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OUTCOMES EVALUATED IN PHARMACOECONOMICAL STUDIES In pharmacoeconomical research, an outcome is a consequence of drug therapy intervention.

The primary drug therapy outcomes that pharmacoeconomical research typically evaluates are clinical outcomes, humanistic outcomes, and economic outcomes. Clinical outcomes include the results of treatment with a drug and may be both favorable and unfavorable. Therefore, when pharmacoeconomical studies develop clinical outcome measures, investigators must consider all potential consequences of a therapy, not just the benefits. In contrast to clinical outcomes, humanistic outcomes look at a therapy from the patients' points of view. These outcomes address such questions as how the patient feels and what they perceive their quality of life to be. A drug that prolongs a patient's life may not be considered beneficial by the patient if he or she believes quality of life has become suboptimal. For instance, a patient with a catastrophic illness may not value a drug that prolongs his or her life in the same way that a patient with a less serious medical problem would. Therefore, humanistic outcomes are very important in assessing the overall value of a medication. Economic outcomes are the costs associated with a therapy. Several different types of costs are measured in pharmacoeconomical research. The first type of costs is direct costs, which may be both medical and nonmedical. Direct medical costs are associated with the drug and the medical care itself and would include acquisition costs, monitoring costs, preparation costs, and physicians' fees. Direct medical costs also include the cost of administrating the medication as well as the cost of treating an adverse drug reaction. Direct nonmedical costs are those that are relevant to providing the therapy and include transportation to a health care facility and ancillary support, such as social services and home care services. Indirect costs result from loss of productivity due to illness. These are costs associated with the morbidity and mortality of a disease. Although these costs are not universally accepted as being important, they may significantly affect the total cost of a disease. Intangible costs are more difficult to assign a dollar value. These are costs associated with pain and suffering of disease and may greatly affect a patient's well-being and quality of life. How does one put a specific dollar amount on pain and suffering? Some pharmacoeconomical studies use survey instruments to assess quality of life to measure these important costs in a nonmonetary way. In reviewing the pharmacoeconomical literature, one should carefully evaluate the costs used in conducting studies to make sure that all appropriate costs have been included. Failure to consider this information may lead to inaccurate conclusions. In addition, one should also determine whether the costs cited are relevant to the organization. Many pharmacoeconomical studies use average wholesale price (AWP) when comparing therapies; however, if the cost to the organization differs significantly from the AWP, then the study results may not be relevant.