Medication Therapy Management and Its Implications

Introduction

The professional pharmacy deals with the proper delivery of drug therapy to patients. However, it has long been confined to mere delivery of drugs without including the use, evaluation, and monitoring of drug therapy for the patients (McGivney et al. 621). The increasing number of adverse drug reactions and drug costs over the years has led the government to focus on the role of pharmacists’ ineffective drug use by patients. As a result, the US government passed the Medicare Modernization Act of 2003 and Medicare Prescription Medication Benefit (Part D), incorporating medication therapy management (MTM) services (McGivney et al. 621).

The act mandates the prescription drug plan sponsors of Medicare Part D and Medicare Advantage Plans implementing drug benefit under Part C to provide medication therapy management to ensure proper drug use and minimization of adverse drug reactions (Maryland 179). The MTM program aims at those beneficiaries of Medicare who are using multiple drugs for multiple chronic conditions, incurring high drug costs (Maryland 179).

It means that the service is primarily targeted at beneficiaries eligible for Medicare Part D and incurring annual drug costs beyond the specified level of the Department of Health and Human Services, which was approximately equal to or more than $4,000 for 2006 (Ploehn 647). The MTM service market can also involve nonbeneficiaries of Medicare Part D who are ready to pay their own money to join the program (Ploehn 647).

Medication Therapy Management (MTM)

The pharmacy profession defined MTM as “a distinct service or group of services that optimize therapeutic outcomes for individual patients that are independent of but can occur in conjunction with, the provision of a drug product” (McGivney et al. 621). Also, the Center for Medicare & Medicaid Services defines MTM as a mechanism for ensuring “medications prescribed for targeted beneficiaries are appropriately used, optimizing therapeutic outcomes and reducing the risk of adverse events” (McGivney et al. 621).

The definition of MTM given by 11 national pharmacy organizations in July 2004 includes the following aspects:

• Obtaining required assessments of the patient’s health status (Maryland 181).
• Establishing a medication treatment plan (Maryland 181).
• Selecting, initiating, modifying, or administering medication therapy (Maryland 181).
• Evaluation of patient’s response to therapy (Maryland 181).
• Following a comprehensive medication review to prevent adverse drug events and other medication-related problems (Maryland 181).
• Documenting data and communicating information to patients and primary care providers when required (Maryland 181).
• Enhancing patient’s understanding of proper drug use through education and training (Maryland 181).
• Providing information and resources to improve patient’s adherence to therapeutic regimens (Maryland 181).
• Integrating MTM into the healthcare management services that are offered to the patient (Maryland 181).

The above aspects are also considered as the core elements of MTM formulated by the American Pharmacists Association and the National Association of Chain Drug Stores Foundation (McGivney 621).

Criteria for Target Beneficiaries

Beneficiaries are mostly patients with multiple chronic diseases, using multiple drugs under Part D and incurring higher annual drug costs than set levels. The main considerations include the existing data on the incidence and prevalence of chronic diseases in the Medicare population, the availability of treatment guidelines, and effectiveness of evidence of drug therapy in the treatment protocols (Maryland 182).

The criteria to identify drug use include the use of multiple drugs, combinations of drugs used, and nonuse of indicated drugs, among others (Maryland 182). The patient’s drug costs are determined by the track record of various healthcare costs that indicate whether or not the costs are beyond the set level (Maryland 182). Other patients who visit multiple physicians and/or pharmacists, and/or lack evidence of coordination of care can be considered for MTM service (Maryland 182).

Requirements for Pharmacies to Participate in MTM Service

Pharmacists should have up-to-date therapeutic knowledge and efficient patient care skills to carry out interpersonal communication, problem-solving and documentation activities (Ploehn 646). Pharmacies are supposed to have an adequate workforce to perform multiple functions such as drug use review, patient counseling, and physician consultations (Ploehn 646). Apart from this, pharmacies need to integrate their patient care services with MTM services and should be able to bill Medicare (Ploehn 646). It is advisable to have patient information sources and facilities for laboratory testing, wellness screenings, and drug information services (Ploehn 647). Compliance with State Practice Act is an essential criterion (Ploehn 647).

Comparison of MTM with Pharmaceutical Care

The term ‘pharmaceutical care was first put forth by Hepler and Strand in 1900; to give a new dimension to the pharmacist and pharmacy responsibilities (McGivney et al. 621). The latest definition can be explained for pharmaceutical care as “a patient-centered practice in which the practitioner assumes responsibility for a patient’s drug-related needs and is held accountable for this commitment” (McGivney et al. 622). However, the concept failed in practice owing to many limitations like the lack of standard payment mechanisms for pharmacist-patient care services (McGivney et al. 622). MTM service can be viewed as a sophisticated version of pharmaceutical care that targets a defined patient population and incorporates standard payments for services provided (McGivney et al. 622).

MTM and Drug Regimen Review

The DRR required in long-term-care facilities (LTCFs) needs direct funding for pharmacists’ services, whereas MTM service is paid by the prescription drug plan (PDP) that receives compensation from the Center for Medicare and Medicaid Services (CMS) (Summers 68). However, the coverage of pharmacists’ payment may vary from PDP to the other (Summers 68). Moreover, there is a certain overlap that many services provided by pharmacists under DRR of LTCF can be considered as MTM services in the ambulatory setting (Summers 68).

Review of Studies

Various studies have been conducted to evaluate different dimensions of medication therapy management. Some of the important studies have been discussed here.

Hansen et al. conducted a study in North Carolina in January 2005 to evaluate the types of cognitive services offered and the number of patients served by pharmacies under MTM (700-1). They also tried to evaluate whether the current and expected practices would meet the potential needs of enrollees (Hansen et al. 701). It was a cross-sectional study, and they surveyed 1,593 community pharmacy managers. They tried to gather information regarding the types and frequency of services offered by pharmacies, along with details of payment for the services (Hansen et al. 702). They mostly contacted pharmacy managers through e-mails or paper mails (Hansen et al. 702). The obtained data were analyzed using descriptive statistics and bivariate analyses (Hansen et al. 702).

The results indicated that the percentage of community pharmacies providing cognitive services increased slightly from a 1999 survey (Hansen et al. 706). Moreover, it was observed that pharmacists with a bachelor’s degree were more likely to offer services than those with a doctor of pharmacy degree (Hansen et al. 703). As a whole, 31 percent of respondents provided MTM services at par with the profession-wide consensus definition (Hansen et al. 703).

Another study was conducted in North Carolina by Christensen et al. to identify the feasibility of a pharmacist-based MTM service for North Carolina State Health Plan enrollees (471). The objectives were to describe identification, resolution, and results obtained after changes in drug therapy about potential drug therapy problems (PDTPs); measure changes in the cost of drug therapy with MTM services, and measure the level of patient satisfaction (Christensen et al. 472).

The participants included 67 patients, who used a large number of prescription drugs, 10 community/ambulatory pharmacists, and approximately 600 participants from two control groups (Christensen et al. 473-5). It was a before/after design with two control groups, using propensity scoring to identify comparison groups (Christensen et al. 471 & 3). Also, MTM reviews were conducted for participating patients by pharmacists (Christensen et al. 475).

Coming to the results, the pharmacists identified an average of 3.6 PDTPs per patient initially, and nearly 50 percent of patients with PDTPs had a change in drug therapy (Christensen et al. 476). Pharmacists offered education regarding medication use, disease management, adherence, and self-cure (Christensen et al. 476). Though there was a noticeable improvement in patient satisfaction and decrease in prescription use, no significant changes were found in patient co-payment or insurer prescription costs (Christensen et al. 471 & 471-8).

In another study, Horning et al. tried to compare the adherence to clinical practice guidelines (CPGs) in patients in long-term care facilities who received pharmacist consultation on disease state management (DSM) with patients in LTCFs who received normal drug regimen review (DRR) (28-35). They compared 107 patients who received DSM service with 304 patients who received DRR services (Horning et al. 29-31).

The results showed that patients with DSM service had better adherence to CPGs against their counterparts (Horning et al. 28 & 31-2). The results confirmed that the CPG adherence for common chronic disease states was higher in patients who had DSM service by pharmacists (Horning et al. 32 & 4).

Stebbins et al. conducted a study based on the PRICE clinic model, designed to increase cost-effectiveness (333-40). It was said that the model was adaptable to medication therapy management program (MTMP) services to aid low-income elderly patients to reduce drug expenses, provide patients with efficient and cost-effective drug regimens, and improve access to necessary medications (Stebbins et al. 333).

The study was done by documenting and analyzing data from 520 patients who were present in the PRICE clinic in 2002 (Stebbins et al. 333). They analyzed the number and type of pharmacist interventions and changes in generic drug use and out-of-pocket costs (OOP) (Stebbins et al. 333& 6). The results indicated that timely intervention by pharmacists led to improvements inappropriate drug use, reduction of OOP costs, and access to needed drugs (Stebbins et al. 338-40).

Daniel and Malone conducted a study to estimate two aspects from Medical Expenditure Panel Survey (MEPS) data for 2002-2003. They were the proportion of elders who might have met the $4,000 expenditure component set by medication therapy management program (MTMP) criteria and estimate on patient-specific risk factors due to reaching the expenditure threshold (Daniel and Malone 142).

They observed various variables like demographics, socioeconomic status, functional limitations, health status, the occurrence of chronic conditions, body mass index, medical and prescription drug insurance, and health care utilization measures (Daniel and Malone 143). They adjusted standard errors of calculating estimates through the Taylor-series linearization approach (Daniel and Malone 143). The results of estimates from 8,035 noninstitutionalized persons aged 65 years or older in the United States led to conclude that 3.3 million of 36.5 million older adults incurred annual drug expenditures as much as $3,810, approximately 35 % drug expenditure by all older adults (Daniel and Malone 142&6). Thus, it meant that older patients with annual drug expenditure beyond the MTMP threshold level had relatively higher drug use and disease burden over others (Daniel and Malone 142, 152&3).

Apart from these studies, many other studies conducted exclusively on the effectiveness of medication therapy management resulted in encouraging outcomes. The studies conducted by Garrett D and Bluml B; Jameson et al.; Bootman et al.; McMullin et al.; Christensen et al.; and Cranor et al. revealed that implementation of MTMP including patient education by pharmacists resulted in a substantial reduction in drug expenditures compared to preintervention estimates (Sound Medication 12-21). The difference was as high as 41% as was evident from the study of McMullin et al. (Sound Medication 15).

Asheville Project

Two studies conducted separately in Asheville, North Carolina, to observe the long-term clinical, humanistic, and economic outcomes of a community-based medication therapy management for asthma, and hypertension, and dyslipidemia have been described here.

Bunting and Cranor observed 207 adult patients with asthma for 5 years to evaluate various outcomes of a community-based medication therapy management (MTM) program (133-47). They performed a quasi-experimental, longitudinal pre and post-interventional study (Bunting and Cranor 134&5). The participants included patients with asthma covered by two self-insured health plans, one professional educator at Mission Hospital, 18 certificate-trained community and hospital pharmacists (Bunting and Cranor 133).

The range of interventions included education for patients; initial check-up and long-term follow-up visits by pharmacists including consultations, monitoring, and recommendations to concerned physicians (Bunting and Cranor 135). The outcome was estimated through factors like forced expiratory volume in 1 second (FEV1), asthma symptoms, and related emergency hospital visits (Bunting and Cranor 135&6).

The results concluded that education and long-term MTM caused significant improvements for the patients and reduction of asthma-related costs (Bunting and Cranor 143-6).

The Asheville study by Bunting, Smith, and Sutherland to determine the effects of long-term MTM program for hypertension and dyslipidemia resulted in sustained clinical improvements for 6 years, an increase of proper CV medication use, and decrease in adverse drug events and medical costs (23-31).

Predilections in MTM studies

Most of the studies involved patients who participated voluntarily due to either self-interest or motivation from employers. Most of them were beneficiaries of Medicare prescription drug benefits (part D). Of the participants, women outnumbered men, which was 72% and 28% respectively in one of the Asheville projects (Bunting and Cranor 137). Moreover, almost all the patients in the listed studies were using multiple medications for multiple chronic diseases. This was almost a prime requirement for selection into the study, as a comparison would be needed on multiple drug use and effects during the course of the studies.

MTM Implications

The initial ambiguity over MTM owing to insufficient standards and performance measures to evaluate MTMPs was later overcome by flexibility given by the Centers for Medicare and Medicaid Services (CMS) in implementing plans for MTMPs (Spooner 586).

The program provides opportunities for pharmacists and other related health care providers to identify patients requiring MTM services along with standard payment for services as per contemporary provider payment rates based on time, clinical intensity, and resources used for the service (Medication Therapy 2). Nonetheless, pharmacists need to render efficient services while maintaining compliance with private sector markets and federal policies (Christensen and Farris 1405).

Also, though MTM activities were relatively new approaches, patients showed favorable attitudes and satisfaction towards pharmacist-provided training and MTM services in various surveys (Doucette et al. 761).

A successful MTM program requires a comprehensive team including physicians, pharmacists, nurses, and others (Bluml 571). For, all the involved parties will have benefits from MTM. To be precise, Clinical institutions can evaluate whether or not the patient expectations for pharmacy services are being met, emphasize to patients the importance of keeping scheduled appointments (Bruce and Jackson 663).

Instead of simply being confined to the delivery of prescribed medicines, pharmacists can have the chance to enhance patient care, and work towards identifying and resolving medication therapy problems (MTM 574). Coming to the patients, a study showed that drug cost savings were reported to be nearly $0.57 per member per month for new prescriptions and $1.07 for all prescriptions (Curtiss 354). Moreover, because MTM programs result in reduced drug expenses and hospitalizations, governments and third-party payment agencies should promote MTM to realize cost savings.

All in all, MTM services have been proved to be effective in clinical, social, and financial dimensions. Moreover, the increased awareness of the public and governments over the lack of public guidance for reducing improper drug use and adverse drug effects makes the MTM Program the best alternative to address major concerns.

References

Bluml, Benjamin M. “Definition of Medication Therapy Management: Development of Professionwide Consensus.” Journal of the American Pharmacists Association 45. 5 (2005): 566-72.

Bruce, Susan P. and Terri Jackson. “Collaborative Research: Benefits for all Involved.” Letters. Journal of the American Pharmacists Association 46. 6 (2006): 663&4.

Bunting, Barry A., Benjamin H. Smith and Susan E. Sutherland. “The Asheville Project: Clinical And Economic Outcomes of a Community-based Long-term Medication Therapy Management Program for Hypertension and Dyslipidemia.” Journal of the American Pharmacists Association 48. 1 (2008): 23-31.

Bunting, Barry A. and Carole W. Cranor. “The Asheville Project: Long-term Clinical, Humanistic, and Economic Outcomes of a Community-based Medication Therapy Management Program for Asthma.” Journal of the American Pharmacists Association 46. 2 (2006): 133-47.

Christensen, Dale B. et al. “Evaluation of a Pilot Medication Therapy Management Project Within the North Carolina State Health Plan.” Journal of the American Pharmacists Association 47. 4 (2007): 471-83.

Christensen, Dale B and Karen B Farris. “Pharmaceutical Care in Community Pharmacies: Practice and Research in the US.” The Annals of Pharmacotherapy 40 (2006): 1400-6.

Curtiss, Frederic R. “Clinical, Service, and Cost Outcomes of Computerized Prescription Order Entry.” Editorial Subjects- in this Issue and in Previous Issues. Journal of Managed Care Pharmacy 11. 4 (2005): 353-5.

Daniel, Gregory W. and Daniel C. Malone. “Characteristics of Older Adults Who Meet the Annual Prescription Drug Expenditure Threshold for Medicare Medication Therapy Management Programs.” Journal of Managed Care Pharmacy 13. 2 (2007): 142-54.

Doucette, William R. et al. “Attitudes of Medicare Beneficiaries toward Pharmacist-provided Medication Therapy Management Activities as Part of the Medicare Part D Benefit.” Research Notes. Journal of the American Pharmacists Association 47. 6 (2007): 758-61.

Hansen, Richard A. et al. “Medication Therapy Management Services in North Carolina Community Pharmacies: Current Practice Patterns and Projected Demand.” Journal of the American Pharmacists Association 46. 6 (2006): 700-6.

Horning, Kristin K., James D. Hoehns and William R. Doucette. “Adherence to Clinical Practice Guidelines for 7 Chronic Conditions in Long-term-care Patients Who Received Pharmacist Disease Management Services Versus Traditional Drug Regimen Review.” Journal of Managed Care Pharmacy 13. 1 (2007): 28-36.

Maryland, Bethesda. “Summary of the Executive Sessions on Medication Therapy Management Programs.” Letters. Journal of Managed Care Pharmacy 11. 2 (2005): 179-86.

McGivney, Melissa Somma et al. “Medication Therapy Management: Its Relationship to Patient Counseling, Disease Management, and Pharmaceutical Care.” Journal of the American Pharmacists Association 47. 5 (2007): 620-8.

“Medication Therapy Management in Community Pharmacy Practice: Core Elements of an MTM Service (Version 1.0).” Journal of the American Pharmacists Association 45. 5 (2005): 573-9.

“Medication Therapy Management Services Definition and Program Criteria.” The Academy of Managed Care Pharmacy: 1&2.

Ploehn, Lisa C. “Ready or Not, Here Comes Medication Therapy Management.” Association Report. Journal of the American Pharmacists Association 45. 6 (2005): 646-8.

“Sound Medication Therapy Management Programs: Appendix B.” 2006 Consensus Document (2005): 11-21.

Spooner, Joshua J. “Medication Therapy Management Services for Long-term Care Patients: No Road Maps for Those Trying to Find Their Way.” Editorial. Journal of Managed Care Pharmacy 11. 7 (2005): 586&7.

Stebbins, Marilyn R., David J. Kaufman and Helene Levens Lipton. “The PRICE Clinic for Low-income Elderly: A Managed Care Model for Implementing Pharmacist-directed Services.” Journal of Managed Care Pharmacy 11. 4 (2005): 333-41.

Summers, Kent H. “Medication Therapy Management Versus Drug Regimen Review.” Commentary. Journal of Managed Care Pharmacy 13. 1 (2006): 68-9.