Pharmacoeconomic data, reporting

External reports are most likely going to be manuscripts submitted to peer-reviewed journals. Placement of pharmacoeconomic articles in nonspecialty journals is important but difficult. Some editors do not understand the intrinsic properties of pharmacoeconomic data, and some reviewers will blindly apply statistical constraints that are inappropriate or not valid to humanistic outcomes (e.g. power calculations to measures of the adverse effects of drugs on QOL measures). 

Most companies have some form of standard operating procedure by which they generate clinical study reports. Pharmacoeconomic data should be handled and reported in a similar manner. In some cases it may be appropriate to issue the pharmacoeconomic component of a study as an appendix to a larger clinical report. This will depend on the... 

While some prospective data collection is required for almost all pharmacoeconomic studies, the amount of data to be collected for the pharmacoeconomic evaluation is still the subject of much debate. There is no definitive means of addressing this issue at present. Phase II studies can be used to develop data that will help determine which resource consumption items are essential for the economic evaluation. Without this opportunity for prior data collection, however, we must rely upon expert opinion to suggest major resource consumption items that should be monitored within the study. Duplicate data collection strategies (prospective evaluation of resource consumption within the study s case report form with retrospective assessment of resource consumption from hospital bills) can be used to ensure that data collection strategies do not miss critical data elements. 

Few studies have prospectively documented the degree of functional impairment before or after specific treatments or have evaluated the pharmacoeconomic differences in treatments for premenstrual and perimenopausal disorders. Data on the economic burden (i.e., health care utilization, related costs, and the loss of productivity) from different menstrual-related disorders are still lacking. Several PMDD studies have reported greater improvement in psychosocial functioning and work capacity with SRls compared with placebo. In all studies, the degree of functional impairment was substantial at baseline and similar to that seen in studies of major depression. The functional improvement correlated with the improvement in premenstrual symptoms and was evident by the second cycle of treatment. 

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