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    OUTCOMES EVALUATED IN PHARMACOECONOMICAL STUDIES

    In pharmacoeconomical research, an outcome is a consequence of drug therapyintervention. The primary drug therapy outcomes that pharmacoeconomical researchtypically evaluates are clinical outcomes, humanistic outcomes, and economic

    outcomes. Clinical outcomes include the results of treatment with a drug and may beboth favorable and unfavorable. Therefore, when pharmacoeconomical studies developclinical outcome measures, investigators must consider all potential consequences of atherapy, not just the benefits.

    In contrast to clinical outcomes, humanistic outcomes look at a therapy from thepatients' points of view. These outcomes address such questions as how the patientfeels and what they perceive their quality of life to be. A drug that prolongs a patient'slife may not be considered beneficial by the patient if he or she believes quality of lifehas become suboptimal. For instance, a patient with a catastrophic illness may notvalue 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 inassessing the overall value of a medication.

    Economic outcomes are the costs associated with a therapy. Several different types ofcosts are measured in pharmacoeconomical research. The first type of costs is directcosts, which may be both medical and nonmedical. Direct medical costs are associatedwith the drug and the medical care itself and would include acquisition costs,monitoring costs, preparation costs, and physicians' fees. Direct medical costs alsoinclude the cost of administrating the medication as well as the cost of treating anadverse drug reaction. Direct nonmedical costs are those that are relevant to providingthe 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 associatedwith the morbidity and mortality of a disease. Although these costs are not universallyaccepted 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 associatedwith pain and suffering of disease and may greatly affect a patient's well-being andquality of life. How does one put a specific dollar amount on pain and suffering? Somepharmacoeconomical 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 costsused 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, oneshould also determine whether the costs cited are relevant to the organization. Manypharmacoeconomical studies use average wholesale price (AWP) when comparingtherapies; however, if the cost to the organization differs significantly from the AWP,then the study results may not be relevant.