Medication Underuse: The Most Underappreciated Quality-of-Care Gap

A patient-centric approach to medications Is the key to identifying drug therapy problems.

With the US health care system’s shift toward provider collaboration and value-based models comes increased attention on proper use of medication therapy. While medication adherence has long been seen as crucial in solving drug therapy problems, a case can be made that it is essential to first address the issue of appropriate medication use. In particular, underuse of evidence-based medications is an underappreciated quality problem, one that is often discovered through a patient-centered approach to care.

Interestingly, we have seen many estimates of the cost of poor adherence, with lack of adherence quoted as the most common and costly drug therapy problem. But is this actually the case? The often quoted $290-billion-plus “adherence problem” can be traced back to a Network for Excellence in Health Innovation research brief from 2009.¹ This research brief relates to earlier research with updated cost-of-illness modeling and clearly states that estimates of the cost of all drug-related problems in the ambulatory setting, including untreated indication, improper drug selection, subtherapeutic dosage, failure to receive drugs, overdosage, adverse drug events, drug interactions, and drug use without indication could result in as much as $290 billion per year in avoidable medical spending or 13% of total health care expenditures (2008 estimate) and contribute to as many as 1.1 million deaths. Perhaps this figure, which lumps all drug therapy problems together as adherence issues, needs closer inspection.

A Look at the Evidence

In 2008, professor Brian Isetts published results from a study utilizing the “pharmaceutical care approach” whereby drug therapy problems were identified within a framework of optimizing the clinical and patient goals of therapy in a commercial population of 285 patients.² The most common drug therapy problems were “untreated indications,” otherwise known as the need for additional medications (34%), and doses too low (20%; 54% in aggregate), both of which are examples of medication underuse. Nonadherence followed at approximately 10%. As these drug therapy problems were identified and resolved, pharmacy spend increased 19%, but facility and hospital costs were ultimately lowered by 56%.

In 2010, data were published from almost 10,000 patients spanning a 10-year period demonstrating that the “untreated indications” accounted for 28% and “dosage too low” for 26% (or over 55% in aggregate) of the more than 38,600 identified and resolved drug therapy problems. Nonadherence accounted for 16.5%.³ Untreated indications ranged from primary prevention, such as immunizations, to the need to add medications to control chronic diseases. Each of these efforts involved collaborative practice, better quality metrics, and reduced overall costs, and they have continued with a recent emphasis on the integral role “whole-patient” medication therapy management (MTM) services are having in the pioneer accountable care organization (ACO) efforts.⁴

Moving From “Adherence” to “Appropriate Use”

MTM silo interventions (see Sidebar) have been helpful in identifying drug therapy problems such as drug—drug interactions and duplicative therapies, or recognizing when gaps in therapy (an indicator of suboptimal adherence) may be the result of financial burden (through proportionate days covered calculations). A medication silo approach can also identify recommended classes of medications that are missing from a patient’s regimen.

The Centers for Medicare & Medicaid Services considers measurement of adherence to be an intermediate outcome measure, with patients achieving an improved outcome through measures that target a specific result.⁵ Unfortunately, although we may improve adherence, we are still unable to ascertain whether the clinical goals of therapy have actually been obtained through better adherence. Without clinical knowledge, these approaches are not aligned to recognize subtherapeutic dosages or additional medications that are needed to achieve clinical goals of therapy for the patient. This has contributed to our lack of appreciation for the significance of underuse as a drug therapy problem and its link to actual patient outcomes versus intermediate adherence measures.

By contrast, comprehensive medication management (CMM), as defined and described by the Patient Centered Primary Care Collaborative (PCPCC), provides a framework of a “whole-patient approach” with guidelines for practice and documentation consistent with patient-centered medical home (PCMH) and ACO integration. The PCPCC defines comprehensive medication management as “the standard of care that ensures each patient’s medications (whether they are prescription, nonprescription, alternative, traditional, vitamins, or nutritional supplements) are individually assessed to determine that each medication is appropriate for the patient, effective for the medical condition, safe given the comorbidities and other medications being taken, and able to be taken by the patient as intended.” It goes on to state, “Comprehensive medication management includes an individualized care plan that achieves the intended goals of therapy with appropriate follow-up to determine actual patient outcomes. This all occurs because the patient understands, agrees with, and actively participates in the treatment regimen, thus optimizing each patient’s medication experience and clinical outcomes.”⁶ ACO/PCMH efforts require a focus on population segmentation and the management of high-risk/ high-cost patients who are often dealing with multiple disease states or complex conditions (eg, cancer, congestive heart failure) who are not achieving clinical goals of therapy and may frequently transition through various sites of care. Successfully integrating whole-patient MTM services based on a framework that includes the elements described by the PCPCC as CMM and consistent with the Joint Commission of Pharmacy Practitioners’ pharmacists’ patient care process⁷ has been shown to not only improve patient outcomes and satisfaction/ engagement, but to lower overall costs and improve provider/team efficiency and access. These approaches require the assessment of each medication for first indication, effectiveness, safety, and adherence based on closing the gaps in therapy to achieve the quality and clinical goals of therapy. There is broad consensus on the importance of appropriate medication use to improve overall outcomes and prevent hospitalizations, readmissions, and serious adverse events in hospitalized patients.⁸ For example, in 2014, of the 33 ACO quality metrics in the Medicare Shared Savings Program, 18 directly or indirectly involved appropriate medication use to achieve the quality targets. Also, as more specialty/personalized medications become available, pressure increases to ensure the medications are appropriate and effective based on clinical outcomes.

We are now seeing this trend across the country as we shift to a focus on the clinical goals of therapy and outcomes. As the clinical picture rapidly changes in transitions of care, so must medication needs change if we are going to prevent hospitalizations or readmissions. The diuretic needs of a patient with congestive heart failure at hospital discharge may be drastically different once at home when the salt intake from that bag of chips is considered and the patient’s weight increases. In a case like this, standard adherence messaging and medication reconciliation attempts that do not account for the clinical change in weight will fail to address the patient’s actual medication needs.

Pharmacist-Led Interventions

At the 2014 American Society of Health-System Pharmacists Midyear Conference, Anthony P. Morreale, PharmD, MBA, BCPS, FASHP, assistant chief consultant for clinical pharmacy services at the Department of Veterans Affairs, shared that 1328 pharmacists under scope of practice agreements had made more than 467,000 disease state interventions and more than 313,000 pharmacotherapy interventions. Many of these interventions included initiating new medications for untreated indications and adjusting dosages to achieve clinical goals of therapy, with impressive improvements in clinical outcomes and returns on investments to support further expansion of pharmacists in Patient Aligned Care Teams.⁹ These results suggest that efforts geared to single disease state improvements (such as those of the Asheville Project or anticoagulation clinics) must progress to whole-patient MTM interventions which assure that untreated indications are addressed, dosages are optimized, and safety is assured before engaging patients on their willingness and ability to adhere to medications.

Conclusion

Pharmacists can be one of the most transformative forces in team-based care as they seek to identify and resolve drug therapy problems, such as underuse and subtherapeutic dosages. Addressing access and affordability of medications, engaging patients, and assuring them that the medications are the most appropriate, effective, and safe in optimizing their outcomes and personal goals will enable the “buy-in” and willingness to take the medications. Having a systematic, patient-centric approach to medications that identifies all drug therapy problems, including underuse, is vital.

MEDICATION THERAPY MANAGEMENT

Currently, medication therapy management (MTM) interventions span various levels of integration and activities. The basic level of effort requires knowledge of the medications currently prescribed, with or without attempts to determine whether the patient is currently taking any OTC products or vitamin/ herbal supplements. Frequent goals at this level are to enhance the safety of medications by checking for drug—drug interactions, duplicative therapies, and medications that may be less expensive (generic substitution) or easier to take/obtain, which may include education for the patient about the medications. The result is to ensure an updated and accurate medication list and better adherence/availability to currently prescribed medications. Efforts range in scope from medication refill synchronization programs/processes, focused adherence efforts, CMS Part D MTM services, and medication reconciliation. Because these efforts do not require knowledge of the clinical status of the patient (eg, current blood pressure levels and optimal goals for the patient), they may be termed “medication silo” approaches.

Another level of MTM efforts focuses on the patient and the optimization of the clinical and personal goals of therapy, rather than solely relying on knowledge of currently prescribed medications as a baseline. This approach requires close collaboration with the care team (physicians and other providers) to be clear on the current clinical status of the patient (eg, current blood pressure levels, glycated hemoglobin levels, etc). It includes the clinical evidence-based or provider goals and a focus on understanding the patient’s goals (eg, ability of a patient with chronic obstructive pulmonary disease to walk up a flight of stairs) to foster knowledge and patient engagement. These MTM interventions are reiterative to continually address and resolve drug therapy problems in optimizing clinical outcomes, and range from single disease state interventions (eg, anticoagulation clinics, blood pressure clinics, diabetes, HIV, oncology, or specialty medication/disease management services) to whole-patient approaches that attempt to address all conditions where drug therapy is indicated.

Terry McInnis, MD, MPH, is president and founder of Blue Thorn, Inc, a health care consulting firm impassioned to successfully “redefine health care” for clients. Dr. McInnis’s career spans practice and executive roles as a physician provider of care in both civilian and military settings. She has led risk/reward contract and redesign/execution of employer-based medical benefits for multinational companies including GE and Michelin. In health care reform efforts, she has led medical policy decisions, payment, and delivery system development and strategy for government, professional societies, patient advocacy organizations, the pharmaceutical industry, and integrated delivery systems to position for risk/value. As chair of the Alliance for Integrated Medication Management, she is a true believer in the critical role a clinical pharmacist can play in transforming health care. Her leadership and teamwork in the Patient-Centered Primary Care Collaborative (PCPCC) resulted in the successful launch and wide-spread adoption of the PCPCC Resource Guide: Integrating Comprehensive Medication Management to Optimize Patient Outcomes.Terry received her MD from Wake Forest University and her MPH and residency in occupational and environmental medicine from Oklahoma University. She is board certified in preventive medicine, a Fellow of the American College of Occupational and Environmental Medicine, and a certified physician executive.

References

• Thinking outside the pillbox: a system-wide approach to improving patient medication adherence for chronic disease. Appendix 1. New England Healthcare Initiative, August 2009. www.nehi.net/writable/publication_files/file/pa_issue_brief_final.pdf.
• Isetts BJ. Clinical and economic outcomes of medication therapy management services: the Minnesota experience. J Am Pharm Assoc. 2008;48(2):203-211.
• Ramalho de Oliveira D, Brummel AR, Miller DB. Medication therapy management:10 years of experience in a large integrated health care system. J Managed Care Pharm. 2010;16(3):185-195.
• Brummel A Lustig A, Westrich K. Best practices: improving patient outcomes and costs in an ACO through comprehensive medication therapy management. J Managed Care Specialty Pharm. 2014;20(12):1152-1158.
• Cranston L, Dixon L. Emerging trends in adherence and quality measurement: what the future holds. Directions in Pharmacy. 2014;1(5):13-15. www.pharmacytimes.com/publications/directions-in-pharmacy/2014/august2014/emerging-trends-in-adherence-and-quality-measurement-what-the-future-holds.
• McInnis T, Webb E, Strand L. The Patient-Centered Medical Home: Integrating Comprehensive Medication Management to Optimize Patient Outcomes. Washington, DC: Patient Centered Primary Care Collaborative, June 2012. www.pcpcc.org/sites/default/files/media/medmanagement.pdf.
• Pharmacists’ Patient Care Process. Joint Commission of Pharmacy Practitioners, May 29, 2014. www.accp.com/docs/positions/misc/JCPP_Pharmacists_Patient_Care_Process.pdf.
• Department of Health and Human Services, Office of Inspector General. Adverse Events in Hospitals: National Incidence among Medicare Beneficiaries. Washington, DC: Office of Inspector General, 2010. Publication OEI 06-09-00090. http://oig.hhs.gov/oei/reports/oei-06-09-00090.pdf.
• Morreale AP. The ASHP federal forum: welcome and keynote. Presented at the 49th ASHP Midyear Clinical Meeting and Exhibition, December 7, 2014, Anaheim, CA.