ＨＭＧ−ＣｏＡ還元酵素阻害剤におけるジェネリック医薬品の情報量の評価

Abstract

The establishment in 2002 of additional remuneration for the use of branded generic drugs in medical treatment has led to an increase in their use. However, debate continues on various issues, a major one the availability of drug information (DI) on such products, since DI is such a vital component in all assessments of the safety and effectiveness of pharmaceuticals. We therefore conducted an objective evaluation of the adequacy of DI on branded generic forms of pravastatin sodium and simvastatin, using the media of drug package inserts and interview forms.On a scale setting the amount of DI provided for the original drugs at 100, the quantities of DI available for generic pravastatin sodium and simvastatin were 34.1±11.0% (Mean±SD) and 37.3±12.2% (Mean±SD), respectively. Comparison of the amounts of DI available at present with those at the time the original drugs first appeared on the market showed increases of 39.4 % for pravastatin sodium and 47.1% for simvastatin.The branded generic forms of the drugs considered in this study have only recently become commercially available. So, information gained through experience of using such drugs in the clinical setting hereafter will be incorporated into future package inserts and interview forms, providing healthcare professionals with fuller descriptions of their uses, interactions, and adverse reactions.