Question
: How has Big Data changed pharmacoeconomics?
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A Basic Course in Pharmaceutical Economics: Background, Rationale, and Suggested Syllabus E. M. Kolassa ABSTRACT. Pharmaceutical economic research is growing as a field of study and as a tool for health-care decision-making. Pharma- cists, especially those in administrative and managerial positions in hospitals and large healthcare systems, are expected to incorporate the results of these studies into their recommendations and daily routines. Past research has shown that pharmacy curricula do not adequately prepare students for performing or using pharmaceutical economic research studies. This paper offers a rationale for the inclusion of a basic course in pha~maceutical economics into the curriculum and provides a syllabus for such a course. INTRODUCTION The field of pharmaceutical economic research, while wide- spread and growing, is still in its relative infancy (1). In theory, the study of the economic and other nonclinical effects of medications should be relatively straightforward, using the techniques and meth- ods favored by such leading authorities as Eisenberg, Drummond, and Feeney. Unfortunately, despite the person-years of work put into the field, and the study of the field, we are left with at least E. M. Kolassa, MB.A., is a research associate at the Research Institute of Pharmaceutical Sciences who has worked in the field of pharmaceutical pricing and economics for over 12 years and a doctoral candidate in Pharmacy Administration at the School of Pharmacy, University of Mississippi, University, MS 38677. Journal of Pharmacy Teaching, Vol. 4(3) 1994 Q 1994 by The Haworth Press, Inc. All rights reserved. 15 16 JOURNAL OF PHARMACY TEACHING three basic problems when attempting to perform, evaluate, or use pharmaceutical economics research. Health-Care Systems Differences: Problem of Applying Results Among the most noticeable flaws in pharmaceutical economic studies is the inconsistency of endpoints measured in the reported literature. While consensus might be reached on the most appropri- ate endpoints for a single healthcare system, international compari- sons are made very difficult because of cultural, demographic, and administrative differences in health-care delivery systems (2). A common resource measurement in studies performed in the United States is hospital length of stay (3). This measure has become more important with the advent of Diagnostic Related Groups (DRGs), a system of healthcare financing used for hospital treatment for Medicare patients that bases reimbursement on a pre- determined set of payments, based on average costs and other capi- tated payment schemes. These cost-containment methods, instituted initially by the U.S. Health Care Financing Administration, sought to control costs by forcing providers to manage health care within the constraints of a budget. The length of hospital stay is a key element in DRG case management, and provides a fairly good surrogate for total hospital costs or charges. Some European nations, on the other hand, do not feel this measure to be as relevant, due to cultural expectations of long stays and the fact that hospitals are owned and managed by central authorities, who view hospital days as fixed costs and not subject to greater efficiencies. Work days lost or saved should be vital statistics in nations where national health-care systems rely upon productive workers. In the United States, however, the majority of Medicare patients are no longer employed, and private health insurers and many other payers are not directly affected by this measure-the number of work days lost or saved have no direct affect on the payers. This lack of attention to work days lost should be changing, as more employers are taking an active role in healthcare decision-making. The Academic versus the Practitioner's Perspective As in many fields of study, pharmaceutical economic studies have yet to be diffused into the general population of practitioners. E. M. Kolassa I7 Some of the more common measures used in pharmaceutical eco- nomic research, such as the Quality-Adjusted Life Year (QALY), are difficult for novices to interpret (4). While these measures are commonly used, their validity and utility are constantly called into question. Several authors have called for agreement that such research must take the broadest view possible, that of society (S ) , while the decision-makers, those who select and administer phar- maceutical therapy, cannot relate the societal effect to the individual patient's immediate needs or to those of the institution in which they are practicing (6). Combined with the difficulty in interpreting and using the result of many of these studies, practitioners, who have not been trained in the field of economic analysis or the several of the social sciences used in pharmaceutical economics (7), must choose between simply accepting that the published studies are factual or ignoring the results of the studies and determining appropriate use of new agents based either on their cost or their effectiveness, but not a combina- tion of the two. A Business-Policy Necessity: Is It Science, Art, or Marketing? Confounding the issues already addressed is the problem that the environment for health care has changed significantly in recent years and the economic consequences of health-care interventions are now of paramount importance. Pharmaceutical manufacturers, along with other providers, payers, and consumers of health care, must concern themselves with these consequences. The lack of agreement on methodologies and research endpoints, or even a commonly accepted definition and purpose for the research, has resulted in an environment with more questions than answers. The lack of hard and fast rules for economic analysis, and no consensus on the use of the studies, renders the field susceptible to the very real problems of charlatans providing spurious study results; moreover, because study design and data interpretation are not well-established, those with a preconceived idea or a biased agenda may generate studies that are misleading. The lack of back- ground in economic analysis among those who need and/or com- mission these studies, commonly either pharmaceutical marketers or government policy makers, and even some performing the stud- 18 JOURNAL OF PHARMACY TEACHING ies, makes it easy for improper conclusions to be drawn from good and bad studies alike (8). DEALING WITH THE PROBLEMS Many of these problems cannot be dealt with in a simple manner. The lack of consensus on the most appropriate measures and meth- odologies is likely to remain, as those who champion one approach argue with those who favor another. The lack of comparable results between different nations is likely to remain, since it would require significant cultural shifts to align these systems. Nevertheless, two approaches, one scientific and already loosely followed and the other the application of basic marketing theory, could go a long way toward dealing with the problems. The f i t is to collect and report the data from economic studies in terms of resource consumption, as opposed to reporting these results exclu- sively in currency-based units. Provision of a model that allows practitioners and others to apply the costs within their own systems would allow for some translation between studies and transferability of the results. This has been done, to some extent, by a few pharma- ceutical companies, such as Roche and Arngen, who provide hospi- tals with computer-based models of the use of their products, and dows the users to provide their own unique cost and protocol information for the model. The end result is relevant information. The second approach is to educate practitioners, to develop in them the ab i t y to interpret and utilize the studies, and to demand from those producing the studies the information that is needed by them. Inclusion of pharmaceutical economics courses and materials in Pharrn.D. programs and continuing education programs is a start, but these must be based not on how to conduct the studies as currently practiced, but how to incorporate economic information into clinical and administrative decisions. With that accomplished, the studies will be performed to meet the needs of the market. AN INTRODUCTORY COURSE IN PHARMACEUTICAL ECONOMICS To prepare future pharmacy practitioners and health economists for their eventual responsibilities, an introductory course in phar- maceutical economics that focuses on learning the basic techniques of the area and the development of the ability to critically evaluate health-related economic studies has been developed. This course will provide practitioners with the knowledge and skills needed to incorporate the results of economic studies into their roles as deci- sion-makers, and supply students of health and pharmaceutical eco- nomics with the background necessary for more advanced studies in the field. The syllabus for this course is presented here. Pharmaceutical Economics The terms ph~acoeconomics and pharmaceutical economics will be used interchangeably in this document. Pharmaceutical eco- nomics is the preferred term of the author, because it is felt to more broadly encompass the areas including and surrounding the use of pharmaceutical agents. Definition Pharmacoeconomics is the description and analysis of the costs of drug therapy to health-care systems and society. Phar- macoeconomic research identifies, measures, and compares the costs (i.e., resources consumed) and consequences of phar- maceutical p~oducts and services. (9) The definition provided here encompasses more than the study of the financial effect of medication u se i t also includes the study of the effects of interventions by pharmacists and others in the drug distribution system. Course Objective To provide students with as broad an understanding of the area as possible, since many may not pursue further study in the area, this course should provide: 1. An overview of the need for and use of pharmaceutical eco- nomic research 2. An introduction to commonly used methods of pharmaceuti- cal economic research 20 JOURNAL OF PHARMACY TEACHING 3. A history of the use and misuse of health economics studies 4. Exposure to the sometimes conflicting views and philosophies of the area 5. An understanding of the diffkulties in performing and using these studies 6. An understanding of the potential new uses of this information The student, upon completion of this course, will have the ability to: 1. interpret and critically analyze published pharmaceutical eco- nomic studies 2. design a valid pharmaceutical economics study protocol 3. integrate the