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 64-year-old man with a diagnosis of aortic valve stenosis presented with chest pain. The patient is a Jehovah's Witnesses and wanted surgery without blood transfusion. Therefore, we planned minimally invasive aortic valve replacement (MICS AVR) avoiding sternotomy. He underwent aortic valve replacement with a mechanical valve (ATS AP360 20 mm) through a right anterolateral thoracotomy at the fourth intercostal space. The value of hemoglobin was 11.2 g/dl after surgery. He recovered uneventfully and was discharged 17 days after surgery. MICS AVR has the advantage of less risk of bleeding, therefore MICS AVR is useful for Jehovah's Witness patients who refuse blood transfusion.

A simplified polymerase chain reaction (PCR) assay was developed for fast and easy screening of mycoplasma mastitis in dairy cattle. Species of major mycoplasma strains [Mycoplasma (M.) bovis, M. arginini, M. bovigenitalium, M. californicum, M. bovirhinis, M. alkalescens and M. canadense] in cultured milk samples were detected by this simplified PCR-based method as well as a standard PCR technique. The minimum concentration limit for detecting mycoplasma by the simplified PCR was estimated to be about 2.5 x 10(3) cfu/mL and was similar to that of the standard PCR. We compared the specificity and sensitivity of the simplified PCR to those of a culture method. Out of 1,685 milk samples cultured in mycoplasma broth, the simplified PCR detected Mycoplasma DNA in 152 that were also positive according to the culture assay. The sensitivity and specificity of the simplified PCR were 98.7% and 99.7%, respectively, for detecting mycoplasma in those cultures. The results obtained by the simplified PCR were consistent with ones from standard PCR. This newly developed simplified PCR, which does not require DNA purification, can analyze about 300 cultured samples within 3 h. The results from our study suggest that the simplified PCR can be used for mycoplasma mastitis screening in large-scale dairy farms.
Animals ; Cattle ; Colony Count, Microbial/veterinary ; DNA, Bacterial/chemistry/genetics ; Disease Outbreaks/prevention & control/veterinary ; Female ; Mastitis, Bovine/diagnosis/*microbiology ; Milk/cytology/*microbiology ; Mycoplasma/genetics/*isolation & purification ; Mycoplasma Infections/diagnosis/microbiology/*veterinary ; Polymerase Chain Reaction/veterinary

Objective: The risk management plan (RMP) is a useful information source for healthcare professionals, including pharmacists, to ensure drug safety. The “risk minimization activities” (RMA) of the RMP are especially important elements for healthcare professionals. It is known that “Medication Guides for Patients” (MGP) and “Early post-marketing phase vigilance” (EPPV) are items listed as part of the RMA. However, the creation of MGPs and the implementation of EPPVs are not performed for all medicines. In a previous study, it was difficult to evaluate this sufficiently with the safety specifications. The aim of this investigation was to evaluate RMAs, especially MGPs and EPPVs, not in terms of the safety specifications of RMP.Methods: The previously published RMPs of 177 drugs were obtained on February 22,2016, and used in the analysis. The relationship between the creation of the MGP and the description in the RMA and the relationship between the conduct described in the EPPV and the description in RMA was investigated for each medicine.Results: An MGP was created in 151 of the analyzed drugs. Of these, it was not listed in the RMA of 40 drugs. In contrast, EPPV was not listed in RMA in 2 out of 33 drugs when underway. EPPV was described in the RMA of 33 of the EPPV finished drugs. The time lag from the end of EPPV until the revision of the RMP was 4.5 month son average.Conclusion: MGPs and EPPVs are created especially for drugs requiring patient education, information provision, or safety monitoring. Therefore, for drugs for which MGPs or EPPVs are required, they should be listed in the RMA. In this study, the time lag of RMP revision was also highlighted as a problem. In order to promote the utilization of RMP by pharmacists, these issues should be resolved.

Objective: Risk Management Plan (RMP) is created and submitted by a pharmaceutical company while applying for new drug approval; it is published to be used by healthcare professionals. For example, healthcare professionals utilize RMP when considering whether to adopt a drug. However, there is no stipulation for the release date of RMPs; moreover, surveys regarding this are limited. We conducted a cross-sectional survey on the relationship between RMP-related timing and regulatory affairs-related timing.Methods: The surveyed drugs were those for which the first version of RMP was notified by PMDA Medinavi (mail delivery service) in FY2014 and FY2018. We examined regulatory affairs-related timing (i.e., “manufacturing and marketing approval date,” “drugprice standards listing date,” and “release date”) and RMP-related timing (i.e., “RMP creation date” and “Medinavi delivery date”).Results: For 7 of 43 items in FY2014 and 5 of 41 items in FY2018, the “RMP creation date” occurred later than the “drug-price standards listing date.” For one item in FY2014, the “RMP creation date” occurred later than the “release date.” For 12 items in FY2014 and 13 items in FY2018, the “Medinavi delivery date” occurred later than the “release date.”Conclusion: No considerable difference was confirmed between FY2014 and FY2018 regarding RMP-related timing and regulatory affairs timing. It was confirmed that there were several items for which the RMP creation occurred later than drug-price standard listing and items for which the publishing notice by Medinavi was delayed for drug marketing release. To promote the utilization of RMPs by healthcare professionals, RMPs must be created and published without delay.

Background: A 30-60 min rest after exercising is generally recommended before taking a bath. Although this was considered an appropriate bathing method, effects of pre-bath rest on recovery from exercise fatigue remain unclear. Here, we aimed to examine the effects on fatigue recovery of pre-bath rest after a workload, with the focus on changes in lactic acid levels. Methods and Results: Ten healthy adult men increased their blood lactic acid levels through a treadmill workload performed in accordance with the Bruce method, then took either a 60-min post-workload rest followed by a 10-min full-immersion 38°C bath (Experiment A) or a 10-min full-immersion 38°C bath followed by a 60-min rest (Experiment B). Body temperature, blood pressure, pulse rate, and blood lactic acid level were measured at three time points: before workload (Test 1), after workload (Test 2), and after bathing/resting (Test 3). Decreases and percent decreases in blood lactic acid levels were calculated by comparing Test 3 results with Test 2 results. These calculated values and the measured values in three tests were compared between Experiment A and Experiment B using paired-t test. There were no significant differences in maximum systolic blood pressure, maximum diastolic blood pressure, maximum workload attained, and maximum pulse rate measurements between Experiment A and Experiment B. Differences in systolic blood pressure and diastolic blood pressure measurements in Tests 1, 2, and 3 were not significant. The pulse rates measured at the final measurement (Test 3) were significantly higher in Experiment A than in Experiment B (90.4 ± 18.2 bpm vs 79.6 ± 11.6 bpm, p = 0.04). No significant differences were observed in other measurement timings. The body temperature measurements at the final measurement were slightly higher in Experiment A than in Experiment B (36.4 ± 0.4 vs 36.1 ± 0.3°C, p = 0.05). No significant differences were observed in other measurements. Blood lactic acid levels before workload (Test 1) were significantly higher in Experiment A (6.6 ± 4.7mmol/L) than in Experiment B (2.0 ± 1.4 mmol/L, p = 0.02), but those at other measurement points (Test 2 and Test 3) were similar. Neither decreases nor percentage decreases in blood lactic acid levels differed between Experiment A and Experiment B. Conclusions: Resting before a post-exercise bath did not change the decreases or percent decreases in blood lactic acid levels after bathing at 38°C, suggesting negligible effects of pre-bath resting on recovery from exercise fatigue.

A 76-year-old man who suffered from consistent back pain was admitted for anti-hypertensive therapy to strictly manage the early thrombosed acute type A aortic dissection (AAAD). On admission, his blood pressure could not be controlled well ; soon he complained of recurrent severe back pain. The second thoracoabdominal enhanced computed tomography revealed the progression of AAAD from DeBakey type II to type I with thrombosed pseudolumen at the descending thoracic aorta ; therefore, emergent surgical intervention by primary central repair was conducted. Paraplegia was diagnosed eight hours after surgery, then cerebrospinal fluid drainage and intravenous administration of Naloxone were started immediately followed by keeping the systemic blood pressure more than 120 mmHg. However, paraplegia had never improved and been persistent with neurological deficit of the lower extremities. We herein report a complicated surgical case of an AAAD patient with paraplegia and review the complex clinical settings.

BACKGROUND: The Japan Environment and Children's Study (JECS) is a nation-wide birth cohort study investigating environmental effects on children's health and development. In this study, the exposure characteristics of the JECS participating mothers were summarized using two questionnaires administered during pregnancy. METHODS: Women were recruited during the early period of their pregnancy. We intended to administer the questionnaire during the first trimester (MT1) and the second/third trimester (MT2). The total number of registered pregnancies was 103,099. RESULTS: The response rates of the MT1 and MT2 questionnaires were 96.8% and 95.1%, respectively. The mean gestational ages (SDs) at the time of the MT1 and MT2 questionnaire responses were 16.4 (8.0) and 27.9 (6.5) weeks, respectively. The frequency of participants who reported "lifting something weighing more than 20 kg" during pregnancy was 5.3% for MT1 and 3.9% for MT2. The Cohen kappa scores ranged from 0.07 to 0.54 (median 0.31) about the occupational chemical use between MT1 and MT2 questionnaires. Most of the participants (80%) lived in either wooden detached houses or steel-frame collective housing. More than half of the questionnaire respondents answered that they had "mold growing somewhere in the house". Insect repellents and insecticides were used widely in households: about 60% used "moth repellent for clothes in the closet," whereas 32% applied "spray insecticide indoors" or "mosquito coil or an electric mosquito repellent mat." CONCLUSIONS We summarized the exposure characteristics of the JECS participants using two maternal questionnaires during pregnancy.
Adult ; Child Health ; Cohort Studies ; Female ; Gestational Age ; Humans ; Japan ; Maternal Exposure ; statistics & numerical data ; Mothers ; statistics & numerical data ; Pregnancy ; Surveys and Questionnaires ; Young Adult