LEARNING OBJECTIVES

After reading this chapter, the pharmacy student, community practice resident, or pharmacist should be able to:

1. Explain how pharmacists are in a unique position to provide medication therapy management (MTM) services.

2. Recognize the differences between MTM and pharmaceutical care.

3. Explain how MTM services are implemented with the five core elements.

4. Discuss how innovative patient care programs have assisted in the development of MTM.

5. Recognize how implementation of MTM services is evolving into the overall health-care structure.

INTRODUCTION

Nearly half of all Americans have at least one chronic illness¹ resulting in millions of patients relying on prescription medications to help maintain their health. This prevalence of medication use creates a significant opportunity for both medical and monetary consequences if these agents are not managed safely and effectively. Unfortunately, evidence suggests that our health system is not performing well in this regard. It is estimated that 1.5 million preventable adverse drug events (ADEs) occur in our health system each year² and the Institute of Medicine (IOM) has declared that for every dollar spent on ambulatory medications, another dollar is spent to treat new health problems caused by the medication.³ Despite the presence of these avoidable adverse events and costs, it has been determined that potentially up to half of patients on persistent medication receive no drug monitoring in 1 year.^4–5 The IOM predicts that with these trends, the number and costs of outpatient ADEs will increase unless effective interventions to improve health-care system delivery and outpatient safety are implemented.

There are multiple factors that contribute to the medication use problems and their negative outcomes. These include patient-centered factors, therapy-related factors, social and economic factors, and disease factors.⁶ Health literacy, cost, concern about adverse effects, lack of urgency about the disease, and an impaired perception of the efficacy of the medications are just a few specific patient-centered examples. Societal issues like poverty, cultural differences, and a lack of a social support structure create obstacles for treating the population as a whole. Lastly, problems with the health-care system such as lack of accessibility, long waiting times, difficulties filling prescriptions, or unpleasant interactions with health-care professionals also affect patient’s medication use experience and may result in medication-related problems.

Pharmacists are in an excellent position to address these problems due to their focused training, unique perspective, and unparalleled access. Pharmacists have the most specific training in drug therapy of all healthcare professionals, which creates an opportunity to evaluate a patient’s medication needs in a manner that is unique to the health-care team. In the ambulatory care environment, pharmacists are the most accessible health-care professionals. While most health-care professionals require an appointment or emergency situation to be accessible to patients, the ease of access to community pharmacists allows them to often serve as the first and/or the most frequent point of contact between a patient and their health-care team.

However, to take advantage of these differentiating characteristics and fully meet the medication-related needs of individual patients and society, the profession must actively engage the health-care reform principles that are underway in the United States. The services that pharmacists deliver must align with “the Triple Aim” of achieving better patient health, improved quality of care, and lower costs. In order to accomplish this, new practice models must be adopted.

The adoption of new practice models more focused on ensuring that patients achieve desired drug therapy outcomes has been occurring over the past 20 years; however, large-scale adoption of this type of practice remains elusive. Despite over two decades of debate and development, there still remains ambiguity and inconsistency in defining the core role of pharmacists and the services through which this role serves patients.

MEDICATION THERAPY MANAGEMENT AND PHARMACEUTICAL CARE—SAME PRACTICE WITH DIFFERENT NAMES?

Pharmaceutical Care: A Definition

In 1990, Hepler and Strand defined pharmaceutical care as “the responsible provision of drug therapy for the purpose of achieving definite outcomes that improve a patient’s quality of life.”⁷ This definition served as a foundation for Strand, Cipolle, and Morley to define responsibilities of a pharmaceutical care practitioner. These include (1) to assure that all of a patient’s drug therapy is appropriate, effective, safe, and convenient to take as indicated and (2) to identify, resolve, and prevent any drug therapy problems.⁸ As a pharmaceutical care practitioner, the pharmacist takes responsibility for a patient’s drug-related needs and is held accountable for this commitment.⁹ Pharmaceutical care is a patient-centered practice with three components: philosophy of practice, patient care process, and a management system.¹⁰

Philosophy of Practice

All pharmaceutical care practitioners share a set of values that guide behaviors, clinical decisions, and professional standards. It is this set of values that unites practitioners and provides the foundation for the other two components of pharmaceutical care: patient care process and a management system. The philosophy of pharmaceutical care practice calls for the practitioner to accept the social responsibility to reduce medication-related morbidity and mortality. This responsibility is met by assessing a patient’s medication-related needs, bringing the necessary resources to meet those needs, and follow up with the patient to determine that these needs have been met. The core element of this philosophy is the patient-centered approach taken to meet a patient’s needs. In other words, the patient remains at the center of attention at all times despite a practitioner’s preferences.¹¹

Patient Care Process

Although each practitioner may carry out the patient care process differently, pharmaceutical care has only one patient care process. This is essential to provide consistent quality care to patients across care settings and to educate future practitioners. As the name implies, the patient care process is patient centered and driven by an individual patient’s needs. However, in order to maintain quality and consistency, the process is practiced systematically. Three steps comprise the process: assessment, care plan, and evaluation. These steps occur continuously to meet a patient’s medication-related needs. During the assessment, the pharmacist determines the patient’s medication-related problems. Drug therapy is evaluated for indication, effectiveness, safety, and convenience. Problems related to medications are identified, including those problems that have potential to cause harm. Before medication-related problems can be solved, a therapeutic relationship must exist between the pharmacist and the patient to ensure that medications are assessed comprehensively. The second step of the patient care process is the care plan. The care plan is created to define goals, determine interventions, and agree upon responsibilities for the practitioner and the patient to meet goals of therapy. The objective of the patient-centered care plan is to identify, resolve, and prevent medication-related problems. The care plan is complete when goals have been set, interventions agreed upon, and responsibilities of the patient and practitioner accepted. The final step of the patient care process is the follow-up evaluation. During the follow-up evaluation, the practitioner collects information from the patient to determine if interventions have been successful in meeting goals set during the assessment and care plan. The follow-up evaluation is also an opportunity to determine if any new medication-related problems have developed. Patients with chronic diseases will require a series of follow-up evaluations.¹⁰

Management System

The third component of pharmaceutical care is a practice management system. In order to have a financially successful practice, new patients must be added to the practice. As described, a systematic approach exists to providing pharmaceutical care to individual patients; likewise, a systematic approach exists for managing a pharmaceutical care practice. A practice management system includes the following: mission statement; physical, financial, and human resources to support the practice; means by which to evaluate the practice; documentation system; and the means by which to reward the practitioner and financially support the practice. The long-term success ofthe practice relies on a supportive practice management system.¹⁰

MEDICATION THERAPY MANAGEMENT: A DEFINITION

After the Medicare Prescription Drug Improvement and Modernization Act passage in 2003, the pharmacy profession needed to define MTM. In 2004, 11 national pharmacy organizations developed a consensus definition of MTM. The American Pharmacists Association (APhA) facilitated the group’s work and had three objectives for the process. The definition had to be inclusive of services and programs provided in diverse pharmacy practice settings and had to document examples of services that could be implemented by a majority of practitioners. Lastly, APhA wanted to create a consensus that all involved organizations could support and utilize as they worked for regulatory changes. The consensus definition states that MTM is a “distinct service or group of services that optimize therapeutic outcomes for individual patients. MTM services are independent of, but can occur in conjunction with, the provision of a medication product.”⁶

APhA/NACDS Core Elements

In 2004, the APhA and the National Association of Chain Drug Stores (NACDS) created a framework within which MTM could be provided in a community setting. This model framework of MTM in community pharmacies was created to improve care, enhance communication among providers, improve collaboration among providers, and optimize medication use leading to improved patient outcomes. In 2004, the framework defined five core elements comprising MTM in the community.^12,13 In 2008, the framework was revised; however, the core elements remained the same. The features of the updated framework include a broad focus on patients in diverse care settings and patients transitioning through health-care settings, collaborating with physicians, and empowering patients. The five core elements of an MTM service model in pharmacy practice include medication therapy review (MTR), personal medication record (PMR), medication-related action plan (MAP), intervention and/or referral, and documentation and follow-up. All elements are essential to provide MTM; however, elements may be modified to meet a patient’s needs.¹⁴

An MTR is defined as “systematic process of collecting patient-specific information, assessing medication therapies to identify medication-related problems, developing a prioritized list of medication-related problems, and creating a plan to resolve them.” The purpose of the MTR is to educate patients about their medications, address medication-related problems, and motivate patients to manage their medications and conditions. An MTR may be a comprehensive assessment of all medications or it may be targeted at one particular disease state. In addition to obtaining a medication history, a pharmacist conducting an MTR may assess the following of the patient: physical and overall health, preferences and values, goals of therapy, cultural or socioeconomic issues, and laboratory values. A pharmacist will also identify and prioritize medication-related problems related to clinical appropriateness, safety, efficacy, and accessibility to the patient. A plan to resolve medication-related problems will be devised that may include patient education, monitoring of therapy, and communication to other providers. Ideally, a patient would receive one comprehensive MTR annually and additional, more focused MTRs throughout the year to address specific problems.¹⁴ A PMR is defined as “a comprehensive record of the patient’s medications (prescription and nonprescription medications, herbal products, and other dietary supplements).” The PMR may be generated manually or electronically; however, it should be written at a literacy level that can be understood by the patient. Information that should be a part of the PMR includes primary care physician, pharmacy/pharmacist, allergies, adverse drug reactions, date last updated and reviewed, and medications. The purpose of the PMR is to give the patient a tool to manage his/her medications. If a medication or any other information related to the PMR changes, the patient should update the PMR; however, the maintenance of the PMR may be seen as a collaborative effort among the patient and his/her pharmacist and physicians. By sharing the PMR with all health-care providers, continuity of care may be facilitated.¹⁴ A MAP is a patient-centered document that lists interventions the patient may employ to self-manage medications. A MAP contains only the actions that the patient will do; however, these actions do not include anything that is outside of a pharmacist’s scope of practice or has not been approved by an appropriate health-care team member. The MAP is an important core element as it promotes patient-centered care and patient self-management of health.¹⁴

Intervention and/or referral represents the fourth core element of MTM. While providing MTM, the pharmacist may need to intervene to resolve medication-related problems. Examples of interventions include collaborating with the patient’s other health-care providers or providing education to a patient. In some instances, the resolution of medication-related problems requires a referral to another provider. For example, a pharmacist may discover a medical problem, a patient is experiencing that needs further evaluation. Resolution of all medication-related problems requires collaboration among health-care providers and self-management by the patient. The final element of MTM is documentation and follow-up. Documentation is essential to MTM delivery because documents provide reports of patient progress and support billing for services. Additionally, documentation has purposes in communication, quality improvement, and continuity of care. Documentation may be paper or electronic, but a consistent format should be used. The PMR and MAP should be included in documentation. Follow-up care is also documented and should be scheduled according to a patient’s medication-related needs.¹⁴

Are Pharmaceutical Care and Medication Therapy Management Interchangeable?

Although pharmaceutical care and MTM may be used interchangeably, it is important not to lose sight of their differences. As previously described, pharmaceutical care is a patient-centered approach taken by a pharmacist who accepts responsibility for a patient’s medication-related needs. Pharmaceutical care has three components, including a philosophy. The philosophy is the foundation of pharmaceutical care and forms the basis for the process and the practice management system. In contrast, MTM lacks a philosophy and relates to a practice management system by way of requiring a documentation system. Components of the patient care process of pharmaceutical care and the five core elements of MTM are similar. Both require an assessment of medication-related needs, development of a care plan, and appropriate follow-up. However, the pharmaceutical care process recommends that the assessment be done in-person, while core elements of MTM suggest that patients may be assessed via telephone. MTM may be aptly described as the strategy to care out the philosophy of pharmaceutical care into everyday practice.^14,15 Patients with medication-related problems may exist in all care settings, including community pharmacies, ambulatory care clinics, hospitals, nursing homes, and within home care agencies. More importantly, patients may experience medication-related problems as they transition across settings of care. Although settings may differ where MTM is delivered, a consistent approach should be used. The core elements of MTM were developed with the consideration that MTM could be delivered in many health-care settings. In 2006, the American College of Clinical Pharmacy (ACCP) released a commentary recommending how core elements could be implemented in the ambulatory care setting. Their major recommendations included expanding the elements to include more guidance on collecting patient information, assessing this information, monitoring and evaluating drug therapy, and documenting services. ACCP recommended that the core elements place greater emphasis on collaboration among health-care providers.¹⁶

RESEARCH SUPPORTING PHARMACISTS AS MTM PROVIDERS

MTM provides many opportunities for pharmacists to improve medication use. Organizations such as the US Department of Veterans Affairs and Kaiser Permanente Colorado have utilized clinical pharmacists for decades to manage pharmacotherapy related to dyslipidemia, smoking cessation, anticoagulation, and solid organ transplant. Both organizations have reported data illustrating positive health outcomes and cost savings. Estimates from a Veterans Affairs pharmacist-run smoking cessation clinic included an annual savings of $691,200 and a net cost benefit to the Veterans Affairs of $551,200.¹⁷ Pharmacists may play a pivotal role in the management of chronic diseases by monitoring and modifying drug therapy and by educating patients. Because pharmacists are present in acute care, community, ambulatory, and home care settings, they are positioned to be a valuable member of the health-care team. A 2008 systematic review evaluated 21 clinical trials to determine the effect of pharmacists’ interventions on diabetes management. Interventions included medication and lifestyle counseling and medication management through in-person visits or telephone follow-up. The primary outcome of interest was change in hemoglobin A_1C (HbA_1C). Measurements of HbA_1C improved by 0.1—2.1 across all trials with greatest improvement shown when pharmacists were given prescriptive authority.¹⁸

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