Effect of Catechol-O-Methyltransferase Genotype on Self-Reported Efficacy and Activity Changes in the Brain Prefrontal Area in Response to a Caffeine Placebo / 医薬品情報学

Objective: The placebo effect can enhance the response to treatment, even in the absence of pharmacological ingredients. One possible factor explaining the likelihood of the placebo effect in individuals is genetic polymorphisms in neurotransmitters. This study focused on gene polymorphisms in the catechol-O-methyltransferase (COMT) as an interindividual variable of the placebo effect.Design・Methods: All 120 participants were explained the effects of caffeine, including its ability to ameliorate drowsiness and increase concentration, and then given a placebo (lactose). The onset of the placebo effect was measured in terms of the degree of caffeine-reduced sleepiness using subjective indices of the Stanford Sleepiness Scale (SSS) and a feeling of drowsiness-Visual Analogue Scale (VAS). The mechanism of the placebo effect was objectively examined in terms of changes in cerebral blood flow in the prefrontal cortex of the brain. In addition, we investigated participants’ susceptibility to the placebo effect by examining genetic polymorphisms in COMT.Results: After taking the drug, sleepiness on the SSS and VAS was significantly improved (p＜0.001), although there was no change in prefrontal cortex activity. Among the 120 participants, 63 had a Val/Val-type polymorphism in COMT (52.5%), 45 had a Val/Met-type (37.5%), and 12 had a Met/Met-type (10.0%). There were no significant differences among COMT gene polymorphisms in the subjective measures of SSS and VAS. However, there was a tendency for the cerebral blood flow changes to be larger in the left hemisphere of the brain in individuals with the Met/Met type.Conclusion: There seems to be a relationship between prefrontal cortex activity and genetic polymorphisms. In particular, there may be a correlation between the expression of a placebo effect and COMT gene polymorphisms.

Pharmacy Customers’ Awareness of the Illegality of Transferring Drugs to a Third Party / 医薬品情報学

Background: Although transferring drugs to a third party, even in a personal capacity, is illegal in Japan, many drug transactions are carried out via internet auction sites. Pharmacy consumers might not be aware of the illegality of transferring drugs to others due to various factors. To clarify pharmacy consumers’ awareness of this issue and its covariates, we carried out a questionnaire survey.Methods: A self-completed questionnaire, consisting of yes/no and multiple-choice questions, was used. The adult patients who visited Keio University Pharmacy were asked to fill out the questionnaire.Results and Discussion: One hundred and fifty-one response sheets were effectively collected from 173 responders. The subjects’awareness of the illegality of transferring drugs was significantly affected by the formulation (oral vs. patches) and pharmacological category of the drug, as well as the source of the drug (prescribed vs. over the counter). Patient education about the illegality of personally transferring drugs, especially patches, might be required to avoid illegal drug transfers, including via the internet.

Challenge and Strategies in Implementing Pharmaceutical Care by Community Pharmacists: / 医薬品情報学

Objective: To clarify challenges and strategies to execute pharmaceutical care by community pharmacists and obtain pragmatic implications for further improvement. Design: Cross-sectional study.. Methods: We conducted a nationwide internet-based questionnaire survey about pharmaceutical care by the Japanese community pharmacists in June and July 2016. Using text data of 161 respondents, we investigated their challenges and strategies in implementing pharmaceutical care. The text data were reviewed and determined for categorization through stepwise process and reconciliation between reviewers. Results: Fourteen categories were retrieved and integrated into 4 domains (pharmacists, patients, other medical professionals, and environment) from 2 dimensions (challenges and strategies). In the challenge dimension (total n＝142), communication capability (n＝26), participation in medical team (n＝17), patients’ understanding of pharmacists’ work (n＝14), lack of timeand staff (n＝14),patient- and people-centered viewpoint (n＝13). Whilein thestrategy dimension (total n＝72), communication capability (n＝21),lack of patients’ medical information (n＝18), patient- and people-centered viewpoint (n＝11), lack of timeand staff (n＝9), and self development (n＝5). As strategies for the communication capability, attitude of acceptance and collaboration, brief explanation,utilization of visual aids, adoption of objective evaluation, various acquisition of patients’ information, active listening, and sharing patients’ information were retrieved as subcategories. The highest level of attention to communication capability implies that community pharmacists certainly recognize their expected responsibility described in the government document titled “Vision for patient-centered pharmacies”. Conclusion: Community pharmacists face many challenges but have some practical strategies. Although part of such challenges is not for pharmacists themselves but for patients, other medical professionals, or entire health system, improving essential skills of pharmacists may havepositiveinfluenceto theother challenges.

Effective Use of Over-The-Counter (OTC) Drugs during a Disaster: / 医薬品情報学

<b>Objective: </b>For effective use of over-the-counter (OTC) drugs that are provided as relief supplies during a disaster, we aimed to develop a list of OTC drugs that can be used during a disaster.<br><b>Methods: </b>We obtained information about OTC drugs useful during a disaster by examining results of previous studies and lists of drugs used during a disaster.  We analyzed this information with the expert pharmacist of disaster support and established a rationale for our list and developed “the List of Useful OTC Drugs During a Disaster” and “the Information Card on Useful OTC Drugs During a Disaster.”<br><b>Results: </b>We developed our list of OTC drugs based on the following parameters: (1) while people with severe disorders (e.g. renal failure) are treated by medical teams, those with minor physical conditions are treated using OTC drugs and (2) those OTC drugs that can be used as substitutes for prescription drugs were preferably selected.  The List of Useful OTC Drugs ()—During a Disaster (containing 56 items) was developed for use mainly by medical professionals.  Further, pharmacists from disaster-relief medical teams may not always be available in disaster-stricken areas; therefore, the Information Card on Useful OTC Drugs During a Disaster was developed to enable disaster victims to independently make a certain level of decision.  The information card contained pictograms to call the attention of the disaster victims.<br><b>Conclusion: </b>Our results can provide a common tool for drug suppliers, medical professionals engaging in relief works in disaster-stricken areas, and disaster victims.

A Survey of Views on Rx-to-OTC Switches in the Patients Afflicted with Lifestyle-related Diseases such as Hypertension, Diabetes and/or Hyperlipidemia / 社会薬学

<p>To clarify the views and needs on Rx-to-OTC switches in patients afflicted with lifestyle-related diseases such as hypertension, diabetes and/or hyperlipidemia, our survey was conducted with 199 patients at a pharmacy in Tokyo, Japan.Of the 199 patients, 159 people were patients afflicted with lifestyle-related diseases.One hundred and ten patients afflicted with lifestyle-related diseases were seventy-year-old and older, and 149 of the patients have been to a hospital at least once in the past year.Thirty-six point five percent of the patients afflicted with lifestyle-related diseases replied that they wanted to use Rx-to-OTC switches when they had been ill and/or injured.The main reasons that they wanted to use Rx-to-OTC switches were “convenience” and “always the same drugs”.On the other hand, the main reason that they did not want to use Rx-to-OTC switches was “I want to have a detailed examination”.Twenty-three point nine percent of them replied that they wanted to switch their prescription drugs to Rx-to-OTC switches. We believe that the usage of Rx-to-OTC switches after the establishment of a support system to secure safety can be the answer to the issues of the rise in medical care expenditures and doctor shortage.</p>

Questionnaire on Reciprocal Patient-Pharmacist Relationships for Good Self-Medication Practices / 医薬品情報学

<b>Objective: </b>It is unclear whether the importance of the healthcare professional’s role and the relationship between healthcare users and providers are well understood in self-medication (SM) practices.  We conducted a self-report survey to examine how the role of healthcare professionals in SM is interpreted and how the reciprocal relationship between consumers and pharmacists in SM is recognized.<br><b>Design: </b>Questionnaire survey.<br><b>Methods: </b>The sample comprised 493 medical professionals (283 pharmacists at hospitals, community pharmacies, and drug stores; 74 instructors at colleges of pharmacy; and 136 personnel of SM-related academic societies).  We mailed questionnaires with informed consent forms from September to November, 2014; those who agreed to participate mailed completed questionnaires back.  We examined how individuals define and interpret SM, clarified each role of pharmacists and consumers regarding several aspects of SM, and collected respondents’ demographic information.<br><b>Results: </b>Of the 493 questionnaires mailed, 125 (25%) were returned.  Over 65% of respondents reported familiarity with the preexisting definitions of SM that include the healthcare professional’s role.  However, when asked to define SM in their own words, only 30% included the role of healthcare professionals.  Among respondents who were not engaged in SM-related research, education or promotion, only 24% included the healthcare professionals’ role.  Also, when asked to describe the concrete roles of both pharmacists and consumers, respondents wrote fewer comments on improving living habits, consulting about health concerns, and implementing self-checks than on serving consumers with over-the-counter drugs and health foods.<br><b>Conclusion: </b>The importance of reciprocal relationships in SM was not well recognized in our sample.  Our results suggest that it is imperative to disseminate information to raise healthcare professional’s recognition on the importance and clarification of some or all roles of theirs in SM.

Development and Evaluation of a Self-Learning Tool for Drug Information / 医薬品情報学

<b>Objective: </b>In pharmacy school, most faculty members use generic names when discussing medicine; however, in clinical clerkships, most staff members use brand names. This sometimes leads to poor communication and understanding between the students and medical staff.  The purpose of this study was to clarify the need for a tool to improve communication and understanding in relation to drug information.  Based on the findings of this survey, our secondary aim was to develop and subsequently evaluate such a tool.<br><b>Methods: </b>To clarify the need for a self-learning tool, we conducted a questionnaire survey on 58 faculty members who teach courses on drug informatics.  Based on their responses, we then developed a self-learning tool that was subsequently evaluated by a total of 78 undergraduate students.<br><b>Results: </b>Most of the faculty agreed concerning the necessity of a self-learning tool for drug information, particularly in regard to the establishment of a more user-friendly system and reduced user fees for students.  The faculty also believed that students should be able to associate the generic drug name with various kinds of information, including its safety, efficacy, and brand name.  All students agreed that the tool was helpful, very easy to use, and could be learned during their commute to school.<br><b>Conclusion: </b>Our results suggest that most faculty members support the idea of having a tool capable of promoting a better understanding and grasp of drug information.  Therefore, our self-learning tool should be helpful in promoting increased knowledge concerning drug information for students in clinical clerkships.

The Actual Status of the Provision of Drug Information in Clinical Clerkships and Development of an Online Self-Learning Tool / 医薬品情報学

<b>Objective: </b>The purpose of this study was to identify existing problems related to the provision of drug information in clinical clerkships.  In addition, we aimed to develop a self-learning tool based on our findings.<br><b>Methods: </b>We conducted a questionnaire survey on students who had completed a clinical clerkship between December 2012 and February 2013 concerning the actual status of the provision of drug information.  Based on responses received from 86 students, we then developed an online self-learning tool.  This online tool was subsequently evaluated by the same 86 students.<br><b>Results: </b>More than 20% of students surveyed reported never having made inquiries at their clerkship site; therefore, we developed an online self-learning tool for inquiry services in which students were able to learn step-by-step how to analyze, search, evaluate and provide inquiries.  A total of 89% of the students who tried this tool reported being satisfied with its use.<br><b>Conclusion: </b>Our results suggest that students in clinical clerkships lack sufficient experience regarding drug information-related inquiries.  Therefore, our online self-learning tool should be helpful in promoting understanding of how to manage such inquiries for students in clinical clerkships.

Estimation of the Dose-Dependency of Systemic Adverse Drug Reactions during the Subtherapeutic Administration of Various Drugs / 医薬品情報学

<b>Objective: </b>Clinical trials are designed to clarify the dose-dependency of drugs.  However, the dose-dependency of adverse drug reactions (ADR), especially in the subtherapeutic range, often remains unclear.  Whether decreasing a drug’s dose would reduce the risk of ADR is of interest to both clinicians and regulators.  This study aimed to clarify the dose-dependency of ADR during subtherapeutic exposure to non-steroidal anti-inflammatory drugs, immunosuppressants, β-adrenoceptor antagonists, or corticosteroids.<br><b>Methods: </b>Data about the ADR risk profiles and the area under the concentration curve (AUC) values of the examined drugs during their subtherapeutic administration, e.g., after their topical or low-dose oral administration, were collected from the literature and compared with data obtained during the therapeutic administration of the drugs; <i>i.e</i>., at the standard oral dosage.<br><b>Results: </b>The drugs that exhibited AUC of ≥20% during their therapeutic administration continued to cause significant systemic ADR during their subtherapeutic administration.  Whilst the drugs that demonstrated AUC of 3-20% during their therapeutic administration continued to cause systemic ADR during their subtherapeutic administration, the ADR tended to be less frequent.<br><b>Conclusion: </b>The dose-dependency of ADR can be estimated by comparing the AUC and ADR risk profile data for a drug obtained during its topical, parenteral, or low-dose oral administration with that obtained during its oral administration at the standard dose.  However, some studies have detected high ADR frequencies even during reduced systemic exposure, suggesting that factors affecting the risk of ADR, <i>e.g</i>., patients’ background data, should be carefully matched between the datasets being compared.

<b>Checklist and Guidance of Scientific Approach to Developing Pharmacovigilance Plan (PVP) in Japan: A Report from a Task Force of JSPE</b> / 薬剤疫学

A Task Force team consisting of members from pharmaceutical companies --a central player to develop and implement RMP (Risk Management Plan)-- as well as health care professionals and members from academia was established in JSPE. The Task Force developed guidance for scientific approach to practical and ICH-E2E-compliant Pharmacovigilance Plan (PVP) stated in Japanese Risk Management Plan issued in April 2012 by the Ministry of Health, Labour and Welfare. The guidance contains the following topics.<br>1．Introduction: JSPE's activities and this task force's objectives for pharmacovigilance activities<br>2．How to select Safety Specification (SS) and describe its characteristics<br>・Selection of SS<br>・Characterization of SS<br>・Association with Research Questions (RQ)<br>3．How to define and describe RQ<br>・What is RQ ?<br>・RQ interpretation in other relevant guidelines<br>・Methodology to develop RQ for PVP with examples<br>・Best approach to integrating PVP for whole aspects of safety concern<br>4．How to optimize PVP for specific RQ<br>・Routine PVP or additional PVP ?<br>・Additional PVP design (RQ and study design, RQ structured with PICO or GPP's research objectives, specific aims, and rationale)<br>・Checklist to help develop PVP<br>5．Epilogue:<br>・What can/should be “Drug use investigation” in the context of ICH-E2E-compliant PVP.<br>・Significance of background incidence rate and needs for comparator group<br>・Infrastructure for the future PVP activities<br>6．Appendix: Checklist to help develop PVP activities in RMP<br>The task force team is hoping that this guidance help develop and conduct SS and PVP in accordance with ICH E2E, as stated in Japanese Risk Management Plan Guideline.

Development of a Method to Determine the Level of Understanding of Package Inserts for Over-the-Counter Medication / 医薬品情報学

<b>Objective: </b>To develop a label comprehension study (LCS) of package inserts for over-the-counter medications in Japan, we evaluated whether it would be possible to detect differences in the level of understanding due to layout, and font size of different types of package insert using the interview method for LCS we developed previously.<br><b>Design: </b>A face-to-face questionnaire investigation.<br><b>Methods: </b>Two different types of package insert (including layout, and font size) for H₂-antagonists (package insert groups A and B) were used.  Study participants (≥18 years old) comprised consumers who visited a drugstore with a dispensing service in Saitama Prefecture.  They were randomly assigned to group A or B and divided by age range (young, 18-39 years; middle-aged, 40-59 years; eldely, ≥60 years).  First, the volunteers read the package insert with no time limitation and then answered 14 scenario-type questions during an interview to determine the level of understanding of the insert.  When both the correct answer and correct reason were given, the response was judged as correct.  The level of understanding of the package insert was calculated as the number of persons giving correct responses divided by all respondents.<br><b>Results: </b>Questionnaire responses from 86 consumers (43 in each group) were obtained.  The mean age in groups A and B was 46.5 years and 47.0 years, respectively.  The mean level of understanding of the package insert (14 questions) in groups A and B was 50.2 and 38.1%, respectively.  By age range, the mean level of understanding of the package insert in groups A and B in the young group was 60.6 and 56.9%, respectively, and there was no statistically significant difference between the two groups.  However, the mean level of understanding in groups A and B was 56.9 and 35.0% in the middle-aged group and 26.3 and 14.5% in the elderly group, respectively.  The mean understanding in group A was therefore higher than that in group B in both age ranges.  The association between understanding and age within groups indicated that with increasing age, understanding was lower in both groups (group A, <i>p</i>=0.001; group B, <i>p</i><0.001).  There was no difference in the level of understanding between the young and middle-aged in group A, but the difference in group B was greater than 20%.<br><b>Conclusion: </b>By comparing two package inserts of products in a similar pharmacological category using our LCS method, it suggested that font size and layout influenced consumers’ understanding of package inserts.  It might be able to evaluate the difference in the understanding of the package insert by using our LCS method.

Survey of Education about Over-the-counter Drugs in Pharmaceutical Universities / 医薬品情報学

<b>Objective: </b>Over-the-counter (OTC) drugs play an important role in medical treatment.  Triage and counseling by pharmacists are important to ensure that self-medication with OTC drugs is effective.<br><b>Methods: </b>We conducted a questionnaire survey to evaluate the education about OTC drugs offered by 79 Japanese pharmaceutical universities, from August to September 2009.  The questionnaire asked whether or not lectures and practical training concerning OTC drugs are given to students, and if so, the number of hours and the school year in which they are given.  Questions about future plans were also included.<br><b>Results: </b>The response rate was 70 %.  Eighty percent of respondent universities gave lectures on OTC drugs, and 98 % expected to do so in the future.  Lectures on OTC drugs were most commonly given in the fourth year.  Fifty percent of universities offered practical training about OTC drugs, and 75 % expected to do so in the future.<br><b>Conclusion: </b>Compared with our 2005 survey, the number of universities offering lectures had increased more than twofold.  Although education about OTC drugs in pharmaceutical universities has improved, it remains insufficient.

Willingness to Pay for Over-the-counter Pravastatin in Self-medication for the Primary Prevention of Myocardial Infarction / 薬剤疫学

Objective:The aim of this study was to measure the value of over-the-counter (OTC) pravastatin as a healthcare-related item by investigating the public's willingness to pay(WTP)in self-medication for the primary prevention of myocardial infarction (MI)if pravastatin were switched to OTC status.<br>Methods:A questionnaire survey was distributed among those receiving health checkups at Kitasato Institute Hospital. For the WTP question format, the double-bound dichotomous choice approach was employed. Participants were randomly assigned to three groups. Group A was provided with a starting price per month of \5,000, group B with \8,000, and group C with \12,000. To investigate factors affecting WTP, Weibull regression analysis was used.<br>Results:The questionnaire survey was completed by 242 individuals(150 men, age range 30-82 years), and the mean WTP was \9,583 per month. Weibull regression analysis showed that age significantly affected WTP. The monthly cost for a physician consultation to receive prescribed pravastatin is \3,540 to \6,590 in the Japanese health insurance system.<br>Conclusion:The WTP was about \10,000 per month, and the WTP based on the questionnaire responses was more than two-fold higher than the present cost for a physician visit. This study clarified the WTP if pravastatin for the primary prevention of MI were switched to OTC status. Further studies are necessary to elucidate whether this would contribute to the promotion of self-medication among Japanese.

A Pharmacologic Study on Risk Factors of Hyperkalaemia or Increased Blood Potassium Associated with ACE-Inhibitor Therapy / 薬剤疫学

<b>Objective:</b> To investigate quantitatively the risk factors of hyperkalaemia or increased blood potassium associated with ACE-inhibitor therapy<br><b>Design:</b> Nested case-control study<br><b>Methods:</b> We used the antihypertensive drug database(72,379 subjects)developed by the RAD-AR Council, Japan and the Institute of Statistical Mathematics based on the post-marketing surveillance(PMS) data of pharmaceutical companies. Of 37,372 subjects taking ACE-inhibitors, the case group was composed of 64 patients who experienced hyperkalaemia or blood potassium increase while taking ACE-inhibitors, and the control group was composed of 1,280 patients(20 patients per case)randomly selected from patients who did not experience hyperkalaemia or blood potassium increase while taking ACE-inhibitors. The relevant factors that can be extracted from the database were the followings: age, WHO classification of hypertension, complications, antihypertensive drugs used before the PMS survey, and concomitant drugs.<br><b>Results:</b> Among the subjects taking antihypertensive agents, 65 patients experienced hyperkalaemia orincreased blood potassium, 64(98.5%)of whom were taking ACE-inhibitors. The factors that were significantly different between two groups(p<0.05)by univariate analysis were WHO classification of hypertension(p=0.005), complications of nephritis/nephrosis(p<0.001), other disorder of urinary system(p<0.001), unclear symptom or diagnosis(p=0.005), taking diuretics as antihypertensive drugs before study(p=0.032), and concomitant treatment with diuretics(p=0.004), vasodilators(p<0.001), and antigout agents(p=0.001). Conditional multivariate logistic analysis of these factors yielded adjusted odds ratio of 21.31 for complications of nephritis/nephrosis(p<0.001), 6.83 for other disorder of urinary system(p<0.001), and 2.30 for concomitant therapy with diuretics(p=0.049).<br><b>Conclusion:</b> The risk factors of hyperkalaemia or blood potassium increase associated with taking ACE-inhibitors were nephritis/nephrosis, other disorder of urinary system and concomitant therapy with diuretics.

Investigation of Label Information on Over-the-Counter Medicines / 医薬品情報学

<b>Objective </b>: 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.<br><b>Methods </b>: 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.<br><b>Results </b>: 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.<br><b>Conclusion </b>: Current descriptions in label information vary among items, products, and pharmaceutical companies.  Rules on describing information on OTC medicine packaging are thus necessary.

A Study of the Evaluation of Drugs for the Introduction of Hospital Use / 薬剤疫学

Objective : The Pharmacy and Therapeutic Committee generally selects formulary drugs by evaluating the comparative data from non-clinical and clinical studies of pharmacologically similar type drugs. Usually there are few data from directly comparative studies among all similar type drugs, and there are only two types of studies, standard drug or placebo-control study. In this situation, it is very difficult to select the superior drug. <BR>Therefore, we conducted a retrospective cohort study to compare the efficiency among three 5-HT<SUB>3</SUB> antagonists and to investigate the possibility of data from this study, as a reference for decision making. <BR>Design : Retrospective cohort study. <BR>Methods : A retrospective cohort was assembled comprising in-patients of to Surgery, Obstetrics and Gynecology, Ophthalmology, Orthopedics, Dermatology, Psychiatry, or Thoracic Surgery Departments, who received chemotherapy and a 5-HT<SUB>3</SUB> receptor antagonist from January to June in 1996. We compared the side effects of nausea and vomiting among patients receiving various 5-HT<SUB>3</SUB> receptor antagonists. Physicians could freely prescribe three 5-HT<SUB>3</SUB> antagonists that were adopted in our hospital during the period. Pharmacists collected information regarding the efficacy of 5-HT<SUB>3</SUB> receptor antagonists on the first prescribed day by reviewing medical charts, nurses' reports and interviews with the nurses. <BR>Statistical Analysis : ANOVA was used for testing the age differences among patients receiving 5-HT<SUB>3</SUB> receptor antagonists. Chi-square was used for testing difference of sex, administration route, number of chemotherapy treatment. Kruskal-Wallis rank test was used for testing the difference of efficacy. Probabilities less than 5% (P<0.05) were considered significant. <BR>Results : Out of 68 patients, 35% received cisplatin and 65% received non-cisplatin anti-tumor drugs. The average age was 53.1±17.4 (49% male, 51% female). A total of 82% received intravenous drip injection. <BR>Percentage of non-changed cases in ingestion ratio was 32% of ramosetron, 50% of ondansetron and 53% of azasetron. There was no significant difference in the ingestion ratio (p = 0.026). <BR>Percentage of non-changed cases with regard to vomiting (complete control) was 80% of ramosetron, 50% of ondansetron, 79% of azasetron. There was a significant difference in vomiting (completecontrol) (p = 0.044). Ondansetron was less effective as an antiemetic function. <BR>Discussion : When no data from a directly comparative study are available to determine the adoption of a new medicine from among numerous candidate drugs, an observational study such as this appears useful.