In order to facilitate the simultaneous search of structural and pharmacological information for drugs, we studied the design of the coding system for pharmacological information.  In this study, pharmacological information was defined as information that describes the nature of principal action, specifically “where and how the drug acts”.  Furthermore, we developed a standardized code generation system for describing such information.  First, in order to describe the drug delivery location, organs and subcellular organelles were assigned hierarchical codes by referring to the hierarchical classification of human anatomy.  Next, drug interacting receptors and their action results were encoded and coupled to the location codes, and procedures for generating pharmacological information codes were developed.  Regarding drug structure information, Cartesian coordinates that describe the planer structure were transformed into sequences of numbers in order to obtain molecular fingerprints, which were then used to generate drug structural information codes.  Drug information was compiled into a database that comprises the two categories of codes (pharmacological/structural codes), and a simultaneous search system was developed that links structural similarity and pharmacological information.  A web-based interface for searching the structural information codes was created, and searches could be performed as expected.

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Objective : To determine how much label information on over-the-counter (OTC) medicines is contained on packaging, we investigated the items, description methods, and area of label information on packages.
Methods : We selected 75 common cold remedy products for investigation and classified the items into 3 categories (“items for use”, “items with a regulation requirement”, “items related to product image”) and measured the space given to each item in the total package area.
Results : All 75 products had “items with a regulation requirement (total 13 items),” but 8 products (only 2 manufacturers) had “consult a physician or pharmacist before use,” which was not a regulation requirement.  There were differences in description methods, especially in “caution” and “product name.”  Sixty percent of the OTC products used non-red characters with no box-frame, and 11% used red characters and box-frames.  The description order was not standardized, but “caution” was located in the lowest space on 80% of products.  Many item descriptions appeared in one place, but “product name” generally appeared in more than 4 places. While 4.5 to 8.0 points were commonly given for “items for use,” 16 to 100 points were given for “product name,” and the difference in number of points was greater than 6-fold among products.  The percentage of average area for “items related to product image” (6.1%) was 2-fold greater than for “items for use” (3.1%) and “items with a regulation requirement” (2.9%).  Almost half of the total package area was blank space.
Conclusion : Current descriptions in label information vary among items, products, and pharmaceutical companies.  Rules on describing information on OTC medicine packaging are thus necessary.

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Objective: Pharmacists are supplied a great deal of information by pharmaceutical companies, but the information contents are various.  Therefore, in this study, we carried out a questionnaire survey to evaluate the information contents that hospital pharmacists and community pharmacists request from pharmaceutical companies as information providers.
Methods: Marketing specialists conducted questionnaire survey on the information contents thinking hospital pharmacists and community pharmacists were necessary of pharmaceutical services.
Results: As a result of the questionnaire survey, it became clear that the tendency and the common items of the information contents thinking each of them was necessary, by the difference of the workplace form of the pharmacist.  Many hospital pharmacists needed the information about the team medical care mainly.  Many community pharmacists needed the information about instruction on the use of drugs and communication between hospital pharmacists and community pharmacists mainly.  All pharmacists needed the information such as safety measures.
Conclusion: It’s preferable that information providers distinguish the information that both hospital pharmacists and community pharmacists need from the information that considered an environmental difference of each workplace, and provide them distinguished for hospital pharmacists and community pharmacists.  These results imply that it should lead to achieving optimal use of drugs.

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Objective: Treatment of tinea unguium with topical drugs alone is difficult, and medication with oral terbinafine hydrochloride is necessary in many cases.  Since Trychophyton infects the nails in not only men but also women at a reproductive age, the influence on a fetus of the drug ingested during early pregnancy is a matter of concern of many women.  The objective of this study was to investigate the influence of oral terbinafine hydrochloride on fetuses.
Methods: The outcomes were investigated in pregnant women who ingested terbinafine hydrochloride and visited the ‘Outpatient Services for Consultation on Pregnancy and Drugs (Teratology Information Services)’ of Toranomon Hospital, and cases were collected.
Results: Fifteen pregnant women ingested the drug during the organogenic period, in which the teratogenic risk is the highest.  All 15 pregnant women gave birth to healthy babies.
Conclusion: This is the first survey concerning newborns delivered by women who ingested terbinafine hydrochloride during pregnancy in Japan.  All investigated women gave birth to healthy babies, and the incidence of congenital abnormalities did not markedly exceed that in the general population.  Since the number of cases was small, it is necessary to perform a cohort study to investigate details of the safety for fetuses.

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Objective: Novel antipsychotic agents less frequently cause extrapyramidal side effects compared to conventional antipsychotic agents, contributing to improvement in the QOL.  Recently, these agents have also been increasingly prescribed to females who may become pregnant.  In Japan, no epidemiological survey regarding the application of novel antipsychotic agents in pregnant women has been published.  In this study, we investigated the influence on fetuses in pregnant women receiving novel antipsychotic agents.
Methods: In pregnant women on novel antipsychotic agents who consulted the Pregnancy and Drug Consultation Outpatient Clinic of Toranomon Hospital, the outcome of pregnancy was confirmed.
Results: Twenty-nine pregnant women took novel antipsychotic agents in the organogenesis phase, in which the risk of teratogenicity is the highest.  The agents consisted of olanzapine in 8 patients, risperidone in 11, quetiapine fumarate in 7, and perospirone hydrochloride hydrate in 4.  The outcomes of pregnancy were full-term delivery in 24 patients, premature delivery in 1, spontaneous abortion in 2, and artificial abortion in 2.  Of the 29 patients, 15 (60%) had continuously taken these agents until delivery.  All 25 neonates were healthy without malformation.
Conclusion: This report describes the first prospective survey in Japan regarding infants delivered by pregnant women receiving novel antipsychotic agents.  All patients delivered healthy neonates; the incidence of congenital anomalies did not exceed that in the general population.  This survey included a small number of patients; cohort studies should be conducted to evaluate the safety in fetuses.

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  Generic drugs have received much attention especially from an economic point of view.  In Japan, the form of medical prescriptions has been revised twice in recent two years to disseminate generic drugs in recent two years.  The pharmacists are irresistibly required the detail knowledge of various generic drugs.  However, sufficient information on generic drugs has not always been provided in comparison with the original drugs.  This study intends to reveal such problems with the generic drugs.  Glibenclamide and gliclazide were selected as the model drugs for this study because these two drugs are often taken together with supplements.  Two approaches were used to compare the original drug and the corresponding generic drugs.  The first approach concerns the amount of information as well as the quality of the information that is provided from manufacturers.  The second approach concerns the physicochemical properties, dissolution test and hardness test.  Regarding the pharmacokinetic information in the package insert of glibenclamide, six generic drugs among eleven samples provided sufficient information while four samples seemed insufficient.  As for gliclazide, three samples among eight did not provide AUC and the time dependence of the blood concentration curve.  The results of the dissolution test revealed that all generic drugs satisfied most of the equivalence to the original drug except for one generic glibenclamide.  On the other hand, different behaviors in the swelling property and the time required to completely disperse were observed.  Two samples for glibenclamide and four samples for gliclazide required a fairly long time to completely disperse.  Irregular and significant variations were observed in the hardness test.  The difference in the dissolution process and hardness test suggested the different drug formulations among manufacturers.

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  In this report, we introduce the importance of a system for sharing information about cancer molecular-targeted medicines from trial to the clinic by the department of knowledge education research, department of breast surgical oncology, department of cardiovascular internal medicine and department of dermatology at St. Luke’s International Hospital in Japan.  At present, information regarding the side effect(s) of a study drug does not reach doctors who are not members of the department in charge of the clinical trial.  The reason for this is because clinical trials are conducted under the legal constraints of GCP (Good clinical practice), and while safety information about any adverse events (side effects) is reported, it is limited to the level of an Institutional Review Board.  When there was an enquiry about a known side effect that had occurred to patients taking molecular-target medicine from a doctor who was not a member of the department in charge of the clinical trial, it became clear that information regarding the clinical trial medicine and non-approved medicine was not reaching the clinic.  We developed an original reporting system for such information that would offer the information using the same format as the clinical trial itself, as well as the department in which the side effect was treated, to resolve the problem of access to side effect information outside of the clinical trial itself.  We show that the reporting of such information leads to resolution of this problem.  We believe that this will relieve the patient and contribute to the clinical trial as well as to the department that deals with such side effects.

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