RESUMO
Objective: The use of generic products is a solution to the increasing healthcare cost in Japan. The pharmaceutical companies are trying to develop several generic products suitable to patient’s taste. The contribution of pharmacist by selecting generic product to each patient and a collection of patient’s opinion for products may accelerate the development of generic products improved usability for patients and medical workers. The present study examined the storage of generic products of sennoside in pharmacies and the patient preference for selection of generic products in 2003 and 2016 in Kumamoto, Japan.Methods: Sennoside was selected as a model drug, since it developed several generic products for long period. The survey on storage of sennoside pharmaceutics and the questionnaire survey for its generic products to patients were conducted at ethical pharmacies. The appearance and the dissolution of sennoside from generic tablets were compared with original product, Pursennid.Results: Thirteen sennoside products were stored in 2003 and 2016. The number of pharmacies that stored generic products increased from 33 to 54% in 13 years. The largest number of patients preferred Pursennid in 2003. In contrast, two generic products were more preferred than Pursennid in 2016. Interestingly, the reasons for preferring products were almost the same between 2003 and 2016, and their majority was color and size of tablet. The generic products tend to have a thinner thickness and larger diameter than Pursennid. The most preferred generic product in 2016 showed a faster dissolution of sennoside than Pursennid. However, the use of generic products is mainly related to their tablet appearances due to unrelation between the pharmacological effect of sennoside and its dissolution in GI tract.Conclusion: In the development of generic products of sennoside, as well as quality, the appearance is an important factor.
RESUMO
<b>Objective: </b>The purpose of this study is to compare the clinical efficacy between original drugs and generic products. Candidate drugs included two types of hydroxymethylglutaryl-CoA (HMG-CoA) reductase inhibitors, simvastatin and pravastatin, because of their importance at reducing the health expenditure for hyperlipidemia.<br><b>Design: </b>We retrospectively evaluated the efficacy (total cholesterol, triglyceride, low-density lipoprotein and high-density lipoprotein levels), safety (biochemical parameters), and medication adherence based on patient data. We set the follow-up period at 6 months before and after substitution. Data were analyzed by paired-sample <i>t</i>-tests (statistical significance level of 0.05).<br><b>Methods: </b>The subjects included in this study were ambulatory patients visiting Nakajima Hospital for dyslipidemia treatment. Selected patients included those taking both the original drug and the generic product; i.e., patients who had substituted the original drug Lipovas® for the generic product Simvastatin OHARA, or those who had substituted the original drug Mevalotin® for the generic drug Pravatin®.<br><b>Results: </b>A total of 118 patients in the simvastatin study and 43 patients in the pravastatin study were candidates for the present study. We found that there were no significant differences before and after substitution. Even though there were differences in some of the biochemical parameters, the range remained within normal levels. With regard to medication adherence, we found no significant differences.<br><b>Conclusion: </b>In this study, we found no significant differences before and after substituting medications with generic drugs. Additionally, we found no subjective symptom changes after substitution. To develop clinical information on generic products and to store such information, it is important that pharmaceutical products be used appropriately.