Advertisement

The Need for More Evidence-based Studies to Justify the Economic Value for the Provision of Medication Therapy Management and Other Clinical Pharmacy Services

      Medication therapy management (MTM) is an example of a clinical pharmacy service, similar in concept to others such as pharmaceutical care services, cognitive pharmacy, and disease state management. It describes a range of services provided independent of dispensing of medications and involves collaboration with patients and other health care providers.
      • Rascati K.L.
      Pharmacy services.
      The provision of these services became necessary due to the increase in medication-related problems, many of which are preventable.
      • Ernst F.R.
      • Grizzle A.J.
      Drug-related morbidity and mortality: updating the cost-of-illness model.
      MTM services are aimed at improving patient's drug use, optimizing clinical outcomes, reducing the risk for adverse events, improving quality of life, and reducing overall health care costs.
      • Bluml B.M.
      Definition of medication therapy management: development of professionwide consensus.
      These services have demonstrated positive clinical, humanistic, and economic outcomes.
      • Anaya J.P.
      • Rivera J.O.
      • Lawson K.
      • et al.
      Evaluation of pharmacist-managed diabetes mellitus under a collaborative drug therapy agreement.
      • Iyer R.
      • Coderre P.
      • McKelvey T.
      • et al.
      An employer-based, pharmacist intervention model for patients with type 2 diabetes.
      • Fera T.
      • Bluml B.M.
      • Ellis W.M.
      Diabetes Ten City Challenge: final economic and clinical results.
      • Ramalho de Oliveira D.
      • Brummel A.R.
      • Miller D.B.
      Medication therapy management: 10 years of experience in a large integrated health care system.
      • Bunting B.A.
      • Cranor C.W.
      The Asheville Project: long-term clinical, humanistic, and economic outcomes of a community-based medication therapy management program for asthma.
      • Garrett D.G.
      • Bluml B.M.
      Patient self-management program for diabetes: first-year clinical, humanistic, and economic outcomes.
      In 2005, a total of 11 national organizations, including the American Pharmacists Association and the National Association of Chain Drug Stores Foundation, identified 5 fundamental components required of any MTM program. These include medication therapy review, personal medication record, medication action plan, intervention and referral, and documentation and follow-up.
      American Pharmacists Association and National Association of Chain Drug Stores Foundation
      Medication therapy management in community pharmacy practice: core elements of an MTM service (version 1.0).
      American Pharmacists Association and National Association of Chain Drug Stores Foundation
      Medication therapy management in pharmacy practice: core elements of an MTM service model (version 2.0).
      Although pharmacists have provided MTM or related clinical services for many years, the Medicare Part D prescription drug benefit expanded pharmacists' opportunities for compensation. While the need to provide these services cannot be overemphasized, pharmacists are faced with a number of challenges. These include: lack of time; high workload; staff shortages; compensation issues; lack of access to patients' records; administrative burdens; poor physician collaboration; and health plan nonuniformity regarding service provision. Patient-identified barriers include: lack of awareness of service availability; lack of perceived need and a low willingness to pay for services; and fear of obtaining recommendations that may be contrary to their physician's plan of care.
      • Oladapo A.O.
      • Rascati K.L.
      Review of survey articles regarding medication therapy management (MTM) services/programs in the United States.
      In addition to the aforementioned challenges, the increasing demand for the demonstration of value for MTM or related clinical services by stakeholders, especially health care administrators and payers, further threatens the sustainability of these services.
      • Harris I.M.
      • Baker E.
      • Berry T.M.
      • et al.
      Developing a business-practice model for pharmacy services in ambulatory settings.
      Value can be defined as outcomes (ie, clinical, humanistic, economic) received in relation to the expenditures for these services.
      • Fera T.
      • Bluml B.M.
      • Ellis W.M.
      Diabetes Ten City Challenge: final economic and clinical results.
      The 4 basic pharmacoeconomic evaluation methods used in estimating value are cost-minimization analysis (CMA), cost-effectiveness analysis (CEA), cost-utility analysis (CUA), and cost–benefit analysis (CBA).
      • Rascati K.L.
      Essentials of Pharmacoeconomics.
      Each evaluation method measures input costs in monetary units but differs in how outcomes or benefits are measured and compared. CMA is the easiest to conduct compared with the other methods; it requires only the measurement and comparison of input costs because outcomes are assumed to be equivalent. CMA cannot be used when outcomes of intervention are different. CEA measures outcomes in natural health or clinical units, which are routinely measured in clinical settings or trials that show improvement in health. Although CEA remains the most commonly used method in the pharmacy literature, its use is limited to comparisons between alternatives that have outcomes measured in the same clinical units. Furthermore, CEA can only be used to compare 1 type of clinical outcome at a time.
      CUA, however, allows for comparisons to be made between different types of health outcomes and diseases with multiple outcomes of interest. With CUA, different outcomes can be summarized into 1 clinical outcome measure, usually the quality-adjusted life-year. CUA also has the advantage of incorporating patient preferences, such as those regarding morbidity and mortality of health events, when measuring outcomes. Its main limitation lies in the difficulty of determining an accurate utility or quality-adjusted life-year value.
      • Rascati K.L.
      Essentials of Pharmacoeconomics.
      A unique feature of CBA lies in the fact that outcomes are measured in monetary units. CBA can be used to compare multiple programs with different outcomes to determine which has the greatest financial benefit. It is especially useful because it is the only approach that can be used to value both indirect (productivity) and intangible benefits along with the direct benefits of an intervention, program, or service. CBA is widely used for planning and evaluation of programs and proposals, as well as for decision support purposes, because it aids in understanding the financial net effect of a decision. Its limitation lies in the difficulty in accurately placing economic values on health outcomes and the lack of universal consensus on 1 standard method for achieving this goal.
      • Rascati K.L.
      Essentials of Pharmacoeconomics.
      Given the current difficult economic climate, coupled with the rise in the cost of providing health care services and the need for providers to meet their commitment to providing good quality services while balancing costs to stay afloat, many decision makers are forced to make hard choices regarding which services or programs to adopt or discontinue. Apart from considering the clinical benefits of services to be provided, also critical to the decision-making process is whether the services to be adopted will result in any cost savings and how significant will the cost savings be compared with those of other competing services. Although a significant number of studies have been published demonstrating the clinical benefits of providing MTM or related clinical pharmacy services to patients, not many studies have been published showing how this translates into monetary returns or savings for the providers and payers to ensure that the provision of services is sustained.
      Of the 4 basic pharmacoeconomic evaluation methods described here, CBA is the most suitable for demonstrating economic value because it is a comprehensive approach at valuing the benefits of an intervention relative to its implementation cost with results presented in a way that payers or decision makers, irrespective of their background, can easily relate to or understand. Apart from conducting CBA, another suitable approach for providing evidence or justification for value is the return on investment (ROI). It measures the cash flow of the investment to the investor relative to the amount invested. It has also been defined as a form of CBA in which the cost of implementing an intervention is compared with the tangible financial gains or benefits expected from the intervention.
      National States Geographic Information Council (NSGIC)
      Advancing statewide spatial data infrastructures in support of the National Spatial Data Infrastructure (NSDI) Economic justification: measuring return on investment (ROI) and cost benefit analysis (CBA).
      ROI is widely used to justify the existence of a current project, offer rationalization for a previous expenditure, and provide a persuasive reasoning to take a specific course of action. A common use of ROI analyses in health care decision making has been in justifying the value of employer-sponsored wellness programs.
      • Henke R.M.
      • Goetzel R.Z.
      • McHugh J.
      • Isaac F.
      Recent experience in health promotion at Johnson & Johnson: lower health spending, strong return on investment.
      • Javitz H.S.
      • Swan G.E.
      • Zbikowski S.M.
      • et al.
      Return on investment of different combinations of bupropion SR dose and behavioral treatment for smoking cessation in a health care setting: an employer's perspective.
      CBA and ROI analyses have also been used by government agencies, managed care organizations, and other private entities to justify the value of certain disease prevention and management programs, and are considered to be important tools for making financial decisions.
      • Sackett K.
      • Pope R.K.
      • Erdley W.S.
      Demonstrating a positive return on investment for a prenatal program at a managed care organization An economic analysis.
      • Luce B.R.
      • Mauskopf J.
      • Sloan F.A.
      • et al.
      The return on investment in health care: from 1980 to 2000.
      The American College of Clinical Pharmacy Task Force on Economic Evaluation of Clinical Pharmacy Services has, over the years, conducted systematic reviews of economic studies on clinical pharmacy services, including MTM services.
      • Schumock G.T.
      • Meek P.D.
      • Ploetz P.A.
      • Vermeulen L.C.
      Economic evaluations of clinical pharmacy services—1988–1995 The Publications Committee of the American College of Clinical Pharmacy.
      • Schumock G.T.
      • Butler M.G.
      • Meek P.D.
      • et al.
      Evidence of the economic benefit of clinical pharmacy services: 1996–2000.
      • Perez A.
      • Doloresco F.
      • Hoffman J.M.
      • et al.
      ACCP: economic evaluations of clinical pharmacy services: 2001–2005.
      • Willett M.S.
      • Bertch K.E.
      • Rich D.S.
      • Ereshefsky L.
      Prospectus on the economic value of clinical pharmacy services A position statement of the American College of Clinical Pharmacy.
      Based on the results of these reviews, ∼16% (n = 50) of articles reviewed (N = 315), published between 1988 and 2005, reportedly conducted CBAs. Furthermore, an independently conducted literature search for studies published between 2006 and 2011 identified ∼21 economic studies on clinical pharmacy services. However, only one half of these studies can be considered to have conducted CBA and/or ROI analyses. Although the majority of these studies reported positive economic values with the provision of MTM or clinical pharmacy services, they also had limitations. These include: absence of a control or comparison group; insufficient detail on the services provided; restriction of input costs to only personnel costs and failure to input other costs involved in the provision of the service; failure to evaluate clinical outcomes and convert them to monetary units; focus on direct drug costs only; absence of incremental CBAs and sensitivity analyses; and failure to evaluate indirect costs.
      Future studies may add more validity to study results by addressing the limitations listed here; however, it is important to be aware of the associated challenges. Having a comparison group (ie, patients who do not receive the service) with similar baseline characteristics as the intervention group will increase the ability to attribute the study outcomes to the services or intervention provided by the pharmacist. In addition, using a more rigorous study design (eg, randomized controlled) further increases the study's internal validity by controlling for biases and confounders. It also provides evidence regarding the strength of the relationship between the clinical pharmacy or MTM services provided and the outcome or benefits obtained. Although this approach sounds promising from a research point of view, it may not be acceptable from an ethical point of view because patients cannot be deliberately denied services that can improve their health outcomes. Also, patients may have non-obvious reasons (eg, lack of perceived need) for why they may not want to receive certain services, many of which may be difficult to control for as covariates in nonrandomized controlled studies.
      Providing detailed descriptions of the services rendered is necessary for replication and extrapolation of study findings to other settings. It also allows for comparison of study findings across similar studies. However, the ability to compare study findings will depend on the extent to which services provided are identical because there is presently no standardization of services. Inclusion of relevant input costs such as salaries, fringe benefits, and opportunity costs, as well as overhead, operating, and equipment costs, is necessary to determine the actual cost at which services are provided. However, the provision of such information will also depend on the extent to which institutions are willing to share confidential information with the public. Furthermore, the evaluation and monetization of relevant outcomes or benefits (both tangible and intangible) will provide more detailed information for determining the value of these services. In addition, the evaluation of indirect costs will provide more information relevant to policy makers and employers because it measures the impact of the services provided on productivity. A major challenge here, as discussed earlier, lies in accurately placing economic values on health outcomes or benefits and the lack of universal consensus regarding the most appropriate approach for evaluating indirect cost.
      In conclusion, the challenges discussed here should not discourage researchers from conducting CBA/ROI analyses to justify the value of clinical pharmacy services. Efforts should instead be geared toward improving their study designs to provide more valid and reliable evidence needed for stakeholders, especially health care administrators and payers, to ensure the sustainability of the services.

      References

        • Rascati K.L.
        Pharmacy services.
        in: Essentials of Pharmacoeconomics. Lippincott Williams & Wilkins, Philadelphia, Pa2009: 197-215
        • Ernst F.R.
        • Grizzle A.J.
        Drug-related morbidity and mortality: updating the cost-of-illness model.
        J Am Pharm Assoc (Wash). 2001; 41: 192-199
        • Bluml B.M.
        Definition of medication therapy management: development of professionwide consensus.
        J Am Pharm Assoc (2003). 2005; 45: 566-572
        • Anaya J.P.
        • Rivera J.O.
        • Lawson K.
        • et al.
        Evaluation of pharmacist-managed diabetes mellitus under a collaborative drug therapy agreement.
        Am J Health Syst Pharm. 2008; 65: 1841-1845
        • Iyer R.
        • Coderre P.
        • McKelvey T.
        • et al.
        An employer-based, pharmacist intervention model for patients with type 2 diabetes.
        Am J Health Syst Pharm. 2010; 67: 312-316
        • Fera T.
        • Bluml B.M.
        • Ellis W.M.
        Diabetes Ten City Challenge: final economic and clinical results.
        J Am Pharm Assoc (2003). 2009; 49: 383-391
        • Ramalho de Oliveira D.
        • Brummel A.R.
        • Miller D.B.
        Medication therapy management: 10 years of experience in a large integrated health care system.
        J Manag Care Pharm. 2010; 16: 185-195
        • Bunting B.A.
        • Cranor C.W.
        The Asheville Project: long-term clinical, humanistic, and economic outcomes of a community-based medication therapy management program for asthma.
        J Am Pharm Assoc (2003). 2006; 46: 133-147
        • Garrett D.G.
        • Bluml B.M.
        Patient self-management program for diabetes: first-year clinical, humanistic, and economic outcomes.
        J Am Pharm Assoc. 2005; 45: 130-137
        • American Pharmacists Association and National Association of Chain Drug Stores Foundation
        Medication therapy management in community pharmacy practice: core elements of an MTM service (version 1.0).
        J Am Pharm Assoc. 2005; 45: 573-579
        • American Pharmacists Association and National Association of Chain Drug Stores Foundation
        Medication therapy management in pharmacy practice: core elements of an MTM service model (version 2.0).
        J Am Pharm Assoc (2003). 2008; 48: 341-353
        • Oladapo A.O.
        • Rascati K.L.
        Review of survey articles regarding medication therapy management (MTM) services/programs in the United States.
        J Pharm Pract. 2012 Apr 27; ([Epub ahead of print])
        • Harris I.M.
        • Baker E.
        • Berry T.M.
        • et al.
        Developing a business-practice model for pharmacy services in ambulatory settings.
        Pharmacotherapy. 2008; 28: 285
        • Rascati K.L.
        Essentials of Pharmacoeconomics.
        in: Lippincott Williams & Wilkins, Philadelphia, Pa2009: 35-100
        • National States Geographic Information Council (NSGIC)
        Advancing statewide spatial data infrastructures in support of the National Spatial Data Infrastructure (NSDI).
        (Accessed April 8, 2011)
        • Henke R.M.
        • Goetzel R.Z.
        • McHugh J.
        • Isaac F.
        Recent experience in health promotion at Johnson & Johnson: lower health spending, strong return on investment.
        Health Aff (Millwood). 2011; 30: 490-499
        • Javitz H.S.
        • Swan G.E.
        • Zbikowski S.M.
        • et al.
        Return on investment of different combinations of bupropion SR dose and behavioral treatment for smoking cessation in a health care setting: an employer's perspective.
        Value Health. 2004; 7: 535-543
        • Sackett K.
        • Pope R.K.
        • Erdley W.S.
        Demonstrating a positive return on investment for a prenatal program at a managed care organization.
        J Perinat Neonatal Nurs. 2004; 18: 117-127
        • Luce B.R.
        • Mauskopf J.
        • Sloan F.A.
        • et al.
        The return on investment in health care: from 1980 to 2000.
        Value Health. 2006; 9: 146-156
        • Schumock G.T.
        • Meek P.D.
        • Ploetz P.A.
        • Vermeulen L.C.
        Economic evaluations of clinical pharmacy services—1988–1995.
        Pharmacotherapy. 1996; 16: 1188-1208
        • Schumock G.T.
        • Butler M.G.
        • Meek P.D.
        • et al.
        Evidence of the economic benefit of clinical pharmacy services: 1996–2000.
        Pharmacotherapy. 2003; 23: 113-132
        • Perez A.
        • Doloresco F.
        • Hoffman J.M.
        • et al.
        ACCP: economic evaluations of clinical pharmacy services: 2001–2005.
        Pharmacotherapy. 2009; 29 (Abstract): 128
        • Willett M.S.
        • Bertch K.E.
        • Rich D.S.
        • Ereshefsky L.
        Prospectus on the economic value of clinical pharmacy services.
        Pharmacotherapy. 1989; 9: 45-56