Objective: The Relief System for Sufferers from Adverse Drug Reactions was created for the purpose of remedying issues such as medical expenses for people who experience an adverse drug reaction despite the proper use of a medicine.

Methods: We used “decision data on adverse drug reaction payments” released by the Pharmaceuticals and Medical Devices Agency to investigate the payment of all medical supplies for adverse drug reactions associated with the HPV vaccine over the 7-year period between 2011 and 2017.

Results: The HPV vaccine had a lower rate of supply than all other medical supplies. Medical costs and medical allowance accounted for the majority of supplies for the HPV vaccine. The most common response was “A causal linkage between adverse reactions and the HPV vaccine cannot be confirmed”, followed by “It is not recognized as medical care requiring hospitalization”.

Conclusion: Many patients with an adverse drug reaction received no medical supplies, mainly for the reason of “undecidable”. With regard to these patients, it may be necessary to carry out a survey so that they can be judged rather than classifying them as ‘undecidable’.

Objective: The purpose of this study was to create a checklist that summarizes checkpoints that should be noted when using the Japanese Adverse Drug Event Report database (JADER). After we created the checklist, we then used it to survey published academic papers that used JADER.

Method: First, we created a draft checklist for research that uses JADER by citing the report of CIOMS working group VIII “Practical Aspects of Signal Detection in Pharmacovigilance”. Then, we conducted a pilot test and revised the draft checklist. Finally, the checklist was completed after the review by a pharmacoepidemiology expert. The checklist was applied to published academic papers that used JADER, and the fulfill rate of each checkpoints was calculated.

Results: A “checklist of important points to be noted during research that uses the data mining method in JADER (mainly signal detection by disproportionality analysis)” was created. We also revealed problems with published academic papers that used JADER. For example, some researchers were thought to be inappropriately using JADER as a source of their research while others used an inappropriate version of MedDRA.

Conclusion: The checklist created in this study summarizes key points that could be noted in research that uses JADER and is thought to contribute to an improvement in quality of research that uses JADER. Additionally, in our investigation of published academic papers that used JADER, we found the possibility that both the role of signal detection and the impact on analysis of JADER using the updated MedDRA version are not well understood.

Objective: The number of pharmacists regularly working at geriatric health service facilities is limited, but many users of such facilities have multiple chronic conditions and receive continuous pharmacotherapy, simultaneously using numerous different types of oral drugs. We examined the outcomes of pharmacotherapeutic intervention provided by hospital pharmacists for geriatric health service facility users.

Methods: We examinedthe outcomes of active pharmacotherapeutic intervention providedby hospital pharmacists for 154 facility users.

Results: After the intervention, there were significant decreases in the mean number of types and price of drugs used, as they decreased from 7.38 to 6.17 and 368.3 to 309.2 yen/day, respectively. The number of prescription drugs changed was 300, and 206 of these changes were proposedby the pharmacists. The efficacy-basedcategories that these drugs belongedto widely ranged. The most frequent reasons for change were the “disappearance of symptoms”, “based on indications”, and “suspected adverse events”. Adverse events variedfrom mildto those that may leadto severe conditions.

Conclusion: Pharmacotherapeutic interventions by pharmacists may optimize pharmacotherapy, reduce polypharmacy, and reduce the financial burden on geriatric health service facilities.

Objective: The use of generic drugs is promoted to reduce medical costs and copayments. However, tumor agents are expensive and generic drugs are not widelyused. Thus, it is necessaryto evaluate the safetyof generic drugs in more detail. We compared the incidence of adverse events between the original drug (Gemzar^®: GEM) and generic drug (Gemcitabine [Sandoz]: GE-GEM) using propensityscore (PS) matching.

Methods: We investigated adverse events in patients who received one course of GEM or GE-GEM. The patient background (age,sex, BSA, cancer type, stage, metastasis, surgical history, and radiotherapy) and administration status (administration route and RDI) were used to calculate the PS.

Results: Among all patients (GEM: 51, GE-GEM: 54), a significantlygreater number in the GE-GEM group had cancer metastasis. On comparison of adverse events, there were significantlymore cases of vascular pain (p＜0.05) in the GEM group, and manycases of nausea (p＝0.08) and rash (p＝0.08). Fortypatients in each group were extracted byPS matching. There were no significant differences in the patient background between the groups, and on comparison of adverse events, the two groups did not significantly differ.

Conclusion: Our studysuggested that there is no difference in side effects between Gemzar^® and gemcitabine [Sandoz]. To compare the incidence of adverse events, it is useful to use PS matching in clinical practice.

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.

Benzodiazepine receptor agonists (BZs) are medications to be used with caution, not only for long-time users, but also for first-time users. This study aimed to compare the use of BZs or central nervous system (CNS) agents in first-time BZs users (FU) and continuing BZs users (CU). Using a large health insurance claims database in Japan, BZs users aged ≥40 years in 2013 who were opioid non-users without hospitalization were classified into FU or CU, by use of BZs in the first half-year. BZs or CNS agent use at the index date (the first date BZs were dispensed in the latter year) was investigated as follows: (1) proportion of patients with prescriptions of BZs for use as needed (BZs-AN), (2) daily number of BZs or CNS agents, and (3) daily standardized dose of BZs or CNS agents. More individuals in the FU group (3,162/16,576; 19%) than in the CU group (7,627/46,088; 17%) received BZs-AN (p＜0.001); 87% of the FU group vs 62% of the CU group used single BZs (p＜0.001), and 53% vs 24% used less than 5 mg/day of equivalent diazepam (p＜0.001). A similar trend was found for CNS agents. Numbers or doses of BZs or CNS agents decreased with increasing age in both groups. However, some first-time users aged 70-74years started with ≥2 types of BZs or ≥10 mg/day of equivalent diazepam. Overall, BZs for outpatients without opioids were started carefully, but a prescription review was necessary for some patients, requiring more effort from healthcare providers.

Objective: In order to ensure the safety of nursing home residents, it is very important to implement appropriate assistance to ensure compliance with necessary medication. The purpose of this study is to identify issues and to plan solutions for medication assistance.

Design: We conducted a workshop involving care workers (CWs), nurses and pharmacists together.

Methods: Using the KJ method, participants extracted problems related to medication assistance and planned solutions in a mixed group of CWs, nurses and pharmacists. Questionnaire surveys were conducted for the participants before, immediately after, and 3 months after the workshop.

Results: A number of important and urgent issues related to medication assistance were identified. There were differences in the recognition patterns of the importance and urgency of the issues among the three categories of participants. In addition, many possible solutions were proposed. Among these solutions, 25% had been implemented by at least two participants. More than 75 % of participants felt that their awareness of the value of cooperation in medication assistance had been improved by participating in the workshop.

Conclusion: These results suggest that a workshop with a group of CWs, nurses and pharmacists in one place is a useful approach for extracting problems and planning effective solutions related to cooperation in medication assistance.