In the US, the Medicare Modernization Act of 2003 required that Medicare Part D insurers provide medication therapy management (MTM) services (MTMS) to selected beneficiaries, with the goals of providing education, improving adherence, or detecting adverse drug events and medication misuse. These broad goals and variety in MTM programmes available make assessment of these programmes difficult. The objectives of this article are to review the definitions of MTMS proposed by various stakeholders, and to summarize and evaluate the outcomes of MTMS consistent with those that may be offered in Medicare Part D or reimbursed by State Medicaid programmes. MTM programmes are approved by the Centers for Medicare and Medicaid Services (CMS). Pharmacy, medical and insurance organizations have provided guidelines and definitions for MTM programmes, distinguishing them from other types of community pharmacy activities. MTM has been distinguished from disease state management because of the focus on medications and multiple conditions. It differs from patient counselling because it is delivered independent of dispensing and involves collaboration with patients and providers. There is no consensus on the recommended mode of delivery (i.e. face-to-face or by telephone) for MTM. A MEDLINE search was conducted to identify articles published after 2000 using the search terms 'medication therapy management' and 'medication management'. Studies with outcomes evaluating community-based programmes consistent with MTMS, regardless of MTMS reimbursement source, were included in the review. Seven publications describing four MTMS were identified. For each of the identified articles, we describe the study design, service setting, inclusion criteria and outcomes. An additional three surveys describing multiple MTMS were identified and are summarized. Finally, ongoing efforts by CMS to evaluate the success of MTMS in the US are described. To date, there are limited outcomes available for MTMS. The wide variety of MTMS offered means that evaluations of individual programmes are necessary. Despite the potential benefits of MTMS, there are numerous challenges to providing MTMS, including reimbursement, justification of the service and stakeholder acceptance of the services. There remains a need for adequately funded, prospective, controlled studies of MTM programmes using strong designs to advance our knowledge of the effectiveness of various interventions and methods of delivery, and for naturalistic studies assessing the impact of CMS approved MTM programmes.

Patients with diabetes and receiving MTMC had greater A1C improvements, compared with controls, of 0.54% (P = 0.0067) at 6 months and 0.63% (P = 0.0160) at 12 months. At 6 months, SBP and DBP decreased in MTMC patients by 6.5 mm Hg (P = 0.0108) and 3.8 mm Hg (P = 0.0136) more than controls, respectively. At 12 months, those receiving MTMC services had SBP and DBP decreases, respectively, of 8.2 mm Hg (P = 0.0018) and 1.7 mm Hg (P = 0.2691) compared with controls. ED and hospital visits were not statistically significantly different between groups. Conclusion and Relevance: This MTMC potentially improved outcomes for referred patients in whom target goals were difficult to achieve and can serve as a model for other similar medication management programs.

OBJECTIVES To evaluate the effectiveness of clinical pharmacists and community health workers (CHWs) in improving glycemic control within a low-income ethnic minority population. METHODS In a two-arm 2-year crossover trial, 179 African-American and 65 Hispanic adult patients with uncontrolled diabetes mellitus (hemoglobin A 1c [HbA1C] of 8% or higher) were randomized to CHW support either during the first or second year of the study. All participants received clinical pharmacist support for both years of the study. The primary outcome was change in HbA1C over 1 and 2 years. RESULTS Similar HbA1C declines were noted after receiving the 1 year of CHW support: À0.45% (95% confidence interval [CI] À0.96 to 0.05) with CHW versus À0.42% (95% CI À0.93 to 0.08) without CHW support. In addition, no differences were noted in change on secondary outcome measures including body mass index, systolic blood pressure, high-density lipoprotein and low-density lipoprotein cholesterol, quality of life, and perceived social support. A difference in diastolic blood pressure change was noted: 0.80 mm Hg (95% CI À1.92 to 3.53) with CHW versus À1.85 mm Hg (95% CI À4.74 to 1.03) without CHW support (p=0.0078). Patients receiving CHW support had more lipid-lowering medication intensifications (0.39 [95% CI 0.27-0.52]) compared with those without CHW support (0.26 [95% CI 0.14-0.38], p<0.0001). However, no significant differences in intensification of antihyperglycemic and antihypertensive medications were observed between patients receiving CHW support and those without CHW support. Patients with low health literacy completed significantly more encounters with the pharmacist and CHW than those with high health literacy, although outcomes were comparable. CONCLUSIONS No significant differences were noted between a clinical pharmacist-CHW team and clinical pharmacist alone in improving glycemic control within a low-income ethnic minority population.

BackgroundGiven the increasing prevalence of diabetes and the lack of patients reaching recommended therapeutic goals, novel models of team-based care are emerging. These teams typically include a combination of physicians, nurses, case managers, pharmacists, and community-based peer health promoters (HPs). Recent evidence supports the role of pharmacists in diabetes management to improve glycemic control, as they offer expertise in medication management with the ability to collaboratively intensify therapy. However, few studies of pharmacy-based models of care have focused on low income, minority populations that are most in need of intervention. Alternatively, HP interventions have focused largely upon low income minority groups, addressing their unique psychosocial and environmental challenges in diabetes self-care. This study will evaluate the impact of HPs as a complement to pharmacist management in a randomized controlled trial.Methods/DesignThe primary aim of this randomized trial is to evaluate the effectiveness of clinical pharmacists and HPs on diabetes behaviors (including healthy eating, physical activity, and medication adherence), hemoglobin A1c, blood pressure, and LDL-cholesterol levels. A total of 300 minority patients with uncontrolled diabetes from the University of Illinois Medical Center ambulatory network in Chicago will be randomized to either pharmacist management alone, or pharmacist management plus HP support. After one year, the pharmacist-only group will be intensified by the addition of HP support and maintenance will be assessed by phasing out HP support from the pharmacist plus HP group (crossover design). Outcomes will be evaluated at baseline, 6, 12, and 24 months. In addition, program and healthcare utilization data will be incorporated into cost and cost-effectiveness evaluations of pharmacist management with and without HP support.DiscussionThe study will evaluate an innovative, integrated approach to chronic disease management in minorities with poorly controlled diabetes. The approach is comprised of clinic-based pharmacists and community-based health promoters collaborating together. They will target patient-level factors (e.g., lack of adherence to lifestyle modification and medications) and provider-level factors (e.g., clinical inertia) that contribute to poor clinical outcomes in diabetes. Importantly, the study design and analytic approach will help determine the differential and combined impact of adherence to lifestyle changes, medication, and intensification on clinical outcomes.Trial registrationClinicalTrials.gov identifier: NCT01498159

A referral-based MTM clinic managed by pharmacists at a university medical center outpatient pharmacy provides care to patients with the goal of improving medication access, medication adherence, continuity of care, medication therapy management, and patient education.