As the introduction for the discussion on generic drugs, I explain the definition of generic drugs in the regulation, data required for NDA of generic drugs, their price in the National Health Insurance Scheme, generic drugs in the National Health Insurance Scheme, the criticism on generic drugs, patents and generic drugs and the market share of generic drugs in Japan, And I also explain circumstances of generic drugs in the United States of America.

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The orange book of FDA shows the therapeutic equivalence between innovator and generic drugs while that in Japan exhibits the equivalence in dissolution. However, the objectives of both books are fundamentally same, since the equivalence in dissolution between two products indicates no significant differences in bioavailability and therapeutic efficacy. The reasons were described in this paper with the history to the birth of Japanese orange book. The Japanese orange book shows generic drugs which were confirmed to be equivalent in dissolution with innovator ones by the reevaluation of the drug quality. It also describes dissolution specifications and dissolution profiles at pH 1.2-6.8, that are useful to understand the quality of drug products and their possible in vivo dissolution behaviors.

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So far, National hospitals have promoted to purchase drugs properly. It has been required in the National Diet that University hospitals and public hospitals including National hospitals should use generic drugs. Our investigation clarified that the result of the purchase in National hospitals were tenth part of the national average. Although the use of drugs is primarily selected from point of view of medical consideration, the use of generic drugs contridutes to the efficiency of national medical insurance and patient service through the reduction of payment for medical care. National hospitals are expected to consider the possibilities of usage of generic drugs actively.

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Introduction of generic prescribing and effective utilization of generic drugs are useful measures for suppression of health care cost. However, medical doctors, pharmacists and patients should have correct understandings of meaning of generic prescribing and advantages and defects of generic drugs. Furthermore, generic drug companies should make efforts in the securement of stable supply, development of system for drug information collecting and service, and thoroughness of manufacturing and quality controls. With respect to the quality control, pharmacists have concerns about the bioequivalence between original drug and generic drug. The drugs with narrow therapeutic range should be used with attention, which are required to monitor the drug levels as they have a tendency to produce some side effects or decrease the efficacy along with the slight change of drug level.
Pharmacists are held accountable for the logical choice of drugs when the generic names are used to prescribe the drugs, because the rational drug should be selected from viewpoints of patient's economic strain and pharmaceutical rationality.

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While generic drugs are widely utilized in USA and European countries, they have not accepted as potential alternatives to original drugs in Japan. No appreciable differences in therapeutic efficacy should exist between generic drugs and their corresponding originals as far as their bioequivalence is assured by legitimate bioequivalence studies. In USA available lists of generic drugs are provided by FDA via printed media (i. e., Orange Book) as well as via electronic media (FDA web site). Encouragement of generic prescription should be afforded through the educational campaign of clinical pharmacology and concept of bioequivalence of therapeutic drugs.

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Myotonic dystrophy (DM) is one of the most common forms of muscular dystrophy, inherited in autosomal dominant fashion. DM is also known as multiple organ disease, complicating with cataracts, baldness, cognitive dysfunction, endocrine abnormalities, and so on. Various kind of tumors have also been reported in DM. We surveyed coincidence of uterine leiomyoma and dysmenorrhea in 30 female myotonic dystrophy patients. As a result, 18 of 30 (60%) patients had uterine leiomyoma. At least 4 patients showed ovarian cyst, The profiles of onset for uterine leiomyoma was similar to general population. The mean age of onset for DM was higher in the patients with uterine leiomyoma than those without uterine leiomyoma. Most patients were suffering from dys menorrhea. Although we do not know the exact reason, we should take care for gynecological complication when we see female DM patients.

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We reported the relations between cause-of-death and age in severe motor and intellectual disabilities syndrome (SMIDS), who died in national hospitals from 1982 to 1999. 2, 354 cases were investigated in this study, the following results were obtained as a conclusion.
(1) The most common cause-of-death in any age-group was pneumonia. Although the rate was inversely proportional to the age at death and became low in the age-group of less than 50, in the age of 50 or more showed the trend which becomes high.
(2) Numbers of malignant neoplasms were 37 cases, and it was 1.6% of the whole. Less than 30 years old was 12 cases (32.4%), and less than 50 years old was 31 cases (83.8%).
(3) Sepsis tended to increase number of death in group of 40 or more years old, and ileus was also similar.

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Several studies have shown an increase in the incidence of fractures of the humerus, especially in older peoples. In the elderly population, most of these fractures have been related to osteoporosis like fractures of the hip. Stable reduction is essential for healing of the fracture and allows early movement of the shoulder. In 4 elderly patients, 3 women and one man with a mean age of 76.5 years, we treated displaced fractures of the humerus using a intramedurally nail (TRUE/FLEX System). At the final review, all the fractures had healed about 3 months, The clinical results were good. We conclude that the treatment of displaced fractures of the humerus in elderly patient using the intramedurally nail provides sufficient primary stability to allow early functional treat ment.

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[in Japanese]

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