Economic, clinical and humanistic outcomes

Kozma, C.M., et al., "Economic, Clinical, and Humanistic Outcomes A Planning Model for Pharmacoeconomic Research," Clin. Therapeut., 15, 1121-1132 (1993). 

Kozma CM, Reeder CE, Schultz RM, 1993. Economic, clinical and humanistic outcomes A planning model for pharmacoeconomic research. Clin Ther 15 1121. 

Many have proposed that evaluation of drug therapy and pharmacists value-added services should include assessments of economic, clinical, and humanistic outcomes. The economic, clinical, and humanistic outcomes (ECHO) model assumes that the outcomes of medical care can be classified along the three dimensions of economic, clinical, and humanistic outcomes (Kozma, Reeder, and Schultz, 1993). Clinical outcomes are defined as medical events that occur as a result of disease or treatment. Economic outcomes are defined as the direct, indirect, and intangible costs compared with the consequences of medical treatment alternatives. Humanistic outcomes are defined as the consequences of disease or treatment on patient functional status or quality of life. All three of these outcomes need to be balanced simultaneously to assess value. 

One framework for looking at pharmaceutical outcomes—whether these outcomes are positive or negative—is the ECHO (Economic, Clinical, and Humanistic Outcomes) model, proposed by Kozma, Reeder and Schulz. According to this model, three main types of... 

A more comprehensive conceptual framework, the ECHO model, places outcomes into three categories economic, clinical, and humanistic outcomes. The model covers the five D s within the clinical and humanistic outcomes and provides an added economic outcomes dimension. As described by Kozma and associates, clinical outcomes are the medical events that occur as a result of the condition or its treatment. Economic outcomes are the direct, indirect, and intangible costs compared with the consequences of a medical intervention. Along with patient satisfaction, an essential humanistic or patient-reported outcome is self-assessed function and wellbeing, or health-related quality of life (HRQOL). This chapter focuses on HRQOL as an outcome of pharmacotherapeutic interventions. 

While clinical outcomes are critical, they are no longer the sole factor reviewed in making a decision to use an intervention. Just as the information requirements increased from safety, to safety and efficacy in the 1960s, the bar has been raised once again, and these requirements now include not only clinical (safety and efficacy), but also economic and humanistic outcomes. This paradigm shift has been represented in a model termed the ECHO (economic, clinical and humanistic outcomes) model, described by Kozma et al (1993). Economic outcomes include direct medical resources used to provide a service or achieve an outcome, including... 

There are different ways to look at outcomes. One method, the ECHO model, purports three basic types of outcomes economic, clinical, and humanistic (Kozma et al., 1993). Economic outcomes include direct costs and consequences, both medical and nonmedical, and indirect costs and consequences. For example, when assessing outcomes from a patient perspective, a medication copayment would be a direct medication cost, whereas gas money to pick up the medication from the pharmacy would represent a nonmedical direct cost. Lost wages from missed work could be regarded as an indirect cost. 

The final customers of the healthcare service are patients and their families, and the final product is health. Health as a product is not easy to define and measure. A way to measure the product of healthcare systems is to look at their outcomes. Today, the outcomes of healthcare systems are considered to be economic, clinical, and humanistic in nature. 

Quality is evaluated by measuring relevant indicators. Outcomes indicators (economic, clinical, and humanistic) will be the major importance in the future for clinical pharmacist services. Clinical pharmacist services must relocate themselves strategically as a proactive agent and lead drug therapy in the healthcare team. 

Links care to the outcomes of interest to consumers of health care, taking into account the multidimensional nature of quality by including clinical, economic, and humanistic outcomes. 

Table 23.1 provides examples of clinical, economic and humanistic outcomes. Each outcome type is not mutually exclusive, for example pain... 

The important first step in developing a pharmacoeconomic strategic plan is to start by finding out what is currently known about the disease and the economic and humanistic burden that it has on patients, payers and providers. The best place to start is with a review of the literature and the Internet to determine what has already been accomplished. This may entail a review of the epidemiology and clinical aspects of the condition to verify that pharmacoeconomic components would be a worthwhile addition to a clinical program. After this review the pharmacoeconomist should then formulate the plan for measuring economic and humanistic outcome, and this will ultimately become a component of the full development plan. 

Instead of focusing strictly on the pharmacy profession, the fourth conference addressed the quality of the entire medication-use system. The objectives were to describe—and publicize—the extent of preventable morbidity, mortality, and excess costs resulting from suboptimal medication use to stimulate discussion of the social and economic impact of dysfunction in the medication-use system to develop a reengineered system for medication use that would optimize clinical, economic, and humanistic outcomes to identify strategies that could be used to evaluate and implement the models developed and to foster greater interprofessional collaboration and a shared commitment to optimal medication use. 

One of the primary applications of pharmacoeconomics in clinical practice today is to aid clinical and policy decision making. Through the appropriate application of pharmacoeconomics, practitioners and administrators can make better, more-informed decisions regarding the products and services they provide. Complete pharmacotherapy decisions should contain assessments of three basic outcome areas whenever appropriate clinical, economic, and humanistic outcomes. Traditionally, most drug therapy decisions were based solely on the cfinical outcomes (e.g., safety and efficacy) associated with a treatment alternative. Over the past lOto 15 years, it has become quite popular also to include an assessment of the economic outcomes associated with a treatment alternative. The current trend is also to... 

Bungay KM, Sanchez LA. Types of economic and humanistic outcomes assessments. In Grauer D, Lee J, Odom T, et al., eds. Pharmacoeconomics and Outcomes, 2d ed. Kansas City, MO, American College of Clinical Pharmacy, 2003 18-60. 

The third step is to establish a framework to evaluate the question. When establishing the framework, pharmacists need to know some basic facts about the programs and diseases they are studying. Pharmacists undertaking these projects first should prioritize their objectives by determining what interventions and outcomes most need to be evaluated. For example, Cynthia Marshall may wish to determine the effect of her monitoring program on cost of care (an economic outcome), blood pressure (a clinical outcome), and quality of life (a humanistic outcome). 

Outcomes research is defined as studies that attempt to identify, measure, and evaluate the end results of health care services. Outcomes research may evaluate not only the clinical effects of health care services but also the economic and humanistic impact of these services. Proponents of outcomes research believe that we should measure not only the clinical and cost impacts of health care but also outcomes that take factors... 

Cost-utility analysis is used when quality of fife is the most important outcome being examined. This is common in disease states in which how one feels or what one can do is more important than a clinical laboratory value or economic outcome (e.g., chronic diseases such as heart disease, diabetes, arthritis, cancer, or HIV/AIDS). Cost-utility analyses compare the direct and indirect costs of an intervention with some measurable level of humanistic outcome, such quality of life or level of satisfaction. The direct and indirect costs of treatment alternatives again are expressed in monetary terms. The humanistic outcomes associated with each intervention can be expressed as an SF-12 or SF-36 health survey score for quality of life (Ware, 1997), as a satisfaction survey score (Mac-Keigan and Larson, 1989), or as quality-adjusted life-years (QALYs). QALYs represent the number of full years at full health that are valued equivalently with... 

For economic outcomes, we can use pharmacoecon-omy as the main tool. " There is a great variety of clinical indicators that we can relate to drugs efficacy and safety. These clinical indicators, obtained with designs from clinical epidemiology (observational and experimental),are excellent to measure clinical outcomes. To obtain indicators for humanistic outcomes, such as satisfaction and quality of life, we have different tools, such as surveys, and different qualitative research methods (interviews, focus groups, etc.). " ... 

Bakst A, Meletiche D, Arnold R, et al. The Avandia Worldwide Awareness Registry (AWARe ) an Internet-based program for evaluation of clinical, humanistic and economic outcomes of patients with type 2 diabetes. International Society for Pharmacoeconomics and Outcomes Research Sixth Annual International Meeting. Philadelphia, Pennsylvania, 2001. 

Namjoshi MA, Risser RC, Feldman PD, et al. Clinical, humanistic, and economic outcomes associated with long-term treatment of mania with olanzapine. Presented at the American Psychiatric Association Annual Meeting, Chicago, May 13-18, 2000. 

Garrett DG, Bluml BM. 2005. Patient self-management program for diabetes First-year clinical, humanistic, and economic outcomes. J Am Pharm Assoc 45 130—7. 

The framework for presenting the evidence in support of a pharmaceutical care practice managemenf system is clinical, humanistic, and economic outcomes data, which are described next. 

Enhanced interaction with the product of professional education programs—the pharmacist—to ensure that graduates can and will continue to provide effective clinical, humanistic, and economic outcomes in the course of their professional careers. 

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