Abstract
The recent tightening of financial resources for medical services in Japan sets the stage for continued expansion of the use of generic drugs. However, safety and efficacy, as well as cost, must be taken into account in any evaluation of a generic drug. In this study, the drug information provided for therapeutically-equivalent drugs was compared to that for the brand-name product as a means of evaluating the generic versions of the drug.
Drug information was evaluated by means of a quantitative analysis of information included in package inserts and “interview forms” (product information sheets). Information per price unit was also calculated. Finally, the ratio of information on generic drugs to information on brand-name drugs (Qua) was calculated. This method was chosen because although the price of pharmaceuticals is regulated in Japan, some brand pharmaceutical manufacturers hold that the prices of drugs are a reflection of the quantity of information provided. We sought, therefore, to compare quantity of information per unit price.
By drug formulation, the Qua ranged from 0.47 ±0.51 to 1.26 ±0.57 (mean±SD). By pharmaceutical manufacturer, the Qua ranged from 0.20 ± 0.50 to 1.48 ± 0.29 (mean ± SD).
It can be concluded that less information is provided for generic drugs than for brand drugs, but the difference in the quantity of information is based on differences in manufacturer policy in provision of information. It then becomes clear that if drug information is to be considered a valuable component of a pharmaceutical product that should figure into the price of that product, there are products that do not present information in line with the current pricing policy.
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