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

Objective: Similarity in drug appearance is one of the major environmental factors influencing dispensing errors, such as picking the wrong medication (picking error).  The purpose of this study is to verify if the index values of appearance similarity calculated objectively for multiple-specification drugs are the factors of picking error.
Methods: Four variables (number of total prescription, deviation of prescriptions between the specifications, sheet size, and color similarity of the sheet surface) were calculated.  The number of total prescription and deviation of prescriptions were extracted from the dispensing system.  Sheet size and color similarity were calculated, respectively, from the area ratio and by the Histogram Intersection method using the press through package (PTP) sheet image.  To evaluate the relationship between the picking error rate and these four variables, univariate and multivariate analyses were performed.
Results: The number of total prescription and the deviation of prescriptions were not significant factors.  In contrast, sheet size and color similarity significantly influenced the picking error rates.
Conclusion: Similarity in appearance between multiple-specification drugs is a risk factor of picking error.  When the multiple-specification pair has the same sheet size or high color similarity, one needs to be caution of picking error.  Further, in the pharmaceutical industry, to reduce the risk of dispensing errors, it is desirable to carry out the devise to enhance the identity of each specification.

Decreased adherence to medications among the elderly has become a problem in recent years. To overcome this problem, the dispensing of one-dose packages of medicines has been suggested. The purpose of this study was to survey elderly outpatients in a regional hospital at the Tokachi Development and Promotion Bureau and to analyze the factors that influence patients’ preference for a one-dose package medicine. The dispensation of one-dose package medication was observed in 20% of elderly outpatients. A correlation between the percentage of dispensed one-dose package medications and the number of agents was observed. Furthermore, dispensing rates of one-dose package medications increased with aging. Within the various departments analyzed, one-dose packaging rate was high in the Departments of Cardiology and Psychiatry. In this study, the correlation between residential municipalities of outpatients and one-dose package medications was examined. In the municipalities with a high rate of aged individuals and high average of household members, one-dose package medication rate was low. Multivariate logistic regression analysis confirmed these factors as significant. That one-dose packaging rates increased with the number of drugs and aging are consistent with the notion that one-dose package medications are designed to increase drug adherence among the elderly. Interestingly, one-dose package dispensing rate was low in areas with advanced aging. Because aging in Japan is expected to advance in the future, it is important to survey one-dose package dispensations.

Objective: Currently, the creation of a pharmaceutical risk management plan (RMP) for new drug information is obliged to pharmaceutical companies.  The created RMP is published on the Pharmaceuticals and Medical Devices Agency (PMDA) website.  RMP is a useful information source to ensure drug safety by healthcare professionals, including pharmacists.  “Risk minimization activities” of the RMP are especially important elements for healthcare professionals because they describe measures to minimize risk to patients.  We conducted a cross-sectional survey of the description of the contents of “risk minimization activities” in the RMP.
Methods: The RMP of 177 drugs that had been published in February 22, 2016 were investigated.
Results: Total risks enumerated for the study drugs were 1,678.  “Routine risk minimization activities” constituted 92.0% of total risks.  The most listed item on “routine risk minimization activities” was “attention on the product labeling of the drug package insert” (91.3%).  Differences in the expression level on “attention on the product labeling” were observed.  On the other hand, the most listed item of “additional risk minimization activities” was “the creation of documents for healthcare professionals” (38.3%) and “implementation of Early Post-marketing Phase Vigilance” (27.1%).
Conclusion: A clear understanding of RMP by healthcare professionals is important.  In the RMP, “risk minimization activities” (especially “additional risk minimization activities”) are the most important contents for healthcare professionals, because they include information of documents created by the pharmaceutical company for patient safety.  The level of description of the contents of RMP varies between drugs.  It is essential that these descriptions be uniform the expression level to be easily and accurately utilized by healthcare professionals.

A 79-year-old woman with prosthetic valve endocarditis (PVE) on aortic position underwent re-aortic valve replacement. Although emergency operation was indicated due to huge vegetation over 20 mm in diameter attached to the prosthesis shown by preoperative transesophageal echocardiography, intraoperative transesophageal echocardiography showed disappearance of the vegetation. The prosthesis was carefully removed and replaced by a new bioprosthesis, though only small vegetation was observed on the removed prosthesis. Sudden blue toe 11 h after the operation and diminished pulse on right pedal artery suggested an acute arterial occlusion of a right lower extremity, requiring an emergency thrombectomy. Pathology diagnosed bacterial embolus with fresh thrombus that was considered apart from the prosthesis at the time of operation.

Salicylamide, a non-steroidal anti-inflammatory drug (NSAID), is used as an analgesic and antipyretic agent. We have previously shown that several NSAIDs have anti-melanogenic properties in B16F1 melanoma cells. In contrast, we have found that salicylamide enhances melanin contents in B16F1 melanoma cells; however, the underlying mechanism is not known. Therefore, we investigated the mechanism through which salicylamide stimulates melanogenesis. Interestingly, salicylamide enhanced diphenolase activity in a cell-free assay. Western blotting and real-time RT-PCR revealed that salicylamide increased tyrosinase expression via transcriptional activation of the Mitf gene. Together, our results indicate that salicylamide could be used as an antihypopigmentation agent for skin and/or hair.

Salicylamide, a non-steroidal anti-inflammatory drug (NSAID), is used as an analgesic and antipyretic agent. We have previously shown that several NSAIDs have anti-melanogenic properties in B16F1 melanoma cells. In contrast, we have found that salicylamide enhances melanin contents in B16F1 melanoma cells; however, the underlying mechanism is not known. Therefore, we investigated the mechanism through which salicylamide stimulates melanogenesis. Interestingly, salicylamide enhanced diphenolase activity in a cell-free assay. Western blotting and real-time RT-PCR revealed that salicylamide increased tyrosinase expression via transcriptional activation of the Mitf gene. Together, our results indicate that salicylamide could be used as an antihypopigmentation agent for skin and/or hair.

　　A 56-year-old woman was referred to our hospital because of an abnormal finding in the right pulmonary hilum on chest X-ray. Enhanced chest computed tomography showed hyperplastic bronchial arteries dilating and winding around the trachea and bronchi. A racemose hemangioma of the bronchial artery with multiple bronchial artery aneurysms (diameter <20mm) was seen displacing the trachea and both main bronchi. Bronchoscopy showed submucosal tumor-like lesions at the distal trachea and in both main bronchi, and a dusky-red elevated pulsatile lesion at the orifice of the left B3b＋c. We performed coil embolization of the bronchial artery aneurysm to prevent abrupt rupture of the bronchial aneurysm.

An 81-year-old man was referred to our hospital with bilateral multiple patchy opacities on chest radiography. His chief complaints were a few months’ history of intermittent mild cough and slightly yellow sputum. Chest computed tomography (CT) showed non-segmental air-space consolidations with ground-glass opacities. Amyloid deposition with organizing pneumonia (OP) was seen in transbronchial lung biopsy (TBLB) specimens from the left S8. Three months later, the infiltration originally seen in the left lower lobe was remarkably diminished, and new infiltrations in the lingual and right lower lobes were detected on chest CT. Amyloid deposition with OP was seen in TBLB specimens from the left S4. Transthyretin was detected following immunohistochemical examination. The presence of wild-type transthyretin (ATTRwt) was proven using genetic analysis. The present report describes a rare case of ATTRwt amyloidosis associated with OP.