Relationship between manufacturer's recommendations and actual drug usage in the pediatric patient

The objective of this study was to determine the relationship between certain "full disclosure" aspects of the package insert and how drugs were used in the pediatric patient. Also, to determine the effect of the pharmacist on the above relationship was a secondary objective, A document well known to many medical field personnel is the package Insert. As a part of the official labeling, the Food and Drug Administration maintains control over much of the package insert content. The package insert has become the object of controversy between the medical community and the FDA because of its legal aura. Of importance to this study is the extent the package insert effects rational drug therapy. The study hospital was a 175 bed, short term, private, non-profit, pediatric hospital. Using a patient medical chart review system, data was collected from two groups of one hundred patients for a total of 200 hundred patients. The groups represented before and after initiation of a unit dose drug distribution system. Along with group designation, other independent variables were length of stay, sex, race, age and admitting service. The number of doses were somewhat arbitrarily assigned as an independent variable. Dependent variables measured were agreement of indications, contraindications, dosage and age recommendations. A scaling method was devised to measure increments of agreement. Results indicate the unquestioned indication agreement between the package insert and evidence in the patient chart occurred in only 62.3% of the drug use occasions. Agreement scores for contraindication and age were much higher. While agreement scores for Group II (the "after" group) remained consistently higher, analysis of variance failed to reveal a significant difference at alpha=0.05. A significant difference was detected for the number of doses. Group II had the signlficiantly lower mean number of doses. Factor analysis was computed for the four dependent variables of indication, contraindication, dosage and age agreement. An element common to all four variables was factored out; virtually all the factor variance was accounted for by this element. This establishes that a relationship does exist. This can be suggestive that these variables must be considered in a collective or time related manner during the drug prescribing process.