Objective: The purpose of this study is to investigate incidents of erroneously dispensed drugs on the assumption that the incidents stem from the similar names of the drugs.  The investigation was also conducted to prevent such dispensing incidents in the future, i.e. to search for factors that can prevent future incidents, and finally to propose a prevention plan which takes each of these factors into account.
Methods: We extracted incident cases related to generic drugs reported by pharmacies in Japan and from those cases examined those that were categorized as cases of erroneously dispensed medicine.  We used this data to categorize the difference in relationship between the drugs which were supposed to be prescribed and those which were erroneously dispensed, and to analyze the association between the “Flowchart for Avoiding Confusion Errors between Similarly Named Drugs” and the name similarity index based on this flowchart.
Results: The types of incident cases due to name similarities of generic drugs were categorized into specification mistakes and brand mistakes.  The edit of the name similarity index were especially important factors for dispensing incidents between generic drugs.
Conclusion: This study focusing on generic drugs revealed the factors that result in dispensing incidents due to name similarity.  Further empirical studies investigating the usefulness of interventions that alter the name similarity index is required.

Good Death Scale (GDS) is a provider assessment scale of quality of dying of terminally ill cancer patients, and its reliability and validity has been confirmed. The aim of this study is translating the GDS into Japanese (GDS-J) according to the standard methods of conducting linguistic validation. In the forward translation, there was a disagreement in the translation of “will” into Japanese translation of “will” of GDS question 3 “Has the patient arranged everything according to his/her own will?” We confirmed linguistic validity in the research team and eventually got approval from the original author in writing and decided on GDS-J. Using the GDS-J, a quality assessment scale for palliative care by provider, it will be possible to evaluate the quality of palliative care to be done by themselves and to be expected to be useful for providing higher-quality palliative care.

The patient, a woman in her 60's with gastric cancer, was diagnosed post-operatively with Schnitzler metastasis, and an artificial anus constructed for her. After receiving chemotherapy, she was admitted to the hospital with both increased lower abdominal pain and nausea. The exacerbation of cancerous peritonitis was suspected and confirmed at the start of continuous subcutaneous administration of octreotide acetate. One week after octreotide administration, the anorexia STAS improved from a score of 4 to a score of 1. Based on the desires of the patient and her household, she transferred to home hospice care, where she maintained good Quality of Life (QOL), again by octreotide acetate administration. Although octreotide acetate is effective in treating nausea, the emesis accompanying cancerous peritonitis, or for the relief of abdominal distension symptoms, there are restrictions associated with inpatient care. In home hospice care, octreotide acetate administration is useful for the maintenance and improvement of a patient's QOL. Therefore, we suggest that octreotide acetate could serve as an important tool for home hospice care. Palliat Care Res 2009; 4(2): 321-329

Purpose: The purpose of this study is to elucidate the characteristics of adverse events in pregnant women, the offending drugs, and patient backgrounds from reports of adverse events.  We performed a case series study.
Methods: We used CARPIS, a database of adverse events and toxication reported in Japan spanning from 1987 to 2014 and created by the Drug Information Center, Meijo University.  We extracted cases of adverse events in pregnant women, their fetuses, and newborns and investigated the age, primary disease, and history of allergies of the women and the intended use of/offending drugs, therapeutic category, and names for adverse events.
Result: We collected 434 cases of adverse events in pregnant women, and 251 pediatric cases with adverse events.  The most frequent offending drug in both groups was ritodrine hydrochloride.  The most frequent adverse event in pregnant women was pulmonary oedema due to the administration of ritodrine hydrochloride.  The most frequently reported adverse events in pediatric cases were transient hypothyroidism and withdrawal symptoms in newborns and birth abnormalities in fetuses and newborns, all of which were caused by drugs given for the underlying diseases of their mothers.
Discussion: We elucidated serious adverse events in pregnant women caused by the administration of ritodrine hydrochloride.  Frequent factors for adverse events were the onset of physiological factors in pregnant women and complicated factors of the mechanism of action of ritodrine hydrochloride.  We need to monitor both mothers and fetuses during the drug administration.  It is suggested that adverse events in pediatric cases are associated with drugs given for underlying diseases in mothers.  Thus, it is necessary to give appropriate information and communicate the risks of taking these drugs before pregnancy.  We believe the results could be helpful in the early detection of adverse events in the future.

Background: Although several dexamethasone phosphate preparations are commercially available and frequently administered with octreotide acetate, their compatibility remains unknown. Aim: We investigated the effect of pH and sodium bisulphate on the stability of octreotide acetate. Measurement design: Octreotide acetate percentage was measured 3 and 10 days after it was mixed with 2 dexamethasone phosphate preparations containing different concentrations of sodium bisulphate as an additive, and in one that did not contain sodium bisulphate. Solutions were also analysed after they were prepared using phosphate buffer to achieve pH values of 4.0, 7.0, and 9.0. The initial octreotide acetate concentration was 41.7 g/mL. High-performance liquid chromatography was used for measurement. Results: The octreotide acetate percentage in the mixture with dexamethasone phosphate without sodium bisulphate was maintained at 95% for up to 10 days. However, mixing octreotide acetate with the other 2 agents resulted in a significant decrease to 85%. The octreotide acetate percentage was ＜90% after sodium bisulphate-containing solution was stored at room temperature under light-protected conditions for 3 days. The percentage of octreotide acetate in the pH 7.0 solution was ＜90% three days after preparation; however, in the pH 4.0 solution, it was maintained at 95% for up to 10 days. Conclusions: Our results suggest that octreotide acetate is hydrolysed in the presence of sodium bisulphate, leading to a decrease in the percentage of octreotide acetate in the solution, which can be avoided using sodium bisulphate-free dexamethasone phosphate preparations.

Objective:In this study,we explored adverse reactions and patient background and performed a case/non-case study on a database of adverse reaction case reports in order aid the prevention of non-prescription drug abuse.Study Design:We conducted a case/non-case study on a database of adverse reaction case reports.Methods:We studied case reports of adverse reactions and addiction in Japan and extracted adverse reaction cases associated with taking antipyretic analgesics,antitussive drugs,antitussive expectorant drugs,hypnotic and sedative drugs,anti-anxiety drugs,and purgative drugs. We divided the extracted cases into an abuse case group (adverse reactions associated with non-prescription drug abuse,and divided its intended purpose or the purpose of abuse at the initial dose)and non-case group(other adverse reactions). We performed univariate logistic regression analysis on each item of investigation in the abuse case group and non-case group and calculated the odds ratio,p-value,and 95%confidence interval.Results:There were many abuse case reports of women 20-40 years old in the antipyretic analgesics abuse case group and many of them had liver/biliary lesions and chronic urological impairment. The most common reason reported for taking the initial dose of each drug was for its intended purpose.Discussion:It is important for pharmacists at community pharmacies and drugstores to be able to recognize the characteristics of patients who might be at risk of abuse and the adverse reactions and patient backgrounds elucidated in this study could be helpful in identifying them.

Aim: The usefulness and safety of strontium chloride (89Sr), a radiopharmaceutical agent for painful bone metastasis, varies from patient to patient, but the reasons for why the usefulness and safety vary have not been elucidated. The purpose of this study is to explore the background factors of patients who experienced pain relief or bone-marrow suppression after 89Sr was administrated. Methods: In the cases of pain relief, we divided the results from a numeric rating scale (NRS) before and after 89Sr administration into effective and ineffective groups as outcomes. In the cases of bone-marrow suppression, we analyzed neutrophil cells, blood platelets, and hemoglobin levels, respectively, before and after 89Sr administration as outcomes. Then, we performed statistical analyses on both case groups. Results: The results showed that the background factors associated with pain relief were weight, the 89Sr dosage amount, NRS, eGFR, SCr, and Ca levels before 89Sr administration and the area of bone metastasis (number of sites reached). We found that background factors associated with bone-marrow suppression have a moderate significant correlation with hemoglobin, NRS, and SCr levels before 89Sr administration after investigating factors which influence neutropenia. In the case of thrombocytopenia, there was a moderate significant correlation with platelet counts before 89Sr administration. In the case of hypochromia, there was a moderate significant correlation with hemoglobin levels before 89Sr administration. Discussion: Our study could elucidate patient background factors associated with pain relief and bone-marrow suppression after 89Sr administration.

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.

The purpose of this study is to clarify the current state of nursing for the sexuality of patients with cancer at the end-of-life. In December 2018, we asked 313 nurses from 18 palliative care units in Kanagawa Prefecture about their awareness, feelings, and behavioral intentions and hands-on experience for the environment in which patients with cancer nurture love with their partners at the end-of-life. The collection rate of the questionnaire was 52.7% (165 cases). Eighty-two nurses (49.7%) had experience supporting the environment in which patients with cancer nurture love with their partners at the end-of-life. The contents of the support were “Recommend physical contact”, “Listening”, “Recommend hug”, and “Take sufficient time when entering the room, such as waiting for a reply after knocking or calling out”. Meanwhile, at ward conferences, only 11 (6.7%) had talked about the environment in which patients with cancer nurture love with their partners at the end-of-life. It has been suggested that, at present, support for the environment in which patients with cancer nurture love with their partners at the end-of-life is left to individuals and not systematically.