (HRMs), is ultimately the patient’s behavioral choice. In much the same way, how an independent pharmacy decides to address quality performance improvement is its choice and often varies. Health Mart, a network of nearly 4000 independent, locally owned community pharmacies across all 50 states, has provided education and tools to empower its members to reduce the number of patients on HRMs. “If you think about the things that independent pharmacies do exceptionally well, it’s rooted in their passion, their sense of innovation, and the strong patient and prescriber relationships they develop,” says Health Mart president Steve Courtman. “These strengths have also helped them to successfully reduce the number of patients on high-risk medications.”

	Providing the pharmacies with both the Electronic Quality Improvement Platform for Plans & Pharmacies (EQuIPP) and foundational education was critical to help increase awareness of key industry changes, to identify quality measures that pharmacies have the most ability to impact, and to guide initial action plans. Over 85% of Health Marts are enrolled in EQuIPP and are able to actively monitor their quality performance. Over the last 2 years, Health Mart has hosted over 200 informal professional meetings called “Town Halls” in communities across the United States, educating several thousand pharmacy owners, pharmacists, and technicians about quality measures including the HRM measure. In addition, Health Mart developed and distributed more than 5000 copies of a “playbook” to help support the pharmacy teams, called Pharmacy Quality Measures: Improving Performance. It outlines 3 key action steps, discussed below, to consider when tackling HRM issues.

	Step 1. Pharmacists must first identify patients 65 years or older who are taking drugs or classes of drugs on the HRM list. Pharmacists utilize the HRM list provided in the playbook to increase awareness within their pharmacy teams to be on the lookout for these medications. In addition, many pharmacists post the HRM list in the pharmacy for quick reference. Health Marts that are also Access Health members have the added benefits of a new HRM edit that alerts them to potential opportunities for intervention within workflow, and of monthly advisor phone calls that help track their performance over time. For example, over a 2-week period in January 2015, more than 68,000 edits were sent to pharmacies using these Access Health Solutions, and at least 25% of those edits resulted in an intervention by the pharmacist and applicable change.

	Step 2. Once a patient is identified, community pharmacists must leverage the trust patients have in them, and the nuanced pharmacist patient relationship, to openly discuss the potential risks of the HRM and ask for permission to contact their prescriber. Health Mart pharmacists have access to behavioral coaching training and many have previously participated in sponsored intervention training programs as well. Within the playbook, stores are provided with conversation starters, open-ended questions, and ways to handle common objections.

	Step 3. Pharmacists must then collaborate with prescribers, who are also working to reduce the number of their patients on HRMs in order to impact respective Healthcare Effectiveness Data and Information Set (HEDIS) measures. Often Health Mart pharmacists have personal relationships with prescribers and prefer to reach out via phone, although they can use an HRM fax template as well. When considering appropriate alternatives, Health Mart pharmacists have access to an online subscription resource called Pharmacist’s Letter, which houses an HRM Substitution Chart.

	Leveraging these key action steps has resulted in a reduction in HRM percentage as well as improvement on all key pharmacy quality measures for the Health Mart network. For example, one innovative Health Mart owner and pharmacist, using these action steps, reduced his HRM performance from 12% to 4% over a 1-year period, and continued to bring the percentage down to only 1%, putting him in the top 20% of performers across all retail pharmacies in the United States. Quality improvements will likely filter into other care settings as prescribers begin turning to community pharmacists for recommendations and assistance in avoiding HRMs.

	Contributors: Tony Willoughby, PharmD, Vice President, Health Mart Chief Pharmacist, McKesson, Texas; and Crystal Lennartz, PharmD, MBA, Director, Health Mart Clinical Development, McKesson, Wisconsin

Independent Pharmacy Teams Up With MedHere Today to Decrease HRM Usage

	L&S Pharmacy in Charleston, Missouri, takes a proactive approach to reduce the utilization of medications that place their elderly patients at higher risk of experiencing an adverse event. Using resources and reports provided by the pharmacy performance consulting group MedHere Today, L&S Pharmacy not only targets for clinical intervention those patients who have routinely filled high-risk medications, but targets them earlier using historical data to prioritize their efforts.

	For a health plan’s performance on the High-Risk Medication (HRM) measure to be negatively impacted, a patient 65 years or older who is taking a high-risk medication must fill a prescription for that medication more than once. L&S Pharmacy’s intervention strategy allows pharmacy staff the opportunity to contact prescribers and recommend safer therapeutic alternatives after the first fill and prior to the second. If the pharmacy’s suggestion is accepted, the medication can be changed to a safer alternative before prescription claims can negatively impact health plan performance on the HRM measure.

	L&S Pharmacy also prioritizes its efforts based upon statistical analyses of prescribers’ acceptance rates for suggested safer alternatives to high-risk medications in elderly populations. By first focusing on medications most likely to be changed to safer alternatives, the pharmacy can have a greater impact on more patients in a shorter amount of time. Moving down their prioritized work list, the L&S Pharmacy staff can efficiently contact patients and prescribers, recommend safer alternatives to high-risk medications, and improve population health in an efficient and measurable manner.

	Contributors: Tripp Logan, PharmD, Senior Performance Consultant, MedHere Today, and Vice President, L&S Pharmacy, Medical Arts Pharmacy, New Madrid Pharmacy, Missouri; and Emily Hanson, PharmD, PGY1 Community Pharmacy Resident, St. Louis College of Pharmacy, L&S Pharmacy, Missouri

As older adults in the United States continue to take high-risk medications despite evidence of poor outcomes, plans seek quality improvement through innovative and varied strategies that include partnering with community pharmacies.