The most common patient care intervention, issuing a prescription, is fraught with continuing challenges for patients, their caregivers, and practitioners. Patients rely on medications across a continuum of care, with expectations for self-management; some experience unintended problems along the way. For older patients, such problems often result in emergency hospitalizations, many of which could be prevented.
Historically, integration to support safe and appropriate medicine use across the U.S. health care ecosystem has been sporadic, including within our siloed Medicare Part D benefit. Other countries, however, are well on their way to better integration.
In the following blog post, we share examples from the United Kingdom and Australia. Fortunately, U.S. practitioners who recognize optimizing medication use as an essential element of population health can look to several recent federal opportunities to support their efforts.
This includes the Center for Medicare & Medicaid Innovation (CMMI) request-for-information (now closed) on health plan innovation that invited collaboration between accountable care organizations (ACOs) and Medicare Part D drug plans; the 10-year evaluation of the Medicare Coordinated Care Demonstration; the National Institute on Aging’s R01 grant on self-management for health in chronic conditions; Medicare’s 2015 physician payment rules; and CMMI’s Transforming Clinical Practices Initiative, an $840 million grant opportunity.
Although these regulatory and research offerings may not feature optimizing medication use as their primary intent, other countries have been re-tooling public policy to do just that, including promoting incentivized population health roles for pharmacists. This is important because they represent a valuable resource to help optimize medications for patients with multiple chronic conditions who are likely to see multiple prescribers, use multiple pharmacies, and may present care coordination challenges.
We recently participated in the World Health Organization-sanctioned, 74th annual meeting of the International Pharmaceutical Federation (F.I.P.) in Bangkok, Thailand where we were among more than 1,300 pharmacy executives, practitioners, policymakers, academics, and pharmaceutical scientists from nearly 90 countries, who gathered to exchange global lessons about optimizing patient and population health. From that meeting, we share a few takeaways about optimizing medications that may directly support, or even transcend, many of the initiatives mentioned above.
Empowered Clinicians Are Essential in Accountable Care
Clinicians who are “empowered to adjust interventions and improve outcomes” represent one element of a global accountable care framework recently developed by Mark McClellan and colleagues and published in Health Affairs. In addition, a practice that “sets clear expectations for each team member’s functions and responsibilities to optimize efficiency, outcomes, and accountability,” as illustrated in CMS’ Transforming Clinical Practice Initiatives milestones, paves the way for empowered team members and optimal medication use.
Recent examples of U.S. programs that support such empowerment and medication management and in turn, returned savings include: Vermont’s integration of pharmacists one day per week into patient-centered medical home primary care practices, resulting in $2.11 in costs avoided per $1.00 spent on pharmacists’ services; Wisconsin’s CMMI-funded Pharmacy Quality Collaborative, whose pilots saw similar returns; and Virginia’s Carilion primary care clinics and hospitals that employ pharmacists who target newly-discharged patients with at least two chronic conditions and four medications, for comprehensive medication management.
Carilion’s CMMI-funded project, which collaborated with Virginia Commonwealth University School of Pharmacy and several community pharmacies, reported preliminary savings estimates of $1.2 million on caring for just over 1,000 patients in 14 months. Reduced medication costs (despite top-line problems of non-compliance and the need for additional drug therapy), and reduced medical, hospital, and emergency room visits, accounted for the predicted savings.
These examples feature more systematic, integrated roles for pharmacists than may be familiar to most practitioners; they represent medication-specific pilots, after all. However, as Table 1 demonstrates, there are new federal opportunities for optimizing medication use.
Table 1: U.S. Federal Opportunities That May Nurture Medication Optimization
²The New England Journal of Medicine
³American Academy of Family Physicians
₄Centers for Medicare and Medicaid Services
₆Department of Health and Human Services
⁷Fifth Report To Congress On The Evaluation Of The Medicare Coordinated Care Demonstration: Findings Over 10 Years
A Global View of Community Pharmacy
As these new stateside initiatives prepare to launch in 2015, we will watch for multi-stakeholder integrated programs to support medication optimization. In other developed countries optimizing medication use is a policy priority. Globally, community pharmacy initiatives have been funded directly, or were at least inspired, by federal calls to action.
This includes England’s in 2013; and the 2008 white paper, Pharmacy in England – Building on Strengths, Delivering the Future, that fostered the Healthy Living Pharmacy concept. It envisions pharmacists as “clinical experts who help people make healthy living choices and achieve the most benefit from their medicines every time.”
Today’s Healthy Living pharmacies provide a broad range of services such as medicines optimization, National Health Service-compensated treatment for common ailments (e.g., coughs, colds, stomach problems), screening for persons at risk of vascular disease; and counseling around sexual health, smoking cessation, alcohol, healthy diet, physical activity, and dementia.
A 2013 National Health Service (NHS) evaluation found that positive outcomes from such pharmacy-based services were most likely for: smoking cessation, emergency sexual health, cardiovascular disease prevention, hypertension, diabetes, and possibly asthma and heart failure. Patients with these conditions may carry a substantial medication burden—increasing their risk of medication-related problems—and/or may require frequent clinician interactions.
To the extent that pharmacists can help to prevent further resource consumption through downstream medical problems, or to preserve time allocation of primary care providers, the goal of optimizing medication use may extend beyond a single patient at one point in time. (In the U.S., a similar evaluation was conducted in 2014 by Avalere Health; CVS Health described its own community-pharmacy initiatives in a June Health Affairs Blog post.)
England’s Healthy Living program incorporates four building blocks of service and funding streams:
Medicines Optimisation is defined as the right medicine, for the right person, and used in the right way to deliver the right outcomes, which may include counseling about healthy lifestyles to support health goals. Funding is integrated into NHS support for community pharmacies.
Wellbeing involves health promotion, prevention and protection, including pharmaceutical public health care and is now funded by local governments.
Self Care includes access to self-treatment and advice for coughs, colds, and other minor ailments; as well as support for managing long-term conditions, and self-ownership of one’s health and wellbeing.
The NHS Five-Year Forward Plan, introduced in October, reinforced this primary care function of community pharmacies. Practitioners receive some support through the community pharmacy contractual framework; patients self-pay.
Such “building blocks” are not unique to U.K. pharmacy practice, but in the U.S., they traditionally have not been supported with federal funds. Notable exceptions are CMMI-funded pilots in North Carolina and California, described in the next section.
Pharmacy Services’ Pathways Support Multiple Chronic Condition Patients
In addition to incorporating four building blocks of service and funding streams, in 2012, four large community pharmacy groups in England launched the Community Pharmacy Future project, which created pharmacy services’ pathways to support chronic condition patients and their caregivers. The project targeted patients with, or at risk of having, chronic obstructive pulmonary disease (COPD); and patients who were prescribed four or more medicines (FOMM).
Following these pathways allows pharmacists to:
- Make clinical interventions related to medicines and adherence;
- Make onward referrals when appropriate;
- Deliver services to agreed national standards;
- Collect outcomes data that can be compared locally and nationally.
Positive results of Community Pharmacy Future pilots, reported in 2014, were estimated to save the National Health Service over £470 million (about $760 million) if they had been implemented in 11,100 pharmacies across England. It is hoped that this pilot could pave the way for specific “commissioned” services for identifying and supporting COPD patients, along with those on multiple medications. (Such services are prioritized for local populations and, through contract negotiation with providers, may be eligible for compensation.)
In the U.S., CMMI has several related pilots underway to support community pharmacists’ roles with patients with multiple chronic conditions. One is managed through Community Care of North Carolina (CCNC) via a three-year, $15 million grant; and is geared to newly discharged, high-need patients. CCNC relies on 120 community pharmacies across the state — their pharmacists make initial home visits and then continue outreach by phone; these services are reimbursed ($70-95 for the initial workup, and a monthly fee of $2-5 for each patient who participates).
Another pilot involves a three-year, $12 million grant awarded to the University of Southern California School of Pharmacy, and AltaMed Health Services in Orange County. Through this collaboration, clinical pharmacists, pharmacy technicians, and physicians work together to help primarily underserved patients, many of whom rely on these medical-home clinics as their sole source of care. The projected return-on-investment is $43 million, according to the University.
Meanwhile, in the United Kingdom, in 2013 the Scottish government launched Prescription for Excellence, an action plan that complements the NHS/Scotland’s “Route Map” to the 2020 Vision for Health and Social Care. In describing the “Excellence” report, the government notes, “Our overriding objective is that all patients, regardless of their age and setting of care, will receive high quality pharmaceutical care using the clinical skills of the pharmacist to their full potential. We want to see all pharmacists, regardless of whether they work in a hospital, community, NHS Board, or other setting, undertaking an enhanced role in preventing ill health and providing a clinical input to a caseload of patients.”
Governance to meet this objective is led by a federal steering committee, along with a multi-stakeholder private sector reference group. In the U.S., a close equivalent to these United Kingdom reports may be a 2011 U.S. Public Health Service report to the Surgeon General, “Improving Patient and Health System Outcomes through Advanced Pharmacy Practice.”
Australia Prioritizes “Quality Use of Medicines”
In Australia, pharmacists have been deployed in primary care roles across the outback, and into the homes of urban- and suburban-dwelling elderly to provide hands-on medication reviews. Such geographically diverse examples are united in principles of accountability and value in medicine use, both of which are embedded in the National Medicines Policy (NMP). First written in 1999, the NMP outlines the government’s approach towards meeting Australians’ “medication and related service needs” to achieve optimal health outcomes and economic objectives.
The NMP covers four objectives:
- timely access to medicines at an affordable cost;
- medicines meet appropriate standards of quality, safety, and efficacy;
- quality use of medicines; and
- maintenance of a responsible and viable medicines industry.
The third objective—quality use of medicines (QUM)—pertains to the judicious, appropriate, safe, and efficacious use of medicines. QUM stipulates that patients receive the most appropriate treatment, along with adequate knowledge and skills to use the treatment optimally. Although health practitioners play a key role in promoting QUM, responsibility is also shared among government agencies, industry practitioners, patients, consumers, and the media. The Australian National Strategy for QUM provides the principles, framework, key stakeholders, and the approach for achieving QUM.
In the U.S., the Department of Health and Human Services’ National Quality Strategy was updated in September; its scope is much broader than medication use, although that is addressed by many commercial and public quality measures (including recent suggestions that patients who prefer not to initiate medication therapy be reflected in such measures, too). A medication-related HHS report, also released in 2014, is the National Action Plan for Adverse Drug Event Prevention. But there is no U.S. equivalent to Australia’s National Strategy for “quality use of medicines.”
Further, the multitude of U.S. prescription drug formularies, developed by private and public health systems and payers, also reflect independent assessments of “quality” medicine use with non-uniform application by plans of drug utilization management tools such as: step therapy, quantity limits, and prior authorization. Formularies are but one tool that prescribers may use to help guide medication decisions; as the Medicare Part D statute prohibits a national formulary, prescribers’ ability to gauge quality from any particular plan formulary may be compromised.
Within the Australian pharmacy context, QUM is implemented through organizations such as the National Prescribing Service (NPS) MedicineWise, which provides consumers and health care professionals evidence-based information about medicines, health conditions, and medical tests. It also offers practical support tools such as medication management apps.
Relatedly, the U.S. National Library of Medicine maintains the website MedlinePlus to provide similar information. Medication apps are offered by organizations such as the American Medical Association and pharmaceutical manufacturers and represent an increasingly popular space for private developers, especially those who focus on older adults and family caregivers.
The not-for-profit NPS MedicineWise is funded by the federal government. Since their inception in 1998, these initiatives and programs have resulted in cost savings to the Australian economy amounting to over $571 million, encompassing decreased instances of medication side-effects, hospital visits, and disability as well as improvements in productivity. In 2013, direct savings from MedicineWise totaled $88 million alone.
The Pharmacy Guild of Australia’s GuildCare programs, launched in 2011, feature a software package that integrates with pharmacy dispensing software. The software helps pharmacists to monitor, screen, and document in-store services they provide; address barriers to non-adherence; and comply with mandated reporting. In this way, these programs help to better equip pharmacists to contribute to QUM, and ultimate accountability and value in medicine use. U.S. pharmacies also invest in similar software packages, available from nearly 200 vendors and organizations, according to their trade group.
Reimbursed Service: In-Home Medicines Reviews for At-Risk Patients
Since 1990, the Pharmacy Guild and the Australian government have crafted five-year agreements governing pharmacy product reimbursement, as well as payment for pharmacists’ services and programs to support optimal medication use. One component of the 2010-2015 agreement (technically, the 5CPA) is the Home Medicines Review (HMR). Patients most at risk of medication misadventures (those with multiple chronic conditions, complex medication regimens, advanced age, etc.) may be referred by their general practitioner to an accredited pharmacist who will schedule and conduct a HMR.
Eligible pharmacists who perform a HMR receive about $180 per visit; a rural transportation supplement of up to about $125 may also be paid. The government allocated $52 million for the HMR program. To conserve funds, a new rule requires a two-year interval for patients to receive HMRs, which has led to concern for persons most at risk of adverse drug events. Prior economic evaluations of the HMR program showed overall health care savings of $554 per review, due to fewer visits to health care professionals, fewer medical tests, and reduced hospital admissions and drug costs.
As community pharmacies transform to embrace a population health mission, countries are redefining pharmacists’ roles. Medicare Part D may unintentionally bypass sustaining some front-line pharmacists’ clinical services; challenges of its medication therapy management (MTM) program, intended to help capture and resolve medication-related problems in patients most at risk of experiencing them, were highlighted by one of us in a March Health Affairs Blog post. MTM-related research challenges, such as uniformly assessing return-on-investment in many “moving target” MTM programs, were identified in systematic reviews published in November and December.
Their inconclusive findings stand in contrast to the positive news from long-term, hands-on pharmacists’ roles in a Minnesota ACO’s holistic comprehensive medication management program that may serve as a best practice guidepost. Fairview (MN) Health System’s MTM program has been expanding for over 15 years, and now employs 18 full-time clinical pharmacists who are embedded in primary care sites.
Their services are paid for by several means, including shared savings, ACO contracts, and some direct fee-for-service contracts. While return-on-investment (ROI) from Fairview’s MTM program for their Pioneer Medicare ACO patients is not yet available, their 10-year study of pharmacists’ MTM services yielded an ROI of $1.29 in cost-savings to the health system per dollar spent on pharmacists.
Few evolving health care practices have the luxury of a 10-year evaluation window to assess a single type of clinician’s contribution to optimizing medication use, especially when the potential for shared savings is typically assessed annually. Similarly, Part D enrollees can change drug plans each year, further diluting the potential for plans to realize downstream savings from avoided medication problems. (This is true especially for stand-alone prescription drug plans, selected by a majority of Part D enrollees that are at risk for drug costs only.)
The five-year duration of Australia’s pharmacy agreements could be an important consideration, not only for accounting purposes but to be more responsive to population health planning when persons with multiple chronic conditions are the norm.
As Australian pharmacists gear up for negotiating the 6th Community Pharmacy Agreement and as U.K. pharmacists gird for their role in the National Health Service’s Five Year Forward plan, U.S. practitioners who are committed to optimizing medications should stay attuned to these and domestic developments, such as those in Table 1, and existing CMMI pilots in California, North Carolina, and Virginia.
A growing number of programs foster pharmacists’ integration via care coordination and team-based care and help prescribers address medication-related quality measures. Contributing to population health in this manner may ultimately be more sustainable than irregular medication therapy management outreach in Medicare Part D. Moreover, tomorrow’s patients are already in the queue.