Objective: Self-medication is promoted to extend healthy life expectancy. Accordingly, it is important for general consumers to properly use over-the-counter drugs. We investigated whether graphical symbols to visually aid the understanding of drug information (i.e., precautions and instructions to consult with a medical professional) provided in over-the-counter drug package inserts are easily understood in light of the International Organization for Standardization (ISO) criterion of 66％ comprehension. Methods: First, two questionnaire surveys were conducted with pharmacy students to calculate their comprehension level of the illustrations. The first round was for modifying illustrations that did not meet the ISO standard, and the second round was for seeing if comprehension had improved. Then, a questionnaire survey targeting general consumers was conducted to see if these illustrations functioned as graphical symbols. Results: When the referent of “Do not take this medicine if your experience falls under the following conditions” was placed in the upper left corner of the symbol, some students answered that this meant, “If you do not take this medicine, you will be under the following conditions,” but when it was placed in the lower right corner, many students accurately understood the intended information. In the student surveys, one illustration each for “cannot be taken/under treatment/heart,” “cannot be taken/under treatment/stomach,” “cannot be taken/under treatment/liver,” and “cannot be taken/under treatment/kidney” all exceeded 66％. Since none of the illustrations exceeded the 66％ comprehension in the survey of general consumers, it was found to be difficult for general consumers to understand drug information from the present illustrations. However, there were several illustrations that improved in comprehension compared to the previous study, which makes the continuation of this study significant. Conclusion: Although there were no illustrations exceeded 66％ comprehension of general consumers, the study shows that continued improvement may result in establishing pictograms for general consumers.

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.

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.

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.

Objective: 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.
Methods: 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.”
Results: 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.
Conclusion: Our results can provide a common tool for drug suppliers, medical professionals engaging in relief works in disaster-stricken areas, and disaster victims.

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.

Objective: 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.
Design: Questionnaire survey.
Methods: 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.
Results: 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.
Conclusion: 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.

Objective: 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.
Methods: 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.
Results: 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.
Conclusion: 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.

Objective: 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.
Methods: 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.
Results: 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.
Conclusion: 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.

Objective: 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.
Methods: 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.e., at the standard oral dosage.
Results: 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.
Conclusion: 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, e.g., patients’ background data, should be carefully matched between the datasets being compared.