Pharmacists active in health care venues need to be able to evaluate generic drugs in terms of eŠectiveness, safety, and economy to ensure that they are used appropriately. As part of the ongoing study of these factors, we carried out an objective evaluation of information provided for generics. A minimum of 20 commercially available products was considered for each pharmaceutical ingredient. The information subjected to evaluation consisted of the text of drug package inserts and information noted on interview forms. Using our own criteria for evaluating drug information, we attempted to quantify the amounts of information provided. Then, based on the numerical values obtained, we calculated information quantities with reference to drug prices to study the relationship between prices and available information for original drugs and their later-developed, generic equivalents. A total of 14 diŠerent pharmaceutical ingredients (327 product items) were considered, with the information quantity for generics amounting to 27.9±17.8-46.3±21.4% (Mean± S.D.) that for the original drugs. Examined on the basis of individual pharmaceutical companies, the corresponding ratio came to . For generics, the relationship between drug price (expressed against a value of 1.0 for original drugs) and information quantity (Qua i ) came to 0.79±0.46-1.90±0.79% (Mean±S.D.). These results clearly point to the importance of evaluating information quantity for generic drugs on a maker-by-maker basis.
The utilization of generic drugs has been promoted, but there is concern about the insu‹ciency of the information provided on generic drugs. To make an objective evaluation of the amount of information supplied by generic drug manufacturers, we tried to quantify the information supply. The information described in the package insert and the interview form were used in the evaluation. We sent a questionnaire to 1000 randomly selected hospitals nationwide to determine the necessity of each information item in medical practice, and weighted the score allotted to each item based on replies from 524 hospitals. We applied these procedures to diclofenac sodium products and found that the score for a branded drug was 60.5 points and that for generic drugs ranged from 1.6 to 58.3 points. This indicates that there were great variations in information supply activities among the manufacturers. The Qua value, which was the ratio of the points of a generic drug per unit price in the drug tariŠ to the points of the branded drug, ranged from 0.1 to 2.4. We think that these procedures will make it possible to select the appropriate generic drugs in medical practice.
Growth in the use of generic drugs remains flat in Japan, and one of the reasons cited is information availability. We previously showed that the amount of information available on generic drugs differs greatly from one pharmaceutical industry to another, though, on average, it is inferior to that for original, brand name drugs. This report looks at information on individual generic drug products, rather than the active ingredients contained therein. In May 2004, we studied ingredients sold by at least 20 pharmaceutical industries. Here, for the same, particular ingredient, we evaluate current availability of generic-specific information (as of August 2005), as well as change over time. On the basis of ingredient, the amount of information provided for generic drugs is 31.1+/-17.5-57.3+/-11.7% that for the corresponding original drugs (Mean+/-S.D.), but in the company-by-company comparison, a large dispersion of 16.6+/-5.0-69.4+/-11.9% (Mean +/-S.D.) is observed. In terms of information content, generic drugs provided less than 50% as much information on "drug interactions", "clinical efficacy", and "outline of side effects", as that for original drugs. The difference between generic and original drugs was smaller in comparisons focusing on information specific to generics than on those including all drug information. Our study also revealed that, over time, some pharmaceutical industries have added to the amount of information provided. When information is a deciding factor, the quantity available at the current time is not the only relevant aspect; it is best to select a pharmaceutical industry that is proactive about supplementing information post-release.
Limited use of generics in Japan has been justiˆed on the basis of problematic quality, distribution and information. Of these three problem areas, the state of provision of information in particular has never been objectively evaluated. We therefore sought to evaluate information according to its necessity and importance to medical practice. To establish criteria for evaluation, we weighted 36 separate pieces of drug information found in package inserts and interview forms according to necessity and importance, based on the results of a survey of nationwide medical institutions with DI o‹ces. We then used the evaluation criteria to evaluate currently available drugs with 20 or more products per formulation. We evaluated 14 formulations (324 products). Generic drugs were found to have 25.3±18.7 to 46.1±14.2 % (Mean±S.D.) the information of brand name drugs when products were compared for quantity of information by formulation. However, comparison according to manufacturer returned a larger range of variation at 14.4±8.6 to 64.3 ±14.2% (Mean±S.D.). These data reveal that manufacturer diŠerences play a large role in the provision of drug information. Drug information was also compared separately by category for both brand name and generic drugs. Generic drugs were found to have insu‹cient information on clinical data, pharmacokinetics, safety, side eŠects, and nonclinical tests. Brand name drugs also scored low points for information on pharmacokinetics. It is imperative that both brand name and generic drugs provide more information on pharmacokinetics.
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