ABSTRACT
We surveyed the safety and effectiveness of 13 drug products under the reexamination system in Japan. Until the time of reexamination, a total of 106,328 case reporting forms were collected in the drug use investigations, while 1340 adverse drug reactions (ADRs) were reported in the spontaneous case reporting on ADRs. In the drug use investigations, the data were primarily obtained on the incidence of unexpected ADRs and the incidence of ADRs in special patient populations. The spontaneously reported ADR provided the data on serious and unexpected ADRs. We established proper use of the 13 products by examining the data for significant risk factors for serious ADRs, including agranulocytosis, jaundice, hypotension, and QT prolongation. We revised the package inserts of the 13 products with the new safety information a total of 50 times and passed on the revisions to health care professionals. We also assessed the safety and effectiveness of the 13 products compared with that before marketing. We summarized the data and submitted them to the Japanese Ministry of Health and Welfare (JMHW). For all 13 products, the same indications and dosage and administration as those approved previously were approved at the reexamination.
ABSTRACT
Pharmaceutical companies are responsible for providing updated, relevant information on the efficacy, safety and quality of drugs to medical professionals and finally to patients. To fulfill this responsibility, we must always endeavour to collect and evaluate the relevant information. We developed a drug information database system called Advanced Medical Online Network of Daiichi (AMOND) to manage various information generated during development of new products and after launch of the products using the classification format for retrieval. This system has been used for 9 years for the purpose of supporting medical representatives who play a primary role in the drug information services in the pharmaceutical industry. This system is incorporated into an on-line network system, and can be directly accessed by more than 1200 people at 11 branch offices and more than 110 subbranches all over the country. We upgraded this system to AMOND-II to improve the function, including retrieval and output abilities. As a result, utilization by users of this system increased six times. We report on the improved system, AMOND-II and our experience of the system.
Subject(s)
Drug Industry , Drug Information Services , Data Collection , Database Management Systems , Drugs, Investigational , Humans , Japan , Online Systems , SoftwareABSTRACT
To examine the increase in eosinophils and basophilic cells in the respiratory areas of infants and young children with asthma (n = 111), we analyzed the numbers of eosinophils and basophilic cells in sputum and nasal smears. The number of children with eosinophilia grades of 2+ or greater (> or = 11 cells/five fields in x1000 magnification) in sputum and nasal smears, respectively, in each age group was as follows: 33% and 21% under 1 year, 59% and 64% at 1 year, and 79-80% and 75-78% at 2-3 years. An increased infiltration of basophilic cells according to age was also observed. Infiltration of these cells began earlier than the appearance of IgE antibodies to mite in blood.
Subject(s)
Asthma/immunology , Basophils/pathology , Eosinophils/pathology , Nasal Lavage Fluid/cytology , Sputum/cytology , Acute Disease , Asthma/pathology , Chemotaxis, Leukocyte/immunology , Child, Preschool , Humans , Infant , Leukocyte Count , Radioallergosorbent TestABSTRACT
Allergic predisposition among infants with bronchiolitis was examined. The number of infants with serum IgE exceeding mean +1 SD was 31/70 (44.3%). The rate of positive radioallergosorbent test (RAST) scores of 1 or more to mites, egg white, or milk was 31/71 (43.7%) and that of scores over 2 was 11/71 (15.5%). Eosinophils and/or mast cells were found in their nasal smears on several occasions. These results indicated that allergic predisposition may be observed among infants with bronchiolitis.
Subject(s)
Asthma/etiology , Bronchiolitis, Viral/complications , Acute Disease , Bronchiolitis, Viral/immunology , Bronchiolitis, Viral/pathology , Cell Count , Eosinophils , Female , Humans , Immunoglobulin E/analysis , Infant , Infant, Newborn , Male , Mast Cells , Nasal Mucosa/cytology , Radioallergosorbent TestABSTRACT
Total IgE and specific IgE antibodies to common allergens were determined by the enzyme-linked immunosorbent assay in children with Mycoplasma pneumoniae or respiratory syncytial virus (RSV) infections. The decrease of total IgE from the acute to convalescent phase was observed in 105 of 134 (78.4%) children with M. pneumoniae infection and in 40 of 49 (81.6%) of those with RSV infection. Similarly, many patients showed a decrease of the responses of specific IgE in the convalescent phase of the infections. The results indicated that these infections might alter the production of total IgE and IgE specific to common allergens unrelated to the infectious agents.
