Background : As the consequence of the decision at the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) progress, drug safety information reporting system in Japan is being revised. This has led to inevitable increases in the number of safety reports submitted to the industries and in turn, the Ministry of Health and Welfare (MHW). In 1997, the MHW announced they would publicize this acquired information starting in 1999. In the USA, Food and Drug Administration (FDA) has released safety related information to the public, acquired over the years since 1969, though such means in the Web page of MEDWatch using the internet.
Purpose : (1) To review accessibility of individual adverse experience (AE) reports in MEDWatch through internet, (2) to give advise to other possible Japanese users on the use of it and, (3) to give recommendation to the new system being developed in Japan by the MHW and/or other regulatory agency.
Method : Case study started by using personal computer.
Results : (1) The information cannot be accessible only using personal computers. Computer expert assistance and big computer are needed to access the information. (2) Information from more than a million AE cases is accessible. (3) Searches for information can be organized by pharmaceutical name, event term, patient demographics, and others. (4) The detailed information such as the course of the individual case from which drug causality could be assessed is not accessible. (5) The improvement of system should be needed for easy access such as “quick search”. (6) More “user friendly” system is desired to be developed by the MHW and/or other regulatory agency in Japan which enable easy and full access of the information.

In enabling consumers to make thetr own judgments regarding the risks of drugs, it is essntial to share information regarding the risks of drugs among stakeholders (governmental agencies, pharmaceutical companies, healthcare professionals and consumers or patients) and to have communication (risk communication).In particular, the communication between governmental agencies and consumers or patients is given a high priority. Hence, its provisions and strategies should be considered thoroughly.
FDA's risk communication efforts are part of a larger drug safety initiative that began in November 2004. In fact, FDA is engaged in verification and strategies aiming at strengthening drug safety. As a part of these efforts, FDA has published the "Guidance Drug Safety Information-FDA's Communication to the Public" and "FDA Strategic Plan for Risk Communication".
In this article, we present the "FDA Strategic Plan for Risk Communication" translated into Japanese and explain the situation of risk communication for drugs from the FDA perspective. We also examine the future of risk communication in Japan.

Introduction: Although fentanyl patch (FP) are often used to treat cancer pain because of the low incidence of adverse effects of this formulation, there are cases in which it is impossible to eliminate the pain despite increasing the doses. We report a patient of advanced gastric cancer with abdominal pain, in whom successful pain control was achieved by opioid rotation from FP to continuous intravenous infusion of morphine hydrochloride. Case Report: The patient was a male in his 60's who had been diagnosed as having primary gastric cancer and complained of abdominal pain, thought to be visceral pain caused by obstruction of the digestive tract. Oral intake became more difficult as the disease progressed. Despite a switch to FP from oxycodone used to treat the abdominal pain and an increase in the dose, pain relief was not achieved. Then, we undertook a partial opioid rotation to continuous intravenous infusion of morphine hydrochloride, which provided adequate pain control. Discussion: One possible reason for the pain relief in this patient is suppression of the gastrointestinal motility by morphine. When adequate pain relief cannot be achieved with one opioid, opioid rotation should be considered. We concluded that the opioid rotation should, however, be performed in a stepwise manner. Palliat Care Res 2009; 4(1): 307-311

The Medication Guides for Patients (MGPs) are being offered as information on prescription drugs for patients by the Ministry of Health, Labour and Welfare (MHLW). The MHLW published the Risk Management Plan in April, 2012, and it noted that the MGPs should be utilized in usual risk minimization activities. It is not clear, however, whether the MGPs are efficiently utilized in actual settings. Hence, we conducted a questionnaire survey of the pharmacists in the pharmacies with dispensing and the hospitals in Mie and Yamagata prefectures to investigate the actual circumstances of MGPs utilization and to understand the existing barriers associated with the use of the MGPs as medication instructions for patients. We sent the questionnaires by mail and obtained responses from 444 facilities (33.9%) of 1,309 facilities. The recognition level of the MGPs was about 30 percent in the dispensing pharmacies, and about 50 percent in the hospitals. The MGPs were utilized as a common communication tool with the patients in approximately 20 percent of the facilities. Many respondents requested that the frequency of important and other adverse reactions should be described in the MGPs, and wider ranges of MGPs should be further implemented.
Moreover, our data suggests the problem is that the present MGPs are mainly applied to special types of patients, such as those with higher literacy level or those who requested a detailed explanation. Thus, it is apparent that it is necessary to review the MGPs contents again to improve their practical benefits and disseminate them more widely.

  A 4–year trial of an undergraduate medical care education program for smoking cessation with the participation of simulated patients is described. Simulated medical care with the participation of simulated patients is thought to motivate medical students to learn clinical skills for smoking cessation. However, simulated medical care for smoking cessation is difficult to plan when both the medical students and the simulated patients are nonsmokers.

Objective: The objective of this study was to examine information quality by quantitatively evaluating newspaper stories on drug therapy using the “Media Doctor” instrument.Methods: A database search was conducted to extract newspaper stories on drug therapy published between July 1, 2017 and December 31, 2017. Two evaluators independently evaluated each story using the “Media Doctor” instrument. Each of the 10 evaluation criteria were rated as “satisfactory” or “not satisfactory.” When the content of the story was not suitable for the evaluation criteria, it was regarded as “not applicable”.Results: Fifty-nine news stories (Asahi: 13, Mainichi: 8, Nikkei: 8, Sankei: 14, Yomiuri: 16) were included. The median number of evaluation criteria that the two evaluators judged as “satisfactory” was 5. The proportions of stories that the two evaluators judged as satisfactory were “1. availability,” 73%; “2. novelty,” 66%; “3. alternatives,” 39%; “4. disease mongering,” 58%; “5. evidence,” 32%; “6. quantification of benefits,” 31%; “7. harm,” 41%; “8. cost,” 22%; “9. sources of information/conflict of interest,” 12%; and “10. headline,” 66%. Conversely, the proportions of stories judged as “not satisfactory” were “1. availability,” 0%; “2. novelty,” 5%; “3. alternatives,” 12%; “4. disease mongering,” 8%; “5. evidence,” 24%; “6. quantification of benefits,” 29%; “7. harm,” 41%; “8. cost,”44%; “9. sources of information/conflict of interest,” 32%; and “10. headline,” 12%.Conclusion: These results suggest that the quality of newspaper stories are insufficient as drug information in terms of the validity of its scientific evidence.

Objective: Health information, including the labelling, must be presented in a manner that is easily understandable to consumers. In recent years, the European Union and the United States have introduced standards for providing health information in a way that is easy for consumers to understand. The Clear Communication Index (CCI) published by the Centers for Disease Control and Prevention (CDC) is a useful tool for this purpose. Unfortunately, there is no such tool in Japan. Therefore, focusing on the package labelling of foods with functional claims (FFCs) sold in Japan, we constructed a Functional Clear Communication Index (F-CCI) and evaluated the FFCs.Methods: The F-CCI was developed by six people, including university staff with pharmacist qualifications and public health experts, by referring to the CDC CCI. The evaluation of FFCs using the F-CCI was performed using the Delphi method, which is one of the formal consensus-building methods in the field of health and medical information. The evaluation was conducted by three qualified pharmacists on five FFC products, and the degree of internal agreement among the evaluators was calculated using Fleiss’ κ.Results: The F-CCI consisted of 18 items that assessed the FFC characteristics. After assessing the labelling of FFCs using the F-CCI, the scores of all the materials ranged between 70 and 80% on the F-CCI, and none achieved 90%, which was considered the acceptable standard (overall κ value_ 0.865). Moreover, it was clear that the ‘readability’ and ‘understandability’ of the labelling were inadequate.Conclusion: The F-CCI developed in this study for the objective evaluation of the labelling of FFC products will act as a tool that will subsequently lead to the proper understanding and use of FFCs by consumers. Further efforts are needed to build and disseminate such tools and user-friendly ways of providing relevant information.

Objective:It is necessary to obtain appropriate drug information (DI)so that appropriate medical care is provided for the consumers,patients. Thorough studies have not been done on institutions that offer DI for patients in Japan and the state of its dissemination. The purpose of this study is to find levels of recognition of the institutions providing medical information and the actual state of its usage.Method:In order to find the levels of recognition of the institutions that provide DI to general consumers and the state of usage of the information provided by them,we conducted questionnaire surveys using online panels. We also conducted a study to find subjective comprehension on DI by the panels. The surveys were conducted twice using the same questionnaire in order to robust the outcomes of the study.Results:We received 1,095 valid responses from the first survey and 1,086 from the second survey respectively. No significant differences were found between the two surveys. Although the levels of recognition vary for the four representative public institutions providing DI,DI provided by these institutions has been barely utilized by the respondents. As the sources of DI that have been used most,almost the same numbers of respondents replied that they used Internet search engines to access them in addition to medical doctors and pharmacists. Regarding the levels of comprehension for the provided DI,the respondents tended to have shown high levels of understanding on maintaining medication compliance,but low on safety information. There was a positive correlation between age and the understanding of the DI.Conclusion: The study implies that the environment to provide DI for patients still needs to be improved, and the respondents didnʼt understand DI enoughly. Therefore,it is necessary to study further for the creation and communication of truly user-friendly DI.

Objectives: It is important for patients to make correct use of drug information (DI) to promote the proper use of medicines. Many patients use the Internet to find DI, but awareness about the websites of public institutions that provide DI is low. This study aimed to identify the actual use of the Internet for DI and associated problems to inform development of a comprehensive DI website for patients.Method: Patients with diabetes were set as a model case for patients who take medicines and need DI. A questionnaire survey was conducted among patients with diabetes who visited community pharmacies in Kagoshima City from March 2019 to October 2019. The survey covered Internet use, DI needs, methods of sourcing DI, and problems obtaining DI via the Internet.Results: There were 349 valid respondents (median age 64 years), of which 52.1% used the Internet at least once a week. Around half of the Internet users searched for DI on the Internet. More than half of these respondents chose a DI acquisition site because it “appeared at the top of search results” and was “easy to understand.” However, around half of these respondents felt that “there is too much information on the internet and I don’t know what is correct.”Conclusion: This study suggests that older patients with a long history of diabetes use the Internet to obtain DI. However, patients face various problems accessing DI via the Internet. It may be necessary to construct a comprehensive website that is easy to use and enhance public health literacy to support the proper use of medicines by patients.