Comparison between Risks Listed in the Risk Management Plan and the Product Labeling of the Drug Package Insert / 医薬品情報学

<b>Objective: </b>Currently, Risk Management Plans (RMPs), plan that provide new risk information about drugs, are published on the Pharmaceutical and Medical Devices Agency (PMDA) website.  The aim of this study was to compare enumerated risks in RMPs to the product labeling (PL) of the drug package insert.<br><b>Methods: </b>The risks listed in RMPs on the PMDA website were assessed on February 10, 2014.  We investigated the documentation of these risks on the PL.<br><b>Results: </b>Seven-hundred and eighty-five risks were enumerated in the RMPs of 77 drugs.  The enumerated risks were classified as “important identified risks” (66%), “important potential risks” (22%), and “important missing information” (12%).  Ninety-four percent of risks listed in RMPs were documented on the PL.  A portion of both the “important identified risks” and “important potential risks” groups were not documented on the PL.<br><b>Conclusion: </b>This study was clearly the relation between risks listed in RMPs and documents on the PL.  Because a portion of the risks listed in RMPs was not documented on the PL, RMPs provide more safety information.  It is necessary to better understanding their characteristics, considering RMPs are a new source of drug information.

Influence of Medicine Shelf Arrangement on Dispensing Error / 医薬品情報学

<b>Objective: </b>Taking the wrong medicine or medication error is a serious concern to patient safety.  The aim of this study was to statistically survey the relation between the placement of drugs on medicine shelf and the occurrence of error in taking a medicine.<br><b>Methods: </b>The study comprised 2 groups.  The incident group contained 43 cases that were erroneously taken in the Obihiro Kosei General Hospital.  The control group contained 43 drug pairs matched by the similarity index of the drug names from among the drugs used in the hospital at random.  The similarity index of drug names was based on 10 quantitative indicators.  The distance of medicine shelf arrangement was represented by three variables: the horizontal distance, the vertical distance and the distance of shelf block.  Conditional logistic regression analyses of the occurrence of medication errors were performed by evaluating the three variables of the distance factor and their interaction for error in taking a similar-sounding named drugs.<br><b>Results: </b>Conditional logistic regression analysis revealed that the vertical distance (OR: 0.64, 95%CI: 0.42-0.99) and the distance of the shelf block (OR: 0.74, 95%CI: 0.57-0.97) were significant risk-reduction factors of medication errors.  Four variables were extracted as the most suitable logistic regression model in terms of the interaction between them.  As the interaction between 3 variables (the horizontal distance, the vertical distance and the distance of shelf block) was significant (OR: 0.93, 95%CI: 0.86-0.99), they may be considered as synergistic risk-reduction factors.  Moreover, the horizontal distance was found to be a risk-enhancement factor (OR: 1.52, 95%CI: 0.93-2.48).<br><b>Discussion: </b>In order to reduce the risk of medication errors due to similar-sounding drug names, placement of drug on the medicine shelf should take into consideration the three coordinates of the distance factor.

Influence of Sensual Similarity of Drug Name on Taking Error / 医薬品情報学

<b>Objective: </b>Similarity of drug names is one factor of dispensing incidents.  The aim of this study was to survey the relation between sensual similarities of drug names and the occurrence of taking errors for pharmacists who actually prepare medicine.<br><b>Methods: </b>A pair of drugs (15 incident pairs and 104 control pairs) was displayed on a computer screen at random.  The subject’s task was to determine the sensual similarity of them.  Thirteen pharmacists who prepared these pairs and caused their incidents participated in the experiment.<br><b>Results: </b>The result showed that the sensual similarity of drug names of incident pairs was found to be highly significant in comparison to one of the control pairs [<i>p</i>=0.026].  However, the similarity in incident pairs is not necessarily high.  It was suggested that the similarity of drug name was not the only factor of taking error.  Multiple linear regression analyses of the sensual similarity in control pairs were performed, in which 10 variables were reported as quantitative indicators of similarity of drug name and were able to be measured on the internet.  The correlation was good [<i>R</i>²=0.828].  However, this regression model was not useful when adjusting to incident pairs.  In incident pairs, the similarity value calculated by the regression model was lower than the measured sensual similarity.<br><b>Conclusion: </b>The result suggested that measured sensual similarity includes other risk factors of taking error, such as appearance similarity and/or efficacy similarity and/or short distance arrangement.  It seemed that the pharmacist’s ability complicated the factor of taking error.

Mirtazapine provided remarkable relief for refractory nausea and vomiting by sunitinib and oxycodone in a patient with renal cancer

<b>Introduction</b>: Mirtazapine is a noradrenergic and specific serotonergic antidepressant (NaSSA) and the previous reports show that may reduce nausea by inhibition of the serotonin 5-HT3receptor. <b>Case report</b>: A 38-year-old woman with advanced renal cancer with distant metastases was administered by sunitinib and oxycodone. Refractory nausea and vomiting developed during the course and mirtazapine at a daily dose of 1.875 mg was begun. The patient's nausea improved during the next day, and furthermore, by increasing the daily dose to 3.75 mg, vomiting was also improved on the third day. The therapy could be continued without withdrawal of sunitinib and oxycodone due to digestive symptoms. Although somnolence might be induced at a daily dose of 15 mg, the present low-dose mirtazapine could improve digestive symptoms without somnolence. <b>Conclusion</b>: We conclude that low-dose mirtazapine is one effective option for refractory nausea and vomiting during administration of sunitinib and oxycodone.

Local drainage for Fournier's gangrene developed in palliative care unit provided pain relief in a terminally ill patient with bladder cancer

This paper presents the case of a man in his 70's with local advanced bladder cancer with hospital-developed Fournier's gangrene. The patient was hospitalized at the palliative care unit, and drainage with incision of the scrotum for symptom relief was performed to relieve severe pain. The patient experienced pain only during changing of the wound's dressing and no pain at rest after the operation. Furthermore, he reached his birthday and spent time in peace with his family. Fournier's gangrene is the necrotizing fasciitis of perineal and anal lesions, in which inflammation progresses rapidly in wide lesions, and it is associated with a high mortality rate. For Fournier's gangrene in a terminally ill patient, current agreement might depend on the patient's goal of treatment. The drainage provided for spiritual care of the patient and his family as well as pain relief. In conclusion, local drainage for Fournier's gangrene can be feasible as a choice of palliative treatment. Palliat Care Res 2011; 6(2): 340-343

The Tendency of the Ambulance Runs Resulting from Bath Accidents in Sapporo and Jozankei Hot Spring Area / 日本温泉気候物理医学会雑誌

  In recent years, since the accidents during bathing had become a social problem, we analyzed the trend of them in Sapporo city and aimed to make the results well-known to citizens for prevention. Although bathing-related ambulance runs were 0 .71% of all the called emergency cases, the accidental death accounted for 7.4% of the total death toll, and was 1.5 times the traffic death. 11.7% of the bathing-related ambulance runs was the accidental death and they are estimated about 100,000 or more affairs in the whole country. The elderly aged 65 and over occupied 83.9% of the accidental death during bathing. The incidence of cardio-respiratory arrest showed a lower value of 17.6 persons per 100,000 populations than that of other cities. In the elderly, the sum of cardio-respiratory arrest and a loss-of-consciousness reached by 1.7 times of accidental death. In hot spring areas, compared with Sapporo city excluding hot spring areas, there was lesser proportion of accidental death and serious injury. The proportion in which children and adult ages get injured by fall was higher in the hot spring areas. Since it is thought that accidental death continues to increase, and the role in which bathing plays as a preventive care such as recovery from fatigue and a health promotion is large, the preventive emergency is absolutely important.

Effect of Neoadjuvant Hormonal Therapy of Surgical Margin Status in Patients with Prostate Cancer Treated by Radical Prostatectomy / Journal of Rural Medicine

(Objective) Neoadjuvant hormonal therapy (NHT) before radical prostatectomy promotes the downstaging of primary lesions. A retrospective analysis was conducted of the relationship between NHT durations and positive surgical margin rates, as well as between positive surgical margin rates and three types of prostatectomy (antegrade radical prostatectomy, retrograde radical prostatectomy, and laparoscopic radical prostatectomy (LRP)).;(Materials and Methods) This study was a retrospective analysis of 257 patients treated with radical prostatectomy during the three years between April 2002 and March 2005. Of the 257 patients, 190 were treated by NHT. NHT durations were classified into “not conducted,” “<1 month,” “1-3 month,” “3-6 month” and “>6 month,” and the relationship between positive surgical margin rates and NHT durations was investigated. Seventy-four patients underwent antegrade radical prostatectomy, 131 were treated with retrograde radical prostatectomy, and 52 underwent LRP. Positive surgical margin rates were investigated according to the types of prostatectomy, as well as according to prostate-specific antigen (PSA) levels upon diagnosis.;(Results) Positive surgical margin rates were 53.8% in the “not conducted” and “<1 month” groups, 38.8% in the “1-3 month” group, 32.4% in the “3-6 month” group, and 10.7% in the >6 month” group. Positive surgical margin rates after open surgery (antegrade and retrograde) tended to decrease when NHT durations were longer, while those after LRP tended to increase inversely. No correlation was observed between PSA levels upon diagnosis and positive surgical margin rates or between presurgical PSA levels and NHT durations.;(Conclusion) Positive surgical margin rates were not significantly different when patients were treated with NHT for 1-3 months, but they tended to decrease when NHT was for >6 months. However, positive surgical margin rates after LRP increased when NHT continued for longer periods of time. This may the result of fibrous adhesion in the vicinity of the prostate due to long-term NHT which made the surgical margins unclear.